Posts Tagged ‘Drug companies’

Psychiatry in Crisis! Mental Health Director Rejects Psychiatric “Bible” and Replaces With… Nothing

Saturday, May 4th, 2013

Scientific American
By John Horgan
May 4, 2013

What is mental illness? Schizophrenia? Autism? Bipolar disorder? Depression? Since the 1950s, the profession of psychiatry has attempted to provide definitive answers to these questions in the Diagnostic and Statistical Manual of Mental Disorders. Often called The Bible of psychiatry, the DSM serves as the ultimate authority for diagnosis, treatment and insurance coverage of mental illness.

Now, in a move sure to rock psychiatry, psychology and other fields that address mental illness, the director of the National Institutes of Mental Health has announced that the federal agency–which provides grants for research on mental illness–will be “re-orienting its research away from DSM categories.” Thomas Insel’s statement comes just weeks before the scheduled publication of the DSM-V, the fifth edition of the Diagnostic and Statistical Manual. Insel writes:

“While DSM has been described as a ‘Bible’ for the field, it is, at best, a dictionary, creating a set of labels and defining each. The strength of each of the editions of DSM has been ‘reliability’–each edition has ensured that clinicians use the same terms in the same ways. The weakness is its lack of validity. Unlike our definitions of ischemic heart disease, lymphoma, or AIDS, the DSM diagnoses are based on a consensus about clusters of clinical symptoms, not any objective laboratory measure. In the rest of medicine, this would be equivalent to creating diagnostic systems based on the nature of chest pain or the quality of fever. Indeed, symptom-based diagnosis, once common in other areas of medicine, has been largely replaced in the past half century as we have understood that symptoms alone rarely indicate the best choice of treatment. Patients with mental disorders deserve better.”

Insel said that the NIMH will be replacing the DSM with the “Research Domain Criteria (RDoC),” which define mental disorders based not just on vague symptomology but on more specific genetic, neural and cognitive data. But then, immediately after making this dramatic announcement, Insel added that “we cannot design a system based on biomarkers or cognitive performance because we lack the data.”

Hunh? So the NIMH is replacing the DSM definitions of mental disorders, which virtually everyone agrees are profoundly flawed, with definitions that even he admits don’t exist yet! What more evidence do we need that modern psychiatry is in a profound state of crisis?

Insel’s statement is also an implicit admission that there is no real theoretical basis for drug treatments for mental illness. As I have pointed out previously, drug treatments have surged over the past few decades, while rates of mental illness, far from falling, have risen.

Ironically, some pharmaceutical companies that have enriched themselves by selling psychiatric drugs are now cutting back on further research on mental illness. The “withdrawal” of drug companies from psychiatry, Steven Hyman, a psychiatrist and neuroscientist at Harvard and former NIMH director, wrote last month, “reflects a widely shared view that the underlying science remains immature and that therapeutic development in psychiatry is simply too difficult and too risky.” Funny how this view isn’t incorporated into ads for antidepressants and antipsychotics.

NIMH director Insel doesn’t mention it, but I bet his DSM decision is related to the big new Brain Initiative, to which Obama has pledged $100 million next year. Insel, I suspect, is hoping to form an alliance with neuroscience, which now seems to have more political clout than psychiatry. But as I pointed out in posts here and here on the Brain Initiative, neuroscience still lacks an overarching paradigm; it resembles genetics before the discovery of the double helix.

Since I became a science writer 30 years ago, I have heard countless claims about breakthroughs in our understanding and treatment of mental illness. And yet as the NIMH decision on the DSM indicates, the science of mental illness is still appallingly primitive. Instead of forming fancy new programs and initiatives and alliances, leaders in mental health should perhaps do some humble, honest soul searching before they decide how to proceed. And they should think of what’s best not for their professions or the pharmaceutical industry but for those suffering from mental illness, who deserve better.

http://blogs.scientificamerican.com/cross-check/2013/05/04/psychiatry-in-crisis-mental-health-director-rejects-psychiatric-bible-and-replaces-with-nothing/

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Shy children now candidates for dangerous psychiatric drugs

Wednesday, October 5th, 2011

NaturalNews
By Elizabeth Walling
October 5, 2011

(NaturalNews) New guidelines for mental illness turn shyness in children from a personality trait into a mental disorder that warrants drug treatment. Drug companies already target children, who fidget too much in class or have trouble concentrating on their homework, with stimulant drugs for treating attention deficit disorder. Now children who sit too quietly or are more withdrawn than their peers will also be targeted with medication for social anxiety disorder or depression.

These new guidelines increase the likelihood that children, who tend to be quiet or sad, will be diagnosed with depression. And children who talk back to adults or lose their temper frequently may be diagnosed with what is called oppositional defiant disorder. A diagnose in either case will likely lead to treatment with powerful psychotropic drugs.

Serious Risks for Children who take Psychiatric Drugs

The idea of turning every spectrum of human emotion into some kind of mental disorder is not only absurd, but it also threatens the long-term mental and physical health of our children.

Millions of children are currently taking one or more behavior-altering medications, despite the fact that these drugs carry the risk of serious side effects. Some of these side effects include suicidal thinking, loss of appetite, nausea, insomnia, sedation, seizures, insulin resistance, acne, tremors, muscle stiffness and more.

Some psychologists also point out that simply drugging children for behaving out of the norm could actually be masking very serious underlying problems. Children, who are the victims of mental, physical or sexual abuse, will often exhibit behaviors such as shyness, sadness or being more withdrawn. These experts warn that trying to seek a quick-fix for negative emotions denies children what they truly need: long-term care and guidance.

Who stands to profit from expanding the guidelines for diagnosable mental disorders? The answer is quite simple: the pharmaceutical companies which manufacture the drugs for treating these conditions. However, when we start labeling children as disordered for simply being quieter than their peers or having an occasional angry outburst, we are stepping into dangerous territory that threatens the future of an entire generation and beyond.

Sources for this article include:

http://www.dailymail.co.uk/health/a…

http://www.telegraph.co.uk/health/h…

http://www.sciencedaily.com/release…

http://www.aboutourkids.org/article…

About the author:

Elizabeth Walling is a freelance writer specializing in health and family nutrition. She is a strong believer in natural living as a way to improve health and prevent modern disease. She enjoys thinking outside of the box and challenging common myths about health and wellness. You can visit her blog to learn more:
www.livingthenourishedlife.com/2009…

Read the article here:  http://www.naturalnews.com/033778_shy_children_psychiatric_drugs.html

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Doctors Paid Millions To Promote Drugs and Medical Devices

Thursday, September 29th, 2011

InjuryBoard Blog Network – September 29, 2011

AstraZeneca paid one Chicago doctor, Dr. Michael Reinstein nearly half-a-million dollars to promote Seroquel. In return, Dr. Reinstein provided AstraZeneca with a vast customer base.

The Chicago Tribune reportedthat drug companies paid more than $25 million to Illinois doctors to promote and use drugs from the pharmaceutical companies. Nearly 40 physicians got payments and perks exceeding $100,000 between 2009 and early 2011.

Eight drug companies paid more than $220 million to doctors and promotional speakers in 2010 to promote their drugs.

Starting in 2013, all drug and medical device companies must report such information to the federal government which will make these disclosures available to the public.

The most controversial payments involve consulting arrangements and promotional speeches. Drug company officials say they are funding talks that provide much-needed medical education, led by physicians who are experts in their fields. Critics say financial relationship between doctors and drug companies can threaten patient care by influencing physicians to prescribe certain medications whether or not they are the best choice.

Until 2009, drug company payments to doctors and other health professionals were closely held as trade secrets. However, some companies have begun reporting this information in advance of the 2013 requirements and pressure from lawmakers or as a condition of settling federal whistle-blower lawsuits.

ProPublica has created a database called Dollars for Docs identifying amounts paid to doctors for promotion of drugs and medical devices. Dollars for Docs has identified more than $760 million in disclosed marketing payments from only 12 companies between 2009 and the 2nd quarter of 2011.

“[The drug company payments] make it look like physicians are not impartial or are in the service of the drug companies, and can cause patients to wonder if physicians’ recommendations for treatment are being made because it was the best option based on their clinical expertise or because they have a relationship with the company,” [Hastings Center research scholar Josephine] Johnston said. “I don’t think many physicians have taken that risk (of patient distrust) as seriously as they should.”

In 2009, the Chicago Tribune reported on the millions of dollars paid by foreign drug maker AstraZeneca to doctors in order to promote its anti-psychotic drug, Seroquel. AstraZeneca paid one Chicago doctor, Dr. Michael Reinstein nearly half-a-million dollars to promote Seroquel. In return, Dr. Reinstein provided AstraZeneca with a vast customer base.

Dr. Reinstein was traveling the country telling doctors that Seroquel would help patients lose weight while the FDA was warning about Seroquel’s link to weight gain and diabetes. Even Seroquel executives called Dr. Reinstein’s conclusion that patients experienced no adverse side effects “suspect” and “hard to believe”. When faced with the choice of protecting patients or protecting profits, AstraZeneca and Dr. Reinstein chose profits over safety.

Johnson & Johnson’s DePuy Orthopaedics division also paid millions — more than $80 million — to surgeons to promote its artificial hip systems. The US Department of Justice brought charges against four medical device companies – including DePuy – in 2007, claiming the companies were using kickbacks to doctors in promoting their products. However, DePuy kept paying doctors:

  • $48 million to doctors in 2009
  • $33 million from January to September 2010

Some surgeons received more than $1 million in single year.

These payments create a direct conflict of interest between doctor and patient. Drug company sponsored research potentially taints results and doctors create the impression – and sometimes the actual effect – of choosing profits and drug company kickbacks over patient safety.

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Dollars for Docs Update: Now With 12 Companies, More Than $760 Million in Payments

Wednesday, September 7th, 2011

ProPublica – September 7, 2011

by Dan Nguyen, Charles Ornstein and Tracy Weber

Drug companies have long kept secret details of the payments they make to doctors and other health professionals for promoting their drugs. But 12 companies have begun publicizing the information. ProPublica pulled their disclosures into a database so patients can search for their doctor.

For decades, drug companies kept the names of their speakers — and how much they paid them — secret. But over the past two years, companies have begun posting this information on their web sites, some as the result of legal settlements with the federal government.

ProPublica took these disclosures and assembled them into a single, comprehensive database that allows patients to search for their physician.

It was not easy. Some of the firms constructed their sites in a way that made it near impossible to analyze or, in some cases, even download their data. And each firm disclosed its data differently. Some, for example, simply included speaking. Others also detailed consulting. Sometimes, research, business travel costs and meals were listed, too.

ProPublica will update the database from time to time as additional companies release their payment data. Federal law requires that all companies publicly report this data beginning in 2013. That information will be posted on a government web site.

Several things to bear in mind about the data:

  • Only the companies that have disclosed payments on their web sites are included. Their combined prescription drug sales amounted to about 40 percent of the U.S. market in 2010. Though a substantial share, the data may not be wholly representative of the industry.
  • The data is from payments made in 2009, 2010 and, in some cases, the beginning of 2011. But not all companies reported payments for every quarter during that period.
  • Companies are continually updating their data, so the most recent additions may not be included in our database.
  • Although most of the money went to physicians, other practitioners, including nurses and pharmacists, also work with pharmaceutical companies and are listed. Some drug firms include these payments; others do not.
  • Practitioner names and addresses (city/state) are listed as the companies released them and may vary. For instance, some companies include a middle initial, and others do not. Some companies also list different cities for the same individual. This may happen because professionals may have practices in multiple locations or because they provided different addresses for payment.
  • As noted above, the companies’ reports cover different periods and include payments for different services. Some companies include payments only to speakers, while others include consultants and advisers, as well as research, meals and business travel. (Details are included on each company’s page.)
  • The reports include both the name of the health provider who performed the service as well as the entity paid. They may be different.
  • Research payments are distinct from speaking and consulting. Payments for clinical studies may include costs associated with patient care, supplies, as well as the time spent by health care professionals treating patients and managing the study. The figure listed may not reflect the actual compensation received by the physician listed as the principal investigator.
  • A physician on the list may be getting money from other companies that have yet to disclose payments.
  • Eli Lilly has in some cases used different middle initials for the same individual.
  • This list does not include payments for speaking at continuing medical education courses, which are run independently from the pharmaceutical companies.

http://www.propublica.org/

 

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Why Drug Companies Are Shy About Sharing On Facebook

Tuesday, August 23rd, 2011

NPR – August 22, 2011
by Nancy Shute

Drug firms fear that being "liked" on Facebook could get them in trouble with the FDA. iStock photo

People love how Facebooklets them comment on and share other people’s posts. But the idea of sharing on social media has got drug companies scared. When Facebook told drugmakers that they had to start allowing comments on their Facebook pages, some of those pages started disappearing.

“Take On Depression” suddenly disappeared. “ADHD Moms” vanished, too. So did “Epilepsy Advocate.” In the past, drug companies had been reluctant to create Facebook pages without a guarantee that they’d be closed to public comments — a unique accommodation on Facebook’s part. But that accommodation ended last week.

Diabetes blogger Amy Tenderichthinks it’s high time the drug companies quit walling themselves off. She’s the founder of  Diabetest Mine,  an independent site. She says: “The notion that they would be able to be able to put up these Facebook pages and then close them off to comments is ridiculous.”

On her site, people with diabetes comment a lot. They share information on what drugs they’re taking, give each other advices on dosages, and tell people which drugs are working for them, and which are causing side effects. For Tenderich and others, the whole point of social media like Facebook and Twitter is to comment on other people’s posts.

But drug companies have to play by different rules. The Food and Drug Administration requires that each a drug manufacturer mentions a prescription drug, they also have to list its risks and side effects. That’s called fair balance.

“You see some of those magazine ads that are three and four pages long and you wonder why they are?” asks Tony Jewell, who supervises drugmaker AstraZeneca’s social media efforts. “It’s because we’re communicating the full risks, benefits and appropriate use of the medicine. That’s a little bit harder to do in a social media channel like Facebook and Twitter.”

One big reason companies cite for killing Facebook pages is that they wouldn’t be able to adequately police comments with inaccurate information about prescription drugs.

“So they might say, ‘Lipitor’s great at whitening your teeth,’ which it’s not approved to do,” says Jonathan Richman. That’s his example of a potentially dicey comment. He’s a group director for the Possible Worldwide ad agency in Cincinnati, and he closely follows the drug industry’s social media efforts on his Dose of Digital blog. “The question becomes, What’s Pfizer’s liability? What action could the FDA take, based on somebody else posting that?”

So far, the FDA hasn’t come down on a single drug company for allowing public comments. The only action the agency has taken against use of social media was last year, when it warnedNovartis that a Facebook “share” widget for the leukemia drug Tasignaviolated fair balance.

But the FDA also hasn’t told the companies how to use social media and still follow the “fair balance” rule. In November 2009, the agency held public hearingson how pharma companies should use social media. But the FDA has yet to issue official guidance. Jewell says that because of that, his employer and other companies are erring on the side of caution.

Tenderich says patients would benefit from a rich interaction with drug makers. She sees more and more drug company employees interacting on her site, giving advice on behalf of their employers. That’s a huge benefit for patients, she says.

The pharmaceutical companies could benefit, too, she says, by learning what problems patients are having with drugs, and how to make them better.

“They could get so much fantastic, free, very high-value feedback,” she says.

http://www.npr.org/blogs/health/2011/08/22/139859210/why-drug-companies-are-shy-about-sharing-on-facebook?ps=sh_sthdl

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Harvard Expert Ties Mental Illness “Epidemic” to Big Pharma’s Agenda

Friday, July 29th, 2011

Minyanville
By Minyanville Staff
July 28, 2011

When the DSM-II was published in 1980, it became “the bible of psychiatry,” writes Angell, who adds, “but like the real Bible, it depended a lot on something akin to revelation. There are no citations of scientific studies to support its decisions.”

For any mental illness or passing mood swing that may trouble a person, the Diagnostic and Statistical Manual of Mental Disorders — better known as the DSM — has a label and a code. Recurring bad dreams? That may be a Nightmare Disorder, or 307.47. Narcolepsy uses the same digits in a different order: 347.00. Fancy feather ticklers? That sounds like Fetishism, or 302.81. Then there’s the ultimate catch-all for vague sadness or uneasiness, General Anxiety Disorder, or 300.02. That’s a label almost everyone can lay claim to.

These codes are used by doctors, psychologists, and regulators to maintain a mutual language; it’s a handy shorthand system for bureaucratic purposes. But over the past few decades, the staggering, ever-expanding influence of the ever-expanding DSM, which is published by the American Psychiatric Association, has also played a lead role in building wealth and off-label product uses for the major drug manufacturers. In an insightful essay in this week’s New York Review of Books, Marcia Angell, a senior lecturer in social medicine at Harvard Medical School and former Editor in Chief of The New England Journal of Medicine, explains how.

The medical director of the American Psychiatric Association (APA), Melvin Sabshin, declared in 1977 that “a vigorous effort to remedicalize psychiatry should be strongly supported."

Angell’s essay is based on a review of three current books examining the psychiatric industry: The Emperor’s New Drugs: Exploding the Antidepressant Myth, by Irving Kirsch; Anatomy of an Epidemic: Magic Bullets, Psychiatric Drugs, and the Astonishing Rise of Mental Illness in America by Robert Whitaker, and Unhinged: The Trouble with Psychiatry–A Doctor’s Revelations About a Profession in Crisis, by Daniel Carlat. She also cites the DSM-IV, the most recent edition of the manual, while her review traces big pharma’s role in our current mental disorder epidemic to the DSM-III, published in 1980.

To begin, Angell describes the psychiatric profession’s backlash against a developing perception in the 1960s and 1970s that the practice was a “soft” almost pseudo science:

In the late 1970s, the psychiatric profession struck back–hard. As Robert Whitaker tells it in Anatomy of an Epidemic, the medical director of the American Psychiatric Association (APA), Melvin Sabshin, declared in 1977 that “a vigorous effort to remedicalize psychiatry should be strongly supported,” and he launched an all-out media and public relations campaign to do exactly that. Psychiatry had a powerful weapon that its competitors lacked. Since psychiatrists must qualify as MDs, they have the legal authority to write prescriptions. By fully embracing the biological model of mental illness and the use of psychoactive drugs to treat it, psychiatry was able to relegate other mental health care providers to ancillary positions and also to identify itself as a scientific discipline along with the rest of the medical profession. Most important, by emphasizing drug treatment, psychiatry became the darling of the pharmaceutical industry, which soon made its gratitude tangible.

Of the 170 contributors to the current version of the DSM (the DSM-IV-TR), ninety-five had financial ties to drug companies, including all of the contributors to the sections on mood disorders and schizophrenia.

These efforts to enhance the status of psychiatry were undertaken deliberately. The APA was then working on the third edition of the DSM, which provides diagnostic criteria for all mental disorders. The president of the APA had appointed Robert Spitzer, a much-admired professor of psychiatry at Columbia University, to head the task force overseeing the project. The first two editions, published in 1952 and 1968, reflected the Freudian view of mental illness and were little known outside the profession. Spitzer set out to make the DSM-III something quite different. He promised that it would be “a defense of the medical model as applied to psychiatric problems,” and the president of the APA in 1977, Jack Weinberg, said it would “clarify to anyone who may be in doubt that we regard psychiatry as a specialty of medicine.”

When the DSM-II was published in 1980, it became “the bible of psychiatry,” writes Angell, who adds, “but like the real Bible, it depended a lot on something akin to revelation. There are no citations of scientific studies to support its decisions.”

Despite its lack of citations, that DSM named 265 disorders doctors were meant to identify by matching (or mostly matching) a list of symptoms in the book with symptoms described by a patient. The drug companies were quick to see this radical shift in psychiatry as an opportunity. From the 1980s until now, as Angell demonstrates, the drug makers have supported the move away from talk therapy to the drug therapy, which also benefits practitioners, since doling out drugs and tweaking prescriptions earns a psychiatrist more money for less time spent with a patient.

Here Angell explains how companies influence the DSM itself. The bold typeface is ours.

Drug companies are particularly eager to win over faculty psychiatrists at prestigious academic medical centers. Called “key opinion leaders” (KOLs) by the industry, these are the people who through their writing and teaching influence how mental illness will be diagnosed and treated. They also publish much of the clinical research on drugs and, most importantly, largely determine the content of the DSM. In a sense, they are the best sales force the industry could have, and are worth every cent spent on them. Of the 170 contributors to the current version of the DSM (the DSM-IV-TR), almost all of whom would be described as KOLs, ninety-five had financial ties to drug companies, including all of the contributors to the sections on mood disorders and schizophrenia.

The drug industry, of course, supports other specialists and professional societies, too, but Carlat asks, “Why do psychiatrists consistently lead the pack of specialties when it comes to taking money from drug companies?” His answer: “Our diagnoses are subjective and expandable, and we have few rational reasons for choosing one treatment over another.” Unlike the conditions treated in most other branches of medicine, there are no objective signs or tests for mental illness—no lab data or MRI findings—and the boundaries between normal and abnormal are often unclear. That makes it possible to expand diagnostic boundaries or even create new diagnoses, in ways that would be impossible, say, in a field like cardiology. And drug companies have every interest in inducing psychiatrists to do just that.

Eli Lilly gave $551,000 to NAMI

In addition to the money spent on the psychiatric profession directly, drug companies heavily support many related patient advocacy groups and educational organizations. Whitaker writes that in the first quarter of 2009 alone, “Eli Lilly gave $551,000 to NAMI [National Alliance on Mental Illness] and its local chapters, $465,000 to the National Mental Health Association, $130,000 to CHADD (an ADHD [attention deficit/hyperactivity disorder] patient-advocacy group), and $69,250 to the American Foundation for Suicide Prevention.”

And that’s just one company in three months; one can imagine what the yearly total would be from all companies that make psychoactive drugs. These groups ostensibly exist to raise public awareness of psychiatric disorders, but they also have the effect of promoting the use of psychoactive drugs and influencing insurers to cover them. Whitaker summarizes the growth of industry influence after the publication of the DSM-III as follows:

“In short, a powerful quartet of voices came together during the 1980’s eager to inform the public that mental disorders were brain diseases. Pharmaceutical companies provided the financial muscle. The APA and psychiatrists at top medical schools conferred intellectual legitimacy upon the enterprise. The NIMH [National Institute of Mental Health] put the government’s stamp of approval on the story. NAMI provided a moral authority.”

And now here we are in 2011, with almost everyone we know taking two or three different mood disorder drugs. (This trend is not limited to mental disorder, mind you. See Disease Branding.)

Work started on the DSM-V in 1999, which is due out in 2013. It will contain many new disorders, such as “binge eating” and “restless leg disorder.” It will also expand existing categories by tacking on words like “spectrum” to the end of a known disorder, Angell reports. “It looks as though it will be harder and harder to be normal,” she writes.

But the curtain gets pulled back further still.

In her review of Daniel Carlat’s book, Angell calls attention to the “disillusioned insider’s” frank admission that when he prescribes a drug, his decision process is largely guesswork. Carlat’s view is that although any psychiatrist will acknowledge that he or she has had great success with mental disorder drugs for say, depression or anxiety, no doctor can say with certainty whether the drugs are working or if a placebo effect has taken effect.

[Carlat's] work consists of asking patients a series of questions about their symptoms to see whether they match up with any of the disorders in the DSM. This matching exercise, he writes, provides “the illusion that we understand our patients when all we are doing is assigning them labels.” Often patients meet criteria for more than one diagnosis, because there is overlap in symptoms. For example, difficulty concentrating is a criterion for more than one disorder. One of Carlat’s patients ended up with seven separate diagnoses. “We target discrete symptoms with treatments, and other drugs are piled on top to treat side effects.” A typical patient, he says, might be taking Celexa for depression, Ativan for anxiety, Ambien for insomnia, Provigil for fatigue (a side effect of Celexa), and Viagra for impotence (another side effect of Celexa).

As for the medications themselves, Carlat writes that “there are only a handful of umbrella categories of psychotropic drugs,” within which the drugs are not very different from one another. He doesn’t believe there is much basis for choosing among them. “To a remarkable degree, our choice of medications is subjective, even random. Perhaps your psychiatrist is in a Lexapro mood this morning, because he was just visited by an attractive Lexapro drug rep.”

Messy. And, of course, the whole system is now being exported to China and other countries where the middle class is growing and the mental health industry is still in a developing stage.

Angell’s latest book is The Truth About the Drug Companies: How They Deceive Us and What to Do About It.

Read the rest of her essay, which examines the controversial use of brain chemistry drugs to treat children, here.

http://www.minyanville.com/dailyfeed/2011/07/25/harvard-expert-links-our-mental/

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The Illusions of Psychiatry

Monday, June 20th, 2011

New York Review of Books  – From the July 14, 2011 issue

by Marcia Angell

United Artists/Photofest Lan Fendors, Louise Fletcher, and Jack Nicholson in One Flew Over the Cuckoo's Nest, 1975

In my article in the last issue, I focused mainly on the recent books by psychologist Irving Kirsch and journalist Robert Whitaker, and what they tell us about the epidemic of mental illness and the drugs used to treat it.1 Here I discuss the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders (DSM)—often referred to as the bible of psychiatry, and now heading for its fifth edition—and its extraordinary influence within American society. I also examine Unhinged, the recent book by Daniel Carlat, a psychiatrist, who provides a disillusioned insider’s view of the psychiatric profession. And I discuss the widespread use of psychoactive drugs in children, and the baleful influence of the pharmaceutical industry on the practice of psychiatry.

One of the leaders of modern psychiatry, Leon Eisenberg, a professor at Johns Hopkins and then Harvard Medical School, who was among the first to study the effects of stimulants on attention deficit disorder in children, wrote that American psychiatry in the late twentieth century moved from a state of “brainlessness” to one of “mindlessness.”2 By that he meant that before psychoactive drugs (drugs that affect the mental state) were introduced, the profession had little interest in neurotransmitters or any other aspect of the physical brain. Instead, it subscribed to the Freudian view that mental illness had its roots in unconscious conflicts, usually originating in childhood, that affected the mind as though it were separate from the brain.

But with the introduction of psychoactive drugs in the 1950s, and sharply accelerating in the 1980s, the focus shifted to the brain. Psychiatrists began to refer to themselves as psychopharmacologists, and they had less and less interest in exploring the life stories of their patients. Their main concern was to eliminate or reduce symptoms by treating sufferers with drugs that would alter brain function. An early advocate of this biological model of mental illness, Eisenberg in his later years became an outspoken critic of what he saw as the indiscriminate use of psychoactive drugs, driven largely by the machinations of the pharmaceutical industry.

When psychoactive drugs were first introduced, there was a brief period of optimism in the psychiatric profession, but by the 1970s, optimism gave way to a sense of threat. Serious side effects of the drugs were becoming apparent, and an antipsychiatry movement had taken root, as exemplified by the writings of Thomas Szasz and the movie One Flew Over the Cuckoo’s Nest. There was also growing competition for patients from psychologists and social workers. In addition, psychiatrists were plagued by internal divisions: some embraced the new biological model, some still clung to the Freudian model, and a few saw mental illness as an essentially sane response to an insane world. Moreover, within the larger medical profession, psychiatrists were regarded as something like poor relations; even with their new drugs, they were seen as less scientific than other specialists, and their income was generally lower.

In the late 1970s, the psychiatric profession struck back—hard. As Robert Whitaker tells it in Anatomy of an Epidemic, the medical director of the American Psychiatric Association (APA), Melvin Sabshin, declared in 1977 that “a vigorous effort to remedicalize psychiatry should be strongly supported,” and he launched an all-out media and public relations campaign to do exactly that. Psychiatry had a powerful weapon that its competitors lacked. Since psychiatrists must qualify as MDs, they have the legal authority to write prescriptions. By fully embracing the biological model of mental illness and the use of psychoactive drugs to treat it, psychiatry was able to relegate other mental health care providers to ancillary positions and also to identify itself as a scientific discipline along with the rest of the medical profession. Most important, by emphasizing drug treatment, psychiatry became the darling of the pharmaceutical industry, which soon made its gratitude tangible.

These efforts to enhance the status of psychiatry were undertaken deliberately. The APA was then working on the third edition of the DSM, which provides diagnostic criteria for all mental disorders. The president of the APA had appointed Robert Spitzer, a much-admired professor of psychiatry at Columbia University, to head the task force overseeing the project. The first two editions, published in 1952 and 1968, reflected the Freudian view of mental illness and were little known outside the profession. Spitzer set out to make the DSM-III something quite different. He promised that it would be “a defense of the medical model as applied to psychiatric problems,” and the president of the APA in 1977, Jack Weinberg, said it would “clarify to anyone who may be in doubt that we regard psychiatry as a specialty of medicine.”

When Spitzer’s DSM-III was published in 1980, it contained 265 diagnoses (up from 182 in the previous edition), and it came into nearly universal use, not only by psychiatrists, but by insurance companies, hospitals, courts, prisons, schools, researchers, government agencies, and the rest of the medical profession. Its main goal was to bring consistency (usually referred to as “reliability”) to psychiatric diagnosis, that is, to ensure that psychiatrists who saw the same patient would agree on the diagnosis. To do that, each diagnosis was defined by a list of symptoms, with numerical thresholds. For example, having at least five of nine particular symptoms got you a full-fledged diagnosis of a major depressive episode within the broad category of “mood disorders.” But there was another goal—to justify the use of psychoactive drugs. The president of the APA last year, Carol Bernstein, in effect acknowledged that. “It became necessary in the 1970s,” she wrote, “to facilitate diagnostic agreement among clinicians, scientists, and regulatory authorities given the need to match patients with newly emerging pharmacologic treatments.”3

The DSM-III was almost certainly more “reliable” than the earlier versions, but reliability is not the same thing as validity. Reliability, as I have noted, is used to mean consistency; validity refers to correctness or soundness. If nearly all physicians agreed that freckles were a sign of cancer, the diagnosis would be “reliable,” but not valid. The problem with the DSM is that in all of its editions, it has simply reflected the opinions of its writers, and in the case of the DSM-III mainly of Spitzer himself, who has been justly called one of the most influential psychiatrists of the twentieth century.4 In his words, he “picked everybody that [he] was comfortable with” to serve with him on the fifteen-member task force, and there were complaints that he called too few meetings and generally ran the process in a haphazard but high-handed manner. Spitzer said in a 1989 interview, “I could just get my way by sweet talking and whatnot.” In a 1984 article entitled “The Disadvantages of DSM-III Outweigh Its Advantages,” George Vaillant, a professor of psychiatry at Harvard Medical School, wrote that the DSM-III represented “a bold series of choices based on guess, taste, prejudice, and hope,” which seems to be a fair description.

Not only did the DSM become the bible of psychiatry, but like the real Bible, it depended a lot on something akin to revelation. There are no citations of scientific studies to support its decisions. That is an astonishing omission, because in all medical publications, whether journal articles or textbooks, statements of fact are supposed to be supported by citations of published scientific studies. (There are four separate “sourcebooks” for the current edition of the DSM that present the rationale for some decisions, along with references, but that is not the same thing as specific references.) It may be of much interest for a group of experts to get together and offer their opinions, but unless these opinions can be buttressed by evidence, they do not warrant the extraordinary deference shown to the DSM. The DSM-III was supplanted by the DSM-III-R in 1987, the DSM-IV in 1994, and the current version, the DSM-IV-TR (text revised) in 2000, which contains 365 diagnoses. “With each subsequent edition,” writes Daniel Carlat in his absorbing book, “the number of diagnostic categories multiplied, and the books became larger and more expensive. Each became a best seller for the APA, and DSM is now one of the major sources of income for the organization.” The DSM-IV sold over a million copies.

As psychiatry became a drug-intensive specialty, the pharmaceutical industry was quick to see the advantages of forming an alliance with the psychiatric profession. Drug companies began to lavish attention and largesse on psychiatrists, both individually and collectively, directly and indirectly. They showered gifts and free samples on practicing psychiatrists, hired them as consultants and speakers, bought them meals, helped pay for them to attend conferences, and supplied them with “educational” materials. When Minnesota and Vermont implemented “sunshine laws” that require drug companies to report all payments to doctors, psychiatrists were found to receive more money than physicians in any other specialty. The pharmaceutical industry also subsidizes meetings of the APA and other psychiatric conferences. About a fifth of APA funding now comes from drug companies.

Drug companies are particularly eager to win over faculty psychiatrists at prestigious academic medical centers. Called “key opinion leaders” (KOLs) by the industry, these are the people who through their writing and teaching influence how mental illness will be diagnosed and treated. They also publish much of the clinical research on drugs and, most importantly, largely determine the content of the DSM. In a sense, they are the best sales force the industry could have, and are worth every cent spent on them. Of the 170 contributors to the current version of the DSM (the DSM-IV-TR), almost all of whom would be described as KOLs, ninety-five had financial ties to drug companies, including all of the contributors to the sections on mood disorders and schizophrenia.5

The drug industry, of course, supports other specialists and professional societies, too, but Carlat asks, “Why do psychiatrists consistently lead the pack of specialties when it comes to taking money from drug companies?” His answer: “Our diagnoses are subjective and expandable, and we have few rational reasons for choosing one treatment over another.” Unlike the conditions treated in most other branches of medicine, there are no objective signs or tests for mental illness—no lab data or MRI findings—and the boundaries between normal and abnormal are often unclear. That makes it possible to expand diagnostic boundaries or even create new diagnoses, in ways that would be impossible, say, in a field like cardiology. And drug companies have every interest in inducing psychiatrists to do just that.

In addition to the money spent on the psychiatric profession directly, drug companies heavily support many related patient advocacy groups and educational organizations. Whitaker writes that in the first quarter of 2009 alone,

Eli Lilly gave $551,000 to NAMI [National Alliance on Mental Illness] and its local chapters, $465,000 to the National Mental Health Association, $130,000 to CHADD (an ADHD [attention deficit/hyperactivity disorder] patient-advocacy group), and $69,250 to the American Foundation for Suicide Prevention.

And that’s just one company in three months; one can imagine what the yearly total would be from all companies that make psychoactive drugs. These groups ostensibly exist to raise public awareness of psychiatric disorders, but they also have the effect of promoting the use of psychoactive drugs and influencing insurers to cover them. Whitaker summarizes the growth of industry influence after the publication of the DSM-III as follows:

In short, a powerful quartet of voices came together during the 1980’s eager to inform the public that mental disorders were brain diseases. Pharmaceutical companies provided the financial muscle. The APA and psychiatrists at top medical schools conferred intellectual legitimacy upon the enterprise. The NIMH [National Institute of Mental Health] put the government’s stamp of approval on the story. NAMI provided a moral authority.

Read the rest of the article here: http://www.nybooks.com/articles/archives/2011/jul/14/illusions-of-psychiatry/

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Feds to start directly targeting drug company execs in health care fraud schemes

Saturday, June 11th, 2011

Natural News – June 10, 2011

by Ethan A. Huff

The days of drug companies simply settling out of court every time they break the law may soon be coming to an end. In a move that represents a significant shift toward punishing individuals for crimes rather than faceless corporations, federal officials say they will begin personally going after CEOs and other company executives whose companies fraudulently bilk Medicare, Medicaid, and other federal programs out of millions of dollars, or that falsely market dangerous drugs.

When a 1996 law was passed that banned drug companies convicted of felony charges from further participating in any federal health programs, Big Pharma quickly devised creative ways to get around it. As a result, drug companies for years have been able to continually break the law without much consequence by simply settling for a few million dollars, and continuing on with shady dealings that raked in a whole lot more (http://www.naturalnews.com/001867.html).

But now, company execs could face criminal charges for crimes committed by their companies, even if they claim to have had no awareness that any crimes were being committed. And drug companies will no longer be able to skirt by after breaking the law — if they cheat the government health system, they will lose any eligibility to participate in it. After all, ignorance of the law or of the illicit dealings of one’s company have never been a legitimate excuse for anyone else to evade justice — why should it be any different for drug companies?

“When you look at the history of health care enforcement, we’ve seen a number of Fortune 500 companies that have been caught not once, not twice, but sometimes three times violating the trust of the American people, submitting false claims, paying kickbacks to doctors, marketing drugs which have not been tested for safety and efficacy,” said Lewis Morris, chief counsel for the inspector general of the Health and Human Services Department (HHS), to The  Washington Post.

“To our way of thinking, the men and women in the corporate suite aren’t getting it. If writing a check for $200 million isn’t enough to have a company change its ways, then maybe we have got to have the individuals who are responsible for this held accountable. The behavior of a company starts at the top.”

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In shift, feds target top execs for health fraud

Tuesday, May 31st, 2011

Associated Press
May 31, 2011

Lewis Morris, general counsel for the Department of Health and Human Services inspector general, poses for a portrait in his office in Washington, Thursday, May 26, 2011. (AP Photo/Jacquelyn Martin)

WASHINGTON (AP) — It’s getting personal now. In a shift still evolving, federal enforcers are targeting individual executives in health care fraud cases that used to be aimed at impersonal corporations.

The new tactic is raising the anxiety level — and risks — for corporate honchos at drug companies, medical device manufacturers, nursing home chains and other major health care enterprises that deal with Medicare and Medicaid.

Previously, if a company got caught, its lawyers in many cases would be able to negotiate a financial settlement. The company would write the government a check for a number followed by lots of zeroes and promise not to break the rules again. Often the cost would just get passed on to customers.

Now, on top of fines paid by a company, senior executives can face criminal charges even if they weren’t involved in the scheme but could have stopped it had they known. Furthermore, they can also be banned from doing business with government health programs, a career-ending consequence.

Many in industry see the more aggressive strategy as government overkill, meting out radical punishment to individuals whose guilt prosecutors would be hard pressed to prove to a jury.

The feds say they got frustrated with repeat violations and decided to start using enforcement tools that were already on the books but had been allowed to languish. By some estimates, health care fraud costs taxpayers $60 billion a year, galling when Medicare faces insolvency.

“When you look at the history of health care enforcement, we’ve seen a number of Fortune 500 companies that have been caught not once, not twice, but sometimes three times violating the trust of the American people, submitting false claims, paying kickbacks to doctors, marketing drugs which have not been tested for safety and efficacy,” said Lewis Morris, chief counsel for the inspector general of the Health and Human Services Department.

“To our way of thinking, the men and women in the corporate suite aren’t getting it,” Morris continued. “If writing a check for $200 million isn’t enough to have a company change its ways, then maybe we have got to have the individuals who are responsible for this held accountable. The behavior of a company starts at the top.”

Lawyers who represent drug companies say the change has definitely caused a stir, but the end result is far from certain.

“People are alarmed,” said Brien O’Connor, a partner in the Boston office of Ropes & Gray. “They want to know what facts and circumstances would cause the Justice Department to indict someone who hadn’t even known about the misconduct. They are doing all they can to achieve compliance.”

Others say high-powered corporate targets won’t go meekly.

“If the government does continue to press its campaign against individuals, we will see the limits of the government’s theories tested,” said Paul Kalb, who heads the health care group at the law firm of Sidley Austin in Washington. “In my mind, there is a very important open question as to whether individuals can be held criminally culpable or lose their jobs simply by virtue of their status.”

Although the Obama administration has increased scrutiny of corporate America generally, this shift in health care enforcement seems to have come up from the ranks, government and corporate attorneys say.

Investigators and lawyers at the HHS inspector general’s office, the Justice Department and the Food and Drug Administration started moving more or less independently toward holding executives accountable. Morris outlined the inspector general’s position in congressional testimony this spring, saying his office will use its power judiciously.

A test case is playing out with an 83-year-old drug company chief executive, Howard Solomon of New York City-based Forest Laboratories. Forest makes antidepressants, blood pressure drugs and other medications. Last month, the inspector general’s office notified Forest that Solomon could potentially be banned from doing business with federal programs.

The power to ban or “exclude” an individual rests with the inspector general. It’s routinely applied to low-level violators, but rarely to people of Solomon’s rank. In the industry, they call it the “death penalty.”

Last year, a Forest subsidiary pleaded guilty to criminal charges as part of a settlement with the Justice Department in which the company also agreed to pay $313 million to resolve long-running investigations. Prosecutors charged that Forest deliberately ignored an FDA warning to stop distributing an unapproved thyroid drug, promoted the use of an antidepressant in treating children although it was only approved for adults and misled FDA inspectors making a quality check at a manufacturing plant.

The company said it had considered the case closed. But then came the inspector general’s letter.

“No one has ever alleged that Mr. Solomon has done anything wrong and excluding him would be completely unjustified,” Herschel Weinstein, Forest’s general counsel, said in a statement. “In prior cases where a senior executive has been excluded, that individual has been accused of wrongdoing and ultimately has either been convicted of or (pleaded) guilty to a crime.”

Forest is fighting the move to ban Solomon. The inspector general’s office refused to comment on the case, and no final decision has been made. In congressional testimony, Morris said that when there is evidence an executive knew or should have known about misconduct, the inspector general “will operate with a presumption in favor of exclusion of that executive.”

Separate from the inspector general’s power to ban, the FDA has resurrected something called the “Park Doctrine,” which makes it easier for prosecutors to bring criminal charges against an executive.

The doctrine, stemming from a 1970s Supreme Court case, allows the government to charge corporate officers in the chain of command with a criminal misdemeanor. They could face up to a year in prison and fines if they had the authority and responsibility to prevent, detect or resolve misconduct affecting the public welfare but failed to do so.

It’s making an entire industry nervous.

Read article here:  http://www.google.com/hostednews/ap/article/ALeqM5jIGsUXYEAKspVXkeAdCDNumbbNFA?docId=d620a807289f47a6b01dfe728972a0b3

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Hickierie Dickory Doc – McGorry Turns Back the Clock

Monday, May 30th, 2011

Seroxat Sufferers – Stand Up and Be Counted
By Bob Fiddaman
May 30, 2011

Patrick McGorry

McGorry’s Delorean continues on it’s trip back to the future in Australia, it’s new passenger, Prof Ian Hickie.

I say new, Hickie has been around for years.

Judging by an article in today’s Australian Telegraph, there seems to be questions being asked regarding the number of Australian children being prescribed antidepressant medication.

Elissa Doherty and Marianne Betts write:

The number of children aged six and under being prescribed anti-depressants has soared by almost 50 per cent since the federal government pledged to investigate the issue, new figures show.

Thing is, just two meetings have been held since Australian Health Minister, Nicola Roxon, ordered an investigation over three years ago!

In the meantime, McGorry’s Delorean [early intervention program] continues to pick up speed…with government backing!

Ian Hickie

Ian Hickie was the inaugural CEO (2000-2003) of ‘beyondblue: the national depression initiative’, which has very successfully sold depression in Australia, with many millions of dollars of government money. This has worked brilliantly for the drug companies, and beyondblue does not accept pharma funding, so the drug companies get the promotion for free. I’ve previously wrote about beyondblue back in November 2008.

Graham “Biff Tannen” Burrows, whom I wrote about here, is now retired but has played a huge role in promoting psychiatric diagnoses and psychotropic drugs in Australia, particularly in the 1990′s.

It would appear that Burrows has been totally in bed with the pharmaceutical companies. More importantly, he influenced government policy in the 1990′s to focus on depression. Without him, it could be suggested that beyondblue would not have come about nor would McGorry’s meteoric rise a decade or so later.

Beyondblue and Hickie paved the way for EPPIC, a psychiatric service aimed at addressing the needs of older adolescents and young adults with emerging psychotic disorders.

Hickie, it would appear, is the Burrows of the 21st century.

McGorry shot to fame last year when he was appointed Australian of the Year. Hickie and McGorry had already been working together for several years, in fact Hickie is a key player in McGorry’s ‘Headspace’).

Anything they say to the Aussie government seems to be taken at face value, this is something that baffles me. We can all make claims about “fixing” mental disorders because they simply cannot be diagnosed. The way forward for Australians is nipping these disorders in the bud by ‘catching them early.’ I cannot believe the Aussie government could fall for this – what evidence has McGorry supplied to back up these claims?

Whatever they say is usually accepted as gospel, and it is very rare for either of them to be criticised, save for a handful of advocates, a few Australian MP’s and the Citizens Commission on Human Rights [CCHR]

SPHERE

The PDF above is a seemingly egregious example of the conflicts of interests that exist: a whole journal supplement based on the SPHERE project clinical audit. The audit was funded by Bristol-Myers Squibb (see p. S54), the manufacturer of Serzone. The publication of the supplement was funded by beyondblue with Commonwealth [Australian] Government money (see title page).

The audit, which used Hickie’s SPHERE questionnaire, found ridiculously high rates of mental disorders. This was reported in the supplement by Hickie, Davenport, Naismith, & Scott (2001, p. 52) as:

‘Sixty-three per cent of people attending general practice have some evidence of mental disorder (including alcohol or other substance misuse) by self-report or GP’s diagnosis of psychological difficulties.’

63%?

That’s some cash cow huh?

Not surprisingly, if you scroll to the bottom of the PDF you will find: Source: Hickie et al. Educational Health Solutions; 2000

McGorry claimed in a recent interview, “…we are trying to do is provide effective treatment for those young people for what they are presenting with and trying to reduce the risks. There are other effective ways of reducing the risk including cognitive behaviour therapy, the use of omega-3 fatty acids and so on.”

With previous involvement of Hickie and the pharmaceutical industry, I’d really love to believe that McGorry would use CBT and omega-3 fatty acids etc to help kids diagnosed with a mental disorder…before they actually get it!

I am left wondering if the Australian government have done their homework on McGorry & Co or if they just like to throw money into projects without first taking a look at the scientific proof – Has the current Australian Prime Minister, Julia Gillard, ever sought to seek evidence about the chemical imbalance myth? Has she taken a good look at the deaths associated with psychiatric drugs?

Here’s an idea for the Aussie PM, ask for scientific proof of McGorry & Co’s time-travelling prediction vehicle, don’t just take it as gospel that it works.

For the record, and so Patrick McGorry and his cronies totally understand, I was raised a Catholic. I denounced myself as one in later years. McGorry & Co can throw the Scientology tag at me if they wish, they have done it in the past when backed into a corner by CCHR. If that is all they have in their armour then I envisage a future of mind altering drugs being prescribed to Australian children on the basis that they may have an illness rather than they actually have an illness. If parents of those children dare question McGorry & co, prepare yourselves for some mud slinging – you may as well sign yourselves up to the Church of Scientology, you’ll be labelled one regardless…and we all know how psychiatrists, such as McGorry, just love to use labels.

How do I know this? Well, like McGorry & Co, I travelled forward in time…in my Tardis – my DeLorean is at the garage in need of a new flux capacitor.

Fid

http://fiddaman.blogspot.com/2011/05/hickierie-dickory-doc-mcgorry-turns.html

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