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Monday, March 4, 2013

Published 2013.03.04 in CommPRO.biz

Bad Pharma, Trials & Travails

“Everybody’s doing it.” That lame excuse seems the only explanation of rampant bad behavior in the Pharma sector. However, it becomes more than bad behavior when it costs lives. Psychiatrist, journalist, author, Ben Goldacre, a Brit with more degrees and credentials than seem possible for one not quite forty years old, has a new book, Bad Pharma.

This quote from the book sums up his case: “Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques flawed by design, in such a way that they exaggerate the benefits. Unsurprisingly, these trials tend to produce results that favour the manufacturer.”

Dr. Goldacre writes a weekly column, “Bad Science,” in the London Guardian. He has a history of well-researched work taking on the quacks and crooks in and on the fringes of medicine. His research on drugs and medical devices spills into America’s Pharma. The more of Dr. Goldacre’s work you read, the more horrified you become. Evidence that bad behavior is not an anomaly; it is common place, driven by the need to meet the quarterly profit marks Wall Street is looking for. And too often supported by doctors on Pharma payrolls who do not speak up publicly for a host of reasons.

How bad is it? This quote from Dr. Goldacre’s book nails it: “Sponsors get what they want. In 2007, researchers looked at every published trial that set out to explore the benefit of a statin. This study found 192 trials in total, comparing one statin against another, or comparing a statin against a different treatment. The researchers found that industry-funded trials were 20 times more likely to give results favoring the test drug.” When a sponsored trial does not deliver the results its sponsor is looking for, they bury it.

In a New York Times story* Johnson & Johnson, a communications community poster child for its response to the 1982 Tylenol nightmare, comes off practicing the worst of the worst. One of several memos from doctors working for J&J came to light in the first of more than 10,000 artificial hip lawsuits J&J is facing. The consultant was blunt in a memo sent to several J&J “C Suiters”. The doctor’s memo indicated that, “An artificial hip sold by the company was so poorly designed that the company should slow its marketing until it understood why patients were getting hurt.” 

This was not the only such report. Reports that languished for almost two years before J&J recalled the faulty hips. We’re not talking about recalling something simple; a hip replacement involves serious surgery. It would be unconscionable to put a single human being through the risks of this surgery once the dangers were known. To expose tens of thousands was criminal. The human beings –the J&J executives– who chose profit before ethics may have thought “Everybody’s doing it.” It’s time to offer a fitting remedy for such a deadly choice, a jail sentence.

*(02/15/13)

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