DAVID GRANOVSKY

Posts Tagged ‘state’

VATICAN SUPPORTS STEM CELLS

In ALL ARTICLES, STEM CELLS IN THE NEWS on April 11, 2013 at 1:03 pm
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Vatican Conference Hopes to Promote Truth on Adult Stem Cell Therapy

Thu, 11 Apr, 2013 09:32 AM PDT
During today’s first session of the Second International Vatican Adult Stem Cell Conference, scientists, doctors and patients had an opportunity to share not only the advances in adult stem cell research, but also the potential it has to transform modern day health ca…

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A Necessary Union Between Science and Faith

Thu, 11 Apr, 2013 07:01 AM PDT
A three day conference on adult stem cell research began today at the Paul VI Hall in Vatican City. The conference was sponsored by the Pontifical Council for Culture, as well as NeoStem, one of the leading developers in the field of cellular therapy.

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FDA’s New Claim: “Your Body Is a Drug—and We Have the Authority to Regulate It!” | The Alliance for Natural Health USA

In BUSINESS OF STEM CELLS on March 21, 2012 at 4:27 am
FDA’s New Claim: “Your Body Is a Drug—and We Have the Authority to Regulate It!”

January 31, 2012

stem cellIn 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-C™ 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 Medical 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 Medical Clinic takes your blood and bone marrow, puts it into a centrifuge machine that separates the stem cells, and cultures it to get more cells before a doctor puts them back in your body to repair damaged tissue. The FDA states that when the stem cells are cultured, they become FDA-regulated drugs. The clinic has argued numerous times that stem cells aren’t drugs because they are components of the patient’s bone marrow 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 same-day procedure.

 

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.”

Editors’ Note: An earlier version of this article reported that when blood and bone marrow were put into a centrifuge to separate the stem cells, the FDA considered the stem cells to be a drug and claimed authority to regulate them. The article has been updated to reflect that FDA only claims authority to regulate as drugs those stem cells which are cultured before being re-injected into the body.

 

FDA’s New Claim: “Your Body Is a Drug—and We Have the Authority to Regulate It!” | The Alliance for Natural Health USA.

 

Related commentary: ABORTION, EMBRYONIC STEM CELLS, CRICHTON and PHARMA:
insidious analysis…i been around the block once or twice and traveled and listened enough to know that things are not always what they seem and the reasons for doing so are rarely what they appear.

women’s rights are getting squeezed and rung out of them like yesterday’s dirty sponge water and while this is a travesty in and of itself I can’t help but believe that this is the beginning of many more injustices and changes which will make our heads spin. is this an effort to establish that: your body is not your own? we no longer have the right to choose what we put in our body (from vaginal probes to GMOs so “my body/their property” seems closer than i care to admit…

For an absolutely chilling account of “My Bodies, Their Property” read this:

“Patenting lives: life patents, culture and development” Forfeited Consent: Body parts in Eminent Domain Page 95 http://books.google.com/books?id=3hFLooYJRIcC&printsec=frontcover
“Intellectual property, medicine and health: current debates” Property and Human Tissue Page 123 http://books.google.com/books?id=ZIaM8LXlGG0C&printsec=frontcover

Basically, if a woman is state or corporate property, then so is her fetal matter; so doctors can remove the biological materials and use it with legal backing? OR, if a woman is genetically resistant to a specific disease, maybe they can just claim her child and use it for testing?

more and more i see actions performed under the umbrella excuse “the good of the many outweighs the needs of the few” How long before the health of the many is worth the death of the one? perhaps this an embryonic stem cell angle? one last gasp of pharma to fool the public into carrying the embryonic stem cell torch despite the FACT that embryonic stem cell treatments don’t work and do cause tumors?

this isn’t out of the realm of reality, if you disbelieve, go read Mike Chrichton’s 2006 book NEXT – “…and that the physician’s university had sold the rights in Frank’s cells to BioGen, a biotechnology startup company. As the book opens Frank is suing the university for unauthorized misuse of his cells, but the trial judge rules that the cells were “waste” that the university could dispose of as it wished. Frank’s lawyers advise that, even if he wins an appeal, the university as a tax-funded organization can still claim the rights to the cells under the doctrine of eminent domain.”

The pharma company then goes after his kids since the genetic material is the same and if they own the father, the own the son (and the sins of the father shall be visited on the sons…the genetic commercial potential tool) M.C. said about this book: “This novel is fiction, except for the parts that aren’t.”

We’ll see…this goes in the category of “i hope i’m wrong but this twisting in my gut is telling me otherwise”

Antidisestablishmentstemcellianism

In OFF THE BEATEN PATH on February 2, 2010 at 1:13 pm

Antidisestablishmentstemcellianism – in opposition to proposals for the disestablishment of the pursuit of adult stem cells as the gold standard for treatment of disease…and the focus on embryonic stem cell research due to twisted concepts and agendas of state and government

Example:

The public has voiced their position of antidisestablishmentstemcellianism against the media, whom over the past 6 years has covered stem cell stories with a complete disregard for the proven benefits of adult stem cells and an almost conspiracy theory-esque focus on “treatment unusable” embryonic stem cells.

When an “adult stem cells” story came out; there was either no coverage or highly negative coverage.

When an “embryonic stem cells” story came out; the coverage was either positive or in the often times scenario when there was very little positive to say, incredibly optimistic and forward looking.

Will Controversial Stem Cell Rider Derail Senate Budget vote?

In ALL ARTICLES, STEM CELLS IN THE NEWS on April 2, 2009 at 3:29 pm

Sen. Steve Ogden, a Republican from Texas, has potentially derailed not only government funding for embryonic stem cell research, but also has a attempted to derail President Obama's $3.6 trillion budget

Will Controversial Stem Cell Rider Derail Senate Budget vote?

Thursday, 02 Apr 2009

Jacksonville – Sen. Steve Ogden, a Republican from Texas, has potentially derailed not only government funding for embryonic stem cell research, but also has a attempted to derail President Obama’s $3.6 trillion budget. The rider states “No funds appropriated under this act shall be used in conjunction with or to support research which involves the destruction of a human embryo.”

The rider was passed by the Senate Finance Committee 6-5, with some members absent. The Senate is debating the budget and as of the time of this writing there is not news on whether it has passed with the addition of the stem cell rider.

President Obama had reversed George W. Bush’s executive order banning embryonic stem cell research. The controversial medical research involves using stem cells from embryos donated by parents who had In Vitro Fertilization and has extra embryos which otherwise would be destroyed. For many parents, donating these embryos to science makes them feel good. Others actually pay to have the embryos frozen forever, or allow them to be “adopted” by others for IVF.

Stem cells based medical research, including adult stem cells as well as embryonic stem cells are thought to hold the potential to treat or cure many diseases including Deafness, Paralysis, Diabetes, and Crohn’s Disease. When President Obama reversed Bush’s executive order, the NIH (National Institutes of Health) was given 120 days to come up with a set of guidelines for any Federal funding of embryonic stem cell research. Since these guidelines are not yet completed, no new embryonic stem cell research is specifically marked for funding in this year’s budget and this budget rider would make it impossible for any of the health agencies to make further determination of with funds allocated in this years budget.

Some of the issues the National Institute of Health will consider when writing guidelines for the use of embryonic stem cells in research are making sure the parents who donate embryos sign informed consent forms to show that they understand and approve of the research methodology. It is speculated that there may be additional language added to the guidelines restricting any embryos used to the products on fertility treatments. As well, it is expected that there be some separation set up between doctors who do fertility treatments and doctors who do stem cell research, to limit any conflict of interest.

Many in the medical and patient advocacy communities are very concerned that the budget will pass with this rider slipped in by a largely absent subcommittee. It is speculated that Sen. Ogden, who is said to be in his last term in office, is attempting to derail the Democrat’s budget vote by adding this controversial rider.

http://www.healthjackal.com/science/2009/04/02/will-controversial-stem-cell-rider-derail-senate-budget-vote/

State of the Union – my 20 day anniversary!

In ALL ARTICLES, VICTORIES & SUCCESS STORIES on February 25, 2009 at 2:23 pm

hooray

A brief look at where The Stem Cell Blog is and where it has come from in only 20 days…

For the past 3 days I have been ranked on the first page of google blog search for keyword “stem cell”.

Word is getting out and people seem to like what I have to say.  I am averaging a 20-30% increase in traffic volume  per day.

I have 82 posts on my blog that are specifically Stem Cell Victories.  I am in awe of the power of adult stem cells to treat and heal.

Always remember that there will always be resistance to changing the established and traditional paths but it is the responsibility of the people to always question those paths and to ensure that they are indeed being taken care of.  No man is a better advocate for himself, then himself.

David Granovsky, STEM CELL BLOGGER https://repairstemcell.wordpress.com

For all things Stem Cell – news, patient advocacy, treatment information, science, politics, religion and more!

PRESIDENT OBAMA – CHURCH & STATE

In ALL ARTICLES, STEM CELLS IN THE NEWS on February 12, 2009 at 12:19 am

barack_obama_church_state_poster

President Barack Obama treads fine line on church, state By Eric Gorski, THE ASSOCIATED PRESS U.S. President Barack Obama, signalling early in his administration that religion belongs in the public discourse, has promised to open a big tent to voices from across the spectrum of belief without crossing boundaries separating church and state. The Democrat’s inaugural pomp was steeped in prayer, and one of his first proclamations included a shout out to “an awesome God.”

Last week, Obama used the platform of the National Prayer Breakfast to unveil a new-look White House Office on Faith-Based and Neighborhood Partnerships that features a team of policy advisers from both religious and secular social service circles. Most are ideological allies, but not all. The question is whether such moves will amount to symbolic window dressing or progress finding common ground on moral issues without stepping on traditional culture-war land mines. Analysts say the first weeks of the Obama era show there’s little question that both major political parties believe religion should be a significant factor in shaping policy.

That’s disappointing to those on the left who advocate strict church-state separation and unconvincing to Obama’s religious critics on the right who believe the president will plow ahead with a liberal agenda regardless of who is advising him. “There’s clearly not going to be any kind of dropping off the cliff in terms of the importance of faith and politics,” said David Domke, a University of Washington communications professor who studies religion and politics. “There was some sense (President George W.) Bush was going to be this high water mark – or low water mark. With Obama, faith is going to have an important role, but with a much broader breadth to it.

” Obama’s retooling of the faith-based office, plagued in the Bush years by accusations that it was underfunded and too political, upset some Obama supporters who hoped it would go away. Its executive director is Joshua DuBois, a 26-year-old former Pentecostal pastor who headed religious outreach for Obama’s Senate office and his presidential campaign. “This is not a religious office or a religious administration,” DuBois said in an interview. “We are going to try to find ways to work with faith-based and community organizations that are secular in nature, and don’t cross the boundaries between church and state. “We understand it is a fine line. But it’s a line we’re comfortable walking.”

Several battles with religious story lines loom ahead. Obama has signalled he would overturn Bush prohibitions on embryonic stem cell research, and Supreme Court vacancies are also possible. James Dunn, former head of the Baptist Joint Committee for Religious Liberty, which advocates church-state separation, said Obama is striving for an elusive middle ground as his presidency begins. “I welcome some ambivalence,” Dunn said. “Obama’s ambivalence is evidence that he doesn’t think everything is just right or wrong, black and white, like we’ve had the last eight years. He’s also willing to listen. I think the challenge is, if he’s willing to listen, we ought to be willing to talk.”

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