Monday, August 30, 2010

Pharmaceutical Corporate Criminals - The Deemed Untouchables?

I thought I would bring this post back to the top today since nothing has really changed in the pharmaceutical world since it's original posting except that just possibly things have continued to get worse and more corrupt beyond all fathoming and imagination. Shall I mention recent events involving AstraZeneca and Seroquel as an example, or GSK's Avandia with that whole diabolical scenario, or a whole host of others in the criminal line of examples that could fill the pages here for many weeks and mouths to come. So let me share once more a post I wrote in Dec. 2009 shining a light on these notorious corporate practices.

Pharmaceutical Corporate Criminals - are rewarded with hundreds of billions in profits while our Justice System and Government enables them to continue their reign of terror like "criminal business as usual"

We have an criminal corporate industry with no conscience raking in hundreds of billions of dollars while destroying the health of countless millions; and not only do we have a government that is sitting on their hands doing nothing the stop this catastrophe; they are actually encouraging this criminal activity in the ruse of this being good economics, politics, and medicine.

We have seen this encouraged criminal activity all before in our banking, savings and loan, mortgage, insurance, energy, automotive, and many other areas of global business with horrendous results.

Now we see it clearly once more on a much grander scale in a completely out of control criminal Pharmaceutical Industry. Those with the power to stop it (Our Government and Justice Departments, medicine, education, and the media), are just a heaping addition to this monumental criminal problem.

This should make every corporate conspiracy theorist salivate with the body of evidence now available.

How do these multinational criminal corporations snub their nose at the law, basic ethical and moral behavior, and negatively effect the health & safety of the American people?

They either control or influence the law, the medical modality, and regulatory bodies at just about every level of our society.
The problem cuts dangerously deep into every time honored institution in America. I have listed examples of the over influence and disturbing conflicts of interest we face as a free people; which is demonstrated by how broad the reach of these Corporate entities really are.

Education - Pharmaceutical Corporations are the leaders in funding research and the supporting a medical modality - which is a huge cash cow that just about every medical university has embraced with open arms and outstretched palms. Our educational and research educational systems have become addicted to the money and prestige' Pharmaceutical Corporations can throw at them.

In return Pharma receives favorable questionable leaning research that has been skewed and tainted by egotistical greed mongers that falsely validate their products to the medical establishment and general public. Moral and ethical responsibility for their behaviors are totally lost in this process unfortunately. Pharma has basically hijacked the research and educational system to do their bidding without taking any responsibility for the dire cost this will continue to cause in real human suffering and death toll.

- Pharmaceutical Corporations have created a money addiction among doctors and influential key opinions leaders that actually create illness and keep people sick ( let us all be reminded that there is no MONEY in healthy people). They have taken a false and questionable scientific/medical modalities which were once considered rare, and effecting very small segments of the population; and have now main streamed them into validated pandemics among the general population of astronomical and historical proportions.

Let us use "Mental Health Sector" as a stellar example:

Conservative estimates are now saying at least a 1/4 of the population is suffering from a life long psychiatric condition that must be medicated long term.

Yet, we can see that this is a manipulated falsehood by using some fairly common sense logical analysis; If these hundreds of new and dangerous medicines actually worked and mental health related supposed disease's were actually being treated; we would logically be seeing a decrease in the numbers of those disabled and afflicted by these aliments.

But this is not the case in all reality; People are not finding relief from these conditions because the treatments and the diagnosis are ineffective/suspect, and not based in traditional unbiased evidenced based hard science.

People are not getting better in fact; and the created pandemic appears to be increasing exponentially to the point now where a targeted market of "normal children" are being recruited as the next great population of life long customers.

Due to the nature of this radicalization and medicalization of human emotions/behaviors modality; medicine has accepted that harmful side effects and damage will occur from the treatments being used. This is an accepted and anticipated reality with Pharmaceutical Corporations waiting in the wings with new and block-busters treatments for those created ailments also.

Pharma is also famous for using lucrative incentives packages including the control and use the "CME" (continuing medical education) which is the educational segment of medicine used for virtually exclusive advertising and marketing platforms made directly to their best sales people "Doctors".

Pharma has created an endless trail of lucrative financial incentives directly to doctors to advertise, promote, and prescribe drugs that may in fact have little or no therapeutic value at all. The other side of this dark coin is that many of these drugs also come with inherent health risk and side effects which are being hidden from consumers and patients.

What is the authoritative establishment in medicine doing about this imposing threat and danger to your health; basically they are burying their heads in the sand and taking the money.

Government has a huge stake in this lucrative pharmaceutical corporate pie. The Pharmaceutical Industry is one of the most powerful and influential lobbyist groups in Washington DC and in every state capital across this nation. Not only do they spend tens of millions influencing your elected representatives, they also are huge contributors into both major party's election coffers.

They have also reached unabated into regulatory bodies at the FDA (Food and Drug Administration) and DOJ (Department of Justice), wielding unbridled control and influence over every medicine approved directly to you the consumer.

They "Pharma" say quite brashly that "WE ARE JUST TOO BIG AND POWERFUL" for any legislative, judicial, or regulatory body to influence or hold accountable.

branches including our courts are not excluded from Pharma's long reaching influence either; The Medical Modality of medicating your emotions and behaviors is now confirmed case law within the justice system.

In fact we now have Mental Health Courts that are based on this very modality that are being used to imprison those deemed mentally diseased (though it's called forced institutionalization and drugging as treatment, they are in fact nothing more than prisons without basic constitutional rights afforded the innocent inmates). In fact that's all the courts are really issuing to those with mental health emotional and behavioral issues.

They have totally bought into Pharma's myth that medication is the only rational treatment for these created pandemic diseases. So now we have courts deciding what your treatment options are, and what basic human rights you may qualify for.

This is paramount to guaranteeing pharmaceutical corporations influential criminal entrenchment in our society for untold decades to come.

I should also mention here how Pharmaceutical Corporations are trying to limit your rights to compensation for the crimes they commit that damage you or your loved ones life. Pharma is hard at work influencing your elected representatives through tort reform and preemption legislation that will make it virtually impossible to hold these criminals accountable for their crimes in civil courts.

We know already that the putrid smallish criminal fines and CIA's (Corporate Integrity Agreements) do nothing what so ever to deter Pharmaceutical Corporations from profiteering further off their continued criminal endeavors. Our Justice Department has shown no willingness or desire to hold these Corporations truly accountable for their blatant transgressions.

All this prior information stated above should add some credence to embolden even the most skeptical citizens to become critical thinkers and demand that immediate action be taken. But there is one key element that really is needed to truly cement these institutionalized crimes into the beyond reproach realm. That is getting the everyday populous to buy into the false message and propaganda.

Mass Media
is that last remaining pad lock validation that is used to bring this perfect storm to a dramatic climax. The Pharmaceutical Corporate Industry has become the largest marketer/advertiser in the world. They spend billions to get their message across through a bombardment of misinformation through direct to consumer advertising on Television, Internet, and in print.

They also rein supreme in Professional Medical Journals using skewed and pseudo science/data/research/clinical studies to ingrain a distorted and false modality right into your local family doctors office.

Then they use a diabolical ruse by funding supposed patient and family advocate organizations that are willing to spread their propaganda directly to patients under the despicable vale of supposed advocacy.

Groups likes NAMI, DBSA, CABF to mention only a few in a much broader scope across all medical supposed advocacy groups/organizations encompassing just about every medical ailment upon the planet at present time. These Pharma funded organizations all walk in lock step with the medication modality because they are paid and funded to do so.

They are beholding to their masters, and their masters are anything but the patients or families; they are in fact the Pharmaceutical Corporations that fund their propaganda campaigns.

Let me personally call out all the major news networks and giant media corporations for not reporting the truth or investigating these crimes being committed upon all of society. CNN, FOX, NBC, CBS, ABC as well as numerous other newspapers, publications, and media giants.

We know these Pharmaceutical Corporations are your new "Cash Cow". We see in every magazine, broadcast, and web-sight the direct influence Pharmaceutical advertisements have on your profitability.

Yet, to not report and ignore the facts/news regarding out of control pharmaceutical corporate crimes because they are your huge "Cash Cow"; goes against all principles of a free press and integrity in journalism.
You have a innate responsibility to the people first and foremost that you obviously must be reminded of here.

I'm definitely not going to be able to portray every detail of this swirling dervish of criminal actions here on this blog; Even if I was a talented enough writer to be able to connect all the dots, and draw a crystal clear picture here for everyone; it would take volumes of data and thousands of pages to even scratch the surface of this validated evil conspiracy.

I will just have to rely on you the reader to read, become knowledgeable, and to demand action and change from your elected representatives.

I have included the following great articles for your reading; because they present a small microcosm of a much larger and entrenched problem we the people must meet head-on, or we will be truly enslaved by real corporate evil with little doubt in the not so distant future.


from Alliance for Human Research Protection


Wednesday, 02 December 2009

Rather than having a deterrent effect, the number of Big Pharma high profile criminal settlements is increasing and the settlements are getting bigger. BIG PHARMA’S CRIME SPREE is a riveting report by David Evans in the current issue of Bloomberg Markets Magazine relying on recent criminal legal settlements. It leaves no doubt about the fact that Big Pharma's business practices are defined by criminal activities. Finding cures is not even remotely a consideration by pharmaceutical executives, as it would present a financial conflict of interest.
Shorter online version :
"Across the U.S., pharmaceutical companies have been pleading guilty to criminal charges or paying penalties in civil cases when the U.S. Department of Justice finds that they deceptively marketed drugs for unapproved uses, putting millions of people at risk of chest infections, heart attacks, suicidal impulses or death. Since May 2004,
Pfizer, Eli Lilly & Co., Bristol-Myers Squibb Co. and four other drug companies have paid a total of $7 billion in fines and penalties. Six of the companies admitted in court that they marketed medicines for unapproved uses."

"About 15% of drug sales in the U.S. are for unapproved uses without adequate evidence the medicines work."

The widespread off-label promotion of drugs for untested, unapproved uses is a manifestation of a health-care system that is dysfunctional as it is costly. Americans are paying exorbitant prices for drugs that put their lives at increased risk of death. Indeed, a conservative estimate by the Institute of Medicine (2000) is 106,000 preventable deaths from non-error adverse prescription drug effects.

In September 2007, New York–based Bristol- Myers paid $515 million—without admitting or denying wrongdoing—to federal and state governments in a civil lawsuit brought by the Justice Department. The six other companies pleaded guilty in criminal cases.

The evidence is inescapable: “Marketing departments of many drug companies don’t respect any boundaries of professionalism or the law,” says Jerry Avorn, a professor at Harvard Medical School. Indeed, rather than having a deterrent effect, the number of Big Pharma high profile criminal settlements is increasing and the settlements are getting bigger.

Bloomberg documents how companies such as Pfizer and Eli Lilly--each has been prosecuted repeatedly for the same crimes--are, if anything, emboldened as repeat offenders--ignoring FDA admonitions, as well as promises made to the Department of Justice not to break the law.

In January, 2004, "the Pfizer unit, Warner-Lambert, pleaded guilty to two felony counts of marketing a drug for unapproved uses. New York–based Pfizer agreed to pay $430 million in criminal fines and civil penalties, and the company’s lawyers assured prosecutor Michael Loucks and three other prosecutors that Pfizer and its units would stop promoting drugs for unauthorized purposes. What Loucks, who’s now acting U.S. attorney in Boston, didn’t know until years later was that Pfizer managers were breaking that pledge not to practice so-called off label marketing even before the ink was dry on their plea."

"Jeff Kindler, who became Pfizer’s general counsel in 2002, supervised the lawyers who made the promises to prosecutors. By 2004, Kindler increased the compliance budget 12-fold."

"What Pfizer’s lawyers didn’t tell the prosecutors was that Pfizer was at that moment running an off-label marketing promotion using more than 100 of its salespeople" who were pitching Bextra for pain, a use the FDA explicitly forbade Pfizer to promote! In 2001, the FDA had rejected Pfizer's application to market Bextra for pain because in clinical trials the drug had shown it could cause heart damage and death.

In her guilty plea (March 30, 2009), Mary Holloway, a Pfizer regional sales manager for the Northeastern US, acknowledged that her team promoted Bextra to doctors without disclosing the risks, and also acknowledged that her team "had solicited hospitals to create protocols to buy Bextra for the unapproved purpose of acute pain relief. Her representatives didn't mention the increased risk of heart attacks in their marketing..."

Kindler became chief executive officer in 2006. In Pfizer’s ethics guide, he says stories about misbehaving companies and executives abound. “Pfizer truly stands apart,” he says. “I am proud of our record.”

Instead of being held accountable for criminal marketing practices Pfizer and its corporate divisions engaged in, on Oct. 1, Kindler was elected to the board of the Federal Reserve Bank of New York.

Includes criminal fines and civil penalties. Source: Court records

Pharmaceutical companies paid about $7 billion in fines or penalties for illegal off-label marketing during the past five years. Here are some of the biggest.
Pfizer September 2009 Bextra, others $2,300.
Lilly January 2009 Zyprexa 1,415.
Serono October 2005 Serostim 704.
Purdue May 2007 Oxycontin 634.
Cephalon September 2008 Actiq, Gabitril, Provigil 425.
Schering-Plough August 2006 Temodar, Intron A 435.
Pfizer (Warner-Lambert) May 2004 Neurontin 430.

Source: Bloomberg / Federal court records
The amounts of Eli Lilly’s fines and penalties have soared during the past 25 years.
$25,000 APRIL 1985: Pleads guilty to 25 misdemeanors for misbranding Oraflex.
$36,000,000 DECEMBER 2005: Pleads guilty to one misdemeanor count for misbranding Evista.
$1,415,000,000 JANUARY 2009: Pleads guilty to one misdemeanor count for misbranding Zyprexa.don’t
But those fines are tiny compared to the revenues from criminally marketed sales:
Eli Lilly Zyprexa sales from criminal marketing yielded the company $36 billion from 2000 to 2008.

And Pfizer's recent $2.3 billion settlement in fines and penalties for the illegal marketing of Bextra, Geodon, Zyvox and Lyrica pales in comparison to the $16.8 billion the company garnered from its criminal marketing of these drugs. Indeed, the total penalties Pfizer has paid in settlements--$2.75 billion, since 2004--is but 1% of the company's revenue of $245 billion from 2004 to 2008.

Dr. Avorn points out that “The Pfizer and Lilly cases involved the illegal promotion of drugs that have been shown to cause substantial harm and death to patients.”

Despite the fact that in five company-sponsored clinical trials, 31 people out of 1,184 participants died after taking Zyprexa for dementia—twice the death rate for those taking a placebo--Lilly aggressively marketed the drug for off-label use in children and the elderly.

Even more shameful than the pharmaceutical industry’s blatant criminal practices, drug companies "find ready and willing partners in physicians" who wantonly prescribe dangerous drugs for untested, off-label uses for cash kickbacks.

Bloomberg reports that "Pfizer's marketing program offered doctors up to $1,000 a day to allow a Pfizer salesperson to spend time with the physician and his patients." If profits “uber ales” is the overriding goal, and human casualties are viewed as so much shrapnel, then Big Pharma has been hugely successful—billions in sales and hundreds of thousands buried.

In 2004, Neurontin sales reached $2.12 billion-- according the prosecutors' sentencing memo, 94% of those sales came from off-label use.

Much like the large financial institutions, Big Pharma companies are shielded by the rationale, "too big to fail." The government is reluctant to use the ultimate sanction which would put an end to criminal marketing—namely, a felony conviction that would render a company's drugs ineligible for reimbursement by state health programs and the federal government.

However, "a legal fig leaf" allows a parent company (such as Pfizer) to continue to receive government federal reimbursement for hazardous drugs that have been criminally marketed--even as one after another of the company's subsidiaries has pleaded guilty.

Pfizer and its executives have thus successfully avoided criminal culpability while paying the settlements but maintaining that it was not responsible for the illegal actions of the dozens of companies it acquired--actions that continued after Pfizer acquired them:

Bloomberg reports:
"From 1995 to 2005, Pfizer purchased more than 20 companies. Since 2004, companies that are now Pfizer divisions have pleaded guilty to off-label marketing of two drugs. Pfizer continued off-label promotions for these medications after buying the firms, according to Pfizer’s Sept. 2 guilty plea and FDA correspondence with Pfizer.
Pfizer first stepped into an off-label scheme in 1999, when it offered to buy Morris Plains, New Jersey–based Warner-Lambert Co. Prosecutors charged that Warner-Lambert marketed Neurontin off-label between 1995 and 1999. Warner-Lambert admitted doing so for one year in a May 2004 guilty plea for which Pfizer paid $430 million in fines and penalties."

Despite all this, "Pfizer maintains its good standing with such agencies because its subsidiaries, Warner-Lambert and Pharmacia-Upjohn, and not the corporation itself, entered the guilty pleas to felony charges."

While Big Pharma executives have evaded justice, Scott Harkonen, one former CEO of a small company, InterMune, has been convicted of illegal marketing of its only drug, Actimmune, for uses not approved by the FDA. He's out on bail, awaiting sentencing.

"As prosecutors continue to uncover patterns of deceit in off-label marketing by pharmaceutical companies, millions of patients across the nation remain in the dark.”

Doctors have become pill pushers who blindly prescribe the latest, most expensive medications based on deceptive marketing by drug company salesmen.

The result is documented in hundreds of thousands of preventable drug-induced deaths, and unsustainable healthcare expenditure. What’s especially disturbing is that nowhere in the proposed healthcare reform bills are life-threatening crimes by pharmaceutical companies in collusion with doctors who abuse their medical prescribing licenses even addressed.

Expanded Bloomberg Market Magazine version with tables, side-bars, upon request

Posted by Vera Hassner Sharav


from pharmagossip

AstraZeneca - Seroquel: the story so far

In November, a federal judge recommended that as many as 6,000 lawsuits against drug giant AstraZeneca for the ill effects of the company’s anti-psychotic Seroquel should be returned to their home state courts for trial. Seroquel, the company’s second-best selling drug with annual sales of $4.45 billion, is notorious for the company’s cover-up of data from clinical trials showing potentially harmful effects from the drug, including diabetes, weight gain, stroke and death.

Just days before the judge’s order, an independent review commissioned by the British government found severe side effects, including stroke and death, suffered by people with dementia when taking Seroquel and other anti-psychotics. In response to the report, the UK government stated, “There is inevitably an element of risk with the prescribing of any medication. However, there is clear evidence that anti-psychotic drugs are currently being over prescribed, when alternative non-pharmacological approaches to dealing with anxiety and behavioural problems are available and should be used.” The report found that only about 20% of dementia patients prescribed antipsychotics receive any benefit from the risky drugs.

A recent Chicago Tribune report found that Illinois nursing homes were cited for thousands of cases in which elderly residents who exhibited no symptoms of psychosis were improperly dosed with Seroquel and other antipsychotics. AstraZeneca paid one Chicago-area psychiatrist nearly $500,000 over a decade for establishing a customer base of thousands of indigent, mentally ill residents in Chicago-area nursing homes.

The litigation against AstraZeneca has exposed a litany of company misdeeds around Seroquel:

  • AstraZeneca covered-up knowledge that use of Seroquel could lead to severe weight gain and diabetes. A New York Times reportOne expert has stated that the risk of diabetes for people on Seroquel is 70 percent greater than for the general population. noted the company’s fraudulent interpretation of studies to minimize the risk began as early as 1997, and noted a 1999 email from a company executive who asked, “…how do we face the outside world when they begin to criticize us for suppressing data.”
  • AstraZeneca engaged in illegal off-label promotions of Seroquel, and company documents suggest that questionable marketing was approved at the highest levels. In one off-label scheme, sales staff were told to use Winnie-the-Pooh characters (Tigger as bipolar, Eeyore as depressed) in order to market the psychiatric drug for pediatric patients. As theNew York Times noted, “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.” Also, a company employee appears to have altered the wikipedia entry for Seroquel, deleting a National Institute of Health warning that teens taking the drug could be prone to suicide. In late October, the company paid $520 million to settle two lawsuits and two federal investigations of illegal promotions of Seroquel.
  • AstraZeneca covered-up a company study showing that Seroquel performed worse than several other drugs; two months after the company learned of the study findings, a doctor paid by the company presented the data at a medical conference as showing Seroquel to be “more effective” than the other drugs.
  • The company’s medical director for Seroquel admitted to lawyers in 2007 that he hadnumerous sexual relationships with women involved in clinical research on the drug, and traded sex for trade secrets.

The recent problems are only the latest in a string of AstraZeneca misdeeds. AstraZeneca was one of three drug makers found guilty in 2008 of defrauding Medicare by overcharging for drugs and encouraging doctors to prescribe their products over competitors through pricing that rewarded the physicians for prescribing certain drugs. Former New England Journal of Medicine editor Marcia Angell has charged that the company’s clinical trials of its top-selling drug Nexium were rigged to show greater efficacy than a cheaper competing product. In 1996, aBusiness Week cover story exposed “dozens of cases” of women who accused then-CEO of Astra USA Lars Bildman and other top executives with sexual harassment. One male sales manager told the magazine, “If ever there was a company where sexual harassment was rampant, this is it.”

In 2008, AstraZeneca CEO David Brennan took home over $2.5 million.

1 comment:

betasheep said...

The buddy-buddy relationship between the FDA and the corporations they are supposed to regulate is called regulatory capture or deep capture.

This isn't an isolated problem in government. Remember those wild, cocaine-fueled orgies between Mineral Management Services employees and the gas and oil drillers they were supposed to be regulating? I should say the Bureau formerly known as the Mineral Management Services, because the name and the department's duties were changed earlier this year when it was discovered that they had simply rubber-stamped the poor decisions that led to the Gulf Oil Disaster.

Or what about the Securities and Exchange Commission? They refuse to pay any attention to the markets and the players that they're supposed to be overseeing. See the problems of the Flash Crash earlier this year. The SEC still refuses to admit those High Frequency Trading algorithms could be a bad thing, because those algos are making the prop desks at the brokerage houses and banks far too much money. And those SEC employees might be looking for jobs in the private sector in the next few years.

Or maybe you've heard about the egg problem lately?

The list of bad behavior and lax oversight goes on and on because the regulators are so deep into the pockets of the people who have the money. Everything could come crashing down around our ears and the people who are supposed to protect us would still be saying, "Nothing to see here. Move along. Everything's fine." Not enough people seem to care about this current state and not enough are willing to do anything about it. We could only wish that the Soma, I mean, Seroquel would make it all go away.

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