FDA criticized after study finds drug-related deaths up

By Bruce Japsen | Tribune staff reporter

September 11, 2007

The number of serious injuries and deaths from drugs reported to the U.S. Food and Drug Administration more than doubled between 1998 and 2005, according to a report in Monday's Archives of Internal Medicine published by the American Medical Association.

The report is expected to add momentum to efforts to reform the federal government's monitoring of prescription drugs.

The story said the dramatic rise in "adverse events" made known to the FDA point out myriad problems with the government's monitoring of drugs before approval and after they are on the market. The study looked at "serious adverse events," occurrences that result in death or injuries including birth defects, disability and hospitalization.

The report suggested the FDA and the health-care system, including doctors, hospitals and other caregivers are lacking in their ability to manage medications. Insulin, for example, was among the top drugs cited for causing disability or other serious outcomes. Although specific reasons for adverse events were not disclosed, the report's author said mismanagement of the medication can cause low blood sugar, which can also lead to balance issues, accidents and unconsciousness.

"There is plenty of blame to go around," said Thomas J. Moore, the study's lead author and a senior scientist for drug safety and policy at the Institute for Safe Medication Practices of Huntingdon Valley, Pa. "This is a direct set of data that shows that the system is failing and it is getting worse. We are in denial about drug safety."

Serious adverse event reports jumped to 89,842 in 2005 from 34,966 in 1998. Meanwhile, the number of "fatal adverse drug events" increased nearly threefold to 15,107 in 2005 from 5,519 in 1998.

"The overall relative increase was four times faster than the growth in total U.S. outpatient prescriptions, which grew in the same period from 2.7 billion to 3.8 billion," the authors wrote.

Most of the drugs causing the problems are not even those that have been pulled from the market such as Vioxx, a painkiller withdrawn in 2004 by its maker Merck & Co. after a study showed an increased risk of heart attacks and strokes. By spring 2005, a second pain pill in the same class known as Cox-2 inhibitors, Pfizer Inc.'s Bextra, was withdrawn for similar reasons, as well as a potentially fatal skin condition.

"Contrary to our expectations, drugs related to safety withdrawals were a modest share of all reported events and declined in importance over time," the authors wrote. "Among the most frequently reported drugs associated with fatal events, we observed a disproportionate contribution of pain medications and drugs that modify the immune system."

The most frequent suspect drugs in death and "serious non-fatal outcomes" were pain narcotics Oxycodone and Fentanyl, which are both in the class of drugs known as opioid analgesics. "We are not managing some of the familiar drugs well," Moore said.

The FDA said the increase in reported "adverse events" is not necessarily a bad thing, particularly if doctors and drug companies are making more reports. Underreporting of adverse events has been a problem in the past, the FDA said.

"More reporting to us gives us more information on which to evaluate a drug's safety once it is on the market," said FDA spokeswoman Julie Zawisza. "Now that we get more reporting, people are saying that there is something wrong. We know that underreporting is a problem, so one would think that when we get more reports it could suggest that the system is actually working better, but we don't know for sure."

A chorus of critics from both major political parties in Congress say the FDA needs to do more.

Under a fiscal 2008 appropriations bill being pushed by Sen. Herb Kohl (D-Wis.), the chairman of a Senate appropriations subcommittee that oversees FDA funding, more money would be allocated "to provide access to databases for drug-safety analysis to hire scientists and other drug-safety experts," the senator's staff said in a statement to the Tribune.

Members of Congress are vowing to strengthen the FDA.

"This report is another indication that the FDA's post-market review of drugs must be rigorous and timely," Sen. Charles Grassley, an Iowa Republican and outspoken FDA critic said in a statement. "The FDA needs to commit itself to considering and acting on the additional data gathered from more adverse events being reported considering the deaths associated with these adverse drug events."

---------

bjapsen@tribune.com

Copyright Issues?