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

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

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

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

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

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

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

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

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

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

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

Ingenix Study in First Trial

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

“Not that I have seen,” she said.

Ingenix Downside

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Closing Recap

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

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

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

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

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

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

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

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

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

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

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

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

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

Paxil Off-Label Promotion

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Glaxo’s Phone Book

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

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

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

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

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

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

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

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

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

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

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

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

Evelyn Pringle

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

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

1031 Deaths of Babies Exposed to Psychotropic Drugs

“There’s no tragedy in life like the death of a child. Things never get back to the way they were.”
– President Dwight David Eisenhower

Below is a link that shows some of the MedWatch reports submitted to the FDA of deaths caused to babies by exposure prenatally and neonatally to psychotropic drugs. This does not include the birth defects and withdrawal syndromes for babies who did survive exposure, which seems to be the only thing we usually hear about in the media concerning the drugs’ risks for babies. These figures are based on about a four year time period and represent from 1-10% of likely actual deaths. Keep in mind that these were preventable deaths of helpless babies which would not have occurred were it not for the exposure to psychotropic drugs prenatally and neonatally.

Go to http://psychdrugdangers.com/MothersAct.html and look through the summary tables for the 1,031 Abortions, Miscarriages & Other Deaths. You can see the breakdown for each drug class.

SSRI birth Defects: Why Weren’t Warnings Issued Sooner?

http://www.lawyersandsettlements.com/articles/11869/paxil-defects-birth-side-effects-12.html

 

February 6, 2009. By Lucy Campbell

Valley Home, AK: When Susan (not her real name) gave birth to her now 5-year old son, he had a lung and heart deformity. Susan had taken the anti depressant Zoloft, albeit briefly, during her pregnancy, and given all she’s subsequently read, now wonders if her son’s birth defects are SSRI-related birth defects.

Pregnant MedicationWhen Susan’s son was born, he wasn’t breathing. The medical staff had to resuscitate him and place him in an incubator. He was then diagnosed with pectus excavatum. “It’s a lung and heart ‘deformity’ I guess you would call it,” Susan said. “It’s supposed to be hereditary but no one in our family has this. My son also has breathing problems, and some type of brain damage which had to be in uterus and caused oral and verbal apraxia.” 

Apraxia is an impairment of the nerves or nervous system that affects a person’s ability to plan, execute and sequence motor movements. Verbal apraxia affects the programming of the articulators and rapid sequences of muscle movements for speech sounds. Oral apraxia involves nonspeech movements e.g., blowing, puckering, licking food from the lips – those kinds of things.

“My son didn’t talk until much later than is considered normal,” said Susan. “When he was 2 he just mumbled. And there were other things like he couldn’t put his tongue in his cheek, for example. He went to speech therapy for 2 years; that helped.”

So far, Susan has yet to receive any kind of diagnosis for her son, beyond those given when he was born, making treatment difficult. “He’s been tested for Autism, and the results were negative, but he does have behavioural problems, like anxiety and disruptive behaviour,” she said. “They think he has sensory processing disorder – but they haven’t given him a diagnosis of that. At one point they thought he had ADHD, and wanted to give him drugs for that but I refused.”

Not surprisingly, Susan has been doing a lot of reading, prompted in part by a need to try and understand what’s happening to her son, and in part by an ad she saw on television some time ago, describing SSRI birth defects.

“I saw a TV commercial and it got me thinking. I never thought that Zoloft may have played a role in his health problems, because my doctor said it was okay to take it,” Susan said.” I’ve read a lot, and I try to help my son. I love him, and I will do what I can for him. I wonder what the outcome would have been if I hadn’t taken Zoloft. As a parent, I want to know why this has happened – what caused it – because it would provide some kind of closure.” 

SSRIs–also known as selective serotonin reuptake inhibitors–are a class of antidepressant. Until about 2005 there were no real warnings of the possibility of birth defects connected with the use of these drugs during pregnancy. All that changed, however, in 2005, when the first public warnings emerged from the Food and Drug Administration (FDA) about the potential for serious heart defects in babies born to women taking SSRI antidepressants during pregnancy. 

SSRI Birth Defects
Susan’s son was born in 2004, before any of the public warnings were issued, together with the studies showing the link between birth defects and SSRI use in pregnancy. 

To say that the situation Susan and her son are in is frustrating would be an understatement. Had Susan known in advance of the possible consequences, she would not have taken an SSRI during her pregnancy. 

Worse, Susan is not the only mother with questions. There are many women with similar stories to tell. Chief among the many questions they would like answered is why weren’t the warnings issued sooner?

Prayer For Relief: California Mother Seeks Whereabouts of Mental Patient Son

FOR IMMEDIATE RELEASE

Prayer For Relief: California Mother Seeks Whereabouts of Mental Patient Son

by Amy Philo
amy@uniteforlife.org, 214-705-0169, 817-793-8028

“My son wrote poetry, did recitations and impersonations, artwork and sketches. He loved reading the Bible. I drew strength from his courage and resilience in the face of all of this. He cared about people. He wanted to make something of himself. My son could read at two years old and now he mumbles.”

Redlands, CA / Tuesday, Jan. 27 / — In a state which has become emblematic of progressive values and civil rights, Enne Currie sits tonight, praying for a just result at tomorrow’s mental health court hearing. A paralegal, Currie has filed numerous legal documents trying to force the system to abide by its own principles. Among these are a demand for information on the whereabouts of her son, Dirul Lewis, a Writ of Habeas Corpus, and various objections to the outrageous abuses being committed for profit or retaliation.

Lewis has been a mental patient for many years. Enne says that Dirul’s doctors experimented on him with drugs known to cause lethal interactions, including Zyprexa and Loxapine. A recent combination of drugs given in the hospital drove Dirul into a temporary coma. This combination was one that Enne, as Dirul’s conservator, had expressly objected to, but which the doctors administered anyway.

Despite over 17 years of attempts to get her son the best care possible, the mental health community continually failed Dirul. Currie even filed a lawsuit seeking to protect her son’s rights and health, but the case was dismissed because she was representing Dirul on her own.

About two weeks ago, Dirul Lewis was moved by his captors in the mental institution to an undisclosed location, and Currie’s conservatorship was cancelled. No hearing or reason was given. When Currie objected, she says she was ignored or dismissed with comments like “He’s been in this system for a long time.”

Enne recalls nursing Dirul as a child until he weaned himself, and says she believes that is how he managed to survive so many years of damaging treatments. Some time prior to his court-sanctioned disappearance, Enne noticed Dirul’s eyes go empty, like he no longer recognized her. Tonight, Enne doesn’t even know whether her son Dirul is dead or alive.

UNITE requests that anyone knowing the whereabouts or condition of Dirul Lewis immediately inform Enne Currie by writing to messages70007@yahoo.com or calling 909-384-2104.

For more information on tomorrow’s hearing, please contact Enne, or check https://uniteforlife.wordpress.com/ for updates.

###

URGENT: Contact The Senate Now To Stop The MOTHERS Act

http://www.uniteforlife.org/SayNoToTheMothersAct.pdf

http://www.uniteforlife.org/senatecontacts.pdf

URGENT: SENATOR HARRY REID IS ONCE AGAIN TRYING TO PASS A PACKAGE OF BILLS INCLUDING THE MOTHERS ACT.

Information:  Several weeks ago, Senate Majority Leader Harry Reid packaged a number of bills together and tried to get the bills passed as one package (The “Coburn” Omnibus Bill).  While the package of bills included some legislation that was positive, it also included The MOTHERS Act. As a mother who was prescribed antidepressants days after giving birth (because my three-day-old son required emergency medical treatment for a life-threatening choking incident and I was very upset by the incident, medical professionals, including my OBGYN, chose to consider my worry about my newborn Postpartum Anxiety — instead of a normal reaction of any new mother concerned about her son), and who was subsequently forced to continue these drugs while involuntarily held in a psychiatric ward, I understand the implications of this screening and “treatment” legislation better than any of its advocates. On the drugs I became suicidal and had thoughts of extreme violence I had never before experienced in my life. 

Please take a moment to do the following to protect mothers who will not be as fortunate as I was in realizing it was the drugs making me psychotic. You can see a video of my son below with the facts about antidepressants. 

Sincerely,

Amy Philo

Founder, UNITE http://www.uniteforlife.org

Please take a moment to:

1)       Watch this video http://www.youtube.com/watch?v=FUiszFyIby4

2)       Print off the message below or click here to print a PDF of the letter.

3)       Sign your name and address to the letter.

4)       Look up your Senators’ fax numbers by clicking here.

5)       FAX YOUR SENATORS IMMEDIATELY. 

DON’T LET THE 110th CONGRESS BE RESPONSIBLE FOR INCREASING ANTIDEPRESSANT-RELATED BIRTH DEFECTS AND INFANT DEATHS. DO NOT PASS THE MOTHERS ACT AS PART OF AN OMNIBUS PACAKGE.

The MOTHERS Act is a highly controversial bill, considering the growing public awareness that antidepressants have serious and even deadly side effects. This bill, if passed, will assuredly increase the number of pregnant women and new mothers being put on antidepressant drugs. There are already too many pregnant women being put on antidepressants evidenced by the FDA’s adverse reaction reports (MedWatch) listed below. This bill will assuredly increase the number of pregnant women and new mothers being prescribed antidepressants documented by the U.S. FDA to cause suicidal ideation, mania, worsening depression and birth defects. FDA’s MedWatch System (Adverse Drug Reactions) Already Has Overwhelming Evidence of Spontaneous Abortions, Premature Babies and Birth Defects from SSRI Antidepressants:

Doctors, other health care providers, pharmacists, lawyers and consumers filed the following adverse drug reaction reports with the FDA’s MedWatch system during 2004-2007 concerning pregnant women taking antidepressants (the most common and recommended treatment for women diagnosed with postpartum depression). In all the reports below, antidepressants were cited as the primary suspected drug to have caused the adverse reaction in pregnant women:

  • 145 spontaneous abortions
  • 150 premature babies
  • 208 babies born with heart disease
  • 218 babies born with defects

The FDA states that only 1-10% of side effects are even reported to their MedWatch database. Using a median range of 5% being reported, the actual number of pregnant women experiencing adverse reactions to antidepressant drugs is estimated as follows:

  • 2,900 spontaneous abortions
  • 3,000 premature births
  • 4,160 babies born with heart disease
  • 4,360 babies born with birth defects

The “Melanie Blocker-Stokes Postpartum Depression Research and Care Act,” also known as “The MOTHERS Act” was named after Melanie Stokes, a new mother who was subjected to a cocktail of psychiatric drugs and electroshock after being diagnosed with post-partum depression. It was only after she had been administered drugs documented by the U.S. Food and Drug Administration (FDA) to cause suicidal ideation that she committed suicideThere is too much controversy over antidepressants to pass any legislation that could increase the administration of these drugs to pregnant women and new mothers. Do not allow the pharmaceutical interests to put new mothers and their unborn children at risk. Do not pass the MOTHERS Act.

 

Signed
________________________________  

(Printed Name)

________________________________

Address & Phone Number

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Sincerely,

Amy Philo
214-705-0169 home
817-793-8028 cell

 

URGENT! Sign the petition against the MOTHERS Act at http://www.thepetitionsite.com/1/stop-the-dangerous-and-invasive-mothers-act
Visit www.uniteforlife.org

Links: http://uniteforlife.org/SayNoToTheMothersAct.pdf 

http://uniteforlife.org/senatecontacts.pdf

http://www.youtube.com/watch?v=FUiszFyIby4&feature=user

Drug Companies – The New Sin Stocks

A personal note: several years ago when I told a close personal acquaintance about these drugs and what they had done to me, as well as the data on their dangers for others, I got nothing but resistance. After a while the person actually decided to tell me that owning stock in drug companies was one of their motivations for not caring. This was around the same time as the “flu vaccine shortage” and the threat of avian flu started to emerge… which was used by Congress to justify passing the “Pandemic Immunity” legislation for vaccine and other drug makers. How many more people have to die? – Amy

http://www.bestsyndication.com/?q=node/16046
Drug Companies – The New Sin Stocks

Submitted by John Carey on August 22, 2008 – 12:55am. 

It is part of the American dream to put a dollar into a company stock today, and get lots of dollars back when you sell. The only modifier to this dream by some is an aversion towards “sin” stocks – avoiding companies that make alcohol, cigarettes, pornography, guns or provide gambling.

But when I suggest that you pitch drug-companies into this same sin-bucket you probably think I’m joking. But I’ll let you in on my reasoning, which includes numerous lawsuits against the companies, lying by the company executives to market their drugs under false pretenses for profit’s sake, and drugs pushed on the public which knowingly harm more people with the side-effects than they ever help.

Side Effects

All drugs have side-effects! Taken for a short time to cure something worse, it is a beneficial exchange. But drug companies can’t make the huge profit for an antibiotic you take for two weeks as they can for a “mental-health” pill you take every day for the rest of your life! 

With the first group of antipsychotics marketed, drug companies freed many people from the state hospitals. But one debilitating side-effect of these drugs (like Thorazine, Haldol and Prolixin) was that they caused involuntary, repetitive, and purposeless movements. In the 1990s, newer drugs called atypical drugs (like Clozaril, Zyprexa, Seroquel, Geodon and Risperdal) largely replaced the older meds and were marketed (at eight to twenty times the cost of the prior drugs) as causing fewer involuntary movements, but they have their own side-effects such as weight gain,diabetes and early death. 

• Tens of thousands of people sued Eli Lilly and AstraZeneca, saying that their drugs, Zyprexa and Seroquel, gave them diabetes and elevatedblood sugar levels. Eli Lilly reports having paid $1.2 billion to settle over 30,000 lawsuits. 

• In 2008, Alaska sued Eli Lilly for the medical costs of Medicaid patients who developed diabetes while taking Zyprexa. One of Eli Lilly’s top executives sent an email encouraging Lilly to promote Zyprexa for a use not approved by federal drug regulators (known as “off label”) and while doctors can prescribe a drug “off label”, it is against federal law for a drug company to encourage this practice. Alaska settled with Lilly for $15 million and now other states are going after this legalized drug pusher. (Global sales of Zyprexa approached $4.8 BILLION in 2007.) Lilly also faces 1,200 cases as well as a federal probe over its marketing tactics. 

• Janssen’s Risperdal got FDA approval to expand the use of the drug to address adolescent schizophrenia, the irritability of autism in kids and for bipolar disorder. In 2006, it was the most heavily prescribed psychiatric drug in New York’s Medicaid kids program, given to 17,393 children. It is also blamed in lawsuits nationwide for side-effects including diabetes caused by weight gain, Parkinson’s-like movement disorders andgynecomastia, in which males grow breasts which have to be surgically removed. 

• The pharmaceutical companies have made astronomical profits since promoting the atypicals to treat mental disorders. Since the drug companies couldn’t claim that the atypicals were better than the old drugs, they paid doctors to say so. This brought about a widespread false belief that the newer medications were safer and worth the additional billions of dollars in taxpayer money to make these the states’ preferred drugs of choice. Since then, the life expectancy of people treated in community mental health centers has plunged to a point twenty-five years LESS than the average due to a higher incidence of cardiovascular disease as a side-effect of these drugs. (For comparison sake, being homeless cuts ten years off your life expectancy.) Chuck Areford said in a 2008 article titled “Antipsychotic Drugs are Doing Harm” that this “… must be ranked as one of the worst public health disasters in U.S. history.” 

Drugs Marketed Under False Pretenses
If you are the CEO of a company, a large part of your multi-million dollar compensation is tied to how well the stock does during your tenure. This has led the companies to promote their drugs much like the rest of Madison Avenue promotes cars or the latest perfume. However, while the brand of car you drive doesn’t adversely affect your health, which psych drug you take to hide your problems does. 

• The entire basis for the use of psychotropic drugs is a THEORY, not a fact! The media presents it as a fact that depression is caused by achemical imbalance. However, even the psychiatric bible clearly states that the cause of depression and anxiety is unknown. Jeffrey Lacasse, a doctoral student co-authoring a study on this is quoted as saying, “… there are few scientists who will rise to its defense, and some prominent psychiatrists publicly acknowledge that the serotonin hypothesis is more metaphor than fact.” 

• In 2006 4-year-old Rebecca Riley died of an overdose of psychiatric drugs that had never been approved or tested for children. She had been taking drugs for ADD and bipolar since she was two years old and died with four prescription drugs in her system. Her heart and lungs were damaged due to prolonged abuse of the prescription drugs. 

• Cheyenne Delp, a five year old, died in 2004 while on five prescription medications. One of the anti-depressants required that she undergo an EKG to determine if her heart was healthy enough for her to take it. The child psychiatrist, Dr. Saran Mudumbi, testified that Cheyenne was out of control and that she suffered from paranoia, depression and anxiety. 

• One of the main psychiatrists pushing treatment of children with psychatric drugs is Dr. Biederman who has financial ties with fifteen drug companies and serves as a paid speaker or adviser to half of them, including Eli Lilly & Co. (Zyprexa) and Janssen Pharmaceuticals (Risperdal). 

• A drug is approved by the FDA for narrow uses, but gets tried off-label on hard-to-treat conditions and the drug company’s sales force stokes up this usage until the research catches up years later that shows the initial enthusiasm was unfounded. With the limited schizophrenic and bipolar market for the atypicals, the drug companies marketed them as safer than their predecessors They came to be tried beyond the approved uses for nursing-home residents, prisoners, and children younger than six years old. Total U.S. sales for this class of drugs reached $13 billion in 2007, doubling the sales just five years earlier. 

• Research by three universities says long-term use of anti-psychotics offers “no long-term benefit for most patients.” And while anti-psychotic medication is not licensed to treat dementia it is being given to 100,000 elderly patients in England to keep them manageable! Studies show that these drugs increase the risk of strokes and other harmful side effects. One study showed that after 3½ years, 60% of the Alzheimer’s patients given a placebo were still alive while only 28% of the group given the anti-psychotic medication were. 

• While an estimated 30-60% of U.S. nursing home patients are placed on antipsychotics, at the Bronx’s Providence Rest nursing home, the staff give massages to the patients. Utilizing this therapy, the nursing home has cut its use of antipsychotics to 2-3%, the lowest rate of any nursing home in New York! 

• The drug companies funded the committees which set up the state plans for defining which drugs to use for which treatments. Drug company profits then soared because the atypicals were listed as the first three choices over the older generic drugs. The states’ medical costs for patient care also soared! Now that the links to the drug company funding and the terrible side-effects have become known, nine states have sued Eli Lilly, four sued Janssen, and two sued AstraZeneca. Dozens of more states have teamed in a joint investigation, seeking billions of dollars in restitution for money they say they overpaid for atypicals through Medicaid. 

• In Minnesota alone, since 2002, drug companies have given $88 million in gifts, grants and fees to Minnesota doctors and caregivers. Several states, including Pennsylvania, are suing some drug makers for promoting their drugs beyond approved uses and commissioning “ghost-written” articles to increase sales

• Drug companies fund and support front groups like NAMI and CHADD and programs such as TeenScreen, in order to create a demand for their products covertly. These groups may not promote drugs directly but rather they promote disorders, legitimizing mental illnesses that have never been validated as true medical diseases. Drug companies cannot make these claims directly but accomplish the same goal through these other groups and programs. TeenScreen, an invention of psychiatrist (with drug company connections) David Shaffer, is a screening program asking children as young as 9-years-old questions like, “Have you often felt very nervous when you’ve had to do things in front of people?” and “Are you Hispanic or Latino?” Based on their answers, TeenScreen refers them to mental health “professionals“, who inevitably decide that these children have symptoms defined as “mental disorders”, writing prescriptions for antidepressants and other psychotropic drugs for children with no objective medical testing. TeenScreen’s staff and advisory board are loaded with ties to Big Pharma. See:http://www.teenscreentruth.com/teenscreen_advisory_board.htm. TeenScreen’s Director, Laurie Flynn was formerly at the helm of NAMI, which received over 11 million dollars in drug company funding from ’96 to ’99: Janssen ($2.08 million), Novartis ($1.87 million), Pfizer ($1.3 million),Abbott Laboratories ($1.24 million), Wyeth-Ayerst Pharmaceuticals ($658,000), Bristol-Myers Squibb ($613,505) and Eli Lilly $2.87 million.

• In 2008 researchers using the Freedom of Information Act, dug out information on Prozac that shows it is no more effective than a placebo! The study included clinical trials that Eli Lilly chose not to publish when they studied the drug. The data showed that patients had improved – but those on the placebo improved just as much! (The only exception was in the most severely depressed patients.) 40 million people take this drug, earning tens of billions of dollars for Eli Lilly. 

Is it the same sin to give capital to Playboy as it is to molest a woman? That is a question that only you can decide (with perhaps help from your pastor), but it doesn’t take much of a leap to imagine someone viewing porn and then going out and committing rape. You aren’t on the corner selling crack but you are just as guilty if you gave the crack dealer $10,000 to finance his supply. 

Who knows what potentials for bad hearts, mis-wired brains and early deaths these drug companies have caused our society in their profit-search for a daily-pill-solution to what ails us? If putting money ahead of people’s lives and preying on those needing real help doesn’t make you a sin company, I don’t know what does. 

So whether you now agree that pharmaceutical company stocks belong in the sin-stock category, or you simply believe that there are just too many liabilities for these companies to be good investments, either reason is enough to remove them from your portfolio forever.

AUTHOR BIO:
John Carey has degrees in Chemical Engineering and Computer Science from Texas A&M University, and has worked for a major oil company for over 24 years. As a humanitarian endeavor, he has researched extensively on the psychiatric drugging of children.

Neither the author of this article nor his family will profit financially in any manner from drug stocks losing value.