The Ugly Business Of Big Bad Pharma

Being Bad comes naturally to Big Pharma, as evidenced by their history in the marketplace. Over the previous decade or more the pharmaceutical industry has raked up a least 20 billion USD in fines for all kinds of absolutely unconscionable unethical and outright criminal 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. And no one went to jail for this!

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 multi million-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.

The following is a litany of offenses committed by Big Pharma since around 2003, and an ugly rap sheet by any other name. By no means a complete account, it shows  the complete lack of ethics  in an industry that exists ostensibly to improve the lives of those who have suffered the misfortune of some illness or disease. As such, it reveals a disgusting lack of concern for the very people who are at the receiving end of their unscrupulous efforts to bring their products to market, regardless I seems – of whether it would kill them or not. Presumably they would prefer the latter, but that isn’t necessarily a deterrent in the relentless and clearly morally blind quest for obscene profits, the sole raison d’être that whole sorry industry is about.

Most recently, drug-maker Pfizer was fined in December of 2016 a record £84.2m ($107m USD) by the UK’s competition regulator after the price charged to the NHS for an anti-epilepsy drug was increased by up to 2,600%. The CMA also fined the drugs distributor Flynn Pharma £5.2m for charging excessive and unfair prices in the UK for phenytoin sodium capsule.

Before September 2012, Pfizer manufactured and sold phenytoin sodium capsules to UK wholesalers and pharmacies under the brand name Epanutin, and the price was regulated. In September 2012, Pfizer sold the UK distribution rights to Flynn Pharma, debranding the drug and making it generic.The drug was no longer subject to price regulation, leaving Pfizer free to sharply increase the price it charged Flynn, which in turn further raised the price it charged the NHS.

In February of 2014 Endo Health Solutions Inc. and its subsidiary Endo Pharmaceuticals Inc. agreed to pay $192.7 million to resolve criminal and civil liability arising from Endo’s marketing of the prescription drug Lidoderm. As part of the agreement, Endo admitted that it intended that Lidoderm be used for unapproved indications and that it promoted Lidoderm to healthcare providers this way.

In November of 2013 Johnson & Johnson agreed to pay a $2.2 billion fine to resolve criminal and civil allegations relating to the prescription drugs Risperdal, Invega and Natrecor. The government alleged that J&J promoted these drugs for uses not approved as safe and effective by the FDA, targeted elderly dementia patients in nursing homes, and paid kickbacks to physicians and to the nation’s largest long-term care pharmacy provider, Omnicare Inc. As part of the agreement, Johnson & Johnson admitted that it promoted Risperdal for treatment of psychotic symptoms in non-schizophrenic patients, although the drug was approved only to treat schizophrenia.

In December of 2012 the European Commission has fined drug makers Johnson & Johnson and Novartis 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. European Commission Vice-President Joaquin Almunia, in charge of competition policy, said the two companies ‘shockingly deprived patients in the Netherlands, including people suffering from cancer, from access to a cheaper version of this medicine, Xinhua reported.

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. US pharmaceutical firm Johnson & Johnson was fined 10.8 million euros while Novartis of Switzerland was 5.5 million euros.

In December  of 2012 Amgen agreed to pay a $762 million fine to resolve criminal and civil charges that the company illegally introduced and promoted several drugs including Aranesp, a drug to treat anemia. Amgen pleaded guilty to illegally selling Aranesp to be used at doses that the FDA had explicitly rejected, and for an off-label treatment that had never been FDA-approved.

Also in December of 2012 Sarnoff-Aventis agreed to pay $109 million to resolve allegations that the company gave doctors free units of Hyalgan (an injection to relieve knee pain) to encourage those doctors to buy their product. Sanofi lowered the effective price by promising these free samples to doctors, but at the same time got inflated prices from government programs by submitting false price reports, alleged the United States. Medicare and other government health care programs “paid millions of dollars in kickback-tainted claims for Hyalgan,” according to the DOJ announcement.

In October 0f 2012 Boehringer Ingelheim Pharmaceuticals Inc agreed to pay $95 million to resolve allegations that the company promoted several drugs for non- medically accepted uses. These drugs included the stroke-prevention drug Aggrenox, the lung disease drugs Atrovent and Combivent, and Micardis, a drug to treat high blood pressure. The FDA alleged that Boehringer improperly marketed the drugs and “caused false claims to be submitted to government health care programs.”

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 May of 2012 Abbott was fined $1.5 billion in connection to the illegal promotion of the anti-psychotic drug Depakote. Abbott admitted to having trained a special sales force to target nursing homes, marketing the drug for the control of aggression and agitation in elderly dementia patients. Depakote had never been approved for that purpose, and Abbott lacked evidence that the drug was safe or effective for those uses. The company also admitted to marketing Depakote to treat schizophrenia, even though no study had found it effective for that purpose.

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 mis-branding 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.

In April of 2010 AstraZeneca was fined $520 million to resolve allegations that it illegally promoted the anti-psychotic drug Seroquel. The drug was approved for treating schizophrenia and later for bipolar mania, but the government alleged that AstraZeneca promoted Seroquel for a variety of unapproved uses, such as aggression, sleeplessness, anxiety, and depression. AstraZeneca denied the charges but agreed to pay the fine to end the investigation.

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 .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.

In a setback in May 17, 2006 for bio-pharmaceutical 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.

And let us not forget Merck & Co. Vioxx maker Merck 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).

Now,  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 (and more and more at outrageous prices) will actually do that. But, clearly, that is only incidental to the real objective of why they are in business: to make as much money as is 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.

Welcome the world of Big Pharma, where apparently corporate scumbags  rule the roost!  What, you have a better word for them?  Be my guest … You wonder how these folks sleep at night.