Tuesday, April 27, 2010

Update: AstraZeneca Cuts Sweet Heart Deal with DOJ, more worthless CIA's and some Cash for poison rangling aka seedy backroom injustice

It appears our illustrious premiere is on his way to another important meeting with those good drug pimp people @ Pharma

AstraZeneca cuts sweet heart deal with DOJ, another worthless CIA (Corporate Integrity Agreement) and some cash for poisoning America - this is just another example of DOJ's special backroom deal making injustice Corporate Style.

Now get this, AZ pays 520 million, but the huge key in this deal is there is NO admission of any criminal wrong doing! I guess they just wanted to make a nice donation to the DOJ's rainy day fund.

What this shady deal does, is leave all those out there damaged or killed by this AZ drug to fend for themselves. By not having to admit to any criminal wrong doing, AZ has saved possibly billions upon billions of dollars in civil damages. Thank You Government and the DOJ for looking out for the people's interest yet again (NOT). It still amazes me that the main stream media has the ignorance to still ask why are the American people so angry at Government (specially when Main Stream Media are one of the biggest benefactors from Big Pharma's advertising money).

You'll have to ask Senator Grassley if ABC, NBC, CBS, CNN, FOX, and many others are going to be called to testify before the senate committee concerning pharmaceutical conflicts of interest related to our shrinking free and balanced press.

To measure how much this agreement will actually change AstraZeneca's behavior, will help those permanently damaged by this drug, or actually curtail future deeds of criminal evil practices of greed mongering over safety and ethics? (this is not their first CIA which AZ has made, last time it was being broken before the inked had time to dry)

Most of you out there would be hurt a heck of a lot more if you got slapped with a ticket for talking on your cell while driving, or a simple J-walking ticket. AZ rakes in more than 4 and 1/2 billion dollars a year pimping out Seroquel. It's one of the most marketed and profitable drugs in the world today.

You don't have to do much of a Google search to read about the termendous damage this drug has inflicted upon thousands up-to hundreds of thousands in America, and that count is just beginning to be truly accumulated as AZ has made a major effort in directly targeting children. That irreparable damage will be revealed and may appear steadily with increasing numbers for many decades to come.

I would have to ponder that even the notorious Doctor boy boobs J. Biederman of Harvard 2nd to God shame would call this DOJ action nothing more than a therapeutic "Tushy Massage", and a complete miscarriage of justice.

Of course would you expect anything more than a friendly tap on the posterior when a former head of AZ and now sleazy deal making spokesperson for Pharma has an open door right into the White House.

Please don't get to riled up swore loyal Democrats, those Republicans are just as guilty when it comes to having greedy hands out waiting to be greased with favors from these corporate drug and money pimps.

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Marketwatch reports - http://www.marketwatch.com/story/astrazeneca-to-settle-seroquel-probe-nyt-2010-04-26


By Wallace Witkowski


SAN FRANCISCO (MarketWatch) -- AstraZeneca PLC /quotes/comstock/13*!azn/quotes/nls/azn (AZN 45.04, +0.12, +0.27%) will pay $520 million to settle charges it marketed its antipsychotic drug Seroquel for unapproved uses, the New York Times reported late Monday on its Web site, citing two unidentified sources. The drugmaker allegedly marketed the drug for use by children and elderly people, populations not approved for the drug. The U.S. Justice Department plans to make an announcement on Wednesday, according to the Times.

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Update from the NewYorkTimes - http://www.nytimes.com/2010/04/27/business/27drug.html?src=twt&twt=nytimesbusiness

For $520 Million, AstraZeneca Will Settle Case Over Marketing of a Drug

By Duff Wilson

AstraZeneca has completed a deal to pay $520 million to settle federal investigations into marketing practices for its blockbuster schizophrenia drug, Seroquel. The Justice Department plans a news conference on Wednesday to disclose details of the case, according to two people close to the negotiations who were not authorized to discuss it publicly.

AstraZeneca becomes the fourth pharmaceutical giant in the last three years to admit to federal charges of illegal marketing of antipsychotic drugs, a lucrative category of medications that have quickly risen to the top of United States sales charts. Aggressive sales and promotional practices have helped expand the use of powerful new antipsychotic drugs for children and the elderly.

AstraZeneca will sign a corporate integrity agreement with the federal government over its marketing of Seroquel for unapproved uses, but will not face criminal charges, the people close to the negotiations said.

The company, based in London, has been accused of misleading doctors and patients by playing up favorable research and not adequately disclosing studies that show Seroquel increases the risk of diabetes.

AstraZeneca still faces more than 25,000 civil lawsuits filed on behalf of patients contending that the company did not disclose the drug’s risks.

The deal would make formal an agreement in principle the company reached last October with the United States attorney in Philadelphia. At that time, AstraZeneca said in a filing with the Securities and Exchange Commission that it had set aside $520 million in respect to the investigation.

The company was facing two federal investigations and two whistle-blower lawsuits involving Seroquel sales and marketing practices. One of the investigations related to physicians who had participated in clinical trials. The other inquiry involved sales staff. Details are expected to be announced Wednesday.

As a result of aggressive marketing, Seroquel has been increasingly used for children and elderly people for indications not approved by the Food and Drug Administration. The drugs have caused rapid weight gain in children, and side effects including deaths have prompted warnings against giving the drugs to elderly patients for dementia.

Although doctors are permitted to prescribe any approved drug for off-label uses, it is illegal for drug makers to promote medications for any purpose not specifically approved by the F.D.A.

Tony Jewell, a company spokesman, declined to comment on Monday. Patricia Hartman, a spokeswoman for Michael L. Levy, the United States attorney in Philadelphia, said she would neither confirm nor deny the report. “We don’t have anything public on AstraZeneca,” Ms. Hartman said.

AstraZeneca, which reported $4.9 billion in Seroquel sales in 2009, plans to report its first-quarter financial results on Thursday.

The company will join a series of American pharmaceutical companies that have admitted to illegal marketing after federal investigations and whistle-blower filings and have signed agreements with the government to monitor and avoid such activity in the future.

In the largest such case, Pfizer paid $2.3 billion last September, including $1.3 billion in the biggest criminal fine of any type in United States history, for off-label marketing of the painkiller Bextra and other drugs. Bextra was withdrawn from the market in 2005. The Pfizer fine included $301 million for off-label marketing of its antipsychotic drug Geodon.

Eli Lilly paid $1.4 billion in January 2009 to settle investigations into illegal marketing of its antipsychotic drug Zyprexa. Lilly’s settlement included a $515 million criminal fine, which until the Pfizer case was the largest such fine ever imposed on a corporation.

In 2007, Bristol-Myers Squibb and a subsidiary paid $515 million to settle federal and state investigations into marketing of its antipsychotic drug Abilify.

The newer generation of antipsychotics has surpassed cholesterol-lowering drugs to become the nation’s top-selling category of medications, accounting for $14.6 billion of the nation’s $300 billion in drug spending last year, according to the research firm IMS Health.

Seroquel, a pill usually taken once or twice a day that sells for more than $4 each, was the fifth-best-selling drug in the United States last year, IMS said. As with other antipsychotics, much of that spending is by the federal government, through the Medicaid and Medicare programs.

AstraZeneca, with American headquarters in Wilmington, Del., has previously denied wrongdoing in the Seroquel investigations. It has paid $656 million to defend itself in court against more than 25,000 civil lawsuits, the company said in an S.E.C. filing in January. Those cases are only recently beginning to reach trial.

The company has argued that people who were found to have diabetes after taking Seroquel already had diabetes or had existing conditions that made them at high risk of the disease.

According to company e-mail unsealed in civil lawsuits, AstraZeneca “buried” — a manager’s term — a 1997 study that showed Seroquel users gained 11 pounds a year, while publicizing a study that claimed users lost weight. Company e-mail messages also refer to doing a “great smoke-and-mirrors job” on unfavorable studies.

Gardiner Harris contributed reporting.

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Some interesting and thought provoking comments on this topic and news I happened to stumble upon around the blogging world - Pharmalot .

MD comment:

Off-label promotion continues to prove highly proifitable for manufacturers. Do the deed, establish new practice paradigms without bothering with establishing safety and effectiveness, reap the revenue, and a few years later, pay a small portion of the profits back to the feds. The cost of the fine is probably more than an investment in clinical trials would have been, but then again the trials might prove something you didn’t want to know. Clinical trials also slow down the process (and the increased revenue) by several years while the patent clock keeps ticking. Not to mention the greater certainty that some clinicians will prescribe off-label if they are given even the slightest “expert opinion” encouragement, whereas the results of clinical trials are 1) risky, and 2) not especially influential in changing presciber behavior. As long as there are Biederman types in the world, a manufacturer can come up with someone to shill for the unapproved use.

There is really no incentive for doing the right thing (nor effective disincentive to discourage bad corporate behavior) for the benefit of providers and patients.

MsPiggy comment:

This is paramount to someone committing a violent felony with malice, intent, and forethought; then getting off with a small fine, probation, and then having their record wiped clean while admitting no culpability for their crime. I believe most would find that completely unacceptable on the part of our judicial system and government.

Then when we have a huge corporation repeatedly and brazenly breaks the law, while injuring or even killing thousands. They get off with another CIA (that they ignored last time they signed one) pay a fine that has already been adsorbed into the price structure of their drug.

Yet some how the people are not completely outraged and protesting in the streets?

welcome to the beginning of the end.

Justice comment:

MsP you’re spot on!

Without sounding too patronising to the general public, people have been administered the opium of the masses (cheap junk TV, cheap junk food, poor education, low expectations) and their senses are dull to what really matters.

The cynical economics of the drug industry is pervasive.

Indeed, welcome to the beginning of the end.

Matthew comment:

Interesting… The thing is, without a criminal conviction, one may not state as a matter of fact that AZ is a bunch of scheming fraudsters, because one would lay oneself open to an actino in libel. So I won’t say that.

Only the Law may say what is fact - we do not have that right. I wonder if that’s why the people who run the legal systems of the world are declining to take these organizations to court, or whether it’s because they’re just following the path of least resistance. That is, provided one can announce a settlement, involving a relatively large sum of money, one may make it look as though one is doing one’s job, even though one has made no effort whatsoever to change the system, and thus the thing that one perceived to be wrong is allowed to proceed, unchecked.

Patron comment:

Agreed! MsP has nailed it.

“Welcome to the beginning of the end.”

In another recent pharmalot post, harpy made an interesting comment, or prophecy if you will:

“I think the end will actually be brought about by Monsanto. look what a great start they’ve made by almost taking out the honeybees!

or some unnatural collusion between the defense contractors, big pharma, and Monsanto will bring about the Zombie Apocalypse. mark my words…”

http://www.pharmalot.com/2010/04/fly-away-depressed-pilots-can-now-take-prozac/#comment-486985

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Here is a link to just a small faction of what the AZ 500 million dollar legal team ( that 500 million figure is just a ballpark guess at this point, and is sure to grow substantially over the next year or two) wanted to conceal from juries in their Seroquel civil litigation. This includes other CIA agreements they have made, and not followed in prior incidences related to drugs/products they market to the public.

http://druganddevicelaw.net/Seroquel%20Order%20re%20motions%20in%20limine.PDF

Now speculating from their past heavy hitter legal maneuvering and behavior, you have to question what is in this sweet heart DOJ deal that will keep much of the most damning evidence concealed from the American public and future juries?

Or course this following link is sure to bring a host of chuckles as AZ outlines what a careful and upstanding corporation they are April 13, 2007.

ASTRAZENECA AND ITS EMPLOYEES COMMITTED TO HIGHEST STANDARDS OF ETHICS AND INTEGRITY

http://docs.google.com/Doc?docid=0AUdYBV0CU-vEZGN0enRta2NfMTFnc3Z4cGNkOA&hl=en

Would you trust this admitted criminal corporation with your health needs?

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UPDATE April 27, 2010

From
soulful sepulcher VIA ABC/NEWS POLITICS

http://bipolarsoupkitchen-stephany.blogspot.com/2010/04/astrazeneca-seroquel-520-million.html

The whistleblower who reported the alleged fraud will get $45 million as a reward

AstraZeneca, one of the country's biggest drug firms, allegedly pulled in hundreds of millions of taxpayer dollars through Medicare and Medicaid kickbacks and scams. Seroquel is used to treat schizophrenia in patients older than 13, and bipolar disorder in patients older than 10.

The FDA approved Seroquel to treat only psychotic disorders, specifically short-term treatments of schizophrenia, bipolar mania and bipolar depression. The government claims that AstraZeneca intentionally marketed the drugs -- by paying kickbacks to doctors -- for a variety of illnesses for which it had never been tested, including aggression, Alzheimer's, anger management, anxiety, attention-deficit hyperactivity disorder, dementia, depression, mood disorder, post-traumatic stress disorder and sleeplessness. It was given to the elderly, children, veterans and inmates, who were treated as "guinea pigs," according to the acting U.S. attorney for the Eastern District of Pennsylvania.


These were not victimless crimes -- illegal acts by pharmaceutical companies and false claims against Medicare and Medicaid can put the public health at risk, corrupt medical decisions by health care providers, and take billions of dollars directly out of taxpayers' pockets," Attorney General Eric Holder said today at a news conference announcing the settlement."

Well, that's sound all fine and dandy Attorney General Eric Holder, but if you really expect the American public to buy your line of -----. then why not a single criminal indictment? why is AZ getting off profiting handsomely for criminal activities ? Do you as Attorney General believe Corporate criminals are less culpable for their crimes than say other criminals with lesser means?

6 comments:

Stephany said...

Once again, Ms.Piggy nails the topic, hands down.

The corruption goes straight to the top, and if there is not anger, outrage and protests to this, then it is proof American society has lost a moral compass, no base for integrity is left.

I am not so sure people actually understand the ramifications of this 520million dollar smack in the face of Joe Citizen.

The next demand for transparency should come in the form of the DOJ and a printed, detailed list of each dollar of the 520$million and specifically who receives what part of it.

There will be no justice in this until citizens revolt, and that is when the corporate criminals need to watch their backs.

Enough is enough!!

Stephany said...

http://bipolarsoupkitchen-stephany.blogspot.com/2010/04/astrazeneca-seroquel-520-million.html

WHISTLEBLOWER GETS $45 MILLION DOLLAR REWARD FROM THE $520 MILLION, BREAKING NEWS

Anonymous said...

Be comforted(or scared poopless) that all of these medicated kids will one day be running this world.

I hope every politician in the world needs a non-family caregiver or (Oh how I wish) ends up in a rest home with the very same kids they medicated. Except now the kids will be the administrators and nurses.

Angels of death are going to really be all the rage.

In Calabasas,CA they just arrested a guy for torturing elders in an elite rest home.

People ultimately get what they dish out.

Anonymous said...

This is strikingly the "Key" element in this sweet heart deal that has everyone shaking their heads. The Department of Justice has completely ignored criminal wrong doing, and used their disgraceful legalism blind fold in a refusal to charge AZ of crimes.

Some may ask the question; what's the big deal about the DOJ not pressing criminal charges when they got so much money? That is exactly the reaction AZ and the DOJ are hoping to get from a general consensus of uniformed public sentiment.

This blatant deception and corruption works on a so many levels, but here are just a few focus points I will bring to the discussion.

1. This plea bargain sends a direct approval and encouraging message to continue doing criminal business as usual. A 540 million dollar fine on a block buster 5 billion dollar a year drug is less than a hand slap. It's a government warm hug and free pass.

The clear and unmistakable message being sent to all of us is that huge Corporations do not have live by the same rules or laws as everyone else. You as a corporate entity can actually injury and kill by the thousands/millions with complete impunity and without any real adverse consequences.

2. By not bringing criminal charges and making this deal to have no admission of wrong doing puts every civil litigation case against AZ in serious jeopardy. This means literally untold billions in direct gain and savings for AZ. Oh yes, and for those killed and suffering permanent disability, the government has just told you and your loved ones by their direct actions that they DON’T CARE ABOUT YOU THE CITIZEN.

3. Though we don't know the complete details today. I suspect the DOJ is going to seal much of the damning evidence in this case as part of this hand holding injustice.

This means the whistle blower and all those investigated details very well may never be known to the public or current litigants.

This is the government publicly grand standing as you have seen today with its most contemptible and corrupt display of malfeasance directed toward the American people in a very long time.

As many have suspected all the long, even the government and our judicial system are in bed cozy and tight with these "TO BIG TO FAIL" or be "HELD ACCOUNTABLE" modern day pharmaceutical juggernauts.

I said months ago that the DOJ was holding back on a deal/prosecution to protect AZ in the first civil litigation cases. Today my worst fears have been realized and come to pass. I see today as a watershed moment marking a significant failure and terrible loss/defeat for all civilized society, a huge blow to the concept of justice, a bellwether moment in finally putting to rest fleeting future hopes of improving our corporate professional and ethical conduct, and most of all as an egregious assault on each of our lives, health, freedoms, and liberties.

Anonymous said...

"AstraZeneca denied the allegations leveled by the government in the civil case settled Tuesday, saying it wanted to avoid the delay, uncertainty and expense of a protracted legal battle."

Stephany said...

PharmaGossip has this video today of an interview with

http://pharmagossip.blogspot.com/2010/06/stings-in-tail.html

one of the 520million$ whistleblowers....the psychiatrist who used the "False Claims" act to file lawsuit against AstraZeneca for Seroquel promotions, etc.

Bloomberg
http://www.bloomberg.com/apps/news?pid=20601109&sid=aa.7mcQL0yNk

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