Posts Tagged ‘Zyprexa’

Cause for alarm: Antipsychotic drugs for nursing home patients

Tuesday, May 31st, 2011

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

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

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

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

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

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

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

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

Another view: In defense of antipsychotics for dementia

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Drugging the Vulnerable: Atypical Antipsychotics in Children and the Elderly

Thursday, May 26th, 2011

TIME
By Maia Szalavitz
May 26, 2011

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

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

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

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

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

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

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

In 2007, for example, DJJ bought more than twice as much Seroquel as ibuprofen. Overall, in 24 months, the department bought 326,081 tablets of Seroquel, Abilify, Risperdal and other antipsychotic drugs for use in state-operated jails and homes for children.

That’s enough to hand out 446 pills a day, seven days a week, for two years in a row, to kids in jails and programs that can hold no more than 2,300 boys and girls on a given day.

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

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

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

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

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

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

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

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

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

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

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

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WSJ: Feds want $1B settlement in J&J Risperdal probe

Friday, May 13th, 2011

FiercePharma
By Tracy Staton
May 13, 2011

Johnson & Johnson could be on the hook for about $1 billion to settle the government probe into its Risperdal marketing. Prosecutors are looking for a settlement about that size, the Wall Street Journal reports, citing sources. That would be the third-largest marketing settlement between a Big Pharma company and the U.S. government; only Pfizer and Eli Lilly have made larger deals with the feds.

Earlier this week, J&J disclosed to the SEC that it had set aside an unspecified amount to cover a potential Risperdal settlement. The company had already taken a $1.4 billion charge against first-quarter earnings to cover legal costs.

The WSJ says J&J officials were surprised that prosecutors were pressing for such a large settlement. Prosecutors are trying to put a settlement of Risperdal marketing claims into context, using as a benchmark Lilly’s $1.4 billion deal to resolve a Zyprexa marketing probe. The difference between the two was that Lilly’s alleged violations extended over a longer period of time, the WSJ source said. The particular allegations against J&J haven’t been disclosed.

The Justice Department has settled a number of marketing cases against Big Pharma over the last several years, and the pace of those deals increased last year. Drugmakers together have paid more than $10 billion to settle government probes; in 2010, the industry’s whistleblower settlements topped the Justice Department charts.

Read article here:  http://www.fiercepharma.com/story/wsj-feds-want-1b-settlement-jj-risperdal-probe/2011-05-13

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Antipsychotic Drugs Deadly for Elderly Patients, Prescribed Anyway

Thursday, May 12th, 2011

ThirdAge.com

by Alex Heig

Antipsychotic drugs prescribed to as many as one in seven patients with dementia at nursing homes increase the risk of death and are not approved for such uses, a government audit has found.

Drugs such as Risperdal, Zyprexa, Seroquel, Abilify and Geodon are “potentially lethal” to many of the patients getting them and in many cases, completely unnecessary and unneeded.

The Centers for Medicare and Medicaid Services said that some of the inappropriate use of antipsychotics can be attributed to drugmakers’ habit of paying kickbacks to nursing homes to increase prescriptions for the medicines.

Medicare officials said that diagnosis information is for the most part omitted from prescriptions so officials are unable to tell whether the prescription is appropriate.

The Food and Drug Administration has warned doctors of the risk of using antipsychotic drugs in elderly dementia patients, but doctors have continued the practice because of a relative lack of other options.

Doctors want to maximize quality of life by treating the patient’s agitation even if that means the patient will die a bit sooner,” said Dr. Daniel J. Carlat, editor-in-chief of The Carlat Psychiatry Report, a medical education newsletter for psychiatrists.

The results of the government audit showed that during the first six months of 2007, 304,983 elderly patients in nursing homes (out of 2.1 million total) had at least one Medicare claim for an antipsychotic medicine.

Meanwhile, 83 percent of antipsychotic prescriptions for elderly nursing home residents were for uses not approved by federal drug regulators, and 88 percent were to treat patients with dementia, for whom the drugs can be lethal.

Federal regulations prohibit any drug paid for by the government from being used for non-approved reasons. Auditors found that 51 percent of claims for antipsychotic medication violated this rule.

Additionally, the government bans drugs used in excessive duration or dose level, even for patients that qualify. Auditors found that 22 percent of claims failed to live up to this requirement.

http://www.thirdage.com/news/antipsychotic-drugs-deadly-for-elderly-patients-prescribed-anyway_05-10-2011?page=1

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Antipsychotic Drugs Called Hazardous for the Elderly

Monday, May 9th, 2011

The New York Times
By Gardiner Harris
May 9, 2011

Nearly one in seven elderly nursing home residents, nearly all of them with dementia, are given powerful atypical antipsychotic drugs even though the medicines increase the risks of death and are not approved for such treatments, a government audit found.

More than half of the antipsychotics paid for by the federal Medicare program in the first half of 2007 were “erroneous,” the audit found, costing the program $116 million for those six months.

“Government, taxpayers, nursing home residents as well as their families and caregivers should be outraged and seek solutions,” Daniel R. Levinson, inspector general of the Department of Health and Human Services, wrote in announcing the audit results.

Mr. Levinson noted that such drugs — which include Risperdal, Zyprexa, Seroquel, Abilify and Geodon — are “potentially lethal” to many of the patients getting them and that some drug manufacturers illegally marketed their medicines for these uses “putting profits before safety.”

The audit is an unusual assessment by the government of whether doctors are treating Medicare patients appropriately in nursing homes. Mr. Levinson suggested that the government should collect information on the diagnoses given Medicare patients so that the government can assess whether the drugs prescribed to them are appropriate.

While common in the private sector, such basic oversight is unheard of in the Medicare program and would almost certainly be opposed by doctors’ groups and many in Congress who view government intrusions into the doctor-patient relationship as inappropriate. In response to the audit, the Centers for Medicare and Medicaid Services said that some of the inappropriate use of antipsychotics in elderly nursing home patients is a result of drug makers’ paying kickbacks to nursing homes to increase prescriptions for the medicines.

Omnicare Inc., a pharmacy chain for nursing homes, paid $98 million in November 2009 to settle accusations that it received kickbacks from Johnson & Johnson and other drug makers for antipsychotic prescriptions.

Medicare officials said that diagnosis information is not generally included with prescriptions so the government cannot assess in real time whether prescription payments are appropriate.

While the Food and Drug Administration has warned doctors that using antipsychotic drugs in elderly patients with dementia increases their risks of death, doctors continue the practice because they have few other good choices, said Dr. Daniel J. Carlat, editor in chief of The Carlat Psychiatry Report, a medical education newsletter for psychiatrists.

“Doctors want to maximize quality of life by treating the patient’s agitation even if that means the patient will die a bit sooner,” Dr. Carlat said.

The government auditors found that of the 2.1 million elderly patients in nursing homes during the first six months of 2007, 304,983 had at least one Medicare claim for an antipsychotic medicine. Nursing home residents received 20 percent of the 8.5 million claims for antipsychotic medicines for all Medicare beneficiaries at a cost of $309 million during those six months.

The auditors found that 83 percent of antipsychotic prescriptions for elderly nursing home residents were for uses not approved by federal drug regulators, and 88 percent were to treat patients with dementia — for whom the drugs can be lethal.

“These results are alarming,” said Senator Charles E. Grassley, Republican of Iowa, who asked for the audit. “Medicare officials need to pay attention.”

Federal rules require that any drugs that are paid for by the government be given only for uses that are approved either by the government or one of three independent drug usage encyclopedias. Auditors found that 51 percent, or 726,000 of 1.4 million claims, for antipsychotic medicines did not meet this criterion and were thus paid for by the government improperly.

Government rules also ban drugs that are used in excessive doses or duration, even if patients are found to have a condition for which the drug is appropriate. Auditors found that 22 percent, or 317,971 of 1.4 million claims, for antipsychotic medicines failed this standard.

Read article here:  http://www.nytimes.com/2011/05/10/health/policy/10drug.html?_r=2

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Internal J&J Emails Detail “Ugly” Chapter in Mismarketing of Antipsychotics

Friday, March 25th, 2011

BNET
By Jim Edwards
March 25, 2011

One of the reasons Johnson & Johnson (JNJ) lost a recent trial verdict over its misleading marketing of Risperdal was because jurors saw the company’s internal emails in which senior staff described their own actions as “ugly” and not “competent.”

Although the emails don’t reveal anything we don’t already know about Risperdal — J&J marketed the atypical antipsychotic for years by playing down the risk of weight gain and diabetes associated with the drug — the communications do give us a rare glimpse into the backbiting that happens inside drug companies when they fall afoul of the FDA. Pharmaceutical companies almost never discuss this kind of thing in public. (The documents can be downloaded at CourtroomView Network.)

In 2003, the FDA became increasingly concerned that use of drugs such as Risperdal and Eli Lilly (LLY)’s Zyprexa led to weight gain, diabetes and, in some patients, an early death. So it wrote to all antipsychotic drug companies to require them to send a “dear health care provider” letter to all U.S. doctors advising them of this risk:

But J&J began trying to figure out whether the “dear doctor letter” could actually be used to promote Risperdal, which executives believed was not as risky as similar drugs. SVP/R&D Scott Reines had seen a previous “dear doctor letter” from Eli Lilly that had used the same sleight of hand, and he asked a colleague, “how much commercial liability would we incur if we sent a similar letter about Risperdal”?:

When J&J’s letter went out, instead of heightening doctors’ awareness of the risk of diabetes it said the opposite: “Risperdal is not associated with an increased risk of diabetes”:

The FDA — unsurprisingly — hit the roof, and sent J&J a warning letter, blasting the company for being “false and misleading.”

Inside J&J, Reines was furious: “The whole management team almost got canned,” he wrote to chief medical officer Joanne Waldstreicher. “The warning letter is ugly … it’s really a black mark for J&J …  [and] no competent person would have let [the 'dear doctor letter'] go out”:

J&J faces up to $36 million in fines as a result.

Read article here:  http://www.bnet.com/blog/drug-business/internal-j-j-emails-detail-8220ugly-8221-chapter-in-mismarketing-of-antipsychotics/7743

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Profiting from mental ill-health

Tuesday, March 15th, 2011

There’s a reason psychiatrists prescribe drugs rather than talking therapy: the latter makes no money for pharmaceutical firms

The Guardian
By Harriet Fraad
March 15, 2011

More than one in ten Americans takes Prozac; the US comprises 5% of the world's population, yet consumes two thirds of psychological medications. Photograph: Stone/Jonathan Nourok/Getty

The New York Times recently led with a front-page splash about psychiatry’s propensity to prescribe pills, “Talk Doesn’t Pay, So Psychiatry Turns Instead to Drug Therapy”. That news is already widely known in the mental health field, but it has vast ramifications for Americans trying to maintain their sanity in our market-driven and medical system for delivering mental healthcare.

What does the turn to drug therapy mean for the mass of Americans?

Mental illness has not decreased with the change from talk therapy to drugs. In fact, as Robert Whitaker’s book diagnoses, mental illness in America has become an established epidemic. So-called miracle drugs like Prozac are taken by 11% of the population – and Prozac is only one of the 30 available antidepressants on the market. Antidepressants are accompanied by anti-anxiety and anti-psychotic drugs. Xanax, America’s leading anti-anxiety medication, is so ubiquitous that Xanax generates more revenue than Tide detergent, reports Charles Barber in his Comfortably Numb.

Anti-psychotics drugs alone net the pharmaceutical industry at least $14.6bn dollars a year. Psycho-pharmaceuticals are the most profitable sector of the industry, which makes it one of the most profitable business sectors in the world. Americans are less than 5% of the world’s population, yet they consume 66% of the world’s psychological medications.

Do these psycho pharmaceuticals work to restore mental health? Actually, the evidence is overwhelming that they fail. Antidepressants, the most popular psycho-pharmaceuticals, work no better than placebos. They work 25% of the time and stop working when the user stops taking them. In addition, they may actually harm patients in the long run. They disrupt brain neurotransmitters and may usurp the brain’s organic soothing functions.

Psycho-pharmaceuticals are less effective in the long run than talk therapy. Talk therapy, like drugs, does change brain and body chemistry; unlike drugs, though, talk therapy has no side-effects. Instead, talk therapy gives a patient tools that usually help to solve future problems. The latest research is most clearly expressed in both Irving Kirsch’s Antidepressants: The Emperors New Drugs and Gary Greenberg’s, Manufacturing Depression, both published last year. Kirsch is one of the world’s leading psychiatrists; Greenberg is one of the world’s most prestigious psychologists. Their views are echoed by many voices in the field of mental health. Why is prestigious and extensive research so widely ignored by doctors and patients alike? Our market-driven healthcare system gives us clues.

All 30 of the available antidepressants have suffered lawsuits within five years of their appearance on the market. These suits are often settled with large payments and gag clauses. The new generation of anti-psychotics are the latest case in point. Anti-psychotics were the single biggest targets of the False Claims Act. Every major company selling anti-psychotics – Bristol Meyers Squibb, Eli Lilly, Pfizer, Johnson and Johnson and AstraZeneca – has either settled investigations for healthcare fraud or is currently being investigated for it. Two recent settlements involving charges of illegal marketing set records for the largest criminal fines ever imposed on corporations. Their corporate logic is expressed in the words of Dr Jerome Avorn, a medical professor and researcher at Harvard: “When you are selling a billion a year or more of a drug, it’s very tempting for a company to just ignore the traffic ticket and keep speeding.”

There is also the widespread practice of paying physicians and psychiatrists heavy subsidies to recommend psycho-pharmaceuticals to their colleagues in small meetings at which a drug company representative is present. If doubt or criticism of the discussed drug is expressed, the doctor’s stipend stops. Another legally acceptable tool is to publish praise of a company’s drug in a scholarly article, which is often written by drug company personnel and simply tweaked by the physician whose name appears on the article. The physician is paid handsomely for such a service.

Under the pressure of legal settlements and embarrassing disclosures, eight pharmaceutical companies began posting doctors’ names and compensation on the web. ProPublica compiled these disclosures, totaling $320m, into a single database that allows patients to search for their doctor. Receiving payments for publishing articles written by drug companies is not illegal.

Two doctors, Dr Joseph Biederman and Dr Timothy Wilens of Harvard University Medical School, illustrate the close and cozy relationship between medical “scholarship” and drug companies. Drs Biederman and Wilens netted $1.6m each from drug companies for their work in recommending powerful anti-psychotic drugs for children. Biederman, Wilens and other extremely well-rewarded child psychiatrists are in part responsible for giving children the diagnosis of paediatric bipolar disorder for which anti-psychotic drugs like Risperidal and Zyprexa are used.

Experts agree that there is no long-term improvement in children’s lives from taking anti-psychotic drugs. In fact, these drugs have a substantiated pattern of metabolic problems and rapid weight gain that often leads to diabetes. The use of bipolar diagnoses and bipolar medications is one small example of how market-driven mental healthcare works in the United States. It illustrates the transformation of US healthcare into a system dominated by some of the richest corporations in the world.

Caring about profit is first, and that is why psychiatry has turned to drug therapy.

Read article here:  http://www.guardian.co.uk/commentisfree/cifamerica/2011/mar/15/psychology-healthcare

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Federal Judge & DOJ back lawsuit accusing Johnson & Johnson of illegal kickback scheme to push antipsychotic drugs on elderly

Tuesday, March 1st, 2011

AboutLawsuits.com

March 1, 2011

A federal judge has refused to toss out a whistleblower lawsuit backed by the Department of Justice (DOJ), which accuses Johnson & Johnson of involvement in an illegal kickback scheme to push their antipsychotic drugs on elderly nursing home residents that did not need them.

Johnson & Johnson sought to have claims brought by the DOJ, a number of whistleblowers and states dismissed, saying that what the plaintiffs are calling illegal kickbacks were completely legal rebates. However, U.S. District Judge Richard Stearns found that plaintiffs had sufficient evidence to go forward with the complaint.

Judge Stearns did remove several plaintiffs from the case, including the states of Nevada, Texas and Illinois, but allowed Kentucky, Indiana and Virginia to stay part of the lawsuit. Whistleblower David Kammerer was also removed from the lawsuit.

The DOJ filed a civil False Claims Act compliant against J&J on January 15, 2010, saying that the company paid millions to Omnicare, Inc. as kickbacks for selling Risperdal to nursing home patients.

In 2009, Omnicare settled charges brought against it by the government for allegedly paying kickbacks to nursing homes to prescribe the drug. At that time, the Justice department investigators indicated that the illegal nursing home drug kickbacks were hidden as data fees, education fees and as payments to attend Omnicare meetings.

According to the DOJ complaint against Johnson & Johnson, the drug maker paid $50 million to Omnicare between 1999 and 2004 to get it to prescribe Risperdal to elderly patients with dementia, and then hid those kickbacks as payments for services that Omnicare never actually provided. Omnicare then enacted intervention programs such as the “Risperdal Initiative” to persuade physicians to prescribe the drug to elderly dementia patients.

Omnicare, the largest pharmaceutical supplier for nursing homes in the U.S., has pharmacists on staff who review patients’ records and then makes recommendations to the patients’ physicians. Those recommendations are followed about 80% of the time, the DOJ said.

The claims were originally made by Omnicare pharmacist Bernard Lisitza in 2003, and the DOJ chose to intervene on Lisitza’s behalf.

Whistleblowers who report a false claim against the government may be entitled to receive a portion of any money that the government recovers from the offenders under the qui tam provision of the False Claims Act. In return, the whistleblower must be the first to bring the case to the government’s attention, and must not publicize the claim until the DOJ decides to prosecute the claim.

Risperdal (risperidone) is manufactured by Janssen, a division of Ortho-McNeil-Janssen, which is a subsidiary of Johnson & Johnson. Risperdal is approved by FDA for the treatment of schizophrenia, bipolar disorder and autism, but it is commonly used among elderly with dementia and sometimes as a form of chemical restraint in nursing homes.

Risperdal is not approved for treatment of dementia, and patient advocates have been pushing nursing homes to reduce the use of the drug among elderly due to the health risk and a lack of actual health benefits. According to a recent report from the United Kingdom, side effects of Risperdal and other similar antipsychotics, like Seroquel, Zyprexa and Abilify, could be linked to as many as 1,800 deaths and 1,620 strokes per year in elderly patients with dementia.

http://www.aboutlawsuits.com/risperdal-omnicare-lawsuit-proceeds-16571/

To see more international drug regulatory warnings and studies on Risperdal and other antipsychotic drugs, visit CCHR’s Psychiatric Drug Side Effects Database here: http://www.cchrint.org/psychdrugdangers/drug_warnings.php

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The New Child Abuse: The Psychiatric Diagnosing and Drugging of Our Children

Friday, December 17th, 2010

The Huffington Post—Dec 17, 2010

by Peter Breggin

Every society has found its own methods to abuse its most vulnerable members: children; women; the elderly; ethnic, racial and religious minorities; the poor; the mentally distressed or distressing; the physically disabled; those with unconventional lifestyles. All of these have been widely abused and all remain victims of abuse to varying degrees in societies throughout the world.

Just as it is certain that these abuses can never be fully eliminated, it is also certain that these same abuses will expand to the degree that individual citizens justify or ignore them and fail to take a stand.

In the past, the most rampant abuses have been justified on moral, religious, patriotic or ethnic grounds. But increasingly we will see the worst abuses rationalized on scientific and medical grounds. It’s the modern way.

Science and medicine have so successfully rationalized and justified our society’s most devastating and pervasive form of child abuse that it remains almost wholly unacknowledged, though it is known to every sentient adult and to most children. Probably every adult and half-grown child in America knows and can identify at least one child who is the victim of this abuse. Those who teach, coach, minister to or otherwise serve children may know dozens or even hundreds of children who are victims of the new child abuse.

Our society’s particular form of child abuse is the psychiatric diagnosing and drugging of our children.

The diagnoses are becoming almost innumerable including LD, ADHD, OCD, oppositional defiant disorder, bipolar disorder, and Asperger’s and autistic spectrum disorders. Increasingly children also fall victim to psychological tests that allegedly identify frontal lobe dysfunctions characterized by inattention or flawed executive functions.

Like the diagnoses, the drugs administered to children have mushroomed to involve every class of psychiatric medication, including stimulants, antidepressants, tranquilizers, mood stabilizers and anti psychotic agents. The FDA has increasingly given official approval for giving children especially deadly anti-psychotics such as Risperdal, Zyprexa, Geodon and Seroquel. Meanwhile, anything that can sedate the child’s growing brain from anti-hypertension drugs to anti-seizure drugs are routinely dispensed with callous disregard for their harmful impact.

It’s not uncommon to find children subdued and crushed by multiple psychiatric drugs. Probably 10 to 20 percent of our children will at some time be diagnosed or drugged. This number includes nearly every child in special education classes, foster care or on SSI/SSDI. Any child singled out by child services and educational or psychiatric authorities is likely to fall victim to psychiatric drugs.

The Psychopharmaceutical Complex is the source of these abuses: the pharmaceutical industry, organized psychiatry and medicine, NIMH, insurance companies and various other groups supported by the drug companies. Few parents are abusers; they are misled and intimidated by the “authorities” and often medicate their children against their better judgment.

Two principles are self-evident: First, convincing children that they have “something wrong” in their heads such as genetically crossed wires or biochemical imbalances is the surest way to rob them of self-esteem, personal responsibility, self-mastery and the hope of an unlimited future. Second, convincing children that they have a psychiatric diagnosis or treating them as if they have one and teaching them to rely on psychiatric drugs is a prescription for their becoming lifelong mental patients.

Two other principles require a little more thought or scientific evidence: First, all psychoactive substances from alcohol and marijuana to psychiatric drugs reduce and compromise the function of brain and mind, and none improve it. Whether or not we like the feelings we get from them, all psychoactive substances impact us precisely by producing a partial disability of our highest mental and spiritual life. More concretely most are poisonous to brain cells. I call this “the brain-disabling principle” of psychiatric treatment and have described and documented it in a lengthy medical text book with more than 1,000 scientific references.

Second, all psychiatric drugs have potentially horrendous and even lethal adverse effects from chronic depression and growth stunting caused by stimulants to diabetes, severe obesity, disfiguring neurological disorders and shortened lifespan caused by “antipsychotic” agents. You can confirm and expand on these observations by googling antipsychotic drugs or reading my various books on the subject, especially “Brain-Disabling Treatments in Psychiatry, Second Edition.” The names of the diagnoses will change. The chemical structures of the drugs will change. The promotional strategies will change. But, in my opinion, it will always be abusive to psychiatrically diagnose and drug children.

Now comes the challenge. Put yourself into the emotional and spiritual life of a child who has been diagnosed and will soon be drugged. Be empathic, but not in a disheartening way. Be empathic by connecting with love to the child’s inherent desire to love and be loved, to benefit from rational discipline, to play and to have fun, to grow up and to take responsibility, to learn, and to reach to his or her self-determined stars.

Are you able to put yourself in that child’s place? How does it feel to be told you’re not normal, that you have a disorder, that you’re special but not in a good or hopeful way? How does it feel to be different, let alone mentally impaired? And what impact will it have on you when the expectations of your parents and teachers are tailored to your limitations?

Be genuinely empathic. Children will say almost anything to adults to cover up their shame or to appease them. Beyond that, the medication spellbinding effects of psychiatric drugs impair the individual’s ability to perceive or evaluate the emotional and cognitive disruption that the psychoactive substances are causing. Put yourself in the child’s place and know what he or she must feel about being stigmatized and marginalized by psychiatric diagnoses.

Now imagine yourself inside the head of the child being drugged. The drug makes you feel different and you don’t like it, but everyone says you need it. You don’t want to have to take a drug to make you normal. But you’re a kid and there’s nothing you can do about it.

Gradually your brain and mind struggle to adapt to the brain-disabling chemical that’s crossed your blood brain barrier and disrupted your normal biochemical functions. As an aspect of medication spellbinding, you become so accustomed to your more flattened emotions and reduced mental acuity that you hardly notice the difference anymore.

And now consider this: All these children will grow up with brains drenched in toxic substances, literally polluted in the extreme. Think about the known adverse effects and dare to imagine the even more subtle changes in the function of the brains of each child, brains forever chemically altered.

These children will never know what evolution or God really intended them to become before these toxic intrusions.

Do not be misled that the medical and scientific authorities, and the weight of the universities and government, wholly support this rampant abuse of children. From the systematic abuse of women, children and minorities throughout the ages to the institution of slavery and the Holocaust, those in authority have condoned and benefited from these abuses. Authority at the top of society always justifies these widespread abuses, otherwise the abuses would never get started, nor would they persist.

Reject the authorities. Rely on common sense, sound ethics and real science. Allow yourself to become empathic toward these abused children. Then become angry, energized, motivated and engaged. Educate yourself. My books and those of many others will introduce you to a new world of science, education and philosophy about childhood and children. Find your own way to protest and to make a difference. Join us at empathictherapy.com in our efforts to protect our nation’s children from psychiatric abuse and to offer them genuine love, inspiration, service and education.

http://www.huffingtonpost.com/dr-peter-breggin/the-new-child-abuse-psych_b_788900.html

Peter R. Breggin, M.D. is a psychiatrist in private practice in Ithaca, New York, and the author of dozens of scientific articles and more than twenty books. His two most recent books are  Medication Madness: The Role of Psychiatric Drugs in Cases of Violence, Suicide and Crime and Brain-Disabling Treatments in Psychiatry, Second Edition: Drugs, Electroshock and the Psychopharmaceutical Complex. Dr. Breggin’s professional website is www.breggin.com. Dr. Breggin and his wife Ginger have founded a new organization, The Center for the Study of Empathic Therapy, Education and Living (www.empathictherapy.com). It will hold an international conference in Syracuse, New York, April 8-10, 2011.

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Once Again Psychiatrists Top the List of Top Prescribers—And Are Heavily Funded by Pharma

Wednesday, December 8th, 2010

Note from CCHR:   The reason why we repeatedly see psychiatrists on the list of top drug prescribers is pretty simple.  It’s so easy to prescribe psychiatric drugs to patients. Think about it.  It’s not like cancer or diabetes, or even high cholesterol where there’s a test to show some disease or imbalance requiring “medication” to treat it.   Sure there are medical conditions that may not have a “test” to prove anything is wrong.  There are some.  But there are no tests to prove anyone has a mental disorder.  Not one.  So psychiatrists can make a killing when it comes to writing unnecessary prescriptions.  Literally.   All while raking in the bucks from Pharma.

San Diego Union Tribune – December 8, 2010

By Christina Jewett

Three San Diego doctors who prescribe medications at the same time they are paid by drug companies as experts on the products figure into a broader national debate about whether playing both roles poses a conflict.

California Watch, a project of the independent, nonprofit Center for Investigative Reporting, compared two sets of data at the center of the debate — one a database of payments by drug companies to doctors nationwide and the other a list of the top antipsychotic prescribers in California’s Medi-Cal program for the poor and disabled.

Among California’s top prescribers, three accepted more than $20,000 in educational or speaker’s fees from the company that makes the drug they prescribe to Medi-Cal patients. All three practice in San Diego County.

Accepting drug company payments and then prescribing the products to patients is not illegal or even unethical, in and of itself. But some inside the profession and out are concerned such marketing could induce over-prescription of drugs or otherwise corrupt the process.

Two of the San Diego-area psychiatrists share a La Mesa office — Samuel O. Etchie and John W. Allen.

Allen was among the state’s top prescribers of Zyprexa, an antipsychotic drug. Allen dispensed 418 prescriptions at a cost to the state of $346,569. This year and last, the drug’s maker, Eli Lilly and Co., paid him about $27,000 to educate other medical professionals.

Allen said he conducts speeches about Zyprexa for Lilly based on information contained in the FDA-approved literature that comes with the drug. He said he speaks for a variety of drugmakers if he has done research and treated patients with the medication.

“I think it’s unfortunate that there’s in implication in articles that we’re robots for drug companies,” Allen said. “We have to have our own experience with medications and find out what works best. We’re not 5-year-olds in front of TV watching cereal and toy commercials.”

Allen said the prescribing numbers reflect the many bipolar and schizophrenic patients he treats in his practice. He said he prescribes a wide variety of medications, new and old.

“Whatever works for the patient is most important,” Allen said.

Etchie, who shares and office with Allen, prescribed Seroquel more than 1,000 times in 2009 at a cost of $449,000 to the state, according to Medi-Cal records collected by the Pro Publica news organization and provided to California Watch. The drug’s maker paid him $25,350 this year to speak to health professionals.

Etchie said he’s been paid by drug companies to give talks for about 10 years, and sees it as a way to keep himself informed about new and approved uses for medications and to share that information with colleagues who may be too busy to keep track of the research themselves. He said his presentations on Seroquel are an overview of the research drugmaker AstraZeneca has given the FDA about the medication.

“Whatever I do in the area of medicine, I want to get paid,” he said. “But my motive in doing this is to keep my knowledge base current and then to pass on that information to colleagues. Whether a doctor prescribes a medication or not is none of my business. I’m not a salesman.”

The third San Diego-area doctor is Harinder Grewal, a child psychiatrist who sees patients throughout the county.

According to Medi-Cal records, she issued nearly 3,000 prescriptions for antipsychotic medications in 2009, half of them for the drug Seroquel. This year AstraZeneca, that company that sells the drug, paid her $21,600 to educate other health workers.

Grewal did not return calls from California Watch or The San Diego Union-Tribune.

Grewal was also among the state’s top prescribers of the antipsychotic medication Geodon. That drug’s maker, Pfizer, spent $3,750 to compensate Grewal for leading an educational forum.

The three doctors showed up on a list provided by Medi-Cal officials to Sen. Charles Grassley, R-Iowa, who is reviewing prescribing rates of psychiatric and pain medications nationwide.

Grassley’s investigation comes on the heels of numerous government lawsuits that have accused pharmaceutical companies of illegally marketing drugs beyond their approved uses. California authorities who provided the information to Grassley’s office warned against viewing the data as a sign of wrongdoing.

Read the rest of the article here:  http://www.signonsandiego.com/news/2010/dec/06/paid-drug-experts-also-prescribe-products/

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