Happy Daze – Antidepressant Drugs Keeping you in”Drug-Induced State’
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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Chicago Psychiatrist Receives Money From Big Pharma
November 11, 2009
ChicagoTribune.com
By Christina Jewett, ProPublica and Sam Roe
Executives inside pharmaceutical giant AstraZeneca faced a high-stakes dilemma.
On one hand, Chicago psychiatrist Dr. Michael Reinstein was bringing the company a small fortune in sales and was conducting research that made one of its most promising drugs look spectacular.
On the other, some worried that his research findings might be too good to be true.
As Reinstein grew irritated with what he perceived as the company’s slights, a top executive outlined the scenario in an e-mail to colleagues.
“If he is in fact worth half a billion dollars to (AstraZeneca),” the company’s U.S. sales chief wrote in 2001, “we need to put him in a different category.” To avoid scaring Reinstein away, he said, the firm should answer “his every query and satisfy any of his quirky behaviors.”
Putting aside its concerns, AstraZeneca would continue its relationship with Reinstein, paying him $490,000 over a decade to travel the nation promoting its best-selling antipsychotic drug, Seroquel. In return, Reinstein provided the company a vast customer base: thousands of mentally ill residents in Chicago-area nursing homes.
During that period, Reinstein also faced accusations that he overmedicated and neglected patients who took a variety of drugs. But his research and promotional work went on, including studies and presentations examining many of the antipsychotics he prescribed on his daily rounds.
The AstraZeneca payments, filed as exhibits in a federal lawsuit, highlight the extent to which a leading drug company helped sustain one of the busiest psychiatrists working in local nursing facilities.
In an interview and in response to written questions, Reinstein said industry payments he has received for speeches and other engagements have had no bearing on his research results or patient care. He said he does not “accept any money from corporations to study their medications. This eliminates any possible conflicts of interest.”
But he does receive money from the Uptown Research Institute, a for-profit business that conducts industry- and government-funded studies on psychotropic drugs to help mentally ill patients.
Reinstein’s office in Uptown is adjacent to the research institute, which is owned by John Sonnenberg, a clinical psychologist who describes Reinstein as “a mentor of mine” and “brilliant.”
Sonnenberg said drugmakers and others pay his institute to do research, and the group, in turn, pays Reinstein a consulting fee of “under $2,000 a month” and has for many years. A decade ago, Sonnenberg said, Reinstein was an active researcher for the institute but since then has served only as an adviser.
“My research organization is separate from him, financially and organizationally,” Sonnenberg said.
While payments from drugmakers to researchers are legal, critics have long argued that they should be publicly disclosed. Legislation to make Illinois one of a handful of states to require disclosure died in Springfield this year but is included in the U.S. House and Senate versions of health care reform proposals.
“We need to know that we can fully trust the relationship we have with our doctor and that another, more lucrative relationship with industry does not outweigh it,” Sen. Herb Kohl, D-Wis., who is pushing for such reform, said in an interview.
Health professionals who have encountered Reinstein have had similar concerns. When he gave promotional presentations about various medications at Grasmere Place nursing home in Chicago, case manager Staci Burton recalled that she was pleased to get free lunches. But she said she wondered why Reinstein put his patients on twice as many drugs as other psychiatrists who treated residents.
“I was thinking, ‘Why are you using so many medications?’ ” Burton, who worked at the facility from 2004 to 2006, said in an interview. “(His patients) would have symptoms, they’d have all these side effects, and their doctor was not listening.”
Psychotropics to lose weight?Chanile Hayes, a South Side resident, says she came under Reinstein’s care at a psychiatric hospital after she suffered a nervous breakdown nearly 10 years ago. She found it odd, she said, when Reinstein told her that taking Seroquel would help her lose weight.
“I couldn’t understand why he wasn’t taking it because he was a plus-sized man himself,” said Hayes, now 37. She is one of thousands of people nationwide suing AstraZeneca on allegations it concealed Seroquel’s links to weight gain and diabetes.
While she is a plaintiff in New York state, a federal suit is playing out in Orlando, Fla. Reinstein is not a defendant in either case, but Orlando plaintiffs have cast him as a key figure: an influential promoter of Seroquel who was financially backed by AstraZeneca. They allege that Reinstein has claimed that the antipsychotic drug helps patients lose weight.
Hayes said she went from 140 pounds to nearly 300 within two years of taking the drug and later developed diabetes.
Reinstein has done studies, funded by AstraZeneca and two other drugmakers, that found that various medications, including Seroquel, carry an unexpected yet welcome side effect: They help some patients shed pounds.
That claim runs counter to established research that links so-called atypical antipsychotic drugs, such as Seroquel, to considerable weight gain. Drugs in this class, approved for schizophrenia and bipolar disorder, can have other serious side effects that include spastic movement disorders and seizures and can cause premature death among the elderly.
A Seroquel flier dated 1999 features a photograph of Reinstein on the cover. Inside, Reinstein describes one patient losing weight and no longer needing insulin shots because his diabetes had improved so much.
In a 2001 promotional telecast to 5,000 physicians nationwide, Reinstein said he had “jokingly kind of suggested to AstraZeneca” that the drug could be used for “taking away excessive appetite.”
“There’s actually some nurses in some of our facilities who have actually requested (Seroquel) because they noticed it really did suppress the appetite, and they wanted to lose weight themselves,” Reinstein said, according to a transcript of the speech, sponsored by AstraZeneca and broadcast from Somerset Place, a Chicago nursing home.
Two years after the speech, the Food and Drug Administration, armed with mounting research, asked AstraZeneca to warn patients of Seroquel’s diabetes risk. The drug’s label now cautions that the medication is linked to diabetes and weight gain — with nearly four times more patients gaining weight on Seroquel than on a placebo.
In his response to reporters, Reinstein characterized Seroquel as “generally weight neutral, although some patients gain weight and others lose weight.”
“I would never recommend” that patients take antipsychotics “to lose weight,” he wrote.
AstraZeneca spokesman Tony Jewell said plaintiffs have not proved that Seroquel was responsible for their injuries. He said the company, based in London, provided appropriate safety data about Seroquel to the FDA.
Chanile Hayes, who said she saw Reinstein during visits to his office, questioned why he prescribed her the drug: “How could you tell me that it would help me lose weight if it doesn’t help (people) lose weight?”
At AstraZeneca, early doubtsIn the corporate halls of AstraZeneca, the company’s scientific staff also questioned Reinstein’s work.
To continue reading this report, click here.
SF Chronicle Promotes Prescribing Antipsychotics for Kids
June 22, 2009
SF Chronicle
by Erin Allday
Increasingly powerful antipsychotic drugs are available on the market. And growing evidence that shows starting these medications early can help children with conditions like bipolar disorder is putting doctors under more pressure than ever to diagnose and treat young people with mental illnesses.
As a result, some doctors say, mental illness, especially bipolar disorder, has been overdiagnosed much the same way attention deficit hyperactivity disorder was in the 1980s.
“ADHD was the diagnosis du jour in the ’80s. Now it’s become bipolar disorder,” said Dr. Andrew Giammona, who heads the psychiatry department at Children’s Hospital Oakland. “We’re in a quick-fix society, and parents want to believe that if we had this treatment we can get it fixed and move on.”
Before the 1990s, bipolar disorder was a rare diagnosis in children under age 19. By 1994, U.S. doctors were reporting about 25 cases per 100,000 young people, and by 2002 that number had jumped to 1,000 cases per 100,000, according to data from the National Center for Health Statistics.
Medication was prescribed for about two-thirds of those patients, according to the National Institute of Mental Health. Antipsychotic medications are among the most popular made by pharmaceutical companies. Earlier this month, a U.S. Food and Drug Administration panel recommended approval of three antipsychotic drugs for use in treating schizophrenia and bipolar disorder in children and teens. The FDA will make a final decision on Geodon, Seroquel and Zyprexa in the coming weeks.
While better drugs and increased diagnoses have been a blessing for many families, at FDA hearings in Washington, doctors and parents voiced concerns that the medication can cause long-term health problems – specifically, extreme weight gain that can lead to metabolic disorders like diabetes.
NOT A TRIVIAL DECISION
“It would be controversial enough if it was just a diagnosis, but the diagnosis comes with these very potent medications,” said Glen Elliot, chief psychiatrist and medical director of the Children’s Health Council in Palo Alto. “My main message is parents need to be apprised that this is a cost-benefit analysis. You don’t trivially put somebody on a medication.”
As with ADHD, many thousands of children and teens really do have a mental illness that can be treated effectively with medication and therapy. Oakland parent Barbara Carlson said her son was 7 when he started having fits of violent rages, smashing windows and throwing chairs. After several days of testing, he was diagnosed with bipolar disorder – but she was reluctant to put him on medication. “He was just so young,” Carlson said. “I thought, ‘He has his whole life ahead of him, what if this is the wrong diagnosis?’ It was very scary to put him on medications.”
Seven years later, she said the drugs have improved his life dramatically. He’s had weight problems, but he’s excelling in school and is active in sports and making friends.
Many mental health experts said they’ve felt pressure from families with troubled children to make a diagnosis and start treatment – a reaction that’s understandable if the child is clearly having problems. But if doctors don’t have the proper training to accurately diagnose a mental illness, children may not get the right treatment, said Dr. Robin Dey, director of mental health services for Northern California Kaiser Permanente.
DEPRESSION AND MANIA
“I tell doctors, ‘You have to be honest with yourself about your own level of experience with this condition,’ ” Dey said. “We have to be honest with ourselves about whether the medications are working, and if they’re not working you need to keep questioning the diagnosis.”
Bipolar disorder is thought to affect about 1 percent of children, although studies vary and some experts believe it affects as many as 5 percent of children.
The disorder in adults is marked by extended cycles of depression and mania, although people can have long periods of time where they have no symptoms at all. During manic periods, adults may get grandiose ideas, feel euphoric and be impulsive and make poor decisions.
Children with bipolar disorder tend to cycle through moods faster than adults, and they are more likely to be extremely irritable than euphoric, said Dr. Kiki Chang, director of the Pediatric Bipolar Disorders Program at Stanford University School of Medicine. Experts note that these children are not just kids with behavior problems.
“An irritable kid is most likely not bipolar, he’s probably just upset about something,” Chang said. “Bipolar kids may be extremely explosive, extremely angry. But they have to have these other symptoms: they’re not sleeping as much, their mind is going faster and they’re making poor decisions.”
HARD TO TELL THE DIFFERENCE
It’s not always easy for doctors to tell the difference between a kid with bipolar disorder and one who’s dealing with teenage angst or has some other problem, like post-traumatic stress. Giammona at Oakland Children’s Hospital said he once diagnosed a child with bipolar disorder only to discover later that the patient had a food allergy that was making him extremely irritable.
“There’s a lot of overlap with other potential diagnoses,” he said. “There can be lots of reasons for symptoms that look like bipolar disorder. Just because they have the symptoms of the disorder doesn’t mean they have it.”
Dale Milfay, vice president of the National Alliance on Mental Illness in San Francisco, said it’s crucial that children with mental illness get a correct diagnosis as soon as possible and start treatment right away. There may be medical advantages to early treatment, she said, but children also benefit from staying in school and developing crucial relationships with friends and family.
“The earlier people are diagnosed, the better their chances,” Milfay said. “But you wouldn’t want these drugs to be overused. There needs to be some real criteria that this is not something a primary care doctor can just diagnose.”
DIAGNOSING AND TREATING MENTAL ILLNESS IN CHILDREN
Three antipsychotic drugs are under review by the U.S. Food and Drug Administration for use in treating schizophrenia and bipolar disorder in children and teens. They are:
Zyprexa, made by Eli Lilly, created to treat schizophrenia and bipolar disorder in children ages 13-17.
Seroquel, made by AstraZeneca, also to treat schizophrenia and bipolar disorder in children ages 13-17.
Geodon, made by Pfizer, to treat bipolar disorder in children ages 10-17.
All three drugs have side effects that include serious weight gain and sedation.
SYMPTOMS IN CHILDREN
Bipolar disorder:
– Intense, rapid mood swings, from depressed to very irritable or euphoric.
– Impulsiveness and poor judgment.
– Inability to sleep.
– Fast talking.
– Hypersexuality.
Schizophrenia:
– Hallucinations and/or delusions.
– Paranoia.
– Inability to tell TV, video games or dreams from reality.
– Trouble thinking clearly.
– Talking about things that don’t make sense to anyone else.
– Inability to be motivated or focused.
FDA Panel OKs Antipsychotic Drugs for Kids as young as 10
June 10, 2009
On Wednesday, an FDA advisory panel said that three widely used antipsychotic medications appear safe and effective overall in treating teenagers and children as young as ten years old with schizophrenia or bipolar disorder.
The Food and Drug Administration’s panel of outside experts backed wider use of the pills — Eli Lilly and Co’s (LLY.N) Zyprexa, AstraZeneca’s (AZN.L) Seroquel and Pfizer’s (PFE.N) Geodon — but expressed concern over long-term effects the medications may have in younger patients.
FDA approval would allow the drugmakers to market them specifically for children and teenagers. The drugs, already approved for adults and are given to youngsters at a doctor’s discretion, combine for $10 billion in annual sales.
Although panelists said the companies’ data showed the drugs, known as atypical antipsychotics, are effective and reasonably safe for children as young as 10 years old, some members said the short-term studies do not show how youngsters would fare when treated over time for the chronic conditions.
“I’m concerned about the lack of true long-term studies” especially in younger patients “who will have a long lifetime, hopefully,” said Ruth Day, a researcher at Duke University.
The FDA will weigh the panel’s recommendations before later making its final approval decisions for the three drugs. Agency officials, speaking to reporters after the two-day meeting, declined to say when they would rule.
The drug companies told panelists on Tuesday that the benefits of treating symptoms of schizophrenia, which causes hallucinations and delusions, and bipolar disorder, which causes dramatic mood swings from manic episodes to depression outweighed the drugs’ risks.
But on Wednesday, a number of FDA’s advisers questioned why the FDA seemed willing to accept the drugs for what could be years of use when some studies only looked at children and teenagers for as little as three or six weeks.
They also said they were troubled not only about the potential increased use among even younger patients, but also the chance the drugs may be misused to treat other conditions such as attention deficit disorder or hyperactivity.
Panelist Kenneth Towbin said he worried that “soon we’ll be seeing 4-, 5- and 6-year-olds being treated.”
“It’s a slippery slope … I just get worried about where this is going,” said Towbin, head of the National Institute of Mental Health’s child psychiatry mood disorders program.
AstraZeneca and Lilly are seeking to sell their drugs for both schizophrenia and bipolar mania, while Pfizer’s is seeking approval only for bipolar disorder. The companies, in separate statements, welcomed the panel’s recommendations.
Zyprexa is Lilly’s top-selling drug with sales of $4.7 billion last year. Seroquel is the second-best-selling product for AstraZeneca with 2008 sales of $4.5 billion. Sales of Pfizer’s Geodon topped $1 billion in 2008.
Two similar drugs are already approved for youngsters — Johnson & Johnson’s (JNJ.N) Risperdal and Bristol-Myers Squibb Co’s (BMY.N) Abilify.
Studies showed Zyprexa, Seroquel and Geodon generally have the same side effects in youth as in adults such as weight gain and sleepiness, the FDA said. Panelist agreed and noted the need for additional treatment options. But they said the question was whether over time there could be an impact on brain development and other reactions not seen in adults.
“Children and adolescents are not just little adults,” said Tana Grady-Weliky, a psychiatrist at Oregon Health and Science University. (Reporting by Susan Heavey, editing by Leslie Gevirtz and Carol Bishopric)












































