bigpharma(ED: One of the joys of researching material for the fantastic happenings in Internet Medicine, is that I stumble upon real gems; this is a great blog, by an MS patient from New York, who not only writes well, but is a super photographer, who takes his pictures from his wheelchair; if in New York, stop by and see him)

Sunday, February 3, 2013

Given the importance of rigorous, verifiable research in the practice of modern medicine, it seems a natural assumption that the doctors who treat us base their actions and recommendations on solid, irrefutable evidence. Evidence-based medicine, is, after all, the mantra that we as patients hear over and over again, especially when it comes to our inquiries into the implementation of alternative therapies that fall outside of the medical mainstream. More often than not we are told that there is simply no evidence for the effectiveness of this or that alternative therapy, and that rather than waste our time and energy on unproven and possibly dangerous unconventional remedies, we should stick to the tried-and-true, which almost always come in the form of pharmaceutical products produced by one of the giant multinational pharmaceutical firms, known collectively as “Big Pharma”.

The logic behind such thinking isn’t necessarily faulty. Untold millions of dollars are spent developing drugs and putting them through laborious clinical trials, the result of which is the evidence upon which “evidence-based medicine” thrives. Absent the data produced by this research model, the practice of medicine would be largely reduced to educated guesswork, based solely on the experiences and impressions of individual medical practitioners, which by definition would be limited in scope and might easily be skewed by subliminal prejudices and statistical aberrations physicians could encounter during the course of their careers. Relying instead on evidence amassed through years of rigid research encompassing thousands of patient hours makes deciding which medicine to prescribe or procedure to recommend an exercise in logic and intellectual reasoning, the cornerstones of all disciplines of modern science.

This all makes perfect sense, and indeed this very reasoning has fueled the rapid advances seen in many fields of medicine over the last half-century. However, if the evidence which is the foundation of evidence-based medicine becomes unreliable, or downright misleading, the entire edifice that is modern medicine stands in danger of collapse. To an extent that is almost incomprehensible, this is the very environment in which patients and physicians now find themselves operating, as the research published in scholarly journals and presented at medical symposiums appears to be increasingly biased in favor of the drugs being researched, to the point that physicians are now basing their treatment decisions on woefully incomplete data sets and trial results that conveniently leave out the negative while emphasizing the positive.

As is documented by British psychiatrist Dr. Ben Goldacre in his book “”Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients”, which was recently excerpted at (click here), the trial evidence upon which doctors base their most important decisions is often misleading at best, and outright dishonest at worst. As more and more medical research is funded by the drug companies themselves, rather than by independent concerns such as foundations or government agencies, the results of that research appear to be becoming less and less reliable. Dr. Goldacre cites studies which show that research funded by pharmaceutical companies is far more likely to favor the drug being tested than studies funded by independent organizations.

One such study, conducted in 2007, looked at every published study investigating the effectiveness of statin drugs, which are commonly prescribed to lower cholesterol. The studies either compared an individual drug to another kind of treatment, or to a competing statin drug. In all, 192 studies were surveyed, and researchers found that pharmaceutical company funded studies were 20 times more likely to give results favoring the test drug than similar trials funded by independent concerns. Other studies looking at different bodies of research found discrepancies that weren’t quite so dramatic, but invariably found that industry funded studies were far more favorable to the drug being researched.

The reasons for this bias are many. Trial results can be manipulated by testing a drug against another drug given at a sub optimal dosage. Patient populations can be manipulated, so that only patients most likely to get better are used in the research. The researchers themselves, even those conducting studies that are properly designed, may be subconsciously biased by the knowledge that their paycheck is being funded by the pharmaceutical company whose drug is being tested. Whatever the reasons, the evidence appears to be irrefutable: the trial results upon which doctors base their treatment decisions are very often biased in favor of the treatment being tested.

To make matters worse – much worse – drug companies routinely fail to report negative research outcomes, never allowing them to see the light of day. The companies conduct many studies on a single drug, and only publish those studies whose findings are positive for the drug in question. Dr. Goldacre writes about a situation in which he did the very best he could as a doctor, only to later find that he had been misled by the very act of doing his due diligence. In deciding on an antidepressant drug on which to put a patient for whom other drugs had proven ineffective, Dr. Goldacre read every published study he could find on a new drug he was considering, which all showed it to be better than placebo, and as good if not better than competing antidepressant drugs. Later, Dr. Goldacre learned that, though he had read all of the available studies, he’d only received a tiny glimpse into the true research record of the drug he was investigating, Reboxetine.

Some time after Goldacre prescribed Reboxetine for his patient, researchers did a comprehensive survey of all the trials that had ever been conducted on the drug, including those that had not been submitted for publication in academic journals by the drug company, collecting their data through numerous requests to manufacturers and regulating agencies. They found that seven studies had compared Reboxetine to placebo. Of those seven studies, only one found the drug had a positive result, the other six found Reboxetine to be no better than a dummy sugar pill. Only the positive study was published for review by physicians. The six failed studies were never submitted for publication. Trials comparing the drug to competing drugs showed a similar pattern. Three trials, totaling 507 patients, found Reboxetine to be more effective than a rival drug. However, other trials, which used data derived from 1657 patients, found that Reboxetine treated patients fared worse than those on other drugs. These findings were again left unpublished, shielded from the view of the physicians.

Tragically, this situation is typical of the industry. The fact that pharmaceutical companies can fund their own studies and decide to only publish positive data is unfathomable. Would we let, say, automobile manufacturers conduct their own safety tests, and without question accept their claims that the cars they make are the safest in the land? Of course not, yet this same practice has been allowed to flourish in an industry upon which the health of the world has come to rely. The situation is outrageous, but is so endemic that remedies are difficult to come by.

The British Medical Journal, a highly respected academic journal better known these days as BMJ, has, as of January of this year, announced that it will only publish studies that allow access to patient data from all of the studies conducted on the drug in question. The editors of the BMJ lay out their case for this action in a hard-hitting editorial published last October (click here). If only other academic journals would follow suit. The pharmaceutical giant GlaxoSmithKline announced in October 2012 that it will open up all research data for investigation by physicians and scientists (click here). While this is an admirable step, it comes only after GlaxoSmithKline was forced to pay $3 billion to the Federal Drug Administration to settle three charges of fraud levied against it (click here), one of which included holding back data and making unsupported claims regarding its diabetes drug Avandia.

Another of the charges in the GlaxoSmithKline settlement was that the pharmaceutical giant used inappropriate tactics to influence physicians to prescribe their drugs, tactics which included paying large speaking fees to doctors and providing them free access to high-priced entertainment. Couple the reality that pharmaceutical companies have been allowed to bury negative trial data with the fact that these companies routinely use their huge sales forces to court practicing physicians with offers of all-expenses-paid trips to “educational symposiums” in exotic locales, free gifts and lunches, and sponsored lectures, and we have what some cases amounts to a completely rigged system.

As circumstances currently stand, physicians find themselves faced with a situation in which they can’t trust the research published in academic journals (often their only resource for such vital information), and many find themselves subject to conflicting influences offered by pharmaceutical companies, the success of whose products lies completely in the hands of these same physicians. The end result can only be that patients in general, who trust their very lives to doctors, can only wonder about the motivation and correctness of the treatment decisions made on their behalf. For MS patients, whose drugs can cost tens of thousands of dollars a year and some of which carry potentially deadly side effects, the gravity of these questions is only multiplied.

It’s a situation that truly boggles the mind.

The below video is a presentation given by Dr. Ben Goldacre on some of these very same issues. It’s really a must watch…


No comments

Be the first one to leave a comment.

Post a Comment