Definitely not acceptable: drug company sues journal over review
- Ike Iheanacho, editor, Drug and Therapeutics Bulletin
With a dismissive kick a cartoon man in a ridiculous hat sends a small drug capsule flying. Questionable frivolity in a serious medical publication, some might say. But they’d be wrong. Trivial as it may look, this iconic image makes a crucial point.
It’s the device used by France’s La Revue Prescrire (and its English language sister Prescrire International) to tag a therapeutic product as “not acceptable”—in other words “without evident benefit but with real or potential disadvantages.” And it’s just the lowest of seven potential ratings. For example, at the other extreme there’s “bravo,” where the man jumps for joy to signal “a major therapeutic advance in an area where previously no treatment was available.”
Generating such views is the lifeblood of independent drug bulletins such as Prescrire, The Medical Letter, the Drug and Therapeutics Bulletin, and many others. For such publications the fence is an uncomfortable place to sit, and a key objective is advising healthcare professionals clearly on whether, or why and how, new treatments should be used in clinical practice.
Such opinions aren’t arrived at easily. In another tradition common among the bulletins, Prescrire’s editorial processes combine extensive mining and scrutiny of data with wide external review and multiple drafting and checking stages to produce the final judgment. You might not like or agree with what’s said about your favourite drug. You can be sure, though, that it’s something the publication is prepared to defend, if necessary.
Such readiness is important, of course, if a drug company chooses to cry foul by taking legal action in response to an unfavourable review. Currently Prescrire is being sued in Paris by the company Astellas in relation to its topical immunosuppressant tacrolimus (Protopic), a treatment licensed for atopic eczema. The publication deemed this drug “not acceptable” as long ago as 2003. It has followed up since with various articles highlighting risks of skin irritation and infection related to treatment and reports of skin cancer in patients taking the drug. Astellas has taken particular exception to a 2009 article that slammed a regulatory decision to extend the drug’s licence to use in maintenance treatment for eczema. However, Prescrire’s editorial staff are confident about their stance and optimistic about the court’s verdict, which is due in the middle of February.
There’s another reason they deserve to win. Central to the company’s argument is the suggestion that tacrolimus’s licensed status automatically invalidates Prescrire’s views. This lame assault on free speech would be funny if it weren’t so scary, given its implication that we should all either praise or stay stoically silent about any lousy product that regulators allow to reach or stay on the market. Truly “not acceptable.”
Footnotes
See bmj.com News: French drug journal is sued for criticising Protopic’s licence extension (BMJ 2011;342:d158, doi:10.1136/bmj.d158) and UK government promises bill to reform English libel law (BMJ 2010;341:c3740, doi:10.1136/bmj.c3740)
Wednesday, February 02, 2011
Definitely not acceptable: drug company sues journal over review -- bmj.com
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