Posts Tagged ‘Seroquel’

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

« Return to news items


Share

Court Files Vindicate Detroit Mom In Stand Off With Police: She Had Legal Authority To Stop Daughter’s Drugging

Friday, April 22nd, 2011

Note from CCHR:  Court documents now vindicate  Maryanne Godboldo in having every legal right to stop administering her daughter an antipsychotic drug documented by international drug regulatory agencies to cause agitation, aggression, cardiac arrest, fatal  blood clots, liver failure, mania, suicide and violence yet this did not stop the state from ordering an assault on this woman in her own home, complete with Swat Teams and a tank.  There can be no doubt that Child Protective Services were in violation of every legal and civil right this mother has to protect her daughter from harm, not to mention her fundamental right as a parent.   We’re not sure why this isn’t being investigated as kidnapping case, because Maryanne Godboldo’s daughter was for all intents and purposes, kidnapped under the authority of Child Protective Services.   We,  as a society, must stand up to the use of force in what our co-founder, Dr. Thomas Szasz calls “The Therapeutic State,” the alliance between psychiatry and government in exerting social control over citizens.  This is not an isolated incident of parents being pressured, coerced, threatened to administer drugs to their child, via “child protective services” on behalf of “the state.”

“In the therapeutic state, treatment is contingent on, and justified by, the diagnosis of the patient’s illness and the physician’s prescription of the proper remedy for it… Today, the therapeutic state exercises authority and uses force in the name of health.  The Founding Fathers could not have anticipated…that an alliance between medicine and the state would then threaten personal liberty and responsibility exactly as they had been threatened by an alliance between church and state.” — Thomas Szasz (read more here http://qr.net/38D )

The Detroit News – April 22

by Doug Guthrie

Detroit — A mother accused of medical neglect for refusing to give her daughter a prescribed drug had authority to halt treatment, court files indicate.

The “informed consent” form signed by Maryanne Godboldo, who sparked a debate over parents’ rights when her daughter was removed from her care March 25, authorized her to give her daughter, Ariana, the antipsychotic drug Risperdal.

“It has been explained to me that I have the right to withdraw this consent at any time and can stop taking the medication at any time,” the form reads.

The agreement was signed June 3, 2010, by Godboldo and a psychiatrist associated with a children’s health organization that later complained to child welfare workers when Godboldo stopped giving her daughter the drug used in treatment of symptoms of schizophrenia and bipolar disorder.

Lawyers for the 13-year-old’s mother and father will be in Wayne County Circuit Court Juvenile Division today attacking the validity of a petition obtained on a medical emergency claim by a county Child Protective Services worker to take the girl from her home by force March 25. Ariana has since been kept in a state facility for mentally ill juveniles.

The social worker’s efforts to take Ariana set off a 12-hour siege after armed police broke open a door at Godboldo’s west side home and a shot was fired. The 56-year-old mother and the girl’s father, Mubarak Hakim, 58, face neglect claims and attempts by state authorities to make the girl a ward of the court and possibly resumption of drug therapy. Godboldo also is charged separately with criminal assault and resisting and opposing the three Detroit Police officers who entered her home.

The case has drawn nationwide attention from groups advocating parents’ rights, concerns about the safety of childhood immunizations and use of psychotropic drugs, and those opposed to government intrusion on personal decisions.

Godboldo has said her daughter’s problems began in 2009, after she took a cocktail of immunizations to catch up with requirements to switch from homeschooling to a regular school environment. Godboldo, who believes her daughter’s problems are from encephalitis caused by a severe reaction to the immunizations, has said drug therapy worsened her daughter’s behavior. Godboldo has said she sought a “holistic’ alternative with the help of another doctor.

The form was signed by Dr. Rajendra Kanneganti, a psychiatrist associated with the Children’s Center of Wayne County. The treatment plan resulted from a mental health assessment of then 12-year-old Ariana after she was found by police wandering naked in her neighborhood last Memorial Day weekend.

The document, signed by the mother on behalf of her minor child, says, “I understand that I will not be forced to take this medication and that I can stop taking it at anytime. I also understand that discontinuation of prescribed medication without consultation with my doctor could cause my condition to worsen.”

“I think that document proves our case,” said Godboldo’s lawyer, Wanda Evans. “She understood she had a right to stop giving the medication. If you sign an informed consent that says you can stop, and you stop, you did the right thing, and CPS (Child Protective Services) is just being nasty.”

Kanneganti did not respond to a Detroit News telephone call.

A legal expert said the signed document might not carry much weight in court.

“In this case you do have these countervailing rights and obligations and they are difficult to assess,” said John Pirich, professor at Michigan State University College of Law. “But, in practice, a court usually looks first at the health, safety and welfare of the child.”

The News obtained access earlier this week to the previously withheld court file. The file was made available only after a lawyer for The News reminded officials that court files are open to the public under Michigan law.

The original petition to remove the child was obtained by case worker Mia Wenk, two weeks on the assignment, who expressed frustration with Godboldo’s lack of cooperation in her investigation of accusations of medical neglect from at least four sources, including the Children’s Center.

Evans said Godboldo consulted another doctor before weaning her daughter from the drug.

“Our intention is to begin an evidentiary hearing (today) on why the girl was removed from the home,” Evans said. “On what authority did they (Protective Services) act when it is a parent’s responsibility to make these decisions?”

Wayne County Child Protective Services workers last week filed an expanded explanation of claims. It quotes the clinical director of the facility where Ariana is being held, saying the girl, “may have a severe case of childhood onset schizophrenia, which would require medication for her to be treated properly.”

However, Assistant Attorney General David Law, representing Protective Services in court last week, said there was no current emergency need to medicate the girl.

dguthrie@detnews.com

« Return to news items


Share

Seroquel Marketing Undeterred by Deceptive-Marketing Settlement

Monday, April 11th, 2011

The Epoch Times – April 11, 2011

by Martha Rosenberg

AstraZeneca has already settled nearly 25,000 personal-injury lawsuits pertaining to its antipsychotic drug Seroquel

Google the word “depression” and the first search result you’ll get will be for the antipsychotic drug Seroquel XR.

Visit WebMD and you’ll find the home page hosts similar ads for Seroquel XR, above and adjacent to the lead news story.

Who would know that AstraZeneca inked the largest multi-state consumer-protection settlement on record relating to deceptive Seroquel marketing on March 14 for $68.5 million? And only a year after inking a similar settlement related to burying side effect and safety information for $520 million with the government!

Who would know AstraZeneca has already settled nearly 25,000 personal-injury lawsuits pertaining to Seroquel, with more to come, says ABC News?

First approved in 1997, Seroquel has enjoyed the camel-nose-under-the-tent phenomenon known as indications creep. First approved for schizophrenia, it was later approved for bipolar disorder and psychiatric conditions in children.

But it was Seroquel’s 2009 approval as a drug for depression that helped it reach its spectacular sales of $5.3 billion in 2010 thanks to the United States’ walloping depression “market” of 20 million depression sufferers.

Seroquel’s blood sugar, weight gain, and heart side effects are well-known. That’s why FDA regulators opposed its use as a first-choice, stand-alone treatment for the 10 percent of the U.S. population with depression when safer drugs exist.

“I saw no clear advantage demonstrated in efficacy,” said Dr. Wayne Goodman, who chaired the FDA panel considering the depression indication. “There were side effects, and I would expect unintended consequences associated with wide-scale use of the drug.”

The drug also can cause increased mortality in elderly patients with dementia-related psychosis, suicide, neuroleptic malignant syndrome, cataracts, seizures, increase in blood pressure, and movement disorders in neonates when their mothers take it.

Seroquel’s fraud trail is also well-known, with more than six conflict-of-interest scandals swirling around Seroquel researchers and promoters. Psychiatrist Richard Borison was sentenced to a 15-year prison sentence in 1998 for a pay-to-play Seroquel research scheme, which helped establish Seroquel’s original perception as being safe.

But how many realize Seroquel’s cost to the individual taxpayer and health insurance consumers at a red-book price of almost $500 per month per person?

Auditors with the Michigan Corrections Department say the state could save $350,000 a month by switching just half of its Seroquel prescriptions to another pill. North Carolina spends $29.4 million per year on Seroquel prescriptions. Who knows how much more states and taxpayers are paying to control the metabolic side effects that emerge from taking Seroquel?

Reports are also starting to surface about the effects $6,000-a-year Seroquel prescriptions are having on rising insurance premiums for private insurance holders.

In fact, the public is really paying twice for irrepressible Seroquel marketing: first, for drug purchases by state and private plans, and, second, in suffering the drug’s side effects.

Martha Rosenberg is a freelance writer who lives in Chicago.

http://www.theepochtimes.com/n2/health/seroquel-marketing-undeterred-by-deceptive-marketing-settlement-54506.html

« Return to news items


Share

Psychiatric drug industry driven by wealth and stealth, not mental health

Tuesday, March 22nd, 2011

Natural News
By Monica Young
March 22, 2011

Drug company corporate websites tell us of their integrity and utmost commitment to people’s health and well-being. The American Psychiatric Association’s website begins with “Healthy Minds. Healthy Lives” and asserts the “highest ethical standards of professional conduct.” Yet a mountain of evidence points to an entirely different picture.

Most recently, thirty-eight state attorneys won a $68.5 million settlement with pharmaceutical titan AstraZeneca for unlawful marketing of antipsychotic Seroquel for unapproved use. These states also charged this company with failing to disclose the drug’s harmful side effects and concealing negative information about its safety and efficacy. “The company’s illegal practices put our most vulnerable populations at risk, including children and older patients with dementia and other debilitating diseases,” states Illinois Attorney General. U.S. sales of Seroquel brought in $5.3 billion for AstraZeneca last year.

Looking further, it’s evident that the pharmaceutical industry is fraught with fraud. For instance, the new generation of antipsychotics is the single biggest target of the False Claims Act. Every major drug company selling the drugs has either settled recent government cases for hundreds of millions of dollars or is under investigation for health care fraud.

Psychiatric drugs are notoriously high-priced. A year’s supply of one top antipsychotic is $7,000. A recent Biosocieties (scientific journal) article, entitled, “Demythologizing the high costs of pharmaceutical research,” exposes that drug companies widely exaggerate research costs to justify these prices. These companies typically cite a 2003 industry-funded study to claim a tag of over $1 billion to research and bring a drug to market. A new independent analysis indicates the figure is closer to $55 million.

Meanwhile drug company CEOs are some of the most excessively paid CEOs on Wall Street. Johnson & Johnson CEO’s publicly reported total compensation for 2009 (the last report available) was $25.6 million, including salary, bonus, stock options and other perks. This is three times the average for CEOs of S&P 500 companies and over 500 times the median American household income. His base salary was raised this year, despite an ongoing lawsuit, backed by the Department of Justice, accusing J&J of involvement in a kickback scheme to push their antipsychotic on elderly nursing home residents.

Drug manufactures spend billions yearly on marketing and advertising, far beyond what they spend on research. Billions go into direct to consumer advertising which drums a mantra to the masses: “ask your doctor if (___ medication) is right for you.” Billions are poured into marketing to doctors, including via drug sales reps – one of the most lucrative sales jobs in the U.S.

One ex-drug sales rep, Shahram Ahari, told a Senate Aging Committee that on top of a base salary for starting reps of $50,000, “there were four quarterly bonuses, an annual bonus, stock options, a car, 401k, great health benefits, and a $60,000 expense account.” He said his job involved “rewarding physicians with gifts and attention for their allegiance to your product and company despite what may be ethically appropriate.”

Another former drug sales rep and author of Confessions of an RX Drug Pusher, Gwen Olsen, says it’s all about the money. She described her hiring process. When asked why she wanted to become a pharmaceutical sales rep, she said she wanted to help people. The regional manager replied, “If that’s the case, you might want to join the Peace Corps…But if money is what motivates you, young lady, let me tell you how you can retire a millionaire.” Gwen reports that every manager she worked for said children are their biggest and most profitable expansion market.

Psychiatrists cash in big time as drug-pushers. The faster they shuffle people in and out for 15-minute medication management visits, the more they fill their deep pockets.

A recent New York Times article “Talk Therapy Doesn’t Pay, So Psychiatry Turns Instead to Drug Therapy,” gives an example of a practicing psychiatrist since 1972. He likens his office now to a bus station. In the old days of 45-minute talk sessions, “he knew his patients’ inner lives better than he knew his wife’s; now, he often cannot remember their names,” states the author. The doctor admits, “I had to train myself not to get too interested in their problems.”

And how much does the average psychiatrist make a year peddling drugs? $191,000.

Worldwide sales of antidepressants, stimulants, antianxiety and antipsychotic drugs exceed $82 billion a year. Yet for all the wealth this has brought these industries, are people truly getting better?

Psychiatric drugs have repeatedly proven to not only be extremely hazardous to one’s health but can be life-threatening and even fatal. Now the Archives of General Psychiatry has released scientific proof that antipsychotic drugs shrink brain tissue. (No wonder psychiatrists are called “shrinks”!)

Science journalist and author, Robert Whitaker, reports that long-term use of psychiatric medications is actually causing more mental illness – not less. He states “what you find with them when you look at long term outcomes, you see more people having chronic symptoms long term than you do in the unmedicated.”

Whitaker also points to disability statistics. Since the boom of psychiatric prescriptions began in 1987, adults on disability for mental illness more than tripled to 4 million. Amongst those on disability, the percentage of children has risen from about 5% in 1987 to over 50% today.

Of course the pill-pushers and their hordes of paid lobbyists, advocacy groups and spokesmen want us to believe that this means more mentally ill are finally getting the drug treatment they really need.

But who wants to believe a bunch of liars anyway?

« Return to news items


Share

Oh That? Seroquel Marketing Undeterred by This Week’s Deceptive Marketing Settlement

Tuesday, March 15th, 2011

OpEdNews  March 15, 2011

by Martha Rosenberg

Google the word “depression” and the first search result you’ll get is for the antipsychotic Seroquel XR.

Visit WebMD and the home page hosts similar ads for Seroquel XR, above and adjacent to the lead news story.

Who would know AstraZeneca inked the largest multi-state consumer protection settlement on record relating to deceptive Seroquel marketing just this week? For $68.5 million? Only a year after inking a similar settlement related to burying side effect and safety information for $520 million with the government?

Who would know AstraZeneca has already settled nearly 25,000 personal injury lawsuits pertaining to Seroquel with more to come says ABC news?

First approved in 1997, Seroquel has enjoyed the camel-nose-under-the-tent phenomenon known as indications creep. First approved for schizophrenia, it was later approved for bipolar disorder and psychiatric conditions in children. But it was Seroquel’s 2009 approval as an add-drug for depression that helped it reach its spectacular sales of $5.3 billion in 2010 thanks to the US’ walloping depression “market” of 20 million.

Seroquel’s blood sugar, weight gain and heart side effects are well known. That’s why FDA regulators opposed its use as a first choice, stand-alone treatment for the 10 percent of the US population with depression when safer drugs exist. “I saw no clear advantage demonstrated in efficacy,” said Dr. Wayne Goodman who chaired the FDA panel considering the depression indication. “There were side effects, and I would expect unintended consequences associated with wide-scale use of the drug.”

The drug also can cause increased mortality in elderly patients with dementia-related psychosis, suicidality, neuroleptic malignant syndrome, cataracts, seizures, increases in blood pressure and movement disorders in neonates when their mothers take it.

Seroquel’s fraud trail is also well known with more than six conflict of interest scandals swirling around Seroquel researchers and promoters. Psychiatrist Richard Borison was sentenced to a 15-year prison sentence in 1998 for a pay-to-play Seroquel research scheme which helped establish Seroquel’s original perception as safe.

But how many realize Seroquel’s cost to the individual taxpayer and health insurance consumers at a Red Book price of almost $500 per month per person?

Auditors with the Michigan Corrections Department say the state could save $350,000 a month by switching just half of its Seroquel prescriptions to another pill. (Anyone know a school that could use $350,000 a month?) And North Carolina spends $29.4 million per year on Seroquel prescriptions. Who knows how much else states and taxpayers are paying to control the metabolic side effects that emerge with Seroquel?

Reports are also starting to surface about the effect $6,000-a-year Seroquel prescriptions, many unnecessary and inappropriate, are having on rising insurance premiums themselves for private insurance holders.

In fact, the public is really paying twice for the irrepressible Seroquel marketing. First for drug purchases in state and private plans (and the advertising) and second in side effects from a drug whose safety continues to be in doubt.

http://www.opednews.com/articles/Oh-That-Seroquel-Marketin-by-Martha-Rosenberg-110315-836.html

« Return to news items


Share

AG Fines Firm For Improper Marketing Of Seroquel

Monday, March 14th, 2011

North County Gazette-  March 14, 2011

NEW YORK—-The state Attorney General’s office has reached a $3.1 million settlement with the major pharmaceutical company AstraZeneca following allegations that it improperly marketed and promoted the antipsychotic drug Seroquel.

*The agreement is part of a record 37-state settlement totaling $68.5 million – the largest ever multi-state consumer protection-based pharmaceutical settlement.

These practices violate consumer protection laws established to protect patients and ensure that health care providers are fully briefed on the medications available, including all known potential benefits and side effects.

It had been alleged that AstraZeneca engaged in deceptive and misleading practices when it marketed Seroquel for unauthorized, or “off-label,” uses and failed to adequately disclose the drug’s serious potential side effects to health care providers, including hyperglycemia and diabetes mellitus.

Seroquel is approved for the treatment of schizophrenia, certain instances of bipolar disorder and depressive episodes associated with bipolar disorder. When it was first introduced to the market in the 1990s, experts thought that it would be less likely to produce Parkinson’s type symptoms and motion disorders such as tardive dyskinesia, and therefore could be used in long-term treatment of schizophrenia.  However, while Seroquel may reduce the risk of these symptoms, it also produced dangerous side effects, including hyperglycemia and diabetes.

New York’s investigation demonstrated that AstraZeneca concealed and minimized the risks of these side effects.  AstraZeneca also marketed Seroquel for off-label and potentially dangerous uses including pediatric use, for use at high dosage levels, for the treatment of symptoms rather than diagnosed conditions, and to treat dementia and Alzheimer’s Disease in the elderly.

Following the Attorneys General’s investigation, AstraZeneca agreed to change its marketing of Seroquel and to cease promoting off-label uses of the drug, which are not approved by the U.S. Food and Drug Administration (FDA).

The settlement, filed in state court, also contains powerful injunctive terms prohibiting the use of financial incentives to manipulate doctors, deterring off-label marketing and requiring that AstraZeneca disclose scientific evidence of dangerous side effects.

In addition, the settlement requires AstraZeneca to provide accurate, objective and scientifically balanced responses to requests for off-label usage information. AstraZeneca must also have policies in place to ensure that financial incentives are not given to marketing and sales personnel for off-label marketing and that sales personnel do not promote to health care providers who are unlikely to prescribe Seroquel for an FDA-approved use.

http://www.northcountrygazette.org/2011/03/14/seroquel_marketing/

*In addition to New York, attorneys general of the following states and the District of Columbia participated in the settlement: Arizona, California, Colorado, Connecticut, Delaware, Florida, Hawaii, Idaho, Illinois, Iowa, Kansas, Louisiana, Maryland, Maine, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Jersey,  North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia and Wisconsin.

« Return to news items


Share

AstraZeneca paying $68.5M to settle off-label marketing charges for anti-psychotic Seroquel

Thursday, March 10th, 2011

ABCNews.com

by Matthew Perrone AP Health Wire, March 10,  2011

Thursday's deal is the second multimillion-dollar Seroquel settlement brought by government prosecutors in the past two years. Last April AstraZeneca agreed to pay $520 million to settle similar allegations brought by the federal Department of Justice.

AstraZeneca will pay $68.5 million as part of a multistate settlement over allegations that the drug developer promoted its blockbuster psychiatric drug Seroquel for insomnia, Alzheimer’s and other unapproved uses.

The New Jersey Attorney General’s Office announced the agreement Thursday, describing it as the largest multistate pharmaceutical settlement of its kind. New Jersey will receive $1.85 million from the deal with 36 other states and the District of Columbia as party to the settlement.

The states alleged that salespeople for AstraZeneca promoted its anti-psychotic Seroquel for off-label, or unapproved uses, and did not disclose side effects of the pill, which include weight gain and muscle spasms.

“Consumers rightfully expect pharmaceutical companies to engage in responsible marketing efforts that are consistent with approved purposes,” said Thomas Calcagni, acting director of New Jersey’s division of consumer affairs.

Seroquel is approved to treat schizophrenia, bipolar disorder and depression, though the majority prescriptions are for off-label uses like insomnia. The drug, approved in 1997, is AstraZeneca’s second-best-selling product, with U.S. sales of $5.3 billion last year. But that success has been marred by frequent allegations that the company illegally marketed the drug and downplayed its risks.

Seroquel’s side effects, including blood sugar increases, weight gain and uncontrollable muscle spasms, have resulted in thousands of lawsuits from patients. The drugmaker had settled nearly 25,000 personal injury lawsuits related to Seroquel at the end of 2010, with 3,950 remaining.

Pharmaceutical companies are prohibited from marketing drugs for unapproved uses, though doctors are free to prescribe them as they choose.

London-based AstraZeneca denied any wrongdoing.

“While we deny the allegations, AstraZeneca believes it is important to bring these matters to a close and move forward with our business of providing medicines to patients,” said company spokesman Tony Jewell, in a statement.

Thursday’s deal is the second multimillion-dollar Seroquel settlement brought by government prosecutors in the past two years. Last April AstraZeneca agreed to pay $520 million to settle similar allegations brought by the federal Department of Justice.

The new settlement stemmed from a separate three-year investigation led by the Attorney General of New Jersey. As part of the agreement AstraZeneca must publish any gifts or payments to physicians on a public website. The company also agreed to make sure that payment incentives to sales representatives do not encourage off-label promotion.

Allegations of off-label drug marketing have become increasingly common in the past decade, with the drug industry eclipsing all others as the source of fraud-related settlements with the federal government. Approximately 80 percent of the $3.1 billion in penalties collected last fiscal year by the government came from the health care sector, including drugmakers, insurers and hospitals, according to Taxpayers Against Fraud.

http://abcnews.go.com/Business/wireStory?id=13105486

« Return to news items


Share

Billion Dollar Drug Company Law Firm Restructures Connecticut Welfare System

Thursday, March 10th, 2011

By Bob Fiddaman and Shelia Matthews
March 10, 2011

For some time now, Sheila Matthews has been suspicious about her home state of Connecticut’s treatment of its most vulnerable children. As a mother of two children and co-founder of Ablechild, her instincts led her to scrutinize the dubious relationships among Connecticut’s Department of Children and Family Services [DCF], the pharmaceutical industry and a billion dollar law firm who has defended the likes of Pfizer Inc and Merck & Co., among others.

Sheila’s investigation has led her on a journey that links a non-profit children’s advocacy group, with assets over $15 million [2009] with nationally-renowned mass tort and class action defense law firms, to the Connecticut DCF – an $865 million bureaucracy, as described by the Connecticut Mirror.

The Connecticut DCF serves approximately 36,000 children and 16,000 families across its four Mandate Areas:

1. Child welfare;
2. Children’s behavioral health;
3. Juvenile Services; and
4. Prevention.

Sheila’s Ablechild has been questioning the Connecticut DCF since 2003, when Ablechild demanded that the Connecticut DCF immediately ban the use of the antidepressant Paxil in its treatment of mental disorders after multiple studies confirmed Paxil increased the risk of suicide in children and adolescents. This was more than a year prior to America’s Food & Drug Association (FDA) announcement that all antidepressants, including Paxil, should bear a black box warning regarding this suicide risk. Ablechild was disturbed that children in state custody were being prescribed this dangerous psychotropic medication. Ablechild’s public pressure paid off, and the Connecticut DCF deemed Paxil unsafe for children and adolescents, and according to the DCF drug approval list, Paxil has not been approved for use in over eight (8) years.

In August 2003, less than one month later, Ablechild reported that the commissioner of the Connecticut DCF held a ‘behind closed doors‘ meeting with Glaxo officials. This meeting was reported by the Associated Press, who wrote:

The maker of the anti-depressant Paxil plans to meet this week with Connecticut officials, weeks after the State stopped using the drug to treat young people in its care.

GlaxoSmithKline, a British pharmaceutical company, is sending its regional medical director and a medical team to meet with officials from the Department of Children and Families. [Source]

Despite repeated requests from Ablechild, the Connecticut DCF refused to inform the public what was discussed at this secret meeting.

Eight years later, Sheila and Ablechild continue to raise concerns and investigate potential wrongdoings and conflicts within the Connecticut DCF. Last month, in February 2011, Sheila attended a meeting sponsored by the Connecticut Behavioral Health Partnership [CBHP], where its medical director, Dr Steven Kant, presented the Husky Behavioral Pharmacy Data. The CBHP is a state vendor that provides mental health services to DCF children. These services are paid, in part, by the State-run insurance program, HUSKY. Incredibly the pharmacy data presentation showed that dangerous psychotropic drugs, like Paxil, are still being prescribed to thousands of children and adolescents. In fact, the Pharmacy Data presentation showed that the HUSKY program, financed by taxpayer dollars, paid drug companies over $60 million for psychotropic drugs for Connecticut’s children and adolescents in 2009 alone – many of which are not approved by the FDA for use in the pediatric population and all of which carry the most serious warning possible regarding the risk of suicide.

According to the pharmacy data presentation: [Which can be downloaded as a Powerpoint presentation HERE]

More than 50% of HUSKY Youth Behavioral med utilizers are on stimulants.
Close to 30% of HUSKY Youth Behavioral med utilizers are on antipsychotics.

The pharmacy data also revealed the following:

Most Frequently Used Behavioral Meds for DCF-Involved Youth

Medications for ADHD

Ritalin (10%)
Adderall (5%)
Vyvanse (4%)
Strattera (3%)

Atypical Antipsychotics

Abilify (11%)
Risperdol (10%)
Seroquel (8%)

Anti-anxiety

Hydroxyzine (2.5%)

Antidepressants

Prozac (4.5%)
Zoloft (4%)
Zyban (3%)
Desyrel (2.5%)
Celexa (2%)

Mood Stabilizers

Lithum (3%)
Depakote (3%)
Lamictal (2.5%)

Curiously, none of the above medications are on the Connecticut DCF list of approved/unapproved drugs listed in its DCF PMAC document.

With this in mind, Sheila Matthews contacted Dr Steven Kant and inquired as to whether any of the above drugs were approved by the Connecticut DCF for use in children.

Dr Kant replied:

… the answer to your question is not that straight forward.. . . Medications may be indicated by age and/or by specific treatment needs so it is not either a simply “yes” or “no”. Also, some medications may have the age indication but for a totally different condition, such as anti epileptic condition. . .Also FDA indications are static, they do not change over time though medical practice is constantly evolving…

Contradicting the very document that lists Connecticut’s approved and unapproved drugs, a “check-off” list that verifies the status of medications, Dr Kant replied, “I don’t think a “check off” for each medication would work in terms of verifying their status.”

With such an ambiguous response from Dr. Kant, we found the DCF Approved Medication List on the Internet. This particular version was revised in 2009.

It appears that the DCF has approved drugs in children that have not been approved for children by the FDA. In fact, the FDA has issued multiple advisories and alerts since 2004 about the increased risk of suicide in children, adolescents and young adults up to age 25 who are treated with psychotropic medications.

And while Fluoxetine (Prozac) is the only medication approved by the FDA for use in treating depression in children ages 8 and older, it still carries a black box warning regarding the risk of suicide.

In contrast, the DCF seems to be ignoring the conclusions of the FDA. Its list of approved medication in children and adolescents include every single antidepressant except paroxetine [Paxil] and venlafaxine [Effexor].

Forest Lab’s citalopram [Celexa] – APPROVED

Forest Lab’s escitalopram [Lexapro] – APPROVED

Solvay Pharmaceuticals’ fluvoxamine [Luvox] – APPROVED

Pfizer’s sertraline [Zoloft] – APPROVED

GlaxoSmithKline’s bupropion [Wellbutrin -also marketed as an anti-smoking cessation drug under the name of Zyban] – APPROVED [1]

Alarmingly, the DCF has produced a guide entitled, “MEDICATIONS USED FOR BEHAVIORAL & EMOTIONAL DISORDERS – A GUIDE FOR PARENTS, FOSTER PARENTS, FAMILIES, YOUTH, CAREGIVERS, GUARDIANS, AND SOCIAL WORKERS” where it writes, “Most of the side effects from the medications are mild and will lessen or go away after the first few weeks of treatment.” The guide also points out possible side effects of SSRI’s/SNRI’s:

SSRIs and SNRIs:

Headache
Nervousness
Nausea
Insomnia
Weight Loss

One of the most dangerous side effects of these medications, suicidal thoughts/ideation, doesn’t even make the 5 bullet-pointed list. The Guide does, however, add the following: “Watch for worsening of depression and thoughts about suicide.”

The DCF Approved Medication List writes:

“The DCF Approved Medication List is a list of psychotropic medications that has been carefully established by the Psychotropic Medication Advisory Committee, a group of DCF and community professionals.”

Sheila has since investigated other advocacy groups that were concerned about the off-label prescribing of psychiatric medications to youths in state custody. This is where she stumbled upon Children’s Rights, a non-profit charity based in New York City.

In 2005, Children’s Rights employed ten (10) attorneys and a staff of 31. It claims to use its expertise to change child welfare red tape and scrutinize failing systems. If the child welfare system fails to respond, Children’s Rights files a lawsuit. If successful, it enforces reform and then monitors its implementation.

In 1989, Children’s Rights had in fact filed a suit against William O’Neill and the Connecticut state Department of Children and Youth Services [DCYS].

The suit charged that an overworked and underfunded DCYS failed to provide services including abuse and neglect investigations, adoption, foster care, mental health care, caseloads and staffing. The case has been pending for over twenty (20) years, and while there have been numerous arguments that DCYS should be more inclusive or has failed to provide certain services, the issue of massive off-label prescription of psychotropic medications has never been brought to the court’s attention.

Children’s Rights is chaired by Alan C Myers, a partner at Skadden, Arps, Slate, Meagher and Flom, a billion dollar law firm which represents the pharmaceutical industry in mass torts and class actions. Myers is also co-head of the firm’s REIT Group [Real Estate Investment Trust].

Also, listed on the Children’s Rights website are individuals and law firms that have served as co-counsel on Children’s Rights’ legal campaigns to reform America’s failing child welfare systems, including:

Missouri - Shook Hardy & Bacon – Eli Lilly Co. and Forest Labs, defended the original Wesbeker Prozac trial in Kentucky and still defend Prozac, Celexa and Lexapro.

New JerseyDrinker Biddle & Reath – GlaxoSmithKline attorneys – defended Paxil as local counsel in Philadelphia cases.

OklahomaKaye Scholer LLP – provides work in Pharmaceutical Products Liability defense and employs an attorney who was former General Counsel of Pfizer, Inc.

A particular success for Skadden Arps occurred in 2010 when it secured a summary judgement ruling for Pfizer Inc. in a suit filed by two insurance companies who sought $200 million in damages for Pfizer’s predecessors alleged “off-label” marketing of its epilepsy drug, Neurontin.

Furthermore, in February 2011, Skadden Arps secured the dismissal of over 200 cases in a multi-district litigation pending against their client, Pfizer Inc. The plaintiffs had alleged injuries related to the use of Pfizer’s anti-epilepsy drug, Neurontin.

Neurontin, the generic version is called gabapentin, is prescribed by psychiatrists for a variety of “off-label” indications. It is often tried as an alternative treatment, when patients are unable to tolerate the side effect of more proven mood stabilizers such as lithium. [2]

Gabapentin has also been associated with an increased risk of suicidal acts or violent deaths.

This is a drug that has been known to cause behavioral problems, which include unstable emotions, hostility, aggression, hyperactivity or lack of concentration.

Children dependent on child welfare systems have rights and, according to its web page, Children’s Rights is dedicated to protecting them.

It should come as no surprise that the site fails to discuss the off-label prescription of non-approved psychotropic medications to children and adolescents, unless this falls under the ‘abuse and neglect’ category?

If Children’s Rights’ motive was to accomplish fixing the child welfare system then why hasn’t it investigated why thousands of children under state care are prescribed “off-label” psychiatric drugs? With a partner in a billion dollar pro-pharmaceutical law firm as its Chair, and supporters who also defend pharmaceutical products, is it safe to assume that its stance on the drugging of children is one that is being ignored?

Children’s Rights push to remove abused and neglected children into safety.

The basic question always comes down to trust. When power, money and a good cause is mixed, it is imperative to check motives. We would be less of a society if we didn’t check out all the facts. Abuse and neglect exist, always has and always will, but society is obligated to ensure those victims are not transformed into “good cause victims” and expensed out. There is no doubt we have a right to question the system and those who claim to promote change for the good of the children within it.

Children’s Rights Chairman, Alan C. Myers, Medical Director of Connecticut Behavioral Health Partnership, Steven Kant and the Connecticut Department of Children and Families may get their knickers in a twist with regard to an advocate of Ablechild and a blogger from Birmingham, UK questioning their motives but hey, what’s the downside of shinning a light on all these players, be they good or bad players?

Sheila’s concern is that Children’s Rights with its multi-million dollar budget and with the help of its billion dollar law firms, will continue to ignore the risks of these unapproved and dangerous medications, under the guise of helping our nation’s most vulnerable children. The question remains: how can the lawyers who defend psychotropic drugs also be the same lawyers who advocate for abused and neglected children to get into state welfare programs which place these children on the same drugs? The conflict is clear and obvious – and it poses an unmistakable danger to children who truly need our help.

[1] Bupropion [also known as Wellbutrin, Zyban] is a non-tricyclic antidepressant.
[2] Gabapentin

Bob Fiddaman is the author of the Seroxat Sufferers blog and the book, “The evidence, however, is clear… the Seroxat scandal.” Chipmunka Publishing.

Sheila Matthews is the co-founder of Ablechild and a mother of two children.

RETURN TO BLOGS PAGE


Share

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

« Return to news items


Share

Seroquel’s Toll—Controversial Antipsychotic Drug Now Marketed for Depression

Monday, January 24th, 2011

Counter Punch—January 24, 2011

by Martha Rosenberg

Even though AstraZeneca’s antipsychotic Seroquel is the fifth best-selling medication in the US according to drugs.com, exceeded only by Lipitor, Nexium, Plavix and Advair diskus, its safety, effectiveness, clinical trial and promotion records are highly checkered.

An original backer, psychiatrist Richard Borison, was sentenced to a 15-year prison sentence in 1998 for a pay-to-play Seroquel research scheme.

Its US medical director Wayne MacFadden had sexual affairs with two different women involved with Seroquel research, say published reports.

Chicago psychiatrist Michael Reinstein received $500,000 from AstraZenenca and wrote 41,000 prescriptions for Seroquel reports the Chicago Tribune and ProPublica.

Psychiatrist Charles Nemeroff who left Emory University in disgrace after a Congressional investigation for unreported pharma income, promoted Seroquel in continuing medical education courses according to the web site of psychiatrist Daniel Carlat.

Florida child psychiatrist Jorge Armenteros was chairman of the FDA committee responsible for recommending Seroquel approvals while a paid AstraZeneca speaker himself, said the Philadelphia Inquirer in 2009.

Psychiatrist Charles Schulz’ high profile pro-Seroquel presentations are suspected of being colored by his AstraZeneca income says the Minneapolis Star Tribune.

And unexplained Iraq and Afghanistan troop deaths are linked to Seroquel reported the Associated Press in August.

Originally approved for schizophrenia in 1997, Seroquel has subsequently been approved for bipolar disorder, for some groups of kids and as an add-drug for depression. This “indications creep” has mostly flown below the public’s radar. Seroquel expansion to treat children in late 2009, for example, was noted as a mere “label change” on the FDA web site. Hello?

Even without its depression indication, Seroquel is big business for AstraZeneca, earning $4.9 billion in sales in 2009. It is the drug that North Carolina’s Medicaid spends the most on: $29.4 million per year, reports the Charlotte News and Observer.

But now, as AstraZeneca rolls out its “Still Trying to Get Ahead of Your Depression” campaign, there are new questions about Seroquel’s safety and effectiveness.

According to an FDA warning letter, an AstraZeneca sales representative during an unsolicited sales call on January 3, 2008 sold Seroquel as a treatment for major depressive disorder to a physician before it was approved for MDD, an infraction which is illegal.

Once Seroquel was approved for depression (as an add-on treatment to an antidepressant for patients with major depressive disorder who not have an adequate response to antidepressant therapy), its leave-behind sheets drew another FDA warning letter.

AstraZeneca implied patients would achieve “remission” from depression with Seroquel XR (extended release) as opposed to with an antidepressant alone, says FDA — a claim not backed up by clinical experience.

Seroquel’s effect on depression has only been demonstrated in two, six-week trials FDA further said and six weeks is “not a long enough time period to adequately assess remission.” (It was approved…why?)

Also the case study of “Catherine F.” depicted in leave-behind sheets is inaccurate says FDA because it suggests Seroquel alleviates “symptoms of sadness and loss of interest when this has not been demonstrated by substantial evidence or substantial clinical experience.” (It was approved…why?)

Even AstraZeneca’s own briefing to the FDA committee in 2009 admits a “failed study” in which both Seroquel and Lexapro “failed to differentiate from placebo” which is Clinical Trial for “didn’t work.”

Nor did AstraZeneca adequately disclose Seroquel risks says FDA which include increased mortality in elderly patients with dementia-related psychosis, suicidality, neuroleptic malignant syndrome, hyperglycemia and diabetes mellitus, hyperlipidemia, weight gain and other serious side effects.

In fact, in addition to risks like cataracts, seizures and increases in blood pressure in children and adolescents, already on the Seroquel label, FDA asked AstraZeneca to add the “risk of EPS and withdrawal syndrome in neonates” a few months ago: movement disorders which can affect mothers’ babies if the mothers are taking Seroquel and stop.

But the FDA might also look at what the government’s other hand is doing. In May the Office of the Army Surgeon General’s final report on the findings of its Pain Management Task Force unabashedly hawks Seroquel for an unapproved use.

“Physicians should consider these medications for sleep disorders,” says the 163-page report,” listing Ambien and Seroquel (quetiapine) “for nightmares” even though Seroquel has never been approved for insomnia, sleep disorders or “nightmares.”

Maybe the government will send itself a warning letter.

http://www.counterpunch.org/rosenberg01242011.html

« Return to news items


Share