In the first Paxil birth defect trial against GlaxoSmithKline, much of evidence focused on the doctors on Glaxo's payroll involved in the corruption of the medical literature and seminars given to promote the off label use of Paxil with pregnant and nursing mothers.
On October 13, 2009, the trial of Kilker v Glaxo ended with a Philadelphia jury awarding $2.5 million in compensatory damages to the family of Lyam Kilker, after finding that Glaxo "negligently failed to warn" the doctor treating Lyam's mother about the risks of Paxil and the drug was a "factual cause" of the child's heart defects.
Glaxo's lead attorney at trial was King & Spalding partner Chilton Varner, and the family's lead attorney was Sean Tracey from Houston.
During his opening statement on September 15, 2009, Tracey told the jury that Doctor David Healy is "one of the most, if not the (most) world-recognized expert on pharmaceutical industry influence and the medicine, he is up there in the top five."
Healy "is going to explain to you how GSK corrupted the medical literature," he said, "how they used their money and influence to have doctors that they paid put out literature into the world so doctors ... could read literature that looked like literature, looked like science, smelled like science, appeared to be science, from very important people, people that were on boards, people that were professors, people that published hundreds of articles."
Healy is going to explain to you that what they didn't tell people ... "is, we are paying these doctors to do all these things," Tracey told the jury.
"There is a book, it looks like a telephone book," he said, "of names of doctors, influential doctors, on their payroll, the names of these doctors you will see on this literature that looks and smells like science."
"And just coincidentally, this science that they are going to parade before you, all seemed to help them," he told the jury. "Some of this happened in the last couple weeks before this trial started."
Advisory Panels and KOLs
While testifying, Tracey had Healy explain the concept of key opinion leaders (KOLs) and drug company advisory boards.
"When a pharmaceutical company is bringing a drug to market," Healy said, "a few years before they bring the drug to the market they look at the academic physicians in the field and work out who will be the key people who will be the advocates for the drug."
"They recruit advisory panels for the drug, which will be senior figures within the field who they believe they will be able to depend on to persuade the rest of their colleagues to think seriously about using this drug," he noted.
In explaining a "national" advisory board, Healy said, when "a drug comes to market, they will have a range of senior people in the field, it could be 10 or 12 different people from different parts of the country whom they think are going to be the most influential in helping to get their drug moving within the market here in the U.S. or the U.K."
"Then there is a further group of people down below," Healy said, "who are called the key opinion leaders or KOL for short."
"These, again, are fairly senior doctors," he told the jury. "These are the people whom it is thought will go out and give lectures on the drug to the doctors who are actually doing most of the prescribing of the drug."
In the early 1990s, Healy was on a Paxil advisory board around the time the drug was launched in the UK. People who did not think Paxil was a great product would usually be dropped from the advisory panel, he told the jury.
In fact, Tracey produced a Glaxo memo that stated: "if after this meeting anyone on the advisory board who doesn't passionately believe Paxil's uniqueness for anxiety should quietly be replaced."
Naming Names
During the trial, Tracey wanted Healy to specifically testify about Doctors, Charles Nemeroff and Zachery Stowe, and apparently Glaxo did not want the jury to hear the sordid tale because their attorneys strongly objected.
On September 16, Tracy argued his case to the judge in chambers outside the hearing of the jury. "Doctor Nemeroff is generally considered, or was before his fall from grace, the most powerful man in psychiatry in the United States," Tracey told the judge.
"Doctor Healy is uniquely qualified to talk about Doctor Nemeroff's role in the corruption of medical literature related specifically to Paxil as orchestrated by GSK and Doctor Nemeroff," he argued.
"Same with Doctor Stowe," Tracey said. "Doctor Stowe specifically carried out a campaign to market through GSK or GSK through Doctor Stowe to pregnant women and women of childbearing age."
"I need to show the jury that an enormous amount of money changed hands between Stowe and Nemeroff and others," he said, "and that all of these doctors were on GSK's Paxil advisory board."
"It goes to the credibility of these doctors," Tracey pointed out.
"These are the doctors that are writing the literature that is out there in the peer-reviewed literature that doctors are relying on," he told the judge.
These doctors were required ethically "by their universities to disclose to the Federal Government how much money GSK was paying them," Tracey said. "They did not do that."
He also wanted the jury to know that "Emory University has actually stripped Doctor Nemeroff of his chair over this very issue of failing to disclose payments from GSK," he told the judge.
Tracey wanted to prove these allegations with testimony from Healy about Senator Charles Grassley's investigation of Nemeroff and Stowe and the results that were made public. In the end, the judge refused to allow Healy to testify about the amounts Nemeroff and Stowe were paid by Glaxo, why Nemeroff lost the chairmanship, or the disciplining of Stowe.
"Whether or not Emory had a battle with them about disclosure is not relevant in my mind,"the judge told Tracey. "What is relevant is that they were prominent individuals who wrote in favor of this drug, that they were on the advisory board, that they received honorariums of money, and that he believes in his opinion that these articles are wrong that they wrote."
"He can offer his opinion that they were wrong and why they were wrong," he said. "I am going to keep out the argument about the doctors being sanctioned for failing to disclose."
Nemeroff's "credibility from Emory would involve a mini trial of the issue with Emory and him," the judge said.
The Emory investigation, in fact, found Nemeroff was paid more than $960,000 by Glaxo, from 2000 through 2006, but listed less than $35,000 on his disclosure forms. All totaled, he had earnings of $2.8 million from speaking and consulting arrangements with drug companies between 2000 and 2007, but failed to disclose at least $1.2 million, according to Senate Finance Committee reports.
In 2008, Stowe was the primary investigator for a National Institutes of Health grant where the stated purpose was "to stimulate vigorous debate with the emphasis on the reproductive safety of antidepressant medications," according to a June 2, 2009 letter to the president of Emory from Grassley.
Glaxo paid Stowe $154,400 for fifty-seven promotional talks in 2007. He also received $99,300 from Glaxo in the first ten months of 2008 for thirty-eight talks for antidepressants, according to Grassley.
During a deposition, Stowe testified that around "80% of his Emory salary ($187,000) comes from his NIH grants," the letter notes. His total Emory salary was $232,000.
In a June 11, 2008 statement on the Senate Floor, in describing his investigation, Grassley said, "I have been looking at how drug companies try and influence medical care in America. Companies can do this by, for example, creating studies favorable to their drugs, by hiring doctors to promote their products, and in some cases even intimidating critics of their drugs."
On this date, Grassley was announcing his investigation of Glaxo regarding revelations in reports filed in Paxil suicide litigation by Dr Joseph Glenmullen, showing the company had manipulated the numbers on adverse events related to suicidality in clinical trials all the way back in 1989, before the drug was FDA approved, to make it appear that Paxil did not increase the risk of suicidal behavior when, in fact, trial subjects on Paxil were eight times more likely to attempt or commit suicide than patients taking a placebo.
"So what did GlaxoSmithKline do with these reports?" Grassley said. "Well, the company tried to hide them."
"They went to the judge and asked to have Dr. Glenmullen's report and all the confirming documents placed under seal-that means that no member of the public could see them," he said. "In fact, Glaxo has been doing everything possible to ensure that this information remains under court seal."
"It seems to me that GlaxoSmithKline tried to hide these reports because they seem to demonstrate what the company knew-that Paxil was associated with an increased risk of suicide based on the company's own studies," Grassley noted.
"Essentially, it looks like GlaxoSmithKline bamboozled the FDA," he pointed out.
For easy reference, psychiatric academics identified by Grassley's investigation to date, as not fully disclosing money from drug companies, include Joseph Biederman, Thomas Spencer and Timothy Wilens at Harvard, Charles Nemeroff and Zackery Stowe from Emory; Melissa DelBello at the University of Cincinnati; Alan Schatzberg, president of the American Psychiatric Association, from Stanford; Martin Keller at Brown University; Karen Wagner and A John Rush from the University of Texas; and Fred Goodwin, the former host of the radio show, "Infinite Minds," broadcast for years by National Pubic Radio, before it was thrown off the air.
Paxil All-Star Team
During direct examination of Healy, Tracey introduced an exhibit on a 2002 forum called, "Perspectives on Psychiatry for the Future, Summary of Program Evaluations," along with a list of doctors who gave presentations.
"What I would like to do is use this document to prove that these are a list of doctors that are out promoting Paxil for the defendant, and to have Dr. Healy explain, as he has published, how GSK sought to change the culture of how doctors view Paroxetine and pregnancy," he told the judge.
Tracey went through several of the presentations and named off doctors that included Daniel Christensen, Zachary Stowe, Philip Perera, Dean Hamer, Dwight Evans, Karen Wagner, Katherine Beebe, and Prakash Masand.
Healy said he believed that most of the doctors mentioned were on the Paxil speaking team.
Zachary Stowe was listed for a presentation on the topic of, "Use of Antidepressants in Pregnant and Breastfeeding Women."
Page 10 of the document asked: "As a result of the program, what changes, if any, will you make in your practice?"
Healy testified that after talks at this type of program, the audience will be asked to rate the points that are made. Tracey read some of the comments made by doctors attending the seminar, which included: "Possibly less fearful of treating pregnant women," "Increased comfort in treating pregnant women," "Increase use of Paxil - Will reassess the use or nonuse of SSRIs in pregnant/lactating clients," and "More aggressive in treatment of special population, children and pregnant women."
Healy testified that this document supported his opinion that Glaxo did influence doctors' prescribing practices with respect to Paxil and pregnancy and "they were quite successful at this."
"I don't think you can find a single comment which says, I will be more cautious about treating pregnant women with Paxil," he pointed out.
The jury was also shown a "Protocol" where Stowe had applied to Glaxo for funds to do research on the issue of Paxil in breast milk. Under the objectives for performing the study, there were five possible boxes to check, and Glaxo checked the box for "image enhancement."
Healy knew of no article that ever appeared in peer-reviewed literature or was published in a reputable journal where the author said the purpose of the study was image enhancement. The odds of getting a paper published in a leading journal "would be remote to nonexistent," if you told the journal that the reason for the study was to enhance the image of the drug, he said.
Tracey then introduced a January 10, 2000 email from Jillian, at the Cohn and Wolfe PR firm, to Scott Sproull and others at Glaxo, that showed Stowe was going on a publicity tour and would issue a press release for the Paxil breast milk study on Emory letterhead to lend credibility to the study in the media.
The email stated: "Scott, please review the attached press release and forward me any comments or edits."
"As you may know," Jillian said, "Dr. Stowe is on board for publicity efforts and Sherrie and I are coordinating time to meet with him next week to arm him with key messages for this announcement, which is slated for February."
"We are sending the release for his review at the same time in efforts to secure distribution on Emory letterhead," the email said, "as you know would provide further credibility to data for media."
Healy had never hired PR firms to disseminate his published literature or lent his name to go on publicity tours for drug companies, he told the jury.
Tracy presented another protocol for a Paxil study, with Stowe as the investigator, where the objective checked was again "image enhancement." As a scientist looking at the design of this protocol, Healy said, "this appears to be part of the positioning of Paxil as a drug that will be favorable to women of childbearing years."
The budget for the study showed that Glaxo would pay $600 for each patient enrolled and the cost would be about $9,000.
Prior to 2005, Healy testified, he was not aware that Glaxo "spent any money to actually determine if the drug could be causing birth defects in human children."
Tracey produced another document from a September seminar held in Philadelphia, at which Kimberly Yonkers was speaking to a Women's Health Advisory Board. Healy said Yonkers was a professor of psychiatry from Yale University and she was on Glaxo's Women's Health Advisory Board.
He told the jury that Yonkers was particularly influential "from the point of view of issues to do with women's mental health."
Glaxo's Speed Dial
During the trial, Tracey wanted to use an exhibit that he referred to as a "telephone book," full of influential doctors on Glaxo's speakers' bureau for Paxil and have Healy go through some of the names.
"What I would like to do is put it into the record and have him identify who these people are," Tracey explained to the judge in chambers, outside the hearing of the jury.
"Many of them are influential psychiatrists who have published on Paxil," he said. "I want him to go through seven or eight names so later when the jury hears literature by these authors they will be able to put it into context."
What I am going to do "is show the jury how all-encompassing their strategy for identifying and cultivating psychiatrists were in the country," Tracey said.
"That's part of Doctor Healy's opinion," he said, "how they identified these hundreds of doctors across the country to change the culture that existed."
While Healy was testifying, Tracey introduced the 171 page list and had Healy identify some of the doctors.
Healy testified that Lori Altshuler is "a figure who is very well known in the field of women's mental health and would have written some key articles on the idea that it may be appropriate to use antidepressant drugs for women who are pregnant."
He identified Vivian Burt as "a person who is a fairly big name in the women's mental health field and, again, a person who is an advocate for using antidepressants in women of childbearing years, and in particular, has talked regularly about the use of Paxil for women of childbearing years."
He said Lee Cohen had been on the Paxil advisory board. "Dr. Cohen wrote an article that has since become quite famous," he told the jury. "It became famous not because of the contents of the article, but because Dr. Cohen and co-authors, most of whom are on this list, failed to disclose the links to GSK or the other companies in the field that they had."
Some of Cohen's co-authors on this study titled, "Relapse of Major Depression During Pregnancy in Women Who Maintain or Discontinue Antidepressant Treatment," included Lori Atshuler, Vivian Burt, Jeffrey Newport, Zachary Stowe, and Aadele Viguera.
On July 11, 2006, with the headline, "Financial Ties to Industry Cloud Major Depression Study," the Wall Street Journal reported that, "the study and resulting television and newspaper reports of the research failed to note that most of the 13 authors are paid as consultants or lecturers by the makers of antidepressants," and "the authors failed to disclose more than 60 different financial relationships with drug companies."
Most of the authors, the Journal said, were psychiatrists at Harvard's Massachusetts General Hospital, Emory University, and the University of California Los Angeles.
The Journal noted that Cohen was a longtime consultant to three antidepressant makers, a paid speaker for seven, and had research funded by four drug companies. Adele Viguera, associate director of the Mass General perinatal psychiatry program and professor at Harvard, failed to disclose a paid speaking relationship with Glaxo.
Lori Altshuler, director of the Mood Disorders Research Program at University of California Los Angeles, failed to disclose that she was a speaker or consultant for at least five antidepressant makers. "Two of her colleagues -- Vivien Burt and Victoria Hendrick -- were also authors who didn't report financial relationships they have with antidepressant makers," the Journal reported.
In an expert witness report for the Novak Paxil birth defect case, Dr Dee Mangin points out that: "The Cohen study was not a controlled study, used a highly selected population likely to have a high relapse rate and not representative of a primary care patient population."
"In addition," she said, "it is not clear that subjects had a tapered withdrawal, which would increase the likelihood of misclassification of withdrawal symptoms as relapse."
Mangin reports that in the year the study was published, one KOL (with the name redacted), received $72,000 from Glaxo in the first 6 months of 2006 alone, for giving 28 talks, which works out to $2,880 per talk.
The next name on the list read to the jury was Katherine Wisner, "a figure who has published quite extensively on the issue of it being often quite good to treat women of childbearing years and even women who are actually pregnant with antidepressants," Healy said.
"She puts forward the point of view that it may be more harmful to leave the condition untreated," he told the jury.
Charles Nemeroff's name was on page 110. "He was probably the leading figure in the field or the leading person on this list," Healy said.
Zachary Stowe was on page 151, and last name read was Kimberly Yonkers. Healy called her "extremely influential."
Convenient Report Appears
During cross-examination, Varner asked Healy about a report that was co-published in the journals, Obstetrics and Gynecology and General Hospital Psychiatry, in September 2009, the very month that the first Paxil birth defect trial was scheduled to start, which she claimed was a joint statement from the American Psychiatric Association and the American College of Obstetrics and Gynecology.
The report was titled, "The Management of Depression During Pregnancy."
"The purpose of this deliberation," Varner said to Healy, "was to come up with a statement from those two organizations that would assist prescribers in making their decisions about how to treat depression in pregnant women, correct?"
"We do not know that this was endorsed by APA," Healy said. "We don't know if it was endorsed by ACOG."
"We don't know whether it was a collection of individuals who just got together and because they belonged to both APA and ACOG, thought that they could put this kind of title on the piece," he told the jury.
"It's correct, is it not," Varner asked Healy, "that ACOG and APA describe some of the risks that were found (with SSRIs) that were, quote, extremely small and not replicated by other studies?"
"It's not correct to say that at all," Healy said. "APA and ACOG have not said this."
"What you got is a number of authors here who are linked to either APA or ACOG who have said this," he told Varner. "The reason that I make this point is I have been party to processes like this on behalf of the British Association for Psychopharmacology and I can tell you exactly, if you want, how statements like this arise."
"I'm not asking that," Varner stated, cutting Healy off.
In fact, during the trial, the jury saw a January 2009 paper published in the ACOG Journal, by authors from Yale, in which Paxil was number two on a list of commonly prescribed "teratogenic" drugs.
It should also be noted that in 2006, about 30% of the American Psychiatric Association's $62.5 million in financing, came from the pharmaceutical industry, which means the group received close to $19 million from drug companies in 2006 alone.
During Healy's testimony, Varner read a portion of the study that stated: "While some linked database reports find that compared to unexposed offspring, those exposed to Paroxetine during the first trimester are at higher risk. These results are disputed by other reports including several large case cohort studies."
The actual study lists citations to papers that supposedly support this statement, which included papers by Louik and Alwan. On redirect, Tracey asked Healy: "Do those two papers stand for that proposition?"
"No, they don't," Healy said. "They both show an increase in risk with Paxil."
Tracey pointed out that this study "curiously enough came out this month."
"It did," Healy said. "This was quite curious in its own right."
They then went over the names of some of the authors that were not read during Varner's questioning. Authors one and two were Kimberly Yonkers and Katherine Wisner. Healy testified that Yonkers and Wisner are affiliated with Glaxo and Yonkers was part of the women's health advisory board for Paxil. "They have been strongly associated with efforts to change the cultures," he told the jury.
The disclosures for the study showed Wisner was on the speaker's board of Glaxo and Yonkers had received a research grant from Eli Lilly in the past year and had received a study drug from Pfizer for a National Institute of Mental Health trial.
Tracey noted that Glaxo was not mentioned in Yonkers' disclosures. "It's curiously not," Healy said.
A likely explanation for Yonkers' non-disclosure is that she is a member of the DSM-V Task Force and according to the conflict of interest statement on the Task Force website, "Yonkers has agreed that, for the calendar year 2007 and continuing for the duration of her work on the DSM-V Task Force, her aggregate annual income derived from industry sources (excluding unrestricted research grants) will not exceed $10,000 during any calendar year."
Diana Dell and Nada Stotland, the past president of the APA, were also co-authors and online disclosures show them listed as members of Glaxo speaker's bureau.
A website called "Bio-med Experts," contains papers authored or co-authored by Yonkers. A "preview profile" lists Yonkers' co-publications with Katherine Wisner, Viguera Adele, Lori Altshuler, Diana Dell, Nata Stotland and a total of five with Lee Cohen.
She also co-authored 12 papers with Martin Keller, six with John Rush, and several with Allen Schatzberg and Zachary Stowe, all of whom were exposed by Grassley's investigation as not properly disclosing all of their financial benefits from drug companies.
Throughout the trial, Glaxo maintained that it did not market Paxil to women of childbearing years or pregnant women. In fact, in her opening statement, Varner told the jury: "You will hear from that chair the folks who made the marketing decisions at GSK."
"They will tell you that GSK did not, repeat, did not target pregnant women, did not target women of childbearing age," she said.
Yet, in a 2003 supplement titled, "Special Issues Related to the Treatment of Depression in Women," for the Journal of Clinical Psychiatry, Yonkers published an article derived from the teleconference, "Treating Depression: New Choices for a Chronic Problem," supported by an unrestricted educational grant from Glaxo, which promoted the use of SSRIs by women from youth to old age.
In the conclusion section, Yonkers wrote, "SRIs (SSRIs) appear to be an efficacious treatment for women suffering from various depressive disorders throughout the life cycle. These agents have expanded treatment options for many women, especially women who experience intermittent symptoms such as with PMDD, and side effects of SRIs are typically less severe than those of TCAs."
"SRIs appear to improve depressive symptoms in pregnant women and women suffering from postpartum depression, and they are a relatively safe option for breastfeeding mothers," she said. "Additionally, their effectiveness appears to be enhanced by estrogen, making them a favorable treatment option for older women suffering from postmenopausal depression."
In 2004, Yonkers, Cohen, and authors that included two Glaxo employees, published a paper in, "Psychosomatic Medicine," on a study titled, "Paroxetine Controlled Release for Premenstrual Dysphoric Disorder: A Double-Blind, Placebo Controlled Trial."
In the November 1, 2006 issue of "Journal of Women's Health," Yonkers, Cohen and others, published a paper titled, "Expert Guidelines for the Treatment of Severe PMS, PMDD, and Comorbidities: The Role of SSRIs."
This work was supported by an educational grant-in-aid from Glaxo, the disclosure advised. "Several treatment modalities are beneficial in PMDD and severe PMS, but the selective serotonin reuptake inhibitors (SSRIs) have emerged as first-line therapy," the abstract states.
"A burgeoning body of literature has emerged that supports the role of the SSRIs as first-line treatment of PMDD and severe PMS," the authors wrote in the discussion section.
Back in December 2005, Yonkers was out doing damage control for Glaxo when the FDA changed the Paxil pregnancy category from C to D, and warned that, "studies in pregnant women (controlled or observational) have demonstrated a risk to the fetus," and said the FDA "has determined that exposure to paroxetine in the first trimester of pregnancy may increase the risk for congenital malformations, particularly cardiac malformations."
On December 14, 2005, the Washington Post wrote, Kim Yonkers "cautioned that the database studies that the FDA had used had limitations: Unlike controlled studies, Paxil may have been prescribed far more than other drugs, skewing the results."
She also claimed the databases sometimes concealed unrelated medical problems that could alter outcomes, the Post reported.
"Depression is still undertreated," Yonkers said. "Pregnant women in particular are immensely undertreated, and you worry about people being unduly frightened."
Yonkers' September, 2009 report noted that in 2003, approximately 13% of pregnant women took an antidepressant sometime during their pregnancy. There are over 4 million babies born each year in the US, according to the CDC, which means about 520,000 pregnant women took antidepressants in 2003, and that would only cover live births. There is no telling how many infants may have died before birth, as a result of their mother's use of SSRIs.
In 2006, Yonkers became president of the North American Society for Psychosocial Obstetrics and Gynecology, after Diana Dell turned the job down. The April 2006 Spring Newsletter discussed this group's annual meeting, held in Hawaii no less. "The symposia at our 33rd Annual Meeting were fabulous, and we all appreciated the luxurious hotel and beautiful Big Island's many charms," the newsletter stated.
"Kim Yonkers' unending drive, and with significant assistance from Meir Steiner and Claudio Soars culminated in our Sponsors contributing generously towards the symposia," it said. The sponsors listed included the drug companies Berlex, Sepracor, and Wyeth.
Although the judge ruled that Healy could not elaborate on the Nemeroff and Stowe saga, during cross-examination, Varner opened the door a crack by directly asking Healy about the reputations of the various doctors shown to be on Glaxo's payroll.
"The last question I have about the documents that you reviewed with Mr. Tracey yesterday goes to the portion of your testimony when you and Mr. Tracey talked about various doctors who had received honoraria from GSK for various speaking engagements," she said.
"And you listed Doctor Altshuler, Doctor Wisner, Doctor Burt, Doctor Yonkers, Doctor Cohen, Doctor Nemeroff, Doctor Stowe, and Doctor Szuba," she pointed out.
"They are generally respected in the medical community?," she asked Healy.
"The issue of the degree of respect within the medical community is one that's open to question at the moment," Healy said.
"It would be interesting to know what the degree of respect for Doctor Nemeroff or Doctor Stowe in the medical community is at the moment," he added.
The latest news on Nemeroff came on January 4, 2010, when Pharmalot carried the headline: "Charles Nemeroff and the House That Glaxo Built?", and Ed Silverman wrote, "the controversial psychiatry professor who became a subject of a US Senate Finance Committee inquiry into academic research and pharma industry influence, is joining the University of Miami's Miller School of Medicine."
"Of course, this means leaving his previous job at Emory University in Atlanta and so he's just purchased a $1.9 million house in the Coconut Grove section of Miami," Silverman said. "The 5,204-square-foot home has six bedrooms and seven bathrooms," according BlockShopper.
Nemeroff "came to the Senate committee's attention because he was accepting sizeable consulting fees from Glaxo at the same that he was the primary investigator on an NIH-funded grant for research into a Glaxo drug," he pointed out.
"In any event," Silverman wrote, "the new home appears big enough to house plenty of consulting materials."
Amazingly, none of the KOLs or advisory panel members on Glaxo's payroll discussed above, who are so "generally respected in the medical community," according to Varner, were recruited to testify for Glaxo in the first birth defect trial.
Ghostbusting
Yonkers now works at Yale, but she received her medical training at the Columbia College of Physicians and Surgeons, and completed a residency and fellowship at McLean Hospital, Harvard Medical School. Lee Cohen and Adele Viguera are still at Harvard.
The month after the trial ended, in November 2009, Grassley sent letters to ten medical schools asking them to describe their policies on plagiarism and ghostwriting and to identify any complaints or investigations of faculty members dating back to 2004. The Universities included Columbia, Yale, Harvard, Duke, Stanford, Johns Hopkins, University of Pennsylvania, Washington University, University of California at San Francisco, and University of Washington.
"Essentially, the companies are using the reputation of prestigious academic researchers and their institutions to promote the sale of drugs and devices," Grassley said in the letters.
"Articles published in medical journals are widely read by practitioners and are relied upon as being objective and scientific in nature," he wrote. "The information in these articles can have a significant impact on doctors' prescribing behavior and, in turn, on the American taxpayer, as the Medicare and Medicaid programs pay billions of dollars for prescription drugs and medical devices. "
"Any attempt to manipulate the scientific literature, which can in turn mislead doctors to prescribe treatments that may be ineffective and/or cause harm to their patients, is very troubling," Grassley said.
"Students are disciplined for not acknowledging that a paper they turned in was written by somebody else," Grassley said. "But what happens when researchers at the same university publish medical studies without acknowledging that they were written by somebody else?"
Back July 2009, Grassley asked eight medical journals to describe their policies and practices regarding ghostwriting. "Articles published in medical journals are widely read by practitioners and are relied upon as being objective and scientific in nature," he said in letters to the journals. "Concerns have been raised, however, that some medical literature may be little more than subtle advertisements rather than independent research."
On January 3, 2010, the New York Times ran the headline: "Harvard Teaching Hospitals Cap Outside Pay".
"Senior officials at the two hospitals, Massachusetts General and Brigham and Women's Hospitals in Boston, must limit their pay for serving as outside directors to what the policy calls "a level befitting an academic role" -- no more than $5,000 a day for actual work for the board," reporter Duff Wilson wrote.
"Some had been receiving more than $200,000 a year," he said. "Also, they may no longer accept stock. "
As an example, the Times noted that Dr Daniel Podolsky was the original chairman of the Partners policy commission in 2007, when "he was the chief academic officer at Partners and a $191,000-a-year board member at GlaxoSmithKline."
Partners HealthCare is also forbidding speaker's fees from drug companies for any employee, "including nearly 8,000 with Harvard faculty appointments," the Times reported.
On October 13, 2009, the trial of Kilker v Glaxo ended with a Philadelphia jury awarding $2.5 million in compensatory damages to the family of Lyam Kilker, after finding that Glaxo "negligently failed to warn" the doctor treating Lyam's mother about the risks of Paxil and the drug was a "factual cause" of the child's heart defects.
Glaxo's lead attorney at trial was King & Spalding partner Chilton Varner, and the family's lead attorney was Sean Tracey from Houston.
During his opening statement on September 15, 2009, Tracey told the jury that Doctor David Healy is "one of the most, if not the (most) world-recognized expert on pharmaceutical industry influence and the medicine, he is up there in the top five."
Healy "is going to explain to you how GSK corrupted the medical literature," he said, "how they used their money and influence to have doctors that they paid put out literature into the world so doctors ... could read literature that looked like literature, looked like science, smelled like science, appeared to be science, from very important people, people that were on boards, people that were professors, people that published hundreds of articles."
Healy is going to explain to you that what they didn't tell people ... "is, we are paying these doctors to do all these things," Tracey told the jury.
"There is a book, it looks like a telephone book," he said, "of names of doctors, influential doctors, on their payroll, the names of these doctors you will see on this literature that looks and smells like science."
"And just coincidentally, this science that they are going to parade before you, all seemed to help them," he told the jury. "Some of this happened in the last couple weeks before this trial started."
Advisory Panels and KOLs
While testifying, Tracey had Healy explain the concept of key opinion leaders (KOLs) and drug company advisory boards.
"When a pharmaceutical company is bringing a drug to market," Healy said, "a few years before they bring the drug to the market they look at the academic physicians in the field and work out who will be the key people who will be the advocates for the drug."
"They recruit advisory panels for the drug, which will be senior figures within the field who they believe they will be able to depend on to persuade the rest of their colleagues to think seriously about using this drug," he noted.
In explaining a "national" advisory board, Healy said, when "a drug comes to market, they will have a range of senior people in the field, it could be 10 or 12 different people from different parts of the country whom they think are going to be the most influential in helping to get their drug moving within the market here in the U.S. or the U.K."
"Then there is a further group of people down below," Healy said, "who are called the key opinion leaders or KOL for short."
"These, again, are fairly senior doctors," he told the jury. "These are the people whom it is thought will go out and give lectures on the drug to the doctors who are actually doing most of the prescribing of the drug."
In the early 1990s, Healy was on a Paxil advisory board around the time the drug was launched in the UK. People who did not think Paxil was a great product would usually be dropped from the advisory panel, he told the jury.
In fact, Tracey produced a Glaxo memo that stated: "if after this meeting anyone on the advisory board who doesn't passionately believe Paxil's uniqueness for anxiety should quietly be replaced."
Naming Names
During the trial, Tracey wanted Healy to specifically testify about Doctors, Charles Nemeroff and Zachery Stowe, and apparently Glaxo did not want the jury to hear the sordid tale because their attorneys strongly objected.
On September 16, Tracy argued his case to the judge in chambers outside the hearing of the jury. "Doctor Nemeroff is generally considered, or was before his fall from grace, the most powerful man in psychiatry in the United States," Tracey told the judge.
"Doctor Healy is uniquely qualified to talk about Doctor Nemeroff's role in the corruption of medical literature related specifically to Paxil as orchestrated by GSK and Doctor Nemeroff," he argued.
"Same with Doctor Stowe," Tracey said. "Doctor Stowe specifically carried out a campaign to market through GSK or GSK through Doctor Stowe to pregnant women and women of childbearing age."
"I need to show the jury that an enormous amount of money changed hands between Stowe and Nemeroff and others," he said, "and that all of these doctors were on GSK's Paxil advisory board."
"It goes to the credibility of these doctors," Tracey pointed out.
"These are the doctors that are writing the literature that is out there in the peer-reviewed literature that doctors are relying on," he told the judge.
These doctors were required ethically "by their universities to disclose to the Federal Government how much money GSK was paying them," Tracey said. "They did not do that."
He also wanted the jury to know that "Emory University has actually stripped Doctor Nemeroff of his chair over this very issue of failing to disclose payments from GSK," he told the judge.
Tracey wanted to prove these allegations with testimony from Healy about Senator Charles Grassley's investigation of Nemeroff and Stowe and the results that were made public. In the end, the judge refused to allow Healy to testify about the amounts Nemeroff and Stowe were paid by Glaxo, why Nemeroff lost the chairmanship, or the disciplining of Stowe.
"Whether or not Emory had a battle with them about disclosure is not relevant in my mind,"the judge told Tracey. "What is relevant is that they were prominent individuals who wrote in favor of this drug, that they were on the advisory board, that they received honorariums of money, and that he believes in his opinion that these articles are wrong that they wrote."
"He can offer his opinion that they were wrong and why they were wrong," he said. "I am going to keep out the argument about the doctors being sanctioned for failing to disclose."
Nemeroff's "credibility from Emory would involve a mini trial of the issue with Emory and him," the judge said.
The Emory investigation, in fact, found Nemeroff was paid more than $960,000 by Glaxo, from 2000 through 2006, but listed less than $35,000 on his disclosure forms. All totaled, he had earnings of $2.8 million from speaking and consulting arrangements with drug companies between 2000 and 2007, but failed to disclose at least $1.2 million, according to Senate Finance Committee reports.
In 2008, Stowe was the primary investigator for a National Institutes of Health grant where the stated purpose was "to stimulate vigorous debate with the emphasis on the reproductive safety of antidepressant medications," according to a June 2, 2009 letter to the president of Emory from Grassley.
Glaxo paid Stowe $154,400 for fifty-seven promotional talks in 2007. He also received $99,300 from Glaxo in the first ten months of 2008 for thirty-eight talks for antidepressants, according to Grassley.
During a deposition, Stowe testified that around "80% of his Emory salary ($187,000) comes from his NIH grants," the letter notes. His total Emory salary was $232,000.
In a June 11, 2008 statement on the Senate Floor, in describing his investigation, Grassley said, "I have been looking at how drug companies try and influence medical care in America. Companies can do this by, for example, creating studies favorable to their drugs, by hiring doctors to promote their products, and in some cases even intimidating critics of their drugs."
On this date, Grassley was announcing his investigation of Glaxo regarding revelations in reports filed in Paxil suicide litigation by Dr Joseph Glenmullen, showing the company had manipulated the numbers on adverse events related to suicidality in clinical trials all the way back in 1989, before the drug was FDA approved, to make it appear that Paxil did not increase the risk of suicidal behavior when, in fact, trial subjects on Paxil were eight times more likely to attempt or commit suicide than patients taking a placebo.
"So what did GlaxoSmithKline do with these reports?" Grassley said. "Well, the company tried to hide them."
"They went to the judge and asked to have Dr. Glenmullen's report and all the confirming documents placed under seal-that means that no member of the public could see them," he said. "In fact, Glaxo has been doing everything possible to ensure that this information remains under court seal."
"It seems to me that GlaxoSmithKline tried to hide these reports because they seem to demonstrate what the company knew-that Paxil was associated with an increased risk of suicide based on the company's own studies," Grassley noted.
"Essentially, it looks like GlaxoSmithKline bamboozled the FDA," he pointed out.
For easy reference, psychiatric academics identified by Grassley's investigation to date, as not fully disclosing money from drug companies, include Joseph Biederman, Thomas Spencer and Timothy Wilens at Harvard, Charles Nemeroff and Zackery Stowe from Emory; Melissa DelBello at the University of Cincinnati; Alan Schatzberg, president of the American Psychiatric Association, from Stanford; Martin Keller at Brown University; Karen Wagner and A John Rush from the University of Texas; and Fred Goodwin, the former host of the radio show, "Infinite Minds," broadcast for years by National Pubic Radio, before it was thrown off the air.
Paxil All-Star Team
During direct examination of Healy, Tracey introduced an exhibit on a 2002 forum called, "Perspectives on Psychiatry for the Future, Summary of Program Evaluations," along with a list of doctors who gave presentations.
"What I would like to do is use this document to prove that these are a list of doctors that are out promoting Paxil for the defendant, and to have Dr. Healy explain, as he has published, how GSK sought to change the culture of how doctors view Paroxetine and pregnancy," he told the judge.
Tracey went through several of the presentations and named off doctors that included Daniel Christensen, Zachary Stowe, Philip Perera, Dean Hamer, Dwight Evans, Karen Wagner, Katherine Beebe, and Prakash Masand.
Healy said he believed that most of the doctors mentioned were on the Paxil speaking team.
Zachary Stowe was listed for a presentation on the topic of, "Use of Antidepressants in Pregnant and Breastfeeding Women."
Page 10 of the document asked: "As a result of the program, what changes, if any, will you make in your practice?"
Healy testified that after talks at this type of program, the audience will be asked to rate the points that are made. Tracey read some of the comments made by doctors attending the seminar, which included: "Possibly less fearful of treating pregnant women," "Increased comfort in treating pregnant women," "Increase use of Paxil - Will reassess the use or nonuse of SSRIs in pregnant/lactating clients," and "More aggressive in treatment of special population, children and pregnant women."
Healy testified that this document supported his opinion that Glaxo did influence doctors' prescribing practices with respect to Paxil and pregnancy and "they were quite successful at this."
"I don't think you can find a single comment which says, I will be more cautious about treating pregnant women with Paxil," he pointed out.
The jury was also shown a "Protocol" where Stowe had applied to Glaxo for funds to do research on the issue of Paxil in breast milk. Under the objectives for performing the study, there were five possible boxes to check, and Glaxo checked the box for "image enhancement."
Healy knew of no article that ever appeared in peer-reviewed literature or was published in a reputable journal where the author said the purpose of the study was image enhancement. The odds of getting a paper published in a leading journal "would be remote to nonexistent," if you told the journal that the reason for the study was to enhance the image of the drug, he said.
Tracey then introduced a January 10, 2000 email from Jillian, at the Cohn and Wolfe PR firm, to Scott Sproull and others at Glaxo, that showed Stowe was going on a publicity tour and would issue a press release for the Paxil breast milk study on Emory letterhead to lend credibility to the study in the media.
The email stated: "Scott, please review the attached press release and forward me any comments or edits."
"As you may know," Jillian said, "Dr. Stowe is on board for publicity efforts and Sherrie and I are coordinating time to meet with him next week to arm him with key messages for this announcement, which is slated for February."
"We are sending the release for his review at the same time in efforts to secure distribution on Emory letterhead," the email said, "as you know would provide further credibility to data for media."
Healy had never hired PR firms to disseminate his published literature or lent his name to go on publicity tours for drug companies, he told the jury.
Tracy presented another protocol for a Paxil study, with Stowe as the investigator, where the objective checked was again "image enhancement." As a scientist looking at the design of this protocol, Healy said, "this appears to be part of the positioning of Paxil as a drug that will be favorable to women of childbearing years."
The budget for the study showed that Glaxo would pay $600 for each patient enrolled and the cost would be about $9,000.
Prior to 2005, Healy testified, he was not aware that Glaxo "spent any money to actually determine if the drug could be causing birth defects in human children."
Tracey produced another document from a September seminar held in Philadelphia, at which Kimberly Yonkers was speaking to a Women's Health Advisory Board. Healy said Yonkers was a professor of psychiatry from Yale University and she was on Glaxo's Women's Health Advisory Board.
He told the jury that Yonkers was particularly influential "from the point of view of issues to do with women's mental health."
Glaxo's Speed Dial
During the trial, Tracey wanted to use an exhibit that he referred to as a "telephone book," full of influential doctors on Glaxo's speakers' bureau for Paxil and have Healy go through some of the names.
"What I would like to do is put it into the record and have him identify who these people are," Tracey explained to the judge in chambers, outside the hearing of the jury.
"Many of them are influential psychiatrists who have published on Paxil," he said. "I want him to go through seven or eight names so later when the jury hears literature by these authors they will be able to put it into context."
What I am going to do "is show the jury how all-encompassing their strategy for identifying and cultivating psychiatrists were in the country," Tracey said.
"That's part of Doctor Healy's opinion," he said, "how they identified these hundreds of doctors across the country to change the culture that existed."
While Healy was testifying, Tracey introduced the 171 page list and had Healy identify some of the doctors.
Healy testified that Lori Altshuler is "a figure who is very well known in the field of women's mental health and would have written some key articles on the idea that it may be appropriate to use antidepressant drugs for women who are pregnant."
He identified Vivian Burt as "a person who is a fairly big name in the women's mental health field and, again, a person who is an advocate for using antidepressants in women of childbearing years, and in particular, has talked regularly about the use of Paxil for women of childbearing years."
He said Lee Cohen had been on the Paxil advisory board. "Dr. Cohen wrote an article that has since become quite famous," he told the jury. "It became famous not because of the contents of the article, but because Dr. Cohen and co-authors, most of whom are on this list, failed to disclose the links to GSK or the other companies in the field that they had."
Some of Cohen's co-authors on this study titled, "Relapse of Major Depression During Pregnancy in Women Who Maintain or Discontinue Antidepressant Treatment," included Lori Atshuler, Vivian Burt, Jeffrey Newport, Zachary Stowe, and Aadele Viguera.
On July 11, 2006, with the headline, "Financial Ties to Industry Cloud Major Depression Study," the Wall Street Journal reported that, "the study and resulting television and newspaper reports of the research failed to note that most of the 13 authors are paid as consultants or lecturers by the makers of antidepressants," and "the authors failed to disclose more than 60 different financial relationships with drug companies."
Most of the authors, the Journal said, were psychiatrists at Harvard's Massachusetts General Hospital, Emory University, and the University of California Los Angeles.
The Journal noted that Cohen was a longtime consultant to three antidepressant makers, a paid speaker for seven, and had research funded by four drug companies. Adele Viguera, associate director of the Mass General perinatal psychiatry program and professor at Harvard, failed to disclose a paid speaking relationship with Glaxo.
Lori Altshuler, director of the Mood Disorders Research Program at University of California Los Angeles, failed to disclose that she was a speaker or consultant for at least five antidepressant makers. "Two of her colleagues -- Vivien Burt and Victoria Hendrick -- were also authors who didn't report financial relationships they have with antidepressant makers," the Journal reported.
In an expert witness report for the Novak Paxil birth defect case, Dr Dee Mangin points out that: "The Cohen study was not a controlled study, used a highly selected population likely to have a high relapse rate and not representative of a primary care patient population."
"In addition," she said, "it is not clear that subjects had a tapered withdrawal, which would increase the likelihood of misclassification of withdrawal symptoms as relapse."
Mangin reports that in the year the study was published, one KOL (with the name redacted), received $72,000 from Glaxo in the first 6 months of 2006 alone, for giving 28 talks, which works out to $2,880 per talk.
The next name on the list read to the jury was Katherine Wisner, "a figure who has published quite extensively on the issue of it being often quite good to treat women of childbearing years and even women who are actually pregnant with antidepressants," Healy said.
"She puts forward the point of view that it may be more harmful to leave the condition untreated," he told the jury.
Charles Nemeroff's name was on page 110. "He was probably the leading figure in the field or the leading person on this list," Healy said.
Zachary Stowe was on page 151, and last name read was Kimberly Yonkers. Healy called her "extremely influential."
Convenient Report Appears
During cross-examination, Varner asked Healy about a report that was co-published in the journals, Obstetrics and Gynecology and General Hospital Psychiatry, in September 2009, the very month that the first Paxil birth defect trial was scheduled to start, which she claimed was a joint statement from the American Psychiatric Association and the American College of Obstetrics and Gynecology.
The report was titled, "The Management of Depression During Pregnancy."
"The purpose of this deliberation," Varner said to Healy, "was to come up with a statement from those two organizations that would assist prescribers in making their decisions about how to treat depression in pregnant women, correct?"
"We do not know that this was endorsed by APA," Healy said. "We don't know if it was endorsed by ACOG."
"We don't know whether it was a collection of individuals who just got together and because they belonged to both APA and ACOG, thought that they could put this kind of title on the piece," he told the jury.
"It's correct, is it not," Varner asked Healy, "that ACOG and APA describe some of the risks that were found (with SSRIs) that were, quote, extremely small and not replicated by other studies?"
"It's not correct to say that at all," Healy said. "APA and ACOG have not said this."
"What you got is a number of authors here who are linked to either APA or ACOG who have said this," he told Varner. "The reason that I make this point is I have been party to processes like this on behalf of the British Association for Psychopharmacology and I can tell you exactly, if you want, how statements like this arise."
"I'm not asking that," Varner stated, cutting Healy off.
In fact, during the trial, the jury saw a January 2009 paper published in the ACOG Journal, by authors from Yale, in which Paxil was number two on a list of commonly prescribed "teratogenic" drugs.
It should also be noted that in 2006, about 30% of the American Psychiatric Association's $62.5 million in financing, came from the pharmaceutical industry, which means the group received close to $19 million from drug companies in 2006 alone.
During Healy's testimony, Varner read a portion of the study that stated: "While some linked database reports find that compared to unexposed offspring, those exposed to Paroxetine during the first trimester are at higher risk. These results are disputed by other reports including several large case cohort studies."
The actual study lists citations to papers that supposedly support this statement, which included papers by Louik and Alwan. On redirect, Tracey asked Healy: "Do those two papers stand for that proposition?"
"No, they don't," Healy said. "They both show an increase in risk with Paxil."
Tracey pointed out that this study "curiously enough came out this month."
"It did," Healy said. "This was quite curious in its own right."
They then went over the names of some of the authors that were not read during Varner's questioning. Authors one and two were Kimberly Yonkers and Katherine Wisner. Healy testified that Yonkers and Wisner are affiliated with Glaxo and Yonkers was part of the women's health advisory board for Paxil. "They have been strongly associated with efforts to change the cultures," he told the jury.
The disclosures for the study showed Wisner was on the speaker's board of Glaxo and Yonkers had received a research grant from Eli Lilly in the past year and had received a study drug from Pfizer for a National Institute of Mental Health trial.
Tracey noted that Glaxo was not mentioned in Yonkers' disclosures. "It's curiously not," Healy said.
A likely explanation for Yonkers' non-disclosure is that she is a member of the DSM-V Task Force and according to the conflict of interest statement on the Task Force website, "Yonkers has agreed that, for the calendar year 2007 and continuing for the duration of her work on the DSM-V Task Force, her aggregate annual income derived from industry sources (excluding unrestricted research grants) will not exceed $10,000 during any calendar year."
Diana Dell and Nada Stotland, the past president of the APA, were also co-authors and online disclosures show them listed as members of Glaxo speaker's bureau.
A website called "Bio-med Experts," contains papers authored or co-authored by Yonkers. A "preview profile" lists Yonkers' co-publications with Katherine Wisner, Viguera Adele, Lori Altshuler, Diana Dell, Nata Stotland and a total of five with Lee Cohen.
She also co-authored 12 papers with Martin Keller, six with John Rush, and several with Allen Schatzberg and Zachary Stowe, all of whom were exposed by Grassley's investigation as not properly disclosing all of their financial benefits from drug companies.
Throughout the trial, Glaxo maintained that it did not market Paxil to women of childbearing years or pregnant women. In fact, in her opening statement, Varner told the jury: "You will hear from that chair the folks who made the marketing decisions at GSK."
"They will tell you that GSK did not, repeat, did not target pregnant women, did not target women of childbearing age," she said.
Yet, in a 2003 supplement titled, "Special Issues Related to the Treatment of Depression in Women," for the Journal of Clinical Psychiatry, Yonkers published an article derived from the teleconference, "Treating Depression: New Choices for a Chronic Problem," supported by an unrestricted educational grant from Glaxo, which promoted the use of SSRIs by women from youth to old age.
In the conclusion section, Yonkers wrote, "SRIs (SSRIs) appear to be an efficacious treatment for women suffering from various depressive disorders throughout the life cycle. These agents have expanded treatment options for many women, especially women who experience intermittent symptoms such as with PMDD, and side effects of SRIs are typically less severe than those of TCAs."
"SRIs appear to improve depressive symptoms in pregnant women and women suffering from postpartum depression, and they are a relatively safe option for breastfeeding mothers," she said. "Additionally, their effectiveness appears to be enhanced by estrogen, making them a favorable treatment option for older women suffering from postmenopausal depression."
In 2004, Yonkers, Cohen, and authors that included two Glaxo employees, published a paper in, "Psychosomatic Medicine," on a study titled, "Paroxetine Controlled Release for Premenstrual Dysphoric Disorder: A Double-Blind, Placebo Controlled Trial."
In the November 1, 2006 issue of "Journal of Women's Health," Yonkers, Cohen and others, published a paper titled, "Expert Guidelines for the Treatment of Severe PMS, PMDD, and Comorbidities: The Role of SSRIs."
This work was supported by an educational grant-in-aid from Glaxo, the disclosure advised. "Several treatment modalities are beneficial in PMDD and severe PMS, but the selective serotonin reuptake inhibitors (SSRIs) have emerged as first-line therapy," the abstract states.
"A burgeoning body of literature has emerged that supports the role of the SSRIs as first-line treatment of PMDD and severe PMS," the authors wrote in the discussion section.
Back in December 2005, Yonkers was out doing damage control for Glaxo when the FDA changed the Paxil pregnancy category from C to D, and warned that, "studies in pregnant women (controlled or observational) have demonstrated a risk to the fetus," and said the FDA "has determined that exposure to paroxetine in the first trimester of pregnancy may increase the risk for congenital malformations, particularly cardiac malformations."
On December 14, 2005, the Washington Post wrote, Kim Yonkers "cautioned that the database studies that the FDA had used had limitations: Unlike controlled studies, Paxil may have been prescribed far more than other drugs, skewing the results."
She also claimed the databases sometimes concealed unrelated medical problems that could alter outcomes, the Post reported.
"Depression is still undertreated," Yonkers said. "Pregnant women in particular are immensely undertreated, and you worry about people being unduly frightened."
Yonkers' September, 2009 report noted that in 2003, approximately 13% of pregnant women took an antidepressant sometime during their pregnancy. There are over 4 million babies born each year in the US, according to the CDC, which means about 520,000 pregnant women took antidepressants in 2003, and that would only cover live births. There is no telling how many infants may have died before birth, as a result of their mother's use of SSRIs.
In 2006, Yonkers became president of the North American Society for Psychosocial Obstetrics and Gynecology, after Diana Dell turned the job down. The April 2006 Spring Newsletter discussed this group's annual meeting, held in Hawaii no less. "The symposia at our 33rd Annual Meeting were fabulous, and we all appreciated the luxurious hotel and beautiful Big Island's many charms," the newsletter stated.
"Kim Yonkers' unending drive, and with significant assistance from Meir Steiner and Claudio Soars culminated in our Sponsors contributing generously towards the symposia," it said. The sponsors listed included the drug companies Berlex, Sepracor, and Wyeth.
Although the judge ruled that Healy could not elaborate on the Nemeroff and Stowe saga, during cross-examination, Varner opened the door a crack by directly asking Healy about the reputations of the various doctors shown to be on Glaxo's payroll.
"The last question I have about the documents that you reviewed with Mr. Tracey yesterday goes to the portion of your testimony when you and Mr. Tracey talked about various doctors who had received honoraria from GSK for various speaking engagements," she said.
"And you listed Doctor Altshuler, Doctor Wisner, Doctor Burt, Doctor Yonkers, Doctor Cohen, Doctor Nemeroff, Doctor Stowe, and Doctor Szuba," she pointed out.
"They are generally respected in the medical community?," she asked Healy.
"The issue of the degree of respect within the medical community is one that's open to question at the moment," Healy said.
"It would be interesting to know what the degree of respect for Doctor Nemeroff or Doctor Stowe in the medical community is at the moment," he added.
The latest news on Nemeroff came on January 4, 2010, when Pharmalot carried the headline: "Charles Nemeroff and the House That Glaxo Built?", and Ed Silverman wrote, "the controversial psychiatry professor who became a subject of a US Senate Finance Committee inquiry into academic research and pharma industry influence, is joining the University of Miami's Miller School of Medicine."
"Of course, this means leaving his previous job at Emory University in Atlanta and so he's just purchased a $1.9 million house in the Coconut Grove section of Miami," Silverman said. "The 5,204-square-foot home has six bedrooms and seven bathrooms," according BlockShopper.
Nemeroff "came to the Senate committee's attention because he was accepting sizeable consulting fees from Glaxo at the same that he was the primary investigator on an NIH-funded grant for research into a Glaxo drug," he pointed out.
"In any event," Silverman wrote, "the new home appears big enough to house plenty of consulting materials."
Amazingly, none of the KOLs or advisory panel members on Glaxo's payroll discussed above, who are so "generally respected in the medical community," according to Varner, were recruited to testify for Glaxo in the first birth defect trial.
Ghostbusting
Yonkers now works at Yale, but she received her medical training at the Columbia College of Physicians and Surgeons, and completed a residency and fellowship at McLean Hospital, Harvard Medical School. Lee Cohen and Adele Viguera are still at Harvard.
The month after the trial ended, in November 2009, Grassley sent letters to ten medical schools asking them to describe their policies on plagiarism and ghostwriting and to identify any complaints or investigations of faculty members dating back to 2004. The Universities included Columbia, Yale, Harvard, Duke, Stanford, Johns Hopkins, University of Pennsylvania, Washington University, University of California at San Francisco, and University of Washington.
"Essentially, the companies are using the reputation of prestigious academic researchers and their institutions to promote the sale of drugs and devices," Grassley said in the letters.
"Articles published in medical journals are widely read by practitioners and are relied upon as being objective and scientific in nature," he wrote. "The information in these articles can have a significant impact on doctors' prescribing behavior and, in turn, on the American taxpayer, as the Medicare and Medicaid programs pay billions of dollars for prescription drugs and medical devices. "
"Any attempt to manipulate the scientific literature, which can in turn mislead doctors to prescribe treatments that may be ineffective and/or cause harm to their patients, is very troubling," Grassley said.
"Students are disciplined for not acknowledging that a paper they turned in was written by somebody else," Grassley said. "But what happens when researchers at the same university publish medical studies without acknowledging that they were written by somebody else?"
Back July 2009, Grassley asked eight medical journals to describe their policies and practices regarding ghostwriting. "Articles published in medical journals are widely read by practitioners and are relied upon as being objective and scientific in nature," he said in letters to the journals. "Concerns have been raised, however, that some medical literature may be little more than subtle advertisements rather than independent research."
On January 3, 2010, the New York Times ran the headline: "Harvard Teaching Hospitals Cap Outside Pay".
"Senior officials at the two hospitals, Massachusetts General and Brigham and Women's Hospitals in Boston, must limit their pay for serving as outside directors to what the policy calls "a level befitting an academic role" -- no more than $5,000 a day for actual work for the board," reporter Duff Wilson wrote.
"Some had been receiving more than $200,000 a year," he said. "Also, they may no longer accept stock. "
As an example, the Times noted that Dr Daniel Podolsky was the original chairman of the Partners policy commission in 2007, when "he was the chief academic officer at Partners and a $191,000-a-year board member at GlaxoSmithKline."
Partners HealthCare is also forbidding speaker's fees from drug companies for any employee, "including nearly 8,000 with Harvard faculty appointments," the Times reported.
.jpg)
.jpg)
.jpg)
.jpg)
No comments:
Post a Comment