Wednesday, Feb 1, 2023

Despite Racketeering, Bribery Charges, Major Drug Companies Beat The Rap 

 

Despite repeated DOJ findings of corrupt marketing by some of the world’s biggest pharmaceutical giants, major drug companies continue to circumvent responsibility for much of their wrongdoing and to enjoy great public trust.

The rap sheets for some of the wealthiest drug companies go back many years, as will be seen below. Yet the billions of dollars they have been forced to pay out in penalties for their misconduct are dwarfed by lucrative profits rolling into the companies’ coffers from ill-gotten gains.

Despite the public disgrace in being repeatedly caught breaking the law, the drug manufacturers have continued to prosper. As witnessed during the Covid-19 pandemic—they have even managed to reinvent themselves as humanity’s ‘saviors.’

A History Stained with Alleged Criminal Neglect

Pfizer CEO Albert Boula claimed during a recent interview that a group of medical professionals intentionally circulating “misinformation” critical of the Pfizer mRNA shot were “criminal.”

The Pfizer CEO must have forgotten the history of his own company. That landscape is stained with tens of thousands of lawsuits alleging criminal neglect and intentional wrongdoing, in marketing dangerous drugs and failing to alert consumers to their life-threatening risks.

Since 2002, the company and its subsidiaries have been assessed $3 billion in criminal convictions, civil penalties and jury awards, writes the Corporate Research Project. These payments were granted as compensation for medical injuries, for false claims by the company, and for hiding research that could hurt its marketing initiatives.

Other payments were penalties for bribing doctors and medical corporations to prescribe and promote Pfizer-manufactured drugs.

Some of the most publicized of these cases were settled in 2001, 2002, 2009, 2010, 2012, 2013 and 2017, as described below.

But the shame and monetary price of having its crimes exposed have not deterred the drug giant. It’s as though the penalties and payouts are all part of the acceptable cost of “doing business.”

‘Children Were Used as Human Guinea Pigs’

In 1996, Pfizer gave the experimental drug Trovan to 200 Nigerian children ill with meningitis, without informing their parents that an approved cure already existed, or that their children were subjects of a medical experiment.

Eleven children died. Many others suffered brain damage, organ failure, or paralysis.

A Washington Post investigation reported that one 10-year-old girl suffering from meningitis was not taken off experimental Trovan and given the alternative proven treatment by Pfizer’s trial managers — even when it was clear that her condition was deteriorating. One of her eyes froze. She lost strength and then died.

It was later claimed that Pfizer did not have proper consent from parents to use an experimental drug on their children, and questions were raised over the deviant ways the trials were operated.

Legal action filed against the company alleged that some participants received a dose lower than recommended with possible intent to manipulate the results, leaving many children seriously and permanently impaired.

In 2001, Pfizer was sued on behalf of 30 of these Nigerian families who alleged their “children were used as human guinea pigs.” The families claimed Pfizer violated the Nuremberg Code and exposed their children to “cruel, inhuman, and degrading treatment.” The case was later dropped by Nigeria’s attorney general.

Subsequently, in 2010, leaked State Department cables alleged that Pfizer had hired investigators to dig up evidence of corruption to blackmail Nigeria’s Attorney General into dropping the $7 billion lawsuit against Pfizer, according to the Guardian.

Ultimately, Pfizer agreed to a vastly reduced settlement of $75 million to the parents of the injured children and those who had died after taking the experimental medication.

Pfizer Diabetes Drug Destroyed Liver

In December 2001, Pfizer agreed to settle a lawsuit over the diabetes drug Rezulin after a jury awarded $43 million to a Texas woman who said it destroyed her liver. The patient was forced to put herself on a transplant waiting list after she took Rezulin for two months.

The settlement was the first of what became a series of payouts involving a drug that has been blamed for scores of deaths and serious liver failures worldwide.

The Rezulin controversy also implicated the FDA, which, according to a Los Angeles Times report, gave the drug fast-track approval despite concerns within the agency over its safety.

It is no secret that federal health agencies in the United States received at least 65 percent of their annual budget from the pharmaceutical companies they are supposed to regulate, which creates unavoidable conflicts of interest for the regulators.

“Drug companies have a fiduciary legal obligation to produce profit for their shareholders. They do not have a legal obligation to give you the best treatment,” commented renowned British cardiologist Dr. Aseem Malhotra on an appearance on Fox News. “But the real scandal is that these regulators who are legally obligated to their fellow citizens fail to prevent misconduct by the drug industry.”

Pfizer Hormone Replacement Therapy Drugs Linked to Cancer

In 2012, nearly 10,000 lawsuits filed against Pfizer by women who had been diagnosed with breast cancer after taking Prempro, were settled for $1.2 billion.

Prempro, a synthetic form of estrogen, was used by millions of women in hormone replacement therapy, promoted for its ability to relieve certain health conditions after the child-bearing years.

The Prempro settlements came after six years of litigation, in which several plaintiffs were awarded tens of millions of dollars. The award includes punitive damages for the drug maker’s actions in withholding information about the risk of breast cancer from Prempro.

Prempro contains a combination of the drugs Provera and Premarin that have controversial safety profiles, and was originally developed by Wyeth. In 2009, the company was bought out by Pfizer.

Most of the complaints about severe side effects were filed after a 2002 study by the National Institutes of Health found that women receiving hormone replacement therapy (HRT) were at a higher risk of breast cancer, strokes and heart attacks.

By that time, Prempro and other HRT drugs had been used by more than 6 million women.

‘Stop-Smoking’ Drug Triggered Suicidal Thoughts

In 2017, Pfizer faced about 3,000 “Chantix lawsuits” filed by people who claimed they experienced suicidal thoughts and psychiatric disorders after using Chantix for breaking their smoking habits.

The drug assists with smoking cessation by blocking nicotine receptors in the brain, reducing cravings and decreasing the pleasurable effects of tobacco products.

A stirring case about the side effects of Chantix was described in the Guardian Australia concerning the death of a 22-year old man.

In a Brisbane, Australian court, “coroner John Hutton testified that Chantix contributed to the death of 22-year-old Timothy John Oldham, who took his own life soon after he began taking the drug to help him quit smoking,” reported Guardian Australia.

“The coroner’s inquest heard that on a drive back from the Gold Coast just hours before his death, Timothy had asked his mother, Mrs. Phoebe Oldham, ‘Mum, do you think I should give up the Chantix? It’s making me feel strange.’”

“I said to him, ‘Timothy, if it’s helping you to give up smoking, maybe you keep it up,’” Mrs. Oldham told the inquest. She noted that the Chantix packaging “did not contain warnings for any potential adverse effects.”

The night before, her son’s behavior had been troubling, Mrs. Oldham told the inquest. She found Timothy sitting on the floor, talking about people coming to get him. She stayed with him all night and made sure he was safe. But the next day she found a taped message on a voice recorder for his mother on the kitchen bench.

“Mum, I love you with all my heart…” the voice message said. “I know it doesn’t make sense right now but it’s for the best, trust me. I’m losing my mind. I’m going crazy. I love you.”

No Warnings About Dangerous Side Effects

When coroner Hutton asked Pfizer’s legal counsel why there was no consumer medicine information leaflet included with in the packaging, he was told, “It’s to ensure the currency of the document, your honor. It’s available in electronic form.”

The coroner cut him off. “When I get my drugs, I don’t go to the computer and start looking up the drugs,” he said curtly. “I rely on the manufacturer to put the updated version of the warnings in the box.”

Mrs. Oldham began circulating a petition which asked for on-the-box warning labels on Chantix packaging and garnered 49,000 signatures, the Guardian article said.

“His death still hurts so deep,” she wrote at the top of the petition. “After taking the anti-smoking drug ‘Chantix’ for just 8 days, my beautiful boy is gone. But despite reports of so many suicides linked to Chantix over seven years [one estimate puts the number at 206], there still aren’t proper side-effect warnings.”

In the United States, Pfizer made out-of-court settlements to 2,700 complainants totaling $288 million after a 2013 class action made a compelling case that Chantix raised the risk of suicide.

In 2014, there was a strengthening of the “black box” warning on the drug packaging alerting users to serious side effects. Chantix has since been recalled.

Neurontin Drug Sales Continue to Soar After Plaintiffs’ Victory

Many of the Pfizer drugs now known to be harmful remain on the market and continue to enjoy lucrative sales.  One of these, Neurontin, was FDA was approved for epilepsy. Pfizer trained its staff to promote this drug for at least 11 off-label uses, including bipolar disorder, migraines, and alcohol withdrawal seizures, the British Medical Journal stated.​

“Even after Pfizer pled guilty in 2002 to numerous civil and criminal charges for illegally marketing the drug, and agreed to pay a $430 million criminal fine, sales of the drug continue to soar for off-label purposes it was not intended for,” wrote the BMJ.

A Harvard researcher, Dr. David Franklin, filed a whistleblower suit under the False Claims Act in 1996, that shed light on this phenomenon. He charged the company with using “fraudulent scientific evidence” to promote off-label uses of Neurontin, the BMJ article reported.

Franklin’s testimony detailed how Pfizer suppressed study results, lavished perks on doctors, and used other promotional efforts to counter any negative publicity about Pfizer’s deceptive practices.

All these maneuvers contributed in pumping up annual sales of Neurontin in excess of $1billion, keeping this drug a strong seller despite FDA warnings about it causing serious breathing problems.

The Bextra Scandal 

Despite the public disgrace and the dropping of company stock values after their executives have been repeatedly caught breaking the law, large pharmaceutical companies have easily rebounded.

This may be partially because federal prosecutors have often backed off from imposing the kind of penalties that might seriously hurt, or even bankrupt the largest drug outfits.

Just as the giant banks on Wall Street were deemed too big to fail, companies like Pfizer, for example, have been considered too big to nail.

A prime example of this mindset was seen in the 2009 Bextra scandal, when Pfizer was charged with major health care fraud. Bextra was part of a new class of Pfizer-issued painkillers known as Cox-2 inhibitors that were supposed to be safer than generic drugs, but at 20 times the price of ibuprofen.

Pfizer planned to market the drug for acute post-surgical pain, although the FDA had refused to grant approval for this use, citing the danger it posed to patients at risk of heart attack and strokes.

But with billions of dollars of profits at stake, Pfizer executives across the country went on a Bextra marketing blitz, targeting anesthesiologists, foot surgeons, orthopedic surgeons and oral surgeons. “Anyone that used a scalpel for a living,” one district manager advised in a document prosecutors would later cite.

Soon, amid reports of heart attacks and life-threatening skin disorders allegedly caused by the drug, the company was faced with an avalanche of lawsuits.

In addition to stroke and heart attack problems, Bextra users had also suffered severe allergic reactions to the drug, including Stevens Johnson Syndrome (SJS), and toxic epidermal necrolysis which causes the patient’s skin to peel off, leading to loss of fluids and risk of infection These side effects have been known to cause catastrophic injury as well as death.

Pharmacia, Inc Takes the Rap for Pfizer

Instead of charging Pfizer with the alleged crimes, prosecutors charged a company affiliate, Pharmacia Inc., “essentially a Pfizer-owned shell company whose only function was to plead guilty,” a CNN special investigation found.

Prosecutors justified this sleight of hand with the argument that since federal law prohibits any company convicted of health care fraud from doing business with Medicare and Medicaid, convicting Pfizer on fraud charges could effectively bankrupt the company.

Pfizer’s collapse would trigger collateral damage that would impact too many other innocent people, prosecutors reasoned. Disrupting the flow of Pfizer drugs to Medicare and Medicaid patients would harm them and also cause significant losses for Pfizer shareholders.

“We have to ask whether by excluding the company [from Medicare and Medicaid], are we harming our patients?” questioned Lewis Morris of the Department of Health and Human Services [HHS] at a news conference.

Imagine being charged with a crime, but an imaginary friend takes the rap for you. That is essentially what happened in the Bextra case.

More than a story about “tough, effective law enforcement,” as the FBI’s Criminal Investigative Division praised their handling of the case, Bextra is a story about the power major pharmaceutical companies continue to wield even when they’ve been caught breaking laws intended to protect Americans.

As a result of the feds’ ruling, it was Pharmacia Inc., a Pfizer subsidiary, that was ‘punished’ by being excluded from doing business with Medicare.  Pfizer, for its part, made the payouts while retaining all its privileges.

Hollow Handshaking

“The world’s biggest drugmaker was slapped with the huge fines after being deemed a repeat offender in pitching these drugs to patients and doctors for unapproved uses,” a Reuters article said.

“The drug company paid out $2.3 billion in fines, penalties and settlements to claimants, to resolve allegations it improperly marketed Bextra and 12 other medicines. These included Geodon, an anti-psychotic drug; Zyvox, an antibiotic; and Lyrica, an anti-epileptic drug.”

A DOJ press release announced with pride that the “American pharmaceutical giant Pfizer Inc. and its subsidiary Pharmacia Inc. have agreed to pay $2.3 billion, the largest health care fraud settlement in the history of the Department of Justice.”

The hand-shaking in the DOJ obscured the true victory here, which was clearly Pfizer’s. The drug company was allowed to hold onto its most lucrative ace card: it was free to continue selling its products to federal health programs.

“After paying out the fines and jury awards, Pfizer lost the equivalent of a mere three months’ profit,” a CNN special report summed up.

*****

Pfizer Promises To Cease Illegal Promotion of Drugs

The 2009 Bextra scandal was only one of many shocking offenses that has tarnished Pfizer’s image. Just three years later, the drug manufacturer was back in the dock, this time on DOJ charges of bribery.

“Pfizer admitted that between 1997 and 2006, it paid more than $2 million of bribes to government officials in Bulgaria, Croatia, Kazakhstan and Russia,” noted a press release issued by the DOJ. “Pfizer also admitted that it made more than $7 million in profits as a result of the bribes.”

“For three years, Pfizer employees and government officials in Italy and six other countries provided free cell phones, photocopiers, printers and televisions to doctors. They arranged for vacations and even made direct cash payments (under the guise of lecture fees and honoraria), in return for promises by doctors to recommend or prescribe Pfizer’s products, a DOJ statement said.

In a criminal complaint issued by the Securities and Exchange Commission (SEC), investigators laid out detailed charges for a total of eight countries: Bulgaria, China, Croatia, Czech Republic, Italy, Kazakhstan, Russia, and Serbia.

Pfizer employees went out of their way to falsely book the expenses under “misleading” labels like “Professional Training,” and “Advertising in Scientific Journals,” the SEC stated.

Pfizer’s penalty of $60.2 million is roughly half a percent of the company annual profits that exceed $10 billion a year, notes CorporateWatch.com.

A minor expense. Just the cost of doing business.

*****

Epidemic of Heart Attacks Tied to Vioxx

With the Bextra verdict, Pfizer held the distinction of being slapped with the highest criminal penalties ever in the country–$2.3 billion. But in 2007, it lost that honor to its rival, Merck.

Merck was forced into a settlement more than twice as big for devastating side effects caused by its painkiller Vioxx, a drug it touted as superior to older painkillers because it caused no gastrointestinal problems.

A study launched by the company had revealed the drug’s dangerous profile, as it showed Vioxx could double the risk of heart attacks and strokes. Marketers at Merck ignored the red flags, apparently deciding that calling attention to them might hurt the company’s competitive edge over the rival drug, Celebrex.

Five years after Vioxx’s launch, Merck bowed to rising consumer complaints of cardiovascular side effects and withdrew the drug from the market. By that time, reported the Lancet, as many as 88,000 people had suffered heart attacks after taking the blockbuster pain-killer, and an estimated 38,000 had died.

Three years and nearly 27,000 lawsuits later, Merck agreed to pay $4.85 billion to settle the claims of a class action lawsuit representing over a thousand people.

The first claimant to file a lawsuit against the pharmaceutical giant over Vioxx was Texas resident Carol Ernst, whose 59-year-old husband started taking Vioxx for arthritic pain in his hands. Less than eight months later, he died in his sleep of a heart arrhythmia.

Based on persistent rumors about Vioxx, Carol suspected the drug was responsible. She became the first of tens of thousands of consumers who sued Merck over allegations that the company had concealed information about the drug’s serious cardiovascular risks, in order to protect sales.

The trial ended with a Texas Jury awarding Carol a stunning $253 million. That award was later reduced to $26 million under Texas damage law. But this case and subsequent court victories of numerous Vioxx plaintiffs convinced Merck to cut its potential losses and agree to the $4.85 billion settlement to resolve all class-action claims.

 

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