A Bitter Pill to Swallow

Well, frumps, I’ve been following a story that first broke in May, 2009, that I think is worth sharing.  It would appear that the only way that regular folks like us are going to hear about it is the grassroots way – via the blogosphere and, from there, word-of-mouth. 

It is a story about drugs (the legal kind) and the companies that make billions of dollars every year convincing doctors to prescribe their brand.  In addition, doctors now find themselves pressured by their patients because of the millions of dollars that drug companies are willing to spend on advertising their brand-names directly to consumers.  So how do doctors make informed decisions with so much hype in the air?

There are medical-scientific professionals who gather data on the effects of drugs on real patients (theoretically both good and bad effects), analyze the data, extrapolate from it and make recommendations based on their findings.  This system is not new.  Doctors make treatment decisions based on continuing education and by sharing information with each other – peer-to-peer reviews, as they are called.  

Smart folks who monitor these things say that, more and more, the good news being published far outweighs the bad as far as pharmaceuticals are concerned.  That might have something to do with the fact that it is the very companies that invent, patent and sell drugs that, more often than not,  pay research labs to test their products and medical publishers to print and distribute the results. 

This information, when packaged by a specialty publisher, can make or break a drug as a product.  If your client is paying millions for you to do this for them, what’s the likelihood that you are going to find that their product is dangerous and should be removed from the market?  

The Curious Case of Merck & Co. and Excerpta Medica

That brings us to recent revelations about Merck & Co and  Elsevier and their subsidiary, Excerpta Medica - major-leaguers in the world of scientific publishing.   Excerpta Medica was the ideal business partner for Merck.  EM was, in the parlance of such things, “passionate” about the success of their exceedingly “deep pockets” client, Merck.  So passionate, that they came up with an innovative new approach to publishing the peer review journals that are so instrumental in getting practitioners to prescribe their client’s drugs:  faking it.  That‘s right . . .

Here’s a snippet from EM’s mission statement  (my underlinings): 

“Our goal is to help clients achieve their objectives by ensuring that health-care professionals, patients, and consumers have the information they need to make informed decisions regarding medical care.”

And

“More often than not, clients are looking for a new, fresh approach to challenges. Excerpta Medica delivers exactly that — comprehensive programs designed specifically for therapeutic areas and business requirements.”

Anyone evenly remotely conversant with corporate-speak can read between these lines – no magic decoder ring required.

New Media Coverage

Here’s how the symbiotic relationship between EM and Merck was exposed:
the Australian, an online Australian (oddly enough) news source ran an article on some documents that had been submitted to an Australian Federal Court hearing a class-action suit against Merck for the sale of Vioxx.  Said documents revealed that: the “Australasian Journal of Bone and Joint Medicine” . . . is a “single sponsored publication” where most of the content is chosen by Merck with some “input from Elsevier”.

Since these revelations, Elsevier has expressed embarrassment over its role and admitted it failed to meet its own “high standards for disclosure.”  In other words:  Merck created a phony, but real sounding, peer-review journal titled the ‘Australasian Journal of Bone and Joint Medicine’ to publish data favorable to its products.

Slashdot carried this:

 ”All this is probably not too surprising in light of Merck’s difficulties with Vioxx, the once $2.5 billion a year drug that was pulled from the market in September 2004, after a study showed it doubled the risk of heart attack and stroke in long-term users resulting in payments by Merck of $4.85 billion to settle personal injury claims from former users, but it bears repeating that ‘if physicians would not lend their names or pens to these efforts, and publishers would not offer their presses, these publications could not exist.’”

Then  the medical librarians of the world weighed in:

Sergio Sismondo, wrote:

“there are many reports of medical journal articles being researched and written by or on behalf of pharmaceutical companies, and then published under the name of academics who had played little role earlier in the research and writing process. In extreme cases, drug companies pay for trials by contract research organizations (CROs), analyze the data in-house, have professionals write manuscripts, ask academics to serve as authors of those manuscripts, and pay communication companies to shepherd them through publication in the best journals. The resulting articles affect the conclusions found in the medical literature, and are used in promoting drugs to doctors.”

From a post entitled “Merck’s Ghostwriters, Haunted Papers and Fake Elsevier Journals” 

In fact, pharma-sponsored trials rarely produce results that are unfavorable to the companies’ products.  For instance, none of the published 56 trials of NSAIDs in arthritis identified by Rochon et al in 1994 had outcomes that were unfavorable to the company that sponsored the trials.  Another study showed that studies funded by a company were four times more likely to have results favorable to the company than studies funded from other sources.

Derek Lowe, writing in the blog Corante opined:

“I’m not sure who to be more mad at here: Merck or Elsevier. This one really looks like a team effort. If Merck wants to assemble a bunch of previously peer-reviewed studies and put them out under some banner to show how wonderful their drugs were, well, that’s fine by me. But that banner shouldn’t be something that’s deliberately designed to look like a peer-reviewed journal itself. And the collection should have a disclaimer on the cover that it’s being paid for by Merck, and the first page of every article should have another box: “As originally reported in (journal citation) – brought to you as a service by Merck”. I wouldn’t have a problem with that at all.”

Finally, a follow-up on Slashdot:

Remember the revelation that pharma giant Merck had paid Elsevier to publish a fake peer-reviewed journal that promoted its products?  Turns out Elsevier has an entire division devoted to publishing fake journals for money: Now, several librarians say that they have uncovered an entire imprint of ‘advertorial’ publications.

Excerpta Medica, a ’strategic medical communications agency,’ is an Elsevier division. Along with the now infamous Australasian Journal of Bone and Joint Medicine, it published a number of other ‘journals.’ Elsevier CEO Michael Hansen now admits that at least six fake journals were published for pharmaceutical companies.”

What to Do, What to Do . . .

Now, frumps, if you’re still with me, don’t you think that it’s odd that this story didn’t hit the newspapers, television news or cable even a teeny bit?  All of the sources here, aside from the Australian paper, are blogs that have done their homework – New Media.  I dare you to find anything about this on traditional news outlets.  I would think that a story like this would rate at least a quarter of the space that’s been allotted for Jon & Kate’s divorce in the Old Media.  But that’s just me . . .

Recently I’ve paid a lot to bail out businesses “too big to fail,” which was a new one on me.  Maybe we have another new category of business: businesses too big to do anything about.

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