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Doctors Paid Millions To Promote Drugs and Medical Devices

admin — Thu, 29 Sep 2011 17:42:12 +0000

InjuryBoard Blog Network – September 29, 2011

AstraZeneca paid one Chicago doctor, Dr. Michael Reinstein nearly half-a-million dollars to promote Seroquel. In return, Dr. Reinstein provided AstraZeneca with a vast customer base.

The Chicago Tribune reportedthat drug companies paid more than $25 million to Illinois doctors to promote and use drugs from the pharmaceutical companies. Nearly 40 physicians got payments and perks exceeding $100,000 between 2009 and early 2011.

Eight drug companies paid more than $220 million to doctors and promotional speakers in 2010 to promote their drugs.

Starting in 2013, all drug and medical device companies must report such information to the federal government which will make these disclosures available to the public.

The most controversial payments involve consulting arrangements and promotional speeches. Drug company officials say they are funding talks that provide much-needed medical education, led by physicians who are experts in their fields. Critics say financial relationship between doctors and drug companies can threaten patient care by influencing physicians to prescribe certain medications whether or not they are the best choice.

Until 2009, drug company payments to doctors and other health professionals were closely held as trade secrets. However, some companies have begun reporting this information in advance of the 2013 requirements and pressure from lawmakers or as a condition of settling federal whistle-blower lawsuits.

ProPublica has created a database called Dollars for Docs identifying amounts paid to doctors for promotion of drugs and medical devices. Dollars for Docs has identified more than $760 million in disclosed marketing payments from only 12 companies between 2009 and the 2nd quarter of 2011.

“[The drug company payments] make it look like physicians are not impartial or are in the service of the drug companies, and can cause patients to wonder if physicians’ recommendations for treatment are being made because it was the best option based on their clinical expertise or because they have a relationship with the company,” [Hastings Center research scholar Josephine] Johnston said. “I don’t think many physicians have taken that risk (of patient distrust) as seriously as they should.”

In 2009, the Chicago Tribune reported on the millions of dollars paid by foreign drug maker AstraZeneca to doctors in order to promote its anti-psychotic drug, Seroquel. AstraZeneca paid one Chicago doctor, Dr. Michael Reinstein nearly half-a-million dollars to promote Seroquel. In return, Dr. Reinstein provided AstraZeneca with a vast customer base.

Dr. Reinstein was traveling the country telling doctors that Seroquel would help patients lose weight while the FDA was warning about Seroquel’s link to weight gain and diabetes. Even Seroquel executives called Dr. Reinstein’s conclusion that patients experienced no adverse side effects “suspect” and “hard to believe”. When faced with the choice of protecting patients or protecting profits, AstraZeneca and Dr. Reinstein chose profits over safety.

Johnson & Johnson’s DePuy Orthopaedics division also paid millions — more than $80 million — to surgeons to promote its artificial hip systems. The US Department of Justice brought charges against four medical device companies – including DePuy – in 2007, claiming the companies were using kickbacks to doctors in promoting their products. However, DePuy kept paying doctors:

$48 million to doctors in 2009
$33 million from January to September 2010

Some surgeons received more than $1 million in single year.

These payments create a direct conflict of interest between doctor and patient. Drug company sponsored research potentially taints results and doctors create the impression – and sometimes the actual effect – of choosing profits and drug company kickbacks over patient safety.

Drug companies pay $25 million to Illinois doctors [Deborah L. Shelton at Chicago Tribune]
Doctor-drugmaker ties: Psychiatrist Dr. Michael Reinstein received nearly $500,000 from antipsychotic drug’s manufacturer [Christina Jewett and Same Roe at Chicago Tribune]
Dollars for Doctors [ProPublica]

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FDA Needs to Ban Antipsychotic Drug Use on Kids

admin — Fri, 23 Sep 2011 17:48:45 +0000

Note from CCHR: While the FDA and its Pediatric advisory panel sit around pondering if one antipsychotic drug is more likely to cause diabetes in children than another while continuing their stall tactic of “let’s study it some more ” routine, we’d like to point out the simple solution: Considering that antipsychotic drugs are already documented by international drug regulatory agencies to cause not only diabetes but obesity, psychosis, blood clots, heart problems, cardiac events, seizures, toxicity, confusion, coma and stroke (and that’s just in kids) as well as brain atrophy (meaning they actually shrink brains); considering there is no medical test to prove any child has a brain malfunction, chemical imbalance or any physical condition requiring the administration of these lethal drugs—and considering these drugs are literally killing kids that have nothing medically wrong with them in the first place— Do the job you are paid by U.S. Taxpayers to do and BAN their use on children. Period.

GAITHERSBURG, Maryland (Reuters) – U.S. pediatric health advisers on Thursday urged drug regulators to continue studying weight gain and other side-effects of antipsychotic drugs as they are increasingly taken by children.

Significant numbers of U.S. children are receiving drugs to tame aggression, attention deficit disorder and other mental problems, even though there is little conclusive data to show exactly how the medications work or whether they damage kids’ health.

Similar to the recommendations the panel has made in previous years, it voted 16-1 to support the U.S. Food and Drug Administration’s routine safety monitoring of the new generation of antipsychotics.

But the panel did so with a caveat that the agency specifically look at how to clarify the drugs’ labels to highlight concerns about their impact on children, namely the risks of weight gain and diabetes.

“There is serious concern that children may be at a higher risk for serious adverse effects and we just don’t have sufficient data to answer that question,” said Dr. Jonathan Mink, a child neurology expert from the University of Rochester Medical Center.

Dr. Jeffrey Wagener, a pediatric pulmonologist from the University of Colorado Medical School, was the one adviser to vote “no” out of concern that wouldn’t get regulators closer to dealing with the risks of using antipsychotics in children.

“I don’t see how the FDA is responding to the December 8, 2009 request by this committee in a thorough fashion,” he said. “It’s taken them two years to not respond to that that we need to be more than in the observational role.”

The FDA in the next month to six weeks will release a revised label for Abilify, a drug sold by Bristol-Myers Squibb Co and Otsuka Pharmaceutical and approved to treat schizophrenia in adolescents, bipolar disorder in children 10 to 17 years old and irritability associated with autism in those as young as six.

“We ask that with this upcoming revision that you carefully consider the language around pediatric use and adverse events,” said Dr. Geoffrey Rosenthal, the committee’s chair and director of Pediatric and Congenital Heart Center at the University of Maryland Medical Center.

Abilify’s new label will detail the drug’s latest clinical trials, warn of metabolic concerns and remind doctors to monitor weight and symptoms of diabetes in all patients, said Dr. Thomas Laughren, FDA’s psychiatry products chief. The pediatric section of the label would contain a reference to those warnings, he said..

Such revisions, which are already incorporated into Johnson & Johnson’s antipsychotic medication Invega Sustenna, are being considered for other similar drugs on a case by case basis, Laughren said.

The new generation of antipsychotic medications has raised a wave of concerns as they are increasingly being prescribed for a host of uses and for younger and younger patients, with little conclusive research addressing their impact on children and sometimes with little evidence they work.

Newer antipsychotics include J&J’s Risperdal, known generically as risperidone; Eli Lilly & Co’s Zyprexa or olanzapine; AstraZeneca’s Seroquel or quetiapine; and Abilify, known generically as aripiprazole.

U.S. researchers have found that the drugs’ use in children increased by 65 percent from 2002 to 2009, primarily through prescriptions for teenagers.

From fall 2009 to spring of this year, 1.9 million prescriptions of Abilify alone were dispensed to patients under 18, including even 875 prescriptions for toddlers younger than 2, according to FDA research.

Most commonly, the prescriptions were for bipolar disorder in teenagers and preschoolers, and for affective psychoses in children between the ages of seven and 12.

Advisers also voted unanimously to require the FDA to show them label revisions and report back in the next year or 18 months on progress in designing more studies of the drugs in children.

http://www.fox43.com/lifestyle/sns-rt-us-usa-fda-antipsychotictre78l77l-20110922,0,216106.story

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Big pharma pays US doctors $150m in 2011

cchrint — Tue, 30 Aug 2011 16:38:50 +0000

PMLive
August 30, 2011

A report by the Financial Times has claimed a group of pharmaceutical companies has paid doctors in the US almost $150m so far during 2011.

Prepared in conjunction with the data provider, PharmaShine, the figures show the money was paid by pharmaceutical firms, including Eli Lilly, AstraZeneca (AZ) and Pfizer, for doctors’ travel and entertainment expenses as well as education and consultancy fees.

Of those companies who have released data, Lilly is reported to have paid $48m and Pfizer to have paid $42m.

AZ, who recently launched a database containing payments made to doctors and institutions, said $24.7m was paid out in associated compensation for the second quarter of 2011, with $8.1m going to individual physicians and $16.6m going to institutions.

In a post on the company’s AZ Health Connections blog, US compliance officer, Marie Martino, gave reason as to why the company was releasing its data.

She said: “AstraZeneca believes it is important to be open about how we conduct our business, and this new reporting expands on a major initiative announced three years ago to provide greater public visibility into how we do business.”

Around 165,000 doctors have received related payments in 2011 so far, compared to 262,000 doctors who received payment in 2010.

The report comes at a time when US government agencies are preparing guidelines to make the publication of industry support for medical professionals compulsory by 2013.

This is part of ongoing US healthcare reforms as an attempt to allow better, more consistent understanding of the pharmaceutical industry’s relationship with healthcare professionals in the US.

In the UK, the Association of the British Pharmaceutical Industry (ABPI) changed its code of practice at the beginning of 2011 to help increase transparency of working practices between the pharmaceutical industry and healthcare professionals to help increase trust.

Companies will have to declare payments to healthcare professionals for services including speaker fees, advisory boards and consultancy, and sponsorship for attendance at meetings on an annual basis. The first declaration will be made in 2013 for payments made in 2012.

http://www.pmlive.com/find_an_article/allarticles/categories/General/2011/august_2011/news/big_pharma_pays_us_doctors_$150m_in_2011

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Australian Psychiatrist Patrick McGorry Aborts Controversial Antipsychotic Drug Trial on Kids Amid Protests

cchrint — Sat, 20 Aug 2011 17:43:20 +0000

Drug Trial Scrapped Amid Outcry

The Age
By Jill Stark
August 21, 2011

FORMER Australian of the Year Patrick McGorry has aborted a controversial trial of antipsychotic drugs on children as young as 15 who are “at risk” of psychosis, amid complaints the study was unethical.

The Sunday Age can reveal 13 local and international experts lodged a formal complaint calling for the trial not to go ahead due to concerns children who had not yet been diagnosed with a psychotic illness would be unnecessarily given drugs with potentially dangerous side effects.

Quetiapine, sold as Seroquel, has been linked to weight gain and its manufacturer AstraZeneca, which was to fund the trial, last month paid $US647 million ($A623 million) to settle a lawsuit in the US, alleging there was insufficient warning the drug may cause diabetes.

Professor McGorry, one of the Prime Minister’s key mental health advisers, planned to conduct the trial at Orygen Youth Health in Parkville, listing it on the Australian New Zealand Clinical Trials Registry last March. It was to investigate whether the drug would decrease or delay the risk of people aged between 15 and 40 with early signs of mental illness developing a psychotic disorder such as schizophrenia.

Last month, psychiatrists, psychologists and researchers from Australia, Britain and the US lodged a complaint with the ethics committee of Melbourne Health, the umbrella health service that includes Orygen.

They argued there was little evidence onset of psychosis can be prevented and it was potentially dangerous to use antipsychotics on people who merely have risk factors for a psychotic illness. They said there was evidence that up to 80 per cent would never develop a disorder.

Professor McGorry insists the decision to scrap the trial was made in June and is unrelated to the complaint, which he said he was only alerted to just over a week ago.

He maintained the trial received ethics approval in July last year but was abandoned due to “feasibility issues” with recruiting participants in European and American sites, which were to form the international arm of the study. He said Orygen had to choose between investing in the drug trial or pursuing another trial using fish oil, which had proven to be useful as an early intervention treatment for schizophrenia in a smaller study. He opted for fish oil because it had less potential for side effects than antipsychotics.

Melbourne Health confirmed the complaint will still be considered by its research ethics committee in September. Yesterday the trial was listed as “prospective” on the clinical trials registry but Professor McGorry said it was being removed.

Earlier this month The Sunday Age revealed a growing backlash against the government’s mental health reforms, with Professor McGorry’s peers claiming his youth early intervention model had been “massively oversold”.

Associate Professor Geoff Stuart of La Trobe University’s school of psychological sciences, who signed the complaint, said questions remained about the trial.

“If these feasibility obstacles can be overcome in future [would] Professor McGorry embark on such a trial again? He was willing to endorse a trial which was exploring the use of antipsychotic medication in an at-risk group. There’s a major ethical issue about medicating four people to supposedly save the fifth when you’re not saving them anyway, you’re just masking their symptoms. We’re talking about kids as young as 15 who could get a full dose of antipsychotics and they’re not psychotic.”

Professor McGorry acknowledged the evidence suggested antipsychotics were not effective as a first-line treatment for the at-risk group. But he said the risks had been exaggerated and he would consider a similar trial on patients for whom other treatments had failed. “I wrote the guidelines which said do not use antipsychotics in ultra-high risk patients, so I’ve never been supportive of it in clinical practice … [but] we should have the freedom to research all available options for this population,” he said.

The controversy over the aborted trial largely centres on “psychosis risk syndrome”, a condition that some mental health advocates want formally recognised. But critics say that could lead to young people being wrongly labelled, stigmatised and medicated for symptoms that may be temporary. They also fear that while Professor McGorry says his Early Psychosis Prevention and Intervention Centres prescribe drugs only to those who have experienced a psychotic episode, his willingness to medicate an at-risk group could mean the criteria will broaden. Professor McGorry insists this will not happen.

Early intervention What is it?

EARLY intervention is based on identifying and treating psychosis in its early stages to prevent patients developing full-blown psychotic illnesses such as schizophrenia.

Patrick McGorry’s Early Psychosis Prevention and Intervention Centres (EPPIC) treat young people who have experienced a psychotic episode with treatments such as psychotherapy, family therapy, medication or a combination. He says early treatment significantly improves the chance of recovery and reduces long-term impairment. But diagnosing psychotic disorders is difficult and McGorry’s critics say there is no reliable diagnostic tool to predict if someone will develop a psychotic illness and there is insufficient evidence intervention can prevent it.

Critics say up to 80 per cent of those with ”psychosis risk syndrome” – which refers to people who only have risk factors such as a family history or a deterioration in mental health – never develop an illness. They fear early intervention will lead to many patients being wrongly labelled as psychotic and medicated unnecessarily.

A recently released literature review by The Cochrane Collaboration found there was insufficient evidence that early intervention could prevent psychosis and that any benefits were not long term. Professor McGorry said it used flawed methodology.

http://www.theage.com.au/national/drug-trial-scrapped-amid-outcry-20110820-1j3vy.html?from=age_sb

August 21, 2011

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Cause for alarm: Antipsychotic drugs for nursing home patients

cchrint — Tue, 31 May 2011 21:17:06 +0000

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

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

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

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

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

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

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

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

Another view: In defense of antipsychotics for dementia

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Creating juvenile zombies, Florida-style

admin — Sun, 29 May 2011 14:42:45 +0000

The Miami Herald – May 28, 2011

By Fred Grimm

They’re children of the new Florida ethic. Zombie kids warehoused on the cheap in the state’s juvenile lock-ups. Kept quiet, manageable and addled senseless by great dollops of anti-psychotic drugs.

A relatively small percentage of young inmates pumped full of pills actually suffer from the serious psychiatric disorders that the FDA allows to be treated by these powerful drugs. But adult doses of anti-psychotic drugs have a tranquilizing effect on teenage prisoners. Prescribing anti-psychotics for so many rowdy kids may be a reckless medical practice, but in an era of budget cuts and staffing shortages, it makes for smart economics.

Florida fairly inundates juvenile offenders with this stuff.

The Palm Beach Post reported last week that the Florida Department of Juvenile Justice has been buying twice as many doses of the powerful anti-psychotic Seroquel as it does ibuprofen. As if the state anticipated more outbreaks of schizophrenia than headaches or minor muscle pain.

The Post found that Florida purchased 326,081 tablets of Seroquel, Abilify, Risperdal and other antipsychotic drugs during a two-year period for the boys and girls who occupy the 2,300 beds in state-run residential facilities. (Most of the state’s juvenile offenders are held in jails operated by for-profit contractors. Records revealing the quantity of medications that private companies pour down their prisoners’ gullets were not available.)

Such drugs, meant for adults, are known to send children into suicidal despair, along with risking heart problems, weight gain, diabetes and facial tics. Yet, the DJJ and its contract psychiatrists push them willynilly onto their young wards.

It’s not as if state officials have been unaware of the risks facing children prescribed “off label” uses (unapproved by the FDA) of these pharmaceuticals. Even as the state doled out Seroquel like candy to kids in DJJ jails, the Florida Attorney General’s office was entering into a lawsuit with 36 other states against drug manufacturer AstraZeneca for promoting dangerous, off-label uses of Seroquel for treating both the young and the elderly. (AstraZeneca agreed to settle the lawsuit in March for $68.5 million and to stop marketing the drug for unauthorized uses.)

It was as if the schizophrenics most in need of Seroquel were roaming the halls of government, not the juvenile jails.

“This is the face of all these budget cuts; what happens when you eliminate social workers and prison guards,” said Broward Public Defender Howard Finkelstein. He suspects that DJJ has compensated for the staff shortages at state lockups by pumping “the most powerful drugs known to man into children who have not been diagnosed for psychiatric problems.”

Finkelstein says he assigned two of his staff attorneys last week to visit juvenile lock-ups and investigate what he calls the “zombification” of young offenders who had been represented by his office.

Florida Attorney General Pam Bondi opened her own investigation last week. Bondi’s staff attorneys are interested in the Post’s report that psychiatrists prescribing off-label uses of such astounding quantities of the profitable anti-psychotics for DJJ prisoners (at taxpayer expense) had been greased by drug manufacturers with some $250,000 in gifts and speaking fees.

The DJJ drug scandal seems all the more maddening considering that it follows a similar uproar just two years ago after the suicide of a seven-year-old Margate foster child. Young Gabriel Myers had been given adult dosages of three anti-psychotics before he hung himself.

The Gabriel Myers Task Force, made up of child advocates, state officials, political leaders and judges from across the state, spent a year investigating whether the Florida Department of Children and Families had administered dangerous drugs as “chemical restraints” for troublesome foster children.

Foster kids, as it turned out, weren’t the only victims of the on-the-cheap ethic. But don’t think of children reduced to zombies. Think of all the money we save on prison guards.

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

cchrint — Sat, 28 May 2011 00:46:01 +0000

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:

Florida’s Department of Juvenile Justice — which houses kids with criminal records — buys twice as much Seroquel as ibuprofen.
The military’s spending on Seroquel increased sevenfold since 2001as veterans’ doctors prescribed it for insomnia and post-traumatic stress disorder.
Seroquel isn’t approved for children under age 13 but there are plenty of researchers studying it in kids anyway.

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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Gem of the Week: Big Pharma in Juvie

cchrint — Fri, 27 May 2011 15:59:04 +0000

Mother Jones
By Jen Phillips
May 27, 2011

GreenColander/Flickr

Instead of the usual Eco-News Roundup of stories from our other blogs, we’re experimenting with a new format. This week, I’m shining a light on a news article from the past 5 days that covered an underreported environmental topic or illuminated a new side of an existing issue. Hopefully this format will be more relevant, and more interesting, than the old Eco-News Roundup.

This week’s gem for reporting on science, health, and the environment goes to… the Palm Beach Post in Florida, for revealing ties between psychiatrists in juvenile halls and manufacturers of antipsychotic drugs. The Post‘s investigation found that a handful of psychiatrists working for Florida’s Department of Juvenile Justice (DJJ) were paid high speaking fees or given gifts by pharmaceutical companies like AstraZeneca. “In at least one case, the number of Medicaid prescriptions a psychiatrist wrote for children rose sharply around the time he was paid, The Post found.” Even worse, the antipsychotics were prescribed by the DJJ doctors were not approved for safe use in children.

Since the Post‘s investigation, the DJJ has launched an internal investigation about the use of antipsychotics in its system. However, as the Post found while reporting, the DJJ’s record-keeping system is in bad shape, making it hard for even DJJ employees to find the information they’re looking for. In addition, not all juvie programs are run directly by the DJJ. “No information was available,” the Post noted, “on the amounts of antipsychotic drugs dispensed in the more than 100 remaining programs for juveniles… run by private contractors.”

Read the Post‘s entire, in-depth investigation at their site, here.

http://motherjones.com/blue-marble/2011/05/big-pharma-juvie-kids-drugs

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Seroquel Marketing Undeterred by Deceptive-Marketing Settlement

admin — Mon, 11 Apr 2011 18:12:35 +0000

The Epoch Times – April 11, 2011

by Martha Rosenberg

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Martha Rosenberg is a freelance writer who lives in Chicago.

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

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

cchrint — Tue, 22 Mar 2011 19:03:25 +0000

Natural News
By Monica Young
March 22, 2011

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

But who wants to believe a bunch of liars anyway?

Read article here: http://www.naturalnews.com/031787_psychiatric_drugs_greed.html

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