Posts Tagged ‘False Claims Act’

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

Tuesday, March 22nd, 2011

Natural News
By Monica Young
March 22, 2011

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

But who wants to believe a bunch of liars anyway?

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Profiting from mental ill-health

Tuesday, March 15th, 2011

There’s a reason psychiatrists prescribe drugs rather than talking therapy: the latter makes no money for pharmaceutical firms

The Guardian
By Harriet Fraad
March 15, 2011

More than one in ten Americans takes Prozac; the US comprises 5% of the world's population, yet consumes two thirds of psychological medications. Photograph: Stone/Jonathan Nourok/Getty

The New York Times recently led with a front-page splash about psychiatry’s propensity to prescribe pills, “Talk Doesn’t Pay, So Psychiatry Turns Instead to Drug Therapy”. That news is already widely known in the mental health field, but it has vast ramifications for Americans trying to maintain their sanity in our market-driven and medical system for delivering mental healthcare.

What does the turn to drug therapy mean for the mass of Americans?

Mental illness has not decreased with the change from talk therapy to drugs. In fact, as Robert Whitaker’s book diagnoses, mental illness in America has become an established epidemic. So-called miracle drugs like Prozac are taken by 11% of the population – and Prozac is only one of the 30 available antidepressants on the market. Antidepressants are accompanied by anti-anxiety and anti-psychotic drugs. Xanax, America’s leading anti-anxiety medication, is so ubiquitous that Xanax generates more revenue than Tide detergent, reports Charles Barber in his Comfortably Numb.

Anti-psychotics drugs alone net the pharmaceutical industry at least $14.6bn dollars a year. Psycho-pharmaceuticals are the most profitable sector of the industry, which makes it one of the most profitable business sectors in the world. Americans are less than 5% of the world’s population, yet they consume 66% of the world’s psychological medications.

Do these psycho pharmaceuticals work to restore mental health? Actually, the evidence is overwhelming that they fail. Antidepressants, the most popular psycho-pharmaceuticals, work no better than placebos. They work 25% of the time and stop working when the user stops taking them. In addition, they may actually harm patients in the long run. They disrupt brain neurotransmitters and may usurp the brain’s organic soothing functions.

Psycho-pharmaceuticals are less effective in the long run than talk therapy. Talk therapy, like drugs, does change brain and body chemistry; unlike drugs, though, talk therapy has no side-effects. Instead, talk therapy gives a patient tools that usually help to solve future problems. The latest research is most clearly expressed in both Irving Kirsch’s Antidepressants: The Emperors New Drugs and Gary Greenberg’s, Manufacturing Depression, both published last year. Kirsch is one of the world’s leading psychiatrists; Greenberg is one of the world’s most prestigious psychologists. Their views are echoed by many voices in the field of mental health. Why is prestigious and extensive research so widely ignored by doctors and patients alike? Our market-driven healthcare system gives us clues.

All 30 of the available antidepressants have suffered lawsuits within five years of their appearance on the market. These suits are often settled with large payments and gag clauses. The new generation of anti-psychotics are the latest case in point. Anti-psychotics were the single biggest targets of the False Claims Act. Every major company selling anti-psychotics – Bristol Meyers Squibb, Eli Lilly, Pfizer, Johnson and Johnson and AstraZeneca – has either settled investigations for healthcare fraud or is currently being investigated for it. Two recent settlements involving charges of illegal marketing set records for the largest criminal fines ever imposed on corporations. Their corporate logic is expressed in the words of Dr Jerome Avorn, a medical professor and researcher at Harvard: “When you are selling a billion a year or more of a drug, it’s very tempting for a company to just ignore the traffic ticket and keep speeding.”

There is also the widespread practice of paying physicians and psychiatrists heavy subsidies to recommend psycho-pharmaceuticals to their colleagues in small meetings at which a drug company representative is present. If doubt or criticism of the discussed drug is expressed, the doctor’s stipend stops. Another legally acceptable tool is to publish praise of a company’s drug in a scholarly article, which is often written by drug company personnel and simply tweaked by the physician whose name appears on the article. The physician is paid handsomely for such a service.

Under the pressure of legal settlements and embarrassing disclosures, eight pharmaceutical companies began posting doctors’ names and compensation on the web. ProPublica compiled these disclosures, totaling $320m, into a single database that allows patients to search for their doctor. Receiving payments for publishing articles written by drug companies is not illegal.

Two doctors, Dr Joseph Biederman and Dr Timothy Wilens of Harvard University Medical School, illustrate the close and cozy relationship between medical “scholarship” and drug companies. Drs Biederman and Wilens netted $1.6m each from drug companies for their work in recommending powerful anti-psychotic drugs for children. Biederman, Wilens and other extremely well-rewarded child psychiatrists are in part responsible for giving children the diagnosis of paediatric bipolar disorder for which anti-psychotic drugs like Risperidal and Zyprexa are used.

Experts agree that there is no long-term improvement in children’s lives from taking anti-psychotic drugs. In fact, these drugs have a substantiated pattern of metabolic problems and rapid weight gain that often leads to diabetes. The use of bipolar diagnoses and bipolar medications is one small example of how market-driven mental healthcare works in the United States. It illustrates the transformation of US healthcare into a system dominated by some of the richest corporations in the world.

Caring about profit is first, and that is why psychiatry has turned to drug therapy.

Read article here:  http://www.guardian.co.uk/commentisfree/cifamerica/2011/mar/15/psychology-healthcare

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Drug Industry Settlements In 2010 Largest Ever—$2.5 Billion

Tuesday, November 23rd, 2010

NPR November 23, 2010

by Carrie Johnson

Image: Carlos Porto

The Justice Department has collected a whopping $3 billion in settlements this year with help from whistleblowers and a powerful law known as the False Claims Act, Assistant Attorney General Tony West announced this morning.

And guess where $2.5 billion of that $3 billion came from? Big Pharma.

This year’s biggest hauls under the False Claims Act include $669 million of the record-shattering $2.3 billion total the government took from Pfizer over its improper promotion of the painkiller Bextra, $302 million from Astra Zeneca over the anti-psychotic drug Seroquel, and $192 million from Novartis.

West told reporters the Civil War era law had become “one of our most successful civil enforcement tools,” allowing the Justice Department to recover “money that otherwise would have padded the bank accounts of defendants who sought profit over quality.”

And he vowed that the Obama administration would do more to go after individual executives who had green-lighted frauds against the federal government by seeking to bring civil and criminal charges that could put them out of business and in some cases, into federal prison.

“We’re going to hold both companies and individuals accountable,” West said.

Justice Department officials say the 2010 health care recovery is the largest in history, and the total recovery is the second largest, up from some $2.4 billion last year. Altogether, they’ve taken in $5.4  billion since January 2009 under the Act.

Congress recently strengthened the law and expanded the ability of whistleblowers to recover money if they alert the Securities and Exchange Commission to financial fraud.

That, West said, could be one of the next fronts in a battle against fraud that’s been intensifying rapidly.

http://www.npr.org/blogs/health/2010/11/22/131517940/drug-industry-settlements-in-2010-largest-ever-under-false-claims-act

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Senator Grassley Investigates Big Pharma’s Treatment of Drug Company Whistleblowers Who File Complaints

Thursday, July 1st, 2010

Bloomberg
By David Voreacos
July 1, 2010

U.S. Senator Charles Grassley asked 16 drugmakers, including Pfizer Inc., AstraZeneca Plc and Eli Lilly & Co., to reveal how they treat whistleblowers who file complaints under the False Claims Act.

Grassley, an Iowa Republican, sent letters June 28 that posed eight questions such as how companies notify employees of the law, how they treat whistleblowers and what changes they have made in response to a 2009 law extending anti-retaliation protections. Grassley’s office provided copies of the letters.

The False Claims Act lets private citizens sue on behalf of the government and share in any recovery. Whistleblowers were paid $2.39 billion from 1987 to 2009, or 16 percent of the $15.19 billion collected in False Claims lawsuits in which the U.S. government joined the case, according to the Justice Department.

“What measures does Pfizer have in place to ensure fair treatment to those filing complaints?” Grassley wrote to Chief Executive Officer Jeffrey Kindler. “Of employees who have filed complaints, have any complained of unfair treatment and/or retaliation after the filing of the complaint?”

The False Claims Act was passed by Congress in 1863 and strengthened three times since 1986. Citizens file so-called qui tam cases that remain sealed from public view as the Justice Department investigates the claims and decides whether to join the suit. Twenty-five U.S. states have their own versions of the law.

Large Settlements

Drugmakers have reached some of the largest settlements in recent years. Pfizer agreed to pay $2.3 billion over improper drug marketing, Lilly paid more than $1.6 billion to settle claims over its marketing of the drug Zyprexa, and AstraZeneca paid $520 million over marketing of its drug Seroquel.

Read entire article:  http://www.bloomberg.com/news/2010-06-30/grassley-seeks-data-from-pfizer-lilly-on-how-whistleblowers-are-treated.html

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