Friday, January 04, 2008

More About the Inexplicable Shutdown of a Quality Research Project

We have posted twice about the inexplicable decision by the US Office for Human Research Protection (OHRP) to shut down an observational study which meant to assess possible effects of a quality improvement initiative aimed at reducing hospital infections (here and here). Maggie Mahar, who also posted about the story in the Health Beat blog, did a little follow up investigation, which she initially reported in a comment on her initial post, and then, in somewhat more detail, on a post on the Health Care blog. It turns out that the history of the OHRP is somewhat questionable, and may be a surprise to many. I, like I am sure others, actually confused the OHRP with the Office of Protection from Research Risks (OPRR). But it turns out, according to Mahar,

As for the ORHP itself, I'm told its a 'strange creature' that was created in 2000 to replace the Office of PRotection from Reserarch Risks. Allegedly, the Office of Protection from Research Risks, which reported to the NIH, had been doing its job too zealously.

The OHRP would report directly to the assistant secretary of health--giving the administration more control over its activities.


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 toxicologist.

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.)

The FDA Counsel was a former lawyer for the tobacco industry? It turns out that was true. He had also previously represented Pfizer. He was also accused of being far too cozy with the pharmaceutical industry while he was at the FDA (see this news article from the BMJ). Apparently Troy was also the first FDA Counsel who was a political appointee (see this news article from JAMA).

A veterinarian was running the Office of Human Research Protection? Curiouser and curiouser. I hope that Maggie Mahar and others will look further into this. Stay tuned.

ADDENDUM (4 January, 2008) - Ms Mahar updated her discussion of the background of the OHRP and OPRR here on the Health Beat blog.

ADDENDUM (18 January, 2008) - Ms Mahar has added several more updates, the most recent here. Also see this post from the Comarow on Quality blog. Comarow interviewed OHRP officials, but still was unable to figure out the reason they shut down the research project.

1 comment:

Anonymous said...

In my view, more urgent than applying IRB to QI, is applying QI to IRB (e.g., audit for implementation of IRB-approved research, quality of informed consent etc...).

Mayer Brezis, MD MPH
Professor of Medicine & Director, Center for Clinical Quality & Safety Hadassah Hebrew University Medical Center, Jerusalem, Israel