Archive for May, 2011

Cause for alarm: Antipsychotic drugs for nursing home patients

Tuesday, May 31st, 2011

CNN
By Daniel R. Levinson, Special to CNN
May 31, 2011

Daniel Levinson, inspector general for the OIG in the Department of Health and Human Services.

When a loved one moves into a nursing home, the support of family and friends is particularly important. This is especially true when the nursing home patient has dementia and can’t adequately advocate on his or her own behalf.

A newly released report from my office — the Office of the Inspector General for the Department of Health and Human Services — makes clear just how crucial it is for families to monitor and ask questions about medications that such patients receive. The report found that too often, elderly residents are prescribed antipsychotic drugs in ways that violate government standards for unnecessary drug use.

Frequently, they are prescribed in ways that don’t qualify as medically accepted for Medicare coverage. In addition, the drugs were predominately prescribed for uses that are not approved by the Food and Drug Administration.

But the most potentially troubling finding of the study is this: Researchers found that 88% of the time, these drugs were prescribed for elderly people with dementia.

This is precisely the population that faces an increased risk of death when using this class of drugs, according to the FDA. That’s why the agency puts its strongest safety warning, called a “black box warning” on these antipsychotic drugs, cautioning about the risk of death when taken by elderly people with dementia.

The report didn’t investigate why patients with dementia are prescribed antipsychotic drugs so often. But a series of lawsuits and settlements that my office helped bring about suggests that many pharmaceutical companies have improperly promoted these drugs to doctors and nursing homes for many years.

Another view: In defense of antipsychotics for dementia

The study began a few years ago, when a member of Congress questioned how many nursing home residents received a class of antipsychotic drugs introduced in the 1990s, among them risperidone and olanzapine. These drugs are known as “atypical” or “second generation” antipsychotics. They replaced the antipsychotic drugs introduced in the 1950s and 1960s to treat schizophrenia — and, incidentially, are far costlier.

The report found about 305,000 nursing home residents (about 14%) had Medicare claims for atypical antipsychotic drugs. Of these, about one in five residents was prescribed these antipsychotics in a way that violated government standards for their use. For example, residents were on a drug for too long, or at too high a dose.

Another finding: A little more than half the antipsychotic drug claims for which Medicare paid should not have been covered. Why? The claimed drugs were not used for medically accepted reasons or there were no records the drugs were actually provided.

To be clear: Most physicians and nursing homes dispense antipsychotic drugs with the best interests of patients in mind. Physicians can use their medical judgment to prescribe drugs for uses unapproved by the FDA, and also to patients for whom the boxed warning applies. Ideally, however, doctors who prescribe in such ways first determine that the benefits outweigh the risks.

Yet it remains a concern that so many elderly nursing home residents with dementia are prescribed antipsychotics. And, unfortunately, examples abound of companies’ improper promotion of these drugs.

Government investigations of Bristol-Myers Squibb, AstraZeneca and Pfizer found that they improperly promoted their antipsychotic drugs for unapproved uses.

Federal prosecution is pending against Johnson & Johnson for allegedly paying millions of dollars in kickbacks to induce Omnicare, the nation’s largest long-term care pharmacy, to recommend the use of Risperdal in treating nursing home patients, many of whom had dementia.

And Eli Lilly pleaded guilty to criminal charges associated with illegally marketing its drug Zyprexa, including to doctors who treat elderly nursing home patients.

Pharmaceutical companies have paid billions to resolve civil and criminal liabilities under federal health and safety laws. But money can’t adequately compensate for corporate campaigns that could put vulnerable, elderly patients at risk.

How do we solve this problem? There’s plenty to do.

Family members of nursing home residents must learn about their loved ones’ medications, the reasons for their use, proper dosages and possible side effects.

Nursing homes and pharmacies that serve the elderly must keep the best interests of the patient in mind when dispensing pharmaceuticals and not base the decision on the improper influence of drug companies.

Doctors, too, should rely on their best medical judgments and engage in an especially careful analysis when prescribing drugs for off-label use.

Government must combat illegal off-label promotion of these powerful and potentially lethal drugs and uphold nursing home safety standards.

And drug companies should follow the laws, and refrain from promoting drugs for unapproved uses — or paying kickbacks to influence doctors and institutions. About 46 million people are enrolled in Medicare. That will only grow as the huge baby boomer population retires. We cannot afford to leave unaddressed the urgent problem of antipsychotic drug use among elderly nursing home residents.

The opinions in this commentary are solely those of Daniel Levinson.

Read article here:  http://www.cnn.com/2011/OPINION/05/31/levinson.nursing.home.drugs/

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In shift, feds target top execs for health fraud

Tuesday, May 31st, 2011

Associated Press
May 31, 2011

Lewis Morris, general counsel for the Department of Health and Human Services inspector general, poses for a portrait in his office in Washington, Thursday, May 26, 2011. (AP Photo/Jacquelyn Martin)

WASHINGTON (AP) — It’s getting personal now. In a shift still evolving, federal enforcers are targeting individual executives in health care fraud cases that used to be aimed at impersonal corporations.

The new tactic is raising the anxiety level — and risks — for corporate honchos at drug companies, medical device manufacturers, nursing home chains and other major health care enterprises that deal with Medicare and Medicaid.

Previously, if a company got caught, its lawyers in many cases would be able to negotiate a financial settlement. The company would write the government a check for a number followed by lots of zeroes and promise not to break the rules again. Often the cost would just get passed on to customers.

Now, on top of fines paid by a company, senior executives can face criminal charges even if they weren’t involved in the scheme but could have stopped it had they known. Furthermore, they can also be banned from doing business with government health programs, a career-ending consequence.

Many in industry see the more aggressive strategy as government overkill, meting out radical punishment to individuals whose guilt prosecutors would be hard pressed to prove to a jury.

The feds say they got frustrated with repeat violations and decided to start using enforcement tools that were already on the books but had been allowed to languish. By some estimates, health care fraud costs taxpayers $60 billion a year, galling when Medicare faces insolvency.

“When you look at the history of health care enforcement, we’ve seen a number of Fortune 500 companies that have been caught not once, not twice, but sometimes three times violating the trust of the American people, submitting false claims, paying kickbacks to doctors, marketing drugs which have not been tested for safety and efficacy,” said Lewis Morris, chief counsel for the inspector general of the Health and Human Services Department.

“To our way of thinking, the men and women in the corporate suite aren’t getting it,” Morris continued. “If writing a check for $200 million isn’t enough to have a company change its ways, then maybe we have got to have the individuals who are responsible for this held accountable. The behavior of a company starts at the top.”

Lawyers who represent drug companies say the change has definitely caused a stir, but the end result is far from certain.

“People are alarmed,” said Brien O’Connor, a partner in the Boston office of Ropes & Gray. “They want to know what facts and circumstances would cause the Justice Department to indict someone who hadn’t even known about the misconduct. They are doing all they can to achieve compliance.”

Others say high-powered corporate targets won’t go meekly.

“If the government does continue to press its campaign against individuals, we will see the limits of the government’s theories tested,” said Paul Kalb, who heads the health care group at the law firm of Sidley Austin in Washington. “In my mind, there is a very important open question as to whether individuals can be held criminally culpable or lose their jobs simply by virtue of their status.”

Although the Obama administration has increased scrutiny of corporate America generally, this shift in health care enforcement seems to have come up from the ranks, government and corporate attorneys say.

Investigators and lawyers at the HHS inspector general’s office, the Justice Department and the Food and Drug Administration started moving more or less independently toward holding executives accountable. Morris outlined the inspector general’s position in congressional testimony this spring, saying his office will use its power judiciously.

A test case is playing out with an 83-year-old drug company chief executive, Howard Solomon of New York City-based Forest Laboratories. Forest makes antidepressants, blood pressure drugs and other medications. Last month, the inspector general’s office notified Forest that Solomon could potentially be banned from doing business with federal programs.

The power to ban or “exclude” an individual rests with the inspector general. It’s routinely applied to low-level violators, but rarely to people of Solomon’s rank. In the industry, they call it the “death penalty.”

Last year, a Forest subsidiary pleaded guilty to criminal charges as part of a settlement with the Justice Department in which the company also agreed to pay $313 million to resolve long-running investigations. Prosecutors charged that Forest deliberately ignored an FDA warning to stop distributing an unapproved thyroid drug, promoted the use of an antidepressant in treating children although it was only approved for adults and misled FDA inspectors making a quality check at a manufacturing plant.

The company said it had considered the case closed. But then came the inspector general’s letter.

“No one has ever alleged that Mr. Solomon has done anything wrong and excluding him would be completely unjustified,” Herschel Weinstein, Forest’s general counsel, said in a statement. “In prior cases where a senior executive has been excluded, that individual has been accused of wrongdoing and ultimately has either been convicted of or (pleaded) guilty to a crime.”

Forest is fighting the move to ban Solomon. The inspector general’s office refused to comment on the case, and no final decision has been made. In congressional testimony, Morris said that when there is evidence an executive knew or should have known about misconduct, the inspector general “will operate with a presumption in favor of exclusion of that executive.”

Separate from the inspector general’s power to ban, the FDA has resurrected something called the “Park Doctrine,” which makes it easier for prosecutors to bring criminal charges against an executive.

The doctrine, stemming from a 1970s Supreme Court case, allows the government to charge corporate officers in the chain of command with a criminal misdemeanor. They could face up to a year in prison and fines if they had the authority and responsibility to prevent, detect or resolve misconduct affecting the public welfare but failed to do so.

It’s making an entire industry nervous.

Read article here:  http://www.google.com/hostednews/ap/article/ALeqM5jIGsUXYEAKspVXkeAdCDNumbbNFA?docId=d620a807289f47a6b01dfe728972a0b3

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Psychiatrists Push to Gain Support for Electroshocking Kids

Tuesday, May 31st, 2011
Note from CCHR:  The audacity of psychiatry never ceases to amaze us.   Take the issue of electroshock ‘treatment’,
a brutal procedure born out of an Italian slaughterhouse when psychiatrist Ugo Cerletti saw how pigs were easier to slaughter after being electroshocked,  and decided to try it on humans.     For decades psychiatrists have attempted to prove the efficacy of sending up to 450 volts of electricity searing through the brain, and for decades they have failed.  The entire premise is so moronic  it’s hard for any rational human being to comprehend how any ‘medical professional’ could justify it as “treatment.”   In fact, this is probably the reason that the public, having a natural and rational abhorrence for electroshock, often don’t believe psychiatrists still shock people.    But they do.   In fact, millions are electroshocked each year, including the ‘ elderly, pregnant women and children.    And now psychiatrists are attempting to legitimize  shocking kids, “hoping” that they can gain support for this plan.   They want to do more “research” which really means experimenting on innocent kids by eletroshocking them.     As cited in the article below, this isn’t quite so easy for them to do,  considering the laws prohibiting and/or restricting the use of electroshock on children – laws, incidentally, which were largely due to the work of CCHR.     So we are going to make this really, really simple.  Electroshocking kids is child abuse.    Period.
To read how psychiatry hopes to legitimize and gain support for electroshocking kids, read below:
May 30, 2011

Electroconvulsive Therapy in Pediatric Psychiatry

Electroconvulsive therapy (ECT) is a controversial practice of dealing with mental disorders and one that has attracted its fair share of detractors. Despite the fact that it was first used as long ago as 1938, it still carries with it a stigma that some find difficult to overlook. One might believe this method is one as harebrained as those employed in the middle ages to rid people of the demons that had possessed their minds. Unlike holes drilled into the skull, the use of ECT as a form of psychiatric treatment has continued into the present day. However, the ethical questions and legislations governing its practice mean that its use in the resolution of the severe symptoms of mental disorders in children is bound to be a delicate topic.

In recent years, the research on the effective ECT has been extended to its application in pediatrics. A recent study provides hope that the may be beneficial in the treatment of the more severe symptoms of autism as well as mood disorders in children. This study, undertaken by Wachtel, Jaffe and Kellner, examined the effectiveness of pediatric ECT in treating the symptoms exhibited by an autistic prepubescent boy with bipolar affective disorder. The 11-year-old child had been diagnosed with autism when he was two and a half years old. This combined with his unpredictable mood swings had resulted in him behaving aggressively towards his own family and caregivers. However the damage meted out to those who looked after him in no way compared to that he inflicted on himself. Photographs included with the research show the child with his face and hands bloodied from self-abuse.

A slew of pharmaceuticals prescribed to subdue these symptoms had no discernible effect on his behavior. As an inpatient, he was put on a new combination of drugs that led to some improvement but the violent symptoms returned in full force shortly after he was discharged. It was possibly the severity of the situation that led to his case being accepted as a candidate for pediatric ECT.

Eight ECT treatments were conducted on a three-times-a-week basis. By the fourth treatment, the child who had been unable to go to school or interact with other children due to “safety concerns” and needed two adult supervisors around him at all times, could now enjoy family outings and community interaction. He was reported to be “happy and calm” and, for what might have been the first time, could sleep soundly through the night. The paper closes with a recent picture of this boy we know only as J., sliding down a tunnel in a public playground smiling broadly for the camera. Following the end of J.’s ECT treatment he still required “maintenance” ECT on a weekly or fortnightly basis to prevent the symptoms from returning. While his therapists work on weaning him off the treatment entirely, his parents and carers continue to report on his ever-increasing cache of achievements, most recently spending five days away at summer camp.

Lee Wachtel has done some extensive work in the field of autism and the catatonic symptoms that accompany it in its more severe forms. She tends to focus her research on disorders that affect children and adolescents and the effectiveness of ECT on cases that are exceptionally severe. In addition to this study, Wachtel together with Griffin, Dhossche and Reti also put together a paper documenting their work with 14 year old autistic boy who was exhibiting the standard symptoms of catatonia including waxy flexibility, mutism and unresponsiveness. In this case, the symptoms were non-violent but more resistant to treatment. A number of variants of electroconvulsive therapy were utilised before a change in behavior was evident. However, those changes in behavior include independent performance of all activities of daily living, an active return to academics via home-schooling, and participation in sports including running, swimming, basketball and even horse-riding as a component of equine therapy.

The use of ECT in pediatrics is inadequately researched, not just because of the stigma associated with the practice,, but also because of legislation that governs the administration of this form of therapy on minors due to ethical concerns. In addition, Croarkin et al say that most psychologists who deal with adolescent and child psychiatry are not sufficiently trained in the use of ECT. Even more sparsely researched are the long term effects of ECT on its recipients. Though a handful of longitudinal studies do exist that attempt to cover this, the standard of the research methods employed remains ambiguous. Studies such as those conducted by Wachtel and others like her demonstrate the almost immediate benefits ECT has to offer in the field of pediatric mental health. However the question remains as to whether these benefits will hold in the long run without causing in any additional damage to the brain. Unfortunately, the answer is one we will have to wait for, but till then we can hope.

http://brainblogger.com/2011/05/30/electroconvulsive-therapy-in-pediatric-psychiatry/

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Hickierie Dickory Doc – McGorry Turns Back the Clock

Monday, May 30th, 2011

Seroxat Sufferers – Stand Up and Be Counted
By Bob Fiddaman
May 30, 2011

Patrick McGorry

McGorry’s Delorean continues on it’s trip back to the future in Australia, it’s new passenger, Prof Ian Hickie.

I say new, Hickie has been around for years.

Judging by an article in today’s Australian Telegraph, there seems to be questions being asked regarding the number of Australian children being prescribed antidepressant medication.

Elissa Doherty and Marianne Betts write:

The number of children aged six and under being prescribed anti-depressants has soared by almost 50 per cent since the federal government pledged to investigate the issue, new figures show.

Thing is, just two meetings have been held since Australian Health Minister, Nicola Roxon, ordered an investigation over three years ago!

In the meantime, McGorry’s Delorean [early intervention program] continues to pick up speed…with government backing!

Ian Hickie

Ian Hickie was the inaugural CEO (2000-2003) of ‘beyondblue: the national depression initiative’, which has very successfully sold depression in Australia, with many millions of dollars of government money. This has worked brilliantly for the drug companies, and beyondblue does not accept pharma funding, so the drug companies get the promotion for free. I’ve previously wrote about beyondblue back in November 2008.

Graham “Biff Tannen” Burrows, whom I wrote about here, is now retired but has played a huge role in promoting psychiatric diagnoses and psychotropic drugs in Australia, particularly in the 1990′s.

It would appear that Burrows has been totally in bed with the pharmaceutical companies. More importantly, he influenced government policy in the 1990′s to focus on depression. Without him, it could be suggested that beyondblue would not have come about nor would McGorry’s meteoric rise a decade or so later.

Beyondblue and Hickie paved the way for EPPIC, a psychiatric service aimed at addressing the needs of older adolescents and young adults with emerging psychotic disorders.

Hickie, it would appear, is the Burrows of the 21st century.

McGorry shot to fame last year when he was appointed Australian of the Year. Hickie and McGorry had already been working together for several years, in fact Hickie is a key player in McGorry’s ‘Headspace’).

Anything they say to the Aussie government seems to be taken at face value, this is something that baffles me. We can all make claims about “fixing” mental disorders because they simply cannot be diagnosed. The way forward for Australians is nipping these disorders in the bud by ‘catching them early.’ I cannot believe the Aussie government could fall for this – what evidence has McGorry supplied to back up these claims?

Whatever they say is usually accepted as gospel, and it is very rare for either of them to be criticised, save for a handful of advocates, a few Australian MP’s and the Citizens Commission on Human Rights [CCHR]

SPHERE

The PDF above is a seemingly egregious example of the conflicts of interests that exist: a whole journal supplement based on the SPHERE project clinical audit. The audit was funded by Bristol-Myers Squibb (see p. S54), the manufacturer of Serzone. The publication of the supplement was funded by beyondblue with Commonwealth [Australian] Government money (see title page).

The audit, which used Hickie’s SPHERE questionnaire, found ridiculously high rates of mental disorders. This was reported in the supplement by Hickie, Davenport, Naismith, & Scott (2001, p. 52) as:

‘Sixty-three per cent of people attending general practice have some evidence of mental disorder (including alcohol or other substance misuse) by self-report or GP’s diagnosis of psychological difficulties.’

63%?

That’s some cash cow huh?

Not surprisingly, if you scroll to the bottom of the PDF you will find: Source: Hickie et al. Educational Health Solutions; 2000

McGorry claimed in a recent interview, “…we are trying to do is provide effective treatment for those young people for what they are presenting with and trying to reduce the risks. There are other effective ways of reducing the risk including cognitive behaviour therapy, the use of omega-3 fatty acids and so on.”

With previous involvement of Hickie and the pharmaceutical industry, I’d really love to believe that McGorry would use CBT and omega-3 fatty acids etc to help kids diagnosed with a mental disorder…before they actually get it!

I am left wondering if the Australian government have done their homework on McGorry & Co or if they just like to throw money into projects without first taking a look at the scientific proof – Has the current Australian Prime Minister, Julia Gillard, ever sought to seek evidence about the chemical imbalance myth? Has she taken a good look at the deaths associated with psychiatric drugs?

Here’s an idea for the Aussie PM, ask for scientific proof of McGorry & Co’s time-travelling prediction vehicle, don’t just take it as gospel that it works.

For the record, and so Patrick McGorry and his cronies totally understand, I was raised a Catholic. I denounced myself as one in later years. McGorry & Co can throw the Scientology tag at me if they wish, they have done it in the past when backed into a corner by CCHR. If that is all they have in their armour then I envisage a future of mind altering drugs being prescribed to Australian children on the basis that they may have an illness rather than they actually have an illness. If parents of those children dare question McGorry & co, prepare yourselves for some mud slinging – you may as well sign yourselves up to the Church of Scientology, you’ll be labelled one regardless…and we all know how psychiatrists, such as McGorry, just love to use labels.

How do I know this? Well, like McGorry & Co, I travelled forward in time…in my Tardis – my DeLorean is at the garage in need of a new flux capacitor.

Fid

http://fiddaman.blogspot.com/2011/05/hickierie-dickory-doc-mcgorry-turns.html

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Drugging our Kids on Antidepressants

Monday, May 30th, 2011

The Daily Telegraph- May 30, 2011

by Elissa Doherty and Marianne Betts

AUSTRALIA – The  number of children aged six and under being prescribed anti-depressants has soared by almost 50 per cent since the federal government pledged to investigate the issue, new figures show.

Federal health department data reveals prescribing rates of the controversial drugs have risen from 852 in 2007-08 to 1264 in 2009-10.

But despite Health Minister Nicola Roxon ordering an investigation three years ago, a Freedom of Information request shows the government held just two meetings.

Five deaths have also been linked to anti-depressants in children aged 10 to 19 since 2009, Therapeutic Goods Administration figures show. In children aged nine and under, 89 adverse reactions were linked to anti-depressants over the same period.

The figures show Zoloft and Prozac were among the most prescribed in the youngest age group, as well as another used for chronic bed-wetting.

Anti-depressants

Australian Childhood Foundation chief executive Dr Joe Tucci said he would have expected the government to act by now.

“I cannot think of a good reason why any six-year-old, or younger, should be treated with antidepressants,” he said. “I think it’s gone up because medication is being used to treat the symptoms and not the cause.”

The Royal Australian and New Zealand College of Psychiatrists said it was alarming any anti-depressants were being prescribed for children and demanded answers.

“I would be very alarmed if these figures were true as there is no indication for an anti-depressant medication given to any child under the age of six,” Child and Adolescent Psychiatry Faculty chair Dr Phillip Brock said.

“I have written to the government before asking if figures in this age group are valid. The fact we are still seeing this kind of data demands an answer.”

Australian Medical Association vice-president Dr Steve Hambleton said doctors were concerned about prescribing medication for young people but were having more success with certain anti-depressants.

He had personally written scripts for two six-year-olds – and they had benefited.

A Health Department spokeswoman said: “The management of a patient’s medical condition, including the prescription of medicines, is a clinical decision between the clinician and patient or carer, taking regard of the patient’s circumstances.”

Black Dog Institute director Professor Gordon Parker said investigation was needed.

http://www.dailytelegraph.com.au/news/drugging-our-kids-on-anti-depressants/story-e6freuy9-1226065161126

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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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29 Fired from Child Psych Unit Following Investigation of Sexual Assault

Sunday, May 29th, 2011

Note from CCHR: This is outrageous. A hospital investigation into a sexual assault charge of a minor in its psychiatric unit  apparently revealed such gross widespread abuse that 29 staff were fired…you read that right, 29 staff.  Yet there is no disclosure of what the hospital investigation uncovered.  How is THAT possible?   They just get to fire their entire staff and not disclose what they found?  Was a  minor sexually assaulted?  Were a number of children assaulted?  Why are there no criminal  charges?   What prompted the firing of 29 employees and why is the state not demanding full disclosure to the public considering that this is a child psychiatric unit?

Boston Globe 0 May 28, 2011

By Liz Kowalczyk

Carney Hospital fired the staff of its adolescent psychiatry unit Thursday, after an investigation into an employee’s alleged sexual assault of a patient uncovered serious patient safety problems.

Hospital president Bill Walczak said he hired former attorney general Scott Harshbarger and his law firm a month ago to investigate the assault allegation and conditions on the 14-bed locked unit for extremely troubled teens.

When he read Harshbarger’s report Thursday, Walczak said he decided to replace the nurses and other staff on the unit.

The report described “serious concerns about patient safety and quality of care on the unit. It was not functioning properly. It was recommended by them to start over on the unit,’’ Walczak said in an interview. “We will have top- notch employees replace those who left. My goal is to make it the best unit in the state.’’

He would not provide details of the alleged assault or patient safety concerns, or comment on why the entire staff was dismissed, given that the allegation involved one employee and one patient.

Walczak said he was told about the accusations a month ago, soon after the incident allegedly occurred, and immediately reported it to state mental health officials and put the unit’s staff on administrative leave.

The hospital did not notify law enforcement because attorneys told its executives that it is up to the patient and his or her family to report the incident to police.

Massachusetts Nurses Association spokesman David Schildmeier said the Dorchester hospital fired 29 employees, including 13 nurses who are members of the union. He said he could not comment about what happened because the MNA had not yet received information from the hospital.

Marylou Sudders, a former state mental health commissioner, said replacing the entire staff is “an extreme measure’’ that may indicate “there was a culture of not reporting or not being assertive in protecting patients. It’s an extraordinary measure to fire everyone. It says to me they have a serious issue and are dealing with it seriously.’’

Walczak said the state Department of Mental Health, which licenses hospital psychiatric units, investigated the allegations this month. He said the hospital submitted a “plan of action’’ — including capping the number of patients on the unit at six for now — which the state accepted, allowing the unit to remain open. The hospital would not release the action plan, in part because he said the investigation is ongoing.

State officials would not provide any information to the Globe yesterday or release its reports on the matter.

“We are working with the hospital to make sure everyone on the unit is safe and that it’s operating properly,’’ said Health and Human Services spokeswoman Jennifer Kritz.

Walczak said the unit has not accepted many new patients during the past few weeks, and that nurses and counselors from other areas of the hospital are caring for four teens who remain there. Steward Health Care, which bought Carney and five other Catholic hospitals in the Caritas Christi network last year, has given the hospital $1.5 million to renovate the unit as a result of the investigation, which Walczak said will make it safer and improve care.

Harshbarger declined to be interviewed yesterday, but he released a statement echoing Walczak’s comments.

“Given the serious nature of what we learned while investigating the recent incidents, and recognizing the importance that Carney leadership places on patient care and safety, we have concluded that the unit cannot continue to function as it is currently composed. In our opinion, it would be prudent to replace the current personnel in order to ensure quality care for these vulnerable patients,’’ he said.

Sudders, the president of the Massachusetts Society for the Prevention of Cruelty to Children, said safety is especially important on locked units because patients are not free to leave.

Lisa Lambert, executive director of the Parent Professional Advocacy League, which works on behalf of mentally ill children, said only the sickest patients are placed in locked psychiatric units and the teens there are often in danger of harming themselves or others and have “more significant and acute mental health issues.’’

In most units, staff are required to check on the teens at designated intervals.

“A lot of times the adolescents there can’t manage themselves or their moods or actions. Parents expect they will be in a place that is safe for them. That is a huge letdown and disappointment when it’s not.’’

http://www.boston.com/business/healthcare/articles/2011/05/28/carney_hospital_fires_teen_psychiatric_unit_staff/

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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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Gem of the Week: Big Pharma in Juvie

Friday, May 27th, 2011

Mother Jones
By Jen Phillips
May 27, 2011

GreenColander/Flickr

Instead of the usual Eco-News Roundup of stories from our other blogs, we’re experimenting with a new format. This week, I’m shining a light on a news article from the past 5 days that covered an underreported environmental topic or illuminated a new side of an existing issue. Hopefully this format will be more relevant, and more interesting, than the old Eco-News Roundup.

This week’s gem for reporting on science, health, and the environment goes to… the Palm Beach Post in Florida, for revealing ties between psychiatrists in juvenile halls and manufacturers of antipsychotic drugs. The Post‘s investigation found that a handful of psychiatrists working for Florida’s Department of Juvenile Justice (DJJ) were paid high speaking fees or given gifts by pharmaceutical companies like AstraZeneca. “In at least one case, the number of Medicaid prescriptions a psychiatrist wrote for children rose sharply around the time he was paid, The Post found.” Even worse, the antipsychotics were prescribed by the DJJ doctors were not approved for safe use in children.

Since the Post‘s investigation, the DJJ has launched an internal investigation about the use of antipsychotics in its system. However, as the Post found while reporting, the DJJ’s record-keeping system is in bad shape, making it hard for even DJJ employees to find the information they’re looking for. In addition, not all juvie programs are run directly by the DJJ. “No information was available,” the Post noted, “on the amounts of antipsychotic drugs dispensed in the more than 100 remaining programs for juveniles… run by private contractors.”

Read the Post‘s entire, in-depth investigation at their site, here.

http://motherjones.com/blue-marble/2011/05/big-pharma-juvie-kids-drugs

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Drugging the Vulnerable: Atypical Antipsychotics in Children and the Elderly

Thursday, May 26th, 2011

TIME
By Maia Szalavitz
May 26, 2011

Maryland Correctional Institution, Jessup, Maryland - Marvin Joseph/The Washington Post/Getty Images

Pharmaceutical companies have recently paid out the largest legal settlements in U.S. history — including the largest criminal fines ever imposed on corporations — for illegally marketing antipsychotic drugs. The payouts totaled more than $5 billion. But the worst costs of the drugs are being borne by the most vulnerable patients: children and teens in psychiatric hospitals, foster care and juvenile prisons, as well as elderly people in nursing homes. They are medicated for conditions for which the drugs haven’t been proven safe or effective — in some cases, with death known as a known possible outcome.

The benefit for drug companies is cold profit. Antipsychotics bring in some $14 billion a year. So-called “atypical” or “second-generation” antipsychotics like Geodon, Zyprexa, Seroquel, Abilify and Risperdal rake in more money than any other class of medication on the market and, dollar for dollar, they are the biggest selling drugs in America. Although these medications are primarily approved to treat schizophrenia and bipolar disorder, which combined affect 3% of the population, in 2010 there were 56 million prescriptions filled for atypical antipsychotics.

In a presentation this week at an American Psychiatric Association meeting, Dr. John Goethe, director of the Burlingame Center for Psychiatric Research in Connecticut, reported that over the last 10 years, more than half of all children aged 5 to 12 in psychiatric hospitals were prescribed antipsychotics — and 95% of these prescriptions were for second-generation antipsychotics. Many of these children didn’t have a condition for which the drugs have been shown to be helpful: 44% of youngsters with post-traumatic stress disorder (PTSD) and 45% of children with attention deficit hyperactivity disorder (ADHD) were treated with them.

Pharmacologically, the ADHD prescriptions make no sense: FDA-approved drugs for the condition raise levels of the neurotransmitter dopamine, while antipsychotics do they opposite, lowering them.

Geothe also noted another study that showed that the number of office visits by children and teens that included antipsychotic drug prescriptions rose 600% from 1993 to 2002. “The obvious second-generation bias is very apparent in these data, as is the irrational use of antipsychotics for indications such as PTSD and ADHD for which there is no controlled evidence whatsoever that these are safe or effective treatments,” says Dr. Bruce Perry, senior fellow at the ChildTrauma Academy in Houston. (Full disclosure: Dr. Perry is my co-author on two books.)

The situation may be similar in state-run juvenile detention systems. Late last week, an exposé by the Palm Beach Post revealed that antipsychotics were among the top drugs purchased by the Florida Department of Juvenile Justice (DJJ), and were largely used in kids for reasons that were not approved by the government — for instance, sleeplessness or anxiety. The Post reported:

In 2007, for example, DJJ 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.

Among the psychiatrists hired by the state to evaluated incarcerated kids, about a third received drug company money, the Post reported. Those 17 psychiatrists wrote 54% of the prescriptions for antipsychotics; the 35 doctors who did not take such payments wrote the rest. In other words, one-third of doctors — all of whom were paid by drug companies — wrote more than half of all antipsychotic prescriptions for the state’s locked-down youth.

The statistics on children in foster care are equally alarming. Youth in foster care are not only three times as likely to be medicated as comparable low-income youth on Medicaid, but more than half are treated with antipsychotics. It is not likely that all or even most of these children have a condition for which antipsychotics have been approved by the government to treat.

Among the problems with unnecessary use of antipsychotic medications is that they can cause serious, sometimes irreversible, damage. Atypical antipsychotics are associated with weight gain and may double users’ risk of Type 2 diabetes. Recent research also suggests that they may shrink the brain and there is little data on how they affect brain development during the teen years, when the brain grows more than at any other time but infancy. Indeed, youth are more vulnerable than any other group to the drugs’ worst side effects (excluding death).

“The majority of antipsychotic medication use in children and adolescents has not been limited to the few age groups or conditions for which there is credible evidence of efficacy and safety,” says Perry. “There is no reason to expect irrational prescribers to change their bad habits.”

He adds that many experts would argue that if doctors began prescribing antipsychotics “responsibly and cautiously” — that is, being mindful of the lack of efficacy data and the evidence of harm — the rate of prescriptions in children would drop by 90%.

Meanwhile, rates of prescriptions for patients at the other end of the lifespan are also out of control. In nursing homes, 14% of residents have been given at least one prescription for a second-generation antipsychotic, according to a government investigation. A full 88% of these prescriptions are given to people with dementia, despite the fact that these drugs may double the risk of death in these patients (there is a black box warning on the drug to this effect). The investigation estimated that $116 million Medicare dollars have been spent filling antipsychotic prescriptions that never should have been written.

So why are these drugs so widely prescribed? Aggressive drug company marketing is only one part of the story. A key reason they are overused in institutional settings is that they are sedating, making patients easier to manage. Secondly, unlike other sedative drugs, they are not associated with misuse (with the possible exception of Seroquel, which has fans among some addicts). In fact, most people resist taking antipsychotics, which is why overmedication is much more common in settings where people are locked-in and compliance can be forced.

The second point — that these drugs are not considered addictive — by itself probably accounts for a big part of why drug companies have been able to get away with so much misleading marketing and the resultant overprescribing. Although prescribing of traditional sedatives like benzodiazepines (Valium, Xanax), which are vulnerable to misuse, is limited by their status as controlled substances, few people enjoy misusing antipsychotics (side effects like weight gain, pleasurelessness, movement disorders and low energy and motivation are not generally sought by recreational drug users), so they can be prescribed for unapproved uses like behavior control and sleep-inducement in children and the elderly.

In other words, addiction is basically seen as a worse side effect than death. The fact that the most vulnerable youth and elderly often cannot advocate for themselves has made it easier to sweep the problem under the rug.

Fortunately, there is at least one bright spot in this depressing picture. The main patent on Risperdal expired in 2007, and those for Zyprexa and Seroquel expire this year. Geodon’s patent expires next year, while Abilify’s comes up in 2015. When most drugs go off-patent, drug companies’ marketing pressure — and profits — will subside, perhaps keeping children and the elderly safer from inappropriate medication.

Read article here:  http://healthland.time.com/2011/05/26/why-children-and-the-elderly-are-so-drugged-up-on-antipsychotics/

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