Paul Thacker: The Tenacious Hero of Reform

"Never doubt that a small group of thoughtful, committed people can change the world. Indeed, it is the only thing that ever has."

Or so said Margaret Mead, and I believe it's true.

One rarely gets the chance to meet such people, but on September 3, 2008, I was sitting in a popular Washington, D.C. Mexican restaurant blocks from the Capitol building, chatting with Paul Thacker. Few have heard of him, but many have heard about his boss, Charles Grassley, the senator from Iowa who has crusaded for transparency in industry-academic relationships. As Thacker and I ate enchiladas and chatted about Grassley's investigations, it became clear that Thacker himself was the spark behind the blizzard of letters and inquiries that ultimately exposed a slew of cozy arrangements between academics and the drug industry.

Now, Meredith Wadman has published this fascinating profile of Paul Thacker in the journal Nature, and it is required reading for anyone interested in the Man Who Brought Down Nemeroff, and more generally in the process of political reform. I won't even quote from it because I want to encourage you to read the article yourself (a subscription is required to read the whole thing). And for more on Thacker, check out this PBS documentary based on his earlier investigative reporting on the manipulated science sponsored by the tobacco industry and by deniers of global warming.

Team Grassley, a Lawyer's Eye View

You might love him or you might hate him (I'm obviously one of his fans), but either way Senator Charles Grassley and his passionate staff have shaken up the world of medicine and have made "conflict of interest" a household term.

Recently, I read this article published on the website LawyersandSettlements.com that provides a succinct rundown of Team Grassley's accomplishments. Lawyers, of course, are particularly big Grassley fans because each one of his investigations creates instant jobs for dozens of attorneys on various sides of the issue. Thus, you can count on them to be particularly vigilant and accurate monitors of the COI body count as it rises. For the confused, the overwhelmed, or the plain curious, this article makes for a nice fact sheet.

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.

Tufts Blows It

I like Tufts. I'm a voluntary faculty member there, and recently the university promoted me to associate clinical professor of psychiatry (from "assistant") even though I'm a loose cannon in the world of psychiatry.

But Tufts officials just made a silly mistake when they rescinded an invitation to Paul Thacker, one of Senator Charles Grassley's aides, to speak at a conference on conflicts of interest in medicine and research. See full coverage of this issue in today's Boston Globe.

According to Christine Fennelly, a Tufts spokesperson, the decision to disinvite Thacker was made because Senator Grassley has sent a letter requesting financial disclosures to Dr. Helen Boucher, an infectious disease specialist at Tufts. The Globe article quotes Fennelly thusly:

"Indeed . . . the administration felt it prudent to not engage someone from the Senator's office while we respond to the Senator's inquiry."

I don't know who made this decision, but it is a poor one for many reasons. It sets a tone of antagonism rather than cooperation, of opacity rather than transparency. It also deprives the Tufts community of Thacker's opinions. I've had several conversations with him and have found him to be a fascinating person, extremely knowledgable about the effects of conflicts of interest in medicine and in many other fields, and someone with a strong moral compass. Before working for Grassley, he was an eminent and award-winning investigative journalist--you can read about some of his accomplishments in this Wikipedia entry. Some of you may recall this influential article in Salon.com entitled "A Climate-Controlled White House," in which it was revealed that the Bush administration pressured top federal scientists to toe the party line on global warming (please--let's just call it "climate change," shall we?) That was Paul Thacker's work.

Thus, in this decision, Tufts is doing everything a top academic center should never do. It is limiting academic freedom, it is ignoring a contrarian point of view, it is rejecting a distinguished thinker, and it is alienating a vocal portion of its own academic community.

Hopefully, the officials will change their minds. I'm pretty sure Thacker won't be offended if he is re-invited, even under conditions of public relations duress.

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.

The APA and Drug Money: We're on it, Senator!

Senator Charles Grassley recently sent a letter to the American Psychiatric Association (APA) requesting detailed information on all of the organization's financing from drug companies. This received extensive coverage in the New York Times, as well as other media outlets. For those interested, the APA sent out this email to its membership about the issue (reproduced on Pharmalot--scroll down on their site to see it).

I find myself in the unfamiliar position of being an APA insider regarding this issue. I was appointed by the current APA president, Dr. Stotland, to the work group she alludes to in the Times article. I announced this work group in a prior post. It was formed in March, and its official mission is:

"The formation of an ad hoc work group of the Board [meaning the Board of Trustees] charged to work with the Medical Director to: identify the categories and amounts of monies received from the pharmaceutical and other industries producing products or services used in psychiatry by the APA and its subsidiaries; determine what direct and indirect financial consequences there would be from discontinuing each category; indicate how the APA could adapt to the attendant change in revenue; and to provide the Board with the elements of a 5 year plan to end or diminish the pharmaceutical revenue received by the APA. The ad hoc work group will report to the BOT with a report and recommendations by October 2008."

So, in defense of the APA, they were already getting quite serious about examining the influence of the pharmaceutical industry well before Grassley's letter. All members of this work group were asked to sign a confidentiality agreement as a condition of participation. I thought long and hard before signing, and ultimately decided that I could be more helpful to the cause of honesty and transparency in the APA by signing and participating than by walking away.

Therefore, I can't reveal any specifics of the work group's discussions. But more generally, I can say that I have been impressed by the thoughtfulness of the discourse. Everybody realizes that this issue is a serious one for the organization, and some sincere, determined work has gone into the deliberations thus far.

Meanwhile, on a related note, over at the arch-conservative pharma-funded site, Drug Wonks, Robert Goldberg rants about Grassley's "obsessions," using the tired and worn out argument that since Grassley himself receives money from companies (imagine, a U.S. Senator receiving campaign contributions from companies and lobbyists, how shocking) he has no business calling the APA or anybody else on the carpet about their finances. Of course, the issue is less the money itself, but rather the need for transparency. The next time somebody feels the need to call Grassley or anybody else a hypocrite, I suggest you check out the Open Secrets website. Here, can read all the financial details you can stomach of anyone in the Congress or the Senate. Not only are legislators required by law to reveal the amounts and sources of all campaign contributions, but they must also reveal everything about their personal finances. Physicians have it a little easier than this.

The Six Million Dollar Man: Witch Hunt? Or Call to Action?

Senator Grassley has called both Alan Schatzberg and Stanford University onto the carpet about inadequate disclosures of Dr. Schatzberg's interests in a pharmaceutical company which he cofounded, Corcept Therapeutics. Grassley's investigation is ongoing, and I assume we can expect to see many other academics taking their own places in the Senate hot seat over the next few months. I assume Grassley is starting with the most dramatic examples of conflict of interest, and unfortunately for my specialty, the first of the all-stars have been psychiatrists.

I won't go into all the details of Dr. Schatzberg's financials, since I have covered them in a prior post here, and they have been covered in more detail at Health Care Renewal here, and at Pharmalot here, where you can also find a comment form Bernard Carroll documenting Dr. Schatzberg's past failed attempts to cash in on his stock holdings.

In this formal statement, Stanford has defended Dr. Schatzberg and the university's conflict of interests policies. Regarding Dr. Schatzberg, I have no problem with him owning $6 million worth of shares in a company trying to bring a new antidepressant to the market. While he may have inappropriately tried to hide this disclosure in the past (judge for yourself by reading this account), he has made no secret of his net worth over the past few years.

However, I do find it incredible that Stanford finds it acceptable for him to serve as the chairman of an academic department. As chairman of psychiatry, Dr. Schatzberg is involved with many decisions having to with hiring staff and funding research. While I have no doubt that he is an ethical person, the fact that he owns $6 million in stocks can never be far from his mind. If it were me, I'd be thinking about it when I woke up in the morning, during my coffee breaks, my meals, and while I was brushing my teeth at night. We're talking $6 million here, people.

Here are some problematic possible scenarios. A young professor in his department is up for promotion. But he is researching a medication in direct competition with mifepristone. Dr. Schatzberg has to make a decision, knowing that this could have an eventual impact on his ability to retire with $6 million.

Another scenario. A psychiatry resident has written a wonderful review paper on antidepressants which has been submitted for a departmental award. In it, the resident has concluded that mifepristone is not a promising agent. Schatzberg has to decide who will get the award.

Equally amazing to me is the American Psychiatric Association has no policy forbidding this level of conflict of interest in candidates for APA president. Shatzberg won the most recent election, and will be installed as APA president next May. What will happen if and when Dr. Schatzberg is asked to make decisions regarding the appropriate relationships between the pharmaceutical industry and the organization?