Archive for August, 2008
With marketing campaigns masquerading as clinical trials, how can we be certain of the safety of our treatments?
By Dana
You’ve heard this story before. Big Pharma, in a bid to stay relevant in an ever-changing landscape, sinks money and resources into a blockbuster clinical trial that appears to be on the up-and-up, but is really just a clever guise for a marketing campaign aimed at drumming up business and revenue for a drug that hasn’t been through the rigors of a traditional clinical review.
The August 19 edition of the New York Times caused eyebrows to raise at the so-called “rapid roll-out” and aggressive marketing campaigns surrounding cervical cancer vaccinations from Merck and Glaxo. Pundits fear the call-to-action messaging consumers are inundated with– in everything from movie previews to product placement on primetime TV– will mask the fact that people should proceed with caution until the impact of the drugs is better defined. As of now, we’ve got throngs of parents clambering to the family PCP to inoculate daughters who aren’t even sexually active—and we don’t even know the risks or long-term effects of the vaccines yet.
And if that weren’t bad enough, Merck also came under fire in the August 19 issue of the Annals of Internal Medicine for ADVANTAGE, a seeding trial centered on the hapless painkiller Vioxx. The group of physicians behind this exposé is scathing in its criticism of the trial, calling ADVANTAGE a “dishonest…corruption of science” and pointing out that the true aim of the study (selling drugs) is shrouded in formalities that make it appear legit. A disappointment, to be sure, for all the patients who participated and consequently doubled their risk of heart attack or stroke.
It’s clear that in the race to lobby for acceptance and drive growth, ethics are compromised, an all-too-common theme in the pharmaceutical industry. For an illustration into the magnitude of this problem, one need look no further than to the NYU study launched earlier this year that reported the U.S. pharmaceutical industry spends almost twice as much on product promotion as it does on R&D.
What effect will the marketing veil of big pharma have on the little guy? It’s simultaneously already vividly apparent and yet to be seen. In today’s world, we decree that transparency be maintained across all echelons of big business, and go so far as to destroy Wal-Mart for fleecing the American populace with a jocular blog. How could that same standard not translate to an industry so intimately connected to our quality of life?
August 21st, 2008
By Cheri
The WSJ recently published an article about the controversies surrounding the research for treatment of line sepsis. While two medical groups have already endorsed this therapy and many US hospitals have adopted it, questions are being raised about the thoroughness of the research. These concerns were amplified when the hospital that conducted the research turned out to be holding patents for a device critical to the therapy and one of the backing groups had financial support from the device manufacturer.
So the question is once again raised in the medical community about transparency. Several months ago flags were raised about ghost writing in peer-reviewed medical journals and before that studies that appeared in NEJM and JAMA fell under scrutiny as the studies were biased and inaccurately favorable to the funding company.
Is this tidal wave of negative publicity for the medical community the tip of the ice berg or has it just been an unfortunate summer for transparency in the community?
August 20th, 2008
By Jackie
A recent recommendation from the U.S. Preventative Services Task Force advised physicians to stop routine prostate cancer screening in men aged 75 and over, citing more evidence of harm than benefit for this age group. Essentially, the issue lies within the flawed PSA test, an infamously inaccurate blood test used to detect prostate cancer. This traditional approach to prostate cancer detection harbors an astoundingly high false positive rate of nearly 75%, leading to unnecessary biopsies that inherently generate significant anxiety for patients and often cause major side effects like impotence and incontinence. In addition, several studies have shown that most prostate tumors grow so slowly, they never actually seriously threaten lives within this age group. It’s no wonder the task force has asked physicians to eliminate PSAs for this age group – it’s a lot more than Grandpa bargained for at 75.
That said, one could argue, 75 is simply not what it used to be. Today’s 75-year-old man is vibrant and active, often enjoying a significantly longer life span than once ago. As such, is it fair to deny a 75-year-old man good care by ceasing prostate cancer detection methods that could potentially save his life? With the PSA’s infamously poor track record, perhaps the answer lies in new, innovative, effective detection methods. For instance, Ikonisys, a next-generation diagnostics company, is currently developing an early, more accurate screening test that identifies circulating tumor cells present in the blood. The sample is placed on a slide and analyzed by Ikonisys’ breakthrough, fully-automated, digital microscopy system which aims to detect “the one cell in a million” that matters. According to a recent article in the British Journal of Cancer, this method has proven to be the closest and most practical solution to prostate cancer detection yet. Innovations like this one show great promise with the potential to reshape the industry.
While we eagerly await these new technologies, I encourage today’s 75-year-old man to engage in discussions with your physician on the appropriate choices to best protect your individual health. In the meantime, continue embracing your youth and proving that 75 is the new 60!
August 6th, 2008
