Dr. Dustin Ballard: Vioxx story linked to debate over U.S. health system
Just two weeks ago, President Obama signed into law a $787 billion stimulus bill that establishes a multiagency council tasked with coordinating $1.1 billion of research into the comparative effectiveness of medical treatments. The goal of the federal investment in CER is to provide clear information about the risks, benefits and costs of various treatments of specific diseases (including drugs, supplements, medical devices and procedures).
Given the volume of information and misinformation available in the health-care arena, the work of the Federal Coordinating Council for CER (Council for CER), if done right, would be extremely valuable. Of course, many excellent resources weighing the pros and cons of medical treatments already exist, as do some well-done reviews of existing medical research (such as the Cochrane Review series), but a centralized and trusted catalog of comparisons would have far wider influence.
Still, comparative effectiveness research has its opponents. Sadly, they don't appreciate how CER could improve care. Instead, they fear a slippery slope leading to "rationing." Comparing treatments, they argue, will ultimately lead to certain higher-priced treatments being denied by Medicare and other payers.
George Will, writing about the excesses of the stimulus bill, opined, "CER, which would dramatically advance government control - and rationing - of health care, should be thoroughly debated." Betsy McCaughey, a senior fellow at the Hudson Institute in New York, went further in an op-ed for Bloomberg News, arguing, "Senators should read these provisions and vote against them because they are dangerous to your health."
Debating the benefits of CER is one thing, calling it dangerous is quite another. At this point, the details of the Council for CER are murky, and there is certainly a chance that the effort could go astray, but the dangerous approach is the status quo. If you don't believe me, consider the case of Vioxx.
You probably remember Vioxx (also known as Rofecoxib), the blockbuster drug of the new millennium that went horribly wrong. Vioxx was marketed as an effective painkiller that lacked the gastrointestinal side effects of anti-inflammatories such as ibuprofen and naproxen. A Vioxx-dedicated force of 3,000 Merck representatives canvassed physicians across the land, handing out pamphlets claiming Vioxx to be "8 to 11 times safer" than the competition. As a result, Vioxx had a great run; from May 1999 to September 2004, 100 million prescriptions were written in the U.S. alone and the drug generated billions of dollars in sales. A great run indeed, until it became clear that Vioxx had a nasty side effect - it caused people to die of heart attacks. How many people? Well, that is not exactly clear and may never be.
A colleague asked me recently if I had any idea how many deaths were attributable to Vioxx and I have to admit I was shocked to learn that the number may be as high as 60,000 (based on estimates by FDA official David Graham). That, by the way, is approximately a 12,000 times higher mortality rate than that of the recent peanut paste salmonella outbreak. Which is interesting because while the Peanut Corporation of America just filed for bankruptcy, Merck & Co. seems to be doing just fine. But, I digress.
If you question the impact of Vioxx on the public's health, check out the U.S. mortality rates in 2003 versus 2004. In 2002, the U.S. Food and Drug Administration (FDA) issued a warning on Vioxx's safety and this led to a 30 percent decrease in prescriptions (6 million) from 2003 to 2004. Interestingly, 2004 also saw a 2 percent decrease (over 50,000) in the total number of U.S. deaths. This drop in mortality was surprising for several reasons:
- It was the largest in 70 years.
- Most of it was in heart-disease related mortality (which decreased by 6.6 percent), despite the fact that there were no major widespread improvements in cardiac care in 2003 or 2004.
- It occurred despite the continued aging of the U.S. population.
- It was not a one-year statistical fluke (there was no major increase in mortality in 2005).
As those who've followed the Vioxx saga know, the real tragedy lies in the fact that, from the beginning, there was evidence that the drug increased the risk of heart attacks. Because of a combination of selective reporting of the data, overly optimistic interpretations of results, ghostwriting of manuscripts, inattentive editing, and aggressive and disingenuous marketing, this evidence was ignored.
I have to think that a well-funded and unbiased CER could have exposed Vioxx's fatal flaw before the death count escalated into the tens of thousands. Even if based only on early studies, a comparison of Vioxx and other available treatments would have revealed that most patients would receive little, if any, benefit by using Vioxx. But since such a comparison did not exist, Merck representatives were able to convince many physicians that they should prescribe Vioxx to patients who didn't need it, and advertising convinced many patients that Vioxx was a miracle drug that they had to have. While the FDA certainly dropped the ball on the safety of Vioxx (and has since tried to improve public access to safety and efficacy information), CER could have greatly mitigated the damage.
So yes, a Council for CER might be "dangerous" - but to companies that disregard the public health in order to make money on ineffective or harmful treatments.
Dr. Dustin Ballard is an emergency physician practicing in Marin County and the author of "The Bullet's Yaw: Reflections on Violence, Healing and an Unforgettable Stranger." His Medically Clear column appears every other Monday.