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Archive for April 8th, 2012|Daily archive page

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: http://repairstemcell.wordpress.com/2012/04/08/medical-board-gives-early-ok-to-adult-stem-cell-rules/
Background History: http://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: http://repairstemcell.wordpress.com/2012/04/08/medical-boards-proposed-stem-cell-policy-under-fire-part-2/
Background History: http://repairstemcell.wordpress.com/?s=perry

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