Group Seeks Charges Over Diet DrugMay 22, 2002 | AP
A diet drug maker didn't properly report the death of a Meridia user and certain other risk information to the government, federal inspectors say.
In one case, drug industry attorneys ordered a halt to attempts to check another Meridia patient's autopsy — while the Food and Drug Administration was told no further information was available, says the FDA inspection report, written in April.
A consumer group used the report Tuesday to ask the government to bring charges against Meridia maker Abbott Laboratories for illegally withholding risk information.
"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, Dr. Sidney Wolfe of Public Citizen wrote Health and Human Services Secretary Tommy Thompson, the FDA's boss.
Abbott defended Meridia 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 argued FDA's scientific advisers had recommended against Meridia's initial approval because it offered only minimal weight-loss benefits while increasing certain patients' blood pressure and heart rate.
Abbott responded there was no evidence suggesting the drug was to blame for any deaths, noting obesity itself increases the risk of heart problems. Nor has the FDA officially blamed the drug for deaths.
But when it approved Meridia's sale in 1997, the FDA did caution that patients with poorly controlled hypertension, heart disease or irregular heartbeat shouldn't use it.
Wolfe's latest complaint stems from an April 3 FDA inspection of Abbott's Meridia safety database. Inspectors wrote that one death hadn't been reported to 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 couldn't substantiate, and that it had "fully responded" to the inspectors' other findings. Regarding FDA's autopsy complaint, attorneys for Knoll Pharmaceuticals — which then owned Meridia — ordered a halt to attempts to get another patient's autopsy records because the doctor and coroner didn't respond to repeated requests for them, said Abbott spokeswoman Melissa Brotz.
FDA was evaluating Abbott's explanations, Bachorik said.