Pharmaceutical reforms are needed

 In the United States, there have been four deaths related to Ketek, and many more have experienced varying levels of liver damage. Paxil has been cited as the cause of several deaths, homicides, and suicides – even those of patients who tried to stop taking the drug. And by some estimates, there have been about 60,000 Vioxx-related deaths due to cardiovascular problems.

There is no denying that there are profound problems with the way our government regulates the pharmaceutical industry. In fact, the FDA is more of a rubber stamp office than “regulator” – once a drug has been approved, the FDA has almost no power to remove it from the market, demand label changes, or even enforce requests for more safety studies. And if pharmaceutical companies purposely deceive the FDA as Merck did with its Vioxx studies and Sanofi-Aventis did with its Ketek studies, there are no fines or penalties of any kind, just letters of “rebuke.”

Consumer Reports has found that most Americans no longer find this acceptable, especially in light of the recent recalls and deaths associated with these and other drugs. According to its survey, nine out of ten people believe that the results from clinical trials should be available to the public. And 60% of those surveyed believe that the FDA has failed to protect consumers from harmful prescription drugs. (This number would likely be higher if more people understood how Vioxx, Ketek, and other dangerous drugs were allowed onto the market despite their poor safety profiles…)

The survey also found that:

96% of Americans believe that the FDA should have the power to require warning labels. Currently, they have to negotiate with the drug manufacturer about the wording of the warning, leading to considerable delays in that warning reaching the public. Case it point: it took Sanofi-Aventis over a year to put its warning about severe liver problems onto its antibiotic Ketek as it negotiated with the FDA over the “correct” wording.

93% of Americans believe that the FDA should have the power to require pharmaceutical companies to do further studies. Currently, the FDA can request these studies, but after a drug has been approved, it has no leverage to ensure that the study is done.

84% of Americans believe that the government should “have the authority to take any action necessary” to make sure each drug on the market is safe. Currently, the FDA has almost no power to do anything once it has approved a drug, and cannot even recall a drug without the company’s consent.

The reasons behind these problems are complex. However many of the problems can be attributed to the close-knit research community of both the “regulator” and the “industry,” the fact that drug companies pay user fees directly to the FDA for its drug approval process, and the fact that consumers want to have possible life-saving drugs on the market as fast as possible. This sets up an environment where a company like Merck can push a drug like Vioxx through the approval process, change research data to meet its numbers, and get the FDA to approve it as quickly as possible, leaving the deadly side effects to be revealed once the drug has been released on the unsuspecting public.

The bottom line, though, is that pharmaceutical companies and indeed all manufacturers who sell products in the U.S. are the ones liable for damages. They must ensure that their products are safe – if not, they could be found to be negligent in a court of law. If you or a loved one has been injured while taking Ketek, Vioxx, or any other drug, contact Jim S. Adler & Associates for a free case review. We will help you understand your rights, and give you the information you need to decide if litigation is the right step for you. Call us directly or fill out the form on this page with the details of your drug injury, and a member of Jim S. Adler & Associates will contact you.