A panel of advisers to the Food and Drug Administration has recommended limits on the use of a controversial antibiotic. The drug has been on the market for two years, and it's been linked to liver failure in a dozen patients. Four of them died.
The drug is Ketek, made by Sanofi Aventis. It's been one big headache for the FDA. Back in 2004, the FDA approved it to treat pneumonia, sinusitis and bronchitis. Friday, the advisers recommended that it only be prescribed in the future for pneumonia.
Here's how the testimony to the panel unfolded. The FDA's Gerald DalPan asked the advisory panel to do something relatively simple:
"Please discuss whether the benefits outweigh the risks for each of the approved indications for Ketek."
The committee heard from FDA staff and Sanofi Aventis that new antibiotics like Ketek are valuable because bacteria are developing resistance to old antibiotics. And the company said its product worked well against the bacteria that cause pneumonia, sinusitis and bronchitis.
Others who testified didn't agree. In fact, this is one of the first times ever that the FDA allowed its own staff members to present two opposing views, one positive and one negative. The negative one focused on serious risks: the rare liver failures, as well as blurry vision in close to one out of every 100 people. The staffer said there was no evidence that the benefits outweighed the risks.
Then former FDA staffer David Ross spoke up. He worked on the initial Ketek application. And he testified that the agency had ignored problems.
"In February 2005, they received the first report: fatal Ketek-related liver failure," Ross said. "They did nothing."
Meanwhile, another problem was being investigated. Some doctors had faked data when they were studying the drug before it was approved. More than four years later, the FDA still hadn't done anything about that.
"In February 2006, they received written warnings from reviewers about fraud with Ketek," Ross said. "They did nothing."
After the meeting ended yesterday, the FDA's John Jenkins said the agency felt there was enough good data on the drug from other studies in Europe to approve it, and they couldn't reveal the fraudulent data until all the facts were in.
"There were multiple perspectives," Jenkins said. "There's a lot of information that Dr. Ross did not share, and I think the agency will have a more formal response in the near future."
David Graham is an epidemiologist with the FDA, who spoke in a private capacity, not representing the agency. He issued the earliest warnings about Vioxx, and he says he knows why the FDA ignored the claims of fraud — and the liver problems — with Ketek.
"The FDA views industry as its client, and that's the only explanation here," Graham says. "FDA saw that it needed to align its interests with the company's, and the company's interest was 'get this drug approved.'"
Some in Congress share Graham's view. Sen Chuck Grassley (R-IA) has been pushing for change at the FDA ever since Vioxx. He says the agency has a long way to go:
"There's got to be respect for the scientific process," Grassley says. "And dissident scientists, that have a point of view that might not be the party line, have to be respected."
Grassley is planning on re-introducing legislation with Sen. Christopher Dodd (D-CT) to give the FDA office that monitors drug safety the power to order a drug off the market. Such a decision is now made by the office that approved the drug in the first place.