Posts Tagged ‘off-label’

JAMA: Spotty results with off-label antipsychotic use

Wednesday, September 28th, 2011

FiercePharma
By Tracy Staton
September 27, 2011

Off-label use of powerful antipsychotic drugs has come in for plenty of debate in recent years. The expensive, newer-generation “atypicals” have been used to treat dementia, depression, anxiety, post-traumatic stress disorder, dementia, attention-deficit hyperactivity disorder…the list goes on. And all this while the Justice Department was investigating Big Pharma for off-label promotion of the drugs.

An updated analysis now finds that antipsychotic drugs’ utility in off-label uses is minimal, but the risks are significant, Medscape reports. Several illnesses didn’t respond at all to antipsychotic therapy, the data showed, including eating disorders and addiction problems. The evidence for treatment of personality disorders was a toss-up. Meanwhile, side effects were sometimes severe, including weight gain, metabolic problems, fatigue, urinary tract symptoms and even an increased risk of death, the researchers said.

A few off-label uses won support from the new data. Anxiety patients got moderate benefit from AstraZeneca’s ($AZN) Seroquel, and OCD sufferers were helped by treatment with Johnson & Johnson’s ($JNJ) Risperdal. Elderly patients with dementia saw a small benefit with antipsychotic use.

“We need to use this information and be wary of prescribing when it isn’t warranted,” said Dr. Alicia Ruelaz Maher, lead author of the JAMA-published study. “I think the biggest takeaway is that instead of just prescribing blindly, we now have evidence to guide us.” And, as Maher told Reuters, “Each individual patient needs to be considered as opposed to, ‘This is good for this condition.’”

http://www.fiercepharma.com/story/jama-spotty-results-label-antipsychotic-use/2011-09-28

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

Monday, August 15th, 2011

MedPage – August 15, 2011

Emily P. Walker

Click image to watch video: Psychiatric Abuse of the Elderly

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

 

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Harvard Expert Ties Mental Illness “Epidemic” to Big Pharma’s Agenda

Friday, July 29th, 2011

Minyanville
By Minyanville Staff
July 28, 2011

When the DSM-II was published in 1980, it became “the bible of psychiatry,” writes Angell, who adds, “but like the real Bible, it depended a lot on something akin to revelation. There are no citations of scientific studies to support its decisions.”

For any mental illness or passing mood swing that may trouble a person, the Diagnostic and Statistical Manual of Mental Disorders — better known as the DSM — has a label and a code. Recurring bad dreams? That may be a Nightmare Disorder, or 307.47. Narcolepsy uses the same digits in a different order: 347.00. Fancy feather ticklers? That sounds like Fetishism, or 302.81. Then there’s the ultimate catch-all for vague sadness or uneasiness, General Anxiety Disorder, or 300.02. That’s a label almost everyone can lay claim to.

These codes are used by doctors, psychologists, and regulators to maintain a mutual language; it’s a handy shorthand system for bureaucratic purposes. But over the past few decades, the staggering, ever-expanding influence of the ever-expanding DSM, which is published by the American Psychiatric Association, has also played a lead role in building wealth and off-label product uses for the major drug manufacturers. In an insightful essay in this week’s New York Review of Books, Marcia Angell, a senior lecturer in social medicine at Harvard Medical School and former Editor in Chief of The New England Journal of Medicine, explains how.

The medical director of the American Psychiatric Association (APA), Melvin Sabshin, declared in 1977 that “a vigorous effort to remedicalize psychiatry should be strongly supported."

Angell’s essay is based on a review of three current books examining the psychiatric industry: The Emperor’s New Drugs: Exploding the Antidepressant Myth, by Irving Kirsch; Anatomy of an Epidemic: Magic Bullets, Psychiatric Drugs, and the Astonishing Rise of Mental Illness in America by Robert Whitaker, and Unhinged: The Trouble with Psychiatry–A Doctor’s Revelations About a Profession in Crisis, by Daniel Carlat. She also cites the DSM-IV, the most recent edition of the manual, while her review traces big pharma’s role in our current mental disorder epidemic to the DSM-III, published in 1980.

To begin, Angell describes the psychiatric profession’s backlash against a developing perception in the 1960s and 1970s that the practice was a “soft” almost pseudo science:

In the late 1970s, the psychiatric profession struck back–hard. As Robert Whitaker tells it in Anatomy of an Epidemic, the medical director of the American Psychiatric Association (APA), Melvin Sabshin, declared in 1977 that “a vigorous effort to remedicalize psychiatry should be strongly supported,” and he launched an all-out media and public relations campaign to do exactly that. Psychiatry had a powerful weapon that its competitors lacked. Since psychiatrists must qualify as MDs, they have the legal authority to write prescriptions. By fully embracing the biological model of mental illness and the use of psychoactive drugs to treat it, psychiatry was able to relegate other mental health care providers to ancillary positions and also to identify itself as a scientific discipline along with the rest of the medical profession. Most important, by emphasizing drug treatment, psychiatry became the darling of the pharmaceutical industry, which soon made its gratitude tangible.

Of the 170 contributors to the current version of the DSM (the DSM-IV-TR), ninety-five had financial ties to drug companies, including all of the contributors to the sections on mood disorders and schizophrenia.

These efforts to enhance the status of psychiatry were undertaken deliberately. The APA was then working on the third edition of the DSM, which provides diagnostic criteria for all mental disorders. The president of the APA had appointed Robert Spitzer, a much-admired professor of psychiatry at Columbia University, to head the task force overseeing the project. The first two editions, published in 1952 and 1968, reflected the Freudian view of mental illness and were little known outside the profession. Spitzer set out to make the DSM-III something quite different. He promised that it would be “a defense of the medical model as applied to psychiatric problems,” and the president of the APA in 1977, Jack Weinberg, said it would “clarify to anyone who may be in doubt that we regard psychiatry as a specialty of medicine.”

When the DSM-II was published in 1980, it became “the bible of psychiatry,” writes Angell, who adds, “but like the real Bible, it depended a lot on something akin to revelation. There are no citations of scientific studies to support its decisions.”

Despite its lack of citations, that DSM named 265 disorders doctors were meant to identify by matching (or mostly matching) a list of symptoms in the book with symptoms described by a patient. The drug companies were quick to see this radical shift in psychiatry as an opportunity. From the 1980s until now, as Angell demonstrates, the drug makers have supported the move away from talk therapy to the drug therapy, which also benefits practitioners, since doling out drugs and tweaking prescriptions earns a psychiatrist more money for less time spent with a patient.

Here Angell explains how companies influence the DSM itself. The bold typeface is ours.

Drug companies are particularly eager to win over faculty psychiatrists at prestigious academic medical centers. Called “key opinion leaders” (KOLs) by the industry, these are the people who through their writing and teaching influence how mental illness will be diagnosed and treated. They also publish much of the clinical research on drugs and, most importantly, largely determine the content of the DSM. In a sense, they are the best sales force the industry could have, and are worth every cent spent on them. Of the 170 contributors to the current version of the DSM (the DSM-IV-TR), almost all of whom would be described as KOLs, ninety-five had financial ties to drug companies, including all of the contributors to the sections on mood disorders and schizophrenia.

The drug industry, of course, supports other specialists and professional societies, too, but Carlat asks, “Why do psychiatrists consistently lead the pack of specialties when it comes to taking money from drug companies?” His answer: “Our diagnoses are subjective and expandable, and we have few rational reasons for choosing one treatment over another.” Unlike the conditions treated in most other branches of medicine, there are no objective signs or tests for mental illness—no lab data or MRI findings—and the boundaries between normal and abnormal are often unclear. That makes it possible to expand diagnostic boundaries or even create new diagnoses, in ways that would be impossible, say, in a field like cardiology. And drug companies have every interest in inducing psychiatrists to do just that.

Eli Lilly gave $551,000 to NAMI

In addition to the money spent on the psychiatric profession directly, drug companies heavily support many related patient advocacy groups and educational organizations. Whitaker writes that in the first quarter of 2009 alone, “Eli Lilly gave $551,000 to NAMI [National Alliance on Mental Illness] and its local chapters, $465,000 to the National Mental Health Association, $130,000 to CHADD (an ADHD [attention deficit/hyperactivity disorder] patient-advocacy group), and $69,250 to the American Foundation for Suicide Prevention.”

And that’s just one company in three months; one can imagine what the yearly total would be from all companies that make psychoactive drugs. These groups ostensibly exist to raise public awareness of psychiatric disorders, but they also have the effect of promoting the use of psychoactive drugs and influencing insurers to cover them. Whitaker summarizes the growth of industry influence after the publication of the DSM-III as follows:

“In short, a powerful quartet of voices came together during the 1980’s eager to inform the public that mental disorders were brain diseases. Pharmaceutical companies provided the financial muscle. The APA and psychiatrists at top medical schools conferred intellectual legitimacy upon the enterprise. The NIMH [National Institute of Mental Health] put the government’s stamp of approval on the story. NAMI provided a moral authority.”

And now here we are in 2011, with almost everyone we know taking two or three different mood disorder drugs. (This trend is not limited to mental disorder, mind you. See Disease Branding.)

Work started on the DSM-V in 1999, which is due out in 2013. It will contain many new disorders, such as “binge eating” and “restless leg disorder.” It will also expand existing categories by tacking on words like “spectrum” to the end of a known disorder, Angell reports. “It looks as though it will be harder and harder to be normal,” she writes.

But the curtain gets pulled back further still.

In her review of Daniel Carlat’s book, Angell calls attention to the “disillusioned insider’s” frank admission that when he prescribes a drug, his decision process is largely guesswork. Carlat’s view is that although any psychiatrist will acknowledge that he or she has had great success with mental disorder drugs for say, depression or anxiety, no doctor can say with certainty whether the drugs are working or if a placebo effect has taken effect.

[Carlat's] work consists of asking patients a series of questions about their symptoms to see whether they match up with any of the disorders in the DSM. This matching exercise, he writes, provides “the illusion that we understand our patients when all we are doing is assigning them labels.” Often patients meet criteria for more than one diagnosis, because there is overlap in symptoms. For example, difficulty concentrating is a criterion for more than one disorder. One of Carlat’s patients ended up with seven separate diagnoses. “We target discrete symptoms with treatments, and other drugs are piled on top to treat side effects.” A typical patient, he says, might be taking Celexa for depression, Ativan for anxiety, Ambien for insomnia, Provigil for fatigue (a side effect of Celexa), and Viagra for impotence (another side effect of Celexa).

As for the medications themselves, Carlat writes that “there are only a handful of umbrella categories of psychotropic drugs,” within which the drugs are not very different from one another. He doesn’t believe there is much basis for choosing among them. “To a remarkable degree, our choice of medications is subjective, even random. Perhaps your psychiatrist is in a Lexapro mood this morning, because he was just visited by an attractive Lexapro drug rep.”

Messy. And, of course, the whole system is now being exported to China and other countries where the middle class is growing and the mental health industry is still in a developing stage.

Angell’s latest book is The Truth About the Drug Companies: How They Deceive Us and What to Do About It.

Read the rest of her essay, which examines the controversial use of brain chemistry drugs to treat children, here.

http://www.minyanville.com/dailyfeed/2011/07/25/harvard-expert-links-our-mental/

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Bad Side-Effects Ahead For Pharma?

Thursday, June 30th, 2011

Forbes – June 30, 2011

by Martin Fridson

In 2006, The New York Review of Books reported that four-year-old Rebecca Riley died of the effects of two prescription drugs—Clonidine and Depakote.

These medications, along with Seroquel, were prescribed for Rebecca after she was diagnosed, at the age of two, with attention deficit hyperactivity disorder (ADHD) and bipolar disorder.  The three drugs are not approved by the Food and Drug Administration (FDA) for treatment of ADHD or long-term treatment of bipolar disorder, nor are they approved for children as young as Rebecca.

The New York Review of Books‘ recent two-part article (1)  by Marcia Angell on the treatment of mental illness with psychoactive drugs (those that affect the mental state) addresses an issue that may one day prove very important to investors in pharmaceutical stocks.  (All statistics and quotations herein are drawn from Dr. Angell’s article.)

It is not illegal for a doctor to prescribe a drug off-label, that is, for a non-FDA-approved use, but a drug marketer cannot lawfully encourage a doctor to do so.  The profits in psychoactive drugs, however, make it tempting to flout the law.  In the past four years, AstraZeneca (AZN), Pfizer (PFE), Eli Lilly (LLY), Bristol-Myers Squibb (BMY) and Forest Labs (FRX) have all settled federal charges of marketing psychoactive drugs off-label, at a cost running into hundreds of millions.

Seeing that pharmaceutical marketing executives are evidently undeterred by the law, Dr. Angell, a senior lecturer in social medicine at Harvard Medical School and former editor in chief of The New England Journal of Medicine, advocates a prohibition on prescribing psychoactive drugs off-label.

A ban would cut into a major growth area for pharmaceutical companies.

This growth is not a function of a few blockbuster drug discoveries. It parallels an extraordinary rise in the portion of the population, particularly children, diagnosed with mental illness.  For example, if diagnoses mirror the actual incidence of juvenile polar disorder, that affliction grew forty-fold between 1993 and 2004.

Have mental disorders genuinely proliferated that dramatically?  Dr. Angell suggests instead that the surge in certain diagnoses reflects a long-run shift in emphasis from “talk therapy” to medication.  This change just so happens to enable psychiatrists to see more patients and earn higher fees.  Not incidentally, with drugs now regarded as the preferred mode of treatment, the increase in diagnoses is a boon to pharmaceutical manufacturers.  The new generation of psychoactives has displaced cholesterol-reducing medications as the biggest-selling class of drugs in the U.S.

Also benefiting from the present arrangement are low-income families that receive Supplemental Security Income (SSI) payments on the basis of mental disabilities.  To qualify, applicants (children included) generally must be taking psychoactive drugs.  Getting into the program usually also ensures that the family will qualify for Medicaid.  The disbursements can be so substantial that MIT economics professor David Autor describes SSI as “the new welfare.”

The parents and two siblings of Rebecca Riley, the four-year-old who died from the effects of off-label drugs, were all on psychoactive drugs and were receiving about $30,000 a year from SSI.  Dr. Angell links the astonishing rise in diagnoses of certain mental disorders to the huge financial stakes of physicians, pharmaceutical companies and SSI recipients.

I do not want to portray this issue as an imminent or mortal threat to pharmaceutical stocks. If a ban on off-label prescription of psychoactive drugs were proposed in Congress, the companies’ lobbyists probably could stave it off for a long time.  Furthermore, the major pharmaceutical companies have widely diversified product lines, so a setback in the psychoactive category, even though it is a major growth area, would not be a body blow.

Still, this topic is one to keep an eye on for investors who hope to gain an edge by seeing beyond the quarterly EPS data.  Psychoactive drugs have been around since the 1950s, but parents can readily observe that their use with children is far more widespread than it was a generation ago.  If advocates such as Marcia Angell can make a persuasive case that the change is not fully justified on medical grounds, yet poses significant health hazards, is it unrealistic to expect a public opinion backlash some day?

[1] Marcia Angell, “The Epidemic of Mental Illness: Why?” The New York Review of Books (June 23, 2011), pp. 20-22 and “The Illusions of Psychiatry” (July 14, 2011), pp. 20-22.  The article is a review of three books on the contemporary practice of psychiatry by Irving Kirsch, Robert Whitaker, and Daniel Carlat.

http://blogs.forbes.com/investor/2011/06/30/bad-side-effects-ahead-for-pharma/

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52% of foster kids are prescribed psych drugs—One of them is fighting back

Thursday, June 23rd, 2011

By CCHR Int
June 23, 2011

At just 6 years of age, still grieving over the death of the only mother he’d ever known, his foster mother, Giovan Bazan received the first of many psychiatric “diagnoses” and drugs that would plague him for the next twelve years of his life. Moved from foster home to  foster home, orphanages and other modes of state care, Giovan was stigmatized with a plethora of psychiatric diagnoses and drugs until the age of 18, when he could finally make his own medical decisions and quit. Now a child advocate working part time at the Division of Family and Children Services (DFCS) in Georgia, Giovan is on a mission: To get a full-time job with DFCS and help enact laws to combat the wholesale labeling and drugging of foster children. In the video below, Giovan tells his story and why he decided to fight back against the abuse of kids in foster care.

(Story continues below)

Foster kids—often removed from family homes because of abuse—are further abused when they are prescribed psychotropic drugs under state care. Many of these children are on cocktails of prescribed drugs, including antipsychotics and antidepressants with documented side effects of diabetes, stroke, mania, psychosis, tumors, coma, suicide and death.

Yet, the rates with which these children are being given drugs has been increasing. The antipsychotic use rate among foster kids increased by 5.6% between 2004 and 2007 (from 11.7 percent to 12.4 percent). Another study in Pediatrics, revealed that youth in foster care covered by Medicaid insurance receive psychotropic medication at a rate more than 3 times that of Medicaid-insured youth who qualify by low family income.

Only half of state child welfare systems have a policy to review usage of these drugs, and those are weak policies at that.

The psychiatric drugging of foster kids has caused so much concern nationally that in July 2010, the Government Accountability Office (GAO) started an investigation into the use of these drugs in foster care, as they are widely used in dangerous combinations, and for so-called “off-label” uses to treat symptoms for which they have not been medically approved. The GAO is looking into the estimated hundreds of millions of dollars of fraud arising from this and is collecting and analyzing data from Florida, Maryland, Massachusetts, Minnesota, Oregon and Texas.

For more information on the psychiatric drugging of children, watch these videos:

Psychiatry—Labeling Kids with Bogus ‘Mental Disorders’


Drugging Our Children—Side Effects

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How Seroquel, a Risky Antipsychotic, Became a “General Purpose” Mental Health Drug

Friday, May 27th, 2011

BNET
By Jim Edwards
May 27, 2011

In 2008, the FDA declared that powerful antipsychotics such as AstraZeneca (AZN)’s Seroquel were being over-prescribed and started a monitoring initiative to curb their use. It hasn’t worked, judging by an analysis of the FDA’s adverse event database by the Institute for Safe Medication Practices.

Seroquel is only approved for schizophrenia, mania and bipolar disorders. It’s a powerful drug that has serious side effects if taken for a long time: It’s associated with weight gain and diabetes, among other problems.

Yet the ISMP found that 47 percent of all adverse events linked to Seroquel since 2004 occurred when the drug was being used for unapproved or “off-label” purposes, such as depression. 21 percent of adverse events are linked to off-label use of Seroquel in depression — a condition for which there are plenty of other available drugs — and 26 percent of events occur with other off-label uses:

The ISMP said:

the adverse event data show quetiapine [Seroquel] has become a general purpose psychiatric drug with most reported injuries occurring outside its core indication for treatment of the most severe mental disorders, schizophrenia and psychosis.

In the off label category more than half the cases were for sleep disorders and insomnia. The next largest group was anxiety, and the remainder was divided among many other medical uses including autism, panic attack, headache, restlessness, nervousness, dementia and agitation.

The report is yet another in a series of publications from a variety of sources that suggest some psychiatric doctors are abusing their patients with Seroquel. In addition to the FDA’s 2008 declaration, consider:

Injuries from Seroquel’s side effects can be severe and permanent. In addition to diabetes they include suicidal/self-injurious behavior, and neurological movement disorders such as tardive dyskinesia, dystonia and parkinsonism.

AstraZeneca’s role in promoting Seroquel for off-label uses is well documented. The company has paid $1.5 billion in legal costs and settlements for its mismarketing of the drug ($520 million to the Department of Justice; another $743 million in legal costs in unresolved cases through March 2011; and $198 million in civil settlements.)

So doctors have no excuse. The FDA — which has almost no jurisdiction over physicians — and the courts have performed their roles. It’s time for the medical profession to take responsibility for the damage it is causing and cut down on its dispensing of Seroquel.

Read article here:  http://www.bnet.com/blog/drug-business/how-seroquel-a-risky-antipsychotic-became-a-8220general-purpose-8221-mental-health-drug/8545

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Unregulated prescription of antipsychotic drugs in elder care facilities on the rise

Monday, May 16th, 2011

Santa Cruz Sentinel -  May 15, 2011

A recent study by the Office of the Inspector General of the United States indicates that residents of some nursing homes may be regularly given atypical antipsychotic drugs as a means of chemical restraint, sometimes to the detriment of their health, including death.

The report, published May 9, states: “For the period January 1 through June 30, 2007, we determined using medical record review that 51 percent of Medicare claims for atypical antipsychotic drugs were erroneous.”

A member of Congress requested the office evaluate the extent to which nursing home residents receive atypical antipsychotic drugs and the associated cost to Medicare. The member expressed concern with these drugs were being prescribed for off-label conditions — i.e. conditions other than schizophrenia and/or bipolar disorder — and/or in the presence of a condition specified in the Food and Drug Administration’s boxed warning.

“We determined that 83 percent of Medicare claims for atypical antipsychotic drugs for elderly nursing home residents were associated with off-label conditions and that 88 percent were associated with the condition specified in the FDA boxed warning,” the Office of the Inspector General found.

The California Advocates for Nursing Home Reform has been concerned about this issue for some time. For more information, visit www.canhr.org/help.html

http://www.santacruzsentinel.com/ci_18067580


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Wellbutrin – To Promote or Not Promote… That is the Question

Friday, May 6th, 2011

Seroxat Sufferers – Stand Up and Be Counted
By Bob Fiddaman
May 6, 2011

Did they or didn’t they?

Lauren Stevens, the Glaxo associate general counsel, who is charged with one count of obstructing an official proceeding, one count of falsifying documents before a federal agency and four counts of making false statements to the FDA, has heard evidence given to a jury by James Millar, GSK vice president of strategic pricing, contracting and marketing.

Millar had originally refused to testify but prosecutors persuaded the US District Judge [Roger W. Titus] to order him to give his testimony.

Millar was head of GSK’s marketing for Wellbutrin and remained insistent that GSK’s promotion of its product was as an antidepressant that carried low risk of weight gain and sexual dysfunction.

GSK have claimed that they worked with doctors to stop the promotion of Wellbutrin for off label use.

In 2002, writes Law 360′s Christopher Norton, “GSK became aware that the company’s two top promotional-speaker doctors were using slides in their presentations including information for off-label uses of the drug, but swiftly took steps to bring the pair into compliance with all regulations.”

Those top two doctors were named as Psychiatrist James Hudziak and physician James Pradko, they were both the most highly paid doctors in GSK’s Wellbutrin promotional stable.

It was Millar who, alongside others at GSK, worked with doctors that GSK, claimed, paid to promote the drug in an effort to ensure the physicians removed any mention of off-label uses from their presentations, especially in the wake of new regulations that began to roll out around 2002, he told the jury, writes Christopher Norton for Law360.

It is alleged that Lauren Stevens lied to the FDA when they sought information from GSK about whether or not they promoted Wellbutrin for weight loss. It’s also alleged that Stevens knew GSK had sponsored programs that promoted Wellbutrin as a weight loss drug. Stevens is also alleged to have known that GSK had paid many doctors to promote Wellbutrin to other doctors which included “off-label” use.

Millar claims that he was sent to monitor Psychiatrist James Hudziak after concerns were raised about his potential use of off-label slides, slides he used at presentations. Millar was apparently able to make Hudziak change the presentation and got him to start using a “company approved” slide kit.

Stevens has claimed that she concealed slides from the FDA showing that GSK was promoting Wellbutrin for illegal unapproved use, she has also claimed that she was advised by a company lawyer to do so.

So, we have GSK saying they did everything in their power to stop doctors promoting the illegal, unapproved use of Wellbutrin… yet we have Stevens, as part of her defence, claiming she concealed slides that showed GSK was promoting Wellbutrin for illegal unapproved use. Not only that – she was told to do so by one of GSK’s lawyers!

The mind boggles at how this company operate.

It seems that Stevens, the former Glaxo associate general counsel, is now turning against the very same people she used to work for. You go girl.

The case against Stevens continues.

Her re-indictment can be viewed HERE

Read article here:  http://fiddaman.blogspot.com/2011/05/wellbutrin-to-promote-or-not.html

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California claims drug giant bribed docs to prescribe

Wednesday, March 23rd, 2011

Ventura County Star, March 22, 2011

Associated Press

photo by Boaz Yiftach

LOS ANGELES – California has joined a whistleblower lawsuit that claims Bristol-Myers Squibb Co. bribed doctors to prescribe its drugs, costing insurers perhaps millions of dollars in the largest alleged health care fraud case ever handled by the state, Insurance Commissioner Dave Jones announced Friday.

The suit claims company salespeople plied physicians with speaking fees, expensive meals, gifts and trips to induce or reward them for prescribing large amounts of its drugs, which were billed to private insurers.

For example, the company invited doctors to attend Los Angeles Lakers games at Staples Center and spent thousands of dollars on luxury suites, the suit claimed.

“Golf outings, basketball camps, samba lessons, you name it,” Jones said at a news conference.

The lawsuit said the aim was to boost prescription levels for legally approved and so-called “off-label” uses of drugs ranging from the antipsychotic Abilify to the blood thinner Plavix.

The company is accused of setting up a speakers bureau that doled out thinly veiled kickbacks in the form of cash payments to influential or high-prescribing doctors for speaking about its products.

One doctor received a $2,500 honorarium even though he never actually spoke, Jones said.

The company denied any wrongdoing.

“Bristol-Myers Squibb believes this lawsuit has no merit and the company will defend itself vigorously,” said Laura Hortas, a company spokeswoman.

California joined a 2007 lawsuit filed by one current and two former employees of the pharmaceutical giant. If they win, the whistleblowers and the state would share damages.

The amended complaint was filed by state insurance department lawyers two weeks ago in Los Angeles Superior Court.

It’s not the first time New York-based Bristol-Myers Squibb has been accused of kickbacks by its own workers.

In 2007, the company agreed to pay $515 million to settle federal lawsuits brought by whistleblowers in Massachusetts and Florida.

The current lawsuit says the company tracked prescription figures, and low-prescribing doctors were threatened with loss of perks.

A sales plan entitled “Rounding Up the Docs!” instructed salespeople at dinner events to get physicians to commit to prescribing for specific types of patients and to monitor the number of new prescriptions by doctors. the suit states.

The company is believed to have made at least 15,000 kickbacks from 1999 to 2005, and investigators suspect that the practice is continuing, Jones said.

The cost of the alleged practice was unclear, but Jones noted the size of the previous federal settlement.

No doctors have been sued or charged with a crime because the insurance department is focusing on the company in its civil action.

The suit seeks unspecified damages that include a $10,000 fine for each prescription obtained through fraud and repayment of any profit the company made from the alleged scheme.

The investigation was continuing.

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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

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