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The Anatomy Of Big Pharma's Political Reach

          The Anatomy Of Big Pharma's Political Reach

[65]Authored by Rebecca Strong via Medium.com,

They keep telling us to “trust the science.” But who paid
for it?

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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 [67]$81 billion a year, making it
the [68]28th most valuable company in the world. Johnson &
Johnson [69]ranks 15th, with [70]$93.77 billion. To put things
into perspective, that makes said companies [71]wealthier than
most countries in the world. And thanks to those astronomical
profit margins, the Pharmaceuticals and Health Products industry
is able to [72]spend more on lobbying than any other industry
in America.

While big pharma lobbying can take several different forms,
these companies tend to [73]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 [74]almost $9.7
million. During the 2016 election, pharmaceutical
companies [75]gave more than $7 million to 97 senators at an
average of $75,000 per member. They also contributed [76]$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) [77]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 [78]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 [79]large portion of these bills
is [80]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 [81]restricts consumers’
rights to sue for damages resulting from taking a particular
medication. They also endorsed the [82]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 [83]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 [84]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, [85]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 [86]accepted money from a drug company. According
to [87]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 [88]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 [89]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 [90]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 [91]linked to a dramatically increased risk of heart
attacks and heart failure. And a [92]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.

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Photo credit: [94]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 [95]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 [96]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 [97]73 ghostwritten articles to play up the benefits of
its arthritis drug Vioxx. It was later revealed that
Merck [98]failed to report all of the heart
attacks experienced by trial participants. In fact, a study
published in the NEJM revealed that an estimated [99]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 [100]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, [101]the FDA issued a public health advisory about
Vioxx and Merck withdrew this product. But it was a little late
for repercussions — [102]38,000 of those Vioxx-takers who
suffered heart attacks had already died. Graham called this
a [103]“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 [104]PLOS Medicine report.) While adverse drug effects
appear in [105]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 [106]through
financial rewards. For instance, Pfizer and AstraZeneca doled
out a [107]combined $100 million to doctors in 2018, with some
earning [108]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 [109]significantly
more likely to prescribe those companies’ drugs. Novartis
comes to mind — the company famously [110]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 [111]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 ([112]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 [113]“sell, sell, sell” OxyContin, and the more they
were able to push, [114]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 [115]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 [116]aware
it was highly addictive and that many people were abusing it,
but that they also encouraged doctors to
continue [117]prescribing increasingly higher doses of
it (and [118]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 [119]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 [120]$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 [121]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 [122]NIH reports that 80% of people
who use heroin started by misusing prescription opioids.

[123]IFrame

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 [124]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 [125]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 [126]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 [127]remain essentially unchanged.

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Photo credit: [129]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, [130]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 [131]at least two randomized
controlled trials before deeming a drug as safe and effective,
but in the case of OxyContin, it got approved [132]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 [133]work for none other than (drumroll, please) Purdue,
with [134]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 [135]“the revolving door”. In fact,
a [136]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 [137]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 [138]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 [139]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 [140]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 [141]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 [142]1,000 times stronger than
morphine and [143]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 [144]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 [145]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 [146]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 [147]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 [148]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 [149]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, [150]banking $3.2
billion annually for this drug by 2006). Finally, a
2007 [151]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, [152]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,” [153]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 [154]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 [155]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 [156]increase the
likelihood of suicidal thoughts in this group. A 1998 [157]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 [158]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 [159]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) [160]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 [161]one of the most
dangerous groups in Iraq.

Another especially worrisome factor is that pharmaceutical
companies are conducting an ever-increasing number
of [162]clinical trials in third-world countries, where people
may be less educated, and there are also far fewer safety
regulations. Pfizer’s [163]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 [164]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 [165]sued Pfizer, and the company
ultimately [166]settled out of court. In 1998, the FDA approved
Trovan only for adults. The drug was later [167]banned from
European markets due to reports of fatal liver disease
and [168]restricted to strictly emergency care in the U.S.
Pfizer still denies any wrongdoing.

[169][IMG]

[170]“Nurse prepares to vaccinate children” by [171]World
Bank Photo Collection is licensed under [172]CC BY-NC-ND 2.0

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 [173]dark track
record of bribery, dishonesty, and fraud.

In fact, big pharma happens to be the [174]biggest defrauder of
the federal government when it comes to the [175]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 [176]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 [177]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 [178]changed in
2005 when the WHO updated its financial policy to permit
private money into its system. Since then, the WHO
has [179]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, [180]providing up to 13% of its
funds — about [181]$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, [182]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 [183]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.”

[184][IMG]

Photo credit: [185]National Institutes of Health

Take a peek at the WHO’s list of [186]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 [187]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 [188]a $100
million alcohol consumption study run by NIH scientists
was [189]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 [190]allowed them to accept private funding through a
nonprofit called the CDC Foundation. From 2014 through 2018
alone, the CDC Foundation [191]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 [192]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, [193]enlisting pharma companies to pay “user
fees,” which help the FDA speed up the approval process for
their drugs.

A [194]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 [195]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 [196]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 [197]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 [198]approve
Biogen’s Alzheimer’s drug Aduhelm — a move [199]widely
criticized by physicians. The drug not only showed very little
efficacy but also potentially serious side effects like brain
bleeding and swelling, in [200]clinical trials. Dr. Aaron
Kesselheim, a Harvard Medical School professor who was on the
FDA’s scientific advisory committee, called it [201]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 [202]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 [203]owns half the patent for
the Moderna vaccine — as well as [204]thousands more pharma
patents to boot. The NIAID is poised to earn [205]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 [206]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: [207]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 [208]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.

[209][IMG]

[210]“Operation Warp Speed Vaccine Event” by [211]The
White House is licensed under [212]CC PDM 1.0

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 [213]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 [214]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 [215]pursuing a False Claims Act lawsuit against
Pfizer and Ventavia Research Group.

Last year, Pfizer [216]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,” [217]writes Nick Dearden, director
  of [218]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 [219]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 [220]2020 study on
Pfizer’s COVID vaccine to see if there were any conflicts of
interest. Lo and behold, the lengthy [221]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 [222]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.

[223][IMG]

Photo credit: [224]Prasesh Shiwakoti (Lomash) via Unsplash

As of the day I’m writing this, about [225]64% of
Americans are fully vaccinated, and 76% have gotten at least
one dose. The FDA has repeatedly promised “[226]full
transparency” when it comes to these vaccines. Yet in December
of 2021, the FDA asked for [227]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 [228]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, [229]PHMPT — a
group of over 200 medical and public health experts from
Harvard, Yale, Brown, UCLA, and other institutions — filed
a [230]lawsuit under the [231]Freedom of Information
Act demanding that the FDA produce this data sooner. And their
efforts paid off: U.S. District Judge Mark T.
Pittman [232]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 [233]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 [234]1,088,560
reports of adverse events from COVID vaccines were submitted
between Dec. 14, 2020, and Jan. 28, 2022. That data
included [235]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 [236]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,” [237]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 [238]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 [239]total immunity from liability with their
vaccines. And no matter what happens to you, you [240]can’t
sue the FDA for authorizing the EUA, or your employer for
requiring you to get it, either. [241]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) [242]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?

[243][IMG]

Photo credit:
@upgradeur_life, [244]www.instagram.com/upgradeur_life

[245]Fauci, [246]President Biden, and the [247]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 [248]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 [249]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, [250]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 [251]lost
custody of their children. These people are frequently labeled
“anti-vax,” which is misleading given that many (like the
NBA’s [252]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 [253]“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 [254]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 [255]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 [256]$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 [257]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.

[258][IMG]

Photo credit: [259]DJ Paine on [260]Unsplash

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 [261]“The
Influence of Money on Medical Science,” a report by the first
female editor of JAMA. Pharmacists, like [262]Dan Schneider,
who [263]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 [264]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 [265]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 [266]true story of one of the greatest corporate
cover-ups in American history — Mark Ruffalo as attorney Rob
Bilott says: “[267]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.



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