Posts Tagged ‘government’

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

Friday, May 27th, 2011

BNET
By Jim Edwards
May 27, 2011

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

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

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

The ISMP said:

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

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

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

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

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

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

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

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AstraZeneca paying $68.5M to settle off-label marketing charges for anti-psychotic Seroquel

Thursday, March 10th, 2011

ABCNews.com

by Matthew Perrone AP Health Wire, March 10,  2011

Thursday's deal is the second multimillion-dollar Seroquel settlement brought by government prosecutors in the past two years. Last April AstraZeneca agreed to pay $520 million to settle similar allegations brought by the federal Department of Justice.

AstraZeneca will pay $68.5 million as part of a multistate settlement over allegations that the drug developer promoted its blockbuster psychiatric drug Seroquel for insomnia, Alzheimer’s and other unapproved uses.

The New Jersey Attorney General’s Office announced the agreement Thursday, describing it as the largest multistate pharmaceutical settlement of its kind. New Jersey will receive $1.85 million from the deal with 36 other states and the District of Columbia as party to the settlement.

The states alleged that salespeople for AstraZeneca promoted its anti-psychotic Seroquel for off-label, or unapproved uses, and did not disclose side effects of the pill, which include weight gain and muscle spasms.

“Consumers rightfully expect pharmaceutical companies to engage in responsible marketing efforts that are consistent with approved purposes,” said Thomas Calcagni, acting director of New Jersey’s division of consumer affairs.

Seroquel is approved to treat schizophrenia, bipolar disorder and depression, though the majority prescriptions are for off-label uses like insomnia. The drug, approved in 1997, is AstraZeneca’s second-best-selling product, with U.S. sales of $5.3 billion last year. But that success has been marred by frequent allegations that the company illegally marketed the drug and downplayed its risks.

Seroquel’s side effects, including blood sugar increases, weight gain and uncontrollable muscle spasms, have resulted in thousands of lawsuits from patients. The drugmaker had settled nearly 25,000 personal injury lawsuits related to Seroquel at the end of 2010, with 3,950 remaining.

Pharmaceutical companies are prohibited from marketing drugs for unapproved uses, though doctors are free to prescribe them as they choose.

London-based AstraZeneca denied any wrongdoing.

“While we deny the allegations, AstraZeneca believes it is important to bring these matters to a close and move forward with our business of providing medicines to patients,” said company spokesman Tony Jewell, in a statement.

Thursday’s deal is the second multimillion-dollar Seroquel settlement brought by government prosecutors in the past two years. Last April AstraZeneca agreed to pay $520 million to settle similar allegations brought by the federal Department of Justice.

The new settlement stemmed from a separate three-year investigation led by the Attorney General of New Jersey. As part of the agreement AstraZeneca must publish any gifts or payments to physicians on a public website. The company also agreed to make sure that payment incentives to sales representatives do not encourage off-label promotion.

Allegations of off-label drug marketing have become increasingly common in the past decade, with the drug industry eclipsing all others as the source of fraud-related settlements with the federal government. Approximately 80 percent of the $3.1 billion in penalties collected last fiscal year by the government came from the health care sector, including drugmakers, insurers and hospitals, according to Taxpayers Against Fraud.

http://abcnews.go.com/Business/wireStory?id=13105486

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Doctors, Drug Companies, Politicians & Corruptions

Friday, August 20th, 2010

The Asian Tribune, August 21, 2010

By Shenali Waduge

They say there’s no money in healthy people. But, why is the pharmaceutical industry the most profitable industry in the world? It is because they have mastered the art of concocting the disorder, creating the drug for the disorder and then bombarding the public with advertisements to convince them they’re afflicted, leaving little choice but to get “prescribed”.

The growth in the pharmaceutical industry began to expand towards the 1970s. Pharmaceutical companies began to form mutual partnerships and began dominating the production of medicines. Advertising boomed making it possible for consumers to be enticed into believing there were miracle cures or drugs that would make people look young forever, increase sexual libido, maintain youthful looking skin with zero after effects or side effects.

Companies spend billions on “inventing” new drugs…they also spend billions on marketing them, USD53billion to be precise. But, how “innovative” are these companies? Most research and clinical trials are carried out at universities and funded by Governments. What happens thereafter is that drug companies “buy these innovations” and quickly patent them and quickly set up manufacturing plants. The only “innovation” done by these companies is to modify the existing drug something as minor as changing the color of the coating! A patented drug generally lasts for 20 years. It is only after rigorous study and testing which takes a good 10 to 15 years that Governmental authorities grant permission to market and sell drugs.

Loopholes in patent systems ensure companies are able to keep generic competitors at bay for years. These patented branded drugs naturally provides high profit margins but before the patent expires and competitors enter with a generic drug sold at far lesser prices, owners of branded drugs put out a generic version before the branded version expires…giving his company a head start in the sale of generic drugs. In 2006, the world had spent US$643billion on prescription drugs with US accounting for almost half of global pharmaceutical market. The US pharmaceutical industry is the most profitable of all businesses in the US.

It would not surprise anyone that companies spent up to $11billion annually on free samples, $6billion on sales representatives, $3billion on vague advertisements, we can only guess how many more billions is spent on bribing doctors, bribing researchers, bribing universities, bribing health officers, pharmacists, providing kickbacks and even running bogus “medical education” programs.

Essentially, what drug companies’ end up doing is using tax payer’s money to pay for medical research which they buy off, they then spend on massive advertising campaigns aimed at misleading the public about the effects of these drugs and “encourage” doctors to prescribe them!

Year in and year out drug companies end up the most successful industry with stunning profits part of which are used to buy off politicians and further promote themselves as champions of social responsibility and good corporate ethics!

There are no business ethics in the pharmaceutical industry – the industry is synonymous with money, profits, power and control. Pharmaceutical companies have mastered how to market social phobia/anxiety disorders in order to sell mind altering drugs. Does it not surprise and make you wonder why scores of people are being treated for mental disorders?

There are teenagers on anti-depressants and anti-psychotics because pharmaceutical companies want to ensure they have customers for life! Some prescription drugs are sold at more than 500,000% markup over the actual cost of their raw ingredients, naturally drug companies will do anything to sell more pills and it is why they end up inventing fictitious diseases and force parents to make addicts out of their children. There are scores of drugs available that are “habit-forming” tranquilizers?

Despite the number of drugs available why are people sicker than ever? Drugs have not helped people instead drug companies have made people addicted to drugs and suffering further from the side-affects of taking so many different combinations of drugs. In the US, over 100,000 Americans die annually from prescription drugs while a further 2million are injured by them.

The dominating companies in global pharmaceutical industry today are MERCK, Roche (fined in the US and Europe for participating in illegal price fixing cartel), Pfizer (ranked no.1, the makers of viagra the wonder drug of the 90s…. and probably soon to put out a drug that may do the opposite of viagra!), Bayer the inventor of Asprin….however hundreds and thousands of people die every year from prescription drugs? 27,000 people died of vioxx which is a nosteroidal anti-inflammatory drug which has been withdrawn over safety concerns associated with heart attacks, strokes. (though first approved in 1999 but withdrawn in 2004) It is believed that over 80m worldwide prescribed it in 2003 and its producer Merck and Co made sales revenues of US$2.5billion.

What is ironic is that there is not a single chronic disease which has been cured as a result of taking prescription drugs. What these drugs have done is to only treat the symptoms. Has chemotherapy proved scientifically accurate? It does shrink tumors but it adds nothing to a patient’s lifespan. The world is becoming sicker, fatter and more depressed than ever. The advice that people should listen to is not being given…eat healthy, avoid processed foods, avoid refined carbohydrates, avoid soft drinks etc…are rarely highlighted.

What’s more our doctors are duping us too…! In the US some mid-sized drug companies have close upon 1000 representatives lobby with companies spending over $5billion annually on sending these representatives to physician offices. The US spends $19billion annually on promotions, influencing doctors and other health professionals. As a result the physicians are lured into prescribing drugs associated with particular drug companies who ensure these physicians are well looked after and patients end up paying far more than they are required to as well as end up having to take another set of prescribed drugs to cut off the side-affects associated with the earlier drug!

Doctors are even paid to conduct fraudulent clinical trials on patients who are encouraged to take drugs for a 12month period to see its affects while the drug company profits through that particular year and the doctors enjoy the kickbacks as well. Some doctors who prescribe a particular drug company’s products and avoided competing drugs are even paid “consulting fees”. It is all a scam, and a vast majority of physicians become party to these unethical medical acts, pocketing the benefits & dosing up their patients with whatever drugs they’ve been told to prescribe. Doctors today are recipients of airfares & hotel expenses, luxury vehicles, even repairs and tyre replacements!

What is poignant and significant is that while physicians who may attend academic sessions with the thought of updating their know-how they are at the risk of being manipulated by pharmaceutical companies who pay high-profile scientists/physicians to speak on topics relevant to their products. Similarly, medical journals also help to promote specific products whose manuscripts are written by the pharmaceutical companies.

Essentially the public is at risk as a result of the direct and indirect relationships between pharmaceutical industry and the physicians. It certainly does breach professional ethics and may even bring dangers to patients.

Read the rest of this article here:  http://www.asiantribune.com/news/2010/08/21/doctors-drug-companies-politicians-corruptions

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People & Power—Drug Money

Tuesday, August 17th, 2010

A 23 minute TV expose on Big Pharma by ALJAZEERA (see video at bottom of this page)

This piece pulls no punches exposing the rampant fraud, fatal drug side effects, off label marketing, criminal practices  and “absolutely jaw dropping” payouts Pharma makes to psychiatrists/doctors.

  • “There is so much money to be made in stealing from the United States Healthcare system,” says Patrick Byrnes, Taxpayers Against Fraud.
  • Lewis Morris, US Department of Health states, “One of the things we are now looking at is going after the executives in these companies and holding them personally accountable.”
  • Sharon Ormsky, FBI Financial Crimes Unit states, “Pharmaceutical fraud is one of our top three threats — everybody is touched by these frauds in the extent that when you look at the billions of dollars that go into healthcare for the United States, a good percent,  3-10% of that is believed to be siphoned off into fraud—that’s  money that  could be going to very needy patients.”

Now the U.S. government is fighting back.  In the last two years alone, the  government has fined six of America’s  top ten pharmaceutical companies for fraud.  Investigations are ongoing against another three.  In this period the industry has had to pay out over 5 billion dollars in fines, and topping the list is drug giant Pfizer, having recently settled civil & criminal charges resulting in $2.3 billion dollars —the biggest fraud case, the biggest criminal case, the biggest false claims act in U.S. history.   ALJAZEERA also exposes Pfizer’s “interesting way of doing business.  Witnesses in the case revealed just how the company persuaded doctors to prescribe its drugs. It entertained them in strip clubs, it told them that the blues teenagers feel when they don’t make the football team was signs of treatable depression and it paid them to endorse Pfizer drugs. One doctor received $150,000 in a year.

Also highlighted is the current scandal regarding antipsychotic drugs, including state law suits, dangerous documented side effects and how federal investigators are now looking into claims drug company Johnson & Johnson illegally marketed their antipsychotic drug Risperdal to children, paying “some of the most influential doctors in the field” in order to accomplish this.  And leading that pack sits none other than the  [now] infamous psychiatrist Joseph Biederman, who has been “credited” with the huge increase of children prescribed psychiatry’s most powerful/dangerous drugs, antipsychotics, while receiving millions in Pharma kickbacks that he failed to disclose.   Biederman is shown on tape being questioned under oath, and when asked “What rank are you?” Biederman responds, “Full Professor.” When asked “What comes after that?” Biederman responds, “GOD.”

This is a 23 minute expose well worth watching.

This is one of the best exposé’s on Big Pharma we’ve seen:

People & Power —Drug Money, produced by ALJAZEERA.  This piece pulls no punches exposing the rampant fraud, fatal drug side effects, off label marketing, criminal practices  and “absolutely jaw dropping” payouts Pharma makes to psychiatrists/doctors.

* “There is so much money to be made in stealing from the United States Healthcare system,” says Patrick Byrnes, Taxpayers Against Fraud.

* Louis Morris, US Department of Health states, “One of the things we are now looking at is going after the executives in these companies and holding them personally accountable.”

*Sharon Ormsky, FBI Financial Crimes Unit states,  ”Pharmaceutical fraud is one of our top three threats — everybody is touched by these frauds in the extent that when you look at the billions of dollars that go into healthcare for the United States, a good percent,  3-10% is believed to be siphoned off into fraud that’s  money that  could be going to very needy patients.”

Now the U.S. government is fighting back.  In the last two years alone, the  government has fined six of America’s 10 pharmaceutical companies for fraud.  Investigations are ongoing into another three.  In this period the industry has had to pay out over 5 billion dollars in fines, and topping the list is drug giant Pfizer, having recently settled civil & criminal charges resulting in $2.3 billion dollars —the biggest fraud case, the biggest criminal case, the biggest false claims act in U.S. history.   ALJAZEERA also exposes Pfizer’s “interesting way of doing business.  Witnesses in the case revealed just how the company persuaded doctors to prescribe its drugs. It entertained them in strip clubs, it told them that the blues teenagers feel when they don’t make the football team was signs of treatable depression and it paid them to endorse Pfizer drugs. One doctor received $150,000 in a year.

Also highlighted is the current scandal regarding antipsychotic drugs, including state law suits, dangerous documented side effects and how federal investigators are now looking into claims drug company Johnson & Johnson illegally marketed their antipsychotic drug Risperdal to children, paying “some of the most influential doctors in the field” in order to accomplish this.  And leading that pack sits none other than the  [now] infamous psychiatrist Joseph Biederman, who has been “credited” with the huge increase of children prescribed psychiatry’s most powerful/dangerous drugs, antipsychotics, while receiving millions in Pharma kickbacks that he failed to disclose.   Biederman is shown on tape being questioned under oath, and when asked “What rank are you?” Biederman responds, “Full Professor.” When asked “What comes after that?” Biederman responds, “GOD.”

This is a 23 minute expose well worth watching.

http://www.youtube.com/watch?v=1TwdsYVHjGA&feature=player_embedded#!

This is one of the best exposé’s on Big Pharma we’ve seen:

People & Power —Drug Money, produced by ALJAZEERA.  This piece pulls no punches exposing the rampant fraud, fatal drug side effects, off label marketing, criminal practices  and “absolutely jaw dropping” payouts Pharma makes to psychiatrists/doctors.

* “There is so much money to be made in stealing from the United States Healthcare system,” says Patrick Byrnes, Taxpayers Against Fraud.

* Louis Morris, US Department of Health states, “One of the things we are now looking at is going after the executives in these companies and holding them personally accountable.”

*Sharon Ormsky, FBI Financial Crimes Unit states,  ”Pharmaceutical fraud is one of our top three threats — everybody is touched by these frauds in the extent that when you look at the billions of dollars that go into healthcare for the United States, a good percent,  3-10% is believed to be siphoned off into fraud that’s  money that  could be going to very needy patients.”

Now the U.S. government is fighting back.  In the last two years alone, the  government has fined six of America’s 10 pharmaceutical companies for fraud.  Investigations are ongoing into another three.  In this period the industry has had to pay out over 5 billion dollars in fines, and topping the list is drug giant Pfizer, having recently settled civil & criminal charges resulting in $2.3 billion dollars —the biggest fraud case, the biggest criminal case, the biggest false claims act in U.S. history.   ALJAZEERA also exposes Pfizer’s “interesting way of doing business.  Witnesses in the case revealed just how the company persuaded doctors to prescribe its drugs. It entertained them in strip clubs, it told them that the blues teenagers feel when they don’t make the football team was signs of treatable depression and it paid them to endorse Pfizer drugs. One doctor received $150,000 in a year.

Also highlighted is the current scandal regarding antipsychotic drugs, including state law suits, dangerous documented side effects and how federal investigators are now looking into claims drug company Johnson & Johnson illegally marketed their antipsychotic drug Risperdal to children, paying “some of the most influential doctors in the field” in order to accomplish this.  And leading that pack sits none other than the  [now] infamous psychiatrist Joseph Biederman, who has been “credited” with the huge increase of children prescribed psychiatry’s most powerful/dangerous drugs, antipsychotics, while receiving millions in Pharma kickbacks that he failed to disclose.   Biederman is shown on tape being questioned under oath, and when asked “What rank are you?” Biederman responds, “Full Professor.” When asked “What comes after that?” Biederman responds, “GOD.”

This is a 23 minute expose well worth watching.

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