Posts Tagged ‘Seroquel’

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Heart Warning Added to Label on Popular Antipsychotic Drug Seroquel

Tuesday, July 19th, 2011

Today the New York Times has reported, “AstraZeneca is adding a new heart warning to the labels of Seroquel, its blockbuster antipsychotic drug, at the request of the Food and Drug Administration, company and agency officials said on Monday.”   And that  “Seroquel is one of the top-selling drugs in the world, at $5.3 billion last year, including $3.7 billion in the United States. Introduced in 1997, it has been approved for schizophrenia, bipolar disorder and severe depression. Seroquel has caused legal problems for AstraZeneca, including a $520 million payment in 2009 to settle government charges of illegal marketing. Thousands of lawsuits are pending over side effects like diabetes.” (read the full article here http://www.nytimes.com/2011/07/19/health/19drug.html )

While this is seemingly good news, look a little deeper—today’s article from Paul Thacker, an investigator for Project on Government Oversight:

Paging Dr. Woodcock…Dr. Janet Woodcock….Do You Have Any Clue What’s Happening Inside the FDA?

There is confusion and then there is confused confusion–a level of incomprehensibility that defies sound, sober attempt at explanation. After confused confusion comes…the FDA.

Case in point: the FDA’s dithering over changes to the label of an antipsychotic drug now widely prescribed to veterans with post-traumatic stress disorder. Last October, POGO sent a letter to FDA Commissioner Margaret Hamburg asking her to look into a potentially dangerous interaction of the drugs Seroquel (quetiapine) and methadone that may be putting veterans at risk.

Prescriptions of Seroquel and methadone are at an all-time high for veterans who are suffering extremely high rates of PTSD after combat. An investigation by the Military Times found that military spending on Seroquel almost quadrupled between 2001 and 2009. Many of these veterans are also taking methadone for pain relief and to control anxiety caused by PTSD. The Military Times found that methadone overdose has caused at least 60 deaths in the military—more than any other drug, legal or illegal.

A separate investigation by the Associated Press noted that military expenditures on Seroquel have jumped sevenfold since the beginning of the war in Afghanistan. The military spent $8.6 million on Seroquel in 2009. Physicians said that they are prescribing it to provide relief from nightmares and anxiety caused by PTSD.

The Associated Press also discovered that Seroquel has become the Department of Veterans Affairs’ (VA) second biggest drug expenditure since 2007. In 2009, the VA spent $125 million on Seroquel compared to $14.4 million in 2001.

Alerting the FDA to this problem, we also sent a study published in 2007 in the Journal of Clinical Psychopharmacology. This study found that Seroquel significantly increases blood plasma levels of methadone.

How did FDA respond? In April, we received a letter signed by Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) at the FDA. According to Dr. Woodcock, there was nothing to worry about:

After assessment of our evaluations, we believe that a potentially dangerous interaction involving quetiapine and methadone is unlikely, and, therefore, no further Agency action is indicated regarding either a revision in labeling that would include new warnings or cautions, or targeted public and professional communications efforts.

To make sure we got the point, she added:

At this point, there is agreement within CDER that an interaction between quetiapine and methadone that confers unreasonable risks to patients is exceedingly unlikely and, therefore, no further action is indicated regarding the labeling for these products or for related communication initiatives.

Less than two months later, in June, the FDA approved changes to the label for Seroquel to note that the drug “should be avoided in combination with other drugs” such as methadone.

What the hell? This is exactly what we asked them to do. Exactly what Dr. Woodcock said didn’t need to be done.

Can somebody please explain this to me? Please!

Anyways, we are now sending a second letter to the FDA asking them, as we did in October, to please issue an action alert to inform patients and prescribers. There is a potential for people to die if they are on Seroquel and methadone, and it seems highly improbable that a military doctor treating veterans with PTSD has the time to read the entire 73 pages of the Seroquel label.

That’s right. It’s 73 fricking pages!!!

That’s not a label, that’s a novella.

We hope the FDA agrees to send out an action alert. But maybe we’ll get a letter from Dr. Woodcock saying that everything is okay, and no further action is indicated…and there’s no need to alarm people by sending out an action alert….

And then they’ll send it anyways.

Paul Thacker is a POGO Investigator.

http://pogoblog.typepad.com/pogo/2011/07/paging-dr-woodcockdr-janet-woodcockdo-you-have-any-clue-whats-happening-inside-the-fda.html

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

Monday, July 18th, 2011

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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Antidepressant Nation

Thursday, July 14th, 2011

Truthdig – July 14, 2011

10 percent of Americans over age six now take antidepressants

A serious conversation is under way in the United States on the subject of psychiatric drugs. The debate consists of three fundamental issues: first, whether antidepressants actually treat depression; second, the vast, growing body of evidence that psychotropic medications alter the brain permanently; and third, the pharmaceutical industry’s continuing, decades-old corruption of American psychiatrists, many of whom have been made by drug companies’ shenanigans into little more than handsomely paid industry shills.

A careful questioning of these issues written by the spectacularly decorated Harvard Medical School lecturer Dr. Marcia Angell appeared as a two-part essay published earlier this summer in The New York Review of Books. In addition to holding a medical degree from Boston University School of Medicine and undergraduate diplomas in both chemistry and mathematics, Angell is a Fulbright Scholar, a board-certified pathologist, author of two books, a member of numerous professional health care associations and a retired 20-year staffer at the New England Journal of Medicine, which she ultimately left as editor-in-chief.

The recent publication of three books, each of which takes up one of the issues raised above, provided the occasion for Angell’s essay. In it, she argues convincingly that antidepressants are not known to do what drug companies and many psychiatrists say they do. It is this claim that drew the attention of practicing psychiatrist and Brown University professor Dr. Peter D. Kramer, who in a New York Times commentary published last Sunday questioned some but not all of what Dr. Angell wrote.

Both articles deserve to be read, but there is a crucial difference between them. While Kramer points to much data that must be taken seriously, his wandering defense of the utility of antidepressants does not undo the diligent, methodical inquiry one would expect from someone with Angell’s credentials—and which she delivers. Otherwise, he too is a critic of Big Pharma’s shady dealings. Kramer nods with genuine concern toward the dangers associated with the prolonged use of psychotropics and, in his conclusion, expresses support for treatment via effective alternatives. Both professionals agree that serious research needs to be done to understand exactly what these drugs are doing. —ARK

Marcia Angell in The New York Review of Books:

Nowadays treatment by medical doctors nearly always means psychoactive drugs, that is, drugs that affect the mental state. In fact, most psychiatrists treat only with drugs, and refer patients to psychologists or social workers if they believe psychotherapy is also warranted. The shift from “talk therapy” to drugs as the dominant mode of treatment coincides with the emergence over the past four decades of the theory that mental illness is caused primarily by chemical imbalances in the brain that can be corrected by specific drugs. That theory became broadly accepted, by the media and the public as well as by the medical profession, after Prozac came to market in 1987 and was intensively promoted as a corrective for a deficiency of serotonin in the brain. The number of people treated for depression tripled in the following ten years, and about 10 percent of Americans over age six now take antidepressants. The increased use of drugs to treat psychosis is even more dramatic. The new generation of antipsychotics, such as Risperdal, Zyprexa, and Seroquel, has replaced cholesterol-lowering agents as the top-selling class of drugs in the US.

Read Part 1: The Epidemic of Mental Illness: Why?

Read Part 2: The Illusions of Psychiatry

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

Tuesday, July 12th, 2011

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?

Thursday, June 30th, 2011

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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US Troops Heavily Medicated on Prescription Drugs, Report Warns

Wednesday, June 22nd, 2011

MyFoxDetroit.com
June 22, 2011

Men and women in the US military are more medicated than ever — and their doctors do not even know who takes what, The Daily reported Wednesday.

The Department of Defense does not keep track of medical prescriptions doled out to service members in combat, despite ongoing pleas from federal officials to do just that.

Last week, a report on the military’s 2012 budget from the House Appropriations Committee remarked that the prescription of pain management drugs is handled inconsistently, especially in battle.

The report also handed down an ultimatum: within two months of the budget’s approval, the committee wants concrete information on “the required steps and potential obstacles toward electronic transmission of prescription drug data.”

A 2010 US Army study found that 14 percent of soldiers had been prescribed an opiate painkiller, with 95 percent of those prescriptions for oxycodone, a notoriously-addictive pharmaceutical best known by the brand name OxyContin.

And since 2001, military spending on prescription medication has skyrocketed. Orders for antipsychotics like Seroquel are up 200 percent, and demand for anti-anxiety drugs like Valium has increased by 170 percent, according to Defense Logistics Agency records.

Many of the antidepressants, antipsychotic drugs and anti-anxiety drugs prescribed are highly addictive. Potential side effects include dulled reaction times, irritability and a heightened risk of suicide.

“The medications they use shouldn’t be so heavily prescribed in combat,” said Dr. Judith Broder, a psychiatrist and founder of the Soldiers Project, a nonprofit counseling service.

“But they can’t afford to send anyone home. They need the bodies — health and welfare are secondary,” she said.

Read article here:  http://www.myfoxdetroit.com/dpps/news/us-troops-heavily-medicated-on-prescription-drugs,-report-warns-dpgonc-20110622-to—_13806740

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Dosed in juvie jail: Troubled doctors hired to treat kids in state custody

Monday, June 20th, 2011

By Michael LaForgia

Palm Beach Post Staff Writer

By the time Florida started paying Dr. Gold Smith Dorval to counsel and medicate jailed children, the Pembroke Pines psychiatrist already had experience with kids in state custody.

He had used them, authorities said, to bilk the government out of money for the poor.

When Dorval pleaded no contest to a felony grand theft charge, it should have barred him, by law, from working for Florida’s Department of Juvenile Justice.

It didn’t.

And, like Dorval, other doctors have emerged from past troubles and gotten jobs at DJJ – with authority to prescribe drugs to kids in state jails, a Palm Beach Post investigation has found.

Some psychiatrists took DJJ jobs after they were cited for breaking the law, making grave medical missteps or violating state rules. Others were hired after they were accused of overmedicating patients, sometimes fatally.

All were empowered to prescribe drugs to jailed kids as powerful antipsychotic pills flowed freely into Florida’s homes for wayward children.

“It’s appalling. A psychiatrist is a psychiatrist. They’re licensed, they’ve been to medical school, and there is a certain trust placed in that person’s judgment when they tell you that this child needs to be medicated,” said John Walsh, an attorney with the Palm Beach County Legal Aid Society who has represented children in juvenile court. “This just illustrates that we always have to be on guard with children.”

In two years, Florida bought hundreds of thousands of tablets of Seroquel, Abilify, Risperdal and other antipsychotic drugs for children housed in state-run jails and programs. The meds were administered in a juvenile justice system that doesn’t track prescriptions and has no way of telling whether doctors are prescribing to make kids easier to control.

In some jails and homes, pills were prescribed by psychiatrists who took huge speaker fees from companies that make antipsychotic drugs, The Post found. In others, the task fell to doctors with troubled pasts.

In response to the newspaper’s first reports, published last month, DJJ Secretary Wansley Walters launched an investigation into the department’s use of antipsychotic drugs. DJJ officials declined to discuss The Post’s latest findings, citing the probe.

Spokesman C.J. Drake acknowledged, though, that the department has struggled to find psychiatrists willing to work in jails and programs. He also said DJJ sometimes has relied on companies that employ a stable of doctors, rather than signing a contract with a single physician.

As a result, Dorval went to work in a Broward County jail for children – even though he would have failed a state-mandated background check required by the contract.

Doctor’s bogus billings

In the late 1990s, Dorval claimed he was providing juvenile delinquents and other vulnerable children with needed therapy. Instead, state investigators said, he used bogus counselors to bill Medicaid for more than $350,000 in fraudulent claims.

He charged the government for offering more than 24 hours’ worth of children’s therapy in a single day, investigators said, and structured the scheme around kids who were homeless or in DJJ custody or foster care.

He tended to bill “for those children that the system ‘lost,’ ” according to an affidavit for his arrest.

Originally charged with four felonies in Broward, Dorval pleaded no contest to one count of grand theft in 2004.

Later, to keep his medical license, he agreed to pay $10,000 and was suspended, reprimanded and put on four years’ probation.

Although a judge withheld a formal finding of guilt, the plea disqualified Dorval from seeing patients in a juvenile jail. Even so, his employer, Miami-based Compass Health Systems, sent him to work at the Broward Juvenile Detention Center between August and December 2007.

No one screened his background beforehand.

In written responses to questions, Dorval said he was doing as he was told when Compass sent him to work in the Broward juvenile jail.

“At that period you cited, the psychiatrist that was seeing patients at the DJJ was out. Therefore I was designated by the management office to go and cover for that psychiatrist, until they switched me again to another place. I was not aware of any wrongdoing,” wrote Dorval, who stressed that he never signed a contract with DJJ. “I am only an employee. Wherever they send me to work I have to go.”

As for the criminal charges, he offered this explanation: “This case was a simple matter that became complicated, because my first lawyer messed me up.” After wrangling over the facts, “they decided to offer me a plea that would allow me to get a chance to fight for my license to practice medicine,” he wrote. “It was a real nightmare that generated in me a post-traumatic syndrome that I will never forget.”

DJJ officials declined to comment on Dorval’s hiring, again citing the investigation.

Compass officials didn’t respond to questions about Dorval.

DJJ had no contract with Compass as of May, records show.

Patient’s death missed in screening

In state-operated jails and programs, the rules say DJJ must screen doctors’ backgrounds and verify that physicians’ hold valid medical licenses. In privately run programs, which house the majority of children in the department’s custody, that responsibility falls to contracted companies.

Such screenings don’t catch everything: Doctors who kept their licenses after the state accused them of serious lapses have gone on to work in juvenile jails and homes.

Dr. Charles J. Dack is an example. For six years, Dack, a Lakeland-based physician who is board-certified in addiction and child psychiatry, prescribed a cocktail of antidepressants and powerful painkillers, including methadone and morphine, to a patient named Mary Tuxbury.

Eventually, Dack ramped up the doses of pills Tuxbury was taking, keeping her “at a toxic level of morphine for approximately two and a half years,” regulators from the state health department said. In March 2002, Tuxbury was found dead. She was 42.

An autopsy showed she died of “multiple drug intoxication, namely opiates and tricyclic antidepressants.”

Regulators charged Dack with failing to meet care standards and inappropriate prescribing. Dack settled the allegations in August 2007. He admitted no wrongdoing but agreed to pay a $7,000 fine and complete a course on “misprescribing” drugs.

A year later, he was hired to care for children at three privately run programs in Central Florida: Wilson Youth Academy, Peace River Youth Academy and New Beginnings Youth Academy. He worked in the homes until April.

Dack didn’t respond to messages seeking comment.

Doctor hired after child’s death

Other DJJ doctors weren’t cited by regulators, but they were accused in court of fatal neglect. Roughly one in eight of the psychiatrists who have worked for DJJ in the past five years has settled a malpractice lawsuit in Florida, records show.

Among these was Dr. Samuel McClure. As a psychiatrist in Orlando, McClure diagnosed an 11-year-old boy named David Morganthal with attention deficit disorder. He prescribed powerful, mind-altering drugs for David – even though the child was much smaller than other kids his age, according to court documents.

One morning in November 2001, David’s mother woke to find her son dead on the floor of her double-wide mobile home. When they laid David out at the morgue, he measured less than 4-foot-2 and weighed 49 pounds.

Lab tests showed his blood contained an unusually high concentration of an antidepressant: about 60 percent more of the medication than doctors had expected.

The drug, mirtazapine, still hasn’t been approved as safe for children. David was taking the drug along with another antidepressant that hasn’t been approved for kids, citalopram.

The autopsy concluded the boy probably died from a seizure and heart problems caused by “reaction to prescription medication.”

Read the rest of the article here: http://www.palmbeachpost.com/news/state/dosed-in-juvie-jail-troubled-doctors-hired-to-1549240.html?viewAsSinglePage=true

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Creating juvenile zombies, Florida-style

Sunday, May 29th, 2011

The Miami Herald – May 28, 2011

By Fred Grimm

They’re children of the new Florida ethic. Zombie kids warehoused on the cheap in the state’s juvenile lock-ups. Kept quiet, manageable and addled senseless by great dollops of anti-psychotic drugs.

A relatively small percentage of young inmates pumped full of pills actually suffer from the serious psychiatric disorders that the FDA allows to be treated by these powerful drugs. But adult doses of anti-psychotic drugs have a tranquilizing effect on teenage prisoners. Prescribing anti-psychotics for so many rowdy kids may be a reckless medical practice, but in an era of budget cuts and staffing shortages, it makes for smart economics.

Florida fairly inundates juvenile offenders with this stuff.

The Palm Beach Post reported last week that the Florida Department of Juvenile Justice has been buying twice as many doses of the powerful anti-psychotic Seroquel as it does ibuprofen. As if the state anticipated more outbreaks of schizophrenia than headaches or minor muscle pain.

The Post found that Florida purchased 326,081 tablets of Seroquel, Abilify, Risperdal and other antipsychotic drugs during a two-year period for the boys and girls who occupy the 2,300 beds in state-run residential facilities. (Most of the state’s juvenile offenders are held in jails operated by for-profit contractors. Records revealing the quantity of medications that private companies pour down their prisoners’ gullets were not available.)

Such drugs, meant for adults, are known to send children into suicidal despair, along with risking heart problems, weight gain, diabetes and facial tics. Yet, the DJJ and its contract psychiatrists push them willynilly onto their young wards.

It’s not as if state officials have been unaware of the risks facing children prescribed “off label” uses (unapproved by the FDA) of these pharmaceuticals. Even as the state doled out Seroquel like candy to kids in DJJ jails, the Florida Attorney General’s office was entering into a lawsuit with 36 other states against drug manufacturer AstraZeneca for promoting dangerous, off-label uses of Seroquel for treating both the young and the elderly. (AstraZeneca agreed to settle the lawsuit in March for $68.5 million and to stop marketing the drug for unauthorized uses.)

It was as if the schizophrenics most in need of Seroquel were roaming the halls of government, not the juvenile jails.

“This is the face of all these budget cuts; what happens when you eliminate social workers and prison guards,” said Broward Public Defender Howard Finkelstein. He suspects that DJJ has compensated for the staff shortages at state lockups by pumping “the most powerful drugs known to man into children who have not been diagnosed for psychiatric problems.”

Finkelstein says he assigned two of his staff attorneys last week to visit juvenile lock-ups and investigate what he calls the “zombification” of young offenders who had been represented by his office.

Florida Attorney General Pam Bondi opened her own investigation last week. Bondi’s staff attorneys are interested in the Post’s report that psychiatrists prescribing off-label uses of such astounding quantities of the profitable anti-psychotics for DJJ prisoners (at taxpayer expense) had been greased by drug manufacturers with some $250,000 in gifts and speaking fees.

The DJJ drug scandal seems all the more maddening considering that it follows a similar uproar just two years ago after the suicide of a seven-year-old Margate foster child. Young Gabriel Myers had been given adult dosages of three anti-psychotics before he hung himself.

The Gabriel Myers Task Force, made up of child advocates, state officials, political leaders and judges from across the state, spent a year investigating whether the Florida Department of Children and Families had administered dangerous drugs as “chemical restraints” for troublesome foster children.

Foster kids, as it turned out, weren’t the only victims of the on-the-cheap ethic. But don’t think of children reduced to zombies. Think of all the money we save on prison guards.

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How Seroquel, a Risky Antipsychotic, Became a “General Purpose” Mental Health Drug

Friday, May 27th, 2011

BNET
By Jim Edwards
May 27, 2011

In 2008, the FDA declared that powerful antipsychotics such as AstraZeneca (AZN)’s Seroquel were being over-prescribed and started a monitoring initiative to curb their use. It hasn’t worked, judging by an analysis of the FDA’s adverse event database by the Institute for Safe Medication Practices.

Seroquel is only approved for schizophrenia, mania and bipolar disorders. It’s a powerful drug that has serious side effects if taken for a long time: It’s associated with weight gain and diabetes, among other problems.

Yet the ISMP found that 47 percent of all adverse events linked to Seroquel since 2004 occurred when the drug was being used for unapproved or “off-label” purposes, such as depression. 21 percent of adverse events are linked to off-label use of Seroquel in depression — a condition for which there are plenty of other available drugs — and 26 percent of events occur with other off-label uses:

The ISMP said:

the adverse event data show quetiapine [Seroquel] has become a general purpose psychiatric drug with most reported injuries occurring outside its core indication for treatment of the most severe mental disorders, schizophrenia and psychosis.

In the off label category more than half the cases were for sleep disorders and insomnia. The next largest group was anxiety, and the remainder was divided among many other medical uses including autism, panic attack, headache, restlessness, nervousness, dementia and agitation.

The report is yet another in a series of publications from a variety of sources that suggest some psychiatric doctors are abusing their patients with Seroquel. In addition to the FDA’s 2008 declaration, consider:

Injuries from Seroquel’s side effects can be severe and permanent. In addition to diabetes they include suicidal/self-injurious behavior, and neurological movement disorders such as tardive dyskinesia, dystonia and parkinsonism.

AstraZeneca’s role in promoting Seroquel for off-label uses is well documented. The company has paid $1.5 billion in legal costs and settlements for its mismarketing of the drug ($520 million to the Department of Justice; another $743 million in legal costs in unresolved cases through March 2011; and $198 million in civil settlements.)

So doctors have no excuse. The FDA — which has almost no jurisdiction over physicians — and the courts have performed their roles. It’s time for the medical profession to take responsibility for the damage it is causing and cut down on its dispensing of Seroquel.

Read article here:  http://www.bnet.com/blog/drug-business/how-seroquel-a-risky-antipsychotic-became-a-8220general-purpose-8221-mental-health-drug/8545

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Antipsychotic Drugs Deadly for Elderly Patients, Prescribed Anyway

Thursday, May 12th, 2011

ThirdAge.com

by Alex Heig

Antipsychotic drugs prescribed to as many as one in seven patients with dementia at nursing homes increase the risk of death and are not approved for such uses, a government audit has found.

Drugs such as Risperdal, Zyprexa, Seroquel, Abilify and Geodon are “potentially lethal” to many of the patients getting them and in many cases, completely unnecessary and unneeded.

The Centers for Medicare and Medicaid Services said that some of the inappropriate use of antipsychotics can be attributed to drugmakers’ habit of paying kickbacks to nursing homes to increase prescriptions for the medicines.

Medicare officials said that diagnosis information is for the most part omitted from prescriptions so officials are unable to tell whether the prescription is appropriate.

The Food and Drug Administration has warned doctors of the risk of using antipsychotic drugs in elderly dementia patients, but doctors have continued the practice because of a relative lack of other options.

Doctors want to maximize quality of life by treating the patient’s agitation even if that means the patient will die a bit sooner,” said Dr. Daniel J. Carlat, editor-in-chief of The Carlat Psychiatry Report, a medical education newsletter for psychiatrists.

The results of the government audit showed that during the first six months of 2007, 304,983 elderly patients in nursing homes (out of 2.1 million total) had at least one Medicare claim for an antipsychotic medicine.

Meanwhile, 83 percent of antipsychotic prescriptions for elderly nursing home residents were for uses not approved by federal drug regulators, and 88 percent were to treat patients with dementia, for whom the drugs can be lethal.

Federal regulations prohibit any drug paid for by the government from being used for non-approved reasons. Auditors found that 51 percent of claims for antipsychotic medication violated this rule.

Additionally, the government bans drugs used in excessive duration or dose level, even for patients that qualify. Auditors found that 22 percent of claims failed to live up to this requirement.

http://www.thirdage.com/news/antipsychotic-drugs-deadly-for-elderly-patients-prescribed-anyway_05-10-2011?page=1

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