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Milton Friedman on the FDA: Risk Avoidance
Put yourself in the position of an FDA official charged with approving or disapproving a new drug. You can make two very different kinds of serious mistakes:
1. Approve a drug that turns out to have unanticipated side effects resulting in death or serious impairment of a sizable number of persons.
2. Refuse approval to a drug that is capable of saving many lives or relieving great distress and has no untoward side effects.
If you make the first mistake, the results will be emblazoned on the front pages of the newspapers. The finger of disapproval, perhaps even of disgrace, will point straight to you.If you make the second mistake, who will know it? The pharmaceutical firm promoting the new drug…will be dismissed as greedy businessmen with hearts of stone…. The people whose lives might have been saved will not be around to protest. Their families will have no way of knowing that their loved ones lost their lives when they did only because of the [in]action of an unknown FDA official.
— Milton Friedman
This is baked into the FDA pie – every process reflects this central approach to risk. The consequence is that tests of efficacy that should take days or weeks (in the case of Corona) will take, according to the government, many months. Vaccines cannot be “proven” for a year or more.
So we have this central tension right now. The FDA is institutionally incapable of sticking their necks out to support rapid tests or hydroxychloroquine or any other treatment. There are too many unknowns and they are paralyzed. The only thing the bureaucrats are sure of is that they should not make any mistakes by acting too fast. That, and anything Donald Trump supports is probably a bad idea, so they should reflexively oppose it. Can you imagine the opprobrium in the Beltway if the FDA is seen to help the President end a crisis?
So now we have the spectacle of Rudy Giuliani interviewing Zelenko and presenting the findings directly to the American people. The President has to engage in asymmetrical warfare against the Deep State in order to do his job.
If this goes as I would like it to, the FDA ends up being so discredited that its role is reduced to a purely advisory one going forward (seals of approval for medicines and devices, but no veto power). That would be a happy result, indeed! Milton Friedman would be thrilled.
Published in General
iWe, thank you for your post. We need to be reminded of the human tendency you describe. The more it’s described, the more steel will go into the spines of those who make those kinds of decisions.
You have to have balls to push back against the tendency to play it safe.
I’m reminded of a Jeff Bezos quotation. It’s not quite on your thesis, but close enough to underscore it: “If you can’t tolerate critics, don’t do anything new or interesting.”
Here’s a better quote, this one by Stone Cold Steve Austin: “Safe ain’t gonna get you [. . .] in this world.”
I find it unconscionable that the federal government would be saying anything other than “We’re sorry. We really blew it. We took all your money all these years, and we spent it on things that don’t matter and ignored the things that do. This is our fault. You’ve been paying us to prevent just this very situation. Do what you think best for yourself and your family. Don’t worry about us.”
I can accept, sort of, requiring tests for safety, that is, no disastrous side effects, but have always rankled at the efficacy requirement. Efficacy can vary widely among people and the authority has to target a normal population. I would leave it to the users to determine if it works for them. I like your idea better.
On a completely unrelated note, I propose the startup of “Placebo Brand Nostrums”, the most widely tested drugs in recorded history have been Placebo!
This concept should be extended to most Federal Agencies. Modern examples include low flush toilets, gasoline cans, child safety seats, EPA vehicle mileage, smoke detectors in every bedroom, so called wetlands, etc. Let each state pass and enforce laws that apply to their jurisdiction. Let individuals petition the Federal Courts where anti-competitive behavior between states exists, such as not allowing transport across state lines due to EPA mileage. Only then have the Congress / President codify regulations that are needed nationally. No more “the Secretary shall…,” make Congress do real work for the country.
Something that needs to be addressed every single time the mention of the FDA or the CDC comes up: If a medicine or treatment protocol comes up that is not owned by one of the companies inside the inner circle of the FDA, and if there is no way for that inner circle to profit to acquire immediately a patent on that substance or protocol, not only is it unlikely that med or protocol will be approved, its use will be made illegal.
I do not say this lightly. I spent thirty years of my life trying to understand why the “safe and approved” aerial spraying of malathion across residential communities in California was not only permitted and mandated by Jerry Brown during his 1980’s tenure as Governor of California, but why it then went on to destroy my well being.
It was not until the end of the 1990’s that I received word via my editor at The Coastal Post that a letter had come to me via the monthly Marin County newspaper. The letter was a detailed description of how the Governor had been buddies with someone who needed to unload tons of Calif produce to companies in Japan. Then Japanese officials would not give approval of Calif produce until they had total confidence that there would be no transfer of Calif’s med fly to the nation of Japan.
Hence the onslaught of spraying of malathion. Not only did I lose my skin pigment to this spraying, babies who were in utero at the time, circa 1981 to 1982, had a high proportion of unusual stomach linings that were detected several years after the aerial med fly spray campaign. These unusual stomach linings often result in stomach cancer.
Despite this nefarious aerial spraying that Brown mandated, he continued to be applauded for being the most environmental official in the USA, and I still hear from friends who live elsewhere how lucky we Californians were to have him as our Gov.
Part Two: So since it is unlikely that Big Pharma can profit from an encouraged use of the Hydroxychloroquine, this will be a remedy that will be pushed aside through any and all possibilities. Doctors who prescribe it might be told that the Big Insurers will no longer offer them malpractice insurance.
Families of patients who might need it could be told their insurance will not cover it. (It is not expensive, so people should be willing to pay for it out of pocket -as if a relative is dying of COVID, better to get a working treatment than to hope the family member survives on life support long enough to be able to get the still-in-development vaccine.)
BTW, my first husband had been treated with Hydroxychloroquine in 1969, when he contracted malaria on an Army base in Virginia. It took a while to even get a diagnosis, as very few Americans at that point in time got malaria while being in the USA. Some old time-y vet who knew James told him to go back to the base doctor and tell him to give him a test for malaria. Without that older service man’s advice, James might not have gotten the treatment in time. He received the same drug when the malaria flared up again in 1972.
What Big Pharma really wants and expects is for the $ 400 per jab vax for COVID 19 to be made readily available. When you do the math, it becomes exceedingly clear why this is desired. So the $ 400 per jab times 330 million people is a cool 132 billion bucks.
When I spent considerable time in Sacramento on business for the California Medical Association about that time, a friend took me into the Capitol to see the newly decorated Assembly chamber. The workmen had sculptured a med fly into the plaster ceiling of the chamber. I don’t know if it is still there. It was in the right rear corner of the ceiling.
There was malaria in California from returning vets in the 70s who had developed it in Vietnam and were then bitten by local mosquitoes which passed it on.
The FDA has approved the large scale trial that is going on in New York. In fact that’s how New York got the drugs for the trial.
And tell me, does the trial take much longer than the course of the disease in a patient? If so, why?
I don’t know if there has been anyone I agree with more than Milton Friedman. His PBS series and book, Free to Choose, changed my life as much as any intellectual influence could. I haven’t taken the time yet to review his criticism of the federal banking system in the Thirties, but as I recall he thought the Great Depression was created by a contraction of the money supply that could have been easily avoided. We are certainly not going down that road this time. I don’t know if he would approve of this massive government stimulus plan but I wish we had his wisdom and guidance today.
There should be room for “neutral” in the FDA – not enough information for A-ok or very bad idea? Then its between you and your doctor. Of course, the reason for FDA approval is about insurance more than anything else. Lack of FDA approval doesn’t stop the supplement markets.
But insurance doesn’t pay for stuff that FDA doesn’t approve. If we had free markets there, I wonder how well an insurance company could do with lower pay outs on FDA “neutral” options. Not fully covered, but not outright rejected, either.
I think insurance companies and beaurcratic avoidance of risk has been part of what is hampering all of us on risk. I don’t know – it’s a perverse cultural artifact, this paralyzing risk aversion that keeps people from acting on their own cognizance.
I don’t think that anyone blew it in a significant way. It is a novel virus. It didn’t help that the ChiComs apparently withheld information.
There was a problem with CDC’s initial test for the virus. This was bad, but I don’t see how it contributed to the spread.
A long time ago (early 90s), I was in a local pizza joint at the university I was attending, and one of the regulars came in.
“I know what I’m going to do with my life. I’m gonna be a professional wrestler!”
We all started poking fun at him. I mean, what sort of living is “professional wrestler” going to be for a young, college-educated guy?
It turns out he did go into wrestling, but he changed his last name, because it was sorta boring.
He changed it to Austin…
Great post, iWe!
I was planning to say exactly this.
The FDA in its present form is an abomination and one of this country’s worst departures from its Constitution. What right do they have to stop people from taking medicine if they are aware of the risks?
If you’re sick and want to try a medicine, would I, BastiatJunior, have the right to stop you because I deem it unsafe? Would your next door neighbor have that right?
If your neighbor and I don’t have that right, why should the government have that right? That question should be asked about everything the government does with very few exceptions. And those exceptions happen to be written down.
You’re right that the FDA’s findings should be non-binding. Also, it should be privatized and subject to competition.
The huge problem that no one has mentioned, except tangentially is…
LAWYERS. Personal-injury lawyers in particular (apologies to my late brother-in-law). Just the threat of a lawsuit prevents so much beneficial action in this country.
The FDA thinking can be summed up in one word, the word that has shaped their institutional culture: thalidomide.
Which was about safety not efficacy
Let’s not forget vioxx in 2002 or 2003
They have failed completely to be prepared and to prepare the country for an infectious disease like this. It has been a possibility for decades. Urbanization and air travel have made this inevitable.
CDC has one job. Apparently it’s too much work. Heads better roll after this nonsense is over.
Shout-out to @mbchoe.
https://www.msn.com/en-us/news/us/fda-issues-emergency-authorization-of-anti-malaria-drug-for-coronavirus-care/ar-BB11SD0U
Note that when Democrats use chloroquine they‘re not acting “despite scant evidence.” A lack of evidence only applies to Republicans.
Note also how important it is to have high standards: It’s not enough that we don’t use drugs that MIGHT do HARM. It’s also necessary to not use drugs that might NOT do much GOOD–at least as long as it’s a Republican President.
Note also how Trump jumped ahead of the evidence and totally said it definitely works, and everyone should take chloroquine, and self-medicate to be safe.
Exactly, if you read the fine print on any bottle of vitamins or herbal supplements you’ll find a standard disclaimer like “These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.” Yet that’s nonsense, why else would anyone take these supplements if not to prevent or treat disease?
The line between a “natural” supplement and a “drug” is pretty arbitrary anyway, so why not allow the sale of drugs with similar disclaimers on them?
The FDA should focus on one thing: safety, do no harm.
They have no business evaluating efficacy.
plus they suck at it
I’m all for eliminating as many non-elected bureaucrats from government as possible. This zero-accountability culture we live in needs to go. Heads must roll, indeed. Bureaucratic heads.
Avoiding risk can make more people die. We advocates for more medical liberty need to remind people of that ceaselessly.
There is heroism. There is bureaucracy. There are no heroic bureaucrats.
There’s never an emanation of a penumbra when you need one.
John Nestor may be an extreme example of how the FDA does business but seems to be somewhat representative of the type. At the FDA from 1968 to 1972 he approved zero drugs for use viewing all to be potentially dangerous. Also he managed to greatly annoy commuters in the DC area be driving only 55 mph in the left lane during rush hour…for those that are interested in the rest of the story there is more here: https://timeline.com/this-man-pulled-into-the-fast-lane-to-drive-55-mph-and-he-pissed-off-all-of-washington-d-c-a55596ca165d
https://youtu.be/ZNS37iwWy6o
3 minute segment with Milton Friedman and a very young looking Peter Robinson