Obama-era change to human testing, now implemented, sparks concerns of Tuskegee syphilis experiment

There’s been a quiet but important sea change in America’s framework for conducting experiments on humans. It centers on a provision tucked into a law, then quietly implemented by the FDA. 

This provision reverses decades of ethical tenets that were designed to prevent horrific research abuses that have occurred in the past, such as the Tuskegee Syphilis Experiments on black men in the 1950s. Government researchers failed to tell the men when a treatment for syphilis was discovered and kept observing them as part of the study for years, as their disease ravaged them.

Ever since the Tuskegee case, U.S. scientists have been required to obtain “informed consent” from research subjects. Among other things, that means they must be told about, and sign off on, all risks of being part of the research. 

James Lyons-Weiler is a scientist who heads the nonprofit Institute for Pure Applied Knowledge or IPAK. He’s also an expert on informed consent.

“An individual that’s enrolled in a clinical trial should know the potential benefits and the potential risks,” Lyons-Weiler explains. “So informed consent includes accurate and understandable communication of the benefits and the 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.”

But all that changed with the 21st Century Cures Act. President Obama signed it into law in his final full month in office.

“In 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 if the people running the clinical trial have convinced themselves and an IRB that the patients enrolled in the trial are at ‘minimal risk,’” says Lyons-Weiler.

The obvious problem is, what constitutes “minimal risk” relies on the honesty and judgement of researchers who may not be honest or have good judgement. 

The changes were finally implemented only recently. Now, in some cases, the federal Department of Health and Human Services allows for the traditional “written informed consent document” to be replaced by an “oral process” in which the doctor has a “Points to Consider” conversation with a prospective study patient. And the researchers can omit information that used to be required: Telling the patient about alternatives to participation in the study, and telling the patient about research related injury that could happen.

Supporters of the loosened rules on informed consent say it will “bring new innovations and advances to patients who need them faster and more efficiently.” The FDA has said the changes will have “benefits in the form of healthcare advances” because studies that would not have been possible if patient consent were required can now be done. 

Patients and consumers weren’t clamoring for the changes, says Lyons-Weiler. He’s convinced the upheaval is driven by pharmaceutical interests that need more people to agree to be in studies and are putting profits over safety.

“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 wanna make more money at the market or get my product to market faster,’ is you’re commoditizing that risk. The individual should be able to state the value of their own life, because for many people, their lives are invaluable, right?” Lyons-Weiler says.

For more on this story, watch “Full Measure with Sharyl Attkisson” Sunday. Attkisson’s most recent book is “Follow the $cience: How Big Pharma Misleads, Obscures, and Prevails.”