Safety and Efficacy

Scott Gottlieb and Mark McClellan had some thoughts on drug trials in the context of the current Wuhan Virus (my term, not theirs) situation. For the most part, they’re right. There’s one aspect of their op-ed, though, that I want to comment on.

…if we don’t know what works, and what doesn’t, we’ll waste time and money on treatments that won’t help and may harm. Even if a vaccine is discovered and approved, the pandemic won’t end unless most Americans get vaccinated, which will require confidence in the product’s safety and efficacy.

The FDA currently must determine both safety and efficacy. That’s misplaced, though, and it misuses both time and money, and it misidentifies the money involved.

The FDA should be intimately involved in determining a drug’s or vaccine’s safety; we don’t need a market of snake oil salesmen claiming the safety of their wares.

But we don’t need Government involved in free markets. The free market here is that of patients and their doctors; they should be free to use—an extension of the Right to Try concept—drugs to mitigate the virus’ infection or likelihood of infection, and they should be free to use vaccines to achieve longer-term protection from the virus as soon as those chemicals have been shown safe.

The right to try given safety also would answer one of Gottlieb’s and McClellan’s concerns about numbers of trials and trial size: there are lots more patients and doctors in the market than would be participating in FDA-supervised trials, every one of those patients and doctors would be volunteers, and their data would be both more broadly based and available much faster than via an FDA-supervised trial or the series of them that might be necessitated by questions arising from a given trial.

Another of Gottlieb’s and McClellan’s concerns is that waste of money. Their concern proceeds from the assumption that it’s the government’s and pharmaceutical companies’ money being wasted. In Gottlieb’s and McClellan’s paradigm, that’s true. But in a free market—those patients and doctors—it’s the patients’ money being spent; it’s their assessment of whether their money is being wasted. Pharmaceutical companies will recoup much, if not all, of their expenses through their sales, and Government need not be involved at all.

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