Last week I did a careful cognitive evaluation on a 59 year old woman who I had been following in the clinic for the last two years. She initially came to treatment in a severe depression which had led to her being unable to work or function in her usual day to day activities. Her depressive symptoms included decreased concentration and attention which were reflected in diminished memory among other problems. Her depression responded well to medication and psychotherapy and within 6 months she was back at work. A month ago she had come in and complained of the return of problems with her memory, in the absence of any signs of depression, and I scheduled her for the re-evaluation.
It is not at all unusual for 59 year olds to complain of memory problems. The Neurologists have even come up with a name for the condition of decreased memory that accompanies aging: the Benign Forgetfulness of Aging. Those of us who are experiencing such forgetfulness do not usually think of it as benign but compared to the accelerated loss of memory that accompanies dementia, the BFA is relatively innocuous. We have also developed prosthetic memories (Google and other search engines) which ameliorate the benign forms of memory dysfunctional.
Ms. A was a highly competent woman who essentially held her extended family together. She had always worked and despite some significant health problems managed her household and a fairly responsible job.
Unfortunately for Ms. A, her cognitive exam was quite troubling. Beyond the usual issues of forgetting where she left her keys, Ms. A also would occasionally forget where she was and what she was doing there. Forgetting an item you went to the store for is annoying, forgetting how to shop in the local market is alarming. She was unable to do calculations and only remembered 1 out of 3 objects at five minutes. There were a number of other findings that supported my conclusion that her memory deficits were real and most likely reflected an early dementia, most likely Alzheimer's Disease.
I referred Ms. A to Neurology for further work up, including a CT scan, and treatment but unfortunately the treatment options for AD are of minimal value and, for most people, do not appear to slow the progression of the illness in any appreciable way.
I described Ms. A because, fortuitously, Glenn Reynolds linked to a very encouraging report last night from the UK on a new treatment for Alzheimer's. While Glenn Reynolds pointed out the good news, the article also implied of much of what has become wrong with the over-bureaucratization of the Medical field:
Daily pill that halts Alzheimer's is hailed as 'biggest breakthrough against disease for 100 years'
A new drug halts the devastating progress of Alzheimer’s disease, say British scientists.
It is said to be more than twice as effective as current treatments.
A daily capsule of rember, as the drug is known, stops Alzheimer’s disease progressing by as much as 81 per cent, according to trial results.
Patients with the brain disorder had no significant decline in their mental function over a 19-month period.
The drug works by targeting the Neurofibrillary tangles, or Amyloid Plaques, that are pathgnomonic of Alzheimer's Disease. Apparently the drug can prevent new tangles from forming and can metabolize existing tangles. Since the tangles begin to form early in life this kind of approach could significantly delay the onset or prevent altogether the development of AD. However:
Eventually the drug could be used to stop the disease in its early stages before symptoms have even appeared, it is hoped.
It could be available to patients within four years although, in the wake of the NHS ban on the £2.50-a-day drug Aricept, there are concerns over whether it would be funded on the Health Service. The trial was carried out by a team at the University of Aberdeen, led by Professor Wischik, who 20 years ago discovered the ‘tau protein’ which makes up the tangles. [Emphasis mine-SW]
There are two important points here. The first important point is that in England, where their National Health Service provides "free" medical care for all, bureaucrats have the right and ability to decide if the treatment is cost effective. This is a potential problem with any new therapy. New therapies are usually more expensive than older therapies for a whole host of reasons. This is not yet a major problem in America but it would certainly become a problem once National Health Care becomes a reality. There are already many cases of insurers deciding, based on their cost-benefit analysis, that certain treatments are too costly for them to pay for; once the government gets into the act, these minor problems will escalate out of control.
The second problem is more acute for the American public. The article suggests that this drug, even though it has already been tested on patients, will not be available in England for four years. The US FDA typically delays the use of new drugs significantly longer and demands significantly more testing than the Europeans, which means that this drug will probably not be available in the US for much more than 4 years. Four years from now will be far too late for Ms. A and anyone else unfortunate enough to be diagnosed with AD in the near future.
The FDA has followed the arc of most large governmental organizations. It started out for a specific noble purpose, to protect Americans from drugs that were inadequately tested. It evolved into a large bureaucracy dedicated to making sure that new drugs are safe (and following the first rule of bureaucracies, enlarging itself and its powers.) It gained the power to force drug companies to fund large and very expensive studies, increasing the cost of new therapies exponentially for uncertain benefits. Even the extensive testing the FDA demands cannot protect against treatment emergent side effects. The FDA, which sees its job as to protect us from harm, has taken the tack usual among bureaucrats, that the risks of any action always outweighs the risks of inaction.
On Monday, Reason at Fight Aging pointed out some of the dangers that the FDA has introduced into our quest for health and longevity:
It's a shame that the people most harmed by the existence of the FDA - and the culture of "I have power over you and you shall do as I say" that supports it - are not up in arms. The most vocal opponents of the FDA over the past decade or so are probably folk in the supplement industry. They, despite the threat of jail, losses, and other indignities for doing no more than providing a desired and responsible commercial service, are by no means the most harmed. No, the most harmed are the dying, and we are all counted in that group while the FDA continues in its position that potential longevity therapies will not be approved. No approval means no funds for development, and hence little evidence to show in support of radical change.
The cancer patients, the Alzheimer's sufferers, and all those with other named medical conditions suffer as well: the FDA and associated regulatory bodies form a huge ball and chain that slows progress in science to a fraction of what it might be. When medical development costs much more due to regulation, you will see fewer new medicines. When government employees have greater incentive to deny than approve, you will see fewer new medicines. This is exactly what happens, and the cost is measured in lives.
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Centralization of power - the state and regulation, in other words - is a form of age-related damage for human societies. It accumulates, piling ever deeper and broader, and leads to degeneration and disease. Look no further than the Soviet Union for an example of where it all leads in the end, but the place we are now is a far cry from the best of all worlds. If you have an interest in a long, healthy life, then you should also have an interest in why modern democracies are greatly slowing progress to that end.
The FDA is a form of arteriosclerosis, delaying the availability of treatments which could prolong and save lives. Every early Alzheimer's Disease sufferer should be offered the opportunity to choose to either take or eschew a medicine that has been admittedly inadequately tested and cannot be proved safe and effective, on the chance that it will help them. The alternative is to deny them treatment options that could forestall one of the cruelest diseases our minds are heir to.
Adults make these life and death decisions for themselves everyday when they take supplements or eat a steak or a buttered role. We still do not have air tight proof that butter is bad for you though there is a great deal of evidence supporting the contention that eating lots of butter will raise your cholesterol and may make you more prone to a heart attack. For many years margarine was touted as a substitute with great health benefits. More recently we have learned margarine, with its trans fats, may be worse than butter! Even so, the scientific debate is not yet closed. The human body is exceptionally complex and we can never be certain a medicine is "safe and effective" when it is meant for the long term treatment of a chronic condition. It is time to let patients make decisions and take responsibility for those decisions. We should offer our best understanding of the scientific evidence, including where the evidence is inadequate, and allow our adult patients to decide for themselves how much risk they are willing to tolerate. The FDA should no longer be in the business of determining when risks are arbitrarily close enough to zero to allow us to make the bet.
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