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JUNE 2007: News on SSRIs, other Psych Drugs and Related Issues

June 5 2007 at 12:30 AM
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UK: Americanised NICE guidance - 4 YEAR OLDS to face quiz on their mental health

June 18 2007, 8:21 PM 

Continuing American influence on any UK government departments in anything that involves the term "MENTAL health".  How many 4 year olds can read and answer:  "I feel optimistic about the future"?  Education standards must have increased very secretly, it was only the other day that the media were describing the shocking number of children who were so well taught by their teachers that they are now illiterate adults!

http://www.telegraph.co.uk/news/main.jhtml?xml=/news/2007/06/03/ntest03.xml

Four-year-olds face quiz on their mental health


By Julie Henry, Education Correspondent, Sunday Telegraph
Last Updated: 12:39am BST 03/06/2007

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They are still grappling with the alphabet, learning nursery rhymes and making toys out of egg cartons.

 
Child with pen and clipboard: Four-year-olds face quiz on their mental health
Children will be asked to fill in a well-being scale

But now children as young as four will be expected to get in touch with their feelings by filling in questionnaires which ask if they are "optimistic about the future" and "dealing with problems well".

Under guidance being drawn up by the National Institute for Health and Clinical Excellence (Nice), primary schools in England will have a duty to improve children's emotional and psychological well-being.

Schools will be expected to combat factors that are "likely to lead to poor mental health or mental disorders" by introducing programmes to help children make the transition to secondary school, teaching "emotional literacy" and providing specialist counselling services and family therapy.

However, the suggestion that schools should measure happiness has been condemned by headmasters as needless bureaucracy that would divert teachers from teaching.

In a document outlining the draft scope of the guidance, Nice says that a school's success in making its pupils happy will be measured by indicators developed by Warwick and Edinburgh universities, which monitor positive attributes, such as confidence, resilience, attentiveness and the ability to form good relationships.

The "well-being scale" involves putting 14 statements to individuals about their thoughts and feelings and asking them whether they feel like that often, rarely, some of the time, all the time, or never - not unlike the self-help quizzes found in women's magazines. Its use in primary school could see data collected from thousands of pupils, from the age of four to 11, on whether they feel, for example, useful, relaxed and interested in other people.

The burden on primaries to improve pupils' mental health is part of wider drive by the Government to force schools to take responsibility for elements of a child's development that were once considered the domain of -parents and part of a good, traditional upbringing. As revealed by this newspaper, emotional literacy classes, which attempt to teach children how to manage anger and jealousy, and develop empathy and self-motivation, have already been introduced in primary and secondary schools after earlier trials.

 
A sample well-being questionnaire


The £20 million initiative has supplied schools with a mountain of documents on how to teach emotional intelligence through assemblies, dedicated sessions or discussions in other curriculum areas. It suggests using "worry boxes", where pupils write down their anxieties and post them into a box, and "emotional barometers", which pupils can use to show classmates the strength of their feeling about a subject.

Mick Brookes, the general secretary of the National Association of Head Teachers, said the plan for schools to measure happiness would be a distraction. "Any teacher worth their salt will be able to tell you all about these things, without having to ask pupils how they are feeling against a long checklist. Where there are children who are getting a raw deal at home and have problems, we certainly need to help them, but lumbering teachers with a 'happiness test' is a distraction," he said.

Some academics claim that forcing children to express their emotions has no educational validity and could be counter-productive and even dangerous. "There is no robust, independent evidence that making children and young people talk about their feelings in formal rituals at schools will develop lifelong emotional literacy and well-being," said Kathryn Ecclestone, a professor of education at Oxford Brookes University.

"Inserting a vocabulary of emotional vulnerability, where children are encouraged to feel different or told they have low self-esteem, is likely to encourage the very feelings of depression and hopelessness it is supposed to eradicate. Although ideas about well-being seem benign, they are based on judgemental assumptions about 'appropriate' feelings and how to deal with them. But if you try to challenge this educational bandwagon, you are accused of being in 'emotional denial'."

According to the Office of National Statistics, one in 10 children under the age of 16 have a clinically diagnosed mental disorder. Boys are generally more likely to have mental problems than girls and mental illness is more prevalent among children from disrupted families, those whose parents have no educational qualifications and those from poorer families and -living in disadvantaged areas.

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Comments

God help us all! What does this stupid Government think schools can do about parents who are mainly absent? Who, when they do have the opportunity to be with their children, dump them on any available babysitter, with the excuse that they have "been working all week so this is MY TIME". Routines that are non-existent, attitudes that prioritise money and the pursuit of money over everything else, especially children, and the complete breakdown of solid relationships that breed confident children, in favour of transitory, Government supported, ( via benefit after benefit for single mothers), short-term, quick turnover, 'deals'. which benefit only men and cause depression in the main child carer, they being women. Schools cannot and should not be expected to 'put right' the problems that have been largely caused by a Government which has rewarded and spoken out, very vociferously, in the case of Alan Johnson and the ilk, against stability, decency and the rights of the child. If children are depressed it is this Government's fault. Their politics have caused all the problems why should teaching staff have to sort it out? Soon schools will be having to take courses in social work. This is all too much.
Posted by judy on June 3, 2007 2:29 PM
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I've got a much simpler, quicker, non-time-consuming test and I'll offer it free to the DfES. This is how it goes. Teacher stands in front of class and says "If you're happy and you know it, clap your hands". Teaching Assistant makes a note of those children who don't clap, who are then identified for counselling or therapy. Simple? I wonder if I could get Alan Johnson to endorse my test!
Posted by Terry Bedding on June 3, 2007 2:09 PM
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The sample statements strike me as entirely fatuous. Any normal human being will answer some of the time to all of them, but would that be positive enough for the interfering busybodies. If my son were still at school this is the sort of twaddle he would have made sure he never completed (along with all the other personal, health etc rubbish, which he steadfstly refused to participate in).
Posted by cyn on June 3, 2007 1:55 PM
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Totally ridculous. These are 4 year olds people.
Posted by Joy on June 3, 2007 1:25 PM
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Surely schools should be for educating children ? Once a child is literate and numerate, they will feel more self confident, ergo happier. When will this government stop interferring into the minutiae of everyones life ?
Posted by Keith Pope on June 3, 2007 1:08 PM
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Pathetic. Rather than continuously turn our kids into overprotected husks why not just leave them alone, let them get on with being children and stop mollycoddling them. This is the reason why this country is falling apart.
Posted by Ian on June 3, 2007 12:18 PM
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How long before people offer expensive coaching lessons in how to beat these tests and come across as an almost fanatically happy and well balanced child? What forms of correction will the state apply to children who "fail or refuse" to come up to a sufficiently high standard of happiness?
Posted by Huw Sayer on June 3, 2007 11:14 AM
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Big Pharma Doesn't Like How It Looks on YouTube

June 18 2007, 8:42 PM 

http://adage.com/article?article_id=117070

"Big Pharma Doesn't Like How It Looks on YouTube
Advertising Age 2007 Jun 4

Critics Use Online-Video Site to Skewer Eli Lilly, Promote Documentary


Forget Congress and the Food and Drug Administration. More worrisome to the pharmaceutical industry these days is YouTube.

A former sales rep for Eli Lilly and Co.'s antipsychotic Zyprexa appears on a YouTube video revealing what Lilly officials told him to say about the drug's side effects.
A former sales rep for Eli Lilly and Co.'s antipsychotic Zyprexa appears on a YouTube video revealing what Lilly officials told him to say about the drug's side effects.

The online-video site famous for exploding Diet Coke bottles is blasting Big Pharma as YouTube gains popularity among drug-industry critics as a means to influence public opinion on the industry. The most damning of the videos are two five-minute segments -- one from a former sales rep for Eli Lilly and Co.'s antipsychotic Zyprexa, who reveals what Lilly officials told him to say about the drug's side effects. The other is a trailer for a 46-minute documentary called "Big Bucks, Big Pharma" from the Media Education Foundation, a Northampton, Mass., group that produces and distributes films intended to "inspire reflection" about American mass media.

'Here to stay'

These budding Michael Moores are a worry to the industry "because there are no internal controls on YouTube," says Dorothy Wetzel, former consumer-marketing chief at Pfizer and now senior VP-management supervisor at Saatchi & Saatchi, New York, where she works on AstraZeneca accounts. "But," she added, "you have to get used to it, because it's here to stay."

"Big Bucks, Big Pharma" is a critical look at the $5 billion practice of direct-to-consumer advertising. The documentary claims the industry manipulates both consumers and physicians with ads, and includes interviews with such notables as Dr. Marcia Angell from Harvard Medical School and the former editor of the New England Journal of Medicine, along with Dr. Bob Goodman of Columbia University Medical Center, founder of No Free Lunch, a nonprofit group that condemns the practice of physicians accepting free lunches and gifts from pharmaceutical sales reps.

"I can't help but think there are millions of people taking drugs they don't need and that may even be harmful," Ms. Angell says in the documentary.

Since the film came out in November, producers not only have been selling it on the Media Education Foundation's website, they have also adopted the Mel Gibson approach of grass-roots marketing. "Big Bucks, Big Pharma" is being seeded with senior-citizen groups, civic organizations and colleges.

No comment

Eli Lilly declined to comment on the Zyprexa video on YouTube, which features the purported sales rep detailing what the company told him to say about the drug's side effects. The New York Times in December reported that studies on the frequency of weight gain among Zyprexa users were under-reported by Lilly.

"We were told ... to downplay those side effects, to focus on the efficacies of the drug," the drug rep says.

He also detailed how he could manipulate drug-study statistics without lying. "An old stats professor once told me that statistics are like prisoners: Torture them long enough, and they'll tell you whatever you want to hear," he said.

Doug Wood, a New York-based attorney for the global law firm Reed Smith, said there is little pharmaceutical companies can do unless they have been slandered.

Fighting back

But the drug companies aren't taking it lying down. In fact, some are trying to use YouTube to their own advantage by posting entertaining and positive films about their products.

GlaxoSmithKline now has its own one minute, 43-second video on YouTube for Restless Legs Syndrome.

Ms. Wetzel said she believes more drug companies and ad agencies will adopt such an approach. "The conversation about health care goes on," she said, "and we're going to have to deal with it."

 

WATCH VIDEOS:   

"BIG PHARMA, BIG BUCKS"

6 videos/parts:

http://www.youtube.com/watch?v=Hh99CN5tLrc&eurl=http%3A%2F%2Fwww%2Enetwork54%2Ecom%2FForum%2F281849%2Fmessage%2F1180946448%2FBig%2BBucks%2BBig%2BPharma%2B%2D%2Ball%2Bsix%2Bparts%2Bon%2BYouTube


 
 
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US: Child Depression Diagnosis & Treament declines after FDA antidepressant warnings

June 18 2007, 8:48 PM 

http://ajp.psychiatryonline.org/cgi/content/full/164/6/A38

Pediatric Depression Treatment Declines After FDA Advisory on Antidepressants

Diagnoses of new cases of major depression in children and adolescents, and their antidepressant treatment, declined sharply over the 2 years following the first Food and Drug Administration (FDA) advisory about suicidality risk for pediatric patients taking selective serotonin reuptake inhibitors (SSRIs). Decreases in SSRIs and non-SSRI antidepressants for depressed patients ages 5–18 are shown by claims in a national database of managed health care plans analyzed by Libby et al. (p. 884). Psychotherapy did not increase after the advisory. This comparison of the 5 years before the FDA advisory in October 2003 with the 2 years afterward encompassed more than 65,000 children and adolescents with a new diagnosis of major depressive disorder. In addition, population-level depression rates fell in 2005 after steadily increasing. Dr. Cynthia Pfeffer comments on these trends in an editorial on p. 843.


Figure 1
View larger version (54K):
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FIGURE 1.



Social and Genetic Factors in Alzheimer’s Disease

Experience with adult day care may reduce the rate of cognitive decline for people with Alzheimer’s disease who later move to nursing homes. Of 432 older Alzheimer’s disease patients evaluated by Wilson et al. (p. 910), 36% were placed in nursing homes over the next 3–4 years. This transition was followed by an abrupt drop in cognitive functioning, but the subsequent rate of decline was slower for those who had previously used day care services. Patients with more education had greater cognitive declines after moving to nursing homes, but prior day care attenuated this association. A possible biological marker of cognitive decline was identified by Chen et al. (p. 916). They found a correlation between an individual’s "dose" of the apolipoprotein E (APOE) {epsilon}4 allele, a risk factor for Alzheimer’s disease, and the rate of brain atrophy during middle age. Magnetic resonance brain images were acquired for cognitively normal people at age 47–68 years and again 2 years later. The rate of whole brain atrophy was highest for people with two {epsilon}4 alleles and lowest for those with none. Dr. James Becker et al. discuss the roles of genes and environment in an editorial on p. 849.

Mechanisms of Change in Psychotherapy

In patients with borderline personality disorder, 10 of 12 symptom domains improved after 1 year of psychodynamic therapy focusing on transference, the patient’s transfer of feelings or conflicts to the therapist. In the comparison of interventions by Clarkin et al. (CME, p. 922), supportive treatment and behavior therapy were followed by improvements in six and five symptom domains, respectively. Transference-focused psychotherapy was associated with decreases in both suicidality and anger, whereas each of the other treatments decreased only one or the other. The relationship between treatment results and the therapist’s focus on emotion in short-term psychodynamic psychotherapy was explored in a meta-analysis by Diener et al. (p. 936). They identified 10 adequately designed studies that examined therapist activities facilitating the experience or expression of emotion by patients with a variety of diagnoses or problems. Emotional facilitation by the therapist was associated with a 30% greater likelihood of improvement, compared with other psychotherapy. Thus, this finding may help answer the question "What makes psychotherapy work? " An editorial on these articles by Dr. Glen Gabbard appears on p. 853.

Course of Borderline Personality Disorder

A 10-year study by Zanarini et al. (p. 929) supports the emerging consensus that borderline personality disorder is a treatable condition with a relatively good prognosis. Among 290 hospitalized patients with borderline personality disorder, half of the assessed symptoms resolved over time and the other half showed marked improvement. The latter symptoms primarily involved aspects of temperament, e.g., chronic dysphoria, abandonment fears, or dependency. Targeting these temperamental symptoms might improve outcomes further.


Related Articles:

The FDA Pediatric Advisories and Changes in Diagnosis and Treatment of Pediatric Depression
Cynthia R. Pfeffer
Am J Psychiatry 2007 164: 843-846. [Full Text]

Gene-Environment Interactions With Cognition in Late Life and Compression of Morbidity
James T. Becker, Luis Tarraga Mestre, Scott Ziolko, and Oscar L. Lopez
Am J Psychiatry 2007 164: 849-852. [Full Text]

Decline in Treatment of Pediatric Depression After FDA Advisory on Risk of Suicidality With SSRIs
Anne M. Libby, David A. Brent, Elaine H. Morrato, Heather D. Orton, Richard Allen, and Robert J. Valuck
Am J Psychiatry 2007 164: 884-891. [Abstract] [Full Text]

Nursing Home Placement, Day Care Use, and Cognitive Decline in Alzheimer’s Disease
Robert S. Wilson, Judith J. McCann, Yan Li, Neelum T. Aggarwal, David W. Gilley, and Denis A. Evans
Am J Psychiatry 2007 164: 910-915. [Abstract] [Full Text]

Correlations Between Apolipoprotein E {epsilon}4 Gene Dose and Whole Brain Atrophy Rates
Kewei Chen, Eric M. Reiman, Gene E. Alexander, Richard J. Caselli, Richard Gerkin, Daniel Bandy, Alisa Domb, David Osborne, Nick Fox, William R. Crum, Ann M. Saunders, and John Hardy
Am J Psychiatry 2007 164: 916-921. [Abstract] [Full Text]

Evaluating Three Treatments for Borderline Personality Disorder: A Multiwave Study
John F. Clarkin, Kenneth N. Levy, Mark F. Lenzenweger, and Otto F. Kernberg
Am J Psychiatry 2007 164: 922-928. [Abstract] [Full Text]

The Subsyndromal Phenomenology of Borderline Personality Disorder: A 10-Year Follow-Up Study
Mary C. Zanarini, Frances R. Frankenburg, D. Bradford Reich, Kenneth R. Silk, James I. Hudson, and Lauren B. McSweeney
Am J Psychiatry 2007 164: 929-935. [Abstract] [Full Text]

Therapist Affect Focus and Patient Outcomes in Psychodynamic Psychotherapy: A Meta-Analysis
Marc J. Diener, Mark J. Hilsenroth, and Joel Weinberger
Am J Psychiatry 2007 164: 936-941. [Abstract] [Full Text]

 
 
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Nigeria Sues Pfizer over experiment leading to children's deaths and disabilities update

June 18 2007, 8:51 PM 

http://online.wsj.com/article/SB118098441137524050.html?mod=hps_us_at_glance_health

Nigeria Sues Pfizer Over Drug Study

Associated Press
Word Count: 545  |  Companies Featured in This Article: Pfizer

ABUJA, Nigeria -- The Nigerian government filed a lawsuit Monday against Pfizer Inc., asking for $7 billion in damages over allegations the pharmaceutical company conducted a drug experiment that led to deaths and disabilities among children more than a decade ago, court papers showed.

The civil case filed in the capital, Abuja, is separate from a legal challenge launched in the northern state of Kano that seeks $2 billion from Pfizer, although all the cases stem from the same mid-1990s drug study. Pfizer has denied the charges in the Kano case, which are substantively similar to those in the Abuja-based ...

 THE FULL WSJ.com ARTICLE IS ONLY AVAILABLE TO SUBSCRIBERS.

 
 
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US: Convicted Felons Bristol-Myers want approval for ABILIFY (antipsychotic) for children

June 18 2007, 8:54 PM 

http://www.app.com/apps/pbcs.dll/article?AID=/20070605/BUSINESS/70605010/1003

Drugmaker wants approval for schizophrenia drug for teens
Posted by the Asbury Park Press on 06/5/07

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Bristol-Myers Squibb Co., which has about 7,700 workers in New Jersey, asked U.S. regulators for permission to sell its antipsychotic drug Abilify to treat schizophrenia in adolescents.

The U.S. Food and Drug Administration will consider whether the pill, cleared for adult use in 2002, can safely treat patients ages 13 to 17, the company said today in a statement. The FDA typically reviews pediatric medicines within six months.

No drugs are approved in the U.S. to treat schizophrenia in teens, although doctors often prescribe them to patients in that age group. Eli Lilly & Co. and Johnson & Johnson have also asked the FDA to clear drugs for use in teenagers. Sales of Abilify surged 41 percent last year, the biggest increase among antipsychotics, helped by studies showing it caused less weight gain than competing drugs.

"I would expect Abilify to gain the most prescriptions from an approval for adolescent use because younger patients appear to be more susceptible to weight gain than adults,'' said Jeffrey Lieberman, chairman of psychiatry at Columbia University in New York.

Drugmakers sold more than $15 billion in antipsychotic medicines last year, according to data compiled by Bloomberg.

About 15 percent of sales came from doctors writing so-called off-label prescriptions for unapproved uses such as treatment of teens, analysts say.

"There's no gold standard for treating schizophrenia in teens, and the first company to get FDA approval for this will have an edge in this very crowded market,'' said Les Funtleyder, an analyst at Miller Tabak & Co. in New York, in a telephone interview.

The shares of Bristol-Myers, based in New York, fell 18 cents to $30.26 at 9:49 a.m. in New York Stock Exchange composite trading. The stock has climbed 16 percent this year.

Johnson & Johnson, of New Brunswick, said the FDA may decide as early as
this month whether its antipsychotic Risperdal can be used for schizophrenia and bipolar disorder in adolescents. FDA action on Indianapolis-based Lilly's antipsychotic Zyprexa was slowed in April, when the agency requested more time to review that pill for the same two conditions.

Abilify had sales of $1.3 billion last year. Sales of Zyprexa grew 3.8 percent to $4.4 billion last year. J&J's Risperdal generated $4.2 billion, an 18 percent increase.

Use of the newer antipsychotics in younger patients has risen sharply in recent years, prompting concern among doctors and parents because the drugs aren't approved for children and can cause weight gain and diabetes.

StoryChat Post a CommentPost a Comment   View all CommentsView All Comments

Lilly is shopping for more bodies. They tried giving the drug to seniors with dementia, off-label (against the law). They have been urging doctors to give it to children off-label (against the law). Now they are trying to "go legal" and give it to adolescents- not for schizophrenia. Adolescents don't get schizophrenia. But they will urge it for every possible use under the sun. The company; most companies, expecially with psychiatric drugs, go for the most vulnerable groups. First, people who are mentally ill. Zyprexa is approved for brief use for bipolar mania: My son was given it for TWO years until he died of it from profound hyperglycemia. Second, old people (all those dead people who had dementia). And now, what we have been expecting, children. Many children take it and the other antipsychotics already, and many are dead or have suffered permanent metabolic harm.

Do not use this drug. It kills.

Posted by: elliel on Tue Jun 05, 2007 11:18 am

Zyprexa promotion


Eli Lilly makes billions on diabetes treatment and also gets $4.2 billion a year in sales of their biggest cash cow Zyprexa which has been scandalized as *causing* diabetes as a major side effect.
In 2004, the American Diabetes Association found that Zyprexa was more likely to cause diabetes than many other antipsychotic drugs.
Zyprexa off label promotion scandal is all over the news now.
Lilly drug reps are alleged to have called their marketing ploy,"Viva zyprexa".

Zyprexa which is only FDA approved for schizophrenia (.5-1% of pop) and some bipolar (2% pop) and then an even smaller percentage of theses two groups.

There are now 8 states (and counting) going after Lilly for fraud and restitution.

--
Daniel Haszard http://www.zyprexa-victims.com

Posted by: DannyHaszard on Tue Jun 05, 2007 11:13 am

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US: FDA official punished for warning re AVANDIA made by convicted felon GSK

June 18 2007, 9:08 PM 

http://www.nytimes.com/2007/06/06/health/06fda.html?hp

Diabetes Drug Still Has Heart Risks, Doctors Warn

Published: June 6, 2007

A medical study intended to demonstrate the heart safety of a well-known diabetes treatment seems, instead, to have added to the controversy over the drug.

Its manufacturer, GlaxoSmithKline, says preliminary results of the clinical trial provide reassurance that the drug, Avandia, an oral medication for Type 2 diabetes that has been used by an estimated seven million people worldwide, does not raise the risk of a heart attack or death from cardiovascular disease.

Influential doctors said that the data published online yesterday in a major medical journal did nothing to ease their concerns about the heart risks. The doctors raised their concerns in three editorials accompanying the Avandia study in The New England Journal of Medicine.

Questions about the safety of Avandia and how regulators have dealt with its risks are to be the subject of a Congressional hearing today. The data could intensify criticism, expected at the hearing, that the Food and Drug Administration should have warned about the potential heart risks years ago.

A supervisor in the drug safety office at the agency said in an interview yesterday that she was rebuked last year after calling for a stronger warning label on Avandia and a competing drug, Actos.

The supervisor, Dr. Rosemary Johann-Liang, said that in March 2006 she approved a recommendation from a safety reviewer at the agency that the drugs be required to carry the strongest warning, a so-called black box warning, because they posed a risk of unusual swelling that could lead to heart failure.

But after officials at the agency who dealt more closely with Glaxo complained, Dr. Johann-Liang said she was ordered to retract her approval of the warning, lost her power to approve such assessments and no longer supervised reviews of the safety of Avandia and Actos.

“This was a very careful review that came to an inescapable conclusion,” Dr. Johann-Liang said in the interview. “They decided to act like the review never happened and punish me for approving it.”

Senator Charles E. Grassley, Republican of Iowa, has investigated Dr. Johann-Liang’s accusations. Mr. Grassley sent a letter on Monday to the Food and Drug Commissioner Andrew C. von Eschenbach demanding that he investigate the case.

“I hope you recognized what is wrong with this picture,” Mr. Grassley wrote. “I also sincerely hope that this is not standard practice within the F.D.A.”

A spokeswoman for the agency, Susan Cruzan, said it was investigating the accusations.

Avandia has been awash in controversy since an article in The New England Journal of Medicine on May 21 and an accompanying editorial cited evidence from clinical trials indicating that Avandia, in addition to the risk of heart failure, could raise a patient’s risk of heart attacks.

Since then, Glaxo and the drug agency have cautioned doctors and patients to await the results of a long-term patient trial, the Record, created to test the heart safety.

It was the interim results of that study that Glaxo rushed to submit for publication by yesterday in advance of the hearing today by the House Oversight and Government Reform Committee. The company had intended the study in the prestigious peer-reviewed New England Journal to be part of a news media blitz to counter negative publicity about the drug, which generates annual revenues exceeding $3.2 billion.

Concerns about the drug were raised in the May 21 article, when Dr. Steven E. Nissen and colleagues from the Cleveland Clinic wrote an analysis suggesting that the popular medication increased the risk of heart attacks by 43 percent. Dr. Nissen’s paper was based on a review of more than 40 studies of the drug. It was also published by The New England Journal of Medicine.

Dr. Nissen, chief of cardiovascular medicine at the prominent clinic, is among witnesses scheduled to testify today along with Dr. von Eschenbach.

In a conference call yesterday with reporters, a vice president for clinical development at Glaxo, Dr. Murray Stewart, an endocrinologist, said data did not support Dr. Nissen’s conclusions. “Nissen suggested that there were more cardiovascular deaths,” Dr. Stewart said. “This does not support that. This shows less cardiovascular deaths.”

Since the study, involving 4,447 people, began nearly four years ago, 29 patients in the Avandia group have died from cardiovascular causes. A greater number, 35, have died of cardiovascular problems in the group taking other drugs.

Several doctors who wrote the accompanying editorials published yesterday, including the Journal editors, saw the results less positively than Glaxo did. The editorials questioned the structure of the study and pointed out that although fewer Avandia patients have died, more had heart attacks than in the group taking other drugs, 43 to 37.

Although those heart attacks represented a relatively tiny number in the overall study, one editorial, by the Journal’s editors, struck an anxious tone. “In short, there is continued uncertainty about the cardiovascular safety of rosiglitazone,” they wrote, referring to the generic name of the medicine.

Of the patients in the Record study, which is to continue through late next year, about half take Avandia in combination with other medications and half take two diabetes medications, metformin with sulfonylurea.

The editorials raised questions about the structure of the Record study. In his editorial, Dr. David M. Nathan, a diabetes expert who teaches at Harvard, questioned the high number of patients who dropped out of the study without explanation and further monitoring, as well as the decision by the creators of the study to use a combination of metformin and sulfonylurea as the comparison group. That combination was associated with a 96 percent increase in diabetes-related mortality in another study, Dr. Nathan wrote.

Glaxo said the metformin-sulfonylurea combination was chosen because it is the most common Type 2 diabetes treatment worldwide.

“The interim results of the Record trial do not provide any assurance of the safety of treatment with rosiglitazone,” Dr. Nathan said, suggesting in his editorial that doctors should use medications other than Avandia.

An editorial by Dr. Bruce M. Psaty of the University of Washington and Dr. Curt D. Furberg of Wake Forest University recalculated Dr. Nissen’s analysis using interim results of the Record study in addition to the studies that Dr. Nissen used. They found that Avandia increased a patient’s risk of having a heart attack 33 percent.

“In my mind, it’s not small,” Dr. Furberg said, calculating that such a risk, extrapolated to the millions of patients who have taken Avandia, would translate to thousands of extra heart attacks.

The company’s decision to release interim results of the Record trial were highly unusual and reflected Glaxo’s concern about the controversy and the concerns of patients in the trial. As a result of the negative publicity about the drug, two patients have dropped out, the Glaxo medical director, Dr. Ronald L. Krall, said yesterday.

Dr. Stewart said the telephones of doctors involved in the Record trial throughout Europe, Australia and New Zealand had been ringing with calls from concerned patients, raising questions about whether the trial can continue. "

 

GSK:  CONVICTED FELONS:

http://www.abc.net.au/news/newsitems/200703/s1882695.htm

"...In fact tests showed ready-to-drink Ribena contained no detectable vitamin C at all.Anna Devathasan and Jenny Suo, the teenagers who first blew the whistle on Ribena three years ago, were in court to hear the company's guilty plea.

GlaxoSmithKline, which last week made similar admissions in Australia, faces fines of up to $2.5 million..."

 

http://www.leighday.co.uk/doc.asp?cat=984&doc=259

"GlaxoSmithKline found guilty of misleading the public

The international watchdog for the drugs industry has published a report finding the drugs company GlaxoSmithKline guilty of misleading the public about one of its products. The finding followed complaints about claims made by a senior executive of the company on national American TV about the anti-depressant drug Seroxat (known as Paxil in the United States)..."

".... GlaxoSmithKline have been found guilty of breach of sections 1.3 and 1.7 of the IFPMA Code of Pharmaceutical Marketing Practices. S. 1.3 states that 'Information in promotional material should be based on an up-to-date evaluation of evidence that is scientifically valid and should not give an incorrect or misleading impression.' S. 1.7 states that 'Where it is permitted by law to communicate directly with patients regarding their prescription medicines, all such information should be accurate, fair and not misleading.'..."

 

http://www.mindful-things.com/psych_news_archive/psych_news_depression.html

"...Court finds GlaxoSmithKline guilty
June 15, 2001 -- GlaxoSmithKline has been ordered by a Cheyenne, Wyoming jury to pay US $6.5 million to relatives of a man who killed himself and three family members after taking Paxil, an antidepressant. Glaxo will appeal the ruling. Although this is the first time a court has come down against a drug maker on charges of inducing violence, Lilly still faces 10 wrongful death suits over its drug Prozac, a cousin to Paxil. No antidepressant manufacturer includes a warning about violent behavior in its prescribing literature.."

 

http://www.aidshealth.org/index.php?option=com_content&task=view&id=851&Itemid=193

"... On October 16, 2003, the Commission announced its findings that GSK had indeed engaged in illegal acts, including excessive pricing and anticompetitive practices.

"...AHF President Michael Weinstein said, "AHF requested voluntary licensing from GSK and demands immediate approval. The time has come for GSK to stop being a rogue company and join the ranks of corporate responsibility".  The text of the filed complaint can be found at: http://www.aidshealth.com/newsroom/news/GSKComplaint.doc..."

 

http://topics.nytimes.com/top/news/business/companies/glaxosmithkline_plc/index.html?query=FRAUDS%20AND%20SWINDLING&field=des&match=exact
"Glaxo Settles US Fraud Charges...

WASHINGTON, Sept. 21 (AP) - GlaxoSmithKline has agreed to pay more than $150 million to settle fraud accusations over the pricing and marketing of two antinausea drugs, the Justice Department said on Tuesday the Justice Department said on Tuesday.September 21, 2005 ..."

 

http://topics.nytimes.com/top/news/business/companies/glaxosmithkline_plc/index.html?query=FRAUDS%20AND%20SWINDLING&field=des&match=exact

"...The civil lawsuit contends that GlaxoSmithKline engaged in fraud by failing to tell doctors that some studies of Paxil showed the drug did not work in adolescents...." June 3, 2004

 

http://query.nytimes.com/gst/fullpage.html?sec=technology&res=9C00E2D6103EF934A1575BC0A9629C8B63&n=Top%2fNews%2fBusiness%2fCompanies%2fGlaxoSmithKline%20P%2eL%2eC%2e

Glaxo Agrees to Post Results Of Drug Trials on Web Site
August 27, 2004

In a settlement that the New York attorney general said would transform the drug industry, GlaxoSmithKline agreed yesterday to post on its Web site the results of all clinical trials involving its drugs.

''This settlement is transformational in that it will provide doctors and patients access to the clinical testing data necessary to make informed judgments,'' the attorney general, Eliot Spitzer, said.

While the case involves only GlaxoSmithKline, the British drug maker, Mr. Spitzer predicted that other companies would follow its lead by posting the results of their studies online. Eli Lilly, for example, has said it would create a Web site on which it would list the results of clinical tests of approved drugs. Other companies, including Johnson & Johnson and Merck, have said they support the concept of a public database that would list trial results.

If drug makers do not act, Mr. Spitzer threatened more lawsuits..."


 
 
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US: Minnesota Physicians Continue to Receive Pharma Company Payments Despite Sanctions

June 18 2007, 9:12 PM 

http://www.medicalnewstoday.com/medicalnews.php?newsid=73094

"Minnesota Physicians Continue To Receive Pharmaceutical Company Payments Despite Sanctions

Article Date: 06 Jun 2007

The New York Times examined Minnesota state medical records showing that more than 100 physicians who had been cited for misconduct by the Minnesota Board of Medical Practice continued to receive drug company payments, and some continued to participate in clinical trials of experimental drugs. Although Minnesota is the only state to make its records public, many experts say the problem is national.

The Times' examination of Minnesota's records on drug company payments found that from 1997 to 2005, at least 103 physicians who had been disciplined or criticized by the state medical board received a total of $1.7 million from drug makers. The median payment during that period was $1,250, and the largest was $479,000. Sanctions issued by the board included reprimands, required retraining and suspension of licenses. Of the 103 doctors, 39 had been disciplined for inappropriate prescribing practices, 21 for substance abuse, 12 for substandard care and three for mismanagement of drug studies.

David Rothman, president of the Institute on Medicine as a Profession at Columbia University, said, "There's no reason to think Minnesota is unique" from other states in the nation. He added, "Clinical trial investigators must be culled from only the finest physicians in the country since they work on the frontiers of new knowledge. That drug makers are scraping the bottom of the medical barrel is an outrage." Karl Uhlendorf, a spokesperson for the Pharmaceutical Research and Manufacturers of America, said the trade group would not comment on the Times' findings.

The Times profiled Faruk Abuzzahab, a Minnesota psychiatrist who received more than $55,000 in drug company payments from 1997 to 2005 despite being disciplined in December 1997. According to the board, Abuzzahab inappropriately discharged from the hospital a suicidal patient who declined to enroll in a clinical trial for which the doctor was recruiting. The patient later committed suicide (Harris/Roberts, New York Times, 6/3). "


 
 
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"Hypothyroidism CLEARLY Linked to Mood Swings" (treatable by thryroid hormone)

June 18 2007, 9:18 PM 

http://interactive.snm.org/index.cfm?PageID=6289&RPID=6272

Hypothyroidism Clearly Linked to Mood Swings

Results of Molecular Imaging of Brain Metabolic Activity With PET Released at SNM's 54th Annual Meeting June 2–6 in Washington, D.C.

WASHINGTON, D.C.—Hypothyroidism is often associated with mood changes like depression lethargy. Researchers, studying underlying brain processes in search of "why" this happens, reported their results at the 54th Annual Meeting of SNM, the world's largest society for molecular imaging and nuclear medicine professionals.

"The aim of our study was to investigate—with positron emission tomography (PET) imaging—how physical health and mental health are interrelated," said Waltraud Eichhorn, a nuclear medicine physician at Johannes Gutenberg University in Mainz, Germany. "We found that hypothyroidism is correlated to regional metabolic changes in the thalamus—an area of the brain that helps process information from the senses and transmit it to other parts of the brain" she said. "In other words, hypothyroid patients—compared to healthy individuals—have decreased metabolism in special parts of the brain that are responsible for processing information, " said Eichhorn. "Remarkably, this reduction in metabolism remains detectable after thyroid hormone replacement therapy," she added.

The thyroid, a butterfly-shaped gland in the neck just above the collarbone, is an endocrine gland that makes hormones and helps set a body's metabolism (how the body gets energy from food). Hypothyroidism, a condition in which your body produces too little thyroid hormone, often leads to exhaustion and depression, affecting millions of Americans, many of them women or the elderly. There are 27 million Americans who have underactive or overactive thyroid glands, but more than half remain undiagnosed, according to recent statistics.

Hypothyroidism can be treated by doses of thyroid hormone. Once the blood levels of thyroid hormone reach a normal range—called euthyroid—lethargy and depression often lift. However, in some patients, the depression persists, which means that successful therapy must address depression directly.

In this study, 10 patients with hypothyroidism underwent a cerebral 18-FDG/PET examination. She indicated that additional research is needed to determine whether special brain regions are responsible for increased depression or anxiety in patients suffering from hypothyroidism.

PET is a safe, highly specialized, noninvasive imaging technique that uses short-lived radioactive substances to produce three-dimensional images of those substances functioning within the body. A special type of camera works with computers to provide precise pictures of the areas of the body being imaged and molecular images of the body's biological functions.

Scientific Poster 1228: W.A. Eichhorn, K. Bose, H. Buchholz, T. Siessmeier and M. Schreckenberger, Nuclear Medicine Department, and U. Egle, Department of Psychosomatic Medicine and Psychotherapy, all at Johannes Gutenberg University, Mainz, Germany; P. Bartenstein, Department of Nuclear Medicine, Ludwig Maximilians University, Muenchen, Germany; and G. Kahaly, Department of Medicine I, Johannes Gutenberg University, Mainz, Germany, "Neuronal Correlates of Overt Hypothyroidism Measured by FDG PET," SNM's 54th Annual Meeting, June 2–6, 2007.


About SNM—Advancing Molecular Imaging and Therapy
SNM is holding its 54th Annual Meeting June 2–6 at the Washington Convention Center in Washington, D.C. Session topics for the 2007 meeting include brain amyloid imaging, hybrid imaging, molecular imaging in clinical drug development and evaluation, functional brain imaging in epilepsy and dementia, imaging instrumentation, infection imaging, lymphoma and thyroid cancer, cardiac molecular imaging, general nuclear medicine, critical elements of care in radiopharmacy and more.

SNM is an international scientific and professional organization of more than 16,000 members dedicated to promoting the science, technology and practical applications of molecular and nuclear imaging to diagnose,manage and treat diseases in women, men and children. Founded more than 50 years ago, SNM continues to provide essential resources for health care practitioners and patients; publish the most prominent peer-reviewed journal in the field (the Journal of Nuclear Medicine); host the premier annual meeting for medical imaging; sponsor research grants, fellowships and awards; and train physicians, technologists, scientists, physicists, chemists and radiopharmacists in state-of-the-art imaging procedures and advances. SNM members have introduced—and continue to explore—biological and technological innovations in medicine that noninvasively investigate the molecular basis of diseases, benefiting countless generations of patients. SNM is based in Reston, Va.; additional information can be found online at http://www.snm.org.


 
 
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UK: Fears over Child Epilepsy Drugs - Urgent Safety Studies needed

June 18 2007, 9:26 PM 

 
Fears over child epilepsy drugs
 
pills
The research looked at drugs given to 8,000 children

Urgent safety studies are needed for newer anti-epilepsy drugs that are being increasingly prescribed for children, say UK researchers.

The British Journal of Clinical Pharmacology report says prescriptions have risen five-fold in 13 years.

Yet the drugs' long-term safety has not been established, say the researchers.

Many medicines are not fully tested on children before licensing, meaning consultants have no official guidance on doses to refer to when prescribing.

The uptake of these drugs has been rapid, yet their long-term safety has not been established
Professor Wong

Instead they often have to estimate a safe and effective dose based on the age and the size of the child.

Lead author Professor Ian Wong, from the Centre for Paediatric Pharmacy Research in London, studied antiepileptic drugs given to nearly 8,000 children over a 13-year period.

The centre is a collaborative project run by the School of Pharmacy at the University of London, the UCL Institute of Child Health and Great Ormond Street Hospital.

Professor Wong and his colleagues found three drugs in particular - lamotrigine, topiramate and levetiracetam - had seen a "massive" rise in prescribing.

Professor Wong said this was concerning.

"The uptake of these drugs has been rapid, yet their long-term safety has not been established and further research must now be seen as a priority."

Side-effects

He said that while newer drugs were less likely to react with other prescribed drugs, it was possible that restrictions in their use might have to be introduced as any side-effects in children became more apparent.

He said multi-organ failure, renal failure, blood disorders and skin reactions had been reported in patients using lamotrigine.

When you are prescribing a drug 'off licence' to a child, it's important to let the family know exactly the implications of this
Dr Colin Ferrie, consultant paediatric neurologist

Dr Jeffrey Aronson, a reader in clinical pharmacology at Oxford University, said many drugs were not tested on children because of the difficulties that including children in clinical trials posed.

"This means that clinicians often have to rely on their experience and scale down adult drugs for paediatric use, which is widely regarded as most unsatisfactory," he said.

Dr Colin Ferrie, a consultant paediatric neurologist at Leeds General Infirmary, said that not only were new trials important, but pharmaceutical companies should be encouraged to carry out "clinically relevant" trials prior to the original granting of a licence.

"Obviously it's an area of concern, and when you are prescribing a drug 'off licence' to a child, it's important to let the family know exactly the implications of this.

"However, it is often possible to find data, either from journal abstracts or the drug company, which can help you calculate a safe and effective dose of a drug."



 
 
admin

US: SANOFI's Weight Loss Pill ZIMULTI Linked to Suicidal Thoughts, FDA says

June 18 2007, 9:32 PM 

 

Sanofi's Pill Linked to Suicidal Thoughts, FDA Says (Update3)

http://www.bloomberg.com/apps/news?pid=20601087&sid=aLTYP48Np18I&refer=home

By Angela Cullen and Catherine Larkin

June 11 (Bloomberg) -- Sanofi-Aventis SA's weight-loss pill may raise the risk of suicide and suicidal thoughts, U.S. regulators said in documents for an expert panel that will recommend whether the three-time delayed drug should be approved.

The medicine, to be known as Zimulti in the U.S., helped patients lose weight at the highest dose of 20 milligrams, the Food and Drug Administration staff said in the documents posted today on the agency's Web site. An agency advisory panel will meet June 13 to discuss whether the product's benefits of reducing weight, cholesterol and blood sugar outweigh its risks.

Zimulti, sold as Acomplia outside the U.S., is the first of a new class of drugs called CB1 antagonists that block receptors in the brain that regulate hunger and food intake, as well as acting directly on fat cells. Paris-based Sanofi expects sales of at least $3 billion a year from Acomplia as its older best- sellers, such as the sleeping pill Ambien, lose patent protection. Profit at Sanofi fell in the first quarter.

``The market is expecting the drug will get approved for obesity, but in light of these comments it could be a quite a close call,'' said Andrew Fellows, an analyst at Helvea Ltd. in London, in a telephone interview.

Shares of Sanofi fell 5 cents, or less than 1 percent, to 67.52 euros at the close of trading in Paris. They've declined 3.7 percent this year, trailing the 16-member Bloomberg Europe Pharmaceutical Index, which has fallen 2.6 percent in the period. Sanofi's U.S. depositary shares, each equal to half an ordinary share, fell 36 cents to $45.14 at 4:02 p.m. in New York Stock Exchange composite trading.

Suicide Concerns

The Sanofi pill was approved last year by regulators in Europe, where it competes with Roche Holding AG's Xenical and Abbott Laboratories' Meridia. Approval in the U.S. would open a market in which a third of the population is considered obese.

The FDA noted two suicides in clinical trials of volunteers testing the drug. The panel will be asked to discuss whether it can establish a causal link between the medicine and suicidal thoughts or actions.

The FDA usually follows the advice of its outside advisers, although it isn't required to do so. The agency will issue a decision by late July. Analysts say the FDA, which has delayed approval of the drug three times, may be wary about Acomplia's side effects.

The agency has come under pressure in recent weeks after a study showed a diabetes drug approved in 1999, GlaxoSmithKline Plc's Avandia, raised the risk of heart attacks.

FDA `Risk Averse'

``It was always suspected that there were safety issues,'' Fellows said. ``In recent times, the FDA has become more risk averse, especially if there is reasonable efficacy but there are question marks over side effects.''

Sanofi is seeking approval of the medicine as an adjunct to diet and exercise for the treatment of overweight people at risk of heart disease or for chronically obese people. The company has asked the FDA to also consider Zimulti as a diabetes treatment.

The drugmaker proposed a risk management plan for the U.S. that would restrict its use, excluding it from patients suffering from psychiatric illness and advising caution in people suffering from epilepsy.

The company is monitoring the drug's use in Europe and South America, where a total of 108,730 people had been prescribed it as of March 1, 2007.

Some patients who took part in clinical trials of Acomplia suffered from mood swings, anxiety and depression. Trial volunteers given the highest dose lost an average 5.3 kilograms (11.7 pounds) over a one-year period compared with a weight loss of 1.4 kilograms (3.1 pounds) among patients given a control pill. Acomplia significantly lowered the level of HbA1c, a measure of blood sugar, to within a safe range.

To contact the reporters on this story: Angela Cullen in Frankfurt at acullen8@bloomberg.net ; Catherine Larkin in Washington at clarkin4@bloomberg.net

Last Updated: June 11, 2007 16:36 EDT


 
 
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US: South Carolina Court upholds conviction in ZOLOFT KILLINGS Chris Pittman

June 18 2007, 9:35 PM 

http://www.usatoday.com/news/nation/2007-06-11-zoloft-killings_N.htm

S.C. court upholds conviction in Zoloft killings

E-mail | Save | Print | Subscribe to stories like this
Christopher Pittman
South Carolina Dept. of Corrections
COLUMBIA, S.C. (AP) — The South Carolina Supreme Court upheld the murder conviction Monday of a teenager who claimed antidepressants led him to kill his grandparents and set their house on fire when he was 12 years old.

The court ruled against several arguments made by Christopher Pittman's attorneys, including the contention that he was denied a speedy trial before he was sentenced to 30 years in prison in February 2005. He was 15 at the time of his sentencing.

Three years earlier, he had shot his grandparents, Joe and Joy Pittman, with a pump-action shotgun as they slept, then set fire to their home in Chester County.

His attorneys argued unsuccessfully that he had been involuntarily intoxicated by the antidepressant Zoloft at the time of the shooting and didn't know right from wrong. In appealing, his attorneys said the trial judge should have used a different standard for jurors to determine involuntary intoxication.

Paul Waldner, one of Pittman's attorneys, said an appeal was possible.


 
 
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US: Convicted Felons ELI LILLY settle more ZYPREXA claims

June 18 2007, 9:40 PM 

http://www.themoneytimes.com/news/20070613/lilly_settles_900_zyprexa_claims-id-104680.html

"Indianapolis -- Indianapolis-based drug giant Eli Lilly and Co. said Tuesday it settled 900 more product liability claims against its top-selling drug Zyprexa.

Four of the claims were scheduled to go to trial in July, The Indianapolis Star reported Tuesday. Thousands of patients sued Lilly, claiming the pharmaceutical firm hid risks of weight gain and diabetes associated with Zyprexa.

Under terms of the settlement, Lilly did not disclose the amount of the settlements, and did not admit any wrongdoing.

"While we continue to believe we would have prevailed had we gone to trial, resolving these claims will help Lilly return its focus to addressing unmet medical needs for patients and physicians," Michael J. Harrington, Lilly's deputy general counsel, said in a statement.

About 750 claims remain unsettled. The company also faces lawsuits from several states -- among them Alaska, Mississippi, Louisiana, Utah and West Virginia -- seeking to recoup Medicaid money spent caring for Zyprexa patients."

 

CONVICTED FELONS - ELI LILLY:

http://www2.indystar.com/library/factfiles/business/companies/lilly/lilly.html

"...Oraflex, the American version of Benoxaprofen, was withdrawn from the market in 1982 - just one month after gaining FDA approval.

A British medical journal found five cases of death due to jaundice in patients taking the drug and the FDA accused Lilly of supressing unfavorable research findings. In 1985, the U.S. Justice Department filed criminal charges against the company and Dr. William Ian H. Shedden. Lilly pleaded guilty to 25 criminal counts and paid a $25,000 fine..."

"The newly released report was prepared as part of a plea bargain with Lilly, which was fined $25,000 last week after pleading guilty to criminal charges of failing to notify the Government of deaths and injuries associated with the drug.

The report is the most detailed account that Federal prosecutors have provided of Lilly's actions in seeking approval for Oraflex. It says that Lilly had extensive information about deaths and ailments associated with Oraflex as early as 1981, but repeatedly failed to provide details to the Food and Drug Administration, as required. ..."

"...Dr. Sidney Wolfe, director of the Washington-based Public Citizen Health Research Group, a consumer-affairs organization, said today that the department's report proved that ''the people in this company should have been put in jail'' and that the fine was a ''slap on the wrist.''


 
 
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UK: Sex offenders to be offered drug treatments.. including ANTIDEPRESSANTS

June 18 2007, 9:45 PM 

Lets hope they don't move up the scale to becoming HOMICIDAL sex offenders on antidepressants.

http://news.bbc.co.uk/1/hi/uk/6746965.stm

Last Updated: Wednesday, 13 June 2007, 08:31 GMT 09:31 UK
Sex crime drug treatments planned
Children
Parents could be able to request information about paedophiles

Plans to offer more drug treatments to sex offenders to try to stop them committing more crimes are being announced by the Home Office.

The treatment involving libido-reducing drugs or anti-depressants would be given on a voluntary basis.

Parents will also be able to ask for checks on whether new partners or people dealing with their children are known sex offenders.

But the Home Office says details will not be available to the wider public.

Convicted paedophiles might also be subjected to lie detector tests if there is a suspicion they are targeting children.

I think we have this notion that all sex offenders want to do bad things all the time. Some of them are desperately struggling with what's going on in their lives, and want help to be stopped
Donald Findlater, Lucy Faithfull Foundation

Home Secretary John Reid told BBC News: "Prison and punishment should take place when people are guilty of child offences but in addition to that we need, after that, to treat them, to supervise them and to share information, where appropriately, with them and in all three areas this is what we are doing today in terms of strengthening our regime."

Some of the most persistent sex offenders are already offered drug treatment, but the Home Office says this provision could be increased.

Mr Reid said sex offenders would be offered drug treatment on a voluntary basis alongside other measures, including supervision.

"The evidence suggests that it's far more effective and only really effective if someone is getting this treatment voluntarily, as part of a treatment course."

He said allowing everyone to have access to information about sex offenders - a measure known as Megan's or Sarah's Law - could drive paedophiles underground, so he had decided on a "middle way".

This allows "vulnerable people, especially young single parents with young families" to find out whether a new partner or other adult who came into contact with their children was a sex offender.

'No honour'

Dr Donald Findlater, director of research and development at the child protection charity the Lucy Faithfull Foundation, told BBC Radio 4's Today programme that some sex offenders would volunteer to take drugs to suppress their sex drives.

"I think we have this notion that all sex offenders want to do bad things all the time. Some of them are desperately struggling with what's going on in their lives, and want help to be stopped.

"Some of them have been very enthusiastic about participating in lie detector tests, and indeed would happily take pills if that will help."

Sara Payne, whose daughter Sarah was murdered by paedophile Roy Whiting seven years ago, told the BBC that drug treatment should be compulsory.

"You're placing an honour based system on people that have already shown they have absolutely no honour.

"These are people that rape, molest our children, take photographs of what they're doing.

"They've already shown that they are the nastiest, I think the nastiest, people in the world because of what they do to children."

Pilot schemes

The review is expected to recommend that parents, for the first time, could have access to information on convicted paedophiles.

For example, mothers could request a police check if they have concerns about a new boyfriend.

At the moment, employers can request a Criminal Records Bureau (CRB) check if a potential employee is going to work with children, while private citizens cannot.

Three pilot areas are expected to be set up.

Widespread access to details about sex offenders, as seen in the US, has been ruled out by the Home Office.

The US law, known as Megan's Law, named after Megan Kanka, seven, who was killed by a convicted sex offender, gives parents access to names and addresses of known paedophiles.

A campaign to launch a "Sarah's Law" - a UK version of the legislation - was launched after Sarah Payne's murder in 2000.

'Strained' services

Children's charity NSPCC said it was pleased there would be no Sarah's Law because it could drive paedophiles underground.

And it warned that opening up the information on offenders could stretch resources for looking after the 30,000-odd offenders living outside prison.

It also called for clear guidelines to prevent inappropriate information being released.

Director Dame Mary Marsh said: "We always urge members of the public to report their concerns, but agencies are already struggling to keep track of known offenders in the community.

"Investigating reports of sexual offences against children, bringing offenders to justice and managing them when released into the community is placing severe strain on agencies."

However, Steve Bevan, from Survivors Swindon, which helps men who have been sexually abused, said people had had a right to know where sex offenders were living.

He told BBC Radio's Five Live: "We could actually run this quite easily, we've just been given another excuse to, that we're not being trusted to have this information.

"I think if it was handled properly, if it's done correctly, we would be able to monitor it ourselves."

A wider publicity campaign will also be promised by the government to remind people that it is not so-called 'stranger danger' which is the biggest threat, but people closer to home.

It is believed 90% of child sex abuse is carried out by someone known to the family. "


 
 
admin

Norway: HORDALAND study - Cod Liver Oil use in Depression Symptoms

June 18 2007, 9:54 PM 

http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed&list_uids=17184843&cmd=Retrieve&indexed=google

1: J Affect Disord. 2007 Aug;101(1-3):245-249. Epub 2006 Dec 19.Click here to read Links

Associations between cod liver oil use and symptoms of depression: The Hordaland Health Study.

Dr. Einar Martens’ Research Group for Biological Psychiatry, Center for Medical Genetics and Molecular Medicine, Haukeland University Hospital, Helse Bergen HF, N-5021 Bergen, Norway; Department of Clinical Medicine and Bergen Mental Health Research Center, University of Bergen, Norway.

BACKGROUND: Clinical trials suggest that omega-3 fatty acids improve the outcome of depression. This study aimed to evaluate the association between intake of cod liver oil, rich in omega-3 fatty acids, and high levels of symptoms of depression and anxiety in the general population.

METHODS: We used data from the "The Hordaland Health Study '97-'99" (HUSK), a population based cross-sectional health survey from Norway including 21,835 subjects aged 40-49 and 70-74 years. Symptoms of depression and anxiety were measured by The Hospital Anxiety and Depression Scale (HADS). We used logistic regression to study associations.

RESULTS: Among the participants, 8.9% used cod liver oil daily. A total of 3.6% had high levels of depressive symptoms. The prevalence of such depressive symptoms among the subjects who used cod liver oil daily was 2.5%, as compared to 3.8% in the rest of the population. The users of cod liver oil were significantly less likely to have depressive symptoms than non-users after adjusting for multiple possible confounding factors (odds ratio=0.71, 95% confidence interval 0.52 to 0.97). These factors included age, gender, smoking habits, coffee consumption, alcohol consumption, physical activity, and education. In addition, we found that the prevalence of high levels of depressive symptoms decreased with increasing duration (0-12 months) of cod liver oil use (multivariate adjusted test for trend, P=0.04). We were only able to study this latter association in a subset of the population aged 40-46 years.

LIMITATIONS: Data are cross sectional.

CONCLUSIONS: The findings indicate that regular use of cod liver oil is negatively associated with high levels of depressive symptoms in the general population.

PMID: 17184843 [PubMed - as supplied by publisher]

 

 


 
 
admin

US: Research shows 'Schizophrenics' NOT taking antipsychotics more likely to recover

June 18 2007, 9:58 PM 

http://psychminded.co.uk/news/news2007/June07/people002.htm

"People with schizophrenia not taking antipsychotics more likely to recover, states research

June 13, 2007
by Angela Hussain

People diagnosed with schizophrenia who are not on antipsychotics are more likely to experience recovery than those taking the medication, according to an American study.

Over 15 years, schizophrenia patients not on antipsychotics showed more periods of recovery than those taking antipsychotics, states a research paper in last month’s Journal of Nervous and Mental Disease.

Researchers reported that, after 10 years, 79% of patients on antipsychotics were psychotic, whereas 23% of those not on medication were psychotic. After 15 years, 65 per cent of patients on antipsychotics were psychotic, whereas only 28% of those not on medication were psychotic.

The study’s authors - Martin Harrow and Thomas Jobe of the department of psychiatry at the University of Illinois in Chicago – concluded that “not all schizophrenia patients need to use antipsychotic medications continuously throughout their lives.”

They stated that certain patient characteristics – such as a “favorable personality” – helped those not on medication to experience recovery.

The study was on 145 patients - 64 diagnosed with schizophrenia, and a control of 81 patients who had another psychotic diagnosis, such as paranoid disorder.

The research was part-funded by America’s National Institute of Mental Health. "


 
 
admin

UK: Same Weight Loss Pill being assessed by NICE for use on the NHS

June 18 2007, 10:13 PM 

US diet pill 'suicide risk' fears
 
 
Eating
The drug works by reducing appetite
A weight loss drug used by thousands of Britons has been rejected by US safety officials because of an increased risk of suicide.

Rimonabant, launched in the UK last summer, has been shown to aid weight loss by reducing appetite.

But a committee advising the US Food and Drug Administration (FDA) voted to ban the pill, saying the manufacturers had failed to show it was safe.

European regulators will review the drug's safety at an upcoming meeting.

Around 37,000 Britons have been prescribed rimonabant which can help users lose up to 10% of their body weight.

Rimonabant has a role, it should be used with care but directed towards the right patient it can be effective and safe.
Dr Ian Campbell, Weight Concern

The drug is currently recommended for obese patients with a risk of developing diabetes or cardiovascular disease.

It works by blocking receptors in the part of the brain that regulate food intake and the body's ability to break down sugars and fats in the blood.

The National Institute of Clinical and Health Excellence (NICE) is currently appraising the drug for use on the NHS.

Safety concerns

The US committee of experts reviewed studies of rimonabant conducted around the world.

They told an FDA hearing that the drug is associated with an increased risk of suicidal thoughts even in those with no history of depression.

Studies had also highlighted significant increases in anxiety, insomnia, and panic attacks in patients given 20 mg of rimonabant compared with placebo.

A recent review of rimonabant by the Cochrane database concluded that more rigorous studies of efficacy and safety were required for a drug where the weight loss in "modest".

The committee warned: "The evidence for increased suicidal tendencies and depression is of particular concern for a drug targeted toward the obese, a population that has been shown to have a significantly higher incidence of depression and eating disorders compared to non-obese individuals."

The FDA is due to consider the panel's decision in July.

Manufacturer's Sanofi-aventis, said they would continue to work closely with the FDA to address the committee's recommendations.

A recent review by the Drug and Therapeutics Bulletin said the drug had not been effectively compared with other, cheaper weight loss drugs, such as Xenical (orlistat) and Reductil (sibutramine), which are both approved for NHS use.

COST OF WEIGHT LOSS DRUGS
Rimonabant: £720 a year
Orlistat: £520 a year
Sibutramine: £480-£570 a year

 

Dr Ian Campbell, medical director of the charity Weight Concern, said UK experts had also raised concerns about the side effects of the drug, namely anxiety and depression, but the increased risk of suicide was small.

"You have to balance the risks with the advantages of quality of life improvement.

"Rimonabant has a role, it should be used with care but directed towards the right patient it can be effective and safe."

He added that the drug should not be used in people being treated for depression or with a recent history of depression. "

 

BUT DR IAN CAMPBELL - the US  Committee of Experts reviewed studies around the world and stated that it causes suicidality in people that don't even HAVE depression. Is Weight Concern another pharma front group by any chance?  Risk of suicide is 'small'?

Each one is a LIFE lost.   Low fat diet doesn't hold that risk.



 
 
admin

Ireland: Antidepressants for Medical Card Holders cost State 40M Euros

June 18 2007, 10:17 PM 

http://www.borderireland.info/arts/artdetail.php?artref=100

 

Anti-depressants for medical-card holders cost State €40m

By Niamh Horan
Sunday May 27 2007

IT is costing the State over €40m a year to supply Irish medical-card holders with free anti-depressants, according to official government figures. In 2005, a total of 176,123 medical-card holders claimed for the medication, costing the state €41,673,390, according to the Health Service Executive (HSE).

The cost of supplying the drugs has risen nearly €4.5m from the previous year, indicating an increase in the number of Irish patients being prescribed anti-depressant medication. In 2004, the state spent €37,087,853 supplying medical-card holders with the drugs as part of the Medical Primary Care Reimbursement Service, a scheme which allows members of the public who satisfy certain criteria to avail of a range of services free of charge.

Meanwhile, the National Advisory Committee on Drugs (NACD) has reported that one in five Irish people has admitted taking sedatives, tranquillisers or anti-depressants during their lifetime.

The results were taken from the 2002/2003 all-Ireland general population drug prevalence survey, which was carried out in conjunction with the Drug and Alcohol Information and Research Unit (DAIRU) in Northern Ireland.

The report focussed on prescribed and unprescribed sedative, tranquilliser or anti-depressant use in the adult population.

It also found that, of that one in five, nearly half said they had used sedatives, tranquillisers or anti-depressants in the last month and 84 per cent of those were taking them on a daily basis.

Use of the drugs was most prevalent among people aged over 35 years, or who were long-term unemployed, or who had left school at primary level.

Geraldine Clare, Chief Executive of Aware says that despite the huge sums of money currently being spent on anti-depressants in Ireland, there is still a significant amount of stigma attached to medication which is being prescribed for mental illness.

"Our experience would be that because of the stigmatisation of depression, people might be reluctant to go forward for help. Also, sometimes the range of treatments isn't available and this type of treatment [anti-depressants] is the only option.

"I think people are less accepting of medication as a treatment for mental illness than they are of it for physical illness. They don't see the two in the same light."

She added, "Overall we are less open-minded to drugs that treat depression than those that treat physical illnesses. There is ambivalence there, and that's not helpful for those who find themselves with the illness."

Meanwhile, a prominent consultant psychiatristhas estimated that anything up to a quarter of a million Irish people could currently be taking anti-depressant medication.

Dr Michael Corry, a consultant psychiatrist at the Institute of Psychosocial Medicine in Dun Laoghaire, says that over-the-counter sales are pointing towards an ongoing increase in consumption of the drugs in Ireland.

"We know from pharmacies and over-the-counter sales, in other words the number of packets that are soldper year in Ireland, that asubstantial number of people in this country are on anti-depressants.

"Through information from the Intercontinental Medical Research Centre, we can estimate that between 200,000 and 250,000 packets of the medication are sold over the counter each year. And that doesn't factor in outpatients or even hospitals who are giving patients the medication."

He added, "The use of anti-depressants is rising at a rate of 10 per cent per year. People are under more pressure than ever before and it seems that many are finding it very difficult to make the necessary changes in their life."

However, the HSE argues that it is not possible to state the exact numbers of people who take anti-depressant medication.

A spokesperson for the service, Paul O'Hare, said, "The figure of 250,000 is consistent with the estimated number of people in Ireland who are suffering from depressive illness at any given time whether diagnosed or not.

"Clearly, people whose depressive illness is undiagnosed will not have been prescribed anti-depressant medication. Also, some people present with symptoms of physical illness such as stomach complaints or fatigue which may result from or be made worse by underlying, undiagnosed depressive illness. This second group of patients may not be prescribed anti-depressants either."

He added, "Also, a small number of patients may be prescribed anti-depressant medication for the treatment of illnesses other than depression. Some medication typically used for treating depression has other therapeutic effects and is used to treat,for example, enuresis and facial pain."

- Niamh Horan"


 
 
admin

BLAIR UK: Suspect Terrorists & Mentally Ill (no crimes) to be HELD in PSYCH HOSPITALS

June 18 2007, 10:52 PM 

HELLO?  NOW WE HAVE SOVIET RUSSIA STYLE ABUSE OF THE PEOPLE BY PSYCHIATRIC HOSPITALS ALONGSIDE AMERICAN STYLE ABUSE BY DRUGGING THE MASSES?

http://news.bbc.co.uk/1/hi/health/6762355.stm

18 June 2007

Mental care bill back in Commons
Mental health patient
The bill calls for people with severe personality disorders to be held

The government will again try to push through powers to detain mentally ill people in England and Wales who have not committed crimes.

The plans, to be debated in the Commons over the next two days, have faced opposition from mental health charities and opposition politicians.

Critics complain that the measures could result in too many people being locked up unnecessarily.

Ministers have been trying to update mental health legislation since 1998.

After a string of defeats in the House of Lords, the government has given some ground on the bill, which amends the Mental Health Act 1983.

Concessions include giving doctors tight rules over the use of orders to force patients to take medicine and place them under detention if required.

We must make sure we have a bill that does address, as well as getting treatment of people, the issues of public safety
Rosie Winterton
Health minister

Speaking ahead of the debate, Health Minister Rosie Winterton told BBC News: "What we have put down is an amendment to make clear that conditions can be set, in terms of community treatment orders.

"But we have said those conditions must be conditions which relate to the treatment of the patient and also are there either for the protection of themselves or others."

She added: "We must make sure we have a bill that does address, as well as getting treatment of people, the issues of public safety."

But, despite concessions, the Conservatives, the Liberal Democrats and some backbench Labour MPs are still likely to vote against the bill.

Further concessions

The shake-up in the law has been driven by Michael Stone's 1998 conviction for the brutal murders of Lin and Megan Russell.

Stone was regarded as a dangerous psychopath and it had been assumed he was not held under mental health powers because his condition was considered untreatable.

This was subsequently found not to be the case as he was receiving treatment but gaps in his care meant he was not given the correct treatment.

Ministers have made some concessions on other aspects of the bill.

Concern had been raised that the bill would allow patients under 18 to be held in adult wards.

The government has now said the bill will contain a clause saying they will be required to be treated in "age-appropriate settings".

People detained under the mental health laws will also be given access to advocacy services to champion their rights.

And the victims of mental health offenders will be given the chance to make representations over their proposed release. "

 

DEJA VU - NEWS FROM 3 WEEKS EARLIER:

 

http://www.dailymail.co.uk/pages/live/articles/news/news.html?in_article_id=457934&in_page_id=1770&ct=5

Revealed: Blair's secret stalker squad

Fears that doctors could be used to lock up terror suspects without trial


by JASON LEWIS - 26th May 2007

 

Tony Blair

The Government has established a shadowy new national anti-terrorist unit to protect VIPs, with the power to detain suspects indefinitely using mental health laws

The Government has established a shadowy new national anti-terrorist unit to protect VIPs, with the power to detain suspects indefinitely using mental health laws.

The revelation is set to reignite the row over the Government's use of draconian measures to deal with terror suspects amid accusations they are abusing human rights.

The Fixated Threat Assessment Centre (FTAC) was quietly set up last year to identify individuals who pose a direct threat to VIPs including the Prime Minister, the Cabinet and the Royal Family.

It was given sweeping powers to check more than 10,000 suspects' files to identify mentally unstable potential killers and stalkers with a fixation against public figures.

The team's psychiatrists and psychologists then have the power to order treatment - including forcibly detaining suspects in secure psychiatric units.

Using these powers, the unit can legally detain people for an indefinite period without trial, criminal charges or even evidence of a crime being committed and with very limited rights of appeal.

Until now it has been the exclusive decision of doctors and mental health professionals to determine if someone should be forcibly detained.

Scroll down for more...

 Robert Halsey

Killed by a stalker: Anna Lindh (right); Risk Expert: The Fixated Threat Assessment Centre's Robert Halsey

But the new unit uses the police to identify suspects - increasing fears the line is being blurred between criminal investigation and doctors' clinical decisions.

It also raises questions about why thousands of mentally ill individuals have been allowed back into the community - including some who have attacked and killed members of the public - while VIPs are being given special protection.

Scotland Yard, which runs the shadowy unit, refuses to discuss how many suspects have been forcibly hospitalised by the team because of "patient confidentiality".

But at least one terror suspect - allegedly linked to the 7/7 bomb plot and a suicide bombing in Israel - has already been held under the Mental Health Act.

The suspect, who was subject of a control order and cannot be named for legal reasons, later absconded from the hospital and his whereabouts are unknown.

The existence of FTAC, part of the Metropolitan Police's specialist operations department which oversees anti-terrorist investigations and royal and diplomatic protection, slipped out in the fine print of a Home Office report.

The report makes it clear FTAC is a counter-terrorism unit and says: "We aim to make the UK a harder target for terrorists by maintaining effective and efficient protective security for public figures."

NHS documents obtained by The Mail on Sunday reveal the unit's role "concerns the identification and diversion into psychiatric care of mentally ill people fixated on the prominent".

The purpose of the centre is "to evaluate and manage the risk posed to prominent people by...those who engage in inappropriate or threatening communications or behaviours in the context of abnormally intense preoccupations, many of which arise from psychotic illness."

The Mental Health Act requires two doctors or psychiatrists to approve someone's forcible detention for treatment.

So-called 'sectioning' allows a patient to be held for up to six months before a further psychological assessment. Patients are then reviewed every year to determine if they can be released.

FTAC's senior forensic psychiatrist Dr David James, who has made a study of attacks on British and European politicians by people suffering pathological fixations, is qualified to order such a detention, as are other members of his team.

Also on the staff is Robert Halsey, a consultant forensic clinical psychologist who is a specialist in risk assessment.

The centre, which is based at a secret Central London location, has a staff of four police officers, two civilian researchers, a forensic psychiatrist, a forensic psychologist and a forensic community mental health nurse. Job descriptions make it clear they implement "interventions".

Human rights activists fear the team, whose existence has never been publicised, may be being used as a way to detain suspected terrorists without having to put evidence before the courts.  [They do seem to have a point there, don't they!]

It also comes amid a continuing row over proposed mental health legislation which will make it easier to 'section' someone deemed a threat to the public.

Last night human rights group Liberty said the secret unit represented a new threat to civil liberties.

Policy director Gareth Crossman said: "There is a grave danger of this being used to deal with people where there is insufficient evidence for a criminal prosecution.

"This blurs the line between medical decisions and police actions. If you are going to allow doctors to take people's liberty away, they have to be independent. That credibility is undermined when the doctors are part of the same team as the police.

"This raises serious concerns. First that you have a unit that allows police investigation to lead directly to people being sectioned without any kind of criminal proceedings.

"Secondly, it is being done under the umbrella of anti-terrorism at a time when the Government is looking at ways to detain terrorists without putting them on trial."

FTAC was set up following an NHS research programme based at Chase Farm Hospital in Enfield, Middlesex, which looked at the threat to prominent figures from "fixated" people.

The team examined thousands of cases and liaised with the FBI, the US Secret Service, the Capitol Hill Police, which protects Congressmen and Senators, and the Swedish and Norwegian secret services.

The Swedish authorities gave the team access to files on the murder of foreign minister Anna Lindh who died from multiple stab wounds after being attacked by a stalker in a Stockholm store in 2003.

The research led to FTAC being set up with a £500,000-a-year budget from the Home Office and Department of Health. NHS documents say: "It is a prototype for future joint services."

No one from FTAC was willing to talk to The Mail on Sunday last week and few Whitehall officials seemed aware of the Centre's existence.

Shadow Health Secretary Andrew Lansley said: "The Government is trying to bring in a wider definition of mental disorder and is resisting exclusions which ensure that people cannot be treated as mentally disordered on the grounds of their cultural, political or religious beliefs.

"When you hear they are also setting up something like this police unit, it raises questions about quite what their intentions are.

"The use of mental health powers of detention should be confined to the purposes of treatment. But the Government wants to be able to detain someone who is mentally disordered even when the treatment would have no benefit.

"Combined with the idea that someone could be classed as mentally ill on the grounds of their religious beliefs, it is a very worrying scenario."

Last night a Home Office spokeswoman said there was "nothing sinister" about the unit or its role in counter-terrorism.

She said: "It comes under the remit of royal and diplomatic protection and is administered by that part of the Home Office.

"Psychiatric investigations are undertaken by psychiatric professionals only. Police officers do not assess people with mental health issues. The police provide the intelligence to ensure that psychiatrists have all the information available to make an assessment.

"This is done not only to protect public figures but also to protect the person fixated with the public figure."

Details of FTAC are revealed as the Government faces a new row over its terrorist control orders after three suspects, supposedly under house arrest, absconded last week.

The suspects, who it is feared may have fled the country, include the brothers of Anthony Garcia, who was jailed last month for his role in a plot to bomb London nightclubs and shopping centres. "


 
 
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US: Court investigates Vaccine link to Autism

June 18 2007, 11:20 PM 

http://www.msnbc.msn.com/id/19168291/

Court investigates vaccine link to autism

Federal hearing will determine compensation for thousands of families

Updated: 7:50 p.m. ET June 11, 2007

WASHINGTON - In excruciating detail, an Arizona mother on Monday described severe autism and devastating health problems that plague her 12-year-old daughter and asked a court to find common childhood vaccines were the cause.

The test case is being closely watched by nearly 5,000 families of autistic children who have lodged similar claims for compensation from a federal fund.

The case of Michelle Cedillo, of Yuma, Ariz., is the first alleging a vaccine-autism link to be heard in the U.S. Court of Federal Claims. It and eight other test cases are important because they will guide the handling of the other pending claims. Most contend that a mercury-rich preservative called thimerosal is to blame for the impaired social interaction typical of the disorder.

Should they prevail, the families will be eligible for compensation from a federal vaccine injury fund established by Congress to ensure an adequate supply of vaccines by shielding manufacturers from lawsuits. No autism claim has been paid from the fund thus far.

Large scientific studies have found no association between autism and vaccines containing thimerosal.

Government attorney Vincent Matanoski dismissed much of what the plaintiffs are expected to present during the three-week hearing as conjecture or speculation.

“You’ll find their hypotheses untested or, when tested, have been found false,” Matanoski said.

Health issues began after vaccination
Theresa Cedillo said her daughter suffered five days of fever, her temperature often spiking to 105 degrees, after receiving a measles, mumps and rubella vaccination at age 15 months. Michelle was a happy, robust, responsive and loving child — in short, normal — but hasn’t been the same since, her mother told the court.

Wearing noise-canceling headphones, Michelle was brought into the courtroom in a wheelchair at the start of the proceedings. She stayed only a short time, moaning audibly several times. Besides autism, Michelle suffers from inflammatory bowel disease, glaucoma and epilepsy. In addition, her bones, weakened by years of malnourishment, are prone to breaks, Theresa Cedillo said. Everything she eats is pumped in through a feeding tube, except for crackers and water.

“Clearly the story of Michelle’s life is a tragic one,” Special Master George Hastings Jr. said in thanking the family for allowing theirs to be the first test case. Hastings pledged he and two other special masters would listen carefully to all evidence.

Theresa Cedillo and husband Michael allege thimerosal-containing vaccines weakened their daughter’s immune system and prevented her body from clearing the measles virus after she was immunized. That theory is one of three alleged by the thousands of plaintiffs. The others claim either thimerosal or the measles vaccine alone caused their children’s autism.

“We hope to find out what happened and hopefully get the help she needs,” said Theresa Cedillo, who takes care of her daughter full time at home.

Easier burden of proof
The burden of proof is easier than in a traditional court. Plaintiffs only have to prove that a link between autism and the shots is more likely than not, based on a preponderance of evidence. But many parents say their children’s symptoms did not show up until after their children received the vaccines, required by many states for admission to school.

“These are families who followed the rules. These are families who brought children in for vaccines. These are families who immunized their children,” Cedillo attorney Thomas Powers said. Later, outside court, he cast aside any suggestion his clients were anti-vaccine.

Autism is characterized by impaired social interaction. Those affected often have trouble communicating, and they exhibit unusual or severely limited activities and interests.

In 1999, the U.S. government asked vaccine manufacturers to eliminate or reduce the use of thimerosal in childhood vaccines to limit infant exposure to mercury. Today, the preservative is no longer found in routine childhood vaccines but is used in some flu shots.

The nine test cases will be heard consecutively over the next year. A ruling in the Cedillo case could take months or longer, attorneys said."


 
 
admin

UK: Press Release on Linda Hurcombe's new book - Depression: Healing Emotional Distress

June 18 2007, 11:37 PM 

 (Received by email)

Sheldon Press

"Depression: Healing Emotional Distress

A holistic view

Linda Hurcombe

Judging by the statistics, you could be forgiven for thinking we are a nation of depressives; an astounding two-thirds of British adults say they suffer from depression, according to the British Association for Counselling and Psychotherapy.

What is going on? With more than £27 million prescriptions for antidepressants being written a year, can depression really be an ‘illness’? Or do the numbers reflect the lack of proper mental health resources and the stresses and isolation of modern life?

When does legitimate grief at life events shade into mental illness, and what is the difference between distress and depression? Well-informed, widely-researched, and punctuated with humour, this book asks some powerful questions about the nature of depression, and looks at how to cope in the face of a condition that robs you of the very skills and energies you need to recover. Topics covered include:

How it feels to be depressed

Depression through history

The spectre of suicide

The disease model of depression and antidepressant drugs

Healing and recovery

How mental and spiritual wellbeing may interlink

Depression is viewed from a holistic viewpoint as a medical, cognitive, lifestyle and spiritual phenomenon.

LINDA HURCOMBE is a writer, editor and educator, and author of Losing a Child, Sheldon Press. A previous editor of Compassion, the quarterly journal of The Compassionate Friends UK.

For further information, a review copy or to interview the author, please contact Fiona Marshall on 020 7592 3953 or  fmarcgakk[AT]spck.org.uk

Depression: Healing Emotional Distress by Linda Hurcombe

is published on 21st June 2007 by Sheldon Press

£7.99 128 pp Paperback

ISBN 978-18470-9014-0


 
 
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UK: Concerned Psychiatrist rejects Blair's OBE in protest re racism in mental health

June 19 2007, 12:59 AM 

Another psychiatrist with ethics.

http://www.blink.org.uk/pdescription.asp?key=14812&grp=5&cat=293

Mental health expert rejects OBE offer

by Matilda MacAttram
24/5/2007

EMINENT PSYCHIATRIST Professor Suman Fernando has written to Tony Blair rejecting his offer OBE in protest at the governments' failure to tackle racism in the mental health service.

cap
Professor Suman Fernando (centre) with Matilda MacAttram and Rev'd Pedro Okoro.

Professor Fernando is deeply concerns over the current Mental Health Bill which he fears will entrench unequal outcomes in the service.

Human rights and race equality campaigners have welcomed the news of the life long health campaigners decision to publicly reject the offer of an honour.

In a letter to Tony Blair, Professor Fernando said he found the offer puzzling since the government has consistently ignored his warnings that plans within the proposed legislation to extend compulsory powers of detention of anyone who comes in contact with mental health services was "deeply flawed".

He wrote: "It seems most strange that the Government say they want to recognise my services to BME Mental Healthcare at a time when they are trying to push through legislation that would make things worse for black people caught up in the mental health system, in spite of strong objections by many people (including myself) expressed both publicly and in private to Government ministers."

exacerbate

In a letter which was copied to prime-minister-in-waiting Gordon Brown, he added: " Much of the failure results from institutional racism, and injustices are evident mostly in the experience of black Caribbean people who are disproportionately sectioned and subject to inappropriate - often damaging ‘care’."

Tony Blair
Tony Blair: presided over huge inequalities in the mental health system.
Under the current 1983 Mental Health Act people from African Caribbean communities are 44% more likely to be sectioned than a British white person, despite black people having similar rates of mental ill health as other ethnic groups.

Prof Fernando is concerned that the proposed changes in the 2006 Mental Health Bill, which will be debated on the floor of  the House of Common’s later this month, will exacerbate the problem of discrimination within the services and make this matter worse.

His comments come at a time when the Government is committed to railroading through the hugely contentious 2006 Mental Health Bill which has been condemned by professionals, race quality campaigners and human rights groups.

The government has just finished overturning every amendment made in the House of Lords  which placed safeguards against injustices which often happen to black people subject to mental health law. 

principles

The Health Secretary Patricia Hewitt has stated publicly that the Bill gives the right balance between protecting the public from people who might pose a threat who have a mental illness.

Race equality experts say this is not the case as under the current law black people  make up over 40% of patients in high secure hospitals such as Rampton, Broadmoor and Ashworth despite being less than 3% of the national population. 

Research also shows that 11% of black people detained in these high secure prison settings for the mentally ill have never committed any crime.

Prof Fernando's letter states: "At the very least what the Government can do is amend the Act... that would oblige professionals to provide a fair and just system that would minimise the risk of injustice and protect the public in a real sense."

An active campaigner for over thirty years, Prof Fernando was one of the experts at Black Mental Health UK’s all parliamentary briefing on the 2006 Mental Health Bill held at Westminster earlier this month.

enlightened

It was clear from the debate held at this meeting that the Government’s concession to add principles to the code of practice rather than the Bill calls into questions Blair administrations commitment to race equality. 

Legal experts at the meeting enlightened delegates that the fact that Government is sovereign and so has it within their power to add race equality principles  to the face of the Bill, the only factor stopping this is political will.

Fernando is clear that in order to ensure equitable mental health care for the future, the 2006 Mental Health in its current state needs to be ditched.

"What a better time than now for Labour to show the country that it will deliver a fair and just mental health system, my plea to Government is to withdraw the Bill as it stands today and get back to consultation mode."

Traditionally those declining honours from the British Government do so privately but Professor Fernando follows in the footsteps of  race quality campaigner like Dr Benjamin Zephaniah who dismissed his award in 2003.

Downing Street was unavailable to comment on whether or not Professor Fernando’s name had been submitted to the Queen for an OBE.

Fernando’s decision has been welcomed by health and race equality campaigners from across the UK as well as countless patients and their families and community groups currently dealing with often long-term damaging effects of  systemic racism  within the mental health services."


 
 
admin

Weight Loss Pill can cause SERIOUS physical & psychological harm AND BIRTH DEFECTS

June 19 2007, 3:21 AM 

http://www.citizen.org/hot_issues/issue.cfm?ID=1633

June 13, 2007

Weight Loss Drug Rimonabant Can Cause Serious Physical and Psychological Harm and Birth Defects, Public Citizen Tells FDA

WASHINGTON, D.C. – The Food and Drug Administration (FDA) should not approve the new diet drug rimonabant (marketed as Acomplia in Europe and known as Zimulti in the U.S.) because it produces only modest weight loss and has been shown to produce serious physical and psychological adverse effects, according to Public Citizen testimony before an FDA advisory committee meeting today. The group argued that more extensive studies of the drug’s effectiveness and safety are needed to fully evaluate its benefit-to-risk ratio.

The testimony about rimonabant was prepared by Dr. Sidney Wolfe, Ben Wolpaw and Elizabeth Barbehenn, Ph.D., all of the Health Research Group at Public Citizen. Wolfe delivered the testimony to the FDA’s endocrine metabolic drugs advisory committee.

Rimonabant inhibits brain receptors involved in eating. But the drug also inhibits other areas of the brain and other organs, raising serious concerns about the drug’s toxicity.

Sanofi-Aventis, the maker of rimonabant, has claimed that in pre-clinical animal studies, the drug “was shown to have very limited potential to induce toxicity,” and that there was no specific organ pathology identified. Yet a report from the European drug regulatory authority acknowledges such adverse effects in animals as increased birth defects, impaired fetal survival, convulsions, liver toxicity, chromosomal aberrations and carcinomas.

“The elusive idea of a magic bullet drug that has a benefit mediated through its action on one receptor site, yet is devoid of risks at a myriad of other sites in the body, is once again exemplified by rimonabant,” said Wolfe. “Other such drugs – including Vioxx, Rezulin and Redux – were eventually removed from the market because of their toxicity.”

Because the receptors are widespread in the brain, rimonabant has been shown to cause extraordinarily broad kinds of psychiatric dysfunction, in addition to increased suicidal tendencies and other depressive symptoms. In clinical studies, patients given 20 milligrams of rimonabant showed significant increases in anxiety, insomnia and panic attacks, as well as increases in aggression and agitation compared to patients given a placebo. In addition, significantly more patients receiving rimonabant required a sedative, tranquilizer or an anti-depressant for adverse events caused by the drug.

“The evidence for increased suicidal tendencies and depression is of particular concern for a drug targeted toward the obese, a population that has been shown to have a significantly higher incidence of depression and eating disorders compared to non-obese individuals,” Wolfe testified.

Wolfe told the committee that another major issue with the drug is the lack of reliable information regarding the long-term effects of its use. Because patients regain weight lost while using rimonabant after they discontinue its use, the drug will have to be prescribed on a long-term basis to be effective. But of the studies performed to date, two lasted two years, while the other three were one year in length.

“Because rimonabant is the first drug of its class, there is no data on its use in humans over an extended period of time,” said Wolfe. “The complete lack of information about the long-term effects of this drug is a serious cause of concern.”

To read the testimony, click here.  "


 
 
admin

"Bennett Inquiry reveals NHS plagued with Racism" DEATH kept secret

June 19 2007, 3:53 AM 

http://www.blink.org.uk/pdescription.asp?key=2811&grp=5

Bennett inquiry reveals NHS plagued with racism

Exclusive by Matilda Macattram
17/12/2003

THE long-awaited Government Inquiry into the tragic death of David ‘Rocky’ Bennett in a mental institution is set to reach damning conclusions over racism in the mental health system

Died in mental health care
Orville Blackwood stopped breathing in a seclusion cell at Broadmoor special hospital after being forcibly restrained and given three times the recommended dose of a tranquilizer in 1991.
Roger Sylvester collapsed in St Ann's hospital, a psychiatric unit in north London, after being restrained by police officers. An inquest this year ruled that Sylvester had been ‘unlawfully killed’.
Munir Majothi , a psychiatric patient in Clifton hospital, York, died because of a "lack of care" according to an inquest. It was noted that the 26-year-old caterer had been given sedative injections in "unusual quantities"

Dubbed the ‘Stephen Lawrence Inquiry of the mental health world’ the inquiry report, released next month, is expected to brand the NHS as institutionally racist.

Blink can exclusively reveal that the Bennett inquiry will condemn the NHS for failing to learn lessons from previous deaths, and in hard-hitting recommendations demand a radical shake-up of the mental health system.

38 year-old black psychiatric patient Rocky Bennett died in October 1998 at a Norwich secure unit after being restrained. An inquest returned a verdict of 'Accidental Death aggravated by Neglect' in May 2001.

Since then the bereaved man’s family have mounted a long-running campaign to bring to light the circumstances surrounding Rocky’s death, leading to this semi public inquiry chaired by retired high court judge Sir John Blofeld.

restraint

Recommendations are expected to include calls for a new unit in the department of health to deal specifically with black and minority issues within the mental health field.

The inquiry may also demand new standards on the use of force when restraining patients, resuscitation procedures, and dealing with racist behavior.

Rocky Bennett, a father-of-two from Peterborough, was about to be released from Norvic secure unit in Norwich after three years in the institution, but died of positional asphyxia on 31 October 1998.

He was subjected to racial abuse from another patient and later became angry that he and not the other white patient were moved off the ward. The inquiry into his death heard that Rocky hit out at nurse Sharon Hadley. He was immediately restrained face down on the floor.

He was then held face down for 25 minutes by as many was five nurses. His family were not informed of his death until two days later.

hope
Rocky Bennett
David ‘Rocky’ Bennett: died of restraint in ‘racist’ mental health system

Rocky’s sister, Dr Joanna Bennett, a lecturer in mental health nursing at South Bank University, told Blink of her hope that the inquiry would bring about much needed changes to the care of mental health patients.

She said: "His life won’t have been lost in vain if this campaign and semi public inquiry lead to positive changes in mental health services.

"The imminent recommendations are a start, but they are only a start. I continue to see that black service users are not getting the level of service that they deserve or require."

As a mental health professional Dr Bennett said that Rocky’s experience was not unique.

"There needs to be national policies in place to ensure that other black men are not subjected to this kind of treatment."

hearings

The inquiry into Rocky’s death has held its’ hearings in Birmingham and includes top medical professionals including Professor David Sallah, Professor Sashi Sashidaran, Joyce Struthers and Dr Richard Stone who previously sat on the Stephen Lawrence Inquiry.

Inquiry chairman Sir John Blofeld said: "Our research through the inquiry has shown black mental health patients are over-medicated and spend too much time in secure wards."

The recommendations will be submitted to health minister Rosie Winterton, and she will decide whether the report is made public.

A source told Blink: "The report promises some hard hitting changes and will be banging on the door of the NHS with some tough recommendations."

The inquiry is expected to look at the problems of disproportionate diagnoses of severe mental illness in black people, and the over-zealous use of seclusion and detention of black patients.

They found that the NHS do not even centrally collect information on deaths of mental health patients.

Mental health services are blamed for a failure to manage frustration and anger and the poor treatment of bereaved families following a death. The NHS will also be blamed for failing to learn from previous deaths caused by restraint.

sectioned

The inquiry heard evidence that Rocky often expressed fears that he would be killed in the mental health institution run by Norwich Mental Health Care NHS Trust.

Dr Ian Gibson, MP for Norwich North, has criticised Norfolk Mental Health Care Trust accusing it of being "blasé" over criticisms arising from Rocky’s death.

A spokesman for the mental health trust was recently quoted as saying: "It has been a long time since Mr Bennett's death and the changes have already been implemented."

Some black health campaigners believed a culture of racism and neglect has infected the mental health system. Department of Health figures show black people are over five times more likely to be detained in high security units.

Even though black communities constitute less than 3% of the national population, official figures show they make up 16% of high security detention, and 30% of medium risk patients. Black people are also six times more likely to be sectioned than white people.

Errol Francis, a consultant at the Sainsbury Centre for Mental Health, told Blink: "This is an under explored area that needs to be looked at."

Lawyer for the Bennett family Sadiq Khan said the inquiry into Rocky’s death has been "the best kept secret there is" receiving little press coverage.

Helen Shaw, from campaign group Inquest, has been supporting the Bennett family in their quest for justice.

She said: "Some positive changes can be made for the future. This Inquiry can provide an opportunity to precipitate change in the treatment of all people with mental heath problems and in particular address the specific needs of black patients."

chaotic

Coroner at Rocky’s inquest William Armstrong told reporters after the neglect verdict: "The horror of listening to what happened that night is going to live with me forever. I am gravely disturbed by the chaotic way in which the situation was managed showing that the mental health service continues to fail to respond to what should have been learned from similar previous incidents."

Dr Joanna Bennett said she hoped the report would bring changes to the system so that "Rocky’s life is not to have been lost in vain." She warned that the report must not sit on shelves gathering dust.

Expected recomendations
  • Details on all deaths within mental healthcare institutions including ethnicity, age, location and mode of death. There is currently no information available about the number of deaths there have been in mental health units in hospitals.
  • A national standard for training and use of force, short term guidance should be issued by the Department of Health suspending the use of the prone position in control and restraint.
  • Proper records of all use of control and restraint on patients, serve as a useful tool in identifying training needs and abuse.
  • A fully equipped resuscitation trolley with proper equipment available, with members of staff trained to use it – recommended for all NHS clinics where there are a significant number of patients.
  • Greater attention to therapeutic engagement with individual patients.
  • A new unit needs to be established to deal specifically with black and minority issues within the mental health world.
  • The disproportionate number of black patients to black professionals in NHS settings in the mental health departments needs to be looked at and commented.
  • Information about care or support workers for relatives of the bereaved should be readily available.


     
     
    CLASS ACTION LAWSUIT ZYPREXA-AUSTRALIA

    ** AUSTRALIA ** CLASS ACTION LAWSUIT ELY LILLY'S ZYPREXA

    June 19 2007, 5:15 PM 

    http://www.theaustralian.news.com.au:80/story/0,20867,21922547-2702,00.html

    Aussies in class action on drug

    PHARMACEUTICAL giant Eli Lilly faces a class action from a group of Australians claiming they have suffered dangerous or life-threatening side effects including weight gain, pancreatitis and diabetes after taking the anti-psychotic drug Zyprexa.

    The class action, the first over the allegedly negative affects of Zyprexa outside the US, started on behalf of a 32-year-old Tweed Heads saxophonist who developed pancreatitis after taking the drug.

    Brisbane law firm Nicol Robinson Halletts expanded the case into a class action after others claimed their health had been harmed by Zyprexa.

    Lawyer Simon Harrison said his team hoped to link the Australian claims to a $1.2billion group of settlements by Eli Lilly in the US over 30,000 similar cases.

    "We are presenting a class action in respect of alleged side effects from the use of Zyprexa, some of which are life-threatening," Mr Harrison said.

    "We'll be alleging Eli Lilly minimised or understated the risk, and we're dealing with associate attorneys in the US with a view to including the class action within the American settlements.

    "The concern that we as plaintiff lawyers have is that information concerning the risks wasn't presented as soon as it should have been."

    Zyprexa, or olanzapine, is used to treat people with schizophrenia or bipolar disorder and has been available in Australia since mid-1997.

    Mr Harrison declined to reveal how many people were involved in the Australian action but said there were litigants from Victoria, South Australia, Western Australia and Queensland, "from middle-aged to early 20s", who had metabolic disorders such as diabetes and pancreatitis.

    A spokeswoman for Eli Lilly said the company was aware of the initial case but did not have details of the class action.

    "Zyprexa remains an effective medication for the treatment of schizophrenia and bipolar disorder and its benefit-risk profile is not altered by this case," she said.

    "An adverse event does not necessarily have a causal relationship to the medicine."

    Since April 1997, the Therapeutic Goods Administration has had reports of 40 deaths and 1231 adverse reactions among people taking Zyprexa.

    Australian Medical Association federal counsellor Martin Nothling, a psychiatrist, said many of the problems associated with anti-psychotic medications could be avoided if the patient was "intensely followed up" by a treating psychiatrist.

    "The benefits outweigh the risks," Dr Nothling said.

    The figures, obtained by the Citizens Committee for Human Rights, co-founded by the Church of Scientology, show 53 cases of abnormal liver function in people taking Zyprexa, 87 cases of weight increase and more than 40 cases of metabolic disorders including diabetes and hyperglycemia.

    Jon Jureidini, head of psychological medicine at the Women's & Children's Hospital in Adelaide, said difficulties interpreting the significance of adverse reaction reports highlighted "broader systemic issues".

    "We don't put enough effort, energy and resources into this problem of monitoring the adverse effects of drugs," he said.

    The TGA did not respond to requests for comment. "



        
    This message has been edited by peagee on Jul 11, 2007 10:51 AM
    This message has been edited by peagee on Jun 19, 2007 5:19 PM
    This message has been edited by peagee on Jun 19, 2007 5:17 PM


     
     
    admin

    CANADA: 12% of antipsychotics go to children from AGED 3 to AGED 8

    June 20 2007, 2:40 PM 

    http://www.canada.com/saskatoonstarphoenix/news/national/story.html?id=5269a8fa-c792-4aee-bb95-a36c9386f798

    Young kids prescribed antipsychotics: report

    Sharon Kirkey, CanWest News Service

    Published: Tuesday, June 19, 2007

    Antipsychotics are being widely prescribed to children with behaviour and mood problems, with a significant proportion going to children under nine, new research shows.

    Ninety-four per cent of 176 child psychiatrists in Canada surveyed are prescribing powerful drugs known as atypical antipsychotics for a variety of disorders and symptoms, including anxiety, attention-deficit hyperactivity disorder and "poor frustration tolerance."

    While most prescriptions were for children 13 and older, a "surprising" number were for the very young: 12 per cent of all prescriptions were for children aged eight or under, including three-year-olds.

    None of the drugs has been officially approved for use in children. Risperidone (brand name Respirdal) was the most commonly prescribed atypical antipsychotic to children, followed by olanzapine (Zyprexa) and quetiapine (Seroquel).

    All are in a different class from Ritalin, a stimulant used to treat attention deficit disorder in children.

    Originally developed to treat schizophrenia and mania, so-called ATAs are now increasingly being used to treat non-psychotic disorders in adults, children and teens.

    "These medications are currently being used off-label without clear guidelines for indications, dosing and monitoring," researchers report in the most recent issue of the Canadian Journal of Psychiatry.

    "There is an urgent need for more data regarding safety and monitoring of these medications in children."

    In the U.S., the number of visits to a doctor that ended with a patient under 20 being prescribed an anti-psychotic soared six-fold between 1993 and 2002.

    The new Canadian survey can't answer just how many children or teens in Canada are on antipsychotics. But it shows prescribing by child psychiatrists and pediatricians who specialize in developmental problems is "ubiquitous."

    "The trouble with a study like this is, it doesn't tell us whether that's a good thing or a bad thing. We just know it's happening," says lead author Dr. Tamison Doey, head of the division of child and adolescent psychiatry for the city of Windsor and an adjunct professor at the University of Western Ontario.

    "Intuitively we all say, 'Geez, these are young kids to be on medicine. But kids that age are put on drugs for asthma, and they're given antibiotics and different sorts of medication. I think we all get a bit concerned if it's something that affects the brain." [!!]

    As doctors become more confident with ATAs, the drugs are filling an important niche, Doey says.

    "We have data to show they are helpful. The concern is we also have data showing that when you stop the medication, many times the problems come back. That means you're maybe looking at having to take these drugs for the long term. Then you start to worry, 'these are kids, what will happen down the road?'"

     

    How odd that  psychiatrists like the above don't notice the data that show that the drugs they are giving out are NOT approved for children, ARE HARMFUL, particularly to children, and that 'problems coming back' are usually from the MEDICATION and from WITHDRAWAL. 

    Its just plain child abuse by [some] ADULT psychiatrists.


     
     
    admin

    UK: Petition to 10 Downing Street re overprescribing of SSRI/SNRI drugs

    July 11 2007, 11:11 AM 

    "Petition on 10 Downing Street website ………

     

    based on the escalating number of prescriptions for the SSRI / SNRI class of drugs, questioning the huge and glaringly obvious anomaly within the 2005 Official National Statistic figures and requesting investigation and explanation.  

     

    This is not a depression and antidepressant drug issue - but one that encompasses every aspect of the NHS – over prescribing and therefore over spending in any area takes funding from another.

     

    The petition should have read as follows - however - due to a restriction of 1,000 characters including spaces in the 'More details' ection - three paragraphs were moved up to the petition.  This has made the petition far too long and lacking in clarity - which I apologise for and hope will not put anyone off supporting it with their signatures.

     

    ****

     

    We the undersigned petition the Prime Minister to...

     

    initiate an urgent investigation into GPs diagnostic rates of depression, the publicised over prescribing trends of SSRI / SNRIs the second generation class of antidepressant drugs - AND explain why according to the Office of National Statistics (ONS) that in 2005 the total number of prescriptions cashed for these drugs only increased by 315.8 thousand - while increases for years 1998 to 2004 and year 2006 have been between 1.2 and 2.2 million per annum - with the median average annual increase excluding 2005 of nearly 1.5 million.  

     

    More info……

     

    As 2005 showed no increase in total prescriptions cashed for other classes of antidepressants to counteract this drop - nor complaints regarding non treatment of ‘depressed’ patients – it is self evident that over prescribing of SSRI / SNRI drugs is an escalating problem and the cost an increasing financial burden on the NHS. 

     

    Was 2005 an extraordinary year when miraculously thousands less people became depressed than any other year? 

     

    Or in the aftermath of the Committee on Safety of Medicines (CSM) ‘Expert Working Group on the Safety of SSRI Antidepressants’ reporting December 2004 -- which found them to be lacking in both efficacy and safety -- did GPs moderate their diagnosis of depression and practice of prescribing SSRI / SNRI drugs as first line treatment?

     

    The new antidepressants were promoted to replace older established tricyclic & MAOI drugs, however total prescriptions for older drugs have not decreased, remaining stable despite SSRI/SNRI prescriptions increasing from 8,270,800 to 20,176,600 over 8 years.

     

    If a drug is efficacious & works, after an initial surge of prescriptions when licensed, prescriptions numbers should stabilise, even reduce as patients recover & come off.

     

    The alarming & continual increase in SSRI/SNRI prescriptions provides clear evidence of drugs not working &/or a ‘withdrawal syndrome’ instrumental in keeping patients on them, a fact known by manufacturers who told medical professionals the syndrome was re-emergence of original symptoms &/or emergence of new mental illness.

     

    The ONS figures demonstrate a problem which left unchecked could see prescriptions increasing by approximately 1.5 million per annum ad infinitum - can the NHS continue to sustain this – or any backlash for not acting in patients better interests?

     

    ****

    The crest for Number 10 Downing Street

    E-Petitions

    Sign a petition

    http://petitions.pm.gov.uk/ONS-SSRI-Anomaly/

    Unfortunately you must be a British citizen or resident to sign the petition – although there are facilities to enable signatures of expatriates and those who are in overseas territories, a Crown dependency or in the Armed Forces without a postcode.

    If you cannot sign yourself - please forward this page to anyone you know who might qualify and be willing to add their support.

    Thanks – Mardi"


     
     
    admin

    'Calls mount for rethink of "Big Pharma" model

    July 11 2007, 11:12 AM 

    http://uk.reuters.com/article/stocksNews/idUKNOA02654720070620?pageNumber=1

    Calls mount for rethink of "Big Pharma" model

    Wed Jun 20, 2007 8:23AM BST
     
    [-] Text [+]

    By Ben Hirschler, European Pharmaceuticals Correspondent

    LONDON (Reuters) - Is the "Big Pharma" model broken? An increasing number of people seem to think so.

    Institutional investors with more than $1 trillion (500 billion pounds) of assets under management were the latest to call on drugmakers to offer better value to both customers and shareholders in a report on Tuesday.

    The critical analysis -- sponsored by Dutch, U.S. and British pension funds and prepared by London consultancy SustainAbility -- follows a report from PricewaterhouseCoopers last week arguing the current business model was unsustainable.

    Investors, meanwhile, have been voting with their wallets by dumping shares in a sector that has stumbled badly in recent months after a series of high-profile product setbacks.

    Stocks in Europe's two biggest drugmakers -- GlaxoSmithKline Plc (GSK.L: Quote, Profile, Research) and Sanofi-Aventis SA (SASY.PA: Quote, Profile, Research) -- have both fallen 10 percent in the past month following body blows to key drugs that have exposed the innate risks in pharmaceuticals.

    Glaxo shares have underperformed the UK market as a whole (.FTAS: Quote, Profile, Research) by 25 percent through the past 12 months, Reuters data shows. The stock trades on around 13 times this year's forecast earnings, in line with the overall market and confounding expectations of the sector's traditional premium rating.

    Glaxo's diabetes drug Avandia was linked to increased heart-attack risk in an influential but controversial analysis on May 21, while Sanofi's key obesity drug Acomplia, or Zimulti, was rejected by a U.S. advisory panel on June 13.

    Both pieces of news lopped billions of dollars off expected revenues at the two drug giants

    SAFETY SCARES

    Worryingly, such upsets are all to familiar. Pfizer Inc. (PFE.N: Quote, Profile, Research) was another big casualty last December, when it lost an all-important successor to top-selling cholesterol drug Lipitor after a clinical trial showed the new pill to be dangerous.

    Such safety scares have damaged confidence among the general public and investors, who fear companies have not got the risk-reward balance right within their research labs.

    "No company can single-handedly overcome the distrust that many feel toward the pharma sector, and redefining the value of medicine today is incredibly complex," said Scott Streator, director of healthcare at the Ohio Public Employees Retirement System, one of the backers of the new report.

    "But balancing pressing health needs and return on investment demands nothing less from all of us."

    The "Pharma Futures" report from SustainAbility, which was also sponsored by Dutch-based ABP Investments and Britain's Universities Superannuation Scheme, paints a stark picture of an industry struggling to adjust.

    The key challenge is research productivity. In the past 10 years, the amount spent on pharmaceutical R&D has almost doubled, yet the number of new molecules approved by the U.S. Food and Drug Administration each year has gone down.

    There needs to be a restructuring of R&D to improve productivity, drive out redundant projects earlier and give a better balance of risks, according to SustainAbility.

    At the same time, firms will have to provide evidence of the economic value of more specialised and tailored drugs -- a view echoed by PricewaterhouseCoopers, which predicts the demise of the current strategy of placing big bets on a handful of "blockbusters". 

    CASH CALLS

    Some investors have simply got tired of waiting for company pipelines to deliver and are calling on drugmakers to adopt the strategies of private equity to improve sluggish returns.

    Many would like firms to take on more debt or else spin off non-core units -- such as Glaxo's Lucozade, Ribena and Horlicks nutritional drinks business -- as a way to accelerate cash returns to shareholders.

    An analysis by Citigroup suggests European drugmakers do have capacity to take on more debt to repurchase shares, but the scope varies widely from company to company.

    Citigroup believes Sanofi has the largest opportunity and could buy back shares worth 19 percent of the group's market capitalisation, in a move that would be a significant catalyst for the stock.

    But Glaxo already gives back the majority of free cash flow to its investors and could probably return only an incremental 6 percent of its market value."

     


     
     
    admin

    Postmortem study show OMEGA-3 DEFICIT in those with Major Depressive Order

    July 11 2007, 11:15 AM 

    Source: Biol Psychiatry 2007; 62: 17-24

    "Omega-3 fatty acid deficiency might play role in depression

    << Back

    22 June 2007

    MedWire News: Postmortem study demonstrates a selective deficit in the omega-3 fatty acid docosahexaenoic acid (DHA) in the orbitofrontal cortex of patients with major depressive disorder (MDD), researchers report.

    These findings suggest a role for omega-3 fatty acid deficiency in the pathophysiology and, potentially, pathogenesis of MDD, Robert McNamara (University of Cincinnati College of Medicine, Ohio, USA) and colleagues say.

    Previous epidemiological surveys and studies of plasma fatty acid levels have suggested a link between omega-3 fatty acid deficiency and MDD.

    In the current study, McNamara and team analyzed the total fatty acid composition of post-mortem orbitofrontal cortex from 15 patients diagnosed with MDD and 27 age-matched controls, using gas chromatography.

    After multiple comparison tests, DHA was the only fatty acid which levels differed significantly in the post-mortem orbitofrontal cortex from patients with MDD, compared with controls, being 22% lower in MDD patients.

    These differences were greater in female MDD patients (–32%) but lower in male MDD patients (–16%). This could not be attributed to lifestyle factors or post-mortem tissue variables, the team notes.

    DHA levels negatively correlated with concentrations of the main monounsaturated fatty acids – oleic acid and vaccenic acid – and this suggests that DHA loss is compensated for by elevations in these fatty acids. In contrast, DHA levels positively correlated with arachidonic acid levels, suggesting concomitant loss.

    McNamara et al comment that, as previous studies have observed reductions in gray matter volume in the orbitofrontal cortex of patients with MDD, it would be of interest to determine whether chronic omega-3 fatty acid treatment can normalize these volume reductions."





     
     
    admin

    NIH workshop Videos on Omega 3

    July 11 2007, 11:19 AM 

    Not by any means new, but the findings in those studies seem to be little utilised - prescribing pharmaceuticals 'easier'?http://videocast.nih.gov/ram/omega1.ram   (introduction) 


    http://videocast.nih.gov/ram/omega2.ram

     

    http://videocast.nih.gov/ram/omega3.ram

     

    http://videocast.nih.gov/ram/omega4.ram

     

    http://videocast.nih.gov/ram/omega5.ram

     

    http://videocast.nih.gov/ram/omega6.ram

     

    http://videocast.nih.gov/ram/omega7.ram


     
     
    admin

    Doctors Prejudiced against Patients with Mental Health Disorders

    July 11 2007, 11:23 AM 

    http://www.medicalnewstoday.com/medicalnews.php?newsid=74958

    Doctors Are Prejudiced Against Patients With Mental Health Disorders

    Main Category: Psychology / Psychiatry News
    Article Date: 23 Jun 2007 - 1:00 PDT

    People who are ill and have psychiatric disorders are not treated as effectively by doctors compared to those who have no mental health problems.

    Dr Alex Mitchell, a consultant psychiatrist, and Dr Darren Malone, a specialist registrar in psychiatry, who work at the Department of Liaison Psychiatry at Leicester General Hospital, reviewed a number of studies focussing on preventative and physical care of patients with and without mental illness.

    They looked at screening for cholesterol, high blood pressure, diabetes, osteoporosis, HIV and cervical and breast cancer and treatment for diabetes, cardiovascular disease, HIV and cancer care.

    Unveiling their findings to the annual meeting, they found that of the 14 studies which looked at health screening, 12 suggested inferior quality of care. Of the 23 studies comparing care for patients with and without mental illness 14 suggested poor quality of care when it came to recommending drug treatment, diagnostic and investigative procedures and surgical interventions.

    Said Dr Mitchell: "People who are mentally ill sometimes don't seek screening, but the more powerful reason is that once the medical team knows a patient has psychiatric problem, they give them poorer quality of care.

    "Doctors don't like dealing with patients with psychiatric problems. They view them as different and they spend les time with them. They don't offer the patient the same intensity of investigation as the non mentally-ill patient. It's prejudicial treatment."

    The Royal College Of Psychiatrists Annual Meeting
    Edinburgh International Conference Centre
    19-22 June 2007


     
     
    admin

    MDU warns doctors on missing Lyme Disease diagnosis

    July 11 2007, 11:25 AM 

    http://www.the-mdu.com/section_GPs_and_primary_care_professionals/topnav_News_3/hidden_Article.asp?articleID=1660&contentType=Media+release&articleTitle=MDU+warns+doctors+on+missing+Lyme+disease+diagnosis

    MDU warns doctors on missing Lyme disease diagnosis

    The MDU is warning its GP and hospital doctor members to ensure they consider a diagnosis of Lyme disease, which is most common in Spring and Summer.

    Media contact: Press Office on 020 7202 1535 or 020 7202 1504
    Publication date: 11 June 2007

    A number of complaints and claims have been reported to the MDU in recent years, which primarily allege a delay in the diagnosis of this condition.

    Dr Claire Wratten, MDU senior medical claims handler, said:

    “The diagnosis of Lyme disesase can be difficult to make because initial symptoms may be non-specific and mistaken for other conditions. While a delay or failure in diagnosis is not necessarily negligent, if the condition remains untreated, patients may develop serious symptoms affecting mainly the neurological, cardiac and musculo-skeletal systems, many months to years after the initial infection.

    “Doctors may see increasing numbers of cases of Lyme disease in the future as recent news reports have indicated a rise in the tick population, some of which carry the disease and can spread it to humans by biting and attaching themselves. In England and Wales 684 cases of Lyme disease were reported last year and Scotland has seen a ten fold increase in the numbers reported 10 years ago with 177 cases last year1 – which is why we are warning our members to be alert to the possibility of the disease in their patients.“

    Despite the increase in incidence of Lyme disease, the MDU says it is likely that an individual doctor will only rarely see a case. In view of this, the MDU has issued the following advice to its members, aimed at avoiding delay or failure in diagnosis:

    • Advise patients to take precaution against tick bites if they are visiting high risk areas. Advice is available on line at:
      Centres for Disease Control and Prevention
      Masta Travel Health
      HPA
    • Be aware that there are various clinical manifestations of Lyme disease.
    • Consider the diagnosis in patients with suggestive symptoms who have walked in areas where the disease is prevalent, such as Scotland, the New Forest and North America. Be aware that only about 20 per cent of patients are likely to recall the tick bite2.
    • If the diagnosis is considered, arrange appropriate tests to exclude or confirm the diagnosis.
    • Be aware of the relevant guidelines on treatment of the condition, for example those from the Health Protection Agency and Centres for Disease Control and Prevention.
    • As with all aspects of patient care, it is important to keep accurate contemporaneous records, and to record both positive and negative findings.
    • Remember that Lyme disease is a notifiable disease in Scotland, but not in England and Wales.

    Reference

    1. English S, Walkers at risk of a menace in the undergrowth, The Times 11 May 2007.
    2. Wormer GP et al, Prospective clinical evaluation of patients from Missouri and New York with erythema migrans-like skin lesions, Clin Infect Dis 2005 41(7)


     


     
     
    admin

    Obesity: Thousands of people on prescription medicines gaining large amounts of weight

    July 11 2007, 11:28 AM 

    http://news.independent.co.uk/health/article2701322.ece




    By Roger Dobson
    Published: 24 June 2007
    Thousands of people who take prescription medicines for everyday conditions are gaining large amounts of weight as an unexpected side effect, scientists have warned.

    Researchers, who found that some patients were putting on up to 22lbs in a year, say that the drugs may even be contributing to the nation's rocketing obesity epidemic.

    All of the patients they studied, on medication for conditions as diverse as diabetes, epilepsy, depression, high blood pressure and schizophrenia, showed evidence of weight increase.

    "Given the common and long-term use of many of these drugs," said the researchers, "it is likely that they play a significant contributory role in the increasing prevalence of obesity."

    A team from Glasgow University and Glasgow Royal Infirmary reviewed and analysed data on drug use by more than 25,000 people to quantify the effects of prescription drugs.

    All of the drugs included in the review are used to treat chronic diseases by large numbers of people. In the UK, it is estimated that around 2.6 million people have been diagnosed with coronary heart disease, for which beta-blockers are widely prescribed. More than 400,000 people have epilepsy, and around 1.3 million people have type 1 or type 2 diabetes.

    "In the light of these figures, the number of individuals in the population receiving treatment with an obesogenic drug is potentially quite high. In Scotland alone, the number of prescriptions dispensed for beta-blockers and tricyclic antidepressants between 2004 and 2005 exceeded one million and two million respectively," says the report.

    With many of the drugs, weight gain was significant and rapid, according to the researchers. Just how they lead to weight gain varies, and is in some cases unknown. Some, like corticosteroids, increase appetite, while beta-adrenoceptor blockers reduce metabolic rate.

    Olanzapine and clozapine, drugs used for psychiatric conditions, resulted in the most weight gain - up to 22lbs in 52 weeks. Insulin for type 2 diabetes was found to increase weight by up to 13.2lbs, while some drugs for depression added up to 8lbs, and some for high blood pressure led to gains of up to 3lbs. A heart drug added 5lbs, while some treatments for epilepsy added more than 12lbs, and some bipolar drugs led to weight gains of around 8lbs.

    The researchers say that many other drugs which are being prescribed and have not been investigated may also have an effect on weight.

    They also suggest that unexpected weight gain may be a reason why some people stop taking prescribed drugs: "Non-compliance with any drug therapy is a widespread problem, and around half of patients prescribed long-term medication for the management of chronic diseases do not comply fully with treatment.

    "Non-compliance is reported as an issue with many of the drugs included in this review, and the weight gain associated with them may contribute to this."

    In future, the scientists suggest, doctors should discuss with patients the risk of weight gain before they start treatment: "This review provides evidence of the weight gain potential of some common drugs. It is perhaps only now, in light of the present epidemic of obesity, that the negative effect on body weight is a pertinent issue. The potential of weight gain should be discussed with patients prior to the institution of therapy."

    Side effects: Prescription problems

    The drugs listed below are prescription medicines implicated in the new research. Each has been identified as possibly being responsible for dramatic weight gain:

    Beta-blockers

    Used to treat high blood pressure, abnormal heart rhythms and panic attacks. The drugs block the effects of adrenalin, slowing the heart rate.

    Corticosteroids

    Generally known as steroids, the drug is used to treat various conditions, from rheumatoid arthritis to stress relief after a trauma or operation.

    Olanzapine

    Used to treat schizophrenia and manic episodes. Is said to help the patient stay in touch with reality.

     
     
    admin

    Johnson & Johnson to use Girl Scouts to sell painkillers and cough medicines to friends

    July 11 2007, 11:34 AM 

    http://www.brandweek.com/bw/news/recent_display.jsp?vnu_content_id=1003600000

    Who's at the Door? J&J With Your Meds

    June 18, 2007

    By Jim Edwards

    NEW YORK -- Johnson & Johnson wants to turn Girl Scout troops into "drug dealers"—but it's all for a good cause. [editing note:  that of upping Johnson & Johnson's profits]

    The drug giant said it will launch a promotion this month, in which churches, charities and nonprofit groups—such as the Girl Scouts—will be encouraged to sell J&J's painkillers and cough medicine to their friends and neighbors. For every purchase of a J&J brand, including Tylenol, Sudafed, BenGay and Motrin, J&J will donate 8% of the sale to the community group. [editing note:  Thats 92% profit to Johnson & Johnson from their new drug users]

    It includes all the OTC brands that New Brunswick, N.J.-based J&J acquired from Pfizer in December, such as Benadryl and Listerine.

    Traditionally, community groups have raised funds by selling anodyne objects like calendars, greetings cards and, most famously, Girl Scout cookies. But the program, called Ucare, offers nonprofits an advantage, said J&J. Because customers will buy their drugs online, activists and volunteers no longer have to lug knickknacks or cookie boxes when they sell them.

    Here's how it works: The volunteer [Editing note: CHILD, GIRL SCOUT] persuades a neighbor to buy their regular over-the-counter medicine from J&J as part of the fund-raiser. The consumer then goes to Ucareorg.com to punch in the code for their specific fundraising group. After that, any product they buy will benefit the community group. (Info is at Ucare's Web site.)

    The push will be backed by a modest number of print and online ads, via Integrated Marketing Services, Norwalk, Conn. One ad asks "Who Cares?" Another reads, "Fundraising Is as Easy as 1-2-3."

    "We're always looking for new, creative, breakthrough ways of getting to our consumer base," said Eric Bruno, vp-marketing at McNeil Consumer Healthcare, Fort Washington, Pa., the unit that handles J&J's nonprescription drug brands. "This program does specifically highlight an increasing trend of wanting to more proactively engage consumers to participate with our brands, versus our brands just speaking to consumers."

    Bruno said J&J execs don't know how big the program could get or whether it will even make money. "We haven't really looked at this, to be candid, at hard volume metrics. We look at it as an opportunity to penetrate the communities which we serve."

     

     

    !



        
    This message has been edited by peagee on Jul 11, 2007 11:36 AM


     
     
    admin

    Pfizer ADMITS to the deaths of eleven children in Nigerian drug trial

    July 11 2007, 11:38 AM 

    Pfizer wins early Nigeria battle
     
     
     
    Hajara
    Hajara survived the trials but cannot now hear or speak
    A Nigerian court has refused to allow more cases to be added to a lawsuit against a pharmaceutical giant accused of improper drugs trials on children.

    Pfizer lawyers argued in Abuja that the amendments had been improperly filed.

    The Nigerian government wants $7bn in damages and compensation for the families of the children who died or suffered serious side-effects.

    Some 200 children took part in trials for a new anti-meningitis drug in 1996. Pfizer says the trials were lawful.

    The court rejected a bid by the Nigerian government's counsel to include 85 new claims - in addition to an earlier 54, agreeing with Pfizer that it had been improperly filed.

    Officials in Kano say more than 50 children died in the experiment, while many others developed mental and physical deformities.

    But Pfizer says only 11 of the 200 children in the drug trial died.

    Hassan Sani
    We did not suspect that the children were being used for an experiment
    Hassan Sani

    Pfizer tested the then unregistered drug in Nigeria's north-western Kano State during an outbreak of meningitis which had affected thousands of children.

    Following pressure, the Nigerian government set up an expert medical panel to review the drug trial.

    It concluded that the experiment was "an illegal trial of an unregistered drug" and a "clear case of exploitation of the ignorant".

    "We did not suspect that the children were being used for an experiment," Hassan Sani, the father of a girl who was tested, told the BBC in Kano recently.

    "The American doctors took advantage of our illiteracy and cheated us and our children. We thought they were helping us," he said.

    Pfizer denied any wrongdoing and said its trial of Trovan was conducted in accordance with Nigerian regulations.

    The Pfizer experiment was cited by many as a reason for the mass rejection of polio vaccinations in many parts of northern Nigeria in recent years.



     
     
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    PSYCHIATRISTS Top the List in Drug Makers Gifts

    July 11 2007, 11:42 AM 

    Article Tools Sponsored By
    Published: June 27, 2007

    WASHINGTON, June 26 — As states begin to require that drug companies disclose their payments to doctors for lectures and other services, a pattern has emerged: psychiatrists earn more money from drug makers than doctors in any other specialty.

    How this money may be influencing psychiatrists and other doctors has become one of the most contentious issues in health care. For instance, the more psychiatrists have earned from drug makers, the more they have prescribed a new class of powerful medicines known as atypical antipsychotics to children, for whom the drugs are especially risky and mostly unapproved.

    Vermont officials disclosed Tuesday that drug company payments to psychiatrists in the state more than doubled last year, to an average of $45,692 each from $20,835 in 2005. Antipsychotic medicines are among the largest expenses for the state’s Medicaid program.

    Over all last year, drug makers spent $2.25 million on marketing payments, fees and travel expenses to Vermont doctors, hospitals and universities, a 2.3 percent increase over the prior year, the state said.

    The number most likely represents a small fraction of drug makers’ total marketing expenditures to doctors since it does not include the costs of free drug samples or the salaries of sales representatives and their staff members. According to their income statements, drug makers generally spend twice as much to market drugs as they do to research them.

    “For the fourth year in a row, our analysis shows that there is a great deal of money being spent in our small state on marketing pharmaceutical products,” said William H. Sorrell, the Vermont attorney general.

    Endocrinologists received the second largest amount, according to the Vermont analysis, earning an average of $33,730. Since the state identified the specialties of only the top 100 earners, these averages represent the money earned by only some of the state’s specialists. There were 11 psychiatrists and 5 endocrinologists in that top group of 100.

    Still, a similar pattern was evident in a Minnesota database that was the subject of a series of articles in The New York Times this year. As in Vermont, psychiatrists earned on aggregate the most in Minnesota, with payments ranging from $51 to $689,000. The Times found that psychiatrists who took the most money from makers of antipsychotic drugs tended to prescribe the drugs to children the most often.

    These and other stories have helped to fuel a growing interest among state and federal officials to document and restrict payments to doctors from drug makers. At a gathering last month at Columbia Law School in New York, state attorneys general from across the country discussed ways to get similar data for their states.

    And today, the Senate Special Committee on Aging, which is led by Senator Herb Kohl, Democrat of Wisconsin, will hold the first of a series of hearings on the issue, which could lead to legislative proposals to restrict and require disclosure of payments and gifts to doctors from drug companies nationwide.

    Several lawmakers on Capitol Hill have expressed interest in such legislation, including Senator Charles E. Grassley, Republican of Iowa. “A federal law requiring public disclosure of payments to doctors could be very effective if it was carefully monitored and consistently applied,” Mr. Grassley said.

    Efforts to require disclosure of payments to doctors began almost by happenstance in 1993, when The Minnesota Legislature passed a law that restricts drug companies from giving doctors gifts valued at more than $100 in any given year. The legislation also required companies to report and make public any consulting fees paid to doctors.

    Lee Greenfield, a former state representative in Minnesota and one of the law’s authors, said it passed with little fanfare or debate after legislators heard stories about doctors accepting gifts of great value from drug makers.

    “Why do we want them bribing doctors to use what may not be the best or most cost-effective drug for the patient purely to get some hand-held TV, we all asked,” Mr. Greenfield said.

    Still, compliance with the law has been spotty. Some companies never responded to the board’s requests for disclosures. Others did so fitfully. A few sent letters saying they did not collect that information and thus could not provide it.

    Minnesota officials never cracked down. Such reports were put in file drawers and largely forgotten until this past year, said Cody Wiberg, executive director of the Minnesota Board of Pharmacy. Mr. Wiberg said he planned this year to pursue companies that fail to report.

    Besides Vermont and Maine, more than a dozen other states have or are now considering similar legislation, said Sharon Anglin Treat, executive director of the National Legislative Association on Prescription Drug Prices.

    Officials in Maine and Vermont said they would try to compare reports of payments to doctors with Medicaid records to explore how marketing practices might influence prescribing by doctors in ways that increased costs to taxpayers.

    “What we want to be able to do is overlay the prescribing information that we have with the drug detailing information,” said Jude Walsh, special assistant to the governor of Maine, John E. Baldacci. “If we see that doctors in a certain southern county in the state are prescribing a lot of a drug and getting a lot of detailing for that drug, that could lead to some record reviews to see what’s happening.”



     
     
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    Low Folate Levels Significantly Linked to Depression. Folic Acid.

    July 11 2007, 11:45 AM 

    Source: J Epidemiol Community Health 2007; 61: 631-637

    Low folate levels linked to depression
    << Back

    28 June 2007

    MedWire News: Low folate levels are linked with depression, concludes a meta-analysis published in the Journal of Epidemiology and Community Health.

    "Folic acid is a cheap and commonly used food supplement, and the identification of low folate status as a plausible specific risk factor for depression raises the possibility of using folic acid supplementation or improved diet in the prevention and treatment of depression at the population level," the authors say.

    Folate is involved in the synthesis of neurotransmitters such as serotonin, and the relationship between low folate levels and depression has been examined in various studies, but with conflicting results, Simon Gilbody (University of York, UK) and colleagues explain.

    Gilbody and team therefore conducted a meta-analysis of 11 observational studies – three case-control studies, seven population surveys, and one cohort study –examining the association between depression and folate.

    Pooling of all estimates for a total of 15,315 patients showed that folate status was significantly related to depression (odds ratio=1.55). This association remained significant after adjusting for confounding factors (odds ratio=1.42).

    Gilbody et al conclude: "Our study is unique in that for the first time all the relevant evidence in this controversial area has been brought together. Although the research does not prove that low folate causes depression, we can now be sure that the two are linked.

    "Interestingly, there is also some trial evidence that suggests folic acid supplements can benefit people with depression. We recommend that large trials should be carried out to further test this suggestion."


     
     
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    SSRIs linked to OSTEOPOROSIS (bone thinning) risk

    July 11 2007, 11:52 AM 

    http://www.channel4.com/news/articles/society/health/ssris+linked+to+osteoporosis+risk/576347

    SSRIs 'linked to osteoporosis' risk

    Last Modified: 25 Jun 2007
    Source: PA News

    Taking commonly-prescribed antidepressants may lead to lower bone density and the risk of osteoporosis in older men and women, new research suggests.

    Two separate studies in the US found that people who used the pills, known as selective serotonin re-uptake inhibitors (SSRIs), developed thinner bones than those who did not take them. Two well-known SSRI brands are Prozac and Seroxat.

    One group of researchers led by Dr Elizabeth Haney, from Oregon Health & Science University, Portland, looked at almost 6,000 men aged 65 and older.

    The men's bone density at the hip and base of the spine were measured in 2000 and again two years later. Hip readings were 3.9% lower for the 160 men taking SSRIs compared with men not using any antidepressants, or taking other kinds of depression medication.

    Similarly, spine bone mineral density was 5.9% lower among SSRI users.

    The other study led by Dr Susan Diem, from the University of Minnesota in Minneapolis, investigated 2,722 women with an average age of about 80.

    Checks on bone mineral density were made between 1997 and 1999, and again about five years later. Participants were asked to show all the medication they had taken within the past two weeks.

    A total of 198 women were taking SSRIs, 7.3% of the total. Their bone density at the hip decreased by 0.82% over the study period, compared with a fall of 0.47% for those taking a different kind of antidepressant or not being treated.

    Both sets of findings were published in the journal Archives of Internal Medicine.

    Dr Haney's team wrote: "These associations are biologically plausible and clinically important. Because SSRI use is prevalent in the general population, our findings have a potentially important public health impact. If confirmed, people using SSRIs might be targeted for osteoporosis screening and preventive intervention."

    These news feeds are provided by an independent third party and Channel 4 is not responsible or liable to you for the same."

     
     
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    Federal Judge allows ZYPREXA Class Action to go Forward

    July 11 2007, 11:56 AM 

    http://www.earthtimes.org/articles/show/news_press_release,131368.shtml

    Prescription Access Litigation: Federal Judge Allows Zyprexa Class Action to Go Forward

    Posted : Thu, 28 Jun 2007 21:38:00 GMT
    Author : Prescription Access Litigation
    Category : PressRelease

    BROOKLYN, N.Y., June 28 /PRNewswire-FirstCall/ -- A U.S. District Court judge today issued a decision allowing to go forward a class action lawsuit that alleged that Eli Lilly & Co. fraudulently marketed the atypical antipsychotic drug, Zyprexa, for uses not approved by the FDA. Judge Jack B. Weinstein, of the U.S. District Court, Eastern District of NY, denied Eli Lilly's motion for summary judgment, as well as a summary judgment motion filed by the plaintiffs.

    The 14-page order highlighted the importance of the Courts in protecting the public in the arena of prescription drugs. The Judge stated:

    "Under the present organization of the pharmaceutical industry, the official federal Food and Drug Administration (FDA), and the plaintiffs' bar, the courts are arguably in the strongest position to effectively enforce appropriate standards protecting the public from fraudulent merchandising of drugs." (Opinion, pp. 3-4)

    The lawsuit, brought by the New York-based Sergeants Benevolent Association Health and Welfare Fund and others, alleged that Eli Lilly illegally marketed Zyprexa for "off-label" purposes (i.e. for uses not approved by the FDA), as well as withholding information about Zyprexa's safety and efficacy. Doctors may prescribe prescription drugs for "off-label" uses but drug companies are prohibited from marketing or promoting drugs for such uses. A 2006 study in the Archives of Internal Medicine found that more than 1 in 7 prescriptions for commonly-used drugs were for off-label uses that lacked scientific support. A study released in January 2007 by the federal Agency for Healthcare Quality and Research found that there was little scientific evidence to support the off-label use of Zyprexa and other atypical antipsychotics.

    The plaintiffs in this case alleged that Lilly's marketing allowed it to charge a higher price than the drug would have been able to command. Lilly sold $4.4 billion worth of Zyprexa in the U.S. in 2006. According to a MarketWatch article, "While U.S. sales of Zyprexa rose 19% in the fourth quarter 2006, Lilly attributed this jump largely to higher prices." ("Lilly CEO: 2007 Zyprexa sales seen flat," Val Brickates Kennedy, MarketWatch, Mar 14, 2007)

    The Court further said in its opinion:

    "Allowing this and like suits to proceed may or may not increase the cost of pharmaceuticals and the efficacy of medical treatment in this country. It does, however, furnish backstop protection against under-regulated potentially dangerous activity by a market where caveat emptor largely rules." (Opinion, p. 12)

    "This ruling underscores the important role that Courts play in protecting patients from illegal drug company tactics," said Alex Sugerman-Brozan, director of Prescription Access Litigation, a national coalition of which the Sergeants Benevolent Association Health and Welfare Fund is a member. "Unfortunately, the FDA has been trying to slam the courthouse doors in the public's face by arguing that consumers' legal claims are 'preempted' by the FDA's authority."

    "We are very excited about this success and are grateful to all those who worked diligently defending the interests of our members," said Ed Mullins, President of the Sergeants Benevolent Association. "We will continue to pursue any action of wrongdoing that impacts on a NYPD Sergeant or their family."

    The case is part of In re Zyprexa Products Liability Litigation, 04-MD-01596, E.D.N.Y. The Judge's ruling can be found at http://www.prescriptionaccess.org/docs/zyprexa-order-6-28-07.pdf

    About the Sergeants Benevolent Association

    The Sergeants Benevolent Association (http://www.sbanyc.org/) is comprised of approximately 10,000 active and retired sergeants of the New York City Police Department. An independent union, it acts as the collective bargaining unit for those officers during contract negotiations with the City of New York, and manages a variety of other projects -- including health and welfare programs, political outreach efforts and community service initiatives -- for the benefit of its members and their families. The breadth of the association's activities is wide, but above all else, the SBA is an advocate for New York's police sergeants, the officers who stand at the Frontline of our nation's largest metropolitan police department.

    About Prescription Access Litigation

    Prescription Access Litigation (PAL) (http://www.prescriptionaccess.org/) is a nationwide coalition of over 130 state, local, and national senior, labor and consumer health advocacy groups in 35 states and the District of Columbia fighting to make prescription drugs affordable. The organizations in the PAL coalition have a combined membership of over 13 million people. PAL works to end illegal drug industry practices that increase the price of prescription drugs beyond the reach of the American consumer, using class action litigation and public education. Since 2001, PAL members have filed 28 sets of lawsuits targeting such practices. News about PAL's cases and public education efforts is published regularly on the PAL Blog at http://www.prescriptionaccess.org/blog

    Contact: Mark Snyder (617) 275-2931 msnyder@communitycatalyst.org Prescription Access Litigation

    CONTACT: Mark Snyder, +1-617-275-2931, msnyder@communitycatalyst.org,
    for Prescription Access Litigation

    Web site: http://www.prescriptionaccess.org/


     
     
    admin

    While ZYPREXA makers (Eli Lilly) Survey finds litigation harms patients (!)

    July 11 2007, 12:08 PM 

    http://ahrp.blogspot.com/2007/06/eli-lilly-settles-900-zyprexa-cases.html

    Eli Lilly Settles 900 Zyprexa cases & Releases a Survey

    Jeopardizing treatment outcomeEli Lilly has settled another 900 Zyprexa cases weeks before going to trial.
    And Eli Lilly Paid for Survey whose findings say, Product litigation leads consumers to stop taking antipsychotics!

    If antipsychotic drugs weren't killing people, a survey paid for by Eli Lilly would be just something to laugh about--

    The headline reads: "New Survey Shows Product Liability Litigation May Jeopardize Treatment Outcomes For People With Severe Mental Illnesses"

    Scrolling down a bit one learns, "This survey was conducted by independent market research company Ipsos- Insight and commissioned by the National Council for Community Behavioral Healthcare and Lilly. The survey was funded by Lilly."

    If ever a "survey" was designed to promote its sponsor's maraketing ambitions --this is it! 402 psychiatrists who dutifully follow a paradigm of care promoted by the continuing medical education courses--Those courses are paid for and controlled by Big Pharma.

    Under industry's influence psychiatrists seem to have lost the ability to think: they have not stopped even to consider how this pradigm of care is inducing disabling chronic diseases and shortening their patients's lives. That is a fact reported by a government sponsored survey of 8 state mental health statistics: Mortality rate among consumers of mental health services is 25 years younger than other U.S. citizens.

    How can treating psychiatrists not notice that their patients are dying???

    The 402 psychiatrists are merely reiterating Eli Lilly's latest spin aimed at diverting attention from the drug-induced carnage.

    Here's the comment I posted on the MedicalNews website:

    This is Eli Lilly propaganda.

    It isn't the lawyers who scare mental health consumers. It's finding out what the serious, potentially lethal risks posed by Zyprexa and the other antipsychotics are.

    When consumers stop using a product because they learn about its lethal defective features--whether it's a defective car or defective prescription drug--those consumers are making an informed decision and they should be commended.


    New Survey Shows Product Liability Litigation May Jeopardize Treatment Outcomes For People With Severe Mental Illnesses Article Date: 14 Jun 2007

    Survey results released today shed light on a new barrier to treatment affecting people with severe mental illness. The findings show fears raised by product liability litigation involving antipsychotic drugs may be putting patients with schizophrenia and bipolar disorder at risk for relapse. These fears add to the already heavy burden that patients face as they work to manage symptoms, stay on their medication and work with their treatment providers to improve their mental and physical health.

    The survey, which was conducted among 402 psychiatrists who treat patients with schizophrenia and bipolar disorder, showed that, even when patients were responding well to their prescribed antipsychotic treatment, many requested a medication change because these drugs are featured in law firm advertisements. Other patients stopped taking their medication, often without telling their psychiatrist, for the same reason.

    "Many of our patients already struggle with accepting their illness and staying on their prescribed treatment, and now they are experiencing new levels of fear due to the increasing incidence of these jarring advertisements," said Dr. Ralph Aquila, assistant clinical professor of psychiatry, Columbia College of Physicians and Surgeons; director, residential community services, St Luke's-Roosevelt Hospital Center, New York, NY. "This irresponsible advertising is hindering the progress of therapy for many of these patients and disrupting the important relationship between them and their healthcare providers. Plaintiffs attorneys need to consider the consequences that these advertisements may have on patients." See rest: [Link]


    ~~~~~~~~~~~~~~~ [Link] Associated Press
    Eli Lilly: Drug Ads Influencing Patients
    TOM MURPHY


    (AP) - INDIANAPOLIS-Eli Lilly and Co., which has faced thousands of lawsuits over its anti-psychotic Zyprexa, says lawyers' ads about the drug are prompting some patients to stop taking mental illness medications when they shouldn't.

    The advertising blitz "presents yet another barrier for patients who suffer from severe mental illness" and increases the risks that people will not get the care they need, said Carole Puls, a spokeswoman for the Indianapolis-based drug maker.
    Lilly on Wednesday released the results of a company-funded survey that asked 402 psychiatrists who treat patients with bipolar disorder or schizophrenia to complete an online questionnaire. More than half of the participating psychiatrists said they believed their patients who stopped medication or reduced the dosage did so after seeing lawyers' advertisements about anti-psychotic drugs.

    Lilly has faced thousands of lawsuits over Zyprexa, which treats schizophrenia and bipolar disorder and generated $4.4 billion in sales last year. Most claims center on allegations that Zyprexa causes diabetes or high blood sugar and that labels on the drug failed to adequately warn users of the risks.

    The drug maker has spent about $1.2 billion to settle roughly 28,000 Zyprexa claims since 2005. Lilly said Tuesday it had settled an additional 900 claims but did not disclose a settlement amount.

    The company still faces product liability lawsuits from roughly 750 patients.

    Some of the lawyers' ads highlight the drug's side effects, while others note the amount Lilly has spent to settle lawsuits.

    The commercials have an "ambulance-chasing feel to them," said Linda Rosenberg, president and chief executive of the National Council for Community Behavioral Healthcare, which represents 1,300 behavioral healthcare organizations and helped design the survey. "All we're concerned about is getting patients talking to their doctors and not getting immediately frightened by an ad," she said.

    Reports about the dangerous side effects of certain drugs often don't address what happens when people stop taking them, said Dr. Nada Stotland, president-elect of the American Psychiatric Association. She was not involved in the Lilly study.

    Stotland said suicides rose and the number of people taking a group of common antidepressants fell a few years ago after the media reported that the U.S. Food and Drug Administration mandated severe "black box" warnings for the drugs. "You can't prove a cause-and-effect, but you can draw a pretty good hypothesis that there's a relationship between suicides going up and people not being treated for depression," she said.

    Attorney William Berg said his firm includes a disclaimer with each Zyprexa ad. "In all of our ads, we tell folks, 'Do not stop taking any medication without consulting your doctor,'" he said. Berg Injury Lawyers, based in Alameda, Calif., has represented more than 100 patients in lawsuits against Lilly. Berg said he runs the ads to let people know about their right to compensation if they experienced side effects that were not properly disclosed. "If we advertising lawyers don't tell people about their legal rights, who will? Eli Lilly sure isn't going to," he said.

    Allen Rothenberg, a Philadelphia attorney whose firm also represents Zyprexa patients, said Lilly withheld information from patients and doctors about the drug."What we do is we even the playing field for the individuals, for the people," he said.

    Puls said Lilly has made doctors aware of Zyprexa's side effects since the drug debuted in 1996.

    "Doctors have been kept fully aware of risks associated with Zyprexa, and we think they're the best ones to determine appropriate treatment, not plaintiffs' attorneys," she said. [Blog Comment: Indeed. Fully aware.]

    Lilly shares fell 53 cents to $56.78 Tuesday.

     
     
    admin

    In any case - Research shows schizophrenics NOT on antipsychotics more likely to recover

    July 11 2007, 12:14 PM 

    http://psychminded.co.uk/news/news2007/June07/people002.htm

    People with schizophrenia not taking antipsychotics more likely to recover, states research

    June 13, 2007
    by Angela Hussain

    People diagnosed with schizophrenia who are not on antipsychotics are more likely to experience recovery than those taking the medication, according to an American study.

    Over 15 years, schizophrenia patients not on antipsychotics showed more periods of recovery than those taking antipsychotics, states a research paper in last month’s Journal of Nervous and Mental Disease.

    Researchers reported that, after 10 years, 79% of patients on antipsychotics were psychotic, whereas 23% of those not on medication were psychotic. After 15 years, 65 per cent of patients on antipsychotics were psychotic, whereas only 28% of those not on medication were psychotic.

    The study’s authors - Martin Harrow and Thomas Jobe of the department of psychiatry at the University of Illinois in Chicago – concluded that “not all schizophrenia patients need to use antipsychotic medications continuously throughout their lives.”

    They stated that certain patient characteristics – such as a “favorable personality” – helped those not on medication to experience recovery.

    The study was on 145 patients - 64 diagnosed with schizophrenia, and a control of 81 patients who had another psychotic diagnosis, such as paranoid disorder.

    The research was part-funded by America’s National Institute of Mental Health.

    Read for yourself:
    Abstract of "Factors Involved in Outcome and Recovery in Schizophrenia Patients Not on Antipsychotic Medications: A 15-Year Multifollow-Up Study; Journal of Nervous and Mental Disease"

    Paper in full (external link):


     
     
    admin

    And people ON antipsychotics have SIGNIFICANT risk of metabolic & cardiac problems

    July 11 2007, 12:17 PM 

    http://bjp.rcpsych.org/cgi/content/abstract/191/1/23

    "Metabolic disease and cardiovascular risk in people treated with antipsychotics in the community

    Paul Mackin, PhD, MRCPsych, David Bishop, MRes, Helen Watkinson, BSc, Peter Gallagher, MPhil and I. Nicol Ferrier, MD, FRCPsych

    School of Neurology, Neurobiology and Psychiatry, University of Newcastle upon Tyne, UK

    Correspondence: Dr Paul Mackin, School of Neurology, Neurobiology and Psychiatry, University of Newcastle upon Tyne, Leazes Wing (Psychiatry), Royal Victoria Infirmary, Newcastle upon Tyne NE1 4LP, UK. Email: paul.mackin@ncl.ac.uk

    Declaration of Interest P.M., I.N.F. and P.G. have received honoraria for educational meetings from pharmaceutical companies. Funding detailed in Acknowledgements.

    Background Prevalence of physical comorbidity in severe mentalillness is a significant public health concern, but comparative data in people with diagnoses other than schizophrenia are sparse.

    Aims To investigate the prevalence of metabolic disease and cardiovascular risk in people with severe mental illness treated with antipsychotics in the community.

    Methods Case-control study of 90 people treated with antipsychotics in the community and 92 age- and gender-matched controls. The prevalence of metabolic syndrome and 10-year cardiovascular risk were calculated.

    Results People on antipsychotics had a significantly worse metabolic profile than controls (F=6.583, d.f.=15,161, P<0.0001). Moreover, metabolic syndrome was more prevalent (OR=3.68, 95% CI 1.71-7.93, P=0.001), as was cardiovascular risk across a number of outcomes. These results are consistent across diagnostic groups.

    Conclusions People with severe mental illness treated with antipsychotics have excess metabolic dysfunction and heightened risk for cardiovascular disease.


    Related articles in BJP:

    Highlights of this issue
    Sukhwinder S. Shergill
    BJP 2007 191: 2. [Full Text]  



    eLetters:

    Read all eLetters

    metabolic syndrome in patients with learning disabilities
    Padmaja Sivakumar
    BJP Online, 5 Jul 2007 [Full text] "

     
     
    admin

    But Marjorie Wallace of SANE still 'pleased' to see Invega-ANOTHER atypical antipsychotic

    July 13 2007, 11:41 AM 

    http://uk.biz.yahoo.com/02072007/250/new-treatment-schizophrenia-licensed-uk.html

    Tuesday July 3, 12:03 AM
    New Treatment for Schizophrenia Licensed in the UK

    SAUNDERTON, England, July 3 /PRNewswire/ --

    - ATTN: UK Editors Only

    Today, Janssen-Cilag Ltd has announced the authorisation of INVEGA(R) (paliperidone), a new treatment for schizophrenia.(1) Schizophrenia can have a major detrimental effect on people's personal, social and occupational lives leading to difficulty in daily living.(2) In clinical trials, people treated with paliperidone experienced reductions in the positive and negative symptoms of schizophrenia, as well as improvements in day-to-day personal and social functioning.(3)-(5)

    Paliperidone (prolonged-release tablets) is the first and only atypical antipsychotic treatment for schizophrenia to use the innovative OROS prolonged-release technology that provides a steady release of medicine over a 24-hour period.(6) The smooth release of medicine reduces fluctuations of drug levels in the blood(5) experienced with some other existing treatments for schizophrenia.

    [BLOG EDIT NOTE:  ITS AN ATYPICAL ANTIPSYCHOTIC, AS IS ZYPREXA etc, AND THE 'PROLONGED RELEASE' IS WHATS 'NEW' and 'INNOVATIVE' ABOUT IT]

    The once a day oral tablet which delivers smooth and constant medication release over 24 hours(6), offers a new treatment option for the one in 100 people in the UK who experience schizophrenia.(7),(8)

    National mental health advocacy organisations recognise the importance of new treatments for schizophrenia. "We are pleased that innovative delivery technologies are being applied to new treatments for schizophrenia," said Marjorie Wallace, Chief Executive at the mental health charity Sane "New treatment options such as Paliperidone are a significant opportunity for more people with schizophrenia to effectively manage their disease, working with their medical team to live more fulfilling and productive lives."

    The authorisation of paliperidone (prolonged-release tablets) is based on results of an extensive clinical development programme enrolling over 1,200 patients in 23 countries around the world as part of three pivotal studies.(3)-(5)

    Janssen-Cilag has been at the forefront of new advancements in mental health for over 50 years having launched Haldol in 1958, Risperdal Oral in the early 1980s and more recently, Risperdal Consta, a long-acting injectable antipsychotic.

    "Paliperidone is a new atypical antipsychotic with an innovative delivery system that can offer a more consistent release of medication," explained Dr. Helen Millar, Consultant Psychiatrist at the Carseview Centre, Dundee, Scotland. "Clinical trials have shown that paliperidone is effective and generally well tolerated. Effective treatments for people with schizophrenia are important in helping to improve everyday functioning."

    Worldwide, it is estimated that one person in every 100 develops schizophrenia, a serious type of mental illness, which can effect men and women equally, often appearing between the ages of 15-25 and 25-35, for men and women respectively.(7),(8) The disease may effect individual patients throughout their lives, with relapses being marked by positive symptoms (hallucinations, delusions and disorganised thinking) and negative symptoms (depression, blunted emotions and social withdrawal).(8)

    The costs of schizophrenia include direct costs (such as the costs of hospitalisation, drug costs, wages of healthcare professionals), and indirect costs (such as social security benefits and other social costs involved in supporting patients). The total direct treatment costs of schizophrenia in England and Wales are estimated to be in excess of GBP1 billion, or around 3% of the total NHS expenditure. Hospitalisations account for the majority of this expenditure (and for approximately 5% of total NHS inpatient expenditure), while drug costs account for 5% only of the direct costs of schizophrenia. Indirect costs of schizophrenia in the UK are estimated to be at least GBP1.7 billion.(9)

    Notes to Editor:

    INVEGA prolonged release tablets were developed by Johnson & Johnson Pharmaceutical Research and Development (J&JPRD). INVEGA prolonged release tablets have been authorised by the Food and Drug Administration since December 2006 and is marketed by Janssen, L.P. in the United States. Upon authorisation by the European Commission, INVEGA prolonged release tablets will be marketed in Europe by the Janssen-Cilag companies.

    Janssen-Cilag Ltd (www.janssen-cilag.co.uk), manufacturer of Risperdal(R) Consta(TM), Risperdal(R) (risperidone) and Risperdal(R) Quicklet(TM) is part of the Johnson & Johnson (NYSE: JNJ - news) family of companies, a leading research-based pharmaceutical company, with more than 110,000 employees worldwide and establishments in approximately 50 countries.

    References:

    (1). Summary of Product Characteristics of INVEGA (paliperidone) prolonged-release tablets, May 2007.

    (2). The National Institute of Clinical Excellence. Schizophrenia - Full national clinical guideline on core interventions in primary and secondary care. 2003

    (3). Marder S, et al. A 6-week US-based placebo-controlled study on the efficacy and tolerability of two fixed dosages of oral paliperidone extended-release tablets in the treatment of acute schizophrenia. Poster presented at APA May 2006; Toronto, Canada, 20-25.

    (4). Davidson M. et al. Efficacy (EFCY.PK - news) , safety and early response of paliperidone extended-release tablets (paliperidone ER): Results of a 6-week, randomized, placebo-controlled study. Schizophrenia Research. 2007: 93; 117 130.

    (5). Kane J, et al. Treatment of schizophrenia with paliperidone extended-release tablets: A 6-week placebo-controlled trial, Schizophrenia Research. 2006: 90; 147-161.

    (6). Karlsson P, et al. Pharmacokinetics, and dopamine D2 and serotonin 5-HT2A receptor occupancy and safety profile of paliperidone extended-release in healthy subjects. Poster presented at WWS; Davos, Switzerland, (5)-11 February 2006.

    (7). http://www.patient.co.uk/showdoc/23069111/: (last updated November 2006)

    (8). Lehman AF, et al. American Psychiatric Association. Practice guidelines for the treatment of patients with schizophrenia, second edition. Am J Psychiatry. 2004 Feb;161(2 Suppl):1-56.

    (9). The National Institute of Clinical Excellence. Guidance of the use of newer (atypical) antipsychotic drugs for the treatment of schizophrenia. June 2002. "


     
     
    admin

    Despite 'INVEGA' having the same deadly side effects as all other atypical antipsychotics

    July 13 2007, 12:31 PM 

    {Editing Note:  When a company calls a psych drug 'new' - they mean the same but with a slight difference.  In this case the drug is the same:   see FDA info sheet below "...Elderly patients with dementia who are treated with atypical antipsychotics, such as Invega...",    but its 'new' because its prolonged release. 

    There's nothing 'new' about Invega's potentially deadly risks, but that doesn't deter front groups such as SANE and the spokespersons of those front groups - in this case SANE's  Marjorie Wallace (who married an aristocratic psychiatrist) from their enthusiasm and active promotion of the drug.  Front groups are VERY EFFECTIVE in purporting to act in the interest of patients while promoting drugs with potentially deadly risks FOR those patients.  Wallace of SANE was last year involved in a 'schizophrenia awareness' campaign called 1 in 100 sponsored by Janssen-Cilag.  It was an extremely successful marketing tactic - Janssen-Cilag have just had their antipsychotic approved in the UK. 

    [NEW SCHIZOPHRENIA CAMPAIGN LAUNCHED AT THE HOUSE OF COMMONS
    27 July 2006   SANE's chief executive, Marjorie Wallace, and head of strategy, Margaret Edwards attended the launch of a new 1 in 100 educational initiative at the House of Commons on 11 July. 1 in 100 aims to promote choice through knowledge, by providing comprehensive information to people experiencing schizophrenia, their families and friends. Entitled, ‘The Picture’s Looking Brighter’, the new campaign sponsored by Janssen-Cilag UK also looks to support a more positive view on schizophrenia...] }

     

    BACK TO THE FAMILIAR SIDE EFFECTS OF ATYPICAL ANTIPSYCHOTICS - this particular information sheet is for INVEDA, deadly effects brought to you by Janssen-Cilag:


    http://www.fda.gov/Cder/drug/InfoSheets/patient/paliperidonePIS.htm

    Patient Information Sheet
    Paliperidone (marketed as Invega)

    PDF Print Version PDF

    This is a summary of the most important information about Invega.  For details, talk to your healthcare professional.

    What Is Invega?

    Invega Extended- Release Tablets are used to treat schizophrenia.  Invega is an atypical antipsychotic medicine. 

    Who Should Not Use Invega?

    You should not take Invega if you are allergic to paliperidone, risperidone or to any of the ingredients in Invega.

    What Are The Risks?

    The following are the major potential risks and side effects of Invega therapy. However, this list is not complete.

     

    • Increased chance of death and strokes in elderly patients with dementia. Elderly patients with dementia who are treated with atypical antipsychotics, such as Invega, have a higher chance for death than patients who do not take these medicines. Invega is not approved to treat dementia.

     

    • QT prolongation (a serious heart problem). Talk to your healthcare professional if you have or had any heart problems. 

      

    • Neuroleptic malignant syndrome (NMS), a life-threatening nervous system problem. NMS can cause a high fever, stiff muscles, sweating, a fast or irregular heart beat, change in blood pressure, and confusion. NMS can affect your kidneys. NMS is a medical emergency. Get medical help right away if you have these symptoms.

     

    • Tardive dyskinesia (TD), a movement problem.  Uncontrollable, slow or jerky facial or body movements that may not go away. Call your healthcare professional right away if you get muscle movements that cannot be stopped.

     

    • High blood sugar and diabetes. These side effects may even lead to death in some patients.  Patients with diabetes or those who have a higher chance for diabetes should have their blood sugar checked often. 

     

    • Dizziness and fainting, caused by a drop in blood pressure may happen with Invega, especially when you first start taking this medicine or when the dose is increased.  Get up slowly when sitting or lying down.

     

    • Impaired judgment, thinking, or motor skills. You should be careful when driving or using machines until you know how Invega affects you.

     

    • Overheating and dehydration.  Invega may make you more sensitive to heat. You may have trouble cooling off, or be more likely to become dehydrated.  Be careful when exercising or doing activities in the heat.

     

    • Other serious side effects may include: seizures, trouble swallowing, suicide, an erection that does not go away, and fever and bruising (thrombotic thrombocytopenic purpura).

     

    • Some common side effects with Invega include: restlessness, involuntary movements, tremors and muscle stiffness, fast heart beat, headache, sleepiness, anxiety, dizziness, upset stomach and nausea.

    What Should I Tell My Healthcare Professional?

    Before you start taking Invega, tell your healthcare professional if you:

    • have or had heart problems
    • have or have had seizures
    • have or had diabetes or increased blood sugar
    • have or had liver disease
    • have or had problems with your esophagus, stomach or small or large intestine
    • drink alcohol
    • are pregnant, trying to become pregnant, or are breast-feeding.

    Invega has not been studied in children under 18 years of age.

    Can Other Medicines Or Food Affect Invega?

    Invega and certain other medicines can interact with each other. Tell your healthcare professional about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.  Invega may affect how your other medicines work.  Know the medicines you take. Keep a list of them with you to show your healthcare professional.

    Especially tell your healthcare professional if you take:

    • blood pressure medicines
    • levodopa and medicines called dopamine agonists

    Avoid drinking alcohol while taking Invega.

    How Should I Take Invega?

    • Take Invega once a day in the morning.
    • Swallow Invega tablets whole with water or other liquid. Do not chew, divide, or crush Invega tablets.
    • Invega can be taken with or without food.
    • The tablet shell will pass though your body and you may see it in your stool.

     

    Link to Invega's Approved Labeling PDF document

    Back to Top     Back to Drug Index

    PDF requires the free Adobe Acrobat Reader

    Date Approved:  December 19, 2006

    Date created: March 30, 2007"

     

     

    There are many people who don't know they have 'mild' cardiac or  liver problems, elevated blood sugar levels, etc as the symptoms can be 'silent' until they hit or are aggravated more obviously.  How are those patients to tell their 'Health Professional' they have a disorder?  Why are doctors not instructed to do thorough tests BEFORE prescribing drugs like these - they are the only ones who CAN test, the patient can't.

     

    PLUS one of the signs of Neuroleptic Malignant Syndrome (as it is also with the very similar Serotonin Syndrome from SSRI/SNRIs) is "CONFUSION", as the drug regulators well know,  alongside high fever (which can cause delirium) etc.  People that PHYSICALLY ILL  don't necessarily understand whats happening, and so the odds of them 'getting medical help right away' are not certain by any means - so who will help those who live on their own as its often someone ELSE who sees how ill the patient is?

    THE RESPONSIBILITY LIES WITH THE REGULATORS AND THE PRESCRIBERS

    THE DRUGS SHOULD NOT BE ON THE MARKET IN THE FIRST PLACE! 


     
     
    admin

    Clinical Guide for Psychs on Managing the Metabolic Abnormalities they give their patients

    July 13 2007, 10:01 PM 

    OK, so I got the title SLIGHTLY wrong (just seems a more honest title to me).

    I wonder if the book also covers a chapter on:

    "How to avoid serious, life-threatening, metabolic abnormalities AND help the patient with 'schizophrenia' to recover from the diagnosed mental illness by NOT prescribing antipsychotics in the first place". 

     

    http://psychservices.psychiatryonline.org/cgi/content/full/58/7/1018

    Managing Metabolic Abnormalities in the Psychiatrically Ill: A Clinical Guide for Psychiatrists

    edited by Richard A. Bermudes, M.D., Paul E. Keck, M.D., and Susan L. McElroy, M.D.; Arlington, Virginia, American Psychiatric Publishing, Inc., 2006, 326 pages, $49 softcover

    Brian B. Sheitman, M.D.

    This volume addresses an extremely important topic for psychiatrists given that many of the medications available for patients with severe mental illness have considerable risk of inducing or worsening weight gain, dyslipidemias, and diabetes mellitus, all risk factors for cardiovascular disease. Furthermore, it is very timely in light of the recent report from the National Association of State Mental Health Program Directors that patients with severe mental illness die, on average, a startling 25 years earlier than patients without these illnesses, with most of this difference because of medical causes.

    The authors, distinguished researchers and experts in their field, divided the book into nine chapters. Chapters 1, 2, and 5 provide an excellent review and update on diabetes, the metabolic syndrome, and cardiovascular disease, respectively. Chapters 3 and 4 review the literature on the overlap of severe mental illness and obesity and diabetes mellitus, respectively. Chapters 6, 7, and 8 focus on the effects of antipsychotic medications on weight gain, glucose metabolism, and serum lipids. Chapter 9, titled "Metabolic Risk Assessment, Monitoring and Interventions: Translating What We Have Learned Into Clinical Practice," then attempts to synthesize this information.

    The clear strength of this volume is the very scholarly literature reviews presented on each of the topics. At the end of the chapters I felt that I had a good grasp of the relevant literature. Furthermore, the reviews of obesity, diabetes, and cardiovascular disease are written in a very readable manner.

    Where the book falls somewhat short of expectations is in not meeting one of the stated objectives, which is to address "the unmet need of the lack of integration of general medical care with psychiatric care, and the related problems of barriers to collaboration and communication among health care providers." Although the authors acknowledge that there is some disagreement among psychiatrists about whose responsibility it is to monitor the general medical conditions of people with mental illnesses, there is an absence of discussion about what the specific issues are and possible collaborative models. I suspect that this may reflect a gap in the research literature because the style of the book is congruent with a research review of the topic.

    Overall, I think this volume is well worth reading. The specific topics are extremely relevant for the practicing psychiatrist. Though 326 pages long, the book is a relatively quick, easy, and painless read. Given the published literature reviewed, it is becoming increasingly clear that what tardive dyskinesia was for the older antipsychotics, metabolic abnormalities are for the atypical antipsychotics. This book not only helps us make sure that we are aware of the issues, but it also provides us with practical aids to monitor for these serious medical conditions. "



     
     
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