If anyone should have the naive belief that pharmaceutical companies are in business to produce drugs to make or keep people healthy, that is only true to the extent that some of the drugs they bring to market will actually do that. However, that is only incidental to the real objective of why they are in business: to make as much money as possible while remaining to stay out of jail in light of the countless accusations of sleazy deception, massive fraud, wholesale corruption, and the despicable and outright criminal failure to disclose critical health information – which can be assumed to have led to many a patient’s death.
I guess these guys just cannot help themselves: Being Bad comes naturally to Big Pharma, as evidenced by their history in the marketplace. Over the last 10 years the pharmaceutical industry has raked up over 11 billion USD in fines for all kinds of absolutely unconscionable behavior, ranging from publishing fake journals to plug their own products, hiding information about the deadly consequences of their drug during the testing phase, to bribing physicians to promote off-label prescription of anti-depressants leading to increased suicides in children.
The following is the sorry lineup of some of the major fines issued to the pharmaceutical industry since 2006 as a result of their sordid and no doubt criminal business practices:
In December of 2013, the European Commission fined US drug maker Johnson & Johnson and Novartis of Switzerland a combined 16 million euros or about $21.95 million on December 11 for delaying market entry of a cheaper generic painkiller in the Netherlands. The commission said in a statement that Johnson & Johnson’s patent on a patch containing the drug Fentanyl expired in 2005, however in July 2005, it signed a so-called “co-promotion agreement” and paid Novartis to delay launching a generic version. The delay lasted 17 months, and was more profitable for both companies than competing honestly would have been. Fentanyl is a pain-killer 100 times more potent than morphine. It is used notably for patients suffering from cancer.
On July 3, 2012, the Associated Press reported that British drug maker GlaxoSmithKline LLC will pay $3 billion in fines — the largest healthcare fraud settlement in U.S. history — and plead guilty to promoting two popular drugs for unapproved uses and to failing to disclose important safety information on a third in the largest health care fraud settlement in U.S. history, the Justice Department said Monday.
In addition to the fine, Glaxo agreed to resolve civil liability for promoting Paxil, Wellbutrin, asthma drug Advair and two lesser-known drugs for unapproved uses. The company also resolved accusations that it overcharged the government-funded Medicaid program for some drugs, and that it paid kickbacks to doctors to prescribe several drugs including asthma drug Flovent and herpes medicine Valtrex.
Glaxo illegally promoted Paxil for treating depression in children from 1998 to 2003, even though it wasn’t approved for anyone under age 18. The company also promoted Wellbutrin from 1999 through 2003 for weight loss, sexual dysfunction, substance addictions and attention deficit hyperactivity disorder, although it was only approved for treatment of major depression.
In January 2009, Indianapolis-based Lilly, the largest U.S. psychiatric drug maker, pleaded guilty and paid $1.42 billion in fines and penalties to settle charges that it had for at least four years illegally marketed Zyprexa, a drug approved for the treatment of schizophrenia, as a remedy for dementia in elderly patients. In five company-sponsored clinical trials, 31 people out of 1,184 participants died after taking the drug for dementia — twice the death rate for those taking a placebo. Those findings were reported in an October 2005 article in the Journal of the American Medical Association.
Lilly already had a criminal conviction for misbranding a drug when it broke the law again in promoting schizophrenia drug Zyprexa for off-label uses starting in 1999. The medication provided Lilly with $36 billion in revenue from 2000 to 2008. That’s more than 25 times as much as the total penalties Lilly paid in January of 2009.
On Sept. 2, 2009, Pfizer unit, Pharmacia & Upjohn, pleaded guilty to instructing more than 100 salespeople to promote Bextra, a drug approved only for the relief of arthritis and menstrual discomfort, for treatment of acute pains of all kinds.
For this felony, Pfizer paid (then) the largest criminal fine in U.S. history: $1.19 billion. On the same day, it paid $1 billion to settle civil cases involving the off-label promotion of Bextra and three other drugs with the U.S. and 49 states. This follows earlier allegations of criminal conduct by one of Pfizer’s units – Warner-Lambert -in January 2004, for pushing doctors to prescribe an epilepsy drug called Neurontin for uses the Food and Drug Administration had never approved. Pfizer agreed to pay $430 million in criminal fines and civil penalties, and pleaded guilty to two felony counts of marketing a drug for unapproved uses. while assuring the U.S. Attorney’s office that Pfizer and its units would stop promoting drugs for unauthorized purposes.
According to the U.S. Attorney’s office: “At the very same time Pfizer was in our office negotiating and resolving the allegations of criminal conduct in 2004, Pfizer was itself in its other operations violating those very same laws. They’ve repeatedly marketed drugs for things they knew they couldn’t demonstrate efficacy for. That’s clearly criminal.”
The penalties Pfizer paid this year for promoting Bextra off-label were the latest chapter in the drug’s benighted history. The FDA found Bextra to be so dangerous that Pfizer took it off the market for all uses in 2005.
Also in 2009, Forest Laboratories was accused of fraud in 2009 related to Lexapro, an antidepressant. In a civil complaint, federal prosecutors alleged that Forest hid from parents and doctors the results of a study indicating that Lexapro might increase the risk of suicide in kids. Meanwhile, the complaint alleges, the company was promoting another clinical trial — financed by Forest, naturally — showing Lexapro’s effectiveness.
Prosecutors also charged the company with providing kickbacks to doctors in the form of sports tickets, expensive meals, and paid vacations.
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.
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.
The US government has been signaling for the last couple years that pharmaceutical executives should expect to become targeted for prosecution or debarment. This in light of the fact that companies regard the risk of multimillion-dollar penalties as just another cost of doing business. This according to a 2006 study by the University of Southern California’s Keck School of Medicine in Los Angeles for the National Institute of Mental Health of off-label use of drugs, including Zyprexa, for the treatment of Alzheimer’s disease.
However, in their most recent effort in 2011 to oust Forest Laboratories’ Howard Solomon from his 30-year tenure as its CEO – following accusations of fraud in 2009 related to Lexapro – have been unsuccessful. The expression “Thick as Thieves” comes to mind when considering a statement made by the company’s board in defense of Mr. Solomon: “Mr. Solomon has always set a tone of the highest integrity from the top.”
Yes, and the moon is made of green cheese.
And then there is Merck. Vioxx maker Merck & Co. concealed heart attacks suffered by three patients during a clinical study of the now-withdrawn painkiller in a report on the study published in the New England Journal of Medicine in 2000, the journal wrote in an editorial released in August of 2005. The editorial, written by the journal’s editor in chief, Dr. Jeffrey M. Drazen, executive editor Dr. Gregory D. Curfman and a third doctor, also alleges the study’s authors deleted other relevant data before submitting their article for publication. Adverse cardiovascular events include heart attacks, strokes and deaths. “Taken together, these inaccuracies and deletions call into question the integrity of the data on adverse cardiovascular events in this article,” the doctors wrote.
And staying with Merck for a moment, how unethical is this: Merck paid an undisclosed sum to Elsevier to produce several volumes of fake medical journals that had the look of a peer-reviewed medical journal, but contained only reprinted or summarized articles–most of which presented data favorable to Merck products–that appeared to act solely as marketing tools with no disclosure of company sponsorship. The journals -The Australasian Journal of Bone and Joint Medicine, which was published by Exerpta Medica, a division of scientific publishing juggernaut Elsevier, is not indexed in the MEDLINE database.
The claim that Merck had created a journal out of whole cloth to serve as a marketing tool was first reported by The Australian and came to light in the context of a civil suit filed by Graeme Peterson, who suffered a heart attack in 2003 while on Vioxx, against Merck and its Australian subsidiary, Merck, Sharp & Dohme Australia (MSDA).
In a setback in May 17, 2006 for biopharmaceutical company Chiron – now Novartis – a federal judge ruled that the company’s medical-method patent covering a drug-device combination used by cystic fibrosis victims cannot be used to bar use of the treatment in lower concentrations. Chiron had been successful in keeping a significantly more efficient nebulizer technology of the market since 1997 because it would require less of the drug TOBI that they had exclusive rights to. The new “vibrating mesh” nebulizer would cut the treatment duration at least in half (more like from 20 minutes down to 5) encouraging children to comply with their treatment regimens, and are small and portable, unlike the heavy traditional compressor type nebulizers patented by Chiron for the delivery of TOBI.
According to Richard P. Doyle, Jr. of Janssen Doyle LLP, the firm representing the defendants in the case, the ruling marked a huge victory for patients and potentially huge losses for Chiron by allowing doctors to prescribe the eFlow nebulizer manufactured by PARI of Germany: “This is a rape and pillaging case on the part of Chiron,” said Doyle. “I’ve never run into somebody so evil. Chiron spent millions of dollars to keep this new technology off the market simply because it would hurt sales.”
You wonder how these folks sleep at night, don’t you?