Does RFK Jr have a guiding philosophy or is he just spitballing?

What are the philosophies of health care regulation? What is Ramaswamy's? Gottliebs? Mine?

One recurring comment after my last few essays on RFK Jr. is that even when he is right, RFK Jr. is right for the wrong reasons. He is a magic-8 ball. He is just spitballing. He doesn’t have a coherent philosophy.

I think this criticism is incorrect. I do not share RFK Jr’s philosophy, but I think he has one. In this essay I will describe the 4 philosophies of health care regulation, including mine. Each philosophy is vulnerable to a type of mistake.

RFK Jr. - Anti-corporate, environmental lawyer level skeptical, pro body autonomy

RFK Jr. has an anti-corporate, environmental lawyer, skeptical philosophy. This means he is concerned about food additives, pesticides, and the role of big Pharma and big Agriculture.

He is pro-bodily autonomy so he opposes vaccine mandates and is pro-choice on the issue of abortion. This is an interesting pairing as so many people support body-autonomy in one case but not the other. Democrats, for example, are pro-choice but were happy to ram unethical COVID vaccine mandates (I call them unethical because the mandates took place when they KNEW vaccines could not halt transmission, in other words, after they knew it could have no third party benefits, which is a longstanding ethical pre-requisite to a mandate).

Body autonomy explains RFK Jr’s views on raw milk as well. If you want to take the 7 in 100,000 risk, that’s on you.

RFK Jr.’s skepticism is intense, and as such he easily imagines that ivermectin and vitamin D and zinc and HCQ work for COVID and there was a conspiracy to suppress these results. In my opinion, these drugs don’t work. Half of people with covid never felt anything and many others had a mild cold. Very sick people benefit from dexamethasone and antibodies, and a few other things, but most of what we did was overkill. Classic medicine by fear.

I think RFK Jr’s philosophy has as its’ strength that he holds corporations to a high standard. As you will see, few do that. As a weakness, he is likely to believe in false safety signals (e.g. MMR, autism), and he is prone to support cheap, repurposed medications that don’t work. If medications cost a lot, he would probably be more skeptical of the evidence, but not if they are cheap. That’s the anti-corporatist in him, and his blindspot.

Vivek Ramaswamy - Pro corporate, pro market, pro autonomy, anti-cronyism

Ramaswamy is a former drug developer. He is a great speaker. He outlined his philosophy in a series of recent tweets.

He thinks FDA sets too many hurdles for companies that are needless. He thinks the FDA should focus on making drug makers run safety studies, but maybe should not be in the business of demanding costly studies that don’t really establish efficacy. He doesn’t think FDA should demand fake efficacy.

Here is a little more history on this topic (edited from my tweets):

From the original Food and Drug Administration act until the Kefauver-Harris (KH) amendment in 1960s, there was only a safety requirement at FDA, and it was poorly enforced. One FDA reviewer famously prevented thalidominde from coming to the US market. This drug caused birth defects in the UK. This led to the KH amendment, which gave FDA an efficacy standard. Strictly speaking, the amendment may have only been tangentially related to thalidomide. I.e it provides no strong assurance that a future approval would not be a teratogen.

Yet it was clearly motivated by the concern that we will have severely unsafe drugs in the US as they did in Europe. Of course, thinking about a drug product can only be done in terms of net benefit. You need to know both the efficacy and harms. No amount of randomized testing can establish the full safety profile. But, randomized testing, when done correctly, can establish efficacy.

From the 1980s and 1990s. The USFDA was pretty strict about efficacy. Efficacy standard was used, and often two randomized control trials was needed. In the early 2000s, based on heavy lobbying, the FDA began the gradual decline of the efficacy standard. What counts as efficacy shifted from clinical endpoints to more surrogate endpoints. Two trials to one. Controlled trials to uncontrolled. Surrogate endpoints are imo meaningless and in many cases do not have a good correlation with clinical endpoints. Yet, they provide the illusion that some efficacy has been demonstrated.

Most clinical studies, and most drug products currently being approved by FDA have inadequate data at the time of approval. The studies are bad. Just think COVID boosters in toddlers. We are approving the majority of new cancer drugs without clear evidence that they improve living longer or better. Meanwhile it costs a fortune and takes a decade to bring a drug to market. Finally, the FDA allows prices to be kept high b/c it weeds out competition. And there is corruption. The majority of cancer drug reviewers who leave FDA work for pharma. It is a sick revolving door.

So we have the worst of both words: high prices, high hurdles, but no real efficacy standard.

In this context. some propose that for some drugs and some purposes, they should only provide a metric of safety. In some ways, this is preferable to the status quo in which a false efficacy claim is made. I am happy to defend the proposition that for some drug products it's better to have no efficacy data at approval than false efficacy data. The final consideration is the lofty price of drugs. By increasing competition and removing the fake stamp of efficacy, you will lower the price.

The weakness to this view is that it may permit some ineffective drugs to be used by people based on marketing, though to be fair, the status quo also does this, just at a much high price.

If you believe in this substack, please subscribe

Scott Gottlieb & Bob Califf - Corporate sell outs, autonomy indifferent, cronyism, selective evidence, status quo

The last few FDA commissioners under both Democrat and Republican presidents are the same. They are pro-corporate, sell outs. They tend to work in Goverment and then consult for or work for Pharma. That’s true of Scott Gottlieb (Trumps last FDA commish who is now on the Board of Pfizer) and Bob Califf (Obama and Biden’s FDA commish who has consulted for Pharma and worked for Verily) They are incrementalists, status quo folks.

They don’t believe all new drug products need randomized trials measuring clinical endpoints. They believe in the illusion of efficacy. Gottlieb approved Lartruvo which was a sarcoma drug. To do so he perverted accelerated approval rules. Instead of a statistically persuasive effect on a surrogate, he extended this to a statistically dubious effect on a hard endpoint. But this change would incentivize drug makers to run trials at random— its actually much more perverse than the old fashioned accelerated approval.

Califf approve Exondys against the advice of primary reviewers. Califf repeatedly lied about vaccines for covid and Paxlovid on social media. He completely made up the lie that “misinformation is the leading cause of death”. I couldn’t believe the irony. He acted less like a commissioner and more like a Pharma ad department in his term.

The philosophy shared by these two is the most dominant philosophy in health care regulation. Make the efficacy bar slightly lower, keep the burden to get the market, ensure high prices, and then when you are done in Government go to Pharma to reap your reward.

American’s voted to shake the Snowglobe by voting for Donald Trump and these status quo, sell outs do not represent that. With them, it will be more of the same, and the American people will be the frog in the pot of water, heating slowly.

The weakness to this view is that it permits many ineffective drugs to be used by people and keeps prices high. It is the worst philosophy.

My view - Anti-corporate, pro-autonomy, evidence based medicine skeptical.

My view is none of the above. I have written two books that flesh it out in detail. I am skeptical of corporate interests. I have never taken a dollar from Pharma, and I think not even a free coffee. I have lectured at Genentech and Pfizer, but I packed a thermos of coffee and fasted all day to avoid any conflict. I did use the water fountain.

My view is not as skeptical as RFK. I believe in most childhood immunization, but I think differences between countries should be explored with cluster RCTs. I do not think MMR vaccines cause autism, but I am sure there are safety signals we may be missing for all drug products, and I think we need a new Phase IV safety detection system. I am sure there was pressure not to find safety signals with COVID vaccines and the handling of VITT and myocarditis was problematic. I think vaccine makers should face litigation, as drug makers do.

I am a practicing doctor, so I know what it is like to make medical decisions without perfect evidence, I do not demand an RCT for everything, as my critics say (just the illiterate ones who don’t read my books), but I despise the cronyism of Gottlieb and Califf, and think government can encourage manufacturers to run better trials that inform the public.

I am sympathetic to the Ramaswamys of the world. I agree that for some products it is better to not have an efficacy claim than a false one. The current system is approving cancer drugs after giving them to 100 or less people with no control arm. How does that establish anything? It is neither safety nor efficacy. It is an illusion used to trick payers and patients.

I am more sympathetic to libertarians than to the corrupt cronyism that has captured both parties.

The weakness of my view is that it would slow the number of new drugs each year, and make Pharma less profitable. In my opinion, we will only use the useless drugs preferentially, but some economists will disagree.

Conclusion

There are 4 philosophies of drug regulation. RFK Jr has one. I have one. Ramaswamy has one. And Califf has one. If we don’t get RFK Jr, we will likely get another corporate sell out. Maybe even Albert Bourla himself. Maybe he won’t have to quit Pfizer,. Perhaps this time, we can have an FDA commissioner who simultaneously runs a Pharma company. It will make the status quo so much easier.