October 20, 2014

FDA’s New Claim: “Your Body Is a Drug and We Have the Authority to Regulate It!”

pin it button FDA’s New Claim: “Your Body Is a Drug and We Have the Authority to Regulate It!”

stem cell FDA’s New Claim: “Your Body Is a Drug and We Have the Authority to Regulate It!”

by Alliance for Natural Health

In another outrageous power-grab, FDA says your own stem cells are drugs—and stem cell therapy is interstate commerce because it affects the bottom line of FDA-approved drugs in other states!

We wish this were a joke, but it’s the US Food and Drug Administration’s latest claim in its battle with a Colorado clinic over its Regenexx-SD™ procedure, a non-surgical treatment for people suffering from moderate to severe joint or bone pain using adult stem cells.

The FDA asserts in a court document that it has the right to regulate the Centeno-Schultz Clinic for two reasons:

  1. Stem cells are drugs and therefore fall within their jurisdiction. (The clinic argues that stem cell therapy is the practice of medicine and is therefore not within the FDA’s jurisdiction!)
  2. The clinic is engaging in interstate commerce and is therefore subject to FDA regulation because any part of the machine or procedure that originates outside Colorado becomes interstate commerce once it enters the state. Moreover, interstate commerce is substantially affected because individuals traveling to Colorado to have the Regenexx procedure would “depress the market for out-of-state drugs that are approved by FDA.”

We discussed the very ambiguous issue of interstate commerce last September—it’s an argument the FDA frequently uses when the basis for their claim is otherwise lacking. As we noted then, the FDA holds that an “interstate commerce” test must be applied to all steps in a product’s manufacture, packaging, and distribution. This means that if any ingredient or tool used in the procedure in question was purchased out of state, the FDA would in its view have jurisdiction, just as they would if the final product had traveled across state lines.

This time the FDA just nakedly says in court documents that the agency wants to protect the market for FDA-approved drugs. No more beating around the bush—their agenda is right out in the open! This appears to be a novel interpretation of the Food Drug and Cosmetic Act (FD&C), as evidenced by the government’s failure to cite any judicial precedent for their argument.

The implication of the FDA’s interpretation of the law, if upheld by the court, would mean that all food, drugs, devices, and biologic or cosmetic products would be subject to FDA jurisdiction. The FDA is expanding its reach even to commerce within the state, which we argue is far beyond its jurisdiction, in order to protect drug company profits.

Last year we ran a two-part series on the current status of federal and state law—and FDA jurisdiction—and how it affects integrative treatments (part one and part two).

The Centeno-Schultz Clinic takes your blood, puts it into a centrifuge machine that separates the stem cells, and a doctor puts them back in your body where there is damaged tissue. The clinic has argued numerous times that stem cells aren’t drugs because they are components of the patient’s blood from his or her own body.

The FDA says otherwise: “Stem cells, like other medical products that are intended to treat, cure, or prevent disease, generally require FDA approval before they can be marketed. At this time, there are no licensed stem cell treatments.” There they go again, saying that components of your body are drugs and they have the authority to regulate them! It’s the only way the agency can claim that adult stem cell therapy is within FDA’s purview.

However, the agency seems to be of two minds. When ESPN magazine was doing a story on stem cell treatments, the FDA stated that US policy is to allow the injection of stem cells that are treated with “minimal manipulation,” which federal regulations define as “processing that does not alter the relevant biological characteristics of cells or tissues”—which is certainly the case with the Regenexx clinic.

Despite this policy, FDA has been attacking the clinic for the past four years. They have tried injunctions and demanded inspections in their attempts to make the company bend; this court battle is merely the latest salvo.

The primary role of adult stem cells in a living organism is to maintain and repair the tissue in which they are found. The hard part has been to get enough of them. But new technology is giving doctors the ability to obtain more stem cells from a patient than previously thought possible, which is why we’re now seeing new treatments. Blood, fat, or tissue is withdrawn from the patient, stem cells are obtained using one of these new processes, and the cells are injected back into the patient where they can repair the patient’s tissue.

Gov. Rick Perry received this kind of stem cell therapy. We and others noted that the governor’s defense of freedom of healthcare choice when it came to his own treatment was starkly at odds with his directive to administer HPV vaccines to young girls against their own (and their parents’) wishes. It’s also at odds with his support for some of the most egregious witch-hunters on the Texas State Medical Board, which he appoints.

Behind Perry’s blatant inconsistency and the latest FDA attempted power grab lies the same problem: a medical system run by special interests under the leadership of the US government, the same government that is supposed to represent “we the people.”

Read the Full Article Here: http://www.anh-usa.org/fda-new-claim-body-is-a-drug/

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Boston Nurses Speak Out Against Mandatory Flu Shots

Boston Nurses Speak Out Against Mandatory Flu Shots

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Last month (September 2014) the Massachusetts Nurses Association sued Brigham and Women’s Hospital over a new policy that required nurses to receive the annual flu vaccine as a condition for employment.

The nurses were, of course, criticized by the medical establishment. They were accused of putting their own interests above the needs of patients. Lynn Nicholas, president of the Massachusetts Hospital Association, stated that the nurses were: “putting a pet peeve of theirs above the safety and well-being of the patients they serve, their families, visitors to the hospital, and their colleagues.”

Pet peeve? Really?

When nurses all across the United States and Canada are willing to sacrifice their jobs and careers to avoid the annual flu shot, it is time to sit up and take notice. This is obviously something much more than a “pet peeve.”

Trish Powers, representing Brigham nurses in Boston fired back a comment that The Boston Globe published. It is titled “Brigham nurses know flu vaccine can do harm.”

Gardasil: The Day Our Daughter’s Life Changed

Gardasil: The Day Our Daughter’s Life Changed

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The Gardasil vaccine has changed Skylee’s life in so many ways and we do not know how many more symptoms will show up and change her life even more than it has already done. Our whole family has been affected by this vaccine and all of our lives have been turned upside down that terrible day in 2013.

If only the doctors would recognize Skylee has gone from being a healthy young girl to an invalid when the only major change in her life occurred on the day she had that single shot of Gardasil.

Will There Be An Ebola Outbreak in America?

Will There Be An Ebola Outbreak in America?

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So here is what inquiring minds want to know:

Why did U.S. health officials in Atlanta and on the ground in Africa ignore the exploding Ebola epidemic last spring?

Why did U.S. government officials fly American aid workers infected with Ebola to the U.S. rather than treating them with experimental drugs at hospitals in Africa?

Why did the U.S. government press the United Nations to adopt a resolution calling for no restrictions on international travel from Liberia and other Ebola-stricken countries?

Why did the Centers for Disease Control, supposedly the world’s leading infection control agency, fail to immediately assist Texas health officials when the first case of Ebola was diagnosed on US soil to guarantee that, at a minimum, the kind of infection control measures used in most nursing homes in America would be carried out?

Why has the Director of the CDC repeatedly stated that the only way a person can transmit Ebola is if they have a fever and said that people cannot get Ebola unless they have direct contact with the body fluids of an infected person – but that under no circumstances is Ebola airborne – when he knows, or should know, those statements could be false?

And why are experimental Ebola vaccines being fast tracked into human trials and promoted as the final solution rather than ramping up testing and production of the experimental ZMapp drug that has already saved the lives of several Ebola infected Americans?

A logical conclusion is that some people in industry, government and the World Health Organization did not want the Ebola outbreak to be confined to several nations in Africa because that would fail to create a lucrative global market for mandated use of fast tracked Ebola vaccines by every one of the seven billion human beings living on this planet.

Similarities Between 1976 Swine Flu Hoax and Ebola?

Similarities Between 1976 Swine Flu Hoax and Ebola?

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Read this before you consider purchasing a hazmat suit to protect yourself from Ebola!

Are we facing an Ebola pandemic that will kill millions, or is this just a marketing plan of the pharmaceutical industry to sell more drugs and vaccines? Is the current strain of the Ebola virus a secret creation of pharmaceutical company scientists, biological warfare researchers, or the fruit of Monsanto’s product development team?

Was Ebola created, or did it just accidentally spill over into humans from an animal host such as African fruit bats?

Is the US government intentionally not taking strong action to prevent Ebola from spreading or is there really minimal risk to Americans? Are there groups that want to decrease the world population through spreading contagious diseases such as Ebola, or is this just another imaginary plan that is being reported by certain conspiracy theory groups?

Is the Ebola virus a local epidemic, a global pandemic, or a hoax? Is life in America as we have known it about to collapse into chaos and martial law, or will we be safe and secure once we take the Ebola vaccine?

Will more people die from the Ebola vaccine than would have died from the disease itself?

All these questions have been circulating through the media over the last few months. The situation with Ebola is certainly a complex muddle of contradictory facts, opposing interpretations, and political intrigue. It reminds me very much of the 1976 Swine flu hoax — commonly called the swine flu fiasco or the swine flu debacle. More:

6 Reasons I Won’t Give My Kids The Nasal Flu Vaccine

6 Reasons I Won’t Give My Kids The Nasal Flu Vaccine

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It’s flu season again, and the push to get everyone in America vaccinated for the flu vaccine is in full swing. Please be aware that those who want you to receive the flu vaccine admittedly do not want you to know about the risks associated with the vaccine. They actively try to suppress information that would educate people on the dangers and risks of the flu vaccine and decrease their sales.

To hear the other side of the vaccine debate from a medical doctor the media would like to censor, please watch the video by Dr. Suzanne Humphries here: Dr. Suzanne Humphries on Vaccine Safety: “They Don’t Want You to Hear the Other Side”

Secondly, please look at the settled cases for vaccine injuries and deaths due to the flu vaccine the U.S. government pays out to victims: Flu Vaccine is the most Dangerous Vaccine in the U. S. based on Settled Cases for Injuries. This information is not published in the mainstream media.

This year, there is a heavy push on to give kids the nasal flu vaccine. Celeste McGovern, writing for GreenMedInfo.com, gives 6 reasons why she will not be giving this vaccine to her children.

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