The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

April 2007 Big Pharma Litigation Update – Drugs – Part II

Evelyn Pringle April 12, 2007

The anti-epileptic drug, Depakote (valproate), marketed by Abbott Laboratories, is one of the most heavily prescribed medications for off-label use. Experts say the evidence of harm caused by Depakote is just beginning to emerge.

According to Harrisburg, Pennsylvania psychiatrist, Dr Stefan Kruszewski, a recognized expert on psychotropic drugs, “we can anticipate a continuing series of tragic outcomes from the massive overuse of Depakote, secondary not only to birth defects and death, but also due to anemias, hepatic disease, obesity, diabetes type II, pancreatitis and other serious systemic and neurological dysfunctions.”

Bayer is under fire for hiding the adverse effects of the anti-clotting drug, Trasylol, used in heart surgery, and will no doubt be hit with plenty of lawsuits in the not to distant future, considering that Dr Dennis Mangano, the lead author of new study in the February 7, 2007, Journal of the American Medical Association, says that the Trasylol may be responsible for 10,000 deaths over five years.

On December 15, 2006, the FDA announced new labeling for Trasylol, and said a study suggests that, in addition to serious kidney damage, Trasylol may increase the chance for death, congestive heart failure (a weakening of the heart), and strokes.

Because Trasylol is administered during surgery, many victims may not even realize they have been injured by the drug. But plenty have, according to Dr Mangano, who says that in 2006, Trasylol, was administered to 246,000 patients.

Another drug on the legal chopping block is the Parkinson’s drug, Permax. As far back as December 2002, doctors at the Mayo Clinic reported heart valve disease in 3 patients who had been taking Permax, similar to damage caused by the Fen-Phen combination.

In 2004, HealthDay News reported that a study had confirmed previous findings that the drug could damage heart valves and surgery would be needed to correct it. Two new studies in the January 4, 2007, New England Journal of Medicine, report that the number of Permax patients who have developed valve damage is higher than expected.

One study, which included 155 patients taking various Parkinson’s drugs, and 90 healthy patients in a comparison group, and found moderate to severe valve problems in more than 23% of the patients on Permax, compared to less than 6% in the comparison group.

The second study found Permax users were 5 to 7 times more likely to have leaky heart valves than patients taking other types of Parkinson’s drugs, and patients taking the highest doses of Permax had a 37 times greater risk.

“This is not a rare side effect,” says Dr Bryan Roth, a professor at the University of North Carolina, who wrote an editorial accompanying the reports in the NEJM.

“That’s an extraordinarily high incidence,” he warns. “That makes this a serious problem.”

Heart valve damage is a life-threatening condition and costly to treat. Replacement requires open heart surgery, where the breastbone is divided, the heart is stopped, and blood is sent through a heart-lung machine, according to the Texas Heart Institute. No drug can reverse valve damage, making replacement surgery the only option. Medical experts are advising all Permax patients to undergo testing for valve damage.

The drug was introduced to the US market by Eli Lilly, but Valeant Pharmaceuticals now sells Permax. On March 29, 2007, Permax was pulled off the market after the FDA reviewed new information that associates it with heart problems.

During the last 2 decades, the antidepressants, known as selective serotonin reuptake inhibitors, or SSRIs, have been prescribed for more unapproved uses than any other class of drugs in history. A June 2005, study in the Journal of Clinical Psychiatry, found that 75% of SSRI prescriptions written were for unapproved uses.

SSRIs have now been linked to suicidality, extreme violence and homicide, several life-threatening birth defects, abnormal uterine or gastrointestinal bleeding, a decrease in bone mineral density, fertility problems, sexual dysfunction, and a severe withdrawal syndrome.

On April 10, 2004, the British Medical Journal, criticized the authors of studies on SSRI’s for exaggerating the benefits and downplaying the harm, including suicidality, and discussed a study of 93 children on Paxil that produced 11 serious adverse events, including 7 hospitalizations, compared to only 2 in children in the placebo group.

The Paxil suicide risk is not limited to children. An August 22, 2005, study by Norwegian researchers of over 1,500 adults, found 7 Paxil patients attempted suicide compared to only 1 attempt in the group on a placebo, and recommended that warnings not to prescribe Paxil to children should also apply to adults.

According to Forest Lab’s Annual Report filed on June 14, 2006, the company is a named defendant in approximately 25 lawsuits, with the majority involving the company’s top selling SSRI drugs, Celexa or Lexapro, for inducing suicidality.

A wrongful death lawsuit was filed in September 2005, by the Pogust & Braslow law firm in Conshohocken, Pennsylvania, on behalf of the family of 32-year-old man who unexpectedly committed suicide soon after being prescribed Lexapro.

A steady stream of lawsuits have been filed against GlaxoSmithKline over Paxil, stemming from the company’s concealment of the drug’s link to suicide, birth defects, violence and withdrawal syndrome.

On March 23, 2006, the California-based Baum Hedlund law firm filed a national class-action lawsuit against Glaxo on behalf of the mother of an 11-year old Kansas boy who committed suicide, and a teenager in Texas who attempted suicide while taking Paxil.

She says, Baum Hedlund has documents obtained in litigation that show there was an awareness of the suicide risk as far back as the late 1970’s, a decade before the first SSRI was approved for sale in the US.

A new round of Paxil lawsuits began on October 16, 2006, when Baum Hedlund filed a case alleging that Paxil use during pregnancy resulted in an infant being born with a life-threatening lung disorder, PPHN. Between 10% and 20% of infants born with PPHN end up dying, even when they receive treatment.

On July 28, 2006, Baum Hedlund also filed a lawsuit on behalf of the parents of an infant who was born with congenital heart birth defects as a result of his mother taking Paxil during pregnancy. Since birth, the child has undergone 3 open-heart surgeries and will likely have to undergo more and possibly a heart transplant at some point in the future.

Based on the company’s legendary history of concealing adverse effects, the lead attorney on the case, Karen Barth Menzies, says believes Glaxo has known about these risks and should have warned prescribing doctors and consumers about these birth defects long ago.

The Houston law firm of Robert Kwok & Associates is handling a Celexa birth heart defects case in Kentucky. The mother was prescribed Celexa during pregnancy, and her baby was born with Shone’s Complex, a form of congenital heart disease that consists of defects that lead to the obstruction of blood flow from the heart to the body.

Legal analysts are predicting that SSRI makers will offer early settlements in cases involving birth defects to avoid having these families appear before a jury.

Pfizer is still being sued left and right over adverse effects related to the epilepsy drug Neurontin. In 2004, the company pleaded guilty to charges involving a massive off-label marketing scheme and agreed to pay the second-largest settlement ever in a health care fraud prosecution of $403 million. By 2002, a full 94% of Neurontin sales were for off-label use, according to the August 16, 2004 USA Today.

Many private lawsuits involve Neurontin-induced suicidality. The Pogust & Braslow law firm is handling a case for Natalie Biedenbender, whose husband committed suicide at age 39, after being prescribed the drug off-label for back pain.

“Although Neurontin is prescribed for scores of off-label indications,” Attorney Derek Braslow reports, “since 1999, the off-label use continues to be most common in the areas where the company focused its illegal marketing efforts, such as bipolar disorder, peripheral neuropathy, and migraine.”

Two lawsuits were recently filed against Novartis and Astellas Pharma, the makers of the topical skin creams, Elidel and Protopic, used to treat eczema. Alan and Dayna Thomson filed a lawsuit in December 2006 after their daughter Haley died after using Elidel, and Ashley McDonald filed a lawsuit in January 2007 after being diagnosed with lymphoma following her use of Elidel.

In another case, Traci Reilly, of Naperville, Illinois, developed breast cancer after applying Protopic and Elidel for a condition that caused patches of discolored skin on her breast.

Protopic and Elidel belong to a class of drugs known as calcineurin inhibitors, so called because they reduce immune activity by inhibiting the activity of the enzyme calcineurin in organ transplant patients. Use of these drugs has long been known to increase the risk of cancer, and the drugs were labeled accordingly for use in transplant patients.

Protopic and Elidel have only been on the market for about 5 years and together have already been prescribed to more than 7 million people. In 2006, the FDA added a black box warning to the skin creams about the cancer risk.

On February 21, 2007, Tom Moore, the author of several books on the pharmaceutical industry, told CBS News that he had studied about 1,200 cases of suspected injuries pertaining to Protopic and Elidel reported to the FDA through 2005 and found more than 100 potential cancer cases in children and adults, with most involving lymphoma or skin cancer.

Filed under: 2007, addict, Birth Defects, cancer, Depakote, Elidel, Neurontin, Permax, SSRIs, suicide, Trasylol

Off-Label Depakote Sales Stronger Than Ever

Evelyn Pringle February 11, 2007

The epilepsy drug, Depakote, earned Abbott Laboratories $384 million in the 4th quarter of 2006, and overall sales rose 18.5% to $1.2 billion last year.

The rising sales are a result of Depakote (valproate) being increasingly prescribed for conditions other than epilepsy like mood disorders, manic depression and migraines. Doctors are also prescribing Depakote as a mood stabilizer in off-label combinations with other drugs for uses that have never been FDA approved or tested for safety and efficacy.

Although in the US, drug companies are prohibited by law from promoting the sale of a drug for an off-label use, once a medication is FDA approved for once indication, doctors are free to prescribe it for other conditions if they believe it will be beneficial to a patient.

However, in recent years the rate of off-label prescribing has become epidemic and many drug companies have paid huge fines after being caught promoting drugs for unapproved uses and many more are currently under investigation for illegal marketing schemes.

In 2001, a study by the Agency for Healthcare Research and Quality (AHRQ) found that about 21% of prescriptions written in the US are for conditions not indicated on the label and cardiac medications and anticonvulsants were the most commonly prescribed for unapproved uses. Most off-label use, the study pointed out, occurs without scientific support.

Depakote is one of the drugs prescribed most often off-label, and experts say its not unusual to find patients on Depakote along with 3 or 4 other medications all at once.

On October 13, 2006, the FDA revised the labeling for Depakote to warn of adverse events associated with use of the drug during pregnancy and said that Depakote should only be considered for women of childbearing years if it was essential for the treatment of their condition and the risks and benefits were fully discussed with the patient.

According to the North American Antiepileptic Drug Pregnancy Registry, Depakote use during the first trimester of pregnancy is linked to a 4-fold increased risk of congenital malformations when compared with other antiepileptic drugs (AEDs). The rate malformations with infants exposed to Depakote was 10.7%, or 16 cases in 149 births.

The Registry is set up to determine the safety of anticonvulsants to help gauge the frequency of malformations, such as heart defects, spina bifida and cleft lip. Only major malformations are included in the Registry, defined as a structural abnormality of the infant with surgical, medical, or cosmetic importance.

The CDC reports that the risk of spina bifida among infants born to mothers receiving Depakote during the first trimester is estimated to be 1% to 2%, compared to 0.14% to 0.2% in the general population according to the American College of Obstetricians and Gynecologists.

Although Depakote is most strongly associated with neural tube defects, the FDA notes that other anomalies have also been reported, such as craniofacial defects, cardiovascular malformations, and anomalies involving various body systems with some fatal.

Drugs that cause malformations are known as teratogens. A teratogen can disturb the development of the fetus, halt the pregnancy, or permit the pregnancy to proceed but produce a congenital malformation or birth defect.

Due to the rate of off-label prescribing, pregnant women may be receiving Depakote for other indications and the FDA warns that the increased risk associated with Depakote in pregnant women treated for epilepsy likely reflects an increased risk in treatment for other conditions as well, such as migraines or bipolar disorder.

Depakote has now been moved into “Category C” for pregnant women, which means animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women, or no animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

In the case of Depakote, numerous animal studies have established drug-induced teratogenicity. Increased malformations, as well as growth retardation and death, have been found in rats, mice, rabbits, and monkeys following prenatal exposure to the drug, according to the FDA’s information listed on Depakote.

Malformations of the skeletal system are the most common structural abnormalities observed in animals, but neural tube closure defects have been seen in mice exposed to plasma Depakote concentrations exceeding 2.3 times the upper limit of the human therapeutic range during periods of embryonic development.

An oral dose equal to about 50% of the maximum human daily dose administered to pregnant rats produced skeletal, cardiac, and urogenital malformations and growth retardation in the offspring. Behavioral deficits have also been reported in the offspring of rats given Depakote throughout most of the pregnancy.

An oral dose of approximately 2 times the maximum human daily dose produced skeletal and visceral malformations in rabbits exposed during organogenesis.

Skeletal malformations, growth retardation, and death have been observed in rhesus monkeys following administration of an oral dose equal to the maximum human daily dose during organogenesis.

The initial report from on-going human study titled, “Neurodevelopmental Effects of Antiepileptic Drugs,” in the August 8, 2006, journal, Neurology, found that major congenital abnormalities were more common in infants exposed to Depakote than those exposed to one of 3 other AEDs.

A team of researchers led by Dr Kimford Meador, of the University of Florida, are conducting a study on pregnant women with treated for epilepsy from October 1999 to February 2004, receiving either Depakote, Dilantin, Lamictal, or Tegretol.

The initial report, focuses on the rate of serious adverse events including fetal death or major congenital malformations defined as structural abnormalities with surgical, medical, or cosmetic importance identified during pregnancy, at birth, between birth and 1 year, or at 73 weeks.

The researchers identified 6 fetal deaths and 22 malformations that included malformed hearts and genitals, cleft palate, and artery deformities, with 20.3% found in women taking Depakote.

Based on these initial findings, the researchers advised that Depakote should not be used as the first choice for women of childbearing potential, and if used, its dose should be limited when possible.

In an interview with Shawna Cutting, posted on Epilepsy.com, Dr Meador explained how he became interested in doing the study. “Over the years,” he said, “I began to think that these effects might be dramatic in children while their brains are developing, because they could add up over many years.”

“That made me think that the effect might be even greater in a fetus because brain development there is so rapid,” he said.

“The process of physical growth and the attainment of intelligence and problem-solving ability that begins in infancy; any interruption of this process by a disease or disorder is called developmental delay,” Dr Meador explained.

He said studies of animals clearly showed that some antiepileptic drugs could affect behavior of the offspring.

His on-going study will track children until they are 2 or 3, but says children need to be followed until they are at least 6. “This age is so important,” Dr Meador said during the interview, “because this is when measures such as IQ begin to match up with adult measures.”

“If you measure a child’s IQ at 3 years of age,” he explained, “it may not predict the child’s development.”

“But a measurement at 6 years of age,” he said, “statistically will predict what will happen when this kid is an adult.”

He also noted that this is an important point because children begin school at that age and whatever is going on will effect their learning and said, a “disturbing report” on a study from England suggested that Depakote was producing worse effects.

Filed under: 2007, Abbott, anticonvulsants, Birth Defects, Depakote, FDA, prices, suicide

Consequences of Rampant Off-Label Prescribing of Depakote

Evelyn Pringle February 7, 2007

The antiepileptic drug, Depakote, is one of the most heavily prescribed medications for off-label use. The Epilepsy Foundation reports that there are an estimated 1 million women in the US with epilepsy, but the number of women being treated with antiepileptics is two to three times higher than the number of women with the disorder.

Experts say the evidence of harm caused by the massive off-label prescribing of Depakote (valproate), marketed by Abbott Laboratories, is just beginning to surface.

According to Harrisburg, Pennsylvania psychiatrist, Dr Stefan Kruszewski, a recognized expert on psychotropic drugs, “we can anticipate a continuing series of tragic outcomes from the massive overuse of Depakote, secondary not only to birth defects and death, but also due to anemias, hepatic disease, obesity, diabetes type II, pancreatitis and other serious systemic and neurological dysfunctions.”

Drugs are FDA-approved for specific indications, but they can be prescribed off-label for other conditions if a doctor deems it appropriate. Although drug makers are prohibited by law from promoting their drugs for off-label uses, its a well known fact that they do it all the time.

“Off-label” includes prescribing drugs for uses that are not listed in the FDA-approved labeling; increasing the recommended dose or duration of treatment; combining one drug with other drugs; or prescribing a drug for patient populations, such as children or the elderly, for whom it was not approved.

The truth is, millions of patients are receiving powerful psychotropic drugs like Depakote that have not been approved for treating their specific illness because drug makers are using every trick in the book to boost profits by getting doctors to prescribe their drugs off-label, and as a result patients are serving as guinea pigs.

Off-label use, by definition, means the drug lacks sufficient clinical evidence to demonstrate safety and effectiveness, and therefore, prescribing a drug for unapproved uses exposes patients to the unknown risks of a medication that has no proven benefit.

Doctors are prescribing Depakote together with other drugs in combinations that have never been tested on any patient population. Experts say its not uncommon to see patients, including very young children, taking Depakote along with 3 or 4 other psychiatric drugs all at the same time.

And, contrary to what the drug makers say publicly, they know exactly how many prescriptions are written off-label for each and every drug they sell because they purchase records that show the prescribing habits for all doctors in the US, from data mining firms so that sales representatives can keep track of the prescribing habits of their doctor-customers.

On August 6, 2006, former sales rep, Kathleen Slattery-Moschkau, told the San Francisco Chronicle, that she received reports on all the doctors in her sales territory broken down by drug category which she said helped her determine which doctors “were worthy of spending my monthly budgets on for lunches, dinners, days at the spa, etc.”

Ms Slattery-Moschkau claims she could immediately measure the success of a perk simply by looking at the prescribing records. “If I brought in lunch one week,” she stated, “I could see the following week if that lunch had an impact.”

For good reason, drug companies are willing to pay top dollar for these records. According to the Chronicle, in 2005, the data main data mining firm, IMS Health, had revenues of $847 million from its “Sales Force Effectiveness Offerings.”

Over the past few years, there have been many reports in the media about the over-prescribing of psychiatric drugs, but not much has been written about the off-label sale of Depakote. “In recent years,” Dr Kruszewski says, “Depakote may have escaped some of the media scrutiny of other antiepileptic drugs, like Neurontin, Topamax and Gabitril.”

“As a clinical investigative psychiatrist,” he states, “my concern is that Depakote is widely used on and off-label for so many neuropsychiatric conditions.”

“It has widespread use,” he notes, “for mood disorders, mood swings, anxiety, drug withdrawal states, agitation, aggression, panic disorders and psychosis.”

“It is not a benign drug,” he warns.

Dr Kruszewski says a number of recent reports by scientific experts, including one on birth defects discussed in Neurology Journal Watch, are worrisome. “Depakote, in a dose-dependent fashion,” he states, “is associated with fetal abnormalities and fetal death.”

“Depakote appears to increase the risk of spina bifida and significantly increases the risk of other neural tube defects,” he notes.

“Fetal serum concentrations,” he explains, “are typically 1.4 times greater than those of the mother and incur a longer half-life.”

“The evidence is uncertain,” he says, “regarding what neurological or other effects are sustained by breast-fed infants of mothers who take Depakote.”

One of the recent studies cited by Dr Kruszewski is the Neurodevelopmental Effects of Antiepileptic Drugs, published in the August 8, 2006, issue of Neurology, which reported that major congenital abnormalities are more common in infants whose mothers received Depakote during pregnancy than infants exposed to other antiepileptic drugs.

To determine whether fetal outcomes varied as a result of exposure to four different drugs, a group of researchers led by Dr Kimford Meador, of the University of Florida in Gainesville, conducted a study on pregnant women with epilepsy from October 1999 to February 2004, enrolled in 25 epilepsy centers in the US and UK. A total of 333 mothers were followed, each receiving either Depakote, Lamictal, Dilantin, or Tegretol.

The researcher’s initial report in this ongoing study, focused on the incidence of serious adverse events including major congenital malformations or fetal death, with major malformations defined as structural abnormalities with surgical, medical, or cosmetic importance detected during pregnancy, at birth, from birth to 1 year, or at 73 weeks.

All total, the researchers found there were 6 fetal deaths and 22 malformations, with 20.3% being attributed to Depakote. The birth defects noted included malformed hearts and genitals, cleft palate, and artery deformities.

The risks of birth defects with Depakote have actually been known for quite some time. Back on April 29, 2004, WebMD warned that infants born to women taking Depakote were more likely to have birth defects, and said that whenever possible women should avoid taking the drug not only during pregnancy, but also during childbearing years.

WebMD discussed a study presented at the annual meeting of the American Academy of Neurology, that found death of the fetus, birth defects, and developmental delays, such as walking and speech delays, occurred in 28% of children exposed to Depakote compared with just 2% of infants exposed to Lamictal.

The research team even presented the data from its 5-year study a year earlier than planned because the findings were so alarming.

Lead researcher, Dr Page Pennell, of Atlanta’s Emory University School of Medicine, told WebMD, “The evidence against the use of [Depakote] by women during pregnancy is mounting, but the message has not gotten out.”

She pointed out that “the drug is being increasingly prescribed for other conditions like migraines, bipolar disorder, and mood disorders.”

Depakote is but one of many psychiatric drugs that are not recommended for pregnant women but were recently found to be prescribed off-label to pregnant teens in foster care in Texas.

In fact, Depakote was one of the drugs most prescribed off-label for Texas foster children in general, and the most prescribed anticonvulsant. In fiscal 2004, there were 18,705 prescriptions written for Depakote and its generic equivalent, totaling $1,652,776, making it the third most prescribed psychotropic drug to foster children, according to Health and Human Services Commission and Texas Comptroller of Public Accounts, in a June 2006, Special Report, Foster Children: Texas Health Care Claims Study.

A review of Medicaid records during the investigation that resulted in the report, revealed several cases in which pregnant girls received “category D” medications such as Depakote. The FDA places drugs in the “D” category only when post-marketing data has shown they pose a clear risk to the fetus.

As a whole, anticonvulsants were the second most expensive psychiatric drug category for foster children that year supposedly prescribed as “mood stabilizers,” at a cost of $4.8 million. According to the Zito/Safer External Review, anticonvulsant use for mood stabilization is a poorly evidenced area of psychopharmacology for children and adolescents. But nonetheless, the Texas Medicaid program was charged an average of $111 per prescription for their off-label use.

In addition to the increased risk of birth defects in infants born to pregnant girls on Depakote, the National Institute of Mental Health reports other serious side effects associated with use of the drug by teenage girls:

“According to studies conducted in Finland in patients with epilepsy, valproate may increase testosterone levels in teenage girls and produce polycystic ovary syndrome in women who began taking the medication before age 20. Increased testosterone can lead to polycystic ovary syndrome with irregular or absent menses, obesity, and abnormal growth of hair. Therefore, young female patients taking valproate should be monitored carefully by a physician.”

Dr Kruszewski says doctors and women of childbearing age both need to be aware of the risks to the fetus from Depakote, if a seizure medication is absolutely necessary during pregnancy. Because women often do not know they are pregnant in the initial 4 to 8 weeks of the first trimester, he recommends that women and their doctors plan ahead to use a different drug before a pregnancy begins.

Filed under: 2007, Abbott, anticonvulsants, Birth Defects, Depakote, suicide

Psychiatric Drugging of Infants and Toddlers in the US – Part II

Evelyn Pringle April 22, 2010

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,” warns the world-renowned expert, Dr Peter Breggin, often referred to as the “Conscience of Psychiatry.”

“We’re bringing up a generation in this country in which you either sit down, shut up and do what you’re told, or you get diagnosed and drugged,” he points out.

Breggin considers the situation to be “a national tragedy.” “To inflict these drugs on the growing brains of infants and children is wrong and abusive,” he contends.

The kids who get drugged are often our best, brightest, most exciting and energetic children, he points out. “In the long run, we are giving children a very bad lesson that drugs are the answer to emotional problems.”

Dr Nathaniel Lehrman believes that giving infants and toddlers “powerful, brain-effecting psychiatric medication is close to criminal activity.”

“Giving them these drugs,” he says, “has no rationale, and ignores the basic fact that youngsters are very sensitive to their environments, both social and chemical, with the juvenile brain easily damaged by the latter.”

Inventing Disorders

During an interview on ABC Radio National in August 2007, Dr David Healy, the noted British pharmacology expert, and author of the book, “Mania: A Short History of Bipolar Disorder,” told reporter Jane Shields: “Just to give you a feel for how crazy things have actually got recently, it would appear that clinicians in the US are happy to look at the ultrasounds of children in the womb, and based on the fact that they appear to be more overactive at times, and then possibly less active later, they’re prepared to actually consider the possibility that these children could be bipolar.”

On April 9, 2009, Christopher Lane, author of the book, “Shyness: How Normal Behavior Became a Sickness,” published an interview on his Psychology Today blog with Dr Healy. In the interview, Healy explained the history behind the drastic rise in the sale of anticonvulsants and antipsychotics as “mood stabilizers,” and the diagnosis of bipolar disorder.

“The key event in the mid-1990s that led to the change in perspective was the marketing of Depakote by Abbott as a mood stabilizer,” Healy tells Lane, and further explains:

“Mood stabilization didn’t exist before the mid-1990s. It can’t be found in any of the earlier reference books and journals. Since then, however, we now have sections for mood stabilizers in all the books on psychotropic drugs, and over a hundred articles per year featuring mood stabilization in their titles.

“In the same way, Abbott and other companies such as Lilly marketing Zyprexa for bipolar disorder have re-engineered manic-depressive illness. While the term bipolar disorder was there since 1980, manic-depression was the term that was still more commonly used until the mid-1990s when it vanishes and is replaced by bipolar disorder. Nowadays, over 500 articles per year feature bipolar disorder in their titles.”

“As of 2008, upwards of a million children in the United States—in many cases preschoolers—are on “mood-stabilizers” for bipolar disorder, even though the condition remains unrecognized in the rest of the world,” Healy points out.

“But there is no evidence that the drugs stabilize moods,” he says. “In fact, it is not even clear that it makes sense to talk about a mood center in the brain.”

“A further piece of mythology aimed at keeping people on the drugs,” he reports, “is that these are supposedly neuroprotective—but there’s no evidence that this is the case and in fact these drugs can lead to brain damage.”

Healy says the FDA’s decision to add a black-box warning about suicide to SSRIs likely had little to do with the switch to prescribing antipsychotics as safer for children. What “was quite striking was how quickly companies were able to use the views of the few bipolar-ologists who argued that when children become suicidal on antidepressants it’s not the fault of the drug,” he points out.

“The problem, they said, stems from a mistaken diagnosis and if we could just get the diagnosis right and put the child on mood stabilizers then there wouldn’t be a problem,” he explains.

“There is no evidence for this viewpoint, but it was interesting to see how company support could put wind in the sails of such a perspective,” he says.

Because having just one label was very limiting, Healy says, child psychiatry “needed another disorder—and for this reason bipolar disorder was welcome.”

He reports that the same thing is happening to children labeled with ADHD. “Not all children find stimulants suitable,” he advises, “and just as with the SSRIs and bipolar disorder it has become very convenient to say that the stimulants weren’t causing the problem the child was experiencing; the child in fact had a different disorder and if we could just get the diagnosis correct, then everything else would fall into place.”

A report titled, “Adverse Events Associated with Drug Treatment of ADHD: Review of Postmarketing Safety Data,” presented at the FDA’s March 22, 2006, Pediatric Advisory Committee meeting bears witness to Healy’s explanation by stating in part: “The most important finding of this review is that signs and symptoms of psychosis or mania, particularly hallucinations, can occur in some patients with no identifiable risk factors, at usual doses of any of the drugs currently used to treat ADHD.”

Between January 2000, and June 30, 2005, the FDA identified nearly 1,000 cases of psychosis or mania linked to the drugs in its own database and those from the drug makers themselves.

The antipsychotics are just as dangerous as the SSRI antidepressants, Healy says. “Long before the antidepressants were linked with akathisia, the antipsychotics were universally recognized as causing this problem,” he explains in the Lane interview. “It was also universally accepted that the akathisia they induce risked precipitating the patient into suicidality or violence.”

“They also cause a physical dependence,” Healy states. “Zyprexa is among the drugs most likely to cause people to become physically dependent on it.”

“In addition,” he points out, “these drugs are known to cause a range of neurological syndromes, diabetes, cardiovascular problems, and other problems.”

“It’s hard to understand how blind clinicians can get to problems like these, especially in youngsters who grow obese and become diabetic right before their eyes,” Healy tells Lane.

As for what he calls the “medicalization of childhood,” in the radio interview, Healy points out that “children always have been unhappy, they always have been nervous, but that’s actually part and parcel of being a child.”

“You have to go through these things,” he said. “This is how we learn to cope with the problems of life.”

Children can best be helped in the safest way, he says, “if they’re just seen and if they actually have the opportunity to talk about their problems, and if they get basic and sensible input about how to perhaps help them cope with these problems.”

Healy said it’s important to remember that severe mental illness is rare in children and that most children with a mental health problem do not need medication. Children are being picked up and put on pills “who really don’t need to be on these pills and who are going to be injured by them,” he warned.

“I think possibly 10 to 15 years up the road,” he told Shields, “we’re going to be looking at a generation of children who will have been seriously injured by the treatments that they appear ever-increasingly likely to be put on now.”

But the administration of multiple drugs at once complicates the situation so that it may be impossible to determine which drugs are most responsible for the adverse reactions children experience, according to Dr Breggin.

“Because so many doctors and so many drug companies will share the blame for mistreating these children, they will be unable to seek redress against individual perpetrators through the courts when they grow up,” he explains.

(This report is one of a series of articles focused on the rising rates of psychiatric drugging in the US and is sponsored by the International Center for the Study of Psychiatry and Psychology)

Filed under: 'ADHD', 2010, antipsychotics, bipolar, Depakote, drugging children, ICSPP, SSRIs, Zyprexa

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Eli Lilly Funds Depression Screening Initiatives

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Matthew Schultz killed by Effexor. Two hours old.

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Big Pharma Victim

  • I haven't been on in awhile thanks to all those who followed 4 years ago
  • @LindsayRush yay IOWA! 4 years ago
  • Another rainy day here in IOWA. Well at least i had a good time swimmin yesterday. 4 years ago
  • Hey everyone hope you have a great day! THanks to all the new followers :) and for those that continue to follow 4 years ago
  • srry if I dont get on here much I mostly just look at my facebook acct. thanks to all the new followers! 4 years ago

The Indiana Star

Christiane Schultz

  • Is not coping well at all. Loss sucks! 5 years ago
  • is scared to bond with this baby, just in case. 5 years ago
  • Happy 6 months today baby. I love you Matthew. 5 years ago
  • Living with loss, sucks. 5 years ago
  • Thinking I need to discuss plans for this baby soon or I will be having it in my doctors office. Where do I deliver? 5 years ago

Amery Schultz

Seeking Parents in Missouri for Celexa / Lexapro Class Action – Call 800-827-0087

TWEET FOR LIFE

BREATH – The Official Blog of MADNAP – momsandmeds.com

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  • Untitled
    Originally posted on The Bitter Pill:Kickstarter is a website for artists to use to raise money and complete awesome projects. The best thing to come to the informed consent movement since Thomas Szasz could just be the new, upcoming film by Dan Jenski, “ADDicted” which basically gives Ritalin, Adderall, Concerta and the like a…
  • Untitled
    Originally posted on The Bitter Pill: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…
  • Antidepressants Again Linked to Preterm Birth & Seizures
    In what was more than likely originally an attempt to prove that depression causes birth complications, researchers from Yale, Tufts, et al found in two new studies that antidepressants increase the risk of preterm birth and seizures. Read more at this link on the newly redesigned UNITE website.
  • Who Could Do This On Purpose
    Read this blog to find out
  • Canadian Regulation on Fetal Exposure to Psychotropic Drugs – Public Input Needed
    Canadian Regulation on Fetal Exposure to Psychotropic Drugs – Public Input Needed (Cross-Posted on The Bitter Pill blog) Amery and Christiane Schultz have been asked to provide input on proposed recommendations regarding psychotropic drugs in pregnancy in Canada. Amery & Christiane are hard-working activists affiliated with UNITE and MADNAP. Please send […]

UNITE ARCHIVES – Victims & Survivors Against The MOTHERS Act: YouTube Playlist

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