Posts Tagged ‘Medicaid’

Glaxo Still Haunted by Faked Paxil Studies in Kids; Crooked psychiatrist expected to plead guilty to criminal charges today

Thursday, August 19th, 2010

“The use of Paxil in children became extremely controversial after it emerged that GSK knew for 15 years, but didn’t tell anyone until 2006, that the drug may carry a risk for suicide. The drug now carries a black-box warning for suicide risk in children.”

BNET
By Jim Edwards
August 19, 2010

A crooked doctor who faked data in a GlaxoSmithKline (GSK) study of the antidepressant Paxil in children pled guilty to criminal charges today, causing groans among GSK’s senior management as the company hopes to fend off a different criminal investigation into whether it manipulated clinical data on its diabetes drug, Avandia. She was sentenced to 13 months in prison.

The two cases are technically completely separate, but they’re both about data manipulation. GSK has been accused of sitting on data showing risks on both drugs; and the FDA previously shut down one of GSK’s factories where both drugs were made.

Thus, the expected guilty plea of Dr. Maria Carmen Palazzo today is a reminder to managers everywhere that cutting ethical corners can cause unwanted chickens to return to their roosts, even years later.

Palazzo was indicted in 2007 on 40 counts of defrauding Medicare and Medicaid at her New Orleans clinic, and 15 counts of conducting fraudulent clinical trials. The charges followed an FDA accusation that she had enrolled 26 children in studies of Paxil for obsessive-compulsive disorder and major depressive disorder. She included children in the trial — which was given the cutesey nickname “Kiddie-Sads-Present and Lifetime” — who did not have the diagnoses being studied. GSK gave her more than $5,000 for each child she enrolled.

At trial, Palazzo was convicted on 39 counts of healthcare fraud and was sentenced to 87 months in prison and forfeiture of $655,000. The clinical trial fraud charges were thrown out, but prosecutors appealed and won a ruling this year reinstating those charges. That appears to be the reason Palazzo is reappearing in court to make a plea.

The use of Paxil in children became extremely controversial after it emerged that GSK knew for 15 years, but didn’t tell anyone until 2006, that the drug may carry a risk for suicide. The drug now carries a black-box warning for suicide risk in children.

Read entire article here:  http://www.bnet.com/blog/drug-business/10-years-later-glaxo-still-haunted-by-faked-studies-of-paxil-in-kids/5545

Read more about Palazzo here:
http://medicaresmostwanted.blogspot.com/2007/06/dr-maria-carmen-palazzo-has-been.html

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Long Awaited Army Report on Suicides Ignores Role of Suicide-Causing Drugs such as Antidepressants/Antipsychotics

Monday, August 2nd, 2010

OpEdNews
By Martha Rosenberg
August 1, 2010

Why are troops killing themselves?

The long awaited Army report, “Health Promotion, Risk Reduction, Suicide Prevention” considers the economy, the stress of nine years of war, family dislocations, repeated moves, repeated deployments, troops’ risk-taking personalities, waived entrance standards and many aspects of Army culture.

What it barely considers is the suicide-inked antidepressants, antipsychotics and antiseizure drugs whose use exactly parallels the increase in US troop suicides since 2005.

In the report Chief of Staff General Peter W. Chiarelli acknowledges antidepressant risks, saying there’s “fair quality evidence that second generation antidepressants (mostly SSRI) increase suicidal behavior in adults aged 18 to 29 years” but adds that “other research evidence shows the benefit of antidepressant use”.

And nowhere does he acknowledge the suicide potential of antiseizure drugs so widely used for pain and as “mood stabilizers” by troops even though the FDA mandated suicide warnings on Lyrica, Topamaz, Depakote, Lamictal, Tegretol, Depakene, Klonopin and 16 others in 2008.

(Lamictal also has the distinction of wasting more taxpayer money than any other drug according to a July American Enterprise Institute report. Medicaid spent an unnecessary $51 million on Lamictal instead of buying a generic last year, thanks to GSK salesmen. You go, guys,)

When asked by NPR’s Robert Siegel if the high number of medicated troops contributed to suicide, Gen. Chiarelli said, “The good thing about those numbers is…the prescriptions were all made by a doctor.” Asked why troops who had not even deployed were among the suicides, Chiarelli said there were other stressors involved.

In June Marine Times reported 32 deaths on prescription drugs in Warrior Transition Units (WTUs) since 2007 and said an internal review “found the biggest risk factor may be putting a soldier on numerous drugs simultaneously, a practice known as polypharmacy.”

But instead of citing dangerous drugs and drug cocktails for turning troops suicidal (and accident prone and at risk of death from unsafe combinations) the Army report cites troops’ illicit use of them along with street drugs. (The word “illicit” appears 150 times in the Army report and “psychiatrist” appears twice.)

No, it’s not the 8,000 urine samples in 2009 which showed prescription drug traces according to the Army report — it’s the fact that 21 percent of the drugs were “illicit.”

No wonder the revised suicide report form suggested by the Army report doesn’t even have a box to enter “adverse reactions to drug or drug combinations.” Instead, it has a box that asks how long before a suicide a patient was “compliant” with the prescription. Was the medication “taken as prescribed? Skipped?” Taken “In excess of prescription? In different manner (e.g., crushed instead of in capsule)?”

Read entire article here:  http://www.opednews.com/articles/Army-Suicide-Report-Ignore-by-Martha-Rosenberg-100801-596.html?show=votes

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Pfizer Makes Bank from DrugsThat Can Kill You—To say Pfizers been accused of wrongdoing is like saying BP had an oil spill

Monday, July 12th, 2010

AlterNet
By Martha Rosenberg
July 10, 2010

The drug company Pfizer is best known for Lipitor, a drug that brings cholesterol down and Viagra, a drug that brings other things up.

But the “world’s largest research-based pharmaceutical company” which sits between Goldman Sachs and Marathon Oil on the Fortune 500, is also closely associated with a seemingly never-ending series of scandals.

To say Pfizer’s been accused of wrongdoing is like saying BP had an oil spill. Other drug companies have a portfolio of products, Pfizer has a portfolio of scandals including, but not limited to, Chantix, Lipitor, Viagra, Geodon, Trovan, Bextra, Celebrex, Lyrica, Zoloft, Halcion and drugs for osteoarthritis, Parkinson’s disease, kidney transplants and leukemia.

During one week in June Pfizer 1) agreed to pull its 10-year-old leukemia drug Mylotarg from the market because it caused more, not less patient deaths 2) Suspended pediatric trials of Geodon two months after the FDA said children were being overdosed 3) Suspended trials of tanezumab, an osteoarthritis pain drug, because patients got worse not better, some needing joint replacements (pattern, anyone?) 4) Was investigated by the House for off-label marketing of kidney transplant drug Rapamune and targeting African-Americans 5) Saw a researcher who helped established its Bextra, Celebrex and Lyrica as effective pain meds, Scott S Reuben, MD, trotted off to prison for research fraud 6) was sued by Blue Cross Blue Shield to recoup money it overpaid for Bextra and other drugs 7) received a letter from Sen. Charles Grassley (R-Iowa) requesting its whistleblower policy and 8 ) had its appeal to end lawsuits by Nigerian families who accuse it of illegal trials of the antibiotic Trovan in which 11 children died, rejected by the Supreme Court. And how was your week?

Nor does Pfizer back down when faced with legal troubles.

Even as it was under the probation of a 5-year Corporate Integrity Agreement (CIA) with Health and Human Services for withholding $20 million in Lipitor rebates owed to Medicaid in 2002, it off-label marketed its seizure drug Neurontin and entered into another CIA in 2004.

Read entire article:  http://www.alternet.org/story/147467/

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Behind the Psychopharmaceutical Industrial Complex; Pharma-funded front groups masquerading as “patient advocates”

Tuesday, June 22nd, 2010

Scoop Independent News
By Evelyn Pringle
June 22, 2010

Non-Profit Advocacy Groups

As a main component of the Psychopharmaceutical Industrial Complex, the so-called “patient advocacy” organizations have become the leading force behind the American epidemic of mental illness over the past two decades.

Drug makers, and their foundations, funnel millions of dollars to these non-profits every year. In return, the leaders recruit their members as foot soldiers to carry out the latest marketing campaigns and to provide a fire-wall so that no money trail can be tracked back to the drug companies.

Gigantic Pyramid

The psychiatric front groups form a gigantic pyramid and once pharmaceutical money enters the system through a major organization, it gets channeled into a huge spider-web that weaves through many groups, making it nearly impossible to keep track of where it came from or where it all went. Often, when the grant reports of the drug companies list a large donation to one organization, the annual reports of the other groups will show smaller gifts from that same organization.

The “charity” groups are exempt from income tax and the “contributions” funneled through them are tax deductible. The money is used for disease mongering campaigns to both market disorders and pressure public health care programs and private insurers to pay for expensive treatments.

“Presenting themselves as patient advocacy groups is highly disingenuous not only to their membership, many of which may have a sincere desire to help a loved one or a family member with mental problems, but to legislators, the press and the American public — for they have consistently lobbied for legislation that benefits the mental health and pharmaceutical industries which fund them, and not patients they claim to represent,” according to Citizens Commission on Human Rights International, a mental health watchdog group.

In a June 2, 2010, commentary titled, “Psychiatric Fads and Overdiagnosis,” on the Psychology Today website, Dr Allen Frances points out that it “is too bad that there is no advocacy group for normality that could effectively push back against all the forces aligned to expand the reach of mental disorders.”

The leaders of the supposedly “non-profits” earn outrageously high salaries, along with excellent benefit packages, while many of the patients they claim to represent are encouraged to seek federal disability payments of under $700 a month, and apply for public housing, food stamps, and Medicaid, to make ends meet. The top officials will often move from a leadership role in one organization to a higher position in another.

The drug makers rely on the front groups to do their bidding any time profits are threatened. For instance, if the FDA is considering adding a black box warning about a deadly side effect to a drug’s label, which may result in a drop in sales, representatives of front groups will show up at the FDA advisory panel hearings to testify against adding the warning.

They will also lobby FDA panels whenever there is a chance to increase profits, such as enlarging the drug customer base. In June 2009, the Psychopharmacologic Drugs Advisory Committee was set to meet to evaluate AstraZeneca’s Seroquel, Pfizer’s Geodon and Eli Lilly’s Zyprexa for use with 13 to 17 year-olds diagnosed with schizophrenia, and 10 to 17 year-olds diagnosed with pediatric bipolar disorder.

On June 8, 2009, nine front groups issued a joint statement urging the panel to vote to approve all three drugs for kids. The groups signing the letter included the American Academy of Child and Adolescent Psychiatry, American Foundation for Suicide Prevention, American Psychiatric Association, Child and Adolescent Bipolar Foundation, Children and Adults with Attention-Deficit/Hyperactivity Disorder, Families for Depression Awareness, Mental Health America, National Alliance on Mental Illness, and the National Council for Community Behavioral Healthcare.

Read entire article:  http://www.scoop.co.nz/stories/HL1006/S00162.htm

Also see:  http://www.cchrint.org/psycho-pharmaceutical-front-groups/

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Psychiatric Drug Abuse of Foster Care Kids Costs Government Billions; Feds now investigating potentially massive fraud

Wednesday, June 16th, 2010

Politics Daily
By David Sessions
June 16, 2010

Seven-year-old Gabriel Meyers didn’t want soup for lunch one Thursday in April, 2009. When his 23-year-old foster brother sent Gabriel to his room for dumping his soup in the trash, Gabriel threatened to kill himself. He kicked his toys around his room, then locked himself in the bathroom.

Police reports say Gabriel was home sick that day from his elementary school in Margate, Fla., under the care of Miguel Gould, his foster father’s son. Around 1:00 p.m., city police responded to Gould’s frantic 911 call and found Gabriel had hanged himself.

A troubled child who had previously suffered from neglect, sexual assault, and abusive parenting, Gabriel spent the previous year shuttling among several foster parents while taking a constellation of antipsychotic medicines, including Lexapro and Vyvanse, to control his depression and attention deficit hyperactivity disorder. Like most children in Florida state foster care, Medicaid paid Gabriel’s medical expenses.

Just one month before his suicide, Gabriel’s doctor prescribed him Symbyax, an anti-depressant restricted for treatment of children. The medication’s FDA-required label features a warning that use of the drug by children or teenagers can lead to suicide.

Symbyax does not meet criteria established by Congress for Medicaid reimbursement., so it is illegal for Medicaid to pay for a prescription of the drug to a child. Sohail Punjwani, the doctor who prescribed Gabriel’s Symbyax, received a stern letter from the FDA about his history of over-prescribing mental health drugs.

According to a number of foster care experts who spoke with Politics Daily, children in foster care, who are typically concurrently enrolled in Medicaid, are three or four more times as likely to be on antipsychotic medications than other children on Medicaid. Alarmingly, many of these drugs are medically prohibited for minors and dangerous to the children taking them. Often young patients under state supervision are also prescribed three or four high-risk drugs at a time — all paid for by Medicaid.

State foster care programs and child protective services have had mixed success addressing the pervasiveness of dosing their clients with prescription psychotropic drugs. Using federal Medicaid monies to purchase dangerous prohibited prescriptions for children, which cost the government up to $600 per dose, is technically a violation of the law.

Now, the Senate Subcommittee on Oversight of Government Management, chaired by Democratic Sen. Daniel Akaka of Hawaii, has asked the Government Accountability Office to look into the drugging of foster care children. The investigators will attempt to account for estimates in the hundreds of millions of dollars of possible fraud arising from prescriptions for drugs explicitly barred from Medicaid coverage. The GAO is collecting data from Oregon, Massachusetts, Florida, Maryland, Minnesota, and Texas, to search for patterns of abuse. This effort marks the first time suspicion of Medicaid fraud related to psychotropic drugs has been examined at the federal level. According to Senate staffers working on the investigation, the committee will likely hold hearings on the matter later this year.

Read entire article:  http://www.politicsdaily.com/2010/06/17/psychotropic-drug-abuse-in-foster-care-costs-government-billions/

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42 percent of all kids in foster care are taking three or more mood-altering drugs

Monday, June 7th, 2010

NewsTimes.com
By Eileen FitzGerald
June 7, 2010

Here’s just one statistic that Danbury school psychologist Charles Manos worries about: 42 percent of all kids in foster care are taking three or more mood-altering drugs.

“All kids in foster care have some story of trauma, like abuse or neglect, so we need to ask the question `How are we dealing with trauma?’” Manos asked.

Overall, children are receiving more prescriptions than ever before to treat medical, emotional and psychological problems, according to a May report from Medco Health Solutions.

More than one in four children with health insurance in the U.S., and nearly 30 percent of all children from 10 to 19, take at least one prescription to treat a chronic condition. The most substantial increases over the past nine years have been in antipsychotic, diabetes and asthma drugs, according to the Medco report.

In some cases, students take medications at home. In many cases, school nurses dispense it.

For instance, Danbury schools health coordinator Sue Levasseur said 80 middle school students receive asthma medication each day at school and another 14 to 15 children receive a psychotropic drug at school.

Part of the school system’s job is to educate parents, said Manos, who has worked in local schools for more than 30 years and also has a private practice.

“I think we have become a society that says it’s OK to medicate the symptoms of kids. Medication is easier. I think as a society we are quick to change behavior rather than understand it,” Manos said.

Behavior medications can be destructive if used improperly, he said.

“Say there is abuse or trauma, and we don’t do an adequate analysis. Then we silence the symptoms through the medications,” Manos said.

“The fact is that medication does not treat a disorder, it treats the symptoms of the manifestation, and people don’t understand that. I think there is a myth that medication treats the disorder.”

Read entire article:  http://www.newstimes.com/news/article/Growing-numbers-of-children-on-medication-514614.php

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Huffington Post: Poor Kids far more likely to be prescribed psychiatric drugs

Thursday, May 20th, 2010

Huffington Post
By Bruce E. Levine
May 20, 2010

Children covered by Medicaid are far more likely to be prescribed antipsychotic drugs than children covered by private insurance, and Medicaid-covered kids have a higher likelihood of being prescribed antipsychotics even if they have no psychotic symptoms. This is reported in the May19, 2010 Journal of American Medical Association (JAMA) article, “Studies Shed Light on Risks and Trends in Pediatric Antipsychotic Prescribing.”

Researchers at Rutgers University and Columbia University found that children and adolescents covered by Medicaid were four times as likely as those with private insurance to receive an antipsychotic in 2004. Among those aged six to 17 years who were covered by Medicaid, 4.2 percent were prescribed at least one antipsychotic drug. In contrast, among those in this same age group who had private insurance, less than 1 percent were prescribed an antipsychotic. Nearly half of these Medicaid-covered pediatric patients receiving antipsychotic drugs had nonpsychotic diagnoses of attention deficit hyperactivity disorder (ADHD) or some other disruptive behavior disorder. In contrast, of the privately insured pediatric patients receiving antipsychotics, about one fourth were diagnosed with ADHD or some other disruptive behavior disorder.

The current issue of JAMA also reports another troubling study published earlier this year in the journal Pediatrics. This study, conducted by Robert Penfold of the Department of Population Medicine at Harvard Medical School and the Harvard Pilgrim Health Care Institute, examined the use of the antipsychotic Geodon (ziprasidone) in pediatric patients covered by Medicaid in Michigan in 2001. Of the pediatric patients who had been diagnosed with a psychiatric disorder and had received Geodon, only 53.3 percent actually had a diagnosis of psychosis. The other children who received Geodon had one or more of the following diagnoses: 24.1 percent were diagnosed with explosive personality disorder, 17.6 percent were diagnosed with depressive disorder, and 13.1 percent of these kids who were prescribed Geodon had oppositional defiant disorder (ODD). What exactly does it take to get an ODD diagnosis?

Read entire article:  http://www.huffingtonpost.com/bruce-e-levine/psychiatric-drugs-and-poo_b_583568.html

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New York Times exposes psychiatric abuse of Foster kids: Children are put in psych wards for disciplinary reasons

Thursday, May 13th, 2010

The New York Times
By A. G. Sulzberger
May 13, 2010

A federal lawsuit is seeking to bar New York City from allowing troubled foster-care children to be kept in psychiatric hospitals after doctors have recommended their release, a practice that routinely adds months to a hospitalization despite laws that require such children to be placed in the least restrictive environment possible.

The suit, filed on Wednesday in United States District Court in Brooklyn, claims that the practice means that children who no longer require hospitalization are being kept in locked quarters where they have limited access to schooling, family visits and even walks outside.

The suit also claims that the Administration for Children’s Services, which oversees the care of about 16,000 foster children in New York City, and its subcontractors have been “using certain psychiatric hospitals as if they are detention centers,” sending some children to hospitals for disciplinary reasons, like breaking curfew, running away or getting in fights, rather than for mental health reasons.

A spokeswoman for the city’s Corporation Counsel declined to comment on the suit, saying the city had not yet had a chance to review it.

The suit was filed by the Legal Aid Society on behalf of three unnamed foster-care children who are currently hospitalized despite doctors’ recommendations that they be released.

“Every day that it continues, plaintiffs’ extended, wrongful confinement in these institutions is causing them irreparable damage,” the lawsuit says.

One of the children, a 6-year-old boy identified as S. M. who was placed into foster care last year, was hospitalized in Westchester in January, after “misbehavior” in his foster home, according to the complaint. The boy, who was in kindergarten, has been ready for discharge since April 2.

Read entire article:  http://www.nytimes.com/2010/05/13/nyregion/13acs.html

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Feds say drug company’s illegal payments to doctors fueled antipsychotic drugs wrongly prescribed to kids

Friday, May 7th, 2010

Seattle Post-Intelligencer
May 6, 2010

AstraZeneca Pharmaceuticals LP will pay Washington state nearly $10 million for improperly marketing Seroquel, a drug used to treat schizophrenia and manic depression.

Federal and state officials say that AstraZeneca illegally paid for doctors to attend meetings at resorts, where those doctors would “advise” the drug maker about marketing messages for unapproved uses. Medical professionals were also paid to serve as authors of promotional articles and to conduct studies for unapproved uses of the drug.

An investigation shows that as a result of these activities, misleading information was distributed about Seroquel, reports the state Attorney General’s Office. This led health providers to wrongly prescribe the drug to children, adolescents, and dementia patients in long-term care facilities – costing publicly funded programs millions of dollars.

Seroquel and other drugs are purchased for recipients of Medicaid, a government program for low-income consumers. Seroquel is approved for the treatment of schizophrenia, bipolar disorder, also known as manic depression, and other conditions.

A government investigation showed that between Jan.1, 2001, through Dec. 31, 2006, the drug was wrongly promoted to treat aggression, Alzheimer’s, anger management, anxiety, attention-deficit hyperactivity disorder, dementia, and sleeplessness. Sequoel isn’t approved by the Food and Drug Administration to treat these conditions.

Read entire article:  http://blog.seattlepi.com/boomerconsumer/archives/204984.asp

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New York Magazine: Shrink Revolt—The controversy over psychiatric diagnoses and the DSM continues

Monday, April 26th, 2010

New York Magazine
By Jennifer Senior
April 25, 2010

Two Jews may, as the saying goes, have three opinions, but that appears to be a fairly modest ratio when compared with psychiatrists. It was inevitable that revisions to the Diagnostic and Statistical Manual of Mental Disorders would invite controversy—it’s the classic reference work for mental-health professionals, and a convenient field guide to understanding crazy exes for the rest of us—but even the American Psychiatric Association, which first appointed the work groups to update the text two years ago, couldn’t have predicted the squabbles now under way. Dr. Allen Frances, the man who chaired the task force that created the current edition (the DSM-IV), has today emerged as the most trenchant, and relentless, critic of the proposed revisions to the upcoming edition (the DSM-5; among the changes is a transition to Arabic numerals). Last Tuesday was the final day those revisions were open to public comment. “And hopefully,” Frances says, “most of them will drop out.”

Basically, Frances believes that the first draft of the DSM-5 is too promiscuous with its labels, both by loosening diagnostic criteria and by introducing a host of new and, to his mind, problematic maladies—like Binge Eating Disorder (more or less defined as gorging on massive amounts at least once a week for three months). By the estimate of one DSM-5 task-force member, Frances says, this disorder already afflicts 6 percent of the population. “And that,” he notes, “is before drug companies start marketing something for it.”

As Frances pointed out in a recent Los Angeles Times editorial, such taxonomic adjustments only seem to further shrink “the ever-shrinking domain of the normal.” Take another DSM-5 proposed addition: Temper Dysregulation Disorder With Dysphoria. Frances fears this may be deployed for kids who have typical temper problems. Or Major Depressive Episode: As it’s redefined, it could now be used to describe someone who’s spent two weeks grieving over a lost spouse, he contends. But the worst offender, in Frances’s view, is Psychosis Risk Syndrome, which attempts to identify and treat youngsters before they become psychotic. In his view, there isn’t any evidence that early intervention with medication helps, while there’s plenty to suggest that many teens could be misidentified. “And that I saw as a public-health danger,” he says, “because there are real drawbacks to being on antipsychotics.” Like weight gain and diabetes. “Those children are also disproportionately on Medicaid,” he adds.

Read entire article:  http://nymag.com/news/intelligencer/65632/

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