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

“Biotech Industry, Universities Oppose State Oversight of Medical Research” – Baltimore Sun

THE PRACTICE OF USING people as guinea pigs  may have been publicly renounced, but  Hopkins was not about  to abandon the business model.

The death of Ellen Roche caught the attention of  legislators  in Annapolis, who had until now been happy to leave regulation of Nazi medical experiments and Tuskegee syphilis studies to the Feds. The recent ghoulish headlines  out  of Baltimore, however, had incited state lawmakers to action. The Baltimore Sun’s Tom Pelton wrote about oversight based on the honor system, which meant there was virtually no regulation of medical  experiments being conducted on human beings.

Hopkins and other research hospitals were not required to report injuries or deaths of research subjects.

“It’s an honor system,” said Arthur Caplan, director of the University of Pennsylvania’s Bioethics Program. “Many adverse events do not get reported because doctors and researchers don’t like to think about themselves causing harm. So if there’s something else to blame it on, like an illness, they will.” At the Sun, Pelton asked for “adverse event” figures from the review boards of the University of Maryland and Johns Hopkins. UM released the numbers from their medical school. Of the approximately 1,000 experiments conducted the previous year, there were 880 reports of “serious adverse events” suffered by volunteers.

Johns Hopkins refused to release any figures.

A state legislator responded by introducing a bill that would shed some light on the whole human research situation, which alarmed the people who ran the show in Baltimore, who feared that transparency and rules to protect patients would derail the Federal Research Gravy Train—an express with daily nonstops from the U.S. Treasury to Johns Hopkins Inc.

Physics Today reported in 2009 that Johns Hopkins University was the biggest recipient of US R&D funds for the 30th year in a row, pulling in more than $3 billion from federal agencies like the National Institutes of Health and the Department of Defense, as well as funding from foundations and industry.

So, ten days before Pam was wheeled into Room One of the Hopkins EP Lab under false pretenses, the leaders of the state’s biotech and medical research industry descended upon the State Capitol in Annapolis to educate lawmakers on the issues of informed consent and patient safety. The message to the legislature was that despite recent unpleasantness, the current hodgepodge of federal regulation was working fine. Why mess with a good thing?

It was a good thing for Hopkins, Inc. because federal law did not cover most of what they did up there.

There were many supporters of the state bill. It had 16 co-sponsors, as well as the support of the state attorney general’s office and two patient safety organizations.

Hopkins vice president Joanne Pollak told the Baltimore Sun that her institution certainly supported the general concept of meaningful oversight. “We support anything that will build the trust of people in participating in the good research that is going on at Hopkins and other institutions in the state,” she said. However, in her humble opinion, the state bill needed some work.

What these well-intended reformers didn’t understand, Pollack explained, was that there was money at stake. A lot of money. She said that the huge flow of federal research dollars into the area would evaporate overnight if the state law got passed as written. She could fix that with an amendment that would make the new state laws compatible with existing federal laws. As a matter of fact, Hopkins had more (and better) lawyers than the legislature, and so they just went ahead and wrote up a new version of the bill, which would be compatible with federal law.

The Hopkins bill was more than compatible with Federal law. It was identical…