Neurontin 0, Placebo 1. Pfizer loses, Placebo wins.

Stephany at soulful sepulcher has a post up on how Neurontin has not shown itself to be more effective for bipolar disorder than placebo in clinical trials.

It's actually kind of funny that this discovery has been made in April 2008 because I'd reported on this back in January of 2007:

So let's recap: gabapentin is FDA-approved for epilepsy ONLY. But gabapentin has a slew of off-label uses.

Don't know what off-label means? It means "not FDA-approved to be prescribed for this use."

Now that we've got that out of the way, gabapentin is prescribed off-label for migraines, bipolar disorder, social anxiety disorder, OCD, treatment-resistant depression, insomnia, multiple sclerosis, neuropathic pain, and in some instances, post-operative chronic pain.

Where did this off-label usage come from? Basically, one journal article published data on beneficial effects for patients on Neurontin for bipolar disorder and then other articles would cite that article as supporting evidence then more articles cited all the other articles that published the positive efficacy data on the drug, creating what UNC researcher Tim Carey calls the "echo chamber effect."  From Fierce Pharma:

Hearing it over and over, doctors were led to believe that Neurontin worked for bipolar patients, and prescribed it to lots and lots of them.

These articles that touted the benefits of Neurontin were cited 400 times. Carey:

It “becomes a rumor mill in which physicians may be exposed to these types of articles, and citations of articles, which then gives credibility to off-label use.”

The conclusion?

“No scientifically acceptable clinical trial evidence supports use” of the drug in bipolar disorder.

Ouch. Hitting Pfizer where it hurts.

Ghostwriting

According to the International Herald Tribune (IHT), the Journal of the American Medical Association (JAMA) has published an article about Merck’s practice of writing research studies and then asking doctors to slap their names on them. This practice has called into question Merck’s marketing of Vioxx, a profitable cardiovascular drug that was pulled off the shelves due to its link to heart attacks.

Merck acknowledged Tuesday that it sometimes hired outside medical writers to draft research reports before handing them over to the doctors whose names eventually appear on the publication. But the company disputed the article’s conclusion that the authors do little of the actual research or analysis.

Continue reading:

One paper involved a study of Vioxx as a possible deterrent to Alzheimer’s progression.

The draft of the paper, dated August 2003, identified the lead writer as "External author?" But when it was published in 2005 in the journal Neuropsychopharmacology, the lead author was listed as Dr. Leon Thal, a well-known Alzheimer’s researcher at the University of California, San Diego.

The second author listed on the published Alzheimer’s paper, whose name had not been on the draft, was Ferris, the New York University professor. Ferris, reached by telephone Tuesday, said he had played an active role in the research and he was substantially involved in helping shape the final draft.
"It’s simply false that we didn’t contribute to the final publication," Ferris said.

A third author, also not named on the initial draft, was Dr. Louis Kirby, currently the medical director for the company Provista Life Sciences. In an e-mail message on Tuesday, Kirby said that as a clinical investigator for the study he had enrolled more patients, 109, than any of the other researchers. He also said he made revisions to the final document.

"The fact that the draft was written by a Merck employee for later discussion by all the authors does not in and of itself constitute ghostwriting," Kirby’s e-mail message said.

Uh, yeah it does.

Continue reading “Ghostwriting”

Your word's as good as nothing

In early February, I went to an interview in the hopes of obtaining an associate editor position at a trade magazine. The editor-in-chief—we’ll call him Joe—met with me in an interview for an hour and a half, maybe even close to two hours. He gave me an assignment to turn around in a week to determine whether he’d want to hire me. He said that if any of the articles I turned in were published, he’d pay me $75 for each of them. Of course, it sounded like a good deal so I agreed to it. I asked him if I could ask him for help if I ran into any trouble. He said, “Sure.”

I also asked Joe how soon I’d find out if I was selected for the position. He hemmed and hawed, hesitating to give me
any estimated time. (This made me uneasy.) I asked him, “Two weeks? A month?” His blue eyes lit up and he enthusiastically said, “Yeah! A month!” I looked at him quizzically and asked him, “Wouldn’t you know whether you would want to hire me after I write those articles for you?” He hemmed and hawed some more then responded, “Let’s see what happens after you write.”

moneyAt the end of my interview, he walks me out of the office building. It was a nice day so I figured he’d stand outside and get some fresh air or just take a smoke break. (Writers and editors have one or two vices: coffee drinking and/or smoking.) I again give my thanks and farewell and proceed to walk down the sidewalk to my car. I feel his eyes watch me as I move toward the parking lot. As soon as I begin to fade from his sight, out of the corner of my eye, I notice he turns around and walks back inside. I stepped inside the car feeling a little nervous now. During the interview, he gave me no reason to feel uncomfortable but at that moment, I realized that it didn’t seem like a job I’d be thrilled to have. Even though I decided I wouldn’t take the position, I forged ahead with my assignment. I didn’t want to take the chance of working for another trade magazine and enduring an uncomfortable run-in with him at a trade conference for not completing an assignment, but I mainly liked the idea of scoring a cool $75!

Continue reading “Your word's as good as nothing”

Desperately Seeking Spikol

Liz Spikol found an article that says Sir Arthur Conan Doyle (author of Sherlock Holmes) could have been schizo. I diagnose him as bipolar with symptoms of psychosis. Really, this many years later, what does it matter? What could we do for him now?
Also from Liz Spikol, she mentions an article that now says ECT (electroshock therapy) is possibly bad for depression. Spikol has mentioned going through ECT in the past and has complained that it has impaired her cognitive functioning and memory. Looks like she’s no longer alone.

Supposedly, the hallucenogenic in magic mushrooms can help stave off severe OCD for four hours up to a full day with reports of effects lasting up to a few days. But there’s no definitive proof since the clinical trial was only used with 9 people.

I guess ya’ll should just head on over to Spikol’s blog because I think I found the last three articles from her. Here: The Trouble With Spikol