Arthritis affects nearly 43 million Americans, or about one of every
six people. In Britain, an estimated eight million people suffer from the
condition. In fact, it's one of the world's most common diseases.
Most experts agree that as the population ages, this number will
increase dramatically. By 2020, 60 million people will be affected by
arthritis in the U.S. alone.
To health care providers, this translates into a global health
epidemic. To drug manufacturers, it means a huge market that can produce
billions of dollars in revenue.
That was undoubtedly one of the incentives for the pharmaceutical
industry to develop a new generation of arthritis drugs, known as
selective COX 2 inhibitors.
However, despite the claims of the drug companies, these drugs may not
be any better than the over-the-counter pain pills traditionally used for
symptom relief. Worse yet, they may pose far greater risks of adverse side
affects.
Those were the conclusions of a team of researchers whose report was
published in the June 2002 issue of the British Medical Journal (BMJ).
Many of the hyped-up claims for the COX 2 inhibitors were based on a
study published in September 2000 which concluded that the COX 2
inhibitor, celecoxib, was associated with a lower rate of stomach and
intestinal ulcers than two older drugs for arthritis. The drug companies
widely publicized the results of this study.
Two brands of COX 2 inhibitors -- Pharmacia/Pfizer's Celebrex and
Merck's Vioxx -- broke records for first-year sales when launched in 1999.
By the end of the first year on the market, U.S. sales soared to nearly $2
billion for these two drugs alone. Celebrex and Vioxx are projected to
produce U.S. sales in excess of $6 billion this year.
However, the COX 2 inhibitors have been linked to an increase in the
risk of blood clots, heart attacks and strokes.
The BMJ report re-examined the original study and found that
only the data for the first six months of the study were published. When
all the data were considered, the published results appeared to be clearly
flawed.
The BMJ researchers believe that an "industry
independent" analysis of all trials of selective COX 2 inhibitors
must be performed to include both published and unpublished data. They
also called for the wide dissemination of the misleading results of the
trial to be counterbalanced by the equally wide dissemination of the
findings of the reanalysis according to the original protocol.
"If this is not done, the pharmaceutical industry will feel no
need to put the record straight in this or any future instances,"
they concluded.
"Although it is extremely important to highlight distortion of
information, it is equally important to recognize that the more
information there is the more issues can arise, and a lack of information
can easily nurture as many illusions as partial publication."
SOURCE: British Medical Journal, June 1, 2002.