Friday, May 20, 2022

Judge Clears Way for Pfizer Whistleblower Lawsuit

A whistleblower lawsuit alleging fraud during Pfizer’s Covid-19 vaccine trials is moving forward, after a district court judge unsealed court papers, including 400 pages of evidence.

Pfizer, one of the largest pharmaceutical companies in the world, has had a troubled history in the last two and a half decades, as a host of lawsuits challenging the efficacy of its drugs and credibility of its claims have won steep civil and criminal penalties.

The drug company has been forced to pay billions of dollars over the years in compensation for medical injuries, false claims 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 2004, 2009 and 2011and 2014.

In the 2009 case—involving one of the highest criminal penalties in history—Pfizer “pled guilty to misbranding Bextra, an anti-inflammatory drug, with the intent to defraud or mislead. The company agreed to pay a record $2.3 billion to settle allegations it improperly marketed Bextra and 12 other medicines,” reported Reuters.

According to court filings, the pharmaceutical company provided doctors with travel arrangements to luxurious resorts to improperly promote the drug, and made misleading claims about the drug’s safety and efficacy, the government said.

The drug was later pulled from the shelves over concerns that it heightened the risk of heart attacks and strokes, the Reuters article said.

In addition to Bextra, the company fraudulently marketed “Geodon, an anti-psychotic drug; Zyvox, an antibiotic; and Lyrica, an anti-epileptic drug. The settlement also resolves allegations that Pfizer paid kickbacks to health care providers to induce them to prescribe these, as well as other drugs,” a Department of Justice press release stated.

Repeat Offender

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

“This historic settlement will return nearly $1 billion to Medicare, Medicaid, and other government insurance programs,” a government spokeswoman said. “Illegal conduct and fraud by pharmaceutical companies puts the public health at risk, corrupts medical decisions by health care providers, and costs the government billions of dollars.”  Just three years later, in Aug. 2012, Pfizer agreed to pay the federal government $60 million to settle allegations that its employees bribed doctors, hospital administrators and regulators in Europe and Asia to win business and boost sales.  The Securities and Exchange Commission attested that Pfizer’s overseas subsidiaries—located in 180 countries—made illegal payments to health care officials in China, Italy, Russia, Croatia and other Eastern European countries.

“As early as 2001, Pfizer sales representatives tried to conceal the bribes by recording them as legitimate business expenses for travel, entertainment and marketing purposes,” the agency said.

Also in 2012, nearly 10,000 lawsuits filed against Pfizer by women who had been diagnosed with breast cancer after taking Prempro, a synthetic form of estrogen, were settled for $1 billion. The drug is still on the market.

Most recently, Pfizer faced about 3,000 “Chantix lawsuits” filed by people who claimed they experienced suicidal thoughts and psychiatric disorders after using Chantix for smoking cessation. The drug was also found to contain dangerously high amounts of varenicline, a carcinogenic. Chantix has since been recalled; in 2014, Pfizer was obligated to set aside about $288 million for liability payments.

In some of the above instances, the company pled guilty to the criminal or civil charges. In other cases, the pharmaceutical giant managed to negotiate settlements in the millions and billions of dollars without actually admitting the charges.

Allegations Of Falsified Data in Covid Vaccine Trials

Pfizer is currently being sued in federal court by a whistleblower alleging serious issues with its Covid vaccine safety trials. These include claims of ‘falsified data’ in the weeks leading up to Pfizer’s 2020 rollout of its vaccine, after it won an FDA-awarded “emergency use authorization” (EUA).

The lawsuit filed by whistleblower Brook Jackson, a trained research auditor, was based on serious lapses of protocol she claimed she observed in her role as regional director of the Ventavia Research Group. This agency and another organization called ICON ran Covid vaccine trial tests for Pfizer at several testing sites in Texas, where 1000 participants were enrolled.

As regional director, Jackson oversaw the drug trials in two of Ventavia’s testing sites, in Fort Worth and Keller. Jackson charged in court filings that the company falsified data, “unblinded” patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial.

[In “double-blinded” trials, neither participants nor staff are aware of who receives the trial drug and who gets the placebo. This is considered vital to a clinical trial that meets the “gold standard.” To “unblind” the participants is viewed as compromising or even disqualifying the trial.]

Jackson filed the complaint in Jan 2021, in the U.S. District Court, Eastern District of Texas, under the False Claims Act. This legislation, which dates back to the Civil War era, rewards whistleblowers who file anti-fraud lawsuits against contractors on behalf of the government.

The law, originally enacted in response to defense contractor fraud during the Civil War, has returned about $67 billion to the U.S. government.

Jackson’s lawsuit includes several charges of fraud and retaliation on the part of both Ventavia and Pfizer. The complaint remained under seal until March, when U.S. District Court Judge Michael Truncale ordered it released and allowed the case to move ahead.

Pfizer ‘Deliberately Withheld Crucial Information’ About Vaccine Safety

According to Jackson’s complaint, Pfizer, Ventavia and ICON “deliberately withheld crucial information from the United States that calls the safety and efficacy of their vaccine into question.” The lawsuit states that “Defendants concealed violations of both their clinical trial protocol and federal regulations, including falsification of clinical trial documents.”

“Due to [the] Defendants’ scheme, millions of Americans have received a misbranded vaccination which is potentially not as effective as represented,” the complaint said.

Core allegations of Jackson’s lawsuit include claims that Ventavia and Pfizer “used false records or statements” as a basis for Pfizer’s financial claims to Medicare, Medicaid, the Department of Defense and other federal agencies that contracted for millions of vaccine doses.

“The integrity of the entire clinical trial was compromised by the trial protocol violations, false source documents, and the false data that resulted, which calls the vaccine’s EUA into question. Had the United States DoD known of Defendants’ false records, it would not have paid Pfizer,” the lawsuit said.

Prior to filing the lawsuit, Jackson said she had repeatedly informed her superiors of substandard laboratory management, patient safety concerns, and data integrity issues.

She also brought to their attention the company’s poor record-keeping, the unblinding of trial volunteers and staff and the hiring of unqualified personnel. Most seriously, she noted the “improperly diluting” of the vaccine, and the failure to keep the vaccines at recommended temperature,” which is crucial for mRNA vaccines such as Pfizer’s.

While Jackson witnessed misconduct only in Texas where she was employed, “Pfizer and Icon’s oversight failures and fraudulent misconduct by Ventavia bring the entire Pfizer-BioNTech clinical trial into question,” her lawsuit argues.

Photographs and Audio Recordings Expose Violations

Frustrated that no corrective actions were being taken to address the issues she brought to the management’s attention, Jackson began to document the failures and breaches of Pfizer’s protocol at Ventavia. Her evidence encompassed audio recordings, company emails and photographs.

One photo, provided to BMJ journalist Paul Thacker who wrote an expose on the case in November 2021, showed used vaccine needles haphazardly discarded. Another showed vaccine packaging materials with trial participants’ identification numbers printed on the containers and left out in the open, which “unblinded” the participants to personnel.

Shortly after taking photographs of improper clinical practices, Jackson called the FDA hotline to sound an alarm about the rampant issues in the clinical trials at Ventavia. She then followed up with an email to the agency in which she outlined the many breaches of Pfizer’s protocol that she witnessed daily.

These failures included participants being placed in a hallway after injection, unmonitored by clinical staff, and lack of timely follow-up of patients who experienced adverse events.

Other breaches of protocol concerned the vaccines themselves not being stored at proper temperatures, and thus losing potency.

Jackson also noted that participants’ information was often mislabeled, and that Ventavia staff who reported problems of this nature were “targeted.”

Within hours of her email to the FDA, Jackson received a response thanking her for her concerns and notifying her that the FDA could not comment on any investigation that might result.

She was fired by Ventavia the very same day, the lawsuit claims.

FDA Turns Blind Eye

Despite being notified of the problems with Ventavia in September 2020, Pfizer has nevertheless continued its relationship with the Ventavia up to the present, hiring it as a research subcontractor for at least four other trials.

These include the conducting of vaccine trials for children, young adults, pregnant women, as well as trials testing the safety of a booster dose.

In addition, the FDA, despite knowledge of the allegations against Pfizer and Ventavia, went ahead and granted Emergency Use Authorization for the Pfizer vaccine in Nov 2020, including for children 5 to 11 years old.

The BMJ, in turn, was targeted for publishing the expose on the company. Facebook deleted the article and issued warnings to its users not to share it.

Jackson’s lawsuit against Pfizer is being watched very carefully as it moves through the courts. Fraud eviscerates all contracts, legal experts say. Pfizer’s immunity from lawsuits for vaccine injury or death will not hold up if courts find that the pharmaceutical companies falsified or hid vaccine data to conceal safety risks.

The stakes could not be higher for Pfizer and Moderna whose stocks are presently taking a dip compared with expectations, according to Wall Street analyst and former Blackrock portfolio manager Edward Dowd, cited in Desert Review.

It remains to be seen whether this represents a fleeting trend or something more ominous for the pharmaceutical titans, Dowd said, “as public awareness about Covid-19 vaccine injuries and deaths continues to grow.”

 

*****

The Case of The Nigerian Children

In perhaps the most notorious of the lawsuits against Pfizer, Nigeria’s largest state, Kano, sued the pharmaceutical giant in 2002 for a 1996 botched drug trial that allegedly led to multiple deaths and deformities in children.

The state accused Pfizer of “secretly using children as guinea pigs to test a new Pfizer drug, Trovan, under the guise of a humanitarian gesture.” The government panel called the Trovan fiasco a “clear case of exploitation of the ignorant.”

The saga began twenty-five years ago, when Pfizer sent a team to Kano, Nigeria, during a meningitis outbreak. “They conducted an unblinded clinical trial involving 200 children, half of whom were given Trovan and half of whom received the gold standard treatment, Ceftriaxone,” writes the Guardian.

Eleven Nigerian children died, five after receiving Pfizer’s product and six after receiving lower-than-normal doses of the older established drug.

A Washington Post investigation reported that one 10-year-old girl suffering from meningitis was not taken off experimental Trovan and given standard, proven treatments by Pfizer’s trial managers — 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 how 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 with brain damage, paralysis or slurred speech.

Public fury against Pfizer mounted to the point where then Judge Shehu Atiku in Kano ordered arrest warrants for the head of Pfizer in Nigeria, Ngozi Edozien, and the senior officials, Lare Baale and Segun Donguro, after they failed to attend court, according to the Guardian.

Pfizer had argued that meningitis and not its antibiotic had led to the deaths of 11 children and harm to dozens of others. But in 2009, after thirteen years of protracted litigation, the company reached an out-of-court settlement with the Kano state government worth $75 million.

The families of four of the children each collected checks for $175,000 from a compensation trust fund, after submitting DNA samples to show that the dead were their offspring.

A separate whistleblower lawsuit was filed in the case by Pfizer’s former medical director for central research and Yale infectious disease specialist, Juan Walterspiel. The specialist alleged that the company fired him in retaliation for warning before and after the deadly Kano fiasco that the study methods were “improper and unsafe.”

Walterspiel further claimed that Pfizer had bribed Nigerian officials to continue the study and cut safety corners because “stock options and bonuses (were) at stake.”  Pfizer allegedly tried to suppress Walterspiel’s allegations but was forced into a settlement after WikiLeaks published diplomatic cables between Pfizer top brass and Nigerian authorities. The cables allegedly showed that Pfizer had attempted to find incriminating information about a Nigerian prosecutor to pressure him to drop the federal lawsuits against Pfizer.   According to media reports, Pfizer repudiated these charges as “preposterous.”

*****

 

Pfizer Pled Guilty, But Drug Sales Continued to Soar

Strikingly, even after Pfizer was forced to make huge liability payouts over charges of fraud, those moments of ignominy failed to make a significant dent on the company’s global revenues. Many of the Pfizer drugs now known to be problematic or useless not only remain on the market but continue to enjoy lucrative sales.

An example is the drug Neurontin, 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.

“Neurontin rang up sales of billions of dollars in the last decade after doctors began prescribing it for an array of other maladies,” the NY Times noted in 2004.

Dr. David Franklin, a microbiologist and former Harvard research fellow, 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.

Dr. Franklin’s complaint detailed how Pfizer suppressed study results; planted people in medical audiences to ask questions intended to cast Neurontin in a favorable light; lavished perks on doctors, and used psychological profiling of physicians. All these maneuvers contributed in pumping up annual sales of Neurontin in excess of $1billion, which gave it “blockbuster” status.

Franklin said that the company’s “profoundly effective” promotional efforts were able to offset any negative publicity about Pfizer’s deceptive and illegal marketing practices.

Elaborating on this point, John Abramson in Sickening; How Big Pharma Broke American Healthcare, describes how “Pfizer sponsored numerous swanky dinners and held meetings where the pharmaceutical company presented misleading data showing remarkable improvement in many illnesses using Neurontin. But they withheld data “which had shown the drug was significantly worse than placebo.”

According to Abramson, doctors are regularly duped into prescribing expensive drugs with extreme side effects, despite evidence that they don’t work, while major pharmaceutical companies rake in record profits.

Clinical Data ‘Kept Secret’ from Medical Journals

At the core of this issue, notes Abramson, “is a corrupted scientific process in which the raw clinical trial data is kept secret from reviewers and medical journals.” Noting that an increasing amount of medical research is funded by drug companies, the author makes the point that the relentless pursuit of ever-higher profits exerts a corrupt influence on the entire medical industry.

The prevailing incentive is to develop treatments that are profitable, rather than to “determine optimal care,” the author explains. Applied to the man in the street who may be taking meds for bipolar disorder but hears that Neurontin is better for him and decides to switch, this kind of fraudulent information can be life-threatening.

“A lot of people say it’s a benign drug, why make a fuss,” said Franklin. “But it’s not benign when patients exchange an effective, much needed drug for a useless one. That is downright dangerous.”

The shocking aspect of the story is that Pfizer funded a study and knew as early as 1998 that Neurontin didn’t work in bipolar disorder, a BMJ article about the drug notes. “But they didn’t publish the results until two years later. Yet we still see it prescribed for bipolar disorder.”

Ironically, the fate of a whistleblower like Dr. Franklin can be greatly rewarding, but is more often disastrous. The years of litigation, slim chance of winning the lawsuit, and the near certainty of losing one’s job and suffering retaliation and “blackballing,” can be devastating.

On the other hand, victory can bring a huge windfall, as in Franklin’s case. As part of the settlement agreement with Pfizer, the microbiologist received $24.6 million under whistleblowing legislation.

Another example of years of litigation culminating in a huge win for the whistleblower is the “Bextra case,” in which Pfizer was forced in 2009 to pay $2.3 billion for its illegal marketing of the drug.  After six years of exhausting legal wrangling, whistleblower Ed Kopchinski was allotted an impressive portion of that settlement, more than $50 million.

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