Transplant Societies Protest FDA Policy in American Journal of Transplantation

[okarol]

Transplant Societies Protest FDA Policy in American Journal of Transplantation

Wed Mar 19, 10:00 AM ET

To: MEDICAL EDITORS

Contact: Beth Drost for American Society of Transplantation, +1-215-884-6499

MOUNT LAUREL, N.J., March 19 /PRNewswire-USNewswire/ -- In an Open Letter to the Federal Drug Administrations (FDA), which appears in the April issue of the American Journal of Transplantation (AJT), the American Society of Transplantation (AST) and the American Society of Transplant Surgeons (ASTS) explain how FDA policy is thwarting the field of transplant medicine in the United States. Flavio Vincenti, MD, president of the AST and one of the letter's authors, described the letter as an appeal to the FDA to reconsider its policy.

    Vincenti maintains that FDA policy has:

    -- discouraged many transplant centers from participating in clinical
       trials of new transplant drugs
    -- driven American patients away from enrolling in clinical trials
    -- caused drug companies to seek patients outside the U.S. for clinical
       trials
    -- weakened clinical trial results of innovative transplant drugs


In summary, FDA policy mandates the use of immunosuppressive drugs in organ transplantation clinical trials (in the control arms) that are no longer the preferred regimen of drugs of transplant physicians. The letter can be reviewed by going to www.a-s-t.org .

About AST

The American Society of Transplantation (AST) was founded in 1982 and is an organization of more than 2,700 transplant professionals dedicated to improving patient care through the promotion of research, education, advocacy and organ donation. AST provides a forum for the exchange of knowledge, scientific information and expertise in the field of transplantation.

If you are interested in speaking with the letter's primary author, Dr. Vincenti, or would like to receive a copy of the letter, please contact Beth Drost at 215.884.6499.

    Contact: Beth Drost
             215.884.6499

http://news.yahoo.com/s/usnw/20080319/pl_usnw/transplant_societies_protest_fda_policy_in_american_journal_of_transplantation