Chapter Seventeen

Two months later, in June 2001:

“Johns Hopkins Admits Fault in Fatal Experiment”

Ellen Roche was a healthy 24 year old lab technician. She figured she’d make a few hundred extra bucks by participating in a study. The consent form she signed made no mention of a drug called hexamethonium, which was not approved by the FDA. The principal investigator for the study had checked with Medline about hexamethonium, which would be used to induce asthma-like symptoms in research subjects, but he did not check Google.

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.

There was outrage, there were mea culpas, and sweeping reforms were promised.

“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, CEO of Hopkins Medicine.

****

Three months later, in July 2001:

Hopkins Investigating Study

“The reports said the doctors questioned whether the researchers received proper permission from patients, whether surgery or other treatments were delayed because of the administration of the experimental drug and whether the drug had been screened for toxicity...”

Four months later, August 2001:

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.

“Neither researchers nor parents, Judge Cathell said, have the legal right to put healthy children into a study that offers them no benefit and carries real hazards. Children who ingest lead can suffer brain damage.

“… 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.

***

Hospital President Ron Peterson & company must still have been hammering away at those safety plans when Pam arrived at the Hopkins Electrophysiology Lab a few months later.

Chapter Eighteen