Archive for March, 2010

UK: Pregnant women warned about antidepressants

Friday, March 12th, 2010

Bounty
March 12, 2010

Women expecting a baby have been warned over taking Prozac while they are pregnant, after a new study found it could be harmful to an unborn child.

According to a study from the Medicines and Healthcare Products Regulatory Agency there is a “small risk” of babies developing heart problems should their mother take the drug early on in their pregnancy.

The researchers behind the study said that pregnant mothers who use Prozac could be twice as likely to have children with a congenital heart problem, such as a murmur, or a hole in the heart.

Read entire article:  http://www.bounty.com/node/2191

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Massachusetts joins federal lawsuit accusing Johnson & Johnson of paying kickbacks to push their antipsychotic drug

Thursday, March 11th, 2010

Fierce Pharma
By Tracy Staton
March 11, 2010

The Massachusetts attorney general joined that federal lawsuit accusing Johnson & Johnson of paying kickbacks to push the antipsychotic Risperdal and other drugs into nursing homes. AG Martha Coakley didn’t stop there; however, her office is also investigating other companies that market antipsychotics to nursing homes in the state.

At issue is whether drug companies are touting antipsychotic drugs for unapproved uses, such as dementia. The FDA has warned that use of the atypical antipsychotics in elderly dementia patients can increase the risk of death. “The inappropriate off-label marketing of antipsychotic drugs to nursing homes is a significant health and safety issue for our seniors,” Coakley says in a statement released by her office (as quoted by the Boston Globe). “We have taken strong action on this issue in the past and are continuing to monitor it very closely moving forward.”

Read entire article:  http://www.fiercepharma.com/story/massachusetts-joins-kickback-suit-against-j-j/2010-03-11

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“ADHD Is Not a Disease”

Wednesday, March 10th, 2010

Total Health Breakthroughs
By Jon Herring
March 10, 2010

“Hey, Phillip… do you mind if I sit here and eat with you?” I asked.

“Sure, whatever…”

“How’s school going? Are you doing well?”

“Not really. I just want it to be summer.”

“Yeah, I remember how that used to feel,” I told him.

Phillip is eleven years old. He’s the son of some family friends and I was at a small party when I saw him sitting by himself. I hadn’t seen him for a few years, so I wanted to remind him who I was and get to know him a little better.

As he became comfortable, he opened up a bit more. He told me his plans for the summer. He told me about his friends and the girl he likes at school. And he also told me that he didn’t care for school all that much.

“It’s hard,” he said. “Plus, I have ADHD, so I don’t pay attention very well.”

“Really? How do you know you have ADHD?” I asked.

“That’s what my doctor said. He said I’ve had it since I was born. That’s why I have to take medicine.”

“Well, I think you’re just fine. How does that medicine make you feel?”

“It used to make me kinda nervous,” he said. “And I couldn’t go to sleep when I took it. Now, it just makes me not want to eat.”

After complimenting Phillip on his manners and intelligence, I changed the subject back to his plans for the summer. But what he said bothered me. Here was a bright young boy who was bored and frustrated in school… who probably had a few behavioral problems… and who had now been labeled as having a “disease” and put on medication.

And, unfortunately, Phillip is just one of millions…

Read entire article:  http://www.totalhealthbreakthroughs.com/2010/03/adhd-is-not-a-disease/

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Internal documents show drug company marketed their antipsychotic Risperdal for unapproved usage on elderly & kids

Wednesday, March 10th, 2010

Bloomberg.com
By Margaret Cronin Fisk, Jef Feeley and David Voreacos
March 10, 2010

Johnson & Johnson made plans to reach $302 million in geriatric sales for its antipsychotic Risperdal just months after federal regulators said the company falsely claimed the drug was safe and effective with the elderly, according to internal documents.

The U.S. Food and Drug Administration told J&J in 1999 that its marketing materials for geriatric patients overstated Risperdal’s benefits and minimized risks. A J&J business plan for the next year called for increasing the drug’s market share for elderly dementia sales, an unapproved use, according to newly unsealed documents in a lawsuit by the state of Louisiana.

“The geriatric market represents Risperdal’s second wave of growth,” J&J officials wrote in the business plan. “The aging population will continue to drive market growth well into the next century.”

Louisiana officials cited the document and dozens of other internal J&J files in its lawsuit claiming the company marketed Risperdal to the elderly and children for unapproved uses. Professor Jerry Avorn of Harvard Medical School, who isn’t involved in the case, called the papers “one of the more egregious examples” of marketing drugs to vulnerable patients.

“By 2010, most grownups in medicine know that drug companies resort to unsavory practices to promote drugs, but seeing such clear evidence in black and white of the details of a campaign like this is still pretty upsetting,” Avorn said.

Read entire article:  http://www.bloomberg.com/apps/news?pid=20601109&sid=ag4Ya8UOIob0&pos=13

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Its about time…With drug companies paying criminal fines of $7 billion, FDA to increase prosecution of Pharma Execs

Tuesday, March 9th, 2010

Pharmalot
By Ed Silverman
March 4, 2010

The FDA plans to increase misdemeanor prosecutions of industry execs as it looks to refocus its Office of Criminal Investigations (see this letter to the Senate Finance committee). The move comes in response to a new report from the General Accountability Office that the OCI suffers from lax oversight, despite increased in funding and staffing over the past decade. In fact, the FDA hasn’t reviewed most OCI offices in more than three years. The OCI investigates counterfeit drugs and other bad stuff, as well as misconduct by FDA employees.

The GAO concluded the FDA “has relied largely on the OCI director to determine which aspects of OCI’s operations and investigations are made known to FDA’s top management.” The GAO found assessments of six OCI field offices aren’t being done on a timely basis. Of 24 total office assessments that should have been completed by August 2009, only 7, or about 30 percent, were completed and one office hadn’t been assessed in over 10 years.

In addition, the FDA lacks performance measures that could enhance oversight by allowing it to assess OCI’s overall success. A few more facts: the OCI has a 230-person operation with more than $41 million in funding. In 2008, the group’s investigations led to more than 400 convictions. The OCI budget rose 73 percent between 1999 and 2008 to $41 million, and the number of employees increased by about 40 percent.

The GAO study, which was first reported by The Wall Street Journal, was requested by Chuck Grassley, the ranking Republican on the US Senate Finance, who has been probing drug safety issues, among other things. A report on GlaxoSmithKline’s Avandia noted that several drugmakers – Pfizer, Lilly, Bristol-Myers Squibb – have recently paid large criminal fines totaling $7 billion. Among the infractions – off-label promotion.

Read entire article:  http://www.pharmalot.com/2010/03/fda-oversight-of-criminal-investigations-is-lax/

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Drugged to Death: Soldiers returning from war are being given deadly cocktails of psychiatric drugs

Tuesday, March 9th, 2010

AlterNet
By Martha Rosenberg
March 9, 2010

Sgt. Eric Layne’s death was not pretty.

A few months after starting a drug regimen combining the antidepressant Paxil, the mood stabilizer Klonopin and a controversial anti-psychotic drug manufactured by pharmaceutical giant AstraZeneca, Seroquel, the Iraq war veteran was “suffering from incontinence, severe depression [and] continuous headaches,” according to his widow, Janette Layne.

Soon he had tremors. ” … [H]is breathing was labored [and] he had developed sleep apnea,” Layne said.

Janette Layne, who served in the National Guard during Operation Iraqi Freedom along with her husband, told the story of his decline last year, at official FDA hearings on new approvals for Seroquel. On the last day of his life, she testified, Eric stayed in the bathroom nearly all night battling acute urinary retention (an inability to urinate). He died while his family slept.

Sgt. Layne had just returned from a seven-week inpatient program at the VA Medical Center in Cincinnati where he was being treated for post-traumatic stress disorder (PTSD). A video shot during that time, played by his wife at the FDA hearings, shows a dangerously sedated figure barely able to talk.

Sgt. Layne was not the first veteran to die after being prescribed medical cocktails including Seroquel for PTSD.

Read entire article:  http://www.alternet.org/world/145892/are_veterans_being_given_deadly_cocktails_to_treat_ptsd

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After $1.4 billion criminal fine for illegal marketing, Eli Lilly tries something new—promoting “ethical behavior”

Monday, March 8th, 2010

IndyStar.com
John Russell
March 8, 2010

Eli Lilly and Co. has agreed to add four new senior positions to “promote highly ethical and compliant behaviors” as part of a settlement of two lawsuits arising from the company’s illegal marketing and promotion of several drugs.

The Indianapolis drugmaker also has agreed to upgrade its policies and procedures to ensure that patient safety “shall be of paramount importance,” according to a government filing the company made today.

Last year, Lilly paid $1.4 billion, the largest criminal fine ever imposed on a U.S. corporation, over the illegal marketing of Zyprexa. The company also pleaded guilty to a misdemeanor and agreed to additional oversight to resolve a 5-year-old federal investigation.

Federal prosecutors had said Lilly unlawfully promoted Zyprexa for agitation, aggression, hostility, dementia, depression and generalized sleep disorder, although the drug was approved only for schizophrenia and bipolar disorder.

The company had also improperly marketed Evista, its osteoporosis drug, and Prozac, its antidepressant.

In response, several shareholders sued the company, claiming it breached fiduciary duty in connection with the illegal marketing, exposing Lilly to substantial risk of damage. The suits are known as “derivative claims” as they were brought by shareholders on behalf of the company, rather than on behalf of shareholders, seeking to force the company to take corrective steps.

Read entire article:  http://www.indystar.com/article/20100308/BUSINESS/3080383/Eli-Lilly-adding-four-ethics-watchdogs

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2,500 in nursing homes put at risk of death from Antipsychotics (note: death risk applies to anyone on antipsychotics)

Monday, March 8th, 2010

Fox News
March 8, 2010

Federal officials say nearly 2,500 Massachusetts nursing home residents were given powerful antipsychotic drugs last year that were not intended or recommended for their medical condition.

The Boston Globe reports that data collected by the Centers for Medicare and Medicaid Services show that 28 percent of Massachusetts nursing home residents were given antipsychotics in 2009. Of that group, more than one out of every five did not have a medical condition that called for such treatment.

Federal officials say the drugs are often given to patients with dementia, which puts them at risk for serious side effects, even death.

An official with the organization that represents the state’s nursing homes acknowledges that the number is too high and says better training is needed.

Read article:  http://www.foxnews.com/story/0,2933,588391,00.html

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Confidential report reveals: Big Pharma trying to stop long-term safety studies of ADHD drugs

Friday, March 5th, 2010

TransWorldNews
By Janne Larsson
March 5, 2010

The companies producing methylphenidate products (like Ritalin and Concerta) are normally competitors, marketing ADHD as a disease and the narcotic drugs as its solution. But when they are threatened with marketing restrictions they have a common interest.

If more scientific long-term studies would be done showing the harmful effects of the drugs it could lead to withdrawal from the market of this class of drugs. Therefore Big Pharma has to stop all such studies not written and controlled by themselves. The only studies they support are those conducted by paid researchers like psychiatry professors Joseph Biederman, Timothy Wilens and Thomas Spencer, where the outcome is known already from the beginning.

The European Commission has 27 May 2009, after a long review by the European Medicines Agency (EMEA), decided to issue warnings about methylphenidate drugs. The Commission has also decided that a number of long-term studies of good quality should be done to investigate different harmful effects of these drugs.

So for example the manufacturers were ordered to submit data how they could do long-term studies of psychiatric adverse effects (e.g. depression, hostility and psychotic reactions) and of cognitive effects (effects on learning, intellectual function) of the drugs. The answer from the pharmaceutical companies was a confidential report Feasibility Assessment of a Study of Long-term Effects of Methylphenidate on Cognition and Psychiatric Outcomes written 30 October 2009 – now made public by a Swedish court.

Read entire article:  http://www.transworldnews.com/NewsStory.aspx?StoryID=244733

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50 Years Ago Thomas Szasz Rocked The World of Psychiatry: The Difference Between A Disease and a Disorder

Thursday, March 4th, 2010

By Dr. Jeffrey Schaler
Assistant Professor of Justice, Law & Society
March, 2010

The Myth of Mental Illness by Thomas SzaszIt is fifty years now since Thomas Szasz rocked the world of psychiatry by writing The Myth of Mental Illness: Foundations of a Theory of Personal Conduct. His work continues to have a profound impact on how we think about disease, behavior, liberty, justice, responsibility, and most important of all, what it means to be human.  Szasz has shown us how the idea of mental illness is used by the state to deprive innocent people of freedom, and guilty persons of justice.  Without the state involved, the medicalization of behavior means nothing.

He has shown us how the idea of mental illness functions as legal fiction within our legal system. In this sense, the idea of mental illness has been used much as the idea that African American slaves were considered three-fifths of a person. Persons labeled as mentally ill are now considered three-fifths of a person. It is as if there was a postscript at the bottom of the Bill of Rights that reads: “PS: For mentally healthy people only.”

The courts will not allow the idea of mental illness to be disproved, in much the same way that the idea that slaves could be three-fifths person was not allowed to be disproved. Today, mental illness as legal fiction maintains the institution of psychiatric slavery.

The Theraputic State by Thomas SzaszMental illness diagnoses have more to do with politics and science fiction, than medicine and science. Take for example the idea that people with a homosexual orientation are mentally ill. The category was excluded from the Diagnostic and Statistical Manual of Mental Disorders – our contemporary “Malleus Maleficorum,” or “Hammer of Witches” – the same way it was included, for political reasons, not scientific reasons. No one discovered that homosexuality was a disease, and no one discovered that it isn’t a disease. They pronounced it as such, in each case, because of political pressure.

About two years after The Myth of Mental Illness was first published, Szasz published another book that has had an equally profound impact on freedom and responsibility. In Law, Liberty and Psychiatry he predicted the following:

“Although we may not know it, we have, in our day, witnessed the birth of the Therapeutic State. This is perhaps the major implication of psychiatry as an institution of social control.”

Thomas Szasz wrote that in 1963.

We live in a Therapeutic State today. Moral management now masquerades as medicine. The state dictates a “duty to be healthy.”

Seventy years ago another state, Nazi Germany, dictated a “duty to be healthy.” Back then, murder masqueraded as medicine. I think you all know what I’m referring to. We don’t need a weatherman to know which way the wind blows.

Today, good health practices have become a social responsibility. Bad health practices are viewed as socially irresponsible behavior. When health and illness are applied to the mind and behavior, this means that people must think and speak and act the right way. Otherwise, they may end up in a prison called a mental hospital.

I am one of the few college professors in the United States, if not in the world, who teaches Szasz’s ideas on a regular basis in college. And in every course, my students have always said at least two things to me: This stuff by Szasz is changing my life. And why hasn’t anyone ever taught his work in class before?

Because professors are punished for teaching Szasz; they can lose their jobs if they do so. I know. I have the scars to prove it. If you read my book, Szasz Under Fire, you will see how the same thing almost happened to Thomas Szasz. He came a hair away from being fired for teaching Thomas Szasz!

The Myth of Mental Illness and the subsequent Law, Liberty and Psychiatry are not so unsophisticated as to deny the existence of behaviors that people find disturbing. Quite to the contrary, Szasz’s writings clarify the difference between behavior and disease, description and explanations for behavior, and the consequences of labeling behavior as a disease within the arenas of law, medicine, social and public policy.

Szasz has simply pointed out what pathologists have always known: A disease refers to cellular pathology. Period. A behavior cannot be a disease. And he has also fought endlessly for the rights of persons labeled mentally ill. He will be ninety years old on April 15. He is still writing one book after another. He writes books faster than I can read them!

He has also shown us how behavior is strategic, the expression of what philosophers call moral agency. Today’s neuroscientists, psychiatrists and clinical psychologists have attempted to reduce man to the category of things. They deny the existence of moral agency. Let me give you one simple example of how this is so.

Conventional wisdom, particularly as it appears in the media, leads people to believe that brains cause behavior, as if the brain could act. Psychiatrists and the neuroscientists they aspire emulate, regard man as a machine, an incredibly complicated machine, but a machine nevertheless. Everything that is human is ultimately reducible to electrical and chemical interactions.

This is especially so when it comes to socially unacceptable, abnormal, disturbing and criminal behavior. Bad brains are said to cause bad behavior. Bad brains, in this, sense refers to problems in the structure and function of the brain.

Now if bad brains cause bad behavior, it only follows that good brains must cause good behavior. In other words, brains that work correctly, brains that are structurally and functionally healthy, cause good and admirable behaviors.

While psychiatrists try to excuse bad behaviors by ultimately blaming bad brains, they inadvertently (or perhaps intentionally) are removing personal responsibility for the good things that people do. When someone commits a heroic deed, for example, shows courage, compassion, and care for others at great personal expense and with great risk of danger, the person is then not choosing to do what is clearly important to do.

The brain, according to this way of thinking, is causing the person to do this good thing, in the same way that a bad brain causes someone to prey on others. There is no need to praise someone for his altruism, heroism, and courage, his brain made him do it.

Some psychiatrists have equated human behavior with seizure activity: An alcoholic reaching for that drink too many is having an epileptic seizure. So is the mother sacrificing her own life for the life of her child.

What is left of the person, if this is so? What is left of the person if brains cause bad and good behavior? What is that represented by the pronoun “I?” What happens to moral agency?

Nothing. From this way of thinking, human beings are reduced to the category of things. Things do not choose, they are caused. Things do not feel. Things are not alive. Things have no conscience, no values, no morality, no ethics. And most important, things do not care, for self or others.

This is the legacy of psychiatry and neuroscience today, when it comes to entertaining biological explanations for behavior. Mind is equated with brain, behavior with disease, good with bad, morality with medicine, and ethics with mechanics. In other words, there is no soul. That which we consider uniquely human is destroyed by psychiatry and neuroscience.

How does this fit into law? Through a simple equation. Liberty and responsibility are two sides of the same coin. If we increase one, we increase the other. If we decrease one, we decrease the other. The more free man is, the more responsible he must be. The more responsible man is, the more he is captain of his own ship.

What institutional psychiatry as an extension of the state would have us believe is this: The more we decrease responsibility, the more we increase freedom. In other words, the more you allow us to be in charge of your life, the more you abdicate responsibility, the more you embrace the paternalism we say is good for you, the more you will be free. For obedience to authority is the greatest political virtue.

What then must we do? Szasz has done his job, what is ours? I believe our job is this: We get psychiatry out of the courthouse. We do not need to destroy psychiatry. It will destroy itself if we sever its invisible umbilical cord to the mother-state. Once psychiatry is available to people by choice only, it will die a natural death. Very few people will seek out psychiatrists if they cannot hire and fire them at will.

Psychiatrists know this. That is why they are so afraid of Thomas Szasz.

And that is why they are so afraid of those who understand what I am saying here. As I tell my students every semester, “don’t believe a word I say. Just think about it and come to your own conclusion.” That kind of independence and autonomy scares institutional psychiatrists and those who run the therapeutic state.

It should.

Jeffrey A. Schaler is an assistant professor of justice, law, and society at American University’s School of Public Affairs in Washington, D.C. Professor Schaler’s work is focused on the “therapeutic state”—the union of medicine and state. He completed his doctoral and master’s degrees in human development at the University of Maryland College Park, where the major emphasis of his research was addiction and social policy. Dr. Schaler is particularly interested in how research in the behavioral sciences is interpreted and applied in public, social, and legal policy arenas. He writes and speaks extensively on the relationship between liberty and responsibility.

Dr. Thomas Szasz is a Professor of Psychiatry Emeritus, State University of New York. He is a well known critic of the moral and scientific foundations of psychiatry and has authored more than 30 books on the subject including the Manufacture of Madness, The Myth of Mental Illness and The Therapeutic State. He is the co-founder of the Citizens Commission on Human Rights (CCHR) and has said of the organization, “We should all honor CCHR because it is really the organization that for the first time in human history has organized a politically, socially, internationally significant voice to combat psychiatry. This has never been done in human history before.”

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