The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

Lawsuits Needed Against Prescribing Quacks

Evelyn Pringle April 24, 2009

On April 21, 2009, the Miami Herald reported that a 7-year-old boy in Florida, Gabriel Myers, had committed suicide by hanging himself with a detachable shower head in a bathroom of the foster care home he was placed in three weeks earlier.

All total, the Herald found the child had been given the ADHD drug Vyvanse, the antidepressant Lexapro, the atypical antipsychotic, Zyprexa, and Symbyax, a drug that contains both Prozac and Zyprexa.

The most appalling part of this story is that Dr Sohail Punjwani, the shrink who was supposedly treating Gabriel, told the Herald that he did not even recall the boy.

That being the case, it probably would have been senseless to inquire about what mental disorders the doctor was allegedly treating. According to the Herald:

“Punjwani defended the use of psychiatric drugs on children, even if they are not approved for such use, saying the lack of approval stems from the reluctance of drug makers and the medical establishment to launch clinical trials on children.

“The anti-psychotic drugs, he added, are used routinely to treat mood instability and insomnia among children.”

Reports in the media indicate that any behavioral changes observed in Gabriel would directly correlate with events involving sexual abuse, neglect, and abandonment, none of which could be erased with pills. Being the shrink could not even remember the child he obviously was not providing therapy to help him deal with these painful issues.

Every drug he was given can cause children to become suicidal. For instance, according to the report, “Child Suicides In Florida Associated With Use Of Psychotropic Drugs,” by records researcher, Ken Kramer, of the 252 cases of suicide in Florida by children under the age of 18 between 2000 and 2004, thirty-six were on ADHD drugs.

Conshohocken, Pennsylvania attorney, Derek Braslow, has handled wrongful death cases involving ADHD drug related suicides, including one suicide by a 15-year-old girl, diagnosed with ADHD by a counselor who sent a recommendation to the family doctor to prescribe Concerta.

“The story of the girl’s suicide should be required reading for every pediatrician and child psychiatrist in the country,” Braslow advises.

“These drugs do one of two things to children and teenagers,” he says. “They either turn them into zombies, making them passive and non-responsive, or turn them into hyper-focused, anxious kids who can’t sleep or eat and become consumed with minor typical issues like friendships, boyfriends and school.”

According to Dr David Healy, the psychopharmacology expert from the UK, and author of the new book, Mania: A Short History of Bipolar Disorder, Zyprexa has the highest suicide rate in clinical trial subjects of any drug in clinical trial history.

Antidepressants such as Lexapro and Prozac carry black box warnings of an increased risk of suicide. Symbyax provides a double whammy by combining Prozac and Zyprexa.

Fifteen years ago, Dr Healy published a paper stating, “the volume of case reports and other studies is sufficient to demonstrate that antidepressants and antipsychotics may induce suicidal ideation in certain individuals under certain conditions.”

Children all over the US have become profit receptacles for the psycho-pharmaceutical industry. A new study by the Agency for Healthcare Research and Quality found the treatment and care of children with mental disorders for the year 2006, to be the highest expenditure of any condition, with a price tag of $8.9 billion. Everyday childhood physical injuries like broken bones and such did not even come close to mental disorders with a cost of $6.1 billion.

The psychiatric drug makers have doctors in every field of medicine profiting by writing prescriptions during office calls that require a few minutes time. Hard telling how much the shrink was making off Gabriel, the patient he could not recall; but the price for Vyvanse at DrugStore.com on December 14, 2008, was $385 for ninety 50mg capsules. Lexapro cost $237 for ninety 10mg tablets. The price for Zyprexa was $1,195 for ninety 10mg tablets in April 2009.

A year’s worth of these three drugs, if purchased at DrugStore.com, would total $21,804.

Big Pharma CEOs are laughing all the way to the bank. In 2007, Sidney Taurel, the CEO of Zyprexa and Symbyax maker Eli Lilly, took home a salary, bonus, and compensation package worth $13 million, according to Fierce Pharma.

Doctors in Florida are notoroious for feeding young children psychiatric drugs, likely competing for the top prescribers in the nation with physicians in Texas and Ohio.

An October 2007 report by researchers at Florida University titled: The Use of Antipsychotic Medications with Children: A Comprehensive and Current View, studied Medicaid fee for service claims data for the period from July 2002 to December 2005.
Children were classified into age groups of 0-5, 6-12, and 13-18 years old. The researchers reviewed data on the diagnoses given to children who were prescribed atypical antipsychotics, and noted the following observations:

“First, antipsychotics are used to treat a wide variety of disorders in youth. Second, a small minority of children received antipsychotic medications for the treatment of psychosis. Third, antipsychotics are relatively infrequently used for the treatment of aggression among children with autism (An FDA approved use for risperidone) since only 6-8% of antipsychotic recipients are diagnosed as autistic. Fourth, antipsychotics are frequently used for the treatment of disruptive behaviors in youth.”

Under the heading, “Diagnoses of Children Receiving Antipsychotic Medications,” the authors wrote:

“The analyses of the diagnoses of children receiving antipsychotics reveal that the medications are used to treat a broad spectrum of disorders. Some of these disorders, for example, attention deficit hyperactivity disorder (ADHD) and major depression, clearly do not call for antipsychotic treatment.”

In the section titled, “Prescribers of Antipsychotic Medications,” the authors reported that “very young children were the least likely to be prescribed an antipsychotic by a psychiatrist and the most likely to be treated by a primary care physician.”

“It is likely that some of these young children never come to the attention of psychiatric specialists,” they said. “Over the 3.5 years of the study, involvement of child psychiatrist with these children, as measured by percentages of scripts written, declined while primary care involvement increased.”

“The large number of general practice physicians writing small numbers of scripts is of concern in that there may not have either sufficient training or experience to assure quality prescribing practices,” the authors warned.

The report noted that the “use of antipsychotic medications with children 0-5 is of concern,” and stated:

“The guidelines developed by the program indicate this practice is generally “not recommended” while recognizing that disruptive aggression in autism is now an FDA indicated use. Only 8% of the young children receiving antipsychotic treatment had a diagnosis of autism.

“ADHD was the most frequently used diagnosis for children 0-5 years on antipsychotic medication. Affective disorder is the next most frequently appearing diagnosis despite Florida’s expert panel’s assertion that the diagnosis is of questionable validity for children under 6 years old.”

In checking the definition of “Affective Disorder,” the Gale Encyclopedia of Neurological Disorders, states: “Major depressive disorder, bipolar disorders, and anxiety disorders are the most common affective disorders.”

For the period of July 2005 to December 2005, the Florida report shows the following prescriptions and diagnoses for the 0-5 age group, including the alarming diagnosis of schizophrenia for 115 infants and toddlers: ADHD 1372, Affective Disorders (other) 255, Other not specified 249, Autism 211, Conduct Disorder 179, Adjustment Disorder 102, Major Depression 25, Anxiety Disorder 22, Tourettes Disorder 10, and Depressive Disorder 9.

For children in Gabriel’s age group of 6-12, the report shows the following, including 474 children diagnosed with schizophrenia: ADHD 5197, Affective Disorders (other) 1553, Conduct Disorder 963, Other not specified 548, Major Depression 537, Autism 445, Adjustment Disorder 449, Anxiety Disorder 224, Depressive Disorder 202, and Tourettes Disorder 55.

The practice of stigmatizing kids as young as infants and toddlers for life with a diagnosis of schizophrenia in order to justify prescribing the expensive antipsychotics is despicable. Dr Healy reviewed the number of Florida children diagnosed with schizophrenia and compared the data to children diagnosed with schizophrenia in North Wales. The current rate of treatment for schizophrenia in 0-15 year olds is four per million in North Wales, he found.

“Florida has a population of 18.25 million so it should have 73 persons with this illness in the 0-15 group,” he says. “But it appears you have 1,409 on antipsychotics – 20 fold higher.”

Since April 2008, Florida has required doctors to obtain prior approval to prescribe antipsychotics to children on Medicaid under the age of six. On March 29, 2009, the St Petersburg Times reported the process had lowered the number of kids on the drugs and compared the number of prescriptions for children five and under for the period of May to December 2008, to the same period in 2007.

Apparently a decrease in mental disorders among infants and toddlers magically occurred between 2007 and 2008, because the antipsychotic prescriptions were as follows:

2007: Below age one – 23, one year-olds – 39, two year-olds – 103, three year-olds – 315, four year-olds – 886, and five year-olds – 1,801.

2008: Below age one – 0, one year-olds 5, two year-olds 26, three year-olds 107, four year-olds 268, and five year-olds 437.

Going after the drug companies has done little to curb the illegal peddling of psychiatric drugs to children. Lilly paid over a billion this year to settle fraud charges over the off-label marketing of Zyprexa, and several more fraud lawsuits are still pending. Johnson & Johnson and AstraZeneca are also facing fraud charges over the off-label marketing of Risperdal and Seroquel.

Forest Laboratories was similarly charged recently for marketing Lexapro and Celexa off-label to kids. GlaxoSmithKline paid a couple million in 2004 to settle charges related to illegally peddling Paxil to children. In recent SEC filings, Glaxo registered a $400 million charge to settle an investigation of the off-label marketing of unnamed products.

In other lawsuits, Glaxo was ordered to reimburse families and third party payors for the cost of off-label prescriptions of Paxil to children. Glaxo also has several Paxil related suicide trials coming up this year.

Thus far, Lilly has paid over a billion to settle out of court with roughly 30,000 people over Zyprexa injuries. Thousands of Risperdal and Seroquel lawsuits have been filed against Johnson & Johnson and AstraZeneca by person injured as well.

Florida has supposedly been monitoring the prescribing habits of doctors with children for the past several years. Gabriel’s shrink was already on a list that the Florida Agency for Health Care Administration had red-flagged as having “problematic” prescribing practices with children since 2006, according to the Miami Herald.

It’s obvious that the only action that might slow the profit driven drugging of helpless children in this country is a steady filing of highly publicized lawsuits against the prescribing quacks all over the US.

A class action against the group of shrinks most responsible for convincing doctors throughout the nation to prescribe cocktails of psychiatric drugs to children, titled “Joseph Biederman et al,” might do wonders as well.

Filed under: 2009, Adderall, anticonvulsants, antipsychotics, drugging children, Gabriel, prices, SSRIs

FDA Panel Throws Life Line to Antipsychotic Pushers

Evelyn Pringle June 15, 2009

On June 11, 2009, FDA News reported that AstraZeneca’s Seroquel, Pfizer’s Geodon and Eli Lilly’s Zyprexa atypical antipsychotics “won an FDA advisory panel’s recommendations for approval to treat schizophrenia and bipolar disorder in pediatric and adolescent patients.”

“The FDA’s expanded marketing approval process for antipsychotics, highly toxic drugs, is unaffected by evidence uncovered by the US Justice Department showing that the studies submitted by drug manufacturers were often flawed, if not fraudulent,” says Vera Hassner Sharav, president of the Alliance for Human Research Protection, in a June 8, 2009 infomail alert.

“Rather than focus on protecting children’s safety, FDA officials are doing their utmost to legitimize irresponsible, off-label prescribing of exceedingly toxic antipsychotics for children–thereby ensuring that far greater numbers of children will be victimized and die,” according to Sharav.

A recent report by the consulting firm Decision Resources found antipsychotics makers spent $993,000,000 in 2006, to promote these drugs to doctors and patients, she reports. In 2008, at more than $14 billion, antipsychotic revenues topped all other classes of drugs in the US, even cholesterol and diabetes medications.

On November 17, 2008, on the popular Furious Seasons website, Philip Dawdy reported that Zyprexa had killed 3,455 people between 1997 and early 2008, based on a review of an FDA staff document with a summary of adverse events in the agency’s database.

From 1993 through the first three months of 2008, 1,207 children on Risperdal suffered serious adverse events, including 31 who died, according to a report in the November 18, 2008 New York Times.

The deaths included a 9-year-old child, receiving Risperdal for the unapproved use of ADHD, who suffered a stroke twelve days after starting the drug. At least 11 of the deaths were in children whose treatment was for an unapproved use.

In May 2009, CBS News reported that Risperdal was causing boys to grow breasts due to increased prolactin levels caused by the drug. The news segment featured a boy who was prescribed Risperdal for ADHD, and had to undergo a double mastectomy to remove the breasts.

Philadelphia attorney, Steve Sheller, represents six boys who developed breasts after taking Risperdal, in lawsuits against Johnson & Johnson. Two have had mastectomies.

On June 3, 2009, Medscape reported that findings presented at the American Psychiatric Association annual Meeting, on the preliminary results from the “Metabolic Effects of Antipsychotics in Children” study, “show that 12 weeks of initial antipsychotic treatment was associated with significant mean increases in overall adiposity and percentage of body fat, as well as a decrease in whole-body insulin sensitivity.”

“Further,” Medscape said, “the investigators found antipsychotic treatment was also linked to significant increases in body-mass index (BMI) percentile and fasting plasma triglyceride levels, both clinically available indicators of adverse metabolic changes associated with increased adiposity.”

In terms of live-long health issues: “This is a serious problem,” says Dr Steven Nissen, chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, and past president of the American College of Cardiology.

“The substantial increase in body fat and increased insulin resistance will almost certainly lead to a higher lifelong incidence of diabetes,” he warns.

“Diabetes is a major cause of heart attack, stroke, kidney failure, blindness, and limb amputation,” Dr Nissen points out.

In an April 2008, editorial, in Psychotherapy and Psychosomatics, titled, “Irrational Healers,” Dr David Healy, author of the new book, “Mania: A Short History of Bipolar Disorder,” writes:

“For fifty years, the antipsychotics were viewed as too dangerous to use outside secondary care and were largely restricted to those with chronic psychotic disorders where the trade-off between hazards and benefits justified treatment.”

“Yet now a new generation of possibly even more problematic antipsychotics is being given to preschoolers, in North America, on the basis that they might have a disorder that most of the rest of the world does not believe happens in children.”

“FDA officials are ignoring the real world tragedies–drug-induced deaths of children,” Sharav warns.

On June 6, 2009, the Topeca Capital Journal reported on the death of a Kansas toddler, Destiny Hager, and the confirmation by an autopsy that the child died of fecal impaction, after taking Seroquel and Geodon, with “antipsychotic drugs present in concentrations considered therapeutic in adults.”

Child psychiatrist, Vernon Kliewer, diagnosed Destiny with bipolar disorder and prescribed the drugs. State regulators recently “completed a two-year investigation of Kliewer that found the doctor violated Kansas law while treating Destiny and five other children,” the Journal reported.

A September 14, 2007 petition filed by the Kansas Board of Healing Arts, says Kliewer diagnosed Destiny with Bipolar Disorder in March 2006, at 3-years-old, and she died on April 4, 2006.

The petition contains 6 counts and details the prescribing of multiple drugs by Kliewer to six children including two more 3-year-olds, one 4-year-old and two 2-year-olds. In one case, he began treating a child at 2-years-old and between January 2003 and November 2006, prescribed a total of 9 drugs for the girl, including Risperdal, Abilify, Seroquel, and Geodon.

“The doctor negotiated a settlement in February with the Board of Healing Arts that didn’t require him to admit wrongdoing,” the Journal said. “He voluntarily stopped treating patients under age 6.”

The Board placed Kliewer’s medical license on indefinite probation and ordered him to pay $13,079 to cover the investigation expenses, the Journal reported. Kliewer must also have another physician monitor his treatment of bipolar patients.

“Tragically, most physicians have not been trained or encouraged to think rationally about the hazards of monotherapy, let alone polypharmacy in children,” says Dr Grace Jackson, author of, “Rethinking Psychiatric Drugs: A Guide to Informed Consent, and the new book, “Drug Induced Dementia – a perfect crime.”

“Mental health professionals have an ethical duty to inform parents about the potential lethality of drug combinations,” she advises.

On June 5, 2009, Dawdy posted a link to the FDA’s briefing package on Furious Seasons, available to members of the advisory panel, and posted portions of the introduction by FDA psychiatry products chief, Thomas Laughren, including the following comments on side effects caused by the drugs:

“Adverse reactions that can occur with drugs in the class of atypical antipsychotic drugs include, among others, somnolence, weight gain, increases in blood lipids and glucose, acute extrapyramidal symptoms, and tardive dyskinesia.

“These risks are of particular concern in pediatric patients because of the life-long nature of these disorders and the fact that these patients are considered particularly vulnerable, in part because they may be exposed for many decades, and in part because of possible effects on growth and development,” Laughren noted.

In April 2009, Gabriel Meyers, a 7-year-old Florida boy, committed suicide by hanging in the bathroom of a foster care home. In the last few days of his life: “He was told his mother no longer had visitation rights, that he would probably be going back to Ohio, where he alleged he had been abused; the doctor changed his medication, he changed foster homes and he got a new counselor,” George Sheldon, secretary of the Department of Children and Families, stated in the May 12, 2009 St Petersburg Times.

In the year leading up to his suicide, Gabriel had been on the stimulant drugs Adderall and Vyvanse, the SSRI antidepressant Lexapro, Zyprexa, and Eli Lilly’s Symbyax, a drug containing both Zyprexa and Prozac, recently FDA approved for “treatment resistant” depression.

Gabriel was on Symbyax and Vyvanse when he died and neither prescription had been authorized by either his parents, or a court order signed by a judge, in violation of Florida law. He was listed as being on only Adderall in the Department of Children and Families’ database.

“On six separate occasions, Gabriel’s caseworker, Lawrence Chusid, documented that DCF had “parental consent” for the child’s medications,” according the May 9, 2009, St Petersburg Times

“But in the hundreds of records in Gabriel’s file released by DCF late last month, there is only one form signed by his mother, Candace, a blanket authorization for medical treatment for her son,” dated June 29, 2008, the Times reports.

The labeling on Prozac and Symbyax, contains a black box warning of an increased risk of suicide in children. Instead of discouraging the concomitant use of these two powerful medications, Lilly has encouraged such practices by “designing its own “combination” capsule which contains both Prozac and Zyprexa,” says attorney, Andy Vickery, of the Houston law firm, Vickery, Waldner & Mallia, who is involved in Zyprexa suicide litigation.

“The actual number and rate of completed suicides for patients in clinical trials on antipsychotic drugs, as submitted to the FDA, is higher on Zyprexa than on any of the other drugs in this class,” he reports.

“Specifically,” he says, “Lilly reported that, of 2500 patients on Zyprexa, there were 12 completed suicides, as compared to none on placebo.”

For several years, a system called the “Medicaid Drug Therapy Management Program,” was supposed to be monitoring the prescribing habits of doctors for children covered by Florida Medicaid. However, Gabriel’s shrink, Dr Sohail Punjwani, had been red-flagged as having “problematic” prescribing practices in every quarter since the monitoring began in 2006.

According to the Miami Herald: “Punjwani defended the use of psychiatric drugs on children, even if they are not approved for such use, saying the lack of approval stems from the reluctance of drug makers and the medical establishment to launch clinical trials on children.”

“The anti-psychotic drugs, he added, are used routinely to treat mood instability and insomnia among children,” the Herald reported.

The doctor told the Herald that he did not even remember Gabriel. On May 12, 2009, the Herald reported that a “lawmaker who chairs a state Senate committee on children has asked the state to investigate the doctor who treated a foster child who killed himself.”

“In separate letters to the Florida Board of Medicine and the Agency for Health Care Administration, state Sen. Ronda R. Storms, a Brandon Republican who chairs the Children, Families and Elder Affairs Committee, requested investigations leading to a “full report,” according to the Herald.

Following Gabriel’s death, DCF Secretary Sheldon directed a review of the files for every Florida foster child to ensure that any child prescribed psychotropic drugs was accurately recorded in the Department’s system. He also directed a verification of the existence of a parental consent, or a court order signed by a judge, authorizing each child to receive such medication.

The results of the review in a May 28, 2009 report indicate: “No record of consent or judicial order was found for 16.2% of the 2,669 children receiving psychotropic medication.”

On December 13, 2006, four-year-old Rebecca Riley died in a Hull, Massachusetts as a result of a drug overdose. At a mere 28-months-old, Dr Kayoko Kifuji, a psychiatrist at Tufts New England Medical Center in Boston, diagnosed Rebecca with ADHD and bipolar disorder, and subsequently prescribed, Seroquel, Depakote, an antiseizure drug, and clonidine, a blood pressure medication.

The medical examiner noted that “Rebecca’s heart and lungs were damaged and found that this was due to prolonged abuse of these prescription drugs, rather than one incident,” according to police reports.

The legal filings show the two other Riley children, ages 6 and 11 at the time of Rebecca’s death, were also diagnosed with bipolar disorder and ADHD, by the same doctor, and kept on the same 3-drug cocktail for years.

Rebecca’s parent have been charged with murder under the theory that they overdosed the child in attempt to sedate her and she did not bring in government disability payments.

On February 7, 2007, the day after the parents pleaded not guilty to the charges, Dr Kifuji entered into a voluntary agreement with the Massachusetts Board of Registration in Medicine to not practice medicine pending an investigation. “The Agreement entered into by Dr. Kifuji will remain in effect until further order of the Board,” the Board’s February 7, 2007 press release stated.

In April 2008, attorney, Andrew Meyer Jr, filed a malpractice lawsuit against Dr Kifuji on behalf of Rebecca’s estate. “This child was subject to mostly telephone prescriptions and a slipshod diagnosis,” he told the Boston Globe on April 4, 2008.

In an editorial titled, “How many more Rebecca Rileys?, in the January 9, 2009 Patriot Ledger, the author of, “From Difficult to Delightful in Just 30 Days,” Dr Jacob Azerrad, wrote: “To diagnose a 2-year-old as bipolar by adult standards is crazy.”

“A key issue is the misuse of psychiatric diagnostic labels to explain bad behavior in children,” he wrote. “This has resulted in the drugging of young children to a degree unprecedented in our history.”

“Our preschool children are far too young to defend themselves,” he said. “It’s up to parents to “say no to drugs” and teach their children that life is meant to be learned and experienced – it’s not just a pill to be swallowed.”

On March 5, 2009, Weymouth News reported that a “psychiatrist who prescribed drugs for the late Rebecca Riley, who was four at the time of her death, can be charged with malpractice.”

“A Suffolk County tribunal determined on March 5 that there was enough evidence to charge Dr. Kayoko Kifuji,” the News noted.

“Rebecca Riley’s doctor now the target of a grand jury,” was the headline in the May 1, 2009 Patriot Ledger. “Already the target of a civil medical malpractice lawsuit, the psychiatrist who prescribed the drugs that killed 4-year-old Rebecca Riley is now the subject of a grand jury criminal investigation,” reporter Lane Lambert wrote.

“If the grand jury does find the … psychiatrist criminally liable for Rebecca’s death, she could face involuntary-manslaughter charges,” Lambert noted.

Evidence of the grand jury investigation surfaced “amid fresh legal action in both the civil and criminal cases,” Lambert said. “Kifuji’s lawyers asked a Suffolk County judge to postpone her deposition in the civil case indefinitely, and close the entire court record to the public.”

Kifuji’s attorney “said a deposition would force the doctor to claim her Fifth Amendment right not to incriminate herself while the grand jury was looking at the case,” according to the report. The judge denied both motions, it noted.

An attorney for Rebecca estate said Kifuji is scheduled to give a deposition in the civil case on July 6, 2009, after the grand jury is finished. In the March 5, Weymouth News article, Kifuji’s attorney said the murder charges against the Rileys make it difficult to decide if she can be faulted for Rebecca’s death.

“This is not something bizarre that she (Kifuji) did,” he said. “A number of fine doctors feel this was appropriate.”

Back on September 30, 2007, Katie Couric interviewed Dr Joseph Biederman, whose research Dr Kifuji has said influenced her, in a 60 Minutes segment tiled “What Killed Rebecca Riley?”

When questioned about the rise in young children with bipolar disorder, Biederman told Couric: “The average age of onset is about four.”

“It’s solidly in the preschool years,” he stated.

The results of an investigation led by Senator Charles Grassley, on behalf of the Senate Finance Committee, revealed that between 2000 to 2007, Biederman earned at least $1.6 million from drug companies but failed to report at least $1.4 to Harvard University.

On February 26, 2009, Biederman was questioned under oath in a deposition for litigation titled, In re Risperdal/Seroquel/Zyprexa Litigation, Case Code 274, Alma Avila as next fried of Amber Avila versus Johnson & Johnson Company et al, in the Superior Court of New Jersey, Middlesex County.

At one point, when questioned about his participation in medical education events as a paid speaker, he blamed a decline in invitations to speak over the past year on Grassley’s investigation and inferred that the investigation was brought on by media hype over Rebecca’s death.

When asked if he had any idea why he received fewer invitations, Biederman said: “There has been some accusations by Senator Grassley about issues of conflict of interest; and while the investigation is going on, I agreed not to speak.”

“What is the nature of Senator Grassley’s investigation of you?” attorney, Fletch Trammell, asked.

“Senator Grassley read, there was an article in The Boston Globe about a little girl in town that the parents are accused of first-degree murder,” Biederman noted.

“In fact, you may have seen it,” he told the attorney.

“The accusation has been upgraded from second-degree to first-degree murder,” he pointed out.

“But because the child was diagnosed with bipolar illness, it captured the imagination of the media and there was an article in The Boston Globe that talked about the diagnosis and how controversial that is and particularly as it pertains to preschoolers,” Biederman continued.

“And in the article the reporter got — I sent my standard disclosure forms, so he wrote that I have extensive relationships with fifteen or so pharmaceutical companies,” he stated.

“So Senator Grassley wrote a letter to the institution, to Harvard and Mass. General, asking for details,” he said. “And that has been the cascade of events.”

“So Senator Grassley became interested in you because of these people who were accused of killing their kid?” the attorney asked Biederman.

“Senator Grassley claims to be interested in issues of conflict of interest and is interested in making sure that the universities have tight conflict-of-interest rules,” Biederman said. “I have no dispute with that.”

“What interactions have you had with Senator Grassley or his staff?” the attorney asked.

“None,” Biederman stated. “Senator Grassley’s interactions are with Mass. General and with Harvard, not with me directly.”

Biederman said the hospital was paying a law firm to represent him in the matter of Grassley’s investigation and for the deposition.

He acknowledged having a professional relationship with Janssen, Eli Lilly, Bristol-Myers Squibb, AstraZeneca and Pfizer, the makers of atypical antipsychotics. “I have a professional relationship with dozens of manufacturers,” Biederman said.

“In the course of carrying out these relationships with all these drug manufacturers, does the relationship always involve them giving you money?” the attorney asked.

“Most of the time,” Biederman replied.

On March 27, 2009, the New York Times reported that, “Federal prosecutors have issued a subpoena seeking information about the work and statements of three prominent Harvard researchers who have been the focus of a Congressional investigation into conflicts of interest in medicine.”

The researchers, Doctors Joseph Biederman, Thomas Spencer and Timothy Wilens – “are named in the subpoena, which was sent … to Fletch Trammel, a lawyer who represents state attorneys general in lawsuits that claim makers of antipsychotic drugs defrauded state Medicaid programs by improperly marketing their medicines,” the Times noted.

Up until June 10, the researchers and doctors in the field of psychiatry identified by Grassley’s investigation included Charles Nemeroff from Emory University; Melissa DelBello at the University of Cincinnati; Alan Schatzberg, president of the American Psychiatric Association, from Stanford University; Martin Keller at Brown University; Karen Wagner and Augustus John Rush from the University of Texas; and Fred Goodwin, the former host of the radio show, “Infinite Minds,” broadcast for years by National Pubic Radio.

But on June 10, the name Zachary Stowe was added to the list, with a Wall Street Journal headline: “Emory Psychiatrist Cited in Conflicts of Interest.”

“Emory University has disciplined a prominent psychiatrist who was being paid by an antidepressant maker at the same time he was conducting federal research about the use of such drugs in pregnant women,” the Journal wrote.

Stowe is the director of the “Women’s Mental Health Program” at Emory. Its website says the focus his “clinical research is the use of psychotropic medications during pregnancy and lactation, the psychobiology of mood disorders during pregnancy and the postpartum period, and the impact of maternal mental illness on fetal and neonatal exposures.”

The latest off-label marketing scheme in the works involves federal legislation expected to come up for a vote soon in the US Senate called the Mothers Act. This one involves a plan to screen all pregnant women for a long list of pregnancy related “mood” and “anxiety” disorders.

After covering the Pharma’s off-label marketing schemes using mental illness screening scams since mid-2004, beginning with TeenScreen, the Mothers Act is no different than the others, aside from the fact that a whole new treatment industry was built up around it, and more profiteers are involved. But then, Pharma could hardly expect to keep selling drugs through middle-man pushers forever, while keeping the massive profits to itself.

Amy Philo, the leader of “Unite for Life,” a coalition of 50 groups against the bill, warns that the Mother’s Act is: “Trolling for Mental Patients in a Maternity Ward Near You.”

“If you’ve never been “Teen Screened” in high school, quizzed by a college counselor about your potential perfectionism, mood swings, or alcohol use- or told you might go crazy if you don’t start taking drug x, consider yourself among the fortunate, fading few,” Amy advises.

“Imagine yourself pushing a baby into the world in a hospital somewhere in America,” Amy says, “only to be greeted by a friendly, neighborhood-psychological-screener the very moment baby begins munching down on his first meal.”

“Would either of you like a DSM-IV Mental Disorder diagnosis code with that milk?”

With no psychiatric drugs FDA approved as safe for use by pregnant and nursing mothers and doctors rightfully reluctant to prescribe any drugs harmful to the fetus, a new customer recruitment scheme was needed and the Mothers Act fit the bill.

Opposition to the Act stems from the certainty that it will lead to more forced drugging of infants with no voice of their own to prevent it, with antidepressants, antipsychotics, and antiseizure drugs that cause birth defects, a withdrawal syndrome and many other serious health problems, through pregnant and nursing mothers.

The Act is modeled after a mandatory screening law enacted in New Jersey, the home state of the bill’s main sponsor, Senator Robert Menendez, and also the home state for many drug companies. Attempts to pass the federal version have failed for the past 8 years.

The postpartum websites strung out all over the internet to promote the bill, many run by people benefiting financially from the new treatment industry they created, argue that the Act does not call for mandatory screening, without mentioning that the screening language was removed last year due to strong opposition.

“There is NO MANDATED screening,” Susan Stone wrote in a blog on the website for her treatment center, PerinatalPro, on May 29, 2009.

On May 12, 2009, the Herald News reported that the Act “lacks one vote for approval” in the US Senate, citing a speech made by Menendez, during a press conference. Menendez told the Herald that the national bill would not mandate screening. “Hopefully, states would adopt screening,” he said.

This statement, in May of this year, clearly shows that the goal of passing the federal legislation is to set the stage for states to pass mandatory screening laws, like the one in New Jersey.

A June 16, 2006, press release, by Menendez and Senator Richard Durbin, announcing the bill stated, the “Act was introduced in response to a recently passed, first-of-its-kind New Jersey law requiring doctors and nurses to educate and screen expectant mothers about PPD.”

The Theraurus on my computer lists “require,” as an alternate word for “mandatory.”

On June 8, 2009, New Jersey.com, ran the headline: “E-mail: Drug lobbyist targeted Menendez to help with importation bill,” and reported that the subject line of the email said: “URGENT”

The email called for New Jersey drug companies to ask Menendez to be their champion on an amendment that would effectively kill any attempt to allow cheaper drugs to be imported from other countries, according to the report.

“We need to locate a Democratic lead cosponsor for the second degree amendment,” the e-mail said.

“Can … [Johnson & Johnson], Merck, Novartis, Pfizer and the other New Jersey companies coordinate and contact Senator Menendez’s office and ask him to take the lead?”

The strategy to pursue Menendez became known when the email from the Pharmaceutical Research and Manufacturers of America, the industry trade group, ended up with Senator John McCain, a drug importation advocate. “And McCain read it on the Senate floor – twice,” the article notes.

“Menendez’s office said that while he supports the drug companies’ position, he did not act as their champion,” according to New Jersey.com.

The Mothers Act refers to “entities,” as being eligible for grants and participating in research and the development of screening methods and treatments and delivery.

The bill states: “The Secretary may make grants to eligible entities for projects for the establishment, operation, and coordination of effective and cost-efficient systems for the delivery of essential services to individuals with a postpartum condition and their families.”

Under definitions, it says the term ‘eligible entity’– “means a public or nonprofit private entity;” and “includes a State or local government, public-private partnership, recipient of a grant under section 330H (relating to the Healthy Start Initiative), public or nonprofit private hospital, community-based organization, hospice, ambulatory care facility, community health center, migrant health center, public housing primary care center, or homeless health center.”

“Lawmakers have not specified what constitutes an “entity” so it will be impossible to know if there are conflicts of interest between those who develop the screening tools and conduct research and the pharmaceutical companies who most certainly will benefit financially from the increased diagnosing,” according to Kelly Patricia O’Meara in May 7, 2009 article, “Stress Testing the Mothers Act.”

“Where is the guarantee that the “entities” are not pharmaceutical front-men?”, she writes.

“Given that this research will be used to develop questions or tests for screening new mothers for possible mental disorders, one might find it important to know that the research has integrity and has been validated by the scientific community, free of pharmaceutical largesse,” O’Meara points out.

The Act also calls for a “a coordinated national campaign to increase the awareness and knowledge of postpartum conditions.” Activities under such a campaign may– “include public service announcements through television, radio, and other means;” which will basically provide the new pregnancy-related treatment industry with a tax-payer funded mass advertising campaign.

It would be interesting to know whether “entities” would include the treatment centers owned by Susan Stone and Karen Kleiman, and whether their programs would be eligible for funding. At the “Postpartum Stress Center,” Kleiman teaches seminars for professional training with ads on her website and the heading: “Become an Expert in the Treatment of Postpartum Mood Disorders.”

The first sentence in “Highlights” for this training states: “This is a crash course on diagnosis, screening, assessment, treatment options.” The fee is $750 for a 10-hour course, but they do throw in a book titled, “The Postpartum Stress Center’s Guide to Enhancing your PPD Private Practice: A checklist for successful practice,” for the $750.

For this gig alone, Karen could make $7,500 per seminar by simply recruiting 10 trainees. Nearly all the websites pitch in to promote conferences and seminars, so rounding up 10, or even 20, trainees would likely not be too difficult.

The website shows 4 seminars a year, meaning Karen could earn roughly $30,000 for 40 hours of teaching people how to “Become an Expert.” And if she could round up 20 trainees per class, she could make $60,000 a year, putting her up there with all the other highly paid speakers within the new industry.

In her May 29, 2009 blog, Susan mentions how the Act might help fund “inpatient maternal mental health” programs all across the US. “Just this morning,” she says, “I completed an interview with Parenting Magazine, which plans to feature an article about the nation’s first inpatient maternal mental health unit at UNC, Chapel Hill, NC, as well as focus on the federal legislation and how this bill might help fund other such programs across the country.”

Many sites provide links to “experts” and treatment programs. For instance, Katherine Stone runs “Postpartum Progress,” and in December 2008, she had links to the “Top Women’s PPMD Treatment Programs & Specialists.”

The first program on the list was Dr Stowe’s at Emory, which primarily focuses on “the evaluation and treatment of emotional disorders during pregnancy and the postpartum period,” the website states.

In 2008, Dr Stowe was the primary investigator of an National Institutes of Health grant where the stated purpose was “to stimulate vigorous debate with the emphasis on the reproductive safety of antidepressant medications,” according to Grassley’s June 2, 2009 letter to the president of Emory.

During a 2008 deposition in a Paxil birth defect case, Stowe said that around “80% of his Emory salary ($187,000) comes from his NIH grants,” the letter notes. His total Emory salary was $232,000.

In 2007, Paxil maker, GlaxoSmithKline, paid Stowe $154,400 for 57 promotional talks. He also received $99,300 in the first ten months of 2008 for 38 promotional talks for antidepressant drugs, according to Grassley.

Stowe’s undisclosed income above was from one drug maker. In August 2007, he was listed as an author on a study titled, “Atypical Antipsychotic Administration During Late Pregnancy: Placental Passage and Obstetrical Outcomes,” in the American Journal of Psychiatry.

According to the disclosure section, Stowe has received research support from Glaxo, Pfizer, and Wyeth. He has served on advisory boards for Wyeth, Bristol-Myers Squibb, and Glaxo, and he has served on speaker’s bureaus and/or received honoraria from Lilly, Glaxo, Pfizer, and Wyeth.

Dr Jeffrey Newport is the associate director of Emory’s Women’s Program. Newport was also an author on the “Antipsychotic,” study. He has received research support from Lilly, Glaxo, Janssen, the National Alliance for Research on Schizophrenia and Depression, NIH, and Wyeth, and, he has served on speaker’s bureaus for AstraZeneca, Lilly, Glaxo, Pfizer, and Wyeth, according to the disclosures.

On June 14, 2007, Katherine Stone posted a blog with the headline: “Upcoming Event in Asheville Features My Psychiatrist!”, in an evening for prescribing clinicians called “Postpartum Mood Disorders: A Systemic Approach to Biopsychosocial Treatment.”

“The key speaker will be Dr. Jeffrey Newport, associate director of the Emory Women’s Mental Health Program here in Atlanta and also my psychiatrist!!!!”, she said. “I have firsthand knowledge that Dr. Newport rocks.”

An online announcement shows Dr Stowe gave a seminar titled, “Atypical Antipsychotics in Major Depressive Disorder: When Current Treatments Are Not Enough.” The moderator for the seminar was Charles Nemeroff, who earned more than $2.8 million from drug companies between 2000 and 2007, but failed to disclose at least $1.2 million to Emory, according to Grassley.

On July 23, 2008, an article by Nemeroff titled: “Weighing Risk and Benefit for Treatment of Depression in Pregnancy and PostPartum,” was available on Medscape. The Medscape website stated, “This article is temporarily unavailable,” on March 17, 2009.

Nemeroff stepped down as chair of the psychiatry department in 2008 after an Emory found he had failed to report more than $800,000 from Glaxo from 2000 to 2006. “That matter is now being probed by the inspector general for the U.S. Department of Health and Human Services,” according to the Wall Street Journal.

Filed under: 'ADHD', 2009, antipsychotics, drugging children, FDA, Gabriel, Kifuji, mothers act, SSRIs, Vyvanse

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