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|