Abbott Should Be Prosecuted for ‘Withholding’ Meridia Info
This really isn’t “bash pharmaceuticals” week…it just works out that way in the medical literature… Besides, they can be such an easy target it is hard not to take aim.
May 22 – Claiming that Abbott Laboratories withheld from the US Food and Drug Administration (FDA) crucial information about adverse events and deaths that may be related to its obesity drug Meridia (sibutramine), the advocacy group Public Citizen on Tuesday called on the government to criminally prosecute the company. The group’s allegations are based on an FDA inspection of an Abbott manufacturing plant conducted in late March and early April. The agency was searching Abbott paperwork and databases for clues to help determine if Meridia played any role in the 34 deaths reported so far in patients taking the drug. In a query of an Abbott database using the keywords “Meridia” and “death,” the FDA found a death that had never been reported. “Abbott had not performed this type of query prior to the inspection,” wrote the agency’s staffer in a report. “They completely withheld information on one death,” claimed Sidney Wolfe, director of Public Citizen’s Health Research Group. That alone is enough to press charges, Wolfe told Reuters Health. The FDA inspector also said that Abbott files on several deaths were missing important data that could be used to prove the drug had caused the patient to die. Public Citizen also alleged that Abbott should be criminally charged for failing to notify the FDA about three adverse events, including one death, within the 15 days required by law. Abbott reported one death 41 days later, and the other two adverse events 232 days and 79 days later, respectively, said Wolfe. His organization petitioned the FDA in March to ban Meridia, claiming that its risks – including elevated blood pressure and heart rate, and abnormal electrocardiograms – outweighed its benefits. Abbott said there has been no definitive causal link between Meridia and the deaths reported to the agency, and pointed out that obese people have a higher risk of cardiovascular death, thus explaining deaths attributed to Meridia. The company also denied that it kept any information from the FDA. “The charges alleged by Public Citizen and Sidney Wolfe are without merit, are not factual, and have been intentionally written to alarm and mislead physicians and patients,” said Eugene Sun, Abbott vice president, in a statement. Abbott has responded to the FDA inspector’s concerns, the statement said, adding that the company “is confident that all confirmed deaths reported to the company coincident with Meridia use have been reported to the authorities as appropriate.” As far as the death that supposedly was unreported, Abbott said its own investigation found the initial report was a “rumor,” that the company was “unable to substantiate.