Will Drug Companies & the FDA Learn …?

When Merck voluntarily recalled Vioxx on September 30th, 5 years and 105 million prescriptions after its debut, users were stunned. How could a drug billed as part of the new, “safer” generation of pain killers double your risk for heart attack and stroke? What’s more, why was it sold for so long?

There were early warning signs that Vioxx was dangerous. In fact, Health Alert readers first learned about them here back on 4/24/03 in Health Alert 74. Today you’ll also learn how Vioxx is a symptom of bigger problems within the drug industry, and how the FDA could be making the exact same mistake judging the safety of other drugs still on the market.

* Vioxx: A Symptom of A Bigger Problem *

One year after Vioxx hit the market executives at Merck learned of a clinical trial showing this new “super-safe” pain reliever might pose a heart risk. They chose NOT to run a study to find out for sure. Instead, they decided to monitor existing Vioxx trials on other issues for cardiovascular side effects and risks.

It’s the safe until proven otherwise philosophy that’s now pervasive in much of modern medicine. So where, you’re probably wondering, was the FDA during all of this? Did they know? As it turns out, they did…

Even before the FDA approved Vioxx an FDA drug reviewer wrote that it could conceivably hurt the heart. Then, in 2000 Merck showed the FDA the results of their own study revealing users of Vioxx suffered greater heart risk than those that used naproxen.

Naproxen is another anti-inflammatory sold over the counter as Aleve. But the FDA did not withdraw the drug. In fact, the FDA approved its new use in children in September of 2004; just weeks before Merck voluntarily recalled Vioxx!

Congress smells something fishy here and has launched an investigation into the FDA’s handling of Vioxx safety.

* So, What about the Other Cox-2’s? *

Of course, the other Cox-2 inhibiting pain relievers are still on the market and drug makers are insisting they’re safe too. In fact, Pfizer is sending out publicity information to doctors telling them they should “feel good” about prescribing Celebrex. But unfortunately, just like Vioxx, studies are revealing a different truth.

A recent study revealed that those taking Celebrex suffered from a decrease of blood flow to the heart. The study also revealed that the incident of heart attack is HIGHER in Celebrex users than in those using ibuprofen.

The moral of the story? The drug industry has failed us in coming up with a new, safer pain-relieving substitute for aspirin and ibuprofen. And the FDA is dropping the ball again by allowing them to remain on the market despite a growing body of research revealing their dangers.

A study led by Dr. Garret Fitzgerald shows the problem may not be a specific drug, but the entire Cox-2 class of drugs. Dr. Fitzgerald found that shutting down Cox-2 long term may kick-start arteriosclerosis-especially in women. Not to mention the fact that years of studies link Vioxx and Celebrex to gastrointestinal hemorrhaging, kidney damage, and heart palpitations. You can find more about these dangers and natural safer alternatives in Heath Alert 74.

In your next Health Alert you’ll see how the FDA is making the same mistakes with 5 other popular drugs touted to be safe.

To Your Good Health,

Al Sears MD