Politics, Capital Markets, Misinformation and the Impact on Biotech: Q&A with Jeremy Levin

Marty Makary is reportedly out as head of FDA. This comes during a turbulent time for health agencies in the US government. Since coming into power last year, the current administration has made significant changes to leadership roles, with entire committees being removed and replaced.

Pharmaceutical Executive recently spoke with author Dr. Jeremy Levin, who’s promoting his new book Biotech in the Balance: Saving a Strategic Industry in an Age of Distrust. During the conversation, he discussed issues caused by current leadership, along with other problems that have been developing for years.

According to him, the industry must address its relationship with the capital markets, address misinformation issues, and push back against the politicization of medical research and development.

Click here for the video version of this interview!

Pharmaceutical Executive: What is the state of FDA at the moment?
Jeremy Levin: FDA, an iconic institution, is undergoing massive change. Its current state is at best, unclear. About 90% of the leadership since last year has gone, so institutional knowledge is profoundly disrupted.

The leadership there is not clear how it's going to be changing or where the direction will be. There have been lot of very good statements, but at this stage, I'm uncomfortable opining on what actually is going on, except the following: number one, there's a lot of disaffected individuals who are very, very troubled by what's happened, and there is a clear sense that we do not have certitude about where we're going.

PE: What are the risks of conflating politics with science?
Levin: The fundamental risk in introducing politics into science is much like what we saw with Lysenko in Russia. The minute you bring policy politics and say that politics override fact, at that minute you change the very fundaments of what has created the industry that we know.

In the pharmaceutical industry, we rely on facts 100%. They cannot. When you do an experiment and it says something that's a fact, you can't simply then change that by politics.

You can try and refute the fact by an experiment, but you cannot make it right or wrong with a political decision. The minute you do that, you completely undercount the foundations of the industry, which is rigorous, scientific, factual truth.

PE: How is misinformation impacting evidence-based medicine?
Levin: There is really no doubt that misinformation plays a terrible role, and the media has a significant role to play in this. Instead of curating, they're simply repeating. And that is not a good thing where you have an enormous volume of different sources of information unparalleled in human history, and each one appears to be telling you the truth.

Quite frankly, the strength and power of this can be seen extremely simply when we go back to the publishing by The Lancet of a fact that they knew at the time to be questionable at best, and the editorial board did not want to publish it. That was saying that there was a link between MMR vaccines and autism.

It took them many years to retract that. That absolutely false article became magnified throughout the industry, and today we harvest this in the form of extraordinary vaccine hesitancy. And that was a magnification. It was one simple publication magnified out of many years.

Frankly, the really troubling part with this is the sad fact that The Lancet did not immediately retract it. When they knew that they had retracted it, they did not galvanize all of the other publications with them to simply say, This is nonsense. We know it was nonsense, and everybody out there better understand it's nonsense.

The very publications themselves are actually helping this by not wanting to go back and clarify that the statement they made was an error. They did it once, and that's it. They will never look back and say this again.

However, the consequence of that simple article is that we've seen measles return in this country. We're going to have a real problem with the next pandemic, because any kind of vaccine presented to large numbers of very well-meaning people who are getting all sorts of information problems, and they're not seeing it.

PE: What is the relationship between the capital markets and biotech?
Levin: The capital markets and biotech are actually completely mismatched. Biotech grew out of a group of amazing individuals, Herb Boyer and others, out in California in 1973, then moving on to found Genentech and meeting a venture capitalist and taking a huge chance, a tiny little step right at the birth of the industry.

Now we fast forward. We have many thousands of companies, totally, about 1000 who are really of consequence and size. But the one thing that has happened is they've simply grown up in a capital market that was never designed for them. The capital markets and the legislation didn't see this as a national strategic asset. It was just another piece of stock to be traded in the capital markets, just like any other.

The difference is the timescale. The timescale from taking a risk in a private company through to finding a medicine is a 10 year period. There are very few other products that look like that.

Furthermore, if you're in the the digital world, you can launch your product after a couple years. And if it needs to be tweaked, you tweak it so the capital markets can adjust with that, and it's all about sales.

In biotech, if your science is slightly wrong, if your clinical trial needs to be thought through again, you are punished unmercifully, and what happens is the stock collapses around you. There are many things that could have been done if there had been a policy adopted and a clear strategic recognition of what biotech does for the United States and for the rest of us. After all, we produce 70% of all the medicines that large farmer sells. This is an extraordinary figure.