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Pharma Crimes Prosecuted, the Major Court Settlements



Business as usual, Capitalism is about profits.  The problem with off-label marketing is that the studies done to support such usage is well below the standards of science, they are then published in select journal, and then such studies are used to market the drugs to doctors who have become pill pushers.  This is the norm for off-label marketing.   


Big Pharma behaving badly: A timeline of settlements


October 5, 2010 — 8:49am ET | By Erica Teichert


http://www.fiercepharma.com/special-reports/big-pharma-behaving-badly-timeline-settlements/big-pharma-behaving-badly-part-2

Sometimes pharma companies bend the rules. And increasingly, they're getting caught. After Novartis' recent
$422.5 million settlement with the U.S. Attorney's office and reader requests, we looked back at other Department of Justice and government fines levied against Big Pharma for improper marketing and other infractions. Those fines range from a relatively light slap on the wrists to multi-billion dollar charges in addition to criminal penalties. 


Eleven companies have paid a total of over $6 billion to the government in 22 months. The biggest offender? Eli Lilly, with three appearances and over $1.4 billion in fines, all for Zyprexa. But those three settlements pale in comparison to Pfizer's massive $2.3 billion charge for mis-marketing a host of drugs, including Bextra, Geodon, Lyrica and Zyvox.


Novartis
With: U.S. Attorney's office for the Eastern District of Pennsylvania
When: Sept. 30, 2010
Scoop: Novartis agreed to a
$422.5 million settlement with the Eastern District of Pennsylvania for its off-label promotion of Trileptal and other allegations against Diovan, Exforge, Sandostatin, Tekturna and Zelnorm.


Forest Labs
With: Dept. of Justice
When: Sept. 15, 2010
Scoop:
After marketing Levothroid, an unapproved thyroid drug, Forest Labs received its penalty, to the tune of $313 million. The settlement also covered Forest's off-label use of Celexa for children's use.


Allergan
With: Dept. of Justice
When: Sept. 1, 2010
Scoop: Allergan's
$600 million DoJ settlement was broken into two parts: $375 million in fines and $225 million in civil penalties, all of which stemmed from its off-label use of Botox for headaches, pain management and cerebral palsy.


Elan
With: U.S. Attorney's Office in Massachusetts
When: July 15, 2010
Scoop: The Irish drugmaker received its
$203.5 million fine for its marketing tactics of Zonegran, an epilepsy drug. Also, the company's U.S. branch pled guilty to a misdemeanor and the company will enter into a corporate integrity agreement with the HHS Inspector General.


Johnson & Johnson
With: Department of Justice
When: April 29, 2010
Scoop: Though J&J's more infamous woes stem from its phantom recalls, two of the troubled drugmaker's subsidiaries received a $81 million penalty for
off-label promotions of Topamax, an epilepsy drug.


AstraZeneca
With: U.S. Attorney's office in Philadelphia
When: April 27, 2010
Scoop: In the same week as the J&J settlement,
AstraZeneca was hit with a $520 million penalty for its antipsychotic, Seroquel. The company misled doctors and patients about the drug's safety.


 


 


Abbott
With: Twenty-three states
When: Jan. 7, 2010
Scoop: In a case involving
23 different states, Abbott Laboratories and its partner, Fournier Industrie et Sante, were ordered to pay $22.5 million for blocking the states from obtaining a cheaper alternative for its cholesterol drug, TriCor.


Eli Lilly
With: Connecticut
When: Sept. 29, 2009
Scoop: Thirteen states total had filed suit against Eli Lilly for Zyprexa marketing issues, but the company was ordered to pay
$25 million to Connecticut in this ruling.


Eli Lilly
With: West Virginia Attorney General
When: August 21, 2009
Scoop: In another Zyprexa case, West Virginia Attorney General Darrell McGraw
levied $2 billion in fines against Eli Lilly. As the motion put it, "At $5,000 per violation, therefore, the State is attempting to fine Lilly approximately $2 billion for use of a product label that was approved by the FDA." In the end, the company agreed to $22.5 million in fines.


Merck
With: 35 states' attorney offices
When: July 15, 2009
Scoop: Merck escaped relatively unscathed from
35 state investigations against the Enhance study of Vytorin, only paying $5.4 million without admitting fault in the cases.


Sanofi-aventis
With: Department of Justice
When: May 28, 2009
Scoop: In an agreement with the federal government, Sanofi paid
$95.5 million total, doled out to the feds, state Medicaid agencies and other public health service agencies, all for its subsidiary Aventis' nasal spray price inflation between 1995 and 2000.


GlaxoSmithKline
With: U.S. Attorney's office in Colorado
When: Jan. 29, 2009
Scoop: After seven years of off-label promotion on nine of its best-selling drugs, GSK was
ordered to pay $400 million to the U.S. Attorney's office in Colorado.


Pfizer
With: Department of Justice
When: Jan. 26, 2009
Scoop: Right after acquiring Wyeth, Pfizer dropped a bombshell in its fourth quarter earnings report;
the company was charged $2.3 billion, the largest fine levied on our list, for off-label promotions of its COX-2 drugs. That settlement lowered the company's 2008 net income by 90 percent.


Eli Lilly
With: Department of Justice
When: Jan. 15, 2009
Scoop: In the first Zyprexa settlement (and one of three on our list), the Department of Justice levied
$1.4 billion in fines against Eli Lilly. Also, as part of the settlement, the company pled guilty to a misdemeanor: violating the Food, Drug and Cosmetic Act.







 


Business as usual, Capitalism is about profits.  The problem with off-label marketing is that the studies done to support such usage is well below the standards of science, they are then published in select journal, and then such studies are used to market the drugs to doctors who have become pill pushers.  This is the norm for off-label marketing.   


Big Pharma behaving badly: A timeline of settlements


October 5, 2010 — 8:49am ET | By Erica Teichert


http://www.fiercepharma.com/special-reports/big-pharma-behaving-badly-timeline-settlements/big-pharma-behaving-badly-part-2

Sometimes pharma companies bend the rules. And increasingly, they're getting caught. After Novartis' recent
$422.5 million settlement with the U.S. Attorney's office and reader requests, we looked back at other Department of Justice and government fines levied against Big Pharma for improper marketing and other infractions. Those fines range from a relatively light slap on the wrists to multi-billion dollar charges in addition to criminal penalties. 


Eleven companies have paid a total of over $6 billion to the government in 22 months. The biggest offender? Eli Lilly, with three appearances and over $1.4 billion in fines, all for Zyprexa. But those three settlements pale in comparison to Pfizer's massive $2.3 billion charge for mis-marketing a host of drugs, including Bextra, Geodon, Lyrica and Zyvox.


Novartis
With: U.S. Attorney's office for the Eastern District of Pennsylvania
When: Sept. 30, 2010
Scoop: Novartis agreed to a
$422.5 million settlement with the Eastern District of Pennsylvania for its off-label promotion of Trileptal and other allegations against Diovan, Exforge, Sandostatin, Tekturna and Zelnorm.


Forest Labs
With: Dept. of Justice
When: Sept. 15, 2010
Scoop:
After marketing Levothroid, an unapproved thyroid drug, Forest Labs received its penalty, to the tune of $313 million. The settlement also covered Forest's off-label use of Celexa for children's use.


Allergan
With: Dept. of Justice
When: Sept. 1, 2010
Scoop: Allergan's
$600 million DoJ settlement was broken into two parts: $375 million in fines and $225 million in civil penalties, all of which stemmed from its off-label use of Botox for headaches, pain management and cerebral palsy.


Elan
With: U.S. Attorney's Office in Massachusetts
When: July 15, 2010
Scoop: The Irish drugmaker received its
$203.5 million fine for its marketing tactics of Zonegran, an epilepsy drug. Also, the company's U.S. branch pled guilty to a misdemeanor and the company will enter into a corporate integrity agreement with the HHS Inspector General.


Johnson & Johnson
With: Department of Justice
When: April 29, 2010
Scoop: Though J&J's more infamous woes stem from its phantom recalls, two of the troubled drugmaker's subsidiaries received a $81 million penalty for
off-label promotions of Topamax, an epilepsy drug.


AstraZeneca
With: U.S. Attorney's office in Philadelphia
When: April 27, 2010
Scoop: In the same week as the J&J settlement,
AstraZeneca was hit with a $520 million penalty for its antipsychotic, Seroquel. The company misled doctors and patients about the drug's safety.


 


 


Abbott
With: Twenty-three states
When: Jan. 7, 2010
Scoop: In a case involving
23 different states, Abbott Laboratories and its partner, Fournier Industrie et Sante, were ordered to pay $22.5 million for blocking the states from obtaining a cheaper alternative for its cholesterol drug, TriCor.


Eli Lilly
With: Connecticut
When: Sept. 29, 2009
Scoop: Thirteen states total had filed suit against Eli Lilly for Zyprexa marketing issues, but the company was ordered to pay
$25 million to Connecticut in this ruling.


Eli Lilly
With: West Virginia Attorney General
When: August 21, 2009
Scoop: In another Zyprexa case, West Virginia Attorney General Darrell McGraw
levied $2 billion in fines against Eli Lilly. As the motion put it, "At $5,000 per violation, therefore, the State is attempting to fine Lilly approximately $2 billion for use of a product label that was approved by the FDA." In the end, the company agreed to $22.5 million in fines.


Merck
With: 35 states' attorney offices
When: July 15, 2009
Scoop: Merck escaped relatively unscathed from
35 state investigations against the Enhance study of Vytorin, only paying $5.4 million without admitting fault in the cases.


Sanofi-aventis
With: Department of Justice
When: May 28, 2009
Scoop: In an agreement with the federal government, Sanofi paid
$95.5 million total, doled out to the feds, state Medicaid agencies and other public health service agencies, all for its subsidiary Aventis' nasal spray price inflation between 1995 and 2000.


GlaxoSmithKline
With: U.S. Attorney's office in Colorado
When: Jan. 29, 2009
Scoop: After seven years of off-label promotion on nine of its best-selling drugs, GSK was
ordered to pay $400 million to the U.S. Attorney's office in Colorado.


Pfizer
With: Department of Justice
When: Jan. 26, 2009
Scoop: Right after acquiring Wyeth, Pfizer dropped a bombshell in its fourth quarter earnings report;
the company was charged $2.3 billion, the largest fine levied on our list, for off-label promotions of its COX-2 drugs. That settlement lowered the company's 2008 net income by 90 percent.


Eli Lilly
With: Department of Justice
When: Jan. 15, 2009
Scoop: In the first Zyprexa settlement (and one of three on our list), the Department of Justice levied
$1.4 billion in fines against Eli Lilly. Also, as part of the settlement, the company pled guilty to a misdemeanor: violating the Food, Drug and Cosmetic Act.





http://www.fiercepharma.com/story/japanese-authorities-arrest-ex-novartis-employee-data-manipulation-scandal/2014-06-11?utm_medium=nl&utm_source=internal


Japanese authorities arrest ex-Novartis employee in data-manipulation scandal


June 11, 2014 | By Tracy Staton



Here's another overseas arrest of a Big Pharma ex-employee. Japanese police brought in Nobuo Shiraishi, a former Novartis (
$NVS) worker linked to discredited studies of the company's blood pressure drug Diovan. Shiraishi is suspected of violating the country's pharma laws by providing false data to researchers, Tokyo prosecutors said in a statement.


As Reuters reports, the allegedly manipulated data was intended for use in advertising Diovan. Japan's false-advertising laws prescribe stiff penalties, including up to two years in prison, a fine of up to 2 million yen ($19,600) or both. The government has already filed a criminal complaint against the company, accusing its Japanese unit of exaggerated Diovan advertising.


It's the latest development in an ongoing probe into Novartis study data. The scandal kicked off with the retraction of Diovan studies, on worries that Novartis employee involvement in the research skewed the results. More recently, scrutiny fell on leukemia drug research; Novartis sales reps allegedly worked directly with researchers and processed data in a study of leukemia drug side effects--including the side effects of Novartis' treatments Gleevec and Tasigna.


Novartis has cracked down hard on its employees as the allegations unfolded. The Swiss drug maker cut executive pay, dismissed two of its Japanese unit's top employees, and launched its own internal probe. The company also apologized publicly for its role in the data scandals.


Its response to Shiraishi's arrest included another mea culpa: "Regarding the arrest of our former employee, we take this seriously," the company said in a statement (as quoted by Reuters). "We will continue to cooperate completely with the investigating authorities, and we again apologize deeply for the concern and difficulties this has caused."


Meanwhile, Japanese media reports that Novartis' internal investigation unearthed 10,000 cases of leukemia drug side effects that were never disclosed. The 10,000 cases stretch back to 2002 and include some that should have been reported to the Japanese government. [Why should the company which is motivated to hide side effects be given the task of reporting them?]  The company tells Japan Times that it's now examining the side-effects data in detail. Japanese officials were already looking into allegations involving 3,000 side-effect reports collected last year.


[The same type of reports of side effects sent to the manufacturer by physician on a voluntary basis operates in the US and Europe.  The manufacturer reviews the reports, categorizes them, comments on them, and eventually sends them to the required regulatory agency, maybe.  Most doctors don’t bother to fill out the voluntary reporting form on their own time.  Many side effects are considered a part of the disease.  And the company is given the task of categorizing the side effects as to whether it is consider a result of the medication—more wiggle room. Review and penalties are a fašade.]


^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^



Novartis side effects unreported


http://www.japantimes.co.jp/news/2014/06/10/national/novartis-side-effects-unreported/#.U6z5s_ldV8E


The Japan New Times, June 10, 2014


Tokyo-based Novartis Pharma K.K. said employees have failed to report up to 10,000 cases of serious side effects caused by its drugs for leukemia and other diseases to an internal department since 2002.


The Japanese unit of Swiss drug giant Novartis AG found this as a result of an in-house probe covering all 4,500 employees that was conducted following the revelation that workers were improperly involved in clinical trials for leukemia drugs at medical institutions.


The reporting failure violated in-house rules, according to the company.


The 10,000 cases are believed to include ones that should have been reported to the government. All of the cases had been reported to the Health, Labor and Welfare Ministry by Monday, the company claimed. Novartis Pharma said the unreported cases are now being examined in detail.


^^^^^^^^^^^^^^^^^^^^^^^^^^^^^


Japan has applied a law governing false advertising to slap the wrists of a few department heads.  In an industry where billion dollar fines are considered a business expense, the $19,600 fine is a joke.  Fine is for under-reporting side effect of a Novartis blood pressure medicine. 


http://www.fiercepharma.com/story/japan-files-criminal-action-against-novartis-exaggerated-diovan-advertising/2014-01-08


Japan files a criminal complaint against Novartis for 'exaggerated' Diovan advertising


January 8, 2014 | By Tracy Staton


The Diovan data scandal in Japan has spawned a criminal action against Novartis ($NVS). The country's Health Ministry lodged a complaint against Novartis today, accusing its domestic unit of exaggerated advertising. 


It's the first-ever action of its kind against a drugmaker, the Japan Times reports. Under the country's pharmaceutical law, anyone found guilty of exaggerated advertising can face up to two years in prison or a fine of up to 2 million yen (about $19,400).


The criminal complaint isn't unexpected; Japanese authorities warned as early as September that Novartis could face criminal penalties for its Diovan promotions. The advertising in question was based on studies suggesting that Diovan (valsartan), a drug for high blood pressure, could prevent strokes and angina.


The problem is that a former Novartis employee had been involved in reporting the stroke-prevention data--and did not disclose his affiliation with the drug maker. Tokyo's Jikei University School of Medicine retracted its Diovan research, published in The Lancet, after determining that some of the data was fabricated. Kyoto Prefectural University of Medicine also said its Diovan data was incomplete.


Novartis has said that it wasn't aware that the studies included fabricated data. But the company cracked down on its Japanese operation in the wake of the scandal. In October, Novartis pharma chief David Epstein cut local executives' pay by 30% and apologized publicly. "I would once again like to apologize for Novartis' involvement in this issue," Epstein said at the time. "Controls have been put in place to ensure this cannot happen again."


Authorities say Novartis has cited the questionable data, supporting Diovan as a preventive tool, about 700 times in ads since 2006.[this would be in advertisments in medical journal.  Moreover, Novartis would write a series of journal articles on their favorable clinical trial.  This retracting 1 journal article of many doesn’t change the message, a message reinforced by copies that Novartis bought from the journal of the published article and distributed to 10s of thousands of doctors.] 


 


 



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Disclaimer:  The information, facts, and opinions provided here is not a substitute for professional advice.  It only indicates what JK believes, does, or would do.  Always consult your primary care physician for medical advice, diagnosis, and treatment. 




Positive bias averaged 32% (range 11 to 69%) in a NEJM article, 2008.  The study of neuroleptic drugs made a comparison of 74 journal articles to the raw data which was obtained by FOIA (Freedom of Information Act) from the FDA. See http://healthfully.org/index/id9.html, or http://content.nejm.org/cgi/content/short/358/3/252