I promised to return with more information about who halted the use of life-saving checklists in Intensive Care Units in Michigan and at Johns Hopkins. (For my earlier posts on this shocking story, click here and here).

The Office of Human Research Protections (OHRP) is the agency that has nixed the use of checklists. Who runs the OHRP?  Until his recent resignation (as of Sept. 30), Bernard Schwetz was the director of OHRP. Who is Schwetz? He is a veterinarian (DVM). That’s right, he’s vet, not a M.D.

What’s even more surprising is that from January 20, 2001 to February 2002, Schwetz, who is also a toxicologist (Ph.D.), was Acting Deputy Commissioner of the FDA. This was not a bright period in the FDA’s history. During Schwetz’s tenure, the FDA’s counsel, Dan Troy, was running the agency from behind the scenes. Troy, a Bush appointee, was well-known as a long-time foe of FDA regulation. In the 1990s, he represented Brown & Williamson Tobacco Corp. in its effort to fend off the FDA, and just months before joining the agency, he had defended Pfizer in another battle with regulation. As a U.S. News & World Report headline summed up his career change: “Mr. Outside Moves Inside: Daniel Troy Fought the FDA for Years; Now He’s Helping to Run it.” (I have documented Troy’s power in my book, Money-Driven Medicine).

As for Schwetz, what can one say about a vet/toxicologist who becomes temporary deputy commissioner of the FDA? “Political appointee” is the phrase that comes to mind.

I’m told that the OHRP is a “strange creature.” It was created in 2000 to replace the small, underfunded Office of Protection from Research Risks. That office reported to the NIH. OHRP, by contrast, reports directly to the Assistant Secretary of Health, putting it under the White House’s control.

OHRP began sending what only can be described as threatening letters to Michigan and Johns Hopkins last summer—on Schwetz’s watch. He announced his resignation at the beginning of August. I haven’t been able to find an explanation for the resignation or whether it is in any way connected to OHRP’s decision about the checklist.

I have been in touch with Dr. Peter Provonost, who invented the
checklist. He tells me that OHRP’s investigation was based on “one
anonymous complaint.”

Finally, I found a 2007 Northwestern Law Review article about OHRP
which charges that OHRP’s “emphasis…on procedure” has contributed to
“an atmosphere in which review of research becomes an exercise in
avoiding sanctions and liability rather than in maintaining appropriate
ethical standards and protecting human participants.”

The article also notes that OHRP’s “ultimate tool for forcing
compliance is to stop an institution from expending federal research
funds on a particular study, in a specified department or school, or
across the entire institution. This is a powerful and dramatic penalty,
and one that is rarely used.”

Yet this is exactly the big gun that OHRP used on the checklist. Why?

Is this simply an example of bureaucratic incompetence, or was someone threatened by the checklist?

The checklist poses no danger to patients. It makes them safer. Was it a threat to some doctors or hospitals?