If you’re like most people, you probably assume that the U.S. Food and Drug Administration is funded by the U.S. government and therefore isn’t catering to private industries.
The agency itself certainly
tries to present itself as independent from the industries it regulates but, in
reality, legal loopholes have led to the FDA receiving money from, and being
captured and corrupted by, private interests.
While the FDA itself does not
accept corporate money, it does receive money funneled via a nonprofit
foundation, which in turn receives money from other nonprofits funded by
private interests. It’s really all a façade because the end result is the same.
Those donating the money ultimately end up with the ability to pull strings,
As explained by NPR
As explained in a 2008
The Critical Path Initiative was part of the FDA’s attempts to
streamline and modernize the drug approval process by having companies pay user
fees. Part of the Reagan-Udall Foundation’s responsibilities was to set goals
and priorities for the Critical Path Initiative, and then award grants to meet
However, critics voiced concern, saying the Reagan-Udall
Foundation might allow the food and medical industries “to sway FDA decisions,”
since it could raise money from private, including industry, sources. To quell
some of these fears, the Reagan-Udall Foundation said it would only accept
grants from government, individual donors and other nonprofits, not industry.
After a few years of scraping by on small, private donations, the foundation received a $150,000 grant from the PhRMA Foundation, another nonprofit foundation funded by drug companies. Being a nonprofit, the PhRMA Foundation fit the description of an acceptable funding source, but just how independent can it actually be when it’s founded and funded by drug companies?
As noted by consumer advocate
Sidney Wolfe with Public Citizen, while the PhRMA Foundation is technically a
nonprofit, “one can hardly expect that they’re going to do things that are not
in the interests of their funders.”
Indeed, and this influence is in addition to the influence food,
drug and medical device companies already have, by way of user fees. Again, the
Prescription Drug User Fee Act established an accelerated application process
for new drugs. The sped-up process is funded through industry-paid fees.
This fee, however, works more like a payoff or soft bribe. When
a company pays the FDA for an accelerated review, the agency no longer has an
incentive to find fault with the product or demand more extensive testing.
Not surprisingly, the
Reagan-Udall Foundation has received large donations from the Bill & Melinda Gates Foundation, which
we now know rarely does anything that doesn’t benefit Gates’ personal bottom
line and overall agenda.
As detailed in “Bill Gates — Most Dangerous Philanthropist in Modern
History?” Gates has used his philanthropy to shape public policy in
ways that benefit his own agenda.
A March 17, 2020,
articleGlaxoSmithKline, Unilever, IBM, Vodafone, the
Mastercard affiliate MasterCard Labs for Financial Inclusion, Scholastic Inc. and NBC Universal
Many of these so-called donations end up benefiting the Gates
Foundation, as it also invests in the very same companies and industries that
it donates money to. This circular economy is why Gates just keeps getting
richer, the more money he gives away.
Part of this wealth growth also appears to be due to the tax
breaks given for charitable donations. In short, it’s a perfect money-shuffling
scheme that limits taxes while maximizing income generation.
If donating to for-profit companies sounds oddly illegal to you,
you’d be right. Gates is a tax evader for doing so — he’s simply getting away
with it. The nonprofit foundation is a disguise to avoid taxes while funding
the research arms of for-profit organizations that his foundation is invested
in, which is illegal.
The image below shows donations received by the Reagan-Udall
Foundation in 2013. Topping the list is the Gates Foundation, whose
contributions for the year amounted to $977,165, followed by a string of drug
In addition to all of
this financial clout, food, drug and medical device makers also have the
ability to exert influence over the FDA via the members
As reported in the
2008 Journal of the National Cancer Institute article,
While the Reagan-Udall
Foundation is the nonprofit arm of the FDA, the agency does not have the
authority to set conflict-of-interest policies for the foundation.
A more recent article,
Lenzer also points out that the Foundation’s board of directors
still has financial ties to the drug and device makers that the FDA is supposed
to regulate. She notes that while no more than four of the 14-member board
should be representatives of FDA regulated industries, in 2017, nine of the
then 13-member board had financial ties to industry at the time of their
To give just one
example of how conflicts of interest can have real-world implications, take the
case of Ellen V. Sigal, Ph.D.
She’s also vice president of the Cancer Moonshot program, and it too is funded by the Gates Foundation. Sigal’s colleague at the Cancer Moonshot Program, Dr. Doug Lowy, is a co-inventor of the HPV vaccine Gardasil, and Sigal’s son, David Sigal, is married to New York State Sen. Brad Hoylman, who recently sponsored a bill to make Gardasil mandatory for all school children in New York.
Hoylman is also supporting a bill that would allow children as
young as 9 to receive the HPV vaccine at school without the knowledge or
consent of their parents. Gates, of course, is also a supporter of HPV
vaccination and funds HPV vaccine research.
Lastly, Sigal is on the board of the Parker Institute, which is
partnered with a company called Inovio. Inovio, which is funded by the Gates
Foundation, is working on a COVID-19 vaccine.
What are the chances Sigal’s son-in-law might support efforts to
make the COVID-19 vaccine mandatory in New York as well? When you start tracing
relationships, it’s amazing how often you find the Gates Foundation involved in
matters relating to forced vaccinations and the destruction of legal
Sad to say, it’s hard
to find a government agency that hasn’t been captured by private interests.
I’ve written several articles detailing the corruption at the CDC, for example,
including “CDC Petitioned to Stop Lying About Pharma Funds,”
“How Conflicts of Interest Have Corrupted the CDC”
and “Public Health Agency Sued for Coke Collusion.”
The same can be said about
the World Health Organization which, of
course, is also funded by the Gates Foundation. In fact, when the U.S. withdrew
its funding, Gates stepped in and became the largest funder — larger even than
Without doubt, the FDA
can be added to the list of agencies that largely serves corporate masters,
hidden as they may be behind nonprofit façades. A recent investigative report
FDA documents obtained
via Freedom of Information Act requests reveal it rarely sanctions or penalizes
researchers or research companies even when grave problems — including fraud —
Inspectors conduct routine visits to research trial sites and
review trial records to make sure research parameters and safety protocols are
followed. They also respond to complaints by whistleblowers.
However, FDA documents obtained via Freedom of Information Act
(FOIA) requests reveal it rarely sanctions or penalizes researchers or research
companies even when grave problems — including fraud — are found. What’s more,
there’s a marked trend toward less and less adequate oversight.
Case in point: Aspen
Clinical Research, run by Dr. Michael Harris, has on numerous occasions over
the past decade been cited for “egregious errors” in its clinical trials, yet
the FDA never followed through on its threats to fine, prosecute or disqualify
Harris from conducting clinical research in the U.S. According to the report,
written by Charles Piller:
According to Piller, this isn’t a rare case. After reviewing
some 1,600 FDA inspection and enforcement documents, Piller’s conclusion is
that the “FDA’s enforcement of clinical research regulations is often
light-handed, slow-moving, and secretive.”
I recommend reading Piller’s report in its entirety. It’s
a sobering read that raises all sorts of questions about drug safety.
If a drug trial is riddled with errors, omissions and
outright fraud and falsification of documents and data — examples of which are
given in Piller’s report — and this research is then used to gain FDA approval,
the chances of that drug being harmful can be considerable. Clearly, oversight
without follow-up and follow-through when problems are found is about as useful
as no oversight at all.
- NPR April 3, 2012
- Journal of the National Cancer
Institute March 5, 2008; 100(5): 296-297
- The Nation March 17, 2020
- Jacobinmag.com November 2015
- PND December 8, 2014
- Reagan-Udall Foundation Board of Directors
- The BMJ 2017;358:j3275
- The Fedup Democrat June 19,
- Science Magazine October 1,
Copyright © Dr. Joseph