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TEXAS – PERRY – STEM CELLS – NEW RULING

In STEM CELLS IN THE NEWS on April 13, 2012 at 4:10 am

Today (Friday) there is a very significant legislation ruling in Texas (prompted by Gov Perry and his use of stem cells during spinal fusion surgery) which if passed will allow the use of stem cell therapy in Texas under a few conditions. How will this effect the patients and the stem cell industry?


Back story:
MEDICAL BOARD Gives Early OK to Adult Stem Cell Rules – Part 1 April 9, 2012
https://repairstemcell.wordpress.com/2012/04/08/medical-board-gives-early-ok-to-adult-stem-cell-rules/
MEDICAL BOARD’s proposed stem-cell policy under fire – Part 2 April 9, 2012
https://repairstemcell.wordpress.com/2012/04/08/medical-boards-proposed-stem-cell-policy-under-fire-part-2/
DRIVING THE FDA DUNE BUGGY INTO THE STEM CELL OCEAN https://repairstemcell.wordpress.com/2012/04/04/driving-the-fda-dune-buggy-into-the-stem-cell-ocean/

This is by no means a political message and I neither endorse nor denounce Gov Perry but I do appreciate the incredible attention he has been able to focus on the benefits of adult stem cell therapies and if this legislature goes through, thousands of patients with no hope can be help with them.

THE DOOR OPENS

In ALL ARTICLES, BEST OF THE BEST, BUSINESS OF STEM CELLS, CATCH UP!, SCIENCE & STEM CELLS, STEM CELLS IN THE NEWS, VICTORIES & SUCCESS STORIES on May 30, 2017 at 11:20 am

UPDATE: JUNE 13TH 

In the next step of what may become the most monumental piece of medical legislature,

THE GOVERNOR OF TEXAS SIGNED HB 810!

HB 810 will be effective on 9/1/17  

I express virtually no surprise what so ever that there has been no media coverage of this.*  The only piece of confirming data I can find is on the Texas Legislature site and in articles written by the tireless and noble Patient Warriors, around the world, who have been fighting for their lives and for this for years.

 

HB-810
[original article below]
………………………………………………………………
Around the world, stem cells have been used for therapeutic application for decades, treating incurable illnesses, recovering terminal patients and improving qualities of life of untold numbers.  In some form or another, Rafael Nadal got them…along with Peyton Manning, Jarvis Greene, Kobe Bryant and Dana White and hundreds or thousands of other athletes and weekend warriors but mostly outside the US because they weren’t available here.
Sadly, we in the US were…a little slow…to get the message. Foolishly allowing ourselves to get embroiled in the distracting political, financial and religious controversies; we have not been allowed to treat our sick and dying. Tragically, listening to the uninformed who said: “they are unproven!” despite thousands of studies and trials from around the world, the US stuck to our guns and enjoyed some of the worst medical care in the world.  I wrote this in 2010:
“We are in fact about 8 years behind most of the developed world in stem cell research. The WHO ranks our health system at 37th, our life expectancy is 30th in the world, infant mortality is 34th in the world and this is all with our Health Expenditures as a % of GDP being almost the highest in the world (we are ranked #2).”
Like many before and after him, Gov Perry made some in roads in 2012 but hit the wall of American “backward thinking.” https://repairstemcell.wordpress.com/2012/04/14/texas-oks-experimental-stem-cell-therapy-limits-questions/
Now, Texas, House Bill 810 amended the bill which was “relating to the provision of certain investigational stem cell treatments to patients with certain severe chronic diseases or terminal illnesses and regulating the possession, use, and transfer of adult stem cells; creating a criminal offense,” and passed the Senate, unanimously.
STEM CELLS FOR SCLERODERMA
This is the bill now:

The bill is on its way to the Governor’s office for signature. This has been a LONG time coming.

A hearty congratulations goes out especially to the tireless patient advocates/patient warriors who said: “no more!” and threw off the yoke of servitude to a medical system which no longer served their self-interests. Their efforts and those of many, many others have inexorably, infinitesimally, pushed the needle over time against multiple immovable objects.

What happens next?  There will be chaos, turmoil and scrambling.  There will be resistance and bad mouthing and nay saying…and in the end, Texas industry will likely generate billions in revenue, treat the un-treatable, recover the unrecoverable, extend the lives of those told to get their affairs in order and become THE center of regenerative medical innovation in the US, if not, the world.

 

……………………………………………..

I now see that there was media coverage; we just apparently beat them all to the punch.  I am more than pleased that this advance is getting mass media coverage!

Stem Cell Therapy Becomes Law in Texas – Hawaii News Now … 2 hours ago – LA JOLLA, Calif., June 13, 2017 /PRNewswire/ — House Bill (HB 810) on stem celltherapy has passed in the Texas state legislature and become law. Patients in …

Health Care – FOX5 Vegas – KVVU  17 mins ago – House Bill (HB 810) on stem cell therapy has passed in the Texas state legislature and become law. Patients in Texas will now have access to this “Right to Try” …

Health Care – WDRB 41 Louisville News  36 mins ago – House Bill (HB 810) on stem cell therapy has passed in the Texas state legislature and become law. Patients in Texas will now have access to this “Right to Try” …

Stem Cell Therapy Becomes Law in Texas – WorldNews  3 hours ago – LA JOLLA, Calif., June 13, 2017 /PRNewswire/ — House Bill (HB 810) on stem celltherapy has passed in the Texas state legislature and become law. Patients in …

– TiGenix Launches Global Phase III Trial for Cx601 (EN – NL – ES …45 mins ago – LA JOLLA, Calif., June 13, 2017 /PRNewswire/ — House Bill (HB 810) on stem celltherapy has passed in the Texas state legislature and become law. Patients in …

TiGenix announces final equity payment for cardiac platform …  41 mins ago – LA JOLLA, Calif., June 13, 2017 /PRNewswire/ — House Bill (HB 810) on stem celltherapy has passed in the Texas state legislature and become law. Patients in …

Hope for Gabe Foundation Races Across America to Bring Awareness …   50 mins ago – LA JOLLA, Calif., June 13, 2017 /PRNewswire/ — House Bill (HB 810) on stem celltherapy has passed in the Texas state legislature and become law. Patients in …

 

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TASK FORCE REJECTS EMBRYONIC STEM CELLS

In STEM CELLS IN THE NEWS on December 31, 2012 at 9:32 am
(BIS Photo/Patrick Hanna)

(BIS Photo/Patrick Hanna)

The National Task Force on Stem Cell Therapy Treatment, which comprises a group of respected doctors, with influence from the archdiocese, proposed to the Minister of Health, Dr. Perry Gomez calling for an overhaul of existing legislation concerning medical tourism in the Bahamas.  Stem Cell research and therapy has the potential to generate over $100 million in the medical tourism industry, according to the government’s task force, which delivered its verdict on the country’s proposed plunge into the controversial science yesterday.  “We put together the framework for stem cell work to be carried out to the benefit of Bahamians in an ethical way and to support the potential for a medical tourism industry, and we delved into the specifics of what can be done and what should not be done.” said Dr Arthur Porter.

-DG

The National Task Force on Stem Cell Therapy Treatment has recommended to the Bahamas Government that embryonic stem cells should not be used to create human stem cells in this country, said the Task Force’s chairman and managing director of the Cancer Centre, Professor Arthur T. Porter.

Professor Porter presented a copy of the Task Force’s recommendations to Minister of Health the Hon. Dr. Perry Gomez during a press conference held at the Ministry of Health, Thursday, December 27, 2012.  The Chairman told Dr. Gomez that the Task Force’s members unanimously support all of the recommendations within the report.

In November 2012, the Bahamas Government appointed the Task Force to develop a series of recommendations regarding the possible use of Stem Cell Therapy in The Bahamas.  The Committee had to weigh all the pros and cons associated with Stem Cell use, including the more controversial use of embryonic Stem Cells. The Task Force also had to look at how adult Stem Cells would be used.

Members of the Task Force include Dr. Robin Roberts, Director, University of the West Indies School of Clinical Medicine and Research, Bahamas Campus; Rev. Angela Palacious, Anglican Archdiocese; Dr. Duane Sands, Senior Cardiovascular Surgeon, Princess Margaret Hospital; Dr. Paul Ward, Chief of Services, Rand Memorial Hospital, Grand Bahama; Dr. Barrett McCartney, Senior Anesthesiologist and Pain Specialist, Doctors Hospital and Dr. Indira Martin, Laboratory Research, Ministry of Health.

Dr. Wesley Francis, President of the Medical Association of The Bahamas; Dr. Glen Beneby, Medical Director, Public Hospitals Authority and Mrs. Michelle Pindling-Sands, Attorney-at-law, also sit on the Task Force.  When the Task Force was first introduced, Professor Porter explained that there are two types of stem cells.

“Embryonic cells usually derive from a five-day embryo or earlier, which have the ability to become any cell in the body whether a brain cell, a fat cell or a nerve cell. They are pluripotent (capable of differentiating into one of many cell types).

“The second type are the adult stem cells, which are smaller in quantity and can be found in most tissue and organ systems, but which lack the flexibility of what they can be, and so scientist have tried to take some of the adult Stem Cells and make them able to be more or less like embryonic stem cells to sort of get around the problem.”  Professor Porter explained that during the Task Force’s deliberations, it was found that there is no need for the use of embryonic Stem Cells, because research is finding that adult Stem Cells can be transformed to be able to act as Induced Pluripotent Stem Cells.  As a result, he said there is no need to focus on embryonic stem cells in The Bahamas.

Professor Porter said the use of umbilical cord blood, which has been used for over 15 years in different parts of the world, should also be permitted in The Bahamas.  “The use of somatic cell nuclear transfer, which is a type of technique in which adult Stem Cells are encouraged to behave, as early Stem Cells should also be used.  “But again recognizing that we are on the frontiers of new science, so the appropriate clinical trials, the appropriate committees, the appropriate ethics support should be given to the use of these areas.”

Professor Porter said many have asked the Task Force for an opinion regarding reproductive human cloning. “The Task Force was quite committed in its opinion that reproductive cloning should not be permitted.”  He added that the Task Force felt that it was important that there be widespread education and consultation with various stakeholder groups that will be involved in making the ultimate decision, so people would become aware of the importance of Stem Cells, some of the ethical issues and be able to opine in this regard.  Professor Porter said the Task Force believed that Stem Cells would be an important part of the country’s medical tourism thrust, but the Government needs to broadly review what is necessary for a successful medical tourism industry.  Dr. Sands added, “We have to understand that this is a rapidly evolving field and there are many countries in the world that have embraced medical tourism and as such have tried desperately to ensure the process of approval or the rapid acceleration of new projects is done in a timely fashion.  “Similarly, efforts have been made to ensure that phenomenal scrutiny of the proposed projects, the participants, etc., is carefully done.

He said legislation in The Bahamas has to be robust enough to protect the integrity and the reputation of the country while at the same time promoting good science and this is an on-going process. “We need to make sure the laws are constantly keeping up with what is happening on the ground.”  Dr. Gomez said after he reviews the report, he would present it to Cabinet early next year so that policies can be made surrounding Stem Cell Therapy in the country.

http://www.bahamaislandsinfo.com

TEXAS OKs EXPERIMENTAL STEM CELL THERAPY LIMITS – questions

In STEM CELLS IN THE NEWS on April 14, 2012 at 5:08 am

U+21E7.gifU+21E7.gifU+21E7.gifPlease rate this article 

Texas OKs experimental stem cell therapy limits

Friday, April 14, 2012

Will this move by Texas lead to a faster process of FDA approval and insurance coverage? – Boonie

 

My gut says: baby steps. They need to define the IRB process and make sure all the pieces of the machine work well. There are many factors which will unfold now.

Will other states fall after Texas like for medical marijuana?

Will Texas stand alone and all US stem cell companies open clinics there?

Will patients go to a clinic in Texas regulated by an IRB with zero experience over a treatment center outside the US with thousands of successes?

Can the FDA approval process be changed from clinical trial to produce drugs INTO a process oriented hybrid?

Will insurance cover it…ie will the American people, many whom think all stem cells are embryonic still so all stem cells = murder, many whom don’t know about the thousands of trials and tens of thousands patients treated, want to ‘foot the bill’ for these Texas treatments?

Many many questions.

Rome. Built. Not one day.

Baby steps…but a step in the right direction.

 

Related articles:

TEXAS OKs EXPERIMENTAL STEM CELL THERAPY LIMITS – explained

In STEM CELLS IN THE NEWS on April 14, 2012 at 3:44 am

U+21E7.gifU+21E7.gifU+21E7.gifPlease rate this article 

Texas OKs experimental stem cell therapy limits

Friday, April 14, 2012

What this means:

1. This is not blind distribution of medicine with no control. The legislature demands full transparency & disclosure (not available to patients in clinical trials). In trials, patients have no idea what they are getting if anything! There is no patient, only guinea pigs.

2. There is oversight control by an Institutional Review Board. There will not be rampant, unchecked treatments or “growth motivated by cash only.”

Standard FDA clinical trials regulate only how DRUGS are brought to market. Adult stem cell therapies are not drugs, they are a procedure, a process, a protocol & must be treated differently in the courts & in practice like PRPs (which are legal. 2x standard?). It was way past time to end the idea: ‘the result of all medical intervention is a prescription drug.’ “Give a small boy a hammer, & he will find that everything he encounters needs pounding,” Texas is unburdened from the yoke of those blinded by a faith in a system that demands the mandatory adherence to “one size fits all,” “one size fits drugs,” “drugs fit all.”

Adult stem cells have a proven record of safety & efficacy in studies & trials around the world – thousands of them. American medical professionals are so Ameri-centric, they throw away or ignore anything conducted outside the USA…when our health system is ranked 37th in the world. This arrogance is suspect. “We’re 7th in literacy, 27th in math, 22nd in science, 49th in life expectancy,178 in infant mortality…” and the US throws away other country’s clinical trials & studies?  Perhaps we should throw away our entire medical system & start from scratch or at least start taking pointers from some other countries on how to improve our health care/medical system…countries who apparently do a better job at it than we do like ranked 27th to 36th: United  Arab  Emirates, Israel, Morocco, Canada, Finland, Australia, Chile, Denmark, Dominica and Costa Rica.

With our CLINICAL TRIAL system, a human patient is used as a Guinea pig & sacrificed for the patient of tomorrow, blindly & randomly given medications or not, given placebos or not or given nothing.  They are Guinea pigs by definition. There is no patient, there is no empowerment, there are no rights, there is no agenda for healing. The health of one patient is sacrificed today for the health of patients of tomorrow whom apparently have more value. Categorization of any human patient as dispensable, even in order to generate data for a drug treatment to be sold to a different patient tomorrow, is reprehensible.  Clinical trials = no agenda for healing today.

With ADULT STEM CELL TREATMENTS, a human is given a therapy today intended to heal that person today. That person. Their health, their survival, that patient is of paramount importance. Their life has value, today. Adult stem cell treatments are simply, a treatment today, paid for today, for a human today to heal today, live today and into tomorrow.

I guess you can be a Guinea Pig for future patients tomorrow or you can be an empowered patient for yourself today.  All this legislature does, is give you the choice. In the end, our choices are all we ever have.

Related articles:

TEXAS OKs EXPERIMENTAL STEM CELL THERAPY LIMITS!!!

In STEM CELLS IN THE NEWS on April 13, 2012 at 1:11 pm

PERRY DID IT!!

I DON’T THINK I BELIEVE IT!!

IS IT POSSIBLE??

IS IT??

https://i2.wp.com/static3.itsuxtobefat.com/uploads/omg.jpg

Texas OKs experimental stem cell therapy limits

National / World News 1:46 p.m. Friday, April 13, 2012

The rules require patients to give their consent and a review board must approve the procedure before using adult stem cells.

Supporters say establishing formal rules will lead to more medical innovation. Critics warned that the rules don’t provide enough protection for patients and could lead to an explosion of doctors promoting unproven, expensive treatments.

Perry had his own stem cells injected into his back.

The Food and Drug Administration hasn’t approved using adult stem cells to help people heal from surgery, but experimentation is common. Some scientists tout the possible benefits, including treatment for heart disease, diabetes and some cancers.

Texas OKs experimental stem cell therapy limits  | ajc.com.

Related articles:

 

 

 

MEDICAL BOARD’s proposed stem-cell policy under fire – Part 2

In STEM CELLS IN THE NEWS on April 8, 2012 at 11:44 pm

PLAYING A SHELL GAME WITH YOUR LIFE

“The policy, thought to be the first of its kind, would allow Texas doctors to provide the unlicensed therapy as long as they have approval from a review panel that assesses the cells’ use for patient safety, as is customary in clinical trials…Patients paying tens of thousands of dollars for therapy likely wouldn’t accept a 50-50 chance of getting a placebo, he noted.”

So the options are:

  • A PAID FOR MEDICAL TREATMENT, IN THIS CASE STEM CELLS PROVEN SAFE AND EFFECTIVE IN OVER 2,500 TRIALS AND STUDIES AND ON THOUSANDS OF PATIENTS: Whereby you educate yourself on stem cell treatments and make a conscious choice as to what is best for your health and pay for a stem cell treatment you will actually receive with virtually zero negative side effects if any (here, you get what you pay for)
  • A FREE CLINICAL TRIAL WITH A DRUG UNTESTED ON HUMANS WHICH MAY OR MAY NOT WORK…OR A PLACEBO…OR NOTHING:  Whereby you play a randomized shell game with your health and life where you go through all the rigors of treatment and follow up, may not be allowed to receive any additional treatments during the trial AND only have a 50% or even a 33% chance of receiving any real treatment which if you do get are almost guaranteed to have negative side effects (here, you get nothing, or maybe a placebo or maybe a treatment but you will not know until after the trial is over…or you die)

GUINEA PIGS:  Bare in mind that a Guinea pig is a model organism used in human subject research (to check the effect of something on humans which has been untested or not fully tested on humans.)  The Guinea pig is presumably sacrificed (as were the other animals in the animal trials) for the greater good, the health of the humans tomorrow. Today’s human Guinea pig is dispensable.

ADULT STEM CELL TREATMENTS: With ADULT STEM CELL TREATMENTS, a human is given a therapy which is intended to heal that person.  That person.  Their health is of paramount importance.  Their survival is important.  Their life has value, today.  Adult stem cell treatments are simply, a treatment today, paid for today, for a human today to live today and into tomorrow.

CLINICAL TRIALS: In a CLINICAL TRIAL, a human is used as a Guinea pig and sacrificed for the humans of tomorrow.  Humans used in clinical trials are unknowingly and randomly given medications or not, given placebos or not or given nothing are Guinea pigs.  They and their health are sacrificed for the health of humans of tomorrow whom apparently have more value.  Clinical trial drugs are a treatment today for a human today whom is completely dispensable in order to generate data for a drug treatment to be sold to a different human tomorrow.

WHY ISN’T WHAT’S GOOD ENOUGH for DRUGS, NOT GOOD ENOUGH for STEM CELL THERAPIES?

The article says:

“Experts also questioned the policy’s allowance of for-profit review boards to oversee doctors’ use of stem-cell therapies, claiming such boards risk losing business if they don’t approve clinical research proposals.”

How is this different from the current situation with prescription drugs?  Let’s change a few words in bold:

“Experts also questioned the policy’s allowance of for-profit review boards to oversee doctors’ use of drugs, claiming such boards risk  losing business if they don’t approve clinical research proposals.”

Isn’t that what is going on every day with the FDA, pharmaceutical companies and doctors?  Seems like this is actually a leveling of the playing field.

WHAT NEXT?

“The Texas Medical Board is scheduled to consider the proposed policy Friday.”

Medical board’s proposed stem-cell policy under fire

By Todd Ackerman – Published 08:06 p.m., Sunday, April 8, 2012

Houston and Texas

Texas’ proposed adult stem-cell regulations, up for approval this week, are under fire for circumventing the Food and Drug Administration and making the experimental therapy commercially available before it’s been proven safe and effective.

The criticism of the Texas Medical Board draft policy, developed in the aftermath of Gov. Rick Perry receiving stem-cell treatment for his back problems, is coming from a host of pre-eminent scientists and institutions, including the influential scientific journal Nature and the International Society for Stem Cell Research.

“Texas officials should take the FDA’s regulatory power over stem cells more seriously,” editorialized Nature. “If the medical board were to act according to its stated pledge to protect patients, then it would make clear the need for clinical validation of adult stem cells before use and rescind the medical licenses of any doctors in breach of rules about using unapproved treatments.”

Dr. Irving Weissman of the ISSCR called the draft “a clever way around the FDA’s appropriate role overseeing clinical trials.” Weissman, director of Stanford University‘s Institute for Stem Cell Biology and Regenerative Medicine, said the policy violates the ISSCR’s guidelines for clinical use of adult stem cells.

The policy, thought to be the first of its kind, would allow Texas doctors to provide the unlicensed therapy as long as they have approval from a review panel that assesses the cells’ use for patient safety, as is customary in clinical trials. But unlike most clinical trials, in which experimental therapy is provided free, the policy would allow Texas doctors to charge for it, typically tens of thousands of dollars.

Mari Robinson, executive director of the Texas Medical Board, denied that the proposed policy represents an alternative path than the FDA. She said that in the absence of definitive direction from the FDA, the board simply wants to ensure that “new and expanding areas of medicine” are safe for patients.

“The FDA has provided no definitive statement about the medical use of adult stem cells, including whether it even has jurisdiction if the cells are taken from patients and given back within the state,” said Robinson. “The board wants to let the field come forward and grow but in a safe manner.”

Robinson, a lawyer, said the courts ultimately may provide the answer about the FDA’s jurisdiction. The federal agency last year filed an injunction to stop a Colorado clinic from treating patients with their own stem cells, arguing its failure to comply with FDA regulations “puts the public’s health at risk.”

Adult stem cells are cells in the body that multiply to replenish dying cells. Though they lack the ability of embryonic stem cells to morph into any kind of tissue, they have shown much promise in recent research treating a variety of conditions. Still, the therapy is mostly in early-stage clinical trials and considered five to 10 years away from FDA approval.

Clinics popping up

Nevertheless, clinics that claim adult stem-cell therapy can treat conditions from Parkinson’s to multiple sclerosis are proliferating, mostly in other countries but increasingly in the United States. The head of a Houston stem cell bank involved in Perry’s procedure says it has stored more than 100 customers’ stem cells, as many as 50 of whom have had them reinjected.

The Texas Medical Board has grappled with the issue since before a Houston surgeon treated Perry last July. Its policy was tentatively approved in February, after months of “stakeholder” discussions, public comment and revision.

But numerous experts in bioethics, stem-cell science and health law last week strongly criticized the finished version. Most expressed concern about why Texas feels the need to set up a process they described as redundant to the one already run by the FDA.

“It also confuses clinical research, which is conducted to find out generalized information about new therapies’ safety and efficacy, with the practice of medicine, which is about using safe, proven methods to treat ailments,” said Douglas Sipp, head of Science Policy and Ethics Studies at Japan’s RIKEN Center for Developmental Biology. “Essentially, Texas is saying research can be done as treatment, that patients can be charged to participate in research.”

Trials threatened?

Robinson disputed the suggestion that every therapy a doctor provides requires FDA approval. She said there already are plenty of alternative and complementary medicines regulated by the state, not the FDA.

Sipp said the policy would make it difficult to conduct randomized trials, the gold standard of research in which some patients receive the therapy and some receive a placebo. Patients paying tens of thousands of dollars for therapy likely wouldn’t accept a 50-50 chance of getting a placebo, he noted.

Experts also questioned the policy’s allowance of for-profit review boards to oversee doctors’ use of stem-cell therapies, claiming such boards risk losing business if they don’t approve clinical research proposals.

The Texas Medical Board is scheduled to consider the proposed policy Friday.

Read more: Medical board’s proposed stem-cell policy under fire
Related Article: https://repairstemcell.wordpress.com/2012/04/08/medical-board-gives-early-ok-to-adult-stem-cell-rules/
Background History: https://repairstemcell.wordpress.com/?s=perry

MEDICAL BOARD Gives Early OK to Adult Stem Cell Rules – Part 1

In VICTORIES & SUCCESS STORIES on April 8, 2012 at 8:55 pm

HUGE NEWS! WHAT THIS MEANS:

  • You can get stem cells in Texas.
  • They have to tell you they are not approved by the FDA.
  • They have be reviewed by an IRB – Institutional Review Board.

Medical Board Gives Early OK to Adult Stem Cell Rules

by Gerald Rich – February 10, 2012

After months of deliberation — and input from Gov. Rick Perry, among others — the Texas Medical Board on Friday gave preliminary approval to a set of rules on adult stem cells in Texas that are less stringent than those originally proposed.

With no opposition, the vote on a topic that has received much scrutiny and skepticism since last spring took only about five minutes.

“It’s been a delicate balance between our absolute goal to protect the public and at the same time [our] desire not to stifle what we feel will be a huge boon to medicine,” said Dr. George Willeford, a member of the board. “Perhaps we’ve been criticized by the media for taking a middle road, but [the middle road] was absolutely necessary.”

In the weeks leading up this meeting, members of many Texas academic institutions had written to the Board to express concern that the rules — “Standards for Use of Investigational Agents” — were too restrictive and created what they felt might be onerous regulations on any treatment that could be undergoing clinical trials.

Discussion of changing the Texas Administrative Code to include regulating these trials began last summer after Perry used adult stem cells to treat a recurring back injury. Perry learned of and advocated for the treatment after Dr. Stanley Jones — a Houston orthopedist, donor and personal friend of the governor — flew to Japan to receive the same treatment for his arthritis.

At the moment, extracting, growing and using adult stem cells is considered largely experimental and can cost anywhere from $10,000 to $50,000. However, those at the meeting expressed hope that this new treatment could eventually become affordable and accessible to more Texans.

Under the rules OK’d on Friday, patients will be informed that using adult stem cells, or any investigational agent, has not been approved by the FDA and that any clinical trials will be approved and overseen by an Institutional Review Board, or IRB.

The board and industry leaders hope this new rule will give them more data on the potential benefits of using adult stem cells. Currently, there is no substantial data to indicate that adult stem cells are beneficial for patients other than those undergoing bone marrow transplants — used for decades to treat leukemia and sickle cell anemia.

In late August, the board’s initial rule had included language requiring consent forms detailing the risks and benefits, and stating that any treatment offered needed to have a favorable risk/benefit ratio.

Now that the proposed change has been approved by the board, the rule will be printed in the Texas Register, where the public can view them and comment on them. Further drafts of the rule may be drawn up, with the final version put to vote for adoption during the April board meeting.

“Some language was removed and some was added,” said Mario Salinas, director of Texans for Stem Cell Research. “Patients are going to be informed as to [the] pros and cons that will ensue from being in a clinical trial. Whatever language was deleted was made better with the new language that was added.”

Glenn McGee, president of strategic initiatives for Houston-based Celltex Therapeutics — which was founded by Jones and Perry donor David Eller, and is a Texas adult stem cell bank — was also in attendance Friday and happy with the proceedings.

“Texas decided, unlike anyone else in the country or anyone in the world, to take a position on how to think about stem cells and the practice of medicine,” McGee said. “I think Texas will become the source for articles about adult stem cell use in peer reviewed articles.”

Editor’s note: An earlier version of this story incorrectly reported that Celltex Therapeutics was the only Texas adult stem cell bank.

Read more: Medical Board Gives Early OK to Adult Stem Cell Rules — Health Reform and Texas | The Texas Tribune.

Related article: https://repairstemcell.wordpress.com/2012/04/08/medical-boards-proposed-stem-cell-policy-under-fire-part-2/
Background History: https://repairstemcell.wordpress.com/?s=perry

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”

HPV VACCINES FOR ALL CHILDREN NOW!

In DISEASE INFO on October 26, 2011 at 1:54 am

WARNING, THE FOLLOWING ARTICLE IS NOT FOR THE FAINT OF HEART!  READ AT YOUR OWN RISK!

[For what it’s worth; writing this article made me nauseous. So much for professional objectivity.]

—————————————-

So you’re considering vaccinating little Susy and little Jimmy?  Of course you are!  You are a responsible parent and we are talking about preventing cancer gosh darn it!

https://i1.wp.com/www.gamstonschool.com/Resources/user/docs/Gamston%20logos/Cartoon%20parents.jpg

Well, here are 47 children that will never ever get cervical cancer or even spread it!  Do you know why?

BECAUSE HERE ARE 47 HPV VACCINE VICTIMS, 11 to 22 YEARS OLD, WHO ARE DEAD:
THE UNLUCKY 47 YOU WILL NEVER READ ABOUT

(this information via)

Do you know why the HPV vaccine is recommended for all children? Because there is no cure for it…or MS or CP or autism or AIDs or any other significant disease out there.

How long will it be before you MUST get a vaccine for ALL diseases whether there is a real chance of contracting it or not?
Only as long as it takes to make the drugs my friends.

And why do we have to vaccinate in the first place?
Because there is not a single disease treatable” with drugs which has been cured since Polio in the 1950s.  

What are vaccines? 

Vaccines are Pharmas way of saying:
WE CAN’T CURE IT, SORRY, NOW PONY UP THE CASH SO WE CAN USE YOU AS A LAB RAT, INJECTING ALL SORTS OF WHO KNOWS WHAT THAT WILL COMBINE IN YOUR AND YOUR CHILDREN’s BODIES WITH THE POLLUTION IN THE AIR WE HELPED CREATE, SODIUM FLOURIDE IN RAT POISON AND YOUR TOOTHPASTE, PESTICIDES, STEROIDS, ANTIBIOTICS, FLOURIDE, RITALIN AND PROZAX AND BIRTH CONTROL CHEMICALS IN YOUR DRINKING WATER, TEFLON FROM YOUR PANS AND FOLATES FROM YOUR PLASTIC AND MIX UP IN A DELIGHTFUL CHEMICAL STEW AND CAUSE WHO KNOWS WHAT KINDS OF ISSUES DOWN THE ROAD.  THEN, WE CAN GET RICHER AND SELL YOU MORE DRUGS FOR UNKNOWN DISEASES TOMORROW WHICH WE WON’T BE ABLE TO CURE BUT WE WILL DEVELOP VACCINES FOR THEM TOO!

Now don’t get me wrong.  I’m all for preventative care.  But there is good prevention and bad prevention. 

Have you noticed this prevention trend?
Eastern medicine believes in eating, exercising and taking care of oneself now to prevent disease.

Western medicine believes in taking a pill now to prevent a symptom.  Prilosec for example is taken daily to avoid acid reflux.

So what’s the difference?

There’s only one problem (there are many but let’s focus on one.)  Long term use of exercise, teas, acupuncture, wheat grass juice or dandelion leaves have virtually no side effects.  Long term use of Prilosec (for example) has these:

Bone Fractures – A fracture is a break in the continuity of the bone. According to the U.S. Food and Drug Administration, long-term use of high doses of Prilosec may cause increased of fractures of the hip, wrist and spine. The risk of fractures is even greater in patients older than 50 years who have used Prilosec for a long-time. The FDA recommends that doctors prescribe low doses of Prilosec and for the shortest duration.

Liver Damage – According to Drugs.com, Prilosec is metabolized in the liver. The liver converts Prilosec into by products which can be easily excreted from the body. Constant exposure of the liver to high doses of Prilosec damages the liver leading to liver failure. Signs and symptoms of liver failure include nausea, right upper abdominal pain, clay colored stool and yellowing of the eyes and the skin.

Esophageal Candidiasis – Esophageal candidiasis as the overgrowth of fungus in the esophagus. Stomach acid is important in preventing growth of fungus in the esophagus. According to Drugs.com, use of Prilosec for a long-time creates a favorable environment for the growth of fungus in esophagus as Prilosec blocks the production of acid in the stomach. Esophageal candidiasis causes painful swallowing which may lead to excess weight loss.

Oh come on David, this isn’t Prilosec, it’s an HPV vaccine for boys to avoid potential cancer, just like the “very safe” HVP vaccine for girls.  Very safe?

For our sweet young ladies! 🙂
“The FDA adverse event reports on the HPV vaccine read like a catalog of horrors. Any state or local government now beset by Merck’s lobbying campaigns to mandate this HPV vaccine for young girls ought to take a look at these adverse health reports.” –  Via

“…ignored the shocking statistics about the HPV vaccine available at the CDC’s Vaccine Adverse Event Reporting System website. The Center received a total of 18,727 reports of adverse events following Gardasil HPV vaccination, with 1,498 of them (8%) considered “serious”—such as blood clots, the neurological disorder Guillain-Barre Syndrome, and 68 reports of death.” – via

“…Gardasil was approved to protect against four [of the 100+] strains of HPV, which can lead to cervical and other cancers, in girls and women between the ages of 9 and 26 years old. Later, the vaccine was approved in boys and young men in the same age range to combat two [of the 100+] HPV strains that can cause genital warts. GlaxoSmithKline’s Cervarix is approved for preventing HPV in females ages 9 through 25.” via

“Cervarix will not prevent diseases caused by HPV types other than types 16 and 18. There are over 100 different types of HPV.” via

It really freaks me out when virtually every site I go to says:  “This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at           1-800-822-7967.”

But I did find this very complete clinical assessment of the side effects:

http://www.drugs.com/sfx/cervarix-side-effects.html

And I’ll just leave you with these:

Get the picture?

Panel Endorses HPV Vaccine for Boys of 11

By GARDINER HARRIS – Published: October 25, 2011

Boys and young men should be vaccinated against human papillomavirus, or HPV, to protect against anal and throat cancers that can result from sexual activity, a federal advisory committee said Tuesday.

The recommendation by the panel, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention, is likely to transform the use of the HPV vaccine, since most private insurers pay for vaccines once the committee recommends them for routine use. The HPV vaccine is unusually expensive. Its three doses cost pediatricians more than $300, and pediatricians often charge patients hundreds more.

The committee recommended that boys ages 11 and 12 should be vaccinated. It also recommended vaccination of males ages 13 through 21 who had not already had all three shots. Vaccinations may be given to boys as young as 9 and to men between the ages of 22 and 26.

The committee recommended in 2006 that girls and young women ages 11 to 26 should be vaccinated, but vaccination rates in the United States have so far been disappointing.

The vaccine has been controversial because the disease it prevents results from sexual activity, and that controversy is likely to intensify with the committee’s latest recommendation since many of the cancers in men result from homosexual sex. The HPV vaccine became a source of contention among Republican presidential candidates after some candidates criticized Gov. Rick Perry of Texas for trying to require that girls in his state be vaccinated. Representative Michele Bachmann falsely suggested that the vaccine causes mental retardation.

But for the public health experts gathered in Atlanta, the vaccine’s remarkable effects were irresistible.

“This is cancer, for Pete’s sake,” said Dr. William Schaffner, chairman of the department of preventive medicine at Vanderbilt University School of Medicine and a nonvoting member of the committee. “A vaccine against cancer was the dream of our youth.”

HPV infection is the most common sexually transmitted disease — between 75 percent and 80 percent of females and males in the United States will be infected at some point in their lives. Most will overcome the infection with no ill effects. But in some people, infections lead to cellular changes that cause warts or cancer, including cervical, vaginal and vulvar cancers in women and anal cancers in men and women. A growing body of evidence suggests that HPV also causes throat cancers in men and women as a result of oral sex.

HPV infections cause about 15,000 cancers in women and 7,000 cancers in men each year. And while cervical cancer rates have plunged over the past four decades because of widespread screening, anal cancer rates in men and women have been increasing. Head and neck cancers have also been increasing, with the share associated with HPV infection increasing rapidly — perhaps because oral sex has increased in popularity.

Parents of boys face some uncomfortable realities when choosing whether to have their child vaccinated. The burden of disease in males results mostly from oral or anal sex, but vaccinating boys will also benefit female partners since cervical cancer in women results mostly from vaginal sex with infected males.

Vaccinating the nation’s 11- and 12-year-old boys will cost almost $140 million annually, but the one-time catch-up among males 13 to 21 will cost hundreds of millions more. The government generally pays for about half of all vaccinations.

The committee has become increasingly concerned about the cost effectiveness of vaccines, since the newest vaccines tend to be very expensive while protecting against diseases that affect fewer people. Vaccinating boys is cost effective when vaccination rates in girls are relatively low, which they are now. Fewer than half of girls between the ages of 13 and 17 have received at least one dose of the HPV vaccine, and fewer than a third have received all three doses.

Only about 1 percent of boys have received the HPV vaccine, even though the vaccine advisory committee has said that boys could be vaccinated against the disease if they or their parents wished.

Vaccinating homosexual boys would be far more cost effective than vaccinating all boys, since the burden of disease is far higher in homosexuals. “But it’s not necessarily effective or perhaps even appropriate to be making those determinations at the 11- to 12-year-old age,” said Kristen R. Ehresmann of the Minnesota Department of Health and a committee member.

Dr. S. Michael Marcy, a clinical professor of pediatrics at the University of Southern California and a committee member, said that the money needed to vaccinate 11- and 12-year-old boys would pay for only a few hours of the war in Afghanistan while potentially saving thousands of lives in the United States.

“I’m constantly being told we don’t have the money. Well, we do have the money,” Dr. Marcy said. “We need a new set of priorities, and we if we don’t set those priorities, who will?”

The vaccine loses effectiveness if it is given after the onset of sexual activity. More than one in five boys and girls have had vaginal sex by the age of 15, surveys show. But there are many strains of HPV, and Gardasil — the HPV vaccine manufactured by Merck — protects against four of those strains. Older boys and young men may receive the vaccine even after becoming sexually active in hopes that it might protect them against an HPV strain they have yet to encounter.

Separately, the advisory committee voted to recommend routine vaccination of diabetics under age 60 against hepatitis B infections, which commonly occur in older diabetics in long-term care facilities where blood sugar levels are checked using unsanitary methods. Diabetics 60 and older may get vaccinated as well, but the panel recommended vaccines only for those under 60 because that is when immune systems respond best to vaccination.

For HPV, the committee voted 8 to 5, with one abstention, to approve a recommendation that males 13 to 21 be vaccinated, with those voting against the recommendation hoping to make the upper age limit 26. Vaccinating men ages 22 to 26 is expensive and is likely to provide relatively few health benefits.

“The bottom line is that not all kids start having sex when they’re 13. Mine didn’t, I promise you,” Dr. Sandra Adamson Fryhofer, a clinical associate professor of medicine at Emory University School of Medicine and a committee member, said to laughter from the audience.

Not only are the committee’s recommendations routinely used by private insurers to determine which vaccines to pay for, but the health reform legislation of 2010 requires insurers that participate in health exchanges to offer vaccines that are routinely recommended by the committee.

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