The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

Nobody Buys Lilly’s Innocence Routine About Zyprexa

Evelyn Pringle February 6, 2007

Eli Lilly is having trouble obtaining and retaining insurance coverage for Zyprexa litigation because apparently insurance companies are no longer willing to buy its wide eyed innocence routine when it comes to the company’s fraudulent off-label marketing schemes.

In filings with the SEC, Lilly admits that it is having problems and that the company may end up having to pay its own Zyprexa costs, but blames it on the insurance industry stating: “We have experienced difficulties in obtaining product liability insurance due to a very restrictive insurance market and therefore will be largely self-insured for future product liability losses.”

As for the insurance that Lilly does have to cover past and future Zyprexa lawsuits, the filing reports that carriers have raised defenses to their liability and are seeking to rescind the policies, and Lilly further warns that, “there is no assurance that we will be able to fully collect from our insurance carriers on past claims.”

Some internal Lilly documents recently leaked to the press, that Lilly somehow managed to have sealed with a court order, reveal that Lilly hid the side effects of Zyprexa identified in its own clinical trials a decade ago and engaged in wide-ranging off-label marketing schemes to make a drug approved by the FDA only to treat adults with schizophrenia and bipoloar disorder into its top selling product bringing in a reported $30 billion thus far.

In light of these insurance problems, Lilly could be likened to a dog chasing its tail. While on one hand, it is being sued for illegally marketing Zyprexa off-label, if it stops the illegal conduct profits will plummet and it won’t have the money to pay the litigation costs.

However, Lilly has apparently decided to take the low road, because to date, settling with 26,500 Zyprexa cases out of court by paying out over $1.2 billion has done nothing to lower the off-label sales figures for Zyprexa. In fact, in 2006, sales of the drug increased 12%, according to SEC filings.

In 2003, the FDA ordered warning labels on all atypicals, of an increased risk of high blood sugar and diabetes and said blood sugar surges in some patients were associated with life-threatening medical conditions or death. In 2005, the FDA added the strongest warning available, a black box, stating that the drugs increased the risk of death in elderly patients with dementia. The warnings did nothing to slow off-label prescribing of Zyprexa.

It is still being freely prescribed for uses never approved or intended. On April 25, 2006, Bloomberg News reported that in 2005, nearly 7 children out of one thousand were taking an antipsychotic, and among senior citizens 65 and older, antipsychotic use was 21 per 1000. Per patient antipsychotic costs for children 19 and under have increased 196%, or nearly triple 2001’s total, according to Bloomberg.

An assessment by Christoph Correll, Child and Adolescent Psychiatric Clinics of North America, January 2006, in USA Today, shows Zyprexa to be the worst of the atypicals for children and lists side effects of diabetes and weight gain with Zyprexa as “severe.”

Zyprexa is not approve for any on-label indication for children but even if it was, schizophrenia is extremely rare in children at about 1 in 40,000 under the age of 18, according to the National Institute of Mental Health, and psychiatrists do not even agree on what criteria should be used to diagnose children with bipolar disorder.

Yet the rate of children treated with atypicals “is growing dramatically faster than the rate for adults,” Robert Epstein, chief medical officer for Medco Health Solutions, pharmacy benefit managers, told USA Today.

Medco did an analysis of outpatient prescriptions for USA Today and found that, in a sampling of about 2.5 million of its 55 million insured members, the rate of children 19 and under with at least one atypical jumped 80% from 2001 to 2005. And that number only represents privately insured kids, and not those in foster care or covered by Medicaid.

In what outraged critics called an unethical and dangerous experiment conducted by Lilly on children, on May 1, 2006, the New York Times, reported that “psychiatric researchers have been experimenting with a bold and controversial treatment strategy: they are prescribing drugs to young people at risk for schizophrenia who have not yet developed the full-blown disorder.”

The study, co-funded by Eli Lilly and the National Institute of Mental Health, and published in the May 2006, American Journal of Psychiatry, involved 60 patients, mostly adolescents, who supposedly scored high on a scale that assessed the risk for psychosis.

The scale rated the severity of over a dozen symptoms including categories such as grandiosity, suspiciousness, and bizarre thoughts. The researchers claimed that from 20% to 45% of the people who scored high would go on to develop full-blown psychosis, in which the symptoms would become extreme.

In the first year of what was scheduled to be a 2-year trial, five of the 31 patients on the drug developed full-blown psychosis, compared to 11 of the 29 who were on placebos. However, by the end of the first year, more than two-thirds of the patients had quit, making it impossible to interpret any differences between the 2 groups.

The only definite finding of the study was that patients taking the drug gained an average of 20 pounds, once again documenting a side effect that has been known for 15 years.

Experts say the rapid weight gain is the most worrisome side effect of Zyprexa because obesity leads to so many other serious health problems like diabetes, hypertension and heart disease.

Public health programs are throwing good money after bad paying for Zyprexa. A recent study published in the October 12, 2006, New England Journal of Medicine, funded by the National Institute of Mental Health, found atypical use with Alzheimer patients was no more effective than a placebo for most patients and put them at risk of serious side effects including confusion, sleepiness and Parkinson like symptoms.

According to the report, about a third of the roughly 2.5 million Medicare beneficiaries in nursing homes have taken atypicals, and their use accounts for an estimated $2 billion in annual sales, much of it paid by Medicare and Medicaid.

All that said, Lilly cannot claim to be unaware of the continued off-label sale of Zyprexa in the US, because it buys the detailed prescribing records for every doctor in the country and provides them to sales representatives so they can better direct the company’s promotion efforts.

Lilly knows exactly which doctors are prescribing Zyprexa, in what dose, and how often, on any given day of the year and that places Lilly in the best position to contact doctors to tell them to halt the off-label prescribing but that obviously has not happened.

Allowing Lilly to keep documents that were produced in litigation hidden even after the cases were settled has done nothing to curb the off-labeling prescribing of Zyprexa either.

And, the fact that a judge would even entertain Lilly’s demands to place the recently released documents back under seal has resulted in outrage voiced by health care professionals all over the US. The pubic health crisis created by Lilly’s off-label sale of Zyprexa for 10 years without warning about the health risks is no small matter.

On November 16, 2005, USA Today interviewed FDA scientist, Dr David Graham, the man famous for blowing the whistle on the mishandling of the Vioxx disaster, who estimates that there are 62,000 deaths each year from the off-label use of atypical drugs.

The allegations made by the plaintiffs in the underlying litigation are all verified in the leaked documents. For instance, the California law firm, Hersh and Hersh, represented plaintiffs in the first settlement, who alleged that Lilly “fraudulently withheld relevant information from potential users of Zyprexa.”

The lawsuits also alleged a failure to warn doctors and patients that Zyprexa carried potentially lethal risks from weight gain and diabetes, and one of the leaked documents dated 6 years ago, written by a panel of diabetes doctors hired by Lilly to assess the diabetes risk, warned Lilly back then that “unless we come clean on this, it could get much more serious than we might anticipate.”

According to Leonard Roy Frank, in “Zyprexa: A Prescription for Diabetes, Disease and Early Death,” in the August 2005, edition of Street Spirit, if Lilly had issued the warnings, “there undoubtedly would have been fewer cases of diabetes and fewer deaths from taking Zyprexa.”

“But truthfulness is not one of Eli Lilly’s strong suits when profits are at stake,” Mr Franks says.

“Telling the truth,” he points out, “would undoubtedly have cut into sales for its blockbuster drug (the fifth best-selling prescription drug in the world), which, in 2004, produced revenues of $4.4 billion, almost a third of the company’s total revenues and more than a third of its profits.”

This is not the first time that the judge’s Zyprexa protective order has been criticized. In 2005, the Swedish Academy of Pharmaceutical Sciences journal ran an article titled, “Lilly is hiding negative information about Zyprexa,” featuring an interview with Dr Curt Furberg, Professor of Public Health Sciences, at Wake Forest University.

Dr Furberg said that he had seen secret documents on Zyprexa in his capacity as an expert witness and stated that the most hazardous effects of Zyprexa were hidden from prescribing physicians and the public.

The hidden Zyprexa evidence is said to be worse than that revealed on Vioxx and Dr Furber’s interview provides good insight into why Lilly would early on agree to pay a $690 million settlement to the first round of Zyprexa plaintiffs, which allowed the company to keep the damaging evidence buried.

According to Lilly, the company has produced approximately 11 million documents and the court has, without any stated reasons, allowed Lilly to designate all 11 million as confidential pursuant to Case Management Order 3, an August 9, 2004, protective order.

Attorneys involved in the case say Lilly was even permitted to designate reports and articles about Zyprexa that appeared in the media as confidential.

In mid-December 2006, Alaskan attorney, Jim Gottstein, obtained some of the sealed documents by issuing a subpoena for Dr David Egilman, another expert witness who evaluated the Zyprexa documents for a law firm in the underlying litigation, to appear for a deposition.

As soon as he received the documents, Mr Gottstein set out to publicize the information by immediately providing copies to journalists and authors including Dr Peter Breggin, Dr Grace Jackson, Dr David Cohen, Dr Stefan Kruszewski, Judy Chamberlin, Vera Sherav, Robert Whitaker, and Alex Berenson at the New York Times.

When articles began appearing in the Times, Lilly obtained an injunction that required Mr Gottstein to return the documents and identify everyone they were disclosed to.

After Lilly received the names, on December 29, 2006, the court issued a second temporary injunction to prohibit the dissemination of the documents by Terrie Gottstein, Jerry Winchester, Will Hall, Bruce Whittington, and Laura Ziegler.

The injunction also barred the disclosure of the information about Zyprexa by many of the most well-known experts on psychiatric drugs in the US, who are also journalists and authors, to include Dr Peter Breggin, Dr Grace Jackson, Dr David Cohen, Dr Stefan Kruszewski, Judy Chamberlin, Vera Sherav, and Robert Whitaker.

At Lilly’s request, in early January, 2007, more names were added to the injunction including two websites belonging to the consumer protection and patient advocacy organization, the Alliance for Human Research Protection (AHRP), at http://www.ahrp.org and http://www.ahrp.blogspot.com, and the web site of the international patient advocacy organization, MindFreedom, at http://www.mindfreedom.org, and Eric Whalen and his web site at http://www.joysoup.net.

The name of New York Times reporter, Alex Berenson, the only journalist who actually quoted from the documents in the press was not included in any injunction. Lilly in fact never asked for an injunction against the Times, and Judge Jack Weinstein announced in one hearing that he was not going to issue an injunction against the Times.

However, for the others journalist, the litigation process has dragged out at snail’s pace and Lilly has been successful in getting the court to bar them from discussing or writing about the public health risk created by the continued off-label prescribing of Zyprexa.

Attorney, Alan Milstein, representing Ms Sharav, the AHRP, and Dr Cohen, has filed a motion asking the judge to unseal the documents in question from the original protective order on the grounds that they should not have been designated confidential to begin with.

At a January 17, 2007, hearing Mr Milstein told Judge Weinstein that the documents are critically important to saving human lives, to prevent human suffering and “this Court should in no way assist Lilly in keeping them from the public.”

The above statement by Mr Milstein is not an exaggeration. According to recently updated estimates by Allen Jones, a former Medicaid fraud investigator, in considering the $10 billion a year spent on atypicals in the US, the death rate would be close to one patient per $162,000 spent on Zyprexa, or nearly six deaths for every million.

Lilly is now seeking civil and criminal contempt charges against Mr Gottstein and Dr Egilman for their part in warning the public, which Mr Gottstein admits will hopefully have a negative impact on the sale of Zyprexa for unapproved uses.

Dr Egilman has recently notified Lilly that he will not be attending what could be seen as his own funeral in refusing to testify against himself at a deposition based on his right against self-incrimination under the Fifth Amendment of the US Constitution.

Several of the authors and journalists restrained by the injunction have obtained private attorneys to file briefs arguing against their inclusion based on rights guaranteed by the First Amendment and some have testified in person or by phone at court hearings.

Attorney, Fred von Lohmann, of the Electronic Frontier Foundation, filed a brief to object to the injunction on behalf of John Doe, referred to as a citizen-journalist who contributes to the Wiki web site and states: “The information that Doe desires to publish on the Wiki (including links to sites where the Lilly Documents can be obtained) plainly relate to a matter of overriding public concern.”

Lilly apparently believes that showing that there has not been widespread viewing of the documents is important. However, after Lilly told the judge that they were not available on the internet and that a grassroots campaign to disseminate them had “fallen flat,” Mr von Lohmann filed a brief saying Lilly “appears to have been incorrect,” and supplied the court with affidavits by two persons who said they easily found and downloaded the files on the internet, and in one instance it only took 19 minutes.

Ted Chabasinski, the attorney for Robert Whitaker, Judi Chamberlin, and David Oaks, the Director of Mindfreedom, is calling for criminal charges against Lilly executives for illegally marketing Zyprexa for unapproved uses, with full knowledge that thousands of patients were being injured and killed. In his latest brief filed on Feb 1, 2007, Mr Chabasinski says the documents that Lilly claims should be kept secret show this:

“Certain executives of defendant corporation, motivated by greed, deliberately engaged in a course of action that they knew would cause, and did cause, the injury and death of thousands of people.

“Because of defendant executives’ depraved disregard for human life, thousands upon thousands of innocent people were left with their bodies bloated, their health ruined, and their lives severely shortened or rapidly ended.”

Mr Chabasinski is advising members of the public to contact state attorneys general to direct their attention to the Times articles and the existence of the secret Zyprexa files and a list of current state attorneys general is posted on the Mindfreedom web site.

Ms Sharav testified at a January 17, hearing that the public needs to be warned “because vulnerable people such as children and the elderly and disabled people are being targeted to take drugs that are doing them more harm than there is any evidence of benefit.”

She freely expressed her views about Lilly which prompted Lilly’s legal team to ask that her comments be stricken from the record but the request was denied. When asked what the secret documents showed with respect to the practices of Lilly, she stated:

“In my opinion, this is about the worst that I have seen. It borders on indifference to human life. Eli Lilly knew that Zyprexa causes hypoglycemia, diabetes, cardiovascular damage and they set about both to market it unlawfully for off label uses to primary care physicians and they even set about to teach these physicians who were not used to prescribing these kind of drugs to, they taught them to interpret adverse effects from their drug Prozac and the other antidepressants which induce mania.

“They taught them that if a patient presented with mania after having been on antidepressants, that that was an indication for prescribing Zyprexa for bipolar which is manic depression. That is absolutely outrageous and that is one of the reasons that I felt that this should involve the Attorney General.”

“The sales of a drug that was approved for very limited indications, for schizophrenia and for bipolar,” Mr Sharav stated. “Each one of these is about one to 2 percent of the population,” she pointed out.

“But the reason the drug became a four and a half billion dollar seller in the United States,” she testified, “is because they encouraged the prescription for children, for the elderly, for all sorts of reasons.”

She said her organization had disseminated a video on U-Tube in which a “former Zyprexa salesman tells exactly what they were taught and how they were taught to defuse doctors’s concerns who saw their patients as he put it blow up.”

Ms Sharav testified that she asked Mr Gottstein for 2 copies of the documents because she wanted to deliver one to the New York State Attorney General.

Attorney, Richard Meadows, who represented some of the plaintiffs in cases settled out of court was called to testify and attorneys were able to establish that the information contained in the leaked documents is basically nothing new.

He admitted that the two central allegations in the underlying lawsuits was that Zyprexa was marketed off-label and that when Lilly sought FDA approval of the drug that Lilly had information that showed that there were dangers in regard to the drug.

Near the end of the hearing, Attorney Milstein argued that the foundation for the injunction was that the Lilly documents were trade secrets and “yet in all of the papers they filed, all they do is say, without any kind of support, that they are trade secrets.”

He objected to the blanket court order for 11 million documents. “You heard the testimony of the plaintiffs’ attorney,” he told the judge, “who said to his knowledge, that virtually every document produced by Lilly in this case is marked confidential.”

In one of the latest development in this bizarre legal battle, Judge Weinstein has issued a court order with the word “Invitation” asking Mr Berenson to appear in court, apparently to guarantee him a front row seat at his own hanging, by giving testimony on whether he participated in what the judge called a “conspiracy” with Dr Egilman and Mr Gottstein to violate the order that sealed the secret documents to begin with.

On the other side of the coin, if the documents remain sealed, Mr Franks warns that users of the drug, doctors, and the public are still almost totally in the dark about the clinical trials and what he calls, “Zyprexa’s shameful history.”

He says Zyprexa was approved based on the results of a six-week clinical trial that involved 2,500 subjects, and two-thirds of them did not even successfully complete it. “Among those who stuck it out,” he reports, “22 percent of the Zyprexa subjects suffered a “serious” adverse effect, compared to 18 percent in the group taking Haldol.”

Besides severe weight gain, Mr Franks says, other adverse effects included shaking, spasms, sedation, diabetic complications, rapid heartbeat, restlessness, constipation, seizures, liver problems, white blood cell disorders, and decreased blood pressure.

There were a total of 20 deaths, including 12 suicides, in the Zyprexa group. Information documenting these deaths was obtained from FDA files using the Freedom of Information Act, by one of the currently muzzled journalists, Robert Whitaker, who wrote that one in every 145 subjects who entered the trials for Zyprexa, and the other atypicals, died in his best selling book, “Mad in America: Bad Science, Bad Medicine, and the Enduring Mistreatment of the Mentally Ill.”

According to Mr Frank, Lilly has another perverse reason for pushing Zyprexa. “It’s a cruel irony,” he says, “that while the company is filling its coffers by selling a drug that can cause diabetes, four of its top-selling drugs are treatments for diabetes.”

“Eli Lilly gets the customer coming and going,” he states.

Filed under: 2007, antipsychotics, drugging children, Eli Lilly, preemptive drugging, Zyprexa

Tracking the American Epidemic of Mental Illness – Part I

Evelyn Pringle June 2, 2010

Over a twenty year span, starting when Prozac came on the market in 1987, the number of people on government disability due to mental illness went from 1.25 million to more than 4 million today. There has been a 35-fold increase in the number of children disabled by mental illness who receive federal disability payments, rising from 16,200 in 1987, to 561,569 in 2007.

These statistics come from a new book titled, “Anatomy of an Epidemic: Magic Bullets, Psychiatric Drugs, and the Astonishing Rise of Mental Illness, in America,” by award winning journalist, Robert Whitaker, who also authored “Mad in America.”

For the book, Whitaker reviewed 50 years of outcomes in the medical literature, for adults with schizophrenia, anxiety, depression, and bipolar illness, and the childhood disorders of ADHD, depression and juvenile bipolar disorder, to see whether medications had altered the long-term course of the disorders and whether drugs could bring on new or more severe psychiatric symptoms.

His intent was to assess whether this paradigm of care increased the risk that a person would become chronically ill, or ill with disabling symptoms, he reports in his “Mad in America” blog, on the Psychology Today website.

“Although we, as a society, believe that psychiatric medications have “revolutionized” the treatment of mental illness, the disability numbers suggest a very different possibility,” he wrote in the April 28, 2010, Huffington Post.

On April 29, 2010, Alternet published an interview with Whitaker by Dr Bruce Levine, with the headline question of, “Are Prozac and Other Psychiatric Drugs Causing the Astonishing Rise of Mental Illness in America?”

The “literature is remarkably consistent in the story it tells,” Whitaker told Levine. “Although psychiatric medications may be effective over the short term, they increase the likelihood that a person will become chronically ill over the long term.”

“In addition, the scientific literature shows that many patients treated for a milder problem will worsen in response to a drug– say have a manic episode after taking an antidepressant — and that can lead to a new and more severe diagnosis like bipolar disorder,” he said. “That is a well-documented iatrogenic pathway that is helping to fuel the increase in the disability numbers.”

During the interview, Whitaker discusses his research on the increase of juvenile bipolar disorder in the US, as an example of how prescribing psychiatric drugs to children can actually cause mental illness.

“When you research the rise of juvenile bipolar illness in this country, you see that it appears in lockstep with the prescribing of stimulants for ADHD and antidepressants for depression,” he reports.

“Prior to the use of those medications, you find that researchers reported that manic-depressive illness, which is what bipolar illness was called at the time, virtually never occurred in prepubertal children,” he explains.

“But once psychiatrists started putting “hyperactive” children on Ritalin, they started to see prepubertal children with manic symptoms,” he reports.

“Same thing happened when psychiatrists started prescribing antidepressants to children and teenagers,” Whitaker says. “A significant percentage had manic or hypomanic reactions to the antidepressants. “

“Thus, we see these two iatrogenic pathways to a juvenile bipolar diagnosis documented in the medical literature,” he states.

The bipolar kids often end up on cocktails of heavy-duty drugs, including antipsychotics such as Zyprexa, Risperdal, Invega, Seroquel, Abilify and Geodon, which cause a host of physical problems and possible cognitive decline over the long term, he told Levine.

“When you add up all this information, you end up documenting a story of how the lives of hundreds of thousands of children in the United States have been destroyed in this way,” Whitaker says.

In fact, he thinks that “the number of children and teenagers that have ended up “bipolar” after being treated with a stimulant or an antidepressant is now well over one million.”

“This is a story of harm done on an unimaginable scale,” he told Levine.

Levine, an author himself of “Surviving America’s Depression Epidemic,” describes “Anatomy of an Epidemic,” as the “most important book on psychiatric treatment in a generation.”

Role of American Psychiatric Association

In 2006, the 38,000 member strong, American Psychiatric Association, received 30% of their funding, or more than $20 million, from the pharmaceutical industry.

This year’s attendees at the group’s annual meeting last month in New Orleans “had to brave 200 protestors chanting “no drugging kids for money” and “no conflicts of interest” to get into the convention hall,” according to Martha Rosenberg’s May 30, 2010 report in OpEd News.

“If there were a take home message at the APA meeting about the blizzard of ADHD, bipolar and personality disorders threatening adults and children, it was don’t wait,” Rosenberg says. “These dangerous conditions, likened to cancer and diabetes, won’t go away.”

“Thanks to genetic advancements, psychiatric disease risks can now be detected and treated before symptoms surface, said presenters, fostering early treatment paradigms that are pretty Brave New World: People being told they have a disease they can’t feel that needs immediate and lifelong treatment at hundreds of dollars a month or their health will suffer,” she reports.

“Preemptive psychiatric drugging is likely the most dangerous idea that has come along since lobotomy,” warns the prolific anti-drugging activist, Vince Boehm.

As far as drugs, there was no star of the show, Rosenberg says. “The Next Big Thing was not a new drug at all but adjunctive therapy also known as adding existing drugs to existing drugs because they don’t work right.”

“Throwing good drugs after bad, popularized with the antipsychotic Abilify,” she explains, “has only been enhanced by a study in the January JAMA that found antidepressants don’t work for mild depression at all.”

“Antipsychotics are also being “enhanced” by adding drugs to offset weight gain and lethargic side effects,” she reports.

“The pharmaco-fraudulence which has taken over psychiatry today is absolutely breathtaking,” says Dr Nathaniel Lehrman, former Clinical Director of Kingsboro Psychiatric Center, Brooklyn NY.

“There is absolutely no rationale for adding antipsychotics to antidepressants in the treatment of depression other than the hope that somehow the patient will feel better when new medication is added when the old is not enough,” he reports.

Lehrman can think of no medication “which is really specific for anything in psychiatry.”

“The effect of all these medications is largely happenstance,” he says. “If something happens to make the patient feel better while taking a particular medication, the latter will be credited.”

Catalog of Mental Disorders

In January 2010, the APA released a draft for the 5th edition of the Diagnostic and Statistical Manual, or DSM-V, also known as the Billing Bible of psychiatry, with the official definitions of normal and abnormal. Criticisms of the revisions and the task force have been non-stop.

In a March, 2010, analysis in Psychiatric Times, Lisa Cosgrove and Harold Bursztajn reported that approximately 68% of the members of the DSM5 task force had financial ties to the pharmaceutical industry, a 2% increase over the task force members of the DSM4 with such ties.

The draft criteria for “Temper Dysregulation Disorder with Dysphoria,” has specifically come under attack as “one of the most dangerous and poorly conceived suggestions for DSM5,” by Dr Allen Frances, who was chairman of the DSM-IV Task Force, in his “DSM5 in Distress” blog on the Psychology Today Website.

“Apparently, the Work Group was trying to correct excessive diagnosis of childhood bipolar disorder—but its suggestion is so poorly written that it could not possibly accomplish this goal and instead would it would create a new monster,” he advises.

“The “diagnosis” would be very common at every age in the general population and would promote a large expansion in the use of antipsychotic medications, with all of the serious attendant risks,” he warns.

“While trying to rescue kids who are now misdiagnosed as bipolar,” Frances says, “it will undoubtedly open the door to the misdiagnosis of normal kids who happen to be temperamental or in difficult family circumstances.”

The syndrome was first called “severe mood dysregulation (SMD),” but the Childhood Disorders Work Group decided to rename it “temper dysregulation with dysphoria (TDD),” because (a) the new name is more descriptive; and (b) the name of DSM diagnoses does not typically include a denotation of severity, according to the group’s report.

In any event, the prescribing of psychiatric drug cocktails will continue no matter what they end up calling the new disorder. If TDD is a form of BD, “first-line treatment would consist of atypical antipsychotic medication and/or mood stabilizers,” the group states in the report. “On the other hand, if TDD is on a continuum with unipolar depressive disorders, anxiety disorders, and ADHD, first-line treatment would consist of serotonergic reuptake inhibitor antidepressants (SSRI’s) and stimulants.”

In a March 8, 2010 article in Skeptic Magazine, Dr John Sorboro warned that the “folks writing the new DSM-V are even considering a new classification of “prodromal” disorders, which means you may qualify for diagnosis of a mental disorder just based on the hunch of your psychiatrist. “

“Psychiatrists get paid for treating mental illness,” he says. “There is a strong motivation for them to look at things they used to attribute to chronic personality, or just life, and see them as psychiatric illness. “

“These changes have nothing to do with any real definitive science or specific tests that can effectively demonstrate who has a disorder,” Sorbora notes. “It’s little more than psychiatry repackaging people with different labels.”

“Who gets what label has a lot more to do with politics and the economics of psychiatry than it does with any true understanding of the developmental or biologic underpinnings of specific behavior let alone whether we choose to see “different” as “disordered,” he points out.

Sorboro says following the money has led many people to seriously question “the motivations of some of psychiatry’s most prolific researchers who shape how people get diagnosed, what disorder label they are given, and what drugs they are prescribed.”

He notes Senator Charles Grassley’s ongoing investigation to determine the full extent of industry fees paid to psychiatric researchers, and that “some of the biggest names in the business have been accused of misconduct.”

The “biggest names in the business,” identified by Grassley thus far, include Harvard University’s Joseph Biederman, Thomas Spencer and Timothy Wilens; Charles Nemeroff and Zachery Stowe from Emory University; Melissa DelBello at the University of Cincinnati; Alan Schatzberg, the president of the American Psychiatric Association from Stanford University; Martin Keller at Brown University; Karen Wagner and A John Rush from the University of Texas; and Fredrick Goodwin, the former host of a radio show called “Infinite Minds,” broadcast for years by National Pubic Radio.

“Among all the problematic suggestions for DSM5, the proposal for a ” Psychosis Risk Syndrome” stands out as the most ill conceived and potentially harmful,” according to Dr Frances, in his “DSM5 in Distress” blog on the Psychology Today Website.

“This is a clearly the prescription for an iatrogenic public health disaster,” he warns.

“The whole concept of early intervention rests on three fundamental pillars- being able to diagnose the right people and then providing them with a treatment that is effective and safe,” he explains. “Psychosis Risk Syndrome” fails badly on all three counts, he warns.

“The false positive rate would be alarming,” he says, “70% to 75% in the most careful studies and likely to be much higher once the diagnosis is official, in general use, and becomes a target for drug companies.”

“Hundreds of thousands of teenagers and young adults (especially, it turns out, those on Medicaid) would receive the unnecessary prescription of atypical antipsychotic drugs,” he warns.

“There is no proof that the atypical antipsychotics prevent psychotic episodes,” he says, “but they do most certainly cause large and rapid weight gains (see the recent FDA warning) and are associated with reduced life expectancy—to say nothing about their high cost, other side effects, and stigma.”

“Imagine the human tragedies that follow the mislabeling of 70% of children as severely mentally ill, who are then exposed to extremely toxic drugs that induce diabetes, cardiovascular disease, and a host of other severe adverse effects,” warned Vera Hassner Sharav, founder and president of the Alliance for Human Research Protection, in a February 10, 2010 Infomail.

Unnecessary Drugging

“We are going to have an epidemic of young adults with yet-to-be-determined neurological problems due to the long term use of psychotropic drugs,” warns Washington DC psychiatrist Dr Joseph Tarantolo, Board Chairperson of the International Center for the Study of Psychiatry and Psychology.

An epidemic is defined as 1% of the population and there will be far more than 1% injured by these drugs, he says.

Every human being is at risk of becoming “psychotic,” he states. “It has been said that in the Nazi Germany concentration camps psychosis was 100%.”

“Once one agrees that something is universal, one is simply trying to describe the human condition, not make a medical diagnosis,” Tarantolo advises.

Dr Stefan Kruszewski, a graduate of Princeton University and Harvard Medical School, has seen many patients who experienced one or more episodes of psychosis from medications, illicit drug withdrawal, acute stress, metabolic conditions, PTSD or other psychiatric diagnoses, “who recovered and did not re-experience problems later in life.”

In his extensive clinical experience with psychotic individuals, “recovery after psychosis has been the “norm,” not the exception,” he says

“More significantly, and somewhat contrary to the prevailing psychiatric professional view,” he notes, “the overwhelming majority of my clients in who I observed this ‘norm’ did NOT require psychiatric medicines to sustain them.”

“And, many of them who were prescribed antipsychotic medications to ‘thwart’ another psychotic episode fared somewhat worse than those who were not prescribed any combination of antipsychotics and mood stabilizers,” he adds.

Dr Thomas Edward Bratter is president and founder of the John Dewey Academy in Massachusetts, a residential, voluntary, educational-treatment school for gifted but self-destructive adolescents. This drug and medicine-free facility uses compassionate psychotherapy.

Most students arrive at the Academy with multi DSM-IV labels to justify prescribing psychotropic poisons and receiving third party payments, Bratter says, and have been “raped by the pejorative psychiatric cartel.”

He calls the “Psychosis Risk Syndrome” criminal because “such a diagnosis ignores the awesome toxic power of a negative self-fulfilling prophesy which maximizes failure by perpetrating the unproven myth of mental illness.”

“There needs to be a class action against those who would endorse this movement,” he says, and Bratter would gladly testify on behalf of children and adolescents who need to be protected from such a toxic and damaging conspiracy.

Toxicology expert, Dr Lawrence Plumlee, is president of the Chemical Sensitivities Disorders Association, and editor of, “The Environmental Physician of the American Academy of Environmental Medicine.”

The Chemical Sensitivity Disorders Association was established to provide information and support to chemically sensitive people; to disseminate information to physicians, scientists and other interested persons; and to encourage research on chemical sensitivity disorders and minimizing hazards to human health.

Plumlee is concerned about the DSM5 proposal by the Somatic Symptom Disorders Work Group, to change the name of the category “Somatic Symptom Disorders,” to “Complex Somatic Symptom Disorder.”

“The new draft DSM manual proposes that chronic fatigue syndrome, fibromyalgia, and multiple chemical sensitivity are “somatiform” disorders requiring psychiatric consultation,” he says. “It’s the same old story of Psychiatry trying to extend its diagnostic labels and drug treatments to new populations.”

This is “an effort by psychiatry to psychiatrize physical illnesses and to try to suppress the complaints of these patients by prescribing psychiatric drugs,” Plumlee says.

“But experience is showing that the psychiatric procedures and drugs are making patients worse,” he advises.

Using psychiatric diagnoses and drugs on diseases of neurotoxicity helps the chemical companies in two ways, he reports. “It fools some people into thinking that poisoned people are crazy, thus getting the poisoners (chemical companies) off the hook,” and two, “it sells more chemicals (psychiatric drugs) to treat those who really need detoxification, not more chemicals in their bodies. “

(Part II of this series with show how tax dollars are being used to fuel the American Epidemic of Mental Illness)

(This series is sponsored by the International Center for the Study of Psychiatry and Psychology http://icspponline.org/index.html)

Filed under: 'ADHD', 2010, antipsychotics, bipolar, Complex Somatic Symptom Disorder, DSM, preemptive drugging, prodome, SSRIs

Tracking the American Epidemic of Mental Illness – Part II

Evelyn Pringle June 7, 2010

Tax dollars are being used to fuel the American epidemic of mental illness by promoting the preemptive drugging of persons supposedly at risk of developing mental disorders, to the great benefit of the pharmaceutical industry.

In March 2010, the US Department of Health & Human Services Substance Abuse & Mental Health Service Administration Center for Mental Health Services announced $16.5 million in funding for “Mental Health Transformation Grants,” one of SAMHSA’s services grant programs.

“In order to complement but not duplicate the efforts of other CMHS programs, FY 2010 funding for MHTG will focus on services for adults with or at-risk for serious mental illnesses,” the agency noted.

Applications were required to implement evidence-based or best practices that would create or expand capacity to address one or more of five Strategic Initiatives, including: “Prevent mental illness through outreach, screening, and early interventions for adults with early signs of mental illness or who are at risk, and promote wellness through holistic treatment approaches.”

An evidence-based practice, or EBP, refers to approaches to prevention or treatment that are validated by some form of documented research evidence. As an example of a practice that could be implemented, SAMHSA listed under “Prevention and Wellness: Early Intervention,” the “Early Detection and Intervention for the Prevention of Psychosis Program (EDIPPP),” along with a link to its website http://www.changemymind.org/.

EDIPPP is a national program replicating the “Portland Identification and Early Referral,” or “PIER,” a treatment research program at the Main Medical Center, in Portland, Maine.

On a webpage for PIER on the Center’s Website, under “Project Overview,” it states: “The goals are to improve outcomes and prevent the onset of the psychotic phase of illnesses like Bipolar Disorder, Major Depression, and Schizophrenia.”

“This is the first program in the United States to identify the entire population of at risk young persons and offer them treatment,” PIER said in a September 26, 2005 press release.

EDIPPP was funded through a $14.4 million million grant for the “National Demonstration of Early Detection, Intervention and Prevention of Psychosis in Adolescents and Young Adults,” from the Robert Wood Johnson Foundation, and is “designed to prevent psychosis in teens and young adults,” according to an April 10, 2007, announcement on RWJF’s launch of the program.

“The national program is expanding PIER’s success during the past seven years in identifying and treating young people experiencing subtle and early symptoms that herald the onset of serious mental illness,” a November 2007 report in Behavioral Healthcare, by Dr James Maier, a research psychiatrist with PIER, notes.

EDIPPP works with people between the ages of 12 and 25, with an average age of persons entering the program between 15 and 16.

“Widespread dissemination of this early intervention model throughout the United States offers tremendous hope and optimism for combating some of the most devastating and costly illnesses that can afflict young people and their families,” Maier claims.

The RWJF grant set up additional EDIPPP sites in Sacramento, California; Salem, Oregon; Ypsilanti, Michigan; and Glen Oaks, New York. A site in Albuquerque, New Mexico was added in 2008.

RWJF also funds a booklet for professionals, on how to prevent mental illness with early detection titled, “Recognizing and Helping Young People at Risk for Psychosis: A Professional’s Guide,” which can be downloaded free off the internet.

From the start, PIER has always been primarily funded by RWJF, according to its website. However, on October 13, 2003, Mental Health Weekly reported that the program had received a $3.9 million grant from the National Institute of Mental Health, and a parallel $2 million grant from the Center for Mental Health Services intended for a related program in early identification of non-psychotic disabilities.

In Portland, young people typically are referred to PIER by high school guidance counselors, pediatricians, or other clinicians who attended presentations about PIER’s work, visited the PIER Website (http://www.preventmentalillness.org), and are familiar with the early warning symptoms that suggest the onset of a psychotic illness, according to the report in Behavioral Healthcare.

Mental Illness According to PIER

In a fact sheet posted to “Dispel the Myths,” the PIER website claims that, “Mental disorders are as easy to diagnose as asthma, diabetes, and cancer.”

“Treatments are effective 60%-80% of the time, success rates that meet or exceed success rates for cutting edge treatment for heart disease,” the sheet states.

“In many cases, PIER does use medications,” the Websites says. “We believe that some of the newer medications effectively improve thinking and combat early symptoms.”

“Research suggests these medications may have a protective effect against changes in the brain that cause mental illness,” it reports.

Under costs, it reads: “For now, services provided by PIER staff are supported by grants. However, if certain medications, medical tests, or neurological assessments are ordered, there will be a charge.”

The PIER program was founded in 2000, by Dr William McFarlane, and after 10 years in operation, on May 28, 2010, the ChangeMyMind website listed only two “case studies and impact stories that illustrate the effectiveness of the Early Detection and Intervention for the Prevention of Psychosis Program.”

Medicated for Life

Virtually every person entering the PIER program is prescribed antipsychotics, such as Risperdal or Invega, marketed by Johnson & Johnson, the parent company of the Robert Wood Johnson Foundation. These prescriptions are off-label because antipsychotics are not FDA approved to “prevent” mental illness in any age group.

An August 2008 article, by Charles Schmidt in Discover Magazine, highlighted the PIER program with a byline that stated: “A new mix of therapy and medication may stave off psychosis among teens at risk.”

Schmidt discussed the case of Camila (not her real name), who entered the program in September 2001, when she was 14. “Camila and her family stuck with PIER for the four-year treatment program, which ended formally in 2005, and still keep in touch with counselors there,” he reports.

However, “Camila’s health still hinges on antipsychotic medication,” Schmidt says. “In the summer of 2007 she went off the drugs for a spell and her strange feelings returned.”

He notes that her reliance on antipsychotics raises issues. “On the one hand, it shows that the threat of psychosis hasn’t really been removed, it’s just been held in check.”

“What we hope is that the benefits of treatment will be lifelong,” McFarlane says in the article. “We don’t have any empirical evidence to support that yet, but what we’ve seen is that young people who still haven’t converted to psychosis after about three years of our treatment don’t seem to be at much risk.”

While he suggests that over time, some patients may be able to go off medications, McFarlane acknowledges that PIER hasn’t developed a plan for managing that process, Schmidt reports.

“As to when or if they can go off medication, that’s hard to say,” he told Schmidt. “I think many of our patients don’t feel a need to stop; they certainly don’t feel oppressed by it. At a certain point it becomes a personal choice.”

A fortune can be made from these life-long antipsychotic customers. In April 2010, the price for one box of Invega, at a middle dose, was $1,373 at DrugStore.com. Risperdal went for $788 per 90 pills. The cost was $1,395 for 100 tablets of Abilify. Seroquel cost $997 per 100. One-hundred capsules of Geodon sold for $918 and Zyprexa cost $1,523 for a hundred 10mg pills.

In 2003, McFarlane told Mental Health Weekly that with about 3% of the population at risk for a serious mental illness, Greater Portland could expect about 75 young people to develop a disorder each year.

RWJF Front Group

The founder of RWJF, Robert Wood Johnson, was chairman of Johnson & Johnson for over 30 years, from 1932 to 1963, as a member of the drug maker’s founding family. Throughout the years, the majority of the Foundation’s money has come from investments in J&J stock. RWJF’s board of trustees has always been stacked with the drug company’s executives. For instance, current and past trustees have held positions at J&J such as President, CEO, Vice President, Chairman of the Board, and Treasurer, and have served along side another family heir on the board, Robert Wood Johnson IV.

RWJF is listed in a Medicaid fraud lawsuit, filed against J&J by whistleblower, Allen Jones, a former federal fraud investigator, and joined by the Texas attorney general, as providing funding for illegal marketing schemes to increase the off-label sales of Risperdal, including funding the development of the “Texas Medication Algorithm Project (TMAP),” which required doctors to prescribe the newest, most expensive antipsychotics, antidepressants, anticonvulsants, and ADHD drugs to patients covered by public programs, like Medicaid and Medicare, who were diagnosed with mental disorders, and a nearly identical set of child drugging guidelines known as the “Texas Children’s Medication Algorithm Project (CMAP).”

In addition to Risperdal and Invega, J&J also markets the ADHD drug Concerta, and Topamax, an anticonvulsant.

A May 11, 2005, report by RWJF on the results of the funding of TMAP grants totaling $2,389,581 to the University of Texas Southwestern Medical Center at Dallas and a grant of $353,747 to the Texas Department of Mental Health and Mental Retardation, describes the supposed “Problem,” that led to the creation of the TMAP drugging guidelines as:

“In the 1980’s and 1990’s, as pharmaceutical companies began producing new and more efficacious medications to treat people with serious mental disorders such as depression, bipolar disorder, and schizophrenia, the question arose of how to choose the most appropriate treatment options. Concerns about wide variation in prescribing practices by physicians and complaints from consumer advocates about the negative consequences of this variation spurred the creation of evidence-based guidelines and medication treatment algorithms.”

The “Contacts” for the grants listed in the report, were Dr A John Rush, for the University, and Dr Steven Shon for the state of Texas. Shon was fired in October 2006, after the Texas attorney general determined that J&J had improperly influenced him to make Risperdal a preferred drug on TMAP. In 2008, Rush was added to a list of psychiatric academics who failed to disclose all the payments they received from drug companies, by Senator Charles Grassley, as part of an investigation conducted on behalf of the US Senate Finance Committee, which oversees Medicaid and Medicare spending.

As a main component of the off-label marketing schemes, the lawsuits against the antipsychotic makers allege that the drug companies “seeded” the medical literature with reports and papers purporting to be written by “experts” when they were actually ghostwritten with the names of experts attached after the fact.

In its report on the TMAP grant results, RWJF boasts that: “More than 50 articles on the Texas Medication Algorithm Project have appeared in the Journal of Clinical Psychiatry, Psychiatry Research, Managed Care, Health Services Research, Journal of the American Academy of Child and Adolescent Psychiatry and other peer-reviewed journals.”

“Over the next two years, Project Directors Rush and Shon and their colleagues plan to publish additional articles on other areas of interest,” the report said.

On August 18, 2008, a Dallas Morning News headline read: “Conflict of interest fears halt children’s mental health project,” in reference to the Children’s Medication Algorithm Project. “A state mental health plan naming the preferred psychiatric drugs for children has been quietly put on hold over fears drug companies may have given researchers consulting contracts, speakers fees or other perks to help get their products on the list,” the News wrote.

To date, four of the five atypical makers have settled fraud charges involving the illegal off-label marketing of antipsychotics, including for use with children. Eli Lilly paid $1.4 billion for Zyprexa, Bristol-Myers Squibb’s fine was $515 million for Abilify, Pfizer paid $301 for Geodon, and AstraZeneca just forked out $520 million for Seroquel.

But the fines are merely chocked up to the cost of doing business. For instance, although AstraZeneca paid a whopping $520 million fine, Seroquel had sales of $4.9 billion in 2009, with more than half coming from the US. Overall, antipsychotics were the top-earning class of drugs in the US, in both 2008 and 2009, with sales of $14.6 billion in 2009, according to IMS Health.

J&J is the only atypical maker that has not settled the off-label marketing charges against it – yet. However, two units of J&J “will pay more than $81 million to resolve criminal and civil claims over illegal promotion of the epilepsy drug Topamax,” according to Bloomberg news on April 29, 2010.

Also, over the past 2 months, J&J’s McNeil division has recalled over 40 varieties of child and baby medications after the FDA found massive safety and manufacturing violations at a plant in Fort Washington, Pennsylvania, including formulations of Tylenol, Motrin, Zyrtec and Benadryl. The FDA also found problems with “strength, quality and purity.”

The FDA’s inspection report notes that J&J received about 46 consumer complaints “regarding foreign materials, black or dark specks [in their drugs] from June 2009 to April 2010.” J&J had knowledge of problems since May 2009, which means it was allowing children and infants to ingest potentially poisonous drugs for a year before the product recall took place.

Time Magazine as Promoter

On June 22, 2009, the RWJF website posted a link to download the full text of an article in Time Magazine, by John Cloud titled, “Staying Sane May Be Easier Than You Think,” who reported: “The most exciting research in mental health today involves not how to treat mental illness but how to prevent it in the first place.”

“In fact,” Cloud said, “many mental illnesses — even those like schizophrenia that have demonstrable genetic origins — can be stopped or at least contained before they start.”

“This isn’t wishful thinking but hard science,” he claimed.

The article discussed a report by the National Academics, “an organization of experts who investigate science for the Federal Government,” nearly two years in the making, “on how to prevent mental, emotional and behavioral disorders.” A quick check found one of the sponsors of the National Academies to be RWJF.

“The report concludes that pre-empting such disorders requires two kinds of interventions,” Cloud said, “first, because genes play so important a role in mental illness, we need to ensure that close relatives (particularly children) of those with mental disorders have access to rigorous screening programs.”

“Second,” he noted, “we must offer treatment to people who have already shown symptoms of illness (say, a tendency to brood and see the world without optimism) but don’t meet the diagnostic criteria for a full-scale mental illness (in this case, depression).”

“Some prevention programs even prescribe psychiatric medications, including antipsychotics and antidepressants, to people who aren’t technically psychotic or depressed,” Time reported.

“This is a big concern,” Joseph Rogers, founder of the Philadelphia-based National Mental Health Consumers’ Self-Help Clearinghouse told Cloud. “Because, gee, if you miss, you can really do more harm with some of these drugs than good.”

“But those who contributed to the National Academies report say preventing the suffering of people with mental illness is worth the risk of some false positives, partly because of the enormous cost of treating mental illness after it’s struck,” Cloud reported.

The article profiled PIER and McFarlane, who was described as “one of the world’s top authorities on preventing mental illness.”

According to Time, the “National Institute of Mental Health is funding a trial of McFarlane’s work, and while he is still writing up his data for publication, his anecdotal results are promising: most of the kids are so far avoiding a first psychotic episode.”

Preemptive Drugging Unsupported

In a 2008 paper titled, Atypical Antipsychotic Agents For the Schizophrenia Prodrome: Not a Clear First Choice,” published in the “International Journal of Risk & Safety in Medicine,” Dr Stefan Kruszewski, a psychiatrist, and Dr Richard Paczynski, a neurologist, both from Harrisburg, Pennsylvania, explain that, “Pharmacologic intervention at the earliest stages of suspected psychotic illness is an intuitively appealing concept and a logical extension of the current approach to many other diseases of the central nervous system.”

“However,” they report, “a critical analysis of the results of structured clinical investigations which have explored the use of ATAPs for new-onset psychotic symptoms raises safety concerns and does not support pre-medication in this setting as a preventive strategy.”

“Over the past several years,” the paper states, “a voice has emerged in the international psychiatric community recommending early prescription of the atypical antipsychotic agents (ATAPs) for adolescents and young adults who appear to show signs consistent with a schizophrenia prodrome. Early use is predicated on the possibility that ATAPs may prevent progression to full-blown psychotic illness in this high-risk population. “

“This trend has been encouraged despite a paucity of data which clearly support the effectiveness of these agents for this indication, and despite evidence of adverse side effects including,” the authors note.

These circumstances prompted their literature review, “focusing on the five published studies that have explicitly addressed the preventative efficacy of the most widely prescribed ATAPs in structured (i.e., non-anecdotal) clinical settings.”

In the summary and conclusion section of the paper, the authors report that the results from the available controlled trials reviewed are in line with several of the conclusions of the naturalistic study by Cornblatt et al. “That is, early prescription of ATAPs to adolescents and young adults seeking medical attention for prodromal psychotic symptoms is associated with high rates of medication non-adherence.”

“Additionally,” they say, “the introduction of ATAPs was not associated with reduction in the rate of conversion to formal psychosis beyond that explainable by chance and/or the introduction of bias secondary to baseline imbalances, inadequate blinding or even differential psychosocial supports.”

“We suggest caution in making any assumptions that justify changes in prescription-writing behavior when it involves patients who are at high risk for developing long-term psychotic illnesses but have never demonstrated sustained psychosis (psychotic illness by DSM-IV criteria),” Kruszewski and Paczynski advise.

“This would include but is not limited to persons with suspected schizophrenia prodrome,” they add.

“Even in the hands of experienced investigators using detailed screening protocols in controlled settings, only one-quarter to one-third of high-risk patients converted to full-blown psychosis,” they report.

“Consequently,” they warn, “if early use of ATAPs continues as a quasi-standard of care for new-onset psychotic symptoms, a large majority of these often young individuals will be exposed unnecessarily to poorly defined but likely substantial risks, including but not limited to obesity, hyperlipidemia, metabolic syndrome, increased rates of type II diabetes mellitus and extrapyramidal syndromes, both acute and chronic.”

“Considerations of safety must come first when the preventative efficacy of these agents remains so poorly defined,” they conclude.

(This series is sponsored by the International Center for the Study of Psychiatry and Psychology http://icspponline.org/index.html)

Filed under: 2010, antipsychotics, drugging children, EDIPPP, front groups, Johnson and Johnson, PIER, preemptive drugging, prodome, RISPERDAL, Robert Wood Johnson Foundation, RWJF, SAMHSA, TMAP

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