Drug Companies Cover Up PPA Dangers
May 15, 2001
Pharmaceutical companies spend billions of dollars each year in an effort to find novel drug therapies and bring them to market before the competition does. While this massive financial effort has lead to many great scientific breakthroughs, it has also depleted companies' funds for post-approval monitoring of these new wonder drugs. "There's very little money spent on [post-approval study]; the emphasis is on getting the drug to market," says Dr. Louis Lasagna, an expert at Tufts University.
Nowhere is this problem more evident than with the current scare over phenylpropanolamine or PPA as it has become known. First manufactured in cold medications over 60 years ago, today, PPA is a staple in the over-the-counter and prescription cold and diet drug industry. Dozens of popular products with household names like Dimetapp, Contac, Dexatrim and Tavist-D contain PPA. More than 7 million people take these products each year assuming they are completely safe.
Odell Buggs no longer makes such assumptions. Ms. Buggs suffered a stroke at the age of 28. Her doctors attributed her stroke to PPA found in the Tavist-D she had taken for a cold. In 1999 Buggs settled a lawsuit with Tavist-D's Swiss manufacturer Novartis, A.G. The company agreed to pay Buggs $1.3 million as long as she agreed to keep quiet about the settlement. Novartis was concerned that word would spread of PPA's dangerous propensity to cause strokes in young women.
While PPA had been around for decades, no one had bothered to study the substance's adverse side effects, including the long held suspicion that PPA may cause strokes. The substance was first used in cold products in 1936, before federal regulation requiring safety evaluations. When such regulation was enacted in 1938 PPA was "grandfathered in." The substance was allowed to remain on the market without any significant study or oversight.
While PPA has been a staple in cold and appetite suppressants, contributing millions to drug companies' bottom lines, none of that money had ever been directed at studying the possible link between PPA and stroke. In the early 1990s the FDA, long concerned with such stroke rumors, ordered the pharmaceutical industry to fund a $5 million Yale University study of the possible PPA - stroke connection. Many believe that it was the finding from Yale researchers that convinced Novartis to settle with Ms. Buggs. The company, but not yet the public, knew that the study confirmed the industry's long feared suspicion that PPA was a killer, even if only rarely so.
In November 2000 the public finally found out about PPA's dangers after an FDA advisory board recommended that PPA should no longer be considered "safe." The advisory board cited the industry funded Yale study as the reason for its determination. The board said that perhaps as many as 500 people annually, mostly young and otherwise healthy women, suffer a type of stroke that causes bleeding in the brain. Known as hemorrhagic strokes, these relatively rare episodes can leave victims dead or with permanent brain damage. Now Ms. Buggs can finally speak up about her experience with PPA. "Now," she said, "people will see."
The pharmaceutical industry has attempted to quell otherwise legitimate criticism over the safety of many of its drugs. PPA is a classic example of the industry's prowess at doing so. While many in scientific circles were convinced that there was a problem with PPA, other industry funded scientists acted to keep such concerns below the public's radar screen. Additionally, drug company lawyers quietly settled over two-dozen lawsuits challenging PPA's safety. All the settlements were based on confidentiality agreements that forced victims to keep quiet about their ordeal. This settlement practice effectively shut the public out of the debate over PPA. It is safe to assume that before November's FDA recommendation few Americans had ever heard of PPA.
Aside from cold medication, the pharmaceutical industry is dependant on PPA in appetite suppressants and other diet drugs than ever before. In 1990 the FDA restricted the use of many non-PPA containing appetite suppressants, leaving PPA diet products the only ones available. Since then the diet drug industry has been aggressive in delaying further inquiry into PPA's safety. According to Senator Ron Wyden, "This is a textbook case, for how a powerful industry that is willing to pull out the stops can be successful in preventing an objective evaluation of an important drug ingredient."
-- Article Courtesy of InjuryBoard.com
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