Friday, June 30, 2006

Judge: Lawsuit against drug firms can continue - Effexor and Zoloft



Judge: Lawsuit against drug firms can continue



 LINCOLN, Neb. (AP) -- A federal judge has refused to dismiss a lawsuit filed by the parents of an 11-year-old boy who committed suicide after taking antidepressant medications.

David and Debra Jackson of Omaha allege their son Jacob's 2002 hanging death was the result of side effects from the antidepressant drugs Zoloft and Effexor.

The lawsuit alleges that Pfizer Inc., the maker of Zoloft, and Wyeth Pharmaceuticals, which manufactures Effexor, failed to adequately test, evaluate and study the pediatric effects of Zoloft before marketing it to the public.

The lawsuit, filed by attorney Andrew Hilger, said Jacob began taking Zoloft on Sept. 9, 2002, on a doctor's recommendation.

Jacob's behavior worsened to include intensified agitation and suicidal desires, the lawsuit said.

Jacob's Zoloft dosage was increased three times between Sept. 17 and Oct. 2 on the recommendations of three doctors, the lawsuit said. On or about Oct. 8, one of the doctors advised a gradual decrease of the Zoloft dosage and prescribed the drug Effexor, the lawsuit said.

Two days later, Jacob was found dead in his parents' basement.

Hilger argued that Nebraska common law requires additional warnings than those given by the FDA relating to the risk of suicide.

U.S. District Judge Joseph Bataillon rejected arguments by lawyers for the drug companies that state law cannot pre-empt FDA regulations.

"Federal labeling laws are minimum standards; they do not necessarily shield manufacturers from state law liability," he said. "The primary purpose of ... the FDA's regulatory scheme is to protect the public. State-law protections reinforce and enhance this objective.

"Defendant's pre-emption argument ultimately fails because Congress has not expressed a specific intent to pre-empt state consumer-protection laws in the area of prescription-drug labeling," Bataillon said. "In the absence of Congress's express statement, defendant must overcome the presumption against implying congressional pre-emptive intent. It has not done so."

Troy Couple Addresses Congress On Drug Safety

Troy Couple Addresses Congress On Drug Safety

POSTED: 3:54 pm EDT June 29, 2006

WASHINGTON, D.C. -- A Troy couple is making a personal plea to Congress to stop the drug industry from hiding important safety information. It is a move that they said could have saved their son’s life.

Daniel and Cathy Harter told Congressional leaders on Capitol Hill that if they had known what they know now about Paxil, their son Steven might still be alive.

Cathy Harter is on a personal crusade to change drug safety guidelines before another life is lost. Harter, along with other families and several representatives Thursday called for hearings on bi-partisan drug safety legislation that has been stalled in Congress.

Cathy blames the Federal Drug Administration and pharmaceutical companies for not revealing the findings of critical side effect studies. Cathy said her 19-year-old son started taking Paxil on Sept. 14, 2004 for anxiety. She said 12 days later she noticed drastic changes in his mood.

She said he was upset and crying. She said she was worried and that this was not like him. Cathy said an hour later, her son was found dead in the family garage. He had committed suicide.

According to Cathy, two weeks after her son’s funeral, the “FDA directed the manufacturers of all antidepressant medications to add a black box warning that describes the increased risk of suicide in children and adolescents.”

The FDA released the following warning. It called for special black box labels on certain antidepressants, like the one Steven took. Studies had indicated that certain drugs caused increased suicidal thoughts in children and adolescents.

The FDA did not respond to requests by NewsCenter 7 for the most recent changes in safety guidelines for antidepressants.

Copyright 2006 by All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Thursday, June 29, 2006

Congressional Members Join Victims Harmed by Prescription Drugs to Protest FDA's Safety Record on Eve of its 100th Anniversary


Congressional Members Join Victims Harmed by Prescription Drugs to Protest FDA's Safety Record on Eve of its 100th Anniversary   Washington, D.C.,  20515   June 28 2006   June 30, 2006 marks the Food and Drug Administration's (FDA's) 100th anniversary. In its press announcement, FDA boasts that it is the "oldest U.S. consumer protection office" providing "Americans with increasingly comprehensive, science-based protections that ensure the highest quality of products essential for health and survival."

Capitol Hill Press Conference - June 29, 2006, 12:30 PM Room 121 of the Cannon House Office Building

Victims of prescription drug-induced injuries disagree with the FDA's characterization of itself and will gather on Capitol Hill, along with Consumer's Union (publisher of Consumer Reports) on Thursday, June 29, 2006 to address FDA's drug safety failures and to urge Congress to pass stalled drug safety measures such as the public registry of drug trials; post-market safety monitoring and enforcement; and limiting new drug advertising and marketing. (See Consumer's Union: Prescription for Change Media Advisory, attached.) Congressional Representatives from Connecticut, Minnesota, New York and Massachusetts will join Consumer's Union and the victims at a 12:30 p.m. press conference in Room 121 of the Cannon House Office Building.

Baum Hedlund client, Kim Witczak, to attend

Prescription Drug safety activist, Kim Witczak, whose husband committed suicide while taking an SSRI antidepressant, is one of the victims who will be telling her story in order to illustrate the real consequences of the FDA's failures and how devastating these failures can be. Her story was featured in the November 2005 issue of Fortune Magazine and was covered in an I-Team feature on WCCO TV in Minneapolis. She has been on NPR regarding drug advertising and has been quoted in a number of news reports on drug safety issues. Ms. Witczak has a website devoted to her husband's memory and raising awareness about the risks of antidepressants and related drug-safety issues:

Wednesday, June 28, 2006

More children dying in foster care, comptroller says

More children dying in foster care, comptroller says

Strayhorn says governor's office is blocking her attempts to investigate foster system

Saturday, June 24, 2006

The number of children who died in the Texas foster care system increased dramatically in the past two years, from 30 in 2003 to 48 in 2005, state Comptroller Carole Keeton Strayhorn said Friday.

Joined by members of advocacy groups, Strayhorn told reporters that Gov. Rick Perry's administration has stonewalled her attempts to gather data that she needs to complete her investigation.

But Perry's camp said the claims by Strayhorn, who is challenging Perry in the November gubernatorial election, ignore legislation passed in 2005, well into her investigation, that calls for comprehensive reform of Child Protective Services. And state officials cited confidentiality concerns about releasing the data.

"With her support evaporating, her poll numbers dropping and her campaign stagnating, Carole Strayhorn seems desperate to change the subject and is sadly not above exploiting child tragedies to do it," said Robert Black, a Perry re-election campaign spokesman.

Mental Health, Education and Social Control

Part 32
By Dennis L. Cuddy, Ph.D.
June 26, 2006

In previous Parts of this series, I have referred to the TeenScreen program regarding mental health. On the TeenScreen website, one reads that "The Columbia University TeenScreen Program is committed to making the mental health of our youth a national priority and offering all parents the opportunity to have their teenagers receive a voluntary mental health screening....Today, the TeenScreen Program is active in more than 400 communities throughout the country." Thus far, TeenScreen has been administered to more than 150,000 children in 42 states and the District of Columbia.

Relevant to TeenScreen's past use of parents' "passive consent," Ken Kramer recently revealed that "newly obtained documents detail a milestone in the fight against TeenScreen. TeenScreen has been using 'passive consent' to bypass parents. If a parent did not return the passive consent form to the school, then TeenScreen considered that the parent consented. What about a child who loses the form or a parent who forgets? They consented!" To show that "passive" rather than "active" or written consent has been used to increase the number of students participating in the program, here is a
link to a letter from a Florida high school.

Concerning education, American teachers over the last half century have been transformed into "social engineers." In the May 1949 edition of PROGRESSIVE EDUCATION, American Education Fellowship president Kenneth Benne stated that "teachers and school administrators (should) come to see themselves as social engineers. They must equip themselves as 'change agents'." And four years later, Arthur C. Clarke in CHILDHOOD'S END (published in 1953, and described by THE NEW YORK TIMES as "a first-rate tour de force") wrote: "Fifty years is ample time in which to change a world and its people almost beyond recognition. All that is required for the task is a sound knowledge of social engineering, a clear sight of the intended goal---and power."

Stop shocking children in New York petition

Please sign petition to stop electrocuting children under the guise of treatment.



Yes, they still shock people's heads and call it treatment.


Yes in the state of New York they still shock children's heads and call it treatment.


ECT (Electro-Convulsive Therapy) is used on religious and political dissidents in China, Cuba and Turkey as punishment and to get people to renounce their faith or viewpoints.


ECT is the last treatment in psychiatry's bag of tricks. It is great to cover up drug reactions and other treatment failures. It is so traumatic that few will even come forward to tell their story. It is also used to cover up rape and other abuse. With today's laws if you do not sue within two years then you cannot sue in the USA (except under certain conditions) and most people who experience ECT are not functional for about that long. It's the perfect crime cover-upper.


There are no long term benefits to ECT but there are many permanent disabilities from it's use. 

Vision Problems, Weakness on either side of body, Blood pressure, Seizures, Headaches,

Memory Loss, Lack of Balance, Heart problems, Chest pains, Nausea, Panic Attacks,

Insomnia, Shakes, tremors, Mental ability deminished



Tuesday, June 27, 2006

Drug Profits, Fraud and Death

June 26, 2006

Drug Profits, Fraud and Death

Big Pharma's Big Graveyard


Over the past six years, ten FDA approved drugs have been withdrawn from the market due to deaths and injuries, leading lawmakers to accuse the FDA of not doing its job in protecting the public from unsafe drugs and to call for measures of improvement.

On June 20, 2006, the New York Times reported that "two influential senators are expected within weeks to introduce a legislative proposal that could drastically change how drugs are tested and approved in the United States."

The Senators behind the proposal are Michael Enzi (R-Wy), chairman of the Health, Education, Labor and Pensions Committee, and Ted Kennedy (D-MA), the ranking Democrat on the committee.

"In broad terms," the Times article by Gardner Harris explains, "the bill would require that drug makers disclose the results of all large human tests of their drugs, known as Phase 3 and Phase 4 trials; create a detailed risk management plan to uncover and control any safety problems that arise after a drug is approved; and pay penalties if they fail to follow through with this plan, according to four experts who were briefed on the proposals."

However, while lawmakers search for ways to ensure that Big Pharma does not continue to conceal adverse reactions that surface during drug trials and to sever the ties between the nation's public health officials and Big Pharma, the Bush administration continues to promote their cozy relationships and help drug companies escape accountability for misconduct.

The best example of the administration's efforts to protect Big Pharma was revealed recently when the FDA announced a preemption rule that would disallow lawsuits in state court against drug makers if a drug has been approved by the FDA.

"We think that if your company complies with the FDA processes, if you bring forward the benefits and risks of your drug, and let your information be judged through a process with highly trained scientists, you should not be second-guessed by state courts that don't have the same scientific knowledge," said FDA deputy commissioner on medical and scientific affairs, Scott Gottlieb.

But in all fairness, the FDA is certainly not the only public health agency in bed with Big Pharma. Nobody can deny the fact that Big Pharma is an equal opportunity corrupter. Its obvious that drug companies have infiltrated every Federal regulatory agency in the US.


Friday, June 23, 2006

"Mental health screening is totally bogus"

Times Herald (Vallego-Bencia-American Canyon, Ca)
Thursday, June 22
By Times-Herald readers

'Critical issue' response
Leslie McGuire ("A critical issue," June 9) makes teenage suicide sound like a problem of magnitude by naming some numbers and omitting other numbers. A very, very small percentage of teens take their lives. The third leading cause is so small as to be insignificant as a number. The event is a tragedy and for the most part it can be avoided.

The fact is the majority of teenagers who do take their lives are on psychotropic drugs. The FDA has warned us of these consequences. Additionally, McGuire fails to mention that TeenScreen was developed by a psychiatrist who was paid by pharmaceutical companies. Do you think the pharmaceutical companies are out to prevent suicide? The only recommendation for teens that get screened is to see someone who can prescribe the very pharmaceuticals that cause depression and suicidal behavior.

If these people really wanted to help prevent teenagers from getting killed, why don't they pony up to the No. 1 and No. 2 killers of teens and save more lives?

The answer: There's no money in it.

Garrison Clarke, Altadena, Calif.

* * * *
Suicide is something everyone would like a solution for. However, it is not an epidemic. In fact, it is very rare. Of all the many other solutions that may be out there, mental health screening is the worst. It usually leads to more people being put on dangerous mind-altering psychiatric drugs. Money should be raised for other more important issues, like illiteracy.

Mental health screening is totally bogus; we will never get anywhere with it. Just research the facts about psychiatric drugs and their relation to mental health screening. And then take a look at their results. No workability. In fact, the usual "solution," psychiatric drugs, have been known to cause suicide in young adults, which was why the FDA issued the black box warning label.

With mental health screening being "the" solution, I'm afraid we would just be digging ourselves deeper into the hole.

Elizabeth Hallquist, Weston, Conn.

Groups protest medicating, labeling of kids

New Haven Register
Groups protest medicating, labeling of kids
Marissa Yaremich , Register Staff

WEST HAVEN — The hot sun blistering down on their black T-shirts, a collective of parents and Scientologist fared Thursday’s scorching weather to send a message to the psychiatry world and to any parent walking into the "Children’s Behavioral Health Expo" at Savin Rock Conference Center. "Don’t label our kids. Don’t drug our kids. Leave our kids alone!" rallied the protestors.
Led by the Citizens Commission on Human Rights of Connecticut, Inc., more than 40 members of parents’ rights and watchdog groups from Connecticut, New York, Massachusetts and Rhode Island repeatedly paced the sidewalk outside the Rock Street facility, waving homemade placards that decried the alleged fraudulent psychiatric labeling and medicinal "drugging" of children.

"We’re opposed to any organization, group or individual that promotes psychiatric labeling and drugs," said Noelle Talevi, spokesperson for CCHR.

Thursday, June 22, 2006

STAR*D Wars Study Failure on Antidepressants

June 18, 2006 at 13:17:35   
STAR*D Wars Study Failure on Antidepressants
by Bruce E Levine 
On March 23, 2006, STAR*D results were major news, front page in the Washington Post. STAR*D, the official acronym for Sequenced Treatment Alternatives to Relieve Depression, was a two-step antidepressant treatment study funded by the National Institute of Mental Health (NIMH), costing U.S. taxpayers $35 million. The NIMH proclaimed that STAR*D showed that ?50 percent of people with depression can get better within the two treatment steps using this approach?; and STAR*D researchers declared, ?A 50 percent remission rate is extraordinarily good, given the nature of these disorders.? The Associated Press and much of the media simply echoed the enthusiasm of NIMH and STAR*D researchers.
But did -- in a scientific sense -- STAR*D treatment work at all? While the Washington Post did point out that STAR*D reveals, ?Antidepressants fail to cure the symptoms of major depression in half of all patients with the disease even if they receive the best possible care,? the following went unreported by all major media outlets:
For STAR*D, NIMH hired researchers with extensive financial ties to the pharmaceutical companies that manufacture the antidepressants that were studied.
STAR*D?s scientific methodology were astonishingly substandard, especially its failure to include a placebo control group. In other antidepressant studies, patients treated with sugar-pill placebos have done as well or better than STAR*D results.

Drugging Children, A Cruel Sign of The Times

Drugging Children, A Cruel Sign of The Times

by Dr. W. Gifford Jones
Wednesday, June 21, 2006
Would I allow Ritalin or other similar drugs to be prescribed to my children because they fidgeted, squirmed in their seat or were inattentive? Hell would freeze over a thousand times before I’d submit to such idiocy. But today an estimated five million Canadian and U.S. children are prescribed medication for this condition.

This year, a committee of the U.S. Food and Drug Administration (FDA) concluded that a "black box" warning should be placed on ADHD medications, warning about heart attack and other risks. It’s the strongest warning possible before a drug is removed from the market. A second advisory panel disagreed so no decision has been reached.

Why the need for a black box warning? It depends on who is giving the opinion. For instance, a report from the Mayo Clinic agrees that ADHD medications can cause heart attack, stroke, hypertension, heart palpitations, an irregular heart beat, psychosis, mania, aggressive behaviour and hallucinations. Some deaths have also been linked to these drugs. This should scare the hell out of any parent. But Mayo claims the risks are small and benefits outweigh these potential problems.

Others, such as Dr. Peter R. Breggin, a renowned researcher in this field, says doctors have become "oblivious to the fact these drugs cause manic and schizophrenic-like disorders." He cites a Canadian study in which a staggering nine per cent of children on this medication developed psychotic symptoms.

He argues that when children on ADHD medication become paranoid and have delusions they’re diagnosed with schizophrenia or bipolar disorder. Rather than working them off the drug they are prescribed more drugs to treat these problems.

Dr. Colleen Clements, a psychiatrist at the University of Rochester, in Rochester, N.Y., writes in The Medical Post that ADHD is a disease with "dubious scientific merit". She worries that "long term psychoactive medication does not allow the developmental process to continue normally and children may be causally put in this illness category with the implied degrading of their normality and worth."

Tuesday, June 20, 2006

Study Sees No Gain in Using Antidepressant to Treat Anorexia

The New York Times
June 14, 2006 Wednesday 
Study Sees No Gain in Using Antidepressant to Treat Anorexia

One of the most widely used treatments for the eating disorder anorexia nervosa, the antidepressant Prozac, works no better than dummy pills in preventing recurrence in young women who have recovered from it, researchers are reporting today.

The study, the most rigorous to date to test the use of medication for anorexia, should alter treatment for an illness that is often devastatingly chronic and that has a higher mortality than any other psychiatric disorder, experts said. Fewer than a third of the study's participants, who also received regular psychotherapy, remained healthy for a year or more, whether they received drug treatment or not, the study found.

Fish oil better for hyperactive children,5936,19538091%5E2682,00.html
Fish oil better for hyperactive children
FISH oils may be a more effective treatment than stimulant drugs for children with attention deficit hyperactivity disorder, the findings of a University of South Australia study show.
The largest clinic-based study of its kind involved 132 children aged seven to 12 with ADHD-related symptoms.
Preliminary findings were released last year, but official findings were unveiled yesterday.
Natalie Sinn, who led the study, yesterday said the results showed Omega-3 fish oils improved the brainpower and concentration spans of hyperactive children, without the side-effects of Ritalin, commonly used to treat the disorder.
Ritalin has been linked to heart problems, hallucinations and aggressive behaviour.
The children were divided into three groups. One group took a daily dose of Omega-3 fish oil, the second group had the same dose plus a multi-vitamin mineral capsule, and the third took placebo capsules.
After 15 weeks, 30-40 per cent of the children in the two groups who took fish oils showed significant improvement in hyperactivity and concentration levels compared to the placebo group.
FAIR USE NOTICE: This may contain copyrighted material. Such material is made available for educational purposes, to advance understanding of human rights, democracy, scientific, moral, ethical, and social justice issues, etc. This constitutes a 'fair use' of any such copyrighted material as provided for in Title 17 U.S.C. section 107 of the US Copyright Law. This material is distributed without profit.

Blunt acts against abuse of mentally ill

Blunt acts against abuse of mentally ill

Gov. Matt Blunt has ordered the Department of Mental Health to immediately call
in the Missouri Highway Patrol whenever any mentally retarded or mentally ill
residents die or are suspected of being assaulted inside private and state-run

Blunt's directive is just one part of a temporary plan to address statewide
abuse and neglect that the department has neglected to adequately address.

Blunt said he made the move Friday to create "a new level of protection and

Besides calling in the Highway Patrol, Blunt's mandate requires the Department
of Mental Health to:

Notify and allow the state Department of Health and Senior Services to help
investigate all cases of abuse and neglect for the next 60 days.

Report every death of a child to the Department of Social Services' State
Technical Assistance Team, which will investigate the deaths for 60 days.

Ensure that the Mental Health Department has a representative participating in
every Child Fatality Review Panel evaluation of deaths of children.

Propose an administrative rule change that will mandate that all deaths inside
state-run and private facilities for the mentally retarded and mentally ill be
reported to a coroner or medical examiner.

Bob Bax, spokesman for the Mental Health Department, issued a statement Monday
to say that the department is grateful for the help.

"The involvement of outside agencies brings expertise to the process and
provides another check on the investigation system that we welcome," he said.
"These steps offer consumers and their families reassurance that these critical
issues are being appropriately addressed."

Roy Washington said it was about time the state got serious about senseless
deaths inside the center. His nephew, George Holmes, died Aug. 4, 2004 - just
hours after Holmes called his stepmother to say he was being beaten by staff at
the Bellefontaine Habilitation Center.

Washington, Holmes' guardian, had to repeatedly demand that his nephew's body
be sent to a medical examiner. He and his wife, Martha, still believe Holmes
was beaten to death, but St. Louis County Medical Examiner Mary Case ruled that
Holmes died of heart failure caused by "extreme agitation." Washington said he
has not heard anything from the Bellefontaine Neighbors Police Department,
which shut the case after Case made her ruling.

"It's a relief that they are finally beginning to look into the system,"
Washington said. "Before it was just hush-hush - everybody scratching each
other's backs."

Monday, June 19, 2006

Zyprexa article by Leonard Roy Frank

This article, with several minor changes, appeared in the August 2005 issue (pp. 7, 19) of Street Spirit, edited by Terry Messman (e-mail address: tmessman (at) Street Spirit, a publication of the American Friends Service Committee, is located at 1515 Webster St., Suite 303, Oakland, CA 94612 (website:



Leonard Roy Frank (


  WARNING: Extreme caution should be exercised in deciding whether or not to take Zyprexa, a psychiatric drug that carries a high risk of weight gain, obesity, diabetes, other diseases, brain damage, and death.


  WARNING: Trying to withdraw from Zyprexa can cause serious and even life-threatening psychological and physical reactions. It is dangerous to start taking Zyprexa; it is also dangerous to stop taking this drug suddenly. Withdrawing from Zyprexa should always be done gradually and, if possible, under medical supervision.


  On June 8, 2005, Eli Lilly & Co. announced that it had agreed to pay $690 million to settle some 8,000 lawsuits filed by people who reported that taking Zyprexa resulted in unwanted weight gain, diabetes, other metabolic diseases, and death.


  Zyprexa, Eli Lilly’s top-selling drug, is used in the treatment of schizophrenia and in the “short-term treatment of acute manic episodes associated with bipolar disorder.”


  More than 2,500 other claimants refused to participate in the settlement presumably in the belief that the amount received by each claimant after legal-cost deductions, $62,500 on average, was insufficient compensation for the pain and suffering Zyprexa caused them.


  On July 21, Eli Lilly came out with its second-quarter financial report showing that $1.07 billion was allocated to cover its liabilities in these lawsuits. That amount exceeded the $690 million settlement by $380 million. The additional sum was the company’s estimate of its liability and defense costs for the unsettled claims. (, July 21, 2005)


  News of the settlement may generate more damage claims in which event the cost to Eli Lilly may be greater than the $1.07 billion already set aside.


  According to Eli Lilly, about 17 million people in 86 countries have taken Zyprexa since its introduction in 1996. Although there’s no way of accurately estimating the number of Zyprexa’s victims, it’s safe to say that this drug has caused diabetes and other diseases in millions of people among whom tens of thousands have died or will die prematurely.


  Despite these facts, the media has paid scant attention to the settlement. Despite these facts, there hasn’t been a single voice of outrage, or even protest, heard in the halls of Congress or on the evening news. And despite these facts, Eli Lilly has made no special effort to warn the public of the potentially disastrous consequences of taking Zyprexa as it continues to rake in profits from the sale of this drug.


  Zyprexa, whose generic name is olanzapine, falls into a class of psychiatric drugs known as atypical antipsychotics. Others in this class are Novartis’s Clozaril (clozapine), Janssen’s Risperdal (risperidone), AstraZeneca’s Seroquel (quetiapine), Bristol-Myers Squibb’s Abilify (aripiprazole), and Pfizer’s Geodon (ziprasidone).


  The first atypical, Clozaril, came on the market in 1990. The manufacturers hailed these drugs as more effective and safer than the conventional antipsychotics such as Thorazine (chlorpromazine), Haldol (haloperidol), and Navane (thiothixene), which have been available since the 1950s.


  Following expensive marketing and promotional campaigns undertaken by the manufacturers of the atypicals, belief in their unsubstantiated claims became widespread with the result that the companies were able to charge much more for the newer drugs than were being charged for the older ones. Today, for example, a month’s supply of Zyprexa costs about $380, 10-30 times more expensive than a month’s supply of a conventional antipsychotic.


  Total worldwide sales for the antipsychotics have grown from less than $500 million in 1993 (almost all conventional antipsychotics) to more than $14 billion in 2004 (all but $1 billion of which came from atypical antipsychotics).


  For more than 10 years the drug companies have consistently downplayed some of the serious risks associated with taking atypical antipsychotic drugs. Psychiatrist E. Fuller Torrey, a leading proponent of drug therapy for schizophrenics, has written about one of the techniques used to mislead physicians and the public: “Psychiatrists trying to evaluate schizophrenia drugs are not told that the expert who minimizes the side effects of Zyprexa receives a $10,000 retainer from Eli Lilly and also owns substantial company stock.” (American Prospect, July 15, 2002)


  Faced with the mounting evidence of their harmfulness, the Food and Drug Administration (FDA) finally required, in 2003, all manufacturers of the atypicals to place on their labels a warning about the increased risk of diabetes for users of these drugs.


  Hersh and Hersh, a San Francisco law firm representing some 400 of the claimants in the recent settlement, charged that Eli Lilly “fraudulently withheld relevant information from potential users of Zyprexa” before 2003. Eli Lilly, went the charge, failed to warn doctors and patients that Zyprexa carried terrible and potentially lethal risks from weight gain and diabetes, which the company knew.


  Such warnings might have led doctors to lower dosage levels in prescribing Zyprexa and to regularly test the blood-sugar levels of their Zyprexa patients. They might even have caused some doctors to stop prescribing the drug.


  With these precautions, there would undoubtedly 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. Telling the truth about Zyprexa 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.


  The drug is of paramount importance to Eli Lilly’s bottom line. The company seems to have developed a Zyprexa addiction, from which withdrawal will be difficult.


  Eli Lilly has also realized indirect profits from Zyprexa sales. It’s a cruel irony 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, with Humulin and Humalog each expected to top $1 billion in annual revenues. Eli Lilly gets the customer coming and going.


  Potential and current users of the drug, doctors, and the public are still almost totally in the dark about Zyprexa's shameful history.


  Based on the results of a six-week clinical trial sponsored by Eli Lilly, the FDA granted the company permission to manufacture and distribute Zyprexa on September 27, 1996. The trial involved 2,500 subjects, and two-thirds of them didn’t even successfully complete the trial. Among those who stuck it out, 22 percent of the Zyprexa subjects suffered a “serious” adverse effect, compared to 18 percent in the group taking Haldol.


  The FDA reviewers found there was an average weight gain of almost one pound a week during the six-week trial period and 26 pounds over a year-long period for the Zyprexa subjects who remained for the extension trial. Other drug effects included shaking, spasms, sedation, diabetic complications, rapid heartbeat, restlessness, constipation, seizures, liver problems, white blood-cell disorders, and decreased blood pressure.


  In addition, there were 20 deaths, including 12 suicides, in the Zyprexa group. Shockingly, these deaths went unreported in the scientific literature. The death cover-ups also took place in reporting trial results of several other atypicals during the 1990s.


  Information concerning these deaths was obtained from FDA documents through the Freedom of Information Act by science writer Robert Whitaker, who wrote that one in every 145 subjects who entered the trials for Zyprexa, Risperdal, Seroquel, and Serdolect had died. (See Mad in America: Bad Science, Bad Medicine, and the Enduring Mistreatment of the Mentally Ill, by Robert Whitaker)


  Bearing in mind these deaths, which occurred during very short trial periods, the FDA’s approval of three of the four atypicals cited above (Serdolect was unapproved) is appalling. It not only condemns the agency’s approval process but raises doubts about the agency’s political independence.


  In the case of Zyprexa, Eli Lilly’s ties to the two Bush administrations are a matter of public record. President George H. W. Bush is a former member of Eli Lilly’s board of directors. In 2000, Eli Lilly made campaign contributions of $1.6 million, 82 percent of which went to President George W. Bush and other Republicans. In 2001, President Bush appointed Mitch Daniel, a former Eli Lilly vice president, to be White House director of the Office of Management and Budget. And in 2002, President Bush appointed Sidney Taurel, Eli Lilly’s current chairman and CEO, to the Homeland Security Council.


  The failure to report the deaths in the reviews of FDA atypical trials published in the professional literature, which psychiatrists and other doctors rely on for guidance in their prescription practices, unmasks the duplicity of the companies involved, the psychiatrists who collaborated with them by writing the articles, and the journal editors who accepted their articles for publication.  


  In recent years some reports of death from the atypicals have appeared in the media, most often one-shot affairs in a few newspapers with little or no follow-up. These deaths were usually associated with weight gain and/or diabetes.


   For example, in February 2001, Frank Olenick, a Winterville, Ohio, truck driver, died after going into a diabetic coma at age 40. His widow Christine Olenick’s lawsuit against Eli Lilly said that he began taking Zyprexa to treat depression and withdrawal symptoms from a painkiller prescribed for a job-related injury.


  Two months later, she rushed her sick husband to a hospital, where a nurse told her his blood-sugar level was 15 times higher than normal, although he hadn’t had diabetes. Mrs. Olenick said he went into a coma an hour later and died. (Indianapolis Star, March 16, 2003)


  In another case, Rob Liversidge, 39, of Silver Spring, Maryland, gained more than 100 pounds while taking Zyprexa for manic-depression. Health problems related to this weight gain ended his government career. A week before he was to start a new job following a long layoff, Mr. Liversidge collapsed and was taken to a hospital where, despite emergency treatment, he went into a coma and died four days later. (Baltimore Sun, March 19, 2003


  Those two cases made it to the newspapers. But the large majority of complications and deaths from Zyprexa are hidden from public view and may not even be recognized as such. An exception was P. Murali Doraiswamy’s review of complications among Zyprexa users voluntarily reported to the FDA over a six-year period.


  Doraiswamy, the chief of biological psychiatry at Duke University, wrote, “Of the 289 cases of diabetes linked to the use of [Zyprexa], 225 were newly diagnosed cases. One hundred patients developed ketosis (a serious complication of diabetes), and 22 people developed pancreatitis, or inflammation of the pancreas, which is a life-threatening condition. There were 23 deaths, including that of a 15-year-old adolescent who died of necrotizing pancreatitis, a condition where the pancreas breaks down and dies. Most cases (71 percent) occurred within six months of starting the drug and many cases were associated with moderate weight gain.” (Pharmacotherapy, July 2002)


  There is also an added risk of death for elderly people with dementia taking Zyprexa and other atypicals. In early 2005 the FDA analyzed the results of 17 placebo-controlled trials involving the atypicals, including Zyprexa. The agency found that older patients with dementia who were given the pills were 1.6 to 1.7 times more likely to die, mostly from heart-related problems like heart failure or infections like pneumonia, as those given placebos.


  Based on this review, the FDA now requires the makers of these drugs to place black-box warnings for elderly patients with dementia on labels for the atypicals. Black-box warnings are reserved for drugs posing the greatest health risks. (New York Times, April 12, 2005)


  But there is no black-box warning for children and adolescents being prescribed Zyprexa, and doctors apparently are prescribing the drug to growing numbers of youngsters. The drug has not been FDA-approved for any childhood condition, but doctors have been prescribing Zyprexa and other atypicals for autism, attention deficit disorder, hyperactivity, withdrawal, and aggression. Children in foster homes are especially vulnerable to this kind of abuse.


  Weight gain may be the most troubling effect of Zyprexa because it, in turn, causes many other problems. The weight-gain issue should not be minimized as was done by Dr. Alan Breier, Eli Lilly’s vice president of pharmaceutical sales and head of the Zyprexa product team who told the Indianapolis Star on April 16, 2003 that Zyprexa, like some of the other antipsychotic drugs, causes weight gain in about half of all users. Excessive weight gain would have been a more accurate way of putting it. Practically everyone taking Zyprexa gains at least some weight attributable to the drug.


  Breier also said that while weight gain is a risk factor for diabetes, it doesn’t of itself necessarily lead to diabetes. Sure, and smoking doesn’t of itself necessarily lead to lung cancer.


  Extreme weight gain can result in obesity, which in recent years has reached near-epidemic proportions in the United States. Obesity further increases the risk of diabetes. There are now 18 million diabetics in this country. With more than half a million current users, Zyprexa is worsening an already critical situation.


  The obesity problem is illustrated in the following excerpt from Sharon Begley’s Newsweek article on March 11, 2002, in some ways favorable to the atypicals, which broadly describes their effects:


  “Although the voices and visions don’t always disappear, the new drugs [i.e. the atypicals] can allow people with schizophrenia to hold jobs and have families. Still, they increase appetite, and may alter metabolism, resulting in what [Richard Wyatt, chief of neuropsychiatry at the National Institute of Mental Health] calls ‘the enormous problem’ of huge weight gain. [Donna Willey, a patient interviewed for the article] gains 20 pounds a year on Zyprexa, and has ballooned from 120 pounds to her current 280. That makes some reluctant to take the drugs. Another side effect is foggy thinking, the feeling that brain signals are trying to push through caramel. Patients may also lose their libido. For all the power of the new drugs, they are treatment and not cure.”


  Lives diminished, lives shortened, lives destroyed! All this misery and suffering, for what advantage? One review of 52 studies involving 12,649 patients concluded, “There is no clear evidence that the atypical antipsychotics are more effective or better tolerated than conventional antipsychotics.” (John Geddes et al., British Journal of Psychiatry, December 2000)


  Eli Lilly executives, however, take no responsibility for the harm they’ve caused. They’ve made no apology. There’s been no contrition. There’s only been denial.


  Eli Lilly’s CEO Sidney Taurel has said of the legal settlement, “While we believe the claims are without merit, we took this difficult step because we believe it is in the best interest of the company, the patients who depend on this medication, and their doctors. We wanted to reduce significant uncertainties involved in litigating such complex cases.”


  These were not off-the-cuff remarks: they were included in Eli Lilly’s press release on the settlement. Such a response would be laughable were the issues less serious for the public and for Eli Lilly shareholders. One can only imagine what these shareholders think about a chief executive who authorized the payment of $690 million in damages for claims that were, in his opinion, “without merit.”


  But given Zyprexa’s profitability, Eli Lilly shareholders have little to complain about. The expense is just a cost of doing business. And besides, what’s a charge of $690 million, or even $1.07 billion, against profits of many billions that Eli Lilly has made from Zyprexa since its introduction nine years ago, to say nothing of the future profits it can be expected to earn?


  How have recent developments in the legal arena affected Zyprexa sales and the price of Eli Lilly’s stock? Worldwide Zyprexa sales fell 10 percent in the second quarter of 2005 compared with the same period in 2004, while in the United States Zyprexa sales for like periods dropped 21 percent. More important, at least in terms of the shareholders’ immediate interests, Eli Lilly’s stock has declined roughly 16 percent from a high of $67.30 during the last 12 months to its current price, at the end of July, of $56.32.


  Because of Enron’s fraudulent accounting practices, many people lost their savings. Because of fraudulent drug-information from Eli Lilly, many more people lost their health or their lives. But unlike the Enron scandal, none of the responsible parties at Eli Lilly has been sent to prison or even been charged with a crime. Bringing Eli Lilly executives to justice is not likely to happen anytime soon.


  Meanwhile, what is to be done? Call it a crime; call it a tragedy; it’s surely a public-safety problem of vast proportions, one demanding government intervention. Warning people who take or might take Zyprexa about its grave risks is not a sufficient safeguard.


  When, in the early 1960s, the drug thalidomide was shown to cause horrible deformities in the newborns of thousands of women, the FDA banned it. Is death a less disastrous drug effect than deformity? How many more people will have to die before the government steps in to protect its citizens by prohibiting the sale of Zyprexa?


Drug Companies Still Peddling Risperdal & Zyprexa


Drug Companies Still Peddling Risperdal & Zyprexa
Monday, 19 June 2006, 11:07 am
Opinion: Evelyn Pringle 
Drug Companies Still Peddling Risperdal and Zyprexa For Off-Label Use
By Evelyn Pringle
According to Kelly O'Meara, author of the newly released book, Psyched Out, America has a drug problem. "It's not as covert as those illicit and illegal "Just Say No" drugs," she says, "but, rather, Americans have become drug users by way of being diagnosed as suffering from one or a number of alleged mental disorders."
"Sharing one's feelings with a doctor," she warns, "more often than not is all it takes to be diagnosed with a psychiatric disorder and prescribed a mind-altering drug to "treat" the disorder."
According to O'Meara, "scattered data from a variety of sources provide a shocking glimpse at not only the direction the drugging of America is heading, but also," she says, "the number of Americans being labeled as mentally ill."
One of the top classes of over-prescribed drugs are the new generation of atypicals antipsychotics that were adopted because of claims by drug makers that they were safer, more effective and produced fewer side effects than the older antipsychotics.

REM Sleep Behavior Disorder at Young Age Linked to Antidepressant Use

Sun Jun 18 23:00:01 2006 Pacific Time

      REM Sleep Behavior Disorder at Young Age Linked to Antidepressant Use

       ROCHESTER, Minn., June 19 (AScribe Newswire) -- A Mayo Clinic study has shown that the onset of REM Sleep Behavior Disorder (RBD) at a younger age appears to be connected to antidepressant use.

       RBD is a sleep disorder where patients act out their dreams, which are often unpleasant and violent, according to Maja Tippmann-Peikert, M.D., sleep medicine specialist, neurologist and study investigator. This acting out results from a loss of normal muscle paralysis in REM (rapid eye movement) sleep, the dream stage of sleep, which normally prevents enacting one's dreams. RBD patients generally act out their dreams in a defensive posture, as if fending off an attacker, says R. Robert Auger, M.D., Mayo Clinic sleep medicine specialist, psychiatrist and primary investigator. The disorder is often recognized by a bed partner.

       Although previously published case reports and a more recently published study have suggested the association between antidepressants and RBD, this study represents the first systematic demonstration of the relationship. Findings will be presented June 19 at the Associated Professional Sleep Societies' SLEEP 2006 meeting in Salt Lake City.

       "Our findings suggest that RBD in younger patients -- in the 30s instead of the usual age of the 50s or older -- is frequently linked to antidepressant use," says Dr. Auger. "I'd interpret this to mean one of three things: 1) in younger patients, antidepressants can cause RBD, or 2) in younger patients, RBD results in psychiatric diagnoses that then result in antidepressant prescriptions, or 3) a common factor is causing both the RBD and the psychiatric diagnoses, which in turn results in antidepressant prescriptions. If medications are implicated in a direct manner, it may be an idiosyncratic effect, it could be related to the dose of medication, or the medications simply may be unmasking an underlying predisposition to RBD."


St. Louis Post-Dispatch Editorial - Failure to protect the vulnerable

Failure to protect the vulnerable
St. Louis Post-Dispatch

For the parents of children born with profound mental retardation, serious psychiatric illness and physical disabilities, life is filled with gut-wrenching, heart-breaking decisions: How do I care for my child? If I can't, who can I trust to love him, tend to his physical needs and keep him safe? How will I know if he's hurt or needs help?

For families unable to care for such children at home -- a decision that often carries with it a lifelong burden of guilt and worry -- the options include one of Missouri's eight large, state-run habilitation centers, two children's centers, nine psychiatric centers or hundreds of privately run group homes scattered throughout the state.

Tragically, Missouri's record of safeguarding its mentally disabled residents can be summarized in one word: Failure.

A lengthy investigation by reporters Carolyn Tuft and Joe Mahr, published last week in the Post-Dispatch, documented 21 deaths related to the abuse or neglect of mentally disabled people in the care of the Missouri Department of Mental Health between 2000 and 2005. Another 24 deaths between 2002 and 2005 were classified by the department as "unexpected." These were not reviewed by state officials until reporters brought them to their attention.

After fighting for months to obtain state records, Mr. Mahr and Ms. Tuft also uncovered 2,287 confirmed cases of abuse and neglect, resulting in 323 injuries since 2000.

The stories are appalling:

— Randy Stuart was found dead, face-down on his bed at South County Habilitation Center, blood dripping from his nose and staining a wall nearby. A medical examiner ruled he died of natural causes. He was 44.

— A worker at Northwest Habilitation Center put Rutherford "Rudy" Wallace in water so hot it peeled the skin off of his legs and genitals. Although he writhed and screamed in pain, no one called 911. He died days later in the hospital from complications from his burns. He was 35.

— Gary Oheim was left lying in one place for so long his bed sores became severely infected. A state caseworker assigned to visit him at a private group home in Bolivar never even went into his room. He died at age 40.


Prosecutors weigh homicide charges in suffocation

The absolute horror of "restraints" used in psychiatric facilities.  And with children, incredibly horrifying.  This child died. How many others will until someone says something?
Posted on Sat, Jun. 10, 2006
Prosecutors weigh homicide charges in suffocation
DEATH:No charges have been filed after a 7-year-old died from lack of air after she was placed in a restraint.
RICE LAKE, Wis. - The counseling center involved in the suffocation death of a 7-year-old patient has been told that it cannot use control holds on patients unless the situation is "so dangerous that police must be called," a spokeswoman for state regulators said Friday.
The Department of Health and Family Services gave the order to Northwest Counseling and Guidance Clinic in Rice Lake as the agency continued its investigation into an incident last month that led to the girl's death, spokeswoman Stephanie Marquis said.
The directive, issued June 2, essentially bans the use of control holds in all but extreme emergencies at the counseling center, Marquis said.
Meanwhile, prosecutors were weighing whether to consider the death of Angellika Arndt a criminal homicide.
Arndt died from complications of chest compression, which caused lack of air from a restraint hold she was placed in by staff members, Barron County District Attorney Angela Holmstrom said.
Holmstrom said the manner of death -- that it was caused by another person -- makes the case a homicide. But she said it's not clear whether the facts meet the criminal definition of homicide.
No charges were filed Friday, a spokeswoman in Holmstrom's office said.
The girl, a resident of Rusk County, died May 26 at Children's Hospital & Clinics of Minnesota in Minneapolis, a day after police were called to the Northwest Counseling and Guidance Clinic on a report that she was unresponsive.
Arndt was a patient at the clinic and had been restrained by staff members for behavioral issues, police said.
Donna Wrenn, executive director of the National Association for the Mentally Ill-Wisconsin, said she was stunned at the medical examiner's ruling in Arndt's death.
"No matter what a child's behavior is, I can't imagine holding them down to the point of suffocating them," Wrenn said. "It's a horrible tragedy. It's unbelievable. Someone needs to be held accountable."

Government's Big Lie: The "Crisis" of Babies With Undiagnosed Mental Illness

 From Magic City Morning Star

Guest Column
Government's Big Lie: The "Crisis" of Babies With Undiagnosed Mental Illness
By Laura Adelmann
Mar 21, 2006, 21:01

To the federal government, many newborns, toddlers and preschoolers are undiagnosed mental cases with dire need of "treatment" (read: drugs).

Following the appalling trend of labeling school children with an ever-expanding list of mental disorders and medicating them with the cocaine-class of drugs like Adderall and Ritalin, government is promoting universal mental health screening and treatment " beginning with babies.

The Federal Mental Health Action Agenda, the blueprint to implementing the New Freedom Commission on Mental Health, is targeting America's youngest by promoting mental health screenings in places like daycares and schools.

In a 2003 speech, Kathryn Power director of the Substance Abuse and Mental Health Services Administration, excitedly reported that mental health assessments " "prevention and intervention" " are increasingly being conducted in "non-mental health settings." She commended one unnamed community for "placing mental health consultants in child care settings." Also touted was the federal "Prevention and Early Intervention Grant Program." Power noted the program's goal is to reach children " and babies " before they "have a diagnosable problem." At that time, Power stated, more than half of the administration's programs were to focus on infants and preschoolers.

Mandatory screening of children against government-defined criteria of what is "mentally healthy" is an Orwellian nightmare; the government will decide if citizens, starting at birth, are "mentally healthy."

Dr. Karen Effrem, a Johns Hopkins-trained pediatrician, researcher and expert on the government's movement toward universal mental health screening, has been sounding the alarm about the dangers of this Big Pharmaceutical movement for years.

She rightly states, "Government sponsored and controlled universal mental health screening, no matter how sweetly wrapped in the fig leaf of parental consent, should never, ever be implemented. It is never, EVER, the proper role of government to set norms for, assess or intervene in the thoughts and emotions of free citizens, much less innocent, vulnerable, and still developing children. It is our thoughts and emotions that make each of us uniquely and individually human, and we use these thoughts and emotions to understand the world and maintain our inalienable right to liberty."

Once a child has been screened, a highly subjective process, their personal medical information will become part of state records, potentially to be used as a screening tool for health care, employment, military or college admissions. An identified child would likely be ushered further into the psychological system for more assessments and "treatment,"a term that's become a euphemism for Big Psychology's first methodology: Drug therapy. And the mental health establishment is not shy about drugging babies. Between 1995 and 1997, psychotropic drug prescriptions for children from 2 to 4 years old grew by 300 percent.