The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

Mothers Act – Bad Movie Rerun

Evelyn Pringle April 16, 2009

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

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

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

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

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

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

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

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

Same old song and dance

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

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

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

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

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

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

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

Childbearing years represent huge market

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

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

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

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

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

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

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

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

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

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

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

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

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

New Best Sellers – Atypical Antipsychotics

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Helpless children harmed

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

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

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

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

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

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

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

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

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

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

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

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

Drugged into Madness

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

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

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

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

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

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

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

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

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

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

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

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

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

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

More Warnings Needed on Reglan Side Effects

Evelyn Pringle May 27, 2010

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)

Filed under: 2010, Baum, drugging children, metoclopramide, pregnant, Reglan, Tardive Dyskinesia

Lawsuits Only Weapon Available Against Giant Big Pharma Pushers – July 11, 2006


Image: empoweringparents.com

Lawsuits Only Weapon Available Against Giant Big Pharma Pushers

First published July 11, 2006

Kelly O’Meara’s coverage of the adverse effects of psychiatric drugs is virtually unmatched by any other journalist in the US. During her 6-year stint with the Washington Times’ Insight magazine, she wrote more than two dozen investigative articles about the link between SSRIs and the bizarre, violent acts committed by patients taking the drugs, which include the majority of children involved in school shootings in the US.

Her new book, “Psyched Out: How Psychiatry Sells Mental Illness and Pushes Pills That Kill,” is about informed consent. “The people need and deserve the whole truth about their psychiatric diagnosis,” Ms O’Meara advises, “and the mind-altering drugs that are prescribed as treatment.”

Experts say the book is a must read for patients considering whether to take psychiatric drugs. The “chemical imbalance in the brain” theory that drug maker’s tell patients they have when marketing the drugs, is debunked in the book by some of the nation’s leading experts, and according to Ms O’Meara, the drug companies themselves have been forced to admit that they do not understand how the drugs work in the human brain during the treatment of an alleged mental illness.

“In fact,” she says, “a test that measures a person’s brain chemicals does not exist.”

“Never in the history of the world has science discovered what the correct brain chemical levels are for any living person,” Ms O’Meara explains, “making it impossible to know if these naturally occurring chemicals are out of balance.”

“If confirmable proof of a chemical imbalance were required prior to filling a prescription for any antidepressants,” she says, “not a single prescription would be written because to date the only known method of determining chemical levels in the brain is during autopsy.”

Even though the atypical antipsychotics are not FDA approved for any use with children, and their package inserts specifically state that their safety and effectiveness with children have not been established, Big Pharma has doctors prescribing them off-label to children of all ages for a long list of so-called mental disorders.

According to a study in the March-April 2006, Ambulatory Pediatrics journal, between 1995 and 2002, the rate of children receiving antipsychotics increased five-fold, to an estimated 2.5 million, or an increase from 8.6 prescriptions for every 1,000 children in the mid-1990s, to nearly 40 in every 1,000 in 2002.

A recent review by USA Today of the FDA’s adverse reporting system from 2000 to 2004, found at least 45 deaths in children under 18 listing atypicals as the “primary suspect.” There were also an additional 1,328 reports of other side effects, including many that were life-threatening.

Other life-long physical adverse effects of these drugs are beginning to emerge in children. The Children’s Hospital of Philadelphia recently found that 19% of newly diagnosed Type 2 diabetic children were being treated with atypical drugs, according to Robert F Kennedy Jr vs the Medical Elite, by Mark Sircus Ac, OMD, on June 22, 2005.

“The most studied adverse effect of the newer generation of antipsychotics,” he notes, “is their association with hyperglycemia, in some cases leading to ketoacidosis, coma, or death.”

“Many of these drugs carry black box warning to alert MD’s about the dangers of diabetes,” according to Mr Sircus.

Psychiatrist, Dr Stefan Kruszewski, also says the atypicals substantially increase the risk of other serious physical illnesses such as heart attack, hypertension, and stroke.

For the past 30 years, Dr Breggin, has served as a medical expert in lawsuits involving psychiatric drugs and has testified in cases involving tardive dyskinesia.

All antipsychotics also now carry a warning about the extremely serious condition of tardive dyskinesia. According to Dr Breggin, the condition is a drug-induced movement disorder that is usually irreversible and there are no adequate treatments for the disorder.

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

The abnormal movements, he says, can afflict any muscle group of the body and can impair the ability to walk, speak, breathe and swallow.

“It is highly variable in expression and severity,” according to Dr Breggin. One variety involves painful spasms of muscles, he says, that can literally torture the victim, and another involves an agonizing inner agitation that drives people to move their arms or legs, or to pace. 

“Some cases,” he advises, “are painful, disfiguring, exhausting and ultimately disabling.”

Dr Breggin has served as an expert in a half dozen tardive dyskinesia cases that resulted in verdicts for the plaintiffs including several cases in which Risperdal caused tardive dyskinesia in children, where the drug was prescribed to control behaviors that were in fact, he says, caused by stimulant ADHD drugs that the child was already taking.

According to Dr Breggin, tardive dyskinesia occurs at a cumulative rate of 4-7% per year in otherwise healthy patients treated with antipsychotics and after only a few years, 20% or more of patients will be afflicted. In older patients, he says, the rate is even higher.

Overall, according to estimates by a 20-year career FDA scientist and researcher, Dr David Graham, the use of atypicals antipsychotics increases the annual death rate in the US by more than 12,000 people a year.

They are approved for a very limited number of psychiatric disorders but once again, drug makers have found way to get doctors to prescribe them off-label for a multitude of unapproved illnesses for age groups that they were never intended..

The off-label prescribing of these drugs is so out of control that according to a July 7, 2006 report by Decision Resources, Inc, a leading research and advisory firm on pharmaceutical and healthcare issues, antipsychotics represented the fourth-highest-ranking class of drugs in worldwide sales in 2005, and two of the top ten drugs in sales are atypicals.

But the icing on the cake as to the absurdity of their widespread use, come from a government study published in the September 22, 2005, New England Journal of Medicine, that determined that the new atypicals are only barely more effective than no drugs at all.

Dr Breggin warns that all stimulant drugs can cause “a continuum of stimulation, including agitation and irritability, anger, hostility, disinhibition, hypomania and mania.”

The stimulant or activation syndrome, he advises, was observed decades ago with stimulant drugs such as amphetamines, Adderall, and Dexedrine, and methylphenidates such as Ritalin and Concerta.

In addition, Dr Breggin brings up an all too common situation with children who are recruited by the mental health industry. “As the child’s emotional control breaks down due to medication effects, mood stabilizers may be added,” he explains.

“Eventually, these children end up on four or five psychiatric drugs at once and a diagnosis of bipolar disorder by the age of eight or ten,” he warns.

Filed under: 'ADHD', 2006, antipsychotics, Breggin, drugging children, Graham, SSRIs, Tardive Dyskinesia

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

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