New FDA Rules Will Curb Drug Industry Profiteering

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."

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."

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.

Vytorin reduced LDL but didn't clear arteries.

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

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

Thornton served on the clinical review team for Erbitux® while at the FDA--the cancer drug at the heart of the Martha Stewart/ImClone scandal--and worries that "a change toward the much stricter endpoint of overall survival," (sic) will chill innovation.

"U.S. cancer-drug development stands on a precipice overlooking a new dark age in which each new product's development is longer and costlier than the last," he writes.

Each new cancer drug is costlier, too, say health policy watchers.

Why does Erbitux® costs $17,000 a month? Avastin $4,400 a month?

Because the drug companies can get away with charging that much writes Robert Bazell, Chief science and health correspondent with NBC news, adding that if Avastin is added to the regimen for treating advanced colon cancer it would add $1.5 billion a year in new national health costs.

In a letter responding to Thornton's oped-- unsubtly titled Grassley's War on Cancer Patients-- Sen. Grassley says Thornton "mischaracterized" the GAO review and that it is an attempt "to make the relationship between the FDA and drug makers less cozy."

He also observes that in addition to "volunteering as president of the Sarcoma Foundation of America," Thornton is the Senior Vice President of Product Development at GenVec, Inc. which makes cancer drugs--a simple Google vett the Wall Street Journal didn't include.

Thornton also served as Chief Medical Officer and Head of Product Development of Ziopharm Oncology Inc. and Managing Director of Clinical and Regulatory Affairs of Angiotech Pharmaceuticals and is on the Board of Directors of the partially drug industry funded Center for Medicine in the Public Interest (CMPI).

But maybe those are his career's surrogate endpoints.

Martha Rosenberg, Staff Cartoonist, Evanston Roundtable

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