FDA Report Faults Diet Drug Maker
Wednesday, May 22, 2002; Page A03
The maker of the diet drug Meridia did not properly report the death of a Meridia user and certain other risk information to the government, federal inspectors said in a report.
In one case, drug industry attorneys ordered a halt to attempts to check the autopsy of another Meridia patient -- while the Food and Drug Administration was told no further information was available, according to an FDA inspection report written in April.
A consumer group cited the report yesterday in asking the government to bring charges against Abbott Laboratories, the maker of Meridia, for illegally withholding risk data.
"The pattern seen by FDA inspectors . . . reveals an Abbott scheme to conceal important information that could establish the causal role" of Meridia in certain deaths, Sidney Wolfe of the consumer advocacy group Public Citizen wrote in a letter to Health and Human Services Secretary Tommy G. Thompson, whose agency oversees the FDA.
Abbott defended the diet drug as safe, calling Public Citizen's allegations "without merit" and "intentionally written to alarm and mislead physicians and patients."
The FDA said it still was trying to determine exactly what happened.
"We're carefully looking at the allegations," said FDA spokesman Lawrence Bachorik. "FDA has inspected that facility and will take the appropriate action if any further action is warranted."
Public Citizen urged the FDA to ban Meridia in March, citing 28 deaths among the drug's users. Wolfe said that FDA scientific advisers had recommended against Meridia's initial approval because it offered only minimal weight-loss benefits while increasing the blood pressure and heart rate in some patients.
Abbott responded there was no evidence suggesting the drug was to blame for any deaths, noting that obesity itself increases the risk of heart problems. The FDA has not officially blamed the drug for any deaths.
But when the agency approved Meridia's sale in 1997, the FDA did caution that patients with poorly controlled hypertension, heart disease or irregular heartbeats should not use the prescription drug.
Wolfe's latest criticism stems from an April 3 report on the FDA's inspection of Abbott's Meridia safety database. Inspectors wrote that one death had not been reported to the FDA, and other "adverse drug information reported to FDA was either not accurate, not supported by source data" or missing key additional facts.
Abbott responded that the allegedly unreported death was a rumor it could not substantiate, and that it had "fully responded" to the inspectors' other findings. Responding to the FDA's autopsy complaint, Abbott spokeswoman Melissa Brotz said that attorneys for Knoll Pharmaceuticals -- which then owned Meridia -- ordered a halt to attempts to get a patient's autopsy records because the doctor and coroner did not respond to repeated requests for them.
© 2002 The Washington Post Company