Accused of hiding drug dangers again, Big Pharma starts 2008 defending itself
By Martha Rosenberg
Online Journal Contributing Writer
Jan 22, 2008, 00:09
If Hillary and Obama think the press is picking on them,
they should look at Big Pharma.
The ink isn't even dry on the massive Vioxx settlement and
already Big Pharma's been accused of burying clinical data, spinning journal
and selling drugs that cause the conditions they're supposed to fix.
Merck and Schering-Plough, it turns out, were sitting on the
ENHANCE clinical trial results of cholesterol-lowering drug, Vytorin for a
reason. Rather than reducing the growth of fatty plaque in the arteries,
Vytorin, a combination of Zetia and Zocor, almost doubled the growth in the
Not only did it take a congressional committee to pry the
truth out of the Big Pharma giants, their response to the clinical belly flop
was that they "would be changing the ENHANCE study's endpoint" -- the
actual result the study was meant to measure. In other words, the sun was in
Nor was it just TV that Big Pharma is accused of using in
service to half truths like "Vytorin treats cholesterol from two sources:
food and family."
Ninety-four percent of positive studies about
antidepressants found their way into medical journals versus 14 percent of
negative ones, says an article in the January 17 issue of the New England
Journal of Medicine, called Selective Publication of Antidepressant Trials and
Its Influence on Apparent Efficacy.
Publishing only pro drug articles deprives researchers of
accurate data, wastes resources, squanders the contributions of investigators
and patients and misleads doctors, says lead author Erick Turner, an assistant
professor of psychiatry at Oregon Health and Science University.
New bone medications also took a hit in a medical literature
analysis in 2008.
After screening 1,825 published papers from 1966 to 2007,
researchers found no evidence that bisphosphonates such as Fosamax or Actonel
are superior to older bone drugs in Systematic Review: Comparative
Effectiveness of Treatments to Prevent Fractures in Men and Women with Low Bone
Density or Osteoporosis in the February 8 issue of Annals of Internal Medicine.
They did find the newer drugs can have serious side effects such as strokes,
blood clots in the lungs or bleeding in the uterus (a January 15 Journal of
Rheumatology paper finds oral bisphosphonate drugs nearly triple the risk of
developing bone necrosis) and that "data are insufficient to
determine the relative efficacy or safety" of all the studied
Some will notice the antidepressant article in the New
England Journal of Medicine and bone drug article in the Annals of Internal
Medicine are unusually short. They lack the obligatory six inches of drug company
financial support to the researchers which most journal articles show at the
end. (In a pro Cox-2 inhibitor article in the December 22, 2007, issue of
Lancet, author Vibeke Strand lists 49 drug companies she's received money from.
Who even knew there were 49 drug companies?)
Thanks to the Vioxx, HRT and Avandia scandals, the public is
no longer shocked to learn that Big Pharma hides side effects like heart
attacks or sells drugs that actually cause the conditions they are supposed to
alleviate, like antidepressants and suicide or bisphosphonates and fractures.
But disease mongering still seems a violation of First Do No
In January, thousands of Northwestern University students
found a "Kick Crohn's Back" brochure in their daily newspaper replete
with checklist -- Does abnormal pain or other Crohn's symptoms force you to
miss school, work or events with friends or family? -- and a photo of a glowing
young couple "going out to dinner and actually eating dinner."
What percentage of 19-year-olds gets Crohn's disease to
justify use of Humira whose side effects include lethal infections and cancer?
Or is the insert meant for the set of all 19-year-olds with rheumatoid
arthritis and psoriatic arthritis, the other diseases Humira treats?
And then there's fibromyalgia, another amorphous, no
cause/no cure/no clear definition condition that lends itself to lucrative
Pfizer spent $40 million advertising Lyrica, approved for
fibromyalgia in June 2007 buttressed by free public service announcements
(PSAs) from the National Fibromyalgia Association (NFA) which directed people
to a web site with the Pfizer logo and phone number.
This "unbranded," "condition-awareness"
marketing as it's called in the industry, sponsored by Pfizer but funneled
through the NFA helped Lyrica post 118,871 new and 203,737 total prescriptions
in December, noted Bear Stearns analyst John Boris, saying he was impressed
with the data points' upward trajectory.
But it also moved the New York Times to ask on its front
page in January "Drug Approved. Is Disease Real?"
And even if the disease is real and not another
self-fulfilling prophesy, Big Pharma will no doubt find itself back in court
with suits over fibro drugs' Zyprexa-like weight gain side effects which start
early in therapy, with gains of as much as 7 percent that do not taper off.
Yes, thanks to a bad start in 2008, Big Pharma has a lot of
"negatives" to overcome. But unlike the presidential candidates, its
troubles won't end in 11 months. They may even get worse.
Martha Rosenberg is
staff cartoonist on the Evanston Roundtable. She can be reached at email@example.com.
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