They're just dropping like Chinese imports -- prescription
drugs that turn out to be deadly after FDA approval.
Not just Vioxx -- recently found to cause kidney problems on
top of the heart attacks for which it was pulled -- but its seven deadly
sisters named by the FDA's Dr. David Graham before Congress in 2004: Crestor,
Meridia, Serevent, Lotronex, Arava, Accutane and Bextra.
After a post-Vioxx damage control campaign -- "FDA has
confidence in the safety and efficacy of Crestor," read AstraZeneca ads
which the FDA pulled; it wasn't that confident -- the cholesterol drug Crestor
was found in the heart journal Circulation to be eight times more likely to
cause rhabdomyolysis, kidney failure or spillage of protein in the urine than
other cholesterol drugs.
Thirty users of Meridia, Abbott Laboratories� weight-loss
drug, died of cardiovascular problems from 1997 to 2003 and 224 other
experienced nonfatal strokes, heart attacks and other cardiovascular ailments
according to FDA reports.
And Accutane manufacturer Hoffman-La Roche, Inc., goes to
trial this October in Madison County, Illinois -- where the first Vioxx trial
occurred -- to defend charges that its acne drug caused Jason Peipert's
inflammatory bowel disease which ruined the young soccer star's career.
Then there's Sanofi-Aventis' notorious antibiotic Ketek --
blamed in the death of four and liver injury or failure of 37 since 2004 --
whose primary clinical trials doctor, Anne Kirkman Campbell, is in federal
prison in Lexington, Kentucky, for forging data for money. (Test subjects
included her entire staff and members of her family.)
Another doctor upon whose clinical data Ketek was approved
conducted trials while his medical license was on probation and was arrested
for cocaine and gun possession soon after.
And the atypical anti-psychotics whose marketing was also
"atypical" with 29 percent of AstraZeneca's Seroquel sales coming
from off-label Alzheimer use though studies say it worsens the condition
and Eli Lilly settling 29,000 lawsuits from inadequate warnings about Zyprexa's
diabetes, weight gain and pancreas infection side effects.
Finally there's GlaxoSmithKline�s Avandia prescribed for 1
million Americans for type 2 diabetes and now known to increase the risk of
heart attack by 43 percent and cardiovascular death by 64 percent.
Avandia is more expensive and dangerous than older drugs and
not more effective, said Dr. Graham to a joint panel of experts convened to
consider the drug in July -- a charge he could also level against the other
suspect drugs and Big Pharma itself.
But instead of pulling
the drugs, the FDA just adds warnings and subtracts uses. (See antidepressants;
HRT).
Ketek is no longer recommended for sinus infections; just
community acquired pneumonia.
Meridia is only recommended for people who have to lose 30
pounds or more who don't have poorly controlled hypertension, a history of
heart disease, stroke or severe liver or kidney disease.
And Accutane users are clearly warned on the drug's label
about suicidal behavior, birth defects and inflammatory bowel disease risks.
Because pulling the drugs not only affects sales, company
image and stock price, it feeds lawsuits. ("The drug was so unsafe they
pulled it from the market.")
Thanks to fast tracking and six-month approvals no one knows
if a drug is dangerous anyway until a critical mass of human guinea pigs
takes/tests it. Only 3,000 clinical trials are usually conducted premarket and
what if the drug harms one in every 3,001? Did you really think lethal tests on
beagles and other mammals keep you safe? Talk about dying in vain.
But finally, pulling a drug after approval just casts light
on the approval process itself which is teeming with conflicts of interest.
Ninety-two percent of FDA advisory meetings in the last decade included a
member with financial ties to drug companies, according to USA Today -- the FDA
calls them sponsors -- and federal law against using experts with financial
conflicts of interest was waived 800 times.
Too bad that can't be on the warning label.
Martha Rosenberg is a Staff Cartoonist at the Evanston
Roundtable. Her work has appeared in the Chicago Tribune, LA Times, San
Francisco Chronicle, Boston Globe, Providence Journal. Arizona Republic, New
Orleans Times-Picayune and other newspapers. She can be reached at: mrosenberg@evmark.org.