Drug Companies Still Peddling Risperdal and Zyprexa For Off-Label Use – June 19, 2006


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Drug Companies Still Peddling Risperdal and Zyprexa For Off-Label Use.

First published June 19, 2006

According to Kelly O’Meara, author of the newly released book, Psyched Out, America has a drug problem. “It’s not as covert as those illicit and illegal “Just Say No” drugs,” she says, “but, rather, Americans have become drug users by way of being diagnosed as suffering from one or a number of alleged mental disorders.”

“Sharing one’s feelings with a doctor,” she warns, “more often than not is all it takes to be diagnosed with a psychiatric disorder and prescribed a mind-altering drug to “treat” the disorder.”

According to O’Meara, “scattered data from a variety of sources provide a shocking glimpse at not only the direction the drugging of America is heading, but also,” she says, “the number of Americans being labeled as mentally ill.”

One of the top classes of over-prescribed drugs are the new generation of atypicals antipsychotics that were adopted because of claims by drug makers that they were safer, more effective and produced fewer side effects than the older antipsychotics.

However, over the past several years, drug companies have been forced to admit to misleading the FDA, physicians, and consumers about the deadly side effects associated with these drugs including an increased risk of suicide.

According to Harvard trained psychiatrist, Dr Stefan Kruszewski, “The drug causes both a severe metabolic syndrome and cardiovascular problems,” he explains, “at the same time that they continue to cause neurological side effects like the older typical antipsychotics.”

Dr Kruszewski says the drug makers knew of many of these side effects but withheld the data from the FDA. “So, what we have now are drugs,” he advises, “whose massive revenues and promotion are based upon faulty disclosures by the manufacturers.”

The new drugs are far more expensive than the older antipsychotics. “A dose of haloperidol” Dr Kruszewski notes, “might sell for 6 pennies while Zyprexa might sell for over $6 per pill.”

Data unveiled March 2006 by investment firm CIBC World Markets verifies the massive amount of spending going for these drugs. CIBC found that in the previous 12 months, of the top 20 drugs by managed care spending, psychotropic drugs accounted for nearly 20%, or $13 billion. The drugs that made the list were Zyprexa ($2.6 billlion), Seroquel ($2.5 billion), Risperdal ($2.2 billion).

Atypicals were approved by the FDA for treatment of adult schizophrenia and bipolar disorder. None of the 6 drugs including Clozaril, Risperdal, Zyprexa, Seroquel, Abilify and Geodon are approved for the treatment of any other disorder in children or the elderly.

But nonetheless, they are being routinely prescribed to patients of all ages, in most cases off-label for uses not approved by the FDA and people are dying from their side effects at alarming rates.

Allen Jones, former investigator in the Pennsylvania Office of Inspector General Bureau of Special Investigations says: “My best effort at correlating dollars spent with deaths from drug side effects suggests that people may be dying from side effects from the schizophrenia drugs alone at the rate of at least one death for each one million dollars spent on these drugs.”

Persons on atypicals have been found to commit suicide two to five times more frequently than the schizophrenic population in general. According to award winning author, Bob Whitaker, “researchers in Ireland reported in 2003 that since the introduction of the atypical antipsychotics, the death rate among people with schizophrenia has doubled.”

In an August 2005 interview with Street Spirit, Whitaker said: “They have done death rates of people treated with standard neuroleptics and then they compare that with death rates of people treated with atypical antipsychotics, and it doubles.”

“In fact,” he said, “in their seven-year study, 25 of the 72 patients died.”

Adult onset of diabetes has been found to occur 10 years earlier than usual and in far greater frequency in persons treated with atypicals. In February 2004, the American Association of Clinical Endocrinologists, the American Diabetes Association, the American Psychiatric Association, and the North American Association for the Study of Obesity issued a joint statement warning of the association between Zyprexa and diabetes.

Back in 2002, P Murali Doraiswamy, chief of biological psychiatry at Duke University, reviewed the FDA adverse events reported by Zyprexa patients and found: Of the 289 cases of diabetes linked to Zyprexa, 225 were newly diagnosed cases. One hundred patients developed ketosis (serious complication of diabetes), and 22 people developed pancreatitis, or inflammation of the pancreas, which is a life-threatening condition. There were 23 deaths, including that of a 15-year-old who died of necrotizing pancreatitis, according to the paper in the July 2002 journal Pharmacotherapy.

The less popular atypical, Clozaril, approved by the FDA on April 28, 1997 and manufactured by Novartis Pharmaceuticals has been linked to pancreatis, diabetes, and hyperglycemia by researchers at Duke University and the FDA in the January 2005 issue of the Journal of the American Medical Association.

According to a paper in the April 2006 American Journal of Psychiatry, Clozaril’s potential side effects include a loss of disease-fighting white blood cells and a potentially fatal inflammation of heart muscle.

The Journal of Clinical Psychiatry reported that the FDA was made aware of more than 140 new-onset cases of diabetes in patients on Clozaril, and three dozen cases involved ketoacidosis, a sometimes deadly complication of high blood sugar levels.

Elderly patients on atypicals are falling victim to strokes. When atypicals arrived on the market, Big Pharma widely promoted their off-label use to doctors who treat elderly patients. In 1999 the FDA cited Johnson & Johnson for downplaying Risperdal’s risks to elderly patients and making false and misleading claims that in addition to schizophrenia, it could be used “for psychotic symptoms associated with a broad range of disorders.”

Despite the FDA’s warning, Risperdal quickly became a leading off-label treatment for dementia and Alzheimer’s disease. In fact, in 2002, about 670,000 such prescriptions were written for Risperdal use in elderly patients, up more than 350% from 1998, according to a Knight Ridder analysis reported on November 2, 2003.

Although in April 2003, J&J sent a letter to doctors warning of the increase in strokes associated with the drug when prescribed to elderly patients, the warning took two more years to reach the public and came 6 months after public health officials in Canada issued a warning and urged doctors to reconsider their use of the drug to treat dementia.

In April 2005, the FDA warned that the atypicals have been linked to deaths from heart failure and pneumonia in elderly dementia patients and instructed drug makers to revise their drug labels to include strong warnings of the increased risk of death.

Six months later, on October 18, 2005, the Associated Press reported a study that showed atypicals used to treat elderly patients with dementia-related aggression and delusions can raise their risk of death.

The researchers in the study pooled the results of 15 previous studies on atypicals Zyprexa, Risperdal, Seroquel and Abilify. Among more than 5,000 elderly dementia patients, those taking any of the 4 drugs faced a 54% increased risk of dying within 12 weeks of starting the drugs, compared to patients taking placebos.

According to the AP article, there were 118 deaths among the 3,353 atypical users versus 40 in the 1,757 patients receiving a placebo and the risks were similar for each atypical.

And yet, research shows that nursing home residents are being fed antipsychotics in record numbers. A study published in the June 13, 2005 Archives of Internal Medicine examined the quality of antipsychotic prescriptions in about 2.5 million Medicaid patients in nursing homes and found that “over half (58.2%),” received antipsychotics that exceeded the maximum recommended dosage, received duplicate therapy, or under the guidelines, had inappropriate indications for the medications to begin with.

The study determined that more than 200,000 nursing home residents received antipsychotic therapy but had “no appropriate indications for use.”

A USA Today analysis of FDA data determined that at least 45 children died from 2000 to 2004 with an atypical listed as the “primary suspect.” In addition, more than 1,300 cases of serious side effects were reported, including some known be life threatening, such a low white blood cell count and convulsions.

According to an analysis of a federal survey by researchers at Vanderbilt Medical School in Nashville, outpatient prescriptions for children between the of 2 and 18 increased about fivefold from under 500,000 in 1995 to about 2.5 million in 2002.

One of the most disturbing, dangerous trends linked to atypicals, USA says is called “polypharmacy”: routinely giving kids several psychiatric drugs. According to child psychiatrist Joseph Penn of Bradley Hospital and Brown University School of Medicine in Providence, “We know very little about the interaction of these drugs, the effects they could be having on kids.”

Penn told USA that he is appalled at how many times he has seen the mega-powerful atypicals prescribed to children suffering from insomnia when they’re taking other medicines.

“I’ve seen hundreds of cases,” he says, “and often parents don’t seem to have been told about the many less risky prescription and non-prescription options out there.”

Kids of all ages are being fed these dangerous drugs in states all across the country. A study directed by Oregon Health & Science University professor David Pollack, found 246 preschool children covered by the Oregon Health Plan receiving antipsychotic or antidepressant drugs. The study, in Oregon Health News, reviewed Medicaid records and found that 41% of the children were given the drugs for attention deficit disorder.

The Children’s Hospital of Philadelphia recently found that 19% of newly diagnosed Type 2 diabetic children were being treated with drugs like Zyprexa, Risperdal, Geodon, Seroquel, Clozaril, and Abilify, according to Robert F. Kennedy Jr vs the Medical Elite, by Mark Sircus Ac, OMD in June 22, 2005.

In February 2006, Florida’s public health officials ordered an independent investigation into why the number of children on Medicaid in that state taking antipsychotics has nearly doubled over the past five years from 9,500 to almost 18,000.

A study published in the June 2006 Archives of General Psychiatry analyzed data from a national survey of doctors’ office visits and found that antipsychotics were prescribed to 1,438 per 100,000 children and adolescents in 2002, up from 275 per 100,000 in the two-year period from 1993 to 1995, according to the June 6, 2006 New York Times.

The researchers determined that about a third of the children on antipsychotics were diagnosed with behavior disorders, including attention deficit problems; a third had psychotic symptoms or developmental problems; and another third were diagnosed with mood disorders. Over all, more than 40% of the children were also taking at least one other psychiatric medication.

“If you’re going to put children on three or four different drugs, now you’ve got a potpourri of target symptoms and side effects,” Dr Julie Magno Zito, an associate professor of pharmacy and medicine at the University of Maryland told the Times.

“How do you even know who the kid is anymore?” Dr Zito noted.

However, Big Pharma’s long arm could not reach the nation’s children if not for their creative promotional schemes. Industry-backed front groups like the National Alliance of Mental Illness and TeenScreen are working overtime to get as many kids as possible hooked into long term drug treatment under the ruse of suicide prevention through mandatory screening of the 52 million students in the nation’s public school system to turn kids into consumers before they leave high school.

The gang behind TeenScreen, claims the survey can detect seven mental health disorders. The program’s Executive Director, Laurie Flynn, told a congressional committee on March 2, 2004, that in the screening process, “youth complete a 10-minute self-administered questionnaire that screens for social phobia, panic disorder, generalized anxiety disorder, major depression, alcohol and drug abuse, and suicidality.”

Critics are outraged over TeenScreen. “The goal is to promote the patently false idea that we have a nation of children with undiagnosed mental disorders crying out for treatment,” according to Forcing Kids Into a Mental Health Ghetto, by Texas Congressman and physician, Ron Paul.

Former Medicaid program investigator, Allen Jones says, “the mandatory screening of all students, with follow-up treatment as required, translates into putting more kids on mind-altering and potentially lethal drugs.”

On June 16, 2006 the Washington Post said, the use “of the psychological evaluations is growing even though there is little hard evidence that they prevent suicides.”

TeenScreen was set up to sell dangerous psychiatric drugs to kids and studies show the scam is working. “The growing use of screening,” the Post noted, “has coincided with a rapid increase in the number of youngsters being prescribed powerful antipsychotic medications such as Risperdal and Zyprexa that have not been specifically approved for use by children.”

“A panel of government experts concluded two years ago that the evidence to justify suicide screening was weak,” the Post wrote, “and that such programs, although well intentioned, had potential adverse consequences.”

The Washington Post quoted Dr David Shaffer, the mastermind behind TeenScreen, and the program’s director, Laurie Flynn, as saying the goal is not to put children on medication but to alert parents to a problem, which they can then discuss with a pediatrician, a psychiatrist or a clergy member.

People even temped to believe that claim need to watch TeenScreen’s video-taped presentation at the annual convention of the country’s top pharma-bankrolled front group known as the National Association for Mental Illness, obtained by ace researcher Sue Weibert, which shows the TeenScreen crew telling the army of NAMI members from all across the US that helping TeenScreen might require them to contact a child’s insurance company to check on coverage or drive a child to an appointment with a shrink.

The video also shows the TeenScreen presenter passing around a pad of paper for the members to sign on as volunteers and agree to rise up against anyone who speaks out against TeenScreen when it moves into a new community.

In the video, the presenter goes on to explains the importance of tricking kids into agreeing to take the survey first, by bribing them with pizza or movie coupons or other perks, because according TeenScreen, the parents won’t agree to the survey so they need to win the kids over first and then send them home to talk the parents into it.

The statement that no drug company money is involved in TeenScreen is also false. The May 2002 issue of the Update Newsletter reporting on the implementation of a TeenScreen program in Nashville, Tennessee said: “Some 170 students responded to a “TeenScreen” survey conducted by NAMI Nashville and Columbia University.”

“TeenScreen was funded,” the newsletter said, “through grants from AdvoCare and Eli Lilly.” In fact, Eli Lilly funded the entire week of events, according to the newsletter.

Another fact not mentioned by TeenScreen to the Post, is that Laurie Flynn, was the former Executive Director of NAMI, until 2000 when she left to become Executive Director of the TeenScreen program.

Last time I checked, the NAMI website listed “Corporate Partners, Grants, and Foundations,” as Abbott, AstraZoneca, Bristol-Meyers-Squibb, Eli Lilly, Forest Lab, Glaxo-Smith-Kline, Jannsen, McNeil, Pfizer, and Wyeth.

So the truth is, during Flynn’s 16 year reign over NAMI, Big Pharma paid her salary. Internal NAMI documents obtained by Mother Jones Magazine, showed that over a period of 3 years, from 1996 to mid-1999, eighteen drug companies gave NAMI a total of $11.72 million, and included Janssen, Novartis, Pfizer, Abbott Labs, Wyeth-Ayerst, and Bristol-Myers Squibb.

Critics say the TeenScreen promoters deliberately inflate suicide numbers. “They are pulling numbers out of thin air – falsely presuming that this crisis is about lack of access to drugs and calling for government to provide more and more of what many of us believe is the wrong kind of treatment,” according to Robert Whitaker in an interview with Kelly O’Meara on May 16, 2003, in Insight News.

In truth, according to a government funded study in the Journal of the American Medical Association: “Despite a dramatic increase in treatment, no significant decrease occurred in suicidal thoughts, plans, gestures, or attempts in the United States during the 1990s,” Trends in Suicide Ideation, Plans, Gestures, and Attempts in the United States, 1990-1992 to 2001-2003, JAMA. 2005;293:2487-2495

As for TeenScreen not advocating for any medication, that happens to be untrue as well. In 1999, Flynn, wrote the forward to a book that was written to specifically promote the atypicals titled, “Breakthroughs in Antipsychotic Medications: A Guide for Consumers, Families, and Clinicians,” by Peter J Weiden, Ronald J Diamond.

On December 11, 2003, the New York Times reported that Dr Shaffer, at the request of a drug maker, attempted to block the recommendation to ban SSRI antidepressants from use in children in the UK by sending a letter to the British regulatory agency claiming there was insufficient data to restrict the use of the drugs in adolescents.

Critic say any child labeled mentally ill by TeenScreen will end up on drugs. “TeenScreen is purely and simply a marketing scam to sell psychotropic drugs,” according anti-child drugging activist, Ken Kramer.

“Mass mental health screening of American children,” Kramer says, “is absolutely, without a doubt, the most serious psychiatric threat to this nation.”

A survey of recently trained child psychiatrists seems to verify Mr Kramer’s assertions. The results of the survey showed that only one in 10 children in their practices did not receive a drug.

According to many experts, the other relatively new class of drugs being promoted through schemes like TeenScreen, the SSRI antidepressants, are playing a duel role in transforming healthy people into disabled individuals. Little attention has been given to the FDA’s warning that certain behaviors are “known to be associated with these drugs,” including “anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (severe restlessness), hypomania, and mania,” according to Dr Peter Breggin.

Dr Breggin, and a host of other experts, say a patient will often experience mania or psychotic episodes caused by the SSRI but instead of the doctor recognizing the drug induced adverse even, the patient is diagnosed as bipolar or schizophrenic and prescribed an atypical, in addition to the SSRI, in what experts refer to as a “drug cocktail.”

The prescribing of a drug cocktail paves the path for a life-long customer for Big Pharma. Since Prozac, the first SSRI, came on the market in 1987, the number of people diagnosed as disabled due to mental illness in the US has gone from 3.3 million to 5.7 million, according to Robert Whitaker, in Anatomy of an Epidemic: Psychiatric Drugs and the Astonishing Rise of Mental Illness in America; Ethical Human Psychol and Psychiatry 2005; 7: 23-33.

When in reality, the SSRI is the cause bizarre behaviors. “You see a fairly significant percentage of patients where new and more severe psychiatric symptoms are triggered by the drug itself,” Whitaker says.

So then, “instead of just dealing with depression, they’re dealing with mania or psychotic symptoms,” he said, “they’re given an antipsychotic to go along with the antidepressant; and, at that point, they’re moving down the path to chronic disability,” Whitaker told Street Spirit in August 2005.

The most widespread physical problem found in children on atypicals is drastic weight gain which increases the risk of diabetes and heart disease. Obese children are twice as likely as normal kids to develop diabetes, according to a new University of Michigan study.

In an effort to determine whether atypicals were worth their enormous cost, the National Institute of Mental Health conducted one of the largest studies ever, the Clinical Antipsychotic Trials of Intervention Effectiveness, and $44 million tax dollars later, published the startling results in September 2005, with the conclusion that the new atypicals “have no substantial advantage” over the old ones.

But this is nothing new. In 2000 the British Medical Journal published the results of a study by Dr John Geddes, who examined clinical trials involving over 12,000 patients and the effectiveness and dangers of the new atypicals and the old antipsychotics in head-to-head trials and concluded:

(1) There is no clear evidence that atypical antipsychotics are more effective or are better tolerated than conventional antipsychotics.

(2) Conventional anti-psychotics should usually be used in the initial treatment of an episode of schizophrenia unless the patient has previously not responded to these drugs or has unacceptable extrapyramidal side effects.

In the latest side effect findings, the results of a US government study released in June 2005, revealed that patients taking Risperdal had a higher incidence of benign tumors in the pituitary gland. The FDA study was presented on June 18, 2005 at a University of Pittsburgh conference and described the methodology and findings as:

The researchers analyzed 2.5 million adverse events reported by doctors, patients, and individuals since 1968. Of the 307 reports of pituitary tumors, 64, or 21%, occurred in patients taking antipsychotics. Forty-eight reports of pituitary tumors were reported in patients taking Risperdal.

According to the June 17, 2005 Wall Street Journal. FDA warnings about the dangers of atypicals have not slowed down their use and obviously the only way to get through to Big Pharma is with litigation. And lawsuits are being filed all over the country in droves.

Although Eli Lilly settled thousands of Zyprexa lawsuit for about $670 million in June 2005, the company now faces thousands more claims, including three state lawsuits and government investigation into its marketing of Zyprexa.

According to Bloomberg News on April 20, 2006, as many as 5,000 new suits have been filed in state and federal courts and more are expected, attorneys for patients in California, Pennsylvania, Mississippi and Texas told Bloomberg.

The lawsuits allege that Lilly knew of the risks associated with Zyprexa but did not warn doctors and consumers. Many of the patients in the new lawsuits claim they took Zyprexa without knowing the risks because Lilly promoted the drug to doctors as an off-label treatment for illnesses other than schizophrenia and bipolar disorder.

Attorneys say Lilly has doctors prescribing Zyprexa for everything from women with post-partum depression to children acting out.

According to the June 12, 2006 New York Times, today more mentally ill patients die from diabetes and complications like heart disease than from suicide. “Uncontrolled diabetes can ruin a person’s life as much as uncontrolled schizophrenia,” Dr Newcomer, a professor of psychiatry at Washington University School of Medicine in St Louis, told the Times.

In a 2003 survey, the city’s health department found that about 17% of adults who reported symptoms of a mental illness, or about 52,000, also had diabetes.

The cost of atypical-induced medical conditions is taking a toll on publicly funded health care programs. “Mental illness is itself a money sponge,” the Times noted, “an expense borne largely by tax dollars.”

“But that cost may be dwarfed,” the article points out, “by the bill to manage the heart attacks and amputations that diabetes bestows.”

Alaska and West Virginia filed lawsuits against Lilly in February 2006, charging the company improperly marketed Zyprexa for unapproved uses costing the states millions of dollars after patients covered by state health care plans, such as Medicaid, developed diabetes and other diseases associated with the drug.

West Virginia is seeking payment for all medical costs related to Zyprexa, as well as reimbursement for the more than $70 million the state paid Lilly for Zyprexa. Under West Virginia law, any damages could be tripled the state alleges in its complaint.

Lilly committed fraud on the people of West Virginia in selling Zyprexa, says the state’s Attorney General Darrell McGraw and seeks to stop Lilly’s deceptive practices, collect damages, and create a fund for those who will develop diabetes and other diseases from taking Zyprexa.

“West Virginia’s Department of Health and Human Services has paid at least $70 million for Zyprexa in its Medicaid program since 1996,” the complaint states.

It claims studies have linked Zyprexa to diabetes since 1998 and that sales representatives misled and deceived doctors about the safety and efficacy of Zyprexa and that Lilly’s advertisements deceptively understated risks and overstated benefits of the drug.

The lawsuit alleges that Lilly promoted “off label” use of Zyprexa for anxiety, sleep disruption, mood swings, attention deficit hyperactivity and dementia. As a result of these actions, according to McGraw, Lilly sold more Zyprexa than it would have sold if it had disclosed the risk of diabetes and other diseases.

“The money paid by the State would not have been paid to Lilly except for its fraudulent conduct,” the complaint states. “Lilly benefited from its misrepresentations and fraudulent conduct by gaining sales of Zyprexa at the expense of other, safe, effective drugs,” it also alleges.

In addition to damages, McGraw is seeking reasonable attorney fees and other costs and fees as well.

Another lawsuit was filed against Lilly in New York in August 2005, on behalf of private health insurers that accuses the drug maker of violating racketeering laws by bankrolling nonprofit groups and paying doctors, consultants and marketing companies to promote Zyprexa as an off-label treatment for numerous unapproved conditions, while downplaying the drug’s adverse effects.

Two more class actions were filed in a federal court in New York, on February 28, 2006. The first lawsuit is asking for reimbursement for all money paid by consumers and non-government health plans for Zyprexa and the second demands payment for monitoring of all people who may have taken Zyprexa but have not yet been diagnosed with pancreatitis, diabetes or high blood sugar.

(1) AG sues drug company for fraud, The Record, March 23, 2006

(2) Off-label drugs take their toll, November 2, 2003, Knight Ridder Newspapers

(3) In Diabetes, One More Burden for the Mentally Ill, New York Times, June 12, 2006

(4) Use of Antipsychotics by the Young Rose Fivefold, New York Times, June 6, 2006

(5) New anti-psychotic drugs carry risks for children, USA Today, May 1, 2006

(6) Polypharmacy Control Is Key for Psych Rx Savings Under Part D, March 17, 2006, Drug Benefit News, biweekly news, data and business strategies for health plans, PBMs and pharmaceutical companies.

(7) Antipsychotic Drug Use Growing Fastest Among Children, Medco Health Press Release, May 2, 2006

(8) Lilly Faces New Lawsuits Claiming Excess Marketing of Zyprexa, Bloomberg News, April 20, 2006

EVELYN PRINGLE
Award Winning Investigative Journalist and Researcher

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