Forget Consumers, Drug Companies Want Profits
A Case in Point is Vioxx, Celebrex, and Other NSAIDs
Jun 2, 2009
Public Citizen, a consumer group directed by Dr. Sidney Wolfe, has become known as a watchdog for the FDA’s pharmaceutical division, performing many of the consumer drug safety and efficacy functions the agency itself should be doing. Drug manufacturers frequently develop new drugs purely for profit to replace older adequate ones whose patents are expiring, even if they have serious or unproven side effects.
Public Citizen’s Health Research Group (HRG) first objected to the FDA fast-tracking Celebrex (celecoxib/Pfizer) in 1998 because no long- term safety studies were done comparing them to older similar drugs (HRG Publication 1465).
Celebrex is a COX-2 selective-inhibitor non-steroidal anti-inflammatory drug (NSAID) for pain, similar to Bextra (valdecoxib/Pfizer) and Vioxx (rofecoxib/Merck). Celebrex and Vioxx were released as a new (competing) form of super painkiller in 1999 and made millions while their manufacturers understated their side effects that included renal failure, cardiac events, strokes, and thrombosis.
Pharmaceutical Consumer Advocacy Crucial
Merck voluntarily removed Vioxx from the market in 2004 with five years of solid income from its sales. At the same time, Kaiser Permanente, the nation's largest health maintenance organization, which oversaw the studies linking Vioxx to cardiovascular risk, said its pharmacies stopped dispensing Bextra due to that drug's safety record.
In late January of 2005, Public Citizen exposed an unpublished clinical trial revealing statistically significant heart dangers for Celebrex users as well. Dr. Wolfe testified (HRG Publication #1725) before the FDA Arthritis and Drug Safety Advisory Committee about the dangers of COX-2 drugs, stating “Given that Celebrex and Bextra are making an important contribution to the estimated 100,000 deaths and 2.1 million serious injuries a year from adverse drug reactions, I hope you will recommend a ban of these two drugs.”
When information from a 2004 lawsuit surfaced revealing serious safety problems with Bextra, the FDA finally removed it from the market in June 2005. At the same time they issued a Public Health Advisory with major warnings for NSAIDs, stating that Celebrex users should contact their physicians for alternate NSAID options, but did not ban it. (HRG Publication #1734).
The Worst Pills Best Pills Newsletter - Do Not Use These Drugs
In February of 2005, Worst Pills, Best Pills Newsletter published Cutting Your Drug Bill While Reducing Your Risk Of Avoidable Adverse Drug Reactions: Six Examples,recommending alternatives to six drugs listed in Drug Topics Magazine in the Top 200 Selling Drugs in the U.S. in 2003, all rated by Worst Pills as DO NOT USE drugs. Combined sales of these drugs was $8.1 billion, with more that 75 million prescriptions that year.
In May 2006, Worst Pills, Best Pills rated Celebrex DO NOT USE!, based on research in the March 2006 Journal of the Royal Society of Medicine revealing it can double the risk of heart attacks compared to older arthritis drugs. In April of 2007, Dr. Wolfe (HRG Publication #1803) challenged Pfizer’s new Celebrex TV advertisement as “dangerous and misleading”, asking the FDA to have Pfizer cease running the commercials immediately.
In February 2009, Worst Pills Best Pills Newsletter published Nonsteroidal Anti-Inflammatory Drugs Can Make Blood Pressure Hard to Control, noting 20 different NSAIDS (Celebrex among them) that can adversely affect blood pressure control.
Consumer Safety vs. Multimillion-Dollar Cox-II Pain Pill Companies
A March 11, 2009 article entitled Doctor Accused of Fabricating Pain Studies appeared on MSNBC revealing Massachusetts anesthesiologist Dr. Scott Reuben had published 21 papers in anesthesiology journals in which he had made up some or all of the data, This data, which had been relied on by doctors treating pain patients, had influenced them to use Vioxx and Celebrex.
Reuben worked on Pfizer research grants for five years, was a member of Pfizer’s speakers bureau, and gave talks on Pfizer drugs. According to the article, the journal Anesthesia & Analgesia has retracted 10 of the studies, and so far, the journal Anesthesiology has retracted three. Dr. Steven Shafer, the editor of Anesthesia and Analgesia, stated “Doctors have been using the findings very widely. [They] had a huge impact on the field.”
It’s clear that for years Public Citizen has been doing the FDA’s work for them protecting consumers against dangerous drugs. Consumer protection organizations generally work behind the scenes, but when headlines such as these surface, it underscores the value of their work and leaves many to only guess how many lives may have been saved as a result of those who listened to their warnings and benefited from their advocacy.
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