Feb 29, 2008 — Lawsuit: Cunningham v. Smithkline Beecham, US DISTRICT COURT NORTHERN DISTRICT OF INDIANA HAMMOND DIVISION
This lawsuit arises from the suicide of 14-year old Scott Cunningham in March 2001. In their complaint, the plaintiffs, Scott Cunningham's mother, father, and brother, allege that his suicide was caused by the prescription anti-depressant marketed under the name Paxil and manufactured by the defendant Smithkline Beecham (GSK).
The plaintiffs allege that beginning in 1994, Glaxosmith-kline (Smithkline) became aware that Paxil was ineffective for the treatment of depression in adolescents and that the drug increased the risk of suicide in adolescent patients. The plaintiffs further contend that Smithkline knew that, despite the lack of approval for use in treating adolescent depression, so-called "off-label" prescriptions of Paxil were sufficient to make the drug the second most prescribed anti-depressant for children and adolescents. The plaintiffs allege that through a series of conferences, articles, and other promotional efforts, including the use of paid "opinion leaders", Smithkline promoted the use of Paxil for children.
April, 2008 — Senator Chuck Grassley starts to investigate payments from pharmaceutical companies to prominent academics, prompted by the discovery that GSK has not been honest about the risks of Paxil. He learns that many high ranking academic physicians are receiving payments for speeches, and research far in excess of the usual limit prescribed by university conflict of interest policies ($10,000).
His investigations are aimed at the following psychiatrists, along with a few doctors in other specialties: Melissa DelBello (U. Cincinnati) Joseph Biederman (Harvard), Tim Wilens (Harvard), David Brent, Jeffrey Bridge, Daniel Casey (VA Medical Center in Portland), David Dunner, Graham Emslie, Daniel Geller, Robert Gibbons, Frederick Goodwin, Martin Keller (Brown), Andrew Leon, John Mann, John March, Charles Nemeroff (Emory), Augustus John Rush (U Texas), Neal Ryan, David Shaffer, Alan Schatzberg (Stanford) and Karen Wagner (U Texas).
July 12, 2008, the New York Times reported "But now the profession itself is under attack in Congress, accused of allowing this relationship to become too cozy. After a series of stinging investigations of individual doctors' arrangements with drug makers, Senator Charles E. Grassley, Republican of Iowa, is demanding that the American Psychiatric Association, the field's premier professional organization, give an accounting of its financing."
Daniel Casey chaired the 1991 FDA hearings which resulted in no warning for SSRIs at that time. David Dunner and John Mann were also decision-makers in these hearings; Graham Emslie, lead on the 1997 and 2002 fluoxetine (Prozac) studies, and one of the listed authors on Study 329, was Co-Chair of the ANCP task force that kept insisting in 2004 that the suicides of young people on SSRIs was due to depression. John Mann was the other Co-Chair. Frederick K Goodwin, Andrew C Leon, Neal D Ryan, David Shaffer and Karen D Wagner were ANCP Task Force members. Martin Keller was the lead on Study 329, as well as a similar study for sertraline (Pfizer). Neal Ryan was originally selected to lead Study 329.
April 11, 2008 — Article: Clinical trials and drug promotion: Selective reporting of study 329, by Jon N. Jureidini, Leemon B. McHenry, and Peter R. Mansfield describes the practice of selective reporting of study trial data that cannot be identified without access to internal company documents.
June 11, 2008 — Letter: Senator Chuck Grassley writes to Michael O. Leavitt, Secretary of the U.S. Department of Health and Human Services. He requests that the FDA look into whether safety information had been withheld in the US:
"I have recently received an expert report prepared for litigation by Dr. Joseph Glenmullen, a professor at Harvard University. Based on documents from GlaxoSmithKline (GSK) and the FDA, Dr. Glenmullen concluded that GSK officials knew back in 1989 that Paxil is associated with an increased risk for suicide. I have attached his report* for your review and consideration. Furthermore, I have learned that Britain's Medicine's and Healthcare Regulatory Authority (MHRA) concluded a four year investigation of Paxil. That report found that GSK had been aware since 1998 that Paxil was associated with a higher risk of suicidal behavior in adolescents. However, the British government did not move forward with criminal prosecutions because the laws at the time were not clear enough as to whether GSK should have informed the regulatory agency.
In response to the MHRA report, Britain's public health minister, Dawn Primarolo, told the Guardian newspaper, "Companies that conduct clinical trials should not compromise people's health by withholding information." The Guardian also reported that the British government plans to introduce new legislation later this year to make clear that drug companies should not withhold safety information. In light of this investigation by the MHRA, I would like you to take a look at the information that agency gathered and determine if the company has withheld safety information here as well. I also request a briefing for my staff on whether or not a review is being conducted by HHS or any of its departments/ agencies regarding whether or not GSK withheld information from the FDA."
*see August 10, 2007
Sept 24, 2008 — CBS news reveals that Dr Martin Keller has been targeted by Senator Grassley:
(UWIRE) - Investigators from the U.S. Senate Finance Committee are scrutinizing Brown University over disclosure of conflicts of interest in clinical research, Provost David Kertzer confirmed Thursday.
Though university spokespeople would not comment on the details of a letter of inquiry from ranking committee member Sen. Charles Grassley, R-Iowa, a source familiar with the investigation has confirmed that the letter names Professor of Psychiatry and Human Behavior Martin Keller, the chairman of the psychiatry department at the Alpert Medical School.
Keller has gained notoriety for authoring a controversial clinical study of the antidepressant drug paroxetine - marketed as Paxil in the United States - which concluded that the drug was safe and effective in adolescents. Keller and some of the study's co-authors have been accused by doctors, lawyers and journalists of having the 2001 study ghostwritten, earning large sums of money from Paxil's maker, GlaxoSmithKline. In addition, some say the researchers manipulated and suppressed data - including those showing increased suicidal tendencies in children taking the drug.
Study 329, as it is referred to by GSK, went on to become one of the most-cited articles in medical literature supporting the use of antidepressants for adolescent depression. At the time, GSK jumped on the favorable results, seeking to promote the use of its product among children, a largely untapped market for antidepressants.
In recent years, new studies and secondary research using old data have demonstrated that Paxil can lead to increased suicidal tendencies in children.
Keller would later acknowledge in a 2006 deposition that he had been accepting tens of thousands of dollars in consulting fees from GSK and Scientific Therapeutics Information - a company acting on GSK's behalf - during and after the years he was conducting crucial research on the efficacy and safety of Paxil in children.
Alison Bass, a former reporter for the Boston Globe, said Keller may have earned more than he acknowledged in tax returns. In a 1999 article for the Globe, Bass reported that Keller had earned a total of $1 million in consulting fees from various drug companies over the fiscal years 1997 and 1998, according to his tax returns from those years.
According to Bass, the tax returns show that Keller received $218,000 from Pfizer and $77,400 from Bristol-Myers Squibb during the same year he was praising Pfizer's Zoloft and publishing positive conclusions on BMS's Serzone. Missing from his tax returns, Bass told The Herald, was the money Keller acknowledged earning from GSK.
October 3, 2008 — Among the most serious violations uncovered by Senator Grassley's investigations is the following:
"A prominent Emory University psychiatrist received at least $2.8 million in consulting fees from companies whose drugs he was evaluating and failed to report a third of it, congressional investigators studying medical conflicts of interest said Friday. The allegations against Dr. Charles B. Nemeroff, the latest in a series of such charges, are the most striking to emerge from the probe, which seems likely to alter the cozy relationships between prominent academics and the drug industry.
Nemeroff received the money from GlaxoSmithKline between 2000 and 2007 while he was the principal investigator on a $3.9 -million National Institutes of Health study of five Glaxo drugs for treatment of depression, Sen. Charles E. Grassley (R-Iowa), who initiated the investigation, said in a letter to Emory published Friday in the Congressional Record. Nemeroff continued to receive large amounts of money for delivering talks to other physicians even after he signed university documents pledging to accept no more than $10,000 a year from any one company, the inquiry found."
Oct 3, 2008 — Under the Title: "Busted " 1boringoldman, a.k.a. Dr Mickey Nardo, with respect to the revelations about Charles Nemeroff that have just hit all the major US news outlets, blogs:
"In the mid 1980's, I was on the full time faculty at Emory in the Department of Psychiatry in charge of the Residency Training Program under an aging Chairman - a man who had founded the Department in the late 1950's. I was and am a Psychiatrist and Psychoanalyst, so my own interest was in psychotherapy/analysis, but we had a well- rounded program - or so I thought. When a new Chairman came from Duke, I liked him, but it became quickly apparent that whatever he thought Psychiatry was, it wasn't what I thought. After a year of being a fish out of water, I resigned, staying for a year to give myself time to figure out where to go next. I had tenure, so I had that luxury. After I left, this new Chairman became Dean of the Medical School and hired his friend Dr. Charles B. Nemeroff as Chairman of Psychiatry. The National Institutes of Health have strict rules mandating that conflicts of interest among grantees be managed or eliminated, but the health institutes rely on universities for oversight. If a university fails, the agency has the power to suspend the school's entire portfolio of grants, which for Emory amounted to $190 million in 2005. But this step is so draconian that the health institutes almost never take it.
Dr. Nemeroff was the principal investigator for a five-year, $3.9 million grant financed by the National Institute of Mental Health for which GlaxoSmithKline provided drugs. Income from GlaxoSmithKline of $10,000 or more in any year of the grant - a threshold Dr. Nemeroff crossed in 2003, 2004, 2005 and 2006, records show - would have required Emory to inform the health institutes and manage the conflict or remove Dr. Nemeroff as the investigator. Repeatedly assured by Dr. Nemeroff that he had not crossed this income threshold, Emory did nothing."