A New Smoking Gun in the APA Textbook Fiasco

A new piece of evidence has been unearthed by Phyllis Vine of MIWatch that the Nemeroff/Schatzberg textbook was indeed ghostwritten by STI, Scientific Therapeutics Information. Somehow, Vine was able to unearth STI's "portfolio" of publications, even though the company has since removed the incriminating pages.

I suppose APA might still hold to its guns, presumably by arguing that STI did no more than help to coordinate the project, perhaps by funnelling funds from SmithKlineBeacham to the American Psychiatric Press. That would be a stretch.

You can look at the suppressed web page yourself here. It is filled with the usual suspects--mostly industry funded supplements of various medical journals, including the Journal of Clinical Psychiatry, the preeminent producer of pseudo-CME supplements. Aside from the Nemeroff/Schatzberg book, STI also displays a book on the management of lipid disorders and a book on fungal infections.  Perhaps an enterprising reader of this blog will track down the funders and writers of those books.

This is all part of STI's portfolio. What is a "portfolio"? It is "A set of pieces of creative work collected by someone to display their skills, esp. to a potential employer." In this case, Nemeroff and Schatzberg got to not only claim the textbook as part of their own portfolios, but presumably they got paid for the honor. Niiiice.

 

APA Admits Ghostwriting, Prints Corrected Textbook Cover...

...in a fantasy world, that is.

The first version is the "corrected" Nemeroff/Schatzberg cover, followed by the current cover. Thanks to John Nardo, who corrected the inaccurate attributions on one of his recent blog postings.

Like a Bad Penny, the Nemeroff/Schatzberg "Textbook" Problem Returns

Do you remember the hoopla a few months back about a textbook apparently ghostwritten by medical writers hired by the makers of Paxil? Charles Nemeroff and Alan Schatzberg were the identified authors, but a letter was posted on the internet showing that STI, a medical writing company, had written a first draft of the textbook. See my posts here and here about the issue. The textbook, as published, ended up being a veiled advertisement for Paxil.

The APA responded by denying wrongdoing in the organization's official newspaper here. They claim possession of various documents proving that the textbook was not ghostwritten. The obvious rejoinder is, "show me the documents." This is exactly what psychiatrists Robert Rubin, Bernard Carroll, and professor Leeman McHenry asked Psychiatric News in this letter to the editor. They make the following entirely reasonable request:

"We call on the APA/APPI to release all the key documents. The contract between STI and GSK will reveal how much influence GSK had on the content and tone of the book, and the role of GSK in approving drafts. Correspondence between Drs. Nemeroff and Schatzberg and STI will make it clear whether they followed the contract.  Transparency also requires release of any GSK marketing/ business plans for the Handbook; the legal release form transferring ownership from GSK to the ‘authors’ and APPI; marketing activities of GSK sales representatives detailing the Handbook; and correspondence among all parties regarding the “unrestricted” educational grant."
 
Psychiatric News has refused to publish it. Here is their rejection letter.

I don't think this issue is going away. It's time for the APA to prove to the world that they were not complicit with a drug company in publishing a "textbook" that artfully hid Paxil's side effects.

Somaxon's Silenor: A Case Study in Sleeping Pill Deception

Sometimes, despite neon warning signs and a voice in our head shouting "DON'T DO IT," we go ahead and do stupid things anyway. 

Welcome to the world of Somaxon Pharmaceuticals, unveilers of the new sleeping pill, Silenor. Billed in their press releases as "the first and only non-scheduled prescription sleep aid that is proven to provide patients with a full night's sleep, including sleep into the 7th and 8th hour," Silenor is simply a branded version of doxepin, a tricyclic antidepressant that has been available in the U.S. since the 1960s, and has long been used as a cheap sleeping pill.

A year ago, Somaxon got FDA's permission to market this me-too drug.  All they had to do was to take little pinches of generic doxepin powder, turn them into tablet form, and do some clinical trials to show it works for insomnia (see, for example, Scharf M et al, J Clin Psychiatry 2008;69(10):1557-1564). They now have an FDA indication for insomnia for the 3 mg and 6 mg doses. The lowest dose of generic doxepin in capsule form is 10 mg, so apparently the Somaxon reps will argue that this dose is too strong, and that Silenor's 3 and 6 mg forms are just right. 

A month's supply of Silenor at 3 mg or 6 mg costs $214, according to Boston area pharmacies. On the other hand, a month's supply of doxepin 10 mg costs $4 at Wal-mart. The rare patients who cannot tolerate 10 mg of doxepin can reduce the dose by opening up the capsules and mixing some of the powder in juice. Or, they can try the liquid doxepin elixir if they really need tiny doses. 

Silenor is a blatant get rich quick scheme that appears to be failing miserably. According to The Street, Silenor had total sales of only $1.4 million in the fourth quarter of 2010. At this rate, Silenor drug reps will have to ditch their cars and hike to doctors' offices with samples in their backpacks.

Shrewd analysts were predicting Silenor's early demise soon after it was approved--see for example, Douglas Krohn's June 2010 article, "The Problem With Somaxon's Silenor."  More recently, up and coming psychiatrist/blogger Steve Balt posted a great investigative piece on his Thought Broadcast blog, entitled "Thank you, Somaxon Pharmaceuticals!" Trying to be fair, Balt contacted medical affairs at Somaxon to see if they had any data showing an advantage of Silenor over 10 mg of doxepin. Interestingly, he was sent a document entitled "Is the 10 mg Doxepin Capsule a Suitable Substitute for the Silenor® 6 mg tablet?" Apparently Somaxon was already armed and ready for me-too accusations.

Balt publishes Somaxon's chart comparing blood levels of Silenor 6 mg vs. doxepin 10 mg. At first glance, it appeared that doxepin practically overdoses patients--until Balt realized that the doxepin data was essentially made up. I won't steal any more of his thunder--please jump over to his blog for the entertaining details. 

Dr. Levin, Modern Psychiatrist--Unfulfilled, Bored--But Wealthy

There's been plenty of buzz about Saturday's front page New York Times story, "Talk Doesn't Pay, So Psychiatry Turns Instead to Drug Therapy," by Gardiner Harris. The story is essentially a profile of Dr. Donald Levin, a 68 year old psychiatrist who has a private practice in Doylestown, Pa.

It is a poignant example of a common situation in psychiatry. Older psychiatrists were trained during a time when there were few effective psychiatric medications, so they cut their teeth on training in psychotherapy. Not surprisingly, doing therapy is fun--it's involves getting paid for having interesting and intimate conversations with people, and helping them to become happier as a result.

In the old days, psychiatrists were paid very well for therapy. In part, this was due to the law of supply and demand--until the late 1940s, psychiatrists alone were allowed to do psychotherapy. But with World War 2 came a critical demand for more therapists to deal with the psychological needs of veterans. Over the ensuing decades, the NIMH granted funds to train psychologists and other non-MDs to deal with the growing public demand for therapy. As the supply of therapists rose, reimbursement for therapy plummeted. 

Of course, as any professional guild must do, the American Psychiatric Association fought this trend ferociously, arguing that only professionals who received medical training had the qualifications to do therapy. In 1949, the president of the APA summarized the opinions of a special "Committee on the Relations of Psychiatry and Clinical Psychology" by saying that the "American Psychiatric Association is strongly opposed to independent private practice of psychotherapy by the clinical psychologists; and The Association believes that psychotherapy, whenever practiced, should be done in a setting where adequate psychiatric safeguards are provided."

To the modern eye it seems absurd that intelligent people could believe that you had to go to medical school to do psychotherapy, but the potential for loss of income often confuses the mind. From the 1950s until the 1980s, the APA continuously lobbied state legislatures to prevent independent credentialing for non-MD therapists, but they eventually lost in every state.

Ironically, many within the APA were eventually happy to off-load their therapy tasks to psychologists and social workers, because a plethora of psychotropic drugs were introduced in the 1980s and 1990s. Psychiatrists no longer needed to do therapy to make good money. But this forced a decision point for many psychiatrists, like Dr. Levin, who loved doing psychotherapy. Would they continue to do psychotherapy--thereby diminishing their incomes--or would they become psychopharmacologists, lucratively churning through patients in 15 minute increments? Dr. Levin chose the latter, and sadly, he is unfulfilled.

Quoting from the New York Times article: “I miss the mystery and intrigue of psychotherapy,” he said. “Now I feel like a good Volkswagen mechanic.” “I’m good at it,” Dr. Levin went on, “but there’s not a lot to master in medications. It’s like ‘2001: A Space Odyssey,’ where you had Hal the supercomputer juxtaposed with the ape with the bone. I feel like I’m the ape with the bone now.”

Many psychiatrists will recognize the sense of tedium and boredom described by Dr. Levin. He went through psychiatric training to do therapy and is now a pill-pusher. 

Of course, one can argue that he is simply living with the consequences of that age-old decision: the choice of  higher income, but less fulfilling work. The world is filled with realtors, lawyers, marketers, managers, etc..., who wish they could make their current income doing watercolors or teaching elementary school or writing novels.

If Levin wanted to do therapy, he could, but, as he said in the article, "Nobody wants to go backwards, moneywise, in their career." We all make our decisions.

Are Dr. Levin's patients happy? Harris interviewed six of them who said they were satisfied with his care--but these were presumably chosen by Dr. Levin and may not be representative of his caseload of 1200. This brings up a host of issues that I'll discuss in a future post. 

New Drug Approved for the Annoyingly Cheerful

FDA Rejects Contrave for Obesity--Big Mistake

As you can read from various sources, including the NY Times, the LA Times, and the Washington Post, the FDA has rejected another anti-obesity drug, Contrave, because of concerns that it might cause heart attacks in patients who take it for years.

FDA's excessive caution was motivated by its experience having been burned by the Fen-Phen fiasco. This was a weight loss drug widely prescribed in the 90s that was pulled from the market after studies showed it caused fatal lung and heart valve problems. 

This new drug, however, is a combination of two medications that have already been widely prescribed and are fairly safe: Wellbutrin and naltrexone. Psychiatrists are familiar with both of them. We prescribe Wellbutrin for depression and smoking cessation, (and off-label for weight loss, for which it has shown efficacy as a stand alone), and we prescribe naltrexone for alcoholism.

As you can see from information published on Clinicaltrials.gov, Contrave is simply a combination of Wellbutrin 400 mg with Naltrexone at a couple of different doses, 48 mg and 16 mg. Clinical trials showed that Contrave helped 50% of obese patients lose 5% of their body weight, while only 10% of patients on placebo lost that much weight. The FDA's advisory panel voted to recommend approval, but the FDA demurred, saying that the company, Orexigen, will have to conduct a huge placebo-controlled long term study to make sure the drug doesn't cause heart attacks (one of Wellbutrin's well-known side effects is a slight increase in pulse and blood pressure, although there were no heart attacks in the Contrave clincial trials).

In my opinion, the FDA made the wrong decision. Obesity is a public health catastrophe, and Contrave's approval would have been predicated on conducting post-marketing safety studies anyway. The good news is that patients can ask doctors to prescribe them the constituents of Contrave, both of which are available in generic form--burpropion and naltrexone. Presumably, this generic combination will be much cheaper than Contrave's pricing anyway!