Provenge, a prostate cancer drug developed by Dendreon Corp, might not be as safe or effective as the company would like patients to believe. If you or your loved one has taken Provenge therapy, you should know that Dendreon may have inflated some of the data from the drug’s clinical trials. If you have concerns about Provenge, contact a New York personal injury lawyer right away.
Why Does the Provenge Data Matter?
When a pharmaceutical company such as Dendreon Corp develops a new cancer treatment, the company must generally file a plan with the U.S. Food and Drug Administration (FDA) to explain how it will test the drug’s safety and effectiveness. The FDA continues to evaluate the company’s research and development of the drug until granting or denying approval. The FDA approved Provenge in 2010.
Critics have raised concerns about the data supporting the Provenge approval. Dendreon’s plan showed that the company would conduct a key trial to measure patient outcomes when receiving Provenge rather than the placebo. The trial would also compare the outcomes of patients aged 65 against the outcomes of patients older than age 65. When reporting the results of the trial, however, the company raised that age to 71 years. According to at least one study published by the Journal of the National Cancer Institute, that change in the age-based analysis could have altered the trial results or hid problems with Provenge.
Drug companies should be held accountable if they mislead the FDA. Patients, their loved ones, and medical professionals should be able to rely on the data used to show whether a drug is safe and effective. Treatment by a new drug should cause hope – not additional worry. A patient who has received Provenge, possibly with unexpected or harmful effects, may need to speak with New York personal injury lawyer who can explain the relevant laws and types of claims.
Do You Have Options After Receiving Provenge?
Gersowitz Libo & Korek, P.C., are New York personal injury lawyers with expertise in negligence, medical malpractice, and other lawsuits. Contact us today by calling for a free assessment. Don’t delay.