Collateral Damage: A Patient, a New Procedure and the Learning Curve

Two Months Later…

Johns Hopkins Admits Fault in Fatal Experiment

Ellen Roche was a healthy 24 year old lab technician. In June of 2001, she pulled a flyer off a bulletin board and went to make a few extra bucks by participating in a study. It was an asthma study, and the participants were left to the assumption that the researchers wanted to test the effectiveness of a new medicine.

So, for $365. Ellen Roche inhaled the gas, and then, basically, her lungs shriveled up. She spent several weeks in the ICU before her parents removed life support. Perhaps if hexamethonium had been listed on the consent form as the drug that she would be inhaling, lab tech Roche might have looked it up on Google, where several sites would have told her that she was in danger.

Hexamethonium was known to cause lung damage; indeed, that was the reason they were giving it to people, and they were giving it in amounts that some doctors characterized as ‘extraordinarily large’—amounts that the FDA would certainly not have approved had they been asked.

The FDA cited lack of informed consent as one of the many study violations.

“Failure to obtain effective informed consents from subjects, in that the sponsor/clinical investigator failed to disclose that inhalation administration of hexamethonium was an experimental use of the drug.”

Participants were told that the main risk was a temporary drop in blood pressure. That’s what it said on the consent form.

University of Iowa Law Professor Nicholas Johnson maintains that Ellen Roche and the other study subjects were unaware of the full extent of the risks to which they were being subjected—such as death from the total destruction of their lungs. The ‘medication’ that they were administered was in fact a lung irritant,  a chemical that lost FDA approval for its original intended purpose in 1972, was not approved by the FDA for this study, was being used experimentally, and at no time in its history had ever been approved in an inhaled form. Johnson says that Hopkins researchers deliberately used a chemical they knew would worsen the subjects’ lung condition, which in fact was the purpose of the study: “To find out how the tubes that carry air into the lungs can stay open even when we breathe irritating chemicals.”

Johns Hopkins researchers wanted to study the ways in which people with asthma respond to substances that constricted their airways. They were deliberately harming people, deliberately causing asthma attacks in healthy subjects—and they did it all with the full permission of management. It was a big scandal and made the papers for a couple of months. The Office of Human Research Protections suspended almost all medical research involving human subjects at Johns Hopkins. The FDA and the Department of Health and Human Services also investigated the case and found that a Hopkins ethics committee and the Hopkins Institutional Review Board had approved the study.

Management was caught flat-footed in the press, but quickly pulled together its damage control act. The Baltimore Sun reported that “Hopkins leaders initially chose to reveal little, at the risk of appearing to have something to hide.”

Then they settled on a strategy of mea culpas and promises of reform, including stirring words from the CEO.  “Her loss can hold meaning for the whole Hopkins family if it reminds us of our obligation to protect the lives of those who seek our help,” said Ed Miller.

Ed Miller said that Ellen Roche had not necessarily died in vain; her death could serve to remind Johns Hopkins Medicine that it has an obligation to safeguard its patients. A much needed reminder for Johns Hopkins, but it appears not to have had any such effect.  The same month that Ellen Roche died, Hopkins got a letter from the FDA that described the shoddy doings at their Breast Imaging Center as “serious underlying problems that could compromise the quality of mammography performed at your facility, and represent a violation of the law”

In August 2001, the New York Times ran this story by Tamar Lewin:

U.S. Investigating Johns Hopkins Study of Lead Paint Hazard

The New York Times- Amid growing concern about the safety of medical research involving humans, the Department of Health and Human Services opened an investigation on Wednesday into a lead-paint study in Baltimore overseen by Johns Hopkins University.

The study was criticized last week in a decision by the Maryland Court of Appeals, which likened it to the infamous Tuskegee syphilis study decades ago. ‘It can be argued that the researchers intended that the children be the canaries in the mines but never clearly told the parents,” Judge Dale R. Cathell said in a scathing decision that compared the Baltimore study to Nazi medical experiments and the study in Tuskegee, Ala., that withheld treatment from black men with syphilis..

 Suzanne Shapiro, the lawyer for Catina Higgins, one of the mothers who filed suit, said that in May, 1994… when Ms. Higgins and her 4-year-old son, Myron, moved into a rented house at 1906 East Federal Street, the lead in Myron’s blood was at a safe level and his mother knew nothing about the study.

“After she moved in, Kennedy Krieger enrolled her in the study, and she signed the informed consent, but no one ever told her, ‘There’s lead in this house, and it can cause brain damage,” said Ms. Shapiro, who specializes in lead-poisoning cases and has other clients who participated in the study.

Ms. Shapiro said that a month later Myron’s blood contained excessive lead, and that he had since had neurological problems.

The study which the Maryland Court of Appeals likened to Nazi medical experiments and the Tuskegee syphilis study was approved by the Johns Hopkins Internal Review Board.

Manuel Roig-Franzia reported in the Washington Post that, despite the uproar, two other lead paint studies continued at the institute. In one, half of the participants–children ages 1 to 8–received a drug known to reduce elevated levels of lead in the blood, while the other half receive a placebo

The March, 2000, issue of the New England Journal of Medicine reported on another study that was even more similar to Tuskegee.  In a Hopkins research effort in Uganda, people were intentionally exposed to AIDS without their knowledge. They monitored 415 couples of which only one partner was infected with HIV. The researchers did not inform the AIDS-free partners.

They wanted to see what would happen, which was that two and a half years later, 90 of the formerly healthy spouses had become infected.

From the November, 2001 British Medical Journal:

Johns Hopkins Admits Scientist used Indian Patients as Guinea Pigs

The university announced last week that it had initiated sanctions against the scientist for participating in clinical trials that did not meet the university’s standards for human research. The scientist had provided the drug to doctors at the Regional Cancer Centre in India’s southern state of Kerala. The doctors injected it into 26 patients with oral cancer between November 1999 and April 2000. The university declined to name the scientist …

Management, of course, was shocked to discover that one of their researchers was playing fast and loose with the rules—even if it was in India. The researcher was sanctioned, banned, exiled.

Further, it was announced that the practice of using patients as guinea pigs would no longer be tolerated at Johns Hopkins.