Thoughts on Lex Fridman's interview with Pfizer CEO
Pfizer CEO shows little humility and mostly defers to regulators
Lex Fridman recently interviewed Albert Bourla, the CEO of Pfizer. Lex asked about the process of creating a vaccine, clinical trials, safety, Pfizer’s reputation among other things.
This is the first time I’ve heard the Pfizer CEO speak so it was interesting. However, some of his answers were less than inspiring.
Full disclosure, I have received two shots of the Pfizer vaccine as well as the Pfizer booster shot.
On drug trials
Lex asked Albert indirectly about the profit motive a drug company has to get their drugs approved and how this could affect the bias of the trials:
Lex: On a philosophical level, on a human level. Do you ever worry that the pressure to cover the costs that were invested to develop a new drug to develop this vaccine harms your ability to conduct unbiased studies?
Albert: Not at all because the studies are highly regulated. Everybody knows what regulators and when I say regulators F. D. A. European authorities, UK authorities, Israeli authorities, the police authorities, Canadian authorities want to see how the study needs to be conducted and what exactly they need to see to approve it or not? So clearly everybody takes into consideration how much money I'm going to invest and what is the chances that I'm going to lose them. But what you can do is just to change the rules of the game so that you won't lose the money. There are very well established methodologies that would say very high precision if your medicine is effective if your medicine is safe and those are there for all and are playing with the symbols,
This is a repeated theme you’ll hear from Albert. There are regulators and regulators are in charge of ensuring safety, efficacy and a unbiased studies. Fair enough, but it doesn’t exactly inspire confidence.
Imagine you went to a seafood restaurant and asked about their food safety, and the owner told you they follow all applicable food safety rules. Yes, I’m sure they do, but I would hope the owner puts thoughts into his process to ensure safety beyond the reach of regulators. That should be the starting point, yes, but to not even consider your company’s role in the process is surprising.
Lex then asked about the expected 75 year review process to release all the Pfizer trial data:
Lex: Do you have an intuition about why is the FDA trying to get 75 years To release the Pfizer data? They're trying to request that we will not be released for 75 years. And then maybe the broader version of that question is, do you think people should have sort of full transparency and immediate access to the data immediate? You know, on the scale of weeks, not years.
Albert: I think the relations with regulators there have been always very transparent and there are a lot of laws that they are forcing regulators to and companies to put out their their interactions and what exactly was discussed now to go into specific details of have some discussions. I don't know what is the reason that FDA wants to take the time and but I'm sure they have very good reasons.
That answer was a total punt, and unlike most other times in the interview, Lex pushed back, asking if Albert sees the FDA as a black box, to which Albert replied:
Albert: But this is not a black box. We know very well what is the process. Everybody knows very well. What are the processes the review process Also it is very detailed. They have scientists of very, very high caliber, not every regulator in the world but the Europeans the bridge the FDA. Clearly they have very, very high caliber of science that they are going into a lot of details and also basically everything for a study is really released by law in the specifications of the product but it's a very detailed document that it is issue and has basically the essence of everything was discussed. I don't know about specific documents if take them time to to release. But clearly this is not a black box type of process.
Basically he’s uninterested or has no thoughts beyond the operational duty of getting drugs approved. Eveyone knows this, it’s all very transparent, however he does not their reasons.
Oh and for those counting, there are 8 “very”s in that paragraph so you can be sure its a very good answer.
On the regulator-pharma revolving door
Lex asked about the revolving door between pharma and regulators:
Lex: He suggested to me that I raised the concern that there is a close working relationship between Pfizer FDA and CDC … The fact that there's people you know that worked at the FDA that not work at Pfizer. That there's a kind of pipeline. Does this worry you that it affects your ability to do great unbiased work?
Albert: I have zero doubts that this is not affecting at all. Their ability to be unbiased and regulate. And in order to for the system also reinforces that by creating significant time barriers. If someone moves from an industry to F. D. A. He won't be able to deal with topics for a period of time and then for even an enhanced period of time with topics that are related with the company he or she may come from. I think this um regulators, they are really very strict bridal song. If anything, I feel sometimes that maybe they should be a little bit more open minded, particularly when it comes to new technologies rather than trying to judge and implement the same framework of valuation to all. They are always as circulators in the conservative side but always always they are unbiased and they are trying the best and it's not only one or two people, they have processes to make sure that they're self checks and balances within the agencies, both in CDC and in the FDA difficult decisions. They bring external experts that they should express easy decisions. There are internal experts that they are debating a lot and if there are disagreements, they elevate them. So I think it's we are lucky to have good regulators. I think I agree with what you said before as with all governmental agencies, there is bureaucracy and the bureaucracy needs to be addressed and by saying, your focus is not relaxing the the bar, the bar needs to remain high, but being uh, focusing on what matters rather than on the, on the detail.
This one surprised me, even for Albert. The fact that he believes that there is absolutely no effect tells me he doesn’t take the threat seriously or just hasn’t thought about it.
He describes the simplest most direct form of influence where someone at Pfizer moves to the FDA, in which case regulations prevent them from dealing with topics relating to Pfizer for some period of time. His idea of corruption is basically Pfizer sending in a mole, which isn’t wrong perse (who’s to say what’s wrong?), its just against regulations.
But anyone that thought about this threat more than a few minutes knows its not that simple. For instance, people working at regulators know that they could potentially have an exit opportunity at a pharma company. So it makes sense for them to not be overly adversarial.
It was shocking to hear him brush off the issue so emphatically. Again this tells me he doesn’t pay any mind to anything besides operational diligence. Another theme you see throughout the interview is offloading everything to regulators without having any responsibility for his organization and the role they play in crafting regulations and managing trials.
So the regulators are perfect? Not exactly. Albert thinks they’re too strict! They should be more open minded. How a pharma CEO can make that claim without at least acknowledging his bias was laughable.
On prior lawsuits
Lex asked about a 2009 settlement that Pfizer was involved in
Lex: In 2009, Pfizer pleaded guilty to the illegal marketing of Arthritis drug Bextra and agreed to $2.3 billion dollar settlement. How do you make sense of the fact that this happened to accompany you love and then you believe in?
Albert: Yes. The Baxter case in 2009 was related to things that happened in 2003. And the things that happened in 2003 were things that basically several of our reps did off label promotion. So they spoke about with the physicians about off label use of the product and they shouldn't. And this is something that it is allowed when physicians are speaking to physicians but it is not allowed for the pharmaceutical companies to refer to these studies because usually our studies that are happening of labor and apparently several of our reps in 2003 they did it and we had to To settle in 2009 and we paid a very big fine. As you said, the fine was related not to the severity of the conduct but the size of the revenues. So the fines are if Baxter was a small product, we would get a small fine. Baxter was a very big product and we've got a very large fine, very bad. What happened in 2003? I don't think that these things happened since then. We have a stellar record from 2009 until now of complying with every single regulation and rule. We have internal processes to make sure that these are not happening by individuals that may have an interest for example, to get the promotion. They may try and do things that they are not the right things. And we have more importantly a culture in this company that really sets aside people that they think differently. So I didn't like what happened in 2003, But I believe a lot has changed in the 20 years that followed For almost 20 years.
He brings up the dates to show that this was long ago and bad things like this don’t happen anymore. Not only was the lawsuit long ago (2009), but the actual crime was even older (2003). The way that I read that though is that it took 6 years for this activity to come to light. That’s a long time, maybe it wouldn’t have come out.
He also makes a point to mention that only the drug companies weren’t allowed to do that, but doctors could. So what they did was a technicality really, not a big deal. Only reason the fine was big was because the product had a lot of sales.
Again he has a very operational world view. They’re not allowed to do this, so they shouldn’t do it. No thought as to the reason this regulation exists. It was a long time ago, they paid the fine and have been perfect since then.
On marketing
Lex asked about the purpose of Pfizer’s marketing:
Lex: So let me ask the general marketing question, do you see this as a conflict of interest, as it might bias the reporting of news that a lot of us, a lot of people, me included, look to these mainstream channels of news.
Albert: … I don't think we have aggressive marketing, what do we do? We go on tv and we are having ads about our products and they are highly regulated. I think it is the right of people to know to learn that if there is a product like that it's very clearly that we cannot say things that there are off label that have not been approved. We need to have every time we go into v as you know, FDA is forcing as to say also the bad things that can happen for medicine sometimes that takes more time than the good things. And I don't think that we are doing aggressive marketing. No, people could be influenced uh in and can be biased in in the podcast or in the other type of media activities that they have for multiple different reasons.
Again Albert defers to the regulators. This is all regulated and they’re complying with the regulations. They even say all the bad stuff they’re supposed to say!
But no one is claiming the Pfizer is breaking the law. They’re claiming that they shouldn’t be able to advertise and influence media. It’s especially odd considering that only two countries (US and New Zealand) allow drug ads at all. But Albert isn’t concerned. He’s just doing what he’s allowed to do and his thought process stops there.
What about the influence they’re exerting on their advertising partners? That too is fine!
Albert: First of all, we have very few very, very few. We have a team that for every single one could be $2,000. They will try to see if there is a conflict of interest in the way we do it. And also what is the reputation of the, of the persons or the programs that we are sponsoring?
This was my favorite answer of the interview. He admits to scrutinizing “the reputation” of publishers for even tiny ad buys, but doesn’t see how this could influence reporting.
What people are afraid of is that publishers know that their coverage is being scrutinized heavily by advertisers. So they make sure not to bring up anything that could upset advertisers. Albert admits as much but doesn’t really see the issue. He’s just following regulations.
Questions not asked
Obviously there was very little follow up, but there were a number of questions not asked.
Lex reached out to listeners to source questions, and the most popular one was about giving out the vaccine patent to developing countries. I’m sure Albert would have dodged that one, maybe something about regulators not allowing him to do so, but it would be worth a shot.
Another question not asked was about the immunity deal from future lawsuits relating to harms had from the vaccine. Would have been great to hear his answer for that one as well.
Final thoughts
There’s a lot more I could say about this interview. It was incredibly disappointing to see how glib a pharma CEO can be about his companies responsibilty in the health of billions of lives beyond his legal obligation. He has no thoughts on mandates, on corruption or on influence drug companies.
Multiple times throughout the interview he said “I’m a scientist” (he’s studied bio-technology in veterinary school) to brush off concerns from non-scientists, but he doesn’t sound like one. He sounds like a politician, or at least one that is not in threat of losing his seat.
I can’t say the interview helped to restore people’s faith in pharma, but I guess its better than nothing. Hopefully we’ll get a real interview with him down the line.
When COVID is past us, i hope to see Nuremberg style trials for those who knowingly and intentionally killed people.
All I'll say about Albert is this "Mousey Mousey".