Sunday, September 6, 2009
PART 2 - the rest of the New York Times blog comment submission-Unpublished
"For any clinician, it is profoundly frustrating not to have more effective meds. Although, until there is essentially a cure for AD the debate of how effective a med truly is will probably wage on. Aricept has been available for almost fifteen years. Last I checked the Federal Employees at the FDA do actually consider study design when reviewing the data. Why would the government whom we trust to take an active role in fixing the broken health care delivery system approve a useless med, or a dangerous med?
The article pays little attention to the inequities of Medicare, in covering Aricept which seems counterintuitive since Medicare has been used as a model and a benchmark for government run health care, or at least much rhetoric has been paid to this in the last three months. The article does simply imply that we need to put our resources elsewhere instead of into cholinesterase inhibitors.
In 1979, my mother at age 62 was diagnosed with AD. My family began to fall down the “rabbit hole” (as the author refers to it) of AD. I was seventeen years old and the Alzheimer’s Association was not even incorporated yet. It was still three years before National Alzheimer’s Awareness week began. AD was not a household word. I do strongly believe that I would have wanted to take the chance even at 20% odds of using one of these medicines to slow the progression of AD. One month or one day or one hour for most families having a more lucid conversation and the sparkle of their loved one present is well worth it. That for some may be a bit too humane and not utilitarian enough.
As a physician I have seen these medications albeit temporarily, improve one’s cognition, not just in Mini Mental status points but by patient and family report. That is significant. Is there utility in this? Yes from a humane standpoint. I have treated many patients, where the side effects are problematic and the medicine is discontinued. Those are simple reasonable facts and follow any standard of care. Is it easy to find families whom are angry because the med did not work? Of course it is, given the nature of the disease and the limitations of current pharmacotherapy. Doctors and meds and by default the giant nefarious drug companies get blamed as much or more as the disease process. This seems to be human nature and roughly parallels the decline of the physician-patient relationship and the uptick of the “consumer-provider” relationship in health care.
These types of articles further detract from the ancient physician healer- patient alliance. They seem to create more apathy towards AD that is already present in many physicians in the medical community, given the ultimate futility in stopping the disease with current treatments.
There really are few clinical scenarios that do not warrant a trial of these medications. The main reason to withhold a trial of these meds is about cost. With that said, we should stop denying our priorities and simply start rationing care. After all AD is fatal anyway.
Does the pharmaceutical industry spend ungodly amounts on marketing and advertising? Absolutely. Perhaps we can simply eliminate this. Perhaps the revenue used in Research and development can be shifted over to the government. Perhaps the government should take over the pharmaceutical industry.
In regard to research, the article did not cover how much the drug industry does spend on R&D. Moreover it did not cover the relatively minimal spending on AD research at the federal level. For example, compare AD to HIV and AIDS related illness. AIDS takes the lives of about 14,000 people a year. AD kills about 72,000 people in the same time period. Federal Funding for Research according to the Kaiser Foundation in 2006 was about 2.6 billion dollars for HIV/AIDS for direct research. Spending on AD research at the level of the NIH is about 659 million. (One quarter of the research dollars while killing five times as many people)
Perhaps we need a more utilitarian approach to rationing care, except it seems like research has already taken that approach. Is it any wonder why we don’t have better meds for AD?
As far as direct to consumer advertising, it is a well known and researched fact that most doctors do not approve of this. The debate on DTC advertising is 50 years old and stems from 1962 and the Kefauver-Harris Amendment to the Federal Food, Drug and Cosmetic Act. The issues of false and misleading advertising and fair balance were addressed back then. In the early 80’s the FDA placed a moratorium on DTC later to be lifted in 1985, with slightly more rhetoric in the guidelines. Perhaps the only positive byproduct of DTC advertising is that it has helped increase awareness. Increased awareness at least generates these discussions. Compare AD to Lewy Body Dementia (about as common of a household word as AD was in 1980). There are not a lot of meds in the FDA pipeline developed to treat LewyBody at this time.
The only aspect of the article that is not as misleading as the TV commercials themselves is the fact that the author has never had a close family member affected by the “rabbit-hole” of Alzheimer’s disease.” From that standpoint the tenor of the article makes good sense. My hope is that some day no person or family shall have to suffer through the devastation, havoc and heartache of Alzheimer’s disease. Right now this article proves that in the collective unconscious of America our hearts are not in the right place in moving towards this ideal."
Joseph J. Sivak MD
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