Friday, August 26, 2005

More Smoke from the "Drug Secrets" Story

The Seattle Times "Drug Secrets" series about researchers being paid to talk to investors about ongoing clinical research continues to generate smoke that seems to be obscuring some important underlying issues.
To me, the biggest such issue is that clinical research should be open, transparent, not confidential or secret (except for the identities of the research subjects, and perhaps in some special cases involving national security).
Let me reiterate four reasons why keeping information about and data from ongoing clinical research secret is bad.
1.It may cause patients to suffer.
Recent examples suggest that commercial research sponsors may try to keep secret data about hazards of medications, devices, and toxic exposures. Such data can at times be apparent before a study is complete. Keeping such data secret allows people to continue to be unknowingly exposed to such hazards. Two of the classic cases of research suppression in the 1990's demonstrated this issue.
  • In the "David Kern case," a textile manufacturer, Microfibres Inc., tried to prevent Dr. David Kern, a general internist and occupational medicine physicians at Memorial Hospital of Rhode Island and faculty member at Brown University, from presenting an abstract that described a case-series of a new pulmonary disease, flock-workers lung, that affected workers at Microfibres Inc. factories. Kern did present the abstract, but under a threat, never carried out, of law-suit, Memorial Hospital of Rhode Island removed Kern as head of the Occupational Medicine program, and refused to renew his contract, even though he was an Associate Professor. Brown University was unable to reverse these moves by the hospital, and Brown officials blamed Kern for signing an agreement to protect trade secrets, even though the agreement was unrelated to the research Kern did on the disease, and his research did not obviously reveal any trade secrets. [1-4]
  • In the "Nancy Olivieri case," Apotex, a pharmaceutical company, acted against Dr. Nancy Olivieri for revealing preliminary data from a trial of deferiprone, a chelating agent for the treatment of iron overload in thalassemia, suggesting that the drug was often ineffective in treating iron overload, and appeared to be associated with hepatic fibrosis. Ultimately, a report by the Canadian Association of University Teachers also held that her academic freedom was abridged, in the context of a negotiation between the University of Toronto and Apotex over a large donation, and that the hospital harassed Dr. Olivieri during her dispute with Apotex (link here for report)
2. It violates the promise made to research subjects that their participation will advance science.
I have never heard of patients in trials run by academic institutions being told that their participation is solely for commercial product development or marketing purposes. As Steinbroook put it, "a basic tenet of research ethics is that the data from clinical trials should be fully analyzed and published. If the knowledge gained from trials is not shared, subjects have been exposed to risk needlessly."[5]
3. It conflicts with the core mission and values of medical schools and universities.
Gagging researchers violates their academic freedom. Gagging researchers is in direct conflict with universities' missions to promote free enquiry. (For example, the mission of Brown University includes "discovering, communicating, and preserving knowledge and understanding in a spirit of free inquiry...." (link here).
4. It may violate the free speech clause of the First Amendment of the US Constitution.
At least for state universities in the US.

So paying researchers to talk to investors about on-going research is bad if this discussion, too, is kept confidential, e.g., restricted only to a few investors (so that the research is still being kept secret from the general public, other researchers, physicians, etc.); or if the amount paid to the researchers is excessive, suggesting that they are being paid to influence the research in some way, not to just talk about it.
But it is not obviously worse than paying researchers (or more likely, the organizations that employ them) to keep the research confidential in the first place.Recent cases of suppression of medical research seemed to have spurred movement to ban what Robert Steinbrook accurately called "Gag Clauses in Clinical Trial Agreements."[5] For example, the American Association of Medical College put out a statement in December, 2004, that it "strongly supports the elimination of restrictive confidentiality clauses in clinical trial contracts between pharmaceutical companies and academic or physician researchers." (link here) In same month, the American Medical Association also resolved "to eliminate from research contracts the confidentiality clauses that prevent medical scientists from communicating their findings in clinical trials." (link here )
Yet most of the discussion of the Seattle Times series seems to focus only the evil of paying researchers to talk about research, and not the evil of paying to keep research secret. In fact, most mentions of gag clauses are as something that it is bad to violate.
For example, we have previously posted on how members of congress have focused on this issue as one involving insider trading.
The Seattle Times' own editorial on the their news series did as well.
But most curious is the response of the American Association of Medical Colleges (AAMC). The Times' reported last week that a memo sent by the AAMC to all medical schools directing them to "tell their doctors to scrupulously honor' confidentiality agreements forongoing research."
Fearing that the news article may have not fully described this message, I secured a copy of it from another medical school, whose dean had put it in wide circulation. It, indeed, did not include a reminder of the AAMC's previous condemnation of the very confidentiality agreements it now called to be "scrupulously" honored.
To badly mix metaphors, we risk taking our eyes off the ball here. Gag clauses for researchers are bad. While urging researchers to adhere to current clauses to avoid personal legal liability, we should urge institutions to explore whether there are legal means to nullify such clauses, and certainly not to sign new ones in the future. Simon Cameron, President Lincoln's Secretary of War, reputedly said, "An honest politician is one who, when he is bought, will stay bought." I hope the confusion now surrounding the "Drug Secret" series will not lead people into saying that about physicians and medical researchers.

1. DG Kern, RS Crausman, TH Durand et al. Flock worker's lung: chronic interstitial lung disease in the nylon flocking industry. Ann Intern Med 1998; 129: 261-272. (link here)
2. Shuchman M. Secrecy in science: the flock worker's lung investigation. Ann Intern Med 1998; 129: 341-344. (link here)
3. Marsh DJ. Intimidation of researchers by special interest groups. N Engl J Med 1997; 337: 1317-1318. (link here)
4. Shuchman M. Consequences of blowing the whistle in medical research. Ann Intern Med 2000; 132: 1013-1015. (link here)
5. Steinbrook R. Gag clauses in clinical-trial agreements. N Engl J Med 2005; 352: 2160-2162. (link here)

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