Ketek, the FDA and a betrayal of trust

"The Ketek story is about the FDA's betrayal of the public trust," Dr. David Graham, former Food and Drug Administration (FDA ) scientist, is on recorded saying. "Unfortunately, Ketek is not an anomaly." Not many people are in a better position to comment than Dr. Graham. He acted as the whistleblower on Vioxx, declared that the FDA review process is "broken," and fought against several different drugs from the inside pulled from the market or now under suspicion including Ketek and Avandia.

The Ketek scandal is particularly horrifying. Before the FDA was to approve the new antibiotic, it required that Aventis (now Sanofi-Aventis) give proof that it was at least as effective at fighting sinusitis and bronchitis as anything else on the market. As is common practice in the pharmaceutical industry, Aventis subcontracted the research to a third-party company, PPD, for $20 million.

In turn, PPD offered doctors across the country $400 per patient they signed up for the clinical trial, called Study 3014. Eventually the study included about 1,800 doctors and thousands of patients.

However it soon became apparent that not all those enrolled in Ketek Study 3014 were legitimate. One doctor in Georgia signed – and got paid for – over 400 patients. This total represented over 1% of all patients in the study. A routine audit of this, their largest enrolling doctor, found that she had signed up everyone in her family and in her office, and even patients who did not know they were signed up. In comparison, another nearby doctor had only found 12 patients who met the standards set by the clinical trial.

When the auditor turned in her report about the doctor, nothing was done by either the research company or Aventis. It wasn't until the FDA, conducting their own routine audit into the Ketek study, found the irregularities and immediately started a criminal investigation. Despite evidence to the contrary, Aventis claimed that they were unaware of the fraudulent study results. In any case, the bogus results were included in the study.

By this time though, the FDA had approved Ketek – and people were already suffering from liver damage and dying from liver failure. Unable (and perhaps unwilling) to remove Ketek from the market, it is still available for sale today despite its lack of verified safety profile, though it is no longer recommended for sinusitis or bronchitis.

The doctor who signed up the 400+ bogus patients for Ketek Study 3014 was found guilty on one count of mail fraud and is serving 57 months in jail.

Perhaps the FDA is entrusted with protecting the public safety, and perhaps there is a betrayal of that trust in light of the several drug recalls and shady research practices, not to mention a recent rash of tainted food. But ultimately it is the companies themselves who are responsible for the safety and effectiveness of their products.

If you or a loved one has suffered liver damage while taking Ketek, or any other major drug side effects, contact JSA. We have over 30 years of medical law experience, and we can help you fight the big pharmaceutical companies to get the compensation you deserve. Don't get left with high medical bills and lost work because of some pharmaceutical company's negligence. Call JSA directly, or fill out the form on this page describing your Ketek injury and start your free case review today.