The ink isn't even dry on the massive Vioxx settlement and already Big Pharma's been accused of burying clinical data, spinning journal articles and selling drugs that cause the conditions they're supposed to fix. Sound familiar?
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 trials.
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 their eyes.
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, 2008 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, 2008 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 drugs.
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 Harm.
In January thousands of Northwestern 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 photo of glowing young couple "going out to dinner and actually eating dinner."
What percentage of 19-years-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 direct-to-consumer self-diagnosis .
Pfizer spent $40 million advertising Lyrica, approved for fibromyalgia in June, in 2007 buttressed by free 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 seven percent that do not taper off.
Yes, thanks to a bad start in 2008 Pharma has a lot of "negatives" to overcome. But unlike the presidential candidates, its troubles won't end in eleven months. They may even get worse.