Archive for August, 2011

Scandalous Off Label Use Of Antipsychotics: Another Warning For DSM-5

Monday, August 8th, 2011

Psychiatric Times

By Allen Frances, MD | August 5, 2011

I never would have entered the DSM-5 controversy were it not for two of its proposals that risk furthering the already frightening overuse of antipsychotic medication, particularly in children and teenagers. DSM-5 plans to introduce two new and untested diagnoses that would offer natural targets for poor drug prescribing–psychosis risk syndrome (AKA attenuated psychotic symptoms) and temper dysregulation (AKA disruptive mood dysregulation). There is no evidence whatever that antipsychotics would confer any benefit on the kids so labeled (and too often mislabeled), but great reason to worry that this would not stop their being used needlessly and recklessly.

The DSM-5 supporters of these two proposals believe my concern is ill founded, or at least excessive. They argue that they would not recommend antipsychotics for the new diagnoses and that there is no FDA approved indication for their use. This misses the crucial point that new DSM categories, once made official, take on an independent life. If they can possibly be misused (and clearly these can), they will be misused. And experience teaches the clear lesson that antipsychotic overuse will insinuate itself insidiously and inappropriately whenever any crack of opportunity opens up.

A recent paper by Mojtabai and Olfson1 presents a chilling testimony to the spreading creep of antipsychotic misuse. In 1996, antipsychotics were prescribed for patients with an anxiety disorder in 10% of office visits. One decade later, this had more than doubled despite there being no evidence that antipsychotics work for anxiety disorders and clear evidence that they cause dangerous side effects. Because antipsychotics have no FDA indication for anxiety disorders, all this massive overprescription was done completely off-label.

This is truly alarming, but unfortunately it is not really surprising. Antipsychotics have managed to become the top class of drugs– generating the highest revenue with sales of $15 billion per year– despite the troubling facts that much of the prescribing is off label, unsupported by scientific evidence, and likely to cause the dreadful side effect of obesity with all its consequent risks. This is an astounding reflection on the lack of caution in everyday medical practice. Used appropriately, antipsychotics are extremely valuable and necessary tools– but what could possibly justify their becoming such promiscuous best sellers?

DSM-5 cannot off-load responsibility for causing harmful unintended consequences– especially when these are so obvious that they smack you in face. It is foolhardy to risk causing a further wave in the antipsychotic deluge. I continue to despair of a process that allows such smart and well meaning people to make such really dreadful decisions.

 https://member.cmpmedica.com/index.php?referrer=http://member.cmpmedica.com/cga.php?assetID=422&referrer=http://www.psychiatrictimes.com/blog/couchincrisis/content/article/10168/1921927

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‘Former Australian of the Year’ Psychiatrist Patrick McGorry Accused of Conflict of Interest

Saturday, August 6th, 2011

Sydney Morning Herald – August 7, 2011

by Jill Stark

”It’s extremely worrying that the government is listening to professional lobbyists who have a massive personal investment in the programs they’re recommending – and they are undoubtedly overstating the evidence. There’s a massive conflict of interest there,” Professor Castle said.

 

Patrick McGorry Photo: Pat Scala

PSYCHIATRISTS, psychologists and patients’ groups say there is a growing backlash against the federal government’s mental health reforms and have accused its expert adviser, former Australian of the Year Patrick McGorry, of a conflict of interest.

Several mental health specialists have told The Sunday Age the focus on early intervention for adolescents and young adults has been ”massively oversold” by the ”McGorry lobbying machine”.

They claim he used his position on the government’s mental health expert working group to recommend funding for programs he founded.

David Castle, head of psychiatry at Melbourne’s St Vincent’s Hospital, said Professor McGorry, – who founded headspace (Australia’s national youth mental health foundation) and the early psychosis prevention and intervention centres – and Professor Ian Hickie, a headspace board member, had overstated the evidence for early intervention for young people at risk of psychosis.

Headspace is a service for 12 to 25-year-olds with mild to moderate problems such as bullying, stress and relationship difficulties. Patients do not require a GP-referral. The early psychosis prevention and intervention centres provide integrated psychiatric, psychological and social support for 15 to 24-year-olds.

Between them, the two services received almost a quarter of the $2.2 billion mental health package in the May federal budget. Both professors McGorry and Hickie were on the government’s mental health expert working group that advised the Prime Minister.

”It’s extremely worrying that the government is listening to professional lobbyists who have a massive personal investment in the programs they’re recommending – and they are undoubtedly overstating the evidence. There’s a massive conflict of interest there,” Professor Castle said.

The row comes after US psychiatrist Allen Frances – chairman of the committee that produced the Diagnostic and Statistical Manual of Mental Disorders IV, the key psychiatric diagnostic source – described Australia’s investment in early intervention as a ”vast untried public-health experiment”, claiming there was little evidence it had long-term benefits.

The dispute is in part a turf war about where limited funding should go. Some argue traditional GP and psychiatrist-led care has failed teenagers and youths who fall between paediatric and adult services, leading to delays in treatment.

About 14 per cent of children aged four to 17 have mental health problems, with depression and anxiety disorders the most common. About 2 per cent suffer from a psychotic illness.

George Patton, professor of adolescent health research at Melbourne’s Royal Children’s Hospital, praised Professor McGorry’s work but said his faith in early intervention was not shared by everyone. ”There’s a real groundswell of concern amongst the senior psychiatric community that we are running ahead of the evidence,” he said.

Professor McGorry rejected the claims, accusing critics of being a small minority who are ”disaffected, destructive and irresponsible”, and who are misusing scientific evidence to protect their turf and the ailing traditional mental health model.

”The reforms around early psychosis and headspace advantage patients and families, and have 20 years of solid evidence behind them, with successful upscaling in hundreds of communities worldwide,” Professor McGorry said.

He said there was no conflict of interest as he and Professor Hickie headed non-profit organisations, and while ideally all services would have received more funding, young people had the most acute needs.

Peter Birleson, former director of mental health services at Melbourne’s Royal Children’s Hospital, disagreed. ”The McGorry machine is distorting things in Australia. There’s people in the UK who look at what’s happening in adolescent and youth psychiatry here and think that it’s completely mad. While McGorry champions the cause of youth and young adults, actually 50 per cent of lifelong mental disorders appear before the age of 14, so there should be a massive shift towards strengthening services to children,” Dr Birleson said.

Professor Hickie said he and Professor McGorry had long advocated for services outside the youth area, and had no more influence than anyone else on the government’s working group.

”People taking cheap shots is disappointing but it’s characteristic of the mental health area. When there’s been very little investment, people end up fighting over the crumbs,” he said.

Louise Newman, past president of the Royal Australian and New Zealand College of Psychiatrists, said the focus on early intervention was too narrow and could lead to young people being overmedicated, prematurely diagnosed and stigmatised.

However, David Crosbie, chief executive of the Community Council for Australia and former head of the Mental Health Council of Australia, said professors McGorry and Hickie were being targeted for challenging current practice. ”I have nothing but admiration for Pat and for Ian, who are prepared to go well beyond what their roles are to try and make a difference – and it’s a pity that other people in the sector couldn’t support improvements for the greater good of mental health.”

Another supporter, SANE Australia’s executive director, Barbara Hocking, said Professor McGorry had championed services he wasn’t involved with and was instrumental in getting more funding for the sector overall.

Money for the early intervention programs came from cuts to the over-budget Better Access scheme, which provides psychological services through GPs, psychologists and social workers.

The cuts were opposed by the Australian Medical Association, the Royal Australian College of General Practitioners, and the Australian Psychological Society, which claim people with anxiety and depression now will be priced out of treatment.

Professor Hickie and Monsignor David Cappo, who is also on the government’s working group, opposed the Better Access scheme. Prior to the budget they, along with Professor McGorry, released a blueprint to transform mental health. It listed 30 ”best buys” in mental health – Better Access was not among them.

Ben Mullings, head of the Association of Counselling Psychology, said the government’s working group could not claim to be independent when panellists were direct beneficiaries of funds.

Victorian Mental Illness Awareness Council director Isabell Collins said she respected Professor McGorry’s commitment to youth but felt other age groups were being neglected.

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A dissenting view: The myth of mental illness

Friday, August 5th, 2011

Online Opinion – August 5, 2011
by Robert Spillane

American psychiatrist Thomas Szasz argued that mental illness is a metaphor: minds can be sick only in the ways that jokes or economies can be sick. If there is no mental illness there can be no 'treatment' or 'cure' for it. Click image for more by Szasz

“No mental illness has, or ever will be, diagnosed on the basis of medical signs, for a simple reason. If people who have been diagnosed with schizophrenia are found to have a brain lesion, they are suffering from a brain illness, not a mental illness. The presence of a medical sign in people who have been labelled mentally ill proves that they are not suffering from a mental illness. Psychiatry is, therefore, that branch of medicine where diagnoses of ‘illnesses’ are made in the absence of objective evidence: they are based, not on what people have, but on what they do and say. And if they act in ways that annoy, upset or offend others, they may find themselves diagnosed as mentally ill and treated medically against their will.” – Robert Spillane

Government publications routinely announce that around 45% of Australians aged between 16 and 85 will experience a mental illness, while 20% will experience a mental illness in any given year. Australian businesses, we are told, lose over $6.5 billion each year by failing to provide early intervention and treatment for employees with mental health conditions. In 2006-7 there were 20.6 million mental health-related PBS/RPBS prescriptions which accounted for $670 million of benefits, or 10.8% of total expenditure.

Mental illness means, literally, an illness of the mind, as opposed to an illness of the brain. But can minds be ill? I argue that they cannot. Mental illness is, therefore, a myth. Since illness affects only the body and the ‘mind’ is not a bodily organ, the mind cannot be ill. ‘Mental illness’ is, therefore, an oxymoron.

In ‘The Myth of Mental Illness’, American psychiatrist Thomas Szasz argued that mental illness is a metaphor: minds can be sick only in the ways that jokes or economies can be sick. If there is no mental illness there can be no ‘treatment’ or ‘cure’ for it.

If, as many people believe, the mind is really a brain process, then mental illness is really brain illness a valid diagnosis of which must be based on objective medical signs, not on subjective communications or complaints. This is no mere semantic quibble since Australian law accepts the distinction between brain illness (e.g. multiple sclerosis) and mental illness (e.g. schizophrenia). People cannot be locked up in a hospital and treated against their will for multiple sclerosis. Similarly, people may be found not guilty of a serious crime because of their ‘paranoid schizophrenia’, but the same rules do not apply to people with brain tumours.

No mental illness has, or ever will be, diagnosed on the basis of medical signs, for a simple reason. If people who have been diagnosed with schizophrenia are found to have a brain lesion, they are suffering from a brain illness, not a mental illness. The presence of a medical sign in people who have been labelled mentally ill proves that they are not suffering from a mental illness. Psychiatry is, therefore, that branch of medicine where diagnoses of ‘illnesses’ are made in the absence of objective evidence: they are based, not on what people have, but on what they do and say. And if they act in ways that annoy, upset or offend others, they may find themselves diagnosed as mentally ill and treated medically against their will.

People change their behaviour with or without the intervention of psychiatrists or psychologists. Such intervention is nowadays called ‘treatment’ when, in some cases, it should be called ‘torture’. When these interventions produce acceptable changes in behaviour, they are called ‘cures’. The cure of mental illness, it is argued, produces a state of mental health which is universally regarded as desirable. But if mental illness is a myth, mental health is too.

Since the middle-1990s the term ‘mental health literacy’ has been used to describe people who endorse an illness ideology and so agree with biological psychiatrists who bemoan the public’s alleged ignorance. Many attempts to reduce prejudice against the ‘mentally ill’ have been based on the attempt to make the public think like biological psychiatrists. This approach is based on the assumption that if you are ill your behaviour is beyond your control and you cannot be held responsible for it. Psychologist, John Read, reports evidence from seventeen countries that reveals that citizens have steadfastly resisted this propaganda, preferring to attribute mental illness to problems in living. Biological psychiatrists, eagerly supported by pharmaceutical companies, have consistently tried to tell people that they are wrong. This ‘illness’ approach to de-stigmatisation ignores the impressive body of evidence that biological explanations actually fuel prejudice.

The authors of the psychiatric bible known as ‘The Diagnostic and Statistical Manual of Mental Disorders’ (DSM-IV-TR) admit that ‘no definition adequately specifies precise boundaries for the concept of ‘mental disorder”. Faced with the undeniable fact that mental illnesses cannot be diagnosed on objective medical grounds, DSM IV nonetheless provides more than 350 examples including: academic disorder, ADHD, expressive language disorder, gambling, gender-identity disorder, mathematics disorder, neglect of child disorder, partner-relational disorder, phase of life disorder, rumination disorder, written expression disorder and premature ejaculation. It seems that when females climax quickly it is ‘sexy’, when males climax quickly it is a mental illness!

In English there are success verbs, like ‘discover’ – one cannot discover something that does not exist. ‘Invent’ is not a success word since one can invent something that does not exist. Brain illnesses are discovered, mental illnesses are invented.

http://www.onlineopinion.com.au/view.asp?article=12427

To find out more about Dr. Thomas Szasz click here: http://www.cchrint.org/about-us/co-founder-dr-thomas-szasz/

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Grassley Wants Website Disclosing Conflicts of Interest—Letter Cites Harvard Psychiatrists Failure To Report Nearly $1 Million

Friday, August 5th, 2011

 In a letter to OMB [ Office of Management and Budget]  Sen. Chuck Grassley warned the administration not to back off from a proposed rule that would create a website to disclose medical researchers’ conflicts of interest. “I am troubled that taxpayers cannot learn about the outside income of the researchers whom the taxpayers are funding, and this flies in the face of President Obama’s call for more transparency in the government. The public’s business should be public. The consequences of a lack of transparency include doctors’ possibly using taxpayer-funded grants to leverage their own financial interests, to the detriment of consumers.” Grassley said he’s worked tirelessly “to shine light on these relationships, including with the help of Sen. Kohl in securing the passage of the Physician Payment Sunshine Act of 2009.” Read the letter here: http://1.usa.gov/r0OLYG

 

The Honorable Jacob J. Lew
Director
Office of Management and Budget
Eisenhower Executive Office Building
1650 Pennsylvania Avenue, NW
Washington, DC 20503

Dear Director Lew:
I write to you today regarding public disclosure of financial relationships between physicians and the drug, device and biologic industries. For the past three years I have worked to shine light on these relationships, including with the help of Senator Kohl in securing the passage of the Physician Payment Sunshine Act of 2009 (PPSA).

Before the passage of PPSA, in summer of 2008, I began releasing the results of my oversight work that demonstrated that universities are not and have not managed their professors’ financial conflicts of interest and that change is needed at the National Institutes of Health (NIH). Specifically, I found:

The Chair of the Psychiatry Department at Emory University failed to report hundreds of thousands of dollars in payments from a pharmaceutical company while researching that same company’s drugs with an NIH grant. The Health and Human Services Office of the Inspector General (HHS OIG) is now investigating the matter.

The Chair of the Psychiatry Department at Stanford University received an NIH grant to study a drug while partially owning a company that was seeking FDA approval of said drug. He was later removed from the grant.

Three psychiatrists at Harvard University failed to report almost a million dollars each in outside income while heading up several NIH grants. Harvard released a report on the matter, and a briefing has been scheduled with my office.
I am concerned about recent reports that the Office of Management and Budget (OMB) may be attempting to weaken conflicts of interest rules proposed in May 2010 by the Department of Health and Human Services (HHS).

According to an article in Nature, OMB has removed the requirement for a publicly available website that would publish the conflicts of interests of researchers funded by taxpayers.1 I am troubled that taxpayers cannot learn about the outside income of the researchers whom the taxpayers are funding, and this flies in the face of President Obama’s call for more transparency in the government. The public’s business should be public. The consequences of a lack of transparency include doctors’ possibly using taxpayer-funded grants to leverage their own financial interests, to the detriment of consumers. Transparency is a backstop against such practices. I urge OMB to follow through and approve a rule that includes a publicly available website. OMB is the final arbiter of this decision. Any weakening of publicly available information requires careful scrutiny.

In order to understand why OMB appears to have concluded that weakening the HHS proposed conflict of interest rule is appropriate, I would appreciate your response to the following requests for documents:

1) Please provide all records relating to communications, including emails, with OMB staff regarding the Department of Health and Human Services’ proposed conflicts of interest rule from May 1, 2010, to the present.

2) Please provide all records, including calendar entries, relating to meetings with Administrator Cass Sunstein, OMB Office of Information and Regulatory Affairs, from May 1, 2010, to the present.

I request that OMB respond to my request by no later than August 25, 2011. Thank you for your attention to this important matter.

Sincerely,
Charles E. Grassley
Ranking Member
See the letter here: http://1.usa.gov/r0OLYG

 

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ADHD drugs linked to heart disease and death

Thursday, August 4th, 2011

NaturalNews – August 2, 2011

by Ethan A. Huff

Click image to watch 1 minute video: ADHD—Labeling Normal Kids 'Mentally Ill'

A major study recently published in the journal Pediatrics — and republished by countless other medical and mass media sources — made the bold claim that stimulant drugs like those used to treat attention deficit hyperactivity disorder (ADHD) in children are not linked to cardiovascular events and death. But a recent analysis by Dr. Robert Tozzi writing for FOX News explains that the study was flawed, and that the drugs will cause cardiovascular events or death, especially in individuals with certain conditions.

Like most studies that allege the safety of pharmaceutical drugs, the Pediatrics study was at least partially, if not completely, funded by the drug industry. It was also deliberately constructed in such a way as to artificially minimize the risks associated with stimulant drugs. As a result, its findings ended up mirroring claims long made by the drug industry that stimulant drugs are safe, and that children do not need to be tested for certain conditions prior to being prescribed them.

The study included two groups of children, one taking stimulant drugs, and the other not taking stimulant drugs. The idea was to simply compare the number of heart events between the two groups, and determine whether or not stimulant drugs are associated with an increased risk of heart events and sudden death.

Well, according to Dr. Tozzi, few, if any, of the high-risk children with conditions that would react negatively in the presence of stimulants were placed in the stimulant group. Most parents of children with such conditions, as well as their doctors, would not normally opt for giving stimulants to their high-risk children, and thus the vast majority of these children were placed in the non-stimulant group.

This inherent and obvious flaw completely debunks the credibility of the study. After all, the whole point of it was supposedly to identify whether or not children need to be pre-screened for certain conditions before being prescribed stimulant drugs. With this in mind, it makes sense to actually identify how children with existing conditions respond to stimulant drugs, otherwise the data is meaningless.

It is difficult to say which is worse — testing dangerous drugs on high-risk children, or not testing dangerous drugs on high-risk children and simply declaring that they are  safe (which is what the drug industry basically did in a recent study). One thing is for sure, though. The propositions made in the study that stimulant drugs are safe and do not raise the risk of heart disease and sudden death are patently false. And many children will likely suffer and die as a result of these lies.

To read all international drug regulatory warnings and studies on Ritalin, Adderall, Concerta and other ADHD drugs visit CCHR’s Psychiatric Drug Side Effects Search Engine”

http://www.cchrint.org/psychdrugdangers/drug_warnings.php

http://www.naturalnews.com/033204_ADHD_drugs_death.html

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Claim: J&J Wrongly Marketed Antipsychotic Drug Risperdal to Kids

Wednesday, August 3rd, 2011

BNET – August 3, 2011
by Jim Edwards
The FDA told Johnson & Johnson (JNJ) in 1997 that its request to market the antipsychotic drug Risperdal for children was “without any justification.” In the following years, J&J’s army of pharmaceutical sales reps made 100,000 sales calls on child and adolescent psychiatrists, justifying this by “qualifying” the docs if they had as few as one adult patient exhibiting signs of schizophrenia, according to a lawsuit.

It was a distinction only a lawyer can love, and now the Massachusetts attorney general is using it against J&J and its Janssen unit, alleging that J&J’s promotion of Risperdal for children was misleading.

J&J had initially asked the FDA to approve the drug for use in children, and the FDA eventually allowed limited use in the over-10s in the 2006 and 2007. But in 1997, without clinical evidence to back its request, the FDA frowned on use of the drug for children. In a latter the J&J, the FDA wrote:

To permit the inclusion of the proposed vague references to the safety and effectiveness in pediatric patients and the nonspecific cautionary advice about how to prescribe Risperdal for the unspecified target indications would serve only to promote the use of this drug in pediatric patients without any justification.

“Promote use of this drug in pediatric patients” is exactly what J&J then did, according to the suit:

From January 1994 through September 2006, Janssen sales representatives directly promoted Risperdal to thousands of child and adolescent psychiatrists and pediatricians even though Risperdal was not approved to treat any pediatric conditions until October 2006.

Doctors were paid $1,000 to attend J&J’s pediatric “advisory board” meetings held at posh resorts, and eventually Risperdal reached a 50 percent share of pediatric antispychotic category, the suit alleges.

Kids grew breasts, docs went to the Four Seasons

This success came at some price to the children receiving the drug, as Risperdal’s side effects include weight gain, diabetes and “galactarhea,” the premature production of breast milk in both boys and girls. One of J&J’s sales reps made this internal sales call note on that issue:

An August 2, 2001 call note (000000244279 ) reports on a sales call with a Braintree doctor: “. . . . She is using Risperdal with great success in kids ala Biederman. She did mention galactarhea so I told her how Biederman is using Dostinex. She is going to get more info on this dopamine agonist. She is going to attend the 4 Seasons event.”

“4 Seasons” is likely a reference to the posh Four Seasons hotel in Boston (its indoor pool is pictured). The Biederman

name is familiar to anyone following the Risperdal saga, of course. Joseph Biederman was the Harvard medical school doctor who was paid by J&J to churn out reams of studies promoting Risperdal in kids. He became infamous when he suggested in a deposition that he was one pay-scale below God.

http://www.bnet.com/blog/drug-business/claim-j-j-wrongly-marketed-antipsychotic-drug-risperdal-to-kids/9344

For more information on Joseph Biederman – http://www.cchrint.org/2011/07/22/pharma-funded-psychiatrists-behind-bogus-child-bi-polar-epidemic-disciplined-for-conflicts-of-interest/

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Attorney General Alleges Jansen Illegally Marketed Antipsychotic Drug – to kids and the elderly

Tuesday, August 2nd, 2011

Coakley alleges Janssen illegally marketed drug

By Jessica M. Karmasek – LegalNewsLine.com

August 2, 2011

BOSTON (Legal Newsline) — Drug manufacturer Ortho-McNeil-Janssen is being sued by Attorney General Martha Coakley for illegally marketing Risperdal, an atypical antipsychotic medication.

Coakley’s lawsuit alleges that Janssen promoted the drug to treat elderly dementia and a number of uses in children and adolescents when these uses had not been shown to be safe and effective and had not been approved by the U.S. Food and Drug Administration.

The complaint, filed this week in Suffolk Superior Court, further alleges that Janssen failed to disclose serious risks associated with Risperdal’s use, including the risk of excessive weight gain, diabetes and, for elderly dementia patients, an increased risk of death.

“Manufacturers should not promote uses of their pharmaceutical products that have not been established to be safe and effective,” Coakley said in a statement Monday.

“Janssen put profits ahead of patient safety by promoting Risperdal for uses that had not been approved and by failing to disclose serious risks associated with Risperdal’s use.”

According to the attorney general’s lawsuit, Janssen’s unfair and deceptive practices included:

* Omitting and/or concealing material facts regarding Risperdal’s efficacy and safety in its communications with Massachusetts health care providers and consumers;

* Concealing, omitting or minimizing the side effects and risks associated with Risperdal’s use;

* Promoting Risperdal to treat elderly dementia without disclosing to prescribers the serious risks associated with Risperdal’s use in dementia patients, including an increased risk of death;

* Promoting Risperdal to treat elderly dementia without disclosing to prescribers that the U.S. Food & Drug Administration had rejected the company’s request to market Risperdal for this use because of unaddressed safety concerns;

* Promoting Risperdal’s use as safe and effective to treat conduct disorder and other conditions in children for more than a decade before receiving FDA approval to market Risperdal to treat any conditions in children;

* Making misleading and deceptive statements to prescribers about Risperdal’s safety, particularly with respect to weight gain and the risk of developing diabetes;

* Paying physicians to participate in sham consulting programs that were, in fact, thinly disguised marketing programs touting unapproved uses; and

* Targeting its sales and marketing efforts to prescribers who rarely, if ever, prescribe Risperdal for its FDA-approved uses, primarily the treatment of schizophrenia and bipolar mood disorder.

According to the attorney general’s complaint, Janssen’s illegal marketing and sales tactics helped the company generate hundreds of millions of dollars in sales in the state.

Citing company documents, Coakley’s lawsuit notes that these illegal tactics helped make Risperdal a market leader in both the children and adolescent and elderly market segments.

 

http://www.legalnewsline.com/news/233450-coakley-alleges-janssen-illegally-marketed-drug

 


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DSM 5 Will Further Inflate The ADD Bubble

Tuesday, August 2nd, 2011

Psychology Today
by Allen Frances, Former Chairman, DSM Task Force

Video: ADHD Labeling Normal Kids "Mentally Ill"

The Child Work Group Fails Again To Learn From Its Experience

Martin Whiteley is an MP who represents Perth in the Australian parliament. He has been actively involved in mental health issues and succeeded in a crusade to curb what had been Perth’s alarming overdiagnosis and overmedication of  Attention Deficit Disorder Disorder (ADD). Mr Whiteley has become expert in the intricacies of ADD and is alarmed that the changes suggested for DSM 5 will greatly exacerbate the ADD fad he worked so hard to tame. Read Mr Whiteley’s careful item by item review and you will be alarmed too:

http://speedupsitstill.com/dsm-5-proposal-adhd-%e2%80%93-making-l…

We are already in the midst of a false epidemic of ADD. Rates in kids that were 3-5% when DSM IV was published in 1994 have now jumped to 10%. In part this came from changes in DSM IV, but most of the inflation was caused by a marketing blitz to practitioners that accompanied new on-patent drugs amplified by new regulations that also allowed direct to consumer advertising to parents and teachers. In a sensible world, DSM 5 would now offer much tighter criteria for ADD and much clearer advice on the steps needed in its differential diagnosis. This would push back ,however feebly, against the skilled and well financed drug company sell. DSM 5 should work hard to improve its text, not play carelessly with the ADD criteria in a way that may unleash a whole set of dreadful unintended consequences- unneeded medication, stigma, lowered expectations, misallocation of resources, and contribution to the illegal secondary market peddling stimulants for recreation or performance enhancement.

The DSM 5 child and adolescent work group has perversely gone just the other way. It proposes to make an already far too easy diagnosis much looser.

How puzzling and troubling. Child mental health has already promoted no fewer than three false epidemics in just 15 years- ADD, childhood bipolar, and autism. Any reasonable group would now be learning from this past experience. For the future, it would be chastened, cautious, and eager to correct the damage it has done- rather than embarking on any reckless new adventures. A prudent DSM 5 would tighten its criteria for ADD and put in a black box warning against the blatant current off-the-DSM-label diagnosis of childhood bipolar. DSM 5 instead does everything wrong it possibly could with ADD and then remarkably takes the mischievous further step of adding yet another new candidate for diagnostic fad (Disruptive Mood Dysregulation Disorder) likely that will increase the already scandalous overprescription of dangerous antipsychotic medication to children. Go figure.

In many circles, the accepted wisdom is that DSM 5 workers are making such unaccountably bad decisions because they want to promote drug sales to kids. To support this accusation, cynics raise the Biederman affair and also APA’s previous excessive financial support from Pharma.

This is one time when the cynics are dead wrong. The DSM 5 work group is making simply disastrous decisions for the purist of reasons. These are not people with close industry ties and their conflict of interest is intellectual, not financial. Experts in child psychiatry are dangerously naïve about the likely misuses of their well meaning suggestions. They are blind, not corrupt.

What is needed is outside supervision to curb child psychiatry’s seemingly endless taste for diagnostic excess. And APA should also realize the grave harm done to its credibility by the appearance that DSM 5 is far too Pharma friendly even if this has not been the real motivation behind the bad DSM 5 proposals.

To make matters worse, the DSM 5 field trial will be completely worthless- providing no information at all about the magnitude of the rate increase in ADD that will occur once DSM 5 opens the floodgates even wider. We did careful field trials before DSM IV to compare the impact on rates of the different possible definitions and predicted a 15% increase for the one finally chosen. Instead, the rates more than doubled- courtesy of pressure from the drug companies. For obscure reasons, DSM 5 is conducting extraordinarily expensive field trials that (again perversely) avoid the only question that really counts- just how high will the rates skyrocket under the even easier to meet new DSM 5 definition.

DSM 5 will be flying completely blind into dangerous territory, unimpeded by adult supervision. The leaders of child psychiatry (who already have the unfortunate track record of producing fads) will now be given a free pass to further feed their blossoming ADD fad. Will they never learn from past mistakes?

http://www.psychologytoday.com/blog/dsm5-in-distress/201108/dsm-5-will-further-inflate-the-add-bubble

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How Did These Babies Die? Question unites grieving families

Tuesday, August 2nd, 2011
BC LocalNews.com – August 1, 2011
by Jeremy Deutsch

Matthew Schultz was only 2.5 hours old when he died on Feb. 21, 2009. A coroner’s report stated there was no anatomical or toxicological cause of death, which was deemed “natural”. Another baby, Greyson Rawkins, was only two months old when he died on March 23 of this year. A coroner’s report found Greyson died of sudden unexplained death in infancy and his death was ruled undetermined. However, the mothers of both babies were taking Effexor while carrying and believe the antidepressant drug may be connected to the deaths of their children. And, as KTW learned, there are widespread medical warnings about pregnant women taking antidepressants.

Two hours is not a lot of time, but for little Matthew Schultz, it was his entire life.

One moment, Amery Schultz held Matthew in his arms. The next moment, his child was dead.

As the Merritt family struggled to deal with their grief, two years later and 45 minutes away in Kamloops, another family would be shattered by the sudden loss of a newborn.

Greyson Maxwell Rawkins was found one morning by his mother, cold and unresponsive.

The two-month old was dead.

Unlike most sudden-infant deaths, which go largely unexplained, both families believe they know exactly what killed their sons — an antidepressant called Effexor.

Matthew was born on February 21, 2009, at 2:21 a.m. at Royal Inland Hospital.

Right from birth, the newborn had poor colouring  and trouble breathing.

Schultz said he and wife Christiane argued with medical staff at the hospital about Matthew’s symptoms, only to be told they was normal.

An hour later, alone in the hospital room, Amery held Matthew in his arms.

He was gently rocking his fifth child to sleep and noted the baby’s lips were a bit purple.

Matthew fell asleep in his father’s lap.

Moments later, a nurse came into the room and noticed the new born was pale and unresponsive.

Matthew was in complete respiratory and cardiac arrest.

Medical staff were unable to revive him and he was pronounced dead an hour later.

“Losing your child — you can’t explain it,” Amery said.

“It tears a hole in your heart that will never heal.”

The B.C. Coroners Service listed Matthew’s death as natural — as far as the coroner was concerned, it was a case of sudden infant death syndrome (SIDS).

However, the Schultzes were not convinced.

The couple started to do their own research and were dismayed by what they found.

Christiane had been taking the antidepressant Effexor, also known by its clinical name venlafaxine, for years prior to Matthew’s birth and during pregnancy.

Three previous children were also exposed to the drug.

Unbeknownst to the couple, venlafaxine had been under a Health Canada warning since 2004.

The government agency had advised that newborns may be adversely affected when pregnant women take a specific group of antidepressants during the third trimester of pregnancy.

The list included venlafaxine.

The Schultzes said their family doctor never told them about the possible risks of taking the drug during pregnancy.

“I asked every pregnancy, ‘Should I get off of these?’” Christiane said.

“But I was told, ‘No, they’re fine, they’re perfectly safe.’”

Convinced Effexor contributed to Matthew’s death, the family awaited the final report from the coroner, hoping to get some answers as to the cause of their son’s death.

They were also hoping the coroner would make recommendations so other families wouldn’t suffer through a similar loss.

But the report, which the Schultzes received on the two-year anniversary of Matthew’s short life and death, surprised and angered the family.

It made no recommendations and found no cause of death.

According to the coroner’s report, a detailed autopsy on Matthew showed no anatomic cause of death, but the possibility was raised of venlafaxine exposure being a contributing factor.

Brain-tissue samples were sent to a research facility in the U.S. for examination to determine if there was an underlying susceptibility to the class of antidepressants.

But the report noted it was unclear how prenatal exposure to Effexor might have contributed to Matthew’s death, if at all.

The report concluded the significance of the exposure to venlafaxine in utero is unknown and made no recommendations.

“At best, I can’t bring my son back,” Amery said.

“But to call his death natural, certainly it’s not.”

He argued the coroners office has ignored what he considers overwhelming evidence the drug played a role in his son’s death.

The report itself listed exposure to venlafaxine under the category of other conditions contributing to death.

Physician and coroner Karla Pederson, with the B.C. Coroner’s Service, looked over the results of the report and is satisfied the office went to great lengths to find the cause of death.

“We are not making a presumption that we know what caused the death of this child, because we do not know,” she said.

When asked if the coroners service is concerned about the use of antidepressants during pregnancy, Pederson noted the drugs are used by thousands, if not millions, of pregnant women around the world without resulting in infant death.

Greyson Rawkins was born on Jan. 24, 2011, at RIH.

Like Matthew Schultz, little Greyson had trouble breathing at birth and spent five days in the hospital before he could go home for the first time.

“He was just different from my first,” said Greyson’s mother, Nicole Rawkins, who noted her second child weighed less and slept much more than her daughter, Layla, now three years old.

During her entire pregnancy, Rawkins said she was taking a prescribed 450-milligram daily dose of Effexor to help her depression.

It was more than five times the amount she took during her first pregnancy.

The 31-year-old Rawkins was also taking another drug called Seroquel, between 100 and 150 milligrams a day, which is used to treat bipolar depression.

She said her doctor never told her of the risks.

After two months, though, Greyson appeared to be doing well.

That was until the evening of March 22 of this year.

Rawkins put Greyson to sleep in his bassinet, in the same room with her and her boyfriend.

But the two-month old was being fussy, so mom brought him into her bed for nursing.

They fell asleep, with Greyson lying on the edge of the bed with his mom.

At around 4 a.m., Greyson’s older sister decided to climb into bed, while Rawkins’ boyfriend moved to a couch.

Five hours later, Rawkins awoke to find her son cold and unresponsive.

“I shook him a bit, but he was floppy,” she recalled.

Emergency services was dispatched, but it was too late.

Greyson was dead.

Rawkins thought she had accidently killed her baby, but that wasn’t the case.

A coroner’s report released at the end of June listed the death as undetermined and classified it as SIDS.

As in the Schultzes’ case, the autopsy noted Effexor and Seroquel as risk factors for SIDS in the case, but added it could not be determined by a pathological exam.

An autopsy on Greyson also stated the respiratory complications at birth were considered likely secondary to withdrawal effects from utero exposure to venlafaxine.

Despite the findings, Rawkins said the blame in Greyson’s death has fallen on her shoulders.

“I wasn’t allowed to grieve because everyone was watching me,” she said.

After getting in contact with the Schultz family and sharing their stories, Rawkins is also certain the antidepressants she had taken for months played a role in Greyson’s death.

The two mothers have been carrying around their own guilt because they unwittingly exposed their children to the drug.

“Every day I look at them and I did that to them because I didn’t look up the safety of the drug,” said Christiane.

“Every day is guilt.”

http://www.bclocalnews.com/news/126547313.html

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Bitter pill for chief of Forest Labs

Monday, August 1st, 2011

Long-serving CEO faces wrath of feds—and Icahn

July 31, 2011 5:59 a.m.

Howard Solomon, 83, has led Forest Laboratories for more than 30 years.

Howard Solomon, the chairman, CEO and president of Forest Laboratories, began his latest annual letter to shareholders by touting the company’s line of promising new drugs: “This year may be the most remarkable year in Forest’s history, or maybe in the history of any pharmaceutical company.”

It may well be that, but not for the reasons Mr. Solomon suggested as Forest faces pressure from both outraged federal regulators and a famous corporate raider.

Mr. Solomon, 83, is one of New York’s most durable and successful CEOs. Over his 34-year tenure, he’s transformed Forest from a tiny company into a giant valued at $11 billion. Along the way, he has generated average annual shareholder returns of 23%—just a hair below Warren Buffett’s 24%. But now, Washington could force Mr. Solomon to abdicate his throne.

Uncle Sam plays hardball

The government, fed up with Forest’s encouraging doctors to prescribe for children antidepressants approved only for adults, has demanded that Mr. Solomon be sent packing. If the company fails to comply, Washington will effectively bar Medicare and Medicaid from buying its drugs. Such a move “could amount to a corporate death sentence,” according to a memo co-authored by Kenneth Breen, a partner at Paul Hastings, a law firm that has represented Forest in the past.

Uncle Sam’s hardball approach, coming six months after the Justice Department extracted three guilty pleas from the company and more than $300 million in fines and penalties, has some people on Wall Street crying foul.

“What the government is doing to Solomon is unfair,” said Ronny Gal, a health care analyst at Sanford C. Bernstein & Co. “I understand the need to hold CEOs to account, but in this case you had a criminal and civil settlement struck months ago, and now the government is coming back with more demands.”

At this point, though, the feds aren’t the only ones breathing down Mr. Solomon’s neck. Carl Icahn has bought 7% of Forest’s stock and is demanding that four of his candidates be elected to its nine-member board at the annual meeting on Aug. 18. Should Mr. Icahn prevail, the new directors will probably push to sell Forest to a larger rival.

Adding to the troubles, Forest’s earnings are expected to fall by more than 50% in the next few years. The cause of the projected decline is a “patent cliff,” a drug-industry malady in which a company’s patent protections on key brand-name drugs expire. In 2013, that will happen with Lexapro, an antidepressant that accounts for almost half of Forest’s $4.4 billion in annual sales.

The company is feverishly trying to develop new drugs and has had some success, such as with an Alzheimer’s treatment that had more than $1 billion in sales in the last fiscal year. Yet that drug’s importance to Forest only compounds the pressure on the CEO, as Medicare accounted for two-thirds of those sales, according to Bernstein research.

Forest’s difficulties date back to 1998, when a subsidiary began promoting the company’s blockbuster antidepressant, Celexa, to children and teenagers, even though it was approved only for adults. According to federal prosecutors, Forest concealed a study showing that the drug was not effective for minors and might even pose risks, including making them suicidal. Forest marketed the drug illegally for four years, the feds alleged.

The company also got in trouble with the Food and Drug Administration, which in a 2003 letter warned Forest to stop marketing an unapproved new drug. Rather than comply immediately, prosecutors said, Forest tried to move as much of the item as possible, going so far as to override computer systems, hire extra trucks and pay staffers overtime at a St. Louis distribution facility before halting shipments a day after receiving the FDA missive.

Forest pleaded guilty last November to obstructing justice, distributing an unapproved drug and distributing a misbranded drug. In addition to agreeing to $313 million in penalties—equal to about a third of earnings in the last fiscal year—Forest signed a Corporate Integrity Agreement with the Department of Health and Human Services’ inspector general. The matter seemed resolved until April, when the agency dropped the bomb and insisted that Mr. Solomon be “excluded” from Forest.

What triggered the action isn’t clear; neither the inspector general’s office nor Mr. Solomon would comment. But in an interview in June with online publication Pharmalot, an assistant inspector general said the office was determined to hold more senior health care executives accountable. “One of our concerns is that we’re not protecting federal health care programs … by continuing to enter into … settlements where the only result is paying money, which is perceived as a cost of doing business,” the official said.

HHS has forced out the chief executive of KV Pharmaceutical, who pleaded guilty to presiding over the production and distribution of oversized morphine tablets. The agency also orchestrated a coup at Purdue Frederick after the CEO and two others pleaded guilty to misbranding OxyContin.

What makes the potential expulsion of Mr. Solomon unusual, Mr. Breen noted, is that he wasn’t charged with personal wrongdoing in the criminal and civil cases against Forest. Mr. Solomon has challenged the exclusion action, but few believe the government will back down.

In transition

“We’re kind of in this in-between world,” Chief Financial Officer Frank Perier conceded during a conference call with analysts last month, adding that Forest’s board had already identified Mr. Solomon’s successor. (Candidates appear to have included Mr. Solomon’s son, David, who was appointed head of corporate development and strategy last November.)

Meanwhile, Forest must also deal with Mr. Icahn. In the conference call, Mr. Perier described two meetings between Forest officials and the activist investor as “substantive but short.” Mr. Icahn has “really not offered any plan or strategy for the company,” he added.

Mr. Icahn has pointed out that Forest’s stock—priced at about $37 late last week—trades for about half as much as it did seven years ago. He has also criticized board members for “putting their personal loyalty to and friendship with Mr. Solomon above their fiduciary duties.”

Mr. Icahn’s slate has a “good chance” of getting elected because many investors want new directors who will keep a closer eye on management, said Mr. Gal of Sanford Bernstein, who added, “The shareholders I’ve talked to say, ‘Why wouldn’t I want that?’ ”

http://goo.gl/UqyYs

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