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
-- 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 http://www.a-s-t.org .
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
|SOURCE American Society of Transplantation|
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