January 02, 2011

New Wine from NAPA?

In a rare moment of bipartisanship, Congress unanimously approved the National Alzheimer’s Project Act. The media called it “historic legislation” and said its passage was a “momentous victory.” But will NAPA, as it is being called, accomplish anything?

NAPA is not a plan of action: it calls for a task force to create a plan of action. Having recently participated in a corporate “value stream” that is intended to lead to the transformation of the way medical care is provided in the multi-specialty group practice where I work, I am aware of the prevailing faith in “planning to plan.” And maybe, just maybe, the interagency council that has been charged by NAPA to create a coordinated “National Alzheimer’s Disease Plan” will come up with a brilliant plan. And maybe Congress will fund the implementation of such a plan: 2 bills are already in the works which would provide for several key ingredients of any plan, research into the prevention and treatment of Alzheimer’s (the Alzheimer’s Breakthrough Act) and enhanced clinical services (the Health Outcomes, Planning and Education for Alzheimer’s Act).

Right now, the best we can do is to give the yet-to-be created council advice. So here are some sober reminders, historical precedents, useful metaphors, and desperate needs to consider:

Sober Reminders
There are currently no effective means of preventing Alzheimer’s disease. An NIH state-of-the-science conference held in April, 2010 concluded, after reviewing every study of a strategy intended to affect the onset of the disease, that “there is currently no evidence of even moderate scientific quality supporting the association of any modifiable risk factor…with reduced risk of Alzheimer’s disease.” The panel looked at dietary supplements, prescription drugs, non-prescription drugs, diet, exercise, and social engagement and could recommend nothing.

Brain diseases are notoriously hard to treat. We don’t have a cure for any non-infectious brain disease. For most of the degenerative neurologic diseases such as multiple sclerosis, there is little in the way of effective treatment. The central nervous system disease for which we arguably have the best treatment, Parkinson’s disease, remains a progressive, debilitating disorder.

The blood brain barrier makes treatment particularly challenging.
The brain is uniquely well-defended against penetration by drugs and other chemicals. The so-called “blood-brain barrier” protects individuals from toxins—and from potentially effective treatment.

Historical Precedents

The Manhattan Project. Everyone loves to cite the Manhattan Project as an example of a government-run project that solved an important and difficult problem. But the creation of nuclear weapons was accomplished by rounding up the smartest physicists and mathematicians in the country and secluding them in Los Alamos until they produced a bomb. It was carried out during wartime. While there were some thorny theoretical problems to be solved, much of the process was essentially an engineering challenge, it involved applying known science to a specific problem. Extrapolating to Alzheimer’s disease research is perilous at best.

Attack on AIDS.
Money was poured into AIDS research, with some stunning results, at least in the US. But unlike Alzheimer’s disease, AIDS is an infectious illness. It is also worth noting that the outcome of the research was containment, not cure, which may likewise prove to be a more realistic goal of Alzheimer’s research than eradication of the disease.
The War on Cancer.
President Nixon declared war on cancer in 1971. We’re still fighting that war, which makes it America’s longest war, longer even than the wars in Afghanistan and Iraq. Between 1971 and 2008, according to an article in Newsweek, the US government, private companies, and foundations, spent $200 billion on the quest for a cure. Progress has been made on a number of fronts, as Siddhartha Mukherjee’s magisterial book, “The Emperor of All Maladies,”
documents. The age-adjusted death rate from cancer rose from 199/100,000 in 1975 to peak at 215/100,000 in 1991, but has since fallen, reaching a low of 184/100,000 in 2005. The death rate from breast cancer fell from 31/100,000 to 24/100,000 in the same period and mortality from colorectal cancer went from 28/100,000 to 17/100,000. But lung cancer mortality has not improved and lung cancer is the most common form of cancer. Cancer stands poised to surpass cardiovascular disease as the leading cause of death in the US. Declaring war does not guarantee victory.

Useful Metaphors
Addressing terrorism is unlike fighting a conventional war. Since the end of the Second World War, the US has been struggling to shape military policy to new realities. Nuclear weapons changed the playing field. So did insurgencies and terrorism. Strategies that made sense in WW II did not work in Vietnam and are not working in Afghanistan. It is dangerous to use old metaphors in dealing with new problems, whether in international conflict or disease.

Desperate Needs
Planning for the future must not neglect the needs of today. There are people alive today with Alzheimer’s disease—an estimated 5.3 million in the US. There will be people with this disease for years to come: by 2050, the number of Americans with the disorder could reach 16 million. It’s important to conduct basic research in the hope of postponing the age of onset of Alzheimer’s disease, containing the disorder, or possibly even curing it. But we must not neglect the realities of today. We have to devote resources to designing better institutional arrangements for individuals with Alzheimer’s. We have to do a better job providing palliative care for sufferers from dementia. The good news is that this is one area of medicine where doing the right thing will save money.