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Time Magazine: Why Are So Many Foster Care Children Taking Antipsychotics?

admin — Wed, 30 Nov 2011 18:06:58 +0000

11/29/2011 by Maia Szalavitz

More than 8% of children in foster care have received antipsychotic medication, and just over one quarter of those in foster care who also receive disability benefits take these drugs, according to a recent studyin the journal Pediatrics.

The question is why? Children in foster care have typically been neglected or abused — indeed, simply removing a young child from his or her parents, even abusive ones, is in itself traumatic — so, not surprisingly, kids in foster care are more likely to suffer from psychiatric and behavioral problems than those who have stable families. Previous data suggest that foster-care children are about twice as likely as those outside the system to receive psychiatric medications.

Whether these problems are leading to higher rates of antipsychotic use, however, is not clear. “I think we have clinicians facing some very challenging situations,” says Susan dosReis, associate professor at the University of Maryland School of Pharmacy and lead author of the study. “But we don’t have information as to why the prescribers decided on these medications for [these particular] youths.”

The numbers suggest that the influence of pharmaceutical company marketing cannot be overlooked. Ninety-nine percent of youth receiving antipsychotic medications in the study were given atypical antipsychotics — the newer generation of these drugs, which are expensive and mostly unavailable in generic form and have been heavily advertised.

All of the major manufacturers of these drugs have been fined by the Food and Drug Administration for illegal marketing practices — in part, for marketing the drugs for unapproved use in children — with some convicted of criminal charges.

Eli Lilly, which manufactures the atypical antipsychotic Zyprexa, paid out $1.42 billion in 2009 — $615 million of that to settle criminal charges. The charges against Lilly involved selling Zyprexa to doctors for use in children, despite the fact that it was not approved for this age group.

Bristol Myers Squibb paid $515 million in 2007 to settle charges that it also illegally pushed its antipsychotic Abilify to child psychiatrists. Pfizer paid out $301 million in a similar case related to its drug Geodon. AstraZeneca paid out $520 million to settle charges over the drug Seroquel. In all of these cases, the drugs were sold for unapproved use in youth.

Read the rest of the article here

Watch one foster kid’s story:

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U.S. doctors steeped in financial ties – drug money from Big Pharma

admin — Mon, 12 Sep 2011 16:46:12 +0000

Natural News – September 11, 2011

by S. D. Wells

Pharmaceutical firms in the United States are shelling out massive funds for doctors travel and entertainment expenses in hopes of boosting sales of new drugs. More than 160,000 doctors have received related payments in 2011 already.

The big push includes free samples, hospital detailing, journal ads, gifting, and the sponsoring of continuing medical education, but patients fear this all leads to doctors prescribing popular, money making drugs instead of following standard of care practices .

Pfizer, Eli Lilly, and AstraZeneca top the list of companies also spending far more on “marketing” than on research, with a total estimated $57,000 billion in overall marketing expenditures in just one year in the United States.

Pharmaceutical giants are claiming they are just trying to be open about how they conduct business, but the statements come at a time of intense scrutiny, and after several prosecutions regarding unlawful marketing practices.

In fact, some of these databases were actually set up as part of settlements of federal criminal investigations into the illegal marketing of drugs to doctors. Many companies have not released any data whatsoever, but Lilly and Pfizer combine to have paid out over 90 million dollars.

United States government agencies are preparing guidelines that will make such information mandatory by 2013. Currently there are over 80,000 pharmaceutical sales reps in the U.S. pursuing about 800,000 pharmaceutical prescribers, so it can be extremely difficult to track the money for one doctor from several sources, or to identify the largest recipients, like an entire hospital, without laborious work by a whole team of computer experts.

By 2013, new federal healthcare laws are expected to make it easier for the public to track a doctor’s payments from multiple companies; however, there may be controversial business opportunities available in the setting up and running of these supposedly transparent websites, such as PharmaShine, which was founded auspiciously by a former attorney for Merck.

Critics are complaining about the extreme conflicts of interest that arise from all the gift giving and promotional items, saying doctor’s can negatively influence the cost of medicine by recommending or prescribing brand name drugs over cheaper generics. In many instances, the reward is substantial for doctors to do exactly that. Over 380 doctors have earned more than $100,000 from drug companies in just the past two years.

But there is also a flip side to these perks. One doctor said he had to follow a slide show presentation word for word in order to receive funding for a speaking engagement promoting certain pharmaceuticals, or there would be changes made to his contract.

On top of all the other problems inherent in proper ethics and disclosure, many prominent doctors at academic medical centers have failed to disclose millions of dollars in drug company payments, and Federal prosecutors say some payments are really kickbacks for illegal or excessive prescribing. Are doctors now moonlighting as drug salesmen in order to keep the perks flowing?

Learn more: http://www.naturalnews.com/033552_doctors_financial_ties.html#ixzz1Xl0pPVaN

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1 out of every 7 Elderly Nursing Home Residents on Antipsychotics—Despite Risk of Death

admin — Mon, 18 Jul 2011 17:37:20 +0000

Modern Medicine – July 16, 2011

Long-term-care (LTC) facilities are overusing antipsychotic drugs. One of every 7 elderly nursing home residents is receiving at least 1 atypical antipsychotic; in 83% of these cases, the drug is associated with a dementia diagnosis, yet the use of atypical antipsychotics in dementia increases the risk of death and is not approved by FDA, according to a report from the Office of the Inspector General (OIG).

Erroneous claims

“Government, taxpayers, nursing home residents, as well as their families and caregivers, should be outraged — and seek solutions,” said Daniel R. Levinson, Inspector General, Department of Health and Human Services (HHS), in a statement. “Despite the fact that it is potentially lethal to prescribe antipsychotics to patients with dementia, there’s ample evidence that some drug companies aggressively marketed their products toward such populations, putting profits before safety.”

OIG analyzed atypical antipsychotic use in LTC at the request of Sen Charles Grassley (R-Iowa). The report, issued in May, evaluated Part B and Part D claims data from January to June 2007. Analysts concluded that 51% of Medicare claims for atypical antipsychotics were erroneous. The claimed drugs were not used for medically accepted indications, not used off label as supported by recognized compendia, or not documented as having been administered to the elderly nursing home resident. The erroneous payments totaled $116 million for the 6 months studied.

Unmet standards

OIG also found that 22% of atypical antipsychotics used in LTC were not administered according to Medicare standards regarding unnecessary drug use in nursing homes. The standards are designed to reduce excessive dosage, excessive duration of therapy, inappropriate use, and lack of appropriate monitoring. Noting that violation of unnecessary drug-use rules may affect nursing homes’ participation in Medicare, OIG recommended that HHS act to reduce unnecessary drug use in LTC.

The report included aripiprazole (Abilify, Bristol-Myers Squibb), clozapine (Clozaril, Novartis), olanzapine (Zyprexa, Eli Lilly), olanzapine/fluoxetine (Symbyax, Eli Lilly), paliperidone (Invega, Janssen), quetiapine (Seroquel, AstraZeneca), risperidone (Risperdal, Janssen), and ziprasidone HCl (Geodon, Pfizer).

http://drugtopics.modernmedicine.com/drugtopics/Modern+Medicine+Now/Antipsychotics-overused-in-LTC-setting-OIG-says/ArticleStandard/Article/detail/730695

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Mass psychosis in the US—How Big Pharma got Americans hooked on anti-psychotic drugs

admin — Tue, 12 Jul 2011 16:44:01 +0000

ALJAZEERA – July 12, 2011

by James Ridgeway

Drug companies like Pfizer are accused of pressuring doctors into over-prescribing medications to patients in order to increase profits - GALLO/GETTY

Has America become a nation of psychotics? You would certainly think so, based on the explosion in the use of antipsychotic medications. In 2008, with over $14 billion in sales, antipsychotics became the single top-selling therapeutic class of prescription drugs in the United States, surpassing drugs used to treat high cholesterol and acid reflux.

Once upon a time, antipsychotics were reserved for a relatively small number of patients with hard-core psychiatric diagnoses – primarily schizophrenia and bipolar disorder – to treat such symptoms as delusions, hallucinations, or formal thought disorder. Today, it seems, everyone is taking antipsychotics. Parents are told that their unruly kids are in fact bipolar, and in need of anti-psychotics, while old people with dementia are dosed, in large numbers, with drugs once reserved largely for schizophrenics. Americans with symptoms ranging from chronic depression to anxiety to insomnia are now being prescribed anti-psychotics at rates that seem to indicate a national mass psychosis.

It is anything but a coincidence that the explosion in antipsychotic use coincides with the pharmaceutical industry’s development of a new class of medications known as “atypical antipsychotics.” Beginning with Zyprexa, Risperdal, and Seroquel in the 1990s, followed by Abilify in the early 2000s, these drugs were touted as being more effective than older antipsychotics like Haldol and Thorazine. More importantly, they lacked the most noxious side effects of the older drugs – in particular, the tremors and other motor control problems.

The atypical anti-psychotics were the bright new stars in the pharmaceutical industry’s roster of psychotropic drugs – costly, patented medications that made people feel and behave better without any shaking or drooling. Sales grew steadily, until by 2009 Seroquel and Abilify numbered fifth and sixth in annual drug sales, and prescriptions written for the top three atypical antipsychotics totaled more than 20 million. Suddenly, antipsychotics weren’t just for psychotics any more.

Not just for psychotics anymore

By now, just about everyone knows how the drug industry works to influence the minds of American doctors, plying them with gifts, junkets, ego-tripping awards, and research funding in exchange for endorsing or prescribing the latest and most lucrative drugs. “Psychiatrists are particularly targeted by Big Pharma because psychiatric diagnoses are very subjective,” says Dr. Adriane Fugh-Berman, whose PharmedOut project tracks the industry’s influence on American medicine, and who last month hosted a conference on the subject at Georgetown. A shrink can’t give you a blood test or an MRI to figure out precisely what’s wrong with you. So it’s often a case of diagnosis by prescription. (If you feel better after you take an anti-depressant, it’s assumed that you were depressed.) As the researchers in one study of the drug industry’s influence put it, “the lack of biological tests for mental disorders renders psychiatry especially vulnerable to industry influence.” For this reason, they argue, it’s particularly important that the guidelines for diagnosing and treating mental illness be compiled “on the basis of an objective review of the scientific evidence” – and not on whether the doctors writing them got a big grant from Merck or own stock in AstraZeneca.

Marcia Angell, former editor of the New England Journal of Medicine and a leading critic of the Big Pharma, puts it more bluntly: “Psychiatrists are in the pocket of industry.” Angell has pointed out that most of the Diagnostic and Statistical Manual of Mental Disorders (DSM), the bible of mental health clinicians, have ties to the drug industry. Likewise, a 2009 study showed that 18 out of 20 of the shrinks who wrote the American Psychiatric Association’s most recent clinical guidelines for treating depression, bipolar disorders, and schizophrenia had financial ties to drug companies.

In a recent article in The New York Review of Books, Angell deconstructs what she calls an apparent “raging epidemic of mental illness” among Americans. The use of psychoactive drugs—including both antidepressants and antipsychotics—has exploded, and if the new drugs are so effective, Angell points out, we should “expect the prevalence of mental illness to be declining, not rising.” Instead, “the tally of those who are so disabled by mental disorders that they qualify for Supplemental Security Income (SSI) or Social Security Disability Insurance (SSDI) increased nearly two and a half times between 1987 and 2007 – from one in 184 Americans to one in seventy-six. For children, the rise is even more startling – a thirty-five-fold increase in the same two decades. Mental illness is now the leading cause of disability in children.” Under the tutelage of Big Pharma, we are “simply expanding the criteria for mental illness so that nearly everyone has one.” Fugh-Berman agrees: In the age of aggressive drug marketing, she says, “Psychiatric diagnoses have expanded to include many perfectly normal people.”

Cost benefit analysis

What’s especially troubling about the over-prescription of the new antipsychotics is its prevalence among the very young and the very old – vulnerable groups who often do not make their own choices when it comes to what medications they take. Investigations into antipsychotic use suggests that their purpose, in these cases, may be to subdue and tranquilize rather than to treat any genuine psychosis.

Carl Elliott reports in Mother Jones magazine: “Once bipolar disorder could be treated with atypicals, rates of diagnoses rose dramatically, especially in children. According to a recent Columbia University study, the number of children and adolescents treated for bipolar disorder rose 40-fold between 1994 and 2003.” And according to another study, “one in five children who visited a psychiatrist came away with a prescription for an antipsychotic drug.”

A remarkable series published in the Palm Beach Post in May true revealed that the state of Florida’s juvenile justice department has literally been pouring these drugs into juvenile facilities, “routinely” doling them out “for reasons that never were approved by federal regulators.” The numbers are staggering: “In 2007, for example, the Department of Juvenile Justice bought more than twice as much Seroquel as ibuprofen. Overall, in 24 months, the department bought 326,081 tablets of Seroquel, Abilify, Risperdal and other antipsychotic drugs for use in state-operated jails and homes for children…That’s enough to hand out 446 pills a day, seven days a week, for two years in a row, to kids in jails and programs that can hold no more than 2,300 boys and girls on a given day.” Further, the paper discovered that “One in three of the psychiatrists who have contracted with the state Department of Juvenile Justice in the past five years has taken speaker fees or gifts from companies that make antipsychotic medications.”

In addition to expanding the diagnoses of serious mental illness, drug companies have encouraged doctors to prescribe atypical anti-psychotics for a host of off-label uses. In one particularly notorious episode, the drugmaker Eli Lilly pushed Zyprexa on the caregivers of old people with Alzheimer’s and other forms of dementia, as well as agitation, anxiety, and insomnia. In selling to nursing home doctors, sales reps reportedly used the slogan “five at five”—meaning that five milligrams of Zyprexa at 5 pm would sedate their more difficult charges. The practice persisted even after FDA had warned Lilly that the drug was not approved for such uses, and that it could lead to obesity and even diabetes in elderly patients.

In a video interview conducted in 2006, Sharham Ahari, who sold Zyprexa for two years at the beginning of the decade, described to me how the sales people would wangle the doctors into prescribing it. At the time, he recalled, his doctor clients were giving him a lot of grief over patients who were “flipping out” over the weight gain associated with the drug, along with the diabetes. “We were instructed to downplay side effects and focus on the efficacy of drug…to recommend the patient drink a glass a water before taking a pill before the meal and then after the meal in hopes the stomach would expand” and provide an easy way out of this obstacle to increased sales. When docs complained, he recalled, “I told them, ‘Our drug is state of the art. What’s more important? You want them to get better or do you want them to stay the same–a thin psychotic patient or a fat stable patient.’”

For the drug companies, Shahrman says, the decision to continue pushing the drug despite side effects is matter of cost benefit analysis: Whether you will make more money by continuing to market the drug for off-label use, and perhaps defending against lawsuits, than you would otherwise. In the case of Zyprexa, in January 2009, Lilly settled a lawsuit brought by with the US Justice Department, agreeing to pay $1.4 billion, including “a criminal fine of $515 million, the largest ever in a health care case, and the largest criminal fine for an individual corporation ever imposed in a United States criminal prosecution of any kind,”the Department of Justice said in announcing the settlement.” But Lilly’s sale of Zyprexa in that year alone were over $1.8 billion.

Turning people into zombies

As it turns out, the atypical antipsychotics may not even be the best choice for people with genuine, undisputed psychosis.

Read the rest of the article here: http://english.aljazeera.net/indepth/opinion/2011/07/20117313948379987.html

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Bad Side-Effects Ahead For Pharma?

admin — Thu, 30 Jun 2011 18:01:54 +0000

Forbes – June 30, 2011

by Martin Fridson

In 2006, The New York Review of Books reported that four-year-old Rebecca Riley died of the effects of two prescription drugs—Clonidine and Depakote.

These medications, along with Seroquel, were prescribed for Rebecca after she was diagnosed, at the age of two, with attention deficit hyperactivity disorder (ADHD) and bipolar disorder. The three drugs are not approved by the Food and Drug Administration (FDA) for treatment of ADHD or long-term treatment of bipolar disorder, nor are they approved for children as young as Rebecca.

The New York Review of Books‘ recent two-part article (1) by Marcia Angell on the treatment of mental illness with psychoactive drugs (those that affect the mental state) addresses an issue that may one day prove very important to investors in pharmaceutical stocks. (All statistics and quotations herein are drawn from Dr. Angell’s article.)

It is not illegal for a doctor to prescribe a drug off-label, that is, for a non-FDA-approved use, but a drug marketer cannot lawfully encourage a doctor to do so. The profits in psychoactive drugs, however, make it tempting to flout the law. In the past four years, AstraZeneca (AZN), Pfizer (PFE), Eli Lilly (LLY), Bristol-Myers Squibb (BMY) and Forest Labs (FRX) have all settled federal charges of marketing psychoactive drugs off-label, at a cost running into hundreds of millions.

Seeing that pharmaceutical marketing executives are evidently undeterred by the law, Dr. Angell, a senior lecturer in social medicine at Harvard Medical School and former editor in chief of The New England Journal of Medicine, advocates a prohibition on prescribing psychoactive drugs off-label.

A ban would cut into a major growth area for pharmaceutical companies.

This growth is not a function of a few blockbuster drug discoveries. It parallels an extraordinary rise in the portion of the population, particularly children, diagnosed with mental illness. For example, if diagnoses mirror the actual incidence of juvenile polar disorder, that affliction grew forty-fold between 1993 and 2004.

Have mental disorders genuinely proliferated that dramatically? Dr. Angell suggests instead that the surge in certain diagnoses reflects a long-run shift in emphasis from “talk therapy” to medication. This change just so happens to enable psychiatrists to see more patients and earn higher fees. Not incidentally, with drugs now regarded as the preferred mode of treatment, the increase in diagnoses is a boon to pharmaceutical manufacturers. The new generation of psychoactives has displaced cholesterol-reducing medications as the biggest-selling class of drugs in the U.S.

Also benefiting from the present arrangement are low-income families that receive Supplemental Security Income (SSI) payments on the basis of mental disabilities. To qualify, applicants (children included) generally must be taking psychoactive drugs. Getting into the program usually also ensures that the family will qualify for Medicaid. The disbursements can be so substantial that MIT economics professor David Autor describes SSI as “the new welfare.”

The parents and two siblings of Rebecca Riley, the four-year-old who died from the effects of off-label drugs, were all on psychoactive drugs and were receiving about $30,000 a year from SSI. Dr. Angell links the astonishing rise in diagnoses of certain mental disorders to the huge financial stakes of physicians, pharmaceutical companies and SSI recipients.

I do not want to portray this issue as an imminent or mortal threat to pharmaceutical stocks. If a ban on off-label prescription of psychoactive drugs were proposed in Congress, the companies’ lobbyists probably could stave it off for a long time. Furthermore, the major pharmaceutical companies have widely diversified product lines, so a setback in the psychoactive category, even though it is a major growth area, would not be a body blow.

Still, this topic is one to keep an eye on for investors who hope to gain an edge by seeing beyond the quarterly EPS data. Psychoactive drugs have been around since the 1950s, but parents can readily observe that their use with children is far more widespread than it was a generation ago. If advocates such as Marcia Angell can make a persuasive case that the change is not fully justified on medical grounds, yet poses significant health hazards, is it unrealistic to expect a public opinion backlash some day?

[1] Marcia Angell, “The Epidemic of Mental Illness: Why?” The New York Review of Books (June 23, 2011), pp. 20-22 and “The Illusions of Psychiatry” (July 14, 2011), pp. 20-22. The article is a review of three books on the contemporary practice of psychiatry by Irving Kirsch, Robert Whitaker, and Daniel Carlat.

http://blogs.forbes.com/investor/2011/06/30/bad-side-effects-ahead-for-pharma/

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AG Fines Firm For Improper Marketing Of Seroquel

admin — Tue, 15 Mar 2011 03:53:59 +0000

North County Gazette- March 14, 2011

NEW YORK—-The state Attorney General’s office has reached a $3.1 million settlement with the major pharmaceutical company AstraZeneca following allegations that it improperly marketed and promoted the antipsychotic drug Seroquel.

*The agreement is part of a record 37-state settlement totaling $68.5 million – the largest ever multi-state consumer protection-based pharmaceutical settlement.

These practices violate consumer protection laws established to protect patients and ensure that health care providers are fully briefed on the medications available, including all known potential benefits and side effects.

It had been alleged that AstraZeneca engaged in deceptive and misleading practices when it marketed Seroquel for unauthorized, or “off-label,” uses and failed to adequately disclose the drug’s serious potential side effects to health care providers, including hyperglycemia and diabetes mellitus.

Seroquel is approved for the treatment of schizophrenia, certain instances of bipolar disorder and depressive episodes associated with bipolar disorder. When it was first introduced to the market in the 1990s, experts thought that it would be less likely to produce Parkinson’s type symptoms and motion disorders such as tardive dyskinesia, and therefore could be used in long-term treatment of schizophrenia. However, while Seroquel may reduce the risk of these symptoms, it also produced dangerous side effects, including hyperglycemia and diabetes.

New York’s investigation demonstrated that AstraZeneca concealed and minimized the risks of these side effects. AstraZeneca also marketed Seroquel for off-label and potentially dangerous uses including pediatric use, for use at high dosage levels, for the treatment of symptoms rather than diagnosed conditions, and to treat dementia and Alzheimer’s Disease in the elderly.

Following the Attorneys General’s investigation, AstraZeneca agreed to change its marketing of Seroquel and to cease promoting off-label uses of the drug, which are not approved by the U.S. Food and Drug Administration (FDA).

The settlement, filed in state court, also contains powerful injunctive terms prohibiting the use of financial incentives to manipulate doctors, deterring off-label marketing and requiring that AstraZeneca disclose scientific evidence of dangerous side effects.

In addition, the settlement requires AstraZeneca to provide accurate, objective and scientifically balanced responses to requests for off-label usage information. AstraZeneca must also have policies in place to ensure that financial incentives are not given to marketing and sales personnel for off-label marketing and that sales personnel do not promote to health care providers who are unlikely to prescribe Seroquel for an FDA-approved use.

http://www.northcountrygazette.org/2011/03/14/seroquel_marketing/

*In addition to New York, attorneys general of the following states and the District of Columbia participated in the settlement: Arizona, California, Colorado, Connecticut, Delaware, Florida, Hawaii, Idaho, Illinois, Iowa, Kansas, Louisiana, Maryland, Maine, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia and Wisconsin.

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Seroquel’s Toll—Controversial Antipsychotic Drug Now Marketed for Depression

admin — Mon, 24 Jan 2011 19:12:14 +0000

Counter Punch—January 24, 2011

by Martha Rosenberg

Even though AstraZeneca’s antipsychotic Seroquel is the fifth best-selling medication in the US according to drugs.com, exceeded only by Lipitor, Nexium, Plavix and Advair diskus, its safety, effectiveness, clinical trial and promotion records are highly checkered.

An original backer, psychiatrist Richard Borison, was sentenced to a 15-year prison sentence in 1998 for a pay-to-play Seroquel research scheme.

Its US medical director Wayne MacFadden had sexual affairs with two different women involved with Seroquel research, say published reports.

Chicago psychiatrist Michael Reinstein received $500,000 from AstraZenenca and wrote 41,000 prescriptions for Seroquel reports the Chicago Tribune and ProPublica.

Psychiatrist Charles Nemeroff who left Emory University in disgrace after a Congressional investigation for unreported pharma income, promoted Seroquel in continuing medical education courses according to the web site of psychiatrist Daniel Carlat.

Florida child psychiatrist Jorge Armenteros was chairman of the FDA committee responsible for recommending Seroquel approvals while a paid AstraZeneca speaker himself, said the Philadelphia Inquirer in 2009.

Psychiatrist Charles Schulz’ high profile pro-Seroquel presentations are suspected of being colored by his AstraZeneca income says the Minneapolis Star Tribune.

And unexplained Iraq and Afghanistan troop deaths are linked to Seroquel reported the Associated Press in August.

Originally approved for schizophrenia in 1997, Seroquel has subsequently been approved for bipolar disorder, for some groups of kids and as an add-drug for depression. This “indications creep” has mostly flown below the public’s radar. Seroquel expansion to treat children in late 2009, for example, was noted as a mere “label change” on the FDA web site. Hello?

Even without its depression indication, Seroquel is big business for AstraZeneca, earning $4.9 billion in sales in 2009. It is the drug that North Carolina’s Medicaid spends the most on: $29.4 million per year, reports the Charlotte News and Observer.

But now, as AstraZeneca rolls out its “Still Trying to Get Ahead of Your Depression” campaign, there are new questions about Seroquel’s safety and effectiveness.

According to an FDA warning letter, an AstraZeneca sales representative during an unsolicited sales call on January 3, 2008 sold Seroquel as a treatment for major depressive disorder to a physician before it was approved for MDD, an infraction which is illegal.

Once Seroquel was approved for depression (as an add-on treatment to an antidepressant for patients with major depressive disorder who not have an adequate response to antidepressant therapy), its leave-behind sheets drew another FDA warning letter.

AstraZeneca implied patients would achieve “remission” from depression with Seroquel XR (extended release) as opposed to with an antidepressant alone, says FDA — a claim not backed up by clinical experience.

Seroquel’s effect on depression has only been demonstrated in two, six-week trials FDA further said and six weeks is “not a long enough time period to adequately assess remission.” (It was approved…why?)

Also the case study of “Catherine F.” depicted in leave-behind sheets is inaccurate says FDA because it suggests Seroquel alleviates “symptoms of sadness and loss of interest when this has not been demonstrated by substantial evidence or substantial clinical experience.” (It was approved…why?)

Even AstraZeneca’s own briefing to the FDA committee in 2009 admits a “failed study” in which both Seroquel and Lexapro “failed to differentiate from placebo” which is Clinical Trial for “didn’t work.”

Nor did AstraZeneca adequately disclose Seroquel risks says FDA which include increased mortality in elderly patients with dementia-related psychosis, suicidality, neuroleptic malignant syndrome, hyperglycemia and diabetes mellitus, hyperlipidemia, weight gain and other serious side effects.

In fact, in addition to risks like cataracts, seizures and increases in blood pressure in children and adolescents, already on the Seroquel label, FDA asked AstraZeneca to add the “risk of EPS and withdrawal syndrome in neonates” a few months ago: movement disorders which can affect mothers’ babies if the mothers are taking Seroquel and stop.

But the FDA might also look at what the government’s other hand is doing. In May the Office of the Army Surgeon General’s final report on the findings of its Pain Management Task Force unabashedly hawks Seroquel for an unapproved use.

“Physicians should consider these medications for sleep disorders,” says the 163-page report,” listing Ambien and Seroquel (quetiapine) “for nightmares” even though Seroquel has never been approved for insomnia, sleep disorders or “nightmares.”

Maybe the government will send itself a warning letter.

http://www.counterpunch.org/rosenberg01242011.html

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Military’s drug policy threatens troops’ health, doctors say

cchrint — Wed, 19 Jan 2011 06:02:17 +0000

NextGov
By Bob Brewin
January 18, 2011

Army leaders are increasingly concerned about the growing use and abuse of prescription drugs by soldiers, but a Nextgov investigation shows a U.S. Central Command policy that allows troops a 90- or 180-day supply of highly addictive psychotropic drugs before they deploy to combat contributes to the problem.

The CENTCOM Central Nervous System
Drug formulary includes drugs like Valium and Xanax, used to treat depression, as well as the antipsychotic Seroquel, originally developed to treat schizophrenia, bipolar disorders, mania and depression.

Although CENTCOM policy does not permit the use of Seroquel to treat deploying troops with these conditions, it does allow its use as a sleep aid, and allows deployed troops to be provided with a 180-day supply, even though the drug has been implicated in the deaths of two Marines who died in their sleep after taking large doses of the drug.

The Army endorsed Seroquel as a sleep aid in the May 2010 report of its Pain Management Task Force, which, among other things, called for a reduction in the number of prescription drugs given to troops. An appendix to that report recommended taking Seroquel in either 25- or 50-milligram doses for sleep disorders.

A June 2010 internal report from the Defense Department’s Pharmacoeconomic Center at Fort Sam Houston in San Antonio showed that 213,972, or 20 percent of the 1.1 million active-duty troops surveyed, were taking some form of psychotropic drug: antidepressants, antipsychotics, sedative hypnotics, or other controlled substances.

Dr. Grace Jackson, a former Navy psychiatrist, told Nextgov she resigned her commission in 2002 “out of conscience, because I did not want to be a pill pusher.” She believes psychotropic drugs have so many inherent dangers that “the CENTCOM CNS formulary is destroying the force,” she said.

Dr. Greg Smith, who runs the Los Angles-based Comprehensive Pain Relief Group, which treats chronic pain and prescription drug abuse through an integrative medical approach called the Nutrition, Emotional/Psychological, Social/Financial and Physical program, said he was shocked by CENTCOM’s drug policy for deployed troops. “If I was a commander I’d worry about what these troops would do,” as a result of their medications, Smith said.

Dr. Peter Breggin, an Ithaca, N.Y., psychiatrist who testified before a House Veterans Affairs Committee last September on the relationship between medication and veterans’ suicides, said flatly, “You should not send troops into combat on psychotropic drugs.” Medications on the CENTCOM CNS formulary can cause loss of judgment and self-control and could result in increased violence and suicidal impulses, Breggin said.

The Army implicated prescription drugs as contributing to suicides in a July 2010 report, which said one-third of all active-duty military suicides involved prescription drugs.

When the suicide report was released, Gen. Peter Chiarelli, the Army’s vice chief of staff, said the service needed to develop better controls for prescription drugs. “Let’s make sure when we prescribe that we put an end date on that prescription, so it doesn’t remain an open-ended opportunity for somebody to be abusing drugs,” Chiarelli said.

But when it comes to the CENTCOM CNS formulary — which for some drugs allows a 180-day supply when troops deploy, followed by a 180-day refill in theater, according to an October 2010 update to the psychotropic drug policy — neither the Army nor CENTCOM sees a need for change.

In an e-mailed statement to Nextgov, Col. John Stasinos, chief of addiction medicine for the Army surgeon general, and Col. Carol Labadie, pharmacy program manager in the Directorate of Health Policy and Services for the surgeon general, said soldiers are supplied with up to 180 days of medications because they “serve in remote areas without easy access to pharmacies. It is important that soldiers on chronic medications do not run out of them during combat operations, because not taking the medications can be as dangerous as taking too much medication.”

Abuse of prescription drugs, Stasinos and Labadie said, can be prevented by improved communication among health care providers, soldiers and commanders. Comprehensive reviews of soldiers’ medication profiles by pharmacists are another way to prevent abuse, they said.

The statement from Stasinos and Labadie added that it is possible that troops could receive a 180-day supply of more than one psychotropic medication.

Navy Lt. Cmdr. William Speaks, a CENTCOM spokesman, echoed comments from the Army. He said the drug-supply policy for deployed troops was “established to ensure personnel who required these medications had an adequate supply before deployment to last through pre-deployment activities and training as well as travel to theater and initial deployment phase.”

He added, “Some of these medications can cause duty-limiting side effects if they are withdrawn abruptly [i.e. if the individual runs out]. This policy prevents that from occurring.”

Speaks said, “Abuse is always a possibility the prescribing clinician must consider … demonstration of clinical stability, medication quantity limits and in-theater review of prescriptions reduces the potential for abuse.”

Suicide and Drug Abuse

The Army’s suicide report drew a link between a significant increase in prescription drug use among troops and the service’s rising suicide rate. It also raised serious concerns about troops trafficking in prescription drugs.

Jackson, the former Navy psychologist, now has a civilian practice in Greensboro, N.C. She said at least one drug on the CENTCOM formulary — Depakote, an anticonvulsant, which military doctors prescribe for mood control — carries serious physical risks for troops. Depakote is toxic to certain cells, including hair cells in the ears, and can lead to hearing loss. Troops in a howitzer battery who already run the risk of hearing loss should not take Depakote, she said.

The medication also can cause what she calls “cognitive toxicity,” also known as Depakote dementia, impairing a person’s ability to think and make decisions. Jackson said that while Depakote has been investigated as an adjunct therapy for cancer, its use has been limited due to the drug’s effects on cognition.

The antidepressant Wellbutrin, also on the CENTCOM formulary, likely poses a long-term risk of Parkinson’s disease, especially for older troops, said Jackson, author of Drug-Induced Dementia: A Perfect Crime (AuthorHouse, 2009).

Jackson and Breggin both expressed deep concerns about Xanax, perhaps the most addictive of all benzodiazepines, a class of depressant medications used to treat anxiety, on the CENTCOM formulary.

Breggin, author of Medication Madness: The Role of Psychiatric Drugs in Cases of Violence, Suicide and Crime (St. Martin’s Griffin, 2009), called Xanax “solid alcohol” and said all the benzodiazepines on the CENTCOM formulary “amount to a prescription for abuse.” He also said there is no rationale for prescribing multiple psychotropic drugs to troops.

Smith said he was “flabbergasted” that military doctors prescribed Seroquel as a sleep aid, as the Food and Drug Administration has not approved such a use and other drugs are more effective. Breggin agreed, calling Seroquel “very dangerous, expensive and not proven to be more beneficial than other drugs.”

Jackson noted Seroquel has the addictive potential of opioids, such heroin.

CENTCOM’s allowance of Seroquel as a sleep aid also seems to fly in the face of a high-level Defense policy set in November 2006. In a memo titled “Policy Guidance for Deployment Limiting Pyschiatric Conditions and Medications,” William Winkenwerder, then assistant secretary of Defense for health affairs, said psychotropic medications that would prohibit troops from deployment included those used to treat chronic insomnia.

Asked if prescribing Seroquel to aid sleep violated this policy, Stasinos and Labadie said in an e-mail, “Seroquel is not prescribed for chronic insomnia. Lower doses have been used to aid soldiers with troubled sleep for anxiety-related nightmares.” They added while other sleep medications are on the CENTCOM formulary, none appears to relieve nightmares as effectively as Seroquel.

Laura Woodin, a spokeswoman for the U.S. division of London-based AstraZeneca, which makes Seroquel, said the drug is not approved by the FDA as a sleep aid or to treat post-traumatic stress disorder. But, she added, mental health professionals often prescribe it to treat conditions not approved by the FDA. “Like patients, we trust doctors to use their medical judgment to determine when it is appropriate to prescribe medications,” Woodin said.

Nightmare

Stan White, a retired high school teacher who lives in the small town of Cross Lanes, W.Va., has observed the effects Seroquel can have. When his son Andrew returned from a tour in Iraq with the Marine Reserve 4th Combat Engineer Battalion in 2007, he was diagnosed with post-traumatic stress disorder and was prescribed three psychotropic drugs, including Seroquel, by the Huntington Veterans Affairs Medical Center, White said.

VA started Andrew on 25 milligrams of Seroquel a day and upped the dose to 1,600 milligrams a day (the CENTCOM-approved dose is 25 milligrams a day). Andrew White died in his sleep Feb. 12, 2008, six months after seeking help.

White said Andrew was so befuddled by his drug cocktail, which included Klonopin, a benzodiazepine, and hydrocodone, an opiate, that his wife, Shirley, had to dole them out forAndrew. White said Seroquel did not diminish Andrew’s nightmares at even such a high dosage.

While talk therapy is widely viewed as one of the most effective treatments for some mental health problems, including PTSD, White said Andrew had only a few such sessions, primarily with a local veterans’ peer therapy group. It was not until the week Andrew died that a VA psychiatrist decided to begin intensive sessions with him.

Stan White says his mission in life today is to expose the dangers of Seroquel. The drug, he said, “turns people unto zombies. I cannot imagine going into battle on Seroquel.”

MEDS AND MREs

Some of the drugs on the CENTCOM Formulary of CNS Medication Restrictions require patients to follow restricted diets, a tall order for deployed troops operating in remote areas and eating a steady round of Meals Ready to Eat field rations, according to Dr. Peter Breggin, a psychiatrist.

At least three of the antidepressant drugs on the CENTCOM formulary are monoamine oxidase inhibitors, which also exist in the intestine and help break down a substance in food know as tyramine.

MAOIs on the formulary include Marplan, Nardil and Parnate, and patients taking these drugs should avoid foods that contain significant amounts of tyramine, which interferes with the action of natural tyramine in the intestines. If not, too much of the MAOI could enter the bloodstream, which could cause a hypertensive crisis due to elevation of blood pressure.

Foods in MREs that contain tyramine include pepperoni and cheese and, among the favorite snacks, raisins and peanuts.

MAOIs also increase the amount of norepinephrine, a hormone, neurotransmitter and blood vessel constrictor, and patients taking these medications should not be prescribed other drugs that could also increase norepinephrine levels. These include amphetamines, dextroamphetamine and Ritalin, which are also on the CENTCOM formulary.

Read article here: http://www.nextgov.com/nextgov/ng_20110118_8944.php?oref=topstory

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Drug Industry Settlements In 2010 Largest Ever—$2.5 Billion

admin — Tue, 23 Nov 2010 16:41:35 +0000

NPR November 23, 2010

by Carrie Johnson

Image: Carlos Porto

The Justice Department has collected a whopping $3 billion in settlements this year with help from whistleblowers and a powerful law known as the False Claims Act, Assistant Attorney General Tony West announced this morning.

And guess where $2.5 billion of that $3 billion came from? Big Pharma.

This year’s biggest hauls under the False Claims Act include $669 million of the record-shattering $2.3 billion total the government took from Pfizer over its improper promotion of the painkiller Bextra, $302 million from Astra Zeneca over the anti-psychotic drug Seroquel, and $192 million from Novartis.

West told reporters the Civil War era law had become “one of our most successful civil enforcement tools,” allowing the Justice Department to recover “money that otherwise would have padded the bank accounts of defendants who sought profit over quality.”

And he vowed that the Obama administration would do more to go after individual executives who had green-lighted frauds against the federal government by seeking to bring civil and criminal charges that could put them out of business and in some cases, into federal prison.

“We’re going to hold both companies and individuals accountable,” West said.

Justice Department officials say the 2010 health care recovery is the largest in history, and the total recovery is the second largest, up from some $2.4 billion last year. Altogether, they’ve taken in $5.4 billion since January 2009 under the Act.

Congress recently strengthened the law and expanded the ability of whistleblowers to recover money if they alert the Securities and Exchange Commission to financial fraud.

That, West said, could be one of the next fronts in a battle against fraud that’s been intensifying rapidly.

http://www.npr.org/blogs/health/2010/11/22/131517940/drug-industry-settlements-in-2010-largest-ever-under-false-claims-act

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Pfizer ends trial after widespread overdosing of children with psych drug

admin — Mon, 18 Oct 2010 17:03:00 +0000

NaturalNews.com, October 18, 2010

by David Gutierrez

Drug giant Pfizer has canceled a scheduled clinical trial of its antipsychotic drug Geodon after the FDA accused it of subjecting child participants in a prior study to “widespread overdosing.”

“After careful consideration, the company decided not to proceed with the study,” Pfizer spokesperson Gwendolyn Fisher said.

Fisher said that although the company had taken “preparatory steps” toward the trial, it had decided to abandon the study in order “to meet regulatory timelines.” No patients were enrolled.

Pfizer is seeking FDA approval to market Geodon for the treatment of bipolar disorder in children between the ages of 10 and 17. An FDA panel already rejected this use once in 2009 by a vote of 10-7, expressing concern that large numbers of participants had failed to complete clinical trials of the drug. The FDA asked Pfizer for further information on the drug’s safety in children, and the company responded by launching pediatric trials of the drug.

In April, the FDA warned the company that researchers in charge of the trials were engaging in “significant violations,” including “widespread overdosing” caused by inadequate company oversight.

Five months earlier, Pfizer had agreed to pay $2.3 billion to settle a collection of federal and state criminal and civil charges that it had improperly marketed Geodon and three other drugs.

Geodon, which made Pfizer $1 billion in 2009, is already approved for the treatment of bipolar disorder and schizophrenia in adults. Its competitors AstraZeneca and Eli Lilly have already secured FDA approval to use their respective antipsychotics Seroquel and Zyprexa to treat bipolar disorder in children.

Treatment of children with antipsychotics remains a controversial practice amid growing concern over major side effects such as severe metabolic changes and weight gain.

Although Geodon’s most recent safety trial has been canceled, the company made it clear that it still plans to secure FDA approval for pediatric use of the drug.

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