The Anatomy of Big Pharma’s Political Reach (II)

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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.”

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 aiming 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 aspect: 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 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 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 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.

Knowing this, 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.

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 Journal of American Medical Association (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 persons 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 occurs 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.

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?

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. 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 personal employers and U.S. states, like 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 is necessary to be earned back. And as long as the legislative system, public health agencies, physicians, and research journals keep accepting pharmaceutical money (with strings attached) – and the justice system keeps letting these companies off the hook when their negligence causes harm, there’s no reason for big pharma to transform. 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 aiming 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.

Author: Rebecca Strong

yogaesoteric
September 30, 2022