Posts Tagged ‘DoJ’

Risperdal drug maker faces $1B in lawsuits, yet mother charged for refusing use on child

Tuesday, August 16th, 2011

NaturalNews – August 16, 2011

by Monica G. Young

Click image to visit CCHRInt's Psychiatric Drug Side Effects Search Engine

What irony. Detroit mother, Maryanne Godboldo, was just charged with child neglect for refusing to obey a Child Protective Services order to give her daughter Risperdal, a powerful psychoactive drug. Meanwhile federal and multiple state prosecutors are suing Johnson & Johnson for deceptively marketing the drug – including mismarketing its use on children – and hiding dangerous adverse effects. J&J now faces a potential $1 billion in damages.

Having earlier observed the drug’s dreadful effects on her child, Maryanne was correctly pursuing holistic treatment for the child instead when the legal battle began. The jury’s ruling, now handed down against the mother, is not only a travesty of justice, but a reflection of psychopharma’s vast propaganda machine. (http://www.naturalnews.com/033295_p…)

Fortunately not everyone is fooled. The US Department of Justice (DOJ) has been investigating J&J for years in regards Risperdal – its sales practices, pay-offs to doctors to promote the drug, and failures to disclose harmful effects. The pharma giant has now tentatively agreed to settle a misdemeanor criminal charge, however the DOJ and US attorney’s office are pursuing additional criminal actions.

The government plans to join civil lawsuits filed by company whistleblowers, aiming to recover millions of dollars paid for prescriptions via government health programs like Medicare and Medicaid.

Already multimillions in fines have been levied against J&J for this powerful antipsychotic which is widely prescribed not only for schizophrenia but mood and anxiety disorders, dementia and other unapproved uses.

In June, a South Carolina judge demanded the company pay $327 million to the state for deceptively marketing Risperdal and concealing its dangers. The judge called J&J’s practices “detestable.” Last October, a Louisiana jury ordered the company to ante up $257.7 million for misleading claims about the drug’s safety.

Recently, Massachusetts Attorney General joined the fight, filing a lawsuit against J&J for illegal marketing and failing to disclose “an increased risk of death” connected with the drug.

In Texas the Attorney General Office has joined forces with whistleblowers, with a jury trial scheduled for this fall. This lawsuit alleges that Janssen, J&J’s pharmaceutical division, intentionally marketed Risperdal for use on children even though it was only approved for adult schizophrenia. The suit also involves a company scheme to boost prescriptions by paying hundreds of thousands of dollars to “experts” to evaluate and recommend the drug state-wide and nationally. Awarded damages are anticipated to be much larger than in South Carolina or Louisiana. Texas has paid more than $500 million for the drug since it was first brought to the market.

Attorneys general in about 40 other states have shown interest in suing the company.

Users speak out – beware of this drug!

(Note from CCHRInt –search Risperdal or antipsychotic drug side effects in CCHR’s Psychiatric Drug Database here http://www.cchrint.org/psychdrugdangers/drug_warnings.php – simply type in Risperdal  in the Red Search box or choose it from the drop down menu)

Risperdal’s documented “side effects” include huge weight gain, diabetes, lethargy, muscular tics, breast development in males, and many more.

Below are just a few sample statements made online by individuals from their experience with this so-called “medication” (the root word of medicate means “to heal”):

“Basically I lost the drive for everything. Total shut down to my outgoing personality. Massive weight gain.”

“Tardive dyskinesia [involuntary movement disorder], diabetes, gained 100 pounds in the first year, was a zombie… I was put on this nightmare drug when I was six. I was forced to take it against my will, and it ruined my life… This is a horrible, HORRIBLE drug, and should be banned.”

“Apathy, not talking, just staring, sleeping constantly, tongue movements, loss of sexual function. This is a very BAD DRUG…a mental straight jacket. DO NOT put children on this drug!!! It’s poison.”

“I gained weight, became very tired, and of course that just led them to put me on antidepressant medications…. I have been on it since fifth grade and hardly knew what was happening to me.”

“My son has gained over 100 pounds… He was an excellent student, received a doctorate and now cannot even remember what he studied. He sleeps all day and cannot work a job. His quality of life is nil. His mouth twitches and he has no control over it… It is like taking a dose of legalized poison every day. This is a LIFE WASTED AND RUINED, a brilliant mind destroyed and tortured. As a mother, it rips out my heart every day.”

Yet per Johnson & Johnson annual reports, global Risperdal sales from 1994-2010 totaled nearly $29 billion.

http://www.naturalnews.com/033336_Risperdal_child_neglect.html

Sources for this article include:

http://www.google.com/hostednews/ap…

http://www.thefix.com/content/jj-su…

http://www.reuters.com/article/2011…

http://www.kxan.com/dpp/news/invest…

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Forest Pharmaceuticals Sentenced to Pay $164 Million for Criminal Violations

Wednesday, March 2nd, 2011

UNITED STATES DEPARTMENT OF JUSTICE

Office of Public Affairs—March 2, 2011

WASHINGTON — Drug manufacturer Forest Pharmaceuticals Inc. was sentenced today by U.S. District Judge Nancy Gertner to pay a criminal fine of $150 million and forfeit assets of $14 million following the company’s guilty plea in November 2010 to one felony count of obstructing justice, one misdemeanor count of distributing an unapproved new drug in interstate commerce and one misdemeanor count of distributing a misbranded drug in interstate commerce, the Justice Department announced. The company, a subsidiary of New York City-based Forest Laboratories Inc., pleaded guilty to charges related to obstruction of an FDA regulatory inspection, to the distribution of Levothroid, which at the time was an unapproved new drug, and to the illegal promotion of the anti-depressant drug Celexa for use in treating children and adolescents.

Today’s sentencing of Forest was the final component of a global resolution totaling more than $313 million to resolve criminal and civil allegations against Forest and its parent company in connection with the distribution and marketing of certain drugs. In September 2010, Forest Laboratories and Forest Pharmaceuticals entered a civil settlement to resolve False Claims Act charges involving three of its drugs: Levothroid, Celexa and Lexapro. As part of the civil settlement, Forest agreed to pay more $149 million, including more than $88 million to the federal government and more than $60 million to the states.

According to court documents, Forest Pharmaceuticals began distributing Levothroid for treatment of hypothyroidism in the early 1990s without first obtaining Food and Drug Administration (FDA) approval. In 1997, the FDA, after determining that the drugs were medically necessary, gave manufacturers a certain amount of time to conduct the necessary studies and obtain FDA approval. In 2001, the FDA stated that it would continue to permit manufacturers of unapproved levothyroxine sodium drugs to distribute their unapproved drugs after Aug. 14, 2001, on certain conditions. One of those conditions was that any manufacturer which had not obtained approval needed to comply with a gradual distribution phase-down of its unapproved drug until it obtained FDA approval. According to court documents, Forest made a deliberate decision to continue distributing its unapproved Levothroid product in quantities far exceeding the amounts permitted by the FDA’s distribution phase-down plan.

The FDA sent a warning letter to Forest Pharmaceuticals on Aug. 7, 2003, informing the company that it was no longer entitled to distribute its unapproved Levothroid product.

According to prosecutors, after Forest received the letter, the company directed its employees at its St. Louis distribution center to work overtime until approximately 1:00 a.m. the following morning and, during that time, to continue shipping as much of its unapproved Levothroid as possible.

Court documents also indicate that Forest obstructed an FDA regulatory inspection relating to Levothroid at Forest’s Cincinnati plant in November 2003. According to prosecutors, management personnel at the Cincinnati plant were aware that serious equipment malfunctions had resulted in testing conditions that, for hundreds of days and thousands of hours, did not comply with the FDA’s requirements for Levothroid that had been manufactured for research purposes. Prosecutors stated that in an attempt to remedy this problem, certain Forest management personnel at the Cincinnati plant decided to use a portable home humidifier in the testing room as a temporary fix. Later, when FDA inspectors saw this humidifier in the testing room during a regulatory inspection of the plant, certain management personnel falsely told the investigators that the portable humidifier was merely being stored in the room and had not been used for humidity control. This conduct was the basis for the felony obstruction charge to which Forest pleaded guilty.

Forest halted its commercial distribution of its unapproved version of Levothroid as of August 9, 2003. Since the fall of 2003, Forest has been commercially distributing a different orally administered levothyroxine sodium drug, also called Levothroid. This resolution does not involve that product.

Regarding Celexa, court documents state that Forest promoted the drug for use in treating children and adolescents suffering from depression despite the fact that the FDA had only approved the drug to treat adult depression. Prosecutors stated that Forest’s off-label promotion consisted of various sales techniques, including directing its representatives to promote pediatric use of Celexa in sales calls to doctors who treated children and adolescents, and hiring outside speakers to talk to pediatric specialists about the benefits of prescribing Celexa to children and teens. Prosecutors stated that in conjunction with this off-label promotion, Forest aggressively publicized the positive results of a double-blind, placebo-controlled Forest study on the use of Celexa in adolescents while, at the same time, Forest Pharmaceuticals suppressed the negative results of a contemporaneous double-blind, placebo-controlled European study on the use of Celexa in adolescents.

” Forest Pharmaceuticals pleaded guilty to obstructing justice and marketing drugs for unapproved uses, including improperly promoting an anti-depressant to children and adolescents,” said Tony West, Assistant Attorney General for the Justice Department’s Civil Division. “As the court’s stiff sentence demonstrates, not only is such conduct unacceptable, taxpayers should not foot the bill for practices that violate the law.”

“Both the criminal and civil cases were predicated upon the fact that Forest Pharmaceuticals made a calculated decision to place a higher priority on increasing corporate sales than on complying with the basic, legal requirements that Congress and the FDA created to protect the American public,” said Carmen Ortiz, U.S. Attorney for the District of Massachusetts.

In addition to its sentence today, and previously agreeing to a civil settlement, Forest also previously signed a Corporate Integrity Agreement with the Department of Health and Human Services, Office of Inspector General (HHS-OIG).

“Today’s sentencing of Forest Pharmaceuticals is a victory for the system designed to protect patients from potentially harmful prescription drugs,” said Daniel R. Levinson, Inspector General of the Department of Health & Human Services. “Attempts to circumvent that system by selling misbranded and unapproved drugs simply will not be tolerated.”

The criminal case was investigated and prosecuted by Assistant U.S. Attorney James E. Arnold of the U.S. Attorney’s Office for the District of Massachusetts and Trial Attorney Jeffrey I. Steger of the Justice Department’s Office of Consumer Litigation. The case was investigated by agents from the FBI, the HHS-OIG, the FDA’s Office of Criminal Investigations and the Department of Veterans Affairs’ Office of Inspector General. Assistance was also provided by the FDA’s Office of General Counsel and the Office of Personnel Management.

http://www.justice.gov/opa/pr/2011/March/11-civ-270.html

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Is J&J Cooking Its Books? Suit Alleges Double-Counting at the Pharma Giant

Wednesday, March 2nd, 2011

BNET – March 1, 2011

by Jim Edwards

A whistleblower lawsuit filed against Johnson & Johnson (JNJ) didn’t get much attention in the media because the unproven accusations within it — paying kickbacks to nursing home pharmacy Omnicare (OCR) — sounded familiar. But the details in the complaint are worth exploring because they go further than the usual allegations of paying for no-work contracts to boost pharmacy distribution of their drugs.

Plaintiff Scott Bartz, a former sales compensation manager at J&J, alleges that the company is cooking its books in two ways, both of which could lead to prison time for senior managers if his allegations are true:

  • The company is overstating its revenues by counting the discounts it pays to drug repackagers under the “cost of goods sold” line on its income statement. COGS are supposed to reflect manufacturing and shipping costs, not price discounts and rebates.
  • The company is double-counting sales of the injectable antipsychotic Risperdal Consta as the drug passes through wholesalers and retailers. The double-counting is part of a “channel-stuffing” scheme in which the company falsely inflates its sales by counting shipments to wholesalers as if they were actual sales at the retail level.

J&J has yet to respond to the suit, which was unsealed in December and didn’t surface in regulatory filings until last week. The company will be comforted by the fact that the Department of Justice has so far declined to intervene. That doesn’t necessarily mean the DOJ believes the case is without merit; the DOJ chooses its cases based on a range of criteria, including policy priorities and available resources. Nonetheless, the accusations should be taken with a pinch of salt until J&J responds.

The last time channel stuffing reared its ugly head in the drug industry was when Bristol-Myers Squibb (BMS) settled fraudulent accounting charges with the SEC for $150 million. In that case, BMS’ former president and CFO were indicted for fraud and conspiracy, but the charges were dropped last year in favor of a pair of deferred-prosecution agreements and $400,000 in fines.

Bartz worked for J&J from 1999 to 2007 and had responsibility for analyzing J&J’s financial and sales data from companies such as IMS Health, a market research company whose information is used as an industry benchmark. In 2004 and 2005, Bartz noted an alleged discrepancy between the amount of Risperdal Consta J&J sold to three wholesalers and the amount that pharmacies actually sold to patients:

  • J&J’s Risperdal Consta sales to wholesalers McKesson, Cardinal and AmeriSource Bergen
  • 2004: $130 million reported; $75 million actually sold
  • 2005: $285 million reported; $145 million actually sold

Bartz investigated, and found further alleged discrepancies. Alkermes, the company that makes Risperdal for J&J, reported worldwide sales to J&J’s Janssen unit worth $1 billion in 2005, Bartz alleges. But Janssen’s net sales of that drug in the same year were only recorded as $664 million; and sales from outlets and other distributors were $390 million, Bartz claims. J&J concealed its channel-stuffing scheme by counting the same sales twice, Bartz claims (click to enlarge):

The discrepancy between the sales J&J racked up with its wholesalers and actual sales at retail and pharmacy level did not go unnoticed, Bartz claims. An IMS Health executive said that there seemed to be “very little sellout” of some Risperdal Consta shipments that J&J had sent to McKesson:

Bartz alleges channel stuffing was widespread at J&J:

Plaintiff has also discovered that the practice of channel stuffing was used in all or most of the J&J products as a means to increase profit margins of distributors such as McKesson, Cardinal and AmeriSource Bergen.

For investors, the most serious allegation Bartz has to make is furnished with the least detail. He claims that J&J inflated sales of the Alzheimer’s drug Razadyne through a number of different schemes, including removing sales from the company’s books only to reinsert them once the books were closed at year’s end, and pretending that discounts J&J offers to repackagers on the drug are manufacturing costs:

That scheme would allow J&J to pretend it is making more money on the drug than it actually is, albeit at smaller margins. Oddly, the net effect of such a scheme on J&J’s bottom line would be a wash, but it would give outside observers the impression that the market for Razadyne is bigger than it actually is.

Bartz claims he was harassed and demoted after he complained to management that he believed the company’s accounting was false. He claims he had a stress-induced heart attack before he was finally terminated in 2007.

http://www.bnet.com/blog/drug-business/is-j-j-cooking-its-books-suit-alleges-double-counting-at-the-pharma-giant/7552

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Federal Judge & DOJ back lawsuit accusing Johnson & Johnson of illegal kickback scheme to push antipsychotic drugs on elderly

Tuesday, March 1st, 2011

AboutLawsuits.com

March 1, 2011

A federal judge has refused to toss out a whistleblower lawsuit backed by the Department of Justice (DOJ), which accuses Johnson & Johnson of involvement in an illegal kickback scheme to push their antipsychotic drugs on elderly nursing home residents that did not need them.

Johnson & Johnson sought to have claims brought by the DOJ, a number of whistleblowers and states dismissed, saying that what the plaintiffs are calling illegal kickbacks were completely legal rebates. However, U.S. District Judge Richard Stearns found that plaintiffs had sufficient evidence to go forward with the complaint.

Judge Stearns did remove several plaintiffs from the case, including the states of Nevada, Texas and Illinois, but allowed Kentucky, Indiana and Virginia to stay part of the lawsuit. Whistleblower David Kammerer was also removed from the lawsuit.

The DOJ filed a civil False Claims Act compliant against J&J on January 15, 2010, saying that the company paid millions to Omnicare, Inc. as kickbacks for selling Risperdal to nursing home patients.

In 2009, Omnicare settled charges brought against it by the government for allegedly paying kickbacks to nursing homes to prescribe the drug. At that time, the Justice department investigators indicated that the illegal nursing home drug kickbacks were hidden as data fees, education fees and as payments to attend Omnicare meetings.

According to the DOJ complaint against Johnson & Johnson, the drug maker paid $50 million to Omnicare between 1999 and 2004 to get it to prescribe Risperdal to elderly patients with dementia, and then hid those kickbacks as payments for services that Omnicare never actually provided. Omnicare then enacted intervention programs such as the “Risperdal Initiative” to persuade physicians to prescribe the drug to elderly dementia patients.

Omnicare, the largest pharmaceutical supplier for nursing homes in the U.S., has pharmacists on staff who review patients’ records and then makes recommendations to the patients’ physicians. Those recommendations are followed about 80% of the time, the DOJ said.

The claims were originally made by Omnicare pharmacist Bernard Lisitza in 2003, and the DOJ chose to intervene on Lisitza’s behalf.

Whistleblowers who report a false claim against the government may be entitled to receive a portion of any money that the government recovers from the offenders under the qui tam provision of the False Claims Act. In return, the whistleblower must be the first to bring the case to the government’s attention, and must not publicize the claim until the DOJ decides to prosecute the claim.

Risperdal (risperidone) is manufactured by Janssen, a division of Ortho-McNeil-Janssen, which is a subsidiary of Johnson & Johnson. Risperdal is approved by FDA for the treatment of schizophrenia, bipolar disorder and autism, but it is commonly used among elderly with dementia and sometimes as a form of chemical restraint in nursing homes.

Risperdal is not approved for treatment of dementia, and patient advocates have been pushing nursing homes to reduce the use of the drug among elderly due to the health risk and a lack of actual health benefits. According to a recent report from the United Kingdom, side effects of Risperdal and other similar antipsychotics, like Seroquel, Zyprexa and Abilify, could be linked to as many as 1,800 deaths and 1,620 strokes per year in elderly patients with dementia.

http://www.aboutlawsuits.com/risperdal-omnicare-lawsuit-proceeds-16571/

To see more international drug regulatory warnings and studies on Risperdal and other antipsychotic drugs, visit CCHR’s Psychiatric Drug Side Effects Database here: http://www.cchrint.org/psychdrugdangers/drug_warnings.php

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Justice to Pharma: “Do the Perp Walk!”

Wednesday, November 17th, 2010

PharmaExec.com – November 17, 2010

by Walter Armstrong

Former GSK counsel is the first target in government’s executive-liability crackdown. Could J&J be next?

The US Department of Justice filed criminal charges last week against Lauren Stevens, a former VP and assistant general counsel at GlaxoSmithKline. Going after pharma execs marks a seismic shift in the government’s efforts to stem the tide of fraud and other illegal pharma marketing practices, which a raft of billion-dollar settlements have so far failed to end. Stevens is charged with obstruction of an investigation, concealment and falsification of documents, and making false statements to the FDA in its 2002 investigation of off-label promotion of the antidepressant Wellbutrin for weight loss, an indication for which it has never been approved but has shown some clinical benefit. The DoJ says that it has evidence, in the vast paper and electronic documentation turned over by GSK, showing that Stevens hid and otherwise misled the agency about some 1,000 instances of GSK-paid doctors promoting Wellbutrin for weight loss to other doctors.

Officials had warned that they would target “repeat offenders,” and GSK certainly qualifies for that dubious distinction. The British firm has racked up some of the biggest settlements of the past decade, including $750 million in October to put to rest civil and criminal charges arising in part from a whistleblower suit filed by a quality-control cop who was fired after she advised temporarily shutting down one of its major manufacturing plants because it was routinely producing adulterated drugs (and selling some of them on the black market) between 2001 and 2005. GSK execs chose instead to look the other way. The former compliance advisor’s cut of the settlement was a record-setting $96 million.

In fact, GSK has been making headlines for all the wrong reasons this year: Prior to the whistleblower suit settlement news came the denouement of the Avandia side effects case revealing that the company had failed to disclose damaging data and otherwise misled the FDA about the diabetes drug’s heart-attack risks.

But the new charges against a former VP in its legal department and all the bad press are almost certainly coincidental, says Daniel Carpenter, a professor of political science at Harvard and leading expert on the FDA. “I am not inclined to read anything political into the fact that it is a Glaxo employee,” he says. “The real symbolic feature of this action is the general message that any criminal proceeding sends to the pharmaceutical industry, namely that the FDA general counsel is now willing to use criminal proceedings—something it has had the power to do for seven decades.” Lauren Stevens, who was said by a GSK spokesperson to be “retired,” has hired a high-profile team of defense attorneys who told the media that their client was innocent and looking forward to her day in court. Be that as it may, if convicted, Stevens could spend at least some of her retirement years in the slammer because the charges are felonies carrying lengthy prison sentences.

BNet’s Jim Edwards has raised the possibility on his Placebo Effect blog that the DoJ may offer Stevens immunity for spilling the beans on other misdeeds at GSK, especially those committed by top management. That lineup include, of course, several of the industry’s most powerful players: former GSK CEO Jean-Pierre Garnier; his successor in 2008, Andrew Witty; Chris Veihbacher, who was GSK’s head of US pharmaceuticals from 2003 to 2008, when he became the CEO of Sanofi-Aventis; and David Stout, the head of global pharma operations from 2003 to 2008.

But the most probable scenario, according to Pharm Exec’s legal sources, is that the DoJ has picked a first case that it is confident it can win a conviction in. And Stevens is likely merely the first shoe to drop. It is widely assumed that the coming months will offer other executives at other firms the opportunity to do a perp walk, with some insiders betting that J&J is next on deck following recent congressional hearings into the company’s recent series of OTC product recalls, including a “phantom” recall of defective Motrin during which consultants posing as consumers attempted to buy out the product.

Slammed for failing to announce an official recall in a speedy fashion, FDA deputy commissioner Josh Sharfstein told Congress last June that J&J had misled the agency about the scope of the retrieval, not to mention its bizarre counterfeit style. But when J&J CEO William Weldon took the hot seat, he countered that his firm had informed the agency of its plans.

One of the two men is lying to Congress, so this line of speculation goes, and if it’s Weldon, the FDA may be expected to pounce—calling its no. 2 a liar only adds insult to injury.

http://blog.pharmexec.com/2010/11/17/lauren-stevens-charged-with-obstruction/

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Is this for real, or just more smoke and mirrors – Big Pharma Executive being prosecuted by DOJ for obstruction of justice & lies

Thursday, November 11th, 2010

Is Something Not Quite Right With Stan – A Mental Health Blog – November 10, 2010

The Big News in Pharma-land is that the DOJ is going after a former GSK lawyer/Exec for a myriad of crimes which could lead to a Fashionable Federal Prison Jump Suit & a very long stay at a Martha Steward Foo Foo Club Fed. The question still remains if this scum bag exec does go to trial and is convicted (or sings like a Canary); what effect this might have on the World Wide Pharmaceutical Drug Cartel Criminal business as usual model?

From the rumblings being heard around the Pharma CEO world it appears this maybe a circle the wagons strategy developing orgy with a huge PR campaign of “we need to be more open and listen themes” while prospects of huge corporate take overs, turf wars, and more profits shine like stars in their beady & greedy CEO eyes ( read here–> AstraZeneca CEO: Pharma Must Be Open, Work With Stakeholders – FoxBusiness.com and here Glaxo sees more industry consolidation - Pharma Not Well Equipped to Handle a PR Cyber Storm-VOX

For a little back story)

This all sounds like a big wonderful hug fest & one giant “can’t we all just get along” moment for all those that have been watching these corporate crimes being waged against society and humanity go unchecked for decades now. But the caution bells are ringing in distance as we have learned the hard way many times before with Big Pharma; words are always cheap, while honesty & accountability is something of an abomination to the holy pharmaceutical corporate stone tablet creed.

So as they say, the proof will lay/lie in the pudding. Will AstraZeneca finally do the right thing when it’s comes to the many thousands injured by Seroquel, will J&J make good on the Risperdal crime settlements and get clean/sober, will GSK come in with a apology mop with groveling pledges of restitution and pay outs for damage caused by Paxil, Wellbutrin, Avandia, as we just name a few of the many ongoing Big Pharma Cartel horrendous criminal actions that have seriously harmed or killed consumers.

If you believe the sweet smell of change is in the air, you might want to ask/consider why is Big Pharma trying to close the honesty door at the same time they are saying they want it to be wide open? read here–>And Here Is The SEC Whistleblower Program

Now if one was to place this in the framed context that Big Pharma is still pumping huge amounts of money into the drug influence game involving doctors and research here—> http://projects.propublica.org/docdollars/ and here–>http://www.madinamerica.com/madinamerica.com/Leo/F7BDF895-0DE9-4605-8C73-A25177CBA9FE.html

Or here where they continue funding front marketing groups – AstraZeneca Funds DBSA http://www.speakaboutdepression.com/ and AstraZeneca funds NAMI -http://www.namimi.org/astrazeneca-bipolar-journey-exhibit-appearing-2010-nami-walks as stellar examples.

One might would get the distinct impression that Big Pharma has no intention of changing their profitable criminal ways, or their seedy business as usual model.  Definitely give us all some food for thought as the DOJ finally appears on it’s face to be taking some substantive action against the world largest criminal organization.

http://bipolar-stanscroniclesandnarritive.blogspot.com/2010/11/is-this-for-real-or-just-more-smoke-and.html

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US Department of Justice Probes Corruption in Big Pharma; Glaxo, Pfizer, Bristol-Myers Squibb, Eli Lilly & Merck

Friday, August 13th, 2010

Financial Times
By Stephanie Kirchgaessner
August 12, 2010

The US Department of Justice is scrutinising payments by leading pharmaceuticals companies for hospitality, consultants, licensing agreements and charitable donations in markets around the world as part of a wide-ranging corruption probe.

GlaxoSmithKline, Pfizer, Bristol-Myers Squibb and Eli Lilly, among others, have disclosed being contacted by the DoJ and Securities and Exchange Commission in connection with the investigation. Merck, the US drugs group, announced last week that it had also been contacted and was co-operating with investigators.

An industry attorney familiar with the probe said that the DoJ was looking at whether pharma companies had ignored a “systematic risk” inherent in the global drugs business and ignored obligations under local and US anti-bribery law.

The highly regulated nature of the business, combined with the fact that healthcare officials in many non-US markets were government funded, made the industry a natural target for such a probe, the person added.

The investigation is at a relatively early stage but is considered a priority for the DoJ.

While hospitality – including meals and all expenses-paid travel for conferences – has long been considered a potential risk for pharma groups, the DoJ’s probe is looking at all aspects of companies’ dealings in non-US markets, people familiar with the matter say. That includes the recruitment of physicians for clinical trials. In some markets, the same physicians may serve on regulatory boards that approve or deny drugs.

The DoJ declined to comment. But last November, Lanny Breuer, head of the DoJ’s criminal division, announced that investigators would be focusing on international corruption in the pharmaceuticals industry for “years”.

Mr Breuer warned a conference of pharmaceutical industry lawyers that prosecutors were gearing up for an investigation of international corruption in the sector. The drugs companies took notice.

That threat has now become a reality. Merck, AstraZeneca, Eli Lilly, Baxter, SciClone, and Bristol-Myers Squibb have in recent months received inquiries from the DoJ and the Securities and Exchange Commission in connection with an industry-wide bribery ­investigation.

GlaxoSmithKline, the UK drugmaker, told the Financial Times on Thursday that it too had received “inquiries” from US authorities, but that it disclosed the issue “reactively” only to selected reporters in April.

Pfizer, the world’s largest pharmaceutical group, said in February that it had voluntarily provided the DoJ and SEC with information concerning potentially improper payments outside the US and was exploring resolution of the matter.

There is perhaps no industry that is as vulnerable to violations of US anti-bribery laws as the pharmaceutical industry. In markets round the world, the companies deal, sometimes thousands of times in a single day, with doctors, clinicians, hospital operators and regulators who are considered under US law to be government officials, because they are employed by state-owned facilities.

Under the Foreign Corrupt Practices Act, the US anti-bribery law, companies may not offer items of value to foreign government officials for profit. One industry lawyer involved in the matter said global pharmaceutical companies operating in countries with state-run medical institutions deal with government officials at every turn of their business: whether it is seeking the go-ahead for a manufacturing site; obtaining drug licences; conducting clinical trials; importing drugs; selling and marketing drugs to physicians; or getting a product on to a hospital’s approved list.

“What most companies will find is that all of these areas are risky and, if they don’t train and educate their people, they are going to find themselves with issues. For example, if you have hired customs brokers, how do you know they aren’t bribing officials?” the attorney said.

According to the law firm Arnold & Porter, the DoJ is particularly interested in corrupt payments that may have influenced the reliability or integrity of data in clinical trials performed outside the US. A recent report by the Department of Health and Human Services found 80 per cent of marketing applications for drugs approved by the Food and Drug Administration in the US had relied on at least one foreign trial.

“Companies may find themselves facing critical legal issues if approval of products rested on the results of studies the DoJ deems corrupt,” Arnold & Porter said in an advisory letter to clients last month.

A person familiar with the investigation confirmed that clinical trials were one of several areas the DoJ was examining.

Alexandra Wrage, the president of Trace, a non-profit organisation that helps companies establish anti-corruption practices, said that alleged wrong­doing at pharmaceutical companies could often centre on inappropriately lavish hospitality, such as wining and dining doctors from state-run hospitals at conferences in Bali or Monaco.

Read entire article here:  http://www.ft.com/cms/s/0/9a8e8f90-a63e-11df-8767-00144feabdc0.html
(free registration required)

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