The Safety vs Effectiveness Choice is Different for Each Patient
In a superb post by Darren at No Coercion, he brings up an obvious point I’m embarrassed to admit I’ve never considered in arguing for abolition of the FDA: the FDA is imposing a single standard of safety and effectiveness which ought to be, in fact, different for each patient. As he notes:
The multitude of voluntary interactions in the free market can quickly and non-coercively identify safe and useful drugs. It happens all the time in other industries. Consider the early adopters–the small group of people who are the first to try a new product. If a new drug for MS is introduced in a free market (i.e. no FDA), most MS patients aren’t desperate enough to jump on it right away. But a smaller group of patients are suffering to such a degree (maybe having tried everything else) that it’s worth it to them to risk the unproven drug, even if there is concern it could kill them. As more of these early adopters move in, data starts to come in (picture something like Consumer Reports for pharmaceuticals or discussion forums on MS sites) indicating the level of the drug’s safety and effectiveness.
As more information comes out from the early users of the drug, the uncertainty starts to diminish, and (if the results are positive) those who are suffering a great deal (but not enough to be in the early adopter group) choose to try the drug (since their personal cost-benefit analysis has shifted based on the new information). This produces even more ‘user data,’ thus continuing the trend of increasing numbers of people using a drug that’s helping them and thus eliminating a great deal of suffering. And it’s all done quickly and voluntarily, with no one having options artificially kept from them by force.
In addition, the manufacturer, not being hamstrung by FDA rules, would be able to constantly improve the formula based on patient results, thus reducing suffering even more.
The point of course, is that the FDA blocks all people from using a drug based on a single standard of how safe and effective it needs to be proven, when the cost-benefit decision is different for each potential beneficiary.
The basic case against the FDA is so strong that I find it hard to understand how anyone who has studied the matter could support it (and virtually no economist who has studied the situation has done so). The decade-plus approval period clearly kills multiples of the number that might have been saved from the delays, the 50% reduction in the number of drugs becoming available each year since the 1962 amendments strengthened its powers makes no sense in a world where advances are occurring at an accelerated pace in all other technological fields, the dominance of the field by large pharmaceutical companies is a direct result of the intolerable cost of approval (around 80% of the cost of a new drug is the cost of satisfying the FDA), and after all that, dangerous drugs are still approved and there are reasons to be suspicious about the politics behind some approvals.
What Darren has done, though, is point out the radically different level of assurance needed by different patients, and the need for such decisions to made individually rather than bureaucratically. Even if the FDA DID eventually only approve drugs safe enough for the average user, they would still be harming (and often killing) people whose situation justified taking more risks.
Nobody is suggesting that drug manufacturers not be accountable for harm resulting from negligence or fraud: indeed, while government agencies are generally punished for causing harm by receiving an increase in their budget, a drug manufacturer that kills its customers will, in a freed market, lose everything to the competition.
As an aside, Darren’s hypothetical example strikes very close to home, as my wife has MS. She ought to have the right to decide when the available evidence on a helpful drug is sufficient for her to see if it can help her, and it is quite likely that the FDA will cause my wife to have to endure unnecessary pain for an extra decade of her life before she gets relief, assuming the costs it has imposed don’t result in that drug never even being developed in her lifetime.