Vioxx® pulled from market: But is this reason to celebrate?
The cable news channel I was watching today proclaimed the startling news that Merck had withdrawn its multi-billion-dollar arthritis drug, Vioxx®, from shelves worldwide because the medication had been linked to severe and even fatal heart complications. The report advised anyone taking Vioxx® to contact their physicians about prescribing alternative medications. The station then broke immediately to a commercial for Celebrex®. As a physician who has been cautioning patients about the ills of both medications, I did not feel the urge to dance like the stars of so many commercials for arthritis remedies. Both Celebrex® and Vioxx® are known as COX-2 inhibitors, a sub-class of non-steroidal anti-inflammatory drugs, or NSAIDS. Older NSAIDS include ibuprofen, naproxen, indomethacin, and many others, including the prototype aspirin. In 1998, fatalities due to NSAIDS among arthritis sufferers rivaled deaths from AIDS.
Ohio (PRWEB) October 3, 2004 - by Dr. James D. Chlovechok
Vioxx® pulled
from market: But is this reason to celebrate?
The cable news channel I was
watching today proclaimed the startling news that Merck had withdrawn its
multi-billion-dollar arthritis drug, Vioxx®, from shelves worldwide because the
medication had been linked to severe and even fatal heart complications. The
report advised anyone taking Vioxx® to contact their physicians about
prescribing alternative medications. The station then broke immediately to a
commercial for Celebrex®.
As a physician who has been cautioning
patients about the ills of both medications, I did not feel the urge to dance
like the stars of so many commercials for arthritis remedies. Both Celebrex® and
Vioxx® are known as COX-2 inhibitors, a sub-class of non-steroidal
anti-inflammatory drugs, or NSAIDS. Older NSAIDS include ibuprofen, naproxen,
indomethacin, and many others, including the prototype aspirin.
Facts:
-In 1998, fatalities due to NSAIDS among arthritis sufferers
rivaled deaths from AIDS.
-CHF from NSAIDS may have exceeded GI toxicity,
which already accounted for 107,000 admissions per year.
-NSAIDS were called
a silent epidemic by a prestigious medical journal, and then, incomplete and
misleading data published in another leading journal turned newer, but still
unimproved, substitutes into a multi-billion-dollar industry.
-NSAIDS
inhibit enzymes in the body called cyclooxygenase, of which there are two
sub-types: COX-1 and Cox-2. The older NSAIDS block both, while the newer ones
target only COX-2. Why is this important?
-According to the New England
Journal of Medicine, in 1998 NSAIDS accounted for 16,500 deaths in the U.S.
among arthritis sufferers alone, and 107,000 people were hospitalized due to
NSAID-related bleeding from the stomach or bowels. The journal editors called
this a “silent epidemic.”
-The deaths among arthritis sufferers due to NSAIDS
approached all deaths in this country from AIDS that year—and far exceeded
deaths from breast cancer, leukemia, lymphoma, or several other feared killers
combined. Worse, the numbers did not include over-the-counter preparations or
uses such as headache, backache, dental pain, menstrual or postoperative pain,
or many others.
-While retired athletes pitched Advil® on television, and
physicians wrote thousands upon thousands of new NSAID prescriptions, where were
the lapel ribbons, fundraisers, or public awareness campaigns concerning this
killer?
-Physicians have been aware of at least one dangerous NSAID
complication: GI bleeding. But this was felt to be due to inhibition of the
COX-1 enzyme. Hence, the search for selective COX-2 blockers. And in 1999—the
year after the New England Journal editorial—Vioxx® and Celebrex® hit the
streets running. Hailed as safer, both were said to lower the incidence of
stomach ulcer and bleeding. Physician offices and professional journals were
bombarded with this news. Billions of dollars of prescriptions were written. But
the whole story had not been told.
-Bleeding is not the only side effect
associated with NSAIDS. In March 2000, the Archives of Internal Medicine
speculated: “The burden of illness from NSAID-related CHF (congestive heart
failure) may exceed that resulting from gastrointestinal damage.” Other studies
indicate half of all hospital admissions for CHF may be due to NSAIDS. And yet
this and other potential side effects were ignored by the researchers and
marketers hailing Vioxx® and Celebrex®
Both drugs were denied labeling
that would indicate a safety advantage.
The possibility of other side
effects did not escape the FDA. Neither did data from the manufacturers’ own
safety studies. Why? For Vioxx®, fewer patients suffered GI bleeding compared to
an older NSAID, but total serious adverse events were actually higher in
subjects taking Vioxx®. And the famed Celebrex® CLASS study, published in the
Journal of the American Medical Association (JAMA), turned out to actually be
combined data from three separate studies. And the lower rate of ulcer bleeding
was preliminary. That’s right. The studies were not even complete. Celebrex®
users indeed had fewer ulcers and GI bleeds in the first half of the study, but
they had more in the second half—and the numbers balanced out. More shocking,
the overall risk of death or adverse effect was higher in those taking Celebrex®
than in those taking the non-specific NSAID.
So, the miraculous safety
advantage of either of these new drugs is a myth. Even before Vioxx® was pulled,
the FDA had sent warning letters to the both Merck and Pharmacia, maker of
Celebrex®, regarding deceptive marketing practices. But what about benefit?
According to efficacy studies, eight patients would have to take Vioxx® for
eight weeks to experience a 20% decrease in joint swelling. And studies of
Celebrex® showed it to be roughly equivalent to naproxen in reducing arthritis
joint pain. No NSAID has ever been shown to favorably alter the course of any
arthritic condition; in fact, while these drugs may temporarily decrease pain,
the studies I have seen demonstrated more rapid destruction of joint tissues
with NSAIDS.
In this country, we have come to expect a lot of medical
science and our physicians. Unfortunately, most of the science is being financed
by those with money riding on experimental results. And these industrial giants
answer not to individual patients, but to stockholders. Physicians answer to
patients, but receive much of their research information via slanted industrial
marketing. And patients are coached through media advertising to “ask your
physician about” this or that drug, or to report symptoms that coincide with a
list of indications for prescribing the preferred medication. And this list will
have been conveniently dropped off at my office along with some free samples, a
few ink pens, and chocolates for my office staff.
I think it is good
that Vioxx® has been withdrawn. But I am not yet ready to celebrate a healthcare
system that puts marketing so far in front of science, or profits ahead of
patients’ interests.
# # #
Source : http://www.prweb.com/releases/2004/10/prweb163995.htm