The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

Zoloft Fails to Outperform Placebo: Class Action

In the studies submitted to the FDA for approving Zoloft (a drug that has killed numerous families, babies, mothers, children), the drug maker covered up the fact that Zoloft failed to outperform placebo, according to a new consumer fraud lawsuit filed by the firms Baum, Hedlund Aristei & Goldman and Pendley Baudin & Coffin.

Many of you already know about the Irving Kirsch reports which examined the combined total of all antidepressant studies including those which were never submitted to the FDA. What you may not be aware of, is the level of manipulation required to achieve the appearance of the effect that Zoloft was as good as or better than placebo in the faked studies that were submitted. If you know of all the horrible effects (aka “side effects”) of antidepressants, you may be wondering, “Where is the supposed benefit if it is all negative, deadly stuff that we are dealing with?”

The answer is, there are no benefits compared with a placebo. According to Attorney Michael Baum of Baum, Hedlund, Aristei & Goldman, the alleged benefits were “achieved” in studies by “unblinding” which means that study researchers know who is on the drug versus who is on the placebo. When the defective unblinded subjects were removed from the study, analyses showed that Zoloft failed to outperform placebo.

This is a travesty and something that one would hope could be caught by the FDA before this drug was ever approved.

The class action is for patients who were prescribed Zoloft for depression.

For more information, see the press release here: http://www.baumhedlundlaw.com/consumer-class-actions/zoloft-placebo-efficacy-class-action.php.

Filed under: antidepressants, Baum, Baum Hedlund, SSRIs, Zoloft

The Problems With Reglan by Evelyn Pringle

May 27, 2010

Targeting Pregnant Women

The Problems with Reglan

By EVELYN PRINGLE

Although a black box warning for tardive dyskinesia was announced by the FDA in February 2009, lawsuits filed against the makers of Reglan (metoclopramide) allege the drug companies knew for decades that the risk of movement disorders was much greater than acknowledged in previous labels.

According to an expert witness report filed in a Georgia lawsuit by Dr Robert Nelson, a former 20-year employee of the FDA and National Institute of Health, “the 1/500 EPS labeling was inaccurate and misleading from the moment the oral dosage form was approved.”

In citing a 2008 study on the causes of TD at a university-based movement disorder clinic, Nelson reports that from 2000-2006, metoclopramide induced TD “was more common than any other cause, accounting for 34.5%” of all cases, or 87 out of 250.

Reglan is approved only for the short term treatment (12 weeks max) of gastroesophageal reflux disease (GERD), in adults who have not responded to other therapies, and for diabetic gastroparesis, for two to 8 weeks.

In the February 2009, letters notifying the drug makers of a need for a black box, the FDA stated, “we have become aware of continued spontaneous reports to the FDA of tardive dyskinesia associated with metoclopramide use. Exposure greater than 12 weeks was evident in a majority of these reports.”

In fact, a telephone survey conducted, by then Reglan maker (AH Robins), back in 1985, “found that 38% of Reglan users took the drug for between one and two years and another 46% of Reglan users took the drug for three to six months,” Dr Bob West, a pharmacologist and toxicoligist, says in a report filed in a Louisiana lawsuit.

Devastating Disorder

Tardive dyskinesia is one of the most devastating of all drug-induced movement disorders, according to Dr Peter Breggin, author of about twenty books, including “Medication Madness.”

“The abnormal movements or spasms can strike any of the muscles that are under voluntary control, including muscles of the face, eyes, mouth, tongue, neck, shoulders, arms, legs, hands, and feet,” he says. “Breathing, speaking, and swallowing can also be impaired.”

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

Reglan can also cause uncontrolled muscle spasms (dystonia), Neuroleptic Malignant Syndrome, Parkinsonism, depression, thoughts of suicide, and suicide. Common side effects include feeling restless, sleepy, tired, dizzy, or exhausted, headache, confusion, and trouble sleeping, according to a June 9, 2009, FDA approved medication guide.

Pregnant Women Targeted

Four months after the black box for TD was announced, a New England Journal of Medicine study claimed that Reglan was safe for pregnant women with morning sickness.

The news of the study was sent out to all the media outlets and a massive off-label marketing campaign followed to promote the sale of Reglan to pregnant women, with journalists publishing almost identical talking points.

Reporter, Linda Johnson, put out articles through the Associated Press newswire which resulted in headlines such as, “Study Suggests Drug Is Safe For Morning Sickness,” popping up all over the internet and for major media stories for a couple weeks.

For instance, in a June 10, 2009, article that appeared in USA Today, on Fox and ABC news Websites, and even in the UK’s Guardian on June 12, 2009, Johnson wrote: “For the first time, a large study shows that pregnant women who suffer morning sickness are not risking harm to their babies if they take a certain anti-nausea drug.”

“The result may lead more doctors to prescribe the drug metoclopramide and women to feel less guilty about using it during their baby’s crucial first few months of development, experts said,” she reported. Johnson never mentioned the black box for TD in her articles.

The June 10, headline for the same article on the MSNBC Website read: “Morning sickness drug shown safe for babies.” On June 11, a Johnson article appeared in the Boston Globe and the same story was in the Durango Herald News as late as June 22.

To begin with, running headlines claiming that Reglan is safe based on the NEJM study was misleading and irresponsible because the majority of women, 2,502 out of 3,458, only took Reglan for 7 days, or less, in the first trimester. The average duration of fetal exposure was about a week. Only 164 took the drug for 22 days or more. Plus, the study only looked at harm at birth with no later follow-up on the babies.

There was no mention in the actual study of the black box for TD, or any other adverse effects, that could harm the mom or the fetus. Yet, the Los Angeles Times ran a June 10, story with claims that the “first study of the anti-nausea drug metoclopramide in pregnant women has found that it is safe for both fetuses and mothers.” The Times failed to mention any side effects but included the main talking point that as “many as 80% of pregnant women suffer morning sickness in the first trimester.”

Huge Customer Base

Over four million women give birth each year in the US, according to the CDC. The study reported that between 50% and 80% of pregnant women get morning sickness. Those numbers translate into between 2 and 3.2 million new Relgan customers in the US alone, year in and year out.

The women in the NEJM study took three 10mg tablets per day. The current price of Reglan at DrugStore.com is $182 for 100 tablets. Each pregnant woman could buy 2 or 3 months of Reglan for the first trimester, plus the study notes that nausea and vomiting “can continue beyond the first trimester.” Two months of the drug at a cost of $364, times 2.5 million women, could potentially ring up $910 million each year.

Successful Campaign

It sounds like the study’s kick-off will definitely boost sales. “I think that women will be comforted by this,” Dr Keith Eddleman, director of obstetrics at Mount Sinai Medical Center in New York, told Johnson in an AP article. “Most women are reluctant (to take anti-nausea medicine) just because of the stories they’ve heard and the perception that taking something in the first trimester can cause harm.”

“There are very few drugs approved for use in the first trimester of pregnancy,” Dr Jennifer Niebyl, a professor of obstetrics and gynecology at the University of Iowa, told Time Magazine on June 10, 2009.

“But this study could lead to metoclopramide getting approved to treat morning sickness because this is good data with big numbers,” she said. “These findings may change practice and help people to be less hesitant to use the drug.”

Dr Laura Riley, a Massachusetts General Hospital obstetrician and spokeswoman for the Society for Maternal Fetal Medicine, told Johnson women are far more cautious than doctors about medication. “For some who are on the fence, it’ll allow them to take it.”

The chairman of obstetrics and gynecology at St John’s Health Center in Santa Monica, Dr James Moran, told the LA Times that he thinks the findings should be replicated but that he “wouldn’t hesitate to use Reglan at all.”

Infants heavily dosed

Reglan is also marketed off-label to nursing mothers to stimulate breast milk even though the medication guide warns women that the drug “can pass into breast milk and may harm your baby.”

Reglan is also used to treat GERD in newborns, especially premature babies. Any use with infants is off-label. Yet a study in the June 2006, Pediatrics journal titled, “Reported Medication Use in the Neonatal Intensive Care Unit: Data From a Large National Data Set,” found Reglan was one of the 10 drugs reported most commonly for the NICU.

A Medline abstract for a paper in the January 2005, Movement Disorders Journal, reported the “first documented case of tardive dyskinesia in an infant,” developed at 2 months “after a 17-day treatment with metoclopramide for gastroesophageal reflux.”

The “Pediatric Gastroesophageal Reflux Clinical Practice Guidelines,” in the October 2009, Journal of Pediatric Gastroenterology and Nutrition, warn that “Metoclopramide commonly produces adverse side effects in infants and children, particularly lethargy, irritability, gynecomastia, galacctorhea, and extrapyramidal reactions and has caused permanent tardive dyskinesia.”

An infant treated for GERD, born to a mother who took Reglan for morning sickness and to increase breast milk, would undergo triple exposure.

Women Need Warnings

“Women need to be aware of the potential risk Reglan poses to themselves and their children,” according to Roger Drake, the lead Reglan attorney at the California-based Baum, Hedlund, Aristei & Goldman law firm, in cases of persons who developed TD.

Concerns about tardive dyskinesia extend to children and infants, especially babies born prematurely, who may have been treated with Reglan to stimulate their digestive system, Drake reports.

He points out that no studies have been conducted to examine the risk of tardive dyskinesia in babies whose mothers take Reglan, even though the drug makers know that Reglan is used in such circumstances.

The adverse effects for babies are the same as for adults, he says, but infants are more at risk because there are no FDA approved dosing requirements established for the safe use of Reglan with children of any age, much less infants.

Baum Hedlund has two decades of experience representing thousands of injured clients against drug companies.

(This article is part of the Reglan Litigation Update Series and is sponsored by the Baum, Hedlund, Aristei & Goldman law firm http://www.baumhedlundlaw.com/drugs2/reglan.php)

Evelyn Pringle is an investigative journalist focused on exposing corruption in government and corporate America.

Filed under: Baum Hedlund, Pregnancy, Tardive Dyskinesia

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?

Filed under: antidepressants, Baum Hedlund, Birth Defects, child endangerment, lawsuits, Melanie Stokes, MGH, mothers act, Paxil in pregnancy, PPD, Pregnancy

MOTHERS Act Promotes Pregnancy as Cottage Industry by Evelyn Pringle

Mothers Act Promotes Pregnancy as Cottage Industry

http://www.scoop.co.nz/stories/HL0812/S00107.htm

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.

 

*************Evelyn Pringle
epringle05@yahoo.com

(Evelyn Pringle is a columnist for Scoop Independent News and an investigative journalist focused on exposing corruption in government and corporate America)

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

Filed under: Amy Philo, antidepressants, antipsychotics, Baum Hedlund, big brother, Birth Defects, choking, Congress, involuntary hospitalization, Isaac Philo, mothers act, ,

Pringle: Pharmaceutical Hustlers Part 2 (SSRI Pushers)

Pharmaceutical Industry Hustlers – Part II

Pushers of SSRI Antidepressants

To gain approval for treating children, all a drug company has to do is submit two positive studies to the FDA to prove a medication is safe and effective for kids. However, after 20 years of feeding the new generation of antidepressants to tens of thousands of kids in clinical trials, the only one ever approved is Prozac.

Collectively, these antidepressants are referred to as SSRI’s (selective serotonin reuptake inhibitors) and include Paxil, Zoloft, Celexa and Lexapro. When the term SSRIs is used, it often refers to their chemical cousins Effexor, Wellbutrin and Cymbalta as well.

The drug companies, “by their sheer economic clout,” have become the single most dominant influence in our healthcare system, and the “ambiguities of children’s mental health and illness make child psychiatry the most vulnerable branch of medicine open to such influence,” says Dr Lawrence Diller, a behavioral-developmental pediatrician and author of, “The Last Normal Child,” in the July 13, 2008, San Francisco Chronicle.

“In this climate,” he explains, “drug company research money, professional medical education and direct advertisements to parents tilt families and doctors to biologically brain-based solutions, rather than non-drug (e.g., parenting and education) approaches.”

That is why we are seeing famous (or infamous) Newsweek cover boys – like a 10-year-old “who has taken 38 psychiatric medications in his short, unhappy life,” he says.

Dr Joseph Glenmullen, author of “Prozac Backlash,” testified at a hearing before the US House Energy and Commerce Committee on February 10, 2005, and explained how important lawsuits have been in unearthing the internal company documents, which reveal the antidepressant-induced suicidality risk. Both the FDA and the pharmaceutical industry knew about this side effect over a decade ago, he said.

Dr Glenmullen noted that the FDA failed to adequately educate doctors and the public and called it a “most dangerous scenario” when neither the doctor nor the patient knows how to recognize antidepressant-induced suicidality.

He pointed out that only Prozac was FDA approved for depressed children, and all other antidepressants studied had failed to demonstrate they were more effective than placebo. He faulted the FDA for failing to require drug manufacturers to tell doctors in the labels that the drugs had been studied and failed to show efficacy.

He noted that one million American children were on antidepressants for everything from shyness to school anxiety to headaches to attention deficit disorder. “How can the FDA allow this to happen when it has acknowledged that the drugs can make children suicidal?” he asked.

“Family doctors write 70% of prescriptions for antidepressants and know little about how to diagnose and treat antidepressant-induced suicidality,” he pointed out.

Once the FDA approves a drug, doctors can prescribe it for any purpose, a practice called off-label prescribing. “Many doctors prescribe many medications off label for children, but none do it as frequently as child psychiatrists,” says Dr Diller.

He advises that none of the psychiatric drugs have been studied for more than two or three months regarding long-term safety or effectiveness with children, with the exception of stimulants used for ADHD. Drug companies oppose this kind of thorough follow-up on drugs “not only because it is expensive, but because they don’t really want to find out whether their drugs continue to work over time or if long-term side effects develop,” he states in the paper, “A Prescription for Disaster,” published by Salon.com on May 23, 2002.

“Currently, that kind of research is a job for the country’s trial lawyers,” he writes.

“But this de facto system of monitoring the effects of drugs requires many casualties before an adverse outcome is discovered or established in the medical and popular literature,” Dr Diller points out.

Highly Paid Hustlers in motion

The “failure of clinical trials to provide safety information about the effects of long-term use is at the heart of the debate about the legitimacy of prescribing psychotropic drugs for children,” according to Vera Hassner Sharav, President of the Alliance for Human Research Protection in the 2003 paper, “Children in Clinical Research: A Conflict of Moral Values,” published in the American Journal of Bioethics.

No SSRI was approved for children before 2003. However, by “the early 1990’s, it didn’t matter that they were not officially approved for use in children: they were commonly given to children as young as 6 years old,” says Professor Jonathan Leo in the 2006 paper, “The SSRI Trials in Children: Disturbing Implications for Academic Medicine.”

He points out that “the child psychiatry profession fully endorsed the use of these drugs well before the FDA approved them, and, in an even odder twist,” he says, “the profession endorsed the use of them well before any of the major studies in children were even published.”

“It appears that one reason for doing the studies in the first place was to justify already well-accepted prescribing patterns,” according to Professor Leo.

“If a trend is created ‘because everyone else is doing it’ then it appears that the child psychiatry profession’s use of these drugs in the late 1990’s more closely resembled a trend instead of a logical scientific undertaking,” he explains.

The first major studies claiming SSRI’s were safe and effective for children began to appear in the late 1990’s. In all the published studies, papers and poster presentations used at medical seminars, conferences and other events to expand the “well-accepted prescribing patterns,” to doctors in every field of medicine, there are the names of the same “Highly-Paid Hustlers,” also known as “key opinion leaders,” because they are supposedly so highly respected by their peers.

They include, but are not limited to, Drs Joseph Biederman, David Dunner, Graham Emslie, Daniel Geller, Robert Gibbons, Frederick Goodwin, Martin Keller, Andrew Leon, John Mann, John March, Charles Nemeroff, John Rush, Neal Ryan, David Shaffer and Karen Wagner.

Dr Biederman and the gang at Harvard almost single-handedly instigated the epidemic in the off-label prescribing of drug cocktails to children, of 2, 3 or even 4 drugs at a time, in combinations that have never been tested on animals much less humans. The mental illness always known as “manic-depression” was now “bipolar disorder,” and in the mid-90’s, Dr Biederman, and a few more “opinion leaders” started claiming that a great number of children were afflicted, possibly even as early as in the womb, some said.

“Most parents have never heard of him, but Joseph Biederman of Harvard may be the United States’ most influential doctor when it comes to determining whether their children are normal or mentally ill,” says Dr Diller, in an article entitled, “Are Our Leading Pediatricians Drug Industry Shills?” in the July 13, 2008, San Francisco Chronicle.

“Biederman and his team,” Dr Diller writes, “are more responsible than anyone for a child bipolar epidemic sweeping America (and no other country) that has 2-year-olds on three or four psychiatric drugs.”

“The science of children’s psychiatric medications is so primitive and Biederman’s influence so great,” he says, “that when he merely mentions a drug during a presentation, tens of thousands of children within a year or two will end up taking that drug, or combination of drugs.”

“This happens in the absence of a drug trial of any kind – instead,” Dr Diller notes, “the decision is based upon word of mouth among the 7,000 child psychiatrists in America.”

”That’s why Iowa Sen. Charles Grassley’s recent revelation that Biederman did not declare $1.6 million in drug company consulting fees is so important, scary and tragic,” he says.

“If true,” Dr Diller notes, “this scandal is yet one more stake in the heart of American academic medicine’s credibility with frontline doctors like him, and more importantly, with the parents of the children he deals with every day.”

Until the “bipolar” profiteering scheme was set in place by publishing a couple bogus studies and then passing them around to doctors all over the country at medical seminars and conventions, manic-depression was unheard of in children. It still is in other counties.

Most parents are not aware of the life-long consequences of a childhood mental-illness diagnosis. Children with medical records showing treatment become ineligible for a wide range of occupations. An early diagnosis can also make it difficult to obtain health insurance for life.

In the age of computerized recordkeeping, there can be no deleting of this damning information. Just as there is no scientific way to prove that anyone has a mental disorder, there is no way to disprove it either. Once diagnosed, a child will never escape the label.

Dr Emslie was busy pumping out new marketing tools last year, this time in the form of a treatment guideline to promote the off-label use of psychiatric drugs to toddlers. However, the “respectable” medical journals continue to publish this kind of trash.

He is the first author on a December 2007 paper in the Journal of the American Academy of Child & Adolescent Psychiatry that reviewed the developmental considerations related to preschool psycho-pharmacological treatment, presenting current evidence bases for specific disorders in early childhood and described the recommended algorithms for medication use in 3- to 6-year-olds.

This “Preschool Psychopharmacology Working Group” claims it was developed to review existing literature and to develop recommendations to guide clinicians considering psycho-pharmacological treatment in very young children. “The purpose of this effort,” the authors note, “is to promote responsible treatment of young children, recognizing that this will sometimes involve the use of medications.”

Not one single psychiatric drug is approved for children under 6; not alone and not together with any other. Yet the Group says it has established algorithms for the treatment of ADHD, disruptive behavior disorders, major depressive disorder, bipolar disorder, anxiety disorders, posttraumatic stress disorder, obsessive-compulsive disorder, pervasive developmental disorders (such as autism) and primary sleep disorders.

On May 5, 2006, United Press International reported on a Duke University study where investigators studied 307 children between the ages of 2 and 5 and claimed they detected signs of depression, anxiety and other mental illnesses. The rate was about the same as with older children and not much lower than within adults, they said. UPI made sure to mention that the research was funded in part by the “pharmaceutical giant Pfizer.”

Judging by the results of this “study,” the “Hustlers” recruited another 30 toddlers as potential customers for daily drug cocktails in one sweep. Notably missing from all the above lists of “disorders” is a condition that could account for half of the stigmatizing labels in one age group, commonly known throughout time as the “Terrible Twos.”

Sad aftermath

Of all the harmful actions of modern psychiatry, the mass diagnosing and drugging of children is the most appalling with the most serious consequences for the future of individual lives and for society, says Dr Peter Breggin, author of the new book, “Medication Madness.”

Many children who end up seeking help from Dr Breggin are already on four or five drugs at one time. He says millions of children are growing up with “drug-intoxicated brains.”

Not only do these medications suppress spontaneity and volition, he warns, but the psychiatric approach teaches children that they cannot, without medication, learn to manage their own behavior. In effect, the children are taught that they cannot exercise and develop self-determination, autonomy or free will, he explains.

Pennsylvania psychiatrist Dr Stefan Kruszewski also warns that “young children who are medicated do not learn to adapt and develop coping strategies as they move through the developmental stages of childhood.”

“They rely on a false belief that drugs can solve problems,” he says, “rather than relying on their own innate creative potential or the help of family, friends, and schooling.”

“Psychiatry was once plagued by ‘boundary violations,’ where physicians exploited the dependence of their patients,” Dr David Healy explains in the 2006 paper, “The Latest Mania: Selling Bipolar Disorder.” But he says:

“All the indications are that we are now in a new era of drug-related boundary violations. There is perhaps nowhere in medicine where this is more obvious than in the case of bipolar disorders, with adults treated with bizarre cocktails and children put on some of the most lethal drugs in medicine.”

“The extensive prescription of these medications for children,” Dr Diller warns, “without adequate testing for safety and effectiveness in children constitutes a hidden time bomb that could explode with still more casualties.”

“Catastrophic side effects may be rare,” he says, “but they become predictable when we treat so many children with so many drugs.”

“There is nothing more despicable than a doctor knowingly telling normal children they are mentally ill for profit,” says Dr Fred Baughman, author of, “ADHD Fraud – How Psychiatry Makes Patients of Normal Children.”

“Because the children made into ‘patients’ are normal to begin with,” Dr Baughman contends, “those who treat them with psychiatric drugs are guilty not of an iatrogenic medical mistake, but a willful for-profit poisoning.”

“What should we call it when children die pursuant to a fraudulent diagnosis,” he asks. “First degree murder? Second degree murder? Justifiable homicide? Manslaughter?”

In an expert report recently submitted in litigation involving a Paxil-induced suicide by a 13-year-old boy, Dr Glenmullen discusses a case where that question begs to be answered when he tells the court: “It is my opinion to a reasonable degree of medical probability that if GlaxoSmithKline had provided a warning all these years, Benjamin Bratt would still be alive today.”

There are many families suffering all over the country as a result of the drugging-children-for-profit schemes set in place by the Highly-Paid Hustlers. “For us it has been four and a half years without resolution or closure,” says Mathy Milling Downing, whose daughter Candace hung herself in January 2004 after being prescribed Zoloft at age 12 because she was nervous when taking tests at school.

“Every day hurts,” Mathy says. “One never gets over the loss.” Prior to her death, the Downings saw no signs of Candace being depressed or suicidal.

They were not told to watch for signs of suicide. The doctor did not inform them that Zoloft was not approved for children, and they were assured that Zoloft was safe.

The Downings would later learn that their daughter’s physician was on Pfizer’s payroll. “Although we realize that Candace’s doctor only made about $12,000 acting as a Pfizer consultant, it’s not the amount that bothers us,” Mathy says.

“It’s the medical compromise. It’s the lack of informed consent. It’s placing economical gain above the well-being of an innocent child and a trusting family,” she states.

“I just want to know when ‘Greed before Need’ will diminish and doctors will once again place a patient’s well-being first,” she says, “before financial gain.”

“What has happened to the Hippocratic Oath that doctors are supposed to take?” Mathy wants to know.

Rough estimates

In “Let Them Eat Prozac,” Dr Healy discusses how he reached his estimates for the high number of suicides and suicide attempts that could be attributed to Prozac alone. An April 2000 paper in the Archives of Psychiatry looked at the rates for suicide attempts on newer antidepressants compared to placebo and reported SSRI rates higher than placebo.

These figures made it possible for him to estimate how many people had made suicide attempts. “If ten per thousand make an attempt on Prozac and five per thousand or less do so on placebo or other antidepressants, and if (as is conventionally estimated) 40 million people worldwide have had Prozac,” he writes, “then there will have been 200,000 more suicide attempts on Prozac than had Prozac not been used.”

“Conventional wisdom is that there is one suicide for every ten attempts,” he explains. “These would give 20,000 suicides over and above the number who would have committed suicide if they had been left untreated or been treated with older agents.”

Dr Healy then accessed the FDA’s Adverse Event Database to look at suicides reported and found there were over 2,000 as of October 1999. “The FDA estimated their database picked up only between one and ten per cent of serious adverse events,” he writes.

“This gives a spread between 20,000 and 200,000 suicides on Prozac,” he concludes.

There is no way to know how many people have suffered needlessly because the drugmakers lied about the suicide risk for so many years. According to Dr Healy, aside from the need to save lives, if emergent suicide linked to a drug is not correctly attributed to treatment, patients suffer a long-lasting injury to their self-esteem and self-confidence as a consequence.

“If patients have engaged in actual suicidal acts as a result of treatment and the connection to treatment is not made, given that prior suicide attempts appear to increase the risk of future successful suicides, it appears possible that the risk of a future successful suicide has been increased accordingly,” he warns in a June 2003 briefing paper on “Antidepressants and Suicide.”

Evelyn Pringle
epringle05@yahoo.com

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

Filed under: antidepressants, Baum Hedlund, Charles Grassley, Congress, Preschool Psychopharmacology Working Group, , , , , , , , , , , , , ,

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