Note to Emory: A Modest Proposal

In support of Dr. Doug Bremner, blogger supreme and Professor of Psychiatry and Radiology at Emory Medical School, I hereby proclaim my own academic affiliation--namely, Associate Clinical Professor of Psychiatry at Tufts University School of Medicine.

Recently, Emory University forced Dr. Bremner to remove its name from his blog because they didn't like things that he had to say. This has resulted in two things: First, Dr. Bremner's blog quadrupled in popularity, and second, Emory is in the midst of yet another PR fiasco. See yesterday's article in Emory's online newsletter Academic Exchange for a good rundown of this issue.

Here's my modest proposal. Between its poor handling of the Charles Nemeroff scandal and now its fumbling over Bremner, Emory should relinquish the use of its own name on any of its official academic material.

Sarah Goodwin, who is unenviably employed as Emory's director of media relations, made the best argument for Emory giving up its name, although she was referring to Bremner in her comments. To satirically adapt her statement for the issue at hand, "Emory has been bungling high profile issues for some period of time," and “if you read Emory's pronouncements over a long period of time, you can see comments it makes that may be of concern."

The university would still be allowed to function, to educate, and to bungle, but it simply would no longer be allowed to print the name "Emory" on its buildings or stationery. Perhaps, like Bremner's blog, the school will see a quadrupling of its enrollment.

Margaret Soltan on Zachary Stowe

The irrepressibly to-the-point Margaret Soltan has a nice post about the Zachary Stowe fiasco on her University Diaries blog. The commenters, too, are eloquent, subscribing to the dictum that brevity is the soul of wit. I suggest you surf on over to her site.

Other coverage of the affair can be read in the Fierce Pharma blog, the Chronicle of Higher Education blog, and the Atlanta Journal Constitution.

The Latest Conflict of Interest Poster Child: Dr. Zachary Stowe

The latest casualty of Charles Grassley’s investigations of conflict on interest is Zachary Stowe of Emory University.

Dr. Stowe is probably the most well known researcher in the risks of breastfeeding while taking antidepressants, and it is sad to see his reputation taking a nose-dive with these revelations.

The news originally broke in this article in the Wall Street Journal , but if you can’t stand the idea of actually paying for content you can find some of the same information for free on this post on the WSJ blog.

The bottom line is that Stowe has run into the same ethical problem as his boss Dr. Nemeroff—he was taking public NIH money to conduct research, while at the same time giving dozens of promotional talks for a company that stood to benefit from the results of that research.

Specifically, GlaxoSmithKline (makers of Paxil and Lamictal) paid Stowe $154,400 in 2007 and $99,300 during the first 10 months of 2008.

When I first saw this story I was rather unfazed and wasn’t even sure it was worth blogging about. Another academic using his NIH-supercharged credibility to make a bundle by hiring himself out to the highest bidders? Yawn, right?

But when I started to look through the publicly available documents, I realized there’s a bit more to this story than meets the eye.

For one thing, Stowe appears to have been deceptive during a recent deposition, when he claimed that on top of his $232,000 Emory salary, he earned an additional 20 – 30% more doing work for pharmaceutical companies. But wait a minute--if he made $154,400 from GSK alone in 2007, by my calculation this is already 66% more salary than he got from Emory. And Stowe did work for lots of other companies as well. Here is his disclosure from a Medscape CME gig he did in March 2007:

Disclosure: Zachary N. Stowe, MD, has disclosed that he has received grants for clinical research, grants for educational activities, and has served as an advisor or consultant to GlaxoSmithKline, Wyeth, and Pfizer. Dr. Stowe has also disclosed that he has served as an advisor or consultant for Bristol-Myers Squibb. Dr. Stowe has also disclosed that he has served on the speaker's bureau for GlaxoSmithKline, Wyeth, Pfizer, and Eli Lilly.

Who knows how much money he was also getting from Wyeth, Pfizer, Bristol-Myers Squibb and Eli Lilly? He may very well have doubled his Emory salary, or more.

Furthermore, the $154,400 disclosed by GSK does not include all the cash they paid Stowe through laundered CME money. For example, here is a CME program Stowe did for Medscape that was funded by GSK. The program is entitled “Long-term health risks of antiepileptic drugs in women” and is essentially a commercial for using Lamictal in pregnant women with bipolar disorder. In it, Stowe begins by saying nasty things about Lamictal’s competitors, Depakote and Tegretol, and then minimizes a large study showing that Lamictal causes cleft palate. I’m sure he got paid a lot for this, and that he did plenty of other similar CME programs that are scattered somewhere throughout the internet.

But wait! There’s more!

We learn from a remarkable series of emails furnished by GSK to Grassley that Stowe gets pretty agitated when he doesn't get enough promotional money. Look at Attachment C of Grassley’s letter if you’d like to follow along here.

First, sometime in August of 2003, a GSK rep emails Stowe that he is “sincerely sorry” but that they have to cancel two scheduled talks (that would have been $2500 a pop, his usual rate) in Wisconsin because attendance was too low.

On 8/19/09, Stowe responds politely, but says that this late cancellation presents "two problems." As it turns out, Stowe schedules only 4 days per month to give talks for drug companies, and the cancellation meant that “others are denied speaking engagements.” He then asks, “What provisions do you propose for my compensation for my lost time?”.

Stowe's second problem is that he had apparently been coordinating this GSK gig with a meeting at the American College of Obstetrics and Gynecology and he would now have to arrange a new flight at the last minute. He believes, therefore, that GSK owes him: “Given the circumstances I think GSK should book and cover the costs of the trip up as well…”

I guess I can understand Stowe’s being upset about a last minute cancellation of a lucrative speaking gig. If he had already paid for a plane ticket for that, then of course GSK would owe him that money. But that’s not the case here. Stowe was apparently planning to mooch off some aspect of the GSK travel to defray some costs associated with a meeting he was planning to go to anyway. Without the GSK money, he now has to pay his own way entirely, and so he wants GSK to fund those costs, even though it has nothing to do with GSK!

You can imagine that whoever got this email was not very happy, and didn’t respond as quickly as Stowe wanted. So Stowe sends off another email on 8/27/03, again pretty polite, admitting that he had once rescheduled these talks, and that since maybe his recheduling affected the attendance, he would settle for getting paid only $2500 for a talk he never gave, rather than insisting on $5000 for two talks he never gave.

But still no reponse from GSK. Stowe fires off another missive on 9/13 saying he was sorry the programs “didn’t work out” and wants to make sure they have his address for a check.

Again, utter email silence from GSK—what lousy handlers they are! So on 9/18, Stowe lets it rip. Warning that he is “no longer in a compromising mood,” he is now demanding $4500, not just $2500, and points out that “you are still getting a $500 discount” because he usually gets $5000 for two talks.

On the same day, he emails a colleague, apparently someone higher up in his department (a wild guess: Nemeroff?) to complain about the issue:

“REP NO RESPONSE – need your input or direction where to take this….I emailed the rep 3 times now with no response, because I had originally rescheduled this from an earlier date I told the rep that I would be okay with the 2,500 instead of the full 5,000 for the last minute cancellations (which I thought was very nice of me). She has failed to respond to 3 emails and I am getting slightly agitated, in fact to the point that she can just find the full 5,000 since my compromise has been ignored. I know that this has no business on your radar screen, but need a name of who to go to. Thanks for your help- talk to you soon. Any feedback on the Miami gig yet?”

I don’t know what the “Miami gig” meant, but I hope he got $5000 out of it!

Finally, on 9/19, somebody from the company responds, saying they will “take care of it.” According to Grassley, eventually Stowe received some compensation, but we don’t know exactly how much.

What to make of all this? It's a creepy insider's look at how entitled our key opinion leaders became at the height of the drug company gravy train in the early to mid 2000's. The only good news is that it is all coming to a screeching halt. According to the WSJ, Stowe has been formally reprimanded by Emory and ordered to cease his promotional talks. Of course, Emory recently announced a new policy that bans such practices anyway, so this may be a bit of overkill.

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."

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!

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."