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.
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.
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.
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.