Draft Chapter Look for silver lining, what goes on behind closed doors.

ejunkie” And she uploaded her manuscript as a PDF file to sell on e-junkie.com (a “digital delivery service for the DIY folks.”) If people want to read Jessica’s whole story, she wrote in the post, at least now they have a way to do it.

draftdraftdraftdraf

*****

As recently as March 2000 the New England Journal of Medicine reported a study reminiscent of Tuskegee (discussed in Part II. D. 1., below) done by researchers from no less prestigious a research institution than Johns Hopkins. In the Rakai region of Uganda they monitored 415 couples of which only one partner was infected with HIV. The researchers did not inform the AIDS-free partners. Thirty months later 90 of the formerly healthy spouses had become infected. The journal’s editor charged that the study was unethical by U.S. standards. “Ethics of Medical Research in the Third World,” AllAfrica Global Media, Feb. 2, 2001. http://allafrica.com/stories/200102020128.html Five people died in a South African clinical trial of anti-AIDS drugs at the Kalafong hospital where participants “claimed they were ill-informed about their rights when they signed consent forms.” Ibid.

Paul M. McNeill, cited above, reports that as a result of providing HIV-infected mothers with placebos as a part of studies in Thailand, Africa and the Caribbean, their children were unnecessarily, and deliberately, permitted to develop AIDS.http://www.uiowa.edu/~cyberlaw/writing/CUNY1213.html

Less than one week after the Johns Hopkins revelations the statewide Sunday paper in his state headlined on page one: “[his university] Faces Probe Over Research.” The story noted that, among other things,  “the issues raised . . . focus on internal review boards that sometimes rushed approval of changes in experiment guidelines and did not document procedures in enough detail.”

A letter to the university in 1999 from the Food and Drug Administration referred to its reviews at the university in 1992, 1995 and 1998. Each of those reviews involved violations that “are of particular importance because many of them have been observed during past inspections where corrections were promised by your institution but not implemented.”

According to the news story, an FDA spokesperson said it is “fairly rare to see issues remain unresolved after several visits, as inspectors suggested was the case at the [university in question].”

A spokesperson for the university tried to minimize, even trivialize, the violations as “minor administrative details.” Said another, “the more complex the research the greater the likelihood there are some failures because we are, after all, all human.”…

I wrote in the initial paper that there are a number of current ethical issues in human subjects research that really are deserving of public education by journalists. Among them is one cited by the April 2000 report of the DHHS Office of Inspector General, “Protecting Human Research Subjects.” Among a great many “disturbing inadequacies” it notes that “The increased commercialization of research and the growing importance of research revenues for institutions heightens the potential for conflicts of interest in clinical research.”

On August 5, 2001, the Washington Post reported that overreaching by pharmaceutical companies had become so bad that “editors at the world’s most prominent medical journals, alarmed that drug companies are exercising too much control over research results, have agreed to adopt a uniform policy that reserves the right to refuse to publish drug company-sponsored studies . . ..” Susan Okie, “A Stand for Scientific Independence: Medical Journals Aim to Curtail Drug Companies’ Influence,” Washington Post, August 5, 2001, p. A1. (The story was carried in the city of the university at which the 1939 study was conducted as, “Journals Adopt New Policy: Editors Aim to Clip Drug Companies’ Influence,” Iowa City Press-Citizen, August 5, 2001, p. 1A, and “Medical Journals Battle Drug Firms’ Grip on Research,” Iowa City Gazette, August 5, 2001, p. 3A.)

The author quotes “several observers of biomedical studies who have become alarmed about the influence of the drug industry on the integrity of medical research.” A University of California professor of clinical pharmacy is quoting as saying that if negative results are published “you can still get pressure put on you for fear that you won’t get any future funding.” Companies not only control access to data, but may even control who writes the papers — or ghost write them for the academics who “are too busy to take all the time needed to create the publication.” She cites examples in which reports of side effects, no benefits, or cheaper alternatives have led to blocked publication or even lawsuits.


Look for the Silver Lining

Theme for the ILGWU? No.

It was a plea by Ron Berger for Hugh Calkins to find some presentable data in a disastrous study on catheter ablation for atrial fibrillation.

“And my colleague Ron Berger says, he says, well you can’t publish these data, we’ll never see another patient again at Hopkins. And I said this is the truth this is what we found, you know the fellow spent a year looking at this data, this is a heck of a message to send to our fellows not to publish it. And he said can you find a silver lining. So we did identify a subset of patients with paroxysmal afib that were young and had a small  left atrium and had blue eyes and had a 70% success rate — but for the rest the success rate was much worse.”

This was around the same time that Hopkins published their ad for afib ablation on their website: Finally a Way toGet Rid of Afib! http://www.hopkinsmedicine.org/hmn/W03/medrounds.cfm

____________________________


What Goes on Behind Closed Doors

http://www.fda.gov/OHRMS/DOCKETS/ac/97/transcpt/3364t1.pdf

Dr. Anne Curtis called the meeting to order. Dr. Tom Stullmuller read the conflict of interest statement. Drs.
Curtis, Jeffery Brinker, Cynthia Tracy and Tony Simmons were granted waivers.

***

Comments are closed.

%d bloggers like this: