Lifesaving Stem Cell Procedure Halted by US Agency, the FDA

Better Humans.com ^ | 06.18.03

[Coleus]

Lifesaving Stem Cell Procedure Halted by US Agency

Dwayne Hunter

Betterhumans Staff

Wednesday, June 18, 2003, 11:25:09 AM CT

A promising stem cell treatment has successfully repaired the severely damaged heart of a US teenager, but a government agency has told doctors to stop performing it.

In February of this year, 16-year-old Dimitri Bonnville of Almont, Michigan was shot in the heart by a nail gun while working on a construction site.

Bonnville suffered a massive heart attack that destroyed about one-third of his muscle cells when doctors from Beaumont hospital removed a three-inch-long nail from his heart.

Doctors quickly determined that the teenager's condition would worsen and that he would likely need a heart transplant eventually.

However, based on lab studies showing that stem cells from blood help to repair damaged hearts and that stem cells from bone marrow improve heart function, doctors performed an experimental procedure by harvesting stem cells from Bonnville's blood and infusing them via catheter to damaged portions of his heart.

As hoped, the transplanted cells regenerated Bonnville's damaged heart and stimulated new blood vessel growth rapidly, giving hope to about 400 other patients eager to try the experiment.

Recent tests show that Bonnville's heart ejection fraction -- a measurement of how much blood is pumped out the heart's main pumping chamber -- is at 40%, compared to 25% following his injury. Normal ejection fraction is 50% to 75%.

"Dimitri has made significant improvement," says Beaumont cardiologist Cindy Grines, who helped develop the protocol for his treatment. "Most patients who have a massive heart attack like Dimitri's would be headed toward congestive heart failure or a heart transplant. Dimitri is playing sports with his friends and becoming more physically active each day."

Must wait for more experiments

Despite the procedure's success, however, the US Food and Drug Administration contacted the hospital 24 hours after it was conducted and ordered doctors not to repeat it until extensive animal experiments and human trials were performed, at which time it would be considered for FDA approval.

Initially, Beaumont doctors didn't feel that FDA approval was necessary because bone marrow transplants are commonly used to treat cancer patients.

But even though many patients are lined up to take a risk with the experimental treatment, the law and regulations in the US prevent them from receiving the treatment.

The procedure is being conducted, however, in some countries in Europe and South America, and results from these countries will be combined with animal and human trials in others for review.

[Coleus]

Stem Cells Heal a Broken Heart
http://www.freerepublic.com/focus/f-news/865104/posts

Please Contact President Bush, your federal legislators and the F'nDA (As Dr. Atkins would Call them many times on his radio show) FDA and request that Doctors can resume this life-saving procedure using ADULT stem cells.

http://www.whitehouse.gov/contact/

http://www.fda.gov/comments.html

http://www.congress.org/congressorg/home/

[Coleus]

`

[TBall]

The FDA approval process must be very madding for both researchers and patients. It has been a long fight for Imclone, but it looks like Eribtux will get a chance in the European markets.

[DoughtyOne]

I see absolutely no reason for the FDA to step in here. This is not a surgical proceedure or an unproven medication.

This is the patient's own tissue, albeit infused in a different area of his body. There are no rejection issues. There are no contraindications based on medication properties. There is no surgical proceedure conducted on the heart.

What gives?

[MHGinTN]

Despite the procedure's success, however, the US Food and Drug Administration contacted the hospital 24 hours after it was conducted and ordered doctors not to repeat it until extensive animal experiments and human trials were performed, at which time it would be considered for FDA approval.

Yet there are those insisting that human embryos be conceived, killed, and harevsted for stem cells, before the animal studies are done ... and I don't hear the FDA speaking out on those exploitations!

[BlazingArizona]

see absolutely no reason for the FDA to step in here. This is not a surgical proceedure or an unproven medication.

Time we saved some federal budget by eliminating the FDA, and its coercive powers, completely.

Let insurance companies set up their own testing operation, modeled after Underwriters' Laboratories, for medicines.

[jwalsh07]

Yet there are those insisting that human embryos be conceived, killed, and harevsted for stem cells, before the animal studies are done ... and I don't hear the FDA speaking out on those exploitations!

Excellent riposte Marvin.

[Coleus]

I see absolutely no reason for the FDA to step in here. This is not a surgical proceedure or an unproven medication. >>>

They've been doing this procedure for many yrs. for cancer patients with no problems so why the fuss now? Power and money and big government.

The FDA loves to exert themselves when there is a success in healing someone without costing a tremendous amount of money. Drs. Atkins http://www.atkinscenter.com and Burzynski http://www.cancermed.com/ found that out many yrs. ago when the FDA tried to close him down.

[MHGinTN]

Some physician competing with the ones who successfully treated Dimitri probably complained to FDA to prevent the competition from getting ahead of them. It happens more than folks would like to know! It's not ethics at work, it's greed at work, blowing a whistle the FDA hasn't the foggiest notion how to control.

[Cicero]

The FDA is a typical bureaucracy, rushing through things that should never be approve and obstructing things that should be approved. What else can you expect? The primary purpose of a government bureaucrat is to cover his ass, increase his rank, and get more subordinates. Doing his job is way down the list.

[DoughtyOne]

Original post
Despite the procedure's success, however, the US Food and Drug Administration contacted the hospital 24 hours after it was conducted and ordered
doctors not to repeat it until extensive animal experiments and human trials were performed, at which time it would be considered for FDA approval.

MHGinTN
Yet there are those insisting that human embryos be conceived, killed, and harevsted for stem cells, before the animal studies are done ... and I don't hear the FDA
speaking out on those exploitations!

It might be a much better response on your part if you could point to one person or instance where any agency had advocated this approach on this issue.  But don't let that stop you for trolling the boards looking for a conflict.

[Coleus]

Yet there are those insisting that human embryos be conceived, killed, and harevsted for stem cells, before the animal studies are done ... and I don't hear the FDA speaking out on those exploitations!>>>

Great Point, something is wrong with our Government.

[DoughtyOne]

I agree with your first comments and don't know much about the second topic.

[TBall]

When I refresh this thread, I see a lower case r next to the report abuse option under my post. Does that mean anything?

[MHGinTN]

I'll ignore your jibe (a little nettle is no nuisance) to reply, it was the FDA and NIH that tried to get Bush to allow Federal funding for ESCR. The President allowed funding for research using the already established cell lines, banning funding for any new conceive and kill programs.

[DoughtyOne]

I knew that but thanks.

[Coleus]

They are alternative medicine practitioners who have been victims of massive FDA enforcement and won each case. Dr. B has the highest cure rate of Brain Cancer in Children in the world and the F'nDA tried to close him down! What saved him was the Constitution (trial by jury) and his testimonials of all the kids he saved and their parents at the trial. The FDA tried to pull a fast one and tried to have the case settled by an administrative law court.

[DoughtyOne]

If it makes any difference to you, I don't see the small case 'r' on my screen.

[Coleus]

I see a capital "R" (Report) below the 2nd "l" in your name. I wouldn't worry about it.

[DoughtyOne]

There are definately instances where the FDA has abused it's authority, even if you don't get into the rhelm of illegal drugs. I just wish there was a way to go after the people in the agency that try to do end runs around the system, as you mentioned with the administrative law court. That's just an end run on the constitution as far as I am concerned, and is every bit as big an offense as denying a minority their constitutional rights, something that wouldn't be tollerated for a moment.