THCB Reader Mail: Maggie Mahar On That Checklist Decision

Frequent THCB contributor Maggie Mahar did a little detective work on the Office of Human Research Protection’s (OHRP) mysterious decision to suspend a trial designed to reduce medical errors by requiring that hospitals follow standardized safety and infection control procedures, a story that Atul Gawande wrote about over the weekend in an op-ed piece for the New York Times.

The logic behind the ruling – namely that patients should have been required to provide their express written consent before participating in a clinical trial, even one involving hospital staff and not some radical new experimental drug or treatment – struck Maggie as slightly, shall we say, strained. Particularly for an administration which boldly ran for office on a campaign platform of vanquishing bureaucratic incompetence and embracing scientific innovation.  Maggie writes:

I read the letters that OHRP sent to Johns Hopkins and Michigan. They are dense with bureaucratic language, but make no sense whatsoever. So then I looked into OHRP and who runs it.

When ORHP began writing letters to Johns Hopkins and Michigan the head of OHRP was Bernard Schwetz. (He suddenly resigned in August, but this all happened on his watch.) Schwetz is a veterinarian. I’m not kidding. He’s a DMV. He also has a Ph.D. and is a toxologist.

When you look into his background, you find out that he seems to be a political appointee. At the very beginning of Bush’s first term, Schwetz was made deputy acting commissioner of the FDA. That’s right a vet was deputy acting commissioner of the FDA for a year. (I have nothing against vets, but this doesn’t make a lot of sense.)

This was not a bright period in the FDA’s history. During Schwetz’s tenure, Dan Troy, who was the FDA’s counsel, began running the FDA from behind the scenes. Troy had a been long-time enemy of the FDA– representing Brown & Williamson in its fight against the FDA and, just a few months before he joined the agency, Troy was representing Pfizer in another battle with the FDA. As one magazine (U.S. News?) put it “Mr. Outside Goes Inside” and proceeded to do his best to dismantle the FDA.(This is all documented in my book, Money-Driven Medicine. Congressmen protested and eventually Troy was forced to resign.)

As for the agency OHRP — it was created in 2000. The agency it replaced had reported to NIH. OHRP would report to the asst. sec of health–in other words, it would be controlled by the administration.

The law journal article that elliottg sent me explains that when ORHP decides to audit a hospital, it is usually in response to a complaint:

“Far more common than compliance audits are what we will call complaint investigations, which arise in response to specific complaints of investigator misconduct or IRB default. These focus on the particular incident raised in the complaint. The majority of complaints come from institutions themselves, which are required to report deficiencies they discover to the OHRP,14 but complaints also come from research subjects and whistle-blowers.”

I have a hard time believing the complaint came from a patient in the ICU (or relative of a patient). What would they have to complain about?

EDITOR’S NOTE: What is it about putting people with extensive work experience with animals in charge of the safety and well-being of human beings that so appeals to this administration? By our count Schwetz is the third case of an appointment at an important health and safety agency going to somebody with a noticeably off-topic resume.

Like Schwetz, former FDA Chairman Lester Crawford is a veterinarian. (Crawford lost his federal job when word got out about his investments in companies regulated by his agency. After leaving office he would be sentenced by a federal court to a year’s probation for violating FDA conflict of interest rules for failing to disclose investments in Pepsico, Wal-Mart and other companies he held at the same time he that he chaired the FDA’s Working Group on Obesity. ) And who can forget the glorious tenure of Michael Brown, who prior to joining the Federal Emergency and Management Agency and masterminding the bunglement of the federal response to Hurricane Katrina in 2005, ran the International Arabian Horse Association? — John Irvine

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