By: Ozren Podnar |
Powerful pharmaceutical industry caught red-handed, forced to pay compensations |
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In the past couple of years pharmaceutical companies have been forced to pay over 13 billion dollars in compensations to settle claims by U.S. Department of Justice regarding fraudulent marketing practices, including the promotion of medicines for uses not approved by the Food and Drug Administration (FDA).
Here are some of the most remarcable cases as compiled by the American non-profit organization ProPublica.
Eli Lilly (january 2009)
Eli Lilly paid 1,42 billion dollars to resolve a government investigation into the off-label marketing of the antipsychotic Zyprexa. Although this drug was approved only for certain psychotic disorder, Eli Lilly advertised it as a treatment for senile dementia.
The government also claimed that the company recruited primary care doctors to promote Zyprexa for non-approved uses.
Pfizer (september 2009)
Pfizer paid 2,3 billion dollars in damages, up to then the highest amount for a health care fraud and the highest compensation in a criminal case in the USA.
Pfizer admitted guilt for misbranding the painkiller Bextra with the "intent to defraud or deceive" since it promoted the drug for the treatment of acute pain at doses which FDA had previously determined too high.
AstraZeneca (april 2010)
AstraZeneca paid 520 million dollars to settle claims it illegally marketed the antipsychotic Seroquel. The drug was approved for the treatment of schizophrenia and later for bipolar disorder, but the government claimed AstraZeneca had advertised Seroquel for several non-approved indications such as aggression, insomnia, anxiety and depression.
AstraZeneca denied charges but agreed to pay the compensation to put an end to the investigation.
Merck (november 2011)
Merck agreed to pay 950 million dollars regarding improper promotion of the painkiller Vioxx, which was withdrawn from the market in 2005 after studies found it raised the risk from heart attack.
The company pled guilty for promoting Vioxx as a treatment for rheumatoid arthritis before it was approved for that use. The said compensation was also related to the allegations that Merck made false and deceptive claims about the drug's safety for the heart in order to boost sales.
Boehringer Ingelheim (March 2012)
Tvrtka Boehringer Ingelheim Pharmaceuticals Inc agreed to pay 95 million dollars to resolve allegations it promoted several drugs for medically unapproved uses.
These medications include the drug for the prevention of heart attack Aggrenox, drugs for pulmonary diseases Atrovent and Combivent, and an antihypertensive Micardis.
FDA alleged Boehringer improperly promoted the drugs and "caused false claims to be submitted to government health care programs."
Abbott (May 2012)
Abbott paid a 1.5 billion dollar fine related to the illegal promotion of the antipsychotic Depakote.
Abbott admitted to having trained special sales teams for targeting nursing homes in order to market the drug for the control of aggression and agitation in elderly demented patients.
Depakote was not approved for that purpose and Abbott had no evidence the drug was safe or effective for such use.
The company also admitted it had advertised Depakote for the treatment of schizophrenia although studies had not established its effectiveness in that disease.
GlaxoSmithKline (July 2012)
GlaxoSmithKline paid 3 billion dollars in compensations to settle civil and criminal liabilities related to its promotion of drugs and failure to report safety data.
This has been the largest health care fraud settlement in the pharmaceutical industry. The company pleaded guilty for promoting Paxil for the treatment of depression in patients under 18, although the drug was not approved for that age group.
GlaxoSmithKline also admitted to not having disclosed safety data about the diabetes drug Avandia to the FDA.
Amgen (December 2012)
Amgen agreed to pay the fine of 762 million dollars to settle civil and criminal charges claiming it introduced and promoted several drugs, including Aranesp, designed to treat anemia.
The company pleaded guilty for the illegal promotion of the use of Aranesp in doses specifically prohibited by the FDA and for indications which were never approved by the FDA.
Johnson & Johnson (November 2013)
Johnson & Johnson accepted to pay the compensation of 2,2 billion dollars to settle civil and criminal liabilities related to prescription drugs Risperdal, Invega and Natrecor.
The government claimed J&J had promoted these drugs for uses that the FDA had not declared safe and effective, targeting elderly and demented patients in nursery homes.
The company was also said to have paid kickbacks to physicians and the health care company Omnicare inc. As a part of the agreement, J&J admitted to having advertised Risperdol for the treatment of psychotic symptoms in non-schizophrenic patients, although the drug was only approved for the treatment of schizophrenia.
Endo (February 2014)
Endo Health Solutions Inc. and its subsidiary
Endo Pharmaceuticals Inc. agreed to pay the fine of 192,7 million dollars to settle civil and criminal charges related to promoting the prescription drug Lidoderm.
As a part of the settlement, Endo admitted to having designed the sale of Lidoderm for unapproved indications and that it promoted Lidoderm to health care providers in such a way.
Statin
Thousands of Americans have filed lawsuits against pharmaceutical companies making cholesterol lowering drugs, according to Health Impact News.
Studies keep on confirming that drugs like Lipitor are dangerous and link the increased use of Statin with the onset of diabetes type 2.
Since the American Diabetes Association published a research into this issue, lawsuits have been coming in from all directions. Most of the lawsuits have been brought by women who have developed diabetes because of taking cholesterol lowering drugs.
According to statistical data obtained from various American law firms, over 1,200 lawsuits were filed by September 2014.
It is a fact that cholesterol is not responsible for heart disease and that the cholesterol lowering drugs give no statistical advantage in extending the duration of life nor in reducing the number of heart attacks.
Despite this, Lipitor is by far the most profitable drug in history as its sales have exceded 140 billion dollars.
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