Posts Tagged ‘antipsychotics’

Drugs Used for Psychotics Go to Youths in Foster Care

Monday, November 21st, 2011

The New York Times, November 20, 2011

by Benedict Carey

Click image to see video on psychiatric drug warnings for kids

Foster children are being prescribed cocktails of powerful antipsychosis drugs just as frequently as some of the most mentally disabled youngsters on Medicaid, a new study suggests.

The report, published Monday in the journal Pediatrics, is the first to investigate how often youngsters in foster care are given two antipsychotic drugs at once, the authors said. The drugs include Risperdal, Seroquel and Zyprexa — among other so-called major tranquilizers — which were developed for schizophrenia but are now used as all-purpose drugs for almost any psychiatric symptoms.

“The kids in foster care may come from bad homes, but they do not have the sort of complex medical issues that those in the disabled population do,” said Susan dosReis, an associate professor in the University of Maryland School of Pharmacy and the lead author.

The implication, Dr. dosReis and other experts said: Doctors are treating foster children’s behavioral problems with the same powerful drugs given to people with schizophrenia and severe bipolar disorder. “We simply don’t have evidence to support this kind of use, especially in young children,” Dr. dosReis said.

In recent years, doctors and policy makers have grown concerned about high rates of overall psychiatric drug use in the foster care system, the government-financed program that provides temporary living arrangements for 400,000 to 500,000 children and adolescents. Previous studies have found that children in foster care receive psychiatric medications at about twice the rate among children outside the system.

The new study focused on one of the most powerful classes of drugs, antipsychotics. It found that about 2 percent of foster children took at least one such drug, even though schizophrenia and bipolar disorder, for which the drugs are approved, are extremely rare in young children.

“It’s a significant and important finding, and it should prompt states to improve the quality of care in this area,” said Dr. Mark Olfson, a professor of clinical psychiatry at Columbia University who did not contribute to the research.

In the study, mental health researchers analyzed 2003 Medicaid records of 637,924 minors from an unidentified mid-Atlantic state who were either in foster care, getting disability benefits for a diagnosis like severe autism or bipolar disorder, or in a program called Temporary Assistance for Needy Families. All of these programs draw on Medicaid financing. The investigators found that 16,969, or about 3 percent of the total, had received at least one prescription for an antipsychotic drug.

Yet among these, it was the foster children who most often got more than one such prescription at the same time: 9.2 percent, versus 6.8 percent among the children on disability, and just 2.5 percent of those in the needy families program.

Antipsychotic drugs, the authors said, also cause rapid weight gain and increase the risk for metabolic problems in many people, an effect that may be amplified by the use of two at once.

Doctors who treat such children are aware of the trade-offs and often prescribe lower doses of the medications as a result. And when they add a second such drug, it is often to counteract side effects of the first medication.

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

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Hundreds of Soldiers & Vets Dying From Antipsychotic–Seroquel

Monday, November 7th, 2011

Market Watch
November 7, 2011

Fred A. Baughman Jr., MD & Stan White (Father of Deceased Veteran, Andrew White) disclose the following:

EL CAJON, Calif., Nov. 7, 2011 /PRNewswire via COMTEX/ — As a neurologist who has discovered and described medical diseases, I (Fred A. Baughman) read the May 24, 2008, Charleston (WV) Gazette article “Vets taking Post Traumatic Stress Disorder drugs die in sleep,” and opened and financed my own investigation into these unexplained deaths.

Andrew White, Eric Layne, Nicholas Endicott and Derek Johnson, all in their twenties, were four West Virginia veterans who died in their sleep in early 2008. There were no signs of suicide or of a multi-drug “overdose” leading to coma, as claimed by the Inspector General of the VA. All had been diagnosed “PTSD”–a psychological diagnosis, not a disease (physical abnormality) of the brain. All were on the same prescribed drug cocktail, Seroquel (antipsychotic), Paxil (antidepressant) and Klonopin (benzodiazepine) and all appeared “normal” when they went to sleep.

On February 7, 2008, Surgeon General Eric B. Schoomaker, had announced there had been “a series, a sequence of deaths” in the military suggesting this was “often a consequence of the use of multiple prescription and nonprescription medicines and alcohol.”

However, the deaths of the ‘Charleston Four’ were probable sudden cardiac deaths (SCD), a sudden, pulseless condition leading to brain death in 4-5 minutes, a survival rate or 3-4%, and not allowing time for transfer to a hospital. Conversely, drug-overdose coma is protracted, allowing time for discovery, diagnosis, transport, treatment, and frequently–survival.

Antipsychotics and antidepressants alone or in combination, are known to cause SCD. Sicouri and Antzelevitch (2008) concluded: (1) “A number of antipsychotic and antidepressant drugs can increase the risk of ventricular arrhythmias and sudden cardiac death,” (2)”Antipsychotics can increase cardiac risk even at low doses whereas antidepressants do it generally at high doses or in the setting of drug combinations.”

On April 13, 2009, Baughman wrote the Office of the Surgeon General (OTSGWebPublisher@amedd.army.mil): “On February 7, 2008 the Surgeon General said there had been ‘a series, a sequence of deaths.’ Has the study of these deaths been published?”

On April 17, 2009 the Office of the Surgeon General responded, “The assessment is still pending and has not been released yet.” More than a year later and still no explanation, nor further acknowledgement that these deaths even took place.

In a press release, (PRNewswire, May 19, 2009) Baughman wrote: “I call upon the military for an immediate embargo of all antipsychotics and antidepressants until there has been a complete, wholly public, clarification of the extent and causes of this epidemic of probable sudden cardiac deaths.”

Googling “dead in bed,” “dead in barracks,” by April 16, 2009, veteran’s wife, Diane Vande Burgt, had Googled 74 probable sudden cardiac deaths. By May 2010: 128, and, by November 2, 2011: 247. Two-hundred-forty-seven!

In April 2010 I was in anonymous receipt of an Army National Guard Serious Incident Report for the 5 months 10/03/09 to 3/7/10. In it were 93 “incidents” including 4 “heart attacks,” 6 “cardiac arrests” and 3 “found dead”; 13 of 93 (14%) probable SCDs.

Pfc. Ryan Alderman, was on a cocktail of psych drugs when found unresponsive, dying in his barracks at Ft. Carson, Colo. Sudden cardiac death was confirmed by an ECG done at the scene. Inexplicably, military officials de-classified his death and reversed the cause, calling it instead, a “suicide.”

Again I challenge the military to produce the evidence.

In June 2011, a DoD Health Advisory Group backed a highly questionable policy of “polypharmacy” asserting: “…multiple psychotropic meds may be appropriate in select individuals.” The fact of the matter is that psychotropic drug polypharmacy is never safe, scientific, or medically justifiable. What it is a means of (1) maximizing profit, and (2) making it difficult to impossible to blame adverse effects on any one drug.

From 2001 to the present, US Central Command has given deploying troops 180 day supplies of prescription psychotropic drugs–Seroquel included. In a May 2010 report of its Pain Management Task Force, the Army endorsed Seroquel in 25- or 50-milligram doses as a ‘sleep aid.’

Over the past decade, $717 million was spent for Risperdal and $846 million for Seroquel, for a mind-blowing total of $1.5 billion when neither Risperdal nor Seroquel have been proven safe or effective for PTSD or sleep disorders.

Ironically, yet not surprisingly, pay-to-play in Washington becomes more egregious every day. Heather Bresch, daughter of U.S. Sen. Joe Manchin, (D-WV) was recently named CEO of WV drug-maker Mylan Inc., that recently contracted with the DoD for over 20 million doses of Seroquel.

Defense Department Health Advisory Group chair, Charles Fogelman, warned: “DoD currently lacks a unified pharmacy database that reflects medication use across pre-deployment, deployment and post-deployment settings.” In essence, through a premeditated lack of record keeping, mandated by law at any other pharmacy or medical office to track potential fatal reactions to mixing prescription drugs, the military is willfully preempting all investigations into the injuries and deaths due to psychiatric drugs.

I call on the DoD, VA, House and Senate Armed Services and House and Senate Veterans Affairs Committees to tell concerned Americans and the families of fallen heroes what psychiatric drugs each of the deceased, both combat and non-combat, soldiers and veterans were on?

It is time for the military and government to come clean.

http://www.marketwatch.com/story/hundreds-of-soldiers-vets-dying-from-antipsychotic-seroquel-2011-11-07

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Are Nursing Homes Over-Drugging Their Residents?

Wednesday, October 26th, 2011

SF Weekly – October 26, 2011

by Peter Jamison

Click image to watch video: Psychiatric Abuse of the Elderly

According to the San Francisco-based organization California Advocates for Nursing Home Reform (CANHR), more than 25,000 California nursing-home residents are being given anti-psychotic drugs. That’s about a quarter of the state’s nursing-home population, and according to CANHR and other elder-rights activists, it’s a figure that’s way too high — particularly considering the negative side effects these medications can have.

“They’re being sedated into zombie-hood,” says CANHR staff lawyer Tony Chicotel. He adds that anti-psychotic medications increase the risk of death among seniors, are prescribed in place of more effective non-drug methods for handling patients with dementia, and are often give without obtaining patients’ consent.

“They’re very rarely asked whether they want to take the medication,” Chicotel says.

For More information watch this video or read all the facts here

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Are Psychiatric Medications Making Us Sicker?

Monday, September 19th, 2011

The Chronicle of Higher Education – September 18, 2011
by By John Horgan

American psychiatry, in collusion with the pharmaceutical industry, is perpetrating what may be the biggest case of iatrogenesis—harmful medical treatment—in history.Dave Plunkert for The Chronicle Review

Three years ago, I was reminded in dramatic fashion of the chasm between psychiatry and more-effective branches of medicine. My 14-year-old son, Mac, while playing lacrosse, emerged from a collision with his right arm askew. I drove him to a local hospital, where an orthopedic surgeon on duty immediately diagnosed the injury: dislocated elbow. He gave Mac an oral and local anesthetic and put him in a portable X-ray machine that showed Mac’s elbow joint on a screen, in real time. Watching the screen, the doctor quickly snapped Mac’s elbow back into place.

Overcome with gratitude to the doctor, I was leading my groggy son out of the hospital when my cellphone rang. An old friend, whom I’ll call Phil, was on the line. He was in the psychiatric ward of a New York hospital, to which his 16-year-old son had been committed. The boy, who was taking antidepressants for depression, had threatened to commit suicide, not for the first time. Thedoctors were recommending electroconvulsive therapy, or ECT.

Knowing that I had written about shock therapy and other psychiatric treatments, Phil asked my opinion. The fact that Phil had called me, a mere journalist, for advice in such a dire situation spoke volumes about the troubles of modern psychiatry.

I first took a close look at treatments for mental illness 15 years ago while researching an article for Scientific American. At the time, sales of a new class of antidepressants, selective serotonin reuptake inhibitors, or SSRI’s, were booming. The first SSRI, Prozac, had quickly become the most widely prescribed drug in the world. Many psychiatrists, notably Peter D. Kramer, author of the best seller Listening to Prozac, touted SSRI’s as a revolutionary advance in the treatment of mental illness. Prozac, Kramer said in a phrase that I hope now haunts him, could make patients “better than well.”

Clinical trials told a different story. SSRI’s are no more effective than two older classes of antidepressants, tricyclics and monoamine oxidase inhibitors. What was even more surprising to me—given the rave reviews Prozac had received from Kramer and others—was that antidepressants as a whole were not more effective than so-called talking cures, whether cognitive behavioral therapy or even old-fashioned Freudian psychoanalysis. According to some investigators, treatments for depression and other common ailments work—if they do work—by harnessing the placebo effect, the tendency of a patient’s expectation of improvement to become self-fulfilling. I titled my article “Why Freud Isn’t Dead.” Far from defending psychoanalysis, my point was that psychiatry has made disturbingly little progress since the heyday of Freudian theory.

In retrospect, my critique of modern psychiatry was probably too mild. According to Anatomy of an Epidemic (Crown Publishers, 2010), by the journalist Robert Whitaker, psychiatry has not only failed to progress but may now be harming many of those it purports to help. Anatomy of an Epidemic has been ignored by most major media. I learned about it only after Marcia Angell, former editor of The New England Journal of Medicine and now a lecturer on public health at Harvard, reviewed the book in The New York Review of Books in June. If Whitaker is right, American psychiatry, in collusion with the pharmaceutical industry, is perpetrating what may be the biggest case of iatrogenesis—harmful medical treatment—in history.

As recently as the 1950s, Whitaker contends, the four major mental disorders—depression, anxiety disorder, bipolar disorder, and schizophrenia—often manifested as episodic and “self limiting”; that is, most people simply got better over time. Severe, chronic mental illness was viewed as relatively rare. But over the past few decades the proportion of Americans diagnosed with mental illness has skyrocketed. Since 1987, the percentage of the population receiving federal disability payments for mental illness has more than doubled; among children under the age of 18, the percentage has grown by a factor of 35.

Between 1985 and 2008, sales of antidepressants and antipsychotics multiplied almost fiftyfold, to $24.2-billion.

This epidemic has coincided, paradoxically, with a surge in prescriptions for psychiatric drugs. Between 1985 and 2008, sales of antidepressants and antipsychotics multiplied almost fiftyfold, to $24.2-billion. Prescriptions for bipolar disorder and anxiety have also swelled. One in eight Americans, including children and even toddlers, is now taking a psychotropic medication. Whitaker acknowledges that antidepressants and other psychiatric medications often provide short-term relief, which explains why so many physicians and patients believe so fervently in the drugs’ benefits. But over time, Whitaker argues, drugs make many patients sicker than they would have been if they had never been medicated.

Whitaker compiles anecdotal and clinical evidence that when patients stop taking SSRI’s, they often experience depression more severe than what drove them to seek treatment. A multination report by the World Health Organization in 1998 associated long-term antidepressant usage with a higher rather than a lower risk of long-term depression. SSRI’s cause a wide range of side effects, including insomnia, sexual dysfunction, apathy, suicidal impulses, and mania—which may then lead patients to be diagnosed with and treated for bipolar disorder.

Indeed, Whitaker suspects that antidepressants—as well as Ritalin and other stimulants prescribed for attention-deficit disorder—have catalyzed the recent spike in bipolar disorder. Though bipolar disorder was relatively rare just a half-century ago, reported rates of it have increased more than a hundredfold, to one in 40 adults. Side effects attributed to lithium and other common medications for bipolar disorder include deficits in memory, learning ability, and fine-motor skills. Similarly, benzodiazepines such as Valium and Xanax, which are prescribed for anxiety, are addictive; withdrawal from these sedatives can cause effects ranging from insomnia to seizures, as well as panic attacks.

Whitaker’s analysis of treatments for schizophrenia is especially disturbing. Antipsychotics, from Thorazine to successors like Zyprexa, cause weight gain, physical tremors (called tardive dyskinesia) and, according to some studies, cognitive decline and brain shrinkage. Before the introduction of Thorazine in the 1950s, Whitaker asserts, almost two-thirds of the patients hospitalized for an initial episode of schizophrenia were released within a year, and most of this group did not require subsequent hospitalization.

Over the past half-century, the rate of schizophrenia-related disability has grown by a factor of four, and schizophrenia has come to be seen as a largely chronic, degenerative disease. A decades-long study by the World Health Organization found that schizophrenic patients fared better in poor nations, such as Nigeria and India, where antipsychotics are sparingly prescribed, than in wealthier regions such as the United States and Europe.

A long-term study by Martin Harrow, a psychologist at the University of Illinois College of Medicine, found an inverse correlation between medication for schizophrenia and positive, long-term outcomes. Beginning in the 1970s, Harrow tracked a group of 64 newly diagnosed schizophrenics. Forty percent of the nonmedicated patients recovered—meaning that they could become self-supporting—versus 5 percent of those who were medicated. Harrow theorized that those who were heavily medicated were sicker to begin with, but Whitaker suggests that the medications may be making some patients sicker.

Several possible objections to Whitaker’s case against psychiatry come to mind. First of all, as Harrow speculates, over time heavily medicated patients may not fare as well as less-medicated patients because the former truly are sicker. Also, the recent surge in mental disability may stem, at least in part, from a decrease in the stigma associated with mental illness, spurring more people to seek and obtain treatment and government assistance. In her review, Marcia Angell called Whitaker’s book “suggestive, if not conclusive,” which seems right to me. At the very least, Whitaker’s claims warrant further investigation.

Between 1985 and 2008, sales of antidepressants and antipsychotics multiplied almost fiftyfold, to $24.2-billion.

Although Whitaker doesn’t address electroconvulsive therapy, its persistence strikes me as yet another symptom of the weakness of modern psychiatry. It fell out of favor in the 1970s, in part because of its negative portrayal in the 1975 film One Flew Over the Cuckoo’s Nest, and yet about 100,000 Americans a year still receive ECT. Studies suggest that the therapy can provide temporary relief from acute depression, but virtually everyone who receives electroconvulsive therapy relapses within a year without further treatment. Proponents claim that ECT has few significant side effects, but this year an FDA panel ruled that ECT should remain classified as a “high-risk” procedure because it can cause persistent memory loss and other side effects. If SSRI’s and other psychiatric medications were truly effective, ECT would long ago have been tossed into the dustbin of failed psychiatric treatments.

So what happened to Phil’s son? When Phil called me, I told him that if my son were suicidally depressed, I’d resist giving him shock treatment unless doctors convinced me there was absolutely no alternative. Phil decided against ECT, and his son, after being released from the hospital, gradually stopped taking antidepressants too. He still struggles with depression, and he smokes more marijuana than Phil would like. But he is healthy enough to be starting college this fall.

http://chronicle.com/article/Are-Psychiatric-Medications/128976/

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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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Big Pharma’s Slimy Crusade to Push Anti-Psychotics on Kids

Monday, August 8th, 2011

The Fix – Aug 5, 2011

by Walter Armstrong, Deputy Editor, The Fix.

Pharmaceutical giants spend billions a year to get doctors to prescribe drugs to American kids. Johnson & Johnson even passes out Legos advertising its latest anti-psychotic, ignoring mounting evidence that the drug causes diabetes, wild weight gain, and grows breasts in boys and girls who take it. Their solution? More pills

Plastic Legos stamped "RISPERDAL" are a fixture at pediatricians' offices nationwide.

In the past decade, America’s pharmaceutical industry has knowingly marketed dozens of dangerous drugs to millions of children, a group that executives apparently view as a lucrative, untapped market for their products. Most kids have no one to look out for their interests except anxious parents who put their trust in doctors. As it turns out, that trust is often misplaced. Big Pharma spends massive amounts to entertain physicians, send them on luxury vacations and ply them with an endless supply of free products. As a result, hundreds of thousands of American kids—some as young as three years old—have become dependent on amphetamines like Adderall and a pharmacopeia of other drugs that allegedly treat depression, insomnia, aggression and other mental health disorders.

The fact that none of these powerful mood-altering medications have been approved by the FDA to treat children under 10 has posed no obstacle to the industry’s marketing masterminds. They’ve waved off objections by some some doctors who wonder how these complex drugs will affect the vulnerable brains and bodies of their young patients. Other experts have warned that children exposed to this multi-molecular barrage on their central nervous systems could potentially be at much higher risk of becoming adults who are addicted to chemicals, prescription and otherwise. But thanks to a billion-dollar advertising campaign, millions of kids across the nation are now taking pills to control a long  litany of “behavioral problems.”

Luckily, Johnson and Johnson is not getting off scot-free. Last week, Massachusetts Attorney General Martha Coakely announced that the state was suing the world’s biggest pharmaceutical firm, Johnson & Johnson, for illegally promoting Risperdal, an “atypical anti-psychotic”,  for off-label treatment of childhood schizophrenia, bipolar disorder, autism, hyperactivity and attention deficit disorder, depression and anxiety, sleep disorders, anger management, mood enhancement or stabilization. As BNet’s Placebo Effect blog recently reported, the list of maladies is grotesquely long. J&J, which prides itself on its high-minded credo of “always putting patients first,” began moving its new drug into this new market as soon as Risperdal won approval in adults—even though the FDA explicitly forbid it from doing so, for the simple reason that the firm had never done a single test of the drug in children who suffered from these or any other conditions.

Though Risperdal was marketed as a less dangerous—if not more effective—alternative to older “typical” anti-psychotics, it quickly became apparent that the drug had many worrisome side effects in adults, including the rapid onset of diabetes and alarming weight gains. But despite a growing weight of evidence about the drugs, J&J only stepped up its promotion of the drug for children—aiming for more conditions and in ever-younger kids—no doubt to squeeze as many profits as possible out of this lemon before the FDA ordered them to stamp a warning on the label or withdraw it from the market altogether.

Unsurprisingly, teens and kids started developing symptoms of drug-induced diabetes and weight gain. Several also developed a bizarre condition called galactorrhea, in which milk flows spontaneously from the nipples of your breasts—girls and boys alike—a happening that is likely to drive even the most balanced teen around the bend. What may be even more bizarre, when doctors alerted J&J sales reps to this side effect, sales reps relayed the warning to their managers, who advised the sales reps to tell the doctors (in a frankly illegal reversal of medical protocol) that rather than take the kids off Risperdal, they could be treated with yet another drug.

The Massachusetts case is the third of about 10 state lawsuits in which jurors will be asked to pass judgment on whether J&J’s Risperdal promotional practices constitute medical fraud. Class-action suits by patients (or parents) claiming injury are also in the works. The Obama administration has shown some guts in not simply allowing the giant drug makers to settle such lawsuits for giant fees ($2 billion is not unusual, however ho-hum to pharma) but in holding individual company executives personally liable for the criminal activity.

In fact this code of misconduct is what we have come to expect from the pharmaceutical industry: Always put profits first, break the law now, pay the fine years later. Given the high-risk nature of drug development—a novel compound costs close to $1 billion and a decade to get to market—Big Pharma has tried all manner of dark arts to increase its odds. Criminal activity, once largely limited to the sales divisions, has overtaken the entire endeavor. Clinical trials that produce negative data—including health risks—are hidden from the FDA. Early signals of serious side effects are covered up, as are promised follow-up studies upon which approval is conditioned. Like other industries, pharma and its lobbyists have regulators and Congress by the balls.

But it’s the corruption of the medical profession by the pharmaceutical industry that has proved most insidious, and nothing illustrates the perilous consequences better than J&J’s illegal marketing of Risperdal to kids. Making 100,000 sales calls on psychiatrists and pediatricians, the company lined the pockets of willing MDs employing familiar pharma ploys, from the small-change items like lavishing free samples, free lunches and—this may be a first—even free colorful plastic Lego blocks printed with the word RISPERDAL for children to play with in the waiting room, to the big-ticket items such as “educational” meetings at fancy resorts and “advisory board” soirees at the Four Seasons. The company even paid certain leading specialists hundreds of thousands of dollars a year to conduct J&J-designed trials and sign their name to J&J-written studies published in the top medical journals—providing a “scientific” spin to the promotional materials. In this amorphous manner, a professional consensus emerged that the atypical anti-psychotics were effective in very young children for attacks of rage, poor impulse control, defiant and oppositional behavior—the transient, irrational, sometimes frightening “acting out” that sends overworked adults around the bend.

By means of this closed circle or deceit and kickbacks, J&J beat out the competition to grab 50 percent of the pediatric market for anti-psychotics. And although many other psychiatrists and pediatricians were arguing that anti-psychotics should never be given to children under 10 in the first place, the white wall of silence in the medical profession generally prevents doctors from becoming whistleblowers unless prodded by investigative news reporting.

Everybody was profiting, it seemed, except for the kids.

Consider Kyle Warren, who as an 18-month-old Louisiana toddler began taking Risperdal prescribed by a pediatrician on the J&J payroll (plastic RISPERDAL Legos and all). Kyle suffered from frequent temper tantrums, and his mother, Brandy Warren, then 22, was a new mother on Medicaid and, as she told the New York Times, “at my wit’s end.” But like any good mother, Brandy kept on searching for the right diagnosis and the right treatment, going from doctor to doctor and amassing a contradictory set of assessments, such as autism, psychosis, schizophrenia, bipolar disorder, and attention deficit hyperactivity disorder. By the time he was age three, Kyle’s daily pill regimen resembled that of someone very old or very sick, including Risperdal, the antidepressant Prozac, uppers for ADHD and downers for insomnia. He was sedated, he drooled, and he was ballooning with fat from the side effects of the Risperdal—but, look Ma, no more temper tantrums!

read the rest of the article here: http://www.thefix.com/content/jj-sued-illegal-promotion-drugs-kids?page=all

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Claim: J&J Wrongly Marketed Antipsychotic Drug Risperdal to Kids

Wednesday, August 3rd, 2011

BNET – August 3, 2011
by Jim Edwards
The FDA told Johnson & Johnson (JNJ) in 1997 that its request to market the antipsychotic drug Risperdal for children was “without any justification.” In the following years, J&J’s army of pharmaceutical sales reps made 100,000 sales calls on child and adolescent psychiatrists, justifying this by “qualifying” the docs if they had as few as one adult patient exhibiting signs of schizophrenia, according to a lawsuit.

It was a distinction only a lawyer can love, and now the Massachusetts attorney general is using it against J&J and its Janssen unit, alleging that J&J’s promotion of Risperdal for children was misleading.

J&J had initially asked the FDA to approve the drug for use in children, and the FDA eventually allowed limited use in the over-10s in the 2006 and 2007. But in 1997, without clinical evidence to back its request, the FDA frowned on use of the drug for children. In a latter the J&J, the FDA wrote:

To permit the inclusion of the proposed vague references to the safety and effectiveness in pediatric patients and the nonspecific cautionary advice about how to prescribe Risperdal for the unspecified target indications would serve only to promote the use of this drug in pediatric patients without any justification.

“Promote use of this drug in pediatric patients” is exactly what J&J then did, according to the suit:

From January 1994 through September 2006, Janssen sales representatives directly promoted Risperdal to thousands of child and adolescent psychiatrists and pediatricians even though Risperdal was not approved to treat any pediatric conditions until October 2006.

Doctors were paid $1,000 to attend J&J’s pediatric “advisory board” meetings held at posh resorts, and eventually Risperdal reached a 50 percent share of pediatric antispychotic category, the suit alleges.

Kids grew breasts, docs went to the Four Seasons

This success came at some price to the children receiving the drug, as Risperdal’s side effects include weight gain, diabetes and “galactarhea,” the premature production of breast milk in both boys and girls. One of J&J’s sales reps made this internal sales call note on that issue:

An August 2, 2001 call note (000000244279 ) reports on a sales call with a Braintree doctor: “. . . . She is using Risperdal with great success in kids ala Biederman. She did mention galactarhea so I told her how Biederman is using Dostinex. She is going to get more info on this dopamine agonist. She is going to attend the 4 Seasons event.”

“4 Seasons” is likely a reference to the posh Four Seasons hotel in Boston (its indoor pool is pictured). The Biederman

name is familiar to anyone following the Risperdal saga, of course. Joseph Biederman was the Harvard medical school doctor who was paid by J&J to churn out reams of studies promoting Risperdal in kids. He became infamous when he suggested in a deposition that he was one pay-scale below God.

http://www.bnet.com/blog/drug-business/claim-j-j-wrongly-marketed-antipsychotic-drug-risperdal-to-kids/9344

For more information on Joseph Biederman – http://www.cchrint.org/2011/07/22/pharma-funded-psychiatrists-behind-bogus-child-bi-polar-epidemic-disciplined-for-conflicts-of-interest/

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Drug firms paid ‘independent’ experts

Thursday, July 28th, 2011

Practice led to AG-whistleblower lawsuit

KXAN.com
By Nanci Wilson
July 27, 2011

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Extent of funding not fully disclosed

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

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

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

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

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

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

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

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

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

Crismon was a professor

at the University of Texas School of Pharmacy in Austin.

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

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

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

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

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

Huge boosts in sales

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

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

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

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

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

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

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

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

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

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

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

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

Alarm bells sounded

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

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

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

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

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

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

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

less than $10,000.

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

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

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

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

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

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

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

It didn’t work.

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

Travel and out-of-state lobbying

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Big-dollar settlements

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

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

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

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

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

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

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

Texas share of the settlement was $3.8 million.

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

Texas share is $2.86 million.

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

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

He is now living in Las Vegas.

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

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

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

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

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

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

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

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

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

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

 

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Five dementia sufferers die every day from antipsychotic drugs

Friday, July 22nd, 2011

The Telegraph – July 22, 2011

By Martni Beckford, Health Correspondent

Five dementia sufferers die each day after being wrongly prescribed “chemical cosh” drugs, the Department of Health has warned.

Click image to read: The Psychiatric Abuse of Our Elderly

Many more hospital patients and care home residents suffer strokes triggered by the antipsychotic medications they are given to keep them sedated.

New GP-led bodies that will purchase services under the reformed NHS are being told to review the prescriptions of all 180,000 dementia sufferers currently prescribed the drugs, and to do all they can to give them alternative treatment.

A Dementia Commissioning Pack published on Thursday by the Department of Health states: “Thousands of people across England who are living with dementia are taking antipsychotic medication that they do not need and that could possibly harm them.

“Evidence tells us that although there are clinical situations where a time-limited prescription of antipsychotic drugs may be appropriate, antipsychotic drugs are often overprescribed and continued when alternative therapies are more beneficial.

“There is an unambiguous case for a substantial reduction in their use alongside the wider adoption of alternative interventions which we know can help to maximise the quality of life for people with dementia and their carers.”

More than 600,000 people in England already have degenerative brain conditions such as Alzheimer’s but the figure is expected to rise to above 1million within a few decades as the population ages.

A Government-commissioned report published in 2009 estimated that 180,000 dementia sufferers are being prescribed anti-psychotic drugs but in as many as 150,000 cases they are unnecessarily being taken, often to keep patients quiet in hospital or nursing homes.

Because the “chemical cosh” drugs are feared to worsen other medical conditions and speed up mental decline, it is estimated that they lead to 1,800 needless deaths – five a day – every year. In addition, they are thought to cause 1,620 strokes, half of which are severe.

The new commissioning pack tells doctors to review all the prescriptions for anti-psychotics by next April; to ensure that they tell hospitals and care homes they work with to look for “therapeutic alternatives”; to publish data on their progress; and to use schemes that pay more to hospitals and other providers if they meet targets.

Sir Ian Carruthers, dementia champion for the NHS, said: “Dementia is one of the greatest challenges society faces today, and it is essential that we get commissioning right so that people can live well in their community, and access more support when they need it.”

http://www.telegraph.co.uk/health/healthnews/8652593/Five-dementia-sufferers-die-every-day-from-chemical-cosh-drugs.html

For more information, read The Psychiatric Abuse of Our Elderly - http://www.cchrint.org/protectelderly/

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Pharma-Funded Psychiatrists Behind Bogus Child ‘Bi-Polar’ Epidemic- Disciplined for Conflicts of Interest

Friday, July 22nd, 2011

Harvard Psychiatrists Disciplined for Conflicts of Interest

Alliance for Human Research Protection – July 21, 2011

by Vera Sherav

Psychiatrist Joseph Biederman was funded millions by Pharma while promoting child "bipolar" disorder

The primary promoters–inventors, one might say– of diagnosing children with “bipolar” disorder, who for over a decade, aggressively promoted the biopolar diagnosis and use of antipsychotics in children, were disciplined by Harvard University and its affiliated Massachusetts General Hospital.

An investigation, prompted by Sen. Charles Grassely, was conducted by Harvard University-affiliated Massachusetts General Hospital. It concluded (earlier this month) that psychiatrist Joseph Biederman and two of his proteges, Thomas Spencer and Timothy Wilens -each of who failed to disclose millions of dollars they had each received from the makers of antipsychotics, the drugs they promoted for the treatment of bipolar in children–had indeed violated the University’s/ and hospital’s conflict of interest reporting  standards.

The three wrote a mea culpa letter stating “we want to offer our sincere apologies…” acknowledging “our mistakes…”

However, no mention was made anywhere about the profound consequences of these psychiatritsts’ commercially-driven clinical recommendations. No mention about the corruption of the scientific literature, about clinical practice that deviated from the Hippocratic Oath, “First, do no harm,” nor was any mention made about the harm suffered by children whose doctors were misled about the safety and efficacy of highly toxic drugs.

Child psychiatrists and pediatricians throughout the US were guided by these exceedingly influential Harvard psychiatrists.

As Sen. Chuck Grassley noted in 2008 in the Congressional Record, “they are some of the top psychiatrists in the country, and their research is some of the most important in the field. {But] They have also taken millions of dollars from the drug companies.”

The companies that paid them millions include: Eli Lilly, Johnson & Johnson, Pfizer, GlaxoSmithKline and Bristol-Myers Squibb.

The Senator brought public attention–and to Harvard University administrators’ attention–the financial conflicts of interest, “Out of concern about the relationship between this money and their research.”

Indeed, documents uncovered during litigation confirmed that the research was scientifically corrupt and commercially-driven. The New York Times reported that Dr. Biederman promised Johnson a& Johnson that a study (yet to be conducted) in preschool children who would be given the company’s antipsychotic, Risperdal (risperidone) “will support the safety and effectiveness of Risperdal in this age group.”

“The psychiatrist, Dr. Joseph Biederman, outlined plans to test Johnson & Johnson’s drugs in presentations to company executives. One slide referred to a proposed trial in preschool children of risperidone, an antipsychotic drug made by the drug company. The trial, the slide stated, “will support the safety and effectiveness of risperidone in this age group.”

Dr. Biederman was the lead author of a trial published last year concluding that treatment with risperidone improved symptoms of attention deficit and hyperactivity disorder in bipolar children.”

Another of Biederman’s Harvard ignoble disciples was Jeff Bostic, who is also at Massachusetts General Hospital. He was named in a 2009 lawsuit joined by the US Department of Justice alleging Forest Laboratories promoted its antidepressants for pediatric use without FDA approval and paid kickbacks to docs to encourage prescriptions. He received $750,000 in payments for giving talks on using these drugs in children.

Strangely, the National Institute for Mental Health, which had awarded thse psychiatrists millions of dollars at taxpayers expense. It appears that NIMH officials did not see fit to even conduct an investigation into the corruption of science and violation of federal regulations. This demonstrates a lack of professional and moral integrity at the NIMH whose administrators think nothing about the misappropriation of public money for commercially-driven, junk research.

http://www.ahrp.org/cms/content/view/828/9/

Backstory from Pharmalot:

Pharmalot

Harvard Docs Disciplined For Conflicts Of Interest

By Ed Silverman // July 2nd, 2011 // 9:03 am

Three years after they were fingered in a US Senate probe into the interplay between academics who receive grant money from both pharma and the National Institutes of Health, three prominent psychiatrists from Harvard Medical School and Massachusetts General Hospital have been sanctioned for violating conflict of interest rules and failing to report the extent of their payments.

In a mea culpa addressed to their colleagues, Joseph Biederman, Thomas Spencer and Timothy Wilens wrote that “we want to offer our sincere apologies to HMS and MGH communities…We always believed we were complying in good faith with the institutional polices and our mistakes were honest ones. We now recognize that we should have devoted more time and attention to the detailed requirements of these policies and to their underlying objectives.”

And what is their punishment? They must refrain from “all industry-sponsored outside activities” for one year; for two years after the ban ends, they must obtain permission from the med school and the hospital before engaging in any of these activities and they must report back afterward; they must undergo certain training and they face delays before being considered for promotion or advancement (you can read their letter here).

The hospital had this to say: “A committee at Massachusetts General Hospital that has been looking into conflict-of-interest questions involving three MGH child psychiatrists has completed its review. Appropriate remedial actions have been taken by the hospital to address specific issues (read the statement). And a Harvard Med School spokesman sent us this: “We confirm that the review of their compliance with the Harvard Medical School Policy on Conflicts of Interest and Commitment has concluded, and appropriate actions have been taken.” He added that the conflicts policy was revised last year.

The sanctions result from a long-standing controversy over the explosive use of antipsychotics in children. Biederman, in particular (see photo), had been one of the most influential researchers in child psychiatry. Although his studies were small and often financed by drugmakers, his work helped fuel a 40-fold increase from 1994 to 2003 in the diagnosis of pediatric bipolar disorder.

For more than a decade, Biederman and his colleagues aggressively promoted the diagnosis and use of antipsychotics to treat childhood bipolar disorder, a problem that once was largely believed to be confined to adults. But the docs maintained this was underdiagnosed in kids and the meds could be used for treatment, even though they had not been approved for most pediatric use at the time. Meanwhile, the relationships with drugmakers were never properly disclosed (back story).

And for years, payments they received from drugmakers were not thoroughly reported to university officials. Yet, millions of dollars in NIH grants, which were administered by the hospital, were awarded to the docs at the same time they were receiving money from various drugmakers that make and sell antipsychotics and antidepressants. Which ones? Eli Lilly, Johnson & Johnson, Pfizer, GlaxoSmithKline and Bristol-Myers Squibb.

At one point, Biederman pushed J&J to fund a research center at MassGen that would focus on the use of its Risperdal antipsychotic in children, well before the med was approved for pediatric use. He was then placed in charge of the institute and began a study of 40 children between 4 and 6 years old who were given Risperdal and Lilly’s Zyprexa, another antipsychotic. At the time, Harvard and MGH rules forbid researchers from running trials with drugmakers if they receive more than $10,000 from a company that makes the drug (back story).

But in June 2008, US Senator Chuck Grassley made a far-reaching statement before Congress that pulled the curtain back on the money involved. The statement is memorialized in the Congressional Record. Referring to the three docs, he said “they are some of the top psychiatrists in the country, and their research is some of the most important in the field. They have also taken millions of dollars from the drug companies.”

“Out of concern about the relationship between this money and their research, I asked Harvard and Mass General Hospital last October to send me the conflict of interest forms that these doctors had submitted to their institutions. Universities often require faculty to fill these forms out so that we can know if the doctors have a conflict of interest. The forms I received were from the year 2000 to the present. Basically, these forms were a mess. My staff had a hard time figuring out which companies the doctors were consulting for and how much money they were making.”

How much were they making? At first, maybe a couple of hundred thousand dollars combined. But at his behest, the med school and hospital asked the docs to take a second look. “And this is when things got interesting. Dr. Biederman suddenly admitted to over $1.6 million dollars from the drug companies. And Dr. Spencer also admitted to over $1 million. Meanwhile, Dr. Wilens also reported over $1.6 million in payments from the drug companies.

“The question you might ask is: Why weren’t Harvard and Mass General watching over these doctors? The answer is simple: They trusted these physicians to honestly report this money.” And as Grassley then noted, there was still more money that went unreported (to read the Congressional record, click here and then check the box for 2008 and type in the name ‘Biederman’ in the search box. Then click on ‘payments to physicians’ to read the complete statement and the chart showing payments to each doc).

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