Acomplia update: Holy Cow!

Since the Junkfood Science Exclusive posted here in December, which examined the clinical trial evidence for Acomplia and revealed troubling complications that weren’t being reported in the news, I’ve been following the Acomplia story. As you’ll remember, it’s the new diet pill that Sanofi-Aventis has been seeking FDA approval to sell here in the United States. Just days after that Exclusive, the FDA made a surprising move and put it on a slow track and deferred decision on whether to approve it until concerns over its side effects were reviewed by an FDA advisory panel on June 13, 2007.

But a few noteworthy things have happened since then that necessitate an update before the June decision.

In January, the German Ministry of Health reported Germany’s health insurance, European Union’s largest market, refused to cover Acomplia for reimbursement based on the evidence. This month, widespread denial of insurance coverage across Europe has been reported. The recent Avandia scare has sparked analysts to predict Acomplia may work against the FDA approving it next month. As Acomplia Report just reported: “[T]ogether with recent publicity about safety issues involving top-selling anemia drugs Aranesp, Epogen and Procrit, have refocused attention on drug safety, rekindling memories of the stunning 2004 withdrawal of painkiller Vioxx from the market.”

An incredible report just published today and written by St. Petersburg Times (Florida) business news reporter, Kris Hundley, may put the breaks on the FDA’s readiness to grant Sanofi-Aventis’ petition. She investigated recent clinical trials conducted for FDA approval of Ketek, a new antibiotic for which the company stood to make hundreds of millions of dollars. Sanofi-Aventis paid a contract research organization $20 million to conduct the trials and it offered doctors $400 per patient to test the new antibiotic. The rest of the story is here:

Drug’s chilling path to market

Anne Kirkman Campbell, a family practice doctor in Gadsden, AL, signed up 400 patients, more than any other doctor in the country. When one patient backed out, Campbell forged the consent form and faked the data. A company hired to oversee the study caught the doctor's forgery, along with unmistakable signs of fraud involving dozens of other patients, and alerted the drugmaker. But the pharmaceutical company, which stood to make hundreds of millions of dollars on Ketek, didn't stop Campbell or report her crime to the Food and Drug Administration. Instead, it included her dubious data in its submission to the agency. Even after federal regulators stumbled on Campbell's fraud and uncovered problems at several other study sites, the FDA approved Ketek....

...Combing patient files, Cisneros found that the doctor had enrolled her entire staff and several family members in the study. Patient consent forms had been signed every few minutes and at times when the office was closed. Medical records had been edited, with notations of “sinusitis" and “bronchitis" added so patients would qualify for the trial....Dr. Campbell ended up with 407 people."...In July 2002, the drugmaker submitted the trial results to the FDA - including data from all 407 patients at Campbell's site....

While the FDA's drug approval division reviewed the Ketek data, its inspectors were conducting routine audits of the biggest study sites. Their first stop was Campbell's office, where they found such flagrant violations that they immediately called in the agency's criminal division. FDA investigators visited nine other high-enrolling sites and discovered serious problems at every one....

The story gets even more incredible and is well worth reading in its entirety. She goes on to reveal discrepancies in other drug approvals and share concerns about the FDA drug approval process:

Last year drugmakers paid the FDA more than $300-million in user fees, accounting for more than half of the agency's drug review budget. “Even if a product doesn't work or we don't know how it works, there is pressure on managers that gets transmitted down to reviewers to find some way of approving it," Ross said. “There's been a cultural shift at the FDA, and the pharmaceutical industry is now viewed as the client."

Ross, an infectious disease specialist, stressed that Ketek was being marketed for common ailments that often get better over time without the use of antibiotics. “This was not a drug that anybody thought was necessary in terms of public health. But it was important for the company financially."... In mid December, an FDA advisory committee discussed the growing evidence linking Ketek to liver failure: 53 reported cases, including two people who needed liver transplants and five deaths.... On Feb. 12, the day before the congressional hearing on Ketek, the FDA sharply curbed the drug's use. With health risks outweighing the benefits of using the drug for common colds, the agency limited Ketek's use to treatment of community-acquired pneumonia. Until then, Ketek had been one of the most successful antibiotic launches in history, bringing Sanofi-Aventis nearly $400-million in U.S. sales.

Clearly, not all medications are bad and there are drugs that have proven lifesaving for countless Americans. And it's never safe to just discontinue any prescription without talking with your doctor. But these black eyes are more than troubling and remind us that when our doctor says we don’t need a medication or antibiotic, don’t be in a rush for a prescription. And take just a moment to consider: Do you really want a prescription to lose a few pounds, or treat restless legs, dry eye, irritable bowel, to get it up, or fuss with minor variations in risk factor numbers?