Dr Leemon McHenry: Perspectives on the Pandemic - "The Illusion of Evidence Based Medicine" Ep 13

As much of the world rushes to receive a lightly-tested pharmaceutical product, we thought it was high time to look again at the (very) big business of medicine. Leemon McHenry, PhD, guides us to the fraudulent core of ghostwritten studies, captured legislators, revolving-door regulatory agencies, pay-to-play medical journals, and the "key opinion leaders" who lend their academic credentials to giant corporations...for a price.

With every stage in the process seemingly structured for corruption, we can only wonder along with Professor McHenry: "Who's looking out for scientific integrity?"

By the time you finish this episode of Perspectives, you might just roll down your sleeve for a rethink.

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Watch more episodes of Perspectives on the Pandemic here:
Episode 1: https://dai.ly/x7ubcws​
Episode 2: https://dai.ly/k7af1wKOAvcoA7w5DkZ​
Episode 3: https://youtu.be/VK0Wtjh3HVA​
Episode 4: https://youtu.be/cwPqmLoZA4s​
Episode 5: https://dai.ly/k3l3VyZ2YQv6Zbw5VqE​
Episode 6: https://youtu.be/3f0VRtY9oTs​
Episode 7: https://youtu.be/2JbOvjtnPpE​
Episode 8: https://youtu.be/WlLmt6_w_AM​

Libby Handros & John Kirby
....

THE ILLUSION OF EVIDENCE-BASED MEDICINE
PERSPECTIVE ON THE PANDEMIC XIII
A Conversation with Leemon McHenry, PhD

Interviewed by John Kirby

Researched by

Libby Handros & Francis Karagodins

TRANSCRIPT

[00:00:02.0] LEEMON McHENRY PhD: The pharmaceutical industry is manufacturing all of these medical journal articles behind the scenes for basically marketing purposes and I was astounded you know because I had this enormous trust in medical journals. You have to realize that a clinical trial on a blockbuster drug published in a top medical journal with the branding of a key opinion leader, that key opinion leaders' university affiliation is worth an enormous amount of money in terms of confidence. What has happened in something like the past 20 or 30 years especially with blockbuster drugs is that we're sold a lot of pharmaceuticals where the risk benefit ratio is not in favor of taking the drug and we have all sorts of instances where people who really didn't need to be on these drugs took these drugs and then had serious adverse events.

[00:01:09.0] So disease mongering is a marketing scheme of pharmaceutical companies to persuade us to use fear and to use our trust and science in an extremely deceptive way in order to persuade us to go on on different kinds of drugs. The oligarchy of corporations here has basically usurped cherished institutions of democracy which involve checks and balances in the system but also scientific integrity so who's looking out for scientific integrity here's the problem.

[00:02:07.0] JOHN KIRBY: We're talking with Leemon McHenry who's the co-author of The Illusion of Evidence-based Medicine. So, Leemon if you could just tell us who you are and a little bit about what it is that you do?

[00:02:17.0] LEEMON McHENRY PhD: I'm a professor emeritus in philosophy and bioethics at California State University Northridge, and I'm a consultant for a law firm called Baum Hedlund Aristei & Goldman in Los Angeles California. So this book that you just mentioned grew out of a series of cases that I worked on as a consultant with Baum Hedlund. And, in particular, I teamed up with a psychiatrist called John Giordini, in Australia, and we wrote a number of articles together on the subjects of corrupted industry sponsored clinical trials and eventually we thought that we had enough for a book. And so, The Illusion of Evidence-Based Medicine was finally produced after trying to find a publisher that had the courage to move forward with it.

[00:03:14.0] JOHN KIRBY: And I want to get back to what is included in that book, but

for the time being I'd like to go back to an article that you wrote a research piece that you

titled “Of Sofas and Spin Doctors: Industry Sponsored Ghost Writing and the Crisis of Academic Medicine.” So first of all let me ask you what is medical ghostwriting? How does it work and how did you discover that it was happening?

[00:03:38.0] LEEMON McHENRY PhD: I was working on a case where Glaxo Smith Klein

was in battle with Eli Lilly over the competition to sell their top antidepressants, and one of the main issues that came up out of this was the problem of withdrawal. Or what they call “discontinuation syndrome”, and one of the lawyers asked me to have a look at some documents that were produced in the case. Moving into discovery and trial and many of them

were medical journal articles that were published about this problem of withdrawal particularly for Paxil. i came back to him and i said you don't have a case the the medical literature is firmly against you and he said that's all ghost written don't you get it

[Music]

[00:04:31.0] LEEMON McHENRY PhD: The pharmaceutical industry is manufacturing all of these medical journal articles behind the scenes for basically marketing purposes. And I was astounded you know because I had this enormous trust in medical journals. And I thought you know of all the kinds of literature that's published of scientific literature that's published surely the the medical journals must be the most rigorous and the most reliable and it turns out the opposite is the case and now I'm firmly of the opinion that medical journals for the most part should not qualify as scientific journals because not only because of the problem of of ghostwriting. But also because of the problem that the peer review system is so weak

that we really can't trust what's going on out there in the medical literature.

[00:05:25.0] JOHN KIRBY: So describe to us what exactly is ghostwriting. How does the process work?

[00:05:31.0] LEEMON McHENRY PhD: In my book, I've identified about four different degrees of ghost writing but let's take the worst case scenario. A pharmaceutical company will conduct a clinical trial and they will hire a medical communication company to write the manuscript for the trial. That person who actually writes the manuscript is working from a kind of template. He or she will be a sort of freelance medical writer as they are called. The pharmaceutical company pays the medical communication company to produce this draft of the manuscript, and then once the draft is completed it goes to the sponsor company namely the pharmaceutical company and all of the marketing executives to approve that the manuscript is on message with their marketing agenda. Then they will find what they call “authors”.

[00:06:44] And these are what we call honorary authors namely academics at university hospitals and academic research centers who will be paid to put their names on these papers. They might have had something to do with a clinical trial. They might have had something to do with the design of the trial. But, they basically didn't do any of the writing of the manuscript. So all of the marketing messages are planted into the manuscript before the so-called author of the paper reviews it and agrees that it would be published in his or her name. And so that's the worst case scenario here for a medical ghostwriting and I think it's just equivalent to fraud because the readers of the medical journals are led to believe that this is a piece of research that is guaranteed by the first author of the manuscript and all of the other people in the paper. And it very often turns out to be the case that none of these people have actually reviewed the data. All they've done is read the paper and agreed to put their name on it.

[00:07:51] JOHN KIRBY: You came up with a phrase the “circle of evidence.” What does that mean exactly?

[00:07:57.0] LEEMON McHENRY PhD: The “circle of evidence” is my term for how if you look at a medical journal article and you think the medical journal article is uh a genuine piece of science and then that genuine piece of science is used for marketing purposes. But it turns out that if the paper is ghost written it's produced by the marketing department in the first place. So marketing just refers us to marketing and we go around in a circle.

[00:08:29.0] JOHN KIRBY: You quote Richard Horton, who's the current editor of The Lancet, saying that the medical journals “have evolved into information laundering operations for the pharmaceutical industry.” So what did he mean by that?

[00:08:42] LEEMON McHENRY PhD: If you think of money laundering is something that you

know criminals do. You've got dirty money that comes out clean money. Now in this case what you've got is dirty manuscripts. That is to say ghost written manuscripts that are fraudulently misrepresenting the science. And they're coming out clean at the other end of the process being produced in the medical journals and looking like genuine respectable pieces of scientific work.

[00:09:32.0] JOHN KIRBY: In the pharma materials they talk about key opinion leaders

[00:09:38.0] LEEMON McHENRY PhD: Yes.

[00:09:39.0] JOHN KIRBY: So the key opinion leader is given lead authorship even though they do not deserve that. They're effectively signing their name to someone else's work. And that someone else there's a go-between of these medical communications companies which seem to me to basically just be kind of medical marketing PR firms.

[00:10:00.0] LEEMON McHENRY PhD: Exactly.

[00:10:01.0] JOHN KIRBY: Essentially plagiarizing the copy of the pharmaceutical company itself. Is that correct?

[00:10:08.0] LEEMON McHENRY PhD: Yeah i mean it's plagiarism. In the sense of you know the so-called person who's taking authorship credit did not write this paper at all. That person might have reviewed the manuscript and made, you know, a couple editorial suggestions. But for the most part, that's about it. So plagiarism means stealing, in this case sort of stealing credit you know now we look down upon these students at university. Students at university could fail a course or be expelled from the university for plagiarism. But it seems to be something that flourishes amongst professors. Which once this sort of thing gets out is very demoralizing

[00:10:53.0] JOHN KIRBY: I take it the key opinion leaders, so-called, are compensated for their work.

[00:11:02.0] LEEMON McHENRY PhD: Yes. Key opinion leaders is a sort of term of flattery that the industry uses to lure medical doctors into their marketing agenda. Their speaker programs, things of this sort, and they are compensated very handsomely for their advice and their opinion. But also they typically become the so-called authors of these papers. Now in this bizarre world of medical communications, you have this strange distinction between a writer and an author. Which I never have been able to make any sense out of. But for them the writer is the person who drafted the manuscript and that person's name might be on the cover page, when it's actually produced and it's submitted for approval to the pharmaceutical industry. and it's only subsequently that that page comes off and another page comes in that includes the so-called author.

[00:12:06.0] JOHN KIRBY: That's amazing so there's another step. The kind of almost crucial step in this process is the submission to the journals. So how does that work?

[00:12:15.0] LEEMON McHENRY PhD: The submission process will typically be handled by the medical communication company. They will produce a package which includes a cover letter written in the so-called author's name. That will include the manuscript for submission and anything else that might be used for the submission process. And there's a crucial transfer of the intellectual property from the pharmaceutical company to the so-called named author of the paper. So now the paper becomes the intellectual property of the honorary author for the purpose of submission to the journal and for the purpose of peer review. And all of that is you know behind the scenes here. We've only discovered this in the process of litigation where we're doing discovery.

[00:13:21.0] MUSIC

[00:13:25.0] LEEMON McHENRY PhD: And the Baum Hedlund law firm has made a real effort to make sure that this goes public. And that we will not settle any cases unless we get them to agree that these documents are made public.

[00:13:43.0] JOHN KIRBY: The journals must be aware that this is a widespread practice. What's their incentive for accepting these papers?

[00:13:51.0] LEEMON McHENRY PhD: The main problem here is many of these journals are terribly conflicted in the sense that they become dependent on pharmaceutical industry money. They're dependent on pharmaceutical industry money and in terms of the enormous revenue they receive in pharmaceutical advertising. Which, by the way, appears side by side to these ghost written articles. Right, so you think, okay, you're getting a piece of science here. That is to say you know the final product of a clinical trial and then you're getting advertising for what might be exactly the same Pharmaceutical. But it turns out it's all marketing disguised to look like science. Now, the problem, here, is that some of the content of medical journal articles is genuine.

[00:14:41.0] We can't you know broadly paint all of the content of medical journals as fraudulent but the problem is the fraudulent articles are so professionally done that it's extremely difficult to distinguish them from the genuine. So, now, what we've got is an article that's submitted to the medical journals and we don't know really whether the editors completely understand the extent to which this paper has been ghost written. And the extent to which the data has been misrepresented by the ghostwriter to make the safety profile of the drug look better and the efficacy profile of the drug looked better. We don't really know that but an enormous number of these medical journals are dependent on publishing these industry trials and so some medical journal editors have gone public and have stated you know that they're aware of the problem.

[00:15:49.0] But then you also find medical journal editors showing up to these conferences

that are put on by publication planners. In other words, the ghost writers and the medical journal editors go to the same conference. And we've got the medical journal editors actively soliciting the ghost written manuscripts from the ghost writers to their journals.

[00:16:11.0] JOHN KIRBY:There was something that you you mentioned, in your both your

article and the book, about this concept of the pharma companies buying thousands of issues of the journal. And that's another incentive, right, for the journals to accept these fraudulent papers. Can you describe that?

[00:16:31.0] LEEMON McHENRY PhD: So that's another way in which the medical journals have become enormously dependent upon revenue from the pharmaceutical industry. You have to realize that a clinical trial on a blockbuster drug published, in a top medical journal with the branding of a key opinion leader and that key opinion leaders' university affiliation, is worth an enormous amount of money in terms of confidence. Let's say for example they want to buy a million copies of these reprints because it's a blockbuster drug, and the sales reps are now going to go distribute the reprints of this journal article. So now, the journal is obviously going to become enormously rich on the basis of the reprint sales of the journal article And also, today, there's another phenomenon, where journal articles have open access and that's replacing the model of the reprint issue. But it's the pharmaceutical industry that's paying for the open access

[00:17:48.0] JOHN KIRBY: Did you participate in the Vioxx stuff or did you just study it for your paper?

[00:17:52.0] LEEMON McHENRY PhD: This is not a case I worked on, so I don't know in a lot of detail. But, I can speak briefly about the fact that there were problems that they knew about when they were conducting their clinical trials with regard to stroke and heart attack. And in this one particular case, they had a manuscript ghost written where they downplayed heart attack cases. And the professor who put his name on this paper was then confronted with the fact that there were patients in this trial that had died of heart attacks and were not in fact reported in the paper. And his response to this was: well I went with the data that Merck gave me. So this I think is the essence of the problem that I referred to before. Where you've got a lead author on a paper who can't guarantee the content of the paper that's been published in his name. Why is that? Well, it's because the data is owned by the pharmaceutical company and they release it according to their own interests.

[00:19:11.0]JOHN KIRBY: What are adverse events and how does ghostwriting help hide adverse events?

[00:19:16.0] LEEMON McHENRY PhD: Well there are a number of ways in which marketing people will slice and dice the data. Once, it has been sort of analyzed by the statisticians and that's you know a very sort of tricky process of statistics as to how all of this can be manipulated. But the one sort of instance that's discussed in my book it has to do with coding. A coding is how you describe an adverse event in terms of some particular kind of term. So let's say, for example, in the case of a particular clinical trial for an antidepressant tested on children. You get lots of adverse events, which include suicidal ideation, suicidal gestures, suicidal attempts, or even completed suicides. This became a problem with regard to antidepressants for children because we got a black box warning from the FDA on that eventually.

[00:20:28.0] And the paper I'm thinking of, in particular, which was study 329. Which is now famous for this particular little tactic. What they did was they coded suicidality or suicidal events as something they called “emotional liability”. So. it was basically, hidden in the coding and emotional liability nobody even seemed to know what that term even meant. But, it basically means anything from crying, on the one hand, all the way to sort of attempting suicide.

[00:21:04.0] JOHN KIRBY: What are the other common ways to manipulate a study that these medical communications companies do on behalf of big pharma?

[00:21.15.0] LEEMON McHENRY PhD: We talk about the way, in which, a clinical trial

is from start to finish. You've got the design of the trial, and that might be done by you know scientists who are recruited, maybe even the key opinion leaders who were recruited, at the very beginning in conjunction with the internal scientists at the pharmaceutical company. Then you have the conduct of the trial which is typically outsourced to contract research organizations. You know it's the big complex effort of the logistics of running the clinical trial, and collecting the data. And then you have the reporting of the trial, which is done by the medical communications company in conjunction with the marketing people. So you've got three different phases here. And in my book what I'm describing, with Dr.Gerardini, is cheating at every different level here.

[00:22:16.0] All right so let's go back to the design. You're asking about how the manipulation can be accomplished from the very beginning in the way in which trials are designed. So there are a number of ways. For example, if you use too high a dose or too low a dose of the drug against a placebo or comparator drug you could rig the trial to sort of get some of the numbers that you want.

[00:22:46.0] JOHN KIRBY:And to adversely impact a competitor drug, right? I mean sometimes these trials are done to slander a rival drug.

[00:22:58.0] LEEMON McHENRY PhD: Exactly. Exactly, you know and, so in that case, you've got a trial that's being conducted for a marketing purpose right from the very start rather than, a genuine scientific purpose. Because you know what they're doing is trying to increase their market share with the other companies by showing competitors that their drug is more effective or more safe. But getting back to the problem with the design and the fiddling with the dosage. It was a very good example of this again in Study 329. Where there was a comparator drug called Imipramine, that was being compared against Paxil and placebo. And they used an enormous high dose of Imipramine, which subsequent sort of researchers have called “elephant doses”, especially for children. And what that did was make the side effect profile of Paxil look better by comparison. Okay so here these are two examples right both coming from one particular study 329 of how in the design of the trial in the coding and in the dosage we can get right from the very start a manipulation of the science.

[00:24:16.0] JOHN KIRBY: What's the next stage and how can manipulation enter into the picture there?

[00:24:21.0] LEEMON McHENRY PhD: There’s a question here about the conduct of the trial in many cases as to how the data is collected. And if it's being done by a for-profit third party that's at service to the sponsor, namely the pharmaceutical industry they want to produce results that the sponsor wants. So for right from the start there's there's a kind of financial interest in the outcome here. Now in one particular case, that's described in our book, we had an unblinding that occurred in the conduct of the clinical trial. Now in this particular case there was a drug, called citalopram, that was being tested on children, and nine of the participants in the trial became unblinded. Okay, so right from the start, we've got a serious protocol violation here.

[00:25:17.0] Because, what we're trying to do is a double-blind placebo-controlled clinical trial. They were dispensed the pink commercial tablets by accident instead of the pills which would HAVE been indistinguishable as placebo. And the study drug which was citalopram, in this case. Now what we discovered again this is only discovered through the sort of discovery process of litigation. Where we get access to all of these documents. What we discovered is that the company decided to include eight of those nine unblinded patients in the analysis of the trial as if they were not unblinded. You've got problems at all stages here of design conduct and reporting. And in this case the conduct and the reporting there was a clear violation and again doctors reading this medical journal article would be completely unaware of this. we

[00:26:26.0] JOHN KIRBY: We see what the incentive is to medical journals because they're taking pharma advertising and they're getting reprint dollars. What about the universities where a lot of these physicians and, you know, PhDs work, what's the incentive for them to be

involved in this fraud?

[00:26:47.0] LEEMON McHENRY PhD: I think universities just like the medical journals are conflicted in the sense that there's an enormous incentive to take in the revenue from pharmaceutical companies to conduct these trials at university research hospitals, for

example. And to have their university professors participate in drug testing. Now one of the problems that we've found with regard to preserving the integrity of science is that when things go badly wrong and then you go back to the universities. And you say: look this occurred under your watch you need to do something about it. Here is a ghost written medical journal article that fraudulently misrepresented the science, it was your university professors who were the principal investigators in this trial. And the first authors on this paper and you need to take responsibility and formally acknowledge this and have the journal article retracted. In other words encourage the retraction from the journal that published it and what we basically find they're silent.

[00:28:09.0] JOHN KIRBY: Let's talk about disease mongering. Define that for us.

[00:28:14.0] LEEMON McHENRY PhD: Disease mongering is another term for selling sickness. There was a pharmaceutical executive, in fact a CEO. I think it was from Merck, he was reflecting on his career on what he could have done better. And he said, you know the main problem is that we were selling drugs to sick people. What we should have realized is that we should sell drugs to healthy people. That way we've enormously expanded our market and we could sell drugs just like bubble gum.

[00:29:00.0] What has happened in something like the past 20 or 30 years is that we're sold a lot of pharmaceuticals where the risk benefit ratio is not in favor of taking the drug. And we have all sorts of instances where people who really didn't need to be on these drugs took these drugs and then had serious adverse events. So, disease mongering is a marketing scheme of pharmaceutical companies to persuade us to use fear and to use our trust in science and extremely deceptive way. In order to persuade us to go on different kinds of drugs. A lot of people are just going to sort of trust, well, it's a drug put out by a pharmaceutical company. It must be safe,and effective, it's been approved by the FDA and so people take the drug.

[00:29:57.0] For example a case like Gardasil, which is a vaccine, has been given to girls. The company called Merck engages in marketing PR firms to produce these campaigns that appear on television called, “One Less”, and these are entirely persuasive to people who fear cervical cancer.

[00:30:24.0] MERCK GARDASIL AD: Each year, in the U.S., thousands of women learn they have cervical cancer. I could be one less one less statistic. One less because now there's Gardasil. The only vaccine that may help protect you from the four types of humaN

papilloma virus, that may cause 70% percent of cervical cancer.

[00:30:41.0] LEEMON McHENRY PhD: But now it turns out that something like pap smear testing is enormously effective and basically does the job. Cervical cancer turns out to have an incidence. It's extremely rare, but now we get cases where patients have been severely harmed by taking this vaccine and end up in wheelchairs for the rest of their lives. Now this is a case where we've got the pharmaceutical marketing which is out of control. We've got instances here where disease mongering has become a serious problem.

[00:31:18.0] MERCK GARDASIL AD: I have cervical cancer from an infection in human papillomavirus. Who knew HPV could lead to certain cancers? Who knew my risk for hpv would increase, as I got older. Who knew that there was something that could have helped protect me from HPV, when I was 11 or 12 way before I would even be exposed to it. Did you know, Mom, Dad?

[00:31:47.0] VAXXED 2: THE PEOPLE’S TRUTH (2019) CLIPS: Well that does suck like not being able to play sports anymore. Because I did do a lot of sports, it was my favorite. // This is an NJ tube. What it does is, basically it goes up my nose and near my throat, and it goes past

my stomach into my duodenum or the first part of the small intestine because my stomach is completely paralyzed.// She got the third shot within two weeks. She was hospitalized and she remained hospitalized for eight solid months.// So they put her on an immunosuppressant and Intraconocel,which is an antifungal medication. I've dumped some of them out. This is what it looks like to be on Gardasil. The after the aftermath of it and this is just one bag we got about 15 more at home.// After all the struggles and fights and we thought she was finally getting a

a little better, she went to sleep and she wasn't feeling good during the day. And I wanted to check on her and she looked like she was very still in her bed. And she had passed away and I tried to revive her but she was gone. I loved her so much I would have given my life first. She was just a good kid and her mom made a bad choice.

[00:33:19.0] LEEMON McHENRY PhD: You know that there are drugs that treat very serious problems here, that's a whole different matter. What we're talking about is is marketing campaigns that are designed to mold and shape public perceptions and to use fear in a very

sort of effective way to persuade patients to go to their doctors and insist that they must have these drugs.

[00:33:46.0] MERCK GARDASIL AD: What will you say? Don’t wait to talk to your child's doctor today. Learn more at hpv.com.

[00:33:53.0] JOHN KIRBY: Now let me ask you what's the role of the FDA, the CDC, the NIH, of regulatory bodies and scientific agencies in this whole kind of charade? To what degree do they participate?

[00:34:09.0] LEEMON McHENRY PhD: Well that's the first thing that most people think about when they hear about the kind of fraud and corruption, that i'm talking about in the pharmaceutical industry. They say, well, wait a minute we've got the FDA, and the FDA is

is one of the most respected regulatory agencies in the world. So how is it possible that what

you're saying could be true? And now we have the phenomena of regulatory capture, where regulators are captured by the industry that they're supposed to regulate. In terms, of different kinds of legislation that is introduced that are basically gifts to the pharmaceutical industry.

From, the senators and congress people who are lobbied for such favorable legislation. And in these cases what we have is a regulatory capture is that the industry becomes a client to the regulators. So we're not really dealing with any sort of rigorous oversight anymore.

[00:35:13.0] CLIP OF PRESIDENT BILL CLINTON: First, we continue working with the business community to get more drugs approved faster. I'd like to ask the congressman now to join me up here so we can sign the bill. Thank you

[00:35:26.0] LEEMON McHENRY PhD: And the other problem is called the “revolving door”.

Where you've got regulators and industry executives that just go back and forth between the pharmaceutical industry and the FDA.

[00:35:43.0] JOHN KIRBY: What do you say to people who say, well, you know only industry executives are, you know, competent enough or know enough about the industry to become regulators?

[00:35:57.0] LEEMON McHENRY PhD: Well, I don’t think that is true. I mean I think that, you know, you could have serious epidemiologists, who are working at universities who would be more ideal for these roles.

[00:36:12.0] JOHN KIRBY: And do we have cases where someone has just been the head of, you know, some branch of the CDC or FDA and then has moved directly into an industry position? Where they had literally just helped along the approval of a given drug and are now, you know, a vice president at the company who received the benefits of that approval?

[00:36:42.0] LEEMON McHENRY PhD: You're exactly on target and that's discussed in my book, when we talk about the case of Forest Laboratories’ Citalopram and the very individuals

in the FDA who gave the drug or its Me2 molecule regulatory approval for use in children.

And when then what we find is that these people, when they when they retire from the FDA

having approved the drug they become a consultant for the very company

that is going to benefit from that. what

[00:37:21.0] JOHN KIRBY: What you're describing and what we've been talking about and the nature of the work you've been doing has been medicine and pharmacology, in the best times. So now we’re in a situation an alleged an emergency and and drugs are you know are being rushed to market without animal trials. So how would you describe the state of the response to COVID-19.

[00:37:54.0] LEEMON McHENRY PhD: Well I’m terribly worried about this for people who are taking this vaccine right now, who are at the front lines. Because it has been rushed to a market so quickly that it is alarming. And I think you know just as you said, if you look at the way in which the testing goes on in the best of times you have every reason in the world to be extremely skeptical about what drugs you take, and about whether or not you are receiving the results of genuine science or marketing. And now you have to imagine under the worst of times, namely a global pandemic, and what we've got is a situation where it's extremely difficult for the top scientists around the world to follow the science when you're getting so many contradictory conclusions and results. What kind of trust and confidence are we willing to put in this?

[00:39:01.0] Now obviously you know we're just going to have to wait and see. We're uh in the middle of all of this at the moment. But it's an interesting question as to whether or not the pharmaceutical companies are going to make this data available to researchers, who might be interested in re-analyzing it and attempting to determine just exactly what the effectiveness and safety results were.

[00:39:28.0] JOHN KIRBY: Final question, what would evidence-based medicine look like, and how do we get back to doing it?

[00:39:38.0] LEEMON McHENRY PhD: Oh brilliant. Yeah. Well, I think that what we first of all need to do is to completely eliminate pharmaceutical companies testing their own drugs. I mean how in the world we get into a situation where we actually trust the manufacturers to do their own testing? The oligarchy corporations here has basically usurped democracy. The sort of cherished institutions of democracy which involve checks and balances in the system. But also scientific integrity. So who's looking out for scientific integrity, here's the problem?

[00:40:29.0] JOHN KIRBY: Is it possible that COVID 19 is the largest and most sophisticated disease mongering campaign, in human history?

[00:40:40.0] LEEMON McHENRY PhD: I would say that we should approach this with extreme skepticism.

[00:40:50.00] PhRMA AD: America's biopharmaceutical companies have one very important thing in common, a common enemy. We're making great progress because we're collaborating in ways that we've never done before. In a matter of weeks we've progressed from potential treatments to antibodies and antivirals that have shown positive results to several promising vaccine candidates. Because science ,science, science is how we get back to normal.