Data to Support the FDA?
Or are the FDA's regulatory powers simply based on assertions?
The arguments I’ve heard supporting the extensive powers of the U.S. Food and Drug Administration can be summarized by the following points:
1. Drug companies are driven by the profit motive. Therefore, they are apt to cut corners and perhaps sell unsafe and ineffective drugs.
2. Even doctors may have perverse incentives to sell us useless or harmful medicines.
3. An objective third party— a federal government agency—can clearly judge drugs. The FDA can pore over the data and decide what’s right.
4. By setting high standards, the FDA’s processes weed out bad actors and bad drugs.
5. The FDA allows us to trust that the medicines we purchase are honestly and accurately labeled and promoted.
6. With the FDA on our side, we face fewer health risks and are healthier overall.
What do these points have in common? They are arguments and assertions. Further, they ignore the scale of the purported problems, other possible solutions, and any potential downsides of FDA regulation.
A deductive logical argument starts with a premise, or multiple premises, and ends with a conclusion. This is called “premise, premise, conclusion.” And yet a premise is an assertion, subject to validation.
Here is how it works:
· Premise one: Drug companies will sell defective drugs to maximize profits.
· Premise two: The FDA will detect and reject defective drugs.
· Conclusion: By protecting us from defective drugs, the FDA improves our health and welfare.
Premises are assertions that can be scrutinized.
Most drug companies care a fair amount about profits. That’s true. But does that encourage them to market defective drugs? Or does it dissuade them from marketing defective drugs? If they sell defective drugs, after all, their reputations will suffer and they may be sued.
What data do the supporters of the FDA have that, absent the FDA, drug companies would market more defective drugs? I can envision using before/after types of trend analyses and active/control types of exposure studies.
Using before/after trend analyses, was the trend in defective drugs reduced after the FDA got its extensive powers? Using active/control exposure studies, do the areas of the world with strong regulatory agencies have better outcomes, after controlling for other measures? Similarly, do the areas of the pharmaceutical market with strong regulatory control have better outcomes?
Conclusions must consider all aspects of the problem.
Even if the answers to the above questions are affirmative, we need to consider the scale of the problem, other solutions, and the costs incurred to derive those benefits.
If we determine that drug companies will market more defective drugs in the absence of the FDA’s regulations, what is the scale of the problem? Will one hundred companies market ten defective drugs each or will just one company market one defective drug? Will a thousand patients be hurt a lot of just a few be hurt a bit?
What if, in the process of preventing ten bad drugs, the FDA prevents 100 good drugs? Is that a worthwhile tradeoff? How much would those 100 good drugs have helped patients? Will 100,000 patients, who could have lived, now die?
What are other possible solutions? What if the FDA just looked for evidence of drug safety and left an assessment of efficacy to the market?
Where is the data and analysis to support the extensive powers of the FDA? I’ve never seen it. Does it exist? Has it been suppressed because it gives the “wrong” conclusions?
My sincere question to those who support the extensive powers of the FDA: Have you collected such data and done such analyses? What were the results? Where can we get those publications?