Kissing Consent

Last week was a tough week for humankind. My heart goes out to the hundreds of refugees and would-be immigrants who drowned trying to flee oppression, war, and poverty, and to the thousands of Nepalese who died or lost everything just because they were in the wrong place at the wrong time. But I also ache for the 78-year-old Iowan man accused of rape—and mercifully exonerated—after being intimate, in some form or another, with his demented wife.

It’s always dangerous to discuss a case based exclusively on information from the media or arguments based in court. So I won’t presume to know what actually happened in the nursing home between Mr. and Mrs. Rayhons in her nursing home bed. But I do worry about the well-being of all those who have dementia. And I think that seeking to deprive people with dementia of one of the few pleasures they may still be able to experience in life is tragic.

The pundits have been pontificating that the Rayhon case is all about informed consent. But is it? Since when is informed consent required for anything other than a medical procedure or a research study? The case seems to me to be more about the quality of life of individuals with diminished cognitive capacity and the medicalization of society than about consent.

Informed consent is a tremendously important concept in medical treatment and medical research. One hundred years ago, future Supreme Court Justice Benjamin Cardozo ushered in the modern era of informed consent when he stated forcefully that “Every human being of adult years and sound mind has a right to determine what shall be done with his own body”—and that performing surgery without consent was assault and battery.

The need for informed consent, and the devastating consequences of performing medical experiments without it, were brought home after World War Two, when Nazi experimentation on hapless prisoners was revealed. The Nuremberg Code, promulgated in 1947 in response to the horrors inflicted in the name of science, established voluntary consent as essential to the ethical conduct of research. A mere twenty years later, the anesthesiologist Henry Beecher divulged to the American medical community that research without informed consent was occurring with alarming frequency. As a result, a regulatory framework was put in place to assure ethical conduct by physician investigators, at least among those applying for NIH funding of their work. Voluntariness is the bedrock of informed consent. But what does all this have to do with intimacy between two members of a married couple?

Not much. Sexual intercourse is not a medical procedure. Deciding whether or not to engage in intimacy is not like deciding whether to participate in medical research. It is something that is normal and expected within the context of the marital relationship. Nor do we expect people with Alzheimer’s disease to sign an informed consent form before they have dinner, acknowledging that they are aware of the risks and benefits of the meal they are about to eat. We don’t ask people with Alzheimer’s disease to formally agree to wear a coat when it’s cold out. What business do doctors, nurses, and nursing home administrators—let alone courts and juries—have interfering in the private relationship between two adults? To be sure, not all sexual relationships are voluntary, even within a marriage. People who have dementia are vulnerable and need protection against abuse. But to apply the standard of informed consent to everyday life, a standard meant for people undergoing cardiac catheterization or surgery, or for taking experimental medications of no proven benefit, is profoundly misguided.

We need to broaden our view of how best to approach people with dementia to go beyond a narrow focus on safety. Of course  physicians and nurses and social workers want those in our care to be safe. But many vulnerable older people do not consider safety their paramount concern. They would rather take the risk of falling than be confined to bed. (It’s worth noting that while conventional restraints do not necessarily prevent falls and are in fact associated with injury, surely it would be possible to tie people down using four-point restraints in such a way that they could not possibly get up and fall.) They would rather live on their own, even though they might become ill and have no one with them, rather than forgo their independence. The interest of many, quite likely most, frail or demented older people, is in maximizing their quality of life. And that means interaction with other human beings.

We know that people with dementia experience emotions long after they have lost much cognitive function. We know they respond to a smile or a hug even if they cannot tell you the full name and birth date of the person who is hugging them. Surely to deprive people with dementia of the possibility of intimacy if they are fortunate enough to be in a relationship with a loving spouse, is cruel and unusual punishment. There are other, better ways to protect the vulnerable.

Helping the Other Half

There’s nothing much new in the latest edition of the Alzheimer’s Association Alzheimer’s Facts and Figures, which came out last month. Once again, the report documents that about 43% of people age 75-84 have Alzheimer’s. Since no more than 75% of all dementia cases are due to Alzheimer’s disease, that means that over half of  people in this age group have dementia of one kind or another.

The proportion varies depending on how dementia was assessed and on the ethnic, geographic, and gender composition of the people studied. But despite an enormous amount of effort and much progress in the domain of understanding the pathophysiology of Alzheimer’s disease, the Alzheimer’s Association reminds us that there is no drug available today that slows or stops the death or neurons that causes Alzheimer’s disease.

The federal government’s National Alzheimer’s Project Act and Obama’s BRAIN (Brain Research Through Advancing Innovative Neurotechnologies) initiative are redoubling the effort to find a cure. That would be terrific—though we should remember that the last concerted effort to wipe out a chronic disease, the War on Cancer, was launched in 1971 and is still being fought.

But what about the other half—those older people who don’t have dementia? Is there anything that medicine should be doing special for them?

A new report from the well-respected, non-governmental, non-profit Institute of Medicine released last week addresses this question. Entitled Cognitive Aging: Progress in Understanding and Opportunities for Action, the report makes ten recommendations for collecting data, engaging in research, developing programs, and providing resources that seek to maximize cognitive function in older people who don’t have dementia. It’s an intriguing report, principally because it focuses on what is most important to older people and is the essence of geriatric medicine—function, rather than disease. The authors cite an AARP survey of members in which fully 87% identified “remaining sharp” as one of their major concerns. Older individuals and their families are concerned with optimizing mental performance. They are alarmed by the recently described disorder, “Mild Cognitive Impairment,” a condition that does not meet the criteria for dementia but affects the ability to function in day to day life, whether or not it progresses to full-blown dementia.

The study is also of interest because of it public health angle—it draws attention to the major societal consequences of age-related cognitive decline, things like traffic accidents (as people with impaired judgment or slow reflexes continue to drive) and financial fraud (resulting from impaired decision-making on the one hand and minimal consumer protections on the other). The recommendation to develop assessment tools, educational programs, and improved regulations, as well as alternative means of transportation, have the potential to maintain quality of life for older individuals and to lower costs.

The report makes common-sense suggestions for preventing age-related cognitive decline: being physically active, remaining socially and intellectually engaged and getting enough sleep. Unfortunately, there is no more evidence that these measures will maintain cognitive function than there is that they will prevent dementia. That is, they might help and they can’t hurt. But to suggest that they are proven to be effective is, alas, to overstate the case.

Despite succumbing to the temptation to offer a little bit of hype along with a lot of wisdom, the report’s authors make a valuable contribution by reminding us to pay attention to the other half. Its broad societal focus is welcome, as is the recognition that it is function rather than disease that matters most to the majority of people as they age.

What We Believe

Kudos to the Huffington Post for running an article about the new report from the FrameWorks Institute, “Gauging Aging: Mapping the Gaps Between Expert and Public Understandings of Aging in America.” And shame on the NY Times, the  Washington Post, the Wall Street Journal, and the other major newspapers in America for ignoring it. That’s not entirely surprising since the report is all about the disconnect between public perception and reality, and the media are to a large extent responsible for shaping popular understanding.

The new study does not report the results of an opinion poll. It is not based on trendy focus group analysis. It seeks to understand what both geriatric experts and the lay public believe about aging and the “assumptions and thought processes” that underlie their opinions. The authors, supported by funding from AARP and a variety of foundations including the John A Hartford Foundation and the Retirement Research Foundation, use a “cultural-cognitive approach” to their work. That means they probe, they explore, they question. They do not rely on “big data.”

So what did they find? They learned a great deal about the gaps between the scientific understanding of aging (by which I mean physiologic, medical, psychological, and sociologic) and the public’s view. They learned so much that I will just touch on some of the highlights here.

Attitudes toward aging: the experts see aging as presenting challenges, but also an opportunity for growth and the possibility of continued contributions to society. The public sees aging as the enemy, to be combatted rather than embraced or supported. In particular, aging is thought to bring with it decay and disability; in fact, older people are very heterogeneous.

Root cause of aging: Americans tend to believe that what happens to them is entirely within their control. If they eat right, exercise, and lead a virtuous life, they can avoid the aging process entirely. The truth is more nuanced, with both genetic and external factors playing a significant role. In a similar vein, the public tends to believe that if older people do become disabled or demented and cannot take care of themselves, then their family rather than the government has an obligation towards them.

What we need in order to age well: The experts see a need to create structures to facilitate older engagement—whether opportunities for part time work, better transportation, or more volunteer positions. A related theme is the need, recognized by experts, for new public policy initiatives to modify today’s reality. The public, by contrast, takes the status quo for granted and assumes it’s up to older people to avail themselves of existing options.

There’s more. Maybe I will write more about this subject next week. Better yet, just read the study. And I look forward to future work from the FrameWorks Institute addressing how to change popular perceptions. Maybe they will shed some light on how to modify the public view of climate change and evolution, too.

Chemotherapy for Alzheimer's?

A provocative opinion piece in JAMA Neurology offers new hope for the treatment of Alzheimer’s disease. University of California Santa Barbara neuroscientist Kenneth Kosik begins by acknowledging that recent drug trials have all failed, this despite the fact that that were designed based on the latest understanding of the pathophysiology of Alzheimer’s disease. The most spectacular recent failures were studies of two separate monoclonal antibodies that were expected to selectively attack amyloid deposition in the brain. This approach was so intriguing that scientists haven’t given up on it yet, despite the lack of success so far—just a few weeks ago the drug company Biogen announced the results of a Phase I trial of yet another monoclonal antibody, this one evidently quite promising. But Kosik has a different idea.

Kosik comments that the typical response to the drug trial failures is either to question whether our understanding of the mechanism by which Alzheimer’s is produced is correct or to conclude that treatment of the disease will need to begin before symptoms develop. He suggests that perhaps where we have gone wrong is in believing that Alzheimer’s disease is homogeneous. In fact, he argues, there are many genetic variants. The best known is the APOE alleles, with the APOE4 allele conferring particularly high risk. And of course there are the relatively rare familial forms of Alzheimer’s disease, which involve mutations in any of several chromosomes. Perhaps if we identify a person’s genome, we can find a particular therapy that will work for that person.

This is the approach that is increasingly used in the treatment of cancer, with a handful of notable successes. In non-small cell lung cancer, for example, there are several mutations typically found in younger patients with no history of smoking. Drugs targeted against these mutations have produced excellent results in patients with the relevant mutation: the drugs Erlotinib (Tarceva) and Crizotinib (Xalkori), when used in appropriate patients, can convert what was previously a uniformly lethal disease (usually within a year) into a chronic illness. Will the same strategy work for Alzheimer’s disease?

Maybe. It’s certainly worth pursuing. And Kosik also has ideas about how to proceed with this kind of targeted, individualized treatment—he recommends what are known as “N of 1 trials,” tests of a potentially useful drug in a single patient rather than the conventional strategy of testing a drug in a large group of people. The proposed strategy would both revolutionize the treatment of a particular disease (Alzheimer’s) and change the search process for new drugs. It’s not likely to change the epidemiologic reality any time soon, but it’s more promising than many radical new ideas. Let's hope NIH or other funding agencies have the wisdom to provide the support needed for this innovative work to go forward.