Unknown Speaker (4:58)

So, based on my research, there's been a push me pull you over informed consent ever since it's existed, with many scientists arguing we need to do important research for the greater good. But we can't get people to agree to be in the study because we tell them about the risks and they don't want to take part in it. They argue, why should we have to give informed consent? There was a famous or an infamous study conducted by government and academic institutions a couple of decades ago called the Support study, in which it was deemed that the parents of premature babies did not get or give informed consent before their babies were enrolled in a risky study in which some of them died. As an outgrowth of that, there was a meeting, I remember, a couple decades ago, maybe 15 years ago, to sort of do a lessons learned. And at this meeting, this government meeting, instead of them apologizing and say, what can we do to make sure this doesn't happen again? About half the researchers argued we shouldn't have to give informed consent at all. We didn't do anything wrong. And I feel like ever since then, they've been pushing to change the rules. What's a little bit of your background and observations on that?

James Lyons Wyler (6:07)

Yeah, sure. So about 1950, 1951, NIH first tried to codify rules that were similar to informed consent. They respect the rights of patients. Those were mostly ignored. And I also surprised that scientists would take the position that their research is more important than the well being of another human being. And there's a number of reasons why the 21st Century Cures act was put into play. Those included that it was a lengthy process to get people into clinical trials. It was an added expense that people overseas weren't doing it. And so we were no longer competitive. And so the, and that we could get results faster. And they put a shine on it by saying we're going to get to cures that are just around the corner faster by doing this. Well, that's a net benefit to society, not a benefit or handling properly. I think the risk of individuals in the trial. So when individuals are enrolled in clinical trials now under the 21st century's Cures act, if the researchers or say the pharmaceutical companies who have a financial interest in getting their product to market as fast as possible, can convince an irb, often who has a long term relationship with the companies, and a financial one too, that there is minimal risk, then it's possible for the IRB to sign off on it. So that when the doctor gives you a script, you go to the pharmacy and the pharmacy might actually hand you a drug that is not the same drug you were taking yesterday. So the consequences to that, to society, may be profound. We already know that there are powerful psychotropic drugs that for one reason or the other, one manner or the other, whether it's going on a dose or off a dose, or too high of a dose or too low of a dose, can cause people to have psychotic breaks and, and commit violence. This is well known and it's a real risk. And patients are warned, do not go off of this, don't just drop the medicine. So let's say that parents have a child who has struggling with mental issues. And there is a huge mental health crisis in America now. And the Doctors decided, the IRBs decided, pharmaceutical companies have decided there's minimal risk to change the drug if a week later that individual has a psychotic break. There's no way for the parents or perhaps the GP to even know that, or law enforcement to know that this is an effect of a drug and this reduces liability. Obviously, if you can't trace it back to the new drug that the person's on. And it's the same thing with cardiovascular drugs, heart medicine, blood pressure medicine. If people suffer because it's not as efficacious, or if it's unsafe in some way, you can't trace it back to the source until the end of the trial. Under the 21st Century Cures act, in the minimal risk clause, patients are supposed to be informed that they were in a clinical trial when the clinical trial ends. But I doubt that that's going to happen.

Unknown Speaker (9:26)

I mean, if here's one thing that doesn't make any sense to me. I believe it says patients don't have to be informed, they're part of a study if the scientist decides there's minimal risk. But if the risks truly are minimal, then what's the harm of telling the patients? Why is there the need to cover up the minimal risk?

James Lyons Wyler (9:45)

If that's true, that's a beautiful point, and I congratulate you on that. Cause I hadn't thought about that one. But a related thought is, is sometimes the argument is, well, it's minimal risk, but they're still going to report on safety. Because part of the clinical trial, say in vaccines, for instance, is to make sure that there's long term safety by retrospective studies. I remember when my boys were growing up, never once did the pediatrician say to me, by the way, we use retrospective studies to study the safety of vaccine trials. Would you like to give informed permission for your children to be part of this long term safety study? When I found out what I know about vaccines, I was livid. I felt like I had been denied my right to really look into it and say, wait a minute, there's long term safety studies, okay, that means that there's long term safety concerns. Then I would start asking questions that I'm a scientist and I was involved in biomedical research and I didn't know. So if they can hide the fact that you're on a clinical trial without giving you prior knowledge about it, you by definition can't make a free, prior informed decision.

Unknown Speaker (11:04)

How big of a shift is this in medical research, in your view?

James Lyons Wyler (11:11)

The shift seems subtle. We go back nine years and look at the arguments about why we need to do more research better. It could lead to individualized medicine, it could lead to more cures, more science faster, find the right patients for the right trial at the right time faster. That all sounds good. Like I said, they put a shine on it. But the history of abuses of clinical trials tell us that it will almost certainly and probably now is being abused. And that is a violation and a contradiction and a reversal of 100 years of development, of ethics ethos, understanding of how we should treat each other in the space of biomedical research, clinical research. I noticed that clause went in, I think it was December 2019. Just before 2016. Sorry, just before it was signed, and I alerted the public and I said, this is going to be a problem. And it wasn't until recently when the FDA came out and said, yes, this is how we're interpreting the 21st Century Secures Act. And they codified it with a new rule. And what was happening there was IRBs themselves, themselves couldn't believe that this was the appropriate interpretation. So they would get an application from a company and the IRB manager would say, okay, well, wait a minute. What is this minimal risk stuff? I don't know about it. And then they would go to the FDA for clarification. And I believe that the phones were probably ringing off the hook for clarification at the FDA because people couldn't believe it. It's a profound shift. These are people's lives. What you're doing when you say, I think that the risk of what I'm going to do to your body is so minimal that you have no say over it, because I want to make more money at the market or get my product to market faster, is you're commoditizing that risk and you're stating the value. When it comes to informed consent, the individual should be able to state the value of their own life. Life. Because for many people, their lives are invaluable, right? People die in clinical trials as a result of these studies. They die or they suffer chronic illness and loved ones lose loved ones to some studies. So I don't want to dissuade anyone from enrolling in a clinical trial. I want to. I'm a supporter of science. I have been all of my adult life. I want to make sure that that's clear. But I believe that IRBs, and I'm going to recommend in a publication that's forthcoming on popular rationalism, that IRBs ignore this clause. The IRBs have the ability to turn a blind eye to the fact that the FDA has the power by the 21st Century Cures act to allow IRBs to do this. It does not mean that IRBs must do this. So it's truly a high calling to IRBs to, you know, be the safeguards.

Unknown Speaker (14:21)

What is it as a takeaway that you think the public should know? In very simple terms, to cut right.

James Lyons Wyler (14:27)

To the chase, if you're on a drug and you get your script filled, always ask, am I being put on a clinical trial?

Unknown Speaker (14:35)

Do they have to tell you?

James Lyons Wyler (14:36)

They have to tell you. They can't deny you the knowledge if you ask. And the reason why is because they're mixing the research with their practice. There's informed consent, as you know, Cheryl, at the level of research, and there's informed consent at the level of practice. As a patient in a practice, you have the entitlement of informed consent for medical practice, and so you're entitled to know what's in the drug and what the risks are for medical practice that supersedes the medical research research.

Cheryl Akison (15:08)

For a lot more on this topic, I hope you'll tune in Sunday, January 19th for full measure. To find out where you can watch it on a TV station near you, go to Cheryl akison.com and click the Full Measure tab. There's a list of stations and times you can always if it's easier for you, watch online at FullMeasure News. The program feeds live about 9:35am on Sundays Eastern time. Fullmeasure News and if you happen to be listening to this after January 19th, no problem because we post the entire program afterwards at fullmeasure News. I hope you enjoyed today's podcast and that you will consider leaving us a terrific review and sharing this with your friends. Check out my other podcast, the Cheryl Atkinson Podcast, and if you haven't already done so, please consider ordering a copy of my bestseller, Follow the Science How Big Pharma Misleads, Obscures, and Prevails. It's a five star real life thriller. Read some of the reviews on Amazon and purchase wherever you like to buy your books. Do your own research, make up your own mind, think for yourself.