| - |
FDA allows drug companies to abuse fast approval process
American patients and shareholders are the victims
|
According to a report by the
Energy and Commerce Committee "Conspiracy of Silence: How the FDA Allows Drug Companies to Abuse the Accelerated Approval Process," the majority of pharmaceutical companies benefiting from the Food and Drug Administration (FDA)’s “accelerated approval” process, a mechanism designed to expedite drugs for patients with life-threatening illnesses, have not conducted the post-marketing studies that are required by law on a timely basis. |
|
|
|
|
|
The report also details information provided by the Security and Exchange Commission
(SEC) indicating that many drug companies have not disclosed information regarding postmarketing studies to their investors. Of the 91
post-marketing studies required by the FDA, 42 studies have not been completed
and half of the unfinished studies have not even started.
Some of these things have resulted in dangerous drugs like
Vioxx, Celebrex, Bextra,
Viagra,
Crestor,
Adderall,
Nexium,
Paxil,
Avandamet,
Tysabri,
Prozac,
Cylert,
Accutane, and many others to stay on the market for varying periods of time. The importance of post-marketing studies is further highlighted by the recent case of the drug Iressa which was approved by the FDA in 2003 under the “accelerated approval” process for treatment of non-small cell lung cancer. In early studies Iressa caused significant shrinkage in tumors in about 10% of patients and was expedited to the market.
AstraZeneca, the company producing Iressa, complied with the FDA and conducted a follow up study of approximately 1700 patients. The study revealed that the cancer therapy showed no survival benefit in comparison to a placebo. The FDA shared the outcome of the study with the public and suggested alternative treatments. The FDA’s announcement of the
AstraZeneca’s important trial prevented patients from spending $1,800 a month for a drug that is ineffective when there are alternative treatments available. The report raises concerns that other companies who have failed to carry out similar commitments could have similar problems.
(Update: FDA
acts on Iressa and while it is not forcing a recall yet,
it is limiting prescription)
 The Markey Report also reveals that pharmaceutical company shareholders may not know about a company’s postmarketing study commitments. According to information provided by the SEC, 68% of public companies have not disclosed any of their post-marketing study commitments to their shareholders in their filings with the SEC. Rep. Markey, author of legislation to create a federal registry of all clinical trials – to ensure that pharmaceutical companies disclose the results of all clinical trials, will introduce new legislation next week aimed at providing information to patients and doctors about “accelerated approval” process drugs and improving the capacity of the FDA to oversee the postmarketing studies.
|
|
|
