Senator's HHS Trip for Antibiotic Data Yields Only Ire
The Washington Post
By Marc Kaufman
After months of trying to get firsthand information from a government official familiar with a controversial new antibiotic, Sen. Charles E. Grassley (R-Iowa) marched into the Department of Health and Human Services headquarters yesterday asserting his congressional right to receive the data.
After a brief meeting with senior HHS and Food and Drug Administration officials, Grassley departed empty-handed and angry.
"This is extraordinary for me," the senior Republican said outside the headquarters. "I haven't had to go to an agency like this since 1983 to get information I requested.
"I smell a coverup."
FDA officials denied any impropriety, saying they were cooperating with Grassley's staff and had sent 400 boxes of documents related to the approval and safety of the drug, Ketek. Some information had to be withheld, the agency said, because of continuing investigations.
The senator, a persistent critic of the FDA, said he went to HHS out of frustration over the agency's refusal to make available one employee involved with an investigation into the antibiotic. A powerful drug approved in 2004 for the treatment of chronic lung and sinus infections, it has been at the center of the newest controversy over the agency's actions in reviewing new drugs and monitoring their safety.
Liver failure and disease associated with the drug have been reported, but the overriding issue involves the integrity of the clinical trials done to establish its safety and efficacy.
The agency acknowledges that there were major improprieties in a 25,000-patient clinical trial done for the drug's developer, Aventis. One person has gone to prison for fraud in connection with that trial, data from several other trial sites have been discarded because basic standards were not met, and the agency told the company it could not say anything about the trial results on its product label.
Nonetheless, the FDA allowed Aventis to use much of the data to support the company's contention that the drug is safe. It also allowed Aventis to present the data to an FDA advisory panel without telling its members of the widespread fraud allegations clouding the trial. Documents show that some FDA employees argued that the trial should have been discarded because of the company's inadequate oversight.
Grassley has pressed to speak with an agent in the FDA's Division of Scientific Investigations who, he said, "is key to understanding what the FDA did when it became clear that the safety study required by the FDA in order to approve the drug was fraudulent and faulty. Did FDA managers turn a blind eye and let the drug maker off too easy, or did the FDA do the right thing?"
In reply, FDA spokeswoman Susan Bro said: "We would like to do whatever we can to help [Grassley] fulfill his constitutional duty as well as ours to the American people. However, we will not compromise an ongoing investigation."
FDA officials also said that having a senator interview a government investigator in the midst of an inquiry raised the possibility of politicizing criminal proceedings.
Ketek is one of the few antibiotics developed and approved in recent years. The agency has made a priority of encouraging companies to work in the field of antibiotics, which inevitably become less useful as bacteria become resistant.
"We don't want to disincentivize companies interested in going after these bad bugs," Bro said.
The maker of Ketek, now named Sanofi-Aventis, did not return a phone call. Earlier this month, the company stopped recruiting children for a study of pediatric use of Ketek. The "pause" followed reports of four cases of serious liver damage in adults using the drug.
Bro said that the FDA-required labeling identifies the risks and that "we are currently looking at whether new data merits additional warnings."
Grassley has emerged in the past two years as a harsh critic of the FDA, which he accuses of being too close to the drug industry. As chairman of the Senate Finance Committee, which oversees Medicare and Medicaid payments, he called a high-profile hearing in 2004 into the FDA's handling of the withdrawn painkiller Vioxx, and yesterday he said he is contemplating calling another regarding Ketek.
"I'm tired of the runaround," he said after leaving the HHS headquarters. He said that he told the agencies' officials that "I know it's probably not your intent to protect companies, to cover for companies."
"But I said that every time that you stand in the way of information getting out that ought to be public, that's the impression you give the American people."
By Marc Kaufman
After months of trying to get firsthand information from a government official familiar with a controversial new antibiotic, Sen. Charles E. Grassley (R-Iowa) marched into the Department of Health and Human Services headquarters yesterday asserting his congressional right to receive the data.
After a brief meeting with senior HHS and Food and Drug Administration officials, Grassley departed empty-handed and angry.
"This is extraordinary for me," the senior Republican said outside the headquarters. "I haven't had to go to an agency like this since 1983 to get information I requested.
"I smell a coverup."
FDA officials denied any impropriety, saying they were cooperating with Grassley's staff and had sent 400 boxes of documents related to the approval and safety of the drug, Ketek. Some information had to be withheld, the agency said, because of continuing investigations.
The senator, a persistent critic of the FDA, said he went to HHS out of frustration over the agency's refusal to make available one employee involved with an investigation into the antibiotic. A powerful drug approved in 2004 for the treatment of chronic lung and sinus infections, it has been at the center of the newest controversy over the agency's actions in reviewing new drugs and monitoring their safety.
Liver failure and disease associated with the drug have been reported, but the overriding issue involves the integrity of the clinical trials done to establish its safety and efficacy.
The agency acknowledges that there were major improprieties in a 25,000-patient clinical trial done for the drug's developer, Aventis. One person has gone to prison for fraud in connection with that trial, data from several other trial sites have been discarded because basic standards were not met, and the agency told the company it could not say anything about the trial results on its product label.
Nonetheless, the FDA allowed Aventis to use much of the data to support the company's contention that the drug is safe. It also allowed Aventis to present the data to an FDA advisory panel without telling its members of the widespread fraud allegations clouding the trial. Documents show that some FDA employees argued that the trial should have been discarded because of the company's inadequate oversight.
Grassley has pressed to speak with an agent in the FDA's Division of Scientific Investigations who, he said, "is key to understanding what the FDA did when it became clear that the safety study required by the FDA in order to approve the drug was fraudulent and faulty. Did FDA managers turn a blind eye and let the drug maker off too easy, or did the FDA do the right thing?"
In reply, FDA spokeswoman Susan Bro said: "We would like to do whatever we can to help [Grassley] fulfill his constitutional duty as well as ours to the American people. However, we will not compromise an ongoing investigation."
FDA officials also said that having a senator interview a government investigator in the midst of an inquiry raised the possibility of politicizing criminal proceedings.
Ketek is one of the few antibiotics developed and approved in recent years. The agency has made a priority of encouraging companies to work in the field of antibiotics, which inevitably become less useful as bacteria become resistant.
"We don't want to disincentivize companies interested in going after these bad bugs," Bro said.
The maker of Ketek, now named Sanofi-Aventis, did not return a phone call. Earlier this month, the company stopped recruiting children for a study of pediatric use of Ketek. The "pause" followed reports of four cases of serious liver damage in adults using the drug.
Bro said that the FDA-required labeling identifies the risks and that "we are currently looking at whether new data merits additional warnings."
Grassley has emerged in the past two years as a harsh critic of the FDA, which he accuses of being too close to the drug industry. As chairman of the Senate Finance Committee, which oversees Medicare and Medicaid payments, he called a high-profile hearing in 2004 into the FDA's handling of the withdrawn painkiller Vioxx, and yesterday he said he is contemplating calling another regarding Ketek.
"I'm tired of the runaround," he said after leaving the HHS headquarters. He said that he told the agencies' officials that "I know it's probably not your intent to protect companies, to cover for companies."
"But I said that every time that you stand in the way of information getting out that ought to be public, that's the impression you give the American people."
