After Hours: Uninformed Consent—A Disturbing Change in Medical Ethics

Summary

Full Measure After Hours

Episode: After Hours: Uninformed Consent—A Disturbing Change in Medical Ethics
Host: Sharyl Attkisson
Release Date: February 27, 2025

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Introduction

In this compelling episode of Full Measure After Hours, host Sharyl Attkisson delves into a pivotal and concerning shift in medical ethics within the United States—uninformed consent. This episode uncovers how recent federal changes are undermining long-standing ethical standards in medical research, potentially putting patients at risk without their explicit knowledge or agreement.

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Background: The Evolution of Informed Consent

Informed consent has been a cornerstone of medical ethics for over a century, rooted in protecting patient autonomy and ensuring ethical research practices. The concept gained significant attention following the Tuskegee syphilis experiments, where Black men were unknowingly enrolled in a study without proper consent, leading to severe harm and ethical outrage.

James Lyons Wyler, head of the nonprofit Institute for Pure and Applied Knowledge (IPAK), provides historical context:

“Informed consent includes accurate and understandable communication of the benefits and the risks. It includes an attempt to understand, to make sure the patients understand the benefits and risks. And then it leaves the decision to the patient to enroll in the trial or not on the basis of their personal assessment of the risks and benefits themselves.”
— James Lyons Wyler [02:29]

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The 21st Century Cures Act and the Minimal Risk Clause

The episode critically examines the 21st Century Cures Act, highlighting a controversial addition known as the minimal risk clause. This clause permits researchers to enroll individuals in clinical trials without their explicit consent, provided the study is deemed to pose minimal risk.

James Lyons Wyler explains:

“The minimal risk clause... allows individuals without their knowledge to be enrolled in clinical trials. These are experimental clinical trials, prospective clinical trials. If the people running the clinical trial have convinced themselves and an IRB that patients enrolled in the trial are at minimal risk... it also most importantly reverses 116 years of learned protections.”
— James Lyons Wyler [01:08]

This significant alteration challenges the ethical framework established to protect patients, potentially reversing over a century of safeguards.

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Ethical Implications and Risks

The relaxation of informed consent requirements raises several ethical and practical concerns:

1. Patient Autonomy:

   • The ability of patients to make informed decisions about their participation is compromised. Without knowing they are part of a study, patients lose control over their medical treatment.

2. Accountability and Safety:

   • James Lyons Wyler warns of the dangers in sectors like mental health and cardiovascular medicine:

     “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?”
     — Unknown Speaker [09:26]

   • He further elaborates on potential severe outcomes, such as undetected adverse effects from psychotropic drugs leading to violence or health deterioration:

     “If you can't trace it back to the new drug that the person's on... it's commoditizing that risk.”
     — James Lyons Wyler [11:11]

3. IRB Integrity:

   • Institutional Review Boards (IRBs), traditionally the gatekeepers of ethical research, may be influenced by pharmaceutical companies with vested interests, undermining their role as impartial protectors of patient welfare.

4. Transparency and Long-term Safety:

   • The minimal risk clause may obscure the need for long-term safety monitoring, leaving patients uninformed about ongoing studies that could impact their health:

     “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.”
     — James Lyons Wyler [09:45]

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Historical Context and Push for Change

The push to alter informed consent protocols is not new. Wyler references past incidents where the lack of consent was justified by the greater good, such as the Support study involving premature babies:

“There was a push to change the rules... About half the researchers argued we shouldn't have to give informed consent at all.”
— Unknown Speaker [06:07]

Despite ethical breaches, there has been a persistent effort within the scientific community to prioritize research outcomes over individual consent, leading to gradual erosion of ethical standards.

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Current State and Future Implications

Wyler underscores that the shift towards uninformed consent is a subtle yet profound change with far-reaching consequences:

“The shift seems subtle... but the history of abuses of clinical trials tell us that it will almost certainly and probably now is being abused.”
— James Lyons Wyler [11:11]

He emphasizes the importance of vigilance and advocacy to uphold ethical standards:

“If you're on a drug and you get your script filled, always ask, am I being put on a clinical trial?”
— James Lyons Wyler [14:27]

Wyler also suggests that IRBs should resist the minimal risk clause, maintaining their role as protectors of patient welfare despite regulatory pressures.

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Key Takeaways for the Public

1. Awareness: Patients should actively inquire whether their treatment involves participation in a clinical trial.
2. Advocacy: Support transparency and uphold the right to informed consent in all medical research.
3. Education: Understand the implications of the 21st Century Cures Act and its impact on medical ethics.

Wyler’s urgent message serves as a call to action for individuals to remain informed and proactive about their medical treatments and rights.

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Notable Quotes

• “Informed consent includes accurate and understandable communication of the benefits and the risks.”
  — James Lyons Wyler [02:29]

• “It's a violation and a contradiction and a reversal of 100 years of development, of ethics ethos...”
  — James Lyons Wyler [11:11]

• “If you’re on a drug and you get your script filled, always ask, am I being put on a clinical trial?”
  — James Lyons Wyler [14:27]

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Conclusion

This episode of Full Measure After Hours sheds light on a critical and underreported issue in medical ethics. By dissecting the changes brought about by the 21st Century Cures Act and the minimal risk clause, Sharyl Attkisson and James Lyons Wyler highlight the urgent need for public awareness and advocacy to protect patient rights and ensure ethical medical practices.

For a deeper understanding, tune in to the full episode on January 19th or visit FullMeasure.News.

Transcript

[Cheryl Akison]

Hi, everybody. Cheryl Akison here. Welcome to another edition of Full Measure. After Hours Today, uninformed consent, a disturbing change in medical ethics that nobody's probably told you about. There's been a quiet but dramatic shift in long standing medical ethics in the United States. The federal government recently loosened the traditional rules that required researchers to get what's called informed consent before people get a treatment or agree to be in a study. This is a sea change in medical ethics, and I'll bet you probably heard little to nothing about it until now. Sunday, January 19th, on my TV show Full Measure, I'll be looking at this issue. And today in this podcast, you'll hear from James Lyons Wyler, who heads up the nonprofit Institute for Pure and applied knowledge, IPAC and opposes this change.

[James Lyons Wyler]

The 21st Century Cures Act. Just before it was signed into law, there was a clause that was added called the minimal risk clause. This clause allows individuals without their knowledge to be enrolled in clinical trials. These are experimental clinical trials, prospective clinical trials. If the people running the clinical trial have convinced themselves and an IRB that patients enrolled in the trial are at minimal risk, obviously that begs questions of definitions, but it also most importantly reverses 116 years. I believe it was or so of learned protections and that I came up with this morning. Learned protections. Reviewing the history and I sent you a paper, an article on it, reviewing the history of informed consent. We have these things in play, these protections in place, specifically to protect the patients from individuals who, for reasons other than the patient's personal benefit, might break the rules or take shortcuts.

[Unknown Speaker]

Can you describe? Well, let me give a little background first. I think informed consent in this country got a great deal of attention after the Tuskegee syphilis experiments, when it turned out the government had been experimenting on black men with syphilis without giving them full consent as to what they were doing. And even after penicillin was deemed to be a treatment, for it withheld the treatment from the test subject so they were harmed by being in the study. As an outgrowth of that expose, informed consent became a very important tenet of medicine. So what is the notion of informed consent? What is it supposed to entail?

[James Lyons Wyler]

Sure. So an individual that's enrolled in a clinical trial should know the potential benefits and the potential risks. So informed consent includes accurate and understandable communication of the benefits and the risks. It includes an attempt to understand, to make sure the patients understand the benefits and risks. And then it leaves the decision to the patient to enroll in the trial or not on the basis of their personal assessment of the risks and benefits themselves. And it's evolved over 100 years or so to the point where patients are supposed to have some benefit from any clinical trial that they're in, or at least the potential to benefit. So, for instance, if a person's already on, say, a blood pressure medication, and there doesn't seem to be any additional real benefit to a new blood pressure medication, it's simply another one that might be brought onto the market and there's no net benefit. It's just as good as technically speaking, under the rules of informed consent. An IRB would have a problem with that. An IRB is an institutional review board. If I were to do a clinical trial right now, I would have to submit it to an institutional review board that would examine it to make sure that it followed the rules of ethics. And the principle of beneficience is what I was talking about. That should benefit patients in the trial, and it should not subject them to unnecessary risks and harm that exceed the benefit to the people in the trial. And that's the beautiful thing. It's not necessarily a benefit to society or something like that. It's to the individuals in the trial.

[Unknown Speaker]

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]

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]

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]

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]

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

[James Lyons Wyler]

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]

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

[James Lyons Wyler]

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]

Do they have to tell you?

[James Lyons Wyler]

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]

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.