Continuing Dissection of the Infamous Study 329

On the 1BoringOldMan blog, semi-anonymous blogger Mickey has been dissecting in detail the infamous Study 329 that GlaxoSmithKline used to promote Paxil (Seroxat, paroxetine) as safe and effective for children and adolescents, when the study data, rigorously analyzed, showed that was not the case.  Study 329 was an important part of the US Department of Justice case against GSK that resulted in a record $3 billion settlement (see this post). 

The posts so far are:
A Pretty Rotten Era  
A Movement
To Make Distortion Possible
The Lesson of Study 329: the Basics
The Lesson of Study 329: Efficacy Drifts to Trends and 2s
The Lesson of Study 329: Conventions and Protocols
The Lesson of Study 329: Uh-oh
The Lesson of Study 329: Data Transparency
The Lesson of Study 329: the Authors

This does not seem to be the end of the series, but the last post yesterday did have a striking conclusion:

But, for the moment, I am stuck on the piece that is, to me, the most fundamental lesson from this story, and unfortunately many similar stories in the industry-funded clinical trial literature that fills our journals. The authors of this study did not function as physicians, clinicians, scientists, or even authors. Some were there because of their previous credentials. Others were there to build up future credentials. But they weren’t there to do what they presented themselves as doing. Researchers are practicing medicine too. I might be seen as naive to see this as the center of this story. If that’s the case, I’ll go to my grave being naive. Medicine has been my life, and this isn’t Medicine.

There’s no place or tradition for physicians, particular physicians in high places, taking part in this kind of bullshit – particularly all the while claiming otherwise. The fact that it has been a widespread practice isn’t an excuse. That’s also an even stronger indictment. There are many principled neuroscientists working in this difficult area of medical science who’ve been tarnished by this kind of pseudoscience. There are many psychiatrists and other practitioners who’ve actually trusted these deceitful articles. And there are untold numbers of patients who’ve been medicated un-necessarily or even directly harmed by this and other capricious advise coming out of these studies – this one in particular. Rather than functioning as the advisers of ill people, these were physicians who actively participated in capitalizing on patients’ illness.

However, despite the seriousness of these concerns, and their corroboration in the Justice Department document that pushed GSK to settle for so much money, my alma mater, Brown University, where Dr Martin Keller, the lead author of Study 329, was Chair of Psychiatry, has consistently refused to revisit the study, and consistently failed to publicly refute the accusations against Dr Keller, nor to accept them and take appropriate action.  The University supposedly conducted an internal investigation of the matter, but has not seen fit to make it public.  When asked again about this, Brown's new President, Christina Paxson, referred the inquiry to the public relations people:

'The recent announcement by the U.S. Department of Justice did not suggest that any further reviews of the paper by the university are immediately warranted,' Darlene Trew Crist said in a written response. 'We have no further statement to make at this time.'

Given the seriousness of the allegations, and the University's mission:

The mission of Brown University is to serve the community, the nation, and the world by discovering, communicating, and preserving knowledge and understanding in a spirit of free inquiry, and by educating and preparing students to discharge the offices of life with usefulness and reputation.

the logic of the administration's refusal to have a public discussion of this case escapes me. As I have said before (in 2008!), the appearance of continued stonewalling, now going on for years, can easily be interpreted to imply that the institution has something really big and bad to hide.

Also see comments by Alison Bass on the Alison Bass blog, and by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog.

ADDENDUM (4 September, 2012) - There have been two additional posts on the 1BoringOldMan blog on Study 329:
the lesson of Study 329: the hurdles…
the lesson of Study 329: naked Emperors, fractious Queens…

ADDENDUM (4 September, 2012) - See also this post on the Alison Bass blog.

ADDENDUM (5 September, 2012) - See this post on the retirement of Dr Keller by Ed Silverman on PharmaLot.

ADDENDUM (10 September, 201) - See the final two posts in the 1BoringOldMan series:
the lesson of Study 329: “we’re only as sick as our secrets”…
the final lesson of Study 329: epilogue…

His conclusion in the next to last post of the series:

Something terrible happened in psychiatry, an alliance between the pharmaceutical industry and a number of our leaders who allowed their academic credentials to be used for commercial purposes. It happened on a large scale, and in the process shamed all of us, whether we were involved or not. Many of the people we looked to to guide us fell into the role of key opinion leaders – a marketing term that meant that they could influence what we did and how we practiced. And in that new role, medical degrees, academic positions, the methods of science, and psychiatric experience became little more than marketing tools in a commercial campaign. Such was the case with Study 329 – an article that has become exemplary because it is now so painfully well known – a symbol for the failings of an era. It needs to be retracted simply because it was wrong on purpose – and we all know it. And yet no involved person, institution, or organization highlighted in that last paragraph has swallowed their pride, or guilt, or denial, or arrogance and called for retraction.

[Italics and bold typeface added for emphasis]

A University President, But No Longer a Goldman Sachs Director

A frequent topic on Health Care Renewal is how leaders of not-for-profit health care organizations now frequently value their "margin," that is, revenue generation more than mission.  (One good example here shows how medical school leaders value faculty most for how much money they bring in, rather than the quality of their teaching, research, or patient care.) 

"Masters of the Universe" as Leaders of Academic Medicine

As we have cast about for reasons behind this important and unfortunate transformation, we noticed that many of the members of the boards of trustees of some of the most prestigious universities that house medical schools, medical schools, and teaching hospitals seemed to be leaders in the finance industry. The importance of that finding became more relevant after the global financial collapse, aka "great recession," became evident.  Since then, we noted the influence of finance leaders on the leadership of Dartmouth College, Harvard University, Yeshiva University, and the Hospital for Special Surgery.

Although it seems that the complex relationships between various "masters of the universe" and academia, particularly academic medicine ought to have generated considerable discussion, they remained almost as anechoic as many of the other issues discussed on Health Care Renewal.

Therefore, with some regret, I will take up the latest example of such relationships from my own alma mater, Brown University.  ((Full disclosure: I am an alumnus of the College at Brown, and of the Medical School. I am a former full-time Brown faculty member, and currently a voluntary Clinical Associate Professor in the  Alpert Medical School.)  (Also note that here we discussed some of the questions about the financial dealings of a prominent member of Brown's Board of Fellows, the inner circle of the Brown Corporation, the equivalent of its board of trustees, who was also the very wealthy leader of a prominent hedge fund.  We noted then that his connection to Brown was not noted in current media stories about the controversy.)

A Goldman Sachs Director as University President

Last week (9 February, 2010), the Brown Daily Herald published an interview with the President of Brown, Ruth Simmons, about her service on the board of directors of Goldman Sachs, one of the most prominent, profitable and controversial investment banks.  Some of the main points were:

- President Simmons seemingly denied responsibility for any of the company's past actions that have inspired criticism:

"There are lots of things in a complex institution that go on." So, "you're not in charge of everything that your friends do and every policy that organizations that you're affiliated with issue."

- She also implied that she joined the board expressly and only to advocate for women and minorities in finance:

"We had a big push to think about how we could improve the knowledge and ability of women to manage their financial affairs." Also, "at the same time, there was a good deal of interest in the fact that women have not done so well in the financial sector and on Wall Street."

The goal was "to make certain fields more accessible to women and minorities through her service on the boards of Goldman, Texas Instruments and Pfizer."

"She called her work with women and minorities on boards meaningful to her in 'a way that a lot of people won't understand.'"

She stated "the seniority she now enjoys on Goldman's board allows her to advocate for programs to help women and minorities."

- She implied that she served on the board to learn something about economics, "her service on Goldman's board gave her the economic savvy to take certain risks...."

So in summary, in her role as a member of the board of Goldman Sachs, one of the most important financial companies in the world, which had major involvement in the events that lead to the global economic collapse, or "great recession," President Simmons claimed that her major role was to advocate particular political positions on the board, implied that she did not know much about the company's core business when she joined the board, and took no responsibilities for any actions of the company which might have inspired criticism.

Presdient Simmons' responses might have made sense were she just a member of an advisory board on diversity.   However, she is was a member of the board of directors.

In this interview, she seemed to ignore her fiduciary duties as a board member to show "unyielding loyalty"  to the stockholders of the company and their interests  [Per Monks RAG, Minow N. Corporate Governance, 3rd edition. Malden, MA: Blackwell Publishing, 2004. P.200.]. She in particular seemed to disavow any responsibility for overseeing the actions of hired Goldman Sachs management. 

It is a testament to the power of the anechoic effect that an interview showing a member of the board of directors of one of the most important and controversial finance firms involved in the global financial collapse seemed to dodge responsibility for the firm's overall direction and financial practices seemed to inspire only one piece of commentary beyond Brown.  Felix Salmon opined

In all the bellyaching about the governance of the biggest banks, and the fact that their boards were spectacularly unqualified to provide any kind of oversight of what they were doing, Goldman Sachs has gone largely unmentioned. But what’s true of Merrill Lynch and Bank of America is true of Goldman too: its executives need some kind of adult supervision, seeing as how they work for their shareholders, rather than just for themselves.

He then noted,

this interview with one Goldman board member, Ruth Simmons, hardly instills in me the confidence that she can or will understand what Goldman is doing, stop them from acting in a reckless manner, or keep a close eye on compensation as she wears her hat as a member of the compensation committee....

A Rapid Resignation


However, what happened next does suggest maybe the times they are "a-changing." On 13 February, 2010, per Business Week

Goldman Sachs Group Inc., the most profitable securities firm in Wall Street history, said Ruth Simmons will leave its board after 10 years because of 'increasing time requirements' in her role as Brown University president.

This despite the small fortune that President Simmons had made learning to develop "economic savvy,"

According to a Feb. 5 filing with the U.S. Securities and Exchange Commission, Simmons owned 27,386 restricted stock units in Goldman Sachs, worth $4.2 million at yesterday’s closing share price of $153.93. According to the filing, the units convert to shares on the first trading day in the third quarter of the year following her retirement from the board.

Simmons also has 10,000 options that she can exercise on the date she ceases to be a director, according to the filing.

Felix Salmon then commented,

I said after Tuesday’s interview with Simmons was published that she seemed to think about her membership on Goldman’s board much more in terms of what it could do for her and her pet causes than in terms of being a shareholder representative tasked with overseeing senior management, and I called for a revamp of the board. Friday’s news is exactly the step in that direction that I was looking for: maybe Simmons took my comments to heart!

Summary

So in the end, the complex relationships among academic, and academic medical leaders and the finance industry are at least less anechoic.

The issue is likely not over at Brown. While the initial Brown Daily Herald interview focused on whether President Simmons' position on the Goldman Sachs board might have lead to a direct conflict of interest, he did not ask whether her position in the leadership of Goldman Sachs had any relevance to the prominence of financial leaders on the Brown Corporation.  In fact, the same day that the Brown Daily Herald published the interview, it published an article on the legal travails of a Brown Corporation who has become one of the richest hedge fund leaders in the world.  The 2008-09 Brown Corporation (webpage no longer works here, but cached here) included three other current or retired Goldman Sachs leaders, a former partner, head of merchant banking, and former leader with less specified responsibilties.  It also included numerous other leaders of various other finance companies. 

In the aftermath of the global economic collapse, and in an ongoing health care crisis, it seems reasonable to hypothesize that some of the problems of academia, and particularly the problems of medical academia, may have been at least enabled by leadership more used to working in an increasingly amoral marketplace than to upholding the academic mission.  I hope that Brown's latest travails will inspire more interest in who now leads academia, especially medical academia, how they got there, and what they have wrought.  Academic medical institutions and other not-for-profit health care organizations need leaders who value their missions more than the money they may bring in.