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Another Heart Attack Waiting To Happen

As if there weren’t enough things giving us chest pain, new studies reveal that Prilosec and Nexium, made by pharmaceutical giant AstraZeneca, increase the risk of fatal heart attacks after years of use.

The heartburn medications follow closely in the wake of controversies surrounding Vioxx, a painkiller also believed to raise the likelihood of heart attack and cardiovascular problems, and Avandia, a diabetic medication thought to elevate similar risks. Prilosec and Nexium are nearly identical in formula, and belong to a group of drugs known as proton pump inhibitors, which reduce or eliminate heartburn by decreasing the stomach’s production of acid. Prevacid, Protonix, and Aciphex are also in this group.

The effect these court and media battles have had on the health care, health insurance, and pharmaceutical industries is significant, and if similar trends continue, could be astronomical. Giants like Merck, the makers of Vioxx, are seeing their stock market prices recover, but for a while, it was questionable.

The issues extend beyond just Wall Street, however, and certainly are a concern to residents of Dallas, Houston, Austin and throughout Texas. Health insurance companies may be less likely to cover drugs from pharmaceuticals with a history of liability problems.

For states like Texas, where twenty-five percent of the population is already going without any health coverage whatsoever, more bad news could crush the state’s ability to provide adequate care. If, for instance, state medical programs began to limit accessibility to medications made by giants like Merck, healthcare facilities already on the edge may go under entirely due to unreimbursed costs, or, worse, be unable to provide sufficient care at all.

The Food and Drug Administration (FDA) was heavily criticized for not warning the public against Avandia, when it knew for more than a year about studies suggesting its link with higher risks of heart attack and angina. Merck faced formidable damage-control issues over Vioxx, and, in fact, is still in court over the fiasco. AstraZeneca might as well take notes; lawsuits are sure to come.

AstraZeneca recently sent the FDA the results of its fourteen-year study on different treatment options for acid reflux disease. It compared patients who elected to have surgery with those taking Prilosec, and found evidence within one year of the study’s inception that those choosing the medication were more likely to have heart attacks, heart failure and heart-related sudden deaths than those who underwent surgery. These findings continued throughout the study.

Several factors could have led to false negatives, reported the drug company, including the fact that surgery patients are often younger and healthier, and fourteen other studies on Prilosec showed no elevated risk at all.

That AstraZeneca knew of the possibility of these risks thirteen years ago, but did not reveal them, only adds to the lack of trust building against the pharmaceutical industry in general. A study on Nexium found similar risks early on, but the effect seemed to dissipate as the trial continued.

“It’s hard to know if this will play out similarly [to Avandia] until we have completed our analysis,” said Dr. Paul Seligman, the FDA’s associate center director for safety policy and communication, when questioned about Prilosec and Nexium.

In a written statement, the agency said that, “based on everything we now know, the FDA’s preliminary conclusion is that the observed difference in risk of heart attacks and other heart-related problems seen in early analyses of the two small long-term studies is not a true effect.”

The course of these analyses eerily parallels that of Avandia, however — just in reverse. Three dozen short-term studies on the diabetes medication revealed heart risks, but the FDA dismissed the evidence after a long-term trial did not produce similar data. Prilosec’s long-term trial, on the other hand, revealed heart risk, while fourteen shorter-term studies did not. The fact that the FDA seemed, in both cases, to have conveniently ignored one set of data in exchange for emphasizing the other, more profitable one, calls the agency’s process of analysis into question. The FDA has since asked for safety data from all makers of proton pump inhibitors.

“We were cognizant from the earliest submission [on Prilosec and Nexium] about whether and how we should say something,” said Seligman.

It’s hard to know whether or not to be comforted by that.

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