Sanofi-Aventis, back in the funny pages again. Whether or not this specific drug turns out to be as bad as it looks, the FDA seems to need some deep, structural and procedural changes in order to avoid future problems.
WSJ.com - Lawmakers Ask FDA About Sanofi-Aventis Drug Lawmakers from both the Senate and House wrote the Food and Drug Administration asking about the agency's handling of Ketek, an antibiotic made by Sanofi-Aventis SA.The two letters from Sen. Charles Grassley, the Iowa Republican who heads the Senate Finance Committee, and House Democrats Edward Markey of Massachusetts and Henry Waxman of California, focused primarily on a large study done to test the safety of the drug. The study ended up being discounted by the FDA because of concerns about fraud and other problems.
In a statement, an FDA spokeswoman said the agency will “welcome this opportunity to continue talking about the scientifically rigorous work” of the FDA. She also said agency officials are assessing reports of liver damage in people who took the drug but “still believe when used as directed, Ketek is safe and effective.” Sanofi-Aventis said in a statement it is “committed to patient safety” and will address questions from the FDA and Congress...
Mr. Grassley's letter also asks why the FDA didn't share emerging concerns about the questionable safety study with an advisory committee that examined the drug. The letter says Mr. Grassley's staffers were told that FDA scientists were instructed that “discussing issues regarding data integrity and the conduct of the safety study would not be 'productive.' ” FDA officials earlier said they believed that telling the committee about the concerns could bias its vote and hurt the continuing investigation.The letter from Reps. Markey and Waxman notes that one FDA memo raised questions about whether Sanofi-Aventis fully disclosed information about possible reports of side effects overseas, where the drug was marketed before it was approved in the U.S. Sanofi-Aventis has said it didn't withhold information required by the FDA.
The House letter also raises an issue concerning trials to test the efficacy of antibiotics. Unlike many other drugs, antibiotics are typically compared with earlier antibiotics, rather than a placebo. To get approval, an antibiotic maker needs to prove that the new drug is about as effective as the older drug, though it can perform a bit worse than its competitor in a study and still be counted as statistically equal
from May 1, 2006 WSJ:
Ketek (pronounced KEY-tech) was approved by the Food and Drug Administration in April 2004. Its maker at the time was Aventis, a French-German company that after a merger is now called Sanofi-Aventis SA and based in Paris. Sanofi-Aventis, the world's third-largest drug company with 2005 revenue of $34 billion, says Ketek is an important weapon against respiratory infections. Last year the pills were prescribed 3.35 million times in the U.S. and brought in $193 million, according to IMS Health.However, reports of severe liver damage among people taking Ketek have surfaced. An internal FDA analysis cited 10 reports of people suffering liver failure after taking Ketek, though it wasn't clear how many cases were caused by the drug. Agency officials say this is a preliminary estimate.
Now documents including internal Aventis emails reviewed by The Wall Street Journal are raising questions about a key clinical trial -- called study 3014 -- of more than 24,000 people that the company submitted to the FDA seeking approval for the drug.
The doctor who treated the most patients in the study, Maria “Anne” Kirkman Campbell, is in federal prison after pleading guilty to defrauding Aventis and others. An indictment says Dr. Campbell fabricated data she sent to the company. The documents show that Aventis was worried about Dr. Campbell early in study 3014 but didn't tell the FDA until the agency's own inspectors discovered the problem independently.
The doctor who treated the most patients in the study, Maria “Anne” Kirkman Campbell, is in federal prison after pleading guilty to defrauding Aventis and others. An indictment says Dr. Campbell fabricated data she sent to the company. The documents show that Aventis was worried about Dr. Campbell early in study 3014 but didn't tell the FDA until the agency's own inspectors discovered the problem independently.
A doctor in California who treated the third-most patients in the study was on probation at the time with the state medical board for gross negligence and failure to keep adequate records. Shortly after his involvement in the study ended, police responding to a domestic-violence call found the doctor at home hiding a bag of cocaine in his underwear and holding a loaded semiautomatic handgun, according to a later complaint by the California medical board. The doctor lost his license.
