Full Measure After Hours

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

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.

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]

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.

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]

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.

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.

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.

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]

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.