Company Profits

Posted on December 10, 2011 by Admin
Company Profits

Company Profits

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In late January of 2005, Public Citizen exposed an unpublished clinical trial revealing statistically significant heart dangers for Celebrex users as well.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).