tag:blogger.com,1999:blog-203525912024-02-21T07:08:59.293-05:00LIFE IN THE END ZONELIFE IN THE END ZONE: A discussion of topical issues for anyone concerned with the final phase of life by Muriel R. Gillick, MDMuriel Gillickhttp://www.blogger.com/profile/13001304171183760292noreply@blogger.comBlogger421125tag:blogger.com,1999:blog-20352591.post-22223471133677524102022-01-03T16:19:00.000-05:002022-01-03T16:19:06.615-05:00Taking Stock<span style="font-size: medium;">A widely accepted view in medical ethics circles is that “substitute
decision-makers,” or individuals who are making a medical decision on behalf of
someone who is unable to make decisions herself, should choose based on what the
patient “would want” if only she could speak up. This notion of “would want” is
based on the fanciful idea that if the patient could temporarily emerge from
coma or dementia or delirium—whatever is getting in the way of her actively
participating in medical decision-making—and could look down at her actual self,
she would have a definite opinion about what course of action to pursue. </span><div><span style="font-size: medium;"><br /></span></div><div><span style="font-size: medium;">There’s
another, sometimes equally fantastic idea at the heart of the substitute
decision making model. This idea relates to how substitute decision-makers
should figure out what the disembodied patient would want for herself. The idea
is that surrogates can infer what the patient would, hypothetically, want if
they consider the past choices the patient has made. Now, this is sometimes
fairly straight-forward. If, for example, the patient was faced with almost
exactly the same situation previously but was at that time able to make a
decision herself, then the surrogate can conclude she would make the same
decision this time. That isn’t strictly speaking true, because there is at least
one critical difference between the earlier situation and the present one, and
that’s precisely the loss of capacity. The patient might, for instance, have
chosen life-prolonging treatment at a time when she was cognitively intact but
now has developed dementia, so receiving the same kind of treatment now as then,
if successful, would entail prolonging a qualitatively very different type of
life. </span></div><div><span style="font-size: medium;"><br /></span></div><div><span style="font-size: medium;">More commonly, the patient never before faced the precise clinical
situation she confronts today, but she behaved in certain predictable ways in
the past that allow the surrogate to extrapolate from then to now. She might
have repeatedly refused to take medications when offered treatment. But does
refusal to take pills against depression or antibiotics for an infection that
was probably, in retrospect, viral, imply that she would refuse potentially
life-prolonging chemotherapy for cancer? </span></div><div><span style="font-size: medium;"><br /></span></div><div><span style="font-size: medium;">What all these scenarios have in common
is the belief that people are consistent across the years, that they have a
constant set of values and beliefs or, better yet, a coherent life narrative.
Palliative care makes use of an analogous framework for different reasons.
Rather than being concerned with what medical treatment people would want if
they could choose for themselves, it is interested in making sure that the last
“chapter of life” fits with the previous “chapters,” forming a unified,
intelligible narrative. Both the ethicists’ goals and the palliative care
clinician’s goals are laudable and the strategies constitute reasonable,
well-intentioned approaches to solving inherently insoluble problems. Yet, in a
very fundamental way, these strategies are at odds with what countless Americans
do every January 1—make New Year’s resolutions. A resolution entails looking
back, much as do the ethics and palliative care paradigms, but then deliberately
opting for a course correction. They are our chance to assert that we don't like
all or part of our past behavior and we want to alter our trajectory. Perhaps we
were very consistent in the kinds of choices we made, but now we see those
choices as selfish or dangerous or otherwise wrong-headed and we aspire to
pursue a course that’s not of a piece with what has come before. Maybe we think
our earlier choices were reasonable when we made them, but circumstances have
changed—before, we were in good health, now we are in poor health; before, we
thought global warming was a theory that might prove incorrect, now we realize
it is a real and present danger; before, we had friends and family, now we are
all alone. </span></div><div><span style="font-size: medium;"><br /></span></div><div><span style="font-size: medium;">The concept of the New Year’s resolution,
<a href="www.history.com/news/the-history-of-new-years-resolutions%20">according to “Inside History,” </a>is at least 4000 years old. The Babylonians promised their gods they would
improve their conduct—in exchange for a good harvest. The Romans under Julius
Caesar also made an annual pact with the gods. Christians ask for forgiveness
for their mistakes and pray for a better future. Jews on the Jewish new year,
Rosh Hashanah, also look both backwards and forwards; then, on Yom Kippur, which
follows just a few days later, they ask those they have wronged to forgive them
and they seek to make amends. In every case, human beings simultaneously
acknowledge the cyclic nature of life, with its predictable repetitiveness, and
recognize the possibility of change. I like the tradition of taking stock. I
think it is useful to review our journey to the present, where we have been both
physically and emotionally, what we have accomplished, where we have failed.
Some years, this process may focus on reviewing our finances or our advance
directives; other years, it may focus on our career or our relationships.
Whatever slice of life we choose to examine, we have the free will, the agency,
the self-control to change. We are not always able to make radical changes, nor
can we escape our genetic limitations or other fixed constraints. As we near the
end of life, we cannot realistically undertake to make changes that would take
many years to implement or that require more energy than we can muster.
Nonetheless, when we take stock, we have the opportunity to interpret our past.
Perhaps we will see our lives not as following a straight path towards the end
but rather as a voyage with many twists and turns.</span></div>Muriel Gillickhttp://www.blogger.com/profile/13001304171183760292noreply@blogger.com0tag:blogger.com,1999:blog-20352591.post-33987491892739268952021-12-21T08:56:00.007-05:002021-12-21T12:50:54.043-05:00Oh My, Oh My, It's Omicron
The Covid epidemic is ramping up again. Cases were up 21 percent over
the past week, according to the <i>NY Times</i>. Even more important, so were
hospitalizations and deaths: hospitalizations rose by 16 percent; and more than
1200 people are dying of Covid daily, which is not as bad as the peak levels of
over 3000 in the winter of 2021 but represents a 9 percent increase over the
course of a week. It’s dramatically more than this past July, when the count was
around 250 deaths per day.
<div class="separator" style="clear: both;"><a href="https://blogger.googleusercontent.com/img/a/AVvXsEg41V8wt-aw5jcsXTzdzx9BMk7fCTtl7TqEpa4Ug-nbGk-gkcKfMKBzIL6mVIv_Ibw190YQu9o1LoGQqqk6z9IyaMbVw0zoaJhX6jpYsvd7mOiWMm2QQ7NGkrDajT1g76NL_E6VZJZ1mgtOybN3VLFpJ2jSYWCe9-Y7LT0L1FNLTlDHP70TBok=s1280" style="display: block; padding: 1em 0; text-align: center; "><img alt="" border="0" width="400" data-original-height="682" data-original-width="1280" src="https://blogger.googleusercontent.com/img/a/AVvXsEg41V8wt-aw5jcsXTzdzx9BMk7fCTtl7TqEpa4Ug-nbGk-gkcKfMKBzIL6mVIv_Ibw190YQu9o1LoGQqqk6z9IyaMbVw0zoaJhX6jpYsvd7mOiWMm2QQ7NGkrDajT1g76NL_E6VZJZ1mgtOybN3VLFpJ2jSYWCe9-Y7LT0L1FNLTlDHP70TBok=s400"/></a></div><div class="separator" style="clear: both;"><a href="https://blogger.googleusercontent.com/img/a/AVvXsEi1elRh32K_mDhb6aKDUAN9sZqgEtW2A27KIN1qNQWG1TTtq_y3i7W_v8ldeoJThbc-zJGLLB052kKaPzHgQoVJzbmgre8ON1sOFzXj4uy1dXa5Og0VyvjUn1E2fWTmvMlGDH1xgC8rTNdp5sGEFYdbwI6E8Ed3U5wLWDmyvVm9502tTc4sTVk=s1930" style="display: block; padding: 1em 0; text-align: center; "><img alt="" border="0" width="400" data-original-height="1056" data-original-width="1930" src="https://blogger.googleusercontent.com/img/a/AVvXsEi1elRh32K_mDhb6aKDUAN9sZqgEtW2A27KIN1qNQWG1TTtq_y3i7W_v8ldeoJThbc-zJGLLB052kKaPzHgQoVJzbmgre8ON1sOFzXj4uy1dXa5Og0VyvjUn1E2fWTmvMlGDH1xgC8rTNdp5sGEFYdbwI6E8Ed3U5wLWDmyvVm9502tTc4sTVk=s400"/></a></div>
But no one is saying much about older people in
nursing homes and assisted living facilities. This is the group that was hit
hard and early when the pandemic first struck the U.S. in February, 2020.
Because those who are old and frail, like most residents of long-term care
facilities, are particularly vulnerable to this disease, their death rate was
the highest of any subgroup in the country. And the toll on the elderly
continued, with the <i>Times</i> reporting earlier this month that<a href="https://www.nytimes.com/2021/12/13/us/covid-deaths-elderly-americans.html"> 75 percent of all
Covid deaths</a> have been in those over 65. <div class="separator" style="clear: both;"><a href="https://blogger.googleusercontent.com/img/a/AVvXsEhpz6tlfh168ebDZTMoPL4bim9h8I_fQwrLeBPWN8zQjwlKGMAsspChyODIWAFuLPeZDWJ8cn6U-URXdQOd8UHrBqjkMWLFcngCsxhOHlfhkBOm1XRs0N0hzDLzLFhtOsAgLTVTQWNZ1ariUTtM63_1szxLjxk8dbJzQxsIF5H_TMxeszRyZj4=s1454" style="display: block; padding: 1em 0; text-align: center; "><img alt="" border="0" width="400" data-original-height="1008" data-original-width="1454" src="https://blogger.googleusercontent.com/img/a/AVvXsEhpz6tlfh168ebDZTMoPL4bim9h8I_fQwrLeBPWN8zQjwlKGMAsspChyODIWAFuLPeZDWJ8cn6U-URXdQOd8UHrBqjkMWLFcngCsxhOHlfhkBOm1XRs0N0hzDLzLFhtOsAgLTVTQWNZ1ariUTtM63_1szxLjxk8dbJzQxsIF5H_TMxeszRyZj4=s400"/></a></div>To date, one percent of the entire
elderly population have died. Several nursing homes have reported small outbreaks,
including at six senior living facilities in Oregon, but few, if any, deaths. So
are nursing homes getting infection control right this time around or is it just
too early for problems to have developed?
The CDC reports data on vaccination
rates, both with and without boosters, in nursing homes and the correlation with
infections is impressive. Cases have been steadily rising among unvaccinated
nursing home residents, they’ve been rising but to a lesser degree among the
vaccinated, and they’ve been essentially flat in all those who have had
boosters. <div class="separator" style="clear: both;"><a href="https://blogger.googleusercontent.com/img/a/AVvXsEiAOHluenKeAeH5YiQsPXT2Am7em_Yi4EdahFo38VGkwmaDM6D7BfGFYqHu14LMf1BmUWpyS7xS4zM60RbEtrKcivO67igPQeZq0zgqaIFbKMx3PF0ilfHI3X0ymej6q8dYaarjvKC9Hn0UBDBsxd1okSTpxTStEfbvFJeKu8B-z4FF90TA9Mk=s1944" style="display: block; padding: 1em 0; text-align: center; "><img alt="" border="0" width="400" data-original-height="880" data-original-width="1944" src="https://blogger.googleusercontent.com/img/a/AVvXsEiAOHluenKeAeH5YiQsPXT2Am7em_Yi4EdahFo38VGkwmaDM6D7BfGFYqHu14LMf1BmUWpyS7xS4zM60RbEtrKcivO67igPQeZq0zgqaIFbKMx3PF0ilfHI3X0ymej6q8dYaarjvKC9Hn0UBDBsxd1okSTpxTStEfbvFJeKu8B-z4FF90TA9Mk=s400"/></a></div>But all this data reflects principally the delta variant, which is
currently the dominant strain of SARS-CoV-2 in the U.S. That’s about to change
as the evidence is persuasive that omicron is going to supplant delta in the
coming weeks. We still don’t know just how bad Omicron is, though preliminary
evidence suggests it causes a milder illness than its predecessors. We also
don’t know precisely how much protection vaccination including a booster
confers, though a booster is better than no booster, and two doses of an mRNA
vaccine are better than no vaccination.
What we do know is that Omicron is much,
much more contagious than Delta, which is much more readily transmissible than
previous variants. The net effect is that long-term care residents will be at
risk if just one person brings Omicron into the facility. That’s all it takes:
one case. And even if most of the long-term care residents who contract Covid
and who have had the vaccine, including a booster, won’t get terribly sick, some
people who get Omicron under these conditions do get sick enough to be
hospitalized and some will die. What that means is that when Omicron arrives in
a nursing home, it will quickly spread throughout the facility, making most
people sick. And if most people get sick, some of them will get very sick and
die. We know that Omicron is coming; how should we prepare?
A recent opinion
piece in the <i>NY Times</i> suggests a <a href="www.nytimes.com/2021/12/09/opinion/omicron-nursing-homes.html">two-pronged strategy</a>: keep the virus out by
testing staff on a regular basis and bolster the residents’ defenses in case
Omicron sneaks in by making sure everyone has received a booster. This strikes
me as an excellent approach. I propose a few modifications. Keeping the virus
out: this is critical. Long-term care institutions are relatively closed
communities. That means the virus can get inside one of two ways: either a
resident goes out, say to visit family or to go shopping, and brings the virus
back, or a staff member contracts the virus and spreads it within the LTC
facility.
The first route is best dealt with by requiring that residents wear
masks when they go out and that they be tested before re-entering the facility
if they have been indoors with a group of people. The second route is the most
common means of spread since staff members often live with families, take public
transportation, and live in areas with high prevalence of Covid. Addressing the
risk of staff inadvertently carrying the virus with them when they come to work
requires regular testing. The<i> Times</i> article proposes a rapid test before each
shift, which is probably optimal given that an aide, for example, might test
negative one day because she has a very low viral load but test positive the
next day after the virus has had a chance to replicate further. That’s a lot of
testing. During the earlier peak, public health authorities established
guidelines that called for the frequency of surveillance to reflect how
widespread Covid is in the surrounding community. Weighing the inconvenience and
cost of frequent testing against the benefit of vigilance in the face of an
organism that multiplies with extraordinary speed, a reasonable balance might be
twice weekly testing.
The lesson we should have learned from our earlier
experience is that waiting is a very bad idea—if we wait to institute the
revised policy until the first case of Omicron appears in the nursing home, we will be too late. The
time to start is now.
Muriel Gillickhttp://www.blogger.com/profile/13001304171183760292noreply@blogger.com0tag:blogger.com,1999:blog-20352591.post-57046279302791782702021-09-14T16:32:00.003-04:002021-09-15T11:44:54.674-04:00Drugged and Docile?<p class="MsoNormal" style="font-family: Calibri, sans-serif; line-height: 32px; margin: 0in;"><span> T</span>his weekend, the <i>New York Times</i> uncovered new, seemingly damaging information about nursing homes, this time unrelated to their mishandling of the Covid-19 epidemic. <a href="http://www.nytimes.com/2021/09/11/health/nursing-homes-schizophrenia-antipsychotics.html">“Phony Diagnoses Hide High Rates of Drugging at Nursing Homes,”</a> is a detailed investigative essay by three reporters that reveals that nursing homes regularly under-report the frequency with which they prescribe sedating, antipsychotic medications for residents with dementia. Such medications, while useful for controlling paranoia and delusions (which may afflict people with dementia), have not been shown to be more generally helpful in controlling the behavioral symptoms of dementia. They are, however, associated with a two-fold increase in mortality and other <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6159703/">adverse effects</a>. As a result, nursing homes have been under pressure for years to limit their use of “chemical restraints,” medications that suppress agitation--including general sedatives and antipsychotics. </p><p class="MsoNormal" style="font-family: Calibri, sans-serif; line-height: 32px; margin: 0in;"><o:p></o:p></p><p class="MsoNormal" style="font-family: Calibri, sans-serif; line-height: 32px; margin: 0in;"> The campaign against the use of anti-psychotics in dementia began with the Nursing Home Reform Act of 1987 (OBRA-8)7, legislation asserting that residents have the right to be free from physical and chemical restraints that are “not required to treat specific medical symptoms.” Then, nearly a decade ago,<a href="www.cms.gov/medicare/provider-enrollment-and-certification/surveycertificationgeninfo/downloads/survey-and-cert-letter-13-35.pdf "> CMS announced a new approach</a>, the National Partnership to Improve Dementia Care and Reduce Unnecessary Antipsychotic Use in Nursing Homes. This strategy provided for training modules for nursing home staff on how to handle residents with dementia; the strategy also involved including as a “quality indicator” the proportion of long-stay nursing home residents receiving an antipsychotic medication. In 2015, this quality indicator was added to the list of measures that comprise the overall rating of nursing homes that CMS publishes on its website, Nursing Home Compare.<o:p></o:p></p><p class="MsoNormal" style="font-family: Calibri, sans-serif; line-height: 32px; margin: 0in;"> The last 34 years have seen a marked decline in the use of antipsychotic medications in nursing home residents. <a href="/jamanetwork-com.ezp-prod1.hul.harvard.edu/journals/jama/fullarticle/363789">The Nursing Home Reform Act</a> of 1987 led to a 27 percent reduction in antipsychotic use. The introduction of psychoactive drug use as a <a href="http://www.healthaffairs.org/doi/10.1377/hlthaff.2016.1439">quality indicator</a> led to a further ten percent fall in prescribing. Today, CMS statistics assert that 15 percent of long-stay nursing home residents regularly receive antipsychotics for some problem other than Tourette’s syndrome, schizophrenia, or Huntington’s Chorea, for which antipsychotics are approved. The new report by the <i>NY Times</i> suggests that the correct figure is more like 21 percent, with the excess accounted for by bogus diagnoses of schizophrenia: the implication is that doctors want to control their demented patients by sedating them, but are discouraged from doing so by CMS regulations, so they get around the rules by falsely labeling their patients as schizophrenic.<img alt="Chart, line chart
Description automatically generated" border="0" height="319" src="blob:https://www.blogger.com/c2894ae4-94d8-49c9-9f90-c2a00101a0d6" v:shapes="Picture_x0020_2" width="468" /> </p><p class="MsoNormal" style="font-family: Calibri, sans-serif; line-height: 32px; margin: 0in;"><o:p></o:p></p><p class="MsoNormal" style="font-family: Calibri, sans-serif; line-height: 32px; margin: 0in;"> The <i>Times </i>argues that “caring for dementia patients is time- and labor-intensive. Workers need to be trained to handle challenging behaviors like wandering and aggression. But many nursing homes are chronically understaffed and do not pay enough to retain employees, especially the nursing assistants who provide the bulk of residents’ daily care.” All true. The <i>Times </i>goes on to argue that nursing homes with poor staffing ratios (facilities that get a 1 or 2 star rating for the adequacy of staff: patient ratios) dole out more antipsychotic medications than those with better staffing ratios (facilities with 4 or 5 star ratings for staffing). <o:p></o:p></p><p class="MsoNormal" style="font-family: Calibri, sans-serif; line-height: 32px; margin: 0in;"><img alt="Chart, funnel chart
Description automatically generated" border="0" height="223" src="blob:https://www.blogger.com/e6ed6512-7dfb-4e30-84c1-6fdda4ef05a2" v:shapes="Picture_x0020_1" width="468" /><o:p></o:p></p><p class="MsoNormal" style="font-family: Calibri, sans-serif; line-height: 32px; margin: 0in;">While this graph strongly suggests an inverse relationship between staffing and antipsychotic use, what is equally striking is that <i>all t</i>he facilities, regardless of staffing, administer antipsychotics to upwards of 15 percent of residents, without appropriate justification. What this suggests, contrary to the <i>NYT</i> implication, is that nursing homes find that no amount of training and no number of staff members can consistently and reliably treat <i>all </i>the behavioral symptoms of dementia.<o:p></o:p></p><p class="MsoNormal" style="font-family: Calibri, sans-serif; line-height: 32px; margin: 0in;"> The unfortunate reality is that we know very little about how to care for people with moderate to advanced dementia who exhibit problematic behaviors. The behaviors I am referring to are not merely inconvenient to staff, such as “wandering” off the nursing unit unattended. They include aggression, paranoia, and delusions. That means hitting or spitting; it means slugging or biting the well-intentioned caregiver who sought to bathe or feed a resident. These behaviors are disturbing to persons with dementia, their caregivers and, in a nursing home setting, other residents. <o:p></o:p></p><p class="MsoNormal" style="font-family: Calibri, sans-serif; line-height: 32px; margin: 0in;"> The Alzheimer’s Association, the American Psychiatric Association, and others have come up with guidelines for managing these symptoms. Their recommendations advise beginning with psychosocial interventions: first tryi to determine the cause of the behavior (perhaps the person slugged the aide who tried to give him a shower because the water was too cold) and then either address the root of the problem (for example, adjusting the temperature of the shower water) or engage in distraction (taking the individual to a “quiet room” with a box of trinkets and other treasures to examine). But then comes the <a href="http://www.alz.org/media/Documents/dementia-related-behaviors-statement.pdf">caveat:</a> “Unfortunately, large population-based trials rigorously supporting the evidence of benefit for non—pharmacological therapies are presently lacking.” The evidence for these approaches is largely anecdotal and commonsensical--as is true for anti-psychotic medication.<o:p></o:p></p><p class="MsoNormal" style="font-family: Calibri, sans-serif; line-height: 32px; margin: 0in;"> What is the solution? The <i>Times </i>seems to suggest we should either penalize physician prescribers, fine nursing homes that over-prescribe, add further regulations, or all three. Another alternative is to substitute “Green Houses” for conventional nursing homes. The Green House is a model of nursing home care that seems to be successful in many domains where traditional nursing homes have failed abysmally, so there is some reason to believe it may be a good way to deal with dementia. The Green House project restricts homes to no more than 12 residents, employs a home-like focus, and cross-trains staff members to meet any and all resident needs rather than using a rigidly siloed model. Green House nursing homes may be the answer: they are associated with high rates of family satisfaction as well as a superior track record in controlling the Covid epidemic. I hope Green Houses have the solution, but I can find no published data on their ability to manage severe dementia. In fact, it’s far from clear Green Houses, which currently provide care to a total of 3000 people (out of a total nursing home population of 1.3 million), in 300 facilities (out of a total of 15,600 nursing homes nation-wide), actually care for people who have dementia and troublesome behavior. Their limited numbers, small size, and high cost (45 percent of residents pay out of pocket compared to 22 percent of residents in usual nursing homes) suggest they may be able to cherrypick their residents.<o:p></o:p></p><p class="MsoNormal" style="font-family: Calibri, sans-serif; line-height: 32px; margin: 0in;"> I am not advocating blanket use of psychotropic medications in nursing home residents. Nor am I endorsing mislabeling patients with psychiatric diagnoses they do not have. Antipsychotics should only be used in people with dementia in well-defined and relatively rare circumstances. Perhaps informed consent by the patient's health care proxy should be a prerequisite. But blaming nursing homes or pointing the finger at nursing home doctors or devising new regulations are not the best ways to serve people afflicted with dementia. What we need is to find better ways to alleviate the suffering of people with dementia. We should recognize that the doctors who prescribe antipsychotics are not necessarily lazy or devious, though any who are should be disciplined; many of them are simply desperate, desperate to provide relief to their patients. <a href="http://blog.drmurielgillick.com/2021/07/all-eyes-are-on-medicare.html">Medicare is poised to spend billions</a> of dollars on aducanumab, a drug recently approved by the FDA for treatment of Alzheimer’s disease despite the paucity of evidence that it works and the abundance of evidence of its association with severe side effects. Perhaps we should instead devote resources to what is likely to be the more tractable problem, the symptomatic relief of Alzheimer’s disease and other dementias.<o:p></o:p></p><p class="MsoNormal" style="font-family: Calibri, sans-serif; line-height: 32px; margin: 0in;"><o:p> </o:p></p><p class="MsoNormal" style="font-family: Calibri, sans-serif; line-height: 32px; margin: 0in;"><o:p> </o:p></p><p class="MsoNormal" style="font-family: Calibri, sans-serif; line-height: 32px; margin: 0in;"><o:p> </o:p></p><p class="MsoNormal" style="font-family: Calibri, sans-serif; line-height: 32px; margin: 0in;"><o:p> </o:p></p><p class="MsoNormal" style="font-family: Calibri, sans-serif; line-height: 32px; margin: 0in;"><o:p> </o:p></p><p><span face="Calibri, sans-serif"> </span> </p>Muriel Gillickhttp://www.blogger.com/profile/13001304171183760292noreply@blogger.com0tag:blogger.com,1999:blog-20352591.post-75048957726708071252021-07-13T17:12:00.006-04:002021-07-14T15:40:22.995-04:00All Eyes are on Medicare<p><span style="font-family: arial; font-size: medium;"> </span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in;"><span style="font-family: arial; font-size: medium;"> When the <a href="http://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-drug">FDA approved Biogen’s new Alzheimer’s drug</a>, aducanumab (brand name Aduhelm) on June 7, the reaction was surprise, dismay and, in some quarters, enthusiasm. But everyone was shocked by the drug company’s audacity in setting the price for the medication at $56,000 per year. As one <a href="http://www.statnews.com/2021/06/28/biogens-alzheimers-drug-medicare-huge-or-catastrophic/">STAT article</a> put it, the only question about the consequences for Medicare, the insurer for close to 97 percent of Alzheimer’s sufferers, was whether the impact would be big, huge, or catastrophic. </span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in;"><span style="font-family: arial; font-size: medium;"><o:p></o:p></span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in; text-indent: 0.5in;"><span style="font-family: arial; font-size: medium;">Pharmaceutical manufacturers figured out some time ago that they could bring out “specialty drugs,” typically targeted against a single relatively rare disease, if they charged ten or even a hundred times more than for an average medication. The list price of crizotinib (brand name Xalkori), for example, used against a relatively uncommon type of lung cancer found in non-smokers, is just under $20,000 for a one-month supply—and patients usually take the drug until they die or develop resistance to it. But aducanumab is intended for <i>all </i>people with Alzheimer’s disease, and according to recent Alzheimer Association estimates, that means <a href="http://www.alz.org/media/documents/alzheimers-facts-and-figures.pdf">6.2 million</a> people over age 65.<o:p></o:p></span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in;"><span style="font-family: arial; font-size: medium;"> The high price is especially disturbing because it’s not even clear that the drug works. A number of studies have been carried out with similar drugs, other monoclonal antibodies that, like aducanumab, were designed to mop up abnormal brain amyloid deposits, which are the hallmark of Alzheimer’s disease—but none of those drugs proved helpful in practice. The trials of aducanumab were likewise discontinued because interim analysis showed the drug was ineffective. Then, in a surprise move, the manufacturer nonetheless applied to the FDA for approval after a reanalysis of the data showed some evidence of benefit when the drug is given in high doses. The independent scientific review panel convened by the FDA to evaluate the data was not convinced, however, with 10 out of 11 members rejecting approval and one abstaining—but the FDA nonetheless approved the drug.<o:p></o:p></span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in;"><span style="font-family: arial; font-size: medium;"> Even if aducanumab does work, “work” means slowing the rate of decline slightly, not stopping or reversing the disease process. And the potential side effects of the drug are considerable: 40 percent of patients experienced brain swelling, in some cases of sufficient magnitude to cause nausea, vomiting, confusion, or visual changes. <o:p></o:p></span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in;"><span style="font-family: arial; font-size: medium;"> <a href="http://www.nytimes.com/2021/07/07/podcasts/the-daily/aduhelm-alzheimers-fda-drug.html?searchResultPosition=3">Patients and their families,</a> who are desperate for an effective drug against this progressive, ultimately fatal disease, are eager to try something with promise, anything. But they are worried about the side effects of aducanamab, about the need for regular MRI scans to monitor for those effects, and about its high cost.</span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in;"><span style="font-family: arial; font-size: medium;"><o:p></o:p></span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in;"><span style="font-family: arial; font-size: medium;"> Most critiques of the new drug—and there are many, the <i>NY Times</i> alone has published eight articles on the subject between June 7, when the FDA announced approval of the drug, and July 9 , and STAT has published at least 16—assume that since it has been approved by the FDA it will necessarily be paid for by health insurers. In the case of aducanumab, that will principally be Medicare. In fact, CMS is <i>not</i> obligated to provide coverage for the drug just because the FDA approved it.<o:p></o:p></span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in;"><span style="font-family: arial; font-size: medium;"> Medicare, like all other health insurance companies, can decide what tests, procedures, and treatments it will cover. The relevant part of Medicare that will be responsible for paying for aducanamab, if Medicare covers the drug, will be Part B: oral medications fall within the jurisdiction of Medicare Part D plans (prescription drug plans), but medications administered intravenously in a physician’s office, such as aducanumab, fall under Medicare Part B. Most determinations of whether to provide coverage for this kind of treatment are made locally, by the private carriers that process Medicare claims. But the decision about coverage can be made nationally if requested by CMS, by the manufacturer, or by members of the medical profession, in which case the decision becomes binding on all the private carriers. Such “National Coverage Decisions” are reviewed by an internal arm of CMS, the Special Coverage and Analysis Group. For particularly controversial decisions, especially if they have social or ethical implications, CMS may request the guidance of the quasi-independent committee, <a href="http://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/MEDCAC">MEDCAC</a>, the Medical Evidence Development and Coverage Advisory Committee. This is a group of 100 experts including economists, ethicists, physicians, scientists and others, from whom a subgroup of 15 is selected to provide in-depth analysis on the particular test or treatment under consideration. <o:p></o:p></span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in;"><span style="font-family: arial; font-size: medium;"> Since its inception, MEDCAC (or its predecessor, the Medicare Coverage Advisory Committee), has issued 348 National Coverage Decisions. These comprehensive analyses have addressed topics as diverse as cardiac pacemakers, Pap smears, and lipid testing. On rare occasions, they have dealt with drugs, for example, an intravenous medicine used in the treatment of heart failure, Nesitiride. When MEDCAC deliberates Medicare coverage for a particular intervention, it can recommend covering the intervention, not covering it, or restricting its use in specific ways. For instance, it advocated coverage of the Left Ventricular Assist Device, an invasive treatment that is almost but not quite an artificial heart, but it required a detailed informed consent process that included a social worker and palliative care expert along with the patient, family, and cardiac surgeon. Ultimately, Medicare approved coverage for the device but set reimbursement at $70,000 (the manufacturer’s price was closer to $200,000) and l<a href="http://pubmed.ncbi.nlm.nih.gov/17468543/">imited insertion of the device </a>to a handful of medical centers across the country. <o:p></o:p></span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in;"><span style="font-family: arial; font-size: medium;"> Medicare is required by federal law to <a href="http://www.cms.gov/Medicare/Coverage/DeterminationProcess">provide coverage</a> for anything that is “reasonable and necessary” for “the diagnosis or treatment of an illness or injury.” Despite years of often contentious debate, there is no precise definition of what this means. The FDA, by contrast, approves drugs and devices if they are “safe and effective.” In the case of aducanumab, it is arguable whether the drug is truly safe and effective, but surely it would be reasonable and necessary for Medicare to restrict the use of aducanumab to early disease (the only group in whom it was tested) and to require an elaborate informed consent process. While Medicare, by established custom, does not reject coverage based on cost-benefit analysis, it could set the price at a level comparable to those of the existing, only marginally beneficial drug treatments for Alzheimer’s disease, drugs such as rivastigmine (brand name Exelon, which has a yearly retail cost, when given as the brand name drug, of $823) and donepezil (brand name Aricept, which has a yearly retail cost, when given as the brand name drug, of $5380).<o:p></o:p></span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in;"><span style="font-family: arial; font-size: medium;"> Given the controversy swelling around Biogen’s new Alzheimer’s drug, the case for Medicare initiating the National Coverage Decision process is strong. The only reason for failing to do so is external pressure, whether by the manufacturer, by members of Congress under the influence of the pharmaceutical industry, or by the public. If CMS opts against this path or convenes MEDCAC only to reject its advice,* as the FDA did with its advisory committee, that would be a compelling reason to make CMS an independent agency, along the lines of the National Science Foundation, that is under control of a bipartisan board and whose director is independent of the President.<o:p></o:p></span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in;"><o:p><span style="font-family: arial; font-size: medium;"> </span></o:p></p><p class="MsoNormal" style="line-height: 32px; margin: 0in;"><span style="font-family: arial; font-size: medium;"> *<i>Between when this essay was drafted on July 9 and edited for publication today, CMS has in fact decided to proceed with a National Coverage Decision.</i></span><span face="Calibri, sans-serif"><o:p></o:p></span></p>Muriel Gillickhttp://www.blogger.com/profile/13001304171183760292noreply@blogger.com0tag:blogger.com,1999:blog-20352591.post-42394701161750171162021-06-07T18:07:00.084-04:002021-06-09T12:48:45.309-04:00Deja Vu All Over Again?<p class="MsoNormal" style="font-family: Calibri, sans-serif; line-height: normal; margin: 0in;"><span style="font-size: medium;"> </span></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><span style="font-family: arial; font-size: medium;">The big news in geriatrics this week was the FDA approval granted to a drug against Alzheimer's disease, the first new drug in 20 years. It reminded me of the day in 1986 when the initial report about what would be the very first FDA-approved drug against this disease appeared.</span></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><span style="font-family: arial; font-size: medium;"><br /></span></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><span style="font-family: arial; font-size: medium;">It was November 13, 1986 and I had been a practicing geriatrician for four years. My weekly copy of the <i>New England Journal of Medicine</i> had arrived right on time, as it did every Thursday. I scanned the table of contents and <a href="http://www.nejm.org/doi/full/10.1056/NEJM198611133152001">one article</a> immediately jumped out at me. It had the suitably serious, scientific-sounding title “Oral tetrahydroaminoacridine in long-term treatment of senile dementia, Alzheimer type.”<o:p></o:p></span></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><o:p><span style="font-family: arial; font-size: medium;"> </span></o:p></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><span style="font-size: medium;"><span style="font-family: arial;">During four years of clinical practice—plus a year of geriatrics fellowship and three years doing an internal medicine residency—I had encountered patients with what we then called “SDAT,” (senile dementia of the Alzheimer’s type) and which we now simple call Alzheimer’s disease. The cognitive impairments of dementia were to me, to family members of the afflicted, and often to the affected themselves, among the saddest of the many disorders that develop among older individuals. Death, while also very sad, was part of the natural order of things, especially when it came after a long and rich life. But dementia in general and Alzheimer’s disease in particular was devastating because it attacked personality; some would say it assaulted personhood itself. While I would go on to spend much of my career thinking about how best to enable people with dementia (as well as those with physical frailty) to live meaningful lives </span><i style="font-family: arial;">despite</i><span style="font-family: arial;"> their limitations, I recognized then and continue to believe today that the condition is a scourge that we should strive to prevent, eradicate, or at least ameliorate.</span></span></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><o:p><span style="font-family: arial; font-size: medium;"> </span></o:p></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><span style="font-family: arial; font-size: medium;">The medication described in the 1986 <i>NEJM</i> article would ultimately be approved by the FDA under the name of Tacrine for treatment of mild to moderate Alzheimer’s disease; it would be supplanted by its first cousin, the drug donepezil, brand name Aricept; and Aricept would <a href="www.reuters.com/article/eisai/update-1-eisai-says-aricepts-u-s-sales-to-more-than-halve-idUSTOE62306Z20100304 ">top $2 billion in US sales</a> by the time it came off patent in 2013. The story of the drug’s development says volumes about Americans’ desperation for a medical fix to Alzheimer’s, about big business, and about our regulatory system. Both the similarities and the differences between the Tacrine story and the tale of the new drug approved by the FDA for the treatment of Alzheimer’s are illuminating.<o:p></o:p></span></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><span style="font-family: arial; font-size: medium;"><br /></span></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><span style="font-family: arial; font-size: medium;">That 1986 study ostensibly showing that Tacrine led to improvements in cognition as well as to overall functioning was based on a whopping 17 patients, only 14 of whom actually completed the study. Its lead author was Dr. William Summers, a psychiatrist at UCLA medical center who had never before published anything of importance and had done very little research altogether. The scientific community immediately began questioning not only Summers’ credibility but also his methodology. Did the 17 patients actually have compelling evidence of an Alzheimer’s diagnosis? Did the “global assessment rating” used to measure outcomes translate into meaningful improvement?<o:p></o:p></span></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><o:p><span style="font-family: arial; font-size: medium;"> </span></o:p></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><span style="font-family: arial; font-size: medium;">After Summers filed for FDA approval for his drug,the FDA investigated Summers and his lab. The agency issued a rare “interim report” in 1991 in which it criticized Summers for the absence of documentation that the study was actually performed as claimed in the <i>NEJM</i> paper. It questioned the randomization process and whether the physicians were, as asserted by Summers, blinded to what drug the patient was receiving. The <a href="http://www.nejm.org/doi/full/10.1056/NEJM199101313240526">best the FDA could say</a> was that there was “no clear evidence of purposeful misrepresentation.”<o:p></o:p></span></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><o:p><span style="font-family: arial; font-size: medium;"> </span></o:p></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><span style="font-family: arial; font-size: medium;">In response, the public vilified the FDA, claiming the agency was “heartlessly impeding the relief of suffering.” David Kessler, the FDA director, received hate mail.<o:p></o:p></span></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><o:p><span style="font-family: arial; font-size: medium;"> </span></o:p></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><span style="font-family: arial; font-size: medium;">Approval of the drug came, but only after the release in 1992 of a <a href="http://pubmed.ncbi.nlm.nih.gov/1404819/">larger more carefully conducted study</a> by the “Tacrine Collaborative.” The trial lasted for 12 weeks and was carried out at 23 centers involving 468 patients. The results, published in the <i>Journal of the American Medical Association</i>, showed a statistically significant improvement in cognition and in overall function, whether measured by physicians or caregivers. And so, the first drug was approved for treatment of Alzheimer’s disease. Sales soared. But questions continued to plague use of the drug—a subsequent study, for example, testing the effectiveness of a higher dose of the drug, found that the higher dose was more effective than lower doses—but more than 2/3 of the patients dropped out of the study. Tacrine was soon effectively replaced by donepezil (Aricept), another cholinesterase inhibitor that differed only from Tacrine in that it is taken once a day rather than twice and has fewer gastrointestinal side effects. Patients and families demanded these drugs, which were soon followed by chemically slightly different but no more effective agents such as Excelon; the drug companies advertised them widely and made a small fortune on their sales; but clinicians remained skeptical. I, for one, believe that the cholinesterase inhibitors are next to useless. None of the numerous studies of the drugs carried out since 1986 have persuaded me otherwise.<o:p></o:p></span></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><o:p><span style="font-family: arial; font-size: medium;"> </span></o:p></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><span style="font-family: arial; font-size: medium;">Fast forward to 2021 and the <a href="http://www.statnews.com/2021/06/07/fda-grants-historic-approval-to-alzheimers-drug-designed-to-slow-cognitive-decline/?utm_source=STAT+Newsletters&utm_campaign=4bdd7cf0f3-breaking_COPY_01&utm_medium=email&utm_term=0_8cab1d7961-4bdd7cf0f3-152530085">approval by the FDA of aducanumab </a>under the brand name of Aduhelm. This is a completely different kind of treatment. Tacrine and Aricept are cholinesterase-inhibitors: they work by increasing the level of the neurotransmitter, acetylcholine, which is dramatically reduced in Alzheimer’s. They are given orally and were never terribly expensive, although Aricept got cheaper when the generic version became available. Side effects, particularly in the case of Aricept, are modest and consist of nausea and very rarely of liver enzyme abnormalities. The new drug, by contrast, is a monoclonal antibody that works to mop up deposits of beta-amyloid from the brain, the chemical widely thought to cause Alzheimer’s disease. It must be given intravenously once a month. The average yearly cost will be set at $56,000. Two years ago, its manufacturer, Biogen, stopped an ongoing clinical trial of the drug after interim analysis failed to demonstrate efficacy. The drug company then re-analyzed the data and claimed it was effective after all, but an FDA Advisory Panel, convened in November, 2020 unanimously concluded there was insufficient evidence of significant benefit to proceed. <o:p></o:p></span></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><o:p><span style="font-family: arial; font-size: medium;"> </span></o:p></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><span style="font-family: arial; font-size: medium;">Multiple other monoclonal antibodies targeting beta amyloid <a href="www.karger.com/Article/FullText/505379 ">have also failed</a>, leading some to suggest that by the time these drugs are given to patients, it’s already too late. Or maybe beta amyloid is a marker for the disease and not the cause of the disease. It is in this setting, that the FDA approval of aducanumab is something of a surprise.<o:p></o:p></span></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><span style="font-family: arial; font-size: medium;"><br /></span></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><span style="font-family: arial; font-size: medium;">What is particularly striking about today’s FDA approval is that it is not based on the clinical effectiveness of the drug. Rather, it is based on its ability to clear the brain of amyloid deposits. There is a long tradition of requiring that drugs cause improvement in clinically meaningful outcomes, not just in “surrogate markers.” Cholesterol-lowering drugs were approved based on their ability to prevent heart attacks, not just on their ability to lower blood cholesterol levels. Antihypertensive drugs were approved based on their effectiveness in reducing strokes, not just on their capacity to lower blood pressure. To be sure, the FDA is holding off on full, unconditional approval until it sees the results of a yet to be performed large clinical trial demonstrating long-term benefit of amyloid plaque reduction. In the meantime, anxious patients and their families will submit to monthly injections of a drug that has been shown to cause symptomatic brain swelling, manifested by nausea, vomiting, visual problems, headaches and sometimes small strokes, in <b>40 percent </b>of cases. </span></p><p><span style="font-family: arial; font-size: medium;"><span face="Calibri, sans-serif">We are a long way from the trials and tribulations of tacrine, but in the end, is the tale of aducanumab any less disturbing?</span><span face="Calibri, sans-serif"> In both cases, there was enormous pressure by the public to approve a drug that offered hope, some hope, however slim, of ameliorating this terrible disease. In both cases, the FDA, after seemingly acting based on scientific considerations alone, seemed to succumb to external pressures. And in both cases, the pharmaceutical industry stood to gain enormously by release of the drug. The FDA currently has an acting director: President Biden has yet to name a new, permanent head. Maybe it's time for the FDA director to become a civil servant, selected by the FDA members, rather than a political appointee. At the very least, the new director, when chosen, should take a long hard look at decision-making within the organization.</span></span></p>Muriel Gillickhttp://www.blogger.com/profile/13001304171183760292noreply@blogger.com0tag:blogger.com,1999:blog-20352591.post-31076334211183343682021-05-21T11:05:00.000-04:002021-05-21T11:05:14.834-04:00Tiptoeing Towards the End Zone<p><span style="font-family: arial; font-size: large;"><span>On January 12, 2006, I launched this blog, which I first called “Perspectives on Aging” and, a number of years later, reincarnated as “Life in the End Zone.” Initially, the frequency of my posts was erratic but then, a year and a half after the blog’s inception, </span><i>NY Times</i><span> columnist Paula Span gave “Perspectives” a boost, recommending it along with just one other blog on aging in her weekly column, “</span><a href=" https://www.nytimes.com/2021/05/17/well/family/jane-brody-birthday.html?searchResultPosition=1">The New Old Age</a><span>.” She sent me an email at the time, telling me that my readers would expect predictability and that I was now obligated to post weekly and on a fixed schedule. </span></span></p><p><span style="font-family: arial; font-size: large;">For years, I faithfully followed Paula Span’s advice, but more recently have been writing only sporadically. Every few years I contemplated retiring the blog, but then I would get an email out of the blue from a reader who told me how useful she found a particular post. Two months before his death in 2019, the distinguished ethicist Dan Callahan, who I was privileged to call a friend, commented in his last email to me that he “particularly appreciated” my piece on “dignity and the insensitive nurses”—a post I wrote about an episode at an area nursing home in which nurses and nursing assistants were cruel and callous to a resident they disliked. How could I stop writing when I received this kind of feedback?</span></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><span style="font-family: arial; font-size: large;"><span>After I published the 400</span><sup>th</sup><span> post I thought surely this was a good time to stop. But then came the pandemic, which disproportionately affected older people. There was a great deal to say, so on March 2, 2020, I began writing more regularly. I wrote about the devastating Covid outbreaks in nursing homes; I wrote about the role of telemedicine; I wrote about vaccines. And then, gradually, as the pandemic began to recede, as vaccination rates in older people soared, and as Covid disappeared from nursing homes, I again found I had less to say. So, when I saw Jane Brody’s column in the <i>NY Times</i> this week, “<a href="https://www.nytimes.com/2021/05/17/well/family/jane-brody-birthday.html?searchResultPosition=3">A Birthday Milestone: Turning 80</a>,” I was inspired. I would write about my own birthday milestone—last week I turned 70.</span></span></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><o:p><span style="font-family: arial; font-size: large;"> </span></o:p></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><span style="font-family: arial; font-size: large;">What Jane Brody says, in a nutshell, is that “the secret of a happy, vibrant old age” is to “strive to do what you love for as long as you can do it.” But she says more about what it takes to live a long and fulfilling life.” First, exercise. Without regular exercise, she opines, “you can expect to experience a loss of muscle strength and endurance, coordination and balance, flexibility and mobility, bone strength and cardiovascular and respiratory function.” Translated into geriatric lingo, what she is saying is that to preserve function, the ability to walk, to do errands, even to dress and bathe without help, regular exercise is important. Next in importance, she says, is “quality fuel,” or a good diet. Here Brody is vague, but stresses avoiding “ultra-processed foods” and eating plenty of fruit and vegetables. Finally, there are “attitude, motivation, and perspective” about which she does not further elaborate.<o:p></o:p></span></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><o:p><span style="font-family: arial; font-size: large;"> </span></o:p></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><span style="font-size: large;"><span style="font-family: arial;">What Brody is talking about is “successful aging.” For years I have wanted to write about successful aging, as it was called by Rowe and Kahn in their <a href="https://www.amazon.com/Successful-Aging-John-Wallis-Rowe/dp/0375400451/ref=tmm_hrd_swatch_0?_encoding=UTF8&qid=&sr=">landmark 1987 work</a> of the same title. </span><span style="font-family: arial;">The idea of successful aging has been the subject of both intense criticism and passionate enthusiasm. One problem is that we all want to lead a “good life,” but we may have very different ideas of what that looks like. Sometimes, what we think we need for a good life turns out not to be what we need at all: people who have a life-altering medical condition, whether Parkinson’s or osteoarthritis or chronic obstructive pulmonary disease may wish they hadn’t developed that disorder but find that they are nonetheless able to lead rich, enjoyable lives. </span></span></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><o:p><span style="font-family: arial; font-size: large;"> </span></o:p></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><span style="font-family: arial; font-size: large;"><span>Since Rowe and Kahn’s original work appeared, the <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6776218/">gerontologic literature</a> has discussed “active aging” (to avoid the invidious comparison between success and its opposite, presumably failure). It has talked about “productive aging,” “healthy aging,” “aging well,” or “a good old age.” </span>But these alternative formulations all stigmatize in much the same way as does “successful aging.” The opposite of active is inactive, of productive is unproductive; the opposite of healthy aging is sick aging and the opposite of aging well is aging poorly. The opposite of a good old age is a bad old age. It seems to me that another way of looking at all this is to distinguish between the steps you should take when you are young and healthy to maximize the likelihood that you will retain certain capacities in old age, on the one hand, and the way you should deal with old age once it has arrived, on the other. </span></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><span style="font-family: arial; font-size: large;"><br /></span></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><span style="font-family: arial; font-size: large;">What people may aspire to, in addition to simply living longer, includes the ability to take care of yourself (physical function), the ability to think and reason (cognitive function), and (emotional function). But as they begin to become old, whether denoted by reaching eligibility for Medicare or suffering physical or cognitive decline or becoming afflicted with chronic diseases, they need to figure out how to make the best of their existing condition. Whether they become short of breath on exertion due to years of cigarette smoking or due to environmental exposures or due to idiopathic pulmonary fibrosis (idiopathic implying that nobody has a clue what causes this progressive, debilitating condition), they have to make decisions about how best to live their lives, given their limitations. And those decisions reflect their personal preferences (what matters most to the individual), their circumstances (their financial, physical, and social situation), as well as what they aspire to for whatever time they have left.</span></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><o:p><span style="font-family: arial; font-size: large;"> </span></o:p></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><span style="font-family: arial; font-size: large;">In light of these distinct considerations—1) planning for the distant future, 2) planning for the near future, or 3) making the most of the current reality—I will offer my personal thoughts on turning 70. These are not prescriptions for other people; they are a description of my thought process, which may serve as an illustration of the kind of process others may wish to go through.<o:p></o:p></span></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><o:p><span style="font-family: arial; font-size: large;"> </span></o:p></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><span style="font-family: arial; font-size: large;">I start with the current reality. I am blessed with good health, which I attribute at least as much to genes and luck as to virtuous past behavior in the realms of exercise and nutrition. I am also fortunate to be financially comfortable enough that I do not need to work. At age 70, I find that I for the most part accept myself as I am, which doesn’t mean I cannot change (either for better or for worse) but rather that I feel I can focus on what I derive satisfaction from doing, not from what I feel I ought to do. That means spending time with my husband, who after 49 years of marriage remains my best friend. It means spending time with my 95-year-old mother and with my three sons, who have become fine and interesting adults. It involves trying to make sense of the world, which I often try to do by reading broadly about about health and medicine, incorporating what I learn from the realms of history, politics, science, sociology, and other disciplines to shed light on current problems. While I will engage in activities that I find meaningful, I will avoid activities that are stressful or create conflict. That has meant giving up seeing patients, which used to make me feel useful and even important, but which increasingly became burdensome as medicine became bureaucratic, patients became litigious, and disease remained as intractable as ever. I also want to devote more time to arguably purely selfish activities such as exploring the worlds of novels and of nature.<o:p></o:p></span></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><o:p><span style="font-family: arial; font-size: large;"> </span></o:p></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><span style="font-family: arial; font-size: large;">When I plan for the near future, say the next five to ten years, maybe longer if I’m lucky, I think of this as investing. Not in the stock market or the bond market, though insuring there will be sufficient retirement money to live comfortably is certainly important, but rather in my physical health and physical functioning. This is where exercise comes in, both aerobic exercise to guard against cardiovascular disease and strength training to remain nimble. Strength will be essential to enable me to continue to climb stairs and lift my new granddaughter and any other grandchildren who may come along. I also need to invest in building and deepening friendships, since I am persuaded that over the long run, the best bulwark against depression will be a strong social network. Finally, I want to continue to find ways to be engaged with the world, not just through friends and family. For me, that means remaining intellectually engaged. <o:p></o:p></span></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><o:p><span style="font-family: arial; font-size: large;"> </span></o:p></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><span style="font-family: arial; font-size: large;">As to planning for the distant future—it’s too late for that. Truly long-range planning involves decisions about diet and exercise when you’re in your 20s and 30s; it entails deciding early on not to smoke; it means getting an education (education decreases but by no means eliminates the chance of developing dementia in later life).<o:p></o:p></span></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><o:p><span style="font-family: arial; font-size: large;"> </span></o:p></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><span style="font-family: arial; font-size: large;">As I enter a new phase of life—which feels more like a new stage because I recently became a grandmother, not because I had a birthday—I am going to make a conscious effort to develop new interests and new activities. Unlike Jane Brody, who advocates doing whatever you are passionate about as long as you can in large measure, I suspect, because she herself continues to be passionate about the same things she has always loved, I find that my enthusiasm for clinical medicine waned, as did my excitement about other aspects of geriatrics. I want to move more in the direction of reading, thinking, and ultimately writing about the history of medicine, and how that can help shape contemporary health policy. Recognizing that interests change over the life course, I gave up the practice of medicine. I’m not quite ready to let go of this blog, but I will write when there is a topic relevant to “life in the end zone” about which I feel strongly. I’m no longer going to peruse the <i>New England Journal of Medicine</i> and <i>JAMA </i>weekly for new developments that I might write about as I increasingly feel that what is published in medical journals no longer excites me the way it once did. I will still read <i>Health Affairs </i>and I’m expanding my horizons to include the <i>Bulletin of the History of Medicine</i>. I expect that my eagerness to blog will wax and wane. I hope you will bear with me as I begin to think about the end zone in a new and very personal way. </span><span face="Calibri, sans-serif"><o:p></o:p></span></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><span style="font-family: arial; font-size: large;"><br /></span></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEim6XDlQYod2FrzBPCZVDiMs7YIOSX6Im2Xz30I2KJFdOuov5dxlISqrCuX7tKxTFKNvkWrNelSITcZO1HG0HMF2SSOv77Tw4iMuv-OCVnshBuCncnsEsaRAyOqpDraxJBsIVlWQQ/s2049/29DEE525-C13D-432A-A9DB-F2B1CD13E7B8.JPG" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="2049" data-original-width="1536" height="320" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEim6XDlQYod2FrzBPCZVDiMs7YIOSX6Im2Xz30I2KJFdOuov5dxlISqrCuX7tKxTFKNvkWrNelSITcZO1HG0HMF2SSOv77Tw4iMuv-OCVnshBuCncnsEsaRAyOqpDraxJBsIVlWQQ/s320/29DEE525-C13D-432A-A9DB-F2B1CD13E7B8.JPG" /></a></div><br /><span style="font-family: arial; font-size: large;"><br /></span><p></p>Muriel Gillickhttp://www.blogger.com/profile/13001304171183760292noreply@blogger.com0tag:blogger.com,1999:blog-20352591.post-53780591785337191032021-04-05T15:12:00.003-04:002021-04-05T15:12:29.885-04:00Covid Cathy Bites the Dust<p><span style="font-family: arial; font-size: x-large;">Now that just under half of older people have been </span><a href="https://khn.org/news/article/older-adults-test-freedom-after-covid-vaccinations/" style="font-family: arial;">fully vaccinated </a><span style="font-family: arial; font-size: x-large;">against Covid-19 and only about a quarter have not received any vaccinations at all,</span><span style="font-family: arial; font-size: x-large;"> </span><span style="font-family: arial; font-size: x-large;"> the burning question is, what can vaccinated people do safely? </span></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><o:p><span style="font-family: arial; font-size: large;"> </span></o:p></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><span style="font-family: arial; font-size: large;">The answer comes in two parts: what can vaccinated people do that does not jeopardize their own health and what can they do without risking harming others? The <a href=" https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated.html">CDC has weighed in</a> on this, focusing principally on the first issue, safety of the individual. Their guidance includes the recommendations that those who are fully immunized (who are at least two weeks out from their second shot) can visit other fully immunized people indoors without masking or social distancing and that they can travel without self-quarantining upon arriving at or returning from their destination.</span></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><o:p><span style="font-family: arial; font-size: large;"> </span></o:p></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><span style="font-family: arial; font-size: large;">To answer the second question, the public health concern, we need to know whether a vaccinated individual can be infected with Covid-19, remain asymptomatic, and transmit the disease to an unvaccinated person. Physicians have been concerned that while the antibody response to vaccination is highly effective in squelching the virus in the lungs, what’s not clear is whether it’s also effective in killing the SARS-Cov2 virus in the nasal passages. If so, vaccinated individuals could indeed be surreptitious sources of disease, like the notorious Mary Mallon, who was an asymptomatic carrier of the bacteria causing typhoid fever, <i>salmonella typhi</i>. Could asymptomatic Covid carriers act like “Typhoid Mary,” perhaps earning the nickname Covid Cathy? At last, we have very reassuring data addressing this issue.<o:p></o:p></span></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><o:p><span style="font-family: arial; font-size: large;"> </span></o:p></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><span style="font-family: arial; font-size: large;">The current issue of <a href="https://www.cdc.gov/mmwr/volumes/70/wr/mm7013e3.htm">MMWR</a>, the weekly journal published by the CDC, reports on the experience of just under 4000 people during the period mid-December and mid-March, 2479 of whom received two shots of either the Pfizer or Moderna vaccines and 989 controls who remained unvaccinated. They also report on 477 people who received one dose, but for simplicity, I will ignore these partially immunized individuals. The investigators leading this small study took one crucial step that has previously been largely lacking: they tested all the participants weekly using the gold standard polymerase chain reaction (PCR) test for the SARS-Cov2 virus—whether or not they had been vaccinated and whether or not they reported symptoms. What did they find?<o:p></o:p></span></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><o:p><span style="font-family: arial; font-size: large;"> </span></o:p></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><span style="font-family: arial; font-size: large;">The outcomes are reported based on “person-days” since the group who were vaccinated got their shots at varying times and therefore differed in the number of days they could have become infected. They found that among the fully immunized, the number of new positive tests/1000-person-days was 0.04 whereas among the unvaccinated, it was 1.38. The bottom line: once you are fully immunized, you are far less likely to test positive for Covid-19 than if you have received no vaccinations.<o:p></o:p></span></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><o:p><span style="font-family: arial; font-size: large;"> </span></o:p></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><span style="font-family: arial; font-size: large;">The study also found that only 23 percent of the people who did develop an infection got sick enough to see a physician, only two people were hospitalized, and no one died. <o:p></o:p></span></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><o:p><span style="font-family: arial; font-size: large;"> </span></o:p></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><span style="font-family: arial; font-size: large;">Until this admittedly small but carefully conducted study appeared, it seemed to me that while vaccinated people could feel personally quite safe, they had to exercise caution in the interest of public health. It wasn’t really true that vaccinated people could socialize indoors with other vaccinated people—until the issue of Covid Cathy was resolved, they had to be worried about about any unvaccinated household contacts their friends might have, lest an asymptomatic carrier inadvertently transmit the virus to a friend, who while also asymptomatic, manages to give the virus to an unvaccinated household member. Now it increasingly looks as though this theoretical concern is not, in practice, of great consequence. <o:p></o:p></span></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><o:p><span style="font-family: arial; font-size: large;"> </span></o:p></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><span style="font-family: arial; font-size: large;">Just because fully vaccinated individuals are reasonably safe today doesn’t mean they will necessarily remain safe tomorrow. Vaccine effectiveness is calculated based on how much less likely a vaccinated person is to get the disease than an unvaccinated one. But if the disease is running rampant in the surrounding community, that is, if it is quite common among the unvaccinated, then while the relative risk of the vaccinated will be unchanged, the absolute risk will go up. And if new variants appear against which the vaccines offer only limited protection, then the relative risk itself will be affected. <o:p></o:p></span></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><o:p><span style="font-family: arial; font-size: large;"> </span></o:p></p><p class="MsoNormal" style="line-height: normal; margin: 0in;"><span style="font-family: arial; font-size: large;">So, keep an ear to the ground—monitor how common the virus is in the community where you live and pay attention to the type and pervasiveness of viral variants. If the situation is stable, enjoy your freedom.</span><span style="font-family: Calibri, sans-serif;"><o:p></o:p></span></p>Muriel Gillickhttp://www.blogger.com/profile/13001304171183760292noreply@blogger.com0tag:blogger.com,1999:blog-20352591.post-80229697191872781762021-03-04T17:37:00.011-05:002021-03-05T13:00:16.601-05:00How I Taught My 95-Year-Old Mother to Make and Receive Video Calls--Most of the Time<p class="MsoNormal" style="line-height: 32px; margin: 0in;"><span style="font-family: arial; font-size: medium;">My 95-year-old mother has been using a computer for email since our then teenage son arranged to gift her his old computer so he could get a new one. That was 25 years ago. But like most people in her age cohort, she has never been comfortable with the technology and has trouble learning anything new related to the computer. The difficulty has gotten worse over time along with her memory. But when Covid hit and visits to the independent living complex where she lives were restricted and then eliminated, the limitations of a landline telephone became all too evident. If my mother could make and/or receive video calls, she could communicate with me, with her three grandsons in California, and with friends. But using the video technology proved to be an endless source of frustration. We tried FaceTime, we tried Skype, we tried Zoom. Nothing worked. <o:p></o:p></span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in;"><span style="font-family: arial; font-size: medium;"><br /></span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in;"><span style="font-family: arial; font-size: medium;">Now, after months of trial and error and refining the approach, I’m pleased to report that my mother can receive—and sometimes initiate—FaceTime calls. I’m so pleased that I’m going to use this blog post to describe in as much detail as I can recall every step necessary to accomplish this feat, suspecting as I do that others may find themselves in a similar predicament.<o:p></o:p></span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in;"></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEijefjU0G0GezjWKfLZI0BNn8ThpyFcet2RGjsrjbX1d56z4Nmy88lal2J_Z_QXY4a9uPO3yDUi7dD5bvXH_U_vbWlppl39b-bAsDa1NeQ-d5WnOTw2eATSRD5jR6TUB4hqxrTHhg/s926/Screen+Shot+2021-03-04+at+5.36.11+PM.png" style="margin-left: 1em; margin-right: 1em;"><span style="font-family: arial; font-size: medium;"><img border="0" data-original-height="926" data-original-width="638" height="320" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEijefjU0G0GezjWKfLZI0BNn8ThpyFcet2RGjsrjbX1d56z4Nmy88lal2J_Z_QXY4a9uPO3yDUi7dD5bvXH_U_vbWlppl39b-bAsDa1NeQ-d5WnOTw2eATSRD5jR6TUB4hqxrTHhg/s320/Screen+Shot+2021-03-04+at+5.36.11+PM.png" /></span></a></div><span style="font-family: arial; font-size: medium;"><span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> Happy geriatric iPad user </span></span></span></span></span></span></span></span></span></span></span></span></span><div><span style="font-family: arial; font-size: medium;"><span><span><span><span><span><span><span><span><span><span><span><span><span><span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> </span></span></span></span></span></span></span></span></span></span></span></span>(not my mother)</span></span></span></span></span></span></span></span></span></span></span></span></span></span><br /><p></p><p class="MsoNormal" style="line-height: 32px; margin: 0in;"><span style="font-family: arial; font-size: medium;"><b>Step 1: </b><span>Choose an appropriate device. I purchased my mother a new 10.2 inch, 32GB iPad. It’s portable, so she can use it while sitting in her favorite recliner. The screen is big enough so that people’s faces appear almost life-size and photographs are easy to see. In principle, Apple products are user-friendly, though as it turned out, my mother is a genius at outwitting the human-computer interface gurus at Apple by coming up with ways to make the system fail. Nonetheless, I think the iPad was probably as good a choice as any and better than some. The rest of the steps below apply primarily to an iPad.</span></span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in;"><span style="font-family: arial; font-size: medium;"><br /></span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in;"><span style="font-family: arial; font-size: medium;"><b>Step 2: </b>Obtain a cover that automatically turns the device off when it is closed and turns the device on when it is opened. Turning the iPad on manually was an unnecessary obstacle.<o:p></o:p></span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in;"><span style="font-family: arial; font-size: medium;"><br /></span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in;"><span style="font-family: arial; font-size: medium;"><b>Step 3: </b>Disable password protection for turning the device on. This may be a bit risky, but my mother was having trouble remembering her password. I “enrolled” her in touch ID, but she usually managed to put her finger in not quite the right place, so it did not work reliably. Nothing is more frustrating than being unable to even turn the thing on.<o:p></o:p></span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in;"><span style="font-family: arial; font-size: medium;"><br /></span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in;"><span style="font-family: arial; font-size: medium;"><b>Step 4: </b>Go to Settings, Accessibility, Assistive Touch. This setting allows my mother to use the iPad even though she has poor fine motor control and touches the screen erratically.<o:p></o:p></span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in;"><span style="font-family: arial; font-size: medium;"><br /></span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in;"><span style="font-family: arial; font-size: medium;"><b>Step 5:</b> Label the home button. I stuck an arrow on either side of the home button to help my mother find it. The device is designed with a very slight indentation signaling the home button, so slight that it’s hard for 95-year-old eyes to see. ➡️ ⏺ ⬅️<o:p></o:p></span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in;"><span style="font-family: arial; font-size: medium;"><br /></span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in;"><span style="font-family: arial; font-size: medium;"><b>Step 6: </b>Make sure Siri is disabled. I initially thought it would be easiest if my mother used Siri to make calls, simply saying “hey Siri, call Muriel Facetime video.” Wrong. She would leave out “FaceTime” or leave out “video” or forget to start with “hey Siri.” She felt compelled to speak in grammatically correct sentences, as though Siri would understand her better that way. When I left Siri enabled, just in case things changed, I found that my mother would sometimes hold the home button down too long and inadvertently invoke Siri, who would helpfully inquire “may I help you?” Having her device suddenly speak really rattled my mother.<o:p></o:p></span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in;"><span style="font-family: arial; font-size: medium;"><br /></span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in;"><span style="font-family: arial; font-size: medium;"><b>Step 7: </b>Put only the most essential icons in the dock. For my mother, this includes the icon for her email, Safari, and for FaceTime video. I’ve recently added the photos icon.<o:p></o:p></span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in;"><span style="font-family: arial; font-size: medium;"><br /></span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in;"><span style="font-family: arial; font-size: medium;"><b>Step 8: </b>Declutter the screen by putting as many of the obligatory icons, the ones you can’t get rid of, on the next screen, not the screen that is opened when the device turns on.<o:p></o:p></span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in;"><span style="font-family: arial; font-size: medium;"><br /></span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in;"><span style="font-family: arial; font-size: medium;"><b>Step 9: </b>Put the handful of phone numbers (with associated names) that are most likely to be used in the FaceTime contacts screen. This way, when my mother taps on the video icon, she will see 4 or 5 names and can choose which one she wants to call. Sometimes she taps on the wrong spot and calls the wrong person, but at least she’s not accidentally going to call Social Security or the Boston Globe, just a different family member from the person she intended.<o:p></o:p></span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in;"><span style="font-family: arial; font-size: medium;"><br /></span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in;"><span style="font-family: arial; font-size: medium;"><b>Step 10: </b>Practice! When visiting my mother, I would get her settled in her recliner with the iPad and call her from another room. For a while she had trouble with the command “slide to answer.” I finally figured out that she was carefully sliding her finger along the words “slide to answer” and assiduously avoiding the green virtual button to the left of the words. Unless she accidentally touched the button, she failed to answer the call. Now I regularly remind her that she needs to slide the <i>button</i> and it works like a charm. Another aspect of practicing is using the system regularly. At one point, my mother was doing great and then we didn’t make any video calls for a few days, by which time she had forgotten about sliding the button rather than the words. Making or receiving a call once a day is probably a good idea.<o:p></o:p></span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in;"><span style="font-family: arial; font-size: medium;"><br /></span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in;"><span style="font-family: arial; font-size: medium;">Sounds simple, doesn’t it? Since it literally took me months to figure this out, I thought I’d pass along what I learned, in case these steps can help someone else.<o:p></o:p></span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in;"><o:p><span style="font-family: arial; font-size: medium;"> </span></o:p></p><p class="MsoNormal" style="line-height: 32px; margin: 0in;"><o:p><span style="font-family: arial; font-size: medium;"> </span></o:p></p></div>Muriel Gillickhttp://www.blogger.com/profile/13001304171183760292noreply@blogger.com0tag:blogger.com,1999:blog-20352591.post-40918025882044929972021-02-26T11:38:00.017-05:002021-02-26T15:14:52.505-05:00Pfizer in Practice<p><span style="font-size: large;"><span style="font-family: arial;">This week brought a medical article worth discussing: the <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2101765">New England Journal of Medicine</a> published the results of a study of the efficacy of the Pfizer SARS-CoV-2 vaccine in the real world. </span><span style="font-family: arial;">The article provides compelling evidence that the vaccine works extremely well.</span></span></p><p class="MsoNormalCxSpMiddle" style="line-height: normal;"><span style="font-size: large;"><span style="font-family: arial;">The data come from Israel, which has been doing a superior job of vaccinating its citizens. As of a week ago, two-thirds of the currently eligible population in Israel had gotten <a href=" https://www.timesofisrael.com/two-thirds-of-eligible-israelis-have-received-at-least-1-dose-of-covid-vaccine/ ">both of the recommended doses</a> (individuals under age 16 and those who have had Covid-19 are not eligible).</span><span style="font-family: arial;"> </span><span style="font-family: arial;">In Israel, health insurance is mandatory for all permanent residents; they</span><span style="font-family: arial;"> must join one of four healthcare organizations called “funds.” The new study reports data from Israel’s largest health organization (Clalit Health Services) and includes information on a stunning 1.2 million people.</span></span></p><p class="MsoNormalCxSpMiddle" style="line-height: normal;"><span style="font-family: arial; font-size: large;">The study’s authors, led by Dr. Noa Dagan, used Clalit's integrated electronic medical record to capture health data for 596,618 people who received both doses of the Pfizer vaccine between December 20, 2020 and February 1, 2021. They then matched them, based on demographic and clinical characteristics, with another group of identical size who had not received any vaccine. Next, they looked at five different outcomes: documented Covid-19 infection; symptomatic Covid-19 infection, Covid-related hospitalization, Covid-related severe illness, and Covid-related deaths. Because the sample was so large, they were also able to collect extensive information about a number of interesting subgroups defined by age or specific co-existing health conditions such as cancer or diabetes.</span></p><p class="MsoNormalCxSpMiddle" style="line-height: normal;"><span style="font-size: large;"><span style="font-family: arial;">The article includes an enormous amount of intriguing data. The most exciting results, from my perspective, address outcomes a week or more after receiving the second dose of the vaccine. At that point, the vaccine conferred 94% protection against symptomatic Covid-19 (95 percent confidence interval 87-98), 87 percent protection against Covid-related hospitalization (CI 55-100), and 92 percent protection against severe Covid (CI 70-100).</span><span style="font-family: arial;"> </span><span style="font-family: arial;"> </span><span style="font-family: arial;">The efficacy in people over 70 was identical to those in younger individuals, and the rate in people with one chronic health condition such as diabetes was only slightly lower than in people without the condition.</span><span style="font-family: arial;"> </span></span></p><p class="MsoNormalCxSpMiddle" style="line-height: normal;"><span style="font-size: large;"><span style="font-family: arial;">These numbers strongly resemble the results that Pfizer and BioNTech reported to the <a href="https://www.fda.gov/media/144416/download ">FDA in their application</a> for emergency approval.</span><span style="font-family: arial;"> </span><span style="font-family: arial;"> </span><span style="font-family: arial;">But, as the study authors point out, Pfizer drew its conclusions based on 44,000 people; the Israeli study is based on 1.2 million people. As a result, when Pfizer calculated the efficacy against severe Covid-19, they drew on a total of 10 cases (one of whom had been vaccinated and 9 of whom had not been); when the Israelis calculated the risk of severe Covid, their estimate was based on 229 cases, vastly increasing the credibility and certainty of the calculation. Moreover, Pfizer’s data was based on the somewhat artificial conditions of a clinical trial: for example, the subjects were all highly motivated to optimize their health and may have regularly worn masks and practiced social distancing; the Israeli study drew on real life experience, in which participants’ behavior reflected community norms.</span></span></p><p class="MsoNormalCxSpMiddle" style="line-height: normal;"><span style="font-size: large;"><span style="font-family: arial;">The new study, like all studies, has its limitations. It excluded people living in nursing homes and medical personnel working on Covid units in the country’s hospitals, arguing that the rate of the disease in their particular communities, i.e. the nursing home or the Covid ward, was highly atypical. The study was performed during a period when the <a href="https://www.washingtonpost.com/world/middle_east/south-african-israel-variants-reinfection/2021/02/15/0c6ff68c-6f68-11eb-8651-6d3091eac63f_story.html">South African variant</a> was very rare in Israel</span><span style="font-family: arial;"> </span><span style="font-family: arial;">so we cannot draw conclusions about the efficacy of the vaccine against this strain. The information on the ability of the vaccine to prevent Covid-related deaths is limited because of the short follow-up period: there were nine Covid deaths in the fully vaccinated and 32 deaths in the unvaccinated group, but these numbers might change when more time elapses. The data on deaths may also be difficult to generalize as Israel has an unusually low case fatality ratio: in Israel, according to Johns Hopkins'<a href="https://ourworldindata.org/coronavirus-data-explorer?tab=map&zoomToSelection=true&country=&region=World&cfrMetric=true&interval=total&smoothing=0&pickerMetric=total_cases&pickerSort=desc"> "Our World in Data,</a>" is currently 0.7 percent whereas in the U.S. it is 1.8 percent.</span></span></p><p class="MsoNormalCxSpMiddle" style="line-height: normal;"><span style="font-family: arial; font-size: large;">Some of the study’s greatest strengths are also potential weaknesses: the “real world” nature of the investigation means it is an observational study rather than a randomized controlled trial, raising the possibility that the differences in outcomes between the vaccinated and the unvaccinated were related to some factor other than their vaccination status. Despite these limitations, the study provides very encouraging information.</span></p><p class="MsoNormalCxSpMiddle" style="line-height: normal;"><span style="font-family: arial; font-size: large;">The fact that the Israelis could carry out their study sends another message over and beyond the efficacy of the Pfizer BioNTech vaccine. The study could only be conducted because Israel did a good job acquiring and distributing vaccine. Early on, the country developed mass vaccination sites. Since everyone is enrolled in a health plan and the plans all have electronic records, there was no need to waste as much time on bureaucracy as we do in the U.S, where more time is spent filling out forms than on administering the shot. The study could only be conducted because of Israel’s electronic health records, which assured that information about who got what dose when, and the age, sex, and chronic medical conditions of each individual was digitally recorded. Finally, the entire rollout was centrally coordinated, assuring efficiency and consistency: from the outset of the pandemic, the Israeli Ministry of Health collected Covid-related data from all four health plans, negotiated to purchase vaccine from Pfizer, and organized distribution. The good news reported in the NEJM article is a result both of the biological properties of an mRNA vaccine that was designed in record time to deal with an international health crisis of enormous proportions, and of the characteristics of a health care delivery system that can actually deliver.</span></p><p class="MsoNormalCxSpMiddle" style="line-height: normal;"><o:p></o:p></p>Muriel Gillickhttp://www.blogger.com/profile/13001304171183760292noreply@blogger.com0tag:blogger.com,1999:blog-20352591.post-78263201853137220822021-02-21T17:51:00.000-05:002021-02-21T17:51:01.679-05:00The Next Big One<p class="MsoNormalCxSpFirst"><span style="font-family: arial; font-size: large;"> As new cases of Covid-19 fall throughout the world but the US approaches 500,000 deaths from Covid-19 and the world nears 2.5 million deaths, it is time to start planning for the next pandemic. </span></p><p class="MsoNormalCxSpFirst"><span style="font-family: arial; font-size: large;"> We have known since the 1918 influenza pandemic, which killed upwards of 50 million people world-wide, that it’s not a question of if, but rather of when. Moreover, recent decades have seen the emergence of several new and terrifying diseases. These diseases have principally been caused by viruses, viruses that jumped species. They moved from their usual host, say a civet or a bat, into people for one of several reasons: climate change may have destroyed their hosts’ usual habitat, forcing them to find a new home where they came into greater contact with humans; alternatively, humans encroached on the hosts’ habitat by clearing forest or planting a crop that deprived the host of its usual food source, again leading the host to relocate; or humans may have developed a taste for certain types of wild animal, bringing the two species into unaccustomed contact and thus facilitating viral transmission.</span></p><p class="MsoNormalCxSpFirst"><span style="font-family: arial; font-size: large;"> As a result of these factors, we have had Zika, SARS, MERS, avian influenza and now Covid-19 in the twenty-first century, and Ebola, Marburg hemorrhagic fever, and HIV in the last part of the twentieth century. These are only the best-known of “zoonoses.” Today, <a href="https://wwwnc.cdc.gov/eid/article/23/13/17-0544_article">75 percent of new infectious diseases are zoonotic </a>in origin and their numbers have been rising steadily. <o:p></o:p></span></p><p class="MsoNormalCxSpMiddle"><span style="font-family: arial; font-size: large;"> The good news is that we know a great deal about how to go about preventing outbreaks, detecting them early, and responding if they nonetheless occur. The bad news is that the world in general and the U.S. in particular have a poor track record of implementing the necessary strategies. Allocating scarce resources now to help alleviate problems that will develop at some unspecified time in the future has proved to be a hard sell. </span></p><p class="MsoNormalCxSpMiddle"><span style="font-family: arial; font-size: large;"> The irony is that we in the U.S., as in many other countries, spend an enormous amount of money on our military. We have accepted the need to devote a large fraction of our budget to the armed forces and to equipment including both “conventional” and nuclear weapons. We have not yet acknowledged that the far greater threat to our national security and our well-being is from lowly viruses, strange biological entities that are not strictly speaking alive since they cannot survive outside a host organism, not from invading armies. <o:p></o:p></span></p><p class="MsoNormalCxSpMiddle"><span style="font-family: arial; font-size: large;"> The <a href="http://www.thebalance.com/u-s-federal-budget-breakdown-3305789#military-spending">current US budget </a>consists of just under $3 trillion on “mandatory spending,” which includes Social Security, Medicare, and Medicaid; and another nearly $1.5 trillion on “discretionary spending,” over half of which is for military spending, including the VA and Homeland Security as well as the armed forces. The base budget for the Department of Defense is $636 billion.</span></p><p class="MsoNormalCxSpMiddle"><span style="font-family: arial; font-size: large;"> By comparison, the CDC (Centers for Disease Control), the site for most of the U.S. epidemic preparedness activities, has a total budget of $6.6 billion, of which $509 million is allocated to “Emerging and Zoonotic Infectious Diseases.” Other disaster preparedness activities are financed through various departments, including Homeland Security, which is part of the military. But as a very rough approximation, it is not far-fetched to say that the <i>core budget </i>for potential epidemics is $509 million compared to the <i>core budget</i> for the military of $636 billion, or <b>.08 percent. </b>This comparison reveals an enormous imbalance between spending on the military and on epidemic preparedness, with too much to fight armed invasions and not nearly enough to combat microbial enemies.<b><o:p></o:p></b></span></p><p class="MsoNormalCxSpMiddle"><span style="font-family: arial; font-size: large;"> If we are to spend more on epidemics—and, arguably, less on bombs and fighter planes—what should we spend it on? A basic framework was outlined at a symposium called “Building Interdisciplinary Bridges to Health in a Globalized World,” organized by the Wildlife Conservation Society in 2004. </span><span style="font-family: arial; font-size: x-large;">The symposium called for an international, interdisciplinary approach to preventing disease, or “One Health, One World.” It articulated its views in a document called the </span><span style="font-family: arial; font-size: large;"><a href="http://www.wcs-ahead.org/manhattan_principles.html">Manhattan Principles</a> which </span><span style="font-family: arial; font-size: x-large;">laid the foundation for what would become an international movement. </span><span style="font-family: arial; font-size: x-large;">The Manhattan Principles is built on</span><span style="font-family: arial; font-size: x-large;"> </span><span style="font-family: arial; font-size: x-large;"> </span><span style="font-family: arial; font-size: x-large;">the recognition that modern epidemics stem from the inter-connections between humans, domestic animals, and wildlife, and that these interactions arise either directly from human behavior (eg agricultural practices, clear cutting forests, and eating wildlife), or indirectly, mediated by climate change that is in turn due to human behavior. Since the problem is fundamentally multidisciplinary, its solution must likewise be multidisciplinary. And since the modern world is interconnected, the solution must be international, involving sharing information.</span></p><p class="MsoNormalCxSpMiddle"><span style="font-family: arial; font-size: large;"> An <a href="www.oie.int/doc/ge d/D5720.PDF ">implementation framework</a> was drawn up in 2008 by a group consisting of representatives from UNICEF, WHO, the World Bank among others. Entitled “A Strategic Framework for Reducing Risks of Infectious Diseases at the Animal-Human-Ecosystems Interface,” it argued for the development of an international system of disease surveillance drawing on multidisciplinary expertise (to include veterinarians, physicians, wildlife specialists, and ecologists). In addition, it sought to help build robust public health systems across the globe and to promote good communication between those systems. Finally, it advocated support for strategic research, to be shared internationally. <o:p></o:p></span></p><p class="MsoNormalCxSpMiddle"><span style="font-family: arial; font-size: large;"> The One Health approach was adopted by the CDC in 2009, which housed it within its National Center for Emerging and Zoonotic Infectious Diseases. It was formally endorsed by the UN, the World Bank, and the EU in 2010. More recently, the <a href="/documents1.worldbank.org/curated/en/703711517234402168/pdf/123023-REVISED-PUBLIC-World-Bank-One-Health-Framework-2018.pdf">World Bank</a> came up with a revised operational framework to fight EIDS as a means of fulfilling its mission to promote prosperity and decrease poverty.<o:p></o:p></span></p><p class="MsoNormalCxSpMiddle"><span style="font-family: arial; font-size: large;"> Our response to future epidemics, when they occur, will hinge on more than international and multidisciplinary collaboration. Scientific developments are likely to have a major impact when future EIDs arise. The new technique of vaccine design using mRNA is vastly accelerating the development of effective vaccines, the most powerful preventive tool available. Work on anti-viral medications is ongoing and could revolutionize treatment of viral diseases much as antibiotics revolutionized the treatment of bacterial diseases. Currently, the only virus for which there is effective treatment is HIV, and that treatment (which took years to develop) involves a multi-drug regimen that converts HIV into a chronic disease but rarely eradicating the infection. <o:p></o:p></span></p><p class="MsoNormalCxSpMiddle"><span style="font-family: arial; font-size: large;"> We also need to strengthen the public health infrastructure in the U.S. Poor coordination, insufficient manpower, and inadequate communication to the public have afflicted domestic public health departments for years. WHO and the World Bank have focused on shoring up public health in much of the world but assumed that the richest countries would serve as models of success. <o:p></o:p></span></p><p class="MsoNormalCxSpMiddle"><span style="font-family: arial; font-size: large;"> The <a href="http://gh.bmj.com/content/3/5/e001137">One World framework could itself be expanded</a> to address climate and the environment more expansively, but the basic formulation is sound. As Andrew Cunningham, Peter Daszak, and James Wood argue in their <a href="royalsocietypublishing.org/doi/10.1098/rstb.2016.0167 ">2017 article</a>, “One Health: Emerging Infectious Diseases and Wildlife: Two Decades of Progress?” little has been done at the policy level to address what remain major threats to health and well-being, as Covid-19 attests. It’s time to adjust our national priorities and focus on what counts. <o:p></o:p></span></p><p class="MsoNormalCxSpMiddle"><o:p><span style="font-family: arial; font-size: large;"> </span></o:p></p><p class="MsoNormalCxSpMiddle"><o:p><span style="font-family: arial; font-size: large;"> </span></o:p></p>Muriel Gillickhttp://www.blogger.com/profile/13001304171183760292noreply@blogger.com0tag:blogger.com,1999:blog-20352591.post-69603134421790766992021-01-11T17:59:00.006-05:002021-01-15T14:11:44.329-05:00The Home Stretch<span style="font-size: large;">For Americans over age 65, the Covid-19 vaccine really is coming soon. States have varying policies on prioritizing distribution of the vaccine, with some states already giving it to those older than 65 and others planning to get to the over 75 group very soon and the 65-74-year-olds shortly thereafter. In all cases, the expectation is that by April, all older Americans will have had the opportunity to be vaccinated. </span><div><span style="font-size: large;"><br /></span></div><div><span style="font-size: large;">If you are reading this post, you have made it this far—so my message today is <i>don’t blow it now</i> by throwing caution to the winds. The virus is striking <a href="https://www.nytimes.com/interactive/2020/us/coronavirus-us-cases.html">more people each day</a> than ever before, and despite the progress in treatment, more people are hospitalized and more people are dying than at any time in the past year. </span></div><div><span style="font-size: large;"><br /></span></div><div><span style="font-size: large;"><br /></span></div><div><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgtkdBwjTWNTjLXW59VAaUyh9Ro5LzWfcvdQnu00_-R94vnGQZSfSn3BB_OzJKkdLFpmolYD4-qYe5zeFetPaQVCM9NViVNiDc9g7RvKmN9nm6xXZr-5UeDJnX46wWcOBrEMPcDPA/s2048/Screen+Shot+2021-01-11+at+4.46.53+PM.png" style="margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="1288" data-original-width="2048" height="318" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgtkdBwjTWNTjLXW59VAaUyh9Ro5LzWfcvdQnu00_-R94vnGQZSfSn3BB_OzJKkdLFpmolYD4-qYe5zeFetPaQVCM9NViVNiDc9g7RvKmN9nm6xXZr-5UeDJnX46wWcOBrEMPcDPA/w631-h318/Screen+Shot+2021-01-11+at+4.46.53+PM.png" width="631" /></a></div><span style="font-size: large;"><br /></span></div><div><span style="font-size: large;"><br />The US also has the dubious distinction of being <a href="https://myemail.constantcontact.com/COVID-19-Updates---January-8--2021.html?soid=1107826135286&aid=70zfihaFqAE">number one in the world </a>in terms of cumulative mortality from Covid-19. </span></div><div><span style="font-size: large;"><br /></span></div><div><span style="font-size: large;">Tired as we all are of masks and social distancing and of just plain staying home, these are the only strategies we have until we are vaccinated—and even then, we’ll need to wait until most of the population has been vaccinated before we can relax. A more infectious strain, isolated in the UK, is here in the US. It may be far more widespread than we know since public health officials are not routinely testing for it. Just because we haven’t found it doesn’t mean it doesn’t exist: it just means we’re not looking for it. </span></div><div><span style="font-size: large;"><br /></span></div><div><span style="font-size: large;">The implication of all this is that it would be prudent not merely to remain careful, but to increase your vigilance.
Writing in the medical news periodical, <a href="www.statnews.com/2021/01/07/national-hi-fi-mask-initiative-needed-with-vaccine-rollouts/ ">STAT</a>, several physicians and an engineer argue that we should wear high filtration masks such as the N-95. We should take their proposal seriously. While N-95 masks are primarily restricted to health care workers, KN-95 masks, which are in many cases equivalent, are available from Amazon, some local pharmacies, and a variety of other on-line sources. Most of these have not been tested for effectiveness or reliability by American government regulators, but many have been subjecting to assessment by one or more international agencies. The CDC has made available a <a href="https://www.cdc.gov/niosh/npptl/respirators/testing/NonNIOSHresults.html ">list of many KN95</a> masks and the results of the assessments. </span></div><div><span style="font-size: large;"><br /></span></div><div><span style="font-size: large;">My recommendation is to start wearing one of the KN-95 masks on this list, choosing one that has a minimum filtration efficiency of at least 95 percent. Wear it indoors in any public space. Do not socialize indoors except with members of your household. Do not take unnecessary risks and don’t let down your guard! </span></div>Muriel Gillickhttp://www.blogger.com/profile/13001304171183760292noreply@blogger.com0tag:blogger.com,1999:blog-20352591.post-35118467650493183972021-01-01T13:20:00.019-05:002021-01-02T11:39:05.506-05:00Looking Forward<p class="MsoNormal" style="font-family: Calibri, sans-serif; line-height: 32px; margin: 0in 0in 0.0001pt;"><span style="font-size: large;"> Once the 1918-1919 influenza pandemic finally came to an end—after killing somewhere between 50 and 100 million people worldwide—Americans did their best to forget about it. Later tragedies such as AIDS and 9/11 figured prominently in much American fiction, but influenza was seemingly forgotten by American writers: Katherine Anne Porter’s short story, “Pale Horse, Pale Rider” and William Maxwell’s novella, “They Came Like Swallows,” are rare exceptions. Historians and journalists writing about the 1918 flu have hypothesized that the pain and suffering inflicted by the flu paled by comparison with that attributable to World War I, which came to an end at the same time, even though ten times more Americans died of the flu than died in combat. Or perhaps Americans were so optimistic about scientific medicine, which was just coming into its own in the twentieth century, that they chose to ignore medicine’s great failure, its inability to diagnose, treat, prevent, or cure influenza. Maybe Americans simply repressed this traumatic episode that killed people in the prime of life, leaving families without a means of support and children without a mother or father. Will the Covid-19 pandemic similarly be forgotten, or will it have a profound and enduring effect on us as individuals and on us as a society?<o:p></o:p></span></p><p class="MsoNormal" style="font-family: Calibri, sans-serif; line-height: 32px; margin: 0in 0in 0.0001pt;"><span style="font-size: large;"> The pundits are already speculating about the long-lasting effects of the pandemic on the real estate market and on the work place, on professional conferences and the movie industry. But what I would like to address is the life lessons we should take away from this devastating and unexpected year. The first is that our lives are tenuous. We in the developed world have come to expect a long healthy life, especially if we are white and middle class. Life expectancy at birth in the US is just under 79 years; if you make it to age 65, you can expect to live another 20 years. Covid-19 showed us that we should not take those years for granted: while 80 percent of the Covid deaths have been in people aged 65 or older, that means that 20 percent have been in people under 65. As of the end of December, 2020, 346,000 Americans had died from the disease, which translates to 69,000 younger people. There’s nothing like awareness of our own mortality to concentrate the mind and encourage us to live life well and to the fullest. This is the first lesson and the one we are perhaps most likely to forget.<o:p></o:p></span></p><p class="MsoNormal" style="font-family: Calibri, sans-serif; line-height: 32px; margin: 0in 0in 0.0001pt;"><span style="font-size: large;"> The second lesson is that what matters most to us as human beings is our relationships with other people. That’s what made “social distancing” so painful; it’s why eliminating family visits to nursing homes was so devastating; it’s why Zoom, FaceTime, and other video chat programs have been such a lifesaver. We need to cultivate our friendships, to nourish them, to work to improve them. The pandemic made us believe that other people are the enemy, which runs counter to our essence as social creatures.<o:p></o:p></span></p><p class="MsoNormal" style="font-family: Calibri, sans-serif; line-height: 32px; margin: 0in 0in 0.0001pt;"><span style="font-size: large;"> The third lesson that I want to emphasize is of a different sort: it is that to make decisions about most anything important and certainly to make medical decisions, we need to understand something about risk. How to behave during the epidemic was all about how to evaluate risk, how to think about risk. Just because most people who don’t wear masks and who go to group gatherings won’t get sick doesn’t mean that these are safe activities. It means that you markedly increase the chance that you will contract the virus if you go around without a mask or attend a group meeting. And understanding risk is more complicated still: how much you increase your risk depends on how widespread the virus is in the surrounding community. If very few people in the vicinity of where you live are sick, then your likelihood of getting the disease is low, even if you fail to take precautions. But as the virus begins to circulate more widely, then precisely the same behavior pattern that was only slightly unsafe before will become far more dangerous. <o:p></o:p></span></p><p class="MsoNormal" style="font-family: Calibri, sans-serif; line-height: 32px; margin: 0in 0in 0.0001pt;"><span style="font-size: large;"> Understanding risk is tricky because the epidemiological measures designed to protect individuals, whether wearing a mask, practicing social distancing, or getting vaccinated, are not perfectly effective. Some people who wear a mask will nonetheless contract the virus; ditto for people who stay six feet away from others. Individuals who received either the Pfizer or Moderna vaccination in the clinical trials were one-twentieth as likely to get sick as those who received a placebo. But that means that just how safe you can feel if you are vaccinated (even if the effectiveness holds up in a much larger population than was tested in the trials) also depends on how widespread the virus is: while vaccination lowers your relative risk of getting sick, if the number of infectious people in the community suddenly increases, say by a factor of ten, your chance of getting the disease also goes up by a factor of ten, even if you've been vaccinated. Grasping the concept of risk is essential—not just to dealing with an infectious disease, but also to deciding whether to undergo screening for prostate cancer, whether to take medication for borderline high blood pressure, and whether to invest in the stock market. </span></p><p class="MsoNormal" style="font-family: Calibri, sans-serif; line-height: 32px; margin: 0in 0in 0.0001pt;"> <span style="font-size: large;"> </span><span style="font-size: large;">Americans, along with people across most of the globe, have lost much from our encounter with the corona virus. We have also gained something: an appreciation for life’s fragility, a recognition of the importance of relationships, and a deeper understanding of risk. It is up to us to remember, both those we have lost and what we have learned. </span></p>Muriel Gillickhttp://www.blogger.com/profile/13001304171183760292noreply@blogger.com0tag:blogger.com,1999:blog-20352591.post-29371816549369354662020-12-07T21:04:00.055-05:002020-12-10T10:40:08.143-05:00Dateline: Pearl Harbor<p class="MsoNormalCxSpFirst"><span style="font-family: arial; font-size: large;">Exactly 79 years ago today, Japanese planes bombed Pearl Harbor, an American naval base on Oahu, Hawaii, catapulting the U.S. into World War II. "A day which will live in infamy," President Franklin Roosevelt would call it--a day which lives on in the memory of the oldest Americans (though not, evidently, of the NY Times, which did not mention it in today's newspaper). The attack, which destroyed more than 300 planes and killed or wounded 3400 Americans, dealt a devastating blow to America’s sense of invulnerability and to our isolationist tendencies. It was also the last time the armed forces of a foreign nation would penetrate the American homeland. And yet, deep into the 21<sup>st</sup> century, the U.S. continues to place disproportionate weight on armed invasion as the major threat to the security of all Americans, young and old.<o:p></o:p></span></p><p class="MsoNormalCxSpMiddle"><span style="font-size: large;"><span style="color: #222222; font-family: arial;">As the Covid-19 pandemic, the devastating wild fires on the west coast, and the unprecedented number of named storms this season demonstrate, America must address several other crucially important problems if its citizens are to remain safe and its democracy strong. Epidemics and climate change are two of the principal non-military threats; cyber-attacks and attacks on science are two additional substantial threats.</span><span style="color: #222222; font-family: arial;"> </span></span></p><p class="MsoNormalCxSpMiddle"><span style="font-size: large;"><span style="color: #222222; font-family: arial;">Why do these non-traditional forms of attack constitute a threat to the national security? <i>Epidemics</i> have the potential to harm or kill tens of thousands, hundreds of thousands, or even millions of Americans; in addition, they can disrupt the economy (either because sick people cannot work or as society limits economic activity to protect health); and they can damage or destroy fundamental institutions such as the health care system by overwhelming its capacity. <i>Climate change</i>, by causing sea level rise, risks destroying coastal property or submerging entire cities; by contributing to natural disasters such as mudslides and wild fires, climate change endangers life and property. Rising maximum temperatures may make parts of the country uninhabitable or cause death from hyperthermia; they might destroy industries such as cod or lobster fishing as entire animal species migrate north in search of cooler waters.</span><span style="color: #222222; font-family: arial;"> </span></span></p><p class="MsoNormalCxSpMiddle"><span style="color: #222222; font-family: arial; font-size: large;"><i>Cyber-attacks</i>, whether carried out by state actors, by international terrorists, or by domestic criminals, can disrupt the financial system, the energy grid, our elections, or other fundamental institutions essential to the health and safety of Americans. <i>Attacks on science</i> constitute a fourth non-traditional threat, one that is just coming to be recognized as endangering both progress and our democracy: progress because a citizenry that rejects science will reject legislators who support science, resulting in diminished funding of the research essential for improvements in health and security; democracy because citizens cannot tell truth from falsehood will not have the information necessary to vote in their best interest. Undermining science will, in addition, exacerbate climate change and increase the likelihood of pandemics.</span></p><p class="MsoNormalCxSpMiddle"><span style="font-size: large;"><span style="color: #222222; font-family: arial;">The idea that threats might not come from a foreign state actor but rather from microorganisms (in the case of a pandemic), from the anthropogenic production of greenhouse gases (in the case of climate change), from a computer hacker (in the case of cyber-attacks), or from lies and propaganda distributed via social media (in the case of the attack on science and, more generally, on truth, knowledge and expertise) represents a fundamental change in the way we need to think about national security. And just as the terrorist attacks of 9/11/2001 led to the creation of the Department of Homeland Security, so too should the current pandemic push us to reconsider the effort we devote to fending off other non-traditional types of attack.</span><span style="color: #222222; font-family: arial;"> </span></span></p><p class="MsoNormalCxSpMiddle"><span style="font-size: large;"><span style="color: #222222; font-family: arial;">Consider the case of microbial threats. The idea of investing in pandemic preparedness is not new: the danger of pandemics and the importance of a coherent response strategy has been acknowledged by public health professionals since the influenza epidemic of 1918-1920. Each of the subsequent pandemics of the 20</span><sup style="color: #222222; font-family: arial;">th</sup><span style="color: #222222; font-family: arial;"> </span><span style="color: #222222; font-family: arial;">century (Asian flu in 1957 and AIDS beginning in 1981), as well as the first pandemics of the 21</span><sup style="color: #222222; font-family: arial;">st</sup><span style="color: #222222; font-family: arial;"> </span><span style="color: #222222; font-family: arial;">century (SARS in 2003, Swine Flu in 2009, and Ebola in 2014), brought renewed interest in both prevention and mitigation. Increased understanding of the origins of these outbreaks has led to a recognition of the importance of surveillance: we now realize that all the major pandemics have been zoonoses, they have arisen from viruses that jumped from one species, such as bats, to another species, humans, because of disruptions in the natural habitat of the original host. Furthermore, realization that global interconnectedness promotes rapid spread of the most readily transmissible organisms has resulted in an appreciation of the importance of international cooperation in combating pandemics.</span></span></p><p class="MsoNormalCxSpMiddle"><span style="font-size: large;"><span style="color: #222222;"><span style="font-family: arial;">Such recognition and realization emerged from thoughtful and comprehensive reports such as the workshop on "ethical and legal considerations in mitigating pandemic disease" sponsored by the Institute of Medicine. Its <a href="/www.ncbi.nlm.nih.gov/books/NBK54157/#__NBK54157">proceedings were published</a> in 2007. </span></span><span style="font-family: arial;">This was followed in 2016 by a chilling report from the National Academy of Medicine, “The <a href="www.ncbi.nlm.nih.gov/books/NBK368391.">Neglected Dimension</a> of Global Security: A Framework to Counter Infectious Disease Crises,” that made explicit the connection between national security and epidemics.</span></span></p><p class="MsoNormalCxSpFirst"><span style="font-size: large;"><span style="color: #222222; font-family: arial;">These documents did not just collect dust in government archives; their conclusions were, to a limited extent, translated into US public policy. Beginning with President Clinton, each presidential administration has put forward a new or revised pandemic preparedness plan. Congress authorized the establishment of a Global Emerging Infections Surveillance program within the Department of Defense in 1997, a program intended to improve surveillance, to foster prevention, and to plan for a response to potential new microbial threats. George W. Bush had his “Biodefense for the 21</span><sup style="color: #222222; font-family: arial;">st</sup><span style="color: #222222; font-family: arial;"> </span><span style="color: #222222; font-family: arial;">Century” plan, precipitated by the anthrax scare, though this focused principally on bioterrorism, the deliberate dissemination of disease-causing organisms by state actors or individual terrorists. Obama had two: the “National Strategy for Countering Biological Threats” in 2009 and the “National Strategy for Bio-Surveillance” in 2012. Trump had his “National Biodefense Strategy” in 2018, which addressed naturally occurring, deliberate, and accidental biological threats, and theoretically centralized the federal response in the Department of Health and Human Services.</span><span style="color: #222222; font-family: arial;"> </span></span></p><p class="MsoNormalCxSpMiddle"><span style="color: #222222; font-family: arial; font-size: large;">These policies sound good on paper. But implementation, coordination, and funding have lagged. For example, the Centers for Disease Control budget allocation for prevention of zoonotic diseases in 2020 was $636 million out of a budget of $6.5 billion; Trump’s proposed 2021 budget asks for $550 million. The total Department of Defense allocation for FY 2021, by contrast, is $933 billion.</span></p><p class="MsoNormalCxSpMiddle"><span style="font-size: large;"><span style="color: #222222; font-family: arial;">More generally, both the current (FY2020) and proposed (FY2021) federal budgets include support for combating pandemics and cyber-attacks, but do little to support combating climate change (the phrase is nowhere to be found) and nothing to defend against attacks on truth or on science. Even when the threats are acknowledged, the programs responsible for combating them are disseminated through multiple disparate agencies, are poorly coordinated, and receive only modest funding.</span><span style="color: #222222; font-family: arial;"> </span></span></p><p class="MsoNormalCxSpMiddle"><span style="color: #222222; font-family: arial; font-size: large;">Pearl Harbor Day should serve as a reminder of how threats to national security have changed in the three quarters of a century since Japanese bombers crossed the Pacific and entered American airspace. For starters, we should have a cabinet level department to take these new threats rather than embedding them into the Department of Defense, which has been structured to focus on the military. Perhaps we should simply reconfigure the Homeland Security Department, which no longer focuses on the prevention of terrorist attacks, the rationale for its establishment, but rather devotes its efforts to the enforcement of immigration policies. Immigration is not a threat to national security; but pandemics, climate change, cyber warfare, and the attacks on truth in general and on science in particular pose a real and present danger.</span></p><p class="MsoNormal" style="font-family: Calibri, sans-serif; line-height: 32px; margin: 0in 0in 0.0001pt;"><span face="Arial, sans-serif" style="color: #222222; font-size: large;"> </span></p><p class="MsoNormal" style="font-family: Calibri, sans-serif; line-height: 32px; margin: 0in 0in 0.0001pt;"><o:p><span style="font-size: large;"> </span></o:p></p><p class="MsoNormal" style="font-family: Calibri, sans-serif; line-height: 32px; margin: 0in 0in 0.0001pt;"><o:p><span style="font-size: large;"> </span></o:p></p>Muriel Gillickhttp://www.blogger.com/profile/13001304171183760292noreply@blogger.com0tag:blogger.com,1999:blog-20352591.post-8475799384048965862020-11-17T13:20:00.004-05:002020-11-19T10:44:43.658-05:00Now Hear This<p><span style="font-family: arial; font-size: large;">On November 9, we learned that the preliminary data from the Pfizer/BioNTech COVID-19 vaccine trial are very promising; exactly one week later, we got similarly good news from the ModernaTX/NIH study. What do the Moderna data show and how do they compare with the Pfizer data?</span></p><p class="MsoNormalCxSpFirst" style="line-height: normal;"><span style="font-family: arial; font-size: large;"><o:p></o:p></span></p><p class="MsoNormalCxSpMiddle" style="line-height: normal;"><span style="font-family: arial; font-size: large;"><a href="www.modernatx.com/sites/default/files/mRNA-1273-P301-Protocol.pdf">Moderna</a> began enrolling patients last summer and has recruited 30,000 volunteers, half of whom received two doses of vaccine and half of whom got placebo, in both cases at 30-day intervals. <o:p></o:p></span></p><p class="MsoNormalCxSpMiddle" style="line-height: normal;"><span style="font-family: arial; font-size: large;">The subjects, adults over the age of 18, were divided into 3 groups: people age 65 or older; people under 65 with known risk factors for coronavirus; and people under age 65 with no known risk factors. The principal outcomes that the researchers are tracking are the ability of the vaccine to safely prevent symptomatic COVID-19 infection and the capacity of the vaccine to stimulate antibody production in recipients. In addition, the researchers are looking at whether the vaccine can prevent severe COVID-19 infections and whether it can prevent asymptomatic infection (as measured by markers for COVID indicating current or previous infection despite the absence of symptoms).<o:p></o:p></span></p><p class="MsoNormalCxSpMiddle" style="line-height: normal;"><span style="font-family: arial; font-size: large;">The newly reported results are based on the 95 enrolled subjects who have thus far been diagnosed with COVID-19. Being diagnosed with COVID-19, according to the definition in the study, means having a positive PCR (polymerase chain reaction) nasal swab after developing symptoms consistent with the disease. What we know is that of these 95 individuals, 5 had received active vaccine and 90 had received placebo. We also know that 20 of the 95 people with the illness were over age 65 and that 11 people developed severe disease, none of whom had been vaccinated. While the specific numbers have not been reported, Moderna has asserted that the efficacy was the same among the different age groups as well as among various ethnic groups (or, more accurately, given the very small numbers of sick people, they were unable to detect any differences).<o:p></o:p></span></p><p class="MsoNormalCxSpMiddle" style="line-height: normal;"><span style="font-family: arial; font-size: large;">What we don’t know is the duration of the protective effect. We don’t yet know whether the vaccine prevented asymptomatic infection, although we should know something about its capacity to do so when the endpoint of the study is reached, namely when 151 enrolled individuals have been diagnosed with symptomatic disease. And we don’t know whether the vaccine is effective in children.</span><span style="font-family: arial; font-size: large;">So, how does the Moderna vaccine compare to the <a href="pfe-pfizercom-d8-prod.s3.amazonaws.com/2020-11/C4591001_Clinical_Protocol_Nov2020.pdf">Pfizer vaccine</a>? <span style="background-color: white; color: #4d5156;"> </span></span></p><p class="MsoNormalCxSpMiddle" style="line-height: normal;"><span style="font-size: large;"><span style="font-family: arial;">They are both mRNA vaccines, a type of vaccine that has never been approved for human use. The efficacy rates reported thus far are extremely similar: from a statistical standpoint, the 95 percent efficacy quoted by Moderna is not any different from the 90 percent efficacy quoted by Pfizer, given the small number of sick patients.</span><span style="font-family: arial;"> </span><span style="font-family: arial;"> </span></span></p><p class="MsoNormalCxSpMiddle" style="line-height: normal;"><span style="font-family: arial; font-size: large;">Both vaccines have to be kept cold to remain viable, but shipment and long-term storage of the Pfizer vaccine has to be at 70 degrees below zero Centigrade while long-term storage of the Moderna vaccine can be at 20 degrees below zero Centigrade; on arrival at your local drug store or physician’s office the Pfizer vaccine can be refrigerated at normal temperatures for up to 5 days while the Moderna vaccine can be refrigerated at normal temperatures for up to 30 days without losing potency. </span></p><p class="MsoNormalCxSpMiddle" style="line-height: normal;"><span style="font-size: large;"><span style="font-family: arial;">The Pfizer vaccine has been tested in children; the Moderna vaccine has not so we just don’t know whether it will work in this age group. Finally, the Pfizer vaccine is to be given as two doses separated by 3 weeks while the Moderna vaccine is given as two doses separated by 4 weeks; efficacy was tested by Pfizer beginning 1 week after the second dose and by Moderna beginning 2 weeks after the second dose. These differences may not reflect actual differences in the two vaccines, simply different protocols instituted for studying them. In sum, it looks as though the two agents are very similar except for differing refrigeration requirements.</span><span style="font-family: arial;"> </span></span></p><p class="MsoNormalCxSpMiddle" style="line-height: normal;"><span style="font-family: arial; font-size: large;">Quite apart from the biochemistry of these vaccine candidates and the data on their efficacy, what do we know about Pfizer and Moderna? </span></p><p class="MsoNormalCxSpMiddle" style="line-height: normal;"><span style="font-family: arial; font-size: large;">Pfizer is the Goliath of pharmaceutical companies. As of March, 2020, it was the largest drug company in the world, as measured by revenue, with annual revenues of $51.75 billion. It has experience in producing vaccines and in recent times was responsible for the development of one of the major pneumonia vaccines. But Pfizer is also a leading offender among the major drug companies in unethical and illegal behavior. In 2009, it achieved notoriety for the largest settlement ever made by a drug company with the Department of Justice: It agreed to pay $2.3 billion for fraud involving the atypical antipsychotic drug Geodon and the painkillers Bextra and Lyrica. It would lose the distinction in 2012, when GlaxoSmithKline settled with the DOJ for $3 billion. </span></p><p class="MsoNormalCxSpMiddle" style="line-height: normal;"><span style="font-family: arial; font-size: large;">Despite signing a “Corporate Integrity Agreement” in 2009, a quick internet search reveals that Pfizer continued to engage in bad behavior: in 2011, it paid $14.5 million for the illegal marketing of Detrol; in 2016, it paid $784.6 million to resolve a lawsuit involving Medicaid fraud; in 2018, Pfizer paid $23.85 million to resolve a suit over Medicare kickbacks. It’s worth noting that most of the big pharmaceutical companies have engaged in fraud, including such names as Johnson & Johnson, Eli Lilly, Abbott, Novartis, and Merck. They seem to regard playing fast and loose with the rules as part of doing business.<o:p></o:p></span></p><p class="MsoNormalCxSpMiddle" style="line-height: normal;"><span style="font-family: arial; font-size: large;">If Pfizer is the Goliath of the industry, <a href="www.biospace.com/article/moderna-therapeutics-biggest-ipo-in-biotech-history/">Moderna</a> is the David of the industry—or was until it went public in 2018, raising $604 million through the sale of its shares and gaining a valuation of $7.5 billion despite never having brought a product to market.<o:p></o:p></span></p><p class="MsoNormalCxSpMiddle" style="line-height: normal;"><span style="font-size: large;"><span style="font-family: arial;">Moderna began as a small biotech startup in 2010 and has focused on mRNA vaccines since its inception. <a href="www.wsj.com/articles/inside-moderna-the-covid-vaccine-front-runner-with-no-track-record-and-an-unsparing-ceo-11593615205">Questions</a> have been raised about the integrity of the company in light of its culture of secrecy and the high-stress environment created by its CEO.</span><span style="font-family: arial;"> </span></span></p><p class="MsoNormalCxSpMiddle" style="line-height: normal;"><span style="font-family: arial; font-size: large;">Some have even <a href="www.thrillist.com/tech/nation/what-does-moderna-therapeutics-do-why-is-it-a-silicon-valley-secret">wondered</a> whether Moderna would be the next Theranos, the unicorn ultimately exposed as a fraud, a story detailed in the chilling account by WSJ investigative journalist John Carreyrou in “<a href="www.amazon.com/dp/B078VW3VM7/ref=dp-kindle-redirect?_encoding=UTF8&btkr=1">Bad Blood: Secrets and Lies in a Silicon Valley Startup.</a>”</span></p><p class="MsoNormalCxSpMiddle" style="line-height: normal;"><span style="font-family: arial; font-size: large;">Moderna has partnered with NIH (specifically the National Institute of Allergy and Infectious Diseases) in its COVID-19 vaccine project. Hopefully, the involvement of a highly reputable, not-for-profit, academically oriented organization has provided a layer of oversight to the drug company.<o:p></o:p></span></p><p class="MsoNormalCxSpMiddle" style="line-height: normal;"><span style="font-family: arial; font-size: large;">So far, the data from both the Moderna/NIH trial and the Pfizer/BioNTech trial look very auspicious (BioNTech, by the way, is a German company devoted to developing immunotherapies, principally as treatment for cancer; it has partnered with Pfizer for years in a thus far unsuccessful effort to produce an mRNA vaccine against influenza). Let’s hope that the record of American Pharma in general, and the questionable past behavior of both principal companies in particular, prove irrelevant to our health.</span><o:p></o:p></p>Muriel Gillickhttp://www.blogger.com/profile/13001304171183760292noreply@blogger.com0tag:blogger.com,1999:blog-20352591.post-40896941090413828252020-11-16T10:19:00.003-05:002020-11-18T10:26:48.420-05:00Vaccine Mania<p class="MsoNormalCxSpFirst"><span style="font-family: arial; font-size: large;">Last Monday, the public woke to the news that the COVID-19 vaccine developed by Pfizer and BioNTech, which has been undergoing testing since the end of July, appears to be working. That is very good news for older people, who have been hardest hit by the coronavirus epidemic, as well as for the younger population, which is bearing the brunt of the current surge in cases. And the news is very timely, as the cumulative number of cases in the U.S. is now over 11 million, with the number of new cases every day higher than ever before. But what, exactly, do we know about how effective this vaccine is likely to be?<o:p></o:p></span></p><p class="MsoNormalCxSpMiddle"><span style="font-family: arial; font-size: large;">The statistic that is cited in the news reports is that to date, the vaccine is 90 percent effective. What that means is that among the 94 people enrolled in the Pfizer/BioNTech study who were diagnosed with symptomatic infection, only 10 percent or about 9 people had received the vaccine; the other 90 percent or about 85 people had been given placebo. This is very encouraging, since the clinical trial enrolled 44,000 volunteers, half of whom received active vaccine and half of whom received placebo: it is very unlikely that such a large differential could have happened by chance. On the other hand, there’s much we don’t know.</span></p><p class="MsoNormalCxSpMiddle"><span style="font-family: arial; font-size: large;">We don’t know, for instance, whether the 90 percent effectiveness rate will hold up in all age groups. The study population does include older individuals—the plan was to try to ensure that 40 percent of those enrolled would be over age 55, though it’s unclear what percent would be in the highest risk group, those in their 80s and older. But we don’t know anything about the age or other risk factors of the 94 people who were diagnosed with coronavirus. Since older people todare being far more risk averse on average than their younger counterparts, it’s possible that none of the 94 people with infection identified so far are older adults.</span></p><p class="MsoNormalCxSpMiddle"><span style="font-family: arial; font-size: large;">We also don’t know whether the vaccine protects people against developing asymptomatic infection. From a clinical perspective, it’s more important to know whether the vaccine prevents people from developing symptoms, but from a public health perspective, we would like to know whether the vaccine keeps the virus at bay just enough so they remain asymptomatic but not enough to prevent them from transmitting the disease to others. Since asymptomatic transmission accounts for many cases today, it would be desirable to know whether the vaccine allows people to become asymptomatic carriers. We are not going to know the answer to that question as the study protocol does not call for enrollees to be tested for COVID-19 unless they develop symptoms.</span></p><p class="MsoNormalCxSpMiddle"><span style="font-size: large;"><span style="font-family: arial;">Finally, we don’t know how long immunity will last, assuming the promising early results are maintained when the study is completed, which will happen once 164 subjects have been diagnosed with COVID-19 (the pre-specified endpoint of the study).</span><span style="font-family: arial;"> </span></span></p><p class="MsoNormalCxSpMiddle"><span style="font-size: large;"><span style="font-family: arial;">What does all this mean for everyone who is eagerly awaiting a vaccine to end this long period of isolation, anxiety, and loss? If the final data, when evaluated by the FDA, possibly by early December, do lead to approval and licensing of the vaccine, older people should be vaccinated as soon as possible—assuming the age-specific effectiveness holds up.</span><span style="font-family: arial;"> </span></span></p><p class="MsoNormalCxSpMiddle"><span style="font-family: arial; font-size: large;"><span>How will life change after you have been vaccinated? First, it should be stressed that “being vaccinated” means receiving 2 injections, 3 weeks apart. The vaccine effectiveness is being measured starting one week after receipt of the second dose, so you cannot expect protection until</span><span> </span><b>one month</b><span> </span><span>after your first shot—and you should be sure to get both shots. Second, while 90 percent effectiveness is pretty good, it’s not perfect. No vaccine is perfect, so don’t wait around for a better one. While you will face a much smaller risk of becoming sick with Covid-19 if you have been vaccinated than if you have not been, how likely you are to encounter the virus will depend on how widespread it is in the surrounding community. If, to take the extreme but unfortunately not entirely improbable case in which the rate of infection in the community goes up ten-fold, then if your risk by virtue of vaccination goes down ten-fold, the net improvement is zero. Of course, if the rate in the community goes up by a factor of ten and you haven’t been vaccinated, your risk also goes up by a factor of ten. In short, you are much better off with the vaccine than without it, but how much better off you will be will be determined by what is going on around you.</span></span></p><p class="MsoNormalCxSpMiddle"><span style="font-family: arial; font-size: large;">So, yes, there is good news about vaccines and yes, you should get the shots as soon as they are available, assuming the early results are confirmed and apply to older people. But don’t throw out your masks and don’t expect to go to movies and concerts or other large indoor gatherings just yet.</span></p><p class="MsoNormalCxSpMiddle"><i><span style="font-family: arial; font-size: large;">As I prepare to publish this blog post, news is breaking about a second vaccine made by the pharmaceutical company Moderna in partnership with NIH. More to come about these results in my next post….</span></i></p>Muriel Gillickhttp://www.blogger.com/profile/13001304171183760292noreply@blogger.com0tag:blogger.com,1999:blog-20352591.post-51355531166036362362020-11-01T18:03:00.002-05:002020-11-01T18:03:58.803-05:00The Corona Century: Looking Backward, Looking Forward<p class="MsoNormalCxSpFirst"><span style="font-family: arial; font-size: large;">For over, 50 years, epidemiologists had been expecting “the big one.” Like earthquakes in California, influenza epidemics have become an inevitable part of the landscape. From year to year, influenza mutates; every so often the strain is particularly virulent and it produces a world-wide pandemic, as happened in 1918 and, on a smaller scale, in 1957, 1968, and 2009. Every year, scientists scrutinize the prevailing type of influenza, anticipating that one day we will see the resurgence of a virus as virulent as the one that killed upwards of 50 million people in 1918-1919. Granted, we have vaccines today that prevent or attenuate many cases of the flu, we have antiviral medications with modest degree of efficacy against influenza, and we have sophisticated supportive respiratory treatments such as ventilators, none of which were available in 1918. As a result, any new influenza pandemic is unlikely to be as devastating as its counterpart 100 years ago—but nonetheless, could wreak havoc in our globalized world. So, it was very surprising when, in March, 2003, scientists in search of the causative agent of the newly described respiratory illness known as SARS (Severe Acute Respiratory Syndrome) peered through their electron microscope and discovered, not influenza, but corona virus.<o:p></o:p></span></p><p class="MsoNormalCxSpMiddle"><span style="font-family: arial; font-size: large;">Coronaviruses had first been identified in the 1960s; they were known to infect cattle, pigs, rodents and chickens; in humans, they were associated with about fifteen percent of colds, but not with any more illnesses. But there it was, with its characteristic crown-like ring of proteins—the agent responsible for the mysterious disease that had killed clusters of health care workers, families, and residents of an apartment complex, principally in China and Hong Kong.<o:p></o:p></span></p><p class="MsoNormalCxSpMiddle"><span style="font-family: arial; font-size: large;">Once the genetic identity of the virus had been established, the race was on to figure out where it came from. It was pretty clear that the virus had jumped species, making SARS a “zoonosis.” What species it came from was never definitively established, though palm civets and raccoon dogs sold in the wild meat markets of Guangdong province, China, to consumers eager for an “exotic” meal are the leading candidates. Growing evidence suggests that the true animal reservoir of the SARS virus (SARS-CoV-1) is the bat, with animals such as civets serving as an intermediary.<o:p></o:p></span></p><p class="MsoNormalCxSpMiddle"><span style="font-family: arial; font-size: large;">Due to good epidemiologic practice, the biology of SARS-CoV-1, and luck, SARS disappeared. The World Health Organization (WHO) announced the containment of the epidemic in early July, 2003, less than four months after it first issued an international alert about the dangers of the disease, and less than a year after it first appeared in China in November, 2002. A total of 8098 people developed the illness, of whom 774 died, or just under 10 percent. All told, the virus appeared in 39 countries. Only China, Hong Kong, Singapore, and Canada had 50 or more cases each. The world breathed a sigh of relief; epidemic prevention programs were developed on paper—and shelved.<o:p></o:p></span></p><p class="MsoNormalCxSpMiddle"><span style="font-family: arial; font-size: large;">And then, in 2012, coronaviruses were back. Or rather, a new coronavirus made its debut: MERS-CoV (for Middle East Respiratory Syndrome). Originally found in Saudi Arabia, it soon travelled to the rest of the Middle East. And stayed there, with the only significant outbreak anywhere else in the world found in Korea in 2015 after the index case had travelled to the Middle East. Unlike SARS, MERS has never disappeared. It remains endemic in the Middle East, where it kills 35 percent of those it infects. Its animal reservoir is probably also a bat, but from bats it infects is camels, and from camels it reaches people. By limiting contact with camels and using case isolation and contact tracing, the total number of confirmed cases in the last eight years is only 2500. More lethal than its SARS-CoV-1 cousin, but less easily transmitted, MERS put coronavirus firmly on the map as a pathogen to be reckoned with, but a relatively minor one, compared to, say, the viruses causing Ebola or AIDS.<o:p></o:p></span></p><p class="MsoNormalCxSpMiddle"><span style="font-family: arial; font-size: large;">Until November, 2019, when yet another atypical pneumonia appeared in China, an illness that would prove to be caused by another coronavirus, this one dubbed SARS-CoV-2. The rest is history, although history that is still unfolding. <a href="https://covid19.who.int">As of October 30</a>, 2020, according to WHO-COVID Dashboard, there have been a total of 44.59 million cases worldwide, with 1.18 million deaths. In the US alone, there have been 8.83 million cases and 227,045 deaths. The pandemic is far from over, with the US reporting 81,599 new cases per day. This latest variant of the coronavirus has proved far more successful than its relatives: it seems to have found the ideal balance of transmissibility and lethality, which has enabled it to achieve far more extensive community spread than any previous coronavirus. COVID-19 (the name given to the disease caused by SARS-CoV-2) kills roughly 2.5 percent of those who are diagnosed with the condition, less than SARS (10 percent) and much less than MERS (35 percent), <b>though in all three cases, the mortality is far higher in individuals over age 65</b>. In addition, it ingeniously developed the ability to spread from asymptomatic hosts, allowing it to escape prompt detection and thus limiting the effectiveness of isolation to contain its spread.<o:p></o:p></span></p><p class="MsoNormalCxSpMiddle"><span style="font-family: arial; font-size: large;">Supported by governments and the WHO, several pharmaceutical companies along with university research labs are scrambling to produce a safe and effective vaccine. But with cases of <a href="https://www.centerforhealthsecurity.org/resources/COVID-19/index.html">COVID-19 continuing to rise</a> in many parts of the world including the US and Europe, the prospects for an end to the pandemic any time soon are not good. Several nations have reintroduced lockdowns: France just announced it would shut down from October 30 until December 1 and Germany declared a partial shutdown for roughly the same period. With the whole world suffering from pandemic fatigue—except, perhaps, Taiwan, which just celebrated its 200<sup>th</sup> day in a row without a single locally transmitted COVID case—it’s hard to even think about life-after-COVID except in terms of “going back to normal.” Odds are that when the disease finally goes into retreat, we will breathe a collective sigh of relief and not want to think about viruses. But that would be a grave mistake.<o:p></o:p></span></p><p class="MsoNormalCxSpMiddle"><span style="font-family: arial; font-size: large;">The current century has already seen three coronavirus epidemics, each with a different variant of this wily microorganism. Most likely, all three normally live in bats and jumped from bats to non-flying mammals and from those mammals to humans. Coronaviruses are RNA viruses, known for their extraordinarily <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6107253/">high mutation rates</a>—as much as a million times higher than human mutation rates, which means they will continue to develop new variants. And these new variants will now and then develop the capacity to infect people, both because humans have encroached on the territory of animals with whom we previously had little contact and because global warming drives animals out of their traditional habitats and into new arenas that are occupied by humans. The really successful ones, like COVID-19, will be transmissible from asymptomatic individuals. They will have the ability to spread to other humans quickly, without or before killing their new human host. And then they will be spread by humans from person to person, from household to household, from country to country, from continent to continent.</span></p><p class="MsoNormalCxSpMiddle"><span style="font-family: arial; font-size: large;">In short, there is no reason to believe that even if we manage to kill or contain SARS-CoV-2, we will have seen the last of the coronaviruses. However appealing it will be to resume normal life, we must not let down our guard. We have to begin <i>now</i> to plan for the next outbreak. We must be sure to learn from our experiences. That means, first and foremost, taking basic preparedness measures such as stocking up on personal protective equipment. It means replenishing the supply of masks and gowns, even if we go for ten years without an epidemic, <i>just in case. </i></span></p><p class="MsoNormalCxSpMiddle"><span style="font-family: arial; font-size: large;"><a href="jamanetwork.com/channels/health-forum/fullarticle/2769600">Planning for the future</a>, as explained by public health lawyer Lawrence Gostin, entails investing in a robust public health system. Such a system must be able to institute traditional measures such as quarantine of those exposed to disease, isolation of cases, social distancing, and mask-wearing. We have to support scientific research so that new pathogens can be identified, tests developed, and treatments tested in a timely fashion. We must restore the FDA and the CDC to their former grandeur, two organizations that, until the current pandemic, were the envy of the world because of their sophistication, wisdom, and integrity. We have to engage in surveillance, constantly monitoring bats and other species for new diseases. <o:p></o:p></span></p><p class="MsoNormalCxSpMiddle"><span style="font-family: arial; font-size: large;">We must recognize that we live in an interconnected world, which means collaborating with other researchers and laboratories across the globe, including those of China and of the World Health Organization. And when a new, disease-causing virus appears, we need to demand transparency from our leaders and our scientists: an informed public, armed with the tools of public health and the fruits of medical science, is crucial to combatting the threats that will inevitably appear. </span><o:p></o:p></p>Muriel Gillickhttp://www.blogger.com/profile/13001304171183760292noreply@blogger.com0tag:blogger.com,1999:blog-20352591.post-17480525874195527692020-10-29T17:11:00.002-04:002020-10-29T17:11:22.412-04:00Vote: Your Health Depends On It<p class="MsoNormalCxSpFirst"><span style="font-size: large;"><span style="background-color: white; background-position: initial initial; background-repeat: initial initial; color: #4d4d4d; font-family: Arial, sans-serif;">Earlier this month, the prestigious <i>New England Journal of Medicine </i>took the unprecedented step of publishing a political position paper in the name of the entire editorial board. Entitled “<a href="www.nejm.org/doi/full/10.1056/NEJMe2029812">Dying in a Leadership Vacuum</a>,” the journal urged Americans to vote out our “current leaders.” They based their argument on the mismanagement of the Covid-19 pandemic by America’s political leaders, naming no names but asserting that “when it comes to the response to the largest public health crisis of our time, our current political leaders have demonstrated that they are dangerously incompetent. We should not abet them and enable the deaths of thousands more Americans by allowing them to keep their jobs.”</span><span style="font-family: Arial, sans-serif;"><o:p></o:p></span></span></p><p class="MsoNormalCxSpMiddle"><span style="font-size: large;"><span style="background-color: white; color: #4d4d4d; font-family: Arial, sans-serif;">While the disastrous handling of the pandemic is the most egregious failing of President Donald Trump, Senate Majority Leader Mitch McConnell, and others who could have made a difference, it is not the only area where our leaders promoted misguided health care policy—with disastrous consequences. I argued in an earlier post that “<a href="www.blogger.com/blog/post/edit/20352591/6758965172738608851">Trump is Bad for Your Health</a>.” </span><span style="background-color: white; color: #4d4d4d; font-family: Arial, sans-serif;">Today, as we approach the end of election season, I am going to spell out why Trump, Pence, their appointees (such as Alex Azar, Secretary of Health and Human Services), their Republican supporters in the House and the Senate, and fellow travelers in state governments (both legislators and governors), will be bad for the health of all Americans, older Americans in particular. <i>It’s not just the pandemic performance </i>that’s the problem: it’s the limitations on access to insurance, the roll-back of regulations that protect the environment, and the attacks on Medicare and Medicaid. </span></span></p><p class="MsoNormalCxSpMiddle"><span style="font-size: large;"><i><span style="background-color: white; background-position: initial initial; background-repeat: initial initial; color: #4d4d4d; font-family: Arial, sans-serif;">Limiting access to health insurance: </span></i><span style="background-color: white; color: #4d4d4d; font-family: Arial, sans-serif;">One of the major “accomplishments” of the Trump administration and endorsed by Republican legislators is its relentless <a href="www.brookings.edu/blog/fixgov/2020/10/09/six-ways-trump-has-sabotaged-the-affordable-care-act/">attacks on the Affordable Care Act</a>. </span><span style="background-color: white; color: #4d4d4d; font-family: Arial, sans-serif;">The administration eliminated the “mandate,” the tax penalty on those who do not purchase health insurance. The mandate is an important part of what allows the ACA to work without driving up the cost of insurance: the fundamental principle of insurance coverage is that it works by distributing the risk over a large population; if people can opt out, only those who are sick will remain insured, raising the cost for everyone. And indeed, with the end to the mandate, health care costs have risen—making this a leading issue for the electorate, young and old.</span><span style="background-color: white; color: #4d4d4d; font-family: Arial, sans-serif;"> </span></span></p><p class="MsoNormalCxSpMiddle"><span style="font-size: large;"><i><span style="background-color: white; background-position: initial initial; background-repeat: initial initial; color: #4d4d4d; font-family: Arial, sans-serif;">Rollbacks of environmental regulations: </span></i><span style="background-color: white; color: #4d4d4d; font-family: Arial, sans-serif;">As of October 15, according to the <i><a href="www.nytimes.com/interactive/2020/climate/trump-environment-rollbacks-list.html">NY Times</a></i>, </span><span style="background-color: white; color: #4d4d4d; font-family: Arial, sans-serif;">the Trump administration has rolled back or is in the process of rolling back almost 100 environmental regulations. Twenty-one involve air pollutants (plus 5 in progress); six involve water pollution (plus 3 in progress); and six involve toxic substances and safety (plus 2 in progress). Estimates are that <u>these changes will result in thousands of extra deaths per year</u>, affecting older people as well as those who love and care for them.</span></span></p><p class="MsoNormalCxSpMiddle"></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhYxOZwoAsybDqVLXEfuO-ElLtNNkQyRh_fgVORUTMGO09q2rsZxI2XYLXy-wUIj898Z_zWZTCNEczmCTREOhTQCGWWvrJKz3bGJB6QHuVoCX39xMOA9KZW3ol31nEUSkDamWN3Rg/s1290/Screen+Shot+2020-10-29+at+1.59.58+PM.png" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><span style="font-size: large;"><img border="0" data-original-height="980" data-original-width="1290" height="304" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhYxOZwoAsybDqVLXEfuO-ElLtNNkQyRh_fgVORUTMGO09q2rsZxI2XYLXy-wUIj898Z_zWZTCNEczmCTREOhTQCGWWvrJKz3bGJB6QHuVoCX39xMOA9KZW3ol31nEUSkDamWN3Rg/w400-h304/Screen+Shot+2020-10-29+at+1.59.58+PM.png" width="400" /></span></a></div><span style="font-size: large;"><br /><span style="background-color: white; color: #4d4d4d; font-family: Arial, sans-serif;"><br /></span></span><p></p><p class="MsoNormalCxSpMiddle"><span style="font-size: large;"><i><span style="background-color: white; background-position: initial initial; background-repeat: initial initial; color: #4d4d4d; font-family: Arial, sans-serif;">Attacks on Medicare: </span></i><span style="background-color: white; color: #4d4d4d; font-family: Arial, sans-serif;">just this month, Trump issued an executive order designed to promote the <a href="/www.americanprogress.org/issues/healthcare/news/2019/10/11/475646/trumps-plan-privatize-medicare/">privatization of Medicare</a>. Ostentatiously and misleadingly titled “Protecting and Improving Medicare for Our Nation’s Seniors,” the order calls for shifting costs to beneficiaries, limiting choice of providers, and moving more and more patients into the private sector by joining Medicare Advantage Plans. </span></span></p><p class="MsoNormalCxSpMiddle"><span style="font-size: large;"><i><span style="background-color: white; background-position: initial initial; background-repeat: initial initial; color: #4d4d4d; font-family: Arial, sans-serif;">Limiting Medicaid: </span></i><span style="background-color: white; color: #4d4d4d; font-family: Arial, sans-serif;">among the many ways in which the Trump administration has undermined the role played by Medicaid in providing health care is a <a href="www.nytimes.com/2020/01/30/health/medicaid-block-grant-trump.html">rule allowing states to cap Medicaid spending</a> for poor adults. Through its endorsement of what are essentially block grants, the federal government is enabling states to reduce health benefits for those who gained coverage to Medicaid thanks to the ACA. </span><span style="background-color: white; color: #4d4d4d; font-family: Arial, sans-serif;">In 2018, 12.2 million people were dually eligible for both Medicare and Medicaid.</span><span style="background-color: white; color: #4d4d4d; font-family: Arial, sans-serif;"> </span><span style="background-color: white; color: #4d4d4d; font-family: Arial, sans-serif;">In addition to opting to cut back benefits under Medicaid, states have the option of refusing to allow Medicaid expansion. This is an approach authorized by the ACA that enables the near-poor to receive health insurance through Medicaid. </span><span class="apple-converted-space"><span style="background-color: white; background-position: initial initial; background-repeat: initial initial; color: #333333; font-family: Arial, sans-serif;">To date, the governors and legislatures of 39 states (and the District of Columbia) have accepted Medicaid expansion; 12 states have not.</span></span></span></p><p class="MsoNormalCxSpMiddle"><span class="apple-converted-space"><span style="font-size: large;"></span></span></p><div class="separator" style="clear: both; text-align: center;"><span style="font-size: large;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg7Z1AA5N_jn63AWU6aTcaLAc4mvl2i05501nucZ3lFwY57LsmIywasyrGinZOWFKhVK0ufHylI179PFqRb5aydTs0GdDiqRifc-N-I1fLbzM34qOhLcKPHL9Uroz1SUompGcvdUg/s1884/Screen+Shot+2020-10-29+at+3.40.05+PM.png" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="1148" data-original-width="1884" height="244" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg7Z1AA5N_jn63AWU6aTcaLAc4mvl2i05501nucZ3lFwY57LsmIywasyrGinZOWFKhVK0ufHylI179PFqRb5aydTs0GdDiqRifc-N-I1fLbzM34qOhLcKPHL9Uroz1SUompGcvdUg/w400-h244/Screen+Shot+2020-10-29+at+3.40.05+PM.png" width="400" /></a></span></div><span style="font-size: large;"><br /><span style="background-color: white; background-position: initial initial; background-repeat: initial initial; color: #333333; font-family: Arial, sans-serif;"><br /></span></span><p></p><p class="MsoNormalCxSpMiddle"><span style="font-size: large;"><span style="background-color: white; color: #333333; font-family: Arial, sans-serif;">Regardless of where you stand on issues such as taxes, immigration, and reproductive rights, whatever your views on foreign policy, your health and that of your children and grandchildren is too important to allow supporters of Trumpian policies to remain in office. Whether they are found in the federal government (as senators, representatives, or in the executive branch) or state government (as legislators or governors), vote them out. Do it now.</span> </span></p>Muriel Gillickhttp://www.blogger.com/profile/13001304171183760292noreply@blogger.com0tag:blogger.com,1999:blog-20352591.post-39989136092807242020-10-16T18:17:00.003-04:002020-10-17T13:43:56.954-04:00Lock 'em up!<p><span face="Calibri, sans-serif"> </span><span style="font-family: arial; font-size: large;"> A provocative, contrarian position paper (somewhat ostentatiously and bizarrely entitled by its authors a “declaration”) is creating a stir by advocating “focused protection” as a means of dealing with the Covid-19 pandemic. The strategy of “focused protection” as defined by the 3 principal architects of the “declaration” recommends 3 different approaches for 3 different segments of the population: for those at highest risk of death from Covid-19, individuals over 85, they recommend a lockdown; for those at moderately elevated risk, including those who are “retired” (aka people over age 65), they advocate a “safer at home” policy—delivery of groceries and other essentials, and staying home except for socially distanced outdoor visits with friends or family; for those under 65, they suggest a resumption of normal activities. This algorithm, they argue, would allow the development of herd immunity in the general population by assuring that roughly 70 percent of them be allowed to contract the virus, leading to the end of the pandemic.</span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in 0in 0.0001pt;"><span style="font-family: arial; font-size: large;"> <a href="www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32153-X/fulltext">Scathing critiques of this proposal</a> are appearing daily. They discuss issues such as the failure to take into account the burdens of Covid-19 short of death (for example, the long-term sequelae that have increasingly been reported) and the ethical and practical problems of effectively locking up all older people who live in congregate housing of any kind, not to mention the ethical and practical problems of vastly restricting the activities of everyone over age 65 who doesn’t live in congregate housing. These are legitimate concerns. I’m going to add to the growing list of critics by focusing on two others: the <i>ageism </i>of the proposal and, what is more surprising, the failure to recognize that a rare event that afflicts a large number of people produces a commensurately large number of casualties.<o:p></o:p></span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in 0in 0.0001pt;"><span style="font-family: arial; font-size: large;"> First, <i>ageism. </i> The authors of the proposal never explicitly acknowledge that the total <a href="/www.statista.com/statistics/241488/population-of-the-us-by-sex-and-age/">population over age 65 </a>in the US is now over 53 million people. This number doesn’t include the millions of people who are in the high-risk category, who would also be locked down, who are under age 65 but have important underlying health conditions. The authors seem to imagine that the most vulnerable individuals, those over age 85, account for most of the excess deaths and that all of them live in nursing homes. In fact, only 4 percent of the elderly population live in nursing homes, or about 1.3 million people. The authors also seem to assume that limiting contact by older individuals with the rest of the world will prevent them from becoming infected; they have apparently forgotten that the effectiveness of sequestration depends on the prevalence of the disease in the surrounding community: if all the nursing assistants and grocery delivery people are allowed to get sick, then their chance of transmitting the virus, even with relatively limited contact, will go up.<o:p></o:p></span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in 0in 0.0001pt;"><span style="font-family: arial; font-size: large;"> Perhaps the lead authors of the paper, all of whom are under age 60, assume that everyone age 65 or older is superannuated. They should be reminded that fully half of the members of the US Senate are over age 65, as of course is the current president and his challenger. Not only do many older people work (16.4 percent, or 8.69 million), but the 65+ set account for a disproportionate share of consumer spending. How will the rest of society be able to “go about their business” without older people to come to their restaurants, stores, and performance venues? And parenthetically, if the 8.69 million people over age 65 who are still working are exhorted to behave just like their younger counterparts, i.e. to “go about their business,” and even assuming that most of these individuals are 65-74 (though this is not strictly true—14 percent of senators, for example, are over age 75), then the projection is that about 152,000 of this group would also die of Covid-19).<o:p></o:p></span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in 0in 0.0001pt;"><span style="font-family: arial; font-size: large;"> Second, a small number multiplied by a very large number can be a large number. Let’s look at the segment of the population among whom the “declaration” suggests the virus should run rampant. Americans aged 55-64, like their younger counterparts, are advised to go about unfettered by regulations. As of 2019, this group included 42.44 million people. If herd immunity is to be achieved, an estimated 70 percent of them would have to contract Covid-19, or 32.68 million people. Now here’s the tricky part. We need to know what fraction of people in a given age group are likely to die from Covid-19. The number that is commonly cited is the case fatality rate, or the fraction of people with documented infections who die. But what we really want to know is the infection fatality rate (IFR), or the fraction of people who have contracted Covid-19, whether they know it or not, whether they are symptomatic or not, who actually die from the disease. Computing that rate depends on accurately determining the prevalence of Covid infection in a particular population and the death rate in that group. T<a href="www.medrxiv.org/content/10.1101/2020.07.23.20160895v6.full.pdf">he best measure I have seen for the IFR</a> for people age 65-74 is 2.5; the IFR for the 75-84-year-old group is 8.5; and the IFR for the 85+-year-olds is 28.3.<o:p></o:p></span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in 0in 0.0001pt;"><span style="font-family: arial; font-size: large;"> But what about those who are 55-64? Their IFR is .75, so the authors of the “declaration” deem them safe. But if 32.68 million people in this age group contract Covid-19, and .75 percent of them die, then that means, by simple multiplication, that there will be 222,810 deaths in this group alone. A small number (.0075) times a large number (32.68 million) is a pretty big number when we’re talking about human lives. <o:p></o:p></span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in 0in 0.0001pt;"><span style="font-family: arial; font-size: large;"> For that matter, why stop with the 55-64-year-olds? Why not consider the 45-54-year-olds? They make up 40.88 million people. If 70 percent contract the virus (after which there should be herd immunity and the virus will vanish), that’s 28.16 million people. The IFR for this group is .068, which translates to 29,708 deaths. Is that acceptable?<o:p></o:p></span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in 0in 0.0001pt;"><span style="font-family: arial; font-size: large;"> To determine what number of deaths is too many, some commentators have compared the numbers to flu deaths; others have <a href="www.ncbi.nlm.nih.gov/pmc/articles/PMC7327471/">compared them to automobile deaths</a>. The fallacy is to assume that either you open society completely (to selected age cohorts) or you have a complete shut-down. That’s no more accurate than assuming that either people are allowed to drive cars and die in automobile accidents or they aren’t allowed to drive and no one dies. The reality for driving is that there are some mitigating steps we can take, such as seatbelt laws and speed limits on roads, which will significantly decrease the risk of death. In the case of Covid-19, mitigation means exactly what the majority of public health experts currently advocate: masks, social distancing, limiting the size of indoor gatherings, and substituting work at home for work in the office whenever possible. <o:p></o:p></span></p><p class="MsoNormal" style="line-height: 32px; margin: 0in 0in 0.0001pt;"><span style="font-family: arial; font-size: large;"> When scientists band together to make an argument that is intended to influence public policy, they write a “position paper” or a “white paper” or an “open letter.” The “Great Barrington Declaration” reveals in its very name that it is something different. It is an ethical perspective masquerading as a technical brief. The authors claim their case for what to do in the setting of the pandemic arises logically from the data. In fact, their strategy, like all strategies for dealing with the outbreak, requires balancing personal freedom and the social good. The “declaration” implicitly assumes that the quality of life of older people is of no consequence and that a society has no special responsibility to its most vulnerable members. It dismisses the anticipated huge amount of death and disability among people under 65 by sleight of hand. Even if this policy could effectively be implemented—if allowing the virus to multiply unchecked would not overwhelm the health care system, causing people suffering from non-Covid conditions to suffer, if older people sheltering in place would remain uncontaminated as the disease becomes rampant in the workers who bring them their food and other services—this is not a policy that most Americans can endorse. The moral fiber of the American people may have been frayed in recent years, but it has not broken entirely.</span><span face="Calibri, sans-serif"><o:p></o:p></span></p>Muriel Gillickhttp://www.blogger.com/profile/13001304171183760292noreply@blogger.com0tag:blogger.com,1999:blog-20352591.post-47096591958137894562020-10-05T12:09:00.009-04:002020-10-05T16:43:45.761-04:00Should Your Doctor Lie to You?<p><br /></p><p class="MsoNormalCxSpFirst" style="line-height: 32px;"><span style="font-family: arial; font-size: large;"><o:p></o:p></span></p><p class="MsoNormalCxSpMiddle" style="line-height: 32px;"><span style="font-family: arial; font-size: large;"> The nation is riveted by President Trump's illness: whether we hate Trump or love him, we want to know how he is faring with Covid-19. We want to understand what this disease looks like in an elderly man with at least one chronic health condition. Unfortunately, what we have been told by the physicians involved in Trump's care has been marred by commissions, distortions, and downright lies.</span></p><p class="MsoNormalCxSpMiddle" style="line-height: 32px;"><span style="font-family: arial; font-size: large;"><span> <span> <span> </span></span></span>There is a long history of presidents wishing to mislead the public about their health and of their physicians colluding in the deception—Woodrow Wilson’s stroke was concealed, Franklin Roosevelt’s high blood pressure and heart problems were downplayed, and John F. Kennedy’s Addison’s disease and chronic back pain were not fully disclosed. But however objectionable we may find this public lack of transparency, President Trump’s personal physician has claimed a different reason for being less than forthcoming. He <a href="//slate.com/news-and-politics/2020/10/trump-doctor-conley-downplayed-dexamethasone-oxygen.html">asserted</a> that he had understated the seriousness of his patient’s condition because he “didn’t want to give any information that might steer the illness in another direction.” That is, Dr. Sean Conley didn’t want <i>his patient</i> to know that his low oxygen levels and high fever were worrisome, so he lied about his condition. Telling the truth, he was asserting, could harm his patient. But is that true?<o:p></o:p></span></p><p class="MsoNormalCxSpMiddle" style="line-height: 32px;"><span style="font-family: arial; font-size: large;"> <a href="www.thepermanentejournal.org/issues/43-the-permanente-journal/original-research-and-contributions/6183-the-truth-about-truth-telling-in-american-medicine-a-brief-history.html">Truth-telling in medicine</a> has been the subject of extensive ethical analysis and of clinical study. The bottom line is that while doctors used to routinely lie to their patients in the belief that they were protecting them, for the last 50 years the standard of care has been to keep patients informed to whatever extent they wish and, based on their accurate understanding of their situation, to engage them in decision-making about treatment.<o:p></o:p></span></p><p class="MsoNormalCxSpMiddle" style="line-height: 32px;"><span style="font-family: arial; font-size: large;"> The <a href="jamanetwork.com/journals/jama/article-abstract/363733">change in practice</a> occurred in the sixties and seventies: in 1961, when a questionnaire was administered to oncologists asking them if they told their patients that they had cancer, fully 90 percent of them said they did not. When the study was repeated in 1979, 97 percent of them said they would tell patients their diagnosis. </span><span style="font-size: large;"><span style="font-family: arial;">The earlier view was based on the paternalistic belief that physicians always knew what was best for their patients and on the conviction that if patients knew they were seriously ill they would become depressed and possibly even suicidal. Between 1961, when the first study was conducted, and 1979, when the second study was carried out, western biomedical ethics came into its own as a field.</span></span></p><p class="MsoNormalCxSpMiddle" style="line-height: 32px;"><span style="font-size: large;"><span style="font-family: arial;"><span> <span> <span> </span></span></span>Physicians and medical ethicists increasingly recognized that there was often no single optimal course of treatment: several different possible approaches might be possible, each with its own likelihood of benefit and each with its own risks; which approach was “right” for a given patient depended on that person’s preferences and values. One person with a particular type of cancer might wish to undergo treatment with chemotherapy that had a high probability of resulting in serious side effects in exchange for a small chance of life-prolongation; another individual with the same disease might opt for a different treatment that was less likely to cause severe side effects but that offered a smaller chance of life-prolongation. Whenever the choice of treatment depended on values as well as technical expertise, the patient had to be included in the decision-making along with the physician. The principle of beneficence, or doing good, and the principle of non-maleficence, or not doing harm, co-existed with the <a href="www.ncbi.nlm.nih.gov/books/NBK543570/pdf/Bookshelf_NBK543570.pdf">principle of autonomy</a>, or the right of patient self-determination.</span><span style="font-family: arial;"> </span></span></p><p class="MsoNormalCxSpMiddle" style="line-height: 32px;"><span style="font-family: arial; font-size: large;"> Choosing the right treatment for a particular patient, in many cases, required that the patient know the truth about his diagnosis. Without knowing the facts, he couldn’t possibly participate in a conversation with his physician about treatment options. Moreover, growing evidence indicated that when <a href="www.ncbi.nlm.nih.gov/pmc/articles/PMC5091929/">patients are engaged</a> in their own health care, they do not become morbidly depressed or overtly suicidal; on the contrary, health outcomes improve. <o:p></o:p></span></p><p class="MsoNormalCxSpMiddle" style="line-height: 32px;"><span style="font-family: arial; font-size: large;"> The regrettable example set by the president’s personal physician notwithstanding, you should expect honesty from your doctor. Yes, you should expect that your doctor will have the communications skills necessary to <a href="www.mdanderson.org/documents/education-training/project-echo/10%2027%2016%20ECHO-PACA%20SPIKES.pdf">impart bad news</a> sensitively. Trust is at the core of the doctor-patient relationship, and trust cannot be built on a lie.</span><o:p></o:p></p>Muriel Gillickhttp://www.blogger.com/profile/13001304171183760292noreply@blogger.com0tag:blogger.com,1999:blog-20352591.post-67589651727386088512020-10-04T10:55:00.001-04:002020-10-04T10:55:30.095-04:00Why Trump is Bad for Your Health<p><br /></p><p class="MsoNormalCxSpMiddle" style="line-height: 32px;"><span style="font-family: Arial, sans-serif;"> <span style="font-size: large;"> For years, older people have been more likely to vote than have their younger counterparts:<a href="www.aarp.org/politics-society/government-elections/info-2018/power-role-older-voters.html "> in the 2016 election</a>, 71 percent of Americans age 65 and older voted, compared to only 46 percent of those ages 18-29. They are likely to exert a major effect on the election again in 2020, especially in those <a href="www.prb.org/which-us-states-are-the-oldest/">swing states with large older populations</a> such as Florida, Pennsylvania, Michigan, and Wisconsin. </span></span></p><p class="MsoNormalCxSpMiddle" style="line-height: 32px;"><span style="font-size: large;"><span style="font-family: Arial, sans-serif;"><span> <span> <span> </span></span></span>Four years ago, 53 percent of <a href="www.pewresearch.org/politics/2018/08/09/an-examination-of-the-2016-electorate-based-on-validated-voters/">voters over age 65 </a>voted for Donald Trump, compared to 44 percent for Hilary Clinton. </span><span style="font-family: Arial, sans-serif;">Whatever these voters thought in 2016, older individuals today should know that Trump is bad for the elderly. He's especially bad for their health.<o:p></o:p></span></span></p><p class="MsoNormalCxSpMiddle" style="line-height: 32px;"><span style="font-family: Arial, sans-serif;"><span style="font-size: large;"> Among the most explicit and egregious ways that Trump has adversely affected the health and health care of older Americans is his failure to lead the country effectively in the coronavirus era. His unwillingness to develop and implement a coherent national strategy and his refusal to accept the science underlying public health recommendations have contributed to the high incidence of COVID-19 and the correspondingly high death rate from the disease—and <b><a href="https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html">people over the age of 65 account for 80 percent of all COVID-19 deaths</a></b> in the U.S. </span></span></p><p class="MsoNormalCxSpMiddle" style="line-height: 32px;"><span style="font-family: Arial, sans-serif;"><span style="font-size: large;"><span> <span> <span> </span></span></span>In addition, the Trump administration has pursued a vigorous policy of seeking to privatize Medicare, the popular and successful source of health care insurance for the vast majority of older people. For example, Trump issued an <a href="https://www.americanprogress.org/issues/healthcare/news/2019/10/11/475646/trumps-plan-privatize-medicare/">executive order</a> in October, 2019 entitled “Protecting and Improving Medicare for Our Nation’s Seniors” <span style="color: #333333;">which, far from either protecting or improving Medicare, aims to bolster private Medicare Advantage plans (a popular choice for some well elderly) to the detriment of fee-for-service Medicare (the long-preferred option for frail older people) while dismantling safeguards on access and shifting costs to beneficiaries. </span></span></span></p><p class="MsoNormalCxSpMiddle" style="line-height: 32px;"><span style="font-family: Arial, sans-serif;"><span style="font-size: large;"> Then there are the more indirect effects of Trump’s policies on the health of our oldest citizens: dramatically curtailing immigration means cutting off the major source of personal care attendants and nursing aides. These are the people who take care of older individuals who need help bathing, dressing, feeding themselves, walking, and going to the bathroom—both in nursing homes and in their own homes. Deregulation is translating into more polluted air and water, worsening existing conditions such as emphysema and asthma. Rolling back steps to control climate change is contributing to relentless global warming, which is not some abstract future problem but a reality today—and it is frail older people who have suffered disproportionately from hyperthermia and death during the recent heat waves and from the fires that have been ravaging the western US.<o:p></o:p></span></span></p><p class="MsoNormalCxSpMiddle" style="line-height: 32px;"><span style="font-family: Arial, sans-serif;"><span style="font-size: large;"> The future under Trump would bring new threats to the health of older Americans. The budget that Trump has proposed for 2021 would significantly cut Medicaid, the federal/state program that is the main funder of nursing homes, where 1.4 million dependent older people live. The budget would also cut SNAP (Supplemental Nutritional Assistance Program) benefits—the food stamps nd other nutritional support for millions of older adults. <o:p></o:p></span></span></p><p class="MsoNormalCxSpMiddle" style="line-height: 32px;"><span style="font-family: Arial, sans-serif;"><span style="font-size: large;"> Purely in terms of self-interest, older Americans should be terrified of four more years of Trump. And, as the<i><a href="www.nytimes.com/2018/12/12/opinion/democrats-republicans-senior-voters-aarp-.html"> NY Times</a></i> argued two years ago, “senior power is the sleeping giant of American politics.” With the latest estimates from the US Department of the Census indicating that the 52 million Americans over age 65 comprise 16.5 percent of the population, gray power is here; it’s time to exercise it.</span><o:p></o:p></span></p>Muriel Gillickhttp://www.blogger.com/profile/13001304171183760292noreply@blogger.com0tag:blogger.com,1999:blog-20352591.post-91075696280461878192020-09-23T11:22:00.001-04:002020-09-24T17:36:13.142-04:00What We Got Wrong<p><br /></p><p class="MsoNormalCxSpMiddle" style="line-height: 32px;"> <span style="font-family: arial;"> To date, 68,000 residents and staff of nursing homes and other long-term care facilities have died from COVID-19, accounting for a significant proportion of U.S. pandemic deaths. According to the editorial board of the<a href="www.nytimes.com/2020/09/05/opinion/sunday/coronavirus-nursing-homes-deaths.html?smid=em-share"> <i>NY Times</i></a>, “…many, if not most of those 68,000 lives could have been spared with careful planning and effective leadership.” There is little doubt that poor management and unwise decision-making, sometimes driven by cost considerations, exacerbated what was already a highly flammable situation. Putting a large number of very old people with multiple underlying health conditions together and then sending in caregivers who live in communities with high rates of coronavirus is asking for trouble. But to blame for-profit chains for the devastation wrought by COVID-19 in nursing homes, as the <i>NY Times</i> does, is missing the forest for the trees. It is like blaming the forest fires raging throughout the western U.S. on gas companies that had not cleaned up the dry brush near their power lines while ignoring the role of climate change and of urbanization that have brought hotter, dryer conditions and dense human habitation in close proximity to forested areas, respectively. A recent article in the <i><a href="/www-nejm-org.ezp-prod1.hul.harvard.edu/doi/full/10.1056/NEJMp2014811">New England Journal of Medicine</a></i> gets it right, suggesting that “the coronavirus has exposed and amplified a longstanding and larger problem: our failure to value and invest in a safe and effective long-term care system.” <o:p></o:p></span></p><p class="MsoNormalCxSpMiddle" style="line-height: 32px;"><span style="font-family: arial;"> The problem began, as Rachel Werner and colleagues from the University of Pennsylvania argue, with the Medicare and Medicaid legislation of 1965, which effectively medicalized long-term care. Long-term care refers to services that help people get by when they cannot perform everyday activities independently; it encompasses housing, personal care, and medical care. By placing almost all government support for the social and daily care needs of frail older individuals under a medical umbrella, the non-medical needs were given short shrift and the medical needs were under-funded. <o:p></o:p></span></p><p class="MsoNormalCxSpMiddle" style="line-height: 32px;"><span style="font-family: arial;"> I’m talking about frailty because it’s frail older people who are the main users of long-term care. Frailty refers to a syndrome of age-associated loss of independent functioning that puts people at risk of illness, decline, and death. Frail people constitute about 15 percent of the elderly population or 8 million people. Most frail elders continue to live in their own homes and get help from caregivers; about one million live in an assisted living facility, where they have their own apartment but eat meals communally, receive a small amount of personal care each day, and can participate in on-site social activities; another 1.3 million live long-term in a nursing home. How does the prevailing long-term care system in the U.S. operate and how do Medicare and Medicaid determine its contours?<o:p></o:p></span></p><p class="MsoNormalCxSpMiddle" style="line-height: 32px;"><span style="font-family: arial;"> In terms of <i>housing, </i>because Medicare and Medicaid are medical programs, they were not designed to cover housing. Medicare does not pay for housing at all: it will pay for short-term “post-acute care” after a hospitalization, either in a rehabilitation facility or a skilled nursing facility because that is viewed as hospital care. Medicare does not pay for long-term residential nursing home care or residential hospice care—it will cover medical care received by an individual who lives in a nursing home or a hospice, just as it covers doctor’s visits and laboratory tests for a person who lives independently in his own home. Medicaid pays for nursing home care for individuals who have “spent down” all their assets and are sufficiently physically impaired to require nursing home in a rare acknowledgement that the line between housing, personal care, and medical care is blurred for frail older individuals.<o:p></o:p></span></p><p class="MsoNormalCxSpMiddle" style="line-height: 32px;"><span style="font-family: arial;"> With respect to <i>personal care, </i>Medicare provides only those home care services that are deemed necessary because of an acute illness. Patients who are hospitalized for pneumonia or a stroke or a heart attack can have personal care services at home (a homemaker or health aide) while recovering from their acute medical problem as long as they are also receiving some type of skilled care at home such as a visiting nurse or a physical therapist. Medicaid is more generous in its coverage of home-based personal care services by not tying them exclusively to a single episode of illness, perhaps recognizing that it is cheaper to pay for a personal care attendant at home on a long-term basis than to pay for the alternative, which is residential nursing home care. Nonetheless, the number of hours of personal care available per person per week is very limited: two hours a day, several times per week, is a typical benefit; four hours a day, seven days a week is a rare extensive benefit. <o:p></o:p></span></p><p class="MsoNormalCxSpMiddle" style="line-height: 32px;"><span style="font-family: arial;"> Lastly is <i>medical care</i>. Because Medicare was initially crafted as an <i>acute </i>medical benefit, intended to address short-term medical care, it provides good coverage for hospitalization and brief post-hospital care in a skilled nursing facility or similar site. It also has comprehensive out-patient coverage, but it was never intended to promote medical care at home—even when “home” is a nursing home. Long-term care, by definition, is chronic. Only recently has Medicare added a chronic disease management benefit in recognition of the reality that fully 68 percent of <a href="www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Chronic-Conditions/Downloads/2012Chartbook.pdf">Medicare beneficiaries have at least two chronic conditions</a>—and another 37 percent have four or more chronic conditions. More recently still, the CMS Innovation Center (authorized by the Affordable Care Act) launched the “Independence at Home” demonstration project, which provides for home-based primary care, but this initiative is capped at 10,000 enrollees. <o:p></o:p></span></p><p class="MsoNormalCxSpMiddle" style="line-height: 32px;"><span style="font-family: arial;"> What are the consequences of a system that sees itself as providing a medical rather than a long-term care benefit? Because coverage of supportive services is modest—whether for home health aides or homemakers or transportation—the system tends to favor institutional care over home care. Services that might enable frail older people to continue to live at home are insufficient, driving them into nursing homes; services that would facilitate treatment of acute medical problems at home are lacking, promoting the use of hospitals. For nursing homes, there are additional consequences. Nursing home regulations, promulgated by CMS but monitored by local health departments, focus on safety and adherence to selected public health measures, such as annual flu shots, rather than on quality of life. Paradoxically, physicians are paid separately by Medicare and are not included in per capita Medicaid payments, a system that promotes highly individualized medical care rather than a focus on the community.<o:p></o:p></span></p><p class="MsoNormalCxSpMiddle" style="line-height: 32px;"><span style="font-family: arial;"> The failure to recognize the importance of long-term is unique to the United States in the developed world.<a href="/www.oecd.org/els/health-systems/47884942.pdf"> European countries provide</a> a comprehensive long-term care benefit for older and disabled individuals. The structure of the benefit and the mix of private and public services available using the benefit are highly variable from country to country. <o:p></o:p></span></p><p class="MsoNormalCxSpMiddle" style="line-height: 32px;"><span style="font-family: arial;"> Most European countries offer universal coverage, with nursing and personal care available to all eligible individuals (based on an assessment of their level of dependency in basic daily activities). Co-payments and deductibles are common, typically subject to income thresholds. In a number of countries, frail older people can choose whether to receive that personal care in their own home, in the home of a family member, or in an institutional environment. In some models, they can opt to receive a cash benefit rather than an in-kind benefit, and can use the cash to maintain their independence, whether by remodeling their home to make it more accessible or to pay for private aides.<o:p></o:p></span></p><p class="MsoNormalCxSpMiddle" style="line-height: 32px;"><span style="font-family: arial;"> In <a href="/www.ancien-longtermcare.eu/sites/default/files/ENEPRI%20_ANCIEN_%20RRNo.73DenmarkREV2.pdf">Denmark</a>, for example, priority is given to community over residential care. A frail older person living in his own home or in a special dwelling for the elderly is entitled to home health services (generally nursing and rehabilitative care) and practical help (assistance with shopping, cleaning, meal preparation and personal care). Both health care and long-term care are public responsibilities. LTC financing and provision are the responsibilities of the local municipality and health services are planned and operated on a regional level. A case management system serves to coordinate the health and long-term care components of care. The system is financed through both local and national taxation.</span></p><p class="MsoNormalCxSpMiddle" style="line-height: 32px;"><span style="font-family: arial;"> The existence of a long-term care benefit would not, by itself, have prevented COVID-19 from sweeping through American nursing homes. But it would likely have decreased the number of frail older people who live in nursing homes and assisted living facilities in the first place. For those individuals who nonetheless required an institutional environment, a long-term care orientation would have meant attention to quality of life, which would have resulted in private rooms and single bathrooms. This sort of living arrangement is far more conducive to limiting the spread of an infection than are the old-fashioned double or even four-bed rooms. <o:p></o:p></span></p><p class="MsoNormalCxSpMiddle" style="line-height: 32px;"><span style="font-family: arial;"> Once we reconceptualize nursing homes as primarily places where people live and only secondarily as sites for the delivery of health care services, we can move on to our next challenge: designing a branch of medicine that addresses both the individual geriatric needs of residents (advance care planning, incontinence treatment, fall prevention, avoidance of polypharmacy, etc.) and community health needs (flu shots, sanitation, good nutrition, etc). If we minimize the number of frail elders requiring institutional care by supplying community services, and we then modify the nature of the medical care provided within those institutions, we can anticipate a lesser toll from the next epidemic—and an improved quality of life for society’s frailest and oldest members.</span><o:p></o:p></p>Muriel Gillickhttp://www.blogger.com/profile/13001304171183760292noreply@blogger.com0tag:blogger.com,1999:blog-20352591.post-15686146955655633782020-08-28T13:04:00.001-04:002020-08-28T13:04:58.687-04:00After the Deluge<span style="font-size: large;"><span style="font-family: arial;">Nursing
homes are at a crossroads. Unpopular before the pandemic, Covid-19 has brought them
to a new low. There was the epidemic itself, which swept through nursing homes
and assisted living facilities, causing an estimated </span><a href="www.nytimes.com/2020/08/18/health/Covid-nursing-homes.html https://data.cms.gov/stories/s/COVID-19-Nursing-Home-Data/bkwz-xpvg/" style="font-family: arial;">40 percent of all thevirus-related deaths in the U.S.</a><span style="font-family: arial;"> Then there was the response to the epidemic: the draconian measures taken to control the outbreak caused social isolation, depression, and sometimes confusion in residents. Next were the institutional consequences: the deaths that inevitably result when vulnerable people became ill (with a mean age of about 85 and multiple
underlying health conditions, nursing home residents are at the highest risk of
contracting and then dying from Covid-19) led to empty beds but the quarantine made it difficult to fill them. Empty
beds meant less revenue, this at a time when costs were rising due to the need
for frequent deep cleaning, personal protective equipment, and supplementary
staff. </span><br /></span><div><div><span style="font-family: arial; font-size: large;"><br /></span></div><div><span style="font-family: arial; font-size: large;">The future looks grim as nursing homes face a loss of confidence in their
ability to provide good care and as state budgets, which determine the level of
nursing home reimbursement through Medicaid (the homes' major source of revenue), are
strained by the recession. What, then, will become of nursing homes after the
deluge? </span></div><div><span style="font-family: arial; font-size: large;"><br /></span></div><div><span style="font-family: arial; font-size: large;">In a <a href="https://www.nextavenue.org/defund-nursing-homes/">provocative essay</a>, Charles Sabatino of the American Bar Association
argues that “it’s time to defund nursing homes.” Institutional care as defined
by the average American nursing home, he suggests, is simply not what old people
or their families want. It’s demeaning, disrespectful, and disgraceful.
Moreover, to those who claim the institutional environment is necessary to keep
the oldest, frailest members of society safe, the monumental failure of nursing
homes to prevent sickness and death during the COVID-19 pandemic provides ample
evidence that even in this arena, the nursing home is a failure. Medicare and
Medicaid, which together fund a large proportion of skilled nursing home care
(Medicare pays for short term rehabilitative care while Medicaid pays for
long-term residential care) hold the key. They should pay for care only,
Sabatino says, if the nursing homes are small and homey, provide all their
residents with private rooms and bathrooms, and embody a culture focused on the
goals, interests, and preferences of their residents—not the nurses, nursing
assistants, administrators, and others who run the institution. </span></div><div><span style="font-family: arial; font-size: large;"><br /></span></div><div><span style="font-family: arial; font-size: large;">Geriatrician,
palliative care specialist, and health care policy expert <a href="//medicaring.org/2020/07/13/should-anyone-live-in-a-nursing-home/ ">Joanne Lynn distinguishes</a> among the various populations found in nursing homes and suggests
different strategies for each group. People recently discharged from a hospital
who need short-term rehabilitation or further medical care that they cannot
receive at home—the “post-acute” patients who stay in skilled nursing facilities
for a few days or at most a few weeks and whose care is paid for by Medicare—can
continue to receive this type of treatment in a hospital-lite environment.
People with severe brain damage, whether from dementia, stroke, or prolonged
lack of oxygen, and who are unaware of their surroundings and do not recognize
their family members can likewise remain in a hospital-style institution. People
who are dying and who need more assistance than can be provided through
home-hospice should not have to go to a skilled nursing facility under the guise
that they need rehabilitation in order to have 24-hour, residential care.
Instead, they should be eligible for inpatient hospice. That leaves the large
fraction of the current nursing home population who are dependent on others for
many of their basic daily needs—bathing, dressing, walking—due to multiple
physical problems and/or moderate dementia. For those individuals, Lynn argues,
the best environment is a model very much like what Sabatino advocates. This
type of facility already exists: it is called the Green House Project. What is
the Green House Project and how did homes built along this model fare during the
pandemic? </span></div><div><span style="font-family: arial; font-size: large;"><br /></span></div><div><span style="font-family: arial; font-size: large;">Green Houses are the brain child of Bill Thomas, a pioneering
geriatrician who has been designing progressively better nursing homes since he
introduced the Eden Alternative—bringing pets and plants into nursing homes—in
the early 1990s. He then went on to mastermind what would become the culture
change movement, or bringing resident-centered care to nursing homes. The model
was fleshed out by the consortium of nursing homes that banded together to form
the Pioneer Network, which advocated breaking large, hospital-style nursing
homes into multiple discrete households, eliminating the centrally-located
nurses’ station to promote integrating nursing care into daily life, and
decreasing the differentiation of labor which compartmentalized care. But while
many facilities endorse culture change, few have implemented its principles on a
wide scale. Enter the Green House. Green Houses are built along the lines
envisaged by the culture change movement—they make use of “universal workers”
rather than siloing staff members into discrete categories and they are built
around honoring the preferences of residents. But the critical difference is
that they are small. Instead of breaking a large institution into multiple
households, the Green House is a single, freestanding household with 10-12
residents. Its guiding principle is that to be homey, it needs to be built like
a home and function like a home. </span></div><div><span style="font-family: arial;"><span style="font-size: large;">The first such home was built in Tupelo,
Mississippi in 2003. </span></span></div><div><span style="font-family: arial;"><span style="font-size: large;"><br /></span></span></div><div><span style="font-family: arial;"><span style="font-size: large;">Today, there are 300 Green House sites across the country.
The big question is whether these facilities in fact improved the quality of
life for their residents. Have they been able to meet the health and safety
requirements imposed upon conventional nursing homes? Have their costs been
higher than those of standard nursing homes? And how did they fare during the
Covid-19 pandemic? The most <a href="www.ncbi.nlm.nih.gov/pmc/articles/PMC5338207/">comprehensive attempt</a> to answer the questions about
quality of life and health and safety requirements is from the THRIVE Research
Collaborative (The Research Initiative Valuing Eldercare), published in 2016.
While the model was seldom fully implemented, the version that was utilized did
not lead to a decline in the “quality indicators” established by the Centers for
Medicare and Medicaid to evaluate nursing home care; it did lead to lower rates
of hospitalization and greater use of hospice care than conventional facilities.
Staff turnover, normally alarmingly high, was lower in Green House facilities. </span></span></div><div><span style="font-family: arial;"><span style="font-size: large;"><br /></span></span></div><div><span style="font-family: arial;"><span style="font-size: large;">Measures of resident and family satisfaction have been harder to come by as
studies tend to be very small and qualitative in nature, but <a href="nymag.com/intelligencer/2020/06/the-american-nursing-home-is-a-design-failure.html">enthusiastic articles</a> have appeared in the popular press—and I cannot remember encountering
any similar level of excitement, however anecdotal, about standard nursing
homes. Based on the limited data available, I have been guardedly optimistic.
But the Covid-19 experience has tipped the scale for me: with 95 percent of
nursing homes and 92 percent of assisted living facilities reporting no cases,
the Green Houses have been remarkably successful. </span></span></div><div><span style="font-family: arial;"><span style="font-size: large;"><br /></span></span></div><div><span style="font-family: arial;"><span style="font-size: large;">Here is what we know—256 out
of the existing 298 facilities supplied data for the period March-May, 2020. In
the 229 nursing homes, which served 2384 elders, there were 32 positive cases
among residents and only one death. In the 24 assisted living facilities serving
224 elders, there were 15 positive cases and 3 deaths. Compare this to all
nursing homes in the US, as reported by CMS: as of mid-August, there have been
just under 50,000 deaths in 1.5 million residents, with slightly below 200,000
confirmed cases and another 120,000 suspected cases. I</span></span></div><div><span style="font-family: arial;"><span style="font-size: large;"><br /></span></span></div><div><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEicd8_XxKhppczu1QeU7iWLPI4F79YtX4KQMegXlSNwfbkC2EIKzn5WlxQhOuWRqSAOL3g4KJ3ZXtztZUXbCBZbrDNKTyWUngBeIjPXujoPcBuxRGbJ3GWk23HKLqZQdNPnj1Nrzg/s1670/Screen+Shot+2020-08-27+at+4.54.18+PM.png" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><span style="font-size: large;"><img border="0" data-original-height="840" data-original-width="1670" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEicd8_XxKhppczu1QeU7iWLPI4F79YtX4KQMegXlSNwfbkC2EIKzn5WlxQhOuWRqSAOL3g4KJ3ZXtztZUXbCBZbrDNKTyWUngBeIjPXujoPcBuxRGbJ3GWk23HKLqZQdNPnj1Nrzg/s640/Screen+Shot+2020-08-27+at+4.54.18+PM.png" width="640" /></span></a></div><span style="font-size: large;"><br /><span style="font-family: arial;"><br /></span></span></div><div><span style="font-family: arial;"><span style="font-size: large;">In summary, Green House
nursing home residents were far less likely than their conventional nursing home
counterparts to contract Covid-19, and if they did get sick, they were far less
likely to die. Small really is better. </span></span></div><div><span style="font-family: arial;"><span style="font-size: large;"><br /></span></span></div><div><span style="font-family: arial;"><span style="font-size: large;">My suspicion is that after the deluge,
when the pandemic finally fizzles, legislators and healthy policy mavens will
look to new regulations to try to prevent or at least diminish the ferocity of
future outbreaks. Requiring nursing homes to have infectious disease
consultants—a rule that was instituted by the Obama administration and undone by
Trump—makes sense. Demanding regular testing for nursing assistants if there is
another viral epidemic with similar characteristics makes sense—as was recently
mandated by CMS for nursing homes during Covid-19. Systematically engaging
residents and families in discussions of their preferences regarding end of life
care before they are faced with a crisis is good generally a good policy,
because nursing home residents are always at high risk of death, not just during
a pandemic. </span></span></div><div><span style="font-family: arial;"><span style="font-size: large;"><br /></span></span></div><div><span style="font-family: arial;"><span style="font-size: large;">But more effective change will not come from regulations. It will
require a wholesale rethinking of institutional long-term care. The Green House
project is a good place to start.</span></span></div></div>Muriel Gillickhttp://www.blogger.com/profile/13001304171183760292noreply@blogger.com0tag:blogger.com,1999:blog-20352591.post-65462181355115300922020-07-30T14:09:00.000-04:002020-07-30T14:09:12.604-04:00Have We Been Barking Up the Wrong Tree?<div class="MsoNormal" style="line-height: normal; margin: 0in 0in 0.0001pt;">
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<span style="font-family: Arial, Helvetica, sans-serif; font-size: large;">More of my blog posts deal with dementia than with any other subject and the news about Alzheimer’s disease over the years has been largely dispiriting, so who would have thought that I would leap at the opportunity to write about a </span><span style="font-family: Arial, Helvetica, sans-serif; font-size: large;">new diagnostic test</span><span style="font-family: Arial, Helvetica, sans-serif; font-size: large;">. But with so much of the medical literature relentlessly focused on COVID-19, it’s reassuring to realize that research on other subjects is continuing. The new study does not report a treatment, let alone a cure for Alzheimer’s disease. Furthermore, the prospect of screening healthy individuals to determine their future risk of developing progressive cognitive impairment is ethically fraught. Nonetheless, in the current climate, this report is good news.</span></div>
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<span style="font-family: Arial, Helvetica, sans-serif; font-size: large;">It’s good news, and not just because it indicates that not all medical scientists have retooled as corona virus researchers, though it does that. It’s good news, and not just because it means it will be possible to target intervention studies to high risk individuals will permit studies to be carried out on smaller numbers of people and over a shorter period of time, though it means that. It’s good news because it shines a bright light on a long-neglected character in the Alzheimer’s story, the tau protein. <o:p></o:p></span></div>
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<span style="font-family: Arial, Helvetica, sans-serif; font-size: large;">Back in 1906, when Alois Alzheimer peered into his microscope at tissue from the brain of a patient who had died of the disorder of cognition that would one day bear his name, he identified two unusual substances that he described as plaques and tangles. The plaques, which were located between neurons, would ultimately be found to be composed of a protein known as amyloid. The neurofibrillary tangles, which were located inside the nerve cell bodies, would eventually be identified as a protein called tau. These two substances have been recognized as the hallmarks of Alzheimer’s disease for over a century.<o:p></o:p></span></div>
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<span style="font-family: Arial, Helvetica, sans-serif; font-size: large;">For years, the roles of amyloid and tau were hotly debated. Some researchers felt that amyloid was the result of Alzheimer’s; others were confident it was the cause. Some scientists were more interested in studying amyloid; others directed their efforts towards tau. But over the course of the last 25 years, amyloid has gained the upper hand. Study after study has sought to improve cognition in Alzheimer’s disease by ridding the brain of amyloid-laden plaques—and each time, the approach failed. </span></div>
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<span style="font-family: Arial, Helvetica, sans-serif; font-size: large;">A great deal of excitement was engendered by immunotherapy back in 2001: the idea was to stimulate the body to create antibodies against amyloid with what was essentially a vaccine—but the study had to be stopped because a subset of patients developed meningitis. Then there was enthusiasm about the use of monoclonal antibodies. Several such antibodies have made it to phase 3 trials in which their efficacy was compared to placebo. In 2014, <a href="http://www.nejm.org/doi/full/10.1056/nejmoa1304839">two studies of Bapineuzumab </a>showed no benefit. In 2018, <a href="http://www.nejm.org/doi/full/10.1056/NEJMoa1705971">Solznezumab was tried</a> for individuals with mild Alzheimer’s and it was unsuccessful. In the same year, additional negative results were reported for <a href="http://www.nejm.org/doi/full/10.1056/NEJMoa1706441">Verubecestat</a> in people with mild to moderate Alzheimer’s. <o:p></o:p></span></div>
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<span style="font-family: Arial, Helvetica, sans-serif; font-size: large;">All these negative studies don’t exonerate amyloid. Maybe the trials are initiated too late in the course of these disease’s development. Maybe the dose is too low. But with anti-amyloid strategies repeatedly striking out, I can’t help but wonder, as have <a href="http://www.nature.com/articles/d41586-018-05719-4">others who know much more</a> about the science than I do, that we’re looking at the wrong target.<o:p></o:p></span></div>
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<span style="font-family: Arial, Helvetica, sans-serif; font-size: large;">Which is why the new study that focuses on tau is exciting. The authors found that their tau antibody test was able to diagnose Alzheimer’s disease as well as or better than more invasive existing tests—when they used the test in patients all of whom had some kind of neurodegenerative disease. That is, the test did well in answering the question: is this person being tested more likely to have Alzheimer’s or, say, Parkinson’s? That’s a very different question from: is this person normal or does he have Alzheimer’s? Not only was the population in which the test was studied composed exclusively of patients with some neurologic condition, not only did the population include a much larger proportion of people with Alzheimer’s than would be found in the general population, but the subjects were far from ethnically or racially diverse. So, it’s a long way from the article in <i>JAMA</i> to a widely useful diagnostic test.<o:p></o:p></span></div>
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<span style="font-family: Arial, Helvetica, sans-serif; font-size: large;">Despite the test’s preliminary nature, it is a compelling piece of evidence that tau should get more attention. Two weeks before the on-line publication of the <i>JAMA</i> study, a small Swiss pharmaceutical company, <a href="http://www.investors.com/news/technology/alzheimers-treatment-study-prods-biotech-company-ac-immune/">AC Immune, announced </a>that together with Johnson & Johnson, it was launching a trial of a vaccine designed to stimulate the body to produce antibodies against tau—leading its stock price to soar by 18.9 percent. Just a few weeks earlier, the giant Swiss pharmaceutical company,<a href="http://www.fiercebiotech.com/biotech/roche-bets-120m-ucb-s-anti-tau-alzheimer-s-antibody"> Roche, announced</a> it, too, was investing in the development of an anti-tau vaccine. <o:p></o:p></span></div>
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<span style="font-family: Arial, Helvetica, sans-serif; font-size: large;">It’s too early to say whether the attack on tau will fizzle, much like the previous attacks on amyloid. But maybe, just maybe, it will be a rousing success.</span><span style="font-family: Times New Roman, serif;"><o:p></o:p></span></div>
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Muriel Gillickhttp://www.blogger.com/profile/13001304171183760292noreply@blogger.com0tag:blogger.com,1999:blog-20352591.post-8856978997461387702020-07-17T10:03:00.001-04:002020-07-17T10:03:48.630-04:00What's the Risk?<div class="MsoNormal" style="line-height: 32px; margin: 0in 0in 0.0001pt;">
<span style="font-family: "arial" , "helvetica" , sans-serif; font-size: large;">Nearly six months into the pandemic, we ought to know the important risk factors for serious illness or death from Covid-19. Whether because of poor record-keeping, lack of international cooperation, or sloppy statistical analysis, the information until now has been limited. </span></div>
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<span style="font-family: "arial" , "helvetica" , sans-serif; font-size: large;">Not just limited; the claims about risk factors to date have been quite misleading. I complained in my </span><span style="font-family: "arial" , "helvetica" , sans-serif; font-size: large;"><a href="http://blog.drmurielgillick.com/2020/05/whats-risk.html">blog post</a> in early May that the rates of certain conditions i</span><span style="font-family: "arial" , "helvetica" , sans-serif; font-size: large;">n patients dying of Covid-19 were actually no different from the rates of those same conditions in older people in general. For example, I noted that one study reported that the rate of high blood pressure in patients with severe cases of Covid-19 was 56.6 percent—but failed to comment that the rate of high blood pressure in the elderly population is 60 percent. Far from indicating that high blood pressure increases the likelihood of severe Covid-19 in older adults, this finding suggests that high blood pressure confers no extra risk or maybe is even protective. </span></div>
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<span style="font-family: "arial" , "helvetica" , sans-serif; font-size: large;">The only consistently observed risk factor for both severe illness and death has been older age, with age greater than 80 representing very high risk. Now, thanks to the existence of widespread, compatible electronic medical records in the British National Health Service (NHS), we have some useful data.</span></div>
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<span style="font-family: "arial" , "helvetica" , sans-serif; font-size: large;">The study, published early on line </span><span style="font-family: "arial" , "helvetica" , sans-serif; font-size: large;">in <i><a href="http://www.nature.com/articles/s41586-020-2521-4">Nature Reviews</a></i>, c</span><span style="font-family: "arial" , "helvetica" , sans-serif; font-size: large;">ompares British patients who died of Covid-19 with all other British patients who are cared for in a group practice that used the necessary software (approximately one-third of the population). By using “a secure analytics platform inside the data centre of major electronic health records vendors, running across the full live linked pseudonymised electronic health records,” and after excluding people under age 18 and those with less than a year's worth of data, the investigators were able to collect health information on over 17 million individuals, including just under 11,000 with Covid-19 related deaths. The results confirm age as the single most potent risk factor, with a small number of other major risks.</span></div>
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<span style="font-family: "arial" , "helvetica" , sans-serif; font-size: large;">T</span><span style="font-family: "arial" , "helvetica" , sans-serif; font-size: large;">o capture the most striking findings, I extracted data from the chart listing the hazard ratios (HRs) and 95% confidence intervals (CI) for Covid-19 death (Table 2) and present 3 separate tables: one highlighting very high-risk characteristics, one highlighting high-risk characteristics, and one showing characteristics associated with no or minimally increased risk. For added emphasis, I highlighted hazard ratios of greater than 3 </span><span style="font-family: "arial" , "helvetica" , sans-serif; font-size: large;">in <span style="color: red;">red</span><span style="color: red;"> and</span><span style="color: red;"> </span>hazard ratios between 2 and 3 in <span style="color: #00b0f0;">blue</span>.</span></div>
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<b><span style="font-family: "arial" , "helvetica" , sans-serif; font-size: large;">Characteristics Associated with Covid-19 Deaths<o:p></o:p></span></b><br />
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<span style="font-family: "arial" , "helvetica" , sans-serif; font-size: large;">The important difference between these charts and previous attempts at quantifying risk is that the hazard ratios reported have been <i>age and sex-adjusted</i> and have been further adjusted for <i>other potential confounders along with age and sex. </i> <o:p></o:p></span></div>
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<span style="font-family: "arial" , "helvetica" , sans-serif; font-size: large;">The conclusion from this analysis is that when we consider the age- and sex-adjusted hazard ratios, there are <i>only four very high-risk conditions: </i>old age, a hematologic malignancy diagnosed within the previous year, severe kidney impairment, and organ transplantation. Within the old age categorization, the hazard ratio goes from 8.62 to 38.29 as the age increases from 70-79 to 80 and older (the reference group is people aged 50-60). The only medical condition that comes close to this magnitude is organ transplantation, with a hazard ratio of 6. </span><br />
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<span style="font-family: "arial" , "helvetica" , sans-serif; font-size: large;">Another handful of conditions are in what I have classified as <i>high-risk</i>: obesity with a BMI of 40 or greater, poorly controlled diabetes, stroke or dementia, a hematologic malignancy diagnosed between 1 and 5 years earlier, liver disease, and other forms of immunosuppression. Incidentally, four out of six of these conditions drop out if we look at the “fully adjusted” column.<o:p></o:p></span></div>
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<span style="font-family: "arial" , "helvetica" , sans-serif; font-size: large;">It’s worth noting some of the chronic conditions that were <i>not </i>associated with increased risk. High blood pressure, as I had previously suggested by comparing the rate in the very ill Covid-19 patients with the rate in the general older population, does <i>not</i> appear to be a risk factor. Mild to moderate asthma, defined in this study as someone with asthma who did not use oral steroids within the previous year, is also <i>not</i> a risk factor.<o:p></o:p></span></div>
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<a href="https://www.blogger.com/blogger.g?blogID=20352591&useLegacyBlogger=true" imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"></a><a href="https://www.blogger.com/blogger.g?blogID=20352591&useLegacyBlogger=true" imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"></a><a href="https://www.blogger.com/blogger.g?blogID=20352591&useLegacyBlogger=true" imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"></a><span style="font-family: "arial" , "helvetica" , sans-serif; font-size: large;">It’s also worth noting that the <a href="http://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/evidence-table.html.">CDC</a> has issued its own guidance about risk factors for Covid-19. Their conclusions, while overlapping with the NHS data, differ in important ways. Most important, their methodology differs. The CDC, lacking a domestic large, comprehensive data base, is forced to draw on evidence from small case series, cohort studies, and some meta-analyses, as well as a much earlier preliminary report from the NHS. T</span><span style="font-family: "arial" , "helvetica" , sans-serif; font-size: large;">he new NHS data, rigorously obtained and meticulously analyzed, should be seen as the gold standard.</span></div>
Muriel Gillickhttp://www.blogger.com/profile/13001304171183760292noreply@blogger.com0tag:blogger.com,1999:blog-20352591.post-25175165266487805472020-07-14T17:10:00.001-04:002020-07-14T17:10:37.672-04:00When Will We Ever Learn?<div class="MsoNormal" style="line-height: 32px; margin: 0in 0in 0.0001pt;">
<span style="font-family: Arial, Helvetica, sans-serif; font-size: large;">Residents of long-term care facilities in the US have been hit harder by the COVID-19 pandemic than have any other group. They have almost all the known risk factors for becoming seriously ill with the disease: they are unambiguously old, with fully 41 percent over age 85, and almost all have one or more chronic diseases, generally multiple conditions that result in their needing personal care. To top it all off, they live in close proximity to one another, typically eating together in a common dining room and often sharing a room with another resident. As a result, nursing home residents account for at least one-third of U.S. COVID-19 deaths. In some states, such as Massachusetts, estimates by early May were that <a href="http://www.bostonglobe.com/2020/05/02/nation/rate-coronavirus-deaths-mass-long-term-care-facilities-among-highest-nation/">nursing home residents accounted for 60 percent of COVID-19 deaths.</a> <o:p></o:p></span></div>
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<span style="font-family: Arial, Helvetica, sans-serif; font-size: large;">We learned from the devastating early experience with COVID-19 how to keep the corona virus from causing havoc in nursing homes. In particular, we came to understand the importance of protecting nursing home residents from staff members who might bring it into the facility. By testing staff regularly and mandating head to toe personal protective equipment, together with other draconian measures such as banning family visitors and restricting resident-to-resident interaction, the rate of illness, hospitalization and death among nursing homes residents plummeted. Now that the virus is again surging in the Sunbelt, with Florida, Arizona, and Texas reporting skyrocketing infection rates, how are nursing home residents faring in those areas?<o:p></o:p></span></div>
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<span style="font-family: Arial, Helvetica, sans-serif; font-size: large;">The answer, in a word, is not well. The <a href="http://ww11.doh.state.fl.us/comm/_partners/covid19_report_archive/ltcf_latest.pdf">Florida Department of Health</a> reported 3072 active cases in nursing homes and assisted living facilities as of July 13, up from 1408 on June 23. The rate had nearly doubled in two weeks. <a href="http://www.wsj.com/amp/articles/covid-19-cases-jump-in-sun-belt-nursing-homes-11594468980">Houston saw an 800 percent increase</a> in cumulative new cases among nursing home residents between the end of May and the end of June—and Texas has more nursing homes than any other American state. </span></div>
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<span style="font-family: Arial, Helvetica, sans-serif; font-size: large;"><a href="http://www.wsj.com/amp/articles/covid-19-cases-jump-in-sun-belt-nursing-homes-11594468980">Why is this happening</a>? Only in mid-July did Florida announce it would test nursing home staff regularly. The government defined regularly as every other week—not likely to be often enough—but many facilities report no testing has taken place as yet. Phoenix nursing homes report a shortage of personal protective equipment, with 25 percent of facilities acknowledging they have only one week’s worth of masks, gowns, and gloves on hand for nursing assistants and other direct care personnel. <o:p></o:p></span></div>
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<span style="font-family: Arial, Helvetica, sans-serif; font-size: large;">So far, death rates have not soared the way they did in New York during the height of its outbreak, but they are beginning to rise. As epidemiologists point out, death is a “lagging indicator:” people first get sick, then some of them become sick enough to require hospitalization; next, some are admitted to the ICU, and then, over a period of weeks, the deaths start coming. The outbreaks began with younger people who ignored public health recommendations to wear masks, limit group gatherings (especially indoors), and maintain physical distance from others. Florida, Texas, Arizona, and other hot spots did not engage in a vigorous campaign to test people with symptoms, to isolate anyone with an infection, and to quarantine exposed individuals. The result was community spread. At that point, the outcome for nursing home residents is entirely predictable. Once COVID-19 is widespread in the community, it is going to make its way into nursing homes, carried by asymptomatic or minimally symptomatic staff members who do not wear adequate protective gear. And vulnerable older people who are dependent on staff members to go to the bathroom, to eat, to dress, and to bathe will themselves become ill. More and more of them will become very sick and many will die. <o:p></o:p></span></div>
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<span style="font-family: Arial, Helvetica, sans-serif; font-size: large;">States that experienced a major outbreak early in the course of the pandemic—in late March and much of April—learned through experience that in the absence of a vaccine or effective treatment, old-fashioned public health methods are the only scientifically sound and morally defensible way to act. The invasion of nursing homes has no doubt already begun in the states with soaring case rates; every hour of delay in instituting the only measures that we have just demonstrated can succeed will result in more viral transmission, more suffering, and more death.</span><span style="font-family: Calibri, sans-serif;"><o:p></o:p></span></div>
Muriel Gillickhttp://www.blogger.com/profile/13001304171183760292noreply@blogger.com0