The Anatomy Of Big Pharma’s Political Reach
They keep telling us to “trust the science.” But who paid for it?
After graduating from Columbia University with a chemical engineering degree, my grandfather went on to work for Pfizer for almost two decades, culminating his career as the company’s Global Director of New Products. I was rather proud of this fact growing up — it felt as if this father figure, who raised me for several years during my childhood, had somehow played a role in saving lives. But in recent years, my perspective on Pfizer — and other companies in its class — has shifted. Blame it on the insidious big pharma corruption laid bare by whistleblowers in recent years. Blame it on the endless string of big pharma lawsuits revealing fraud, deception, and cover-ups. Blame it on the fact that I witnessed some of their most profitable drugs ruin the lives of those I love most. All I know is, that pride I once felt has been overshadowed by a sticky skepticism I just can’t seem to shake.
In 1973, my grandpa and his colleagues celebrated as Pfizer crossed a milestone: the one-billion-dollar sales mark. These days, Pfizer rakes in $81 billion a year, making it the 28th most valuable company in the world. Johnson & Johnson ranks 15th, with $93.77 billion. To put things into perspective, that makes said companies wealthier than most countries in the world. And thanks to those astronomical profit margins, the Pharmaceuticals and Health Products industry is able to spend more on lobbying than any other industry in America.
While big pharma lobbying can take several different forms, these companies tend to target their contributions to senior legislators in Congress — you know, the ones they need to keep in their corner, because they have the power to draft healthcare laws. Pfizer has outspent its peers in six of the last eight election cycles, coughing up almost $9.7 million. During the 2016 election, pharmaceutical companies gave more than $7 million to 97 senators at an average of $75,000 per member. They also contributed $6.3 million to president Joe Biden’s 2020 campaign. The question is: what did big pharma get in return?
When you’ve got 1,500 Big Pharma lobbyists on Capitol Hill for 535 members of Congress, it’s not too hard to figure out why prescription drug prices in this country are, on average, 256% HIGHER than in other major countries.
— Bernie Sanders (@BernieSanders) February 3, 2022
ALEC’s Off-the-Record Sway
To truly grasp big pharma’s power, you need to understand how The American Legislative Exchange Council (ALEC) works. ALEC, which was founded in 1973 by conservative activists working on Ronald Reagan’s campaign, is a super secretive pay-to-play operation where corporate lobbyists — including in the pharma sector — hold confidential meetings about “model” bills. A large portion of these bills is eventually approved and become law.
A rundown of ALEC’s greatest hits will tell you everything you need to know about the council’s motives and priorities. In 1995, ALEC promoted a bill that restricts consumers’ rights to sue for damages resulting from taking a particular medication. They also endorsed the Statute of Limitation Reduction Act, which put a time limit on when someone could sue after a medication-induced injury or death. Over the years, ALEC has promoted many other pharma-friendly bills that would: weaken FDA oversight of new drugs and therapies, limit FDA authority over drug advertising, and oppose regulations on financial incentives for doctors to prescribe specific drugs. But what makes these ALEC collaborations feel particularly problematic is that there’s little transparency — all of this happens behind closed doors. Congressional leaders and other committee members involved in ALEC aren’t required to publish any records of their meetings and other communications with pharma lobbyists, and the roster of ALEC members is completely confidential. All we know is that in 2020, more than two-thirds of Congress — 72 senators and 302 House of Representatives members — cashed a campaign check from a pharma company.
Big Pharma Funding Research
The public typically relies on an endorsement from government agencies to help them decide whether or not a new drug, vaccine, or medical device is safe and effective. And those agencies, like the FDA, count on clinical research. As already established, big pharma is notorious for getting its hooks into influential government officials. Here’s another sobering truth: The majority of scientific research is paid for by — wait for it — the pharmaceutical companies.
When the New England Journal of Medicine (NEJM) published 73 studies of new drugs over the course of a single year, they found that a staggering 82% of them had been funded by the pharmaceutical company selling the product, 68% had authors who were employees of that company, and 50% had lead researchers who accepted money from a drug company. According to 2013 research conducted at the University of Arizona College of Law, even when pharma companies aren’t directly funding the research, company stockholders, consultants, directors, and officers are almost always involved in conducting them. A 2017 report by the peer-reviewed journal The BMJ also showed that about half of medical journal editors receive payments from drug companies, with the average payment per editor hovering around $28,000. But these statistics are only accurate if researchers and editors are transparent about payments from pharma. And a 2022 investigative analysis of two of the most influential medical journals found that 81% of study authors failed to disclose millions in payments from drug companies, as they’re required to do.
Unfortunately, this trend shows no sign of slowing down. The number of clinical trials funded by the pharmaceutical industry has been climbing every year since 2006, according to a John Hopkins University report, while independent studies have been harder to find. And there are some serious consequences to these conflicts of interest. Take Avandia, for instance, a diabetes drug produced by GlaxoSmithCline (GSK). Avandia was eventually linked to a dramatically increased risk of heart attacks and heart failure. And a BMJ report revealed that almost 90% of scientists who initially wrote glowing articles about Avandia had financial ties to GSK.
But here’s the unnerving part: if the pharmaceutical industry is successfully biasing the science, then that means the physicians who rely on the science are biased in their prescribing decisions.
Photo credit: UN Women Europe & Central Asia
Where the lines get really blurry is with “ghostwriting.” Big pharma execs know citizens are way more likely to trust a report written by a board-certified doctor than one of their representatives. That’s why they pay physicians to list their names as authors — even though the MDs had little to no involvement in the research, and the report was actually written by the drug company. This practice started in the ’50s and ’60s when tobacco execs were clamoring to prove that cigarettes didn’t cause cancer (spoiler alert: they do!), so they commissioned doctors to slap their name on papers undermining the risks of smoking.
It’s still a pretty common tactic today: more than one in 10 articles published in the NEJM was co-written by a ghostwriter. While a very small percentage of medical journals have clear policies against ghostwriting, it’s still technically legal —despite the fact that the consequences can be deadly.
Case in point: in the late ’90s and early 2000s, Merck paid for 73 ghostwritten articles to play up the benefits of its arthritis drug Vioxx. It was later revealed that Merck failed to report all of the heart attacks experienced by trial participants. In fact, a study published in the NEJM revealed that an estimated 160,000 Americans experienced heart attacks or strokes from taking Vioxx. That research was conducted by Dr. David Graham, Associate Director of the FDA’s Office of Drug Safety, who understandably concluded the drug was not safe. But the FDA’s Office of New Drugs, which not only was responsible for initially approving Vioxx but also regulating it, tried to sweep his findings under the rug.
“I was pressured to change my conclusions and recommendations, and basically threatened that if I did not change them, I would not be permitted to present the paper at the conference,” he wrote in his 2004 U.S. Senate testimony on Vioxx. “One Drug Safety manager recommended that I should be barred from presenting the poster at the meeting.”
Eventually, the FDA issued a public health advisory about Vioxx and Merck withdrew this product. But it was a little late for repercussions — 38,000 of those Vioxx-takers who suffered heart attacks had already died. Graham called this a “profound regulatory failure,” adding that scientific standards the FDA apply to drug safety “guarantee that unsafe and deadly drugs will remain on the U.S. market.”
This should come as no surprise, but research has also repeatedly shown that a paper written by a pharmaceutical company is more likely to emphasize the benefits of a drug, vaccine, or device while downplaying the dangers. (If you want to understand more about this practice, a former ghostwriter outlines all the ethical reasons why she quit this job in a PLOS Medicine report.) While adverse drug effects appear in 95% of clinical research, only 46% of published reports disclose them. Of course, all of this often ends up misleading doctors into thinking a drug is safer than it actually is.
Big Pharma Influence On Doctors
Pharmaceutical companies aren’t just paying medical journal editors and authors to make their products look good, either. There’s a long, sordid history of pharmaceutical companies incentivizing doctors to prescribe their products through financial rewards. For instance, Pfizer and AstraZeneca doled out a combined $100 million to doctors in 2018, with some earning anywhere from $6 million to $29 million in a year. And research has shown this strategy works: when doctors accept these gifts and payments, they’re significantly more likely to prescribe those companies’ drugs. Novartis comes to mind — the company famously spent over $100 million paying for doctors’ extravagant meals, golf outings, and more, all while also providing a generous kickback program that made them richer every time they prescribed certain blood pressure and diabetes meds.
Side note: the Open Payments portal contains a nifty little database where you can find out if any of your own doctors received money from drug companies. Knowing that my mother was put on a laundry list of meds after a near-fatal car accident, I was curious — so I did a quick search for her providers. While her PCP only banked a modest amount from Pfizer and AstraZeneca, her previous psychiatrist — who prescribed a cocktail of contraindicated medications without treating her in person — collected quadruple-digit payments from pharmaceutical companies. And her pain care specialist, who prescribed her jaw-dropping doses of opioid pain medication for more than 20 years (far longer than the 5-day safety guideline), was raking in thousands from Purdue Pharma, AKA the opioid crisis’ kingpin.
Purdue is now infamous for its wildly aggressive OxyContin campaign in the ’90s. At the time, the company billed it as a non-addictive wonder drug for pain sufferers. Internal emails show Pursue sales representatives were instructed to “sell, sell, sell” OxyContin, and the more they were able to push, the more they were rewarded with promotions and bonuses. With the stakes so high, these reps stopped at nothing to get doctors on board — even going so far as to send boxes of doughnuts spelling out “OxyContin” to unconvinced physicians. Purdue had stumbled upon the perfect system for generating tons of profit — off of other people’s pain.
Documentation later proved that not only was Purdue aware it was highly addictive and that many people were abusing it, but that they also encouraged doctors to continue prescribing increasingly higher doses of it (and sent them on lavish luxury vacations for some motivation). In testimony to Congress, Purdue exec Paul Goldenheim played dumb about OxyContin addiction and overdose rates, but emails that were later exposed showed that he requested his colleagues remove all mentions of addiction from their correspondence about the drug. Even after it was proven in court that Purdue fraudulently marketed OxyContin while concealing its addictive nature, no one from the company spent a single day behind bars. Instead, the company got a slap on the wrist and a $600 million fine for a misdemeanor, the equivalent of a speeding ticket compared to the $9 billion they made off OxyContin up until 2006. Meanwhile, thanks to Purdue’s recklessness, more than 247,000 people died from prescription opioid overdoses between 1999 and 2009. And that’s not even factoring in all the people who died of heroin overdoses once OxyContin was no longer attainable to them. The NIH reports that 80% of people who use heroin started by misusing prescription opioids.
Former sales rep Carol Panara told me in an interview that when she looks back on her time at Purdue, it all feels like a “bad dream.” Panara started working for Purdue in 2008, one year after the company pled guilty to “misbranding” charges for OxyContin. At this point, Purdue was “regrouping and expanding,” says Panara, and to that end, had developed a clever new approach for making money off OxyContin: sales reps were now targeting general practitioners and family doctors, rather than just pain management specialists. On top of that, Purdue soon introduced three new strengths for OxyContin: 15, 30, and 60 milligrams, creating smaller increments Panara believes were aimed at making doctors feel more comfortable increasing their patients’ dosages. According to Panara, there were internal company rankings for sales reps based on the number of prescriptions for each OxyContin dosing strength in their territory.
“They were sneaky about it,” she said.
“Their plan was to go in and sell these doctors on the idea of starting with 10 milligrams, which is very low, knowing full well that once they get started down that path — that’s all they need. Because eventually, they’re going to build a tolerance and need a higher dose.”
Occasionally, doctors expressed concerns about a patient becoming addicted, but Purdue had already developed a way around that. Sales reps like Panara were taught to reassure those doctors that someone in pain might experience addiction-like symptoms called “pseudoaddiction,” but that didn’t mean they were truly addicted. There is no scientific evidence whatsoever to support that this concept is legit, of course. But the most disturbing part? Reps were trained to tell doctors that “pseudoaddiction” signaled the patient’s pain wasn’t being managed well enough, and the solution was simply to prescribe a higher dose of OxyContin.
Panara finally quit Purdue in 2013. One of the breaking points was when two pharmacies in her territory were robbed at gunpoint specifically for OxyContin. In 2020, Purdue pled guilty to three criminal charges in an $8.3 billion deal, but the company is now under court protection after filing for bankruptcy. Despite all the damage that’s been done, the FDA’s policies for approving opioids remain essentially unchanged.
Photo credit: Jennifer Durban
Purdue probably wouldn’t have been able to pull this off if it weren’t for an FDA examiner named Curtis Wright, and his assistant Douglas Kramer. While Purdue was pursuing Wright’s stamp of approval on OxyContin, Wright took an outright sketchy approach to their application, instructing the company to mail documents to his home office rather than the FDA, and enlisting Purdue employees to help him review trials about the safety of the drug. The Food, Drug, and Cosmetic Act requires that the FDA have access to at least two randomized controlled trials before deeming a drug as safe and effective, but in the case of OxyContin, it got approved with data from just one measly two-week study — in osteoarthritis patients, no less.
When both Wright and Kramer left the FDA, they went on to work for none other than (drumroll, please) Purdue, with Wright earning three times his FDA salary. By the way — this is just one example of the FDA’s notoriously incestuous relationship with big pharma, often referred to as “the revolving door”. In fact, a 2018 Science report revealed that 11 out of 16 FDA reviewers ended up at the same companies they had been regulating products for.
While doing an independent investigation, “Empire of Pain” author and New Yorker columnist Patrick Radden Keefe tried to gain access to documentation of Wright’s communications with Purdue during the OxyContin approval process.
“The FDA came back and said, ‘Oh, it’s the weirdest thing, but we don’t have anything. It’s all either been lost or destroyed,’” Keefe told Fortune in an interview. “But it’s not just the FDA. It’s Congress, it’s the Department of Justice, it’s big parts of the medical establishment … the sheer amount of money involved, I think, has meant that a lot of the checks that should be in place in society to not just achieve justice, but also to protect us as consumers, were not there because they had been co-opted.”
Big pharma may be to blame for creating the opioids that caused this public health catastrophe, but the FDA deserves just as much scrutiny — because its countless failures also played a part in enabling it. And many of those more recent fails happened under the supervision of Dr. Janet Woodcock. Woodcock was named FDA’s acting commissioner mere hours after Joe Biden was inaugurated as president. She would have been a logical choice, being an FDA vet of 35 years, but then again it’s impossible to forget that she played a starring role in the FDA’s perpetuating the opioid epidemic. She’s also known for overruling her own scientific advisors when they vote against approving a drug. Not only did Woodcock approve OxyContin for children as young as 11 years old, but she also gave the green light to several other highly controversial extended-release opioid pain drugs without sufficient evidence of safety or efficacy. One of those was Zohydro: in 2011, the FDA’s advisory committee voted 11:2 against approving it due to safety concerns about inappropriate use, but Woodcock went ahead and pushed it through, anyway. Under Woodcock’s supervision, the FDA also approved Opana, which is twice as powerful as OxyContin — only to then beg the drug maker to take it off the market 10 years later due to “abuse and manipulation.” And then there was Dsuvia, a potent painkiller 1,000 times stronger than morphine and 10 times more powerful than fentanyl. According to a head of one of the FDA’s advisory committees, the U.S. military had helped to develop this particular drug, and Woodcock said there was “pressure from the Pentagon” to push it through approvals. The FBI, members of congress, public health advocates, and patient safety experts alike called this decision into question, pointing out that with hundreds of opioids already on the market there’s no need for another — particularly one that comes with such high risks.
Most recently, Woodcock served as the therapeutics lead for Operation Warp Speed, overseeing COVID-19 vaccine development.
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 children with 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?
Backing the Big Four: Big Pharma and the FDA, WHO, NIH, CDC
I know what you’re thinking. Big pharma is amoral and the FDA’s devastating slips are a dime a dozen — old news. But what about agencies and organizations like the National Institutes of Health (NIH), World Health Organization (WHO), and Centers for Disease Control & Prevention (CDC)? Don’t they have an obligation to provide unbiased guidance to protect citizens? Don’t worry, I’m getting there.
The WHO’s guidance is undeniably influential across the globe. For most of this organization’s history, dating back to 1948, it could not receive donations from pharmaceutical companies — only member states. But that changed in 2005 when the WHO updated its financial policy to permit private money into its system. Since then, the WHO has accepted many financial contributions from big pharma. In fact, it’s only 20% financed by member states today, with a whopping 80% of financing coming from private donors. For instance, The Bill and Melinda Gates Foundation (BMGF) is now one of its main contributors, providing up to 13% of its funds — about $250–300 million a year. Nowadays, the BMGF provides more donations to the WHO than the entire United States.
Dr. Arata Kochi, former head of WHO’s malaria program, expressed concerns to director-general Dr. Margaret Chan in 2007 that taking the BMGF’s money could have “far-reaching, largely unintended consequences” including “stifling a diversity of views among scientists.”
“The big concerns are that the Gates Foundation isn’t fully transparent and accountable,” Lawrence Gostin, director of WHO’s Collaborating Center on National and Global Health Law, told Devex in an interview.
“By wielding such influence, it could steer WHO priorities … It would enable a single rich philanthropist to set the global health agenda.”
Photo credit: National Institutes of Health
Take a peek at the WHO’s list of donors and you’ll find a few other familiar names like AstraZeneca, Bayer, Pfizer, Johnson & Johnson, and Merck.
The NIH has the same problem, it seems. Science journalist Paul Thacker, who previously examined financial links between physicians and pharma companies as a lead investigator of the United States Senate Committee, wrote in The Washington Post that this agency “often ignored” very “obvious” conflicts of interest. He also claimed that “its industry ties go back decades.” In 2018, it was discovered that a $100 million alcohol consumption study run by NIH scientists was funded mostly by beer and liquor companies. Emails proved that NIH researchers were in frequent contact with those companies while designing the study — which, here’s a shocker — were aimed at highlighting the benefits and not the risks of moderate drinking. So, the NIH ultimately had to squash the trial.
And then there’s the CDC. It used to be that this agency couldn’t take contributions from pharmaceutical companies, but in 1992 they found a loophole: new legislation passed by Congress allowed them to accept private funding through a nonprofit called the CDC Foundation. From 2014 through 2018 alone, the CDC Foundation received $79.6 million from corporations like Pfizer, Biogen, and Merck.
Of course, if a pharmaceutical company wants to get a drug, vaccine, or other product approved, they really need to cozy up to the FDA. That explains why in 2017, pharma companies paid for a whopping 75% of the FDA’s scientific review budgets, up from 27% in 1993. It wasn’t always like this. But in 1992, an act of Congress changed the FDA’s funding stream, enlisting pharma companies to pay “user fees,” which help the FDA speed up the approval process for their drugs.
A 2018 Science investigation found that 40 out of 107 physician advisors on the FDA’s committees received more than $10,000 from big pharma companies trying to get their drugs approved, with some banking up to $1 million or more. The FDA claims it has a well-functioning system to identify and prevent these possible conflicts of interest. Unfortunately, their system only works for spotting payments before advisory panels meet, and the Science investigation showed many FDA panel members get their payments after the fact. It’s a little like “you scratch my back now, and I’ll scratch your back once I get what I want” — drug companies promise FDA employees a future bonus contingent on whether things go their way.
Here’s why this dynamic proves problematic: a 2000 investigation revealed that when the FDA approved the rotavirus vaccine in 1998, it didn’t exactly do its due diligence. That probably had something to do with the fact that committee members had financial ties to the manufacturer, Merck — many owned tens of thousands of dollars of stock in the company, or even held patents on the vaccine itself. Later, the Adverse Event Reporting System revealed that the vaccine was causing serious bowel obstructions in some children, and it was finally pulled from the U.S. market in October 1999.
Then, in June of 2021, the FDA overruled concerns raised by its very own scientific advisory committee to approve Biogen’s Alzheimer’s drug Aduhelm — a move widely criticized by physicians. The drug not only showed very little efficacy but also potentially serious side effects like brain bleeding and swelling, in clinical trials. Dr. Aaron Kesselheim, a Harvard Medical School professor who was on the FDA’s scientific advisory committee, called it the “worst drug approval” in recent history, and noted that meetings between the FDA and Biogen had a “strange dynamic” suggesting an unusually close relationship. Dr. Michael Carome, director of Public Citizen’s Health Research Group, told CNN that he believes the FDA started working in “inappropriately close collaboration with Biogen” back in 2019. “They were not objective, unbiased regulators,” he added in the CNN interview. “It seems as if the decision was preordained.”
That brings me to perhaps the biggest conflict of interest yet: Dr. Anthony Fauci’s NIAID is just one of many institutes that comprises the NIH — and the NIH owns half the patent for the Moderna vaccine — as well as thousands more pharma patents to boot. The NIAID is poised to earn millions of dollars from Moderna’s vaccine revenue, with individual officials also receiving up to $150,000 annually.
Operation Warp Speed
In December of 2020, Pfizer became the first company to receive an emergency use authorization (EUA) from the FDA for a COVID-19 vaccine. EUAs — which allow the distribution of an unapproved drug or other product during a declared public health emergency — are actually a pretty new thing: the first one was issued in 2005 so military personnel could get an anthrax vaccine. To get a full FDA approval, there needs to be substantial evidence that the product is safe and effective. But for an EUA, the FDA just needs to determine that it may be effective. Since EUAs are granted so quickly, the FDA doesn’t have enough time to gather all the information they’d usually need to approve a drug or vaccine.
Pfizer CEO and chairman Albert Bourla has said his company was “operating at the speed of science” to bring a vaccine to market. However, a 2021 report in The BMJ revealed that this speed might have come at the expense of “data integrity and patient safety.” Brook Jackson, regional director for the Ventavia Research Group, which carried out these trials, told The BMJ that her former company “falsified data, unblinded patients, and employed inadequately trained vaccinators” in Pfizer’s pivotal phase 3 trial. Just some of the other concerning events witnessed included: adverse events not being reported correctly or at all, lack of reporting on protocol deviations, informed consent errors, and mislabeling of lab specimens. An audio recording of Ventavia employees from September 2020 revealed that they were so overwhelmed by issues arising during the study that they became unable to “quantify the types and number of errors” when assessing quality control. One Ventavia employee told The BMJ she’d never once seen a research environment as disorderly as Ventavia’s Pfizer vaccine trial, while another called it a “crazy mess.”
Over the course of her two-decades-long career, Jackson has worked on hundreds of clinical trials, and two of her areas of expertise happen to be immunology and infectious diseases. She told me that from her first day on the Pfizer trial in September of 2020, she discovered “such egregious misconduct” that she recommended they stop enrolling participants into the study to do an internal audit.
“To my complete shock and horror, Ventavia agreed to pause enrollment but then devised a plan to conceal what I found and to keep ICON and Pfizer in the dark,” Jackson said during our interview.
“The site was in full clean-up mode. When missing data points were discovered the information was fabricated, including forged signatures on the informed consent forms.”
A screenshot Jackson shared with me shows she was invited to a meeting titled “COVID 1001 Clean up Call” on Sept. 21, 2020. She refused to participate in the call.
Jackson repeatedly warned her superiors about patient safety concerns and data integrity issues.
“I knew that the entire world was counting on clinical researchers to develop a safe and effective vaccine and I did not want to be a part of that failure by not reporting what I saw,” she told me.
When her employer failed to act, Jackson filed a complaint with the FDA on Sept. 25, and Ventavia fired her hours later that same day under the pretense that she was “not a good fit.” After reviewing her concerns over the phone, she claims the FDA never followed up or inspected the Ventavia site. Ten weeks later, the FDA authorized the EUA for the vaccine. Meanwhile, Pfizer hired Ventavia to handle the research for four more vaccine clinical trials, including one involving children and young adults, one for pregnant women, and another for the booster. Not only that, but Ventavia handled the clinical trials for Moderna, Johnson & Johnson, and Novavax. Jackson is currently pursuing a False Claims Act lawsuit against Pfizer and Ventavia Research Group.
Last year, Pfizer banked nearly $37 billion from its COVID vaccine, making it one of the most lucrative products in global history. Its overall revenues doubled in 2021 to reach $81.3 billion, and it’s slated to reach a record-breaking $98-$102 billion this year.
“Corporations like Pfizer should never have been put in charge of a global vaccination rollout, because it was inevitable they would make life-and-death decisions based on what’s in the short-term interest of their shareholders,” writes Nick Dearden, director of Global Justice Now.
As previously mentioned, it’s super common for pharmaceutical companies to fund the research on their own products. Here’s why that’s scary. One 1999 meta-analysis showed that industry-funded research is eight times less likely to achieve unfavorable results compared to independent trials. In other words, if a pharmaceutical company wants to prove that a medication, supplement, vaccine, or device is safe and effective, they’ll find a way.
With that in mind, I recently examined the 2020 study on Pfizer’s COVID vaccine to see if there were any conflicts of interest. Lo and behold, the lengthy attached disclosure form shows that of the 29 authors, 18 are employees of Pfizer and hold stock in the company, one received a research grant from Pfizer during the study, and two reported being paid “personal fees” by Pfizer. In another 2021 study on the Pfizer vaccine, seven of the 15 authors are employees of and hold stock in Pfizer. The other eight authors received financial support from Pfizer during the study.
Photo credit: Prasesh Shiwakoti (Lomash) via Unsplash
As of the day I’m writing this, about 64% of Americans are fully vaccinated, and 76% have gotten at least one dose. The FDA has repeatedly promised “full transparency” when it comes to these vaccines. Yet in December of 2021, the FDA asked for permission to wait 75 years before releasing information pertaining to Pfizer’s COVID-19 vaccine, including safety data, effectiveness data, and adverse reaction reports. That means no one would see this information until the year 2096 — conveniently, after many of us have departed this crazy world. To recap: the FDA only needed 10 weeks to review the 329,000 pages worth of data before approving the EUA for the vaccine — but apparently, they need three-quarters of a century to publicize it.
In response to the FDA’s ludicrous request, PHMPT — a group of over 200 medical and public health experts from Harvard, Yale, Brown, UCLA, and other institutions — filed a lawsuit under the Freedom of Information Act demanding that the FDA produce this data sooner. And their efforts paid off: U.S. District Judge Mark T. Pittman issued an order for the FDA to produce 12,000 pages by Jan. 31, and then at least 55,000 pages per month thereafter. In his statement to the FDA, Pittman quoted the late John F. Kennedy: “A nation that is afraid to let its people judge the truth and falsehood in an open market is a nation that is afraid of its people.”
As for why the FDA wanted to keep this data hidden, the first batch of documentation revealed that there were more than 1,200 vaccine-related deaths in just the first 90 days after the Pfizer vaccine was introduced. Of 32 pregnancies with a known outcome, 28 resulted in fetal death. The CDC also recently unveiled data showing a total of 1,088,560 reports of adverse events from COVID vaccines were submitted between Dec. 14, 2020, and Jan. 28, 2022. That data included 23,149 reports of deaths and 183,311 reports of serious injuries. There were 4,993 reported adverse events in pregnant women after getting vaccinated, including 1,597 reports of miscarriage or premature birth. A 2022 study published in JAMA, meanwhile, revealed that there have been more than 1,900 reported cases of myocarditis — or inflammation of the heart muscle — mostly in people 30 and under, within 7 days of getting the vaccine. In those cases, 96% of people were hospitalized.
“It is understandable that the FDA does not want independent scientists to review the documents it relied upon to license Pfizer’s vaccine given that it is not as effective as the FDA originally claimed, does not prevent transmission, does not prevent against certain emerging variants, can cause serious heart inflammation in younger individuals, and has numerous other undisputed safety issues,” writes Aaron Siri, the attorney representing PHMPT in its lawsuit against the FDA.
Siri told me in an email that his office phone has been ringing off the hook in recent months.
“We are overwhelmed by inquiries from individuals calling about an injury from a COVID-19 vaccine,” he said.
By the way — it’s worth noting that adverse effects caused by COVID-19 vaccinations are still not covered by the National Vaccine Injury Compensation Program. Companies like Pfizer, Moderna, and Johnson & Johnson are protected under the Public Readiness and Emergency Preparedness (PREP) Act, which grants them total immunity from liability with their vaccines. And no matter what happens to you, you can’t sue the FDA for authorizing the EUA, or your employer for requiring you to get it, either. Billions of taxpayer dollars went to fund the research and development of these vaccines, and in Moderna’s case, licensing its vaccine was made possible entirely by public funds. But apparently, that still warrants citizens no insurance. Should something go wrong, you’re basically on your own.
Pfizer and Moderna COVID-19 vaccine business model: government gives them billions, gives them immunity for any injuries or if doesn’t work, promotes their products for free, and mandates their products. Sounds crazy? Yes, but it is our current reality.
— Aaron Siri (@AaronSiriSG) February 2, 2022
The Hypocrisy of “Misinformation”
I find it interesting that “misinformation” has become such a pervasive term lately, but more alarmingly, that it’s become an excuse for blatant censorship on social media and in journalism. It’s impossible not to wonder what’s driving this movement to control the narrative. In a world where we still very clearly don’t have all the answers, why shouldn’t we be open to exploring all the possibilities? And while we’re on the subject, what about all of the COVID-related untruths that have been spread by our leaders and officials? Why should they get a free pass?
Photo credit: @upgradeur_life, www.instagram.com/upgradeur_life
Fauci, President Biden, and the CDC’s Rochelle Walensky all promised us with total confidence the vaccine would prevent us from getting or spreading COVID, something we now know is a myth. (In fact, the CDC recently had to change its very definition of “vaccine ” to promise “protection” from a disease rather than “immunity”— an important distinction). At one point, the New York State Department of Health (NYS DOH) and former Governor Andrew Cuomo prepared a social media campaign with misleading messaging that the vaccine was “approved by the FDA” and “went through the same rigorous approval process that all vaccines go through,” when in reality the FDA only authorized the vaccines under an EUA, and the vaccines were still undergoing clinical trials. While the NYS DOH eventually responded to pressures to remove these false claims, a few weeks later the Department posted on Facebook that “no serious side effects related to the vaccines have been reported,” when in actuality, roughly 16,000 reports of adverse events and over 3,000 reports of serious adverse events related to a COVID-19 vaccination had been reported in the first two months of use.
One would think we’d hold the people in power to the same level of accountability — if not more — than an average citizen. So, in the interest of avoiding hypocrisy, should we “cancel” all these experts and leaders for their “misinformation,” too?
Vaccine-hesitant people have been fired from their jobs, refused from restaurants, denied the right to travel and see their families, banned from social media channels, and blatantly shamed and villainized in the media. Some have even lost custody of their children. These people are frequently labeled “anti-vax,” which is misleading given that many (like the NBA’s Jonathan Isaac) have made it repeatedly clear they are not against all vaccines, but simply making a personal choice not to get this one. (As such, I’ll suggest switching to a more accurate label: “pro-choice.”) Fauci has repeatedly said federally mandating the vaccine would not be “appropriate” or “enforceable” and doing so would be “encroaching upon a person’s freedom to make their own choice.” So it’s remarkable that still, some individual employers and U.S. states, like my beloved Massachusetts, have taken it upon themselves to enforce some of these mandates, anyway. Meanwhile, a Feb. 7 bulletin posted by the U.S. Department of Homeland Security indicates that if you spread information that undermines public trust in a government institution (like the CDC or FDA), you could be considered a terrorist. In case you were wondering about the current state of free speech.
The definition of institutional oppression is “the systematic mistreatment of people within a social identity group, supported and enforced by the society and its institutions, solely based on the person’s membership in the social identity group.” It is defined as occurring when established laws and practices “systematically reflect and produce inequities based on one’s membership in targeted social identity groups.” Sound familiar?
As you continue to watch the persecution of the unvaccinated unfold, remember this. Historically, when society has oppressed a particular group of people whether due to their gender, race, social class, religious beliefs, or sexuality, it’s always been because they pose some kind of threat to the status quo. The same is true for today’s unvaccinated. Since we know the vaccine doesn’t prevent the spread of COVID, however, this much is clear: the unvaccinated don’t pose a threat to the health and safety of their fellow citizens — but rather, to the bottom line of powerful pharmaceutical giants and the many global organizations they finance. And with more than $100 billion on the line in 2021 alone, I can understand the motivation to silence them.
The unvaccinated have been called selfish. Stupid. Fauci has said it’s “almost inexplicable” that they are still resisting. But is it? What if these people aren’t crazy or uncaring, but rather have — unsurprisingly so — lost their faith in the agencies that are supposed to protect them? Can you blame them?
Citizens are being bullied into getting a vaccine that was created, evaluated, and authorized in under a year, with no access to the bulk of the safety data for said vaccine, and no rights whatsoever to pursue legal action if they experience adverse effects from it. What these people need right now is to know they can depend on their fellow citizens to respect their choices, not fuel the segregation by launching a full-fledged witch hunt. Instead, for some inexplicable reason I imagine stems from fear, many continue rallying around big pharma rather than each other. A 2022 Heartland Institute and Rasmussen Reports survey of Democratic voters found that 59% of respondents support a government policy requiring unvaccinated individuals to remain confined in their home at all times, 55% support handing a fine to anyone who won’t get the vaccine, and 48% think the government should flat out imprison people who publicly question the efficacy of the vaccines on social media, TV, or online in digital publications. Even Orwell couldn’t make this stuff up.
Let me be very clear. While there are a lot of bad actors out there — there are also a lot of well-meaning people in the science and medical industries, too. I’m lucky enough to know some of them. There are doctors who fend off pharma reps’ influence and take an extremely cautious approach to prescribing. Medical journal authors who fiercely pursue transparency and truth — as is evident in “The Influence of Money on Medical Science,” a report by the first female editor of JAMA. Pharmacists, like Dan Schneider, who refuse to fill prescriptions they deem risky or irresponsible. Whistleblowers, like Graham and Jackson, who tenaciously call attention to safety issues for pharma products in the approval pipeline. And I’m certain there are many people in the pharmaceutical industry, like Panara and my grandfather, who pursued this field with the goal of helping others, not just earning a six- or seven-figure salary. We need more of these people. Sadly, it seems they are outliers who exist in a corrupt, deep-rooted system of quid-pro-quo relationships. They can only do so much.
I’m not here to tell you whether or not you should get the vaccine or booster doses. What you put in your body is not for me — or anyone else — to decide. It’s not a simple choice, but rather one that may depend on your physical condition, medical history, age, religious beliefs, and level of risk tolerance. My grandfather passed away in 2008, and lately, I find myself missing him more than ever, wishing I could talk to him about the pandemic and hear what he makes of all this madness. I don’t really know how he’d feel about the COVID vaccine, or whether he would have gotten it or encouraged me to. What I do know is that he’d listen to my concerns, and he’d carefully consider them. He would remind me my feelings are valid. His eyes would light up and he’d grin with amusement as I fervidly expressed my frustration. He’d tell me to keep pushing forward, digging deeper, asking questions. In his endearing Bronx accent, he used to always say: “go get ‘em, kid.” If I stop typing for a moment and listen hard enough, I can almost hear him saying it now.
People keep saying “trust the science.” But when trust is broken, it must be earned back. And as long as our legislative system, public health agencies, physicians, and research journals keep accepting pharmaceutical money (with strings attached) — and our justice system keeps letting these companies off the hook when their negligence causes harm, there’s no reason for big pharma to change. They’re holding the bag, and money is power.
I have a dream that one day, we’ll live in a world where we are armed with all the thorough, unbiased data necessary to make informed decisions about our health. Alas, we’re not even close. What that means is that it’s up to you to educate yourself as much as possible, and remain ever-vigilant in evaluating information before forming an opinion. You can start by reading clinical trials yourself, rather than relying on the media to translate them for you. Scroll to the bottom of every single study to the “conflicts of interest” section and find out who funded it. Look at how many subjects were involved. Confirm whether or not blinding was used to eliminate bias. You may also choose to follow Public Citizen’s Health Research Group’s rule whenever possible: that means avoiding a new drug until five years after an FDA approval (not an EUA, an actual approval) — when there’s enough data on the long-term safety and effectiveness to establish that the benefits outweigh the risks. When it comes to the news, you can seek out independent, nonprofit outlets, which are less likely to be biased due to pharma funding. And most importantly, when it appears an organization is making concerted efforts to conceal information from you — like the FDA recently did with the COVID vaccine — it’s time to ask yourself: why? What are they trying to hide?
In the 2019 film “Dark Waters” — which is based on the true story of one of the greatest corporate cover-ups in American history — Mark Ruffalo as attorney Rob Bilott says: “The system is rigged. They want us to think it’ll protect us, but that’s a lie. We protect us. We do. Nobody else. Not the companies. Not the scientists. Not the government. Us.”
Words to live by.
Sat, 04/09/2022 – 22:30