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What is the Doctor’s Role in theVioxx Disaster?

By Chris Rangel MD ⋅ January 28, 2005 ⋅  Email this post ⋅  Print this post ⋅ Post a comment

Vioxx disaster; Who do we blame for the extent of the damage?

DB has several posts this week about this antiarthritic pain medication’s fall from grace (grace in this case = Billion dollar per year sales). One particular post based on a New Yorker article on the subject spawned a comment that suggests that doctors share at least some of the blame.

“[I] feel like I’m approaching a dead horse with a stick, but don’t doctors share the responsibility for the some twenty million Americans with vioxx prescriptions (those with the ability to safely take aspirin or ibuprofen, that is)? Maybe I don’t understand the prescription process - is it that patients are demanding drugs as consumers, and doctors are just the gatekeepers to their consumption? Wouldn’t a doctor have the ability (responsibility) to say ‘what you have would be better treated with tried-and-true x’ - rather than filling a prescription for the latest shiny package with the cool name?”

Well, yes! Physicians do act as “gate keepers” in that they temper the demands of their patients with what they believe is the safest and most appropriate treatment for a particular condition. But the decision making ability of physicians is limited to what information they have on the drugs they prescribe.

When the COX2 inhibitors (Celebrex and Vioxx) first came out they were touted in the medical journals as a safer nonsteroidal pain medication for patients with peptic ulcer disease, gastritis, or those at increased risk for these diseases. There was and is no proof or any claim that these drug are any better than the older and cheaper nonsteroidal over the counter (OTC) pain medications. However the drug companies heavily marketed these drugs directly to consumers (esp. on the nightly TV newscasts) and suddenly hundreds of thousands of patients were asking their doctors about these new medications (just like the ads told them to do).

At the time (late 90’s early 00’s) these medications were thought to have no more serious side effects than the OTC NSAIDs and were generally regarded as safer because of their decreased gastric toxicities. These drugs were seen as a great advancement in the treatment of arthritic patients for whom long term use of OTC NSAIDs are known to cause 20-30 thousand cases of serious gastrointestinal complications per year. These patients also liked the once a day dosing of these drugs as opposed to the every 6-8 hours needed for the other NSAIDs.

However, because of the heavy direct to consumer advertising by Pfizer and Merck a huge number of patients came to their doctors asking for these drugs even if they needed only short term treatment for aches and pains and had no history of and no increased risks for gastrointestinal side effects. If anything, direct to consumer advertising proved that it worked to increase demand for these drugs among all patients. Because of the low side effect profiles of COX2 inhibitors many physicians “gave in” to these patients and wrote prescriptions as long as the patients understood that these medications were no more effective and were much more expensive than the older NSAIDs.

When the initial data suggesting a link between Vioxx and an increased risk of cardiovascular events came out Merck alerted physicians and suggested that they avoid use of Vioxx in patients with a history or at increased risk for cardiovascular events (this is what I did with my practice from about 2002 to 2004). All was happy in Vioxx land until last year when a second study came out confirming the cardiovascular risk link and Merck panicked and pulled the drug from the market and then all hell broke loose.

Are the gatekeeper doctors really to blame?

Drug companies spend an astounding $5.3 Billion per year on direct to physician (DTP) advertising in promoting new medications with the goal of trying to change/influence prescribing habits but a recent study suggests that DTP promotions are far less effective than previously thought. Rather, it appears that direct to consumer advertising by the drug companies (another $2.5 Billion per year) is far more effective in getting patients to demand certain medications from their physicians.

Despite their “gatekeeper” role, most physicians are highly receptive to the demands and expectations of their patients because . . after all . . patients are also consumers/clients and if they are not satisfied with their care they will go elsewhere. Considering the initial beliefs that COX2 inhibitors had low side effect profiles it’s no wonder that many physicians handed out these prescriptions like they were candy. As such, Celebrex and Vioxx became ubiquitous in many a patient’s medicine cabinet and when Vioxx was recalled and the headlines screamed “Vioxx causes heart attacks and strokes” many of these same patients reached for their phone books and thumbed through the “A” section listings for “attorneys”.

Even though the increased risks of cardiovascular events with long term Vioxx use are very small, the immense size and scope of this disaster in large part has to do with the direct to consumer advertising that was so massively promoted by Merck. These ads made Vioxx appear to be as harmless and as safe as any other direct to consumer product and omitted any mention of the risks to benefit ratio that is inherent in the use of any prescription medication. James Surowiecki who wrote the New Yorker article in question perfectly sums up this problem with risk perception and the use of prescription medications.

“Instead of getting people to think about drugs in terms of costs and benefits, these ads encourage people to think of medicine in the same way they think of other consumer goods. It would be one thing if Merck had marketed Vioxx only to people who really needed it, people who couldn’t take ibuprofen or aspirin safely. Instead, the company marketed it aggressively to everyone, so that some twenty million Americans had Vioxx prescriptions. That’s why the potential damages against Merck are so vast. If juries have a hard time accepting a risk-benefit trade-off when it comes to drugs, it’s in part because the drug companies have convinced them that no such trade-off has to be made.”

The very status of a medication as “prescription only” implies that there is an inherent risk-benefit factor that every patient who takes such a medication should be aware of. However, direct to consumer advertising of prescription medications all to often implies that not only do significant risks not exist but that no new risks will be uncovered during the routine use of these new medications. Ironically Merck shot itself in the foot with its direct to consumer advertising of Vioxx and this should stand as a warning to the other drug companies that advertise their prescription medications direct to consumers. Obviously there needs to be major changes in direct to consumer advertising of prescription medications.