December 10, 2009
By Kate Johnson
The media is more often criticized than praised when it comes to reporting health and medical stories, but one recent example highlights an important role for the media in the field of medicine.
The pharmaceutical giant Roche is facing pressure from the medical community about accountability – and the media is playing a valuable role.
This week, the British Medical Journal published a string of articles, an editorial, and an account of a media/medical journal investigation that “cast doubt not only on the effectiveness and safety of oseltamivir (Tamiflu) but on the system by which drugs are evaluated, regulated, and promoted,” writes Fiona Godlee, editor in chief of the BMJ.
It’s a long and complicated story – but in a nutshell, the BMJ was frustrated with its attempts to update a Cochrane review of oseltamivir in the treatment of influenza. Roche, the pharmaceutical company that manufactures oseltamivir, was being “less than forthcoming” with raw data about the drug, and authors of a key company-sponsored study told the BMJ they were unable to supply the data, according to the journal. When a British TV science reporter heard from the BMJ that attempts to obtain Roche data relevant to his story had hit dead ends – he decided to jump into the investigation. The resulting joint investigation by the BMJ and Channel 4 News,“exposed a complex interplay between politics, public health planning, availability of trial data, publishing, and drug regulation,” writes Deborah Cohen, features and debates editor at the BMJ.
In the end, Roche turned over some, but not all of the data. But the BMJ hit its deadline and had to publish its Cochrane update with incomplete data.
“Our Cochrane review team has tried to obtain the data needed to verify claims that oseltamivir (Tamiflu) lowers serious complications of influenza such as pneumonia. We failed, but in failing discovered that the public evidence base for this global public health drug is fragmented, inconsistent, and contradictory, writes Peter Doshi, in a BMJ analysis piece. “We are no longer sure that oseltamivir offers a therapeutic and public health policy advantage over cheap, over the counter drugs such as aspirin.”
Blogging on this bizarre turn of events, medical writer Adam Jacobs comments I’d love to know why the Cochrane reviewers and the BMJ thought it appropriate to involve a TV company in a systematic review.
All in all it was a bad day for science, writes Jacobs. But of course, as a journalist, I see it differently. In my view, the inclusion of a TV news channel added extra power to the BMJ’s investigation and – to borrow a line from Neil Armstrong – while it might have been a small step in the investigation of oseltamivir, it was a giant leap for science.
True, as Jacobs points out, the end result is no reliable answer to the question of whether Tamiflu prevents complications of flu. “The whole point of Cochrane reviews is that they are supposed to be systematic, in other words to include all the available data. To knowingly publish a review that excludes 8 relevant studies because they weren’t willing to wait until they had got hold of the data seems extremely irresponsible,” he writes.
However, BMJ editor in chief Fiona Godlee defends the move. “Should the BMJ be publishing the Cochrane review given that a more complete analysis of the evidence may be possible in the next few months?,” she writes. “Yes, because Cochrane reviews are by their nature interim rather than definitive. They exist in the present tense, always to be superseded by the next update. They are based on the best information available to the reviewers at the time they complete their review. The Cochrane reviewers have told the BMJ that they will update their review to incorporate eight unpublished Roche trials when they are provided with individual patient data.”
Leaving the evidence about oseltamivir aside, the publication of such a detailed account of the obstacles Roche placed in the way of scientific investigation offers the public some rare and illuminating insight of the power of Big Pharma.
In her editorial entitled “Why don’t we have all the evidence on oseltamivir?” Godlee asks “Were ghost writers involved in some of the manuscripts, as alleged by former employees of the medical communication company hired by Roche?…And why were serious adverse events under-reported?”
Casting the net beyond this one incident, Godlee sees it as an example of a much wider problem.
“The current system isn’t working. Worse than that, it gives a false sense of security. The system’s failures have left a legacy of drug evaluations for which, in the absence of better information, we must assume the same levels of confusion and uncertainty as for oseltamivir.”
In another commentary entitled “We want raw data, now”, she says “It can’t be right that the public should have to rely on detective work by academics and journalists to patch together the evidence for such a widely prescribed drug.”
Whether it’s right or wrong – it is what it is. Detective work is what’s required – and thankfully, medical reporters are keen, qualified and (sometimes) paid to do this work. Many leaps can be made when they team up with medical academics.
The BMJ gives Roche space for a full rebuttal and a point-by-point response, which, though voluminous, fail to clarify the issue. But the company’s objection to the media’s involvement is clear. “We believe this is in conflict with accepted standard practice: the merits of scientific studies, and debate relating to them, are of course to be conducted primarily in a scientific or clinical forum rather than via a production company.”
I disagree. Thanks to Adam Jacobs for the scoop.