Diabetes Drugs Dealt Stronger Scrutiny

It will be a breath of fresh air if the FDA follows through in this new effort to better police the pharmaceutical industry in light of known risks to patient health from diabetic drugs.

FDA panel urges more testing for diabetes drugs
By MATTHEW PERRONE, Wed Jul 2, 2008

Diabetes drugs should face tougher safety standards that could cost manufacturers millions but protect patients from unforeseen heart risks, a government panel has recommended.

Advisers to the Food and Drug Administration voted 14-2 on Wednesday that all new diabetes drugs should undergo longer studies to assure they don't increase risks of heart problems. The agency currently doesn't screen for heart risks associated with diabetes drugs.

The opinions from diabetes experts, cardiologists and statisticians come less than a year after the FDA was criticized for its handling of heart risks connected with a widely used GlaxoSmithKline pill. The drug was approved in 1999 but the agency didn't add a warning about potential heart risks until last November.

The majority of the panel said drug companies could begin safety testing before they submit drugs to the FDA, and finish the studies after the drugs are on the market. The testing would take an estimated five to seven years to complete, and likely cost tens of millions of dollars.

At least one panelist doubted whether the proposed studies would actually uncover heart risks, and added they could delay important medical breakthroughs.

"If you wait this amount of time for testing you're going to be preventing certain drugs from getting out there that may be better than what we already have," said Dr. Eric Felner, a pediatric specialist at Emory University School of Medicine.

The FDA is not required to follow the panel's advice, though it often does.

GlaxoSmithKline PLC, AstraZeneca and Novartis AG are among the companies developing diabetes treatments to compete in the domestic market, which grew to more than $6 billion last year, according to pharmaceutical research firm IMS Heath.

Takeda Pharmaceuticals' Actos, GlaxoSmithKline's Avandia, and Eli Lilly and Amylin Pharmaceutical's Byetta currently dominate the U.S. market.

Nearly 24 million Americans have Type 2 diabetes, which can lead to kidney failure, blindness and heart disease.

The FDA was pressured to reconsider how it approves diabetes medications after an analysis released last year showed GlaxoSmithKline's blockbuster drug Avandia may increase patients' risk of heart attack.

The agency currently approves diabetes drugs based on their ability to lower blood sugar. But Dr. Steven Nissen, who authored the analysis on Avandia, said Tuesday that criterion has little value if drugs also increase heart problems.

Nissen, the chairman of cardiology at the Cleveland Clinic, said the FDA is operating under "the irrational belief that lowering blood sugar using virtually any pharmacological means will produce" better results for patients.

He recommended the FDA require drug companies to prove their drugs do not have significant heart risks before granting approval.

"The fallacy here is that we will never know everything we'd like to about a drug before it goes on the market," Dr. Ray Woosley, president of the Critical Path Institute in Tucson, Ariz., said in a phone interview Tuesday. "If we held up drugs until we did know everything a lot of people would die."

The institute is a nonprofit partnership with the FDA that aims to speed up the development of new drugs.

Approving drugs based on biological measurements, like blood sugar levels in diabetics, is thought to be a promising method for speeding-up drug development because the results can be gathered relatively quickly. But that approach is under scrutiny, as some lawmakers and medical experts believe the FDA should not approve drugs without evidence they improve more meaningful measures like patients' life span.

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