He said he told the officials, "I know it's probably not your intent to protect companies, to cover for companies." But every time "you stand in the way of information getting out that ought to be public, that's the impression you give the American people."
He is "committed to getting to the bottom of the matter," he told the Wall Street Journal on June 13, 2006.
About two week after his visit to the FDA, on June 30, 2006, the agency issued a warning that Ketek could cause acute liver failure after only a few doses and advised physicians to monitor patients on Ketek closely. In the two years that Ketek was on the market through April 2006, the FDA said it received reports of 12 cases of acute liver failure, and 23 cases of serious liver injury. Of those cases, four people died and one patient required a liver transplant.
On September 5, 2006, US Representatives, Edward Markey (D-MA), John Dingell (D-MI), Henry Waxman (D-CA), and Bart Stupak (D-MI), of the House Energy and Commerce Committee, and Chairman of the Senate Finance Committee, Senator Grassley, sent a letter asking the Government Accountability Office (GAO) to investigate the FDA's reliance on non-inferiority studies, which experts say are not appropriate for approving drugs like Ketek that have serious, even lethal side effects.
According to Rep Markey, who organized the group that sent the letter, "The Bush Administration's FDA has been working hand in glove with the drug industry for six years, leaving Americans vulnerable to dangerous drugs and insufficient information about the side effects of those drugs."
"This practice," he stated, "has lead to growing bipartisan concerns about the direction the FDA has been taking."
The most common way of establishing the effectiveness of a drug is to compare the outcome of a patient taking the test drug to the outcome of a patient taking a placebo. However, if the likely outcome of taking a placebo might be death or other serious health conditions, then the effectiveness of the drug must be established by some other method.
One method used involves the use of a "non-inferiority" study, in which one group of test subjects is given a drug of known effectiveness and a second group is given the drug for which effectiveness needs to be established.
The new drug's effectiveness is considered established if it performs in a similar manner, within some statistical range, to the known medication. Over the years, many concerns have been raised about the use of non-inferiority trials. So the letter from members of Congress asks the GAO to evaluate the FDA's reliance on these studies.
"A comprehensive GAO study of the FDA's use of these controversial studies and questionable approval processes," Rep Markey said in a statement, "is essential if we are to ensure that the FDA is not abandoning it's commitment to safeguarding public health."
Senator Grassley said, "These studies which were used to approve the antibiotic Ketek - are dubious because they don't provide any evidence that a particular drug is any better than nothing at all."
According to Rep Waxman, "An antibiotic that is no better than a placebo can't fight off an infection."
"Worse," he added, "it can subject you to serious, even life-threatening side effects without any compensating benefit."
"Americans deserve to have confidence that an FDA-approved drug will be both safe and effective," Rep Waxman noted.
(Note: You can view every article as one long page if you sign up as an Advocate Member, or higher).
