Drugs Used for Psychotics Go to Youths in Foster Care

Published: November 20, 2011

Foster children are being prescribed cocktails of powerful antipsychosis drugs just as frequently as some of the most mentally disabled youngsters onMedicaid, a new study suggests.

The report, published Monday in the journal Pediatrics, is the first to investigate how often youngsters in foster care are given two antipsychotic drugs at once, the authors said. The drugs includeRisperdal, Seroquel and Zyprexa — among other so-called major tranquilizers — which were developed for schizophrenia but are now used as all-purpose drugs for almost any psychiatric symptoms.

“The kids in foster care may come from bad homes, but they do not have the sort of complex medical issues that those in the disabled population do,” said Susan dosReis, an associate professor in the University of Maryland School of Pharmacy and the lead author.

The implication, Dr. dosReis and other experts said: Doctors are treating foster children’s behavioral problems with the same powerful drugs given to people with schizophrenia and severe bipolar disorder. “We simply don’t have evidence to support this kind of use, especially in young children,” Dr. dosReis said.

In recent years, doctors and policy makers have grown concerned about high rates of overall psychiatric drug use in the foster care system, the government-financed program that provides temporary living arrangements for 400,000 to 500,000 children and adolescents.

Previous studies have found that children in foster care receive psychiatric medications at about twice the rate among children outside the system.

The new study focused on one of the most powerful classes of drugs, antipsychotics. It found that about 2 percent of foster children took at least one such drug, even though schizophrenia and bipolar disorder, for which the drugs are approved, are extremely rare in young children.

“It’s a significant and important finding, and it should prompt states to improve the quality of care in this area,” said Dr. Mark Olfson, a professor of clinical psychiatry at Columbia University who did not contribute to the research.

In the study, mental health researchers analyzed 2003 Medicaid records of 637,924 minors from an unidentified mid-Atlantic state who were either in foster care, getting disability benefits for a diagnosis like severe autism or bipolar disorder, or in a program calledTemporary Assistance for Needy Families. All of these programs draw on Medicaid financing. The investigators found that 16,969, or about 3 percent of the total, had received at least one prescription for an antipsychotic drug.

Yet among these, it was the foster children who most often got more than one such prescription at the same time: 9.2 percent, versus 6.8 percent among the children on disability, and just 2.5 percent of those in the needy families program.

Antipsychotic drugs, the authors said, also cause rapid weight gain and increase the risk for metabolic problems in many people, an effect that may be amplified by the use of two at once.

Doctors who treat such children are aware of the trade-offs and often prescribe lower doses of the medications as a result. And when they add a second such drug, it is often to counteract side effects of the first medication.

Still, the relatively high rates of these drug combinations in such a young and vulnerable group have prompted policy makers across the country to take notice. A consortium of 16 states, in collaboration with Rutgers University, has drawn up guidelines to improve care for foster children and others dependent on state aid.

“The psychiatrists who are treating these kids on the front lines are not doing it for money; there are very low reimbursement rates from Medicaid,” said Dr. Ramesh Raghavan, a mental health services researcher at Washington University in St. Louis. “There’s enormous anguish because everyone knows that this is not what we should be doing for these kids. We as a society simply haven’t made the investment in psychosocial treatments, and so we are forced to rely on psychotropic drugs to carry the burden.”

$$$$$$$ That's some burden you're carrying.What is the next step? generic version, it's cheaper than name brand and we can still bill Medicaid the same.Kids? what kids?

Sunday, November 20, 2011

This could be coming to a pharmacy near you: AstraZeneca and Targacept(a stem from RJ Reynolds Tobacco Co) are combining efforts to bring an nicotine receptor antidepresssant to the table, though the early returns on the prospective drug didn't look like it could compete with AstraZeneca's antipsychotic Seroquel.

Seroquel will soon be in generic form and AstraZeneca will need to fill that portfolio gap with something... like a new blockbuster. Seroquel has been touted as an antidepressant through clever marketing campaigns, and of course we all know that Seroquel got to market at all because of buried trial data to make the drug look good on paper.

28,000 or so lawsuits later we know how that went. Diabetes and weight gain seem to be the norm with Seroquel, though company spokespeople will tell you otherwise.

Savvy consumers might not want to deal with breaking in a new antidepressant co-created by a Big Tobacco company wanting to break in on that antipsychotic action. Instead, they might want to trySmoking quetiapine Seroquel, as in Mac Ball because quetiapine isn't as innocent as it appears.

Abstract

Quetiapine abuse has been a cause for increased concern among clinicians. Several reports have highlighted this in the past. Reports of quetiapine abuse have varied in their routes of administration. The authors have had experience in managing several patients who have admitted to the use of quetiapine outside of prescription settings. This article examines the case of a recent patient on the authors’ inpatient unit who admitted to a novel route of abuse. While quetiapine’s abuse potential in the black market is well known, motivations for the abuse of quetiapine have varied in the past. Anxiety and insomnia has been amongst the reported motivations. Combination abuse of quetiapine with cocaine, called “Q ball,” have been reported previously. Quetiapine serves as a substitute for heroin when used in this combination. This article highlights a previously unreported combination of quetiapine with marijuana used in the inhalational route in what is termed a “Maq ball.”

The drug, called TC-5214, has been deemed a potential big seller as the first in a new class of medicines that work by modulating neuronal nicotinic receptors. The companies have theorized that overstimulation of these receptors, or proteins, is associated with depression.

Shares of Targacept, a small U.S. drugmaker that began as part of R.J. Reynolds Tobacco Co, plunged 58 percent to $7.97 in heavy afternoon trading on the Nasdaq. Partner AstraZeneca fell 3.2 percent in London.

Data from three other Phase III trials of TC-5214 are expected by the first half of next year. Should the results prove favorable, the companies aim to seek approval for the drug in the United States in the second half of 2012 and in Europe in 2015, a spokeswoman at AstraZeneca said.

Leerink Swann analyst Seamus Fernandez, who had expected the drug to see $1 billion in sales by 2017, yanked the forecast due to the failed trial results.

"TC-5214 was the most promising pipeline candidate and possessed the strongest commercial synergies with the AstraZeneca portfolio," Fernandez said in a research note, noting it could still be approved if ongoing studies succeed.

TC-5214 is being assessed as an add-on therapy for patients who do not do well on standard antidepressants. It would compete with drugs like AstraZeneca's older Seroquel and could help the company once Seroquel faces cheaper generics.

AstraZeneca agreed in 2009 to pay as much as $1.24 billion for rights to TC-5214, including an upfront payment of $200 million. The drug has been one of the few potential bright spots in its pipeline."

EL CAJON, Calif., Nov. 7, 2011 /PRNewswire/ -- As a neurologist who has discovered and described medical diseases, I (FAB) read the May 24, 2008, Charleston (WV) Gazette article "Vets taking Post Traumatic Stress Disorder drugs die in sleep," and opened and financed my own investigation into these unexplained deaths.

Andrew White, Eric Layne, Nicholas Endicott and Derek Johnson, all in their twenties, were four West Virginia veterans who died in their sleep in early 2008. There were no signs of suicide or of a multi-drug "overdose" leading to coma, as claimed by the Inspector General of the VA. All had been diagnosed "PTSD"—a psychological diagnosis, not a disease (physical abnormality) of the brain. All were on the same prescribed drug cocktail, Seroquel (antipsychotic), Paxil (antidepressant) and Klonopin (benzodiazepine) and all appeared "normal" when they went to sleep.

On February 7, 2008, Surgeon General Eric B. Schoomaker, had announced there had been "a series, a sequence of deaths" in the military suggesting this was "often a consequence of the use of multiple prescription and nonprescription medicines and alcohol."

However, the deaths of the 'Charleston Four' were probable sudden cardiac deaths (SCD), a sudden, pulseless condition leading to brain death in 4-5 minutes, a survival rate or 3-4%, and not allowing time for transfer to a hospital. Conversely, drug-overdose coma is protracted, allowing time for discovery, diagnosis, transport, treatment, and frequently--survival.

Antipsychotics and antidepressants alone or in combination, are known to cause SCD. Sicouri and Antzelevitch (2008) concluded: (1) "A number of antipsychotic and antidepressant drugs can increase the risk of ventricular arrhythmias and sudden cardiac death," (2)"Antipsychotics can increase cardiac risk even at low doses whereas antidepressants do it generally at high doses or in the setting of drug combinations."

On April 13, 2009, Baughman wrote the Office of the Surgeon General (OTSGWebPublisher@amedd.army.mil): "On February 7, 2008 the Surgeon General said there had been 'a series, a sequence of deaths.' Has the study of these deaths been published?"

On April 17, 2009 the Office of the Surgeon General responded, "The assessment is still pending and has not been released yet." More than a year later and still no explanation, nor further acknowledgement that these deaths even took place.

In a press release, (PRNewswire, May 19, 2009) Baughman wrote: "I call upon the military for an immediate embargo of all antipsychotics and antidepressants until there has been a complete, wholly public, clarification of the extent and causes of this epidemic of probable sudden cardiac deaths."
Googling "dead in bed," "dead in barracks," by April 16, 2009, veteran's wife, Diane Vande Burgt, had Googled 74 probable sudden cardiac deaths. By May 2010: 128, and, by November 2, 2011: 247. Two-hundred-forty-seven!

In April 2010 I was in anonymous receipt of an Army National Guard Serious Incident Report for the 5 months 10/03/09 to 3/7/10. In it were 93 "incidents" including 4 "heart attacks," 6 "cardiac arrests" and 3 "found dead"; 13 of 93 (14%) probable SCDs.

Pfc. Ryan Alderman, was on a cocktail of psych drugs when found unresponsive, dying in his barracks at Ft. Carson, Colo. Sudden cardiac death was confirmed by an ECG done at the scene. Inexplicably, military officials de-classified his death and reversed the cause, calling it instead, a "suicide."

Again I challenge the military to produce the evidence.

In June 2011, a DoD Health Advisory Group backed a highly questionable policy of "polypharmacy" asserting: "…multiple psychotropic meds may be appropriate in select individuals." The fact of the matter is that psychotropic drug polypharmacy is never safe, scientific, or medically justifiable. What it is a means of (1) maximizing profit, and (2) making it difficult to impossible to blame adverse effects on any one drug.

From 2001 to the present, US Central Command has given deploying troops 180 day supplies of prescription psychotropic drugs—Seroquel included. In a May 2010report of its Pain Management Task Force, the Army endorsed Seroquel in 25- or 50-milligram doses as a 'sleep aid.'

Over the past decade, $717 million was spent for Risperdal and $846 million for Seroquel, for a mind-blowing total of $1.5 billion when neither Risperdal nor Seroquel have been proven safe or effective for PTSD or sleep disorders.

Ironically, yet not surprisingly, pay-to-play in Washington becomes more egregious every day. Heather Bresch, daughter of U.S. Sen. Joe Manchin, (D-WV) was recently named CEO of WV drug-maker Mylan Inc., that recently contracted with the DoD for over 20 million doses of Seroquel.
Defense Department Health Advisory Group chair, Charles Fogelman, warned: "DoD currently lacks a unified pharmacy database that reflects medication use across pre-deployment, deployment and post-deployment settings." In essence, through a premeditated lack of record keeping, mandated by law at any other pharmacy or medical office to track potential fatal reactions to mixing prescription drugs, the military is willfully preempting all investigations into the injuries and deaths due to psychiatric drugs.

I call on the DoD, VA, House and Senate Armed Services and House and Senate Veterans Affairs Committees to tell concerned Americans and the families of fallen heroes what psychiatric drugs each of the deceased, both combat and non-combat, soldiers and veterans were on?

November 7, 2011

By Samuel Rubenfeld

AstraZeneca PLC said Monday in a securities filing that it was criminally indicted in Serbia for alleged bribery.

The indictment, which according to the filing was served in August, accuses local AstraZeneca employees of having “made allegedly improper payments to physicians” at the Institute of Oncology and Radiology of Serbia.

In the filing, the company said it has filed a number of procedural motions to dismiss the charges.
“We intend to vigorously defend the matter and have filed anumber of pending preliminary procedural objections that ask the Serbian criminal court to dismiss the indictment,” Tony Jewell, an AstraZeneca spokesman, said in an email. “This case is still in preliminary stages, so we are not in a position, at this time to comment further or to predict the outcome.”

The disclosure was made when AstraZeneca reported third-quarter earnings on Oct. 27; the Financial Times reported it (sub req) at the time. Monday’s filing, the 6-K required of foreign issuers, was a bundle of press releases made by the company during October.

Last year, the director of the Institute—as well as several others, including the head of AstraZeneca’s Belgrade office—were arrested in an alleged bribery scheme that involved favoring some pharmaceutical companies’ products when purchasing cancer-treatment medicine.

The pharmaceutical industry is already staring at an industry-wide probe in the U.S. into alleged foreign bribery. AstraZeneca was one of several companies that disclosed it was being investigated for possible violations of the Foreign Corrupt Practices Act, which bars companies and individuals from bribing foreign officials to get or keep business.

Johnson & Johnson settled in April, agreeing to pay $70 million to U.S. authorities. In its latest annual report, AstraZeneca said it’s cooperating with U.S. authorities on the probe, and it couldn’t predict the scope, duration or outcome of the investigation.
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How many times have we heard this line of literal bullshit from AstraZeneca's PR department “We intend to vigorously defend the matter and have filed anumber of pending preliminary procedural objections that ask the Serbian criminal court to dismiss the indictment,”

Which really means AstraZeneca plans to spend what ever it takes and pull out all the stops to yet again get away with serious crimes that undoubtedly adversely effect the health and well being of countless numbers of consumers. While walking away unscathed, without accepting responsibility or being held accountable for their many detestable crimes....as they say "Just part & the cost of their criminal business as usual profitable operation".

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