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Former FDA Officer Worries New Rules Will Curb Industry Profiteering

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The "bully tactics" and "intimidation" of drug industry operatives could cause "thousands of additional cancer deaths," cries an angry doctor in a May 29 oped in the Wall Street Journal.

But Mark O. Thornton, MD, MPH, PhD, is not talking about the lobbyists and reps embedded in doctors' and lawmakers' offices even as patients and constituents wait for access.

He's talking about Sen. Charles Grassley (R., Iowa), ranking member of the Senate Finance Committee.

You see, even though "Mr. Grassley did some good after the Vioxx episode, by focusing on the woeful manner in which postmarketing drug safety is managed and regulated by the FDA," writes Thornton, who the Journal identifies as a former medical officer in the Office of Oncology Products at the FDA who "volunteers as president of the Sarcoma Foundation of America," the Senator "and his staff should have kept their eyes on the ball."

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Instead, Grassley wants the Government Accountability Office to investigate why the cancer drug Avastin was approved for use in metastatic breast cancer two months after the FDA's Oncologic Drugs Advisory Committee (ODAC) rejected approval--and on the basis of data that showed improvement in PFS--progression free survival, the period of time a patient doesn't get worse--but no improvement in overall survival.

Even drug reps were surprised it was approved.

"Not going to happen on basis of data presented to date," posted an anonymous salesman on industry chatroom cafepharma when approval rumors first surfaced. "Think about it. What is the label going to say? Improvement in PFS but not sure of clinical relevance of this. No improvement in overall survival. FDA is not going to do it."

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Just because Vioxx caused 27,000 cardiac deaths, Avandia was found to increase cardiovascular death risk by 64 percent and Vytorin proved worthless in improving cardiovascular health all after approval, "The senator is demanding a full-scale review of each and every product ever approved," whines Thornton, "to ensure that drugs approved on surrogate endpoints are both safe and effective."

Imagine that.

Of course surrogate endpoints--short-term criteria a clinical study is judged on in lieu of mortality or survival data--vaulted to national fame when Merck and Schering-Plough sought to alter theirs in the suppressed ENHANCE study to keep Vytorin from looking like a national con job.

Surrogate endpoints spell Ka-Ching to the drug industry because it can start blitzing a drug while safety data is still out and Wall Street is sitting up and listening.

And if the drug turns South as it's used by the first patients/guinea pigs, it's cheaper to ask for forgiveness than permission; Merck, after all still made money on Vioxx despite its $4.85 billion settlement with tens of thousands of plaintiffs.

But the problem with surrogate endpoints is: your actual mileage may vary.

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Vytorin reduced LDL but didn't clear arteries.

Avandia lowered blood sugar but raised not lowered heart attack risk.

New osteoporosis drugs stop bone turnover but cause instead of prevent fractures. Oops.

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Martha Rosenberg is an award-winning investigative public health reporter who covers the food, drug and gun industries. Her first book, Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health, is distributed by Random (more...)
 

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