Archive for the ‘The Law & CODEX’ Category

FDA, Vaccine Makers Under Seige: The Beginning of the Beginning for Health Freedom?

Tuesday, February 26th, 2008

Two hopeful items have surfaced recently.
Reuters reported last month “French judges probe firms over vaccinations
PARIS, Jan 31 (Reuters) – French authorities have opened a formal investigation into two managers from drugs groups GlaxoSmithKline and Sanofi Pasteur over a vaccination campaign in the 1990s, a judicial source said late on Thursday.

Judge Marie-Odile Bertella-Geffroy also opened an investigation for manslaughter against Sanofi Pasteur MSD, a joint venture between Sanofi Aventis (SASY.PA: Quote, Profile, Research) and Merck (MRK.N: Quote, Profile, Research), the same source said.

The investigations follow allegations that the companies failed to fully disclose side effects from an anti-hepatitis B drug used in a vaccination campaign between 1994 and 1998.

There was no immediate comment from the companies or the two managers involved.

From 1994 to 1998, almost two thirds of the French population and almost all newborn babies were vaccinated against hepatitis B, but the campaign was suspended after concerns arose about possible secondary effects from the treatments.

Some 30 plaintiffs have launched a civil action in the case, including the families of five people who died after vaccination. (Reporting by Thierry Leveque; Writing by James Mackenzie; Editing by David Holmes) RECENT CIVIL ACTIONS FOR DAMAGES AGAINST BIG PHARMA BY STATE ATTORNEYS GENERAL IN THE USA REGARDING THE “ANTIPSYCHOTIC” DRUGS RACKET

by Justice Lover

The following report was emailed to me today by ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP):
Promoting Openness, Full Disclosure, and Accountability

Cong. Bart Stupak and Cong. John Dingell, the chairman of the House Energy and Commerce Committee, threatened to hold Health and Human Services Secretary Michael Leavitt in contempt for refusing to turn over FDA briefing documents subpoenaed by the committee in its probe over an antibiotic and a blood thinner linked to four deaths.

Sec. Leavitt oversees the FDA and other health care agencies. The documents in question were used to prepare FDA Commissioner, Andrew von Eschenbach,MD, for his appearance before House lawmakers last year. The commissioner testified that FDA did not use the flawed safety study to approve Ketek. But Cong. Stupak called that statement untrue and subpoenaed von Eschenbach’s notes to determine if he lied under oath.The agency has said there was no intention to deceive the public.

Cong. Stupak called on Dr. von Eschenbach to step down because he has demonstrated “a total lack of leadership.”

Underscoring FDA officials’ disregard for the agency’s mission–which is to protect the public health, and ensure that scientifically validated information is disseminated about prescription drugs–the agency has just issued proposed guidelines that would overturn the prohibition against drug manufacturers disseminating information to encourage doctors to prescribe their drug for “off-label” unapproved uses.

In essence, top FDA officials are serving as industry’s handmaiden by attempting to legitimize illegal marketing activities.

Representative Henry Waxman, said the proposed rule “caters to the industry’s desire to market their products without adequate testing or review.” The Food, Drugs, and Cosmetics Act prohibits companies from promoting off-label uses of approved drugs.FDA would protect these manufacturers from deceptive marketing by accepting industry-sponsored and industry controlled articles containing false and misleading information. Such commercially sponsored articles have been shown to inflate the claimed benefits—while concealing the lethal risks.

The proposed FDA rule would legitimize the very activities that have led State Attorneys General and the Justice Department to sue Big Pharma companies.For example, 18 states are suing manufacturers of the so-called ‘atypical’ antipsychotic drugs–the most toxic harm-producing psychotropics–for off-label marketing:

9 states are suing Eli Lilly regarding Zyprexa: Alaska, Louisiana,Mississippi, Montana, New Mexico, Pennsylvania, South Carolina, Utah and West Virginia. 6 states are suing Janssen regarding Risperdal: Arkansas, Louisiana,Montana, South Carolina, Texas and Pennsylvania. 3 states are suing AstraZeneca regarding Seroquel: Pennsylvania, SouthCarolina, and now, Montana . See the complaint posted at http://www.helenair.com/extras/complaint.pdf

AHRP applauds Cong. Stupak for calling a spade a spade.We would further recommend calling for the removal of the top echelon of FDA’s Center for Drug Evaluation and Research (CDER).These officials have systematically relegated scientific evidence to file drawers and lent the seal of approval to lethal drugs that caused tens of thousands of Americans to die. That is a colossal disservice of an agency mandated to protect the public health.

-END-

This is what happens when public pressure and education efforts are focused on Congress. Despite the huge amounts of money drug companies spend to buy Congress, when the offenses are hurting their constituents, and their constituents tell them so, or when the offenses are so outrageous that even Congress cannot ignore them, things CAN change.

The Natural Solutions Foundation works with Congress to educate them now. We would like to be able to lobby directly and, for that, need to set up a 501 (c) 4 organization so that we can do just that. Of course, that takes a bit of money, not a lot, really, when you consider what is at stake. If you want to help fund this activity, send an email to Ralph Fucetola, ralph.fucetola@usa.net with “Lobbying” as the subject line. We need about $5,000 to set up the organization and about $3,500 per month to cover expenses. Now is a ripe time for this activity: there is growing public and judicial action on our side. But, of course, we cannot do this important work without the funding necessary. When you think about it, the amounts are minuscule compared to what industry spends, yet our impact far outweighs the dollar input we need in order to make it.

To be clear, the reason that our impact, our footprint, as they say, is so large is because Natural Solutions Foundation supporters take the action steps that we recommend and write to Congress when we ask them to. that means that we are a known, and significant, force because constituents – you – are involved in these issues in large numbers. So between these two forces, we are a force to be reckoned with!

And don’t forget to set up your recurring tax deductible donation (http://www.healthfreedomusa.org/index.php?page_id=189) which gives us the financial life-blood we need to protect your health and health freedom.

Thanks!
Yours in health and freedom,
Dr. Rima

Rima E. Laibow, MD
Medical Director
Natural Solutions Foundation
www.HealthFreedomUSA.org
www.GlobalHealthFreedom.org

The GM Files: GM Contamination Set to Worsen: London Guardian

Sunday, February 24th, 2008

Consequences of GM Crop Contamination ‘Are Set to Worsen’

Tue Feb 19, 2008 4:58 pm (PST)

Consequences of GM Crop Contamination `Are Set to Worsen’
Published on Monday, February 18, 2008.

Source: London Guardian

The consequences of contamination between GM crops and non-GM
varieties will be much more serious with the next generation of GM
crops, an influential group of US scientists has warned.0218 04

Mixing between GM and non-GM varieties has already caused serious
economic losses for producers in lost sales and exports. But the
consequences of mixing will be much more serious with new crops that
are altered to produce pharmaceuticals and industrial chemicals, the
scientists argue. The crops could harm human health and be toxic to
wild animals.

“What would be the impact societally, economically if for example,
cornflakes were contaminated by some sort of drug or chemical? I think
it would be a vast impact economically,” said Karen Perry Stillerman,
senior food and environment programme analyst with the Union of
Concerned Scientists.

“I think it’s really hard to say [what impact contamination would
have] because there is a variety of different drugs and chemicals that
might be manufactured in plants this way,” she added. “Our perception
is that some of them might be toxic, but all of them would certainly
cause tremendous economic upheaval.”

The group presented its findings at the American Association for the
Advancement of Science conference in Boston.

Huge research effort

Up to now, commercial GM varieties have been restricted mainly to
modifications for herbicide tolerance or resistance to pests. But a
huge research effort is going into a new generation of crops that are
genetically modified to produce drugs, hormones, vaccines and
industrial chemicals such as the precursors of plastics.

Although public opinion in Britain and the rest of Europe remains
firmly against GM crops in general, it is more favourable to crops
with medical benefits. But the Union of Concerned Scientists said that
these are precisely the crops that pose the greatest risks if they
exchange genes with wild relatives or conventional versions of the
same crop.

So-called “pharma crops” can offer advantages over current methods of
drug manufacture. Vaccines produced this way could be grown cheaply in
developing countries and simply given to patients in the food. That
would remove the need for sterile needles and refrigerators to keep
vaccine doses cold – a major obstacle for delivering therapies in poor
countries.

Prof Paul Gepts, a plant geneticist at the University of California,
Davis, said past experience suggests that “contamination” events
cannot be avoided. “Gene flow is really a regular occurrence among
plants. So if you put a gene out there it’s going to escape. It’s
going to go to other varieties of the same crop or to its wild
relatives,” he said. “It’s clear that zero contamination is impossible
at present.”

Major economic losses

There have been a handful of examples in the US and elsewhere of genes
from GM varieties not cleared for human consumption getting into
nearby food crops and hence the human food chain. This has led to
major economic losses for producers in lost sales, exports and
clean-up costs, but there have been no proven cases of damage to human
health.

“With the products we are talking about, there’s the potential for
that to be much more serious than what we have seen so far,” said Prof
Robert Wisner at Iowa State University.

According to Gepts, most of the ideas for keeping crops apart are
inadequate, because pollen and seed are carried on the wind, by
animals and birds and on farm machinery. He said the only way to be
sure that food crops would not be contaminated by drug genes or genes
for industrial chemicals would be to use non-food crops such as tobacco.

Alternatively, GM food plants could be grown in greenhouses or
underground to prevent pollen escaping, he said.

Call for ban

The Union of Concerned Scientists is calling on the US Department of
Agriculture to ban the growth of GM pharma crops outdoors unless they
are species that are not eaten by people or livestock.

The USDA is currently putting together new guidelines on GM that are
expected to be completed by the end of the year. Currently, no GM
crops that produce industrial chemicals or pharma crops are grown
commercially, although there are some field trials under way in the US.

Similar issues will apply in the UK and Europe if pharma crops are
approved. So far, though, only a handful of GM crop varieties are
grown in Europe.

Educating Congress; making your voice heard…

Tuesday, February 19th, 2008

Below is a copy of an email exchange from Ralph Fucetola to Charles Frohman, our Washington Educationalist responding to Charlie’s followup email to several Congressional Aides involved in health freedom issues, subsequent to our trip to Washington earlier this month (edited for context).

——————–

Charlie,

Thank you for emailing this concise recitation of our concerns. We were really
happy to meet with Senator Mikulski’s aides, since we so much admire the Senator’s
leadership in matters such as:

* creation with Sen Harkin of the Center for Complementary Medicine
* introducing bill to require labeling of cloned animals

I was wondering if we could be of any assistance supporting honest labeling of
cloned animal products; perhaps we could encourage our grassroots/netroots
members to ask their Senators to become co-sponsors.

Let’s continue the dialog; certainly I hope to be back in Washington soon,
with General Stubblebine and Dr. Laibow.

Ralph Fucetola JD

—— Original Message ——
Received: Tue, 12 Feb 2008 04:10:57 PM EST
From: “Charles D. Frohman”
To: (HELP Mikulski\) …
Subject: Thanks for meeting – natural therapies/nutrients under FDA/Codex threat

> Thanks … for meeting with the Natural Solutions
Foundation this past Thursday. I welcome “replies to all” from Ralph or Dr.
Laibow, to correct or supplement what I write below.
>
> As explained in our meeting by “vitamin lawyer.com ” Ralph Fucetola JD (who would
serve as a wonderful witness in potential hearings), the vast majority of
Americans want access to natural food, nutrients and therapies, and NSF hopes
Ms. Mikulski can ask HELP Chairman Kennedy to hold hearings on the smothering
Guidelines from FDA, such as:
>
> * requiring impossible scientific agreement on claims,
> * threatening illegality to modalities by calling them “untested CAM products,”
> * guaranteeing bankruptcy with untenable manufacturing practices,
> * banning safe nutrients (such as ephedra and bioidentical hormones) by
using unfair risk analyses previously reserved for dangerous pharmaceuticals, and
> * ignoring the role of pharmaceutical mixing when reviewing Adverse Event
Reports for nutrients
>
> These hearings need also to examine FDA’s 1995 “harmonization” requirements
with the United Nation’s Codex Committee, which:
>
> * uses WTO santions to impose its anti-natural therapies threats onto every
nation on Earth, including the U.S.,
> * follows the anti-natural therapies bias of FDA’s own representatives,
> * has a Vitamin Committee that follows the European standard of treating
natural nutrients as toxins, and limits dosage to 15% above the naturally
occurring equivalent (a pathetically low standard, since the orange, in the
case of Vitamin C, is grown in soil that is depleted by poisonous Big Agri
chemicals, many of which were banned until reintroduced by Codex)
> * requires irradiation of imported food,
> * requires Monsanto’s growth hormone in imported milk
> * prohibits Genetically Modified labeling, in case people think GMOs are risky
>
> As you can see, Ellen-Marie, the natural therapies preferred by a vast
majority of Americans are threatened, and despite the congressional education
by NSF of HELP and Energy and Commerce members going back to last Spring, no
one in Congress yet has agreed to shine a light on FDA and Codex. May we
count on the Mikulski office to help move this process forward? If you do,
please let us know and we’ll be glad to let our several hundred thousand
member grassroots list know of your Leadership.
>
> Meanwhile, below is our most recent eNewsletter. Please feel free to sign
up, so you can become more familiar with our heavy involvement with countries
around the world in opposing Codex and, here in the U.S., opposing FDA’s
aggressive policies.
>
> Blessings,
>
> Charlie Frohman
> www.GlobalHealthFreedom.org
> www.cfrohman.com

Natural Solutions Foundation: Pick of the Health Freedom Pack

Tuesday, February 19th, 2008

When the Natural Solutions Foundations identifies and health freedom problem and finds a strong solution to it, not only do we articulate it, we put it into action. Frankly, that is what distinguishes us from the rest of the pack. We use the “Boots on the ground” approach, not the blah, blah, blah one.

Some of the pack are folks/organizations who have been around since the flood and have talked and talked since way back then, but haven’t really put much muscle into shifting the scene to make a big difference (or we would not be where we are now, fighting so hard on so many fronts to maintain our health freedoms!) Some of the people/organizations are folks who are basically either nay-sayers or naive enough to pass on other people’s information (or disinformation) while some are new “groups” created to siphon off your support to interfere with our effective solutions. Their motivation is anyone’s guess.

Congress has no idea about the impact of the FDA’s corruption on your life (and death). We decided that they needed to know much more about these issues to protect the US, reign in the FDA, divest it of its food regulatory powers, etc., so we implemented a powerful and professionally organized Congressional Education Program in which we visit members of Congress and their senior staff members on a regular basis to tell them what their constituents (you) are experiencing, what they want and what they need changed. Members of Congress are now coming to us asking for language they can include in bills and resolutions to make things right. So Congress is now coming to us for solutions to your problems! We are, of course, happy to oblige. Boots on the ground. Solutions in play.

The Solution is Natural So It Works!

Now, don’t get me wrong: the more information gets passed around, the better, so that larger and larger numbers of people become better informed about all of the health freedom issues. While that helps the Natural Solutions Foundation in our job of information dissemination, unless an organization has “boots on the ground” the way the Natural Solutions Foundation does, and unless it presents active, effective and workable solutions to the complex problems of health and health freedom here and abroad, not much actually gets accomplished!

Since we provide both strong analysis of the problems facing national and international decision makers and provide workable solutions to solve the problem and protect the well-being of the people involved, the Natural Solutions Foundation is a welcome ally in dealing with complex problems here and abroad.

Thanks for your continuing support and dissemination of information to your lists!

Yours in health and freedom,
Dr. Rima

Rima E. Laibow, MD
Medical Director
Natural Solutions Foundation

www.HealthFreedomUSA.org
www.GlobalHealthFreedom.org

Congress and the Natural Solutions Foundation “Boots on the Ground”

Tuesday, February 19th, 2008

Every time you take action and send an email to Congress, you are building the health freedom constituency. Not only are you letting Congress know about a particular issue, you are also letting Congress know that there is a tidal wave of voters who are watching and who care about the fact that health decisions, all of them, are private decisions, not the business of government! And you make it easier for the Natural Solutions Foundation to gain access to Congressional decision makers to let them know what we want them to do – and to not do. They know, when we walk into their offices, who we are because you have told them who you are and what you want and do not want from them. “Oh, the Natural Solutions Foundation”, they say, “We get lots of emails from your people. How can we help?” You, through your activism, provide entree to the halls of legislative power. You are the real power behind the Natural Solutions Foundation.
Some say that your communication does not matter. They are wrong. In the press of events and impacts on Congress, Members and their staff actually miss a great deal and, as a long time Senior Aide to a California Representative answered when I asked him how he keeps on top of all the issues and legislation in the Congressional system, “There is no way we can do it by ourselves. We depend on people who care about something to tell us about it and keep us informed about the legislation and the issues!”
What that means is that every time the Natural Solutions Foundation goes to Congress (and we try to go at least once a month for several days at a time), we go prepared with fact sheets, Congressional Briefings, information on legislation and suggestions for solutions to problems the Congressperson either is involved with or should be. The response is astonishing. The staffers value our input and we have been asked by members of Congress for language for new legislation to fix problems we identify and care about (often created by the industry friendly actions of agencies like the FDA) .
Earlier this month, Natural Solutions Foundation Trustee Ralph Fucetola and our Congressional Education Director, Charlie Frohman, visited Congress. Click here (http://vitaminlawyerhealthfreedom.blogspot.com/2008/02/educating-congress.html) to read Ralph’s report. Here is Charlie’s letter thanking the staff for their time (http://www.healthfreedomusa.org/index.php?p=529) and here () is Ralph’s follow up letter to Congress. need letter
On another, related front, natural supplements like DHEA, although protected by DSHEA (the Dietary Supplements Health and Education Act, 1994) which classifies nutrients as foods rather than drugs, are under attack as if they were steroids. Senator Hatch, a long time friend of supplements, defended them once again and the Natural Solutions Foundation is watching. Here (http://vitaminlawyerhealthfreedom.blogspot.com/2008/02/senator-hatch-defends-dietary.html) is Ralph’s blog on the subject.
Ralph beat back the FDA when they tried to ban DHEA last time so he is uniquely qualified to report on this battle. And it bears watching, of course, because the piecemeal attack on supplements does not let up. To the Pharma Phriendly FDA, any stick will do to beat a dog and they are determined to beat the natural medicine dog to death since it steals thAnd then there’s the problem of an out-of-control FDA. Yesterday, according to the AP, Rep. Bart Stupak (D-MI), who heads an investigative panel that conducts oversight of the agency, said in an interview with The Associated Press that FDA Commissioner Andrew von Eschenbach should step down because ‘it’s just a total lack of leadership.’ Stupak, chairman of the Subcommittee on Oversight and Investigations, said he had lost confidence in the commissioner and other top FDA officials over the handling of inspections and oversight by the agency.”

We agree and have been meeting with Congress for months on these issues. Can we take credit for this position by the Congressman? We cannot be not sure, but our boots on the ground certainly have helped to bring about this crisis in Congressional confidence in the FDA.

Take for example the FDA policy (which they have foisted on Codex and are implementing in the US as well) of criminalizing your right to communicate about, or use, the health benefits foods confer. Remember the FDA 2007 CAM Guidance setting up the FDA’s “right” to turn any food used for health purposes into “an untested drug” (like cherry juice, since it is good for arthritis)? The Natural Solutions Foundation found out from the FDA Receiver of Dockets that paper comments (e.g., letters) were not tabulated, only archived at the FDA Reading Room, and that the FDA website was “broken” and could not accept comments. Two Natural Solutions Foundation Trustees called the FDA Receiver of Dockets and persuaded her to give us HER email address so our supporters could let the FDA know how they felt about this Guidance. That meant that the Natural Solutions Foundation website was the only electronic means available in the US to submit comments to the FDA on this wildly misguided Guidance. Five hundred and eighty eight thousand Natural Solutions Foundation supporters visited our site to tell the FDA just how bad an idea they thought their Guidance was.

Of course, all of this activity costs money. We know you value our efforts to educate and help Congress do the right thing for health freedom. That’s why it makes sense to give generously and make a recurring tax deductible donation (http://www.healthfreedomusa.org/index.php?page_id=189) to the Natural Solutions Foundation. Now would be a great time! Your activism and your financial support are the life blood of health freedom.

And don’t forget to sign up for the free, secure Health Freedom eAlerts (http://www.healthfreedomusa.org/index.php?page_id=187) and ask your contacts and friends to do the same. Your voices protect our health freedom.

Thanks for your support!

Yours in health and freedom
Dr. Rima

Rima E. Laibow, MD
Medical Director
Natural Solutions Foundation
www.HealthFreedomUSA.org
www.GlobalHealthFreedom.org