Showing posts with label Alan Schatzberg. Show all posts
Showing posts with label Alan Schatzberg. Show all posts

Monday, April 11, 2011

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.

 

Tuesday, April 5, 2011

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.


Monday, December 13, 2010

Note to Nemeroff and Schatzberg: Time to Apologize

Two famous psychiatrists ought to understand the defense mechanism called "projection." People use projection when they feel guilty about something--instead of admitting their guilt, they find somebody else to accuse. This is the key to explaining the latest twists in the scandal involving Charles Nemeroff and Alan Schatzberg. 

POGO (the Project on Government Oversight) has posted letters from Nemeroff and Schatzberg's attorneys here . Ironically, the two letters are verbatim replicas of each other, and yet are signed by two different attorneys--in other words, at least one of the letters was ghostwritten! Someone should complain to the American Bar Association. 

At any rate, the letters are not completely devoid of merit. Both POGO and the New York Times appear to have overinterpreted this letter from STI to Dr. Nemeroff. The letter, dated February 4, 1997, laid out a plan for how Sally Laden and Diane Coniglio were going to "develop" a textbook that was eventually published by the APA in 1999, titled "Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care." In the letter, Diane Coniglio was identified as the "primary technical writer and project manager," and Sally Laden described herself as the "technical editor." Laden personally assured Dr. Nemeroff that "I will be working closely with Diane [Coniglio] at all times...."

It seems clear that Laden and Coniglio understood that their job was to write the entire first draft of the textbook--ie, to ghostwrite the book. Laden went on to provide a detailed timeline, which specified that three successive drafts would be written by the Coniglio/Laden team, and would be sent to both Nemeroff/Schatzberg and SmithKline Beecham for review. 

Both POGO and the New York Times can be be forgiven for having interpreted this letter as being pretty good evidence that the textbook was, in fact, written primarily by Coniglio and Laden, with plenty of input from SKB. But Nemeroff and Schatzberg are saying that they completely ignored this letter, that they wrote the book entirely on their own, and that Laden and Coniglio contributed in only the most menial of ways, by looking up references and such--no more than editorial gruntwork. Their lawyers are accusing POGO of causing "serious damage" to their clients' "personal and professional reputations." They have demanded corrections, retractions, apologies, and first-born sons. 

So far, both POGO and the New York Times have responded--to a degree. The New York Times posted this "correction" basically clarifying that the STI letter did not constitute solid evidence that ghostwriting actually occurred. POGO did something similar, amending both the letter they sent to NIH and their blog posting. But Nemeroff's and Schatzberg's lawyers still aren't satisfied, and responded with a second round of letters.  They are stuck on, among other things, this demand that POGO formally "apologize" to Schatzberg: "Finally, your letter does not comment on Dr. Schatzberg's demand fro an apology in addition to the retractions. Please advise when and in what form the apologies from POGO and Mr. Thacker will be forthcoming." POGO has refused to apologize. 

As a psychiatrist concerned about the reputation of my profession, I think what we really need is an apology from both Nemeroff and Schatzberg, since they are the ones who demonstrated the most unethical behavior of all these participants. Since they are both very busy and very important men,  I'll be happy to ghostwrite the following first draft of their official apology, as follows:

"We, Charles Nemeroff and Alan Schatzberg, apologize for having collaborated with SmithKline Beecham in their funding of the 1999 textbook, "Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care." This collaboration resulted in SKB formulating a plan for the ghostwriting of the book. While they did not actually write the textbook, we violated professional and academic ethics by manipulating the content of the book in order to encourage readers to choose Paxil over its chief rival, Zoloft, for the treatment of anxiety disorders. We did this by highlighting the positive studies regarding Paxil's efficacy, while simultaneously ignoring Paxil's negative side effects--side effects about which we were fully aware when we wrote the book."

If they would like a timeline for the completion of this apology, I can invite Sally Laden and Diane Coniglio to help out. They both seem to be excellent silent partners. 

Friday, December 3, 2010

Nemeroff and Schatzberg's “Textbook” Pushed Paxil

So I finally got the book, ripped open the manila envelope from an Amazon reseller, and found out exactly what a $120,000 “unrestricted educational grant” will buy: an advertisement for Paxil. Not obvious, not blatant. But artfully crafted, subtle, smooth—more in the style of Nemeroff than Schatzberg. Nemeroff was clearly the mentor in this project.

Much ink has been spilled about whether the book was or wasn’t ghostwritten by a PR firm called STI. This letter from STI to Dr. Nemeroff appears to be a smoking gun of evidence, yet Nemeroff, Schatzberg, and the American Psychiatric Association vehemently deny that this was ghostwritten. (Read the APA's denial here). Rumor has it that Schatzberg is sicking his attorneys on anyone who dares to suggest what seems to be crystal clear based on the documents. But who cares, really? If it was ghostwritten, that's unethical. If it wasn't ghostwritten, it's actually worse for these academics--because the final result is such a finely crafted piece of promotion that any reputable "author" should be embarrassed and ashamed. This is truly a case of "damned if you do, damned if you don't."

You open the book, and the first thing that slaps your retina is a chapter on anxiety disorders. I’ve read a lot of psychiatry textbooks, probably over a hundred, and I can confidently report to you that I have never seen a textbook on general psychiatry (whether written for psychiatrists or PCPs) that begins with a big honking chapter on anxiety disorders. Most begin with tips on diagnosis, basic principles of psychopharmacology, mood disorders, or other topics. But they never begin with anxiety disorders.

How could this possibly matter, you might ask? Because in 1999, the book's publication date, Paxil was in the midst of a blockbuster sweet spot, buoyed particularly by FDA's 1999 approval of the drug for social anxiety disorder. Like all good drug reps, Nemeroff & Schatzberg lead with their product's strength. Thus, on page 18, we hear the rather startling statement that "social anxiety disorder is the most common anxiety disorder and the third most common psychiatric disorder in the US, preceded only by depression and alcohol dependence." That's based on a credulous acceptance of the inflated 13% prevalence figure for social anxiety that was published in 1994. This figure was also the basis of the famous "1 out 8 people have social phobia" line parroted by SmithKline Beecham in their marketing material at the time. Two pages later readers are reassured that there exists a solution to this public health catastrophe: "Currently, only one antidepressant (paroxetine) is FDA approved for the treatment of social anxiety disorder."

Does this prove blatant bias? Is it deceptive? No on both counts. It just lays the groundwork, softening the mark, as a drug rep would say. The entire first chapter is positioned front and center as a way of creating a platform for a series of boasts about Paxil's efficacy. Someone made the decision to organize the book this way, and someone had a reason to do so.

The actual deceptions begin in the chapter on antidepressants on page 77. Here's where Nemeroff and Schatzberg educate PCPs about the confusing array of antidepressants available. Then and now, if you were to ask your average psychiatrist how he or she chooses an SSRI, you would hear that they are equally effective, but that they differ based on side effect profiles. And since the late 1990s, it has been generally acknowledged that the SSRI with the most troublesome side effects is Paxil.

But not according to Nemeroff and Schatzberg's Paxil-funded textbook. Taking a break from the world of general scientific knowledge, this chapter says, essentially, that all SSRIs have some side effects, and that any differences among them are minor.

For example, both Prozac and Paxil have long been known to increase the levels of other drugs that patients may be taking. This is called "drug-drug interactions." In 1999, Paxil and Zoloft reps were sniping at one another over this issue. Zoloft reps were crowing about how "dirty" Paxil was, pointing out that Zoloft, at usual doses, caused hardly any drug drug interactions. Paxil reps, for their part, were desperately trying to downplay this.

So how do Nemeroff and Schatzberg handle this issue? They create
Table 47 on page 85, entitled “Common Drug Interactions with SSRIs”. Here, there is no distinction between Paxil and Zoloft. A primary care doctor would falsely conclude that there was no reason to favor Zoloft over Paxil in patients also taking medications like propranolol or Vicodin or amitryptyline. Based on this deceptive table, they might well have favored that wonderful anti-social anxiety drug, Paxil--with potentially serious medical consequences for their patients.

Interestingly, several years later, when Nemeroff was paid by a different drug company, he had a financial incentive to play up Paxil’s drug interaction liabilities. In this CME article funded by Bristol-Myers Squibb to push their antidepressant EMSAM, here’s what Nemeroff and his co-authors had to say about SSRIs and drug interactions: "Not all antidepressants affect CYP enzymes. Antidepressants that do not substantially inhibit any CYP enzyme at their usual therapeutic doses include the SSRIs citalopram, escitalopram, and sertraline [Zoloft];… fluoxetine and paroxetine [Paxil] at 20 mg/day produce approximately a 500% increase in the AUC of CYP2D6 dependent drugs.” This article was eventually cited by ACCME as being blatantly biased in favor of EMSAM, and the company that produced it promptly went out of business.

Not only did Nemeroff and Schatzberg omit data about Paxil's drug interaction dangers, they also neglected to discuss data available in 1999 showing that Paxil caused more sexual dysfunction, more weight gain, and more sedation than other SSRIs.

To sum up, in 1999, Nemeroff and Schatzberg published a textbook called "Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care."
It was funded by SmithKline Beecham with a $120,000 "unrestricted educational grant." Documents posted on the internet hint strongly that the book was ghostwritten by a PR firm hired by the drug company. And an analysis of the book's content shows that it was crafted to encourage primary care doctors to prescribe Paxil preferentially over its competitors, such as Zoloft.

This is yet another heaping of shame upon psychiatry. Rather than sending bullying lawyer letters to whistleblowers, I suggest that the authors issue the following statement: "We hereby apologize to the medical community and to the public for having published this textbook. In 1999, financial relationships with the pharmaceutical industry of this type were considered acceptable. In retrospect, by having legitimized what was essentially a promotional document for SmithKline Beecham, we realize that we did a disservice to the physicians who read the book, and who falsely assumed that the information was objective. We, in conjunction with the American Psychiatric Association, officially retract this textbook in its entirety."

Tuesday, November 30, 2010

It's a Textbook! It's an Ad! It's Nemeroff/Schatzberg!

Drs. Nemeroff and Schatzberg are back in the limelight, once again dragging the good name of psychiatry through the mud. According to today's New York Times, in 1999 SmithKline Beecham, the maker of Paxil, funded and ghost-wrote a textbook for which this ethically-challenged duo took credit.

What were they thinking?

I imagine the conversation went something like this.

N: "Let's write a textbook for primary care doctors."
S: "Sounds good. But I don't have the the time."
N: "Neither do I."

S: "Hmmm."

N: "Hmmm."

S: "So what do we do?" [N grins.] "Wait, you're not seriously considering--"
N: "Why not? What are you, suddenly Dr. Holier Than Thou?"
S: "All right, don't remind me about Corcept and your 60,000 shares. What's your plan?"

N: "Simple. We know that SmithKline Beecham's Paxil is losing market share to Pfizer's Zoloft. I'll call my friends there, ask them for an 'unrestricted educational grant.'"
[S nudges N. N grins and winks. But then S frowns.]
S: "The money will be nice, but who's going to write it?"

N: "SmithKline will hire a PR firm to do it. All we have to do is review it and make some final tweaks."

S: "But isn't that a little sleazy, even for us? You know they'll play down Paxil's disadvantages--that it causes more sexual side effects, more weight gain, and more drug interactions than Zoloft."

N: "Some studies show that's true, others are more equivocal."

S: [Lightly socks N on the shoulder] "Don't BS me, you sound like you're giving one of your Paxil drug talks to naive country docs."

N: "You know me too well!"
S: "As usual you're very persuasive. I'm in."
N: "I think this is the continuation of a beautiful friendship...."



Sunday, January 6, 2008

Donna Norris for President (of the APA)

These days, when you think politics, you are probably picturing the likes of Obama, Clinton, or Huckabee, but at least for the next few weeks, think Donna Norris.

Yes, it's time for all good psychiatrists to open that official APA ballot and check off their choices for who will make crucial decisions about the American mind over the next couple of years (the actual term is one year, but there is a preparatory "president-elect" year). Rarely have the distinctions between the candidates been more stark.

In one corner, we have
Donna Norris, M.D., a child and adolescent psychiatrist who has been active in APA governance for 25 years. She is currently the secretary-treasurer of the APA, chair of the Ethics Appeals Board, and a past speaker of the APA Assembly. More to the point, she is concerned about the pharmaceutical industry's influence on our profession. She chairs a special task force in charge of screening all potential members of the DSM-5 committee for commercial conflicts of interest. On a more personal note, she receives no financial compensation from drug companies, depending on her private practice for all of her income.

By contrast,
Alan Schatzberg, M.D., has no APA governance experience, although he once served as vice president of the Northern California Psychiatric Society. Even more troubling, he was involved in what many consider an ethical breach in 2002, when he wrote an article endorsing mifepristone for psychotic depression without disclosing the full extent of his financial involvement in Corcept, the company that has tried to develop the drug for this purpose. At that time he owned 3 million shares; the current value of these shares is about $12 million. Currently, Schatzberg is the editor-in-chief of a journal entitled the "International Journal of Sleep and Wakefulness" which is funded wholly by Cephalon, a pharmaceutical company that sells Provigil. The purpose of this pseudo-journal appears to be to convince readers that sleepiness is a huge public health problem and that Provigil is the mainstay of treatment.

I sent both Dr. Schatzberg and Dr. Norris a series of questions exploring their views on conflict of interest, and Dr. Schatzberg ignored me (Dr. Norris responded promptly).