FDA drug safety bill passes in the U.S. Senate; health
freedom advocates outraged at betrayal of American consumers
News Target
Wednesday, May 09, 2007 by: Mike Adams
The U.S. Senate passed the FDA "drug safety" bill today (S.1082) with a 93-1
vote. A key amendment that would have called for genuine drug safety protections
for consumers -- the Grassley amendment 1039 -- was defeated by a single vote
(47 to 46). The new law deepens financial ties between Big Pharma and the FDA,
doubling the amount of money directly paid to the regulator by drug companies,
but it fails to explicitly protect foods and nutritional supplements from
overreaching FDA regulation efforts. The new law also failed to end Big Pharma's
monopoly stranglehold on American consumers, further blocking the ability of
citizens, businesses, cities and states to import equivalent medications from
countries like Canada (where drugs are far safer than those sold in the United
States, by any measure).
Health freedom advocates such as Byron Richards of Wellness Resources (www.WellnessResources.com),
John Hammel of the International Advocates for Health Freedom (www.IAHF.com),
and myself (www.NewsTarget.com)
sought to garner enough grassroots support for achieving the inclusion of key
amendments in the bill, such as the Dorgan amendment which, for four days,
appeared to end the medical monopoly that currently forces American consumers to
pay the highest prices in the world for prescription drugs. Although hundreds of
thousands of consumers contacted their lawmakers to demand an end to the
monopoly price fixing currently operating in the United States, lawmakers seemed
confused and could not bring themselves to support any amendment that would have
threatened the profits of Big Pharma. Ultimately, the Dorgan amendment was
quickly defeated by the Cochran amendment, trapping Americans in a monopoly
medical market that would be considered illegal by nearly everyone if a
corporation like Microsoft attempted something similar.
S.1082 ultimately passed with amendments that primarily support the agendas of
Big Pharma and the FDA, expanding the powers of both. Very few provisions were
accepted that addressed the serious issues of corruption, conflicts of interest,
television drug advertising or genuine drug safety.
Health freedom advocates are now characterizing the final bill as the, "Big
Pharma Protection Act of 2007" due to its emphasis on protecting the monopoly
drug market in the United States while doing very little to accomplish its
stated goals of increasing the "safety" of prescription drugs.
Analysis by Mike Adams (opinion)
The passage of S.1082 is a terrible defeat for Americans, but a huge victory for
Big Pharma and the FDA. The bill expands the FDA's powers and keeps in place a
hugely profitable Big Pharma monopoly over U.S. consumers that is right now
bankrupting our nation.
At every step, Big Pharma-funded lawmakers voted to minimize any real safety
scrutiny and chose instead to dress up their drug-promoting agendas as "public
safety" measures. In the end, the only thing that's really safe is the revenue
stream of drug companies. An illegal monopoly on prescription drugs has now been
officially sanctioned by the U.S. Senate, and organized medicine today is now
unquestionably operating as a system of organized crime. Lawmakers have been
paid off, regulators have been influenced, and the media is being bought with
advertising dollars. Big Pharma now has a near-total chokehold over everything
to do with medicine in the United States, from what is taught in medical schools
to what's accepted as "scientific" by the medical journals. The takeover of
America by drug companies is now nearly complete.
Of note, the most profitable corporations in the world -- the drug companies --
have now demonstrated majority control over the United States government. From
this point forward, government and private industry will now act as one
incestuous, unstoppable entity to trap American consumers in a system of
fraudulent medicine designed to do nothing more than extract dollars from their
pockets. No meaningful reform will be tolerated. No limits on FDA tyranny will
even be openly discussed.
During this rare window of opportunity for real, positive change that could have
protected Americans from the predatory marketing practices of
criminally-operated drug companies, our lawmakers utterly failed us. Our
Senators have sold out to Big Pharma influence, and through their votes, they
have doomed the United States to inevitable medical bankruptcy that threatens
the future of the nation itself.
As corporations continue to flee the U.S. due to overwhelming health care costs,
our own Senators believe a monopoly drug racket should continue to be
protected! They believe that the FDA should have even more power over
consumers, and that the American people should be treated as medical guinea
pigs, involuntarily taking part in a massive drug experiment called, "Test the
drugs on the population." Any real safety issues will only be dealt with after
the fact -- after they've killed hundreds of thousands more Americans.
Chemical warfare against the American people
With the passage of S.1082 and the emboldening of the FDA and Big Pharma, a war
has been declared on the American people, and it is far more dangerous than any
terrorist action. It is a war against Americans' health, and the U.S. Senate has
now condemned itself as a band of sellouts for giving official legislative
approval for the waging of that war against Americans. It is a war that will
produce millions of casualties over the next decade. Dropping a nuclear bomb
over a major American city would kill fewer people than the FDA / Big Pharma /
Big Government agenda will now kill, thanks to the actions of our lawmakers.
(And that's using statistics from the Journal of the American Medical
Association, by the way.) As shameless as ever, this dangerous law has been sold
to consumers as a "drug safety" bill.
But prescription drugs are not safe, even if they are purchased at the highest
retail prices in the world. (Paying more for a drug does not make it safer.)
FDA-approved prescription drugs have killed far more Americans than all the
terrorists events recorded in American history, combined! The FDA is the
single greatest threat to the health and safety of the American people, and
today, with the passage of S.1082, the U.S. Senate has clearly said that it
believes the FDA should have even more power over the people. Apparently, enough
Americans have not died yet. The body count has not yet reached a number
sufficient to override campaign funding bribes paid to senators by drug
companies. The pharmaceutical holocaust is not yet large enough to demand real
reform.
It is my belief that with this vote, U.S. Senators have betrayed their nation.
They have sold out the health and safety of the American people to the
wealthiest and most profitable corporations in the world: Drug companies. Our
senators have stolen from the poor and given to the rich. They've allowed a
criminal price-fixing enterprise to continue dominating medicine in America
today, and they've failed to take any meaningful action to deliver what
Americans demand the most: Free market access to medications that are provably
safe and effective.
Our Senate has failed us, just as conventional medicine and the FDA have failed
us. Today is a sad day in the history of these United States, for it is a
signpost that announces the fact that from now on, our government shall
operate solely in the interest of corporations.
Lincoln's Gettysburg Address once described a government "of the people, by the
people and for the people." Today, that dream is unquestionably lost. As my
CounterThink cartoon depicts below, we are now a nation of the corporations, by
the corporations and for the corporations.
The U.S. Senate has now positioned itself as the adversary of the American
people when it comes to any decisions involving health or medicine, and most
people in this nation have no idea what just happened. Our Prozac-popping
populace is too mind-numbed by prescription drugs to save themselves from a
medicated future of personal and national bankruptcy. I advise all remaining
sane citizens to start making plans now to protect themselves from the new
merger of Big Pharma and Big Government. S.1082 has all come down to one thing:
a Big Medical Scam.
Analysis by Byron Richards (opinion)
The Senate has sold out the American people. Anyone voting for change in the
last election can now plainly see the shenanigans of a Democratic-controlled
Senate. Under Republicans no FDA reform ever took place. Big Pharma owns so many
Republicans that all meaningful legislation to curtail the deaths and injuries
of American citizens at the hands of Big Pharma and the FDA had been completely
thwarted for the past six years. Under Democratic control sweeping FDA reform
favorable to Big Pharma was proposed and the majority of meaningful reform was
blocked or seriously watered down. Which is worse? As Kennedy stated in his
opening remarks today, S1082 (the Kennedy/Enzi FDA bill) was an "elaborate
scheme."
The final passage of S1082 was never in doubt (final vote was 93-1). In fact,
Kennedy and Enzi gave Big Pharma a 40 yard head start in a 100 yard dash; it
wasn't much of a contest. Their legislation perpetuated the user fees allowing
Big Pharma to buy mob-like protection from the FDA. The bill created the
Reagan-Udall Foundation for the FDA to hold FDA-related patents and allowed the
FDA to license technology to drug companies -- thus turning the FDA into a drug
company with vested interests in specific medicines. None of these blatant
conflicts of interest, which are also primary safety issues, seemed to bother
any senators at all.
Hypocrisy Gone Wild
The bill claimed to be a safety bill and all arguments from either side on any
issue were always presented as safety related. Thus, every Senator was using the
same set of words to describe both sides of the issue. Each side claimed the
other was using the safety term hypocritically, resulting in a bewildering
debate. All of this was staged to confuse the public and perpetuate a myth that
safety legislation was being meaningfully debated.
What was really being debated was the extent to which the Big Pharma monopoly
would be allowed to continue, an issue that was too politically incorrect to
describe publicly. The debate was actually about how sharply Big Pharma's
exorbitant profits and reckless behavior would be curtailed compared to how many
Americans would be exposed to injury and death at the hands of Big Pharma.
Earlier in the week a fight broke out between a contingent of Democrats lead by
Senator Kennedy (D-MA) and a larger contingent lead by Byron Dorgan (D-ND).
However, when the Kennedy clan joined the Republicans their odd Big
Pharma-sponsored coalition held an advantage. This group of Senators undermined
the free market and perpetuated the high cost of drugs in this country compared
to all others countries -- a 50 billion dollar gift to Big Pharma.
Double talk became the order of the day. On the one hand it was funny to watch,
as Democrats attacked each other. On the other hand it was sad to watch, as this
pathetic debate will result in window-dressing reform, with enough Big Pharma
loopholes to drive a Mack Truck through. Attempts by well meaning senators to
correct flagrant flaws in the legislation were either watered down to the point
of nonsense or blocked entirely.
Many key issues were not addressed, such as the FDA's legal position to prevent
citizens from suing drug companies, the massive (and oftentimes illegal) off
label promotion of drugs by the legion of Big Pharma sales reps, medical
journals that are full of fraudulent Big Pharma promo pieces that misrepresent
the safety and efficacy of drugs currently on the market, and a large percentage
of doctors on the take from Big Pharma.
Big Pharma Wins Key Amendment Votes
On the final day it all boiled down to two keys votes. One vote was on the
Grassley amendment #1039 which would have given true power to scientists in the
FDA responsible for regulating the safety of drugs already on the market. The
FDA and Big Pharma were adamantly opposed to this amendment. The vote was Big
Pharma 47 -- Americans 46, defeating the amendment. This vote was not only a
sell out of Dr. David Graham and other FDA scientists who have gone to Congress
as whistleblowers to save American lives, it was an "acid-test" vote on who is
truly on Big Pharma's payroll.
Click here to see how your senators voted.
The other key vote came on the Durbin amendment #1034. This amendment sought to
prevent Big Pharma from placing "experts" on FDA Advisory Committees -- which
make the final decisions on the safety of drugs. Durbin argued the obvious point
that hundreds of millions of dollars are at stake as well as the lives of
Americans and that such flagrant conflicts of interest must be stopped. He
pointed out that the FDA Advisory Committee that ruled on the safety of Vioxx
had 10 "experts" on the Big Pharma bankroll, resulting in over 50,000 deaths.
Kennedy and Enzi argued that these conflicts of interest were necessary and a
fact of life and needed for science to progress. The vote was Big Pharma 47 --
Americans 47, and in this case the tie went to Big Pharma and the amendment was
defeated.
Click here to see how your senators voted.
Two-faced senators threw a dog bone to those promoting safety, as a second
Grassley amendment that called for stiffer civil penalties against Big Pharma
wrongdoing was approved.
The Senate has punted when given a major opportunity to protect the health and
well being of Americans. S1082 is the best "safety" legislation that Big Pharma
money could buy.
The Voice of Health Freedom was Heard
Many thousands of Americans flooded the Senate with objections to a clause
relating to the Reagan-Udall Foundation for the FDA, which could be used to
target dietary supplements by evaluating them as drugs for safety purposes.
While Enzi refused to change the language, we created such an uproar that
assurances are officially in the Congressional Record that this legislation is
not to be used to harass dietary supplements.
And we headed off a potential attack by Durbin -- who for some reason is always
trying to get vitamins classified as drugs (more safety hypocrisy). Key to this
effort was myself writing for NewsWithViews.com, Mike Adams writing for
NewsTarget.com, and John Hammell of the International Advocates for Health
Freedom. Support also came from many other groups who forwarded the message. All
of our efforts resulted in the following testimony on the floor of the Senate as
reported in the Congressional Record.
May 2, 2007:
Mr. HATCH. My office has been inundated by calls from people throughout the
country who believe that this legislation, specifically the provision
establishing a Reagan-Udall Institute, will overturn the Dietary Supplement
Health and Education Act of 1994. That has not been my reading of the bill, but
I wonder if other Senators have heard similar concerns?
Mr. HARKIN. Yes, I have received a good many calls as well. And, I have to say
that I would be very concerned, as I know the Senator from Utah is, if anything
in the bill we are considering, S.1082, would overturn DSHEA, a law we fought
side-by-side to see enacted.
Mr. ENZI. It might be helpful if I explained the provision you are discussing,
as my office has received many calls as well and I believe the callers are not
informed about this matter. Subtitle B of title II of S. 1028 establishes the
Reagan-Udall Foundation for the Food and Drug Administration. That simple
purpose of that nonprofit Foundation is to lead collaborations among the FDA,
academic research institutions and industry designed to bolster research and
development productivity, provide new tools for improving safety in regulated
product evaluation, and in the long term make the development of those products
more predictable and manageable.
Mr. KENNEDY. That is exactly the purpose of the Foundation, which was included
in the drug safety legislation Senator Enzi and I introduced last year. The
Foundation will be financially supported by industry and philanthropic donated
funds. A chief scientist at FDA will promote intramural research and coordinate
it with efforts at the Foundation.
Mr. HATCH. That explanation is very helpful. What, specifically, would the role
of the Foundation be with respect to dietary supplements?
Mr. KENNEDY. Let me make absolutely clear that the Reagan-Udall Foundation will
in no way override, overturn or conflict with the Dietary Supplement Health and
Education Act. Nothing in this bill would have that effect.
Mr. ENZI. Yes, we took great pains to make certain there would be no conflict
with DSHEA. Regarding foods, and dietary supplements are generally regulated as
foods, the general directive of the Foundation is to identify holes in the
evaluation of food safety and identify ways to address those deficiencies
through collaborative research with industry.
Mr. HARKIN. So to make this absolutely clear, what you are saying is that the
bill we are debating would in no way interfere with consumers' access to dietary
supplements?
Mr. HATCH. To add to that point, it seems that the language could, in fact, help
dietary supplement consumers, because it would allow collaboration between
government and industry to conduct research on issues that might be helpful to
supplement consumers?
Mr. KENNEDY. Yes, that is the case.
Mr. ENZI. I agree with Chairman Kennedy's assessment.
Mr. HATCH. I thank you for those assurances and that clarification.
Mr. HARKIN. This has been a very helpful discussion, because Senator Hatch and I
could never support legislation that would interfere with DSHEA and we are glad
to receive the assurances of the chairman and the ranking Republican on the
committee.
On May 1 we sent out another urgent call to action because Durbin was planning
an end run around DSHEA that would further attack dietary supplements. Once
again the people flooded the Senate and on May, 3, 2007, Senator Hatch responded
to the concerns we raised. The Congressional Record states:
Mr. HATCH. Mr. President, a number of questions have been raised about how
the Durbin amendment on food safety, adopted yesterday by a unanimous vote,
would affect regulation of dietary supplements….
For the edification of my colleagues, section 201ff of the Federal Food, Drug
and Cosmetic Act, FFDCA, contains the definition of dietary supplements. That
definition includes a proviso that supplements are to be considered foods,
except in the instance when a product makes a drug claim. In other words, by
Federal law, dietary supplements are generally considered to be foods.
It is for this reason that the language of the original Durbin amendment
establishing a new adulterated food registry could have been read to apply to
dietary supplements.
This raised problems for me, and indeed for our colleague Senator Harkin, since
we had spent more than 2 years working with Senators Durbin, Kennedy, and Enzi
to draft, pass and enact the Dietary Supplement and Nonprescription Drug
Consumer Protection Act, Public Law 109-462. That law authorizes a new program
so that reports of serious adverse events related to the use of a dietary
supplement or over-the-counter drug would be reported to the Food and Drug
Administration, FDA, on a priority basis.
As I said, the Durbin amendment contemplates a new adulterated food registry.
Under the provisions establishing that registry, reports of adulterated foods
would be made by many, if not all, of the same parties who are required to file
reports of serious adverse events associated with the use of dietary supplements
under Public Law 109-462. And so passage of the Durbin amendment could be seen
to supersede the law we enacted last year for supplements, which I am relieved
to hear was not the intent of our colleague, Senator Durbin.
Consequently, the amendment we adopted yesterday contains language that Senator
Harkin and I suggested to make certain that dietary supplements would not be
covered by the new food safety language and thus last year's law would not be
superseded. To reassure those who are interested in the Dietary Supplement
Health and Education Act, DSHEA, I wanted to take a moment to outline those
changes.
First, there is new language in the section establishing the adulterated food
registry to express the sense of the Senate that: (1) DSHEA has established the
legal framework to ensure that dietary supplements are safe and properly labeled
foods; (2) the Dietary Supplement and Nonprescription Drug Consumer Protection
Act has established a mandatory reporting system of serious adverse events for
nonprescription drugs and dietary supplements sold and consumed in the United
States; and (3) the adverse events reporting system under that act will serve as
the early warning system for any potential public health issues associated with
the use of these food products.
In addition, language contained in the Durbin amendment modifies the definition
of supplement contained in 201ff of the FFDCA so that supplements will not be
considered foods for the purpose of the new adulterated foods registry. This in
no way would alter the time-honored conclusion of the Congress that supplements
are to be considered foods. On the contrary, all it would do is exempt
supplements from the registry.
These changes, all contained in the amendment which was approved yesterday, make
clear that there are no new dietary supplement requirements in the Food and Drug
Administration Revitalization Act. It is my hope this will reassure the many who
have expressed concern that Congress was inadvertently repealing Public Law
109-462.
The voice of the people has been heard. Let us not forget these promises nor let
the FDA forget them -- as the questionable language regarding the Reagan-Udall
Foundation for the FDA still remains.
Waking up the American public to the larger issue of drug safety is a much more
challenging task. Kennedy and Enzi are claiming that the Reagan-Udall Foundation
for the FDA is nothing but a friendly non-governmental research foundation. I
will fully document in a subsequent article that this is not the case. It is
actually the tool by which Big Pharma and Big Biotech will lock in their profits
for the next 50 years, as FDA joins them in the drug development and marketing
business. This is one of the greatest safety threats in the history of America.
The battle now moves to the House and then to a conference committee. The
legislation is being ramrodded through before the general public knows what is
happening. Mainstream media, a primary client of Big Pharma, is intentionally
failing to explain the true meaning of S1082. There is still time for Americans
to determine their fate.
###
About the author: Mike Adams is a natural health researcher and
author with a strong interest in personal health, the environment and the power
of nature to help us all heal He is a prolific writer and has published
thousands of articles, interviews, reports and consumer guides, impacting the
lives of millions of readers around the world who are experiencing phenomenal
health benefits from reading his articles. Adams is a trusted, independent
journalist who receives no money or promotional fees whatsoever to write about
other companies' products. In 2007, Adams launched EcoLEDs, a manufacturer of
mercury-free, energy-efficient LED lighting
products that save electricity and help prevent global warming. He also
launched an online retailer of
environmentally-friendly products (BetterLifeGoods.com) and uses a portion
of its profits to help fund non-profit endeavors. He's also a noted technology
pioneer and founded a software company in 1993 that developed the
HTML email newsletter software
currently powering the NewsTarget subscriptions. Adams volunteers his time to
serve as the executive director of the
Consumer Wellness Center, a 501(c)3 non-profit organization, and practices
nature photography, Capoeira, Pilates and organic gardening. He's also author of
numerous health books published by
Truth Publishing and is the creator of several consumer-oriented grassroots
campaigns, including the Spam. Don't Buy
It! campaign, and the free downloadable
Honest Food Guide. He also created
the free reference sites
HerbReference.com and
HealingFoodReference.com. Adams believes in free speech, free access to
nutritional supplements and the ending of corporate control over medicines,
genes and seeds. Known as the 'Health Ranger,' Adams' personal health statistics
and mission statements are located at
www.HealthRanger.org
DISCLAIMER:The information in HeatTreat.ca is not intended as a substitute for appropriate medical professional help or advice but is to be used as a sharing of new knowledge, information and as an aid to a new understanding about back and neck pain and its treatment. A trained, appropriate health professional should always be consulted for back pain or any health problem. HeatTreat.ca provides links to other articles and web sites as a service to our readers and is not responsible for the information, services, or products provided by these web sites, health professionals, or companies. See "Terms and
Conditions" for use of this Site
