Why so many Americans take COX-2 Inhibitors

COX-2 inhibitors are an incredibly succesful class of drugs, with sales in the hundreds of millions of dollars since their introduction in the late 1990s. Tens of millions of Americans switched from older pain relievers like aspirin, Ibuprofen (Advil) and Naproxen (Aleve), to COX-2 inhibitors like Vioxx, Celebrex and Bextra. The COX-2 inhibitors promised to be easier on the stomach than the older painkillers, which could cause a range of problems from upset stomachs to stomach ulcers. But did those seeking stomach pain relief actually get it? And why did so many Americans switch to COX-2 inhibitors?

USA Today reported in February 2005 that, according to a study published on January 24, 2005 in the Annals of Internal Medicine, almost two-thirds of individuals who took COX-2 inhibitors in 2002 had a low risk for gastrointestinal problems, the main "selling point" for the use of COX-2 inhibitors. Between 1999 and 2002, only 2% of participants were at a "high risk" for gastrointestinal side effects and should have used COX-2s over older medications. This means that there was a very small segment of the population that actually needed to switch over to COX-2 inhibitors; most patients were fine to stay on standard pain relievers.

In addition, some of the COX-2 inhibitors were not actually easier on the stomach at all. Celebrex has "never sufficiently demonstrated that [it] reduces the rate of serious gastrointestinal problems compared with existing painkillers like ibuprofen. The world's best-selling COX-2 [inhibitor] has never been proven to the FDA's satisfaction to have the stomach-protecting benefits that originally were supposed to be the point of that category of drugs" (The New York Times).

Remarkably though, during the study the usage of COX-2 inhibitors by those who didn't need it increased nearly 25%. So why were so many Americans using COX-2 inhibitors?

Randall Stafford of Stanford University, as reported by Kaisernetwork.org, said that marketing efforts by Merck, which in 2000 spent over $160 million to promote Vioxx, contributed to the increased number of COX-2 inhibitor prescriptions. Merck and Pfizer spent hundreds of millions of dollars in direct to consumer advertising to promote their COX-2 inhibitors, while often failing to mention the increasing evidence of severe coronay risk.

Both companies were repeatedly warned by the FDA on their marketing tactics:
The FDA issued a warning on Janurary 9 to Pfizer "that television and print advertisements for its painkillers Celebrex and Bextra misled consumers. Five advertisements failed to disclose side effects and other risk information and made 'unsubstantiated effectiveness claims'" (The New York Times). These ads include two television commercials and a 27-minute infomercial that omit any information on Celebrex's safety and risks. Pfizer had no comment on the Bextra material, including a patient brochure and a television commercial.

Merck even went so far as to release a press release entitled "Merck Confirms Favorable Cardiovascular Safety Profile of Vioxx". On September 17, 2001, an FDA director sent a warning letter to Merck Chief Executive Raymond stating: "You have engaged in a promotional campaign for Vioxx that minimizes the potentially serious cardiovascular findings that were observed in the Vioxx Gastrointestinal Outcomes Research (VIGOR) study, and thus, misrepresents the safety profile for Vioxx. Specifically, your promotional campaign discounts the fact that in the VIGOR study, patients on Vioxx were observed to have a four to five fold increase in myocardial infarctions [heart attacks] compared to patients on the comparator nonsteroidal anti-inflammatory drug (NSAID), Naprosyn (naproxen)."

The Wall Street Journal stated that the FDA also "chastised Merck for suggesting to physicians that the reason patients taking Vioxx had a higher incidence of heart attacks in the study was that naproxen has heart benefits". The warning letter can be found on the FDA's website. The FDA went on to call Merck's press release ("Merck Confirms Favorable Cardiovascular Safety Profile of Vioxx") "simply incomprehensible" in light of the "serious cardiovascular events".

In February 2005, The New York Times published an expose on how Merck offered financial inducements to hundreds of important doctors nationwide to prescribe Vioxx over Celebrex and Bextra. Company records indicated that Merck "neutralized" doctors unfavorable to Vioxx with financial gifts to the doctors' own clinics or grants for corporate-sponsored clinical studies.

The New York Times stated that if this evidence "holds up" it will provide a telling example of how an avalanche of marketing can propel the use of new drugs far beyond reason, posing needless risks to patients. There is little doubt that intense advertising and promotional campaigns inevitably snared many patients who should not have taken them, the growth in COX-2 use over time was primarily among patients least likely to benefit."

If you or a loved one have taken a COX-2 inhibitor like Vioxx, Celebrex or Bextra and have experienced any side effects, including blood clots, heart attacks, strokes or even sudden death, contact us immediately at 800-966-4999 and see why our law firm has recovered over $100 million on behalf of our clients.

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