Omega-3s Help Fight Schizophrenia, Huntington’s, and Other Nervous-System

January 11, 2010 by joel  
Filed under Health

January 11, 2010

Natural News

By S.L. Baker

Research just published in the journal Behavioral Neuroscience provides evidence that adequate omega-3 fatty acids are needed for healthy nervous systems. That could explain why low levels of omega-3s are associated with the information processing difficulties experienced by people with bipolar, obsessive-compulsive, and attention-deficit hyperactivity disorders; schizophrenia; Huntington’s disease and other illnesses affecting the nervous system. What’s more, this research suggests that increasing dietary omega-3s may be a natural way to prevent and treat those conditions.

Scientists at the Laboratory of Membrane Biochemistry and Biophysics at the National Institute on Alcohol Abuse and Alcoholism studied two forms of omega-3 essential fatty acids found in certain foods including fatty fish and some algae: docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA). The human body can only acquire these key nutrients by metabolizing their precursor, linolenic acid (LNA), or from foods or dietary supplements with DHA and EPA in a readily usable form.

EPA has been shown in numerous previous studies to have anti-inflammatory and cardiovascular protective effects DHA, although less studied, is also crucial to the body. In fact, it makes up more than 90 percent of the omega-3s in the brain, retina and the nervous system.

For their study, the research team fed four groups of pregnant mice and their offspring four different diets with no or varying types and amounts of omega-3s. Then, after the newborn mice grew into mature animals, the scientists recorded how they responded when exposed to a sudden loud noise.

This classic test of nervous-system function normally makes healthy animals flinch. However, if animals with a normal nervous system are exposed first to a softer tone before the loud one, they flinch much less. Scientists believe that’s due to an adaptive process known as sensorimotor gating which causes an initial stimulus to prepare the body for future stimuli.

The results of the tests showed that only the mice raised on DHA and EPA, but not their precursor of LNA, demonstrated normal, adaptive sensorimotor gating. These healthy animals responded in a significantly calmer way to loud noises if they had first heard softer tones. The mice in all other groups, however, were startled almost as much by the initial soft sound as by the loud noise that followed.

The reason? The scientists concluded that when DHA was deficient the nervous system was in an abnormal state that left the animals almost constantly startled and easily overwhelmed by sensory stimuli. “It only takes a small decrement in brain DHA to produce losses in brain function,” lead researcher Norman Salem Jr., PhD. said in a statement to the media.

The researchers think this important information may be very significant for humans — because weak sensorimotor gating is a hallmark of many nervous-system problems including Huntington’s disease, schizophrenia and bipolar disorder. And they’ve suggested that omega-3s could have therapeutic potential for these and other diseases marked by nervous system problems.

Moreover, the research underlines the dangers of the typical American diet of processed foods and lots of meat — making it far higher in omega-6 fatty acids than omega-3s. That imbalance reduces the body’s ability to incorporate omega-3s and, as a result, “we have the double whammy of low omega-3 intake and high omega-6 intake,” stated Dr. Salem. “It is an uphill battle now to reverse the message that ‘fats are bad’ and to increase omega-3 fats in our diet.”

Editor’s note: NaturalNews is opposed to the use of animals in medical experiments that expose them to harm. We present these findings in protest of the way in which they were acquired.

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Top Scientists Predict Widespread Sterilization

December 29, 2009 by Andrew  
Filed under Health

December  27, 2009

The Times Online

By Bryan Appleyard

Nothing much is going to happen in the next 10 years. Of course, that’s not counting the diesel-excreting bacteria, the sequencing of your entire genome for $1,000, massive banks of frozen human eggs, space tourism, the identification of dark matter, widespread sterilisation of young adults, telepathy, supercomputer models of our brains, the discovery of life’s origins, maybe the disappearance of Bangladesh and certainly the loss of 247m acres of tropical forest.

As I said, just another decade really.

These days, “just another decade” always means 10 years of future shock. Science, technology and the contemporary mania for change combine to stun the imagination. It is the way we live now, in a condition of permanent technological revolution.

In 2000 — remember? — the internet all but died when the dotcom stock market bubble burst. You could stand on top of the World Trade Center. And mobile phones were just, er, phones. Today, you still get up and eat breakfast, but, outside, it’s a different world.

Next? Well, as Woody Allen said, if you want to make God laugh, tell him your plans for the future. But, taking a punt, I reckon the brain is the one to watch. Science has been zeroing in on the 2lb 14oz of grey and white custard-like stuff between your ears for some time now. It’s not been easy. In spite of the evidence of The X Factor, the human brain is very complex custard indeed. But some people are getting very excited.

“By 2020, genetics and brain simulation will be giving us personalised prescriptions for marriage, lifestyle and healthcare.” This is Henry Markram, director of the Blue Brain project in Switzerland, an attempt to reverse engineer the brain by building one from the ground up inside a supercomputer.

“We won’t need a psychologist to tell us why we feel unhappy. All we’ll need to do is log into a simulation of our own brain, navigate around in this virtual copy and find out the origins of our quirks … Computers will look at a virtual copy of our brains and work out exactly what we need to stop our headaches, quiet the voices talking in our heads and climb out of the valley of depression to a world of colour and beauty.”

Gosh. But isn’t there still that pesky problem of other people and their brains? It’s their quirks that tend to get in the way of my happiness. No problem, we can climb inside each other’s brains.

“The big thing for me is being able to link two brains together for communication.” This is Kevin Warwick, a cybernetics scientist at Reading University. “This could have great implications for teaching. Sometimes, no matter how you explain something, it takes forever for the penny to drop.

It would also help to avoid misunderstandings.”

But, eek, what would it be like?

“Well, just like The Matrix with a plug in the back of the head into the brain, or yes, like a Bluetooth earpiece. It would have to be bidirectional, though, so thoughts could travel from you to someone else and back,” says Warwick, who has already implanted a microchip in his own arm so that he can open doors without needing to use a doorknob.

James Watson, co-discoverer of the structure of the DNA molecule, thinks gene sequencing will be the key to unlock the custard and even stir it. “Disorders like Alzheimer’s disease, epilepsy, Parkinson’s disease, schizophrenia, bipolar disease, unipolar depression, obsessive-compulsive disease, attention deficit disorder and autism will finally have their genetic guts open for all to see.”

Some of the most impenetrable and harrowing mental illnesses known to man will, Watson believes, be understandable and maybe even curable.

“The exact location and biological function of the DNA variants causing many depressive disease and related disorders cannot be revealed too soon,” he says.

Colin Blakemore, professor of neuroscience at Warwick and Oxford, agrees that brain diseases are the really big nasties. “Some leave sufferers horribly aware as they lose the ability to walk, to talk, to swallow. Others corrupt and destroy the mind, leaving an empty body. Some, such as CJD, are very rare, others frighteningly common. About 700,000 people in the UK have dementia.”

We are seeing more of these diseases because death rates from cancer and heart disease are falling so people are living long enough to develop them. Hope for cures is coming from stem-cell research, genetic and molecular analysis.

“There will be a breakthrough. My hunch is that research on motor neurone disease will provide crucial clues and by 2020 we will know why cells die in some, perhaps many, of these diseases. It could be another decade before we see the impact on health, but by 2020, we must be on the way to this ultimate goal of modern medical science,” says Blakemore.

Meanwhile, sex — you knew it was coming — will be even more recreational than it is now. The pill will continue to be the primary contraceptive device, says its inventor, Carl Djerassi, but sterilisation will be catching up.

“At present, people tend to have children and then are sterilised later on in life. In the future, sterilisation will happen earlier on in a person’s life, with gametes, male and female, extracted and stored in a reproductive bank account… Already we know that male sperm can be frozen for decades, but it is far more difficult to freeze women’s eggs. The problem is not yet solved — this is where research should be directed.”

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Happy Daze – Antidepressant Drugs Keeping you in”Drug-Induced State’

November 23, 2009 by Andrew  
Filed under Health

November 23, 2009

Natural News

By David Gutierrez

Contrary to the impression promoted by the psychiatric and drug industries, psychiatric drugs do not work by correcting a chemical imbalance in the brain, Joanna Moncrieff of University College London wrote recently in an opinion piece for the BBC. Instead, such drugs merely put people into “drug-induced states” that make it harder for them to experience the symptoms of their illness.

“Magazines, newspapers, patients’ organizations and Internet sites have all publicized the idea that conditions like depression, anxiety, schizophrenia and bipolar disorder can be treated by drugs that help to rectify an underlying brain problem … just like a diabetic needs to take insulin,” Moncrieff writes. “The trouble is, there is little justification for this view.”

Moncrieff notes that prior to the 1950s, mental health workers largely saw antidepressants as psychoactive drugs, primarily sedatives, that eased the symptoms of depression without addressing the underlying cause – much as over-the-counter cold drugs may stop a runny nose without affecting the cold virus. This view was eventually replaced by the idea that depression, schizophrenia, anxiety and other mental health conditions result from chemical imbalances in the brain, imbalances that can be corrected by the right “magic bullet.”

“However, this transformation was not based on any compelling evidence,” she says.

Moncrieff holds to the older view, that “drugs used in psychiatry are psychoactive drugs, like alcohol and cannabis. They affect everyone, regardless of whether they have a mental disorder or not.”

Antipsychotics, she notes, mute people’s emotions and thoughts, which can reduce the effects of psychosis as a side effect. Anti-anxiety drugs are central-nervous system depressants, like alcohol.

“If you told people that we have no idea what is going on in their brain, but that they could take a drug that would make them feel different and might help to suppress their thoughts and feelings, then many people might choose to avoid taking drugs if they could,” she writes. “People need to make up their own minds.”

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Unnecessary Psychotic Drugs Being Prescribed to Dementia Patients

November 13, 2009 by Brandy  
Filed under Health

November 13, 2009

Telegraph

Only around 36,000 of the 180,000 people on the drugs in the UK derive any benefit from them, it said.

Overprescribing of the drugs is linked to an extra 1,800 deaths a year among elderly people.

Phil Hope, the care services minister, promised to crack down on the practice, including appointing a new national clinical director for dementia.

He also promised measures to ensure more use of psychological therapies rather than relying on drugs.

Anti-psychotic medicines are licensed to treat people with schizophrenia and are used off-licence for dementia patients in care homes and hospitals.

In his review, Sube Banerjee, professor of mental health and ageing at the Institute of Psychiatry at King’s College London, said the rate of use of anti-psychotic drugs could be cut to one third of its current level with appropriate action.

He said this could be done safely over three years.

Jeremy Wright, chairman of the All Party Parliamentary Group on Dementia, called for more training to be given to care home staff and for greater involvement of the patient’s family and friends over the decision on whether to prescribe.

He told BBC Radio 4’s Today programme: “We need to give people other ways of avoiding the problem and that means making sure staff who work in care homes are properly trained in dementia.

“We need to involve family members and friends and loved ones much more in the decision to prescribe and the decision to keep prescribing these drugs.”

He added: “If we can deal with training, if we can deal with regular reviews and if we can involve family and friends much more often, we will start to reduce the incidence of this very widespread over-prescription.”

Nadra Ahmed, chairman of the National Care Homes Association, said the blame did not lie solely with care homes.

She explained it was GPs who made the decision to prescribe dementia sufferers with anti-psychotic drugs.

She told the programme: “One of the things we need to get absolutely clear here is these drugs are prescribed by general practitioners, they are not prescribed by the care home providers. This is about medical conditions which are obviously reviewed by GPs.

“We have clients who come into our homes, sometimes already on these drugs and actually very good providers do tend to use their initiative and try to manage the conditions and wean people off drugs.

“Very often what happens is that GPs are just not giving us enough time in our services to come and review the medication and people can be on this medication and once they’re on it, people, quite rightly, are reluctant to take them off.”

She also rejected claims that some care home providers sedate dementia sufferers as it makes them easy to manage.

There are around 700,000 people with dementia in the UK. That figure is expected to soar in the coming decades as life expectancy lengthens.

Rebecca Wood, chief executive of the Alzheimer’s Research Trust, said: “It’s critical that the dangers of wrongly-prescribed anti-psychotics are understood and Government action is taken to prevent putting more people at risk.

“Alzheimer’s Research Trust scientists at the Institute of Psychiatry are investigating alternative safer means of reducing agitation among dementia patients.

“We must urgently develop safe and effective treatments for people with dementia.

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Dementia Drug Use Killing Many

November 13, 2009 by Andrew  
Filed under Health

November 13, 2009

BBC News

By Nick Triggle

Needless use of anti-psychotic drugs is widespread in dementia care and contributes to the death of many patients, an official review suggests.

About 180,000 patients a year are given the drugs in care homes, hospitals and their own homes to manage aggression.

But the expert review – commissioned by ministers – said the treatment was unnecessary in nearly 150,000 cases and was linked to 1,800 deaths.

The government in England has agreed to take steps to reduce use of the drugs.

These include:

* Improving access to other types of therapy, such as counselling
* Better monitoring of prescribing practices
* Guidance for families explaining what they can do if they are worried about drug use
* Specialist training in dementia for health and social care staff
* Appointment of a new national director for dementia to oversee the measures

The review – and the government pledge to take action – comes after long-running concerns about the use of anti-psychotic drugs.

Over the past 30 years, the NHS has increasingly turned to the treatment, which was originally aimed at people with schizophrenia, as it has struggled to cope with the rise in people with dementia.

‘Different mindset’

There are currently 700,000 people in the UK with the condition, but this is expected to rise to one million in the next 10 years because of the ageing population.

The review, led by King’s College London expert Professor Sube Banerjee, accepted that for some people anti-psychotic drugs would be necessary.

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Psychiatric Meds in Children Leading to Rapid Weight Gain

October 29, 2009 by Andrew  
Filed under Health

October 27, 2009

U.S News

By Nathan Seppa, Science News

Many young children and adolescents taking drugs for severe psychiatric problems gain substantial weight and, in some cases, show increased levels of LDL cholesterol and triglycerides in their blood, researchers report in the Oct. 28 Journal of the American Medical Association.

Although the data from this study need to be replicated over a longer time frame, the findings nonetheless raise worrisome questions about anti-psychotic drugs that often benefit children who have schizophrenia, autism, tics, severe bipolar disorder or aggressive behavior.

“We are between a rock and a hard place here,” says study coauthor Christoph Correll, a psychiatrist at the Zucker Hillside Hospital in Glen Oaks, N.Y. These mental disorders are severe and can lead to suicide or to educational problems and emotional scars, he says. On the other hand, weight gain during youth predisposes an individual to chronic health problems later in life, he says.

Weight gain has been noticed before in children and adolescents taking commonly prescribed drugs for severe psychiatric problems. But studies seeking to link that weight gain to the medications were often muddied because patients had taken one of the drugs beforehand at some point—and may have already put on weight from it or reset their body metabolism to adjust to the drug somehow.

In the new study, Correll and his colleagues monitored 272 children, ages 4 to 19, between 2001 and 2007. Of these, 257 were getting psychotropics for severe problems for the first time, and 15 others refused the drugs but agreed to be seen by a doctor. The drugs were olanzapine (Zyprexa), quetiapine (Seroquel), risperidone (Risperdal) or aripiprazole (Abilify). Restricting the study to first-timers eliminated problems encountered in earlier studies.

After a median follow-up period of nearly 11 weeks, these patients had gained 10 to 19 pounds on average, depending on the drug. Kids on Zyprexa gained the most, on average, while those taking Abilify gained the least. The 15 patients who had refused drug treatment gained less than one pound on average during the monitoring period.

The pace of weight gain seems to level off over time, Correll says, but further study will be needed to clarify that trend.

“This is a really good study of relatively short-term effects,” says Christopher Varley, a child psychiatrist at the University of Washington School of Medicine and Seattle Children’s Hospital. But longer-term data are needed, he says, “because you never really treat a kid with one of these conditions for only 12 weeks—it’s more like six to nine months or a year or two.”

Correll’s team intends to monitor as many of the patients as possible over a longer time period.

Child psychiatrist Linmarie Sikich of the University of North Carolina at Chapel Hill School of Medicine says that she and her colleagues have seen many patients lose weight after coming off these drugs. So far, researchers don’t have enough data to clarify why some patients lose the weight and others don’t, she says.

The biological mechanism underlying the weight gain also remains obscure, Varley says. But some effects are evident, such as carbohydrate cravings. “The appetite of these youngsters dramatically goes up,” he says. At the same time, the drugs have a mild sedative effect. “They’re not out running around, expending calories.”

Sikich says some evidence suggests that the drugs may block the body’s satiety signal.

Meanwhile, patients in this study taking Zyprexa showed increased LDL cholesterol and triglycerides, types of fat in the blood. Patients getting Seroquel also had higher triglycerides. The other drugs showed little change in these metabolic markers.

“This does leave a difficult decision, but I think we’re getting increasing guidance,” Sikich says. Clinicians would prefer to prescribe the drugs with the mildest side effects, she notes.

While all four drugs are cleared for adults, the U.S. Food and Drug Administration has specifically approved only Abilify and Risperdal for pediatric use thus far. Earlier this year, a panel of experts recommended that the FDA approve all four drugs for certain severe psychiatric problems in children. The regulatory body has yet to rule on that.

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Court Doccuments Reveal Psych Drugs Misused on Children

October 28, 2009 by JP  
Filed under Health

October 28, 2009

Natural News

By David Gutierrez

Internal documents acquired as part of a series of lawsuits show that pharmaceutical giant AstraZeneca planned as early as 2001 to market its antipsychotic drug Seroquel for uses not approved by the FDA.

Under U.S. law, drug makers are prohibited for marketing their drug for any use not approved by the FDA. Doctors are still permitted to prescribe drugs, however, for any use they wish.

Seroquel (generic name quetiapine) was approved for the treatment of psychotic disorders in adults in 1997. In 2001, the FDA extended this approval to cover schizophrenia. In 2004, it was approved for use of bipolar mania, and in 2006 it was approved for bipolar disorder.

Yet AstraZeneca is now the defendant in thousands of lawsuits claiming, among other allegations, that the company actively marketed the drug for use in children and adolescents, and also sought to market it as a treatment for dementia in the elderly.

In some of the retrieved documents, AstraZeneca employees and employees of a consulting firm hired by the company reference plans to “broaden Seroquel use on- and off-label,” specifically mentioning adolescents and people suffering from Alzheimer’s or Parkinson’s disease. Areas where the company could promote this use are listed, including sales calls and meetings with medical professionals or patient advocacy groups.

In a 2001 public relations plan, the company says that it seeks to “encourage and support [Seroquel] use outside schizophrenia into a broad range of other patient populations including bipolar disorder and the elderly.” The document calls for “aggressive market penetration” of the drug in the demographics of adolescents, the elderly and bipolar patients.

This came five years before the drug’s approval as a treatment for bipolar disorder. To date, the drug has never been approved for use in children, adolescents or patients with dementia or Parkinson’s disease.

AstraZeneca has applied for FDA approval to use Seroquel as a treatment for adolescent schizophrenia and acute bipolar mania in children and adolescents. No antipsychotic drugs have yet been approved for use in children, as there is nearly no evidence on their safety or effectiveness in that population.

The Seroquel lawsuits are only one of a number of recent scandals in which pharmaceutical giants have been accused of illegally promoting off-label drug use. Eli Lilly recently agreed to pay a $1.42 billion settlement to end charges that it promoted its antipsychotic Zyprexa (olanzapine) off-label.

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Antipsychotics Cause Weight Gain in Kids

October 28, 2009 by JP  
Filed under Health

October 28, 2009

U.S. News

By Nathan Seppa

Many young children and adolescents taking drugs for severe psychiatric problems gain substantial weight and, in some cases, show increased levels of LDL cholesterol and triglycerides in their blood, researchers report in the Oct. 28 Journal of the American Medical Association.

Although the data from this study need to be replicated over a longer time frame, the findings nonetheless raise worrisome questions about anti-psychotic drugs that often benefit children who have schizophrenia, autism, tics, severe bipolar disorder or aggressive behavior.

“We are between a rock and a hard place here,” says study coauthor Christoph Correll, a psychiatrist at the Zucker Hillside Hospital in Glen Oaks, N.Y. These mental disorders are severe and can lead to suicide or to educational problems and emotional scars, he says. On the other hand, weight gain during youth predisposes an individual to chronic health problems later in life, he says.

Weight gain has been noticed before in children and adolescents taking commonly prescribed drugs for severe psychiatric problems. But studies seeking to link that weight gain to the medications were often muddied because patients had taken one of the drugs beforehand at some point — and may have already put on weight from it or reset their body metabolism to adjust to the drug somehow.

In the new study, Correll and his colleagues monitored 272 children, ages 4 to 19, between 2001 and 2007. Of these, 257 were getting psychotropics for severe problems for the first time, and 15 others refused the drugs but agreed to be seen by a doctor. The drugs were olanzapine (Zyprexa), quetiapine (Seroquel), risperidone (Risperdal) or aripiprazole (Abilify). Restricting the study to first-timers eliminated problems encountered in earlier studies.

After a median follow-up period of nearly 11 weeks, these patients had gained 10 to 19 pounds on average, depending on the drug. Kids on Zyprexa gained the most, on average, while those taking Abilify gained the least. The 15 patients who had refused drug treatment gained less than one pound on average during the monitoring period.

The pace of weight gain seems to level off over time, Correll says, but further study will be needed to clarify that trend.

“This is a really good study of relatively short-term effects,” says Christopher Varley, a child psychiatrist at the University of Washington School of Medicine and Seattle Children’s Hospital. But longer-term data are needed, he says, “because you never really treat a kid with one of these conditions for only 12 weeks — it’s more like six to nine months or a year or two.”

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Prescribing the Prescribed Drugs?

September 8, 2009 by Andrew  
Filed under NWO

September 4, 2009

BBC News

By Patrick Jackson

About one in every hundred people faces being diagnosed with schizophrenia at some stage in their life.

Probably the last thing they and their families want to be told is that there are questions over the quality of the treatment on offer.

But there is concern in the US that drug companies have been influencing psychiatrists over what anti-psychotic drugs to prescribe.

Dr Herbert Meltzer, who pioneered the use of clozapine in America, passionately denies such interference is the norm.

He was challenged by US medical journalist Robert Whitaker over the need for medication at all when the two debated on the BBC’s World Today programme.

‘Cherry-picking’

Whitaker pointed to academic studies in Vermont and Illinois as evidence that too many schizophrenia patients are kept on medication for too long.

In the Vermont case, patients discharged in the 1950s and 1960s were studied 30 years on.

Dr Courtenay Harding determined that one-third had completely recovered and all of those ex-patients had stopped taking anti-psychotic drugs.

“You need a paradigm of care which recognises that some percentage of patients would do better off medication and that should be built into the system,” Whitaker concluded.

Suggesting the journalist was “cherry-picking” academic studies, Meltzer warned against making generalisations based on the Harding study “because there was no evidence that these people needed medication to begin with”.

Acknowledging that psychotic symptoms might diminish in time because of biological changes in the brain, he pointed out that schizophrenia was “not just a disease of delusions and hallucinations [but] a disease of cognition”.

Without medication, Meltzer said, there was no possibility of recovery from this cognitive impairment.

‘Losing faith’

Controversy over alleged conflicts of interest has been dogging the world of US psychiatry:

• In July of last year, Senator Charles Grassley demanded clarity over the finances of the American Psychiatric Association (APA)

• The US Department of Health and Human Services is investigating payments to the former head of Emory University’s psychiatry department, Charles Nemeroff

• Harvard University is conducting an internal investigation into psychiatry professor Joseph Biederman, who is accused of failing to disclose payments from drug companies in full

Robert Whitaker suggests the American public is “losing faith in psychiatry as an honest profession”.

“What has happened over the past 30 years is that the academic psychiatrists now receive money from the drug companies through a lot of channels: they are members of speaker bureaus, they act as consultants, they are on advisory boards,” said the author of Mad in America: Bad Science, Bad Medicine, and the Enduring Mistreatment of the Mentally Ill.

“I do think there is an incredible crisis for psychiatry right now in American society because we do not believe what we are told.”

Herbert Meltzer accepted that some pharmaceutical companies had encouraged over-treatment in the past, and that there had been instances of “bad apples” in the industry.

But if exaggerated claims had been made for some anti-psychotic drugs, they had not been made by pharmaceutical industry publications, he insisted.

“I am responsible for the atypical anti-psychotic drugs and I never made a penny in terms of the profit from bringing forward the models that led to the profusion of drugs in that era,” he added.

Meltzer contended that there would be no effective psychotropic treatments for serious mental illness today without the joint efforts of pharmaceutical companies and academics.

“There is no single drug – whether for schizophrenia, bipolar disorder, major depression or anxiety – that has ever been produced by a governmental agency,” he said.

Free lunches over

While concurring that pharmaceutical firms had an important part to play in bringing new treatments to market, Whitaker called for researchers to keep a greater distance.

“What we need is a group of independent physicians who will have a critical perspective as they figure out how to best use those drugs,” he said.

“I would agree but unfortunately there are very few people who have nothing to do with drug companies but who are still as knowledgeable as the rest of us,” Meltzer replied.

“But when you look at the aggregate of what we do, it is incorrect to characterise it as self-serving and abusing the public trust.”

In a sign of the sensitivity that now attaches to the US pharmaceutical industry, the APA recently put an end to medical education seminars and meals sponsored by drug companies at its annual meetings.

“There is a perception that accepting meals provided by pharmaceutical companies may have a subtle influence on doctors’ prescribing habits,” Dr James Scully, the APA’s medical director and chief executive officer, said in a statement.

Click here for the full report from BBC News

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Suicide Warnings for 2 Anti-Smoking Drugs

July 2, 2009 by mike  
Filed under Health

July 2, 2009

New York Times

by Gardiner Harris & Duff Wilson

WASHINGTON — Federal drug regulators warned Wednesday that patients taking two popular drugs to stop smoking should be watched closely for signs of serious mental illness, as reports mount of suicides among the drugs’ users.

But officials emphasized that fear should not stop patients from taking the smoking-cessation medicines, Chantix, made by Pfizer, and Zyban, made by GlaxoSmithKline, which also sells it under the brand name Wellbutrin, for depression.

“Stopping smoking is a goal we should all be working towards,” said Dr. Curtis J. Rosebraugh, director of a drug evaluation office at the Food and Drug Administration. “We don’t want to scare people off from trying a medication that could help them achieve this goal. You should just be careful.”

Pfizer will add a so-called black box warning — the F.D.A.’s most serious caution — to the packaging information for Chantix.

The Pfizer drug, introduced in 2006, has about 90 percent of the market for prescription smoking-cessation drugs, according to IMS Health, a health care information company. Even so, Chantix sales — $846 million in 2008 — had been less than Pfizer had hoped because of previous warnings of its side effects.

Glaxo will expand its existing black box warning on Wellbutrin, citing suicidal thoughts by patients who use it for depression, to include Zyban, which has had only modest sales in the smoking cessation market.

Both companies will also be required to conduct clinical trials to assess the mental health risks associated with the drugs’ uses. Pfizer is already enrolling schizophrenia patients in a trial.

Because smokers and people trying to quit are statistically more likely to be depressed and suicidal, officials for both companies said it was difficult to identify the specific impact of the drugs on those risks. “Nicotine withdrawal itself can be very difficult for people to endure,” Dr. Steve Romano, a Pfizer vice president, said Wednesday.

Analysts said the F.D.A. action would have little effect on sales because of previous indications of the drugs’ psychiatric risks.

“I think the market and physicians have already been sensitized to this,” said Catherine J. Arnold, an analyst for Credit Suisse.

“I’m not panicking,” said Jami Rubin, an analyst for Goldman Sachs, “Sales are already down a lot. It is and will remain a small niche product.”

Chantix had already experienced a slight sales decline last year from the $883 million achieved in 2007. And this year’s first-quarter sales of $177 million were 36 percent below the corresponding period last year.

Ms. Arnold predicted that sales would probably continue falling to around $740 million for all of 2009, but that demand for smoking-cessation treatments would enable it to grow modestly after that — to perhaps half of the $2 billion in annual sales Pfizer had originally hoped for the drug.

European officials first alerted the F.D.A. in 2007 to problems associated with Chantix. In September of that year, Jeffrey Carter Albrecht, a keyboard player from the pop-music group Edie Brickell and New Bohemians, was killed by a neighbor who had complained that Mr. Albrecht was banging on his door, ranting. Mr. Albrecht’s girlfriend blamed Chantix, which she said had made him hostile.

The widely publicized event led to a cascade of similar reports and scrutiny by F.D.A. safety officials, who have now received 98 reports of suicides and 188 reports of suicide attempts among those taking Chantix.

As officials looked more closely, they found to their surprise that Zyban has similar associated risks. The agency received 14 reports of suicides and 17 reports of suicide attempts among those taking Zyban.

No one knows why the drugs are associated with mental problems. In some cases, patients could be experiencing nicotine withdrawal, but some of the reports involved patients who had yet to stop smoking. And many of the events happened just as patients began or stopped therapy, officials said.

“If this is nicotine withdrawal, it really doesn’t matter,” said Dr. Robert Temple, an F.D.A. official. “You need to pay attention to them.”

The agency’s action requires the drugs’ makers to mention the risk of suicide in advertising, and it prevents the companies from using “reminder” ads, during which consumers are encouraged to talk to their doctors about a health issue but the product’s name is not mentioned.

Click here for the full report from the New York Times.

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