Ghost writing Medical Research and Its Repercussions, from the Atlantic

Playing Doctor

How to spin pharmaceutical research
By Carl Elliott

This is another article about the corruption of medical research, but this one focuses on a more subtle aspect of industry sponsored research: the ghost writer. It has an amusing intro where we meet a ghost writer, Dave, and how he is taught to "spin" research findings to highlight the beneficial aspects of a given drug. You should really read the whole article, it's not too long.

The mechanics of the ghostwriter’s job are fairly simple, David says. Early on, a medical-communications agency and its pharmaceutical-company sponsors will agree on a title for an article and a potential author, usually an academic physician with a reputation as a “thought leader.” The agency will ask the thought leader to “author” the article, sometimes in exchange for a fee. The ghostwriter will write the article, or perhaps an extended outline containing the message the company wants to transmit, and send it along to the physician, who may make some changes or simply sign it as written and submit it to a journal, usually scrubbed of any mention of the ghostwriter, the agency, or the pharmaceutical company. David says he rarely even sees the published articles he writes.

Every so often, the issue of ghostwriting moves out of medical schools, where it is generally tolerated or ignored, and into the wider public sphere, where it is treated as a moral scandal. The most recent burst of outrage came in July during an investigation by the U.S. Senate Finance Committee, which has been looking into whether GlaxoSmithKline tried to steer attention away from the cardiac risks of its diabetes drug Avandia (whose use was recently restricted by the Food and Drug Administration). The committee found not merely that GSK had “downplayed scientific findings” to minimize the apparent risks of Avandia, but that it had used a ghostwriting campaign for the drug. (The company had called the ghosting effort “Case Study Publication for Peer Review,” or CASPPER.)

Ghostwritten articles surface again and again in litigation (in cases concerning Vioxx, Fen-Phen, Zyprexa, Premarin, Neurontin, and Zoloft, to mention just a few). Years before the Avandia scandal, GlaxoSmithKline paid $2.5 million to the State of New York to settle a lawsuit alleging that it had concealed studies suggesting an increased risk of suicidal behavior in children and teenagers taking Paxil, most notoriously in an article “authored” by Dr. Martin Keller of Brown University. One 2003 study in The British Journal of Psychiatry found that ghostwriters working for a single medical-communications agency had produced more than half of all medical-journal articles published on Zoloft over a three-year period.

It goes on to say that the moral outrage is often about "plagiarism," when the real crime, as David puts it, is that "spinning the data perverts science." Depressingly enough, it looks as though it is not going to stop any time soon. The journals have some weak rules about acknowledging some "editorial assistance," but allow the practice to continue. As an example, the Paxil article as noted above, has not been retracted in any way, so probably goes on being cited by unwitting practitioners. The ghost writers are well paid, but just tools to the greater enterprise of the pharmaceutical sales, and are not the real problem. As it says in the article " Medical writing has little glamour, and whatever moral purpose it might once have carried has been rubbed away by the constant friction with commerce." So for scientists by training, like Dave, this work can be quite demoralizing. Unfortunately, the whole set up is also quite dangerous.

Here are some previous posts dealing with the similar issues. Here, here, here, and here.

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When "Oversight" means "Overlook"

In yet another depressing instance of profit motive undermining patient well-being we are presented with the story of a private company, "Coast Independent Review Board", charged with overseeing the safety of new drugs and medical devices (An Overseer of Trials in Medicine Draws Fire Published: March 26, 2009 NYtimes.) "Coast,"located firmly inland in Colorado Springs, was snared by undercover federal agents when it approved a make-believe surgical device rejected by two of Coast's competitors.
"Where was the due diligence of your company?" demanded Congressman Stupak at a Congressional hearing on Thursday March 26th. In retort, remaining as combative and self-righteous as any thug worth his salt, the CEO Drueber griped that he could not imagine why anyone would design a fake trial. (You mean besides catching frauds?) "I cannot believe that my government did this to me and my company. It is unconscionable.”
What is "unconscionable" is a company that is willing to sign off on potentially dangerous drugs or devices for a fee. There have been recent hearings on patient deaths from unsafe devices which were allowed because of fraudulent data submitted to the FDA. The charges against Coast are not trivial. In recent years, review of new medical devices and drugs has shifted from academic medical institutions to private review companies that are paid by the company that develops the new device. This setup can lead to corruption of the process as seems to have happened at Coast.
Following the money we find out from the article that "over a five-year period, Coast reviewed 356 study proposals and rejected only one, according to data presented at the hearing. Meanwhile, since 2004 the company’s revenue has more than doubled, to $9.3 million in 2008."
It cuts down on outlays if you don't actually do the work of reviewing and increases profits if drug companies seek you out because you're known to overlook rather than oversee.
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