Senator’s Letter to Health & Human Services to: The Honorable Kathleen Sebelius

Secretary

Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201

Dear Secretary Sebelius,

We write to you today in hopes of receiving greater understanding of a recent New England Journal of Medicine study that indicates a disturbing trend of clinical trials explicitly excluding gay and lesbian patients. The study found that gay and lesbian patients were barred from participating in clinical trials of drugs, mostly but not all dealing with sexual function. It was found that in some studies participants had to be in a “relationship with a person of the opposite sex” or the study contained explicit inclusion and exclusion criteria based on sexual orientation. We would like to ascertain if the Food and Drug Administration (FDA), National Institutes of Health (NIH) or any other federal health agency has any such restrictions on clinical trials and if so what medical rationale exists for such restrictions. We would also like to inquire to what extent restrictions such as these could result in inaccurate medical information and flawed trials.

The Journal studied a clinical trial database that had information on clinical trials sponsored by the National Institutes of Health, other government agencies, and private industry. Using keywords, their search resulted in 243 studies that had criteria excluding gay men and lesbian patients from participating. On closer examination of these 243 studies a troubling uptick in the incidence of exclusions can be seen. In studies conducted prior to 2000 only 2 studies were shown to absolutely exclude gay men or lesbians. However, from 2000-2004 that number grew to 9 and from 2005-2009 it almost tripled to 26. The Journal’s conclusion was that, “Exclusion of lesbians and gay men from clinical trials in the United States is not uncommon,” and that most likely these participants don’t know and aren’t notified that their sexual orientation is the reason they are excluded.

Obviously, we would all agree that absent a medical rationale for these exclusions, holding clinical trials that prohibit the use of gay and lesbian patients is discriminatory and unnecessary. Individuals that are willing to participate in these trials are supporting medical research and advancements – it doesn’t make sense and violates our values if any qualified potential participant is turned away solely based on their sexual orientation.

We look forward to your reply on this issue. Thank you for your consideration.

Sincerely,

John Kerry Jeff Merkley Kirsten Gillibrand

U.S. Senator U.S. Senator U.S. Senator

Sherrod Brown Robert Menendez

U.S. Senator U.S. Senator