Ketek and the FDA: Medicinal Terrorism?

Washington, DCThere are those who feel that the real threat to the American people isn't terrorism: it's the seemingly endless supply of dangerous prescription drugs that carry approval by the US Food and Drug Administration (FDA). Ketek is alleged to be one of them, after patients have died or been seriously harmed from the antibiotic.

Ketek can cause heart-rhythm problems, can lead to liver disease, and could interact poorly with other medications. Some doctors, who advocate sticking with tried and true performers regard Ketek with disdain, and maintain that it's continued presence on the market is a mistake.

Millions of prescriptions for Ketek have been issued since Ketek went on the market four years ago—a drug that was given FDA approval amidst a great deal of controversy with regard to a clinical trial process that some say resembled a scene from the Keystone cops. The latter was badly handled, some results questionable to the point of fraud, and the FDA's own reviewers appeared to be summarily ignored by an agency entrusted to ensure the safety of the medicinal supply chain on behalf of the American people.

However Ketek appears to be yet another poster boy of what can, and will go wrong.

"For (the) F.D.A. to refer to its being reassured by post marketing data from Latin America and Europe as a basis for declaring 'Ketek is safe,'" said Dr. David Graham, a reviewer for the FDA, "is in my opinion a great abuse of such surveillance data."

Dr. Graham is said to have been one of four FDA reviewers who sounded the alarm with regard to Ketek prior to approval. In spite of murky data and a sea of red flags, Ketek was given the nod anyway.

Graham has been reported as saying that Ketek is at least as toxic to the liver as three other drugs that have since been pulled from the market. He wants the same fate for Ketek.

"It's as if every principle governing the review and approval of new drugs was abandoned or suspended where telithromycin (Ketek) is concerned," he wrote in an email. "We don't really know if the drug works; no one is claiming it works better than other, safer drugs; and we're flying blind as far as safety goes, except for our own A.D.R. data that suggests telithromycin is uniquely more toxic than most other drugs."

He wants it off pharmacy shelves, and he has an ally in Congress. Senator Charles Grassley has long been a champion of the overall health of the American people and a frequent critic of the FDA.

"It's no surprise to learn that the F.D.A. didn't listen to Dr. Graham on the dangers of Ketek," he said. "The F.D.A. has made it their business to discredit Dr. Graham and others who aren't willing to cater to the drug companies."

Ketek was approved, under allegedly suspicious circumstances, in 2004. In February 2007 the FDA restricted the use of Ketek to patients suffering from pneumonia only, and added its sternest warning to Ketek after receiving an increasing number of reports concerning liver failure.

This past January a Congressional subcommittee voted to subpoena current, and former FDA investigators to testify with regard to fraudulent clinical data that supported the approval of Ketek four years ago.

In the meantime, confidence in the FDA continues to wane when a drug like Ketek, which has been found to be a risk for liver failure and has contributed to the deaths of some patients, somehow achieves approval in the midst of such questionable research, and the agency's alleged willingness to disregard, and discount the opinions of its own scientific reviewers in an effort to grant a major pharmaceutical company sought-after approval status.

Such conduct, together with chronic under-funding and anemic resources gives one pause to wonder who the FDA really serves—the American people, or drug companies—and whether the real threat lies there, and not with terrorism.

At least, Americans are serving notice that they will not succumb to such conduct without a fight, and those who have been harmed, or the families of those who have died after being prescribed Ketek, are signaling their displeasure in the courts of law.