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.

 

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.

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. 

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."

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...."

Former Emory Psychiatrist Criticizes Nemeroff

Dr. John Nardo, a former director of the psychiatry residency at Emory University, recently wrote the following letter to Adriane Fugh-Berman (founder of the website PharmedOut.org) concerning Dr. Charles Nemeroff. With Dr. Nardo's permission, I am publishing the letter in order to contribute to the ongoing debate about Nemeroff and particularly about his controversial recent appointment as the chair of the University of Miami's Department of Psychiatry.

Dear Dr. Fugh-Berman,

I am a retired Psychiatrist/Psychoanalyst in Georgia. After my Psychiatry residency at Emory [1974-1977], I stayed on the faculty while pursuing Psychoanalytic Training, and within a year found myself directing the Psychiatric Residency [for the next 8 years]. It was a hard time in Psychiatric Education. State, Federal, Private Hospitals, and Institutional support was evaporating as the "Community Mental Health" movement waned and Managed Care began its rise. When our aging Chairman retired, our new Chairman came full of zeal for drug research. After a year, I read the tea leaves, gave up my tenure, and moved to private practice - a dinosaur early in my career. I stayed on the faculty but mostly taught in the Community and in our Psychoanalytic Institute [in the Department of Psychiatry]. It was a fine career, even if it wasn't the one I planned.

The new Chairman was moving up, and so soon after I left, he moved to Administration. He replaced himself with the infamous Dr. Charley Nemeroff, which is why I'm writing. Meeting Dr. Nemeroff made me feel a lot better about changing gears. He seems, as you might imagine, a charlatan - very smart but always working a deal. He brought in Pharm money, so the residency was revitalized. That made Emory happy. He spent most of his time on the road, doing his CME thing, his political thing, whatever. I had another life, but watched my friends who had stayed roll their eyes. I will admit to some gleeful feelings when he was finally exposed and deposed in 2008. The rest of the world just found out what many in Atlanta had always thought.

I must say that I was dumbstruck when he was hired as Chairmen at Miami and I began to follow things more closely. Retirement allows such things. I was surprised how much feeling it all brought back. I was not an anti-biologist way back when. I had come to Psychiatry from a career in a research oriented academic internal medicine specialty. It wasn't Charley's orientation that bothered me, it was that I thought his research was at best trivial. It took me a while to figure out that it was his Pharm connections that lead to his success - that and his political connections [like the recent business with Dr. Insel at the NIMH].

Knowing my interest in all of this, last week my friends filled my email box with reports of the brochure for the GPPA [Georgia Psychiatric Physicians Association] Summer CME Meeting in August.

There he was, the featured speaker. So in spite of Dr. Goldschmidt's [Dean at Miami] reassurances, Charley is doing CME with this topic, "Management of Bipolar Disorder: Problems and Promises" - the operative word being "Promises." "Charlie committed to me that he would never make these mistakes again, and I am scrutinizing his activities to make sure that that remains the case," he said [Dr. Goldschmidt]. "As far as I can tell, Charlie does not engage in that type of behavior anymore, and I can tell you that if he was, I would know it."

There are no COI disclosures on the GPPA web site or in the brochure for the Conference Funding or for Charley, nor on the web site set up for COI by the University of Miami. I wrote asking about that. From the GPPA, I was told, "Thank you for your message. Financial disclosures from all faculty members are printed in the participant syllabus and included in the first slide of each speaker's presentation at the meeting. We have not received disclosures from all faculty at this point, which is why they are not published until the meeting. Is there a particular speaker you're wondering about? I'd be happy to share whatever information we have." I responded "Dr. Nemeroff," and never heard anything back. I wrote the University of Miami [twice] and finally got "Your question has been forwarded for response."

I was tempted to sign up for the GPPA and going to hear him just to see if he'll actually do it again, to see if "Promises" are the Atypical Antipsychotics in Depression, drugs made by companies that pay him. That's what he has done in the past. But pleasantly for me, there's a nice vacation already planned during that time, and frankly, sitting through one of Charley's talks again seems like a punishment for sins committed in some former lifetime. But whether he does it again or not, for the poster child for COI infractions [and worse] to be giving a CME with no COI disclosures is bad enough in its own right.

I'm an old guy that lives in a log cabin in the Georgia Mountains, so my muckraking resources are limited. I've written about it on a blog I keep for friends. That's the extent of my power these days. So I'm passing it on to you for whatever use it might be, or to pass on yourself if you can think of anyone else who might be interested. I've already written Dr. Carroll of HealthCare Renewal and Evelyn Pringle who is doing a series on this topic.

I appreciate the work you and PharmedOut are doing on this front, and wish you well in your attempts to do something about the PHARM invasion. In my specialty, that invasion has been particularly virulent, maybe fatal.

John M. Nardo MD

Uh Oh! Thomas Insel gets pulled into Nemeroff's World

One truism of professional life is that some favors, no matter how alluring, should be politely turned down. The trick is predicting which bestowers of favors spell D-A-N-G-E-R, and which do not. Unfortunately, it looks like Dr. Tom Insel, the director of the National Institute of Mental Health, made the mistake of accepting multiple favors from Charles Nemeroff, and he is now paying the price.

Several media outlets have covered this developing saga, or scandal, or Greek tragedy (following the analogy of the Trojan horse, the most famous examples of bad judgment in gift-accepting). The best and most thorough coverage is in this article in The Chronicle of Higher Education, which broke the story. Also, see today's coverage in the Washington Post, and ongoing coverage in Health Care Renewal.

Here's the digest of key events. Charles Nemeroff is a psychiatrist and researcher who makes friends easily, gives great talks, and exudes charisma and power. He's probably a genius and has an encyclopedic knowledge of neuroscience. Unfortunately, he has shown repeatedly that he is willing to bend institutional rules and play loose with the truth in order to accomplish his various financial and professional objectives. His self-imposed trials and tribulations are well known to readers of this blog.

The Low Points:

--2002: Nemeroff co-authored a review article saying wonderful things about an investigational antidepressant, mifepristone, without disclosing that he had a significant financial stake in the product. Nemeroff said that he would have disclosed the conflict of interest if the journal had only asked him to: "If there is a fault here, it is with the journal's policy." (see this coverage in the New York Times).

--2006: Nemeroff co-authored a positive review article about vagus nerve stimulation. The Wall Street Journal soon reported that Nemeroff neglected to disclose his significant financial relationships with Cyberonics (the maker of VNS), and that the article itself was possibly ghost-written by a medical writer hired by Cyberonics. This time, Nemeroff could not convincingly blame the journal, because he was the journal's editor-in-chief! He was soon forced to quit the post. (See my article covering the debacle here).

--2007: Nemeroff co-authored an industry-funded CME supplement to the journal CNS Spectrums which his "co-author" Linsey Devane called "ridiculous" and "inaccurate," and he claimed that Nemeroff had encouraged him to be involved "for the sake of selling CME time." (See my coverage here). Eventually, the ACCME determined that the article violated its Standards for Commercial Support because it was biased in favor of the Bristol-Myers Squibb's drug EMSAM.

--2008: Both the New York Times and the Wall Street Journal simultaneously broke the story that Nemeroff had consistently failed to disclose payments from GlaxoSmithKline for promotional talks, even while he was in charge of an NIH grant studying the company's drugs. This led to Nemeroff's resigning his chairmanship of the Emory University Department of Psychiatry.

Given Nemeroff's track record, I am surprised that Tom Insel agreed to endorse his standing with the NIH to Dr. Goldschmidt, the dean of University of Miami's medical school. The proper thing would have been for Insel to politely decline to discuss Nemeroff at all. In today's Washington Post, Insel is backtracking, saying that "I didn't recommend him" for the Florida job. But Goldschmidt's recollection of the phone conversation was that Dr. Insel "confirmed to me that Charlie was absolutely in fine standing" with the NIH, according to the Chronicle for Higher Education.

What a mess for Insel, for the University of Miami, for the NIH, and once again, for Charles Nemeroff. Now Senator Grassley is involved and is requesting all relevant information concerning the relationship between Insel and Nemeroff. Presumably, Insel's lapse of judgment in this matter was a result of his long-time friend "Charley" calling in favors--but exactly what those favors are will be determined once the documents are released.

File this under: "To be continued...."

Spurred by Nemeroff Debacle, Emory Reforms Ethics

According to the Atlanta Journal-Constitution, Emory University School of Medicine has announced a new ethics policy that, among other things, forbids any Emory faculty from speaking for drug companies and bans gifts from industry.

You can read the updated ethics policy here.

Regarding industry-funded CME, the report makes the intriguing statement that:

"Revisions in national and School of Medicine guidelines and policies on continuing medical education are underway. Therefore, this policy currently contains only limited revisions at this time."

I assume this is an oblique reference to the recent hard-hitting report from the Institute of Medicine, which has recommended that a new system of CME funding be developed within two years that will prevent direct industry funding of courses.

At any rate, Emory's updated ethics code still allows its faculty to speak at industry-supported CME events, but does not allow such courses to occur in any Emory-affiliated buildings. In addition, the policy states that:

"Preferably the event will have more than one industry sponsor, and possibly an institutional cohost."

Charles Nemeroff, Unleashed

It looks like Dr. Charles Nemeroff has found a way to wriggle out of the already loose leash clapped around his neck by Emory University.

For those who have forgotten about Dr. Nemeroff’s recent trials and tribulations, here’s a brief recap. He was the principal investigator of a $3.95 million NIH grant to study several drugs by GlaxoSmithKline. But he was at the same time making hundreds of thousands of dollars doing promotional talks for the same company, orders of magnitude higher than the NIH maximum allowed. In order to skirt these regulations, Nemeroff simply lied to Emory officials. According to the New York Times, he signed a letter dated July 15, 2004, promising Emory that he would keep his earning from GlaxoSmithKline to less than $10,000 per year. But that same day, Nemeroff was at the Four Seasons Resort in Jackson Hole, Wyoming, where he was earning $3000 for a talk for GSK, part of $170,000 in income he earned from the company that year—17 times the figure that he had agreed to.

Emory removed him as department chair shortly thereafter, but inexplicably kept him on as full professor and allowed him to re-apply for more NIH grants within two years. Nemeroff’s public statement revealed an alarming lack of remorse: “I regret the failure of full disclosure on my part that has led me to the current situation. I believe that I was acting in good faith to comply with the rules as I understood them to be in effect at the time.” Translation: “I’m bummed out that this is happening to me. I didn’t do anything wrong.”

Meanwhile, Emory’s “punishment” still allows Nemeroff to take drug company money for promotional talks in the guise of ACCME accredited activities. According to Emory’s letter: “He will be limited to accepting payment for ACCME-accredited speaking engagements sponsored by academic institutions or professional societies.”

But Dr. Nemeroff has already found a way to escape from this restriction. In February, Dr. Nemeroff will co-chair this CME series supported by Bristol-Myers Squibb called “Measurement Based Care Strategies for Depression.”

It is “jointly sponsored” by the University of North Texas Health Science Center (UNTHSC) and an obscure outfit called “Letters & Sciences.” Letters & Sciences (L & S) is presumably a MECC but a Google search shows that they have no website. They are listed as being an “approved provider” of CE credit for nurses by both the New Jersey State Nurses Association (NJSNA) and the California Board of Registered Nursing.

It is clear that L & S is on a Bristol-Myers Squibb gravy train, making their money by producing promotional CME encouraging doctors to prescribe plenty of Abilify for bipolar disorder and depression. They teamed up with UNTHSC to produce this recent CME series as well, which presumably pushes the use of Abilify for kids.

By teaming up with this shadowy MECC, Nemeroff is complying with the letter of his punishment but is playing fast and loose with its spirit. In specifying that Nemeroff is limited to CME events “sponsored by academic institutions and professional societies,” Emory is asking that legitimate institutions create and control the content. But in this case, we see the usual CME shell game in which a private MECC is creating the content and is paying a nominal “co-sponsor” to provide CME credit.

If I were Senator Grassley, I’d be sending letters to L&S, UNTHSC, ACCME, Nemeroff, etc…, asking:

--How did L & S obtain the grant from BMS for this program?
--What is L & S? Where are they? Who is on their staff? Which medical writers are creating the content? How much money are they making from BMS? What percentage of their total income comes from events supported by BMS?
--What, exactly, is UNTHSC doing as “co-sponsor” of the event? Are they simply extracting a healthy fee from L & S, in return for a cursory review of their paperwork and disclosure forms? Or are they actually managing the event and producing content?

Leashes always chafe, especially when the wearer feels no guilt. Sometimes, however, loosening the leash is precisely the wrong thing to do.

Hat tip to Bernard Carroll.

Nemeroff’s Effexor Love-Fest: It’s CME-Like!

According to the Wall Street Journal Health Blog, in 2000 Dr. Charles Nemeroff organized a Wyeth-funded supplement of a journal which he also edits, Depression and Anxiety, paying himself and 13 other academics $3000 each. This money was disbursed from an “unrestricted educational grant” given to Emory by Wyeth. The fact that the supplement was paid for by Wyeth was, unfortunately, not disclosed to the readers.

Also from the Wall Street Journal, we learn here that Emory’s defense of Nemeroff’s undisclosed hundreds of thousands from GSK is that some of the payments were not for promotional talks, but for “CME-like” talks.

Nobody seems to have an inkling what "CME-like" means. But after reading through Nemeroff's Effexor Love-fest supplement, I'm getting an idea.

Here is how Dr. Nemeroff introduces the supplement:

“There is little doubt that the introduction of venlafaxine has had a remarkable impact on clinical practice. I have had more than 25 patients who have failed multiple trials with virtually all of the antidepressants available who have responded to venlafaxine often with complete remission.”

And here are some random phrases culled from the abstracts of the 13 other CME-like articles, done up in Wyeth's green and purple Effexor color scheme:

Venlafaxine is a unique antidepressant medication with well documented efficacy and safety in the acute treatment of major depressive disorder

easy to monitor and dose

may also be effective in the treatment of dysthymic disorder and bipolar II depression

facilitate successful treatment of patients.

low potential for drug interactions

appropriate first-line medication for GAD

may be particularly effective for the severely ill

good tolerability

may be effective for conditions such as stroke, anxiety, and neuropathic pain

may be useful in children and adolescents with a variety of psychiatric disorders

effective in reducing anxiety in patients with depression

efficacy...in several other conditions including panic disorder, social anxiety disorder, obsessive compulsive disorder, trichotillomania, ADHD, chronic pain, and fibromyalgia

an attractive choice for geriatric patients

So here is a working definition of CME-like:

--Too academic-sounding to be an advertisement

--Too commercially biased to be CME

--Ergo...it's CME-like!

Biederman, Goodwin, Greed, Arrogance

Thanksgiving week was a busy one for revelations of greed among two of our top academics in psychiatry: Dr. Joseph Biederman and Dr. Frederick Goodwin.

Apparently, in 2002 Dr. Biederman solicited hundreds of thousands of dollars for a "Johnson & Johnson Center for the study of pediatric psychopathology." One of the publically stated goals of the center was to “move forward the commercial goals of J.& J.” I'm shocked, just shocked. Actually, this is not really as horrendous as it seems. Researchers like Biederman are always on the hunt for research funding. They prefer NIH funding, but that is increasingly scarce, so they hold out their hats to industry.

When you take research money from industry you are always making a deal with the devil. Your intentions are to produce serious research, but you know that your funders are not in the business of charity. They want to "move forward the commercial goals" of their companies, and you know that going in. Ideally, this represents a "confluence of interests," using buzz-phrase popular among advocates of academic-industry collaboration.

In theory, there's nothing inherently wrong with such collaborations, as long as the nature of the relationship is disclosed, and as long as the principal investigator takes great care to play by all the rules, both legal and ethical. Unfortunately, the New York Times article and a follow-up posting in Pharmalot imply that Biederman did not play by the rules. For example, Harvard and MGH rules stipulated that researchers doing company-funded trials are not allowed to get paid more than $10,000 in consulting or speaking income from the funding company. Biederman made much more than this and did not disclose it.

Basic ethical guidelines dictate that if a company doesn't pay you a requested grant, you should not respond by pressuring colleagues not to use that company's drug. But e-mails unearthed in court documents imply that Biederman did just that:

Mr. Bruins wrote that Dr. Biederman was furious after Johnson & Johnson rejected a request that Dr. Biederman had made for a $280,000 research grant. “I have never seen someone so angry,” Mr. Bruins wrote. “Since that time, our business became non-existant (sic) within his area of control.” Mr. Bruins concluded that unless Dr. Biederman received a check soon, “I am truly afraid of the consequences.”

Dr. Biederman comes across as petty and retaliatory. Is he also a brilliant, productive researcher who cares about children? Of course. But there is no excuse for this level of arrogance and greed.

Next up: Frederick Goodwin. Another brilliant, smart researcher who cares deeply about people with mental illness. He is former chief of NIMH, and co-writer of the major textbook on bipolar disorder.

He is also a passionate defender of the free enterprise system and an enemy of those who criticize the pharmaceutical industry. For example, he is on the board of directors of the rabidly pro-pharma organization, Center for Medicine in the Public Interest (CMPI), and has teamed up with its Vice President Robert Goldberg (not one to be tangled with--see this earlier slimefest on my blog) on articles such as this diatribe against Marcia Angell and Arnold Relman which is posted on the website of the conservative Manhattan Institute.

Okay, but so what? He's a conservative, I'm a liberal, this tent is big enough for both of us.

My main beef with Goodwin stems from his participation in a May 2007 symposium at the annual meeting of the American Psychiatric Association. The symposium was organized by my friend and colleague Nassir Ghaemi, and was entitled "Uneasy Partners: The Pharmaceutical Industry and the Psychiatric Profession." There were five speakers. Dr. Ghaemi reviewed the landscape of the controversies, I did a talk showing that 46/46 industry-sponsored symposia at the the 2006 meeting promoted a drug made by the sponsoring companies, David Healey discussed disease mongering, and both Howard Kushner and David Osser talked about the need for evidence-based medicine. Finally, Dr. Goodwin came to the podium as the "discussant," presumably to comment on our presentations.

But instead of discussing our talks, Goodwin decided to use Marcia Angell's book, The Truth about Drug Companies, as target practice. Angell was not on the program, and her book was only mentioned in passing by one of the presenters. But Goodwin seemed to despise her and her book. He went through her main points, rebutting them systematically, arguing that pharmaceutical companies are wonderful, that medications are very helpful, that there is nothing wrong with making money, and that drug companies are not as profitable as everybody thinks. Then, he went on a bizarre tangent about how one of the major networks is filled with scientologists.

I must say, I was amazed, dumbfounded, and profoundly embarrased for my profession. I had never met Goodwin before, but, like other psychiatrists, I revered him as a legend in the field. That all came crashing down as I watched him make a series of strident statements that were largely irrelevant to any of the points made during the symposium. He entertained the audience by being charismatic and at one point got a very cheap laugh by ridiculing the non-industry sponsored symposia at the meeting.

So when I heard about Goodwin's lack of disclosure regarding The Infinite Mind, I was not surprised--only saddened. He, and Biederman, and Nemeroff, and many other less well known hired guns are bringing the profession of psychiatry to its knees.

New York Times' Judith Warner on Nemeroff

When Judith Warner, a major columnist for the New York Times, writes a piece focusing on American psychiatrists, and entitles it "Diagnosis: Greed," you know the profession is in serious trouble.

Bringing a fresh perspective to an issue that readers of this blog may be seeing as a dead horse, Warner points out that the astonishing revelations of psychiatrists earning millions from drug companies is part and parcel of the broader financial ruination that we are witnessing daily. Just as lack of government regulation and oversight allowed our economy to collapse because of the rise of subprime mortgage-backed securities, the lack of regulation of the physician/pharmaceutical relationship has led to a medical culture of greed and the collapse of confidence in our profession.

To quote Warner:

Nemeroff didn’t bring down any banks, didn’t freeze the American credit markets, hasn’t plunged the world economy into recession. But his extensive, excessive and untransparent ties to the pharmaceutical industry are all too common, unfortunately, among his cohort of “thought leaders” in psychiatry and other medical specialties. And these relationships have led to a dangerous crisis of confidence in the basic integrity and validity of America’s medical research.

The APA and other medical organizations are beginning the process of reforming themselves. I think we need to speed things up. There isn't a moment to lose.

Detailing Deception, or, Nemeroff by the Numbers

As more information surfaces about Dr. Charles Nemeroff, the picture becomes more complicated and more sordid. Below is a table of Dr. Nemeroff's income from GlaxoSmithKline (GSK) vs. his disclosures, from the Grassley letter.

From 2000 to 2006, GSK paid Nemeroff a total of $960,488. Note that this was not research grant money, or money for Emory's psychiatry department. These were fees that went into his personal bank account, which he earned by either sitting on GSK's Advisory Board, or speaking to doctors about GSK products. His typical fee for a talk was $3500 plus expenses, but sometimes he made more.

Of this $960,488, the total amount he disclosed to Emory was $34,998.

By 2004, Emory officials knew that Nemeroff was hiding financial information from the university, and its conflict of interest committee investigated. On June 24, 2004, the committee issued this confidential report, which was obtained and posted by the New York Times. The committee found that Nemeroff committed "serious" violations of Emory's conflict of interest policies regarding his financial relationships with Eli Lilly, Janssen, Merck, and Cypress Pharmaceuticals. They created a series of conflict of interest management plans for each of these relationships. It is not known whether he followed these plans, because the Senate inquiry has focused on his relationships with GSK.

If your head is beginning to spin, it is understandable. Nemeroff's financial entanglements were (and are) extensive, complex, and of a scale possibly unprecedented in psychiatry. Luckily, Senator Grassley's office prepared a timeline of deception which I have pasted in miniature below, but which you can read in full scale on the last page of Grassley's letter to Emory.


As Emory's investigation proceeds, I assume we will find out more. Meanwhile, Nemeroff has temporarily resigned as chairman pending the results of the inquiry. My prediction is that we will be hearing about differing definitions of "consulting," along the lines of Clinton's infamous "it depends on what the word is is."

Curtains for Nemeroff

For Charles Nemeroff, it was never a question of whether it would all come crashing down, but when it would happen.

That time is now.

In simultaneously published news accounts, both David Armstrong of the Wall Street Journal and Gardiner Harris of the New York Times have detailed the extent of Dr. Nemeroff's cynical pattern of subterfuge regarding his involvement with the pharmaceutical industry.

In a prior post on this blog, I had referred to Dr. Nemeroff as "Charles Bling Bling Nemeroff," and later apologized for having gratuitously insulted him. I formally rescind that apology.

Why am I getting so exercised about this? Read the articles and you'll understand. But here's a sneak preview.

From the New York Times:

In one telling example, Dr. Nemeroff signed a letter dated July 15, 2004, promising Emory administrators that he would earn less than $10,000 a year from GlaxoSmithKline to comply with federal rules.

But on that day, he was at the Four Seasons Resort in Jackson Hole, Wyo., earning $3,000 of what would become $170,000 in income that year from the British drug giant — 17 times the figure he had agreed on.

And from the Wall Street Journal:

In an Aug. 4, 2004 letter to a university dean, Dr. Nemeroff said he had "taken the necessary steps to be in compliance with the recommendations" of the Emory conflicts-of- interest committee, "namely my consulting fees from GSK will be less than $10,000 per year throughout the period of this NIH grant, its renewals and final collections of data. GSK has been informed of this change and certainly understand the reasons for this decision and is supportive of my compliance with the university recommendations."

But according to Glaxo records, Dr. Nemeroff exceeded the $10,000 limit that month. The payments included a $3,500 fee for a teleconference with the Louisiana State University Psychiatry Department; talks on Paxil at two restaurants in New York —the Passion Fish Restaurant in Woodbury and Burton and Doyles in Great Neck – that paid a total of $7,000; and a $3,500 payment for another teleconference.

In all, according to the Times, Nemeroff "earned more than $2.8 million in consulting arrangements with drug makers between 2000 and 2007, failed to report at least $1.2 million of this income to his university...."

What's the big deal? Nemeroff is the creme de la creme of American psychiatrists. Isn't he entitled to substantial renumeration? Sure. But the problem is, while he was raking in bucket-loads of money from Glaxo, he was also the principal investigator of a 5 year, $3.9 million grant from NIMH to study five Glaxo drugs.

NIMH is part of the National Institutes of Health (NIH), which has a strict conflict of interest policy saying, essentially: "We'll award you this big grant from public money to do important medical research. But in return, we and the taxpayers want to be assured that you are using our money ethically. We don't want you to be making any side deals with companies that might have a vested interest in the results of your NIH research. If you do cut any deals, we insist that you make no more than $10,000 per year, and that you fully disclose these arrangements to your university."

NIH is funny that way. They're really into honesty and integrity.

Dr. Nemeroff broke so many of their rules, so frequently, and so blatantly, that this episode seems more like a fictional allegory to tell your kids at bedtime than the real-life scandal that it is.

Emory promises to investigate. Let's hope they do it quickly, and, if the claims are confirmed, that they promptly relieve Dr. Nemeroff of his duties. His continued chairmanship of Emory's Department of Psychiatry constitutes an embarrassment to the university and to the entire profession of psychiatry.

DeVane Mounts Defense of his CNS Spectrums Article

Lindsay DeVane, the Medical University of South Carolina professor who had described this article in CNS Spectrums as "commercial crap," is now defending said crap from its detractors.

Possibly responding to this letter just published in Psychiatric News, in which Harvard psychiatrist Alan Stone advocates officially "shaming" unethical colleagues who participate in ghost-writing, Dr. DeVane sent me the following e-mail:

"Dear Dr. Carlat, I am writing to say there should be no doubt about the integrity of the CNS Spectrums publication as an i3 CME certified activity. In particular, my unflattering characterizations of the CNS Spectrums article reflect the inherent limitations in providing practicing clinicians with fundamental descriptions of complicated issues. The initial draft of the article that was eventually published was written directly from the transcripts of the live CME televised broadcast last December and was not ghost-written. All three co-authors were heavily involved in multiple edits before agreement was reached on a final manuscript. Although my opinion is that antidepressant drug-drug interactions of major clinical significance are rare events, we all know that interactions can occur and the need for such awareness was a theme in the broadcast and article. My Neuropsychopharmacology commentary allowed a more complete discussion of some scientific issues, but there should be no question about the integrity of the CNS Spectrums publication as a CME activity. Lindsay DeVane."

I can only assume that Dr. DeVane must have been severely pressured by multiple parties to change his tune. You can read his earlier, and very different take, on the article in my prior posting here. At that time, Dr. DeVane called the first draft of the article a “ridicuous text… parts of it were inaccurate, simplistic, and [contained] over-generalizations.” The fact that he is now saying that this article was "written directly from transcripts of the live CME televised broadcast" is not exactly an endorsement of that Hawaiian event, which was funded by Bristol-Myers Squibb.

And although he is now saying that "all three co-authors were heavily involved in multiple edits before agreement was reached on a final manuscript," in his earlier letter, he stated, "I haven't even read the CNS piece, but from what you say, I probably shouldn't as it's likely embarassing. Please ignore it for purposes of interpreting my researchand views."

By the way, the founder of CNS Spectrums, James LaRossa, who knows all the players involved in this scandal quite well (in fact, he now publishes a different journal with both Nemeroff and DeVane on the masthead), said of the CNS Spectrums piece, "I am willing to bet dollars to doughnuts that Nemeroff never saw proofs of the article either."

As La Rossa commented further, "In truth, the CME business has become rotten to the core." I couldn't agree more.