September 29, 2014

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

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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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And yet, hospitals across the country are mandating that healthcare workers receive the flu vaccine as a requirement to keep their employment. The main reason for this policy of forcing employees to receive the flu vaccine is not based on solid science that it protects patients (the science actually points towards no patient benefits), but based on funding requirements for medical reimbursements through Medicare and Medicaid, and through the Affordable Health Care Act, that require healthcare facilities to have a high compliance rate of employees receiving the flu vaccine.

Nurses, doctors, and other healthcare workers across the country are fighting back, however.

This week, he Massachusetts Nurses Association sued Brigham and Women’s Hospital in Boston to block a policy to require nurses to get flu shots as a condition of employment.

And this is not the first lawsuit in the country. Others have also taken action to protect their right to refuse medical treatments that are mandated as a condition to retain employment.

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Doctors today are over-prescribing diagnostic tests and drugs, and patients need to learn how to say “no” to their doctors. This message, surprisingly, is coming from the mainstream media. While this has been a clear message for many years now in the alternative media, that message is now going “mainstream.”

Whistleblowers Dent the ‘Deep State’ of the U.S. Vaccine Program

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In speaking with an autism lawyer, who represented three African-American boys at the turn of the century, he told me he ushered their cases through Vaccine Court, only to have them dismissed, like my son’s case of harm caused by Thimerosal, in one sweep.

The whistleblowers haven’t negatively impacted the Vaccine Deep State yet. But when their cases go to trial, combined with a CDC-sponsored Danish scientist turned-U.S.-Department- of-Justice-fugitive in Poul Thorsen—he was indicted of stealing $2 million from the agency —the harm to the U.S. vaccine program could become unwieldy, as irreparable as the Ray Rice domestic violence issue now threatening the NFL.

For that to happen, the U.S. DOJ would have to extradite Poul Thorsen from Denmark to stand trial. And if that unicorn coming out of the forest event ever took place, the bed the CDC made with the Dane a decade ago would shake the Vaccine Deep State to its core.

After three years of non-action, will Attorney General Eric Holder, who happens to be African-American, finally be spurred to extradite the most wanted man in the autism community?

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According to PR Week, State Farm has decided to drop an ad starring comedian Rob Schneider from its rotation due to his “anti-vaccine views” after a social media outcry.

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I am immediately dropping State Farm.

I have used State Farm for my car and home insurance for about 15 years. I just sent an email to my agent, letting her know how disappointed I was to learn that State Farm had caved in to the pharmaceutical vaccine industry, an industry rife with fraud and corruption, simply because one of the actors in their advertisements sees fit to warn parents on the dangers of vaccines.

State Farm, you have lost me as a customer.

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