Yes, We Can Pretend We Did It All On Our Own (The MOTHERS Act – How at least $13 to $16.4 million in pHARMa dollars buys a bill)

pHARMa: Putting a price on the lives of American moms and babies

Oh, what did you see, my blue eyed son?
And what did you see, my darling young one?
I saw a newborn baby with wild wolves all around it
I saw a highway of diamonds with nobody on it
I saw a black branch with blood that kept drippin’
I saw a room full of men with their hammers a-bleedin’
I saw a white ladder all covered with water
I saw ten thousand talkers whose tongues were all broken
I saw guns and sharp swords in the hands of young children
And it’s a hard, it’s a hard, it’s a hard, and it’s a hard
It’s a hard rain’s a-gonna fall.

– Bob Dylan

Two days ago, The MOTHERS Act and several other dangerous psych programs passed the house after being stuck in the 2400 page Senate Health Care Bill. Today, President Obama, a former co-sponsor of The MOTHERS Act in the Senate, signed the bill into law.

Two years and two months ago Dr. Ann Blake Tracy, Camille Milke and I, as heads of CHAADA, UNITE, COPES and ICFDA collaborated on a press release to be sent to the public, media and Congress regarding our opposition to The MOTHERS Act. We created a petition and within days we had hundreds of signatures from around the country. I spent the next two months calling people all day and sending emails, writing press releases and trying to update my website with the numerous radio shows where we would spread the word about the fight to save America’s mothers from an invasive government screening program.

Continue reading “Yes, We Can Pretend We Did It All On Our Own (The MOTHERS Act – How at least $13 to $16.4 million in pHARMa dollars buys a bill)”

FAX / CALL REPS IMMEDIATELY – URGENT: Reps Should Remove MOTHERS Act and Other Dangerous Psycho-Pharma Programs From Health Bill

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Update 3/21/10:

Download and print this PDF. Fax the first two or five pages (your choice) to the numbers at the end of the document. Then start calling!!!!!!!!! Stop The MOTHERS Act!!! Stop Health Care Bill!! http://www.box.net/shared/5b7cbk7npu

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http://tinyurl.com/stoppsych

URGENT: Reps Should Remove MOTHERS Act and Other Dangerous Psycho-Pharma Programs From Health Bill

The MOTHERS Act is in the Health Care bill. We need people to start faxing and calling your representatives NOW as a vote is scheduled for this week. Call, fax, or email immediately. Make sure your representative knows to vote NO on Health Care. See below for information on this and other provisions of the bill.

Re: The MOTHERS Act – If you also wish to fax in information on that bill specifically, the PDF is here: http://www.box.net/shared/810kj0b8g7

To find your Representative and get their contact information, go to http://www.congress.org/congressorg/directory/congdir.tt to look them up (you need to enter your zip code). You can also call the U.S. Capitol Switchboard at (202) 224-3121.

The following information on The MOTHERS Act was publicized on a pro-MOTHERS Act website. Note that required screening has been added into the recently passed Senate health care bill in something called the Mikulski Amendment.

“If you are interested in reading the bill’s specific language, you can go to this link and click on “Full Text of Bill as Passed”. The language referencing The MOTHERS Act initiatives can be found on pages 595-604, section 2952 “Support Education and Research for Postpartum Depression.”

Also, the Mikulski Amendment, which includes SCREENING for postpartum depression also passed in another part of the healthcare reform bill. It was actually the FIRST Amendment included in healthcare reform. Finally, women and mothers are being heard.”

Health Care Bill Filled with Psycho/Pharma Industry Agenda

Information: The Health Care Bill undergoing reconciliation is filled with mental health provisions intended to prop up psychiatry as well as the pharmaceutical industry with billions in future income. Though there were some differences in recent Senate and House bills, key mental health components of the recent House bill carried over in both versions (page and section references from recent House version):

MOTHERS Act

The bill includes the language of the MOTHERS Act, to “expand treatment for postpartum conditions” and calls for the development of “improved screening and diagnostic techniques,” but makes no provisions to ensure any entities doing such research are free from conflicts of interest or pharmaceutical funding.  For example, Screening for Mental Health, Inc., and its sub-organization Signs of Suicide, who heavily promote and conduct mental health screening, received $4,985,925 from pharmaceutical companies prior to 2008, and ten leading psychiatric researchers have been exposed in the last year for failing to disclose millions of dollars in pharmaceutical payments.  Yet this bill contains no provisions for full disclosure of conflicts of interest for any “entity” that could receive federal taxpayer funded grants, do research or promotional campaigns – such as the provision in the bill calling for a national PR campaign using TV, radio public and other public service announcements to urge women be screened and seek treatment for postpartum depression.  The bill also calls for “clinical research” for the development of new treatments (drugs), but again, no guidelines for ensuring that any researchers/research entities are free from pharmaceutical funding or conflicts of interest. Section 2529, Page 1418

Mental Health Parity

The bill mandates Mental Health Parity, or equal insurance coverage for mental disorders as what are covered for physical diseases, whether under their regular health insurance or whether a person gets their new coverage through the Health Insurance Exchange.  Psychiatric patients are traditionally “cured” when their insurance benefits run out.  In this bill, those benefits never run out.  Considering there are no medical tests to verify the existence of any psychiatric disorder, and without anything other than a psychiatrist’s opinion about whether or not the person’s “illness” is “cured,” this legislation becomes nothing more than taxpayer funded billions to the psycho/pharmaceutical industry who will continue their jihad of mass drugging of Americans.  This provision could easily encompass all 374 diagnoses in psychiatry’s diagnostic manual, covering everything from Phase of Life Problem to Arithmetic Disorder.  Section 214, Page 100

Home Visitation Programs for Families with Young Children or Families Expecting Children

The bill creates a home visitation program for families with young children or which are expecting children or who have certain “risk factors.”  The program provides assessments regarding matters of “age appropriate behaviors,” for children, prevention of family violence and referral to outside services.  – Section 1904, Page 1177

School Based Health Clinics

The bill includes funding for School Based Health Clinics that will include subjective psychiatric mental health screening (called mental health assessments) of children, and “referral to a continuum of services including emergency psychiatric care, community support programs, inpatient care, and outpatient programs” as part of their “comprehensive primary health services.”  This is a direct feeder line for the psycho/pharmaceutical industry directly into our schools. – Section 2511, Page 1352

Wellness Program Grants for small employers

The grants in the bill serve as an incentive for employers to include “mental health” as part of the Wellness Program Grants to businesses.  Part of the program entails a “Behavioral Change Component” that encourages “healthy living through counseling” and may include programs relating to “tobacco use, obesity, stress management, depression and mental health.” – Section 112, Page 67

Federally Qualified Behavioral Health Centers

The bill creates new “Federally Qualified Behavioral Health Centers” and in order for existing community mental health centers to qualify, they have to provide, among other things, “mental health screening, assessment, and diagnosis,” as well as “outpatient clinic mental health services, including screening, assessment, diagnosis, psychotherapy and medication,” in addition to “crisis mental health services including 24-hour mobile crisis teams.”  – Section 2513, Page 1367

Your voice needs to be heard in Washington on this outrageous bill. Call, fax, or email your Representative and tell them that you are opposed to the above points in the Health Care Reform bill. To find your Representative and get their contact information, go to http://www.congress.org/congressorg/directory/congdir.tt to look them up (you need to enter your zip code). You can also call the U.S. Capitol Switchboard at (202) 224-3121.

50 Years Ago Thomas Szasz Rocked The World of Psychiatry: The Difference Between A Disease and a Disorder

50 Years Ago Thomas Szasz Rocked The World of Psychiatry: The Difference Between A Disease and a Disorder

By Dr. Jeffrey Schaler
Assistant Professor of Justice, Law & Society

The Myth of Mental Illness by Thomas Szasz

It is fifty years now since Thomas Szasz rocked the world of psychiatry by writing The Myth of Mental Illness: Foundations of a Theory of Personal Conduct. His work continues to have a profound impact on how we think about disease, behavior, liberty, justice, responsibility, and most important of all, what it means to be human.  Szasz has shown us how the idea of mental illness is used by the state to deprive innocent people of freedom, and guilty persons of justice.  Without the state involved, the medicalization of behavior means nothing.

He has shown us how the idea of mental illness functions as legal fiction within our legal system. In this sense, the idea of mental illness has been used much as the idea that African American slaves were considered three-fifths of a person. Persons labeled as mentally ill are now considered three-fifths of a person. It is as if there was a postscript at the bottom of the Bill of Rights that reads: “PS: For mentally healthy people only.”

The courts will not allow the idea of mental illness to be disproved, in much the same way that the idea that slaves could be three-fifths person was not allowed to be disproved. Today, mental illness as legal fiction maintains the institution of psychiatric slavery.

Read more…

Over Six Hundred and Counting – Paxil Birth Defect Cases by Evelyn Pringle

Over Six Hundred and Counting –  Paxil Birth Defect Cases
by Evelyn Pringle

Since Paxil came on the market in 1992, there have been three separate types of failure to warn lawsuits filed against GlaxoSmithKline over Paxil; birth defects, suicide, and addiction.

Roughly 150 suicide cases were settled for an average of about $2 million, and about 300 cases involving suicide attempts were settled for an average of $300,000, according to a December 14, 2009 report by Bloomberg News. Glaxo paid an average of about $50,000 each to resolve about 3,200 cases linking Paxil to addiction problems. The drug giant has also paid about $400 million to end antitrust, fraud and design claims, Bloomberg reports.

All total, Glaxo has paid out close to $1 billion to resolve Paxil lawsuits since the drug came on the market in1992. The company’s provision for all legal matters and other non-tax disputes as of the end of 2008 was listed as $3.09 billion in its annual report.

The first birth defect trial, in over 600 cases filed, resulted in a verdict for the plaintiffs on October 13, 2009, and an award of  of $2.5 million in compensatory damages for the the family of Lyam Kilker, who was born with three cardiac birth defects after his mother took Paxil while pregnant.

In the Kilker trial, Glaxo’s lead attorney was King & Spalding partner, Chilton Varner, and Sean Tracey, from Houston, led the family’s legal team.

Andy Vickery, of the Houston firm of Vickery, Waldner and Mallia, is the lead attorney in several Paxil birth defect cases.  The first case set for trial is unique in that it involves, Delaney Novak, an infant born with heart defects on April 4, 2002, to Laura and Derek Novak, after Laura was prescribed Paxil off label for migraine headaches.

The Novak case is also unique among the Paxil birth defect cases because Delaney’s parents had their insurance with United Healthcare, and Laura was part of the study that Glaxo contracted for, which resulted in the initial warning letter about birth defects in September 2005.

According to Vickery, Glaxo conducted a study on Wellbutrin (bupropion), another antidepressant, after discovering a possible link to birth defects. “The review found no problems with Wellbutrin, but discovered that a significant number of mothers who had been prescribed Paxil (nearly twice as many as those who had not taken the drug) had children born with heart defects,” he says.

Doctors Ra-id Abdulla, David Healy, Shira Kramer and Suzanne Parisian testified as the experts for the plaintiffs in the first trial. All told the jury they believed Paxil caused Lyam’s heart defects. Doctors Abdulla, Healy and Kramer are also expert witnesses in the Novak case.

Ingenix Study in First Trial

The Ingenix study, with lead researcher, J Alexander Cole, was conducted using data from the Ingenix Research Data Mart, containing insurance information from UnitedHealthcare. The study was not supposed to look at Paxil.

During the testimony of several witnesses in the first trial, the jury was shown a February 7, 2003 email in which Glaxo employee, Graham Cottam, stated that he had informed Anne Bell, the project leader for Paxil, about plans to do the Ingenix pregnancy study on Wellbutrin, and “Anne wanted to be sure that we will not be looking specifically SSRIs or Paxil.”

Doctor Suzanne Parisian, a former FDA scientist, testified that the initial 2002 proposal was “to do a large database study for Bupropion in pregnancy.”

There was “nothing that addresses Paxil,” she told the jury. The “procedure had never been designed to specifically look at Paxil.”

But when the data was broken out for Paxil in the original study, it “showed the increased risk and the pregnancy was changed to Category D,” she explained.

The FDA later requested that Paxil be studied, according to the testimony of Glaxo employees and documentation, she said.

The famous neuropyschopharmacologist and professor of psychiatry from Cardiff University in Wales, Dr  David Healy, explained that Glaxo had hopes that the study would show Wellbutrin as an antidepressant that did not cause birth defects and the company could apply to the FDA to have it classified as a pregnancy category B drug instead of a C.

“It would give the message,” he said, “that this of the drugs we have available to use for women of childbearing years, this would be one of the safer ones.”

Healy told the jury that there was “no reason from the scientific point of view why they would not want to also look at Paxil.”

“And this appeared to be the FDA’s view,” he said, “because FDA said, well, you looked at Bupropion, why don’t you look at Paxil, also,” a couple years later.

When asked whether by the year 2003, he could think of any scientific reason not to do a pregnancy study with Paxil, Healy replied, “No, I can’t.”

In fact, Tracey showed the jury an internal company email written by a Glaxo employee two years later in August 2005, around the time that the results on Paxil from the Ingenix study came out, who asked the question: “Why hasn’t the company gathered data on this until now, 13, I think, years after the product was approved?”

In the case of the study on Wellbutrin, there were only 16 reports of birth defects that indicated there was a signal to do the study, Parisian told the jury. While an internal analysis conducted by Glaxo on Paxil in 2000, showed 79 cases of birth defects.

In September 2005, the conclusions of the Ingenix study were: “The use of paroxetine in the first trimester of pregnancy was associated with an increased risk of congenital malformations compared with other drugs.”

“To your knowledge, prior to 2005 did GSK ever do a single epidemiological study to determine whether or not Paxil caused birth defects?” attorney, Adam Peavey, asked Parisian.

“Not that I have seen,” she said.

Ingenix Downside

During the testimony of Dr Shira Kramer, an epidemiologist, Tracey put up a slide on the Cole paper that was published in 2007.

The paper was on a study conducted by epidemiologists who were employed by Glaxo to do the research, Kramer explained. It was a continuation of the Ingenix study that looked at Wellbutrin and then Paxil. One of the co-authors was Sara Ephross, an employee of Glaxo.

Kramer was asked to explain the importance of the Cole study. “First of all,” she said, “it was a cohort study comparing … people exposed to Paxil … to people who were exposed to other SSRIs.”

“So one very key thing for you to remember is that here the … unexposed group is not people who were not exposed to SSRIs, they were exposed to SSRIs,” she told the jury.

“That’s a very important point,” she said, “because if SSRIs are a risk factor for cardiac defects, birth defects, then the relative risk that will be generated in this study is going to be lower than it normally would if truly people were unexposed to SSRIs.”

“The other thing that is important to keep in mind,” she told the jury, “is that the information was obtained from an administrative claims database called the Ingenix Research Data Mart. “

“There was no individual, either examination or interviewing of anyone,” she explained. “The information was extracted from administrative claims data that was available.“

“The other thing that’s important,” she said, “is that initially the population that was studied covered the years 1995 to 2002, and then after the fact an additional two years were added to the study.”

“The published results, based on all of the years that were eventually included in this study, were an odds ratio for all cardiovascular malformations related to Paxil exposure of 1.46, which means that individuals who took Paxil were at 46 percent increased risk of their child having a cardiovascular malformation diagnosed at birth compared to individuals who took other, other SSRIs,” Kramer explained.

“In the second odds ratio of 1.68,” she said, “showing a 68 percent increased risk, now we are comparing women who took Paxil either alone or in combination with another SSRI, compared to the other SSRI group, either alone or in combination with other SSRIs, mono- or polytherapy.”

The published study contained an asterisk that said: “An interim analysis performed by Cole, et al, using births occurring between ’95 and 2002 found an odds ratio of 2.0 for the association between first trimester Paxil use and cardiac birth defects.”

Kramer was asked to explain what that statement was referring to. “Initially, the study was designed to include the years 1995 through 2002 with a sampling ratio of controls to cases of 7 to 1,” she said. “That was the protocol.”

“And when that analysis was done, the odds ratio, instead of being 1.46, which ultimately is what was published, was actually higher, it was 2,” she told the jury.

“That means that the exposed group had a risk of a child with a cardiac malformation two times that of the group not exposed to Paxil,” she added.

The odds ration got smaller when the Glaxo researchers, the authors of the study, “added in two additional years of data with a different sampling ratio,” Kramer explained.

It is not appropriate for an epidemiologist to do that, she said, because “you are changing the rules after you look at the data.”

It “really raises the questions as to, are you trying to influence the data,” she noted.

“I can say very clearly,” she told the jury, “that that is not considered to be appropriate conduct, scientific conduct. “

“What you are supposed to do is set up a study protocol in advance and follow it, and not change it after you have looked at the results,” Kramer explained.

It is not appropriate to find out the results and change it in the middle, she said, “for obvious reasons, it looks like you are manipulating the data to make it come out looking a certain way.”

“And if you want to do an unbiased, fair study,” she told the jury, “the only appropriate plan of action is to develop a study protocol ahead of time, to follow it, and to analyze the results and not to fool with it, not to fiddle with it and not to change it.”

While testifying, Kramer explained the meaning of “underpowering” a study. You need to have “a sufficient number of people in a study in order to test a certain research question,” she said.

“And if you are going to apply statistical tests to the data that you generate,” she told the jury, “you need to have enough people in that study to have generated enough cases of the outcome and you need to have enough people who are exposed.”

“Now, this case,” she said, “we have got a relatively rare exposure to Paxil, we have a relatively rare outcome, which is congenital cardiac birth defects, so you need to study very, very large populations in order to achieve statistical significance at these levels that we have been discussing.”

She said the “investigators, the research team,” dictates the size of the study.

Kramer went over the reasons why the odds ratio in the Cole study might be attenuated, or lower. It’s “very clear that there are certain characteristics of this study that are making this odds ratio probably lower than it really would be given certain characteristics of the study design,” she told the jury.

“One of the them is that the controls are really not unexposed to the SSRIs,” she said. “They are exposed to drugs in the same class.”

We have “observed in epidemiological literature that other SSRIs are associated with an increased risk of cardiac malformations,” she told the jury. “Therefore, it is likely that since that’s the comparison group, we have got an odds ratio in this study that’s lower than it probably would be.”

The second reason was that the analysis only included live births. “So you are missing fetuses who were miscarried,” she said. “And then there are many miscarriages that are due to birth defects.”

“You are missing fetuses that are aborted, electively aborted, because of known cardiac or other congenital malformations,” she told the jury. “You are missing stillbirths.”

And with a follow up for only nine months, she said, “you are missing congenital cardiac defects that aren’t detected until later.”

“So you have got a fairly substantial population that is not really being captured in this study of exposed fetuses,” she pointed out.

Closing Recap

During closing arguments, Tracey reminded the jury about the email with Anne Bell’s statement to make sure Paxil was not included in the Ingenix study, and said: “This document … two years before this child is born, they are affirmatively saying: We do not want to look at Paxil in pregnancy.”

In her closing argument, Varner told the jury: “Now, Mr. Tracey has talked to you about Anne Bell this morning.”

“He has said that GSK would have done anything to avoid looking at the risk for Paxil,” she pointed out.

“Well, ladies and gentlemen,” Varner said, “GSK funded the study that did look at Paxil for the risk and published preliminary findings in August of 2005.”

As soon “as even a possible link emerged in all of 2005, GSK reacted promptly and proactively to notify both FDA and doctors,” she told the jury.

“It went immediately to FDA. It immediately changed its label,” she said. “And it immediately sent out letters to doctors telling them about the changes.”

In his final summation, Tracey told the jury, “I want to talk to you about the Ingenix study because Ms. Varner said something that is very, very important.“

“She said when they found out what she says is August of 2005, within 21 days, they changed the label. Within 21 days, the doctors got the news,” he recounted.

What “she forgets to tell you is that two years prior to this, Anne Bell said, Don’t study the drug,” Tracey told the jury.

“Had they not listened to Anne Bell,” he said, “had they studied the drug in 2003, Michelle David wouldn’t be sitting here because the warning would have gone out like that.“

“We would have been two years ahead of the game,” he pointed out.

“GlaxoSmithKline did not want to study the drug,” Tracey told the jury. “The FDA made them study Paxil.”

“It was not some sort of voluntary we’re just a good drug company trying to get along,” he said. “It was we don’t want to study it and they’re forcing us to study it.”

Paxil Off-Label Promotion

Paxil is not FDA approved for use by pregnant women, so all mothers who gave birth to infants with heart defects received the drug off label. In Andy Vickery’s first case set for trial, Delaney Novak was born with heart defects after his mother, Laura, was prescribed Paxil for migraine headaches, another unapproved use.

Dr Dee Mangin is an expert witness in the Novak case. Her research and published work has focused on rational prescribing, and the influence of drug company promotion both to physicians and direct to consumers. She submitted a report on October 13, 2009, which outlines Glaxo’s off label promotion of Paxil around the time of Laura’s pregnancy.

In her report, Mangin defines off-label use as the “practice of prescribing drugs for a purpose outside the scope of a drug’s approved label – often an unproven use or one that has not been widely tested.”

“While it is legal to prescribe off label in the United States, it is illegal for companies to promote off label use,” she notes.

“The risks of off label promotion,” she says, “are that it could lead to exposure of patients to the risks of a medicine for no benefit, and furthermore they maybe denied other more effective treatment.”

“GlaxoSmithKline from 2000,” Mangin says, “mounted a multifaceted and targeted national promotional campaign that employed explicit strategies designed to promote sales of Paxil in pregnant women and women of reproductive age.”

An exhibit cited in the report from a “Paxil Tactical Marketing Plan in 2000,” states: “New Paxil data with high media interest, hot flash, postpartum, depression, pregnancy, and lactation will position Paxil as the drug of choice for women.”

“One of the known reasons that physicians change their prescribing behavior is as a response to the volume of evidence containing the same message that the physician is exposed to,” she wrote. “The so-called “Carpet Bombing” technique used in the Paxil campaign feeds directly into this.”

“There are a number of strategies companies can use to highlight use for off label conditions including distribution of individual scientific articles discussing the off label indication and use of the drug as well as mentions of off label use by key opinion leaders in continuing medical education,” the report explains.

“In relation to the off label prescribing for migraine,” Mangin says, “there is no evidence of any effectiveness over placebo for SSRIs in migraine prevention.”

Yet a paper titled, “Paroxetine in the Treatment of Chronic Daily Headache,” by Carol  Foster, MD, and Jacklyn Bafaloukos, RN, that was distributed to doctors, specifically states: “The dramatic improvement in the patients in our study suggests that paroxetine appears to be a safe and effective drug for the treatment of chronic daily headache.”

“The strategies outlined where reprints about treatment of migraine with paroxetine, large numbers of form letters containing summaries of studies of use in headache were sent to physicians and detailing and providing free samples to physicians likely to treat women with migraine were therefore encouraging use of Paxil and exposure to its risks when in reality it is no more effective in this situation than a sugar pill,” Mangin reports.

Encouragement “of unapproved use for migraine further attempted to expand the market beyond that which was medically justified and likely to lead to unnecessary exposure to the risks of Paxil,” she advises.

In an August 11, 2009 deposition, Laura’s doctor testified that Glaxo sales representatives would commonly leave reprints of articles on off label uses and salespeople did discuss the literature on the off label use of Paxil for migraines with him. One of the sales representatives visiting the doctor at the time stated in a deposition that it was his habit to distribute all such articles.

But most importantly, the doctor said he would not have prescribed Paxil to Laura had Glaxo told him back in 2000, or early 2001, that there was an association between Paxil and birth defects. He further noted that there was no benefit from Paxil that would outweigh the risks of birth defects and that he had not used Paxil in his practice since the Dear Doctor letter warned about birth defects.

Delaney suffers from a septal heart defect. “None of the information from the medical records of the family or their statements on potential genetic, environmental and pharmaceutical causes of heart defects indicates any other factor more likely to have caused her condition than the Paxil exposure,” Mangin points out.

“It is clear that if the prescribing doctor had been informed of the risk of heart defects, Laura Novak would not have been exposed to Paxil,” she notes.

In the report’s conclusion, Mangin states: “It is my opinion that this promotional campaign for Paxil was inappropriate given the scientific knowledge and what was known by the company at the time.”

“The degree of comfort with the use of this medication in the reproductive years and pregnancy is likely to be influenced by GSK’s misleading promotional campaign where concerns were minimized, efficacy was overstated, the idea of off label prescribing was seeded for migraine, and lastly the marketing specifically targeted a group at higher risk in terms of safety concerns – pregnant women and women in the reproductive age group,” she reports.

“This Paxil promotional campaign was irresponsible, and potentially disastrous from a public health perspective as it was likely to expose a much greater proportion of the population to these potential harms,” she concludes.

Glaxo’s Phone Book

During closing arguments on October 8, 2009, Tracey told the jury regarding Glaxo: “They have a telephone book full of doctors.”

Referring to an exhibit introduced during the trial, he said: “This is all the doctors that they pay to give speeches on their behalf to push their drug, to sell it, to convince other doctors to prescribe their drug.“

While Healy was testifying, Tracey had him go over some of names of doctors in the book that included Lori Altshuler, Vivian Burt, Lee Cohen, Charles Nemeroff, Jeffrey Newport, Zachary Stowe, Katherine Wisner and Kimberly Yonkers.  None of these doctors appeared to testify on Glaxo’s behalf in the trial.

What “they did was aggressively market this drug to women,” Tracey told the jury.

All “these names of people that they ghost-wrote articles for to get the doctors … to sell the drug,” he noted.

Doctor Healy told you that “they altered the prescribing practices in this country,” he recounted. “What they set out to do, they succeeded in doing. They got doctors to prescribe the drug to women.”

“And they did it,” Tracey said, “by having seminars where they would put these doctors, experts in the field, on their payroll, that the doctors would go and listen to, unwittingly knowing what they are really hearing is a marketing campaign.”

In reference to another exhibit viewed during the trial, Tracy said: “This document describes that it worked. When the doctors came out, these are the comments they made after attending these seminars: Will prescribe Paxil to pregnant women. My comfort in treating depression in pregnancy has increased. Treating pregnant patients with confidence. Will feel more comfortable giving Paxil to pregnant women.”

In citing $765 million in the US alone, between 1997 and 2005, Tracey told the jury: “This is the number for over a nine-year period this company spent to convince doctors to sell their drug, to prescribe their drug to women of childbearing years.”

“And they got a heck of a return on it,” he said. “Net. After expenses. Almost 14 billion dollars for a nine-year period.”

“Out of the 700 million dollars they spent trying to sell this drug to people,” Tracey stated, “there is not one shred of evidence in the record about how much money they spent to try to figure out whether it was going to induce birth defects.”

“And as far as I can tell in the record,” he said, “after they bought it, they did one animal study and they didn’t spend another penny.”

Evelyn Pringle

(The Paxil Birth Defect Litigation Update Series is sponsored by the Houston law firm of Vickery, Waldner and Mallia at http://www.justiceseekers.com )

(Evelyn Pringle is an investigative Journalist and Researcher focused on exposing corruption in government and corporate America)

Ghostbusting in Paxil Birth Defect Litigation by Evelyn Pringle

Ghostbusting in Paxil Birth Defect Litigation
by Evelyn Pringle

A month before the first Paxil birth defect trial against GlaxoSmithKline was set to begin, the Associated Press ran the headline, “Glaxo Used Ghostwriting Program to Promote Paxil,” in reporting on a program called “CASPPER,” which allowed doctors to “take credit for medical journal articles mainly written by company consultants.”

“Drug companies frequently hire outside firms to draft a manuscript touting a company’s drug, retain a physician to sign off as the author and then find a publisher to unwittingly publish the work,” the Associated Press said on August 19, 2009. “Drug company salespeople often present medical journal articles to physicians as independent proof that their drugs are safe and effective.”

Between 2000 and 2002, articles from the CASPPER program appeared in five medical journals. On August 21, 2009, Jim Edwards on BNET, described the CASSPER ghostwriting brochure. The document shows that the intent of CASSPER was to flood the market with ghostwritten information, he said. It stated: “Paxil Product Management has budgeted for 50 articles for 2000.”

The trial in Kilker v Glaxo ended on October 13, 2009, with a jury in Philadelphia finding that Glaxo “negligently failed to warn” the doctor treating Lyam Kilker’s mother about Paxil’s risks and the drug was a “factual cause” of Lyam’s heart defects. The family was award $2.5 million.

Ghostwriting 101

The world-renowned neuropsychopharmacologist from the UK, Dr David Healy, testified as an expert witness for the plaintiffs in the Kilker trial.

While testifying, Healy explained the process of ghostwriting to the jury.  He said ghostwriting probably began seriously in the 1980s. “It’s where an article appears under the name of usually a fairly distinguished person in the field,” he testified.

But it involves more than just the true author being concealed, he told the jury. “It’s a process where the ghostwriters work for companies who are very good at getting articles into the best journals in the field, like the New England Journal of Medicine, and recruiting some of the best known names in the field to be the apparent authors of the articles.”

“They may come from one of the big named universities like Princeton or whoever, but the actual fact the person who appears to be the author isn’t the true author,” he said. “If you were to read the article, you often don’t get any hints of who the true author of the article actually was.”

Ghostwriting impacts doctors in the real world trying to make decisions on whether to prescribe a drug in several ways, Healy told the jury. For instance, he said, if he was doing his own writing, he “would write an article on the drug, warts and all.”

“But if the article has been written by a ghostwriter working for one of the pharmaceutical companies,” he said, “the chances are the warts are somehow going to vanish.”

“The article will talk about the good aspects of the drug and will leave out the risky issues which are probably the most important things for the practicing doctor to know,” he explained.

If the ghost author comes from an extremely distinguished university, doctors reading the article will think it has to be right, he said. “The simple fact that the article is going to be apparently written by this big named person and appears in an extremely good journal means that most average doctors will think this has to be true,” he told the jury.

It’s not just the case of the doctor who reads the article being deceived, he said. “It’s the fact that the credibility of the institution is and the name is being used to sell the drug, as well.“

Healy came face-to-face with ghostwriting when one of the drug companies offered to ghostwrite his articles, he said. Since then, he has researched the ghostwriting process to assess how common it is.

The assessment found that “at least half, maybe more, of the articles that appear in major journals under the names of the best known people in the field, are ghostwritten when they have to do with pharmaceutical drugs,” he told the jury.

“If they have to do with the drugs that are being sold at the moment, the ones that are fashionable at the moment, then these articles are highly likely to be ghostwritten even when they appear in the very best journals,” Healy said.

Ghostwriting Up Close

While testifying, Healy told the jury that he was familiar with companies that Glaxo hired to ghostwrite literature and put other doctors’ names on it. “I think the leading firm in the field was one called STI,” he said. “This stands for Scientific Therapeutics Information.”

The jury was shown a July 28, 2003, document sent to the Glaxo product manager for Paxil, by Sally Laden, working for STI, which stated: “Thank you for offering me the chance to work with you to write two review articles.”

“This letter summarizes my fees for this project,” Laden wrote. “The safety paper is priced higher because of a greater number of named authors and the anticipated additional work involved in assessing the CR data in progress.”

For the development of the manuscript, and up to five drafts, the price quoted was $12,000. One of the topics for a manuscript was on the safety of antidepressants in breast-feeding.

“The first draft will be the first run through the material,” Healy told the jury. “She will have put the article together laying out the issues, laying out the references, structuring the paper up in the way that the journal she actually expects that this paper is going to go to will want the article structured.”

Draft 2 goes back to Glaxo again and the author, whoever is actually going to put their name on the paper. Then draft 3 goes back to Glaxo and the author for sign-off, and then there will be a final version that goes to the journal, Healy explained. Then draft 5 is revisions from journal reviewers, he said.

He noted that Laden said the safety paper is more expensive because there was going to be more authors. “I should emphasize that more authors here does not mean more authors writing the paper,” Healy told the jury. “It means more names appearing on the authorship line.”

“She has to recruit people and the people whose names are on the authorship line get paid for being authors,” he explained.

Sally Laden’s “name has appeared on a range of different articles that have been produced for GlaxoSmithKline, not just on the issue of giving drugs to women of childbearing years but across the board,” Healy said.

During Healy’s testimony, the family’s lead attorney from Houston, Sean Tracey, introduced the actual manuscript by STI. “This is an article that is going to go to a journal,” Healy said. “It has been authored by Ms. Laden, contrary to what appears there.”

The names Zachary Stowe and Jeffrey Newport appeared on the authorship line. Healy noted that Draft 4 stated: “Final article cover page to be removed.”

“The cover page will be removed,” he explained, “because the journal will treat the article quite differently if they think that the true author is not on the authorship line.”

Healy said the paper was an example of ghostwriting. “It is going to go to a journal called Psychopharmacology Bulletin,” he testified. “And in this particular issue of the journal where this paper later comes out, every paper in that issue of the journal has to do with Paxil.”

The jury was then shown the actual article that was published and it was the exact same article but without Laden’s name on it.

Healy testified that Stowe runs the women’s mental health program at Emory University and publishes on SSRIs and women’s health issues, with publications favorable to Paxil, and also gives seminars and talks for other doctors which outline “how it can be a good thing to treat women of childbearing years with Paxil.”

He was not allowed to tell the jury how much Glaxo had paid Stowe over the last year or two, which was revealed by an investigation led by Iowa Senator, Charles Grassley, as the ranking Republican on the US Senate Finance Committee. The amount Stowe got paid “is not public knowledge where you can show me a document that says it,” the judge said.

However, Stowe’s Glaxo earnings are most certainly public knowledge.  A google search in December 2009, with the following three key words in quotes, “Stowe” “GSK” “paid,” brought up 15,800 hits.

On June 10, 2009, in reference to Stowe, the Wall Street Journal reported, “Emory University has disciplined a prominent psychiatrist who was being paid by an antidepressant maker at the same time he was conducting federal research about the use of such drugs in pregnant women.”

The National Institute of Mental Health said “it is reviewing Stowe’s activities, prompted by a letter from a U.S. Senate committee that said Stowe received $253,700 in 2007 and 2008 for “essentially promotional talks” for the drug maker GlaxoSmithKline,” the June 11, 2009 Atlanta Journal-Constitution reported.

The charts with dates for Stowe’s promotional talks reveal that many times he gave two talks for Glaxo on the same date and made five grand per day, in addition to payment for all traveling expenses. On one date, he billed $96 for meals alone.

For ready reference, the list of academics in the field of psychiatry identified by Grassley’s investigation thus far, as not fully disclosing money from drug companies, includes 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.

The supplement to the Spring 2003, “Psychopharmacology Bulletin,” found online, sure enough shows the ghostwritten paper, “Clinical Management of Perinatal Depression: Focus on Paroxetine,” with the names Stowe and Newport, along with papers by Martin Kelly, Charles Nemeroff, Alan Schatzberg, Karen Wagner, and Kim Yonkers, for a total of fourteen Paxil papers altogether.

Under “Disclosure,” the article ghostwritten by Laden stated: “This work was supported by an unrestricted educational grant from GlaxoSmithKline. Doctor Stowe serves as scientific advisor for and receives research grants from Pfizer and GlaxoSmithKline. He also receives grant support from Wyeth.”

The disclosure that the work was supported with a grant from Glaxo would not tell a doctor reading the paper that it was actually written by somebody else, Healy said.

While testifying, Healy explained that an “unrestricted educational grant, if I were to receive one, it would assume that I am saying things that are relatively favorable to the pharmaceutical company who has given me the educational grant.”

“If I am saying things hostile to the drug,” he said, “I will not get an unrestricted educational grant, although the word “unrestricted” suggests that I should.”

Stowe’s undisclosed income above was from Glaxo alone. In August 2007, he was listed as an author on a study titled, “Atypical Antipsychotic Administration During Late Pregnancy,” in the American Journal of Psychiatry.

According to the disclosure section, Stowe has received research support from Glaxo, Pfizer, and Wyeth, has served on advisory boards for Glaxo, Wyeth, and Bristol-Myers Squibb, and has served on speaker’s bureaus and/or received honoraria from Glaxo, Lilly, Pfizer, and Wyeth.

The second author on the ghostwritten paper, Jeffrey Newport, is the associate director of Emory’s Women’s Program. Newport was also an author on the “Atypical Antipsychotic” study. He has received research support from Glaxo, Lilly, Janssen, the National Alliance for Research on Schizophrenia and Depression, NIH, and Wyeth, and, he has served on speaker’s bureaus for Glaxo, AstraZeneca, Lilly, Pfizer, and Wyeth, according to the disclosures.

The next person the jury heard about was Charles Nemeroff. He was also an author on the atypical study. Nemeroff was the Chief of Psychiatry at Emory, until he lost the position last year, Healy told the jury. “He’s possibly best known or was the best known psychiatrist in the United States.”

“He influenced an awful lot of heads of departments, professors of psychiatry, general people within the field of academic mental health, and through them and an awful lot of prescribing doctors here in the U.S. And, indeed, perhaps worldwide,” Healy testified.

A link to “Articles” on the Emory website in mid-2009, brought up roughly 90 studies and papers that include the co-author Nemeroff.

Healy said he believed Nemeroff was one of the founding members of the Paxil advisory board and he participated in continuing medical education seminars with talks on Paxil.

Nemeroff would have been “the key person in producing the kinds of talks with slides that would have been held for large audiences of doctors, and then those slides and talks would have been distributed out to different doctors in the field who hadn’t been at the major meetings as he gave his talk,” Healy told the jury.

During his testimony, Tracey showed Healy a document from a continuing medical education seminar titled, “Fertility, Mood and Motherhood,” and Healy said the material for the seminar was prepared by Glaxo for Nemeroff.  It was again supported by unrestricted educational grant from Glaxo and Nemeroff “was reimbursed for his role in this,” Healy pointed out.

Healy was also not allowed to testify about Nemeroff’s fall from grace at Emory, how much he was paid by Glaxo, or his failure to disclose over a million dollars from drug companies.

Dr Bernard Carroll, a past chairman of the department of psychiatry at Duke University Medical Center, summarized the Nemeroff saga well on the Healthcare Renewal website on November 3, 2008, in writing: “The fallout to date includes his severance from several NIH-funded projects at Emory University School of Medicine, a freeze of NIH funding for a major center grant, and his stepping down from Emory’s chair of psychiatry while an internal investigation proceeds.”

During her cross examination of Healy, Glaxo’s lead attorney, Chilton Varner, presented an exhibit showing a continuing medical education presentation given by Nemeroff.

“Can you see that in this continuing medical education program Doctor Nemeroff says that paroxetine, sertraline, fluvoxamine, (are) not associated with increased risk of teratogenicity or other complications?” she asked Healy.

“Yes, I do,” he replied.

In small print, the disclosure for the presentation showed Nemeroff had received research grants and participated in the speakers bureau and consulted for Glaxo, Eli Lilly, Solvay and Pfizer.

During re-direct, Tracey asked Healy to tell the jury what the actual results of the study that Nemeroff was discussing in the presentation showed, and specifically when Paxil was looked at alone. The results “showed that there was a 1.8-fold increase in the odds ratio of a birth defects to the women who have been taking Paxil during pregnancy,” Healy testified.

“Overall, for this group of drugs there was an increase in risk,” he said, “but specifically for Paxil the risk was greatly increased.”

“And beyond that,” Healy stated, “what isn’t included here in the conclusions, overall there was a — on this group of drugs, there was a doubling of the rate of miscarriages on the drug compared with the rate of miscarriage for the women who are being compared who weren’t on the drug.”

“There was also an increased rate of women going on to voluntarily abortions on the drug,” he added.

One of the lead authors on the study was Gideon Koren. “Doctor, without giving any details,” Tracey asked Healy, “do you know whether Doctor Koren has ties to the pharmaceutical industry?”

“I know he has,” Healy said.

During his opening statement, Tracey told the jury that 1998 was a big year for Paxil because a study came out by a doctor named Gideon Koren, and a researcher named Kulin, that looked at Paxil and two other SSRIs.

The study compared women who took SSRIs, to women who didn’t take any SSRIs, and the number of birth defects in the two groups was the same. “So Doctor Koren concluded that SSRIs appear to be safe,” Tracey said.

“Within, literally within 24 hours,” he told the jury, “GSK’s marketing machine cranked up and they faxed this information to their entire sales force.”

And the sales force took this information and began to use it to sell to women, he noted. “What they didn’t tell anybody was this,” Tracey said. “That when you separated Paxil out from the other SSRIs, you saw that Paxil was causing birth defects, that there was an increased risk of birth defects in this study in these women when you looked at Paxil by itself.”

“That was not in the paper,” he said. “That information was not found out until two years ago.”

While testifying, Healy was barred from telling the jury about Koren’s involvement in one the biggest academic research scandals in history a few years back when he sent vicious anonymous letters to discredit fellow researchers and denied doing so until DNA evidence from postage stamps proved he was lying years later. In September 2003, the Canadian Association of University Teachers reported on the disciplining of Koren in the CAUT Bulletin as follows:

“The Ontario College of Physicians and Surgeons has formally reprimanded University of Toronto professor of medicine Dr. Gideon Koren. He had written anonymous harassing letters about Dr. Nancy Olivieri and three colleagues during Olivieri’s dispute with the Hospital for Sick Children, the University of Toronto and Apotex Inc. He then had lied repeatedly to conceal his responsibility. The college also cited him for additional misconduct, in research.”

The Teachers Association further explained in the Bulletin: “The college’s finding of research misconduct was in relation to a study on a drug to treat a blood disorder in children that Koren and Olivieri had once collaborated on. Olivieri identified risks that the drug was ineffective and caused liver damage, and voiced her concerns despite legal warnings from its maker, Apotex. Koren differed and, contrary to accepted norms, published an article on the drug using data from other researchers, including Olivieri, without their knowledge or consent.”

“Koren had received hundreds of thousands of dollars in funding from Apotex after the company had terminated the drug trials in its efforts to prevent Olivieri from disclosing risks to patients, as well as the hundreds of thousands of dollars in funding he had received during the trials,” the newsletter reported, citing an journal article by the authors of “The Olivieri Report.”

Apotex marketed a generic version of Paxil, or paroxetine.

The penalty had been jointly proposed to the discipline committee through prior agreement between Koren’s attorney and counsel for the college, the Bulletin noted.  In its decision, the committee said it was “deeply troubled by this case” and “seriously considered administering a more severe penalty” than that proposed, as it wished “to express unequivocally its condemnation of Dr. Koren’s misconduct.”

Glaxo Money Still Flowing

In a December 14, 2009 report on Pharmalot, Ed Silverman noted that Glaxo had published a list of fees paid out to US healthcare professionals for speaking and consulting services for the three month period of April 1, 2009 to June 30, 2009. “By its own tally, Glaxo paid $14.6 million to approximately 3,700 US docs and other healthcare professionals,” he reported.

Although Glaxo paid out millions of dollars over the years to the doctors discussed in this article, not one of them was called to testify as an expert in the first birth defect trial.

Evelyn Pringle

(The Paxil Birth Defect Litigation Update Series is sponsored by the Houston law firm of Vickery, Waldner and Mallia at http://www.justiceseekers.com )

(Evelyn Pringle is an investigative Journalist and Researcher focused on exposing corruption in government and corporate America)