Today we begin with a sea change in America’s framework for conducting experiments on humans. The biggest surprise is— you probably know little to nothing about it. It surrounds with a provision tucked into a law, then quietly implemented by the FDA. It reverses decades of ethical tenets that were designed to prevent horrific abuses that have occurred in the past. Today’s cover story is uninformed consent.

The following is a transcript of a report from “Full Measure with Sharyl Attkisson.”
Watch the video by clicking the link at the end of the page.

James Lyons-Weiler: It’s a profound shift. These are people’s lives.

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

Sharyl: What is the notion of informed consent? What is it supposed to entail?

Lyons-Weiler: 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. 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.

The concept of “informed consent” emerged from an American tragedy: the U.S. government’s experiment on black men with syphilis in Tuskegee, Alabama in 1932.

The Tuskegee Syphilis Experiment clip – The men with syphilis were not told they were infected and were not treated even after penicillin was discovered to be an effective cure for the disease in the 1940s. Over the course of the experiment, 128 participants died of syphilis or syphilis related complications.

The unethical government research was exposed in 1972. An outcry led to installment of core ethics in human research. They required researchers to tell patients about the risks of being in a study, and get their explicit consent to take part. Also ethics experts on Institutional Review Boards or IRBs must oversee the studies. And the studies have to potentially benefit the people taking part.

Lyons-Weiler: 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.

But even under the post-Tuskegee rules, there have been shocking violations of informed consent rules by unethical researchers testing potentially profitable drugs or treatments.

In 2000, I uncovered the tragic case of Gage Stevens. A researcher at Pittsburgh Children’s Hospital, Dr. Susan Orenstein, talked Gage’s parents into enrolling him in a study on an acid reflux medicine called Propulsid, made by Johnson & Johnson.

CBS News clip, 2000:

Sharyl: What was your impression of what the risks of this drug were?

Gretchen Stewart/Gage Stevens’ mom: Very minimal! Hardly anything.

Dr. Orenstein told Gage’s parents the test drug was approved for children—it wasn’t. Sadly, Gage died. After my investigation, the coroner determined his death was from his “participation” in the “drug study.” The FDA cited Dr. Orenstein for a faulty study consent form that was coercive and didn’t clearly state the risks, among other violations.

Years later, an equally disturbing case of informed consent violations. It was a federal experiment on 1,300 extremely premature infants. Parents say they had no idea their babies could be injured or killed. The study was named “SUPPORT.”

2016 Full Measure clip:

SUPPORT stands for “Surfactant Positive Airway Pressure and Pulse Oximetry Randomized Trial”. Funded with $20.8 million tax dollars, it was a collaboration among the National Institutes of Health and two dozen research bodies, including Duke and Yale Universities and medical schools.

Bernita Lewis also agreed to enroll her baby, Christian, in the SUPPORT study at the same hospital.

Bernita Lewis: Christian was born at 27 weeks.

Sharyl: How much did he weigh?

Lewis: He was one pound 9 ounces. He was very tiny.

She says a hospital worker told her the study was just to collect data.

Lewis: She asked would I be interested in Christian being in a study. They wanted to use his medical records to help babies in the future and I told them ‘absolutely’. They could use any records they wanted to use.

Sharyl: Did she tell you there was a possible risk of death?

Lewis: No, there were no risks discussed.

Years later, parents found out their baby’s oxygen levels were randomly set not for the good of the infants but for the purposes of the study. And, under the study, their oxygen monitors were rigged to give false readings. That’s so hospital personnel wouldn’t adjust the babies’ oxygen to help them. Some died as a result.

When the misconduct was exposed, the government agency that polices study ethics told researchers they violated informed consent regulations for their “failure to describe the reasonably foreseeable risks of blindness, neurological damage, and death.”

Lewis (2016, Full Measure): I was angry and I couldn’t believe that some people who vowed, who took oaths to protect people, would actually do this. That was mind-boggling.

Sharyl: If you had been told the risks involved and what they were really going to do, would you have signed him up?

Lewis: Absolutely not. No.

Yet in the aftermath of the SUPPORT Baby Oxygen scandal, there were no apologies from the government or researchers, and no one was held to account.

Instead, many in the research community came together in a push to loosen the rules on informed consent. They finally got their wish with a provision embedded in the 21st Century Cures Act. President Obama signed it into law in his final full month in office.

Lyons-Weiler: 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.”

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.

Scientists, who frequently are paid to conduct studies for drug companies, say they’ve had increasing difficulty getting enough patients to enroll in studies when they’re told of the risks. And they argue the greater good can’t be served if they can’t do their studies.

Lyons-Weiler: I’m surprised that scientists would take the position that their research is more important than the wellbeing 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 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.”

The changes can be found on the website of Health and Human Services or HHS. In some cases, HHS now allows for a “written informed consent document” to be replaced by an “oral process” where the doctor has a “Points to Consider” conversation with a prospective study patient. And the researchers can omit what 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.

Lyons-Weiler says under the new rules, researchers can even enroll you in a study without telling you at all. For example, your doctor could change your normal medication without disclosing to you that he’s doing it as part of a study.

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.

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 putting profits over safety.

Lyons-Weiler: 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. And you are stating the value when it comes to informed consent. The individual should be able to state the value of their own life, because for many people, their lives are invaluable, right? People die in clinical trials as a result of these studies or suffer chronic illness and loved ones lose loved ones.

Sharyl (on-camera): For more on this and other Full Measure stories, listen to our podcast Full Measure After Hours.

Watch video here.