Lies of omission. That’s what my mother calls them.
The kind where you provide small amounts of information strictly on a “need-to-know” basis. I never considered it lying – just not telling the whole truth. If someone didn’t get the pertinent information – that was their own fault. “You didn’t ask me THAT,” used to be my defense when I got caught in one of my webs. And, yes, inevitably – I always got caught.
Recently, pharmaceutical giant Merck & Co. has gotten caught in a lie of omission over its blockbuster arthritis drug Vioxx – and the company is responding like a 13-year-old caught with a cigarette behind his back.
I’m sure you’ve seen the commercials for Vioxx. They end with a reminder to “ask you doctor” about this new drug for arthritis. Well, lots of people followed that advice – Vioxx is one of the fastest selling drugs in the world, and sales are expected to reach $2 billion or more by 2002. Not bad for a drug that received FDA approval just a little over a year ago.
But you may not see those Vioxx ads too much longer – or, at least, they won’t be quite the same. The FDA has ordered Merck to halt all promotion of Vioxx because the ads minimize the popular drug’s safety risks – particularly a startling increased risk of heart attack.
The finding came out in a Merck-sponsored study that first appeared in The New England Journal of Medicine in late 2000. It found that people over 40 with rheumatoid arthritis who took Vioxx had FOUR TIMES the risk of heart attack as comparable people who took naproxen, the NSAID found in over-the-counter painkiller Aleve and other prescription pain medications.
Believe it or not, that little tidbit snuck under the radar for a while. The Merck study was not designed to track the drugs’ effects on heart health; it was supposed to demonstrate that Vioxx caused fewer ulcers and other GI problems than naproxen. It accomplished that goal; among the study’s 8,076 participants, the people taking Vioxx had about half the incidence of upper GI “events,” as compared with those who took naproxen. (Vioxx’s active ingredient, rofecoxib, is in a new class of drugs called Cox-2 inhibitors which had been roundly praised for effectively eliminating pain without causing gastrointestinal damage, as NSAIDs like naproxen can do.)
Merck submitted the study to the FDA to help prove that Vioxx should not be required to carry a gastro-intestinal warning on its label. And it proceeded to blanket the public with marketing campaigns touting Vioxx’s lower risk of gastro-intestinal problems.
But, eventually, the truth caught up with them. Some doctors and researchers quietly started asking questions about the cardiovascular findings in the Merck study. Finally, the FDA asked Merck about the findings.
Merck claims that the findings only demonstrate the blood-thinning effects of naproxen on cardiovascular health, not that Vioxx actually harms the heart. And, to be fair, their advertisements do reveal that Vioxx does not thin the blood.
But others wonder if there’s more to the story. Some doctors and researchers are calling for more research into the possible mechanisms behind the four-fold increase in heart attacks in the Merck study. The FDA noted that there’s no proof that the heart attack discrepancy can be completely explained away by naproxen’s blood thinning benefits. “In fact, the situation is not at all clear,” stated the FDA in its response to Merck.
And then in late September, the FDA issued the cease-and-desist order on Vioxx ads. We don’t yet know how Merck will respond – but stay tuned.
Granted, the cardiovascular risk from Vioxx is fairly small – the numbers work out to an increase of four heart attacks per 1,000 patients. But it is still significant, and it joins an already extensive list of warnings, contraindications, precautions, and possible side effects on the Vioxx label.
And remember that Vioxx does nothing to rebuild worn cartilage or address the underlying causes of arthritis. It only helps manage the pain. Why accept the risks associated with it when there are so many safe, natural alternatives for relieving arthritis pain and helping heal damaged joints?
HSI has written about dozens of natural arthritis therapies. In June 2001, we told you about the topical deep-tissue oil “Pain Away,” which combines 10 proven painkillers in a formula that blocks the pain message sent to your brain. In July 2000, we covered the Ayurvedic herbal formulas like Boswellia, which has been proven to inhibit the action of the inflammatory agents that lead to joint stiffness and arthritis pain. A recent e-Alert brought you an update on Lyprinol, the natural remedy derived from New Zealand green-lipped mussels. We originally covered Lyprinol in our December 1999 issue, when we first learned about this natural therapy that is proven to inhibit the 5-lipoxygenase pathway, one of the biochemical pathways involved in inflammatory response.
And in our December issue, we’ll tell you about another promising arthritis treatment. Currently, we are researching the analgesic properties of JointCare – a formula of several Ayurvedic (Indian) herbs from Himalaya USA. This mixture of extracts from guggul, Indian madder, horseradish tree and five other Indian plants has proven effective in relieving pain caused by rheumatoid arthritis and osteoarthritis. Furthermore, toxicity studies (lasting up to two years) have concluded that the formula doesn’t induce adverse side effects. We’ll continue our research and bring you full details in December’s HSI Members Alert.
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