The Bitter Pill

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Ghostbusting in Paxil Birth Defect Litigation

Evelyn Pringle March 1, 2010

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.

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

Filed under: 2010, Birth Defects, CASPPER, front groups, ghostwritten, Glaxo, Kilker, KOL, Paxil, Paxil birth defect litigation, pregnant, SSRIs, Study 329, Vickery

Battle of the Experts – Paxil Birth Defect Litigation

Evelyn Pringle February 22, 2010

In the first Paxil birth defect trial that resulted in a $2.5 million verdict against GlaxoSmithKline, the infant, Lyam Kilker, was born with three heart defects; an atrial septal defect, a ventricular septal defect, and an interrupted aortic arch, after his mother took Paxil while pregnant.

Pregnant women cannot participate in clinical trials on drugs due to the risk of harm to the fetus. But after a drug has been on the market for a while, epidemiology studies can review the medical records of women who have taken a new drug while pregnant and the records of women who were not exposed to the drug while pregnant and compare the outcomes of the infants.

The plaintiff’s experts, Doctors Ra-id Abdulla, David Healy, Shira Kramer and Suzanne Parisian, all testified that they believed Paxil (paroxetine) caused Lyam’s defects, based in part, on the scientific literature on studies available on Paxil to date.

Battle of the Experts

During her opening statement, Glaxo’s lead attorney, Chilton Varner, told the jury, the “experts in the case diverge sharply on how they interpret that body of scientific literature.”

The “plaintiffs’ experts say that these scientific studies prove causation, they prove that Paxil causes cardiac defects and IAA,” she noted.

“They get there by … lumping all cardiac defects together and looking at the numbers for cardiac defects as a group,” she said, “They also get there by rejecting any application of the tool of statistical significance.”

“The plaintiffs’ experts will tell you they believe that as long as there is a difference between the two groups, and the Paxil group is higher than the control group, that’s enough,” Varner told the jury.

“GSK’s experts, on the other hand, are anti-lumping,” she said. “They say that you can’t lump all heart defects together because they form for different reasons at different times by different processes and that you can’t use evidence as to one kind of defect to imply that it also applies to another kind of cardiac defect.”

“And GSK’s experts will tell you that statistical significance matters,” she stated, “that without applying the tool of statistical significance, you have no idea whether the difference between the two groups is real and meaningful or whether it is simply the operation of chance or coincidence.”

Dr Shira Kramer, an epidemiologist, testified as an expert for the plaintiffs and explained epidemiology studies to the jury. She described the difference between association and causation as meaning that a single study with a finding of an elevated risk of birth defects would only show an association.

“When you have a body of literature which shows through multiple studies consistently elevated findings, then you move from association in one study to causation, that this factor causes the disease,” she told the jury.

During closing arguments, the family’s lead attorney, Sean Tracey, told the jury that, “Defense lawyers can’t stand the word ‘causal.’”

“Causal” is the “kiss of death” for a defense lawyer, he said, because they know that is one of the questions the jury will be asked.

“The second question you are going to be asked,” he told the jury, is “Do you find that Michelle David’s ingestion of defendant’s drug Paxil was a factual cause in bringing about the heart defects?”

While testifying, Kramer also explained what is meant by relative risks and confidence intervals. “Our real interest in epidemiology is to measure rates of disease and excess risk,” she said. “But we also want to know really how precise is this measure.”

“And the precision of this measure is very much tied to the size of the population that you are studying and the number of exposed people,” she explained.

“In other words,” she said, “if we were to go into a large population and do the same study a hundred times, how many times out of a hundred would we find the same exact answer?”

“It is similar to tossing a coin,” she noted. ”If you are looking at the proportion of heads and tails in a coin toss, and you toss that coin a thousand times … you are going to come up with that 50/50 proportion pretty much all the time.”

“That’s a very precise answer,” she pointed out.

“So if you think about it that way,” Kramer said, “the larger the sample size, the larger the number of people that you study, the more precise your study estimate of that relative risk is.”

“And we estimate the precision of this relative risk by calculating something called confidence interval,” she told the jury. “If you were to repeat this study, let’s say 95 times out of a hundred, what would that range be?”

For instance, where the relative risk in a study is 2, and they calculate statistically a 95 percent confidence interval with a range of between 1.5 and 2.5, the actual relative risk would fall somewhere in this range. That “means 95 trials out of a hundred would generate results in this range,” Kramer stated.

A test that is not statistically significant should not be discarded, she said. The “practice of statistical significance testing has been very much rejected in epidemiology because it was never developed really to study health or biomedical or human health problems.”

“This whole issue of rejection of a hypothesis, yes-no answers,” she explained, “was created for agricultural and industrial studies, whether or not a certain widget would be produced more efficiently in one production method than another or whether one field is more productive than another in an agricultural setting, these are easy yes-no answers and don’t impact human health.”

“But, unfortunately,” she said, “it was for a long time memorialized into epidemiological practice because it was easy and because before computers, these statistical tables were published, it was just easy to look up these probability values, it was easy to say, oh, yes, oh, no, to statistical answers”

“But, in fact, they don’t take account of the importance and the toll on human health,” Kramer told the jury.

A single-minded focus on significance testing is dangerous from a public health perspective, she said, because “it leads to discarding very important and relevant data and studies.”

Studies Designed to Fail

During his opening statement, Tracey told the jury: “You are going to hear from experts in this case that there are ways to design studies to fail.”

“If you truly don’t want to know the truth,” he said, “very smart people can design studies that won’t show you the truth.”

While testifying, in regard to studies, Kramer was asked to explain what is meant by “inclusive by design.” It’s “a very, very serious problem that has been written about quite a bit,” she told the jury.

The reason for “the tremendous amount of concern and literature on this topic,” she said, “is many of these studies look like they have been designed to fail.”

It’s the “deliberate design of epidemiological studies in such a way as to make it, if not impossible, extraordinarily difficult to detect relationship between an exposure and an outcome or a disease,” Kramer explained.

“It’s to design in or not to design in certain features of a study which would make it almost impossible to find the information that one is seeking,” she added.

In the Paxil studies, many of the “designed characteristics have been such that they would minimize or make it more difficult to detect an increased risk,” she said. “And despite that, these studies have shown consistency in showing an increased risk of cardiac malformations associated with first trimester Paroxetine exposure.”

This is what “is so compelling about these studies,” she told the jury, “despite the fact that just about every aspect of these studies would tend to drive that relative risk down or make it difficult to detect an elevated risk, we are seeing them study after study after study.”

“The pressure is always against the ability to detect increased risk in the way these studies are designed,” Kramer said. “And, yet, despite that, we are seeing consistently elevated risks associated with Paxil, which is very, very important, very compelling, and very alarming actually.”

Whether a study will be inclusive by design is decided by the researchers conducting and authoring the study, she said.

Kramer explained that a “meta-analysis is an analysis of all the data that have been generated on a subject, so it’s an agglomeration, a statistical analysis of all the data to come up with a summary risk for all of the studies together.”

“It’s an attempt to overcome the issue of small sample sizes,” she said, “so the individual doing the meta-analysis will take all of the studies and will actually combine all of the results into summary statistics so that there is more power and there is some attempt to come up with a summary of all of the data that have been generated to date.”

Glaxo’s Meta-Analysis

The famous neuropsychopharmacology expert from Wales, Dr David Healy, also testified for the plaintiffs. During his testimony, the jury was presented with two charts from Glaxo’s own website, showing the results of its own internal meta-analysis of the existing epidemiological studies.

The analysis had only been put on the website recently, he noted, maybe last year. One chart showed all birth defects lumped together, or combined, and the other showed cardiac birth defects.

In discussing the chart on combined birth defects, Healy said, “what everybody here needs to see is … the little dots in the middle of the lines.”

If you “look at the pattern of dots there, you will see that of all the studies that have now been done, most of the dots fall on the right-hand side,” he noted. “This means that there is an increased risk that Paxil causes birth defects.”

“What I want you to look at here … is the consistency,” he told the jury. “The dots are all falling on the right-hand side of the line, which shows an increased risk.”

“When GlaxoSmithKline added all this up,” Healy said, “you see the dot at the bottom, that is statistically significant.”

“They say there is no chance that Paxil is not causing these birth defects. Chance is gone. It is causing the birth defects,” he told the jury.

With the chart on cardiac birth defects, “again, you see the patterns of dots are mostly on the right,” Healy pointed out.

“What you see here at the end,” he said, “shows you a 1.5-fold increase in risk.”

This “comes from their Web site,” he stated, “I have had no part in trying to generate these data at all.”

While testifying, Healy discussed several of the studies in Glaxo’s analysis, including the abstract for a presentation given at a conference in 2001, referred to as Unfred, which also had an author named Chambers. The full paper on the study, with Chambers as the author, had never been published but the data from the study was in Glaxo’s database.

“These data almost 10 years later,” Healy said, “showing a fivefold increased risk in heart defects and a tenfold increased risk in birth defects in general has not been published.”

Second Expert

During her testimony, Kramer also went over Glaxo’s meta-analysis and explained what it showed.

“GSK determined that the odds ratio for cardiac malformation as a broad class was 1.48,” she told the jury. “That is a 48-percent increased risk where they have combined data from all of the studies that they could find to date.”

“They also found an odds ratio of 1.67 for septal defects,” she said. “That is a 67-percent increased risk of septal defects associated with first trimester Paroxetine exposure for all the studies, for the three studies where there was actually data on septal defects.”

“And then for their summary odds ratio for right ventricular outflow tract obstruction defects,” she added, “the two case control studies which actually looked at those types of defects they found a summary odds ratio of 2.85.”

Most of the studies in the meta-analysis did not break down the cardiac defects into subcategories, Kramer said. “Either because they simply didn’t have enough individuals in their studies or they set up their study rules which preclude them from doing so.”

It would be inappropriate to conclude that if a specific cardiac defect was not found in these studies that Paxil did not cause it, she said. “It would be very much inappropriate and erroneous to assume that because that subcategory is not mentioned … that there is no increased risk associated with it.”

Kramer also testified about the Wurst study, which was published only 12 or 13 days before she testified. The “GlaxoSmithKline meta-analysis that we just discussed was not published,” she told the jury. The “Wurst study is the published version … but updated with one additional study.”

She was asked whether there was anything new, novel or different in the Wurst study. “Well, the only thing that is different in … the published version versus unpublished version,” she said, “is that they did not publish any subgroupings of cardiac abnormalities, birth defects in the published version.”

They only “analyzed and published the summary odds ratio for all cardiac birth defects combined,” she noted.

“And that summary odds ratio was very similar to the first one,” she said. “It’s 1.46. That is a 46-percent increased risk for all cardiac defects combined.”

During cross-examination, Glaxo attorney, Todd Davis, told Kramer, “despite every single one of those studies looking at that those different patient populations over different time periods, there is not a single case in any of the studies that you talked about … that identifies a patient who was exposed to Paroxetine or Paxil who had an IAA …”

He noted that Lyam “was diagnosed with an interrupted aortic arch Type A,” and asked Kramer: “Can you — can you point to the jury in your report where you mention anything about interrupted aortic arch of any kind?”

“I probably didn’t because there is no specific study that analyzed that specific defect as a stand alone category,” she replied.

Kramer pointed out that “the epidemiological studies that have been conducted never individually analyzed the rates of the risk of interrupted aortic arch Type A associated with first trimester Paxil exposure.”

Because it is so very rare, she said, it would be impossible to do given the required sample size of “something over a million” subjects in order to conduct such a study.

“And since no such study was ever done,” she told the jury, “you would not expect to find any specific study that would have been able to analyze interrupted aortic arch Type A as a specific subgroup.”

Most of the studies, she said, “just reported on all cardiac malformations as a group and even those that … did any kind of subgroup analysis restricted them to the most common subgroups.”

There were several studies where they restricted any analysis to subgroups where they had at least 200 women whose child suffered a specific birth defect, “which would automatically exclude IAA Type A,” she pointed out.

The Louik paper restricted the analysis to subgroups of 100, she said. But the “Louik study itself very clearly lists IAA as a specific cardiac malformation under conotruncal defects in their appendix where they list specific subgroups that they looked at and considered,” she told the jury.

Louik Study

The Louik study was funded by Glaxo and conducted out of the Slone Epidemiology Center For Birth Defects. While Kramer was testifying earlier, Tracey put up a slide entitled, “Louik, et al – GSK involvement,” and told her to tell “the jury what GSK’s involvement in this study was both publicly and then privately.”

Davis objected to this testimony. “There is nothing in Doctor Kramer’s expert report that discusses anything about communications with GSK that somehow impacted the Louik study, so there has been no notice to GSK that she would be offering those opinions today,” he argued to the judge, while the jury was out.

“Your Honor,” Tracey told the judge, “this issue is something that has been percolating for a number of years.”

“This information about GSK’s involvement and manipulation of the Louik study is something that has recently come to light,” Tracey said. “In fact, the deposition of their epidemiologist, Sara Ephross, was taken after Doctor Kramer’s, the deadline for Doctor Kramer’s report.”

“And, in fact, last week, while we were in trial,” he told the judge, “a Federal Court in Boston has ordered the Slone Epidemiology Center and GSK to turn over documents related to their involvement in this study.”

“Quite frankly,” he said, “the only people prejudiced by this are the plaintiffs, because GSK knows exactly what they did and when they did it, and we have been trying to get this information for some time.”

The judge excluded testimony by Kramer about the email exchange between Dr Loiuk and Ephross.

But the comments by Louik, not seen by the jury, that appeared in court filings, stated in part: “we did not accept your changes. We are trying to avoid reinforcing the widely held perception that ‘statistical significance’ is a standard by which to judge the validity of a study finding. Significance is a function of study size, and while a single non-significant result might not be credible, in this case it supports findings from other studies and should not be dismissed for reasons of significance alone.”

In affidavit filed in the Federal Court that ordered the release of the communications between Glaxo and the Slone Center, Louik wrote: “We rejected all of GSK’s suggestions that might have served to weaken our findings and conclusions.”

“GSK suggested that our ‘overall’ findings did not support the hypothesis that Paxil increases the risk of cardiac defects,” she stated. “We rejected that suggestion as well.”

Birth Defect Numbers Halt

In the beginning, when Paxil was approved in the US, although Glaxo did not list the number of birth defects cases reported on the label, if a doctor contacted the firm wanting information, Glaxo sent out medical information letters that included the number of birth defects reported.

Tracey entered three such letters into evidence. The first letter listed 36, the second 42, and the third 64. Then in the late 1990s, instead of including the number of birth defects, the medical information letters started only listing the percentages, and after that they went to listing nothing, Tracey told he jury in closing arguments. “It goes from numbers to percentages to nothing.”

During the trial, a Doctor Hobbiger testified that Glaxo enacted a policy not to give doctors the numbers because doctors were incapable of putting it into context. “The funny thing about that to me,” Tracey told the jury, “is why were the doctors capable of putting the numbers in context when the numbers were low?”

“How did they magically become incapable of rational thought once the numbers became high?,” he pointed out.

He noted that a big thing happened in1998. Glaxo analyzed all the data they had been receiving on Paxil, and the person writing the report made the following finding: “The number of reports we have of women with birth defects is an alarmingly high number. We should not see this number of birth defects. It’s four to five times what we would expect to see.”

“This is an internal document that nobody has ever seen before, not the FDA, not anyone,” he said.

Earlier in the trial, Tracey had showed the jury a letter from 1984, in which the FDA specifically told Glaxo they needed to tell the FDA “whether or not you receive any alarming information either in animal studies or in the human population.”

“And in1998 this is their language, not mine,” Tracy told the jury. “The incidence rate of congenital abnormalities as observed in data reported in this document is 13.3 percent.”

This is a problem, he said, because the background rate “is 2-1/2 to 4 percent, depending on who you believe.”

The 13.3 percent “is three to four times what they would expect to see,” Tracey point out.

Birth Defect Info Request Refused

During the trial, the jury learned that in May and June, 2001, Glaxo received two emails from a woman specifically asking for any information Glaxo might have on birth outcomes of babies born to mothers who took Paxil.

The woman reported that she had recently gotten married and immediately became pregnant because they wanted lots of children. But when she was six months along, the woman had to terminate the pregnancy after tests showed the baby had a rare heart defect and would likely not survive to term or survive the necessary open heart surgery to save his life if born alive.

“To say the least, I was absolutely distraught with this news,” the woman said. “I thought this was something that I did … because I stayed on the Paxil for selfish reasons.”

“I wanted to know if you could direct me to any information you might have of any woman that has taken Paxil and still had healthy babies,” the woman wrote, near the end of May 2001.

“My husband and I are ready to try again to get pregnant in the next month or two,” she said. “I am so nervous.”

The woman had been on Paxil for over four years and said she loved how the drug worked for panic attacks. “I don’t want to stop taking my miracle pill,” she wrote. “But, then again, if there is a chance that this might hurt or affect the baby, I want to know upfront.”

“And I will somehow stop taking it for the time being,” she added. “Please contact me as soon as possible. Please don’t forget about me.”

The woman sent a second email on June 1, 2001, and stated: “This response is in regards to an e-mail that I had sent you previously.”

“I was asking to see if you have any or are in the process of any clinical trials for women who are currently on Paxil and pregnant,” she said. “I wanted to find out information to see how many women were on Paxil during pregnancy and if they were able to successfully have healthy babies.”

“I love the product, and I don’t think I could have gotten through my panic attacks without the wonderful help of this miracle drug,” she told Glaxo.

“I just want to start to try and get pregnant again soon,” she wrote. “I do not want to put my unborn child through anything that would hurt him/her.”

“Please, if you do not have this information, where is this information held?” she wrote. “Does anyone do studies like this? Please, any information you may give me would be great.”

Glaxo wrote her back on June 6, 2001. “We are attaching a copy of our current product information for Paxil. Please review the section on use during pregnancy,” the letter read.

“Further questions about your treatment should be directed to the physician, pharmacist or healthcare provider who has the most complete information about your medical condition,” they said. “Because patient care is individualised, we encourage patients to direct questions about their medical condition and treatment to their physician.”

“We believe that because your physician knows your medical history, he or she is best suited to answer your questions,” Glaxo wrote. “Our drug information department is available to answer any questions your physician or pharmacist may have about our products.”

Glaxo sent the woman basically a form letter on June 13, 2001, asking for her signature on an authorization to get her medical records, but provided no answers to the woman’s questions.

On a Glaxo internal document with the same date, the box “almost certain” was checked for “Relatedness assessment to medication.” There is no higher category of certainty that the drug caused the defect than the box checked.

A Glaxo employee at the time, Jane Nieman, was listed as the contact person on a report sent to the FDA. Before trial, Tracey took Neiman’s deposition and questioned her about Glaxo’s policy for reviewing adverse event reports prior to showing her the documents about the mother who aborted her baby that said it was “almost certain” that Paxil caused the heart defect.

Portions of the deposition were played for the jury. Before Nieman knew about the documents, she testified that when a causality assessment was made a physician was involved and it was a team effort. “I think it is very much a team,” she said. “I think that’s really how they worked.“

“They would look at the case and they would form a medical opinion as to whether there was a possible, probable or no causality,” she stated.

Tracey told the jury that Nieman was “stunned” when she saw the document with the box checked, “almost certain,” so he asked her whether she was uncomfortable with the fact that the assessment was made. “It was made. It’s a fact,” she said in the deposition. “I don’t feel uncomfortable with it.”

Later in the deposition, Nieman claimed she did not know who checked that box. “Somebody from GSK filled that in,” she said. “There’s a possibility someone made a mistake and checked the box wrong.”

During the trial, Glaxo had Doctors, Stephen Hobbiger and Judith Jones, tell the jury that the checked box was definitely a mistake because they don’t do causality assessments in the US citing “almost certain,” that they only do it that way in France.

During cross-examination, Tracey showed Jones a causality assessment from Canada that had “almost certain,” and she said well, maybe they do it that way in Canada. He then showed her one from the US that also had “almost certain.”

In the documents sent to the FDA, Glaxo did not include the words “almost certain,” according to testimony by Dr Suzanne Parisian, a former FDA official.

Parisian said Glaxo also never changed the Paxil label after receiving the report and the rules are that a drug company has to change or strengthen the warning on the label, if “they have reasonable evidence of an association with the report for their product and an adverse experience.”

Smoke and Mirrors

“The bottom line of the scientific evidence that will come to you from GSK’s experts will be that there is no way based on the current state of the scientific evidence to state to a reasonable degree of medical certainty that Paxil causes birth defects in general or causes cardiac defects in general or causes Lyam Kilker’s specific defect of an IAA,” Varner told the jury during her opening statement.

Throughout the trial, Glaxo attorneys focused on Lyam’s IAA defect and harped on about “statistical significance,” when as described above, the studies were designed to ensure that a “statistically significant” increased risk in rare cardiac defects would never be detected.

During closing arguments, Tracey told the jury he wanted to talk about Glaxo’s “obsession” with ignoring the fact that Lyam had three cardiac defects.

“All they want to talk about is this interrupted aortic arch,” he pointed out.

“The reason is very clear,” Tracey said. “It’s because they know it’s rare.”

The “reason that they want to talk about it so much is because they know this, they’re never going to look for this,” he told the jury.

“They’re never going to do a study looking for interrupted aortic arch,” he pointed out.

“The only ones that would have the money, time and effort to undertake a study of 1.5 million women would be them,” Tracey said. “And they know it’s never going to get done.”

“So they’re in a can’t lose position if you buy their argument,” he told the jury.

The study is “never going to get done because they’re the only people that would do it and they’re not going to,” he said.

“They admit, though,” he pointed out, “that they have two cases now in their own database of interrupted aortic arch.”

During closing arguments, Tracey recounted how he had put up Glaxo’s own meta-analysis from the company’s website, with 9 different studies, including their own, and “each and every one of them says Paxil increases the risk of heart defects,” he pointed out.

“And this is a document that I know pains them,” Tracey said. “Because … the author of their own meta-analysis, Charlie Poole, the author that they hired …, when he looked at the data privately, privately, outside of courtrooms, he said: This begs the key question. Do we think the best explanation at present is that first trimester paroxetine use increases the birth prevalence of cardiac malformations? I do.”

“I do,” Poole said. “Outside the courtroom,” Tracey told the jury.

“But when this document got published, by the time it went through everybody’s hands, by the time the editing was over, that statement disappears,” he said. “It is not in the peer-reviewed literature.”

In her closing, Varner told the jury, “the final fact that matters is that no regulatory agency or medical organization has ever concluded or said that Paxil causes birth defects. Only plaintiffs’ experts have said so and in this courtroom,” she said.

In his final summation, Tracy said, “I want to put something to bed that Ms. Varner said immediately, and that’s this: Ms. Varner said that no regulatory agency in the world has ever said Paxil is a teratogen.”

“That is simply untrue,” he told the jury. “This is what the FDA says right here, There is positive evidence of human fetal risk,” reading from a letter from the FDA.

He also noted that Paxil’s label, under “Teratogenic Effects” states: ”Epidemiological studies have shown that infants exposed to first trimester exposure to paroxetine have an increased risk of congenital malformations, particularly heart defects.”

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

Filed under: 2010, Birth Defects, Glaxo, Kilker, Paxil, Paxil birth defect litigation, pregnant, Vickery

Sex and Psych Drugs – Young Couples Beware

Evelyn Pringle June 2, 2009

Although the adverse effects of women taking psychiatric drugs while pregnant related to birth defects and infant withdrawal syndrome are often discussed or reported, the serious adverse effects on the sex lives and reproductive systems of millions of young couples are rarely mentioned.

Whatever the reason, due to the ever widening marketing campaigns by the psycho-pharmaceutical industry, young people need to be warned before they get conned into taking psychiatric drugs.

Sexual dysfunction, including lack of libido, orgasmic dysfunction and delayed ejaculation, are common side effects of using SSRI antidepressants, according to the May 2005 report, “The Marketing of Depression: The Prescribing of SSRI Antidepressants to Women,” by Dr Janet Currie. The report warns:

“There are concerns that not all sexual dysfunction may fully resolve after termination of treatment. Since SSRIs are prescribed more often for women, women are more frequently affected by SSRI-induced sexual dysfunction. Because SSRIs can also lead to a worsening of depression, paradoxical effects, emotional blunting or detachment, reduced emotional activity, memory loss and confusion, these effects, in conjunction with sexual dysfunction, can negatively affect intimate relationships.”

In 2006, Dr Antonei Csoka, from the Department of Obstetrics, Gynecology and Reproductive Sciences, at the University of Pittsburgh, and Dr Stuart Shipko, in private practice, in Pasadena, California published a paper titled, “Persistent Sexual Side Effects after SSRI Discontinuation,” in Psychotherapy & Psychosomatics.

The paper documented three cases of fairly severe and permanent sexual dysfunction resulting from prior use of SSRIs in two men and one women.

“These case studies have important clinical implications,” the authors note. “They suggest that when patients develop sexual dysfunction as a side effect of SSRIs, clinicians should be alert to the possibility that restoration of sexual function may not correlate temporally with medication cessation.”

In recent studies, “doctors have specifically asked about sexual difficulties, and found that they are present in up to 83% of patients,” the authors report.

“Patients are often willing to continue taking SSRIs despite sexual side effects, but the possibility of increasing the probability of dysfunction remaining after discontinuance should be taken into consideration,” they state. “Such persistent side effects could even worsen the long-term prognosis of depression.”

“I suspect that these three cases are just the tip of the iceberg and that possibly thousands of people are similarly affected,” Dr Csoka told this author in an email.

In July 2005, WebMD noted that sexual side effects can cause significant problems of their own. “For both men and women, this means being unable to initiate, participate fully in, or enjoy sex, and that can lead to a crippling loss of self-confidence that can, in turn, undermine depression recovery,” the article pointed out.

On the website, Prozac.com, under possible side effects of Prozac, “decreased sex drive” and “impotence” are listed. It also states Prozac “can cause changes in sexual desire and satisfaction.”

After five years of tracking Big Pharma’s disease mongering and off-label marketing schemes, I can say without a doubt that the sickest plot ever devised is the legislation moving through the US Senate right now referred to as the “Mothers Act,” for short.

This is the sickest of all marketing schemes because it is aimed at young couples in child bearing years and reaches into the cradle where the brains and bodies of the most vulnerable victims will be forcibly drugged through pregnant and nursing mothers without any voice of their own in the matter.

Although the language in the Act says postpartum conditions refers to “postpartum depression” and “postpartum psychosis,” the campaigns run through websites like Postpartum Support International, Postpartum Progress and PerinatalPro, are using the bill as a vehicle to diagnose pregnant and nursing mothers with a whole list of pregnancy related “mood” and “anxiety” disorders to further a new cottage industry in the works for treating these women.

For instance, one website is run by Karen Kleiman, who happens to have her own counseling agency called the “Postpartum Stress Center,” and quite a few books to sell. On this website you can even buy some books directly with paypal and bypass Amazon.

“The Postpartum Stress Center specializes in the diagnosis and treatment of prenatal and postpartum depression and anxiety disorders,” the homepage says.
Services offered at the Center include, “Screening for prenatal and postpartum depression and anxiety,” and “Psychiatric evaluation and follow-up.”

The postpartum websites continuously argue that the Act does not promote screening women, but the bill they tried to slip through Congress last year specifically called for screening women and referring them for services. The language in the 2008 bill stated: “To ensure that new mothers and their families are educated about postpartum depression, screened for symptoms, and provided with essential services, and to increase research at the National Institutes of Health on postpartum depression.”

The truth is, universal screening has always been the goal of this blatant off-label marketing scheme because no psychiatric drug has been FDA approved as safe for use by pregnant women and screening opens the door for drug treatment. The screening language was removed only after strong objections were raised about the prospect of requiring all women to be screened and referred to treatment.

The history of the attempts to pass this legislation clearly shows screening was the plan. For instance, Dr Katherine Wisner is professor of psychiatry, obstetrics, gynecology and reproductive sciences and epidemiology at the University of Pittsburgh School of Medicine, and her work in promoting screening as well as drug use by pregnant and nursing mothers is constantly cited on the postpartum websites.

In an editorial in the December 2006, Journal of the American Medical Association, Dr Wisner recommended “that the United States take steps to implement a universal screening program, in which all women are screened between two- and 12-weeks postpartum,” the University reported in a December 5, 2006 news release with the heading, “JAMA Editorial Notes Childbearing Presents Unique Vulnerability for Psychiatric Illness, Making Effective Screening, Education and Treatment Essential.”

“Those presenting with symptoms of a psychiatric disorder should be treated immediately after diagnosis,” Dr Wisner said in the University news release.

The Mothers Act is said to be modeled after a New Jersey law in the home state of the bill’s main sponsor, Senator Robert Menendez. “The State of New Jersey has been the first to address the problem on the governmental level by legislating that all women receive screening and education for postpartum depression; the law went into effect in October (2006),” the University pointed out.

Six months prior to the JAMA editorial calling for “universal screening” and “treating immediately,” on August 5, 2006, Medical News Today ran the headline: “Commonly Used Anti-depressants Safe And Effective For Treating Postpartum Depression,” for a study led by Dr Wisner published in the Journal of Clinical Psychopharmacology.

The researchers compared the tricyclic, nortriptyline, and Pfizer’s Zoloft, but there was no placebo group to see if the drugs worked any better than a sugar pill, which countless studies have shown they rarely if ever do.

“We’ve been treating postpartum depression based on the assumption that drugs that work for a woman with depression under usual circumstances will work for a woman who experiences depression after giving birth, but there have not been studies that provide scientific proof that this was an effective and safe course of treatment,” Dr Wisner told Medical News.

“Treating these women based on that assumption was simply not good enough, and we felt compelled to provide scientific evidence to guide postpartum depression treatment decisions,” she stated.

The disclosure by Medical News said Pfizer provided the Zoloft for the study but did not provide any direct financial support for the conduct of the study. It was noted that Dr Wisner is a member of Pfizer’s speaker’s bureau and has a grant from Pfizer for a study of ziprasidone (antipsychotic Geodon) pharmacokinetics during pregnancy, and is also a member of the speaker’s bureau for GlaxoSmithKline.

A 2005 paper in JAMA reported that Dr Wisner had received grant funding from Pfizer and “is a member of the speaker’s bureau for Pfizer, GlaxoSmithKline, and Shire.”
Dr Wisner is also “a distinguished fellow of the American Psychiatric Association,” the University website notes.

In a running list of Mothers Act supporters, the PerinatalPro website, which is actually another site run by the owner of a treatment center, Susan Stone, with a book for sale, lists the APA as endorsing the bill. This Big Pharma front group will probably go down in history as the most notorious disease mongering association of all time.

A prime example of disease mongering at its worst can be found in a May 21, 2008 headline by US News and World Reports stating: “Postpartum Depression Strikes New Fathers, Too,” with a story based on research presented at the APA’s annual meeting.

Ten percent of new fathers and 14% of new mothers are affected by depression, psychologist James Paulson, assistant professor of pediatrics at Eastern Virginia Medical School in Norfolk, told US News.

“If untreated, a father’s postpartum depression can be harmful to the child as well as to both parents,” the article noted.

On May 8, 2008 WebMD reported that then APA President, Dr Nada Stotland, said first-time new dads are at greatest risk for postpartum depression and apparently the causes of this newly discovered mental disorder are as follows:

“The life changes for a new dad are enormous. Just thinking about the costs of raising the kid to 21, maybe for life, can be terrifying. And all the unspoken fears: Will my wife still be as interested in me? Will my baby be as cute as my brother’s baby?”, Stotland explained to WebMD.

Stotland has served on the speakers’ bureaus of Glaxo and Pfizer, according to Slate Magazine. In 2006, the pharmaceutical industry accounted for about 30% of the APA’s $62.5 million in financing, the July 12, 2008 New York Times reported.

Pfizer’s 2008 grant report shows donations of more than $700,000 to this “non-profit.” Lilly gave grants totaling more than $600,000 in both the first and second quarter of 2008. In 2007, the APA received over $400,000 from Lilly and another $450,000 went to the American Psychiatric Foundation.

Last summer, an investigation by the Senate Finance Committee, led by Iowa Senator Charles Grassley Senator accused the now president of the APA, Dr Alan Schatzberg of Stanford, of failing to disclose payments of over $70,000 from Johnson & Johnson and Lilly in filings with the University. The Senator also revealed Schatzberg’s stock ownership of millions of dollars in a company seeking to commercialize a depression drug. Schatzberg has since stepped down as chair of the psychiatry department at Emory.

On May 29, 2009, Katherine Stone wrote on the Postpartum Progress website: “The MOTHERS Act is not sponsored by the pharmaceutical industry.”

“Its only sponsors,” she said, “are the Senators (Menendez) and Representatives (Rush) who created it and brought it to a vote, thanks to the unending insistence of Carol Blocker, the mother of Melanie Blocker Stokes, who committed suicide while suffering from postpartum psychosis.”

“Its endorsers, I might point out, include the American College of Obstetricians & Gynecologists, the March of Dime, the National Healthy Mothers Healthy Babies Coalition, the Children’s Defense Fund and NOW,” she says, and also mentions a new one, the National Perinatal Foundation.

However, Katherine did not mention the main supporters listed on PerinatalPro, including the Depression and Bipolar Support Alliance, Mental Health America (MHA), National Alliance for the Mentally Ill (NAMI), National Council for Community Behavioral Healthcare, and the Suicide Prevention Action Network USA and the APA.

This sudden omission might have something to do with an article I wrote titled, “Just Say No to the Mothers Act,” in which I showed all the drug company money directly flowing to these front groups in great detail.

On June 2, 2009, Amy Philo, the leader of “Unite For Life,” a coalition of 50 groups against the Mothers Act, posted the dollar amounts funneled to these main supporters of the Act on her website, based on estimates from specific excerpts from the “Just Say No,” article, also posted on the site. The total she came up with was between $13,095,010 and $16,487,497.

The variation in the total amount resulted from the fact that front groups will often list how much companies give by wide margins For instance, the 2007 Annual Report for the Depression and Bipolar Alliance says the group received between $150,000 and $499,000 from AstraZeneca, Pfizer, and Wyeth. Abbott, Cyberonics, Lilly, Forest, Glaxo, Organon, and Otsuka American Pharmaceuticals gave between $10,000 and $149,999.

The 2006 annual report for Mental Health America shows the group received over $1 million from Lilly, Bristol-Myers, and Wyeth in 2006. Pfizer and Janssen gave between $500,000 and $1,000,000, and AstraZeneca and Forest Labs donated between $100,000 and $499,000. Glaxo gave the group between $50,000 and $100,000.

As I have previously pointed out, Pfizer’s 2008 grant report shows a $20,000 grant to a Mental Health America group in Georgia to sponsor: “Project Healthy Moms: Education for Prevention/Treatment for Perinatal Depression Disorders.”

Next, I found a June 8, 2008 newsletter put out by the Georgia group that advertised Katherine Stone as the speaker for the lectures paid for by Pfizer. However, the Georgia group called the program: “Project Healthy Moms: What You Need To Know About Perinatal Mood Disorders.”

E-news said attendees of her presentation would learn in part: “One size does NOT fit all: Why postpartum depression is just part of a spectrum of mood disorders women may experience & what to look for.”

Without disclosing the large amount, e-news stated: “This special hour of learning is made possible by a grant from Pfizer.”

But in checking the Georgia group’s website yesterday, the ad there contained no mention of the fact that Pfizer paid the tab.

Pfizer markets drugs now commonly called “mood stablizers,” such as the anticonvulsants Lyrica and Neurontin, and the antipsychotic Geodon, 3 antidepressants including Zoloft, and Viagra, a big seller, likely due in part, to all the sexual side effects caused by psych drugs.

After Senator Grassley demanded an accounting, the National Alliance for the Mentally Ill, the executive director, Michael Fitzpatrick, admitted that “pharmaceutical companies contributed an average of 56% of national NAMI’s budget annually for the period 2005 to 2009,” in an April 28, 2009 letter to NAMI leaders and members.

Amy’s total does not include money to the National Healthy Mothers Healthy Babies Coalition, which receives money from Wyeth, Glaxo, J&J, Merck, and Sanofi Pasteur.

The total amount funneled through the Suicide Prevention Action Network USA is not available because it recently merged with the American Foundation for Suicide Prevention and Pfizer and Lilly were the only drug companies with public disclosures of their grants to both groups.

Dr Charles Nemeroff, another disgraced shrink who recently stepped down as the chair of the department of psychiatry at Emory University after 17 years, took over the presidency of the Foundation for Suicide Prevention for a 3-year term in 2008. Nemeroff’s resignation came after Senator Grassley revealed that he had earned more than $2.8 million from drug companies between 2000 and 2007, but failed to disclose at least $1.2 million to Emory. Amy included this amount in the estimated total.

The list of members on councils and committees on the Foundation’s website includes Alan Lipschitz, MD, from Glaxo, Steven Romano, MD, of Pfizer, David Norton from Johnson & Johnson, and Cathryn Clary, MD of Pfizer, along with APA president, Alan Schatzberg, and Dr Frederick Goodwin, who had his radio show thrown off the air last fall after Senator Grassley revealed that he failed to tell listeners that he was receiving millions of dollars from drug companies.

The “Directors” of the Foundation include Pfizer’s Cathryn Clary, and Philip Ninan, MD of Wyeth Pharmaceuticals.

Katherine has herself listed online for hire on LinkedIn with a lead-off pitch that reads: “Talented, award-winning marketing and PR professional returning to the workforce after brief sabbatical as full-time mom.”

“Skills include experiential marketing concept development, brand positioning, marketing strategy, social networking, and public relations campaign development and execution,” she writes.

“Used break from full-time employment to become an expert at social media, creating most widely-read blog in the U.S. in her niche,” the summary says in obvious refererence to the Postpartum Progress site.

At the end, Katerine includes a paragraph on her days as an agent for the the public relations firm Cohn & Wolfe. This firm’s clients have included Lilly, Merck, Novartis, Pfizer and the American Foundation for Suicide Prevention.

Another website with links to all the others, is run by Lauren Hale, the Postpartum Support International Georgia coordinator. Her site seems dedicated to minimizing any negative information that comes out about taking psych drugs while pregnant or harm to the fetus. Once a commentary or article is posted on her site, the other gals usually put up a link to it on theirs to get maximum exposure on the internet.

For instance, on April 29, Hale used her site to discount some of the top experts in the field quoted in the May 2009 Vogue article, “Pregnant Pause,” by Alexis Jetter, which stated: “With a flurry of recent reports challenging the safety of antidepressant drugs for unborn babies, doctors and concerned mothers-to-be are rethinking the guidelines.”

“What alarms doctors is the sheer number of pregnant women who use SSRI antidepressants – perhaps as many as 250,000 in the U.S. each year – when we still know so little about how the drugs effect babies,” Jetter reported.

“SSRI usage dramatically increases the chances that a baby may be miscarried, born prematurely or too small, suffer erratic heartbeats, and have trouble breathing,” she noted.

The rise to 250,000 appears to be quite a jump considering that back in the May 2005 Journal of the American Medical Association, researchers estimated that in any given year about 80,000 pregnant women in US were prescribed SSRIs.

In the article, Jetter quotes Dr Adam Urato as saying, “these antidepressants are portrayed almost like prenatal vitamins that will level out their mood and lead to a healthier baby. But antidepressants have not been shown to decrease rates of miscarriage or birth defects or low birth weight. On the contrary, they’ve been shown to increase those problems.”

Hale’s commentary was titled, “Thoughts on exploring a “Pregnancy Pause,” and she also sent it to Vogue. “I methodically refuted and balanced the article’s bias against medicating with anti-depressants during pregnancy,” she writes on her site.

On May 6, Karen Kleiman provided a link to “Thoughts” on her website and told readers, “Please take the time to read her very thoughtful and well-researched post.” The same day, Katherine also posted a link on Postpartum Progress with the headline, “Hale Responds to Vogue Piece on Antidepressants in Pregnancy.”

Not surprisingly, Hale specifically singled out the comments made by Dr Urato in the Vogue article. In 2006, Urato was responsible for exposing the fact that the financial ties of the authors to SSRI makers were not disclosed in a paper titled, “Relapse of Major Depression During Pregnancy in Women Who Maintain or Discontinue Antidepressant Treatment,” published in the Journal of the American Medical Association, which led to major media coverage and a public admonition by the editor of JAMA reporting that seven authors had failed to reveal their financial ties to drug makers.

A letter from Urato was also published in JAMA, stating that being the study dealt in part with the question of stopping antidepressants during pregnancy, the readers should be aware of the potential for pro-drug bias.

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 noted, were leading psychiatrists at Harvard’s Massachusetts General Hospital, Emory University, and the University of California Los Angeles.

The American Psychiatric Associations’s pumping up SSRI sales at their annual meeting via a new male diagnosis of PPD may cause problems for couples who want more children for more reasons than lack of interest in sex by one or both partners. On October 24, 2006, the Guardian reported that a study by doctors at the Cornell Medical Center found that two patients who had normal sperm counts and mobility before taking SSRIs had a severe deterioration of both when they began taking the antidepressants.

The doctors, who were treating the two men for infertility, found that when the men stopped taking the SSRIs, their fertility problems disappeared only to resume again when they went back on SSRIs.

The problem is believed to be caused by an adverse effect of SSRIs on both the concentration and swimming ability of sperm. The men were tested over a 2-year period and Dr Peter Schlegel, who presented the research at the American Society for Reproductive Medicine conference, in New Orleans, explained that:

“The patients had normal sperm counts and motility before medication. On the medication they have severe deterioration of both. The same patients going on and off medication had the same pattern. It shows a strong association.”

Impotence and delayed ejaculation are well-known side-effects of SSRIs but now Dr Schlegel says he believes the drugs may be preventing sperm from getting into semen.

“These were men with normal sperm counts that went to nearly zero when they were on these antidepressants but returned to normal when they were off them. It’s a dramatic effect and it’s never been described before,” he advised in the Guardian article.

“We believe that while it’s had a profound effect on these two men,” he said, “it could be having a significant but more subtle effect on many more men.”

Two years later, on September 24, 2008, Bloomberg News reported another study from Cornell University that found Paxil may impair fertility by damaging DNA in sperm.

The study of 35 healthy men who were given the antidepressant “found that the amount of damaged DNA in the men’s sperm rose to 30.3 percent after four weeks, from 13.8 percent,” the report noted.

“We suspect the other SSRIs would have similar effects,” Dr Schlegel told Bloomberg.

The treatment for all these “mood” and “anxiety” disorders women will be screened for as a result of the Mothers Act, includes not only antidepressants, but also drugs used as “mood stabilizers,” such as the antipsychotics Zyprexa, Seroquel, Risperdal, Invega, Geodon and Abilify, and antiseizure medications, along with benzodiazepines like Ativan and Xanax and sleeping pills such as Ambien or Lunesta.

In most cases patients are given combinations of different types of drugs at the same time. In fact, two different drug classes, Zyprexa and Prozac, are combined in Lilly’s Symbyax, and prescribed for “treatment resistant” depression. This one is a real money maker, selling at $1,564 for ninety 12-25mg capsules on DrugStore.com in May 2009.

For a simple diagnosis of “postpartum obsessive-compulsive disorder,” after her first pregnancy, Katherine Stone took “Effexor, Celexa, Seroquel, Risperdal, Wellbutrin, Luvox, Cymbalta, and etc.,” according to a line in a story about the treatment she received on her website, which was removed after I wrote about it.

In a blog describing her treatment during her next pregnancy, where she admits she took Cymbalta throughout, Katherine identifies her shrink. “I saw my fabulous psychiatrist at Emory every month (Hi Dr. Newport!),” she writes.

That would be the Dr Jeffrey Newport at Emory University who has received research support from Lilly, Glaxo, Janssen, and Wyeth, and has served on speaker’s bureaus and/or received honoraria from AstraZeneca, Lilly, Glaxo, Pfizer, and Wyeth, according disclosures in the August 2007 study titled, “Atypical Antipsychotic Administration During Late Pregnancy: Placental Passage and Obstetrical Outcomes.”

Another author listed on this antipsychotic study is Charles Nemeroff.

On April 29, 2009, Philip Dawdy’s headline on the popular website Furious Seasons, read: “10 Percent Of Depressed Patients Now Take Antipsychotics,” based on statements made during a conference call by executives of Abilify maker Bristol-Myers Squibb.

“Forget about Prozac Nation, this is Atypical Nation,” he said. “Antipsychotics are now the top revenue producing class of drugs, topping even statins.

The labeling on Risperdal says Risperdal “can raise the blood levels of a hormone known as prolactin, causing a condition known as hyperprolactinemia. Blood levels of prolactin remain elevated with continued use.”

“Some side effects seen with these medications include the absence of a menstrual period; breasts producing milk; the development of breasts by males; and the inability to achieve an erection,” the label notes.

A Patient Fact Sheet by the American Society for Reproductive Medicine, explains that, “Hyperprolactinemia is a condition in which too much prolactin is present in the blood of women who are not pregnant and in men.”

“In women, this results in a decline in the body’s production of progesterone after ovulation which, in turn, can lead to irregular ovulation and infrequent menstruation, cause you to stop menstruating altogether, or cause your breasts to start producing milk, a condition called galactorrhea,” it states.

“Men also can experience galactorrhea,” the Society says. “High prolactin levels in men can also lead to impotence, reduced libido, and infertility.”

A 2005 paper titled, “Medication-Induced Hyperprolactinemia,” from the Mayo Clinic reports that other classes of medications that cause hyperprolactinemia include antidepressants.

“The clinical consequences of hyperprolactinemia include galactorrhea and hypogonadotropic hypogonadism, the latter manifesting as oligomenorrhea or amenorrhea in women, erectile dysfunction in men, and loss of libido and infertility in both sexes,” the paper states.

A July 1, 2000 paper in the American Family Physician, by Dr Nancy Phillips, lists psychoactive medications that cause “disorders of desire” as antipsychotics, barbiturates, benzodiazepines, SSRIs, Lithium and Tricyclic antidepressants.

The list of drugs that cause “disorders of arousal” also includes benzodriazepines, SSRIs and Tricyclic antidepressants. These drugs, as well as antipsychotics and amphetamines (ADHD drugs) are reported to cause “orgasmic dysfunction” in the paper.

Purely to increase profits, people are encouraged to take psychiatric drugs for life and in some cases can never get off because the withdrawal syndrome is so severe.

It would be interesting see how many patients would be willing to begin a life-long treatment regimen if doctors were required to warn that it could mean the end of a normal sex life.

It would also be interesting to know how many patients are given the opportunity to check with their partners to see how long they will remain in a sexless relationship.

Correction: The article above mistakenly says that Alan Schatzberg stepped down as chair of the psychiatry department at Emory. He is at Stanford and he has not stepped down as chair of the psychiatry department. The statement should have been that Schatzberg of Stanford has “resigned his position as principal investigator on a federal research grant in response to the committee’s scrutiny,” the Stanford Daily reported.

Filed under: 'ADHD', 2009, AFSP, anticonvulsants, antipsychotics, APA, front groups, MHA, mothers act, NAMI, PPD, pregnant, sex, SSRIs

Mothers Act Promotes Pregnancy as New Cottage Industry

Evelyn Pringle December 5, 2008

Women of childbearing years represent the most lucrative market for the makers of psychiatric drugs. The knowledge that infants were being born with birth defects and suffering a withdrawal syndrome when these drugs were used during pregnancy was hidden for decades. Knowledge of these terrible risks would have caused a major drop in sales to this customer base.

Ever since the warnings about birth defects started trickling out a few years ago, the drug companies apparently have been plotting to find ways to reverse their negative impact. But the most sinister plot ever developed is a bill moving for approval in the US Senate right now called the “Melanie Blocker-Stokes Mother’s Act,” to set up the screening of all pregnant women for mental illness.

The bill is promoted under the ruse of screening for postpartum depression. But a true picture of the target population of this massive drug pushing scheme is evident in the propaganda submitted to support the passage of the original bill in the US House of Representatives and the programs already in place in various states.

The legislation was first introduced in the House in January 2007 by Illinois Democrat Bobby Rush. Under “Background and Need for Legislation,” House Report 110-375 states in part:

“Depression is twice as common in women as it is in men, with its peak incidence during the primary reproductive years–ages 25 to 45. Because women are more likely to experience depression during these years, they are especially vulnerable to developing depression during pregnancy and after childbirth.”

In February 2007, the “Postpartum Mood Disorders Prevention Act,” was introduced in Illinois. The orchestrated attempts to pass this bill included planting reports in the media with claims that pregnant women are at risk for a whole list of mental disorders. For instance, on March 1, 2007 an article in the Naperville Sun stated:

“New moms face increased risks for not only postpartum depression, but also bipolar disorder, schizophrenia, obsessive-compulsive disorder, anxiety and other disorders, according to one of the largest studies of psychiatric illness after childbirth.”

The websites set up by the industry-backed front groups supporting the Mother’s Act have links to programs that claim new mothers need to be screened for “postpartum” depression, bipolar disorder, schizophrenia, psychosis, anxiety disorder, panic disorder, obsessive-compulsive disorder, post traumatic stress disorder, and eating disorders.

When extending the drug-net to all pregnant women, the groups omit the term “postpartum” and claim women need to be screened for “perinatal” (which means both before and following birth) disorders. In December 2007, Illinois enacted “The Perinatal Mental Health Disorders Prevention and Treatment Act,” with the stated purpose “to increase awareness and to promote early detection and treatment of perinatal depression.”

But here again, the mention of “depression” only is deceiving because the websites of hospitals in Illinois show they are screening for the entire gamut of disorders mentioned above. Advocate Good Samaritan Hospital in Downers Grove offers “Perinatal Depression Support Services.”

“Any woman who is thinking about becoming pregnant, is pregnant, or had a baby within the past year can be affected by depression or other mood disorders,” their website says.

“Mental health screening under the guise of identifying individuals who are impaired from some supposed mental disturbance is typically simply another front for pharmaceutical marketing,” according to Dr Bose Revenel, co-author with psychologist John Rosemond of the new book, “The Diseasing of America’s Children.”

“Most are funded or the initiative is provided via pharmaceutical companies and medications are typically promoted as a supposed ‘solution,’” he says.

“The problem here is that, among other things, the drugs promoted have been shown to have potentially serious side effects and their effectiveness compared to placebo only trivial,” Dr Revenel reports.

“Furthermore,” he says, “the campaign ignores safe and potentially effective interventions such as dietary and nutritional changes and supplements as well as cognitive therapy – all of which are completely free of potential adverse effects, with effectiveness that rivals or exceeds that of the drugs.”

“If the screening only picked up women likely to benefit from treatment, then maybe it would be justified,” says Dr David Healy, a leading expert on psychiatric drugs from the UK and author of “The Creation of Psychopharmacology.”

“But screening will pick up a quarter or a third or more of all pregnant women and will lead to many of these being treated who do not need treatment,” he warns. “Over 25% of women might be diagnosed where very few of those are likely to need treatment.”

Although no psychotropic drug has FDA approval for use during pregnancy, the recommended treatment for all these so-called “disorders” consists of the newest most expensive antidepressants, antipsychotics, and anticonvulsants. The common practice is to prescribe three or four different drugs at a time for years on end.

The antipsychotics that will benefit as a result of the Mother’s Act include Seroquel by AstraZeneca, Risperdal marketed by Janssen, a division of Johnson & Johnson, Geodon by Pfizer, Abilify from Bristol-Myers Squibb, Novartis’ Clozaril, and Eli Lilly’s Zyprexa.

Lilly also sells two antidepressants, Prozac and Cymbalta, and Symbyax, a combination of Zyprexa and Prozac. The other SSRI (selective serotonin reuptake inhibitor) and SNRI (selective norepinephrine reuptake inhibitor) antidepressants include GlaxoSmithKline’s Paxil and Wellbutrin, Pfizer’s Zoloft, Celexa and Lexapro from Forest Labs, Luvox by Solvay, and Wyeth’s Effexor.

Pregnancy as a cottage industry

New Jersey Democrat Robert Menendez is the lead sponsor of the Mother’s Act in the Senate. New Jersey is home to a long list of drug companies. The bill was first introduced in May 2007, but was stuck in committee until Senate Majority Leader Harry Reid introduced an $11 billion omnibus package called “Advancing America’s Priorities Act.” Senator Reid tried to get the Act passed on July 22, 2008 by slipping it in the omnibus, but failed.

The Act is supported by a drug-funded coalition bent on turning pregnancy into a cottage industry. On September 25, 2008, Susan Dowd Stone, a member of “Postpartum Support International (PSI),” self-described as the “bill’s lead organizational sponsor,” issued a Legislation Update, obviously to pump out propaganda through the internet.

“Hundreds of thousands of women across the country suffer at the hands of postpartum depression every year, and they deserve better than the ideological games being played with legislation intended to bring them relief,” Senator Menendez declares in the Update.

“This is a cause I am committed to seeing through, and I will continue to stand up on behalf of mothers suffering from this condition until the blockade is cleared,” he vows.

“We will again await its inevitable passage at the next Congressional session when reason may more strongly prevail,” Ms Stone writes in the Update.

A gal named Katherine Stone runs the “Postpartum Progress” blog, described as the “most widely-read blog in the United States on these illnesses.” She serves on PSI’s board of directors as the public relations outreach chairwoman.

Her blog provides links to the “Top Women’s PPMD Treatment Programs & Specialists.” Dr Shari Lusskin is listed as a “top” specialist. She is an advisory council member for PSI. On her website under “Pregnancy-related Mood Disorders,” the standard talking point about “pregnancy related mood disorders” being prevalent is restated as follows:

“Panic Disorder, Generalized Anxiety Disorder, Obsessive Compulsive Disorder, and Eating Disorders may also develop or worsen during pregnancy and postpartum. Women with Bipolar Disorder, Schizophrenia, or Schizoaffective Disorder are particularly vulnerable during pregnancy and postpartum.”

A May 28, 2005 presentation brochure shows Dr Lusskin is a paid speaker for Glaxo, AstraZeneca, Pfizer and Wyeth.

The postpartum blogs are also used to sell books written by the “experts” and promote drug company funded conferences. For instance, on May 13, 2008, Postpartum Progress put out an ad for a June 25, 2008 conference at the University of Minnesota, titled, “Motherhood, Mood Disorders & Anxiety: Before & After Pregnancy.” The listed sponsors included AstraZeneca and the National Alliance for Mental Illness (NAMI), the most notorious industry backed front group on the planet.

Eli Lilly is logically the top giver to NAMI and many other front groups because it has the most drugs to peddle. Several class action lawsuits currently filed against Lilly specifically allege that Lilly funneled money to NAMI to aid in the off-label marketing of Zyprexa.

Between 2003 and 2005, Lilly donated $3 million to NAMI, according to the May 28, 2006 Philadelphia Inquirer. Lilly’s disclosure records show NAMI groups received more than $700,000 from the company in the first quarter of 2008. NAMI’s 2007 Annual Report lists Abbott Labs, AstraZeneca, Bristol-Myers, Eli Lilly, Forest Labs, Glaxo, Janssen, Pfizer, Wyeth and Solvay as “Corporate Partners.”

The NAMI website reports that the “National Depression Screening Day” and the “Stop a Suicide Today” campaign are endorsed by the American Psychiatric Association and are conducted in partnership with the American Association of Suicidology, Suicide Prevention Action Network USA, the National Suicide Prevention Lifeline, Suicide Prevention Resource Center, and Mental Health America.

In 2006, the pharmaceutical industry accounted for about 30% of the American Psychiatric Association’s $62.5 million in financing, according to the July 12, 2008 New York Times. Lilly’s first quarter grant report for 2007 shows Lilly provided the APA with two grants worth over $412,000. The Suicide Prevention Action Network received $10,000 from Lilly in the first quarter of 2007.

Mental Health America’s annual report shows the group received over $1 million from Bristol-Myers, Lilly and Wyeth in 2006. Janssen and Pfizer gave between $500,000 and $1,000,000, and AstraZeneca and Forest Labs donated between $100,000 and $499,000. Glaxo gave the group between $50,000 and $100,000 in 2006.

Other funding sources listed on the MHA website include three treatment centers for eating disorders with links to their websites. The National Association of Anorexia Nervosa and Associated Disorders estimates that the average cost of private inpatient treatment is $30,000 or more a month, according to an April 27, 2006 report by Women’s enews.

On May 21, 2008, the president of the Depression and Bipolar Support Alliance (“DBSA”), Sue Bergeson, posted a message on Bipolarconnect.com, saying Illinois Senator Dick Durbin’s office had called to say they were having “a hard time making headway” with the Mother’s Act. She informed readers that “more than 800,000 women will develop a diagnosable postpartum mood disorder this year! And this number doesn’t include the 7.5% of women who will develop major depression during pregnancy.”

At the end of the article, Ms Bergeson provided a link and urged people to take “30 seconds” to send a letter to their Senators.

The 2006 Annual Report of DBSA shows AstraZeneca gave the group more than $500,000 in 2006. Companies that donated between $150,000 and $499,000 include Abbott, Bristol-Myers and Wyeth. Forest Labs, Glaxo, Janssen, Pfizer, and Shire Pharmaceuticals each gave between $10,000 and $149,000. Lilly is listed in the section titled, “Matching Gift Companies,” in the report.

Battle lines drawn

A number of influential advocacy groups have come out against the Act including the International Center for the Study of Psychiatry and Psychology; Alliance for Human Research Protection; International Coalition For Drug Awareness; Law Project for Psychiatric Rights, Mindfreedom International, AbleChild, and the National Association for Rights Protection and Advocacy.

The website, UniteForLife.org is run by Amy Philo, the Texas mother at the forefront of the “Unite for Life” campaign against the Act. Amy’s story provides a poster perfect example of what will happen to hundreds of thousands of women all over the county if the bill is passed.

Amy was labeled mentally ill and told she needed to be on drugs by a nurse making a home visit simply because she got very upset after watching her first-born infant almost choke to death a few days after he was born.

When she followed the nurse’s advice and went to the doctor, the Ob-Gyn would not even take two minutes to listen to Amy talk about what had happened or allow her to explain why she was experiencing such over-whelming fear and anxiety.

Instead of viewing this young mother’s reaction to the near-death of her infant as a normal response, the doctor told her she had a panic attack and sent her home with samples packets of the antidepressant, Zoloft, to prevent postpartum depression, apparently expecting her to get over her traumatic experience by taking a pill.

There were no warning labels on the samples and the doctor did not alert Amy to any of the potential side effects. “He told me Zoloft was perfectly safe for me and the baby and it would make my baby happy too,” she recalls.

Within three days, the Zoloft pushed Amy into a state where she started having thoughts of first killing her baby and later of killing her husband, her mother, herself and even her pets. When Amy confessed to having these thoughts, instead of recognizing the side effects of Zoloft and stopping the drug, the medical professionals upped the dose, locked her up in a mental ward away from her baby, and tried to add Zyprexa, to the mix.

They never told Amy why they wanted her to take Zyprexa, but the sheet they gave her said it was for schizophrenia, she recalls. Amy refused to take it because she wanted to nurse and was afraid the drug would harm the baby.

She finally lied her way out of the hospital by claiming she no longer had the bizarre thoughts because she wanted to be with her baby and family. But in reality, Amy battled the obsession with suicide and homicide for months waiting for Zoloft to work.

“The constant ideas of homicide were followed by thoughts of suicide to protect my son from me,” she says. “I never had thoughts like this in my life before I took Zoloft.”

They also tried to get Amy to take the sleeping pill, Ambien, the anti-anxiety drug, Klonopin, and Celexa, another antidepressant, even though she was nursing. “I always just said no to those,” Amy says.

The Ob-Gyn told Amy that she might have to remain on Zoloft for life and without the drug she was not in control enough to have more children. The pediatrician told her, “what’s really scary is that PPD seems to get worse each time and you have a 90% chance of getting it after your next baby,” she recalls.

She finally quit taking the Zoloft against medical advice and the obsessive thoughts of homicide and suicide stopped and never returned. Amy and her husband have since had a second child with no problem whatsoever without the Zoloft.

She recently obtained copies of her medical records, which show she was labeled with obsessive-compulsive disorder and major depression. Those stigmatizing labels will remain in her records forever with no acknowledgment that Zoloft caused the ordeal.

“Antidepressant-induced mania commonly results in a false diagnosis of a new disorder leading to stigmatization and a possible lifetime of unnecessary, harmful treatment with drugs,” says Dr Peter Breggin, author of the new book, “Medication Madness,” and the man often referred to as the “conscience of psychiatry.”

Drug companies have a big financial incentive to promote these drugs. According to DrugStore.com, a 30-day supply of 20 mg Zyprexa costs $725.93. A 30-day supply of 100 mg Zoloft is $104.84. Klonopin costs $65.93 for 30-days of 2 mg tablets. The price of a 30-day supply of 10 mg Ambien is $145.99, and 20 mg Celexa costs $96.99 for 30-days. Amy’s two-day stay in the mental ward cost her family’s insurance company about $8,000 and an $800 co-payment for Amy and her husband.

The assertion that all these sick women are going without treatment is absurd. More prescriptions are written for psychiatric drugs every year in this country than for antibiotics or diabetes medications. On June 30, 2008, CNN Money reported that, for the “sixth year in a row,” antidepressants were the number one class of drugs prescribed in the US in 2007. CNN cited a report by the pharmacy benefit manager, Medco Health Solutions, that said 16% of women ages 20-44 take antidepressants.

In 2007, the branded atypical antipsychotics generated $15.9 billion in manufacturer sales in the seven major global markets, with $12.3 billion of those sales in the US, according to an April 2008 report by Sandra Chow on the Decision Resources website.

Thousands of infants harmed

In a September 18, 2008 letter to members of Congress urging them to vote against the Mother’s Act, Unite For Life reported that the estimated number of antidepressant-caused infant deaths and injuries over the past four years, based on data from the FDA’s MedWatch, were: 4,360 babies born with serious or life-threatening birth defects; 4,160 babies born with potentially fatal heart defects or heart disease; 2,900 spontaneous abortions; and 3,000 premature births.

The so-called experts supporting the Mother’s Act constantly minimize the risks. However, a study titled, “Acute Neonatal Effects of Cocaine Exposure During Pregnancy,” in the September 2005 Archives of Pediatric and Adolescent Medicine describes adverse effects for cocaine exposed babies eerily similar to those in babies born to mothers taking antidepressants:

“Several central and autonomic nervous system findings, which included hypertonia, jitteriness or tremors, high-pitched cry, difficulty arousing, irritability, excessive suck, and hyperalertness, were noted more frequently on the initial physical examination in the cocaine-exposed cohort. During the hospitalization, the diagnoses of seizures and autonomic instability were more frequently noted in cocaine-exposed infants.”

The warnings and precautions section on current labeling for SSRIs and SNRIs contains the following statement:

Neonates exposed “late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. … Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These features are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome.”

Besides the agony endured by these infants and their families, the additional medical costs are enormous. In 2005, commercial insurers paid an average of $4,247 per day for babies in neonatal intensive care, according to Thomson Healthcare. Direct health care costs for a premature baby average $41,610 or 15 times higher than the $2,830 for a healthy, full-term delivery, a March of Dimes May 2007 report on Preterm Birth estimates.

Advocates of the Mother’s Act claim mental illness poses a greater risk to the mother than drug use to fetus. “The problem with this claim is that there is no consideration for the immense stress a mother has to endure when her baby is sick due to this drug use,” says Kate Gillespie, an attorney who handles birth defect litigation at the Los Angeles based Baum, Hedlund, Aristei & Goldman law firm.

“Not to mention the far greater stress that is created by having to constantly deal with life and death health issues, like severe heart defects and respiratory problems, such as persistent pulmonary hypertension of the newborn, caused by SSRI medication,” she notes.

Baum Hedlund is currently representing over 200 families whose babies were born with birth defects ranging from congenital heart defects to PPHN after the mothers used SSRIs.

(Written as part of the SSRI Litigation Round-Up, Sponsored by Baum, Hedlund, Aristei & Goldman’s Pharmaceutical Litigation Department http://www.baumhedlundlaw.com)

Filed under: 'ADHD', 2005, AFSP, anticonvulsants, antipsychotics, Baum, Birth Defects, DBSA, MHA, mothers act, NAMI, PPD, pregnant, prices, SSRIs

Mothers Act – Bad Movie Rerun

Evelyn Pringle April 16, 2009

The promotion of the Mother’s Act is like a rewind of a bad movie dating back to the 1960’s when rock stars were singing songs about “mother’s little helpers.”

Women fought for years to gain acceptance of the fact that many female health problems were real and not symptoms of hypochondria. The psycho-pharmaceutical cartel’s profit-driven invention of an epidemic of pregnancy-related mental disorders will wipe out a century of work toward that acceptance.

Sadly, the end result of this latest marketing scheme will be that the relatively few women who truly do suffer from postpartum depression will not be taken seriously.

The Mother’s Act legislation has already passed in the US House of Representatives. A majority vote in the Senate would represent a major coup for a multibillion dollar industry.

“Like many of the acts of Congress, the real beneficiary will not be the mothers and their children but the “mental health” workers who will be handsomely paid and the drug companies that are behind this legislation,” says Steve Hayes, the director of he Novus Medical Detox Center, in the center’s July 31, 2008 newsletter.

“The drug store chains will expand more because more people will be hooked on these dangerous drugs,” he points out.

“Doctor’s offices will be more crowded because we know that these dangerous drugs often lead to serious health side effects that will require medical treatment,” he writes.

The advocacy groups battling against passage of the Mother’s Act are nearly equal in number to the Act’s supporters, and include Unite for Life, AbleChild, the International Center for the Study of Psychiatry and Psychology; Alliance for Human Research Protection; International Coalition For Drug Awareness; Law Project for Psychiatric Rights, Mindfreedom International, and the Citizens Commission on Human Rights.

Same old song and dance

The Mother’s Act technique has been used again and again in this country. A new sub-group of people is identified as not receiving enough treatment for mental disorders and the drug makers funnel money to front groups to fund the disease marketing campaign and set up screening programs.

The internet is now flooded with reports about the rise in pregnancy related disorders and the places to find treatment. Websites with names like “Postpartum Progress” and “PerinatalPro,” provide links to programs that claim women need screening for postpartum depression, bipolar disorder, schizophrenia, anxiety disorder, panic disorder, obsessive-compulsive disorder, post traumatic stress disorder, and eating disorders.

However, nowhere to be found, are reports about the sub-groups targeted in the past and all the depressed and anxious patients who became mentally healthy as a result of being screened and treated.

Dr David Cohen, a professor of Social Work at Florida International University and co-author with Dr Peter Breggin of the book, “Your Drug May Be Your Problem,” gave a keynote address titled, “Needed: Critical Thinking About Psychiatric Medications,” at the International Conference on Social Work in Health and Mental Health, in Quebec City, Canada in May 2004, and noted the following:

“For the past 50 years, physicians in the West have been prescribing
psychotropic drugs systematically to hundreds of millions of people to alter undesirable and disruptive emotions and behavior.”

“For the treatment of every single psychological affliction in men and women, in all ethnic groups, from the toddler to the aged, taking psychotropic drugs is now the cornerstone remedy, all other efforts secondary.”

“Despite the reliance on psychopharmaceuticals, however, not even modest improvements in the incidence, prevalence, relapse rate, duration, or long-term outcome of any condition routinely treated today with psychotropics, such as depression and schizophrenia, can be discerned.”

Childbearing years represent huge market

Childbearing years cover women from roughly sixteen to fifty and the Mother’s Act proves the drug makers will go to any lengths to hold onto this market.

“The labels for antidepressants warn of the increased risk of SSRI-induced suicidality in youth and young adults, the women most likely to become pregnant,” Dr Breggin, author of the new book, “Medication Madness,” points out. “So the drugs not only threaten to cause the death of the mother through suicide but the death of the child through lethal birth defects as well,” he advises.

“The exposed fetus is at risk for a variety of potentially serious disorders, from cardiovascular anomolies to withdrawal symptoms at birth,” Dr Breggin warns.

“If pregnant women feel anxious or sad,” he says, “they should seek counseling or family therapy with the child’s father involved, along with other sources of emotional support.”

In February, with little to no fanfare, the FDA said it was once again evaluating the risk of birth defects of SSRI and SNRI antidepressants due to the number of adverse event reports.

Pregnant women and nursing mothers are rarely told that antidepressants take anywhere from three to six weeks to work, if they work at all. “We know that the natural history of depression means that many patients will improve within weeks whether treated or not,” says Dr David Healy, author of “Let Them Eat Prozac.”

“The overwhelming majority of women who are prescribed antidepressants are at little or no risk for suicide or other adverse outcomes from their nervous state,” he points out

“Treatment runs the risk of stigmatizing the person,” he says, “as well as giving them problems that they didn’t have to being with.”

“Only one in ten women will likely have a true response to an antidepressant even if they are depressed, so nine women will be subject to the risks for the one who might benefit,” he states.

According to Jonathan Leo, an Associate Professor at Lincoln Memorial University in Tennessee, whose website, Chemical Imbalance is focused on debunking the “chemical imbalance” in the brain myth, the public health argument goes something like this:

“Helping one out of every ten does not sound very good but if you give the medications to 10 million people then you are helping one million.”

“This may be of little consolation to the nine million people exposed to potential side-effects,” he points out.

In December 2008, the FDA announced that anticonvulsants, widely prescribed as “mood” stabilizers, would now carry a warning about an increased risk of suicidality. They are also known to cause serious birth defects.

New Best Sellers – Atypical Antipsychotics

For a decade and a half, the new antidepressants were not only the best selling psychiatric drugs in the US, they became the top selling class of medications.

However, in 2008, antipsychotic revenues, at more than $14 billion, topped all other classes of drugs in the US, surpassing even cholesterol medications. The rest of the world apparently has not gone mad because the US accounted for over $3 billion of the close to $4.5 billion of worldwide sales of Seroquel, the fifth top selling drug in the US last year.

Anticonvulsants were the fourth class of drugs in terms of revenue, with over $11 billion in sales. Antidepressants held the fifth position, earning their makers more than $9.5 billion in 2008.

Like the SSRIs before them, the atypical antipsychotics are now prescribed off-label for everything from mild depression to anxiety to sleep problems to PTSD and ADHD, and for one reason. They are the biggest money-makers. The prices at a middle dose as of April 2009 on DrugStore.com were: Abilify 90 tablets $1230, Geodon 100 capsules $787, Invega 100 tablets $1168, Risperdal 90 tablets $716, Seroquel 100 tablets $839, and Zyprexa 90 tablets $1195.

The drugs were originally approved only to treat schizophrenia and later the manic episodes in patients with bipolar disorder. The National Institute of Health estimates that schizophrenia effects 2.4 million adults in any given year and 5.6 million adults have bipolar disorder.

“The story’s pretty clear, and pretty embarrassing for the profession of psychiatry, which has allowed itself to be led by marketing,” Dr Robert Rosenheck, a psychiatrist at Yale who has studied the expanded use and effectiveness of the atypical antipsychotics, told the LA Times on April 13, 2009.

“We know now what these companies’ strategies are: The number of people with schizophrenia is limited, so the road to profitability goes through soccer moms. They need to market these drugs to ordinary people who have dissatisfactions in life,” he said.

Antipsychotics come with serious side effects, some of them lethal. “The atypicals can cause a severe metabolic syndrome consisting of obesity, diabetes and cardiovascular problems,” according to Harrisburg, Pennsylvania psychiatrist, Dr Stefan Kruszewski.

Diabetes is a major cause of vascular disease and the number one cause of adult blindness, end-stage kidney disease and non-traumatic amputations, according to a 2006 report by the National Association of State Mental Health Program Directors.

“The atypicals have some of the same neurological side effects as SSRIs,” Dr Kruszewski says. “They also cause tardive dyskinesia, an often irreversible movement disorder.”

“Tardive dyskinesia looks so “strange” or “bizarre,” that it is often mistaken for a mental illness rather than a neurological disorder,” Dr Breggin reports.

“One variety,” he explains, “involves painful spasms of muscles that can literally torture the victim, and another involves an agonizing inner agitation that drives people to move their arms or legs, or to pace.”

“In some cases, the severe pain of tardive dyskinesia causes patients to become exhausted and ultimately disabled,” he reports.

“Tardive dyskinesia occurs at a cumulative rate of 4-7% per year in otherwise healthy patients treated with antipsychotics,” Dr Breggin says. “After taking the drugs for only a few years, 20% or more will be afflicted and older patient have an even higher risk.”

Helpless children harmed

There is no way to predict the adverse effects on the organs and bodies of children who receive psychiatric drugs filtered through pregnant and nursing mothers.

A study in the February 2004 journal, Pediatrics, reported abnormal sleep patterns, heart rhythms, and levels of alertness in babies exposed to SSRIs in the womb. The lead author, Dr Philip Zeskind, told the Sunday Telegraph: “What we’ve found is that SSRIs disrupt the neurological systems of children, and that this is more than just a possibility, and we’re talking about hundreds of thousands of babies being exposed to these drugs during pregnancy.”

“These babies are bathed in serotonin during a key period of their development and we really don’t know what it’s doing to them or what the long-term effects might be,” he warned.

A year and a half later, Christine K sat in a neonatal intensive care unit and watched and waited as her baby lie in an incubator with tubes and needles stuck all over his body for four days.

After a single bout of psychosis following a traumatic event in her life, a psychiatrist labeled Christine schizophrenic and kept her on Paxil, Risperdal and Depakote for five years. When she became pregnant, the shrink told her the drugs were safe for the fetus. In fact, she insisted that Christine keep taking them even when she asked to go off the concoction six months into her pregnancy after reading that Paxil could harm her baby.

After looking up more information on the internet, Christine decided to wean herself off the drugs in her seventh month against doctors’ advice. However, when she tried to explain that she quit taking the medications long before the infant was born, Christine was informed that he would still have to remain in intensive care due to the fact that he had been exposed to the drugs in the womb early on.

For the first two years of life, the baby would not sleep for any length of time – waking up every two or 3 hours. For the first three months, his whole body would jump at the least little sound even when he was asleep. He could not suck hard enough to nurse and resisted bottles. For the first year, he required hours of feeding attempts each day to make sure he received enough formula.

He was three last October and still has a strong aversion to eating – “including cake, cookies and all the things kids will normally eat even if nothing else,” his mother says.

“He was well over 2-years-old before he started sleeping through the night,” she reports.

In addition to the extra hospital costs for intensive care, “in the first three years of his life, this child has needed more medical care and doctor’s appointments than my other three children combined,” Christine reports.

In this case, the problems were nondescript. Doctors do not know enough about the effects of psychiatric drugs on the developing fetus to know if or how to treat them. “All I can do is watch and wait and hope they resolve on their own,” she says.

Christine is by no means a supporter of the Mother’s Act. She was scared and worried for a year after her son came home from the hospital but not from postpartum depression, she says. “It was mostly guilt and fear over what the drugs may have done to my baby.”

Drugged into Madness

The drugging cycle with women often starts with a loose diagnosis of postpartum depression. “My daughter was one of those poor souls prescribed an antidepressant for a “possible” case of mild postpartum depression with no warning about the adverse effects of the drug,” says Marcia Christensen of Australia.

“This caused a devastating cascade of events with further prescribing of multiple classes of antidepressants, atypical antipsychotics, Lithium and electro-convulsive therapy,” Marcia recalls.

“She made several attempts on her own life, developed type I diabetes and had her liberty denied over a 3 year period,” Marcia recounts.

Her daughter, Rebekah Beddoe, has documented the family’s ordeal in the book “Dying for a Cure,” in which she describes her decline from an ambitious, successful career women to a chronic mental patient as a result of being diagnosed with postpartum depression.

After a kick-off with Zoloft, Rebekah was on six different drugs within two years, diagnosed with a myriad of different disorders and feeling like a psychiatric hospital might be her permanent home. Electric shock treatment came in the midst of numerous suicide attempts.

She credits a BBC documentary on SSRIs with saving her life because she immediately recognized that the bizarre behaviors began shortly after she took the first drug. Rebecca decided they had to go and gradually weaned off each medication one by one. It took her 9 months to get off the antidepressant because the withdrawal problems were so severe.

Rebecca and Christine are not rare cases. Mixtures of antipsychotics, antidepressants and anticonvulsants, now used as “mood” stabilizers, are regularly prescribed for the all “anxiety” and “mood” disorders sought to be marketed via the Mother’s Act. Drug cocktails represent dollar signs. A woman like Christine, taking Depakote, Paxil and Risperdal, can easily ring up over $15,000 a year for the drug makers alone in the US.

The doctors make out like bandits as well. “Psychiatry has increasingly replaced psychotherapy with something called “medication management,” which largely consists of symptom assessment and prescription updates,” Dr Bruce Levine, author of, “Surviving American’s Depression Epidemic,” reports in the August 13, 2008 Huffington Post.

“Medication management typically takes ten or fifteen minutes and is scheduled every two to three months,” he explains.

While psychiatrists bill about half as much as they do for a psychotherapy hour, they can conduct a minimum of four sessions for every one psychotherapy session, he says.

Many psychiatrists do five- or ten-minute sessions, so they can complete five or six in the same hour that it would take to do a psychotherapy therapy session, including preparation and note writing, Dr Levine reports.

“The bottom line,” he says, “is that psychiatrists who offer only medication management routinely make nearly triple the income as do psychiatrists who provide mostly psychotherapy.”

(Article sponsored by the Houston law firm of Vickery, Waldner & Mallia)

Filed under: 'ADHD', 2009, anticonvulsants, antipsychotics, mothers act, NAMI, pregnant, SSRIs, Tardive Dyskinesia, Vickery

TeenScreen Sets Up Shop In Illinois

Evelyn Pringle June 20, 2005

A controversial plan to screen all Illinois school children for mental health disorders is set to become a reality on June 30th, if the Governor accepts the final proposal from the Illinois Children’s Mental Health Partnership (ICMHP).

Illinois became the first state to hop on the bandwagon for President Bush’s New Freedom Commission’s (NFC) plan to subject all American school children to mental health screening. In 2003, Illinois Lawmakers passed the $10 million Illinois Children’s Mental Health Act (ICMHP), creating a Children’s Mental Health Partnership, which many expect to become a model for other states.

The Final Report by the Illinois Children’s Mental Health Task Force was released in April 2003 and it is filled with intrusive and expensive recommendations. The ICMHP held hearings in various locations across the state in 2004 to gather public feedback on the plan.

While its proposals seem harmless enough at first glance, comments from parents during the hearings raised many valid concerns. The State, critics said, no longer assumes that Illinois children are mentally healthy, it presumes all children need mental health screening.

The Task Force Report calls for a comprehensive, coordinated children’s mental health system comprised of prevention, early intervention, and treatment for children ages 0-18 years and for a statewide data-reporting system to track information on each person, and social-emotional development screens with all mandated school exams (K, 4th, and 9th),

The Task Force wants to: Start early, beginning prenatally and at birth, and continue throughout adolescence, including efforts to support adolescents in making the transition to young adulthood.

Karen Hayes, associate director of Concerned Women for America-Illinois published an Opinion Piece in the Illinois Leader on July 23, 2004 and had a great idea. She said maybe the legislators should be mentally evaluated.

Concerned parent, Joseph Volpendesta, feels the same way. “Mental Health screening might be much more usefully employed on these people who come up with these brainstorms; it is obvious that they have far too much time on their hands and too little regard for those of us who are paying the bills. What is needed, and at the earliest opportunity, is a bill to rescind this piece of legislative claptrap. … There is no doubt in my mind where the mental health screening is most needed and it ain’t the kids,” he said in a letter to the editor of the Illinois Leader June 13, 2005.

TeenScreen Customer Recruitment Scheme

At the center of the controversy is program called TeenScreen designed by pharma backed officials at Columbia University. TeenScreen is supposedly a suicide-prevention program and is recommended by the NFC, even though a recent US Preventive Services Task Force study found “no evidence that screening for suicide risk reduces suicide attempts or mortality.”

Columbia claims the TeenScreen survey can assess the symptoms of 8 disorders associated with the risk of suicide or mental illness. On March 2, 2004, the program’s Executive Director, Laurie Flynn, testified at a congressional hearing and said that in screening process, “youth complete a 10-minute self-administered questionnaire that screens for social phobia, panic disorder, generalized anxiety disorder, major depression, alcohol and drug abuse, and suicidality.”

In May 2004, Illinois lawmakers passed a resolution approving the implementation of TeenScreen in public schools, which said in part: (1) “Columbia TeenScreen Program”, has been proven successful, offers technical assistance for implementation of a screening program, and provides all the components for such a program at no charge at this time; (2) that we recognize that mental illness and suicide among young people are public health crisis in this State and that all residents of Illinois should make the identification of mental disorders and the prevention of suicide among the young people a public health priority; (3) that every young person should be screened … to identify mental illness and prevent suicide; and (4) That such a screening and identification process should employ sound, evidence-based tools.

The problem is that TeenScreen is not an evidence-based tool. The program had already been in place for 6 years in Tulsa, Oklahoma when the suicide rate rose drastically, causing Michael Brose, the leader of a mental health partnership organization there, to say, “To the best of my knowledge, this is the highest number of youth suicides we’ve ever had during the school year — a number we find very frightening.”

TeenScreen is an invention of the pharmaceutical industry and is nothing more than a customer recruitment scheme to help generate high volume sales of costly psychiatric drugs. By infiltrating the nation’s public school system, it will generate millions of new prescription drug customers.

“More screened kids means more money for psychiatrists and the pharmaceutical industry,” said Vera Hassner Sharav, president of the Alliance for Human Research Protection, a patient advocacy group, to the Chicago Tribune on June 5, 2005.

“It is important to understand that powerful interests, namely federal bureaucrats and pharmaceutical lobbies, are behind the push for mental health screening in schools…the pharmaceutical industry is eager to sell psychotropic drugs to millions of new customers in American schools,” said Rep Ron Paul, R-Texas, who happens to be a physician.

TeenScreen made its Illinois debut last fall at the Brimfield High School in the Peoria area and reports indicate that several more Illinois schools will be implementing the program next year, according to investigative reporter, Rhonda Robinson.

TMAP & IMAP

Do the big drug companies have so much power? Why else would this be happening? It looks like a way to make more young people dependent on prescription drugs earlier in life when all they really need is to deal with growing up, just like we all did before there was a drug for every ailment and new ailment to justify even more new drugs,” parent, Dennis McLouth, of Roseville, Ill, wrote in a letter to the Editor of the Illinois Leader on June 13, 2005.

My answer to Dennis is yes the drug companies are that powerful, and it gets worse. The NFC recommends a drug treatment program called the Texas Medical Algorithm Project (TMAP) that specifically requires doctors to prescribe the newer generation of psychiatric drugs to children, including the antidepressants known as the Selective Serotonin Reuptake Inhibitors [SSRIs] that can lead children to commit suicide or other violent acts.

According to the American Hospital Formulary Service Drug Information 2005, the “FDA now states that it has determined that antidepressants increase the risk of suicidal thinking and behavior in children and adolescents with major depressive and other psychiatric disorders.”

Dr Ann Blake Tracy, is the executive director of the International Coalition for Drug Awareness and the author of “Prozac, Panacea or Pandora: Our Seratonin Nightmare.”

She testified at a February 2004, FDA hearing on the adverse effects of SSRIs, and said, “Research on serotonin has been clear from the very beginning that the most damaging thing that could be done to the serotonin system would be to impair one’s ability to metabolize serotonin. Yet that is exactly how SSRI antidepressants exert their effects.”

Tracy said that for decades research has shown that impairing serotonin metabolism will produce numerous health problems including “pains around the heart, difficulty breathing, tension and anxiety which appear from out of nowhere, depression, suicide — especially very violent suicide, hostility, violent crime, arson, substance abuse, psychosis, mania,” and the list goes on and on.

“How anyone ever thought it would be ‘therapeutic’ to chemically induce these reactions is beyond me,” she said.

In one study reviewed by the FDA panel, in a pool of 931 depressed patients taking SSRIs listed on the TMAP, versus 811 depressed patients taking a placebo, there were 52 suicidal acts by people on the SSRIs versus 18 on placebo.

The drug companies withheld the studies that showed the drugs were basically ineffective on kids and that they were in fact dangerous. Most of the studies that have surfaced over the past couple years were unearthed during the discovery process of recent law suits against drug companies.

Pediatrician, Dr Karen Effren, questions whether the TMAP list should be used at all. “If data is withheld about the dangers or lack of effectiveness of the new psychiatric drugs, why should physicians believe and carry out the recommendations of the New Freedom Commission for treatment, such as the Texas Medication Algorithm Project (TMAP) that uses those drugs as paid for the state incentive grants?”

These same sentiments had already been expressed in January 1999, by Peter Weiden MD, who was one of the participants on the original panel that approved drugs to be on the TMAP list, when he openly criticized the process in the Journal of Practice in Psychiatry and Behavioural Health.

Weiden pointed out the fact that drug company money was involved in the approval of the list. “Another problem is potential bias from funding sources. The 1996 Guidelines were funded by Janssen (makers of Risperidone [Risperdal]) and most of the guidelines’ authors have received support from the pharmaceutical industry. This potential conflict of interest may create credibility problems, especially concerning any recommendations supporting the use of atypical antipsychotics.”

Other drug companies besides Janssen were involved in the creation of the list. And drug company money was also used to grease the palms of politician who would ultimately have to approve the TMAP scheme.

For instance, Eli Lilly helped fund the guidelines and also has well-known ties to both Bush administrations. After Bush Sr left the CIA in 1977, he became a member of Lilly’s board of directors. When he left the company to become Reagan’s VP in 1980, he forgot to mention that he still owned stock in the company at the same time that he was lobbying for tax breaks for Lilly, even though it manufactured drugs in Puerto Rico.

Bush Junior made Eli Lilly CEO, Sidney Taurel, a member of the Homeland Security and his former director of the Office of Management and Budget, Mitch Daniels, was also a former senior vice president of Lilly.

In the 2000 election the company contributed over $1.5 million to political candidates, with over 80% going to Bush and the Republican Party.

According to the Center for Responsive Politics, in his 2 bids for the presidency, Bush has been the number one recipient of either party for campaign donations from the pharmaceutical industry. The same Robert Wood Johnson IV, who has ties to the foundation that funded the TMAP, is also heir to the Johnson & Johnson fortune, and raised over $100,000 for Bush’s 2000 campaign, and over $200,000 for campaign 2004.

The Robert Wood Johnson Foundation also helped fund the Illinois Children’s Mental Health Task Force, which produced the report that the Illinois’ Children’s Mental Health Act of 2003 is based on, according to investigative reporter Rhonda Robinson.

The Illinois version of the TMAP list, is IMAP and it is already in place in 23 Illinois counties, Robinson reports.

Tax Dollar Funded Drug Pushers

Let there be no mistake about it, kids sent to shrinks will end up on drugs. In 2002, a survey of recently trained child psychiatrists found that only one in 10 children in their practices did not receive a medication. See Stubbe DE, Thomas WJ: A survey of early-career child and adolescent psychiatrists, J Am Acad Child Adolesc Psychiatry 2002.

A recent review of prescription data for 300,000 children ages 19 and younger, by Medco Health Solutions in 2004, concluded that for the first time in history, spending for medications for childhood behavior problems eclipsed expenditure for any other drug category, including antibiotics.

The final draft of the Illinois plan issued this month wants to: Promote effective use of Medicaid’s Early Periodic Screening, Diagnosis and Treatment benefit in Illinois to support voluntary screening of children ages birth to eighteen years, and wants to “Clarify for providers the diagnoses that create eligibility for children to obtain Medicaid services.”

I wonder how many people are curious as to what might be in store for the kids they want to screen at age 0. To answer that question, an investigation of the drugs being prescribed to Illinois kids on Medicaid might be helpful.

On April 25, 2005, the headlines of the Ohio Columbus Dispatch read: DRUGGED INTO SUBMISSION, EVEN BABIES GETTING TREATED AS MENTALLY ILL, Doctors prescribed sedatives and powerful, mood-altering medications for nearly 700 Ohio babies and toddlers on Medicaid last summer, according to a Dispatch review of records.

An investigation by the Dispatch revealed that at least 696 Ohio children who were newborn to 3 years old received mental-health drugs paid for by Medicaid in July 2004. Hydroxyzine was prescribed most often, with about three-quarters of the kids on it. The drug, a long-acting antihistamine, relieves itching caused by allergies, controls vomiting and reduces anxiety, but is given to young children most often for its sedative effects.

In addition, more than 90 kids were on another antihistamine, 48 were taking anti-anxiety medication and 28 were prescribed antidepressants, including the SSRIs Paxil, Prozac and Zoloft. Twenty-seven received Valium, and 18 were on antipsychotics.

This revelation set off alarms in Ohio. “It’s troubling,” said John Saros, executive director of Franklin County Children Services. “How do doctors even determine that a 2-year-old is anxious? There’s a reason they call it the terrible twos.”

All total, nearly 40,000 Ohio children on Medicaid were taking drugs for anxiety, depression, delusions, hyperactivity and violent behavior when the investigation was conducted July 2004, according to the Dispatch.

Illinois’ new program keeps stressing that treatment should be funded by Medicaid. That means drugs folks. Over-drugging kids on Medicaid in Ohio is not an isolated practice. Its happening all over the country.

On January 15, 2005, the Miami Herald reported that nearly 1,900 children under the care of Florida’s child welfare system are taking antidepressant drugs, despite a strong federal warning that such medications are linked to an increased risk of suicidal thinking.

Similar findings held true in Tennessee for kids covered by the State insurance program. A study conducted in 2004 by Dr William Cooper, an associate professor of pediatrics at Vanderbilt University in Nashville, determined that the use of antipsychotic drugs among low-income children in Tennessee had nearly doubled between 1996 and 2001.

Cooper’s report, published in the August 3, 2004 issue of the Archives of Pediatric Adolescent Medicine, found that young people who are not psychotic are being prescribed antipsychotic drugs for which there was no data on safety or effectiveness.

The study revealed that the proportion of TennCare children who were prescribed antipsychotics nearly doubled in six years. The most dramatic increases were among those aged 13 to 18 (116%) and those 6 to 12 (93%). Cooper also found use among preschool children had increased by 61%.

If the Illinois Governor signs the new law on June 30th, in addition to children, all pregnant women will be screened for depression during pregnancy and for up to 1 year following a baby’s birth. The treatment for depression mandated by the IMAP drug list will be the SSRI antidepressants even though new studies indicate that SSRIs taken by pregnant women can have serious adverse affects on the unborn fetus.

“Newborn babies could be at risk of suffering withdrawal symptoms if their mothers are prescribed antidepressants during pregnancy,” according to Reuters on February 4, 2005.

Professor Emilio Sanz of the University of La Laguna in Tenerife, Spain, conducted a study that showed that SSRIs can cause convulsions, irritability, abnormal crying and tremors in newborn babies.

For the study, Professor Sanz and his team of researchers searched the World Health Organization database from 72 countries for the adverse drug reactions associated with the use of SSRIs, Reuters reported.

Karen Hayes thinks the whole plan stinks. “Proposing that state government set mental health competency standards for all Illinois pregnant women and children to age 18 stuns human sensibilities,” Karen Hayes wrote, “this proposal calls for collection of mental health data of women and children, together with bureaucratic linkage of this information.”

She’s got that right because according to the plan, the State of Illinois will: Improve accountability, data tracking and reporting for children’s mental health in relevant programs and services and will (1) Institute contract and monitoring changes to increase the accountability of current children’s mental health providers; (2) Develop a statewide data tracking and reporting system to collect information on key indicators of children’s social and emotional development, and mental health status; (3) Develop policies and protocols for the sharing of databases among relevant state and local agencies; (4) Explore the development of uniform reporting forms and test in select programs for the tracking, reporting and planning of services.

Follow The Tax Dollars

The task force says it wants to maximize the use of Medicaid/KidCare by streamlining enrollment, capitalizing on federal reimbursement and implementing key cost-saving strategies, with savings deposited into a Children’s Mental Health Fund.

It wants to (1) Improve Medicaid reimbursement for prevention, early intervention and treatment services; (2) Recognize diagnoses for young children described in DC:0-3 and pay for mental health services for children with any of these diagnoses; (3) Clarify for providers the diagnoses that create eligibility for children to obtain Medicaid services.

Translation: That means to make sure “treatment” (aka pills) will be paid for, people will be trained to only diagnose kids with disorders that are covered Medicaid.

The task force plan leaves no funding stone unturned. It even wants to “Change the Illinois KidCare and Medicaid eligibility procedures to allow for self-attestation of a family’s financial circumstances in lieu of current financial documentation requirements,” which means all I have to do is swear I’m poor to qualify for Medicaid in Illinois.

Drug companies smell the tax dollars and they want these Illinois kids. Over 2 million children were enrolled in Illinois public schools, pre-K through 12th grade, during the 2001-02 school year. Over 960,000 children were enrolled in Medicaid and KidCare in 2002, and a recent study in Chicago claimed that nearly 50% of inner-city adolescents demonstrated signs and symptoms of depression.

So lets do the math and see how much the psychiatric-industrial complex stands to gain. The plans says to: Ensure that all children enrolled in Medicaid receive periodic developmental screens … as mandated under the Early and Periodic Screening Diagnostic Treatment program.

Lets say the initial diagnostic visit to the shrink costs $150, what’s 150 times 960,000?

The report said 50% of Chicago inner city kids were depressed so we’ll use that percentage for the kids on Medicaid. Half of 960,000 means 480,000 kids are set to be prescribed anti-psychotic drugs right from the get go.

Off hand I don’t know how much all the different drugs cost, but I have personal knowledge that the cost of Risperdal in 2001, was close to $500 for a 30 day supply.

In 2001, The Miami Herald published a series of stories about the common use of Risperdal among children in state care. Child-welfare advocates said the drug routinely was being used by foster care providers as a ”chemical restraint” on children whose unruly behavior was a frustration to caretakers.

Risperdal is on the IMAP list as the leading drug used to combat schizophrenia and other types of psychotic disorders, and earns Janssen about $2.1 billion in annual sales. The drug is prescribed to more than 10 million people worldwide, according to the Herald.

I suspect a heavy-duty calculator will be needed to calculate dollar amounts for the potential cost of Risperdal prescriptions to the tax payers of Illinois.

Tax Payers May Foot Entire Bill

No doubt about it, the promoters of this scheme are looking to grab tax dollars from every public trough known to man. The plan lists a host of public funding sources to be examined and includes: Medicaid and SCHIP, the Social Services Block Grant, Temporary Assistance for Needy Families, the Child Care and Development Fund, the Title V Maternal and Child Health Services Block Grant, Parts B (Special Education) and C (Early Intervention) of the Individuals with Disabilities Education Act (IDEA), Juvenile Justice, and state funding sources.

In her opinion piece, Karen Hayes questioned the feasibility of such a large public funded program, “Our government bureaucracies continue to struggle with the job of tending to the social needs of needy Illinois families, and … trying to educate our children in basic academics. How is it that these same bureaucracies can now be asked to take on the additional role of being the mental health evaluator and caretaker of all pregnant women and children in Illinois?”

“At a time when budget concerns are on the front pages of most Illinois newspapers,” Karen wrote, “we are being asked to give input to one of the costliest expansions of government and bureaucracy we have seen in recent years.”

“In summary,” Hayes said, “it is neither beneficial to children, nor to taxpayers, to ask government bureaucracies to set competency standards for mental health. With some amount of lightheartedness, may I propose that the mental health of the perpetrators of this concept be evaluated?”

Another parent agrees with her. “The Illinois Legislature ought to have their own heads subjected to adolescent mental health screening for even considering passing such legislation,” said Jack Kime, in a June 13, 2005 letter to the Illinois Leader, “If there is anything more dangerous than having the government put such a program in place, I don’t know what it might be,” he said.

Filed under: 2005, antipsychotics, Bush, drugging children, FDA, Illinios, Johnson and Johnson, NFC, pregnant, RWJF, SSRIs, suicide, TeenScreen, TMAP, Zero to Three

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