Tamiflu, the anti-viral drug widely prescribed to treat influenza, is in the medical news again and not just because it’s flu season.  Roche, the Swiss company that makes this topselling flu drug, has once again refused to release all of iths study results—crucial, considering that Roche conducted all the studies. And once again, there is the Cochrane Collaboration, the independent, international organization that evaluates medical research, calling public attention to Roche’s unethical behavior. Whatever we know about Tamiflu’s safety and effectiveness is pretty much what Roche wants us to know.

It is common for drug companies to “cherry pick” their results, keeping the negative to themselves and giving only the favorable findings to the regulatory agencies and medical journals.  The Cochrane reviewers learned that they had been bamboozled after they published their upbeat conclusion about Tamiflu in 2006.  Cochrane reviews are usually updated every few years.

Only when the Cochrane reviewers led by Tom Jefferson, MD, started work on the update did they learn that Roche had withheld studies and that there were substantial problems with those that had been released.  They were chagrined to learn that their 2006 Cochrane review, which found anti-viral drugs were effective in reducing flu symptoms and complications, was based on incomplete data from Roche. And that 2006 Cochrane review had played a major role in allowing Roche to promote its drug as safe and effective. In turn, this led many countries to stockpile the drugs whenever a pandemic was anticipated.

Here are the latest findings published this month in the Cochrane Library (subscription only): Tamiflu does have an effect on symptoms in people who have the flu. It shortens the duration of “symptoms by a day— 21 hours or so.”   The reviewers noted that they were not able to come to a conclusion about any other—far more important—outcomes such as lower rates of death, hospitalizations, or pneumonia, due to the fact that Roche continues to withhold crucial data.  This despite five requests to the company. (The new findings refer not only to Tamiflu but also its knockoff Relenza.)

This project was funded by the U.K.’s National Institute for Health Research. It involved as exhaustive search of all clinical trials, all of which were funded by the manufacturers. All showed serious bias, and Tamiflu-related harms were omitted from the few trials that were published. The reviewers had access to some of the data Roche submitted to the FDA when seeking initial approval for Tamiflu, as well as some of the postmarket reports of adverse effects to the FDA and other drug regulatory authorities in Europe and Japan.  The Cochrane reviewers decided there were too many gaps in information for them to proceed with a planned meta-analysis. In other words, they could not do an update of their old (inaccurate) Cochrane review.

What makes this story all the more shocking is that Roche is getting away with its unethical behavior, despite the high-profile status of the Cochrane reviewers. Despite the extensive coverage of their quest in the December 8, 2009 issue of the British Medical Journal.

The FDA’s current position on Tamiflu and Relenza was praised by the Cochrane reviewers:  “The FDA only allows claims of effectiveness of both drugs for the prevention and treatment of symptoms of influenza and not on other effects (such as interruption of person-to-person spread of the influenza virus or prevention of pneumonia. There is evidence to suggest that both drugs are associated with harms (Tamiflu: nausea, vomiting; Relenza probably asthma). The FDA described the overall performance of both drugs as ‘modest’.”  Note: All of the above refers to flu drugs prescribed to healthy adults, i.e., they do not have asthma or other serious chronic conditions. A separate Cochrane team reviewed the Tamiflu/Relenza studies that applied to children. click here

The Cochrane reviewers said there is “an urgent need for independent research”, which usually means taxpayer-funded studies. As a taxpayer, I can’t see why these two drugs merit any more study.  By the time trustworthy studies become available, the patents on both drugs would have run out, thus rendering them unworthy of the usual expensive drug company-led promotional campaigns.  Tamiflu was introduced in 1999. In one decade worldwide sales soared to nearly $3 billion in 2009 alone, largely due to the $billions spent by many countries (including the U.S.) stockpiling the drug during the bird flu and H1N1 “pandemics.” But sales dropped off sharply in late 2010. Maybe the word is finally getting out.

For more information about Tamiflu

Beware of Tamiflu Read about the World Health Organization’s influence on worldwide sales.

Tamiflu: Serious questions remain  This 2010 post provides a context for the today’s post.

Flu death risk overrated  Here’s the final death count for the H1N1 “pandemic.”

Maryann Napoli, Center for Medical Consumers(c)