Vioxx, Ketek and drug safety reform

The Food and Drug Administration (FDA) follows a complex process to approve drugs for sale on the open market. Essentially, it is up to the FDA to determine whether or not any particular drug is safe for use, relative to the patient’s condition. Obviously patients with Stage IV cancer and little hope of alternate treatments will be more willing to take risks with their medications than someone who is simply trying to get over a non-life threatening illness.

Yet when the Sanfori-Aventis, the makers of Ketek, recommended that its antibiotic be used for bronchitis and sinusitis, it should never have gotten FDA approval. Similarly, Vioxx and other Cox-2 inhibitors should have been more closely monitored for cardiovascular side effects before it was put on the market – if at all.

One could argue that these are just two examples that “fell through the cracks” out of thousands of approved drugs on the market today. However, the truth of the matter is that lives could have been saved and injuries prevented. In the case of Vioxx, it was found that other traditional drugs worked just as well without the horrific side effects. And Ketek, with its identified (but largely unpublicized) risk of liver injury, failure, and patient death, is an inappropriate treatment for illnesses that will probably get better over time without any medication.

The Vioxx lesson of 2004, and now the Ketek lesson of 2007 points to not cracks but gaping holes in the way the FDA handles its drug approval process. Former FDA scientists, doctors, patients, even members of Congress are shouting for reforms. Ten years ago, when Congress last made sweeping changes to the FDA approval process, it was to help companies get their drugs to market faster for the benefit of the patients. Now we see that drugs are not getting the full safety profile they deserve. Even worse, the FDA does not have the power to order new research or even recall a drug once it is approved. The agency can request new data (rarely is this followed through) and request that a company voluntarily withdraws its drug, but it is powerless to do anything if the company does not comply.

Its links to the pharmaceutical companies themselves are a little too close for some as well. Besides its Prescription Drugs User Fees, which accounts for about 40% of the FDA budget funded directly from the industry, many at the FDA feel they have an obligation to the pharmaceutical companies, not the consumer. Others use the FDA as a way to showcase their abilities to the drug companies, paving the way for a more lucrative career in the private sector after public service.

The unfortunate thing is that doctors and consumers alike still believe that a drug is “safe” if it is approved by the FDA. And since the agency has no legal responsibility for any drug it approves, perhaps we should become our own investigative scientists and understand what it is we are taking ourselves, and not rely on the government to tell us what is safe.

If you or a loved one has been injured taking Ketek, Vioxx, or any other medication, contact a Vioxx lawyer with Jim S. Adler & Associates for a free case review. Ultimately it is up to the drug manufacturer to ensure that its products are safe for you to use, and that it reveals all the possible side effects to you before you take it. Failure to do so can be seen in a court of law as an act of negligence, making you eligible for compensation to cover medical bills, lost wages, other financial losses, and mental anguish.

Call Jim S. Adler & Associates directly to start your free case review, or fill out the form on this page with the details of your Ketek, Vioxx, or other medication injury.

Additionally, Jim S. Adler & Associates has offices located at City Place Building, 2711 North Haskell Ave., Suite 2100 LB40, Dallas, Texas 75204-2887; San Pedro Plaza, 7330 San Pedro Ave., Suite 700, San Antonio, Texas 78216-6237; and Bank of America, 12605 East Freeway, Suite 400, Houston, Texas 77015-5619 (serving Channelview, Texas).