January 18, 2012
Researchers Question Effectiveness Of Tamiflu, Roche Withholds Trial Data
A group of independent scientists has challenged the manufacturers of the anti-flu treatment Tamiflu to substantiate the treatment´s effectiveness by releasing previously withheld research data.
In a recent report released by the non-profit Cochrane Collaboration, researchers stated that although Tamiflu does help relieve flu symptoms an average of 21 hours more quickly, it did not appear to reduce spread of the virus or the chances of being hospitalized for flu-related illnesses.Tamiflu, manufactured by the Swiss firm Roche Holding AG, has been purchased and stockpiled by several governments based on the claim that it prevents the spread of the flu.
Yet the report published this week in the British Medical Journal points out that although Roche raked in some $3.4 billion in Tamiflu sales at the height of swine-flu scare in 2009 alone, there is no substantial evidence indicating that the drug actually curbs the spread of the virus.
The Cochrane Collaboration and the British Medical Journal say that current data does not support Tamiflu´s claims, and they have called on Roche to publish the results of eight previously unreleased trial studies of the medication.
If governments are paying millions to stockpile the drug, the report says, then they need to be sure that this is a sound investment of taxpayer funds.
The report alleges a “gap between evidence and policy” and notes that national pandemic-response strategies in the US and UK have been built around research that hasn´t even been submitted for peer review.
In a phone interview with Bloomberg's Naomi Kresge, the journal´s head investigations editor Deborah Cohen said: “It may be that shortening symptoms for 21 hours is a good value for money [but] I remain to be convinced.”
“The bottom line is that people need to have access to all the data. They need to be able to do an independent review,” she added.
This report published this week is a follow-up to another written in December 2009 in which Cochrane at that time already stated that Tamiflu´s effectiveness could not be evaluated because Roche refused to release data from its studies.
In response, Roche released thousands of pages of clinical study reports for password-protected medical and research websites.
Cochrane has stated that it currently has access to over 3,000 pages of study reports from 10 Tamiflu trials, yet added that these were only the first four to five sections from each report and excluded critical result data.
But in a separate report, three of the reviewers commented that the tables of contents that they were provided indicated that the data were incomplete.
“What we´re seeing is largely Chapter One and Chapter Two of reports that usually have four or five chapters,” said the article´s lead author, Peter Doshi of Johns Hopkins University.
Cochrane researchers subsequently sought the assistance of the regulatory agency the European Medicines Agency (EMA). Under the so-called Freedom of Information law, the group was able to procure an additional 25,453 pages of date, covering 19 trials.
However, the non-profit alleges that even this date appears to be incomplete.
The groups has since submitted a request to the US Food and Drug Administration (FDA) which they believe has the complete reports. The FDA has yet to respond to the requests.
On the Net:
- Cochrane Collaboration
- Roche Holding AG
- British Medical Journal
- Johns Hopkins University
- Image Courtesy Andrew Wales/Wikimedia Commons (CC BY 2.0)