Vioxx patients misled by Merck advertising
In a finding that could have significant impact on Vioxx litigation, researchers at Stanford University have found that Vioxx was prescribed to patients who were unlikely to benefit much from this drug but would be subject to a higher risk of heart attacks and other serious side effects.
How could Merck do this? Through slick, direct-to-consumer advertising about Vioxx that talked only of the benefits and never highlighted the risks. In other words, the researchers find that Cox-2 drugs are not necessarily better at treating pain than nonsteroidal anti-inflammatory drugs (or over-the-counter painkillers that cost pennies), and people at low risk for stomach bleeding got no real benefit from using drugs like Vioxx and Pfizer's Celebrex and Bextra (which continue to remain on the market), yet were exposed to the drugs' increased risk of heart attacks and strokes and paid a lot more. (Related article: Recall prospects for Celebrex and Bextra rise after side effects found)
While direct-to-consumer advertising for Cox-2 drugs is on hold for the time being (Vioxx has been recalled, and in an agreement with the FDA, Pfizer has stopped all advertising for Celebrex and Bextra till a thorough review of the safety of the drugs is completed in February), it is important to recall that over the life of Vioxx, Celebrex, and Bextra, hundreds of millions of dollars were spent on advertising on what are essentially lifestyle drugs (ones that do not cure a disease but improve quality of life). Pfizer actually got so aggressive with marketing of Celebrex and Bextra (particularly after recall of Vioxx) that FDA issued a warning earlier this month about its misleading ads. (Related article: Pfizer warned by FDA on misleading Celebrex and Bextra ads and Celebrex and/or Bextra recall likely?)
Dr. Eric Topol, world-renowned cardiologist and an authority on side effects of painkillers on the heart, writes in the Journal of American Medical Association, "...but valdecoxib (Bextra) and celecoxib (Celebrex) have never been definitively confirmed to protect against gastrointestinal complications. While coxib superiority over NSAIDs for relief of arthritic pain has not been shown, many individual patients report pain relief with a coxib but not an NSAID. With the considerably higher cost, marginal efficacy, and known cardiovascular risks of the remaining agents on the market, valdecoxib and celecoxib, it would seem prudent, at the least, to avoid using these agents as first-line therapy." (Related article: FDA should have never approved Vioxx)
Doctors generally do not appreciate direct-to-consumer advertising since it forces them to prescribe drugs that are not always the best for their patients, and in many cases, they have to prescribe a drug when no prescription is necessary (in other words, over-prescription occurs). United States is one of the only two countries in the world to allow direct-to-consumer advertising for prescription drugs. Any discussion to ban this advertising has been met with howls of protest from drug companies and advertising agencies. Dr. Topol has called for a complete ban on direct-to-consumer advertising so that doctors can decide what is best for their patients rather than being told by (mostly clueless, poorly informed) patients what drug they want. He says, "The combination of mass promotion of a medicine with an unknown and suspect safety profile cannot be tolerated in the future. An aggressive position going forward is necessary not only for ensuring the safety of prescription medicines but also to restore a solid foundation of public trust."
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