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Several injured at carnival in Angels Camp
Posted by: Spencer Pahlke
May 18, 2008

These carnival cases are always scary--high speed movements and many people involved can often mean severe injuries.  Mike Kelly recently handled a defective product matter very similar to this one arising from a fall of more than 50 feet from a ride at the Orange County fair.  As we've come to expect from Mike, it resulted in a very favorable settlement.

In the Angels Camp accident, 23 or 24 people were involved--the number varies based on the news source (News 10 says 23, the AP says 24).  The ride--called the Yo Yo--is basically a vertical column with several arms radiating out from it.  On each arm is a basket, which holds people on the ride.  A properly operating one is shown here (courtesy of Ocala.com):

 

 The ride up in Angels Camp malfunctioned such that the radiating arms quickly collapsed to the ground, sending all the riders some 25 feet downward before striking the ground.  Three were seriously injured, and 20 were less seriously injured.  Our best wishes go out to the families for a quick and full recoveries.

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Merck's "independent" authors
Posted by: Spencer Pahlke
May 17, 2008

I know this happened a few weeks ago, but I've got to blog about it. As it turns out, Merck is so helpful in the studies written by "independent doctors" about its products that it actually does the writing for them. How convenient is that?

In the Vioxx litigation, attorneys for the plaintiffs uncovered millions of documents related to Merck's development and marketing of Vioxx. The authors of the JAMA article, entitled, "Guest Authorship and Ghostwriting in Articles on Rofecoxib," searched the database of documents for articles related to clinical trials, authorship of articles, and the development process for getting those articles published. This turned up 20,000 relevant documents, of which some 250 spoke directly to Merck's efforts to have favorable articles published about its various products.

I'll avoid a rehashing of the methodology of the research conducted for the article (though it's well laid out in the article here), and get to the conclusions.

Among the early clinical trials and their associated published articles, the researchers found articles related to 20 protocols between numbers 010 and 902. Among these 20 protocols, all the initial manuscripts were drafted by internal Merck scientists. Then, surprisingly, 16 of the 20, when actually published, were "written" by "external, academically affiliated investigator[s]." Of course, "written" is used lightly: with protocol 078, for instance,

there are minor differences in language and organization between the draft and final versions of the manuscript (particularly in the abstract, as opposed to the text), the results presented are almost identical, reinforcing that the trial itself and the analyses were complete before the academically affiliated investigators were involved in the manuscript.

Even more shocking is an email in the JAMA article. Written by an outside publishing company and sent to Merck, it provides a list of several articles that already have titles--and were already being drafted--before they had an author. That's a little strange.

Finally, why would doctors sign on as external authors? Here's some indication:

Documents were found describing Merck compensating investigators with honoraria for agreeing to serve as authors on review manuscripts to ghostwritten on their behalf by medical publishing companies. Honoraria varied, ranging from $750 to $2500.

It's pretty frustrating that, for these sums of money, patients and doctors alike were misled as to the actual authorship of articles that could have directly affected treatment decisions.

But I think it's a bit more nuanced. For these doctors to be willing to accept these payments--which must pale in comparison to their usual salaries--there must be little in the way of obstacles to accepting such payments. Perhaps such practices are common in the medical publication industry, meaning that these external authors had little pause about accepting payment. Of course, if that's the case, the public deserves far more disclosure of these financial connections.

Finally, as the authors point out, this was a unique situation because the Vioxx litigation provided unprecedented access to Merck documents. Without the litigation, we would never have learned that Merck writes so many articles for external authors. Not only does the litigation directly help those injured (or killed) by Vioxx, it has the added benefit of shedding some light on these shady publication practices.

As I've said several times before, this access to justice and access to information is at grave risk due to federal preemption of state lawsuits. The Supreme Court will consider blocking products liability actions like the ones brought against Merck for the dangers presented by Vioxx.

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