September 15, 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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Dr. Oz Warns About Mercury in Flu Shots

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Dr. Oz spent considerable time covering the issue of thimerosal being used as a preservative in the annual flu vaccine. Thimerosal contains mercury, a well-known neuro-toxin. Dr. Oz interviewed Dr. Mark Hyman and former U.S. Senator and Attorney General Robert F. Kennedy, Jr. on his show to discuss mercury in vaccines.

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CDC’s Purchase of $4 Billion of Vaccines a Conflict of Interest in Overseeing Vaccine Safety

CDC’s Purchase of $4 Billion of Vaccines a Conflict of Interest in Overseeing Vaccine Safety

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Do you trust the U.S. Centers for Disease Control (CDC) to oversee vaccine safety, when they have an annual budget of over $4 billion to purchase vaccines from drug companies? In 2015, they want to increase that amount by another half a billion dollars.

Dr. Brian Hooker says the CDC should not be trusted to oversee vaccine safety, and after 10 years of fighting legal battles with the CDC via Freedom of Information requests to secure raw data on vaccine safety studies, he now has solid evidence to back up his claim of fraud within the CDC.

In a shocking news story that rocked the online world but was almost totally ignored by the mainstream media a couple of weeks ago, senior vaccine scientist Dr. William Thompson was revealed as a whistleblower within the CDC, admitting that the CDC had withheld information from a key study in 2004 that supposedly showed that the MMR childhood vaccine was safe.

The CDC was forced to issue a response, and Dr. Hooker has now shown that the CDC response is clearly trying to cover up ethical lapses and explain away key data that was omitted from their original study. This data which was hidden from the public for more than 10 years was not favorable towards their own bias and what they wanted the public to believe about vaccines and autism. Dr. Hooker has clearly shown that the CDC has a conflict of interest, and cannot be trusted with research on vaccine safety when it is spending more than $4 billion of taxpayer funds to purchase vaccines from drug manufacturers.

So what’s next? Will this fraud within the CDC be allowed to continue? There are reports that there are other whistleblowers within the CDC that would like to come forward, but are too fearful at this point. Dr. William Thompson is now represented by one of the top whistleblower attorneys in the nation, and has reportedly turned over more than 1000 documents to Congressman Bill Posey.

The pharmaceutical industry is the richest and most powerful political lobby in the world, however. Will there be enough members of Congress to come forward and oppose them? Does the American public even care enough about this issue to take action and threaten lawmakers who refuse to act and remove vaccine safety oversight from the CDC? Will they demand that taxpayer funds NOT be increased by over a half billion dollars next year to fund the purchase of more vaccines that are produced by pharmaceutical companies who are convicted criminals, and whose products have not been proven safe? More:

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She was full of life UNTIL she received her first and only Gardasil vaccine and this is a decision I regret every second of every day – if only I could turn back the clock!

Bill & Melinda Gates Foundation Vaccine Empire on Trial in India

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While fraud and corruption are revealed on almost a daily basis now in the vaccine industry, the U.S. mainstream media continues to largely ignore such stories. Outside the U.S., however, the vaccine empires are beginning to crumble, and English versions of the news in mainstream outlets are available via the Internet.

One such country is India, where the Bill & Melinda Gates Foundation and their vaccine empire are under fire, including a pending lawsuit currently being investigated by the India Supreme Court. Narayana Kumar of The Economic Times of India has just written a scathing report of fraud and scandals surrounding the Gates vaccine empire: Controversial vaccine studies: Why is Bill & Melinda Gates Foundation under fire from critics in India?

Kumar starts out his 4 page article by focusing on the current case before the India Supreme Court regarding deaths and injuries occurring during drug trials carried out over Merck’s HPV vaccine Gardasil. Vaccine trials were conducted on thousands of girls between the ages of 9 and 15. Many of the girls fell ill, and at least 7 died, and the lawsuit is alleging that in most of these cases, the girls and their parents did not even know what kind of vaccine trial they were participating in.

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A new study just published in the British Medical Journal reports that taking benzodiazepines, common drugs prescribed for anti-anxiety and insomnia, is associated with a higher risk of Alzheimer’s disease. Common benzodiazepines include Valium (diazepam), Ativan (lorazepam), Xanax (alprazolam) and Klonopin (clonazepam). The authors of the study reported in the British Medical Journal that the use of benzodiazepines for three months or more was associated with a 51% increased risk of Alzheimer’s disease.

In an accompanying commentary written by Zosia Kmietowicz, it was pointed out that in 2012 the American Geriatrics Society had updated its list of inappropriate drugs for older people to include benzodiazepines, precisely because of their unwanted cognitive side effects. Yet almost half of the elderly population continues to be prescribed these dangerous medications, and are continuing to take them.

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