Thursday, December 1, 2011

AstraZeneca Seroquel - the continued marketing of death & mayhem for profit - what about the victims?



In the past couple of days many readers may have come across a couple of headlines news articles highlighting & confirming how little has really changed when it comes to the pharmaceutical criminal cartels marketing of poisons such as Seroquel for massive profits & horrifying results. Yet, the body count continues to rise, and still AstraZeneca & others go about the nasty business of running their dubious operations as if it was just simply "Business as Usual". Now we have dog & pony puppet show Senate hearings giving some mouth air time to the ongoing carnage where very little has been done, quite obviously far far to late...

As they say; read it and weep... no one is really talking or thinking about the victims; they are the forgotten throw away lives that just get buried somewhere underneath the headline pronouncements of meaningless big dollars fines and hollow accountability promise banter; it's always all about the money... that's the up side down and backwards sad real world reality of our government & failed enforcement bodies in America.
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Inspector Highlights Psych Drug Use Among Elderly

Published December 01, 2011
Associated Press

Government inspectors told lawmakers Wednesday that Medicare officials need to do more to stop doctors from prescribing powerful psychiatric drugs to nursing home patients with dementia, an unapproved practice that has flourished despite repeated government warnings.

So-called antipsychotic drugs are designed to help control hallucinations, delusions and other abnormal behavior in people suffering from schizophrenia and bipolar disorder, but they're also given to hundreds of thousands of elderly nursing home patients in the U.S. to pacify aggressive behavior related to dementia. Drugs like AstraZeneca's Seroquel and Eli Lilly's Zyprexa are known for their sedative effect, often putting patients to sleep.

But the drugs can also increase the risk of death in seniors, prompting the Food and Drug Administration to issue multiple warnings against prescribing the drugs for dementia. 

Antipsychotics raise blood sugar and cholesterol, often resulting in weight gain. An inspector for the U.S. Department of Health and Human Services told the Senate Committee on Aging that the federal government's Medicare program should begin penalizing nursing homes that inappropriately prescribe antipsychotics, according to written testimony obtained by the Associated Press.

The Centers for Medicare and Medicaid Services provides health coverage to nearly 80 million senior, poor or disabled Americans.

HHS Inspector General Daniel Levinson proposed that Medicare force nursing homes to pay for drugs that are prescribed inappropriately, and potentially bar nursing homes that don't use antipsychotics appropriately from Medicare.

A report by Levinson's office issued in May found that 83 percent of Medicare claims for antipsychotics were for residents with dementia, the condition specifically warned against in the drugs' labeling. Fourteen percent of all nursing home residents, nearly 305,000 patients, were prescribed antipsychotics. The HHS Inspector General's office Medicare claims during a 2007 six month period.

Doctors are permitted to prescribe drugs for off-label uses, though it is illegal for drug companies to promote uses that haven't been cleared by the FDA. In recent years several pharmaceutical companies have paid huge fines to the Department of Justice in cases involving off-label marketing of antipsychotics.

In January 2009, Eli Lilly & Co. Inc. agreed to plead guilty and pay $1.4 billion for illegal promotion of Zyprexa, including marketing to nursing home doctors. The company told its sales representatives to use the slogan "5 at 5," to persuade doctors that giving 5 milligrams of the drug at 5 p.m. would make dementia patients sleep through the night.

AstraZeneca PLC has paid nearly $600 million in two separate settlements with federal and state prosecutors over alleged off-label promotion of its drug Seroquel.

further coverage here @ c-span

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Why Are So Many Foster Care Children Taking Antipsychotics?


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


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

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

MORE: Drugging the Vulnerable: Atypical Antipsychotics in Children and the Elderly

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

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

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

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

The new study by dosReis and colleagues included records of more than 600,000 children enrolled in Medicaid in 2003, including those in foster care, those receiving disability benefits for mental diagnoses, and those on the welfare program called Temporary Assistance for Needy Families.

Overall, nearly 3% of all youth on Medicaid received at least one prescription for an antipsychotic medication that year, which is itself a high proportion, especially given that the main condition that antipsychotics are approved to treat —schizophrenia — is extremely rare in children. The rate of schizophrenia in children under 12 is an estimated 2 cases per 1 million children; it affects fewer than 1% of older teens. Antipsychotics are also approved to treat bipolar disorder, a diagnosis that is highly controversial in children. Some studies suggest that it affects 0.2% to 0.4 % of children, and up to 1% of adolescents.

And yet, between 1994 and 2003, rates of bipolar diagnoses in youth under 19 rose by a factor of more than 40, according to the National Institute on Mental Health. It seems unlikely to be a coincidence that this rise occurred during the period when atypical antipsychotics were being illegally marketed for children.

Indeed, most of the antipsychotics used in foster-care youth were for conditions that the drugs were not approved to treat. Fifty-three percent of prescriptions were written for attention deficit/hyperactivity disorder (ADHD), a condition that is ordinarily managed with drugs that have the opposite pharmacological effects as antipsychotics. The stimulant medications like Adderall and Ritalin, widely used for ADHD, tend to increase levels of dopamine, while antipsychotics tend to decrease it.

Moreover, 38% of youth in foster care and 34% of foster-care youth receiving disability benefits received simultaneous prescriptions for more than one atypical antipsychotic, for more than three months — a practice that the researchers said "has demonstrated greater adverse effects with only marginal benefits." Worryingly, black youth were 27% more likely to receive two or more antipsychotics than whites.

"Essentially, medications like antipsychotics can help with mood instability and aggressivity," says dosReis, explaining that the drugs are often used to treat symptoms rather than conditions. Very little research is available on medication use in children to guide these practices.

"One of the things I would like to see come out of this research is starting to think about monitoring and evaluating the quality of care [these children are receiving]. We're not supporting or condoning these practices. One extreme says that no one should get these medications, and that's as irrational as saying we should be using more," she says.

MORE: Study: Antipsychotics Show No Benefit for Treating Veterans' PTSD

The risks of long-term prescribing of atypical antipsychotics to children, whose brains are still developing, are not known. What is known, however, is that the drugs cause severe weight gain in children, and that taking more than one antipsychotic drug may double, even quintuple, the risk of diabetes in youth. In adults, the weight gain associated with use of just one antipsychotic medication increase the risk of diabetes two- to four-fold, which has serious deleterious consequences for long-term health.

Although children in foster care may be genetically and environmentally at higher risk for mental illness, the disproportionately widespread use of antipsychotics in this group is troubling. "This study confirms the need for developmentally and trauma-informed practices in the vulnerable foster-care population," says Dr. Bruce Perry, founder of the ChildTrauma Academy. "Misunderstanding the pervasive effects of abuse and neglect leads to the mislabeling of behavioral and emotional symptoms in these children and then to overmedication." (Full disclosure: Dr. Perry is my co-author on two books.)

"The frustrating reality is that there are many evidence-based non-pharmacological interventions that have proven effectiveness and have no adverse effects," Perry says. Sadly, however, no one is spending billions to push them.

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Not enough evidence! Read this disturbing testimony before the Senate & Congress,

highlight:
  • Children in Foster care were prescribed mind altering drugs up to 4.7 more times than children not in care.
  • Thousands of children had received more than the recommended dose of mind altering drugs
  • Over 600 children in state care were on 5 or more mind altering drugs at any given time
  • 5,265 infants [under the age of 1] were prescribed mind altering drugs.





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