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.