22. Over-the-Counter" Diet Pills Cause Deaths

Source: MUCKRAKER Date: October 1994 Title: "Over-the-Counter Diet Pills and Cerebral Hemorrhages" Author: Diana Hembree

SSU Censored Researcher: Jessica Nystrom

SYNOPSIS: On the morning of October 12, 1990, 41-year-old Arlette Cannata took a popular diet pill called Acutrim, advertised as a safe and effective way to lose weight. Later that day she collapsed, was rushed to a local hospital, and died minutes later of a cerebral hemorrhage, or stroke.

An autopsy found the pill's active ingredient, phenylpropanolamine, in her bloodstream, and a physician at Johns Hopkins University School of Medicine later concluded the stroke was caused by the drug.

Arlette Cannata's case is just one of a number in a decades-long controversy surrounding the use of over-the-counter diet pills and cold medications containing phenylpropanolamine hydrochloride (PPA). The drug has a chemical structure similar to that of amphetamine, or speed, and like speed, can trigger a sharp rise in blood pressure, sometimes resulting in stroke. PPA is found in many brands of popular diet pills such as Acutrim and Dexatrim, as well as in cold remedies such as Contac and Dimetapp.

This rare but alarming side effect has sparked a controversy within federal health agencies over whether to tighten restrictions on the widely available drug. It also has raised larger questions about whether such decisions are made quickly and effectively enough to protect consumers.

A year after Cannata's death, Food and Drug Administration officials learned that drug-industry data show 92 people had suffered PPA-linked strokes during an 11year period. More than a dozen medical case reports have linked PPA to life-threatening strokes in previously healthy individuals; some strokes have occurred even at the recommended dosages.

Dr. Thaddeus Prout, an associate professor at the Johns Hopkins University School of Medicine, defied "anyone to find another unregulated drug with such a record of disaster." PPA, he said, "should be returned to the logical and safe place for purchase: the pharmacy."

Dr. Sidney Wolfe, of the Public Citizen Health Research Group, said that "Over-the-counter diet pills should not be on the market -- they're dangerous." He also criticized the slowness of the FDA's review process as "unacceptable .... This has been going on for two decades."

While most people who take the drug report no problems, for years medical experts have warned that a small number of PPA users have severe reactions to it, including seizures, psychosis, and strokes. Many others have reported less severe symptoms, ranging from headaches and nausea to anxiety and irregular heartbeats. Experts point out that some medical conditions increase the risk of PPA-induced strokes and that people being treated for high blood pressure, diabetes, and heart, thyroid, or kidney disease should not take diet pills.

Drug manufacturers contend problems with PPA products are overstated and insist the drug is both safe and effective.

In a study published by the Western Journal of Medicine, James McDowell, a neurologist, noted that these drugs seem to pose a danger even to healthy people, and added, "I can't understand why there hasn't been more outcry over this."

COMMENTS: Investigative journalist Diana Hembree said that to date her story about over-the-counter diet pills and cerebral hemorrhages has not been carried by a wire service, the television networks, or a newsweekly. "Besides appearing in the Center for Investigative Reporting's internal publication, Muckraker, the story has been sold to a handful of outlets: the Philadelphia Inquirer, Fox-TV's 'Front Page,' and the San Francisco Chronicle (where it appeared on 12/4/94). I feel the story is still underreported because there has been no wire pickup or network coverage to date.

"The millions of Americans who take PPA-containing diet pills-the majority of whom are women would greatly benefit from wider exposure of this subject. They would know they may be risking their lives each time they take over-the-counter PPA diet pills, which have been known to cause strokes in previously healthy individuals even at the correct dosage. As one doctor told me, physicians always have to weigh a drug's potential risks against its benefit. In the case of PPA, however, the doctor concluded that the risk of stroke completely outweighed any possible benefits. `Diet pills are not a crucial drug like penicillin,' he added, `and they haven't even been proven effective."'

Hembree said the large pharmaceutical companies that make PPA, and their directors, benefit from the lack of media coverage. "By settling nearly all diet pill/stroke lawsuits out of court, with gag orders and sealed records, non-prescription drug manufacturers have effectively prevented news of stroke dangers from reaching the public. Such secrecy has also delayed the push for better regulation of such drugs."

In an update, Hembree stated that the Food and Drug Administration (FDA) "is overseeing a study of PPA and stroke by the Nonprescription Drug Manufacturers' Association, which will complete its study in 1995. The FDA will pull PPA products off the shelves if the trade association documents a stroke risk. However, the FDA already has criticized the trade association for what critics called apparent sabotage of the epidemiological study-not including a 'control' group, for example. Although this omission has since been remedied, such maneuvers have left some health advocates wary of the study."