[PAA-Discuss] Fwd: Pharmalot - Just How Close Was Nemeroff With Glaxo?

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Subject: Pharmalot - Just How Close Was Nemeroff With Glaxo?


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http://www.pharmalot.com/2011/09/just-how-close-was-nemeroff-with-glaxo/

Just How Close Was Nemeroff With Glaxo?

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By Ed Silverman // September 13th, 2011 // 10:59 am


For all the chatter and concern about financial relationships between 
academia and industry, the case involving Charles Nemeroff made him a 
poster boy for the controversy. For those who may not recall, he was an 
Emory University professor who was sanctioned for failing to disclose 
that he had accepted about $500,000 in payments from GlaxoSmithKline 
while he was also the primary investigator for a National Institutes of 
Health study of the Paxil antidepressant, which is sold by the 
drugmaker (see here).
The details emerged thanks to a US Senate Finance committee probe into 
undisclosed conflicts of interest. At issue was the extent to which 
such relationships may unduly influence medical research and practice. 
The senate probe reached out like an octopus and ensnared various 
drugmakers, universities, medical journals and the NIH itself, 
specifically the National Institutes of Mental Health (see this). Since 
then, various companies and institutions have gradually adopted new 
policies concerning disclosure.
As for Nemeroff, he now chairs the psychiatry department at the Miller 
School of Medicine at The University of Miami, where he is, once again, 
seeking grants from the NIH, according to sources. But for those 
wondering just how close he may have been to Glaxo, an e-mail has 
emerged that suggests the largesse extended by the drugmaker for his 
many speaking engagements made him feel like an ally.
To be specific, in June 2004, an attorney named Greg Martin wrote 
Nemeroff to ask if he would consult on some planned litigation 
concerning the likelihood that the Paxil antidepressant might lead some 
adolescents to attempt or commit suicide. The two had apparently worked 
together in the past while Nemeroff was a professor at Duke.
And so Martin wrote that he was contacted by the family of a suicide 
victim who was taking Paxil at the time of his death and the lawyer 
goes on to note how he read that Glaxo was accused by the former New 
York attorney general of suppressing clinical trial data. “Before we 
get involved in these cases, I’d like to get a better handle on the 
science,” Martin writes.
How does Nemeroff respond? “Dear Greg,” he writes, “I wouldn’t serve as 
an expert on such a case and I would advise you to steer clear of them 
as well.” A few years later, however, Glaxo was spending hundreds of 
millions of dollars to settle such cases (read this). But Nemeroff was 
apparently thinking more about Glaxo.
As the top of the e-mail thread indicates, he promptly forwarded the 
exchange to Alan Metz, who was the Glaxo vp and medical director for 
North America at the time. You know, just in case Glaxo execs wanted to 
keep tabs on what lawyers were thinking about possible litigation. For 
the drugmaker, consulting payments can come in handy.
You can read the e-mail thread here.













http://www.forbes.com/sites/paulthacker/2011/09/13/how-an-ethically-challenged-researcher-found-a-home-at-the-university-of-miami/


Pharma & Healthcare
9/13/2011 @ 8:03AM |13,465 views

How An Ethically Challenged Researcher Found A Home at the University 
of Miami

By Paul Thacker




Three weeks ago, the National Institutes of Health announced new rules 
to govern federally-funded researchers and their financial conflicts of 
interest. Three years in the making, the policy will affect over 38,000 
scientists at 2000 organizations as the NIH attempts to ensure that 
biomedical research, paid with taxpayer dollars, remains objective.

But none of these changes might have happened were it not for Dr. 
Charles Nemeroff.

A renowned chairman of psychiatry at Emory University, Nemeroff was a 
proponent for drugs sold by GlaxoSmithKline, such as the antidepressant 
Paxil. While earning hundreds of thousands of dollars jetting around 
the country and giving talks about Paxil to doctors at fancy 
restaurants, Nemeroff also managed a multi-million dollar grant from 
the NIH to research drugs under development by Glaxo.

The ensuing scandal became central to an investigation by Senator 
Charles Grassley into undisclosed payments from companies to prominent 
physicians—a practice that puts patients at risk and drives up 
healthcare costs. As Grassley’s lead investigator on the matter, I had 
a ringside seat as arguably the most powerful psychiatrist in the 
country was forced from prominence, eventually leaving Emory.

At my new job with the Project On Government Oversight (POGO), a 
government watchdog, I have continued to study the cozy relationships 
between physicians and corporations.  I also observed as Nemeroff left 
Emory for a new job at the University of Miami which has a medical 
school operating under financial strain. But why would this school 
snatch up a physician with such a history?

According to new emails and other materials shown to me, UM officials 
had serious concerns about Nemeroff’s history of ethical blunders. 
However, these emails suggest that Nemeroff’s perceived ability to 
raise money trumped those concerns. At one point while negotiating with 
UM for a job, Nemeroff even dangled the possibility of a new funder for 
the school if he was hired. These emails imply that, despite new 
federal rules, the public must remain vigilant to ensure that medicine 
is practiced with the highest regard for ethics and patient safety.

Officials at UM did not respond to detailed and repeated questions 
about the emails, which include communications by UM President Donna 
Shalala, who is now facing public scrutiny over a separate ethics 
scandal involving UM’s football program.

GHOSTS FROM THE PAST

Last November POGO released documents alleging that Nemeroff and other 
academic physicians of putting their names on scientific publications 
drafted or managed by Scientific Therapeutics Information, a public 
relations firm retained by Glaxo. The practice is called ghostwriting, 
and it appears to be quite pervasive in medical research, although some 
universities call it a form of plagiarism.

Among the documents we made public was a timeline and first draft of a 
book whose purported authors are Nemeroff and Alan Schatzberg, a 
professor at Stanford. Daniel Carlat, a psychiatrist and author, bought 
the book and wrote on his blog that it read like “an advertisement for 
Paxil. Not obvious, not blatant. But artfully crafted, subtle, smooth.”

In This Story: Intro | Ghosts From The Past | A History Of 
Conflict|Welcome To The Sunshine State|Mistakes Were Made|“Couldn’t Be 
Better”

Nemeroff denies any wrongdoing. In a statement to the Miami Herald, he 
characterized any charge of ghostwriting as “blatantly false and 
inaccurate.”

Pascal Goldschmidt, Dean of the University of Miami’s Medical School, 
leaped to Dr. Nemeroff’s defense, telling the Herald:

It is unfortunate that two individuals who have contributed so much to 
the medical discipline of psychiatry…and to the health of so many 
patients with dreadful psychiatric illnesses here in the U.S. and 
beyond, are exposed to such an unreliable and unfounded challenge to 
their reputation.

To me the question is why the University of Miami is so protective of 
Nemeroff.

  A HISTORY OF CONFLICT

In August 2003, Melody Peterson of the The New York Times wrote that 
Nemeroff, chairman of psychiatry at Emory, failed to report his 
conflicts of interest in an article published in a medical journal.

According to the Times, Nemeroff favorably described a lithium patch 
and gave kudos to products sold by Corcept Therapeutics and Cypress 
BioSciences.  However, he did not disclose his own patent for the 
lithium patch nor his financial interests in the two companies.

”I have always been totally compliant, probably gone overboard, with 
disclosure,” Nemeroff told the Times. ”If there is a fault here, it is 
with the journal’s policy.”

In This Story: Intro | Ghosts From The Past | A History Of 
Conflict|Welcome To The Sunshine State|Mistakes Were Made|“Couldn’t Be 
Better”

A second incident happened in July, 2006, when the Wall Street Journal 
wrote about a journal article praising Cyberonics’ treatment for 
depression.  According to the executive director of the medical society 
that publishes the journal, Nemeroff and his colleagues didn’t disclose 
their financial ties to Cyberonics in the manuscript they submitted to 
the journal as required.

Dr. Nemeroff told the Journal that there was “no intent whatsoever on 
my part or any of my co-authors to hide the fact we were working in 
collaboration with Cyberonics.”

And that was that, until October, 2008, when Nemeroff landed on the 
front page of the New York Times, in a story charging that he had 
failed to report over a million dollars in payments from various 
companies including GlaxoSmithKline.

Written by Gardiner Harris, the story was based on internal Emory 
documents made public by Senator Grassley.  The story also reported on 
a GlaxoSmithKline spreadsheet detailing dozens of marketing talks that 
Dr. Nemeroff gave to push Glaxo’s drugs to doctors.

The story noted:

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 
that company — 17 times the figure he had agreed on.

As the story broke, Emory announced that Nemeroff was stepping down as 
chairman but would remain on faculty in the psychiatry department.  The 
National Institutes of Health also suspended one of Nemeroff’s grants.

At the end of 2008, Emory took action: Dr. Nemeroff would not be 
reinstated as chair nor would he be allowed to submit grants to the NIH 
for two years.  He was expected to cooperate with any investigation and 
would only be allowed to serve on the boards of only four companies 
with compensation for each limited to $10,000 annually.

Finally, Nemeroff could no longer give` promotional talks, nor solicit 
gifts from industry.

That’s when the University of Miami entered the picture.    


WELCOME TO THE SUNSHINE STATE
According to previously undisclosed records, Nemeroff visited Pascal 
Goldschmidt at UM in the summer of 2009 to negotiate a potential job.  
They also apparently discussed creating a new center to promote ethics 
in academia and industry.
“I talked about the center to Ken Goodman, co-director of the UM Ethics 
Programs, the center would sit under the general umbrella of the Ethics 
Program,” Goldschmidt wrote to Nemeroff.  “Ken is intrigued by the idea 
and would like to meet with you during your next visit.”
On June 27, 2009, Richard Bookman, UM Vice Provost for Research, 
emailed Goldschmidt a link to the documents on Nemeroff that the Senate 
Finance Committee made public.
Goldschmidt wrote back, “I have spent a while on it and bunch of 
newspaper articles. The key question is why did he think it was OK to 
simply ignore and almost challenge the NIH rules?”
But Nemeroff sweetened the deal by letting Goldschmidt know that a 
potential donor had stepped forward to support the Psychiatry 
Department if he relocated to UM.
In an email to Nemeroff, Dr. Goldschmidt seemed barely able to control 
himself.  “Superexciting the news about the donor!  Thanks for getting 
us the info, I am, and I know you are, looking forward to getting 
beyond these issues….”
In early September, a reporter at the science journal Nature began 
working on a story about conflicts of interest in medicine and sent 
Nemeroff several questions about his ethical past.  Dr. Nemeroff 
forwarded a draft of his response to Goldschmidt.
“Please let me know what you think,” Nemeroff wrote. “I leaned heavily 
on your thoughts, for which I am very grateful.”
“The answer is perfect.  I found a typo now corrected.  Cheers, Pascal.”

MISTAKES WERE MADE
In the article, which came out on September 16, 2009, Nemeroff was 
quoted, “I made mistakes in the area of conflict of interest for which 
I am sorry and remorseful. However the mistakes I made were honest 
mistakes.” He explained that “my actions were, in my view at the time, 
in keeping with my understanding of the current Emory policies.”
“I also plan to use my recent experience to help others avoid problems 
with conflict of interest from the lessons I have so painfully learned.”
Three days after the article was published, Nemeroff emailed Miami with 
a list of his current and future external obligations.  Under the 
constraints placed on him by Emory, he was only allowed to ally himself 
with four companies, and each could only pay him $10,000 annually.  But 
what was once four, now apparently was five.
Novadel Pharma wanted him on their board and was paying $50,000 a 
year.  “I would estimate time out of the office as 2-4 days per year,” 
Dr. Nemeroff wrote.
Cenerx was paying $20,000 for Dr. Nemeroff to sit on their Scientific 
Advisory Board, and AstraZeneca wanted him on their advisory board as 
well for another $50,000 for two in person meetings.
In his email, Dr. Nemeroff wrote, “This was reduced by my request to 
$10,000 this past year but I would, naturally, like to go back to the 
original contract.”
Dr. Nemeroff also asked to serve on the board of Mt. Cook which was low 
on funding, but “may be reinvented with new capital.”  And 
PharmaNeuroboost wanted Nemeroff to chair its Scientific Advisory 
Board, with a compensation of $40,000 for three annual meetings.
He also noted that several other companies were asking him for one time 
consulting gigs. “I seek your guidance on these,” Nemeroff wrote.
Over the next week, the administration discussed ways to handle Dr. 
Nemeroff’s outside activities “prospectively” to include penalties for 
failure to comply. But by the end of the month it became clear that Dr. 
Nemeroff was a shoo-in for the position.
“[B]oth the [National Institute of Mental Health] and Emory have 
cleared him of illegal activities,” wrote William O’Neill, Miami’s Dean 
of Clinical Affairs.  He added that Nemeroff was cleared to receive 
federal research funding.  “His ‘wrongdoing’ consisted of a lack of 
reporting of substantial industry consulting fees.”

“Thanks Bill!” wrote back Goldschmidt.

“COULDN’T BE BETTER”

As summer gave way to fall, rumors circulated that UM was going to hire 
Nemeroff and had retained a public relations firm to deal with any 
controversy.  Stories began leaking to the blog Pharmalot.  But when a 
blogger at The Scientist wrote another post, a UM employee emailed the 
story immediately to UM President, Donna Shalala, who had once served 
as Secretary of the U.S. Department of Health and Human Services.

    Subject: TRUE?

    Dear President Shalala,

    In connection with your letter today to UM Faculty and Staff, I 
would like to know if this physician will be employed by UM Miller 
School of Medicine, and if so, why, based on his failure to disclose?

The reference to a letter concerned an email sent by President Shalala 
that day to the UM Community.  In her email, Shalala laid out new 
conflicts of interest rules at UM to increase the integrity of medical 
research and place the school as a national leader.  “That integrity is 
the very bedrock of our institution and the foundation for the trust 
that students, patients, academic colleagues, and society place in us.”

Three days later, the UM sent a press release announcing that Dr. 
Nemeroff had been hired as chair of the Psychiatry Department.  No 
mention was made of the ethical controversies clouding his past.

That same day, a former UM faculty member emailed President Shalala:

    Dear President Shalala:

    As a former UM faculty member, I would like to add my expression of 
dismay to those which you have undoubtedly already received concerning 
the hire of Charles Nemeroff as chair of the medical school’s Dept. of 
Psychiatry.  While his extensive connections within the Pharma industry 
are no doubt an alluring asset, his seeming lack of integrity in 
simultaneously accepting “consulting fees” from the very company 
(Glaxo) whose products were the basis of an NIH grant on which he was 
the [Primary Investigator] is absolutely outrageous.  Yet, both he and 
Emory knowingly treated this unethical, corrupt behavior as “business 
as usual”, at least until Sen. Grassley named Nemeroff as a target of 
his conflict-of-interest investigations and HHS launched an 
investigation; and Nemeroff voluntarily left Emory under this cloud.

    Your “Dialogue” of Nov. 2 is an affirming statement of ethical 
principle, and your initiatives to implement University-wide ethical 
behavior are overdue and welcome.  Yet, one is forced to ask the 
question: how can one reconcile the tenor of that statement with the 
immediately prior hiring of so questionable an individual to such a 
prominent position?  Does the university not perceive that this may be 
seen as the worst sort of hypocrisy?

Shalala responded within minutes.  “Actually yours is the only one I 
have received.  Thanks for your views.”

Safely ensconced at his new home, in mid-December, Nemeroff emailed his 
contacts at PharmaNeuroboost, thanking them for meeting with him in 
Florida.

    You will recall that thus far as chair of the SAB, I have received 
only $10,000 of the promised $40,000 due to the limitations I had 
during my affiliation with Emory University. You can, however, now go 
ahead and remunerate me for the remaining $30,000….

Apparently, things were moving along swimmingly.  After the 2010 New 
Year, President Shalala emailed him, “How are things going?”

Nemeroff’s response? “Couldn’t be better. Love Miami. Leadership of the 
school and health system have been terrific. Suffered through the bowl 
game….Hope to see you soon.”









         

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