Could New FDA Rules Curb Drug 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 op-ed in the Wall Street Journal.

But former FDA officer 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 post-marketing drug safety is managed and regulated by the FDA," writes Thornton, the senator "and his staff should have kept their eyes on the ball." The Journal identifies Thornton as a former medical officer in the Office of Oncology Products at the FDA who "volunteers as president of the Sarcoma Foundation of America."

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 the industry chat room 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 that your actual mileage may vary.

Vytorin reduced LDL but didn't clear arteries.

Avandia lowered blood sugar but raised, rather than lowered, heart attack risk.

New osteoporosis drugs stop bone turnover but cause, rather than prevent, fractures. Oops.

Thornton served on the clinical review team for Erbitux -- the cancer drug at the heart of the Martha Stewart/ImClone scandal -- while he was at the FDA, and he worries that "a change toward the much stricter endpoint of overall survival" 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 in his op-ed, unsubtly titled "Grassley's War on Cancer Patients."

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.