• How Big Pharma Hides Its Failures And The FDA Looks The Other Way

    Posted April 12, 2013: by Bill Sardi

    British physician Ben Goldacre, said to be a specialist at picking apart the bogus claims of pharmaceutical companies, speaks out in a recent oral presentation that can be viewed here.  His new book, Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients, documents the problem.

    For example Dr. Goldacre points to clinical trials for 12 antidepressant medications, 38 that were positive studies and 36 that produced negative results.  Of the 36 negative studies, 33 were never published (22 studies) or published in a way that conveyed a positive outcome (11 studies), compared to 37 of the 38 positive studies that were published.

    The most recent review, says Dr. Goldacre, shows that about half of all clinical trials are buried and aren’t available for doctors to scrutinize before they prescribe these prescription potions for their patients.

    Dr. Goldacre describes the full extent of the problem in the back pages of the New York Times recently.  According to Dr. Goldacre, the Food and Drug Administration Amendments Act of 2007 was supposed to fix the problem. All new clinical trials conducted in the United States are required to post summaries of their results at clinicaltrials.gov within a year of completion, or face a fine of $10,000 a day.

    But investigator Goldacre points to an audit in 2012, published in the British Medical Journal, the first open audit of the process, which found that 80% of the trials covered by the legislation had ignored reporting requirements. “Amazingly, no fine has yet been levied,” writes Dr. Goldacre.

    There was an earlier fix to this problem in 2005 where medical journal editors demanded all clinical trials be registered before they begin so unpublished studies could easily be spotted.  But the editors broke their promise.  More than half of all trials published in leading journals were not properly registered and 25% were not registered at all says a report in the Journal of the American Medical Association.

    Dr. Goldacre was able to get this problem into political discussion in Great Britain and even get the Prime Minister there to comment on it.  But so far, nothing has been done, no fines issued or paid.  Even then, fines paid by pharmaceutical companies appear to be nothing more than a slap on the wrist.

    Dr. Goldacre also points to Tamiflu, the billion-dollar drug prescribed to head off flu symptoms.  A report published in PLoS Medicine underscores the problem.  The U.S. stockpiled nearly $1.5 billion of Tamiflu in the 2009 H1N1 flu outbreak.  “Tamiflu was heralded as the key pharmacologic intervention for use during the early days of an influenza pandemic when a vaccine was yet to be produced. It would cut hospitalizations and save lives, said the US Department of Health and Human Services.”  The Centers for Disease Control said Tamiflu would “reduce the chances of developing complications from influenza.”

    These claims dated back to a combined analysis of ten clinical trials that were conducted in the late 1990s.  The FDA approved Tamiflu in 1999 even though Tamiflu had not been shown to reduce complications, and required an explicit statement in the drug’s label to that effect.

    Dr. Goldacre says this is not just a money-grubbing game going on without deadly consequences.  In the 1980s the failure to published a negative study involving the drug lorcainide and subsequent drugs that were intended to control abnormal heart rhythms resulted in over 100,000 needless deaths in America.

    Dr. Goldacre points out that many of the FDA-approved drugs in current use, drugs that were approved in older clinical trials (prior to 2008), have not been properly scrutinized by disclosure of all the unpublished studies involving these drugs.  Big Pharma is not forthcoming on this issue.

    What we see here is complicity by public health agencies (CDC, Department of Health & Human Services) in prolonging this ruse.  If government is complicit, where can the public direct its outrage?  – Copyright 2013 Bill Sardi, Knowledge of Health Inc.

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