The Sooner the FDA Is Disbanded, the Better For Us All
The Food and Drug Administration must go. And salt should be sown where once it stood. This organization is costly, is a gargantuan waste of time and causes needless deaths by slowing down innovation. The sooner is it disbanded, the better.
This seems a bit harsh. Ok, excessively severe. Does not the FDA stand between us and pharmaceutical firms that would exploit us but for its heroic efforts? Does not the FDA ensure the quality of, wait for it, food and drugs? Does not the FDA serve as an excellent traffic cop in this field? No, no and no. Rather, this bureaucracy stands in the path of the very assurance with which they presumably provide us.
Their mandate is to ascertain that any products brought to market must pass a two stage test. One, they must be safe, and two, they must be effective. Some commentators argue that while the first mandate may be a reasonable one, the second is unnecessary and only slows down the rate of progress. As long as a new offering is safe, it addresses the foundational medical requirement, “First, do no harm.” Whether or not it is also effective should be up to the patients and their doctors. To insist upon the second as well as the first necessarily slows down new development.
This is all well and good, but we should also question the second test, safety. The FDA is a monopoly. It, and it alone, makes all such determinations. But one of the most basic discoveries of the dismal science it that monopolies lead to extra costs, poor service and lack of accountability.
How else, then, can these functions of safety and effectiveness be attained. Milton Friedman hit the nail on the head in his book Capitalism and Freedom; he proposed, instead, a certification industry. The problem with the FDA is that it constitutes a licensing arrangement. Go ahead without its imprimatur, and you go to jail (and do not collect that proverbial $200). In contrast, without a certification, you may still bring your goods to the consumer, but without official approval. This system works in a myriad of other contexts. There are Certified Public Accountants; but any old book keeper can help you with your tax returns. For stocks and bonds there are Moodys, Standard and Poor and Fitch. The Good Housekeeping Seal of Approval and Consumers’ Reports serve similar functions as do commercial testing laboratories. Why not, also, have a group of private firms independently evaluating food and drugs? We rely on competition as the bulwark of our free economy. Why not here also?
Not only is the FDA a monopoly, it is also a governmental institution. That means no matter how many mistakes it makes, it can never, at least not automatically, go out of business. Its employees are human beings, and we are the mistake making animal. At least private monopolies are somewhat subject to market forces. Without bailouts, or the “too big to fail” philosophy, it is possible for them to no longer darken our doorsteps. Not so for the FDA (nor for the Post Office, the Motor Vehicle Bureau, the Departments of Agriculture, Education, etc.). Any private certification company approving of Thalidomide (great for morning sickness, but created birth defects) would quickly enough be bankrupted.
This brings us to Louis Falo and Andrea Gambotto. These gentlemen, both Professors at the University of Pittsburgh, are hot on the trail of a Covid 19 vaccine. The former, a dermatologist, the latter a surgeon, have concocted a medicine called PittCoVac. It is to be administered to the skin via a patch exhibiting 400 tiny needles. One of its benefits is that it need not be continually refrigerated, a consideration very important especially in the underdeveloped world. I asked Dr. Andrea Gambotto for the earliest date on which he concluded he and his team had success with this new drug on mice regarding a disease biologically related to the coronavirus. His response: March 5, 2018. My follow up question to him was for the date on which he applied for FDA approval for use on human subjects. He gave me a one word response: “Confidential.” I don’t know about him, but if I were in his shoes, I would have applied for this permission as soon as Covid 19 reared its ugly head. When was that? Some date this as of November 2019. Certainly, it was well entrenched, and recognized as such, by February 2020.
Doctors Falo and Gambotto are now only waiting FDA approval for use with human subjects. Let me repeat that: this experimental drug is now waiting FDA approval for use with human subjects. Anyone see anything wrong with that? The FDA is now fiddling while Rome is burning.
Surely, there are some people, then at death’s door, who would have given their eye teeth and more, to be the first human subjects for PittCoVac. Safety and effectiveness be damned, in their view. They just wanted one last roll of the dice before meeting their mortal coil. Several of them have now passed beyond human care, thanks to the FDA! It is now not days, not mere weeks, but perhaps several months since Falo and Gambotto have applied for an FDA license for use on human subjects. That is far too long. Is it totally unjust to think of Agency bureaucrats holding up the works as being guilty of manslaughter? Only if PittCoVac really works, and we will not know that for quite a while yet.
With a private certification agency overseeing matters, human beings, on an informed consent voluntary basis might have already determined whether or not PittCoVac would be one of our answers.
Yes, this government bureaucracy has in its power the ability to in effect temporarily cancel its always unwarranted control. Right now, it has given the go-ahead to Remdesivir, a product of Gilead Sciences, under its Emergency Use Authorization policy. Thank goodness for this, as it may well save precious human lives, even though, I suspect, the motivation for this was more political than scientific. At present, some are calling for a packing of the Supreme Court. No one is mentioning setting up a governmental alternative to the FDA, hence in effect “packing” it. It is to head off any moves in this direction that might well explain its decision via Remdesivir.
But this humane decision undercuts the very case for its existence! One would think that now with the dire threat of a pandemic we would need the safety and efficiency provided by the FDA even the more. But it now lays down its “weapons” when they are presumably needed the most. What would we think of soldiers who disarmed in the face of the enemy? We would surmise they were not needed. “Emergencies” occur all the time. There are always a few patients, with no other options in sight, who would like to take a chance on a non-FDA approved remedy. If the FDA utilized its Emergency Use Authorization in all these cases, there would be in effect no FDA; it would be converted from a licensing agency into one properly limited to certification.
Says Michael Milken in this regard: “We send 19-year-olds into war zones knowing that no matter what we do, some number – greater than zero – will lose their lives or their limbs. But we tell a patient who is going to die not to try something because it could be dangerous.”
Henry I. Miller, writing in the Wall Street Journal (April 23, 2020), has a very different suggestion in mind to meet this challenge: streamline the FDA process. To wit, he urges:
* animal studies to be allowed to take place at the same time as Phase I clinical trials
* lower wait times from 30 to 10 days from application to start of Phase I
* “publish a template ‘master protocol’ for streamlined Covid 19 vaccine development”
* unblind trial results earlier
* share data better
* allow approval for only parts of Biologics License Applications
* accelerate approvals for drugs tested on limited populations
* establish approval reciprocities with other countries.
None of these proposals are counterproductive. Mr. Miller is to be congratulated for making them. But none have so far been effected by that dinosaur, the FDA. Why is it that in reading this list, “rearranging deck chairs on the Titanic” comes to mind? The reason is that these suggestions leave in charge the very people responsible for not implementing them in the first place. What else can be expected from a governmental bureaucratic monopoly?
End, don’t mend, the FDA