AUSTIN,
Texas (AP)—The Texas Medical Board on Friday approved new rules on
experimental stem cell therapies such as the one Gov. Rick Perry
underwent during back surgery last year, despite objections they don’t
do enough to protect patients and could led to an explosion of doctors
promoting unproven, expensive treatments.
The
rules require patients to give their consent, and a review board must
approve the procedure before doctors use stem cell treatments.
Supporters
say establishing formal rules will lead to more medical innovation by
opening doors for researchers in Texas. At the same time, board members
acknowledged they don’t know how many doctors are already performing
stem cell procedures, and several who voted in favor said the rules
provide the first layers of patient protection.
“We’re trying to be safe. It’s the wild, wild west right now,” said Dr. Scott Holliday, an anesthesiologist from Arlington.
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 possible benefits of stem cell treatments, including
treatment for heart disease, diabetes and some cancers. Others argue
adult stem cell experimentation actually increases the risk of cancer
and can cause blood clots.
Perry,
who appointed the board, had stem cells taken from the fat in his own
body that were then grown in a lab. They were injected into his back and
his bloodstream during an operation to fuse part of his spine.
Celltex
Therapeutics Corp. of Houston, which is co-owned by Dr. Stanley Jones,
Perry’s friend who performed his operation, supported the rule approved
Friday.
Nathan
Kottcamp, a Celltex attorney, testified before the board and dismissed
predictions of an explosion of new stem cell labs promoting therapies.
Harvesting stem cells is a complex, expensive process that cost patients
up to $35,000, Kottcamp said.
Texas doctors using stem cell treatments are ethical and trying to help their patients, Kottcamp said.
“Critics seem to believe stem cell theories are little better than snake oil,” he lamented.
Jones
appeared before the board last year to tout stem cell therapies and
said thousands of Americans are going to other countries for treatments.
Texans should be able to get care in their home state, he said.
Supporters
of the rules said requiring treatments to be approved by review boards
is a critical step in favor of patient safety. Boards could be attached
to medical schools or hospitals, or be accredited, independent
for-profit review boards.
But
Leigh Turner, an associate professor at the University of Minnesota’s
Center for Bioethics & School of Public Health who has complained to
federal regulators about Celltex, warned that doctors will be able to
“shop around” for a for-profit review board that will give them a
favorable ruling.
“(Review board) is not necessarily high-quality review,” Turner said.
Texas
joins at least 10 other states, including California, Illinois and New
York, who have enacted rules governing stem cell research.
Board
member Dr. W. Roy Smythe, a surgeon from Temple, voted against the
rules, saying they do too little to protect patients or rein in doctors
touting unproven treatments.
“This
doesn’t put the cat in the bag. It allows more cats to proliferate,”
Smythe said. “I believe in giving patients hope. I’m against giving
false hope that empties patient’s bank accounts.”
Source: The Associated Press
