With the Healthcare "Summit" underway, it is worth considering one of the less well discussed effects of increased government involvement in healthcare, an increased involvement that is inevitable as the government takes over more and more control of the healthcare system. One area that has been insufficiently discussed has to do with a fundamental difference between government bureaucracies, medical researchers and business entities when it comes to healthcare. The fundamental guiding principle of our current healthcare bureaucracy is the "precautionary principle." The precautionary principle animates much of the government in its metastasizing role as our guarantor of last resort. Bureaucracies by their nature are risk averse. After all, no bureaucrat has ever lost his job or faced public humiliation because he impeded the development of a risky treatment. On the other hand, when patients are harmed by new products, the unfortunate technocrat who approved it faces Congressional scrutiny and public opprobrium.
Yesterday, John Stossel discussed how our regulatory process deprives desperate patients of the admittedly slim chance for cure or remission, by denying experimental treatments, based on the precautionary principle:
People suffer and die because the government "protects" us. It should protect us less and respect our liberty more.
The most basic questions are: Who owns you, and who should control what you put into your body? In what sense are you free if you can't decide what medicines you will take?
This will be the subject of my Fox Business program (tonight.)
We'll hear from people like Bruce Tower. Tower has prostate cancer. He wanted to take a drug that showed promise against his cancer, but the Food and Drug Administration would not allow it. One bureaucrat told him the government was protecting him from dangerous side effects. Tower's outraged response was: "Side effects -- who cares? Every treatment I've had I've suffered from side effects. If I'm terminal, it should be my option to endure any side effects."
Of course it should be his option. Why, in our "free" country, do Americans meekly stand aside and let the state limit our choices, even when we are dying?
This week, the New York Times has presented a series of articles on the difficulty Doctors and patients have had gaining FDA approval to take experimental medicines which might (and for those lucky few who received it, did) prolong life and improve the quality of life for victims of Malignant Melanoma, a deadly skin Cancer that if not caught early has a one year mortality rate close to 100%. These patients were not allowed to make their own, reasonably informed decisions, about the risk of taking an experimental drug versus the certainty of death because the FDA was "protecting them."
But it is not only the FDA which impedes medical progress. Our outmoded medical malpractice system is used by tort lawyers to extract immense amounts of money from the healthcare system. With the precautionary principle as their guide, they are able to destroy companies and take drugs off the market, even when those drugs are helpful to large numbers of people while increasing the risk of untoward events for a small fraction. I commented on this in regards to Vioxx when that drug was under siege:
The liability crisis is self-explanatory; people who have been harmed by a product essentially find a lawyer who will help them play the lottery, which is our court system, in order to make a fortune out of their injury. [The outcome] Depend[s] on the venue [and] the choice of jurors (who rarely have any expertise in understanding the complicated physiology involved in medication reactions, and the trade-offs involved in taking medicines, all of which have side effects that can be life threatening for some unlucky people.)
The entitlement philosophy and Nanny state are less obvious offenders. In both cases, people are implicitly given the message that they are never to be held responsible for the misfortunes which befall them. Additionally, the philosophical foundation of the Nanny state, which are Utopian, holds out the idea that all needs and desires should be fulfilled by someone else (the Nanny state, deep pocketed corporations, the "rich"). When people are injured or even disappointed, someone must be held responsible.
I suppose it is possible that Merck knew that Vioxx caused heart attacks and kept it on the market for venal reasons, but that is nonsensical. In our litigious climate, what company is going to risk being destroyed for some short term gain, when they know the trial lawyers are just waiting to get a crack at them.
Much more likely is that in post marketing surveys, an uptick in heart attacks was noticed at some point; in the situation of a new drug, when it comes onto the market and large numbers of people take them, treatment emergent side effects are the rule, not the exception. It is never clear at first, with small sample sizes, whether an effect is real or an artifact, so the usual practice is to wait until the data become clearer. In the case of Vioxx, it did become clear that after 18 months of high dose use, the risk of a heart attack doubled (from 1% to 2% in the older population who are most likely to need Vioxx.) In response Merck panicked (they have lawyers, too) and pulled it off the market. Their action, rather than helping them, did not protect them from an avalanche of lawsuits. They are currently 1 for 2 in lawsuit verdicts.
For some people, Vioxx was the only drug that alleviated their back pain sufficiently to improve their quality of life. As a result, there are people who are now no longer able to work, taking more dangerous drugs and undergoing more dangerous procedures because Vioxx is no longer available to them.
I am selfishly very concerned with healthcare innovation. The next 30 years (a period of time of acute interest to me) should see incredible advances in medical treatments. Reason, at Fight Aging, has discussed this many times:
An article that looks at one small part of the destruction caused by the FDA caught my attention, and particularly these snippets:
Since 2005 the FDA has approved 18 new cancer drugs, many of them breakthrough products. But the pipeline contains hundreds more that will never get to market because corporate developers aren't able, or willing, to come up with the money, time, and patients necessary to establish acceptable data.
The clinical trial process now is a three-part, years-long effort that effectively kills off all but a handful of once-promising drugs.
It would have been the first new drug for prostate cancer in 20 years
Twenty years! Just stop a moment and think about how far and fast biotechnology and medical science has moved in the past twenty years. Think about what the far less regulated computing industry has achieved in the same timeframe. We live in the early years of the biotechnology revolution, with something amazing and new demonstrated in laboratories every week. Yet the dominant regulatory body for one of the most advanced regions of the world has managed to stop the clock at 1988 for a major disease, the subject of research in a hundred laboratories worldwide.
This sitation exists in every field of medicine, and all participants labor under the crushing burdens imposed by regulators incentivized to stop progress from happening.
Regulation, based on the idea that people are too ignorant, simple minded, (ie stupid), or emotional to make informed life and death decisions for themselves are a major hindrance to medical innovation. It is true that the researchers and physicians at the FDA (and I am singling out the FDA because it is the government agency most involved) have more knowledge than the average layman about the particulars of any drug. They could use that knowledge to help determine a range of known risks and allow Patients and their Doctors to determine what level of risk (the known plus the unknown risks) are acceptable to any particular patient. But this is not part of what is being discussed in the Healthcare Summit; such empowerment of individuals is not currently being considered by those who imagine they can make such decisions for us better than we can for ourselves.
The current Democratic plans all include increased government control over healthcare. The idea of panels to determine treatment efficacy is superficially appealing but the reality is that such guidelines, once established, would serve to entrench status quo treatments (after all, short of billion dollar trials, how could any new procedure be shown to be superior to the traditional, usually cheaper, way of doing things.) The opportunity costs of the Precautionary Principle in healthcare are extraordinary yet are never made part of the debate, to the impoverishment of us all.