FDA Faces Avandia Decision
WASHINGTON—Against a backdrop of legal maneuvering and internal struggles at the Food and Drug Administration, a panel of outside medical experts will convene Tuesday to debate whether the agency should pull diabetes drug Avandia from the U.S. market.Avandia, which some studies have linked to increased heart-attack risk, has sparked a battle that could redefine how the FDA responds to drug-safety concerns, particularly involving products already approved and on sale.
New FDA analyses released Friday criticized Avandia—the onetime blockbuster to treat Type 2 diabetes, which affects roughly 23 million Americans.
There is much at stake for the FDA, Avandia maker GlaxoSmithKline PLC and Avandia's rival drug Actos, made by Takeda Pharmaceutical Co. The pharmaceutical industry, in particular, is worried that the fallout will delay new drug approvals.
"This is a defining moment" for FDA Commissioner Margaret Hamburg and Deputy Commissioner Josh Sharfstein, said former FDA Commissioner David Kessler in an interview.
Both leaders arrived last year with the new Obama administration as the Avandia controversy was growing.
Dr. Kessler said a crucial question is: "Who at the FDA will decide what happens to Avandia?" Will it be the commissioner and her deputies, or the drug division, whose longtime chief, Janet Woodcock, has defended the drug?
The agency's drug division has been accused by medical researchers and some of the FDA's own scientists of demanding too much proof of a drug's dangers before withdrawing it.
Dr. Kessler said the group that controls Avandia's fate will also control the direction at the FDA on drug safety, approvals and withdrawals.
A news briefing about the panel's two-day meeting highlighted the struggle over the studies, and the quandary at the agency over contending studies of the drug's safety.
"There is not complete unanimity within the FDA about the interpretation of this data," Dr. Woodcock told reporters. Drug withdrawal decisions, she said, are often complicated by the lack of "definitive proof" of risk with drugs that show "signals" of serious problems.
But Dr. Sharfstein indicated that definitive proof of risk is not the main factor, saying the issue is about "public health."
Asked who would make the ultimate decision on Avandia, Dr. Sharfstein answered, "The FDA is going to make a decision on behalf of the public."
Avandia already is the target of extensive litigation.
"Glaxo is at a crossroads here," said trial lawyer Ed Blizzard of Houston, citing thousands of lawsuits and pressure from safety advocates, politicians and some at the FDA to pull Avandia.
"Strategically, they need to get as many [cases] as possible out of the way soon, in case the FDA asks them to withdraw the drug," said Mr. Blizzard, a veteran of pharmaceutical-liability cases including Merck & Co. painkiller Vioxx, which was pulled from the market. Glaxo has settled about 700 cases in recent weeks, which is "good for Glaxo," said Mr. Blizzard, who isn't handling any Avandia lawsuits.
The company faces roughly 11,000 suits in federal and state courts, most of them consolidated into a few cases, according to a person familiar with the litigation.
"We are fully prepared to defend any litigation because we are confident that when courts and juries look at actual clinical data...the facts will support our position," said Glaxo spokeswoman Mary Anne Rhyne.
One issue in Glaxo's favor, said both industry and plaintiffs' lawyers, is that since diabetes often leads to cardiovascular problems, it can be hard to prove Avandia directly caused a heart attack or stroke.
The Avandia decision also will be watched by Wall Street, where some analysts are looking for FDA signals on future drug actions. "It has broader ramifications," said Tim Anderson of AllianceBernstein Holding LP.
Another close observer: Actos maker Takeda. Some studies have shown that Actos is equally effective as Avandia in lowering glucose but isn't as closely linked to heart problems.
Sales of Avandia slid to about $1.2 billion in 2009 from about $2.5 billion in 2006, while sales of Actos topped almost $4 billion last year.
Avandia's problems began in 2007, when studies began linking it to a major study linked it to a 43% increased heart-attack risk. Since then, more studies have indicated sizable risks for cardiovascular issues. Glaxo countered with a 2009 study it funded, called Record, that doesn't show such an increase.
An FDA review of Record, released Friday, castigated the Glaxo study, saying it was poorly designed and conducted. "We judge [Glaxo's] results to be inaccurate," wrote FDA physician Thomas Marciniak.
Glaxo's spokeswoman said the study "was conducted according to good clinical practices and the data are reliable."
Write to Alicia Mundy at alicia.mundy@wsj.com
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