Sunday, October 3, 2010

Novartis pulls the Latest AstraZeneca as the profitable pharmaceutical corporate crime wave continues unchecked by DOJ and Our Government


Novartis pulls the latest AstraZeneca as the profitable pharmaceutical corporate crime wave continues unchecked by the DOJ and Our Government

In the ominous spirit of our Government rewarding and actually financing corporate crime with your tax dollars as with the never ending secession of corporate bail outs we have seen over the past few decades. There is little doubt now that the next huge criminal scandal coming down the Washington DC belt way has made it's way directly into your medicine cabinet, doctors office, and even your child's mind and body.

This time around it's Swiss drug giant Novartis Pharmaceuticals that pulls an AstraZeneca - and once again the DOJ and our Government gives a patented "get out of jail free card" for the ongoing egregious corporate crimes that pay, and they pay so very well that there is no reason to stop running the drug cartel business as usual.

It's just another sunny day in pharmaceutical corporate America as another drugmaker agrees to settle their well planned & calculated crimes with the federal government using the profitable business as usual model. This time, Novartis will pay $422.5 million for illegally promoting its Trileptal epilepsy med for unapproved uses, such as bipolar disorder and neuropathic pain, along with five other drugs - Diovan, Zelnorm, Sandostatin, Exforge and Tekturna.

The fine includes roughly $237 million to settle four lawsuits brought by whistleblowers (Which gets divided up between the lawyers and former drug cartel employees) , while $185 million goes toward criminal penalties ( which may get funneled back to different states in smaller sums, that then will go right back into the pool that buys thier drugs from the very same corporations that committed the crimes in the first place. It's more like a sophisticated carnival shell game than it is a deterrent for corporate crime. Just for some laughs, this is the guilty plea).

This is the latest in a river of settlements involving the big pharmaceutical drug cartel.

Allergan paid $600 million for illegally marketing Botox

Forest Laboratories paid $313 million for improperly promoting drugs.

Pfizer, which paid a $2.3 billion fine for similar crimes

Eli Lilly paid $1.4 billion for ditto crimes

AstraZeneca paid $520 million more huge crimes

Bristol-Myers Squibb paid $515 million. as just more criminals

Johnson & Johnson - How much for tainted children medicines & pain relievers while lying to the FDA & Congress????

All of these fines came with new CIA (Corporate Integrity Agreement), while most offending Corporation are repeat criminal offenders. These fines are actually so low in comparison to the profits made by these illegal practices and drugs falsely marketed, that it would be very much like someone receiving a mere parking ticket for committing first degree mass murder.

Consequently, these recent deals are fueling cries to have individual executives held accountable for marketing fraud. But don't hold your breath about any meaningful legislation passing anytime soon, since these very corporations committing these hideous crimes also happen to have the largest lobby in Washington DC & are some of the biggest $ givers/influence peddlers of campaign contributions/slush funds to individual Representatives and to each of the main political parties.

The House passed a bill that would ban corporate execs from doing business with Medicare and Medicaid if their companies were convicted of fraud (yet we already have the laws that would ban corporations from medicare and Medicaid that have never been enforced).

  • If we actually wanted to change this criminal culture, we would charge the CEO's with criminal penalties & send them to prison.
  • Expire corporate patents & allow those cheaper generics to come to market in their place.
  • Put these criminal corporations out of business & sell them off in bits/pieces.
  • Ban Corporations under CIA's or repeated/multiple offenses from both DTC (direct to consumer) Advertising & all promotions to doctors
  • Make fines match or go beyond profits earned by the criminals activities.
  • Our Government and the DOJ should also being going after these corporations and thier upper management with criminal charges for the damage and deaths caused by their illegal criminal acts.
Our Government and the DOJ could end this ongoing criminal culture tomorrow if they had the will to do so. But those sitting at the top snubbing their noses down upon us commoners don't hold their like kind special friends by the same standards of law and accountability.

You would Just have glance at Wall Street, Our Banking, Mortgage, Insurance system, or all those other corporate elites that were able to walk away from their huge monumental crimes while being rewarded with literally billions upon billions of your tax dollars for their blatant criminal acts.

In this case, Novartis signed a five-year meaningless Corporate Integrity Agreement that stipulates the drug maker can be excluded from federal health care programs, including Medicare and Medicaid; which will never happen no matter how horrible their violations might be. CIA's make great press releases and are the bread & butter of PR propaganda campaigns ran by these corporations in renewing their tainted public image. But the cold reality is that they are not enforced or is there any future intentions by these corporations to follow the commitments they make on paper, when breaking the law and subverting justice are so much more profitable.

The CIA also requires the Novartis board to annually review compliance with the help of an outside expert and certify its effectiveness and certain senior execs annually certify their departments are compliant. Novartis must also post on its website info about payments to doctors, such as honoraria, travel or lodging.

“These are not always a victimless crime that’s just about money. These companies are engaged in actions in which there are times that result in people killing themselves or hurting others,” says Patrick Burns of Taxpayers Against Fraud, a non-profit that supports whistleblower lawsuits. “We need to start excluding executives from the programs. what you need to do is make it personal for the people who planned, ignored or green lit fraud. we’ve got to change the way people do business. health care is not a game. its not just about marketing.”

REPEAT OFFENDER: The Novartis settlement is not surprising in the least. Last January, the drug maker pleaded guilty to a misdemeanor to resolve criminal allegations for improperly promoting Trileptal.

Since 2005, the US Attorney in Phildelphia wa pursuing civil and criminal investigations into off-label marketing and increased its reserves to cover civil claims relating to the Trileptal investigations to $397 million (see this).

So you might be asking yourself, when do we finally lower the hammer on these corporate criminals and stop this insanity in it's tracks. You might look no further than those corrupted clowns of both parties you elected to represent you? Do you really have to ask who they really work for anymore?

Novartis is a repeat offender. A year ago, the drugmaker paid a $72.5 million fine to resolve federal civil claims and state Medicaid claims after a probe by the US Attorney in San Francisco into off-label marketing of TOBI, a cystic fibrosis treatment. And in 2005, a Novartis unit called OPI Properties paid $45 million for fraudulently marketing nutritional products.

So what value does your Government place on the health and well being of their citizens? It appears not nearly the value they place on from huge contributors and pals in world wide corporate cartel network.

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Came across this interesting article in NYTimes Business Section which is an interesting read. I'll just cherry pick a few of the highlights and you can go read this long article for yourself.

http://www.nytimes.com/2010/10/03/business/03psych.html?_r=1&src=twt&twt=nytimeshealth

Side Effects May Include Lawsuits

By DUFF WILSON
Published: October 2, 2010

FOR decades, antipsychotic drugs were a niche product. Today, they’re the top-selling class of pharmaceuticals in America, generating annual revenue of about $14.6 billion and surpassing sales of even blockbusters like heart-protective statins.

While the effectiveness of antipsychotic drugs in some patients remains a matter of great debate, how these drugs became so ubiquitous and profitable is not. Big Pharma got behind them in the 1990s, when they were still seen as treatments for the most serious mental illnesses, like hallucinatory schizophrenia, and recast them for much broader uses, according to previously confidential industry documents that have been produced in a variety of court cases.

more than a half-million youths take antipsychotic drugs, and fully one-quarter of nursing-home residents have used them. Yet recent government warnings say the drugs may be fatal to some older patients and have unknown effects on children.

Every major company selling the drugs — Bristol-Myers Squibb, Eli Lilly, Pfizer, AstraZeneca and Johnson & Johnson — has either settled recent government cases for hundreds of millions of dollars or is currently under investigation for possible health care fraud.

“It’s the money,” says Dr. Jerome L. Avorn, a Harvard medical professor and researcher. “When you’re selling $1 billion a year or more of a drug, it’s very tempting for a company to just ignore the traffic ticket and keep speeding.”

Contentions that the new drugs are superior have been “greatly exaggerated,” says Dr. Jeffrey A. Lieberman, chairman of the psychiatry department at Columbia University. Such assertions, he says, “may have been encouraged by an overly expectant community of clinicians and patients eager to believe in the power of new medications.”

“At the same time,” he adds, “the aggressive marketing of these drugs may have contributed to this enhanced perception of their effectiveness in the absence of empirical evidence.”

Others agree. “They sold the story they’re more safe, when they aren’t,” says Robert Whitaker, a journalist who has written two books about psychiatric medicines. “They had to cover up the problems. Right from the start, we got this false story.”

Such marketing, according to analysts and court documents, included payments, gifts, meals and trips for doctors, biased studies, ghostwritten medical journal articles, promotional conference appearances, and payments for postgraduate medical education that encourages a pro-drug outlook among doctors. All of these are tools that federal investigators say companies have used to exaggerate benefits, play down risks and promote off-label uses, meaning those the F.D.A. hasn’t approved.

Lawyers suing AstraZeneca say documents they have unearthed show that the company tried to hide the risks of diabetes and weight gain associated with the new drugs. Positive studies were hyped, the documents show; negative ones were filed away.

According to company e-mails unsealed in civil lawsuits, AstraZeneca “buried” — a manager’s term — a 1997 study showing that users of Seroquel, then a new antipsychotic, gained 11 pounds a year, while the company publicized a study that asserted they lost weight. Company e-mail messages also refer to doing a “great smoke-and-mirrors job” on an unfavorable study.

“The larger issue is how do we face the outside world when they begin to criticize us for suppressing data,” John Tumas, then AstraZeneca’s publications manager, wrote in a 1999 e-mail. “We must find a way to diminish the negative findings,” he added. “But, in my opinion, we cannot hide them.”

Slides for one new antipsychotic drug contended that it had no neurological side effects. “They made it all up,” Dr. Kruszewski said. “It was never true.”

While drug companies are prohibited from promoting drugs for conditions for which they have not been proved safe and effective, their paid consultants, researchers and educators may do that for them verbally and in company-sponsored studies.

“They can give a small hint, and people will take the bait,” says Dr. Robert Rosenheck, a professor of psychiatry and public health at the Yale School of Medicine, who has received research support from drug makers and federal agencies. “Psychiatric disorders are vaguely defined enough that you can stretch definitions,” he says. “So many treatments are completely ineffective, people are willing to try anything.”

Analysts said that given the profits that were to be made, the murkiness of mental disorders, and holes in the regulatory regime, marketing excesses were bound to occur.

“If you have a lot of money on the table and you have clinical uncertainty over mental health conditions, where you don’t have a blood test or objective test for it, you see it’s kind of a combustible mixture,” says Dr. Mark Olfson, a Columbia University psychiatry professor and researcher.

DOCUMENTS produced in recent litigation and in Congressional investigations show that some leading academic doctors have worked closely with corporate benefactors to expand the use of antipsychotics.

The most well-known is Joseph Biederman, a Harvard medical professor and Massachusetts General Hospital researcher. His studies, examining prevalence of bipolar psychological disorders in children, helped expand practice standards, leading to a fortyfold increase in such diagnoses from 1994 to 2003. The increase was reported in a 2007 study by the Archives of General Psychiatry.

Between 2000 and 2007, he also got $1.6 million in speaking and consulting fees — some of them undisclosed to Harvard — from companies including makers of antipsychotic drugs prescribed for some children who might have bipolar disorder, a Senate investigation found in 2008.

ACCORDING to the Justice Department, drug companies trained sales reps to rebut valid medical concerns about unproved uses of antipsychotics. For example, the department says, Lilly produced a video called “The Myth of Diabetes” to sell Zyprexa, which became its all-time best-selling drug, even though evidence showed that Zyprexa could cause diabetes, as well as other metabolic problems.

Lilly salespeople also promoted a “5 at 5” drug regimen in nursing homes — 5 milligrams of Zyprexa at 5 p.m. to settle down agitated older patients for the night. A Lilly spokesman declined to say when those sales campaigns occurred. But in 2005, after a new analysis of 15 previous studies, the F.D.A. issued a public health advisory saying the use of antipsychotics to calm older dementia patients would increase risk of death from heart failure or pneumonia. The F.D.A. asked drug makers to add a special warning about that on packaging.

In its suit against AstraZeneca, the government produced documents showing that the company paid a Chicago psychiatrist, Dr. Michael Reinstein, nearly $500,000 over a decade to do research, travel and speak for it — even as he led a Medicaid practice he had described to the company as one of “the largest prescribers of Seroquel in the world.”

Lew Morris, chief counsel for the inspector general of the Department of Health and Human Services, says he is serious about bolstering government efforts to reform or punish drug makers for illegal sales of antipsychotics.

Mr. Morris says some companies are “too big to debar” from government contracts, since doing so would just hurt patients needing medicine. But he says discussions are under way about forcing one health care company to sell off a subsidiary accused of fraud. And directors who ignore information may face more risk of shareholder suits, he says.

But more than 1,000 False Claims Act lawsuits are still under way, most of them focused on health care and many on lucrative antipsychotic drugs. For that reason alone, critics say they think the industry still hasn’t gone far enough to change questionable practices.

“The drug industry still rewards sales,” says Stephen A. Sheller, a lawyer who has represented whistle-blowers in the Lilly and AstraZeneca cases. “And it’s still easy to market these drugs to doctors who are rushed.”

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I encourage you to read the entire article, but I also ask you become involved and make your voice heard. To this point the only voice really being heard is the one of MONEY talking. That's needs to change, before it's to late to change course from the serious damage and unimaginable number of deaths lurking so ever close upon our civilization's horizon.


2 comments:

betasheep said...

These are the two most astounding quotes from the article and they have little to do with the litigation:

“If you have a lot of money on the table and you have clinical uncertainty over mental health conditions, where you don’t have a blood test or objective test for it, you see it’s kind of a combustible mixture,” says Dr. Mark Olfson, a Columbia University psychiatry professor and researcher.

and

...Dr. Robert Rosenheck, a professor of psychiatry and public health at the Yale School of Medicine, who has received research support from drug makers and federal agencies. “Psychiatric disorders are vaguely defined enough that you can stretch definitions,” he says. “So many treatments are completely ineffective, people are willing to try anything.”

I can't believe I heard two run-of-the-mill, mainstream psychiatry professors say there was very little "clinical certainty" over psych diagnoses, which were "vaguely defined." This doesn't sound like "science" to me.

Stan said...

The only real science in the mental health arena , is the business science of money and power. The rest is mainly hype, marketing, and speculation.

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