Posts Tagged ‘Zyprexa’

Time Magazine: Why Are So Many Foster Care Children Taking Antipsychotics?

Wednesday, November 30th, 2011

11/29/2011 by Maia Szalavitz

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 studyin 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.”

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.

Read the rest of the article here

Watch one foster kid’s story:

 

 

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Drugs Used for Psychotics Go to Youths in Foster Care

Monday, November 21st, 2011

The New York Times, November 20, 2011

by Benedict Carey

Click image to see video on psychiatric drug warnings for kids

Foster children are being prescribed cocktails of powerful antipsychosis drugs just as frequently as some of the most mentally disabled youngsters on Medicaid, 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 include Risperdal, 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 called Temporary 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.

read the rest of the article here:  http://www.nytimes.com/2011/11/21/health/research/study-finds-foster-children-often-given-antipsychosis-drugs.html?_r=3&adxnnl=1&adxnnlx=1321895404-XjlZbL3lXs10CI4v4o6z6w

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FDA Needs to Ban Antipsychotic Drug Use on Kids

Friday, September 23rd, 2011

Note from CCHR:  While the FDA and its Pediatric advisory panel sit around pondering if one antipsychotic drug is more likely to cause diabetes in children than another while continuing their stall tactic of  “let’s study it some more ” routine, we’d like to point out the simple solution:  Considering that  antipsychotic drugs are already documented by international drug regulatory agencies to cause not only diabetes but obesity, psychosis, blood clots, heart problems, cardiac events, seizures, toxicity, confusion, coma and stroke (and that’s just in kids) as well as brain atrophy (meaning they actually shrink brains); considering there is no medical test to prove any child has a brain malfunction, chemical imbalance or any physical condition requiring the administration of these lethal drugs—and considering these drugs are literally killing kids that have nothing medically wrong with them in the first place— Do the job you are paid by U.S. Taxpayers to do and BAN their use on children.   Period.

GAITHERSBURG, Maryland (Reuters) – U.S. pediatric health advisers on Thursday urged drug regulators to continue studying weight gain and other side-effects of antipsychotic drugs as they are increasingly taken by children.

Significant numbers of U.S. children are receiving drugs to tame aggression, attention deficit disorder and other mental problems, even though there is little conclusive data to show exactly how the medications work or whether they damage kids’ health.

Similar to the recommendations the panel has made in previous years, it voted 16-1 to support the U.S. Food and Drug Administration’s routine safety monitoring of the new generation of antipsychotics.

But the panel did so with a caveat that the agency specifically look at how to clarify the drugs’ labels to highlight concerns about their impact on children, namely the risks of weight gain and diabetes.

“There is serious concern that children may be at a higher risk for serious adverse effects and we just don’t have sufficient data to answer that question,” said Dr. Jonathan Mink, a child neurology expert from the University of Rochester Medical Center.

Dr. Jeffrey Wagener, a pediatric pulmonologist from the University of Colorado Medical School, was the one adviser to vote “no” out of concern that wouldn’t get regulators closer to dealing with the risks of using antipsychotics in children.

“I don’t see how the FDA is responding to the December 8, 2009 request by this committee in a thorough fashion,” he said. “It’s taken them two years to not respond to that that we need to be more than in the observational role.”

The FDA in the next month to six weeks will release a revised label for Abilify, a drug sold by Bristol-Myers Squibb Co and Otsuka Pharmaceutical and approved to treat schizophrenia in adolescents, bipolar disorder in children 10 to 17 years old and irritability associated with autism in those as young as six.

“We ask that with this upcoming revision that you carefully consider the language around pediatric use and adverse events,” said Dr. Geoffrey Rosenthal, the committee’s chair and director of Pediatric and Congenital Heart Center at the University of Maryland Medical Center.

Abilify’s new label will detail the drug’s latest clinical trials, warn of metabolic concerns and remind doctors to monitor weight and symptoms of diabetes in all patients, said Dr. Thomas Laughren, FDA’s psychiatry products chief. The pediatric section of the label would contain a reference to those warnings, he said..

Such revisions, which are already incorporated into Johnson & Johnson’s antipsychotic medication Invega Sustenna, are being considered for other similar drugs on a case by case basis, Laughren said.

The new generation of antipsychotic medications has raised a wave of concerns as they are increasingly being prescribed for a host of uses and for younger and younger patients, with little conclusive research addressing their impact on children and sometimes with little evidence they work.

Newer antipsychotics include J&J’s Risperdal, known generically as risperidone; Eli Lilly & Co’s Zyprexa or olanzapine; AstraZeneca’s Seroquel or quetiapine; and Abilify, known generically as aripiprazole.

U.S. researchers have found that the drugs’ use in children increased by 65 percent from 2002 to 2009, primarily through prescriptions for teenagers.

From fall 2009 to spring of this year, 1.9 million prescriptions of Abilify alone were dispensed to patients under 18, including even 875 prescriptions for toddlers younger than 2, according to FDA research.

Most commonly, the prescriptions were for bipolar disorder in teenagers and preschoolers, and for affective psychoses in children between the ages of seven and 12.

Advisers also voted unanimously to require the FDA to show them label revisions and report back in the next year or 18 months on progress in designing more studies of the drugs in children.

http://www.fox43.com/lifestyle/sns-rt-us-usa-fda-antipsychotictre78l77l-20110922,0,216106.story

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Doctors rarely face consequences for drug kickbacks

Tuesday, September 20th, 2011

The News Tribune – September 20, 2011
by Tracy Weber and Charles Ornstein; ProPublica

Despite their power to secure large settlements from drugmakers, the suits have failed to resolve the culpability of physicians

Two years ago, drugmaker Eli Lilly pleaded guilty to illegally marketing its blockbuster antipsychotic Zyprexa for elderly patients. Lilly paid $1.4 billion in criminal penalties and settlements in four civil lawsuits.

But a doctor named as a co-defendant in one suit – for allegedly taking kickbacks to prescribe the drug extensively at nursing homes – never was pursued.

Last year, Alpharma paid $42.5 million to settle federal allegations that it paid kickbacks to doctors to prescribe its painkiller Kadian.

“Health-care decisions must be based solely upon what is best for the individual patient and not on which pharmaceutical company is paying the doctor the biggest kickback,” Rod Rosenstein, U.S. attorney for the District of Maryland, said in a statement announcing the settlement.

But the doctors, accused of trading prescriptions for paid speaking gigs, faced no consequences.

At least 15 drug and medical-device companies have paid $6.5 billion since 2008 to settle accusations of marketing fraud or kickbacks. However, none of the more than 75 doctors named as participants was sanctioned, despite allegations of fraud or of conduct that put patients at risk, a review by ProPublica found.

Reporters reviewed hundreds of pages of court records and interviewed current and former federal prosecutors, state medical board officials, attorneys for whistle-blowers and, when possible, the doctors. For each doctor identified in a suit, ProPublica checked for state medical board discipline, penalties from the Medicare program and federal criminal charges.

In many of the cases, it appears that not even a cursory investigation was done to see whether the physicians had behaved inappropriately.

“Doctors have kind of gone under the radar,” said Tavy Deming, a Philadelphia lawyer who represents drug company whistle-blowers.

Amid concerns about the influence of drug company money on medicine, whistle-blower lawsuits have emerged as a headline-grabbing tool for holding manufacturers accountable.

Yet, despite their power to secure large settlements from drugmakers, the suits have failed to resolve the culpability of physicians. Doctors often are not named as defendants, even though descriptions of their alleged misconduct are used to bolster the suits. And even when settling, many companies, including Alpharma, continue to deny the allegations.

After cases are resolved, the internal company documents used as evidence remain confidential, preventing further exploration of the physicians’ behavior. Patients have no way of knowing whether their doctor’s judgment has been compromised, and doctors might be tarnished by spurious accusations.

Medical boards, which normally pursue tips or complaints of wrongdoing, do not routinely scan for such cases. Justice Department lawyers, wary of spending more time and effort on a case, say they usually are not interested in going after lesser players.

Tony West, the assistant attorney general who oversees civil litigation nationwide for the Justice Department, declined through a spokeswoman to discuss the issue. In announcing settlements with the drug companies, however, West has said that kickbacks undermine doctors’ credibility. Medical decisions, he said in one news release, should be “guided by a patient’s needs, not tainted by illegal incentives or fraud.”

Sen. Charles Grassley, Iowa, the ranking Republican on the Judiciary Committee, said in a written statement that it takes “two sides to perpetuate this fraud” and that both need to be held accountable.

“Otherwise, regardless of how big of a civil settlement a drug company makes, the incentive to cheat the taxpayers will still be in place for those willing to take part,” said Grassley, who has led investigations into conflicts of interest in medicine.

In recent years, pharmaceutical and medical-device companies have been barraged by whistle-blower lawsuits detailing how the pursuit of profit allegedly fueled fraud and corruption.

The suits are typically filed by former employees who say the companies promoted drugs for unapproved uses or paid doctors to prescribe drugs or use medical devices. The suits seek to recover millions – even billions – of dollars spent on these products by government health programs.

For Justice Department lawyers, big drug companies make attractive targets. They are flush with profits and determined to avoid crippling legal defeats. Their bureaucratic sprawl often leaves a trail of incriminating email and memos.

The massive financial settlements they are willing to pay are often modest in light of their annual sales and profits. Zyprexa, for example, had U.S. sales of nearly $3 billion in 2010. Kadian, Alpharma’s painkiller, brought in nearly $263 million, according to IMS Health, which tracks prescription drug sales.

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Two High Ranking Senators – Grassley & Kohl – Question Use of Psych Drugs in Nursing Homes

Monday, August 15th, 2011

MedPage – August 15, 2011

Emily P. Walker

Click image to watch video: Psychiatric Abuse of the Elderly

WASHINGTON — Two high-ranking senators have urged the Centers for Medicare and Medicaid Services (CMS) to take a closer look at potential over-prescribing of atypical antipsychotics to nursing home residents.

There are eight atypical antipsychotics approved by the FDA to treat schizophrenia and/or bipolar disorder, including clozapine (Clozaril), aripiprazole (Abilify), and quetiapine (Seroquel).

Atypical antipsychotics are not approved to treat dementia, and must carry black box warnings that elderly people who take atypical antipsychotics have an increased risk of death, compared with those who take placebo pills for dementia.

Still, it’s clear that these drugs are being used in nursing homes to control behavioral problems related to dementia. A 2011 report from the Department of Health and Human Services Office of the Inspector General (OIG) found that 14% of all nursing home residents with Medicare had claims for antipsychotics and 88% of the atypical antipsychotics prescribed off-label were for dementia.

And in 2009 Elli Lilly, the makers of olanzapine (Zyprexa), pled guilty and paid $1.4 billion to the federal government for allegedly targeting doctors who worked in nursing homes and assisted living facilities to prescribe olanzapine off-label to elderly patients with dementia.

In their letter, Sens. Charles Grassley (R-Iowa) and Herb Kohl (D-Wisc.), urged CMS administrator Donald Berwick, MD, to examine the issue of overuse of antipsychotics in nursing homes more closely. The letter is a follow-up to one the senators sent in May after the release of the OIG report, which the senators themselves requested.

The newest letter, sent Aug. 1, requests that CMS investigate what role pharmacy benefit managers — who manage prescription drug coverage for Medicare beneficiaries living in nursing homes — play in fueling the possible overuse of atypical antipsychotics in elderly people in long-term-care facilities.

Pharmacy benefits managers may receive rebates from drug companies for prescribing certain drugs, and CMS should look at their role in “unnecessarily increasing the use of antipsychotic drugs and to subsequently take action to address such practices and curb excess use.”

The letter also urges CMS to consider requiring that physicians, who off-label prescribe drugs with black box warnings to seniors, certify that a Part D provider will cover the drug.

If CMS followed the senators’ advice, Medicare payments for antipsychotics that “lack a medically-accepted indication” should be drastically reduced, the senators said.

“Taking such proactive steps will create disincentives for entities that administer pharmacy benefits to allow these practices to flourish while also providing CMS with clearer means to recoup erroneous payments,” Grassley and Kohl wrote.

A recent study found that the prescription cost for a typical antipsychotic increased from $38 to $41 between 2004 and 2008, while the price tag for an atypical antipsychotic rose from $226 to $323, the researcher found. Overall, the cost of typical antipsychotics in the U.S. was $600 million in 2008, while the cost of atypical drugs reached $9.9 billion.

That same study concluded that atypical antipsychotic use is growing, especially among seniors, and the drugs are increasingly prescribed off-label, sometimes without convincing evidence to support that use.

In 2008, 91% of the prescriptions written for atypical antipsychotics were for circumstances where the evidence for the efficacy was uncertain, the researchers found.

However, a separate study found that after the FDA issued a black box warning about the risks of using the drugs to soothe behavioral problems in dementia patients, there was a decline in prescribing the drugs to patients in the VA medical system.

http://www.medpagetoday.com/Geriatrics/Dementia/28052

 

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Drug firms paid ‘independent’ experts

Thursday, July 28th, 2011

Practice led to AG-whistleblower lawsuit

KXAN.com
By Nanci Wilson
July 27, 2011

Watch video: Allen Jones, former investigator, Office of the Inspector General, Pennsylvania

AUSTIN (KXAN) – When Cliff Gay was told to switch medications to treat his bipolar disorder, he never dreamed a significant gain in weight and then to twice-daily injections of insulin would follow.

In 1999, Gay’s doctor recommended he begin taking Zyprexa, which then was a new antipsychotic medication. At the time, Gay says it seemed like a good idea.

“The side effects were going to be less,” he said.

Gay says he immediately noticed a profound change — not so much in his symptoms, but in his appetite. Within a few months, he put on about 60 pounds, and that was followed by diabetes.

Records maintained by the U.S. Food and Drug Administration show that such stories are not uncommon among patients across Texas who, who beginning in the middle to late 1990s, were switched to medications called “atypical antipsychotics.”

Many who have been put on the new class of drug reported similar gains in weight over time.

Doctors working in state hospitals and community mental health centers began switching patients to the atypical antipsychotics because they were deemed the best treatment by an expert panel convened by the Texas Department of Mental Health and Mental Retardation.

But a detailed examination of public records documents on file in a whistleblower lawsuit that has been joined by the Texas Attorney General’s Office allege that the experts hired to evaluate the drugs and make recommendations for their usage were also accepting hundreds of thousands of dollars in payments from the companies developing and marketing the medications.

It started in the middle 1990s when MHMR contracted with University of Texas and some of its professors to evaluate the medications and develop a set of treatment guidelines.

The program was named the Texas Medication Algorithm Project, or TMAP. The result was step-by-step guidelines for treating major depression, bipolar disorder, schizophrenia, attention-deficit hyperactivity disorder.

TMAP was supposed to be based on the latest science, evaluated by an independent group of experts in the field.

But a 2004 lawsuit filed by whistleblower Allen Jones and the Texas Attorney General’s Medicaid Fraud Division against Janssen Pharmaceuticals, a division of Johnson & Johnson, suggests that the project was actually a vehicle for boosting sales of expensive new drugs that government funded studies found were not more effective, but cost far more than conventional medications.

According to records compiled from company documents, Janssen was making substantial payments over several years to the decision makers, many of whom were University of Texas professors.

While the professors were under contract with the state of Texas to provide their expert opinions on medications, records show many were also being paid by the companies whose drugs were being evaluated.

The suit alleges that Janssen improperly influenced the development of TMAP and compromised the objectivity of the decision makers by paying consulting fees, funding research and providing extravagant meals and lavish travel.

Such relationships were not always disclosed in TMAP manuals distributed to state hospitals and community mental health centers.

The depth of the financial relationship between the drug companies and the Texas Department of Mental Health weren’t always disclosed, either.

Extent of funding not fully disclosed

Steven Shon, who then was medical director for Texas MHMR, publicly reported in media interviews pharmaceutical company funding for TMAP was only $285,000.

However, documents obtained through the Texas Public Information Act show far more funding from the companies whose drugs were recommended as a first-line treatment in the TMAP guidelines.

Donations to the Texas Department of Mental Health/Mental Retardation from pharmaceutical giants Eli Lilly, Pfizer, GlaxoSmithKline, Abbott, Bristol-Myers Squibb, Forest, AstraZeneca, Novartis, Janssen and Forest and Wyeth-Ayerst totaled more than $1.2 million.

An additional $2.8 million was donated by the Robert Woods Johnson Foundation, which stock portfolio benefits from sales of Janssen’s medication.

Shon claimed he never personally received any money from the drug companies. A claim that was disputed in financial records turned to the court over by Janssen.

According to court records, Janssen paid Shon nearly $30,600 in honoraria and travel expenses. An additional $17,000 was directed to Association of Korean Americans at Shon’s direction.

In June, 2002, Janssen hosted a meeting and paid the travel expenses for seven TMAP decision makers. The meeting was held at the lavish Mansion on Turtle Creek Resort in Dallas with the purpose of advising Janssen on its newest antipsychotic.

Attendees included Steve Shon MD, Madhukar Trivedi MD, Tricia Suppes MD, John Rush MD, Larry Ereshefsky MD, Lynn Crismon, John Chiles MD and Alexander Miller MD.

Trivedi, Suppes, Rush and Ereshefsky were employees of University of Texas Southwestern Medical Center in Dallas.

Crismon was a professor

at the University of Texas School of Pharmacy in Austin.

Chiles and Miller were professors at University of Texas Health Science Center in San Antonio.

According to an expert report filed in the Janssen lawsuit, the meeting cost the company $114,000. The report says that the investment paid off. Shortly after, emails between some of the TMAP decision makers and Janssen discuss where the company wanted to place its newest antipsychotic on the guidelines.

The expert report, notes that other similar meetings were held at resorts in Scottsdale, Ariz., and the Ritz Carlton in Amelia Island, Fla. In most cases, participants were paid an honorarium.

Court records show Janssen paid Crismon, now the dean of the UT College of Pharmacy, more than $61,200 for various consulting fees and speaking engagements, including some that took place in state hospitals and community MHMR clinics.

Janssen reported paying Alexander Miller, professor at UT Health Science Center in San Antonio, $82,485.42. John Chiles, a UT professor at the time, was paid $151,254.73. Crismon, Miller and Chiles served on the TMAP panel at the time they received the payments.

Huge boosts in sales

The pharmaceutical companies funded trips for certain members of the TMAP team for travel to other states to expand TMAP to other states. More than a dozen states adopted the guidelines.

It meant huge sales for the drug companies because TMAP not only recommended their drugs for disorders in which the FDA had granted approval.

But for some illnesses that were not approved. Doctors are allowed to prescribe a drug with FDA approval for any reason, but manufacturers are only allowed to promote drugs for disorders that have been approved by the FDA.

While TMAP was touted as evidence-based or based on science and actual experience, the medications chosen to be included in the guidelines raised questions to exactly what evidence was considered by decision makers.

For example, several of the participants were involved in one of the largest independently funded studies to determine which medications provide the best treatment for schizophrenia.

The Clinical Antipsychotic Trials of Intervention Effectiveness Study, known as CATIE compared several of the new antipsychotics, risperidone (Risperdal), olanzapine (Zyprexa), quetiapine (Seroquel) and ziprasidone (Geodon) with an older, cheaper drug, perphenaxine (Trilafon).

The results, announced in 2005, found the new drugs, which cost roughly 10 times as much, had no substantial advantage over the older medication.

Despite the scientific findings, the TMAP team continued to recommend the more expensive drugs as a first-line treatment.

In 2008, the TMAP guideline for major depression was revised. The first non-medication treatment was added. The Vagal Nerve Stimulator, or VNS, manufactured by Cyberonics, is a medical device that is surgically implanted and sends electrical impulses to the brain.

The studies provided to the FDA during the approval process were conducted by several of the members of the TMAP team, including John Rush of the University of Texas Southwestern Medical Center in Dallas.

Reviewers with the FDA found the evidence submitted to the FDA to be lacking.

They recommended against approval. However, their decision was overruled and the device was approved.

Alarm bells sounded

The reviewers sounded an alarm, and the U.S. Senate Finance Committee launched an investigation into the approval process. Its findings raised questions about how the device could be approved by the FDA absent the scientific data showing the product was safe and effective.

In a speech on the floor of the Senate about the investigative report, U.S. Senator Charles Grassley said the conclusions of the person overruling the decision raise serious questions.

He read from the override memo, “I think it needs to be stated clearly and unambiguously that [certain VNS data]failed to reach, or even come close to reaching, statistical significance with respect from its primary endpoint. I think that one has to conclude that, based on [that] data, either the device has no effect, or, if it does have an effect, that in order to measure that effect a longer period of follow-up is required.”

The FDA approved the VNS with the condition that the company would conduct further studies and report the results to the FDA.

The Centers for Medicare/Medicaid refused to pay the estimated $25,000 bill for VNS treatment for depression. Most insurance companies wouldn’t pay, either.

But that didn’t deter the TMAP team from including the VNS on the revised guideline for treating depression. Such decisions were made behind closed doors and records revealing which members approved the inclusion are not available.

Rush’s relationship with Cyberonics was not fully disclosed to the University of Texas in his annual Statement of Financial Interest filing. His filing dated Aug. 7, 2006, lists his role as a member Cyberonics Speakers Bureau with an annual income equal or

less than $10,000.

But in records submitted to the office of U.S. Sen. Charles Grassley, R-Iowa, by Cyberonics, Rush was paid $100,000 in 2006 by the maker of the VNS. Cyberonics also reported paying Rush more than $75,000 in 2003 and 2004, and $62,000 in 2005.

Of the 10 decision makers who worked on the revision to the TMAP guideline for depression, six reported they owned stock or had a financial relationship with Cyberonics, including the project director, Crismon. Such disclosures were made to their employers or though industry publications.

The UT School of Pharmacy reported Cyberonics was the source of funding for a $54,938 research project in which Crismon was the principal investigator.

In a news release by Cyberonics, the company said the purpose of funding the research was to use the data to convince Medicaid and insurance companies to pay for VNS.

“By demonstrating the cost-effectiveness of VNS Therapy for treatment resistant depression (TRD) through this standardized, extensive and thorough analytical approach,” the release said, “it is our expectation that many more payers will come to recognize and understand the unique safety, effectiveness and cost effectiveness of VNS Therapy and grant psychiatrists and Americans with TRD access to VNS Therapy through national and regional coverage policies.”

Several TMAP panel members wrote letters urging the Centers for Medicaid to reconsider and pay for VNS treatment for depression.

Cyberonics cited it’s inclusion in the revised TMAP guideline for depression as reason for the government to pay.

It didn’t work.

CMS ruled the evidence did not show the treatment was effective for treating depression. A year after the ruling, the revised TMAP guideline was published recommending VNS, although many patients in the states hospitals and community centers would have had to pay out-of-pocket for the treatment.

Travel and out-of-state lobbying

Some of the TMAP team members were instrumental in expanding its usage across the nation. Largely funded by the drug companies, UT professors and state employees traveled to other states to lobby state legislatures and conduct training sessions.

But not all doctors in Texas centers and state hospitals were on board with the program. Emails between the TMAP team blamed a reluctance to change.

Texas MHMR paid two University of Texas at Dallas professors $100,000 to design a change management program.

Doctors were still reluctant, so the state made complying with the TMAP program a condition of its contract with community centers. The centers were required to show they were in compliance or would lose a percentage of their medication funding.

TMAP was at one time heralded. It was included in recommendation by the White House New Freedom Commission Report.

Psychiatrist Daniel Fisher, who was appointed to the commission said, members were encouraged to include TMAP in the recommendations, but never told of the pharmaceutical company involvement or that members of the consensus panel that developed the guidelines received money from the drug companies.

Fisher said he was stunned to learn the depth of involvement of the drug companies.

“This is the story of the century,” he said.

The pharmaceutical involvement came as a surprise to Cliff Gay. He was asked to participate in TMAP activities early on in the development. His role was as a patient and family advocate.

“I am totally blown away by the amount of money that was put into this thing,” said Gay. “I didn’t find out about the extent of the payments until I went to work for NAMI Texas.”

According to expert reports filed in the lawsuit against Janssen, NAMI, the National Alliance on Mental Illness in Texas, played a big role in helping TMAP and the pharmaceutical companies.

The expert report quotes from internal Janssen memos and depositions, efforts to utilize advocacy groups to their advantage, particularly NAMI Texas executive director Joe Lovelace.

The expert report filed in court reads “Lovelace received funding from J&J not only for the organization but personally, noting in his deposition that he deposited the monies in his wife’s law firm account because “she needed the money…there was a loss there.”

One of Janssen’s employees explained that “Lovelace desired to partner with Janssen as a consultant.”

Lovelace became a frequent speaker for J&J between 2000 and 2003. The report details the value of Lovelace when company officials asked if he would have NAMI members “come up to testify and relate their personal stories”, he responded by noting the when he had a chairman of a legislative insurance committee from Amarillo, he “made sure that a person in his church sat down in front of him.”

Lovelace no longer works for NAMI Texas. He is now the Associate Director of Behavioral Health for Texas Council of Community Centers.

TMAP’s rapid expansion began to crumble in 2004, when the first whistleblower lawsuit was filed against one of the drug companies involved. The State of Texas

Attorney General’s office joined in the lawsuit and filed suits against the other companies. Attorney Generals in other states filed suits, too.

Big-dollar settlements

To date, all but one of the suits has settled.

Bristol-Myers Squibb paid $15.7 million to Texas under a national settlement for allegations relating to its anti-depression drug, Serzone.

According to the press release issued by the Attorney General, the investigation also revealed BMS unlawfully marketing and promoting, Abilify, an atypical antipsychotic drug. It’s marketing partner, Otsuka paid $220,OOO to settle that claim.

Eli Lilly paid more than $30 million to Texas in a state and federal lawsuit over the marketing of its drug Zyprexa. In total, Eli Lilly paid $1.6 billion in criminal fines and reimbursing the government for charges to Medicaid.

The Texas Attorney General and 42 other states reached a $33 million agreement with Pfizer to settle claims of its marketing of Geoden to health care providers.

In a separate action, Pfizer also settled another case involving Geoden and another medication by paying $55 million to Texas as part of a $1 billion multi-state agreement.

Texas and 38 states reach a $68.5 million settlement with AstraZeneca stemming from a federal suit charging the company with unlawfully marketing Seroquel.

Texas share of the settlement was $3.8 million.

Janssen settled multiple Medicaid fraud and deceptive drug marketing cases related to its drug, Topamax, by agreeing to pay $50.7 million to several states.

Texas share is $2.86 million.

The Texas case against Janssen is pending and scheduled to go to trial in November.

Shon was fired as medical director for the state of Texas on Oct. 9, 2006. However, he was allowed to stay on the payroll in an unpaid capacity until he qualified to retire with full benefits.

He is now living in Las Vegas.

Crismon was promoted from professor to Dean of the UT School of Pharmacy. His work on TMAP was cited in the press release announcing his promotion. He continues to consult on guidelines for mental health treatment through a contract with the Reach Institute.

Rush left the University of Texas Southwestern Medical Center and is now working for Duke University in Singapore.

The other TMAP professors are still employed at various University of Texas System campuses.

Crismon declined to grant an interview for the report. KXAN’s request for an interview with Chancellor Francisco Cigarroa was denied, but UT System Vice Chancellor Barry Burgdorf said outside employment arrangements decisions are made by the individual campuses within the system.

“Supervisors are charged with evaluating requests to approve outside employment by assessing whether the potential outside employment constitutes a conflict of commitment — whether the time required to fulfill the outside employment would interfere with UT job duties — or a conflict of interest,” said Burgdorf, also the system’s general counsel.

“With regard to conflicts of interest in some cases the employee requesting approval of outside employment is required to enter into a conflict of interest management plan designed to prevent potential conflicts from maturing to an actual conflict,” he added. “Many times approved outside employment is synergistic with UT employment such as when a faculty member works for a start -up company spun out from UT using technology invented by the faculty member.”

In 2010, The Texas Department of State Health Services approved recommendations by a committee tasked to review the TMAP to stop using the guidelines.

Cliff Gay said he feels betrayed. He is among those who they were supposed to be helping.

“I don’t think any of them could look me in the eye and tell me they were doing it for me,” said Gay. “They did it for the money. It’s all about the money.”

http://www.kxan.com/dpp/news/investigations/drug-firms-paid-independent-experts

 

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According to Psycho/Pharma—1 In 66 Americans Is A Psycho

Wednesday, July 20th, 2011

Business Insider – July 20, 2011

by Robert Johnson

Image: wikipedia commons

Outselling even common drugs to treat high blood pressure and acid reflux, antipsychotic medications are the single top-selling prescription drug in the United States.

Once reserved for hard-core, One Flew Over The Cuckoo’s Nest type of mental illnesses to treat hallucinations, delusions or major thought disorders; today, the drugs are handed out to unruly kids and absent minded elderly.

A recent story in Al Jazeera by James Ridgeway of Mother Jones illuminates the efforts by major pharmaceutical companies to get doctors prescribing medicines like Zyprexa, Seroquel, and Abilify to patients for whom the drugs were never intended.

Focusing on psychiatrists because they rely on subjective diagnoses, the drug reps have been so successful that they’ve changed the criteria for mental illness and disability payments. Ridgeway quotes former New England Journal of Medicine editor Marcia Angell.

“[T]he tally of those who are so disabled by mental disorders that they qualify for Supplemental Security Income (SSI) or Social Security Disability Insurance (SSDI) increased nearly two and a half times between 1987 and 2007 – from one in 184 Americans to one in seventy-six. For children, the rise is even more startling – a thirty-five-fold increase in the same two decades. Mental illness is now the leading cause of disability in children.” Under the tutelage of Big Pharma, we are “simply expanding the criteria for mental illness so that nearly everyone has one.” Fugh-Berman agrees: In the age of aggressive drug marketing, she says, “Psychiatric diagnoses have expanded to include many perfectly normal people.”

Particularly vulnerable because medication decisions are often out of their hands the old and the young suffer most.

For kids: the number diagnosed with bi-polar disorder rose 40-fold between 1994 and 2003 and one in five comes away from a psychiatrist with a prescription for an antipsychotic.

Dosing the elderly at nursing homes has become so common that sales reps have coined the term “five at five” — meaning 5 milligrams of Zyprexa at 5 pm to sedate difficult residents.

For all their nefarious wrangling, in 2009, Lily agreed to pay $1.4 billion, including a $515 million criminal fine. The largest ever in a health care case and the largest criminal fine on any corporation in the U.S.

That year, Lilly sold $1.8 billion of Zyprexa alone.

http://www.businessinsider.com/zyprexa-antipsycotics-top-selling-drugs-in-us-2011-7

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

Monday, July 18th, 2011

Modern Medicine – July 16, 2011

Long-term-care (LTC) facilities are overusing antipsychotic drugs. One of every 7 elderly nursing home residents is receiving at least 1 atypical antipsychotic; in 83% of these cases, the drug is associated with a dementia diagnosis, yet the use of atypical antipsychotics in dementia increases the risk of death and is not approved by FDA, according to a report from the Office of the Inspector General (OIG).

Erroneous claims

“Government, taxpayers, nursing home residents, as well as their families and caregivers, should be outraged — and seek solutions,” said Daniel R. Levinson, Inspector General, Department of Health and Human Services (HHS), in a statement. “Despite the fact that it is potentially lethal to prescribe antipsychotics to patients with dementia, there’s ample evidence that some drug companies aggressively marketed their products toward such populations, putting profits before safety.”

OIG analyzed atypical antipsychotic use in LTC at the request of Sen Charles Grassley (R-Iowa). The report, issued in May, evaluated Part B and Part D claims data from January to June 2007. Analysts concluded that 51% of Medicare claims for atypical antipsychotics were erroneous. The claimed drugs were not used for medically accepted indications, not used off label as supported by recognized compendia, or not documented as having been administered to the elderly nursing home resident. The erroneous payments totaled $116 million for the 6 months studied.

Unmet standards

OIG also found that 22% of atypical antipsychotics used in LTC were not administered according to Medicare standards regarding unnecessary drug use in nursing homes. The standards are designed to reduce excessive dosage, excessive duration of therapy, inappropriate use, and lack of appropriate monitoring. Noting that violation of unnecessary drug-use rules may affect nursing homes’ participation in Medicare, OIG recommended that HHS act to reduce unnecessary drug use in LTC.

The report included aripiprazole (Abilify, Bristol-Myers Squibb), clozapine (Clozaril, Novartis), olanzapine (Zyprexa, Eli Lilly), olanzapine/fluoxetine (Symbyax, Eli Lilly), paliperidone (Invega, Janssen), quetiapine (Seroquel, AstraZeneca), risperidone (Risperdal, Janssen), and ziprasidone HCl (Geodon, Pfizer).

http://drugtopics.modernmedicine.com/drugtopics/Modern+Medicine+Now/Antipsychotics-overused-in-LTC-setting-OIG-says/ArticleStandard/Article/detail/730695

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Antidepressant Nation

Thursday, July 14th, 2011

Truthdig – July 14, 2011

10 percent of Americans over age six now take antidepressants

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

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

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

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

Marcia Angell in The New York Review of Books:

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

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

Read Part 2: The Illusions of Psychiatry

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

Tuesday, July 12th, 2011

ALJAZEERA – July 12, 2011

by James Ridgeway

Drug companies like Pfizer are accused of pressuring doctors into over-prescribing medications to patients in order to increase profits - GALLO/GETTY

Has America become a nation of psychotics? You would certainly think so, based on the explosion in the use of antipsychotic medications. In 2008, with over $14 billion in sales, antipsychotics became the single top-selling therapeutic class of prescription drugs in the United States, surpassing drugs used to treat high cholesterol and acid reflux.

Once upon a time, antipsychotics were reserved for a relatively small number of patients with hard-core psychiatric diagnoses – primarily schizophrenia and bipolar disorder – to treat such symptoms as delusions, hallucinations, or formal thought disorder. Today, it seems, everyone is taking antipsychotics. Parents are told that their unruly kids are in fact bipolar, and in need of anti-psychotics, while old people with dementia are dosed, in large numbers, with drugs once reserved largely for schizophrenics. Americans with symptoms ranging from chronic depression to anxiety to insomnia are now being prescribed anti-psychotics at rates that seem to indicate a national mass psychosis.

It is anything but a coincidence that the explosion in antipsychotic use coincides with the pharmaceutical industry’s development of a new class of medications known as “atypical antipsychotics.” Beginning with Zyprexa, Risperdal, and Seroquel in the 1990s, followed by Abilify in the early 2000s, these drugs were touted as being more effective than older antipsychotics like Haldol and Thorazine. More importantly, they lacked the most noxious side effects of the older drugs – in particular, the tremors and other motor control problems.

The atypical anti-psychotics were the bright new stars in the pharmaceutical industry’s roster of psychotropic drugs – costly, patented medications that made people feel and behave better without any shaking or drooling. Sales grew steadily, until by 2009 Seroquel and Abilify numbered fifth and sixth in annual drug sales, and prescriptions written for the top three atypical antipsychotics totaled more than 20 million.  Suddenly, antipsychotics weren’t just for psychotics any more.

Not just for psychotics anymore

By now, just about everyone knows how the drug industry works to influence the minds of American doctors, plying them with gifts, junkets, ego-tripping awards, and research funding in exchange for endorsing or prescribing the latest and most lucrative drugs. “Psychiatrists are particularly targeted by Big Pharma because psychiatric diagnoses are very subjective,” says Dr. Adriane Fugh-Berman, whose PharmedOut project tracks the industry’s influence on American medicine, and who last month hosted a conference on the subject at Georgetown. A shrink can’t give you a blood test or an MRI to figure out precisely what’s wrong with you. So it’s often a case of diagnosis by prescription. (If you feel better after you take an anti-depressant, it’s assumed that you were depressed.) As the researchers in one study of the drug industry’s influence put it, “the lack of biological tests for mental disorders renders psychiatry especially vulnerable to industry influence.” For this reason, they argue, it’s particularly important that the guidelines for diagnosing and treating mental illness be compiled “on the basis of an objective review of the scientific evidence” – and not on whether the doctors writing them got a big grant from Merck or own stock in AstraZeneca.

Marcia Angell, former editor of the New England Journal of Medicine and a leading critic of the Big Pharma, puts it more bluntly: “Psychiatrists are in the pocket of industry.” Angell has pointed out that most of the Diagnostic and Statistical Manual of Mental Disorders (DSM), the bible of mental health clinicians, have ties to the drug industry. Likewise, a 2009 study showed that 18 out of 20 of the shrinks who wrote the American Psychiatric Association’s most recent clinical guidelines for treating depression, bipolar disorders, and schizophrenia had financial ties to drug companies.

In a recent article in The New York Review of Books, Angell deconstructs what she calls an apparent “raging epidemic of mental illness” among Americans. The use of psychoactive drugs—including both antidepressants and antipsychotics—has exploded, and if the new drugs are so effective, Angell points out, we should “expect the prevalence of mental illness to be declining, not rising.” Instead, “the tally of those who are so disabled by mental disorders that they qualify for Supplemental Security Income (SSI) or Social Security Disability Insurance (SSDI) increased nearly two and a half times between 1987 and 2007 – from one in 184 Americans to one in seventy-six. For children, the rise is even more startling – a thirty-five-fold increase in the same two decades. Mental illness is now the leading cause of disability in children.” Under the tutelage of Big Pharma, we are “simply expanding the criteria for mental illness so that nearly everyone has one.” Fugh-Berman agrees: In the age of aggressive drug marketing, she says, “Psychiatric diagnoses have expanded to include many perfectly normal people.”

Cost benefit analysis

What’s especially troubling about the over-prescription of the new antipsychotics is its prevalence among the very young and the very old – vulnerable groups who often do not make their own choices when it comes to what medications they take. Investigations into antipsychotic use suggests that their purpose, in these cases, may be to subdue and tranquilize rather than to treat any genuine psychosis.

Carl Elliott reports in Mother Jones magazine: “Once bipolar disorder could be treated with atypicals, rates of diagnoses rose dramatically, especially in children. According to a recent Columbia University study, the number of children and adolescents treated for bipolar disorder rose 40-fold between 1994 and 2003.” And according to another study, “one in five children who visited a psychiatrist came away with a prescription for an antipsychotic drug.”

A remarkable series published in the Palm Beach Post in May true revealed that the state of  Florida’s juvenile justice department has literally been pouring these drugs into juvenile facilities, “routinely” doling them out “for reasons that never were approved by federal regulators.” The numbers are staggering: “In 2007, for example, the Department of Juvenile Justice bought more than twice as much Seroquel as ibuprofen. Overall, in 24 months, the department bought 326,081 tablets of Seroquel, Abilify, Risperdal and other antipsychotic drugs for use in state-operated jails and homes for children…That’s enough to hand out 446 pills a day, seven days a week, for two years in a row, to kids in jails and programs that can hold no more than 2,300 boys and girls on a given day.” Further, the paper discovered that “One in three of the psychiatrists who have contracted with the state Department of Juvenile Justice in the past five years has taken speaker fees or gifts from companies that make antipsychotic medications.”

In addition to expanding the diagnoses of serious mental illness, drug companies have encouraged doctors to prescribe atypical anti-psychotics for a host of off-label uses. In one particularly notorious episode, the drugmaker Eli Lilly pushed Zyprexa on the caregivers of old people with Alzheimer’s and other forms of dementia, as well as agitation, anxiety, and insomnia. In selling to nursing home doctors, sales reps reportedly used the slogan “five at five”—meaning that five milligrams of Zyprexa at 5 pm would sedate their more difficult charges. The practice persisted even after FDA had warned Lilly that the drug was not approved for such uses, and that it could lead to obesity and even diabetes in elderly patients.

In a video interview conducted in 2006, Sharham Ahari, who sold Zyprexa for two years at the beginning of the decade, described to me how the sales people would wangle the doctors into prescribing it. At the time, he recalled, his doctor clients were giving him a lot of grief over patients who were “flipping out” over the weight gain associated with the drug, along with the diabetes. “We were instructed to downplay side effects and focus on the efficacy of drug…to recommend the patient drink a glass a water before taking a pill before the  meal and then after the meal in hopes the stomach would expand” and provide an easy way out of this obstacle to increased sales. When docs complained, he recalled, “I told them, ‘Our drug is state of the art. What’s more important? You want them to get better or do you want them to stay the same–a thin psychotic patient or a fat stable patient.’”

For the drug companies, Shahrman says, the decision to continue pushing the drug despite side effects is matter of cost benefit analysis: Whether you will make more money by continuing to market the drug for off-label use, and perhaps defending against lawsuits, than you would otherwise. In the case of Zyprexa, in January 2009, Lilly settled a lawsuit brought by with the US Justice Department, agreeing to pay $1.4 billion, including “a criminal fine of $515 million, the largest ever in a health care case, and the largest criminal fine for an individual corporation ever imposed in a United States criminal prosecution of any kind,”the Department of Justice said in announcing the settlement.” But Lilly’s sale of Zyprexa in that year alone were over $1.8 billion.

Turning people into zombies

As it turns out, the atypical antipsychotics may not even be the best choice for people with genuine, undisputed psychosis.

Read the rest of the article here: http://english.aljazeera.net/indepth/opinion/2011/07/20117313948379987.html

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