Thursday, July 19, 2007

Unexpected Consequences of an Arms-Length Research Relationship

The New England Journal of Medicine recently published an analysis of a court decision that raises some interesting implications for the relationship between a pharmaceutical company and an academic medical center (AMC) with regard to conduct of drug trials and rights of patients.

Briefly, in Abney v. Amgen, March 2006, the US Court of Appeals upheld a ruling that Amgen had no contractual obligation to provide an experimental drug to research subjects after completion of the study, even though the consent form indicated that that would be possible. The drug, glial-cell-line-derived neurotrophic factor (GDNF), was instilled via catheter into the brains of patients with Parkinson's disease. The study concluded that GDNF was not effective. However, individual patients who believed that they had been benefited demanded that the drug be provided for an additional 2 years, as the consent form had promised. The court ruled that the consent form was an implied contract with the institution doing the research (in this case, University of Kentucky) but not with Amgen since Amgen did not directly control the research process.

Mello and Joffe, in their commentary, address the legal vs. the ethical issues. Legally, a drug company can avoid some accountability by keeping this sort of arms-length relationship with the AMC. But ethically, it seems that if patients were promised the drug after a trial is over, somebody owes them that drug, unless the study has showed that the drug is actually dangerous. (They argue that the mere demonstration of lack of efficacy is not a sufficient reason to deny the drug to a patient who is fully informed but who requests it.) They advise AMC's to assure that if they enter into a contract with a drug company, then the contract contains provisions that will allow the AMC to keep relevant promises with the research subjects.

I mention all this because, in HOOKED, I argue for even more than the usual arms-length contractual relationship between drug company and AMC; I urge instead a real firewall through the creation of an NIH-type research body that can take drug industry funds, and offer competitive grants to do the desired research, without money changing hands directly between the company and the academic investigators. If this idea of the neutral research institute were to become reality, then it would be even easier to assure that any promises of this sort could be kept, as a condition for the company getting the research done in the first place. (We would still need to ask--is it wise to promise this to research subjects, in the event that the research demonstrates that the drug is ineffective overall? Or should any such promise be contingent upon demonstrating efficacy as well as safety? Or is it more respective of individual variability among subjects to promise the drug in any case?)

Mello MM, Joffe S. Compact versus contract--industry sponsors' obligations to their research subjects. N Engl J Med 356:2737-43, June 28, 2007.

Abney v. Amgen, Inc. 443 F.3d 540 (6th Cir. 2006).

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