FDA: Another Government Regulatory Disaster -- II of III

Important News from Health Lover, Ilena Rosenthal:
http://ilenarose.blogspot.com

http://www.huffingtonpost.com/deirdr..._b_130279.html



When the FDA grants approval on products marketed to consumers, the
vast majority of Americans feel comfortable that the agency has
performed its due diligence and the risk of injury or harm is
non-existent.

Since its inception in 1906 as the Bureau of Chemistry, however, the
FDA has been mired in an incestuous conflict-of-interest culture.
Despite horrific reports on approved drugs harming and killing
thousands of Americans, the public at large remains unaware of the
agency's corrupt history.

According to its mission statement, "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."

While operating under the illusion of a government regulatory agency
responsible for ensuring products are safe, time and time again we
have witnessed the FDA acting as an agency that has abandoned the
public's interest and under the control of the very industries it is
charged with regulating.

Over the past thirty years, there have been countless articles and
books detailing startling revelations about the pervasive influence of
industry on the regulatory process and exasperating attempts to change
the strangle-hold that corporations have on the FDA.

Following three frustrating years as FDA Commissioner, Dr. Herbert Lay
resigned and told the San Francisco Chronicle, "The thing that bugs me
is that people think the FDA is protecting them. It isn't. What the
FDA is doing and what the public thinks it's doing are as different as
night and day" (January 2, 1970).

In a Wall Street Journal article, "Drug Firms Use Financial Clout to
Push Industry Agenda at FDA" (Sept. 1, 2006), Anna Wilde-Mathews
summarized how a heavily lobbied Congress allowed industry to seize
more control over the under-funded agency.

Regulators usually don't negotiate their budgets with the
industries they oversee... For most of its history, the FDA was funded
entirely by Congress. But in the early 1990s, companies unhappy with
the pace of drug approvals agreed to pay the FDA millions of dollars
in 'annual fees to help speed its performance. Because the industry
and the agency renegotiate every five years over the size of fees -
and what they,' can be used for - drug makers can have considerable
input, into which programs receive funding. Each time the arrangement
has been renewed, the FDA has gained new funding. In return, industry
has wrung concessions. In the 1997 deal, the review time for a
standard application dropped from 12 months to 10 months. In 2002, the
FDA agreed to a number of changes, including a new deadline for how
fast the agency would respond to companies' requests for meetings
about their drug applications.

And herein lies the problem. We have a government that sees nothing
wrong with this meddling and is apparently incapable of correcting it.
As if this insidious collaborative arrangement weren't bad enough,
when well-intentioned FDA scientists attempt to bring safety concerns
to the attention of their superiors, they are threatened and told to
keep silent or worse, change their recommendations.

It would be impossible to chronicle the sordid history of collusion
and corruption of the nation's premier regulatory agency. But a
re-examination seems warranted in light of the FDA's recent
declaration that bisphenol A (BPA) is "safe."

Although consumer watchdog organizations have always been critical of
industry influence over government agencies and the "revolving door"
relationship between the two, most Americans were not aware of the
serious and systemic problems plaguing the FDA until 2003. This is
when newspapers around the country reported that an FDA drug safety
analyst, Dr. Andrew Mosholder, warned his superiors that children
taking antidepressants like Paxil and Zoloft increased their risk of
becoming suicidal.

When the Senate Finance Committee and the House Energy and Commerce
Subcommittee on Oversight and Investigations began to hold hearings on
Mosholder revelations, drug company executives began pointing the
finger back at FDA officials and blaming them for withholding
information from physicians and patients. A safe thing to do, since
neither are held
accountable.

("FDA Urged Withholding Data on Antidepressants," Washington Post,
Sept. 10, 2004).
http://www.washingtonpost.com/wp-dyn...-2004Sep9.html

According to an article published in the Washington Post:

Regulators suppressed the negative information on the grounds that
it might scare families and physicians away from the drugs, according
to testimony by drug company executives. For at least three
medications, they said, the FDA blocked the companies' plans to reveal
the negative studies in drug labels, and in one case the agency
reversed a manufacturer's decision to amend its drug label to say that
the drug was associated in studies with increased hostility and
suicidal thinking among children... More than two-thirds of all
studies of antidepressant use among depressed children have failed to
show the drugs are effective.

By the end of 2004, criticism of the FDA intensified both in Congress
and in the press.

In dramatic testimony before the U.S. Senate Finance Committee, Dr.
David Graham, a senior official in the FDA's Office of Drug Safety,
described the FDA as a "profound regulatory failure." In an
illuminating and disturbing interview with PBS, Dr. Graham repeated
some of what he told the Senate Committee. The scientist turned
government whistle-blower explained how he was pressured by his
superiors to change the conclusions of his study that found 30,000 to
55,000 deaths caused by Vioxx, Merck's blockbuster arthritis drug.
When Graham refused, FDA officials withheld the public release of the
full text but shared it with Merck.

"You have an agency that was completely oblivious to safety,
completely insensitive to safety, that basically was willing to
tolerate a 500% increased risk of heart attack with no demonstrable
counter balancing benefit for the drug because it suits their clients
to allow the drug to be marketed in America."

When asked, "who is the FDA working for?" Graham replied, "A
former manager of mine from the Office of Drug Safety told me that
industry was our client. And when I said to him, 'No, the public is my
client' he said, I was wrong and it was industry."

"I would argue that the FDA, as currently configured, is incapable
of protecting America against another Vioxx. We are virtually
defenseless," said Dr. Graham.

After reviewing the Vioxx clinical trials, Dr. Richard Horton,
editor of The Lancet, wrote a scathing article accusing Merck and the
FDA "acted out of ruthless, shortsighted and irresponsible
self-interest."

The Vioxx scandal outraged the scientific and medical community,
members of Congress and the public, which brought greater scrutiny on
the FDA but not much of anything else. If you think anything has
changed after Dr. Graham exposed the dirty dealings within the walls
of the FDA and the antidepressant and Vioxx investigations, think
again.

In September 2005, citing "unwarranted interference in agency decision
making" on the part of then Commissioner Lester Crawford, Susan F.
Wood, assistant FDA commissioner for women's health and director of
the Office of Women's Health, resigned from the position she had held
for five years. In an email to FDA staff, Dr. Wood said, "I can no
longer serve as staff when scientific and clinical evidence, fully
evaluated and recommended for approval by the professional staff here,
has been overruled."

Soon after Wood's exit, Dr. Crawford abruptly resigned as FDA
Commissioner after the Wall Street Journal disclosed his stock
ownership in companies regulated by the agency. Crawford later plead
guilty to the conflict-of-interest charges.

Following Crawford's plea, Mike Adams, long time FDA critic and author
of "Grocery Warning," told reporters, "Crawford's guilty plea now
establishes as indisputable fact what myself and other FDA critics
have been saying for years. The agency is headed by white-collar
criminals who deliberately make regulatory decisions that are in the
best interests of drug companies, junk food giants, rather than
protecting the health of the public."

It is no secret that industry-funded studies were used for decades to
hide the damaging affects caused by asbestos, tobacco, and lead. It is
no secret that industry spends millions every year to make sure their
interests are protected - at the FDA, other federal agencies and in
the halls of Congress.

Whether we are talking about food, chemical or drug safety, FDA
officials routinely rely upon industry-funded research as the
convenient excuse for not taking action on dangerous products when
safety concerns arise. This is called creating "scientific
uncertainty," and has proven quite successful in thwarting regulatory
action.

For years, Senator Chuck Grassley (R-IA) has been one of the FDA's
harshest critics and a leader in pressing for FDA reforms,
transparency and accountability. Having served as chairman of the
Senate Finance Committee during the Vioxx and antidepressants
hearings, Grassley began investigating the approval of the antibiotic
drug Ketek after learning the drug was approved even though the agency
knew "safety tests on the drug had been forged." Manufactured by
Sanofi-Aventis SA, Ketek was linked to 12 cases of liver failure
including four deaths.

In a press release, Grassley said, "The allegations of misconduct in
this [Ketek] case are as bad as I've heard yet. It looks like the FDA
caught the drug company red-handed and let them get away with it. On
top of that, the FDA failed to set the record straight and, in fact,
continues to cite a discredited safety study as a principle reason to
feel okay about using this drug."

ABC News later reported Grassley "was sent home empty-handed" by FDA
officials "who refused the powerful Republican access to information"
and "wanted to speak to the FDA investigator who uncovered the fraud"
about Ketek's approval.

"The study with the forged test results was conducted at a former
weight loss clinic in Gadsden, Alabama. Dr. Maria Anne
Kirkman-Campbell is serving five years in prison for falsifying safety
test results on Ketek."

"A former nurse, Michelle Snedeker, told ABC News she was ordered
to forge documents and report data on people who had not even been
given Ketek. The doctor was paid $400 for each of the 407 subjects
that she enrolled for the study."

As Grassley pressed for the denied documents, a defiant Dr. Andrew von
Eschenbach, acting director of the FDA, refused to provide the
information to the Senate Committee on Finance.

So much for the power of congressional oversight.

On February 12, 2007, the FDA finally announced that Ketek would get a
"black box" warning. "The changes include the removal of two of the
three previously approved indications -- acute bacterial sinusitis and
acute bacterial exacerbation of chronic bronchitis -- from the drug's
label. The agency has determined that the balance of benefits and
risks no longer support approval of the drug for these indications."
The warning also states that "Ketek is contraindicated (should not be
used) in patients with myasthenia gravis, a disease that causes muscle
weakness."

Years later The New England Journal of Medicine published an article
written by a former FDA physician, David B. Ross, M.D., Ph.D., who
participated in the Ketek review:

The review of Ketek was thus marked by pronounced departures from
accepted review practices. In addition to the use of fraudulent data,
the substitution of uncontrolled postmarket safety reports for
controlled clinical trial data, and the acceptance of trials that
could not show efficacy, there was also overt internal pressure
brought to bear on FDA reviewers to alter their conclusions.

But did any of these revelations change the way the FDA evaluates
internal dissent regarding safety concerns? Did congressional
investigations result in the agency cleaning up its act? Did von
Eschenbach's refusal to cooperate with a congressional investigation
prevent him from becoming FDA Commissioner? Absolutely not.

Senior officials continue to censor and intimidate honorable
scientists trying to do their jobs and committed to protecting the
public.

Two years following Dr. Graham's testimony before Congress, another
FDA scientist, Rosemary Johann-Liang, was reprimanded when she
recommended GlaxoSmithKline's diabetes drug Avandia be given a "black
box" warning label to alert physicians and consumers about its heart
failure risks. Again, Johann-Liang's supervisors refused to act on her
report.

"I really advocate for drug safety, and a lot of times the agency
doesn't want to hear that there are problems. I think, in general,
there is a culture of 'the drug is always innocent," Johann-Liang told
USA Today one day before leaving her job as deputy director of the
Division of Drug Risk Evaluation.

Only after the New England Journal of Medicine published a study that
found patients using Avandia doubled their risk of heart failure
compared to individuals not taking the drug, did FDA officials finally
accept Dr. Johann-Liang's report and give the drug the strongest
"black box" warning label. By that time, the drug had already been
prescribed for millions of Americans.

In a speech on the senate floor, Senator Grassley told his colleagues
that as many as 20 heart attacks a day might be caused by Avandia.
Grassley has been angry and frustrated by the attitude and actions of
senior FDA officials and has introduced legislation aimed at
establishing an independent drug safety review board.

In reality, the last thing industry wants is FDA reform... unless it
is on their terms. And this is where all the lobbyists and campaign
contributions are most effective. The political influence of the dirty
money bestowed on lawmakers, partnered with industry's bankrolling of
the FDA from user fees, has led to catastrophic consequences to
hundreds of thousands of Americans.

In response to on-going congressional attacks, FDA officials blame a
myriad of agency failures on the lack of funding. But the problems at
the FDA are not because of lack of money. Good scientists like Andrew
Mosholder, David Graham, and Rosemary Johann-Liang were doing their
jobs and reporting safety concerns to their superiors. Warnings could
have saved thousands of lives. The problem is a lack of accountability
and conscience in the FDA hierarchy who so casually turn a blind eye
to dangerous and deadly drugs, chemicals and food products.

When large financial institutions fail, people lose their investments.
But when the FDA fails, people lose their lives. Children lose
parents. Parents lose their children. Had Dr. Graham not come forward,
it is very probable the FDA would still be telling Americans Vioxx is
"safe," just as they are now proclaiming BPA "safe," and the arthritis
drug would still be on the market, quietly injuring and killing tens
of thousands of unsuspecting Americans.

Federal officials who intentionally deceive the public and mislead
physicians through the illegal practice of hiding data that shows
children taking antidepressants have a greater risk of committing
suicide, because they are concerned that the public would lose
confidence in antidepressants are not regulators are criminals. They
should be treated as such.

Besides a complete overhaul, a few prosecutions might be just the
medicine the FDA needs.

In article ,
Ilena Rose wrote:
Important News from Health Lover, Ilena Rosenthal:
http://ilenarose.blogspot.com

http://www.huffingtonpost.com/deirdr..._b_130279.html



When the FDA grants approval on products marketed to consumers, the
vast majority of Americans feel comfortable that the agency has
performed its due diligence and the risk of injury or harm is
non-existent.

For foods, they should assume it is LOW, but it
cannot be non-existent.

For drugs, even that cannot be assumed. If one
reads the information about a given drug, it will
be stated that there is a substantial risk of
various side effects. This is unavoidable.

Since its inception in 1906 as the Bureau of Chemistry, however, the
FDA has been mired in an incestuous conflict-of-interest culture.
Despite horrific reports on approved drugs harming and killing
thousands of Americans, the public at large remains unaware of the
agency's corrupt history.

It is not corrupt; benefits have to be balanced
against risks. If we want to really avoid risks,
we will have no drugs.

In fact, I disagree with the FDA having only an
approval/disapproval policy, with only a few
exceptions. At each time, the current information
should be available, to be used with each person's
individual risk/benefit information added.

According to its mission statement, "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."

The first statement and the second up to the
semicolon are contradictory. The FDA has been
rightly accused of slowing advances in public
health by its lengthy procedure to approve drugs.
The part after the semicolon can only be achieved
by giving both medical people and the public the
necessary information for an intelligent decision
making process. It is a major effort for even
someone like me, knowledgeable in the problems
of producing such a decision, to even come close
to getting the information.

An approved drug is just as effective in all the
years during which it is undergoing trials, and
also a drug later found to be dangerous is just
as dangerous until the bad effects show up years,
or even decades, later. It is always necessary
to balance the potential good and the potential
harm. The FDA cannot do the impossible; they are
not doing the best possible, and that might well
produce more drugs found dangerous.

--
This address is for information only. I do not claim that these views
are those of the Statistics Department or of Purdue University.
Herman Rubin, Department of Statistics, Purdue University
Phone: (765)494-6054 FAX: (765)494-0558

"Herman Rubin" wrote:

It is not corrupt

http://www.wnd.com/news/article.asp?ARTICLE_ID=55403
LIFE WITH BIG BROTHER
Plan to call fruit juice 'drug' delayed
Comment period extended to May 29 after plan publicized

--------------------------------------------------------------------------------
Posted: April 27, 2007
1:00 a.m. Eastern


By Bob Unruh
© 2007 WorldNetDaily.com


A public comment period on a Food and Drug Administration plan to classify
vitamins, supplements, herbs and even fruit juice as "drugs" has been
extended from April 30 to May 29 after the proposal was publicized in a
report by WND.

The extension, which was confirmed in an FDA posting, will allow consumers
additional time to comment on the plan, Docket No. 2006D-0480, that
opponents say even could classify water as a drug when it is used to "treat"
dehydration.

The American Association for Health Freedom, which had petitioned the FDA
several weeks ago for an extension, noted that "During April 2007 the FDA
came under tremendous pressure from AAHF supporters and many others to
extend the CAM Draft Guidance comment period. On April 25, 2007, the FDA
website announced the extension of the closing date for public comment from
Monday, April 30 to Tuesday, May 29."

On NewsTarget.com self-described Health Ranger Mike Adams noted that the
extension came "following widespread criticism by the public" of the plans.

The plan by the agency directed since 2006 by Andrew C. von Eschenbach is
the "Complementary and Alternative Medicine Products and Their Regulation by
the Food and Drug Administration," which despite the extension remains on a
fast track for implementation.

But parents' groups, natural remedy interests, food and herb businesses and
others are horrified. A group called Gentle Christian Mothers alerted its
constituency in no uncertain terms.

"Please Read!!! The FDA is trying to regulate all things that are considered
by them to be treatment for disease. They want to regulate vitamins, herbs,
alternative therapies (things like hot stone therapy), even down to juices
and holy water," the warning said. "It might mean having to go to a doctor
or medical professional for vitamins."

"It does represent a potential major expansion on how foods, therapies, and
products could be regulated," said a statement from the Virginia Chapter of
the Certified Natural Health Professionals. "Of further concern, is that
this document could be used by health freedom 'opposition' and regulators to
pressure Congress to change legislation. The language in the document gives
us great concern and we cannot allow an agency such as the FDA to finalize
the document in its present form."

The groups are urging their constituents, and others, to contact the FDA and
express an opinion, or send concerns in writing to: Dockets Management
Branch (HFA-305), 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 and
reference Docket No. 2006D-0480.

"The document, if approved, specifically medicalizes complementary and
alternative therapies, along with the products, supplements, devices and
even foods often part of those therapies. By using 'treatment' rather than
'therapy,' - 'medical' rather than 'modality;' the document terminology sets
traditional and alternative approaches to well-being and health inside
allopathic or conventional medicine in the United States," said Regina
Wilshire on her Weight of the Evidence blog.

Members of the Organic Consumers Association also added their voice to the
issue, reiterating the AAHF statement that "What the FDA is stating is that
they believe that any person (or product) that states 'drink some vegetable
juice to prevent [insert disease]' is actually making a drug claim; and if
vegetable juice is not recognized by the FDA as a legally available drug in
the United States, the person (or manufacturer) making the claim is now
subject to prosecution if they are not a medical professional licensed to
practice medicine."

"Who is going to fund a $50,000 investigational new drug application to get
carrot juice approved as a drug, or the follow-on millions in research
dollars to conduct a study on the toxicity ($200,000) and efficacy of carrot
juice ($3 million and up.) Keep in mind this would have to be done
separately for any disease process carrot juice might have an impact on,"
the statement said.

The Health Ranger website noted that among other likely developments if the
FDA has its way:


Growing and selling common garden herbs will get you arrested as a drug
dealer.

Massage oils and handheld massagers will be regulated as "medical devices."

Weight machines will be regulated as "medical devices" and require FDA
approval before being sold or used.

Raw sprouts and other anti-cancer foods will be regulated as drugs.

Bottled water that "treats" dehydration will be regulated as a drug.

Foods, supplements, vitamins and homeopathic remedies will disappear from
store shelves, pending FDA "review."

Vitamin store owners will be arrested and prosecuted for "practicing
medicine without a license."
"This could be potentially devastating, not just to my business but to any
business relating to supplements," Sophy Winnick, a Felton, Calif., mother
of four who has been selling Youngevity products for 10 years, told the
Santa Cruz Sentinel. "People better get on the horn about this."

The FDA's "draft guidance" on the issue first appeared in December, but
federal officials said it was printed in the Federal Register on Feb. 27,
prompting the growing storm of protest.

The FDA has reported that approximately one-third of all adult Americans
have reported participating in or using some form of "complementary and
alternative medicine" and officials estimate nutritional supplement sales
total about $5 billion a year in America.

Adams' alert said what this would mean to consumers, "is that things like
vitamins and herbs would be controlled by the FDA, and could possibly
require prescriptions from a naturopath, herbologist or some other
physician, all of which would require you to pay a health insurance company
and contribute to the already back-breaking cost of healthcare in America.

"There are those who do not trust the U.S. government to act in the interest
of its citizens over the interests of pharmaceutical companies and health
insurance providers," he said. "Those people have good reason to feel this
way, and the amount of dangerous - DEADLY, even - pharmaceutical drugs that
get recalled . is testament to the fact that human beings can be used as
guinea pigs because the FDA allows the pharmaceutical industry to release
drugs that haven't been properly tested."

According to his website, Adams suffered from degenerative disease, was
nearly obese and diabetic by 30. He became a student of nutrition and
natural therapies and gave up all pharmaceuticals, over-the-counter drugs,
caffeine and pursued a natural foods diet with exercise.

He lost 50 pounds, his diabetes symptoms vanished and his blood pressured
reached 105/60, so he began a writing and teaching career on his own
transformation.

As WND recently reported, Merck and Co. had been donating to state
legislators across the nation who in return were working to require young
girls to be given Merck's $400 vaccine that prevents a virus that is spread
only through sexual contact.

WND also has reported on the mandatory anthrax shots for members of the
military, even though they had not been fully tested, and the possibility
that government officials also could order civilians to be vaccinated.

An essay by Roger Wicke at Rocky Mountain Hi Herbal noted, "The unstated
purpose of the FDA, and similar organizations in many other countries, is
and always has been the protection of major pharmaceutical company profits.
Expensive testing protocols act as a way to keep drugs and herbs within the
control of the international cartels. While such tests may make sense for
newly synthesized drugs with no track record in cultural tradition or
popular usage, they are inappropriate for herb and food products, especially
those with a long history of usage."

The FDA, in its announcement, said the federal government has been
investigating and monitoring "complementary and alternative medicine" since
1992. It also said "depending on the . therapy or practice, a product used .
may be subject to regulation." It also noted there's nothing in any law to
exempt alternative medicine products from regulation.

"Not content to dominate the drug trade and send your prescription drugs
into the $tratosphere, the Food & Drug Administration is now trying (yet
again) to take over the entire health food and nutritional supplement
industry so they can shut it down forever, leaving expensive FDA-approved
drugs - with their myriad side effects - as your only option for treating
anything from Alzheimer's to zits," wrote Jim Rutz, in a WND column.

"The FDA hacks are pooh-poohing the significance of the new guidelines as
toothless suggestions that merely 'clarify' and 'change nothing.' Yeah,
right. In truth, they're following the classic procedure for passing
outrageous laws that wouldn't have a chance without an incremental,
camel-nose-under-the-tent approach," he said.

"In reality, 2006D-0480 would eventually change everything, including your
life expectancy. The FDA realizes that alternative medicine has far, far
more solutions to chronic diseases than mainline medicine does ... and that
panics them."

WND also has reported on an agreement by the FDA and the Federal Trade
Commission to a Trilateral Cooperation Charter with counterparts in Canada
and Mexico under the auspices of NAFTA and the Security and Prosperity
Partnership of North America that will elevate the crackdown on public
access to food supplements and vitamins.

"The purpose is to make an end run around any domestic law that interferes
with food and drug multi-national corporate profits," John Hammell, a critic
of the plan, told WND.

Hammell is the founder of International Advocates for Health Freedom, an
advocacy group created to fight globalists' efforts to regulate alternative
health treatments, including herbs, dietary supplements, and vitamins.

"A key goal of the Trilateral Cooperation Charter is to limit the public's
access to food supplements and vitamins that are fundamental to many types
of alternative medicine," Hammell said. "The Trilateral Cooperation Charter
is determined to attack the Dietary Supplement Health and Education Act of
1994 by moving to merge our food and drug regulations with those of Canada
and Mexico, both of whom are far more restrictive on dietary supplements."

He believes the agenda of the Trilateral Cooperation Charter reflects a
globalist desire to advance the interests of the large pharmaceutical
companies by reining in the food supplements industry worldwide.

He points to efforts such as the Codex Alimentarius Commission that was
created in 1963 by the Food and Agricultural Organization and the World
Health Organization, both official groups within the United Nations.

"The Codex Alimentarius Commission claims that their main purpose is to
protect the health of consumers and ensure fair trade practices in the food
trade worldwide," Hammell explained to WND. "But the truth is that the Codex
Alimentarius Commission is dominated by corporate multi-national interests
that do not have as their primary concern the health interests of the people
they claim they are in business to protect, not if that health interest is
better served by alternative food supplements and alternative medicine. They
have a business with disease - it's not in their best interests that people
be healthy."

http://www.newstarget.com/z021810.html

NewsTarget.com printable article
Originally published April 25 2007

FDA's attempts to slip its CAM Guidelines under the radar fail; deadline for
public comment extended to May 29
by Mike Adams

Following widespread criticism by the public over proposed CAM Guidelines
that the agency tried to slip under the radar (see below), the Food and Drug
Administration has now extended the deadline for public comment to May 29.
(It was previously April 30). The CAM Guidelines (click here to read them
yourself) represent a new era of thinking at the FDA and describe the
agency's intentions to regulate herbs, functional foods, therapeutic oils,
nutritional supplements and even physical devices such as massage rocks as
either "drugs" or "medical devices." Click here to read our previous story
describing the CAM Guidelines. These guidelines have been widely described
as a brazen FDA attempt to destroy naturopathy and alternative medicine.

The FDA was petitioned on April 22 by health freedom attorney Ralph
Fucetola, a trustee of the non-profit Natural Solutions Foundation
(www.HealthFreedomUSA.com), to extend its deadline for public comment. The
petition also specifically requested that the FDA hold public hearings on
the issue, but no decision has apparently been made on that issue.

It now seems that the FDA attempted to sneak the new CAM Guidelines under
the radar, hoping the public would never notice the guidelines until they
had already been adopted and approved. The original CAM Guidelines document
was quietly posted by the FDA on the day after Christmas, 2006, yet did not
appear in the Federal Register until several months later. By the time the
document was able to be found and commented on by the natural health
community, only about thirty days remained in the public comment period.
Thanks to public pressure and the Natural Solutions Foundation petition, the
public comment period has now been extended by an additional thirty days to
May 29th.

To date, more than 108,000 comments have been received by the FDA on their
CAM Guidelines. The issue has received widespread coverage in the natural
health community, including articles on NewsTarget.com. The Natural
Solutions Foundation says that an additional 267,000 people attempted to
post comments but were unable to do so. NewsTarget previously suggested that
comments posted to the FDA might be intentionally ignored or deleted, and
according to the NSF, letters that are written to the FDA about this docket
are routinely ignored.



Your comments are still needed to protect health freedom
The most effective way to make your voice heard on this topic is to either
post your comments electronically, or write your representative in
Washington to apply pressure on the FDA from the legislative side.

Click here to post your comments directly to the FDA on the FDA Docket
Management Comment Form. Keep in mind that all comments become part of the
official FDA record, so write your comments carefully.

The Natural Solutions Foundation also has a web comment form posted here,
which uses the "Democracy In Action" engine to send comments to the FDA and
adds your name to a petition asserting our collective right to health
freedom. This petition needs approximately another 90,000 electronic
signatures to be taken seriously by the FDA, so please consider signing this
petition as well.



"My middle name is not Darth Vader" claims FDA official
Late last week, John Weeks from The Integrator Blog (click here for the full
interview) published an interview with Philip Chao, the only FDA official
referenced in the CAM Guidelines document.

That interview asks the important question: Why was the CAM Guidelines
document posted in the Federal Register on February 27, with a comment
deadline of April 30, when the document itself says there will be a 90 day
comment period? The Integrator asks, "Can't you see how, with a suspicious
public out there and all this hoopla that just extending to 90 days from
February 27 makes some sense."

Later in that interview, Philip Chao is asked if his middle name is Darth
Vader. His response? "No it is not." This is the first time, to my
knowledge, that an FDA employee has officially denied his name is Darth
Vader.



The campaign to keep you uninformed
Interestingly, opinions are split in the health freedom communities over the
interpretation of the CAM Guidelines and the involvement of those trying to
stop it. NewsTarget has been strongly pressured by certain health freedom
individuals to censor its reporting on this topic and remove any mention of
the Natural Solutions Foundation or its website.

We have also been told by some health freedom activists that the CAM
Guidelines can be safely ignored and pose no threat whatsoever to health
freedom. Common sense, however, dictates otherwise. Any document in which
the FDA openly states its intention to regulate vegetable juice as a drug is
clearly and unquestionably a threat to health freedom, regardless of the
noise level in the current health freedom debate.

It is my belief that those individuals and organizations attempting to
silence the reporting on these CAM Guidelines are, in fact, working in
opposition to health freedom, regardless of their self-proclaimed stance on
the issue. Actions speak louder than words. Anyone can claim they're in
favor of health freedom, but unless they're actually fighting for it where
the rubber meets the road, so to speak, they're only standing in the way of
those of us who actually are making a difference. Stopping these CAM
Guidelines from becoming official FDA policy is, in my view, one very
important action item that deserves our effort right now. There are many
more, but this is one that we cannot ignore.

If you believe in your right to purchase herbs, supplements, homeopathic
remedies or other naturopathic or "alternative" health items, please
consider posting your comments using one (or both) of the links listed
above.



The petition to extend the deadline
The April 22nd petition letter to extend the FDA deadline is reprinted, in
part, below:

April 22, 2007

FDA Docket No. 2006D-0480
Request to Extend Time Period for Comments

Reference is made to the Federal Register, February 27, 2007 (Volume 72,
Number 38, Page 8756-8757),
http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-3259.htm, entitled: Draft Guidance
for Industry on Complementary and Alternative Medicine Products and Their
Regulation by the Food and Drug Administration.

In the filed comments NSF submitted to the FDA, the organization emphasized
what we see as the important distinction between "treatment of disease" and
its non-medical alternative, under AMA Ethics Code Opinion 3.04, "therapies
that may benefit." The comments raised three demands:

1. That FDA hold public hearings before finalization of the draft guidance.

2. That FDA change the title of the guidance to use the phrase
"Complementary and Alternative Modalities" and not the prejudicial
"Complementary and Alternative Medicine" as in the draft.

3. That FDA recognize "therapies that may benefit" as not the same as
"treatment of disease" and therefore not to be regulated as "medicine."

The organization also alerted its supporters, in keeping with its
educational purposes. Many of theses individuals filed their own or
supporting comments. As of the date of this request, over 108,822 have done
so, by one count. This does not include about 267,063 people who tried to
post comments but did not succeed, yet. Many of these remaining people may
still want to submit comments, but may not be able to do so by April 30,
2007, a stated deadline for comments. While the Federal Register Notice
states such a time limit for the filing of comments, there is other
indication of a 90 day comment period, after the date of publication in the
Register. This would extend to period until May 28, 2007.

Therefore, we are unsure of the effective end of comment period date, and as
many more people want to comment, we must now request a clarification of the
final date for the filing of comments and, if that date is April 30, 2007,
Natural Solutions Foundation and the undersigned hereby request a 180 day
extension of the period to comment, or such other extension as the Agency
may consider reasonable. This issue is of such evident concern and
importance to so many Americans that a substantial extension is required.

Kindly inform me by return email or facsimile of the Agency's decision in
this regard. The Foundation reserves all rights.

Thank you,
Ralph Fucetola JD, Trustee



Assert your right to health freedom, or you'll lose it
Understand that we, the members of the natural health community, are at war
with the FDA. Even though we are peaceful people who would not initiate such
a war, that war has been declared upon us. We must fight this effort to
regulate our natural medicines out of existence, and we must do so through
every peaceful means at our disposal: Signing petitions, writing letters,
even perhaps marching in the streets with protest signs if it comes to that.

Do not stand by idly and let the Food and Drug Administration turn America
into a medical police state, funded by Big Pharma and enforced by armed FDA
agents. (See the true history of armed FDA raids here.) Preserving your
access to alternative medicine products is something worth fighting for. We
must meet the FDA's attempts at medical tyranny head on, with overwhelming
public outrage, and we must keep at it until we restore the freedoms we have
been promised by the founding father of our nation.

Today, America is neither a free democracy, nor a totalitarian police state.
But it could go either way. And the direction it heads from this day forward
is up to people like you. Will you demand your freedom? Or will you let it
be slowly, secretly slipped away, one federal document at a time, until you
wake up one day and find yourself standing alone in a world or medical
tyranny where all the healers have been imprisoned, the herbs have all been
banned and the public is chemically controlled under a system of lifetime
medical treatment that keeps the drug corporations wealthy?

Think about where this is all headed. The CAM Guidelines spell out the path
the FDA wants to take us down. It's up to people like you to stop that
effort and help restore genuine health freedom in our world.

In article ,
Ilena Rose wrote:
Important News from Health Lover, Ilena Rosenthal:
http://ilenarose.blogspot.com

http://www.huffingtonpost.com/deirdr..._b_130279.html



When the FDA grants approval on products marketed to consumers, the
vast majority of Americans feel comfortable that the agency has
performed its due diligence and the risk of injury or harm is
non-existent.

For foods, they should assume it is LOW, but it
cannot be non-existent.

For drugs, even that cannot be assumed. If one
reads the information about a given drug, it will
be stated that there is a substantial risk of
various side effects. This is unavoidable.

Since its inception in 1906 as the Bureau of Chemistry, however, the
FDA has been mired in an incestuous conflict-of-interest culture.
Despite horrific reports on approved drugs harming and killing
thousands of Americans, the public at large remains unaware of the
agency's corrupt history.

It is not corrupt; benefits have to be balanced
against risks. If we want to really avoid risks,
we will have no drugs.

In fact, I disagree with the FDA having only an
approval/disapproval policy, with only a few
exceptions. At each time, the current information
should be available, to be used with each person's
individual risk/benefit information added.

According to its mission statement, "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."

The first statement and the second up to the
semicolon are contradictory. The FDA has been
rightly accused of slowing advances in public
health by its lengthy procedure to approve drugs.
The part after the semicolon can only be achieved
by giving both medical people and the public the
necessary information for an intelligent decision
making process. It is a major effort for even
someone like me, knowledgeable in the problems
of producing such a decision, to even come close
to getting the information.

An approved drug is just as effective in all the
years during which it is undergoing trials, and
also a drug later found to be dangerous is just
as dangerous until the bad effects show up years,
or even decades, later. It is always necessary
to balance the potential good and the potential
harm. The FDA cannot do the impossible; they are
not doing the best possible, and that might well
produce more drugs found dangerous.

--
This address is for information only. I do not claim that these views
are those of the Statistics Department or of Purdue University.
Herman Rubin, Department of Statistics, Purdue University
Phone: (765)494-6054 FAX: (765)494-0558

That's a good thing. I doubt Purdue would approve of lies.