Expert Testimony on Ketek
What follows is a sampling of quotes from knowledgeable people about Ketek and its various symptoms and side effects, and the resultant lawsuits:
“I am unaware of any unique or life-saving advantage offered by telithromycin [Ketek] that might offset or balance against either an absence of safety data or evidence of unusually high hepatoxicity [liver toxicity].”
—Dr. David Graham of the FDA’s Office of Drug Safety in a
July 2006 internal memo
“Both patients taking Ketek and their doctors [should] be on the alert for signs and symptoms of liver problems.”
—Dr. Steven Glason of the FDA
“We clearly now understand that there is risk of serious liver injury with Ketek.”
—Dr. John Jenkins, director of the FDA’s Office of New Drugs in
June 2006
“There are questions about whether this drug [Ketek] should stay on the market, and there’s great legitimacy to those questions. Ketek is another example where the FDA accommodated a drug maker and turned a blind eye to serious safety concerns.”
—Senator Charles Grassley, unimpressed with the FDA’s 2006
warning about Ketek
“It’s good to see the FDA doing due diligence with Ketek.”
—Senator Charles Grassley, applauding the FDA’s move to consider
removing Ketek from the market
“[N]o one is claiming it works better than other, safer drugs…we are flying blind as far as safety goes.”
—Dr. David Graham
“The benefits and risks do not support continued approval for Ketek for…non-serious and self-limited illnesses.”
—Dr. John Jenkins
“[N]o one is claiming it works better than other, safer drugs…we are flying blind as far as safety goes.”
—Dr. David Graham
“How does one justify balancing the risk of fatal liver failure against one day less of ear pain?”
—Dr. Rosemary Johann-Liang, of the FDA’s Office of Drug Safety, after
Sanofi-Aventis tested Ketek on nearly 4,000 children in 12
countries to determine its effectiveness in treating ear infections
and tonsillitis
“I am very concerned that the FDA approved Ketek even though it may be neither safe nor effective, and that the FDA has allowed the sponsor to give this drug to children in clinical trials.”
—Representative Edward Markey
“FDA approved the drug on flimsy data without resolving the safety issues, and it failed to penalize Sanofi-Aventis. Americans deserve more vigilance from FDA and from the companies that make critical medical treatments.”
—Representative Henry Waxman