Putting Big Pharma on Trial in the COVID-19 Era, Part 2

Guest author Rebecca Strong describes Pharma's entanglements with the federal government

Yesterday I published a guest post from freelance journalist Rebecca Strong. It seems the file many have been too large for some email servers, so here is the link to Part 1 of this series in case you did not see it in your inbox yesterday:

Putting Big Pharma on Trial in the COVID-19 Era, Part 1

I am happy today to publish here Part 2 of Strong’s excellent investigative piece on the influence of big Pharma. Stay tuned for Parts 3 and 4 coming soon. —Aaron Kheriaty

“Nurse prepares to vaccinate children” by World Bank Photo Collection is licensed under CC BY-NC-ND 2.0

Big Pharma Lawsuits, Scandals, and Cover-Ups

While the OxyContin craze is undoubtedly one of the highest-profile examples of big pharma’s deception, there are dozens of other stories like this. Here are a few standouts:

In the 1980s, Bayer continued selling blood clotting products to third-world countries even though they were fully aware those products had been contaminated with HIV. The reason? The “financial investment in the product was considered too high to destroy the inventory.” Predictably, about 20,000 of the hemophiliacs who were infused with these tainted products then tested positive for HIV and eventually developed AIDS, and many later died of it.

In 2004, Johnson & Johnson was slapped with a series of lawsuits for illegally promoting off-label use of their heartburn drug Propulsid for children despite internal company emails confirming major safety concerns (as in, deaths during the drug trials). Documentation from the lawsuits showed that dozens of studies sponsored by Johnson & Johnson highlighting the risks of this drug were never published.

The FDA estimates that GSK’s Avandia caused 83,000 heart attacks between 1999 and 2007. Internal documents from GSK prove that when they began studying the effects of the drug as early as 1999, they discovered it caused a higher risk of heart attacks than a similar drug it was meant to replace. Rather than publish these findings, they spent a decade illegally concealing them (and meanwhile, banking $3.2 billion annually for this drug by 2006). Finally, a 2007 New England Journal of Medicine study linked Avandia to a 43% increased risk of heart attacks, and a 64% increased risk of death from heart disease. Avandia is still FDA approved and available in the U.S.

In 2009, Pfizer was forced to pay $2.3 billion, the largest healthcare fraud settlement in history at that time, for paying illegal kickbacks to doctors and promoting off-label uses of its drugs. Specifically, a former employee revealed that Pfizer reps were encouraged and incentivized to sell Bextra and 12 other drugs for conditions they were never FDA approved for, and at doses up to eight times what’s recommended. “I was expected to increase profits at all costs, even when sales meant endangering lives,” the whistleblower said.

When it was discovered that AstraZeneca was promoting the antipsychotic medication Seroquel for uses that were not approved by the FDA as safe and effective, the company was hit with a $520 million fine in 2010. For years, AstraZeneca had been encouraging psychiatrists and other physicians to prescribe Seroquel for a vast range of seemingly unrelated off-label conditions, including Alzheimer’s disease, anger management, ADHD, dementia, post-traumatic stress disorder, and sleeplessness. AstraZeneca also violated the federal Anti-Kickback Statute by paying doctors to spread the word about these unapproved uses of Seroquel via promotional lectures and while traveling to resort locations.

In 2012, GSK paid a $3 billion fine for bribing doctors by flying them and their spouses to five-star resorts, and for illegally promoting drugs for off-label uses. What’s worse — GSK withheld clinical trial results that showed its antidepressant Paxil not only doesn’t work for adolescents and children but more alarmingly, that it can increase the likelihood of suicidal thoughts in this group. A 1998 GSK internal memo revealed that the company intentionally concealed this data to minimize any “potential negative commercial impact.”

In 2021, an ex-AstraZeneca sales rep sued her former employer, claiming they fired her for refusing to promote drugs for uses that weren’t FDA-approved. The employee alleges that on multiple occasions, she expressed concerns to her boss about “misleading” information that didn’t have enough support from medical research, and off-label promotions of certain drugs. Her supervisor reportedly not only ignored these concerns but pressured her to approve statements she didn’t agree with and threatened to remove her from regional and national positions if she didn’t comply. According to the plaintiff, she missed out on a raise and a bonus because she refused to break the law.

At the top of 2022, a panel of the D.C. Court of Appeals reinstated a lawsuit against Pfizer, AstraZeneca, Johnson & Johnson, Roche, and GE Healthcare, which claims they helped finance terrorist attacks against U.S. service members and other Americans in Iraq. The suit alleges that from 2005–2011, these companies regularly offered bribes (including free drugs and medical devices) totaling millions of dollars annually to Iraq’s Ministry of Health in order to secure drug contracts. These corrupt payments then allegedly funded weapons and training for the Mahdi Army, which until 2008, was largely considered one of the most dangerous groups in Iraq.

Another especially worrisome factor is that pharmaceutical companies are conducting an ever-increasing number of clinical trials in third-world countries, where people may be less educated, and there are also far fewer safety regulations. Pfizer’s 1996 experimental trials with Trovan on Nigerian childrenwith meningitis — without informed consent — is just one nauseating example. When a former medical director in Pfizer’s central research division warned the company both before and after the study that their methods in this trial were “improper and unsafe,” he was promptly fired. Families of the Nigerian children who died or were left blind, brain damaged, or paralyzed after the study sued Pfizer, and the company ultimately settled out of court. In 1998, the FDA approved Trovan only for adults. The drug was later banned from European markets due to reports of fatal liver disease and restricted to strictly emergency care in the U.S. Pfizer still denies any wrongdoing.

But all that is just the tip of the iceberg. If you’d like to dive a little further down the rabbit hole — and I’ll warn you, it’s a deep one — a quick Google search for “big pharma lawsuits” will reveal the industry’s dark track record of bribery, dishonesty, and fraud.

In fact, big pharma happens to be the biggest defrauder of the federal government when it comes to the False Claims Act, otherwise known as the “Lincoln Law.” During our interview, Panara told me she has friends still working for big pharma who would be willing to speak out about crooked activity they’ve observed, but are too afraid of being blacklisted by the industry. A newly proposed update to the False Claims Act would help to protect and support whistleblowers in their efforts to hold pharmaceutical companies liable, by helping to prevent that kind of retaliation and making it harder for the companies charged to dismiss these cases. It should come as no surprise that Pfizer, AstraZeneca, Merck, and a flock of other big pharma firms are currently lobbying to block the update. Naturally, they wouldn’t want to make it any easier for ex-employees to expose their wrongdoings, potentially costing them billions more in fines.

Something to keep in mind: these are the same people who produced, marketed, and are profiting from the COVID-19 vaccines. The same people who manipulate research, pay off decision-makers to push their drugs, cover up negative research results to avoid financial losses, and knowingly put innocent citizens in harm’s way. The same people who told America: “Take as much OxyContin as you want around the clock! It’s very safe and not addictive!” (while laughing all the way to the bank).

So, ask yourself this: if a partner, friend, or family member repeatedly lied to you — and not just little white lies, but big ones that put your health and safety at risk — would you continue to trust them?

To be continued…