Texas Approves New Stem Cell Rules

Daily News Article   —   Posted on April 19, 2012

(by Nathan Koppel, The Wall Street Journal, WSJ.com) –  [The Texas Medical Board on Friday approved new rules on experimental stem cell therapies] that would make it easier for doctors to offer experimental treatments using adult stem cells without federal approval [which requiries patients to give their consent and a federal review board to approve the procedure before using adult stem cells.]

The Texas Medical Board, which licenses and disciplines doctors in the state, recently drafted stem-cell rules at the behest of Dr. Stanley Jones of Houston, who in July injected Gov. Rick Perry with the governor’s own stem cells to try to aid his recovery from a back injury.

The governor, who appoints all the members of the Medical Board, has encouraged the agency to create rules governing adult stem-cell treatments, which involve removing a patient’s stem cells and reinserting them in the hopes of aiding muscle, nerve or blood cells damaged by such conditions as cancer, osteoarthritis or multiple sclerosis.

“It is my hope that Texas will become the world’s leader in the research and use of adult stem cells,” Mr. Perry wrote in a July letter to the president of the Texas Medical Board.

But critics say the proposed rules give doctors too much leeway to perform stem-cell procedures that haven’t been proved safe or effective.

“The guidelines are skewed to favor business interests instead of patient safety,” said Leigh Turner, a bioethics professor at the University of Minnesota. Many adult stem-cell procedures, he said, are experimental and can give rise to blood clots and other complications.

The procedures in question are different from embryonic stem-cell research, which some religious and political groups [Conservatives and many Republicans] oppose on the grounds that it…destroys human embryos [human lives].

But adult stem-cell procedures also have been controversial. Some, such as bone-marrow transplants, have a proven track record, but physicians increasingly seek to offer more innovative treatments that can cost thousands of dollars.

One obstacle to doctors has been the Food and Drug Administration [FDA], which requires physicians to seek the agency’s approval before offering experimental, adult stem-cell treatments. Doctors complain the FDA approval process can be costly and time-consuming.

The FDA said in a statement it doesn’t comment on state regulations or proposed regulations. “Our position on stem cells remains the same. The FDA has regulatory authority over human cells, tissues and/or cellular and tissue-based products.”

The [new] Texas rules would allow doctors to bypass the FDA so long as they satisfy other conditions before offering certain experimental adult stem-cell treatments, including obtaining patient consent and securing approval from an…independent review board, a committee that monitors medical research and is often affiliated with a hospital or university.

But such boards are a poor substitute for FDA oversight, according to some scientists who say the boards have varying standards and levels of expertise.

Some “might be more strict than others,” said Bettie Sue Masters, a chemistry professor at the University of Texas Health Science Center in San Antonio. Boards might be strong-armed by the physicians who are paying the boards’ fees, she added.

Lucy Nashed, a spokeswoman for Mr. Perry, said he has left it to the Texas Medical Board to devise the proper regulatory framework. “The governor believes that Texas has the potential with this kind of technology to find treatments for cancer and other diseases,” she said. The board has the authority to enact the rules itself.

Irvin Zeitler Jr., Texas Medical Board president, said the agency wrote the rules in part because the FDA doesn’t have clear regulatory authority over adult stem-cell treatments. “The board has no intent to circumvent federal law,” he said. Independent boards, he added, can provide effective oversight.

Supporters say the new rules would give doctors and patients more autonomy. “These rules will make accessible emerging technologies that are proving to be safe and effective,” said Dr. David Harris of Austin, who specializes in sports injuries.

[The board said it will establish a registry to track the outcomes of each stem cell treatment performed on a patient. Details of that have not yet been worked out.

No date was set for the new Texas policy to take effect, but it will be at least 30 days, staffers said.   FDA approval for the national use of adult stem cells is thought to be five to ten years away.]

[NOTE: This article was published at wsj.com on April 12, 2012.]

Copyright 2012 Dow Jones & Company, Inc. All Rights Reserved. Reprinted here for educational purposes only. Visit the website at wsj.com.