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more “invisible” studies — the sordid story of tamiflu


 “It is not enough that trial results are seen in secret, behind closed doors, by regulators alone: especially when, as with Tamiflu, regulators around the world disagree about the benefits of a treatment. It is also not clear that even regulators see everything. It is particularly concerning to see that the MHRA seems to have told the Committee that regulators had all the information on all trials on Tamiflu. The evidence to the Committee from the Cochrane Collaboration shows that was not the case. We are only able to see this apparent discrepancy because the evidence for Tamiflu has now been subject to half a decade of intensive investigative work by several groups around the globe. This is extremely concerning, and the problem for other treatments may be even greater….   Future generations will look back at this absurd situation in the same way that we look back on medieval bloodletting”   Dr Ben Goldacre from a recent article called, Public Accounts Committee Issues Damning Report on Clinical Trial Results Being Withheld.  

“We were surprised and concerned to discover that information is routinely withheld from doctors and researchers about the methods and results of clinical trials on treatments currently prescribed in the United Kingdom.”  House of Commons London in a report called The Stationery Office Limited House of Commons Committee of Public Accounts Access to Clinical Trial Information and the Stockpiling of Tamiflu.

“Oseltamivir’s benefits in those who are otherwise healthy do not appear to outweigh its risks…..  [and] no benefit has been found in those with other health problems”  Coenen, B; Van Puyenbroeck, K; Verhoeven, V; Vermeire, E; Coenen, S (2013). “The Value of Neuraminidase Inhibitors for the Prevention and Treatment of Seasonal Influenza: a Systematic Review of Systematic Reviews” from Dr. Tom Jefferson’s article on the subject in PloS one.

Bad Science.  It’s what brought us the monster created by Doctor Frankenstein.  It also happens to be the name of Dr. Ben Goldacre’s website — much of which pertains to the joys of EVIDENCE-BASED MEDICINE.   Let’s go back in time and look at some “Bad Science” I dealt with last summer.  In June of last year, I wrote a post on “Invisible Drug Studies” called, “INVISIBLE & ABANDONED“. 

The article pertains to the (devious) ways which Big Pharma drives drug studies whichever way they need to by simply not publishing studies that don’t turn out the way they hoped they would (click on the link above to see how dramatically this skews the data).   Not surprisingly, it turns out that this problem is bigger than we ever dreamed possible.

Just days ago, the British Parliament released a scathing report on this problem of “Invisible Studies” as pertains to a product called TAMIFLU (Oseltamivir — an antiviral marketed for its supposed ability to prevent or slow the spread of Flu within one’s body, once you are already sick). 

It seems that for years, Tamiflu manufacturer, Roche, has been withholding pertinent information concerning the safety of this drug.  Some of the things that we know from the studies on Tamiflu that were not buried aren’t any too complimentary of the drug either.  Here is a quote from one such study.  “It does not appear to change the rate of complications from influenza, such as the risk of hospitalization or pneumonia. However, it can increase rates of vomiting.” 

Yay.  Not only does it not help, the additional puking leaves you wondering if the cure was worse than the disease!  We see similar types of situations with lots of our nation’s DRUGS. Why is all of this so bad?  Besides the obvious, it is just one more example of this thing we call “evidence”, and the fact that when such large amounts of money are involved, we simply can’t trust that happy threesome of Big Pharma, Big Government, and the Medical Industry.   Think I’m being a bit harsh or “over-the-top”?  Just click on the link. 

When you couple the ethical problems associated with developing and licensing so many of these prescription drugs and the studies used to approve them, with the fact that only about 1-10% of drug reactions are ever reported to the proper authorities (HERE and HERE), you have a brewing catastrophe on your hands.  And sooner or later this catastrophe is going to affect people’s lives — running over them like a runaway freight train.  Interestingly enough, just last week, I put up A COUPLE OF POSTS concerning this very thing.  The problem is, getting politicians to do anything about this problem is a real challenge because, as I just mentioned, they’re all in bed together.  Case in point.  Donald Rumsfeld.

Over the course of his career, Rumsfeld, the Secretary of Defense under both Gerald Ford and George W. Bush bounced back and forth between the private and public sectors like a kangaroo on a pogo stick.  Has this been profitable for him to be on both sides of the industry?  Just read the appalling HISTORY OF ASPARTAME and decide that for yourself.  Or you could read a couple of tidbits about his involvement with Tamiflu, below.

 “In January 1997, Donald Rumsfeld, a Board member since 1988, was appointed Chairman of the company [Gilead Science, the developer of Tamiflu]. He stood down from the Board in January 2001 when appointed United States Secretary of Defense at the start of George W. Bush’s first term as President. Federal disclosure forms indicate that Rumsfeld owned between US$5 million and US$25 million in Gilead stock. The rise in Gilead’s share prices from US$35 to US$57 per share will have added between US$2.5 million to US$15.5 million to Rumsfeld’s net worth.”   Taken from a Halloween 2005 article on CNN Money by By Nelson D. Schwartz, of Fortune (Rumsfeld’s Growing Stake in Tamiflu).   

Is any of this going to change anytime soon?  Don’t hold your breath.  As long as the stakes are so high and the money so big, you know darn good and well it isn’t going to change.  And don’t kid yourself, nationalized healthcare is not going to solve this problem.  The Tamiflu incident was exposed in Britain — the shining example of centralized healthcare.  Oh; and be sure to read by brother’s article in a medical trade journal (he’s an ER doc) HERE.


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