November 27, 2003
FDA Stands In The Way Of Promising Heart Stem Cell Therapy

The buttheads at the US Food and Drug Administration are standing in the way of rapid trials to test the efficacy of the use of blood stem cells to treat heart disease.

“After we went public, FDA told us not to conduct any similar procedures,” says Steven Timmis, the cardiologist at Beaumont who performed the bone marrow transplant. “We had also proposed a 100-patient randomized clinical trial, but FDA has denied this.”

The doctors did not seek FDA approval prior to the transplant because it was an emergency operation and they believed the procedure was allowed because the teen received injections of stem cells from his own blood. Transplants of bone marrow, the primary source of stem cells, have been performed routinely in the United States for more than 30 years.

The teenager first received a drug that increases the production of stem cells in the bone marrow. The stem cells are released into the bloodstream. The doctors then collected the cells from his circulating blood.

In 1999, researchers showed that bone marrow stem cells injected into mice with damaged heart muscle homed in to the damaged tissue and restored function. Since then, clinical trials in Britain, Germany, Hong Kong, China, and Brazil have shown that heart patients with heart disease who are injected with their own bone marrow stem cells improve significantly.

When people have heart disease that is going to kill them in a few months or a few years it is time for the government to butt out and let people choose what risks they want to take with their lives. This sort of report infuriates me. The FDA is insisting that the researchers spend a couple of years on animal trials when groups in other countries are charging ahead of US researchers and getting promising results.

The doctors working on this method at Beaumont Hospital in Royal Oak Michigan tried it out as an emergency treatment on a 16 year old kid named Dmitiri Bonneville who had nail gun nails puncture his heart in an accident. The kid would probably be dead by now and instead the emergency treatment worked and he's running around being a kid again. But the FDA doesn't like surprise trials of treatments with press conferences to announce the unexpected results. That sort of thing is not controlled by expert bureaucrats sitting in committees passing expert judgement and so we can't have that.

The FDA's jurisdiction is questionable since use of one's own tissues (homologous use) is supposed to be allowed without approval. So the FDA is claiming the pressure at which the catheter is injecting the cells is experimental.

In my very strongly held view anyone with a terminal illness should be free to try any experimental therapy that they can find a medical doctor to deliver. Will there be abuse? Sure. But do we own our own lives or not? Also, greater freedom to experiment will accelerate the rate of medical advance and more lives will be saved than will be lost by failed experimental therapies. Keep in mind that if the people allowed this exception are ones who have only a few years or months or weeks or days to live they may feel the gamble is worth it. Who are government bureaucrats to make a value judgement about such a decision?

Update: Some other blogs are linking to this item and the comments made on those blogs indicate that there seems to be some misunderstanding about why the FDA is taking the position they are taking toward the Michigan researchers. The FDA's position has nothing to do with the controversy over human embryonic stem cells. The stem cells used by the Michigan researchers are not embryonic and there is no substantial religious opposition to the use of non-embryonic stem cells. To those misinterpreters: Back off on the intense reflexive unthinking irrational partisanship. This is not a story about ethical objections to a promising medical treatment. The FDA is not following the instructions of the Bush White House on this question. This is just the FDA acting the way it normally acts under both Democratic and Republican administrations. If you don't like it then you ought to tell your Congressional representative that the FDA has too much power to prevent terminally ill people from trying experimental therapies..

Share |      Randall Parker, 2003 November 27 03:30 PM  Biotech Organ Replacement


Comments
Fly said at November 27, 2003 4:56 PM:

I believe the FDA is often too cautious. An individual and their doctor should be able to take responsibly for their treatment with little hindrance from the FDA. The US tort system will restrain doctors from abusing their responsibility.

Having said this, I’d like to argue for the other side on this issue…

http://www.usatoday.com/tech/news/2003-11-26-stem-cell-death_x.htm

It is not clear from this article that the stem cell treatment had anything to do with the boy’s death. Treating desperately ill patients could lead to many sad outcomes that have little to do with the stem cell treatment. Without close monitoring and supervision a flurry of bad results could taint this field.

There is worldwide race to develop new stem cell cures using humans as test subjects. (Desire for fame combined with a sincere desire to help desperate patients?) Humans don’t make good mice. Can’t try many treatment variations. Can’t cut ‘em up. Hard to determine long term effects. They are expensive. Their relatives tend to complain and sue when the outcome is disappointing. Given the close biological similarity between mice and men it seems reasonable to develop a therapy in mice before applying it to humans.

If a few doctors report success using stem cells to repair heart disease, many patients may demand a treatment that hasn’t been explored in mice. Negative outcomes could taint the field and ultimately hinder the funding and acceptance of a powerful new medical technology.

PS What are the potential dangers of stem cell therapy?

Zack Lynch said at November 28, 2003 9:16 AM:

The FDA holds itself as a gold standard among the national health regulatory agencies. It's an intelligent organization that will adapt to changes that come from the outside though. It's a global economy and those governments that support proactive health developments will attract capital that will ultimately force the FDA to play catch. This won't occur for another 5-10 years however. Information from new biochips is still just trickling in and system's biology supported by biosimulation is just getting moving in other countries to the level that they will be able to support a less restrictive new health guidelines. Look to Singapore and India to move quickly here to gain competitive advantage.

Barbara Finney said at January 27, 2005 7:58 AM:

The FDA is a corrupt body that is and has been a menace to healthcare. They should be shut down. There job was supposed to be to protect the public from dangerous drugs, bad food, that sort of thing, but instead there are constant problems with food. And as for drugs, what a joke, my mother died from sevearal of their "approved" drugs as did my father many decades ago. Drugs kill, but the FDA pushed the worthless crap on people while always denying and cutting down safer alternatives or new innovative methods that could save and restore countless lives. My mother-in-law is now dying of severe heart failure as a secondary complication of thyroid problems. She has like a 10% ejection factor. SHe will likely die soon if she can't get some procedure like the bone marrow cell injections. The FDA SUCKS!!! They should be dragged into the streets and flogged as we did in days of old to persons who brought harm to others throught their stupidity.

Antonio Silva said at November 5, 2006 10:12 AM:

Reply to Barbara Finney:

It may be too late, but look up VesCell.com

They have already treated about 150 people with adult stem cells in Asia, and, according to data released at the American Heart Association, are running about 75% successful.

One great thing about them is that they have a large number of "Patient Volunteers" who will talk to anyone about their own experience with VesCell.

Jules said at April 18, 2009 12:34 PM:

The FDA is incorrect in their classification of adult stem cells as drugs. A patient's own stem cells are their and NOT the jurisdiction of a federal agency. Adult stem cell therapy has already demonstrated to be successful in a variety of applications. By restricting adult stem cell therapy, the FDA will cause thousands of patients to suffer needlessly.

If you are a patient who believes your own stem cells are yours and do not constitute a drug subject to regulation by the FDA, please join the Safe Stem Cells Now movement: www.safestemcells.org

If you are a medical provider who opposes regulation of a patients of stem cells please join The American Stem Cell Therapy Association (ASCTA) at: www.stemcelldocs.org

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