By Dr. Mercola
The US Food and Drug Administration (FDA) is looking to
increase their budget by $821 million next year, which would
make their proposed 2014 budget a hefty $4.7 billion.
The additional money would help the FDA improve food safety,
monitor imports and create measures to protect against chemical
and biological threats, FDA Commissioner Margaret Hamburg told
Congress, outrageously noting that:1
“FDA is a true bargain among federal agencies.”
This has to be one of the biggest delusions of the 21st
century.This is one “bargain” that is not such a good deal for
Americans’ health, as the FDA is also the federal agency
responsible for a growing list of policy decisions that favor
big industry at the expense of public health.
And if their nearly $1-billion budget increase is approved, they
stand to fall even further into the drug companies’ trenches …
94 Percent of the FDA’s Budget Increase Funded by Drug Companies
Out of the extra $821 million the FDA is seeking, 94 percent,
or $770 million, would come from user fees paid by the drug
industry. While some of the FDA is funded by taxpayers, most of
their budget comes from such user fees, which are paid by the
drug companies to hasten the review and approval of their
products.
Industry user fees were first introduced in the early 1990s
in an effort to help speed up the FDA's approval process; prior
to that, the FDA had been funded entirely by Congress.
This is one of the main reasons why the FDA’s track record
for keeping you safely out of harm’s way has failed so miserably
over the years, as user fees allow the drug industry to have
major leverage over the FDA, and that control
is continuing to increase year after year.
The FDA is even trying to have about $83 million in industry
user fees exempted from the sequester (mandatory budget cuts to
federal agencies that began in 2013), as these fees are supposed
to be withheld due to the sequestration. Yet, with a budget
already surpassing the $4-billion mark, the FDA has done little
to keep Americans safe from dangerous foods and drugs. Instead,
they:
- Quietly withdrew their intent to ban low-dose
antibiotics in animal feed, allowing the spread of
antibiotic-resistant “super-germs” linked to this practice
to continue unabated
- Approved the first genetically modified plant intended
for the treatment of a human disease, opening the door for
biotech companies such as Monsanto, which also has vested
interests in the pharmaceutical industry, to design more
drugs created from genetically engineered plants and/or
animals
- Is considering allowing the unlabeled use of the
artificial sweetener aspartame in dairy products
- Approved a generic version of Actos – the brand name for
a drug used to treat type 2 diabetes – even though it is
presently embroiled in thousands of lawsuits alleging that
the drug causes severe side effects including heart failure,
macular edema and bladder cancer
- Attempting to
regulate stem cell procedures at a Colorado clinic, even
though the stem cells being used in the procedure come from
the patient’s own body, which means they are essentially
claiming that they can regulate a part of your body
FDA Allows Drugs to Remain on Market Despite Uncovering
Fraudulent Safety Data
What do you get when the federal agency in charge of
monitoring drug safety is funded largely by the companies
producing those very same drugs? A massive conflict of interest
and an agency that is more interested in serving the drug
industry than the American public.
This is not speculation; it’s been shown to be the truth,
time and time again. In 2011, the FDA found out that many
studies conducted at Cetero Research, a major drug research lab,
from 2005 to 2009 were fraudulent, involving manipulated data
and tampered records.2
About 100 drugs were already on the market, approved, at least
in part, based on these fraudulent studies.
Yet, the FDA made no warnings to the public, instead allowing
the potentially dangerous drugs to remain on the market while it
quietly ordered re-testing to be done. In Europe, however,
multiple drugs were pulled from the market following the
revelation. Even today, the FDA has never released a list of the
affected drugs, saying this would reveal trade secrets.
Unfortunately, this wasn’t an isolated case. As
Scientific American and ProPublica reported:3
“Turns out that wasn't an anomaly: The agency's slow,
secretive response in the Cetero case mirrors how it handled
an earlier instance of scientific misconduct at another
contract research organization, MDS Pharma Services.”
When the FDA found that four years’ worth of data produced by
two MDS facilities were potentially fraudulent, it again refused
to post a public list of the 217 affected drugs, some of which
were already being sold. Despite requiring re-testing of many of
the medications, the FDA assured the public that the drugs were
safe – an impossible truth since they were approved, in part,
based on faulty research. At least five of MDS’ senior
executives later went to work for Cetero Research.
Scientific American continued:4
“In January 2007, three and a half years after first
finding problems at MDS, the FDA informed drug makers that
studies done by MDS between 2000 and 2004 needed to be
reevaluated. FDA officials told the media that 217 generic
drugs were potentially implicated, 140 of which were already
approved for sale.
The agency was unsure how many new drugs might have
relied on studies carried out by MDS, according to news
accounts, so it asked the manufacturers of every new drug
approved between 2000 and 2004 -- some 900 medicines -- to
check to see if MDS had conducted any relevant tests. 2The
FDA made no effort to warn doctors or patients that it now
had doubts about the data underlying some of the drugs it
had approved. Instead, the agency sounded a public 'all
clear.'”
The FDA Is Failing at Its Stated Mission
Now, with the FDA requesting even more money from
the drug industry, it’s likely that such egregious biases in
favor of the industry are only going to continue. They simply
cannot risk biting the proverbial hand that feeds them …The
FDA's mission statement reads as follows:
"The FDA is responsible for protecting the public
health by assuring the safety, efficacy, and security of
human and veterinary drugs, biological products, medical
devices, our nation's food supply, cosmetics, and products
that emit radiation. The FDA is also responsible for
advancing the public health by helping to speed innovations
that make medicines and foods more effective, safer, and
more affordable; and helping the public get the accurate,
science-based information they need to use medicines and
foods to improve their health."
In 2007, a report bearing the revealing title "FDA
Science and Mission at Risk" by the Subcommittee on Science
and Technology,5
detailed how the FDA cannot fulfill its stated mission
because:
- Its scientific base has eroded and its scientific
organizational structure is weak
- Its scientific workforce does not have sufficient
capacity and capability, and
- Its information technology (IT) infrastructure is
inadequate
Furthermore, the report found that "the development of
medical products based on 'new science' cannot be adequately
regulated by the FDA, and that the agency does not have the
capacity to carry out risk assessment and analysis.
Additionally, the agency's science agenda "lacks coherent
structure and vision, as well as effective coordination and
prioritization."
The fact that the FDA does not have its ducks in a row, so to
speak, has sorely misplaced its priorities, and is not working
to fulfill its mission is clearly evidenced in the numerous
cases where hundreds and sometimes thousands of complaints about
dangerous drugs (like Vioxx and Avandia), vaccines (like
Gardasil), and additives (like aspartame) are stubbornly
ignored, while SWAT-style teams armed to the teeth are sent to
raid supplement makers, whole food businesses, organic farmers,
and raw dairies when oftentimes not a single incidence of harm
can be attributed to their products.
Hospitals Make More Money From Surgical Complications
The FDA has little incentive to change its current structure
or work harder to uncover drug dangers, lest they put billions
of dollars of their funding at risk. Likewise, a revealing new
JAMA study found that major surgical complications
actually earn hospitals more money on privately insured or
Medicare-covered patients.6
This isn’t exactly shocking, of course, since the more
complications suffered, the longer the hospital stay and the
more associated medications, tests and procedures that will be
ordered. Hospitals are a business, after all, and the more
“services” used by any one patient, the more money they make.
Where money is concerned, a hospital therefore has no
incentive to reduce surgical errors and other medical mishaps,
which may actually be a key moneymaker for them. And, as the
Health Business Blog astutely reported,7
unlike most businesses, which suffer financially when mistakes
occur, hospitals get to charge you even more money to treat you
for avoidable complications or mistakes they make. Decreasing
surgical complications may therefore have adverse financial
consequences for many hospitals, the researchers concluded.
More Reason to Take Control of Your Health
Minor changes to the existing structure will not be enough to
change the current medical paradigm, which is designed to
profit from your ill health. A complete reform of the
system would instead be needed, and there are powerful forces at
play that do not want this to happen.
As much as possible, be proactive in using a
healthy
lifestyle to support and protect your health and, if illness
does occur, use natural methods that will allow your body to
heal itself without the need for the deadly drugs being pushed
on you by the drug companies and the FDA.
© Copyright 1997-2013 Dr. Joseph Mercola. All Rights Reserved.