Boehringer, A Journal Article & Discredited Pharma
7 CommentsBy Ed Silverman // January 27th, 2012 // 11:21 am
Last year, a publication in the UK called Future Prescriber ran an article written by two physicians that touted the virtues of Trajenta, a treatment for Type 2 diabetes that Boehringer Ingelheim and Eli Lilly were about to jointly market in Europe. However, there were some problems with the article, which prompted a general practitioner to complain about a host of exaggerations and misleading statements.
How did this happen? The article is the latest example of a drugmaker and a publication working together to promote a medication in a way that can cause the average practitioner to get the wrong impression about the safety, effectiveness or cost of a drug, according to the Prescription Medicines Code of Practice Authority, which reprimanded Boehringer for several breaches of its code.
In short, Boehringer was chastised for going overboard, since the drugmaker and the publisher agreed on the topic, Boehringer committed to buying 2,000 reprints. According to the PMCPA, the original proposal stated the article would be independently commissioned, peer reviewed and published within the main pages of the journal. And there would be no input from Boehringer other than for checking for medical accuracy. But the PMCPA saw things differently.
“For the company to consider it anything other than a promotional item demonstrated a serious lack of understanding of the (PMCPA) code. High standards had not been maintained and ruled a breach of the code. The (PMCPA) panel considered that Boehringer Ingelheim’s involvement with the publication brought discredit upon and reduced confidence in the pharmaceutical industry,” the PMCPA wrote.
What was wrong with the article? The list is long. In no particular order, Boehringer was mentioned only at the bottom of the article, obscuring its involvement. The doctor who complained noted that the authors of the article had previously received support from both drugmakers. The article also incorrectly stated Trajenta was approved in the UK and was ready to launch. At the time, the drug had received a positive opinion from the European Medicines Agency, but was not actually approved.
This is a key point, by the way. The doctor who filed the complaint with the PMCPA, which is a voluntary industry organization, charged that the decision to underwrite and promote the article, and the alleged lack of scrutiny to various statements offered as fact, actually suggested that the drugmakers “were keen to promote Trajenta prior to (marketing) license” issued by regulators.
Getting back to the list of problems: the title and the body of the article both incorrectly suggested Trajenta represented a new class of DPP-4 inhibitors, a type of diabetes meds, and the article also incorrectly suggested the drug was safer to use than a rival med, Onglyza.
Lilly, however, was given a pass. The PMCPA determined that the drugmaker was not aware of the article until it was contacted by Boehringer Ingelheim, since the chain of events purportedly occurred before their marketing alliance was agreed upon. “Given the exceptional circumstances the panel did not consider that Lilly was responsible for the article at issue, and ruled no breach of the code,” the PMCPA decided.
EDM Machines
Just another reason why drug companies and media outlets should not publish without fact checking. Its a good thing they got caught. With all the false hype about it, people could have been waiting for a drug that may not ever get to market. Nice post.
company insider
More junk journal articles getting caught before big phamra can do real damage, nice job.
Jon
First time I’ve read of Lilly getting a pass on anything, ever.
Robert
Leave it to that unethical company Boehringer…they are always in some sort of mess…But this probably fell through the cracks as they are still trying to explain the “Piss Barrels” that were found at Ben Venue in a closet across the hall from a manufacturing line.
Andy Prough, CFE
Good thing that physician spoke up! Conflicts of interest of that nature are very difficult to police. In the U.S., implementation of the proposed “Physician Payment Sunshine Act Regulations” by CMS later this year will be of benefit to investigators.
Bill Cooney
Has anyone bothered to read BI’s side of the story?
In their response to the PMCPA, BI made it clear that they reviewed the article for accuracy and specifically requested, well in advance of the print date, that the publication NOT publish the article because “it contained multiple factual inaccuracies and breaches of the Code.” The publisher refused on the grounds that the article was “independently commissioned.”
That’s a rock-solid defense based on a set of simple, straightforward facts. But even if one believes that BI should not initiate such arrangements with publications, why did their substantial defense merit no mention by Pharmalot? The report above goes into great detail about the “problems” with the article, but ignores the pivotal fact that BI tried to stop its publication. Even big pharma companies deserve fairer treatment than that.
Ed Silverman
Hi Bill,
Thanks for the note and you raise a good question. You are correct to suggest that mention of the explanation offered by Boehringer could have been noted. What you see in this post reflects a summary that was provided by the PMCPA which, unlike the ruling, did not cite the explanation from Boehringer. Here is that link…
http://www.pmcpa.org.uk/?q=node/998
Whether the explanation is rock solid, unfortunately, remains unclear, if only because the PMCPA apparently did not seek information directly from the publisher. Nonetheless, the PMCPA determined that Boehringer was required to take responsibility, since it entered into the arrangement and was aware, from the outset, that the material was promotional.
That said, your point is duly noted and more diligence will be applied in the future to ensure that responses contained in complete rulings are noted in posts.
Thanks for writing,
Ed