Drug Companies’ Efforts to Outmaneuver the FDA “Disturbingly Common”

Time (8/12, Park) reports that  the FDA panel’s recent decision to recommend keeping Avandia (rosiglitazone) on the market is “a move worth billions of dollars to GSK but that also may have put millions of patients at risk.” The move is also an example “of the drug industry’s outmaneuvering FDA regulators,” which is “disturbingly common, say both scientists and policymakers who follow drug approval and safety monitoring.”

Documents Indicate Glaxo Hid Test Data on Risks of Avandia

The New York Times (7/13, A1, Harris) reported that, according to recently obtain documents, SmithKline Beecham (the precurser to GlaxoSmithKline) spent years attempting to cover up a study that found that Avandia (rosiglitazone) was “riskier to the heart.” In an email message dated March 29, 2001, Dr. Martin I. Freed wrote, “Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK.”

The Wall Street Journal (7/13, Mundy) reported that Dr. Rosemary Johann-Liang (a former FDA official) said that there were early reports written by company researchers that noted scientists’ concerns about heart risks of taking Avandia.

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FDA Advisory Panel to Review Data Regarding Safety of Avandia

CNN (7/9, Hellerman) reported that, “A decade after critics first accused the Food and Drug Administration of downplaying side effects from Avandia (rosiglitazone), the agency says it will reveal on Friday the data it is reviewing ahead of an advisory panel meeting about the safety of the popular diabetes drug.” The meeting is scheduled for July 13 and 14, and follows  two new studies suggesting that Avandia may cause serious or even life-threatening heart problems — and a third study that seems to show just the opposite.”

An editorial in the USA Today (7/9) stated, “Since 2005, evidence has mounted that the blockbuster diabetes drug Avandia (rosiglitazone maleate) might increase the risk of cardiovascular complications — including heart attacks, one of the major causes of death among diabetics.”

NY Times Suggests that Patients Seek Avandia Alternatives

The New York Times (7/5) suggested in a recent editorial that the recent controversy over the diabetes drug Avandia (two major studies indicating that Avandia raises the risk of cardiovascular ailments) that patients should ask their doctors about alternative medications.

Healthcare Experts Not Surprised at Avandia Findings

The Los Angeles Times (7/2, Lazarus) reported that, following recent research linking Avandia (rosiglitazone) to increased heart risks, healthcare experts and federal regulators are not surprised.  Sidney Wolfe, director of health research for the advocacy group Public Citizen, stated that a key problem with the FDA’s drug-approval process is that a much greater emphasis is placed on the effectiveness of a medication than on its safety.

Avanda Controvery Exposes FDA’s Murky Drug Approval Guidelines

The Associated Press reports (7/1, Marchione) that the FDA did not have firm rules for deciding when a drug is too risky to stay on the market.  “Each drug has its own complex story,” said Dr. Joshua Sharfstein, the FDA’s principal deputy commissioner. Regarding the debate surrounding the GlaxoSmithKline diabetes pill Avandia (rosiglitazone), Sharfstein indicated that the case will not be decided in reference to Vioxx (rofecoxib) but would stand on its own.  The FDA sought advice from a group of outside scientists (The Institute of Medicine) and scheduled a special meeting in July to hear from experts on its endocrinology and drug safety panels. Sharfstein stated that “the internal staff analyses of risks have not been released yet, and will shed more light on the situation.”

NHTSA Raises Number of Deaths Associated with Toyota Acceleration

The Associated Press (5/26, Thomas) reported that NHTSA said that 89 deaths in the past ten years can be attributed to “unintended acceleration in Toyota vehicles,” adding that NHTSA said that ”from 2000 to mid-May, it had received more than 6,200 complaints involving sudden acceleration in Toyota vehicles. The reports involve 89 deaths and 57 injuries over the same period. Previously, 52 deaths were blamed on the problem.”

Henry Waxman Questions Toyota’s Assurances of Safe Engine Electronics

The Los Angeles Times (5/21, Puzzanghera) reported that, at the hearing into the cause of Toyota’s sudden acceleration crisis, House Energy and Commerce Chairman Henry Waxman said that Toyota “still had not done the testing required to determine the cause. . . ” Waxman further stated that his “panel’s investigation had raised serious questions about the scope of Toyota’s efforts to locate an electronic fault.”

Toyota Pays $16.4 Million Fine

The Associated Press (5/19) reported that Toyota paid a $16.4 million fine for its sluggish response to its gas pedal recall crisis, although no official announcement has been made.  House lawmakers plan to hold a hearing Thursday to examine the company’s review of report of sudden unintended acceleration and whether electronic issues caused the safety problems.  NHTSA Administrator David Strickland and Toyota’s USA Sales Chief Jim Lentz are scheduled to testify.