http://www.lawyersandsettlements.com/articles/00707/ssri-doctors.html

Doctors Ignore Black Box Warnings On SSRIs

April 2, 2007. By Evelyn Pringle

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Washington, DC: The FDA has issued numerous public health advisories and black box warnings over the past several years about the increased risk of suicidality associated with selective serotonin reuptake inhibitor antidepressants, but many doctors ignore them.

In October 2004, the FDA added a black box warning about an increased risk of suicidality in children and adolescents after a review of data showed a doubling of the risk of suicidality associated with the drugs.

In December 2006, the FDA's Psychopharmacologic Drugs Advisory Committee held a public hearing to review the suicidality data on adults and recommended that the black box warning to be extended to young adults.

SSRIs sold in the US include Prozac, by Eli Lilly, Paxil, by GlaxoSmithKline, Zoloft, by Pfizer, and Celexa and Lexapro, by Forest Laboratories, along with some generic versions.

In the briefing material for the hearing, the FDA for the first time admitted that SSRIs also increase the risk of suicidality in patients over 18. In fact, the data presented showed the rate of suicidality in adults more than doubled from about 3 cases per thousand to seven.

As usual, proponents advocating for stronger warnings on SSRIs were up against a stacked deck at the hearing. During his testimony before the committee, former Federal fraud investigator, Allen Jones, identified numerous conflicts of interests among the panel.

He testified that doctors and patients alike have been betrayed by the governmental agencies that are supposed to protect them, and that, "the love affair between the pharmaceutical industry and our government institutions has to end."

This particular committee, he told the audience, included 3 people with financial ties to the industry who were granted waivers. One was granted to Dr Andrew Leon, Mr Jones said, even though he receives between $10,001 and $50,000 a year as a member of a data-monitoring board for an undisclosed company that sells antidepressants.

According to the Center for Science in the Public Interest, the same Dr Leon has also been a consultant for Cyberonics, the maker of the Vagus Nerve Stimulation System, a hoped-for successor of Electroconvulsive (Shock) Therapy, to treat depression. Forest Labs has also funded Dr Leon's research.

Another waiver was granted to Jean Bronstein, Mr Jones said, because she owned stock in two drug companies that make antidepressants.

Mr Jones also pointed out that another member, Bruce Pollock, was designated a non-voting member because he receives as much as $10,000 per year serving on advisory boards or speakers' bureaus for SSRI makers Forest Labs, GlaxoSmithKlinie, and Pfizer.

The FDA report released for the hearing stated in part: "When results are analyzed by age it becomes clear that there is an elevated risk for suicidality and suicidal behavior among adults younger than 25 years of age that approaches that seen in the pediatric population."

However, the FDA is now trying to claim that the increased risk only occurs until people reach the age of 25, a claim that critics are saying is just plain silly. The theory is contrary to a study reported on May 1, 2006, by the London Free Press from Toronto's Institute for Clinical Evaluative Sciences, which showed seniors 66 and up who were prescribed SSRIs were nearly 5 times more likely to commit suicide during the first month on the drugs than those patients given the older class of drugs used to treat depression.

Records researcher, Vince Boehm, who tracks all studies on SSRIs, says, "It makes no difference how old a person is, the danger is still there."

"I'll concede that maturity and life's experiences offer an arguably slim buffer of safety," he notes, "but this is an extremely fragile safety net." Mr Boehm says nothing magical happens at 25. "We've made a numbers game out of this," he warns, "a macabre form of Russian Roulette."

A leading expert on SSRIs, psychiatrist, Dr David Healy, author of, The Creation of Psychopharmacology, agrees and says, "The idea that you would have a risk in one age group but not in another is just wrong."

Dr Healy testified at the hearing about the manipulation of data from clinical trials. The industry controls the studies, and with the help of the FDA, he told the audience, drug makers have miscoded the data so that the articles in the medical journals that represent clinical trial data on the drugs are misleading.

Another SSRI expert, psychiatrist, Dr Peter Breggin, author of, "The Antidepressant Fact Book," also testified and said, "America's drug watchdog needs to come clean because it's been approving depressants as antidepressants."

"The primary data on suicidality," he said, "has been generated in short-term controlled clinical trials planned by drug companies, carried out by drug company hacks, and evaluated by drug company employees at corporate headquarters."

"If that kind of carefully cultivated evaluation bears such bad fruit," Dr Breggin noted, "imagine what the real data must show."

Many grieving family members testified and described the same kind of horror stories that the FDA has been hearing since the first hearing on the dangers of SSRIs back in 1991.

Gwen Olsen, a former drug company sales representative, gave the panel a first-hand account of how easy it was to influence prescribing doctors by offering them free meals, gifts, and gimmicks to gain access and present them with manipulated data.

Ms Olsen now lives with the fact that her 20-year-old niece committed suicide while going through withdrawal from Paxil, first by trying to hang herself from a ceiling fan and when the fan broke, she doused herself with gasoline and set herself on fire.

Beverly Hatcher described her mother as having no history of depression but yet killed herself after 16 days on Paxil. Tony Noll, whose father also committed suicide, told the panel, "I came to speak to you on behalf of the statistically insignificant."

Rosemary Dorsett testified that her son was screened for depression during a physical, and was given Prozac by a GP, after which he became an insomniac, lost weight, heard voices, and shot himself in the chest. She emphasized that her son loved life and the suicide was totally out of character.

Mary Ellen Whitter also told the panel that her teenage daughter loved life and was happy until shortly after graduation when she was prescribed Paxil for sleep problems and anxiety, and hung herself 7 days later.

In total disregard of the drugs' new warnings, doctors continue to prescribe SSRIs to children all over the US. A study in the August 2006, Archives of General Psychiatry, found that children, aged 6 to 18, who took antidepressants for depression in an inpatient setting were 52% more likely to attempt suicide in the 60 days following discharge from the facility, than children who were not taking the drugs.

For this study, the researchers analyzed data from the national Medicaid Analytic Extract Files, including information from all 50 states, and determined that children who filled prescriptions for antidepressants after an inpatient stay were 15.62 times more likely to die by suicide than patients who were not taking antidepressants.

"These findings," said lead author, Dr Mark Olfson, MD, a professor of psychiatry at Columbia University, "serve to reinforce some of the concerns that have been raised and really emphasize the importance of paying close attention to changes in mood and actions of severely depressed young people as they start antidepressant medication."

Despite the warnings on SSRI labels to watch patients closely for signs of suicidality, a recent study found that less than 18% of patients on the drugs received even the minimum level of follow-up care in the most critical time after being prescribed SSRIs.

According to the report in the August 2006, American Journal of Managed Care, nearly half of the patients had no follow-up visits during the first month, and fewer than 18% saw a practitioner for mental health follow-up care during that time.

Dr Healy says, all patients need to be warned that, if they feel strange or anxious they should return to their doctor. But his concern, he says, "is that doctors indoctrinated by drug company input and faced with a patient saying they feel worse will double the dose rather than reducing it or switching to a different treatment."

http://ahrp.blogspot.com/2007/04/spending-on-psych-drugs-up-150.html

Spending on psych drugs Up 150% Diagnosis of Depression 25% Inflated

According to a new report by the U.S. Agency for Healthcare Research and Quality (AHR&Q), U.S. spending on psychotropic drugs climbed from $7.9 billion in 1997 to $20 billion in 2004--that's an increase of 150% in just seven years. After years of marketing, these drugs now carry the most severe Black Box label warnings.

The sharpest rise in spending was for antipsychotic drugs (a.k.a. neuroleptics) which were approved only for use in managing schizophrenia and bipolar disorder--together these account for 2% of the population. Yet total purchases to treat these conditions more than tripled -- from $1.3 billion to $4.1 billion.

These second generation neuroleptics are the most toxic of all psychotropic drugs: they interfere with normal metabolic, endocrine, and cardiovascular function. Their mechanisms of action induce debilitating chronic disease--including hyperglycemia, insulin-resistant diabetes, stroke and heart attacks.

Antidepressants, the AHR&Q study found, accounted for more than half ($12.1 billion) of the total expenditures for psychotherapies in 2004. These drugs trigger psychosis and antisocial aggressive, violent, manic behavior posing threat of harm to self (suicide) and others (homicide). The drugs have not proven a clinical benefit. Instead, they have worsened the symptoms for which they were initially prescribed, such as stress or difficulty falling asleep. Antidepressants and antipsychotics have been shown to undermine mental and physical health in some persons for whom they were prescribed. The drugs disrupt normal mental and physiological functions and have been shown to induce psychosis, hallucinations, and suicidal behavior.

Why, people may ask, are these drugs so widely prescribed and how did they become blockbuster sellers? The answers are found in the unintended consequence of ill-advised laws that gave drug manufacturers too much influence on government policy
[Link] and in documents unearthed in litigation and in the subjective non-empirical diagnostic criteria. Company documents show that drug companies have engaged in aggressive marketing of these drugs despite knowledge of their hazardous effects--and they have actively influenced the diagnostic prescribing criteria.

A just released report in the Archives of General Psychiatry by investigators from New York University, Columbia University, University of Pennsylvania, and Rutgers, delivers a major blow to the validity of psychiatry's diagnostic criteria. The authors examined the distinctions used for diagnosing "major depression" and found that 25% of those "diagnosed" with "major depression" in accordance with the criteria set forth in psychiatry's diagnostic guide-the DSM -IV--are not clinically depressed. They are responding normally to traumatic life events.

The Washington Post correctly notes, "The finding could have far-reaching consequences for the diagnosis of depression, the growing use of symptom checklists to identify those who may be depressed, and the $12 billion-a-year U.S. market for antidepressant drugs." The most aggressive of these diagnostic chekclists is TeenScreen with its 84% false-positive misidentification rate.

The DSM-IV is a product under the influence of industry as has been documented by Drs. Lisa Cosgrove and Sheldon Krimsky: [Link] and [Link]

Further evidence of corruption behind the spiraling sales statistics for psychotropic drugs is documented in company reports and memos. Alex Berenson of The New York Times disclosed the content of Eli Lilly Zyprexa documents showing that the company concealed the evidence of harm produced from physicians and the public [Link]. Instead, the airwaves were flooded with false and misleading advertisements whose claims are contradicted by the evidence of the drugs' safety hazards. [Link] The FDA failed to intervene.

Industry, in collaboration (i.e. collusion) with influential mental health professionals and industry funded "advocacy" groups--including the American Psychiatric Association, the National Institute of Mental Health, Mental Health America, the American Academy of Child and Adolescent Psychiatry, the National Alliance for Mental Illness--succeeded in getting these drugs listed as first line treatments in psychiatry's prescribing guidelines hospital formularies.

TMAP--the Texas Medication Algorithm Project--is Big Pharma's psychotropic drug sweepstakes. [Link]

The academic architects of TMAP and TMAP promoters in state government and academia, should be questioned under oath to determine how the flow of cash from industry influenced the formulation and adoption of TMAP by numerous state mental health departments.

Of note: New York Governor Eliot Spitzer appears to have completely reversed his informed legal action in the public interest when, as Attorney General, he filed suit against GlaxoSmithKline to persuade drug companies to disclose the facts about drug safety to the public. As a newly elected governor, he made a political appointment to appease the mental health drug industry cartel.

Eliot Spitzer appointed Michael Hogan, PhD, Commissioner of NYS Office of Mental Health. Dr. Hogan was a pivotal promoter of TMAP and the expanded use of the most expensive psychotropic drugs when he headed the Ohio Office of Mental Health, and chaired the President's New Freedom Commission on Mental Health which gave TMAP a federal seal of approval. Dr. Hogan also serves on the National Advisory Council of TeenScreen, the other market expansion scheme. [Link]

[Link]THE WASHINGTON TIMES
Spending on psychotherapeutic drugs soars
By Joyce Howard Price April 1, 2007

Spending on antidepressants and other prescription drugs to treat mental disorders climbed from $7.9 billion in 1997 to $20 billion in 2004, an increase of more than 150 percent, a new federal report says.

"It is quite an increase. It is an important thing to take note of," said Marie N. Stagnitti, the report's author and a senior survey statistician with the U.S. Agency for Healthcare Research and Quality. The agency is part of the Department of Health and Human Services.
Purchases of psychotherapeutic drugs rose from 141.9 million to 244.3 million during the seven-year period. The number of people who reported buying these drugs increased from 21 million to 32.6 million during that time.
The study found that antidepressants accounted for more than half ($12.1 billion) of the total expenditures for psychotherapies in 2004. Spending for those drugs, which include commonly prescribed medicines such as Prozac, Paxil and Zoloft, more than doubled from $5.1 billion in 1997.

The total number of antidepressant purchases skyrocketed from 88.3 million in 1997 to 161.2 million in 2004, and the number of people who reported making such purchases increased from 15.3 million to 24.8 million.
The study found that the sharpest rise in spending was for antipsychotic agents, or medications used to manage schizophrenia, bipolar disorder and other psychotic disorders. Total purchases to treat these conditions more than tripled -- from $1.3 billion to $4.1 billion.
Likewise, total expenditures for central nervous system stimulants to treat pain and control seizures nearly tripled during the seven years --from $600 million to $1.7 billion. The number of people who said they bought at least one of these drugs increased from 2.1 million to 3.3 million, and the total number of purchases of such prescriptions swelled from 11.8 million to 19.7 million.
Meanwhile, purchases of sedatives, hypnotics and medicines to ease anxiety nearly doubled from $900 million to $2.1 billion. Total purchases of those drugs climbed from 24.5 million to 39 million, and the number of people who said they bought at least one of those drugs surged from 5.4 million to nearly 8 million.
Ms. Stagnitti said she is interested in doing more research in this area to determine factors involved in the increase. She thinks it is important to determine how socioeconomic background and insurance coverage influence access to drugs to improve mental health.
Attempts to get reactions Friday from professional or advocacy organizations such as the American Psychiatric Association and Mental Health America were unsuccessful.
But the National Institutes of Mental Health (NIMH) said on its Web site the "burden of psychiatric conditions has been heavily underestimated."
It said a massive study called the "Global Burden of Diseases" found that mental illness accounts for more than 15 percent of the disease burden in established market economies, such as the United States. "This is more than the disease burden caused by all cancers," NIMH said.

[Link]Washington Post
Criteria for Depression Are Too Broad, Researchers Say Guidelines May Encompass Many Who Are Just Sad
By Shankar Vedantam
Tuesday, April 3, 2007; A02

Up to 25 percent of people in whom psychiatrists would currently diagnose depression may only be reacting normally to stressful events such as a divorce or losing a job, according to a new analysis that reexamined how the standard diagnostic criteria are used.

The finding could have far-reaching consequences for the diagnosis of depression, the growing use of symptom checklists to identify those who may be depressed, and the $12 billion-a-year U.S. market for antidepressant drugs.

Diagnoses are currently made on the basis of a constellation of symptoms that include sadness, fatigue, insomnia and suicidal thoughts. The diagnostic manual used by doctors says that anyone who has at least five such symptoms for as little as two weeks may be clinically depressed. Only in the case of someone grieving over the death of a loved one is it normal for symptoms to last as long as two months, the manual says.

The new study, however, found that extended periods of depression-like symptoms are common in people who have been through other life stresses such as a divorce or a natural disaster and that they do not necessarily constitute illness.

The study also suggested that drug treatment may often be inappropriate for people who are experiencing painful -- but normal -- responses to life's stresses. Supportive therapy, on the other hand, may be useful -- and may keep someone who has been through a divorce or has lost a job from going on to develop full-blown depression.

The researchers -- including Michael B. First of Columbia University, the editor of the authoritative diagnostic manual -- based their findings on a national survey of 8,098 people. They found that those who had experienced a variety of stressful events frequently had prolonged periods in which they reported many symptoms of depression. Only a fraction, however, had severe symptoms that could be classified as clinical depression, the researchers said.

An estimated one in six Americans suffer depression at some point in their lives. Under the more limited criteria the researchers urged, that number would be 25 percent lower.

"The cost of not looking at context is you think anyone who comes under this diagnosis has a biological disorder, so should more or less automatically get antidepressant medication, and everything else is superfluous," said lead author Jerome Wakefield, a New York University researcher who studies the conceptual foundations of psychiatry. "There is a trend to treat people in this somewhat mechanized way."

Said First: "One issue this would play out at is at the level of medication. If someone has a normal grief reaction, you wouldn't give that person an antidepressant, you would favor counseling. If someone has major depression you would be more likely to medicate. So this could influence how clinicians think about medications or psychotherapy."

Drawing the line between normal and abnormal suffering has long been controversial in psychiatry, because people who have no disorders often experience the same symptoms as those who do, but their reactions typically are less prolonged and intense. Where to draw the line involves a degree of subjective judgment: If the criteria are too strict, some people who are depressed may not receive help.

After First oversaw the writing of the current edition of the manual, for example, a number of doctors contacted him about difficulties they had in applying the diagnosis, First said. One described a patient who was feeling acute grief after the death of her dog. The manual says doctors need not diagnose depression if symptoms follow the death of a loved one, and the doctor wanted to know whether the death of a pet met the criterion.

That question, First said, illustrated how difficult it was to establish a set of criteria that could encompass the complexity of human sorrow: The death of a spouse or a family member, he said, was only one of many things that could cause an acute grief reaction.

But he warned that people who are in pain after a divorce or other stressful event should not conclude that they simply ought to "buck up." They should seek the counsel of clinicians who would take the time to explore what caused the symptoms and whether they need treatment.

Still, Wakefield and Allan Horwitz, a researcher at Rutgers University who studies the sociology of mental disorders, said their study, which was published in this month's issue of the Archives of General Psychiatry, pointed out that sadness has increasingly come to be seen as pathological in the United States. They have written a book called "The Loss of Sadness: How Psychiatry Transformed Normal Sorrow Into Depressive Disorder."

Pharmaceutical companies, the psychiatric profession and patient advocacy groups have all contributed to the phenomenon, Horwitz added. Companies stand to make more money from the one-size-fits-all approach, researchers find the cookie-cutter model of disease makes it easier to do studies, and psychiatry has come to think of itself as "the arbiter of normality," he said.

Patient groups, Horwitz added, think that the stigma attached to mental illnesses would be reduced if they were shown to be more common.

"The way in which people interpret their emotions is changing," Horwitz said. "People are starting to think that any sort of negative emotion is unnatural, that they can take medication and feel better. What that can also do is . . . make it less likely for people to make real changes in their lives that might be better than medications."

http://news.independent.co.uk/business/news/article2422712.ece

Pfizer drug distribution deal triggers market investigation

By Susie Mesure, Retail Correspondent

Published: 05 April 2007

WASHINGTON -- The top Republican on the Senate Finance Committee has asked Eli Lilly and Co. to turn over documents related to the safety and marketing of its blockbuster antipsychotic drug Zyprexa.

Zyprexa is at the center of lawsuits by patients, states and shareholders over whether Lilly knew Zyprexa could trigger diabetes in some people and whether Lilly marketed Zyprexa for unapproved purposes.

Contact Star Washington Bureau reporter Maureen Groppe at (202) 906-8118 or at mgroppe@gns.gannett.com. mgroppe@gns.gannett.com. "

http://www.lawyersandsettlements.com/articles/00740/schizophrenic-seroquel.html

April 11, 2007. By Evelyn Pringle

Patients Diagnosed Schizophrenic and Bipolar To Boost Seroquel Sales

Washington, DC: For over a decade, drug makers have been influencing doctors to diagnose patients, especially those covered by public health care programs like Medicare and Medicaid, with mental illnesses to justify the over-prescribing of the new class of drugs known as "atypical" antipsychotics.

For instance, Seroquel, marketed by AstraZeneca, is only FDA approved to treat acute manic episodes associated with bipolar I disorder and schizophrenia, and yet it is one of the most widely prescribed drugs in the world.

Astra reports that over 16 million patients have taken Seroquel since it came on the market in 1997, and the drug had sales of close to three and a half billion dollars in 2006, according to SEC filings.

Decision Resources, an advisory firm on health care matters, reported that in 2005, two of the top 10 selling drugs worldwide were atypicals.

A new study by the US Agency for Healthcare Research and Quality, found that between 1997 and 2004, spending on antipsychotics more than tripled from $1.3 billion to $4.1 billion and the largest purchasers of atypicals are public health care programs.

The other drugs in this class include Eli Lilly's Zyprexa, Bristol-Myers Squibb's Abilify, Johnson & Johnson's Risperdal, and Pfizer's Geodon.

These drugs were promoted as working better than the old "typical" antipsychotics in addition to having fewer of the serious side effects associated with the older drugs. Both of these claims have now been proven false, but unfortunately tens of millions of people have already taken the new drugs.

A study funded by the National Institute of Mental Health, entitled the "Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE)," compared the atypicals against the older medication, perphenazine and found the atypicals were no more effective than the older drug although they cost 10 to 20 times more. By comparison, the cost of perphenazine was $50 a month, and Zyprexa was $545.

But the results of this $40-odd million dollar tax payer funded study is not news. Back in December 2000, the British Journal of Psychiatry reported a review of 52 studies involving 12,649 patients and stated: "There is no clear evidence that the atypical antipsychotics are more effective or better tolerated than conventional antipsychotics."

Over the past several years, studies have linked the atypicals to a number of serious health problems including insulin resistance and diabetes. According to an October 2006, report by the National Association of State Mental Health Program Directors, diabetes causes tissue damage in many organs, is a major cause of vascular disease, and is the number one cause of adult blindness, end-stage kidney disease and non-traumatic amputations.

Insulin resistance, the report says, is closely linked to developing metabolic syndrome, which includes hypertension, high cholesterol, increased blood clotting and eventually insulin dependent diabetes.

Astra is currently facing nearly 10,000 lawsuits in state and Federal courts over injuries and deaths caused by Seroquel, and Eli Lilly has already agreed to pay well over a $1 billion to settle cases out-of-court with approximately 26,000 Zyprexa victims.

In February 2007, the state of Pennsylvania filed a lawsuit against AstraZeneca, and other atypical makers, alleging the drug giant illegally marketed Seroquel off-label for unapproved uses.

The state is demanding reimbursement for the cost of the drug and medical care provided to patients who developed serious health conditions while taking the drug. The lawsuit alleges Astra concealed the risks of Seroquel and exaggerated the benefits while persuading doctors to prescribe it for uses not FDA approved as safe and effective.

Astra, the complaint alleges, cost Pennsylvania's Medicaid and drug assistance for the elderly program millions of dollars for "reimbursing for non-medically accepted indications and non-medically necessary uses," of Seroquel, as well as "significant sums of money for the care and treatment" of patients injured by the drug.

Legal experts say millions of people have been duped into taking the atypicals with massive off-label marketing campaigns based on lies, distortions, and rigged-for-profit clinical trials.

Attorney, Derek Braslow, of the Conshohocken, Pennsylvania law firm, Pogust & Braslow, says the schemes usually follow a familiar pattern. "First," he explains, "the drug maker promotes the drug as significantly more effective than the current standard of care when in reality, its effectiveness is questionable."

"Second," he says, "they market the drug to doctors as safer when not enough studies have been conducted to determine whether it is safe and perhaps, the studies were designed in a way that would never detect the risk in the first place."

"Third," Mr Braslow notes, "the companies promote the drug off label for all types of indications and for all age groups."

But prescribing doctors have played a major role in medicating patients for profit with the new atypicals. Drug companies are prohibited from promoting a drug for off label uses outside of the FDA-approved indications because for conditions or patient population not listed on the label the drug has not been proven safe and effective.

However, through a major legal loophole, doctors have the authority to decide whether the risk of prescribing a drug for an unapproved use is justified by the benefits. Which means all companies have to do is convince doctors, by whatever means, to prescribe a drug for unapproved uses and deny the drug maker's involvement in their decisions.

Unfortunately, it is the unwitting patients who will endure the stigma of a life-long label as a result of the atypical drugging for profit scheme. When people think about schizophrenia or bipolar disorder they picture patients who hear voices, are delusional, and possibly dangerous to themselves or others. The people misdiagnosed to boost the sale of these drugs, including scores of innocent children, will face a lifetime of suspicion and discrimination by society as a whole.

The Pennsylvania lawsuit says the drug maker influenced doctors to prescribe Seroquel off-label to children for behavior disorders like attention-deficit. The atypicals are not approved to treat children for any condition but a review of records from HMOs and Medicaid programs by researchers at Vanderbilt University found a dramatic increase in the use of the drugs with children, particularly for behavioral disorders, according to the March/April 2006, Journal of Ambulatory Pediatrics.

The study found that between 1995 and 2002, there were 5,762,193 outpatient medical visits by children, aged 2 to 18 years old, at which an antipsychotic was prescribed. The drug companies have doctors in every field of medicine prescribing atypicals to kids, with 32% of the almost 6 million prescriptions, written by pediatricians, family physicians, emergency department doctors, or other types of providers.

The study authors specifically said that there had been no increase in mental disorders that could justify the prescribing increases "as recent studies do not suggest significant increases in the incidence of schizophrenia."

According the study report, these medications have not been studied at all for behavioral disorders and yet, the most common diagnosis was attention deficit disorder or conduct disorder, accounting for 29.0% of all prescriptions.

Critics says, the logical question to ask is how would a pediatrician or family physician, whose practice does not ordinarily include diagnosing or treating mental disorders, ever come up with the idea to prescribe Seroquel to a child for any reason without the input from the drug maker.

As for the benefits of treating kids who are schizophrenic, an August 2006, study by the New York Psychiatric Institute found that the older drugs work far better. The average response rate in children among 8 studies employing the new antipsychotics was only 55.7%, compared to a 72.3% with children in 13 studies who received the older drugs.

The Pennsylvania lawsuit alleges the drug maker influenced doctors to prescribe Seroquel off-label for dementia in elderly patients. On April 11, 2005, after a study revealed that elderly patients with dementia who were taking atypicals were far more likely to die prematurely, the FDA announced the addition of black box warnings about the increased risk of death on the labels of atypicals.

A June 13, 2005, study in the Archives of Internal Medicine, reviewed atypical use by approximately 2.5 million Medicaid patients in nursing homes and found that over half received medications that exceeded the highest recommended dose, received duplicate therapy, or had inappropriate indications for the drugs to begin with. All total, the study determined that more than 200,000 nursing home residents received atypicals but had "no appropriate indications for use."

On October 12, 2006, a study in the New England Journal of Medicine reported that the atypical drugs most commonly used to treat people with Alzheimer's were no more effective than placebos for most patients, and caused serious side effects including confusion, sleepiness and Parkinson's disease like symptoms.

The FDA has acted as an accomplice in allowing atypical makers to suppress other adverse events found in their own clinical trials. According to Dr David Healy, a world-renowned expert on psychiatric drugs, a great deal of data is available on the rates of suicides and suicidal acts in clinical trials on atypicals. He says Zyprexa probably has the highest suicide rate in clinical trial history and calls the absence of available data on suicidal acts and Zyprexa "striking."

By using the Freedom of Information Act to obtain data from the FDA, award-winning journalist, Robert Whitaker, author of, Mad in America, reported that one in every 145 patients who participated in the clinical trials with the atypicals died.

On March 1, 2007, four days after the Pennsylvania lawsuit was filed, Astra became the target of another investigation, when US House of Representative, Henry Waxman (D-Cal), chairman of the House Oversight and Government Reform Committee, sent a letter to Astra, requesting information related to the exact same charges alleged in lawsuit.

The lawmaker's letter asks for a list of all Seroquel trials, studies, or reports; all presentations given to employees who promoted Seroquel; information shown to physicians; presentations related to physician prescribing patterns, continuing medical education, and off-label use; and all documents and correspondence related to funding for nonprofit professional organizations or consumer patient groups.

Critics say the culpability of the doctors in over-prescribing drugs that cause such serious diseases and adverse events cannot be ignored. This critic says, labeling people mentally ill for profit, especially innocent children and the elderly, is an indefensible crime and that all the monsters that engaged in this 10-year off-label marketing scheme should be arrested and sent to prison, and the jailer on duty should throw away the key. "

http://www.nzherald.co.nz/section/466/story.cfm?c_id=466&objectid=10433476

Jerome Burne: When medicine is dangerous
Tuesday April 10, 2007

When you go to your GP, you can rest assured that any drugs you are given have been tested to make sure they work and are safe. Or can you?

Hidden in medical journals are many reports about myriad drugs that are prescribed with no scientific evidence to show they work for the problem you've got.

Last year, the British medic Professor Michael Baum used this fact to mount an attack on CAM (complementary and alternative medicine). He urged Britain's National Health Service trusts to fund only treatments "based on solid evidence", and won a lot of support.

After all, drugs have to be rigorously tested, so why shouldn't the alternatives?

Prescribing a drug for a condition it has not been tested to treat is known as "off-label" prescribing. When a drug gets a licence, it is for a particular use - to treat asthma, lower cholesterol - and the drug company has to provide evidence that it does this better than a placebo.

The scale of the "off-label" problem was revealed in a paper published in the US Archives of Internal Medicine recently. It showed that 21 per cent of the 160 most commonly prescribed drugs in the US were given to people on an off-label basis.


For instance, 46 per cent of heart drugs (except those to lower cholesterol or reduce blood pressure) were prescribed off-label, while in the case of Neurontin, licensed for epilepsy and nerve pain, 98 per cent of its uses were for unrelated conditions such as bi-polar disorder and depression. In the US the Food and Drug Administration is under pressure to recognise the possibility that Neurontin increases suicide risk.

Of course doctors should be allowed to use their experience and judgment to prescribe unlicensed drugs where other treatments have failed. But the study - conducted at Stanford University - showed that for nearly three-quarters of the off-label uses, there was "little or no scientific support".

Off-label prescribing has a long history. In the 1980s, people with a mildly irregular heartbeat were given Tambocor or Enkaid, which reduced the risk of sudden death in people with severe arrhythmia. Around 200,000 Americans with a mild version were given the drugs on the assumption that it would help them, too. However, when a proper trial was finally done it showed that it doubled or tripled their risk of death.

What also needs to be examined is the role the drug companies play. Encouraging off-label prescribing, for instance, is a cheaper way of increasing drug sales than conducting large trials for every new use.

Reports in both the British Medical Journal and the Lancet have shown that sleeping pills are neither very safe nor very effective, but they still feature regularly in the top 20 most prescribed drugs in both Britain and the US. An extensive review recently found that counselling and psychotherapy were not only more effective but also without side-effects.

If evidence-based medicine was really what was on offer, counselling is what insomniacs would be offered. But try getting that from your GP.

Children are particularly vulnerable to being given drugs with little or no evidence base.

Recently the journal Science reported that "between 50 and 90 per cent of drugs used on adults have never been tested or licensed for children ... as a result 100 million children in the European Union are often prescribed off-label or unauthorised drugs".

The risk was well illustrated by a scandal involving 60,000 children prescribed antidepressant SSRI drugs off-label in Britain. In December 2003 the drugs watchdog - the MHRA - advised doctors that, with the exception of Prozac, no other SSRI should be used for children because SSRIs doubled the risk of suicide.

A major study in the Lancet had shown that four other SSRIs were not only unlikely to produce any "clinically important improvement" in children with depression but, in one case, had a rate of "suicide-related events" 14 times greater than a placebo (an inactive substance used for comparison).

However, questions in the House of Commons revealed that 18 months later more prescriptions for those SSRIs were being issued than for Prozac.

The tendency for people to turn to non-drug treatments for less acute conditions starts to look less like a "flight from reason" and more like a rational option.

The ideal that treatments should be properly tested is an excellent one but the notion that drug-based medicine has a monopoly on testing is a myth - and myths have no place in good science.

- INDEPENDENT

* Jerome Burne is the author, with Patrick Holford, of Food Is Better Medicine Than Drugs: Your Prescription for Drug-Free Health.

13:02pm 22nd April 2007

This explains the dim things they say, and their inability to argue properly.

Take the latest massacre in the USA.

Almost every Left-wing commentator in this country has smugly blamed the event on the fact that guns are easy to buy in America.

Well, so they are, and so they have been for centuries.

But, as it happens, they are much harder to buy, and much harder to carry round with you, than they were 40 years ago when massacres were unknown.

And in 2002, there was a similar massacre at Erfurt in Germany, which has very strict gun laws. It must follow from these facts that there is no direct connection between relaxed gun laws and massacres.

True, guns make it easier for a deranged person to kill a lot of people.

But in countries with strict laws, illegal guns tend to be easily available to bad or unhinged people.

Also take note of this: the Virginia Tech killer is reported to have been on 'prescription medication' for 'depression'.

So was Jeff Weise, the culprit of the Red Lake shootings in Minnesota in May 2005.

So were the authors of several other such incidents, including Eric Harris, one of the murderers in the notorious Columbine shootings of April 1999, and 15-year-old Kip Kinkel, who slaughtered his parents and two schoolmates in Oregon in 1998.

These are the ones we know about. I suspect that these half understood drugs may have been involved in a lot more such incidents.

There are some suggestions that pills given to young people accused of having the fictitious 'disease' ADHD may also have been involved.

If this is so, then it will not be long before the same horrible events start happening with much greater frequency in British schools and campuses, where the same drugs are increasingly prescribed, where the same liquid manure is pumped into young minds by TV and computer screens, and where illegal weapons are, daily, easier to obtain..."

The reporter is getting there, but doesn't seem to have seen the homicide list:

http://ssri-uksupport.com/files/homicidesSSRISandADHDmedications.pdf

BBC put this on and someone captured much of it which you can watch online below:

http://www.youtube.com/watch?v=EwP2PP8CU0Y

"...Commentator - "Laing was now a celebrity in America and was one of the leaders of what was called the 'Anti-psychiatry movement'.
Psychiatry, Laing said, was a fake science used as a system of political control to shore up a violent collapsing society. Its categories of madness and sanity had no reality. Madness was simply a convenient label used to lock away those who wanted to break free."

"Hundreds of young psychiatrists came to Laing's talks and one of them was inspired and decided to find a way of testing whether what Laing said was true or not. Could psychiatrists in America distinguish between madness and sanity?..."

"He was called David Rosenhan and he devised a dramatic experiment. He assembled 8 people, including himself, none of whom had ever had any psychiatric problems.

Each person was sent across the country to a specific mental hospital. At an agreed time, they all presented themselves at their hospital and told the psychiatrist on duty they were hearing a voice in their head that said the word "Thud". That was the only lie they should tell otherwise they were to behave and respond completely normally."

Question - "and then what happened?"

David Rosenhan - "They were all diagnosed as insane and admitted to the hospital."

Question - "All of them?"

David Rosenhan - "All of them."

Question - "And were any of them insane?"

David Rosenhan - "No. There was nobody who could have judged these people as insane. ... but I told friends, I told my family, I get out when I get out; that's all. Be there for a couple of days and then I get out. Nobody knew I would be there for 2 months!"

Commentator - "Once admitted, all 8 fake patients acted completely normally yet the hospitals refused to release them and diagnosed 7 as suffering from schizophrenia and one from bipolar disorder. They were all given powerful psychotropic drugs.

They found there was nothing they could do to convince the doctors they were sane and it quickly became clear that the only way out would be to agree that they were insane and then pretend to be getting better.

David Rosenhan - "The only way out was to point out that they're correct. They said I was insane, I am insane, but I am getting better. That was an affirmation of their view of me."

Commentator - "When Rosenhan finally got out and reported the experiment, there was an uproar. He was accused of trickery and deceit and one major hospital challenged him to send some more fakes to him, guaranteeing that they would spot them this time.

Rosenhan agreed and after a month, the hospital proudly announced that they had discovered 41 fakes. Rosenhan then revealed that he had sent no-one to the hospital." 

http://www.healthcarerepublic.com/news/PHARMACIST/652765/NICE-amends-depression-anxiety-guidance/

NICE amends depression and anxiety guidance

25-Apr-07

http://iccheshireonline.icnetwork.co.uk/0100news/0100regionalnews/tm_headline=man-died-after-reaction-to-medication&method=full&objectid=18961965&siteid=50020-name_page.html

Man died after reaction to medication

Newscast online

http://www.rte.ie/news/2007/0424/9news_av.html?2241667,null,230

In case it doesn't come up auto (there's others on the same page) its the one called:

" 'Unhealthy influence' of pharmceutical industry criticised "

and pdf report:

http://www.ssri-uksupport.com/AdverseEffectsOfPharmaceuticalsReportIreland.pdf

"Houses of the Oireachtas  Joint Committee on Health and Children  Eighth Report

April 2007..."

Group Urges Suicide Screening for Psychiatrists

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David Shaffer of TeenScreen

The North Dakota chapter of Citizens for Common Sense today issued a call to action in hopes to curb the rampant suicide in the psychiatric industry. An alarming study has conclusively shown that psychiatrists have more than double the suicide rate of teenagers. This is alarming in the extreme as various psychiatrists are running groups that supposedly address teen suicide. TeenScreen, based in New York, is one of the most controversial of these groups. Despite public outcry, TeenScreen has set up shop in 400+ schools and are using psychiatric diagnoses from the DSM IV and ICD10, psychiatry's manuals of mental disorders.


"Well heck, that's like hiring a kleptomaniac as a store detective, ain't it?" says Clem Studson, treasurer and handyman for CCS. "I mean come on people, if psychiatrists can't solve the problem amongst their own crew, why don't we turn the teen suicide problem over to somebody who does seem to have the answers, like people who attend Star Trek conventions. In our latest study, it seems that they have an extremely low suicide rate. They do have a slightly elevated rate of wearing fake ears and saying silly things like ‘Kirk here' and ‘capun - we haven't got the power' but we reckon that's covered by the first amendment somehow."

Also, whereas screening a young child for mental illness can result in dashing that person's hope for the future and turning a normal rambunctious teenager into a permanent mental patient and drug user, screening psychiatrists carries none of the same liabilities. Many groups and individuals consider that psychiatrists are pretty much a lost cause anyway.

The call to action clearly states that psychiatrists should immediately contact a teenager or attendees to a Star Trek convention in their area, where they can get the help they need. Though no one has specifically asked the teenagers or Trekkies whether they will provide the screening, Citizens for Common Sense urges psychiatrists to try anyway and hope for the best. Mr. Studson adds, "You're a member of the most distrusted and ridiculed industry on the planet; your group has the highest rate of suicide and arrests for abuse and fraud. What have you got to lose?"

Psychiatrist David Shaffer of TeenScreen in New York could not be reached for comment, unless you consider "get lost, I'm busy screening my gerbil" as a comment.

http://www.news.com.au/heraldsun/story/0,21985,21633842-662,00.html

"CHILDREN as young as three are taking antidepressants despite Federal Government warnings of their dangerous side effects.

Yet according to Health Department figures 1047 prescriptions were written for children up to four over nine months last year, and in 2006 some 145,410 scripts were given to people under 20.

The under four age group figure was met with scepticism by the Royal Australian and New Zealand College of Psychiatrists, but the Health Department insisted there were infants on antidepressants.

The Herald Sun knows of a three-year-old on antidepressants, though her guardian asked not to be identified.

The reasons the child has been prescribed the drugs has been kept under wraps.

SSRI (selective serotonin reuptake inhibitor) antidepressants, which include Prozac, treat depression, anxiety and obsessive compulsive disorder.

But research has shown they increase the risk of suicidal thoughts among children.

The Therapeutic Goods Administration has cautioned against their use in children, leaving it up to the judgment of doctors. "

Not just TeenScreen,  newborn babies have been placed in the 'target area' for some time:

http://www.fmhi.usf.edu/institute/pubs/pdf/ahca/2002infant-toddler-mhs.pdf

http://www.unison.ie/irish_independent/stories.php3?ca=9&si=1821883&issue_id=15572

The Sunday Independent (Ireland)
The drugs don't work, warn top psychiatrists
TOM PRENDEVILLE

A DAMNING indictment by the country's most eminent psychiatrists paints a picture of patients' lives being needlessly put at risk by a cocktail of dangerous drugs, and a profession which is in the back pocket of vested interests in the pharmaceutical industry.

"The psychiatric world has to be cleaned up - it's appalling. There are over 200,000 people on over-the-counter tranquilliser drugs," says Dr Michael Corry, a consultant psychiatrist.

"In Ireland, there are 25,000 people on Zyprexa and 20,000 people on Seroxat. With Seroxat, there is a one-in-500 suicide risk. They get totally overwhelmed by a sense of disinhibition, and they literally feel they can't go on, and they kill themselves."

Coincidentally, a damning Oireachtas report on the adverse side effects of pharmaceuticals, which was released last week, has come to more or less the same conclusions.

The report stated that "the influence of the pharmaceutical industry is unhealthy". It also called into question the relationship between the pharmaceutical companies and psychiatric doctors, who are financially rewarded in the form of payments for ghostwriting medical-research reports, get free travel, research grants and numerous other perks.

The all-party committee report also took a swipe at the widespread prescribing of psychiatric drugs. "Their [drugs] use in therapy represents unwarranted medical intervention in what are often normal emotional difficulties," they said. "The side effects include behavioural disorders, physical illness, dependence and even suicide."

The report went on to say that some of the drugs "were of doubtful benefit" and that "where side effects are well known, they seem not to be appreciated or are ignored by prescribers".

The Oireachtas Committee is now calling for the setting up of a Patient Safety Agency.

Other senior doctors raise the issue of the use of drugs such as Clozaril, a widely used schizophrenia drug which can produce a litany of life-threatening reactions.

"It's a very dangerous drug - and it's not the only one," said Dr Corry, who runs the Dun Laoghaire-based Institute of Psychosocial Medicine.

"It's an absolute scandal that the Medicines Board has licensed these drugs - surely they can unlicense them, seeing as we have clear irrefutable evidence they are dangerous?"

Professor Pat Bracken, consultant psychiatrist and clinical director of the West Cork Mental Health Service, says that many of the woes befalling psychiatry can be directly traced to the vast influence which the pharmaceutical industry now wields over the academic faculties that teach psychiatry - an influence gained through the doling out of vast research grants.

"There are growing concerns about the way in which the pharmaceutical industry has come to dominate psychiatry," he warns. "The profession should be independent and be seen to be independent. And if it is not, it is a concern for everyone."

http://www.seniorjournal.com/NEWS/Politics/2007/7-04-30-ConsumersUnion.htm

Consumers Union Calls for Congress to Act Now on Drug Safety

FDA questions about Zyprexa data highlights Senate vote this week

April 30, 2007 - The news last week that the Food and Drug Administration is examining whether the maker of Zyprexa failed to submit clinical trial data about the harmful side effects of the antipsychotic drug underscores the urgent need for Congress to pass drug-safety legislation, says Consumers Union. The Senate is slated to vote on a package of reforms this week.

“We’ve seen too many cases where drug companies downplayed, hid or ‘forgot’ their clinical trial data that showed harmful side effects, and patients ultimately suffered,” said Bill Vaughan, senior policy analyst for Consumers Union, publisher of Consumer Reports.

“Congress has got to put a stop to this gaming of the safety system by the drug companies, and pass real reforms now that make drug-risk information public.”

The New York Times reported that the FDA has questions about an Eli Lilly & Co. document from February 2000 that found patients taking Zyprexa in a clinical trial were three and half times as likely to develop high blood sugar as a placebo.

The document was not submitted to the FDA, and a few months later Lilly provided data to the agency that showed almost no difference in blood sugar between patients who took Zyprexa and those who did not. Untreated high blood sugar can eventually lead to diabetes.

In explaining the discrepancy, Eli Lilly told the Times the document was a preliminary analysis, and a final quality check of the data found that the analysis was incorrect.

The Senate is tentatively slated to vote this week on a major prescription drug bill that includes numerous safety reforms. The legislation includes requiring drug companies to register and make public most clinical trial results, as well as giving the FDA the authority to require label changes, post-market safety studies and other tools to monitor drugs for safety issues once they are on the market.

 “The Senate has an opportunity to pass a common-sense bill that will better protect patients from drug risks, while still ensuring life-saving medicines get quickly to market,” Vaughan said. “Patients and their doctors need to know the risks of a drug, and Congress has the power to stand up to the drug companies and make that happen.”