Dan Mitchell article Coronavirus and the Failure of Big Government: A Closer Look at the FDA

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Coronavirus and the Failure of Big Government: A Closer Look at the FDA

In my five-part series on coronavirus and the failure of big government (here, here, here, here, and here), the Food and Drug Administration (FDA) received some unflattering attention.

Whether we’re examining its performance regarding equipment, testing, or vaccines, the bureaucracy has hindered the private sector’s ability to quickly and effectively respond to the pandemic.

Today, let’s devote an entire column to problems with the FDA.

Historically, the big issue is that the bureaucracy is too cautious and risk-averse.

The argument from the FDA is that a lengthy and expensive process for approving drugs is necessary to avoid the risk of a drug with bad side effects.

And there are benefits to that approach, with thalidomide being the obvious example.

However, there are also costs. Most notably, the FDA’s onerous approval process means that it takes a long time before consumers get access to many life-saving and life-improving drugs.

The net result is that the FDA has killed more people than it has saved.

If you think that is hyperbole, read this summary of academic research from the Independent Institute.

…requiring a lot of testing has at least two negative effects. First, it delays the arrival of superior drugs. During the delay, some people who would have lived end up dying. Second, additional testing requirements raise the costs of bringing a new drug to market; hence, many drugs that would have been developed are not, and all the people who would have been helped,even saved, are not. …three bodies of evidence suggest that the FDA kills and harms, on net. …It is difficult to estimate how many lives the post-1962 FDA controls have cost, but the number is likely to be substantial; Gieringer (1985) estimates the loss of life from delay alone to be in the hundreds of thousands (not to mention millions of patients who endured unnecessary morbidity). …Deaths owing to drug lag have been numbered in the hundreds of thousands. …in recent years thousands of patients have died because the FDA has delayed the arrival of new drugs and devices

Oh, and it’s worth mentioning that the FDA process means companies much charge higher prices to compensate for the expensive approval process.

But let’s look at where we are today and explore the FDA’s role in fighting the coronavirus.

We’ll start with this tweet about the bureaucracy’s unhelpful role last year as the pandemic was getting worse.

But I mostly want to focus on what the FDA is doing today to make our lives less safe.

Professor Garret Jones of George Mason University has a column in the Washington Examiner excoriating the bureaucracy’s deadly delays in approving another vaccine.

Good enough for Britain. Good enough for the European Union. Not good enough for the United States. That’s what the U.S. Food and Drug Administration thinks about the evidence for the Oxford-developed, AstraZeneca-made COVID-19 vaccine: the cheap, refrigerator-friendly, easy-to-transport injection that, so far at least, is 100% successful at keeping people with COVID-19 out of the hospital. The Oxford vaccine has been given to more than a million British citizens, and the EU is now scrambling to find as many doses as it can… So why hasn’t the Oxford vaccine been approved for use in the U.S.? Because the FDA made clear that AstraZeneca needed to finish its lengthy trials in the U.S., above and beyond the trials AstraZeneca had already run in the United Kingdom, Brazil, and South Africa. …My colleague at George Mason University, Alex Tabarrok, refers to the “invisible graveyard” — those dead because lifesaving drugs and vaccines were delayed or never invented. Every day we delayed vaccine approval in 2020 was a day that COVID-19 could spread unabated, killing people in the U.S. in the hundreds of thousands. And that deadly delay continues in 2021. …The FDA should approve the Oxford vaccine immediately. Since it doesn’t require fancy freezers, it will easily reach small towns and local clinics in a way that current COVID-19 vaccines in the U.S. can’t.

Since I have friends who have died from the virus, it’s infuriating that the FDA is hindering the approval and deployment of the AstraZeneca vaccine.

Heck, I would love the chance to get it myself, yet a bunch of cossetted bureaucrats are telling me that my life should be at risk instead.

If you’re wondering why the FDA is mindlessly causing needless danger and death, this tweet from Professor Jones may tell us everything we need to know (he also mentioned Pelosi’s unhelpful role in the column cited above).

Why is she putting people’s lives at risk?

Is it because she reflexively supports red tape? Is it because she’s getting campaign contributions from Pfizer and is trying to keep a competing vaccine off the market? Is it because Astra-Zeneca’s vaccine was developed in the U.K. and she opposed Brexit?

I don’t know the answer, but I’m 99.99 percent sure she’s already been vaccinated and isn’t at risk like the rest of us.

What about the FDA’s motivations?

Dr. Henry Miller’s recent column in the Wall Street Journal has some insight on why the bureaucracy is willing to put our lives in danger.

…countless patients could benefit, if Food and Drug Administration regulators were less risk-averse. I know that from firsthand experience. …As the head of the FDA’s evaluation team, I had a front-row seat. …during the early 1970s, as the supply of animal pancreases declined and the prevalence of diabetes increased, fears of drug shortages spread. Around the same time, a new and powerful tool—recombinant DNA technology, or gene splicing—became available. …Eli Lilly & Co. immediately saw the technology’s promise for producing human insulin…Insulins had long been Lilly’s flagship products, and the company’s expertise was evident in the purification, laboratory testing and clinical trials of Humulin, its new human insulin. Lilly’s scientists painstakingly verified that their product was pure and identical to pancreatic human insulin. …In May 1982 the company submitted to the FDA a voluminous dossier providing evidence of the product’s safety and efficacy. …My team and I were ready to recommend approval after four months’ review. But when I took the packet to my supervisor, he said, “Four months? No way! If anything goes wrong with this product down the road, people will say we rushed it, and we’ll be toast.” That’s the bureaucratic mind-set. …A large part of regulators’ self-interest lies in staying out of trouble. One way to do that, my supervisor understood, is not to approve in record time products that might experience unanticipated problems.

Sadly, this FDA mindset hasn’t changed.

As a result, Americans are needlessly dying.

P.S. Professor Alex Tabarrok has another example of senseless regulation from the FDA.

P.P.S. Here’s my column on the CDC’s unhelpful role in dealing with the pandemic.

P.P.P.S. And here’s what I wrote about the international bureaucrats at the World Health Organization.

P.P.P.P.S. When dealing with other advanced nations, we should adopt the principle of “mutual recognition” so our consumers have the option of benefiting from products approved elsewhere, such as the Astra-Zeneca vaccine.

P.P.P.P.P.S. In an all-too-typical example of Mitchell’s Law, politicians and bureaucrats have created a process than makes drugs very expensive. They then respond by agitating for price controls rather than fixing the underlying problem.

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Quotations: Economists’ Judgments about the FDA

Permitting 1: Significant Liberalization Supported, Definite Judgment

Gary Becker argues for eliminating the efficacy requirements, to improve health and to encourage lower-priced pharmaceuticals:

“[T]he prices faced by Americans can be lowered without price controls while drug development is encouraged, rather than stifled. A major step would be to eliminate FDA regulations introduced in 1962 that raise the cost of bringing drugs to market and artificially slow the process . . . Eliminating all requirements except a reasonable safety standard would vastly reduce drug prices in the U.S., as companies would be encouraged to develop additional compounds to compete for customers.” (Becker 2002)

“[To] return to a safety standard alone would lower costs and raise the number of therapeutic compounds available. In particular, this would include more drugs from small biotech firms that do not have the deep pockets to invest in extended efficacy trials. And the resulting increase in competition would mean lower prices—without the bureaucratic burden of price controls. In turn, cheaper and more diverse drugs would induce insurance companies and public providers to cover many more new drugs, even when their efficacy was uncertain . . .” (Becker 2004, 94)

“To be sure, some sick individuals would try ineffective treatments that would otherwise have been prevented from reaching market under present FDA regulations. But the quantity of reliable health information now available with only a little initiative is many times greater than when the efficacy standard was introduced four decades ago . . .” (Becker 2004, 94)

“As part of any relaxation of the efficacy standard, the FDA could further facilitate public access to relevant information. For example, it could allow drug labels to list separately claims that are supported by clinical evidence and those that are not. And it could be proactive in reporting what is known about the value of drugs in treating diseases, making data available through the Internet and other consumer-friendly media.” (Becker 2004, 94)

Noel D. Campbell: “There is an alternative to reform: abandon the current regulatory process and embrace the free market that has worked so well for so long in other fields. Free-market third-party certification promises safe and effective devices—quickly and efficiently—and gives consumers the freedom to choose the amount of risk that best suits them. The market provides consumers with the full remedies and protections of our legal system, and it frees businesses from the crippling costs of undue regulation.” (Campbell 2000, 342)

Milton Friedman: “By now, considerable evidence has accumulated that indicates that FDA regulation is counterproductive, that it has done more harm by retarding progress in the production and distribution of valuable drugs than it has done good by preventing the distribution of harmful or ineffective drugs.” (Friedman and Friedman 1990, 205–6)

“The way the FDA now behaves, and the adverse consequences, are not an accident, not a result of some easily corrected human mistake, but a consequence of its constitution in precisely the same way that a meow is related to the constitution of a cat.” (Friedman and Friedman 1990, 209)

“The FDA did far less harm than it does now before the Kefauver amendments altered the pressures and incentives of the civil servants.” (Friedman and Friedman 1990, 210)

“‘The FDA has already done enormous harm to the health of the American public by greatly increasing the costs of pharmaceutical research, thereby reducing the supply of new and effective drugs, and by delaying the approval of such drugs as survive the tortuous FDA process.’ When asked, if you could do anything to improve health in America, what would you do? Friedman replied: ‘No more licensing of doctors. No more regulation of drugs. Not of any kind. Period.’” (Pearson and Shaw 1993, 39, quoting their correspondence with Milton Friedman)

Dale H. Gieringer: “[T]he benefits of FDA regulation relative to that in foreign countries could reasonably be put at some 5,000 casualties [not lives] per decade or 10,000 per decade for worst-case scenarios. In comparison, it has been argued above that the cost of FDA delay can be estimated at anywhere from 21,000 to 120,000 lives per decade. . . . Given the uncertainties of the data, these results must be interpreted with caution, although it seems clear that the costs of regulation are substantial when compared to benefits. However, one conclusion that can be drawn with certainty is that the FDA fails its own criterion for public health: the FDA’s new drug approval system is in no way proven ‘safe and effective.’ ” (Gieringer 1985, 196)

David Henderson: “The tragedy is that these regulations are not necessary. The FDA may have some expertise when it comes to drug safety and efficacy, but on the only issue that matters—your trade-offs between various risks—you are the expert, and the FDA’s scientists are rank amateurs.” (Henderson 2002, 277)

Robert Higgs: “It [the FDA] could issue to products that meet its standards a seal of approval. Consumers would then know that a certified product had passed whatever tests the FDA considered appropriate to demonstrate its safety and efficacy. Consumers would be free, however, to disregard this information if they did not value it. They would be free to purchase products lacking FDA certification, and sellers would be free to sell uncertified products without government obstruction or penalty. Note that no one would be forced to use products lacking FDA certification. Sellers also seek product certification from private testing organizations, whose seals of approval might become more sought after than those of the FDA.” (Higgs 1995c, 99–100)

“The lack of demonstrable benefits from FDA device regulation is hardly surprising. Even if the FDA did not exist, normal market incentives combined with the terrors of product liability litigation are more than sufficient to encourage manufacturers to produce reasonably safe and effective products . . . The emergency care providers, hospital administrators, and medical practitioners who purchase the bulk of the devices have experience and knowledge and access to ample expert information about products from reliable sources such as ECRI, TUV Product Service, and a variety of trade and professional publications. They fervently desire to help, not hurt, the patients they serve, and their reputations depend on their success in doing so. In short, neither device purchasers nor patients need the FDA’s ‘help.’ The agency’s intrusion has clearly created far more cost than benefit . . .” (Higgs 1995b, 81)

Walter E. Williams: “Here’s the modus operandi: If FDA officials mistakenly approve a device that has unanticipated harmful effects, their necks are on the chopping block because the victims are highly visible. Career-minded FDA officials don’t like that kind of exposure. They prefer the hidden mistake, erring on the side of overcaution by needlessly delaying approval. When FDA officials err on the side of overcaution, their victims are invisible. After all, you didn’t know there was a device available that could have saved a loved one’s life, as would have been the case had the angioplasty procedure occurred in Belgium or some other European country. . . . The FDA is long overdue for overhauling. In the process, Congress should allow for private medical-device certification.” (Williams 1996)

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I found this article below from “Reason Magazine” very thought provoking

Deliberately Infect Healthy Young People To Test Coronavirus Vaccines, Propose Bioethicists

An idea that could really speed up vaccine development

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U.S. military physician Walter Reed and his medical colleagues famously had mosquitoes bite volunteers in order to establish that the disease was in fact borne by the flying pests. This finding was the basis of successful mosquito control efforts to reduce the incidence of the disease in tropical areas. The volunteers in these experiments were paid $200 to participate and $500 if they contracted yellow fever. These substantial payments, made in gold, would amount to approximately $8,000 and $20,000 respectively in today’s dollars.

Now Rutgers University bioethicist Nir Eyal and his colleagues are proposing something like Reed’s “human challenge” study as a way to speed up the development of a vaccine against the novel coronavirus that is responsible for the ongoing COVID-19 pandemic. The idea is that vaccine developers can cut more directly to what is essentially a phase three clinical trial. In phase three, vaccines already tested for safety are generally given to a large group of folks who are at risk of the targeted infection and monitored for a considerable period of time to see how many of the vaccinated people actually come down with the disease versus a group of unvaccinated people.

As Eyal explains in Nature, the proposed idea would “gather a group of people at low risk from any exposure—young and relatively healthy individuals—and ensure that they are not already infected. You give them either the vaccine candidate or a placebo and wait for enough time for an immune response. And then you expose them to the virus.” So instead of waiting around for the virus to find (vaccinated and unvaccinated) folks in the wild as researchers do in regular phase three trials, you speed things up by bringing the virus to them.

Setting aside the misery of illness, the risk of death rate for folks under age 50 is about 1 in 200. Eyal argues that such a trial would be ethical on the grounds that we allow people to engage in risky activities all of the time such as volunteering for emergency medical services that increase their risks of exposure. In addition, volunteers in the trial who are being carefully monitored for the disease would likely be safer than folks relying on the general health care system to treat them.

The authors argue that such human challenge studies, by accelerating vaccine evaluation, could reduce the global burden of coronavirus-related mortality and morbidity. If both test subjects and researchers volunteer to take this on, let’s do it.

Milton Friedman on Donahue – 1980 (First Appearance)

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