How Fascism Creates Science-Biased
Medicine in Federal Policies
February 25, 2015
Story at-a-glance
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In the most serious cases of fraud and misconduct in
clinical research, the FDA can classify it as “official
action indicated” (OAI)
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Researchers found 60 clinical trials that had been
classified as OAI, and these trials had been used for data
in 78 published articles
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Out of those 78 studies, only three included mentions of the
violations found by the FDA
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The violations included fraud, incompetence, and misconduct
By Dr. Mercola
As stated in their mission statement, the US Food and Drug
Administration (FDA) is responsible for protecting public health by
assuring the safety and efficacy of drugs, biological products,
medical devices, food, and more.1
It’s a tall order, no doubt, but the FDA makes many glaring
omissions or, some might say, blatant oversights that put the
public’s health at risk. Yet, the public is quite understanding and
tolerant of the FDA’s mistakes and industry-friendly positions.
For instance, even as they continue to
ignore the risks of antibiotics in animal feed, deceive
you about
mercury amalgams, and allow Americans to consume questionable
foods that are banned in other countries…
There is no major public uproar or demand for a (much-needed)
overall of the agency. But it is hard to defend an agency that
continually acts against the best interests of the public
they’re entrusted to defend.
Now, due to the efforts of a professor and his students at the
Arthur L. Carter Institute of Journalism at New York University, we
have yet another example of the FDA failing to warn
Americans, in this case about grave concerns due to falsifications
in published data.
FDA Uncovers Fraud, Incompetence, and Misconduct in Clinical Trials…
Says Nothing
The FDA reviews several hundred clinical trial locations that
conduct research on human participants each year in order to be sure
they’re engaging in good clinical practice. But what happens when
they find evidence of questionable procedures or practices?
In the most serious of cases, the FDA can classify it as
“official action indicated,” or OAI. This is reserved for “severe”
forms of clinical trial violations, including "objectionable
conditions or practices" that warrant compulsory regulatory action,
as opposed to "voluntary action indicated" for lesser violations.”2
Now, if a trial had been deemed OAI by the FDA, you might assume
that you’d see evidence of that when reading the results of studies
based on said data. But that would be a liberal assumption.
Researchers conducted a review of FDA inspection reports between
1998 and 2013.
They found 60 clinical trials that had been classified as OAI,
and these trials had been used for data in 78 published articles.
Out of those 78 studies, only three included mentions of
the violations found by the FDA!
And we’re not talking about small, innocent mistakes. The
violations included fraud, incompetence, and misconduct. This means
that anyone browsing a medical journal might be making decisions
based on fraudulent published studies.
Studies that the FDA knows contain grave errors… but
chose not to say anything about. While you might not
personally read this misleading data, your doctor might. As the
study’s lead researcher, Charles Seife, noted:3
“Your physician makes decisions based upon what he knows
from the peer-reviewed literature… If that literature is tainted
in some way without the physician knowing, then the physician is
making treatment decisions based upon bad data."
Widespread Scientific Fraud, Limb Amputations… Even a Related
Homicide Case!
In all, the study found about 2 percent of the close to 650 FDA
inspections were classified as OAI. Among the violations was a trial
in which patients were treated with stem cells to treat poor blood
flow in a leg.
The trial reported that all patients reported
improvement in their limbs… but one person had to have a foot
amputated two weeks after the treatment.
In another case, the FDA said “systematic and widespread
scientific fraud” made a trial of the blood-thinning drug
rivaroxaban unreliable. But no mention of this fraud is made in the
journals that published its findings.4
In another particularly egregious case, a researcher falsified
documents that lead to the death of a chemotherapy patient. The
researcher pleaded guilty to fraud and went to prison for criminally
negligent homicide … but again, the related published studies make
no mention of this.5
Of the 57 OAI trials:6
- 22 had falsified information
- 14 trials had researchers who failed to report adverse
events
- 42 trials had violations of the trial’s protocols
- 35 trials had record-keeping errors
- 30 trials had researchers who failed to protect patient
safety or acquire informed consent
FDA Says They’re Moving Toward Transparency, Yet Heavily Redacts
Information
The FDA devotes an entire section of its website to transparency
and says they’re engaged in an “agency-wide effort to open the doors
of the agency.”7
Yet, most of the documents obtained by students for the featured
study were heavily redacted.
In some cases, Seife noted, you couldn’t even tell what drug was
being tested… and he believes his team would have uncovered even
more violations if not for the redaction.8
In a scathing review in Slate, Seife wrote:9
“Reading the FDA’s inspection files feels almost like
watching a highlights reel from a Scientists Gone Wild
video. It’s a seemingly endless stream of lurid vignettes—each
of which catches a medical researcher in an unguarded moment,
succumbing to the temptation to do things he knows he really
shouldn’t be doing.
Faked X-ray reports. Forged retinal scans. Phony lab
tests. Secretly amputated limbs. All done in the name of science
when researchers thought that nobody was watching. That
misconduct happens isn’t shocking.
What is: When the FDA finds scientific fraud or
misconduct, the agency doesn’t notify the public, the medical
establishment, or even the scientific community that the results
of a medical experiment are not to be trusted. On the contrary.
For more than a decade, the FDA has shown a pattern of
burying the details of misconduct. As a result, nobody ever
finds out which data is bogus, which experiments are tainted,
and which drugs might be on the market under false pretenses.
The FDA has repeatedly hidden evidence of scientific
fraud not just from the public, but also from its most trusted
scientific advisers, even as they were deciding whether or not a
new drug should be allowed on the market.
Even a congressional panel investigating a case of fraud
regarding a dangerous drug couldn't get forthright answers. For
an agency devoted to protecting the public from bogus medical
science, the FDA seems to be spending an awful lot of effort
protecting the perpetrators of bogus science from the public.”
Conflict of Interest Rampant in GRAS Panels
When the 1958 Food Additives Amendment was enacted, the exclusion
of GRAS items from the formal FDA approval process for food
additives was meant to apply to common food ingredients such as
vinegar, i.e. items known through their historical use as being
safe. Nowadays, however, countless manufactured ingredients end up
slipping through this loophole.
A company can simply hire an industry insider—a completely
conflicted "expert"—to evaluate the chemical, and if that individual
determines that the chemical meets federal safety standards, it can
be deemed GRAS without any involvement from the FDA. A study
published in JAMA Internal Medicine revealed that the
individuals companies select to make these “expert” determinations
often have conflicts of interest.10
In fact, of the 451 GRAS notifications reviewed:
- 22 percent of the safety assessments were made by an
employee of the additive manufacturer
- 13 percent were made by an employee of a consulting firm
selected by the manufacturer
- 64 percent were made by an expert panel selected by either a
consulting firm or the manufacturer
The researchers concluded that conflicts of interest in approvals
of GRAS food additives are rampant and deserve attention from the
FDA: “Between 1997 and 2012, financial conflicts of interest
were ubiquitous in determinations that an additive to food was GRAS.
The lack of independent review in GRAS determinations raises
concerns about the integrity of the process and whether it ensures
the safety of the food supply, particularly in instances where the
manufacturer does not notify the FDA of the determination. The FDA
should address these concerns.”
The FDA has created a voluntary program that asks food companies
to submit their safety assessments for FDA review. If the agency
cannot find any major problems with the company's argument for GRAS
status, a "no questions" letter is sent to the company. However, if
questions about safety are raised by FDA scientists, the
company can simply withdraw its voluntary submission, and go on
using the chemical as if nothing has happened.
This legal loophole in the law allows food manufacturers to
market novel chemicals in their products based on nothing but their
own safety studies, and their own safety assessments—the results of
which can be kept a secret. As Marion Nestle, Ph.D., Paulette
Goddard professor in the Department of Nutrition, Food Studies and
Public Health at New York University, said:11
“How is it possible that the F.D.A. permits manufacturers to
decide for themselves whether their food additives are safe?”
How Independent Are Vaccine Supporters?
Conflict of interest is pervasive not just in the food industry
but also in the medical field. As attacks against those who support
vaccine choice rage on at an all-time high, it is important to
understand who’s behind some of the most prominent vaccine
supporters. In an investigation by CBS News correspondent Sharyl
Attkisson, she revealed strong financial ties between the vaccine
industry and the American Academy of Pediatrics (AAP), for starters.
Among them, the agency received:12
- $324,000 from Wyeth, maker of the pneumococcal vaccine
- $433,000 from Merck, the same year AAP endorsed their HPV
vaccine
- Additional contributions from Sanofi Aventis, maker of 17
vaccines
The pro-vaccine group Every Child by Two has also received money
from the vaccine industry, as has Dr. Paul Offit, who is one of the
most outspoken defenders of vaccine safety. Dr. Offit received a
reported $350,000 grant from Merck to develop a rotavirus vaccine,
and has served on the scientific advisory board for Merck. He
received another estimated $6 million when Children's Hospital of
Philadelphia (CHOP) sold the patent for the RotaTeq vaccine he
developed. He was also on the CDC advisory board that approved the
addition of a rotavirus vaccine to the US National Immunization
Program (NIP) in 1998—a decision that paid off handsomely.
The original rotavirus vaccine added to the NIP, which was made
by a competitor, was pulled from the market due to adverse effects.
The RotaTeq vaccine replaced it, and he continues to receive royalty
payments from the sale of RotaTeq to this day. (According to
Wired Magazine,13
Merck's revenue from RotaTeq was $665 million in 2008 alone, of
which Offit and his RotaTeq co-creators are said to receive a
percentage.)
Hit Lists, Pay Offs, and Fake Journals All Par for the Course
Drug giant Merck has fortunately stopped promoting the mandatory
use of Gardasil,
the useless human papillomavirus (HPV) vaccine. Their campaign
to promote it (back in the 2000s) was dubbed by some as the Help
pay for Vioxx Litigation campaign (Vioxx is linked to heart
attacks and was pulled from the market after it had killed more than
60,000 people). As noted by CorpWatch:14
“…revelations of money trails and the rush to make a new
vaccine mandatory created a backlash and forced Merck, on
February 20th [2007], to publicly abort its lobbying campaign
for mandatory vaccination of school girls.”
Two legislators from Maine, Marilyn Canavan and Andrea Boland,
painted a particularly poignant picture of who’s really running the
show. At a conference organized by the non-profit organization Women
in Government (WIG), they described one-sided “presentations” (not
discussion) aimed at getting the female legislators on board with
vaccination. According to CorpWatch:15
“Boland, a first-time legislator, joined Canavan, a WIG
state director, at a small planning session, where she was taken
aback by the extent to which corporations influenced WIG. ‘When
discussing what the agenda for next year would be,’ participants
were told to 'wait to see who's funding things.'" Similarly
before fixing the program for next year, they ‘had to see what
the sponsors want,’ said Boland.”
Merck is the same company that created a fake “peer-reviewed”
journal called The Australasian Journal of Bone and Joint
Medicine to promote pro-Vioxx articles.16
Merck even had a hit list of doctors who had to be "neutralized" or
discredited because they had criticized the painkiller Vioxx. Those
who made it onto Merck’s “hit list” said they experienced instances
of intimidation, including suggestions that Merck would stop funding
the institution or interfere with academic appointments.
This clearly gets in the way of academic freedom, researchers’
ability to accurately report their findings, and doctors’ ability to
speak out against a drug they believe is harmful. But then that is
what Merck was after. Adding to the issue, of course, is that this
is probably not an isolated occurrence. Drug companies could be
keeping any number of lists of people who are interfering with their
ability to sell and make profits, and my guess is that they are at
work “neutralizing” those people as we speak. In fact, I would bet
on it.
Only Two Countries Allow Direct-to-Consumer (DTC) Drug Advertising
The US is one of them (New Zealand is the other). What is DTC
advertising? It’s that barrage of ads you see on TV and in magazines
and newspapers, or on the radio and Internet. They're ads telling
you to run right out and ask your doctor if this or that pill would
be right for you. Some drug companies have even taken to advertising
highly specialized medical devices, like heart stents. It's a
marketing bonanza that's turned America into a medicated mass of
people who've been brain-washed into thinking that taking pills will
make everything better―even for ailments you might not have.
But it's a brilliant move for Big Pharma, who has now turned the
consumer into their very own sales rep, and a persuasive one at
that. Not only is there a correlation between the amount of money
drug companies spend on DTC advertising and the brand of drug
patients request from their physicians, but the data shows DTC
advertising rapidly converts people into patients. As mentioned by
Alternet:17
"It's a disgusting, dishonorable way to generate
sales--but it works. In 2008, the House Commerce Committee found
that every $1,000 spent on drug ads produces 24 new patients,18
and a 2003 research report found that prescription rates for
drugs promoted with DTC ads were nearly seven times greater than
those without such promos.19
Ethics aside, these consumer hustles have proven to be
profit bonanzas."
As you might suspect, the use of DTC ads has grown rapidly since
it was first approved in the U.S. in 1997. At that time, the ads
could only be run along with lengthy consumer information warning of
risks and side effects, so few companies used them. In 1997, the FDA
revised the rule so that rather than providing a full disclosure,
companies only needed to meet an "adequate standard" when it came to
describing risks to consumers. Although viewed as a relatively
recent phenomenon, drug advertising has a long and sordid history,
as reported in the American Journal of Public Health:20
“Although the public health impact of direct-to-consumer
(DTC) pharmaceutical advertising remains a subject of great
controversy, such promotion is typically understood as a recent
phenomenon permitted only by changes in federal regulation of
print and broadcast advertising over the past two decades. But
today's omnipresent ads are only the most recent chapter in a
longer history of DTC pharmaceutical promotion (including the
ghostwriting of popular articles, organization of
public-relations events, and implicit advertising of products to
consumers) stretching back over the twentieth century.”
In an Era of Bias, Conflict of Interest, and Confusion: Take Control
of Your Health
Virtually every measurable index indicates that despite the
ever-increasing amounts of money invested, if you live in the US
your chance of achieving optimal health through the conventional
medical system is getting progressively worse. As just one
example, while the US spends more than twice the amount on
health care as other developed nations, we rank 49th in
life expectancy worldwide—far lower than most other developed
nations ... When it comes to your health, you simply cannot accept
claims at their face value… Quite often—definitely too frequently
for comfort—treatment recommendations are biased in favor of a
specific drug simply because people making the decisions stand to
profit from it.
Whatever your health problem might be, I strongly recommend
digging below the surface using all the resources available to you;
including your own commonsense and reason, true independent experts'
advice and others' experiences to determine what medical treatment
or advice will be best for you. Ultimately, you are responsible for
your and your family's health, so be sure you feel completely
comfortable with any related decisions you make. If you're facing a
health challenge, choose healthcare practitioners who really
understand health at a foundational level and have extensive
experience helping others (and don't be afraid to ask for references
and seek corroboration).
Of course, I always advise taking control of your health, which
you can easily do by reviewing my
comprehensive nutrition plan that summarizes my 30 years of
clinical experience and treating 25,000 patients. I put this
together so you can stay well and avoid having to rely on
information that gives the perception of science when it is
actually too heavily flawed or manipulated to benefit your health.
Most of us live in free enough countries where we still have the
ability to take back control of our health… we just need to grab the
initiative.
Copyright 1997- 2015 Dr. Joseph Mercola. All Rights Reserved.
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