Monday, June 2, 2014

Tamiflu and Drug Trial Transparency

Ben Goldacre, British writer and blogger, looked into a growing scandal and the actual governmental cost of making pharmaceutical decisions based on very little information.  He wrote the book Bad Pharma and became a leader in the European push to open up the transparency of clinical trials.  

In 2009 facing a potential flu pandemic, the British government stockpiled (LB) 500 million worth of Tamiflu to cover 80% of their population.  Roche, the makers of Tamiflu, claimed that their drug reduces the serious complications, including pneumonia, from the flu and the number of hospitalizations.  A 2008 Cochrane review gave the green light to Tamiflu after reviewing the available evidence.  Their evidence?  All positive implications of Tamiflu stemmed from one article funded by the industry that summarized ten other summaries, eight of which had not been published.  With big money and high hopes riding on the national , Cochrane initiated a new review and the evidence began to swing in the opposite direction.

Cochrane reviewers contacted the writers of the summary to look at their data, but unfortunately their files were missing.  Turning to Roche, the company offered to help, but put in roadblocks along the way.  Initially, they required a secret confidentiality agreement about the data they hand over.  Then Roche claimed another group was conducting a review elsewhere.  Finally, the company sent some excerpts of research documents, but far less than necessary to complete a thorough review of Tamiflu.  Roche began attacking the credibility of the reviewers and complaining that journalists had been included in their correspondence.  Five years later, after growing scrutiny, Roche relented and provided their data.

Even before receiving Roche’s data, Cochrane had noticed several problems with the clinical studies conducted on Tamiflu.  “Double-blind studies” used a different color placebo or large Phase Three trials were never even published.  With the full data, the Cochrane Review issued its opinion on Tamiflu.  It failed.  Tamiflu does not significantly reduce the number of hospitalizations or the cases of pneumonia.  While it may reduce the duration of your flu by a few hours, Tamiflu can produce serious side-effects.  Remember that the UK bought enough to cover their population in the case of a pandemic.  Cochrane applied the incidences of side effects to a million patients – 11,000 psychiatric cases, 31,000 headaches, and 45,000 people vomiting. 

Clinical transparency is important.  Many medical decisions are based on only a fraction of the appropriate data.  Doctors and pharmacists believe they make recommendations about medications on evidence.  That evidence only applies to what is publicly available.  The Cochrane group ran around and jumped through hoops to get the information needed to make a decision.  Companies will not provide more information than required.  And there are billions of reasons why.  

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