Archive for October, 2010

Carrollton Mother In Murders-Suicide Took Depression Meds

Friday, October 8th, 2010

Note from CCHR:  While the US FDA and international drug regulatory agencies finally issued black box warnings that antidepressants can cause suicide, (they were aware of this as far back as 1991), they have failed to issue black box warnings on antidepressant and other psychiatric drug inducing violence and homicide,  despite these facts:

The FDA’s Safety Information and Adverse Event Reporting Program reported “homicidal ideation” as an adverse event of one antidepressant, Effexor

• 10 out of the last 12 U.S. school shooters were under the influence of psychiatric drugs at the time of the shooting (with others, their records remain sealed)

• July, 2009, the FDA warned the antidepressants Zyban and Wellbutrin could cause changes in behavior, hostility, agitation, depressed mood, suicidal thoughts and behavior, and attempted suicide.

In May 2009, The Japanese Ministry of Health, Labor and Welfare revised the label warnings on newer antidepressants stating, “There are cases where we cannot rule out a causal relationship [of hostility, anxiety, and sudden acts of violence] with the medication.”

For all drug regulatory warnings and studies on antidepressants and other psychiatric drugs causing violence, go to http://www.cchrint.org/psychdrugdangers/drug_warnings.php and simply type in violence in the Search field

Also watch these special reports from Fox National News http://www.youtube.com/watch?v=tdvL5v8s2ec http://www.youtube.com/watch?v=9S-7aNPf33A


WTOV 9  CARROLLTON, Ohio

October 8, 2010

The Carroll County coroner said a woman who police said killed her two young children before taking her own life on Wednesday had been taking medication for depression.  Coroner Mandal Haas said Thursday that 24-year-old Madison Hallett hadn’t given any indication that she would kill her children.

Police said Hallett first shot and killed her 6-year-old daughter, Natalya Marie Carosiellie, while the girl was in bed. Hallett then went to another bedroom, where police said she shot and killed her 18-month-old son, Drayden W. Hallett-Warnick, while he was sleeping in his crib.  Police said Hallett then turned the gun on herself, and her body was found next to her son’s crib.Next to Natalya’s bed, police said they found five handwritten letters from Hallett.

In one of the letters, she apologized to police for the gruesome scene they were forced to investigate.  Carroll County Sheriff Dale Williams said Hallett’s suicide notes essentially said she was tired of life as it is and didn’t want her children to go through that. Hallett was an Army reservist and her father said she was set to be deployed in about a month. She was also a third-year student at Kent State University’s Tuscarawas campus, where she made straight-As studying nursing and criminal justice.

Read the rest of this story here:  http://www.wtov9.com/news/25326599/detail.html

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Confronting Bigots Intolerant of Alternative Mental Health Treatment

Wednesday, October 6th, 2010

Huffington Post, October 6, 2010

by Bruce E. Levine

“Webster’s Dictionary” defines bigot as “a person who is utterly intolerant of any differing creed, belief, or opinion.” Despite the success of alternative mental health treatments for many people, there still exists bigotry against these approaches.

For many self-defined “ex-mental health patients,” “mental health treatment consumers,” and “psychiatric survivors” who attended Alternatives 2010 Conference (September 29 through October 3 in Anaheim, California), D.J. Jaffe’s September 30, 2010 The Huffington Post piece, “People with Mental Illness Shunned by Alternatives 2010 Conference in Anaheim” was insulting. Mr. Jaffe writes of the Alternatives 2010 Conference:

By failing to include ‘people with mental illness’ in the list of ‘consumers’ and ‘survivors’ who are invited, they are sending a not-so-subtle message: mentally ill not welcome.

Mr. Jaffe’s statement can most politely be described as disingenuous. Mr. Jaffe knows full well that the Alternatives Conferences are attended by many people who have been in fact diagnosed with schizophrenia, schizoaffective disorder, bipolar disorder, and other serious mental illnesses, but who have found that neither their diagnoses nor their standard treatments have been helpful. In other words, not only does the Alternative Conference welcome people who have been labeled as mentally ill, the conference celebrates them, and provides them an arena and a platform.

Why is there a need for alternatives to standard drug treatments? A long-term outcome study of schizophrenic patients who were treated with and without psychiatric drugs was published in 2007 in the Journal of Nervous and Mental Disorders. Funded by the National Institute of Mental Health, research psychologist Martin Harrow, at the University of Illinois College of Medicine, discovered that after 4.5 years, 39 percent of the non-medicated group were “in recovery” and 60 percent had jobs. In contrast, during that same time period, the condition of the medicated patients worsened, with only six percent in recovery and few holding jobs. At the fifteen-year follow-up, among the non-drug group, only 28 percent suffered from any psychotic symptoms; in contrast, among the medicated group, 64 were actively psychotic.

Read the rest of the article here: http://www.huffingtonpost.com/bruce-e-levine/confronting-bigots-intole_b_749836.html

For more information on the success of treating patients diagnosed “schizophrenic” without the use of psychiatric drugs,  read about the work of psychiatrist Loren Mosher, former Chief of Schizophrenic Research for the National Institute of Mental Health (NIMH) and founder of Soteria House http://www.moshersoteria.com/about.htm

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Booming Sales of Antipsychotic Drugs Often Fueled by Illegal Marketing Tactics

Wednesday, October 6th, 2010

FairWarning, October 6, 2010

By Jessica Roberts 

Antipsychotic drugs, once used to treat only the most serious mental illnesses, have emerged as the top-selling class of pharmaceuticals in the U.S., generating annual revenue of about $14.6 billion. Yet much of the sales boom has been achieved with illegal or controversial marketing tactics by major pharmaceutical companies to promote uses of the drugs that have not been approved by the U.S. Food and Drug Administration.

The result, according to an account by The New York Times, is that every major manufacturer of antipsychotic drugs — Bristol-Myers Squibb, Eli Lilly, Pfizer, AstraZeneca and Johnson & Johnson  — has recently settled criminal or civil government cases for hundreds of millions of dollars or is under investigation by the Department of Justice for possible health care fraud. The criminal fines paid by Eli Lilly and Pfizer last year set records last year for the largest criminal fines ever imposed on corporations, although in the case of Pfizer, the case was built only partly on the marketing of an antipsychotic drug.

In their defense, the companies say that they follow tight business ethics guidelines and that all possible side effects of their medicines are fully disclosed. Recently, however, the government has warned that some of the drugs may be fatal for older patients and have unknown effects on children. And critics question how drugs approved by the agency for use by 1 percent of the population, to treat illnesses such as schizophrenia and bipolar mania, could have turned into top sellers, prescribed for everyone from preschoolers to octogenarians.

At least part of the answer lies in the companies’ marketing tactics. The Times reports that civil and criminal lawsuits against big pharmaceutical companies have revealed hundreds of documents showing that some company officials knew they were using questionable tactics when they marketed these powerful, expensive drugs.

According to analysts and court documents, these tactics have included payments, gifts, meals and trips for doctors, biased studies, and ghostwritten medical journal articles. These all are meant, federal investigators say, to promote the benefits and downplay the risks of the drugs, while encouraging off-label uses — that is, uses the FDA has not approved but which doctors, if they choose, can pursue with their patients anyway.

Drug companies skirt restrictions on promoting off-label uses by hiring consultants, researchers and educators to handle the job, delivering the marketing message verbally and through company-sponsored studies. “They can give a small hint, and people will take the bait,” Dr. Robert Rosenheck, a professor of psychiatry and public health at the Yale School of Medicine, told the Times. “Psychiatric disorders are vaguely defined enough that you can stretch definitions.”

The Justice Department claims drug companies trained sales representatives to rebut valid medical concerns about unproved uses of antipsychotic drugs. For example, the department says, Eli Lilly produced a video called “The Myth of Diabetes” to sell Zyprexa, which became its all-time best-selling drug, even though evidence showed that Zyprexa could cause diabetes.

Read the rest of this article here: http://www.fairwarning.org/2010/10/booming-sales-of-antipsychotic-drugs-often-fueled-by-illegal-marketing-tactics/

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Note to all press running “ADHD linked to depression/suicide” study—its bogus

Tuesday, October 5th, 2010

by CCHR International

A cursory look at the study purporting that “ADHD in Children Linked to Depression and Higher Suicide Risk” revealed its obvious and glaring flaws, and we are forced to ask why so-called medical websites such as WebMD or Medical News Today were unable to accomplish what took us about ½ hour to uncover—what was clearly omitted from this “study.”

The study claims that “Children who are diagnosed with ADHD (Attention-Deficit/Hyperactivity Disorder) have a higher chance of developing  depression and/or attempting suicide during their teenage years, or 5 to 13 years after being diagnosed, say researchers in a new article published in Archives of General Psychiatry..”

Why none of the press or medical websites are questioning what drugs the “ADHD” children in this study were already taking and what effect this could have on developing depression or suicidality…. we leave to the reader.   But this is fact; the stimulant drugs such as  Ritalin, Concerta, Adderall, etc, that are prescribed to children diagnosed with  “ADHD” have been documented by the FDA to have side effects including hallucinations, delusional thinking, mania, psychosis, aggression, violence, hostility, drug dependence and suicide and depression. The documented side effects and international drug regulatory warnings on these drugs (including withdrawal) can be found here: http://www.cchrint.org/psychdrugdangers/drug_warnings.php

The study itself reveals that the “ADHD” children being studied were from Pittsburgh and Chicago—and this key fact; all the “ADHD” children from Chicago  were recruited from a child psychiatric clinic and  42% of the “ADHD” children from Pittsburgh were also recruited from a psychiatric clinic.

The fact that the children diagnosed ADHD were recruited from psychiatric clinics nearly guarantees they were already taking psychiatric drugs or minimally had been on these drugs at some point to “treat” their ADHD diagnoses.   Moreover,  those “ADHD” children in the study who the researchers claim “developed depression,” not only should we know whether they were already on stimulant drugs which caused these side effects, but also if they were subsequently prescribed antidepressants to “treat” the depression,  considering antidepressants carry black box warnings for suicidality and also are known to cause worsening depression.

The main issue here is why none of those publishing and thereby promoting the content of this study as factual bothered to pose these simple, logical questions, or read the study themselves before passing it on as factual, potentially influencing the public at large with something that could effect their lives or the lives of their children.

As a side note…Two of the listed study authors are:

Dr. Andrea Chronis-Tuscano,  has received research support and honoraria from McNeil Pediatrics.  McNeil Pediatrics  is a division of Ortho-McNeil Janssen pharmaceuticals Inc which sells Concerta.

Dr. William E.  Pelham has received research support from Eli Lilly and honoraria from Janssen Pharmaceuticals.

And that, is the story that isn’t being told.

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Drug Firms Face Bribery Probe from US Department of Justice

Tuesday, October 5th, 2010

Justice Department, SEC Seek Information From Companies on Payments to Overseas Officials

Wall Street Journal, October 5, 2010

by Michael Rothfeld

Federal investigators are looking at ways that drug makers could be paying bribes overseas to boost sales and speed approvals, according to letters sent to the companies and people close to the matter.

Big companies—including Merck & Co., AstraZeneca PLC, Bristol-Myers Squibb Co. and GlaxoSmithKline PLC—in recent months have disclosed they are being investigated for possible violations of a 1977 law that makes it illegal for companies whose stock is traded in the U.S. to bribe government officials in other countries to get business.

[PHARMA]

The companies said they are cooperating with the government, with several adding that the investigation is industry-wide and broader than their companies specifically. Many said they have policies meant to ensure compliance with the Foreign Corrupt Practices Act.

So far, none of the companies has been accused of wrongdoing, and the investigation ultimately may not result in charges.

The Justice Department and the Securities and Exchange Commission requested that companies voluntarily report any violations of the FCPA. Some companies, including SciClone Pharmaceuticals Inc. and Eli Lilly & Co., disclosed receiving subpoenas from the SEC. Baxter International Inc. also has said it is being investigated.

The investigation is targeting transactions in Brazil, China, Germany, Italy, Poland, Russia and Saudi Arabia, people familiar with the matter said.

The Justice Department and the SEC declined to comment.

Such requests from the government typically kick off internal investigations at companies, which generally comply with the requests in order to win leniency from the government if a violation is found.

A lawyer for one drug company said the industry has been vexed because the recent requests were so broad and because the investigations, across operations in several countries, can cost millions of dollars.

“If you don’t have any specifics, a lot of this is just guesswork,” the lawyer said. “Everyone was running around to get in the door to meet with the government so they can better understand what the issues are.”

Letters from the government to one of the companies, which were reviewed by The Wall Street Journal, identified four types of possible violations: bribing government-employed doctors to purchase drugs; paying company sales agents commissions that are passed along to government doctors; paying hospital committees to approve drug purchases; and paying regulators to win drug approvals.

People familiar with the situation said the other companies received similar letters.

The requests are similar to the government’s actions in an older bribery probe involving medical devices. In that investigation, settlement talks are ongoing with several companies, according to a person familiar with the matter.

Representatives for Merck, AstraZeneca, Bristol-Myers, Glaxo and Baxter declined to comment on the probe beyond saying they were cooperating fully with the government.

A SciClone spokeswoman declined to comment beyond the company’s SEC filings, in which it said it was subpoenaed for documents relating to its practices in China. A Lilly spokesman referred to an SEC filing in which the company said the U.S. government expanded to other countries an investigation of its Polish subsidiaries that began in 2003.

U.S. officials and European regulators have become increasingly aggressive in investigating foreign bribery cases in recent years. U.S. officials recently have threatened to file charges against executives and not just their companies.

The pharmaceutical industry is particularly vulnerable because government plays a bigger role in administering medicine in many foreign countries than it does in the U.S. and drugs are highly regulated, which creates contact with public officials. Doctors and hospital administrators often are government employees overseas.

Some of the alleged bribes could involve payments to doctors to influence drug trials, people familiar with the situation said. Justice Department officials have said publicly that drug companies also could face charges if they bribe government officials in the guise of payment for travel, meals, entertainment or speaking fees.

Read the rest of this article here: http://online.wsj.com/article/SB10001424052748704847104575532091781199092.html

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“Just another prick in the wall” — Psychiatry’s Quest for Dominance and Control

Monday, October 4th, 2010

Psychiatry’s quest for total dominance and control


By Dominik Ritter, Psychologist
October 4, 2010

When thinking about psychiatry I find it hard to escape the comparison with the work carried out at assembly lines of large manufacturing companies and the process involved when faulty products are called back for inspection and repair. All mass produced goods are meant to basically look and function in the same way. The same can be said about the people in a state that promotes the idea of a moral code of conduct (e.g. Diagnostic and Statistical Manual of Mental Disorders, DSM). Through socialization and education we learn about what behaviours are appropriate and how one should feel and think about things. If individuals are judged to be “damaged” or “just not right”, they are sent away to be properly assessed and corrected. A whole army of “Quickfitters” is there to sort you out when you seem to have broken down and not function properly anymore, even if you don’t want that (well, actually, especially then).

It all seems to be about the intolerance of diversity and difference and the quest for total dominance and control, which results in the persecution and punishment of those individuals who step out of line as they are deemed to be out of order and in urgent need of corrective measures. The faultiness, that one is accused of, really boils down to a lack of conformity and obedience, i.e. behaving, thinking and feeling as directed by those who think they know best (e.g. mental health professionals).

Now, doesn’t that all sound strangely familiar? It is frighteningly similar to Huxley’s “Brave New World” (1932). Huxley’s world is built upon the principles of Henry Ford’s assembly line, i.e. mass production, homogeneity, predictability, and consumption of disposable consumer goods. From the beginning of life, members of every class are indoctrinated by recorded voices repeating slogans while they sleep to believe that their own class is best for them. Any residual unhappiness is resolved by an antidepressant and hallucinogenic drug called soma.

So what happens once you find yourself in the (dis-)comfort of a so called “mental hospital”? To understand this one first needs to call these facilities by their appropriate names. Correctional facilities or conversion centres are probably the most adequate terms to be applied to these institutions. The main task of these facilities is to stop you misbehaving and to start acting according to their rules. Resistance and protest, which is very understandable in situations when your liberty is taken away from you and you are being forced to comply and conform, is quickly regarded as just another expression of the seriousness of your faultiness and thus requires more intensive treatment (i.e. more force and violence).

It is true that psychiatric interventions (e.g. pharmacological, electroconvulsive, and conversational treatments) are often successful. But what does that actually mean? In psychiatric terms this means that one has managed to reduce (in terms of frequency and/or intensity) or remove particular symptoms (i.e. a bunch of undesirable behaviours). This could be because he/she simply does not want to be a mental patient any longer and just plays along according to the psychiatric rules. This can of course mean that one is denying one’s own thoughts, feelings, values, and aspirations, in order to please one’s masters, captors and owners. Alternatively, he/she might actually believe that psychiatric interventions are an effective way of combating what he he/she believes to be a psychological problem. Beliefs are important here, just as in the religious sphere of theological interventions such as confessions (being repentant, paying penance and being ultimately forgiven for one’s sins). However, just like in the case of religion, having undergone successful theological treatment does not prove that one has been possessed by a demon (or that one’s behaviour has been caused by some sort of mental illness) or that one would otherwise have been condemned to go to hell (or destined to suffer from a lifelong mental illness). So what is it that has ultimately been treated or cured? I would argue that one has abolished misbehaviour, and replaced it with compliance and obedience. One has simply been successfully shut up (both literally and metaphorically).

Man’s hunger for power seems insatiable. Many pursuits of mankind (e.g. religion, politics, science, etc.) have been attempts to control and dominate, and they remain locked in a constant battle with each other over maximising their influence and power. Science, for example, has always followed its agenda to control and dominate nature (e.g. natural resources, diseases, etc.), something that in modern history has been expanded to include other human beings, as they are simply regarded as byproducts of nature. Psychiatrists, who arguably represent the discipline of medicine, have for hundred of years argued that social problems are caused by mental illness, and maintained that they should be given sole power to cure the diseased minds. This has resulted in psychiatry having successfully created a monopoly for the assessment and response to all sorts of human affairs. It has grown to an immensely powerful institution (only rivalled by totalitarian systems) of being able to define what constitutes “mental illness” (legislative power), judge what kinds of behaviours, thoughts and feelings signify “mental illness” (judiciary power), and punish those who are judged to be “mentally ill” by means of enforced incarceration, drugging, shocking, and moral therapy (executive power).

Rather than having to think about having to make the effort of time-consuming, large scale and wide ranging changes within society, the idea that there is simply something wrong with a bunch of individuals and that everything is going to be alright once their heads have been sorted out,  seems  comforting and appealing. Any form of dissent, disobedience  or non-conformity in relation to the predominant mental health ideology quickly becomes labelled as a form of mental illness. Let’s take the example of one of the most widespread psychiatric diagnoses amongst children and adolescents in the world, i.e. ADHD (Attention Deficit Hyperactivity Disorder). I argue that this psychiatric diagnosis pathologises childhood behaviour of not paying attention, having a lot of energy, and not wanting to sit still for hours on end. What these children might be guilty of are the “crimes” of striving for independence and autonomy, questioning the usefulness of the curriculum, their assignments and homework, and challenging the arbitrariness of authority of being told what they should do and what they shouldn’t do. As a society we seem to have very rigid ideas of what we expect from each other, often to an extent that can only be described as questionable in terms of purpose, stifling and hindering any kind of progress. In short, it maintains the status quo, the way things have always been. But who benefits from all this? I would argue that it ultimately serves an elite class in society that holds the power to make decisions, such as the decision to punish children who misbehave according to their standards, by calling them names, drugging them, or imposing some form of moral therapy (e.g. correct ways of behaving, thinking and feeling). As already stated above, the psychiatric ideology provides an easy explanation and an easy solution. We are spared the inconvenience of having to venture down a different avenue, to explore a path off the beaten track. Psychiatry leads the way and we follow like stupid cattle. When we focus on something like “ADHD” we no longer think about more important issues such as the usefulness of the current national curriculum (e.g. what we think is important to teach our children; whether our education system is educating at all), classroom sizes, grading systems, the promotion of competitiveness at the expense of collaboration, lack of teaching resources, inadequate teacher training, staff turnover, etc.

What I have said about ADHD, can be applied to all so called psychiatric disorders, e.g. depression, autism, schizophrenia, personality disorder, etc. What all these psychiatric labels have in common is that they are applied when psychiatrists are of the opinion that there has been some form of misconduct, i.e. a transgression of a moral code. Throughout history and across cultures societies have always provided their own codes of conduct and guidelines of how one should behave and how to respond to people who broke the rules. The point I would like to make here, though, is that we are talking about morality (i.e. good and bad) here and not about science as psychiatry would have it. While one can argue that in the natural sciences things are being discovered (e.g. electricity, magnetism, etc.) the same cannot be said in the case of psychiatry. Here things are not discovered but simply defined. If mental illnesses were real illnesses (such as that of the brain) and not simply metaphors they would be called brain illnesses. Psychiatry, however, is not about what you have (a disease of the liver or heart that can be objectively measured) but about what you do. Various behaviours are simply clustered into symptom groups and given scientific sounding names. So, for example, if you are shy and do not enjoy going to parties you can easily be classified as suffering from an anxiety disorder called social anxiety disorder. One can easily create one’s own scientific sounding labels by arguing that certain behaviour patterns signify the existence of some underlying psychopathology. For example, one could label people who do not like to eat meat or use any kind of animal products as suffering from some kind of deep rooted animal anxiety. Likewise, one could come up with a similarly ludicrous idea of declaring people who happen to like to stand on their head while singing the national anthem as suffering from some kind of subversive personality disorder. The point here is that one simply does not discover underlying mental illnesses but simply attempts to arbitrarily categorise behaviours into groups and give them names. A real important issue here is that of name giving, that is to define things, which when done by a more powerful group (e.g. priests, doctors, academics, and politicians) and applied to a less powerful group (e.g. believers, ordinary citizens, patients, and students) is always problematic.

A final concern I have is the general view of people that is promoted by the therapeutic industry. It is argued that many people are simply too sick, unwell, disordered or distressed and therefore unable to help themselves. It creates an image of people in today’s society as vulnerable, weak and incompetent emotional wrecks who are in desperate need of some sort of help from the therapeutic state. This image of people being too stupid to sort out their own personal affairs gets repeated over and over again so that it becomes  deeply ingrained into our minds. Surely, the therapeutic apparatus is only one of many other sectors (e.g. litigation, education, child rearing, politics, etc.) that have continued to rob people of their experience, competence, right, duty and responsibility to deal with every day life and sort out their own difficulties. This continued professionalisation of everyday life has condemned people to passivity, indifference, and ignorance. It is no longer up to the general public to manage their own lives. It is up to the technocrats to do that for them, which according to this elitist class is in their very best interest.

Dominik Ritter is a psychologist, writer,  lecturer, social critic, and founder of the Blue Panthers Party, a critical psychiatry group.

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Antipschotic Drugs—Side Effects May Include Lawsuits

Monday, October 4th, 2010

The New York Times
By Duff Wilson
October 2, 2010

FOR decades, antipsychotic drugs were a niche product. Today, they’re the top-selling class of pharmaceuticals in America, generating annual revenue of about $14.6 billion and surpassing sales of even blockbusters like heart-protective statins.

cover
Department of Justice Statements on the Five Major Companies Selling Anti-Psychotic Drugs:
AstraZeneca
Bristol-Myers Squibb
Eli Lilly
Johnson and Johnson
Pfizer

While the effectiveness of antipsychotic drugs in some patients remains a matter of great debate, how these drugs became so ubiquitous and profitable is not. Big Pharma got behind them in the 1990s, when they were still seen as treatments for the most serious mental illnesses, like hallucinatory schizophrenia, and recast them for much broader uses, according to previously confidential industry documents that have been produced in a variety of court cases.

Anointed with names like Abilify and Geodon, the drugs were given to a broad swath of patients, from preschoolers to octogenarians. Today, more than a half-million youths take antipsychotic drugs, and fully one-quarter of nursing-home residents have used them. Yet recent government warnings say the drugs may be fatal to some older patients and have unknown effects on children.

The new generation of antipsychotics has also become the single biggest target of the False Claims Act, a federal law once largely aimed at fraud among military contractors. Every major company selling the drugs — Bristol-Myers Squibb, Eli Lilly, Pfizer, AstraZeneca and Johnson & Johnson — has either settled recent government cases for hundreds of millions of dollars or is currently under investigation for possible health care fraud.

Two of the settlements, involving charges of illegal marketing, set records last year for the largest criminal fines ever imposed on corporations. One involved Eli Lilly’s antipsychotic, Zyprexa; the other involved a guilty plea for Pfizer’s marketing of a pain pill, Bextra. In the Bextra case, the government also charged Pfizer with illegally marketing another antipsychotic, Geodon; Pfizer settled that part of the claim for $301 million, without admitting any wrongdoing.

The companies all say their antipsychotics are safe and effective in treating the conditions for which the Food and Drug Administration has approved them — mostly, schizophrenia and bipolar mania — and say they adhere to tight ethical guidelines in sales practices. The drug makers also say that there is a large population of patients who still haven’t taken the drugs but could benefit from them.

AstraZeneca, which markets Seroquel, the top-selling antipsychotic since 2005, says it developed such drugs because they have fewer side effects than older versions.

“It’s a drug that’s been studied in multiple clinical trials in various indications,” says Dr. Howard Hutchinson, AstraZeneca’s chief medical officer. “Getting these patients to be functioning members of society has a tremendous benefit in terms of their overall well-being and how they look at themselves, and to get that benefit, the patients are willing to accept some level of side effects.”

The industry continues to market antipsychotics aggressively, leading analysts to question how drugs approved by the Food and Drug Administration for about 1 percent of the population have become the pharmaceutical industry’s biggest sellers — despite recent crackdowns.

Some say the answer to that question isn’t complicated.

“It’s the money,” says Dr. Jerome L. Avorn, a Harvard medical professor and researcher. “When you’re selling $1 billion a year or more of a drug, it’s very tempting for a company to just ignore the traffic ticket and keep speeding.”

NEUROLEPTIC drugs — now known as antipsychotics — were first developed in the 1950s for use in anesthesia and then as powerful sedatives for patients with schizophrenia and other severe psychotic disorders, who previously might have received surgical lobotomies.

But patients often stopped taking those drugs, like Thorazine and Haldol, because they could cause a range of involuntary body movements, tics and restlessness.

A second generation of drugs, called atypical antipsychotics, was introduced in the ’90s and sold to doctors more broadly, on the basis that they were safer than the old ones — an assertion that regulators and researchers are continuing to review because the newer drugs appear to cause a range of other side effects, even if they cause fewer tics.

Contentions that the new drugs are superior have been “greatly exaggerated,” says Dr. Jeffrey A. Lieberman, chairman of the psychiatry department at Columbia University. Such assertions, he says, “may have been encouraged by an overly expectant community of clinicians and patients eager to believe in the power of new medications.”

“At the same time,” he adds, “the aggressive marketing of these drugs may have contributed to this enhanced perception of their effectiveness in the absence of empirical evidence.”

Others agree. “They sold the story they’re more safe, when they aren’t,” says Robert Whitaker, a journalist who has written two books about psychiatric medicines. “They had to cover up the problems. Right from the start, we got this false story.”

The drug companies say all the possible side effects are fully disclosed to the F.D.A., doctors and patients. Side effects like drowsiness, nausea, weight gain, involuntary body movements and links to diabetes are listed on the label. The companies say they have a generally safe record in treating a difficult disease and are fighting lawsuits in which some patients claim harm.

The cases, both civil and criminal, against many of the world’s largest drug makers have unveiled hundreds of previously confidential documents showing that some company officials were aware they were using questionable tactics when they marketed these powerful, expensive drugs.

Such marketing, according to analysts and court documents, included payments, gifts, meals and trips for doctors, biased studies, ghostwritten medical journal articles, promotional conference appearances, and payments for postgraduate medical education that encourages a pro-drug outlook among doctors. All of these are tools that federal investigators say companies have used to exaggerate benefits, play down risks and promote off-label uses, meaning those the F.D.A. hasn’t approved.

Lawyers suing AstraZeneca say documents they have unearthed show that the company tried to hide the risks of diabetes and weight gain associated with the new drugs. Positive studies were hyped, the documents show; negative ones were filed away.

According to company e-mails unsealed in civil lawsuits, AstraZeneca “buried” — a manager’s term — a 1997 study showing that users of Seroquel, then a new antipsychotic, gained 11 pounds a year, while the company publicized a study that asserted they lost weight. Company e-mail messages also refer to doing a “great smoke-and-mirrors job” on an unfavorable study.

“The larger issue is how do we face the outside world when they begin to criticize us for suppressing data,” John Tumas, then AstraZeneca’s publications manager, wrote in a 1999 e-mail. “We must find a way to diminish the negative findings,” he added. “But, in my opinion, we cannot hide them.”

Tony Jewell, an AstraZeneca spokesman, said last week that the company had turned over all that material to the F.D.A. as part of the approval process and updated its label over the years to show the latest safety information.

Dr. Stefan P. Kruszewski, a Harvard-educated psychiatrist who once worked as a paid speaker for several drug makers, became a government informant and now consults for plaintiffs suing drug companies. Earlier in his career, he spoke at events for Pfizer, GlaxoSmithKline and Johnson & Johnson as an advocate of antipsychotics. He said one company offered him incentives of $1,000 or more every time he talked to an individual doctor about one of its drugs.

“When I started speaking for companies in the late 1980s and early ’90s, I was allowed to say what I thought I should say consistent with the science,” he recalls. “Then it got to the point where I was no longer allowed to do that. I was given slides and told, ‘We’ll give you a thousand dollars if you say this for a half-hour.’ And I said: ‘I can’t say that. It isn’t true.’ ”

Slides for one new antipsychotic drug contended that it had no neurological side effects. “They made it all up,” Dr. Kruszewski said. “It was never true.”

Read entire article:  http://www.nytimes.com/2010/10/03/business/03psych.html?_r=2

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Many Jailed Teens Get Anti-Psychotic Drugs As Sedatives

Saturday, October 2nd, 2010

The Crime Report

Saturday, October 2nd, 2010

Many youths incarcerated in juvenile facilities are getting potent anti-psychotic drugs intended for bipolar or schizophrenic patients, even when they have not been diagnosed with either disorder, reports Youth Today. State juvenile systems answered a survey on their use of these anti-psychotics – called “atypicals.” Only 16 states responded, meaning that a majority of states either would not or could not demonstrate that they were even monitoring the use of these medications on incarcerated juveniles.

The atypical anti-psychotics were being used to treat a wide variety of diagnoses, including intermittent explosive disorder, oppositional defiant disorder, and even the more common attention deficit and hyperactivity disorder. Critics believe most of these diagnoses are simply a cover for the fact that prisons now use drugs as a substitute for banned physical restraints that once were used on juveniles who aggressively acted out. “Fifty years ago, we were tying kids up with leather straps, but now that offends people, so instead we drug them,” says Robert Jacobs, a former Florida psychologist and lawyer who now practices psychology in Australia. “We cover it up with some justification that there is some medical reason, which there is not.” Supporters of prescribing the atypicals believe using the drugs as sedation isn’t necessarily bad. “It prepares youth so they can respond to treatment,” says LeAdelle Phelps, a former juvenile facility director and adolescent psychologist. “By reducing aggression and by having calming, soothing effects,” the anti-psychotic makes residents “more malleable.”

http://thecrimereport.org/2010/10/02/many-jailed-teens-get-anti-psychotic-drugs-as-sedatives/

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Sex, Lies and Pharmaceuticals—How Female Sexual Dysfunction (a “mental disorder”) was invented by the drug industry

Friday, October 1st, 2010

The Independent
By Jeremy Laurance
October 1, 2010

Female sexual dysfunction – which is claimed to affect up to two thirds of women – is a disorder invented by the pharmaceutical industry to build global markets for drugs to treat it, it is claimed today.

Drug companies have invested millions in the search for a female equivalent of Viagra, so far without success. But while doing so they have stoked demand by creating a buzz around the disorder they have created, according to Ray Moynihan, a lecturer at the University of Newcastle in Australia.

Corporate employees worked with medical opinion leaders, ran surveys aimed at portraying the problem as widespread and helped create the diagnostic instruments to persuade women that their sexual difficulties deserved a medical label. But sex problems in women are far more complex than they are in men, encompassing lack of desire, lack of arousal and lack of orgasm and the drug industry’s narrow focus is failing them.

Mr Moynihan, who first investigated the drug industry’s role in female sexual dysfunction a decade ago, says it illustrates a wider problem about the creation of new diseases, and the widening of existing boundaries for treatment with designations such as pre-diabetes, pre-hypertension and pre-osteoporosis, for which the latest treatments are aggressively promoted.

In his new book, Sex, Lies and Pharmaceuticals, which is previewed in the British Medical Journal, he says: “Drug marketing is merging with medical science in a fascinating and frightening way. Perhaps it is time to reassess the way in which the medical establishment defines common conditions and recommends how to treat them.”

In 2005, Pfizer, makers of Viagra, funded a survey which showed 63 per cent of women had sexual dysfunction and that testosterone and Viagra might be helpful. In 2006, Procter and Gamble, makers of a testosterone patch for women, sponsored a survey showing one in 10 postmenopausal women had hypoactive [low] sexual desire disorder (the company sold its drug business in 2009). In 2008, Boehringer Ingelheim, makers of flibanserin which is claimed to boost the female libido, sponsored a survey which also showed one in 10 women was in need of help.

Efforts by the companies to meet the need have subsequently foundered. Pfizer pulled Viagra from the market for women after trials showed it had no greater effect than placebo. Procter and Gamble’s testosterone patch was rejected in 2004 in the US, over fears it raised the risk of cancer and heart disease and Beohringer Ingelheim’s drug, flibanserin, was rejected by the US Food and Drug Administration in June on the grounds it had failed to deliver the agreed benefits while carrying the risk of serious side effects.

Mr Moynihan warns that although the drugs have so far failed, more are in the pipeline and claims that “the drug industry shows no signs of abandoning plans to meet the unmet need it has helped to manufacture”. A spokesman for Pfizer said: “We currently have no plans to develop medicines for FSD.”

Read entire article here:  http://www.independent.co.uk/life-style/health-and-families/health-news/female-sexual-dysfunction-was-invented-by-drugs-industry-2094578.html

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