Resource Logo
CDC HIV/AIDS/Viral Hepatitis/STD/TB Prevention News Update

MASSACHUSETTS: Promotion for Vertex Drug Would Mislead, FDA Says




 

Boston Globe (05.31.12)

The Food and Drug Administration’s Office of Prescription Drug Promotion has issued a letter requesting that Vertex Pharmaceuticals Inc. not distribute promotional material that FDA says exaggerates the benefits of the hepatitis C drug Incivek. Sent May 25, the letter said a Vertex-submitted “branded story” of a patient taking Incivek “is misleading because it overstates the efficacy, omits material facts, and minimizes important risk information.” The story was to be part of a promotion of a type common among drugmakers. Patients who are paid travel expenses and a modest honorarium by drug companies speak about their experiences in treatment; they are accompanied by nurses who discuss the therapy with prospective patients. According to the “James ‘J.P.’ M, Hepatitis C Mentor” story posted on FDA’s website: “Six months after the treatment ended, I found out I’d cleared the virus. That made me feel so good. I was happy to know I’d be around a little longer to see my son grow up.” In addition to noting the word “cleared” incorrectly implies eradication of the virus from the body, FDA regulatory review officials Sheetal Patel and Michael Sauers wrote, “This branded story misleadingly implies that most or all [patients] infected with hepatitis C will successfully achieve sustained virologic response” on Incivek. Although the letter was not a formal warning, Vertex spokesperson Nikki Levy said the company is reevaluating the material. “We take the FDA’s feedback very seriously,” said Levy. “The material they’re referencing hadn’t been used publicly,” she said, and will not be used “until we’ve addressed the FDA’s concerns.”



 


Copyright © 2012 -CDC Prevention News Update, Publisher. All rights reserved to Information, Inc., Bethesda, MD. The CDC National Center for HIV, STD and TB Prevention provides the following information as a public service only. Providing synopses of key scientific articles and lay media reports on HIV/AIDS, other sexually transmitted diseases and tuberculosis does not constitute CDC endorsement. This daily update also includes information from CDC and other government agencies, such as background on Morbidity and Mortality Weekly Report (MMWR) articles, fact sheets, press releases and announcements. Reproduction of this text is encouraged; however, copies may not be sold, and the CDC HIV/STD/TB Prevention News Update should be cited as the source of the information. Contact the sources of the articles abstracted below for full texts of the articles.



Information in this article was accurate in June 4, 2012. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.