Tag Archives: bmj

BMJ wants raw data for all drug trials to be shared

Under the headline “We want raw data, now,” BMJ editor Fiona Godlee recounts the story of how BMJ had to pressure a drug company into releasing full study reports verifying their claims as to the effectiveness of oseltamivir (Tamiflu).

Tamiflu. Photo by Richard Sunderland via Flickr.

Godlee says that researchers updating their Cochrane review of the drug “failed to verify claims, based on an analysis of 10 drug company trials, that oseltamivir reduced the risk of complications in healthy adults with influenza. These claims have formed a key part of decisions to stockpile the drug and make it widely available.”

Only after Roche was questioned by the BMJ and Channel 4 News did the manufacturer commit to making “full study reports” available. Godlee says that some questions remain, including how patients were recruited and why some neuropsychiatric adverse events were not reported.

Godlee argues that “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,” saying that “Individual patient data from all trials of drugs should be readily available for scientific scrutiny.”

When is an embargo not an embargo?

How about when a press release was never issued? None was available when the UK media reported results of a study about the effects of caffeine in pregnancy – before BMJ had a chance to publish online. Just the same, BMJ editor Fiona Godlee is a bit peeved. She acknowledges that, technically, there was no breach, but she maintains coverage still amounted to publicity before publication.

How did this happen? The UK’s Food Standards Agency, which funded the study, held a stakeholders meeting before BMJ issued its embargoed press release. “It was probably from this meeting that the study’s findings, and the government’s new guidelines on caffeine intake during pregnancy, were leaked,” she writes in an editorial. In this case, she continues, there was no harm done – the media got the story right.

Godlee was responding, in part, to an earlier BMJ blog post by FSA communications director Terrence Collis, who wrote the agency was less than “delighted” to get its study published in BMJ. Why? The FSA wants to show its research is high quality, but “we are even keener that the advice that reaches consumers is as clear as possible – and gets there as quickly as possible. This makes waiting around for journals to decide whether they are going to publish a real pain.” And that, he acknowledged, left time for leaks.

Some other thoughts about embargoes:

What do you think about embargoes and, specifically, this situation?

Study: Health journalists face ‘entanglements’

A paper just published in BMJ discusses financial ties between medical journalists and the companies they cover. The authors look at three areas of “entanglement”: education of journalists, awards for journalists, and the actual practice of journalism.

The paper points out that industry sponsorship of training of journalists can raise concerns, pointing specifically at the University of North Carolina’s master’s degree in medical journalism, the American Medical Writers Association and the Unity convention.

It also looks at sponsored award programs, such as those sponsored by Eli Lilly, Boehringer Ingelheim and Roche, and says “journalists who accept such prizes may be engendering conflicts of interest.”

The third area of concern, according to the paper, involves “entanglements” – including situations in which companies or their public relations firms provide patients for journalists to interview or when journalists quote sources without disclosing their financial ties to the industry. It also says that television network Accent Health, which is owned by CNN, “overtly offers sponsors, including drug companies, the chance to boost sales of their products.”

The paper does point to AHCJ and its policies as a “way forward:”

“A way forward may be provided by the Association of Health Care Journalists, which has tough rules barring advertising or sponsorship from private, for-profit healthcare entities, including drug companies, device manufacturers, and insurers. And it is encouraging that some media outlets are now asking reporters to routinely report conflicts of interest of quoted sources.”