A New Treatment for Prostate Cancer that the FDA won’t Approve
Posted by kandylini on May 18, 2008
Source: Erin Colgan, Live 5 News.
Eight months ago 67 Year old Gary Tauscher flew with his wife to Puerto Vallarta, but it wasn’t for the sunny beaches. Tauscher was getting treated for Prostate cancer.
“When cancer happens to you, you really take a deep breath and you think of all the implications that go with that.”
Implications like suffering from incontinence or impotence, a common side effect of radiation. But months later Tauscher a retired pharmacist is cancer free with none of those symptoms. Tauscher’s treatment? A non FDA approved procedure he learned about on the internet called HIFU. It’s short for high intensity focused ultrasound. Because it’s not approved patients must leave the country just to have it done.
One of the most experienced urologists with this treatment is Dr. Stephen Scionti on Hilton Head Island.
“Virtually every other developed country in the world has access to technology built right here at home in the US,” Scionti said.
According to Scionti what sets this cancer treatment apart is that it kills the cancer without taking away a man’s quality of life.
“For men the very thought of having to be in a pad or a diaper or giving up our sex life is scary,” Scionti said.
HIFU requires no actual surgery. A medical device is inserted through the rectum where it then takes ultrasound pictures of the prostate. Once the cancer is identified these highly focused ultrasound rays heat the tissue killing both it and the cancer. However the surrounding tissue remains in tact.
“It’s like a smart bomb that’s very precise and that avoids collateral damage,” Scionti said.
In Europe patients studied over the past 10 years have shown remarkable results with HIFU.
But regardless there are still hundreds of doctors here in the U.S. who remain skeptical.
“Many times we’ll only look at data that comes from the US,” Scionti said.
That data is coming. The FDA is performing clinical trials, but any move to approve HIFU is still at least 5 years away. Until then men like Gary will have to foot the bill and travel overseas for this controversial treatment.
On average patients pay about 25 thousand for the treatment because insurance won’t cover it. But if this treatment is approved it could one day save insurance companies millions compared to radiation.
As for FDA approval, HIFU is the only prostate cancer treatment that has been required to undergo testing and gain this approval.
HIFU said
Currently its in Stage III clinical trials in the US. My gut feeling is the approval will be 4-5 years away.
Ron said
I also had HIFU by Dr. S. Scionti. He is the best! I tell everyone I meet about him (the most experienced HIFU doc outside Europe)& my picture perfect procedure & outcome.
My local urologist wouldn’t tell me about the clinical trials in my hometown for HIFU, then I found out they only have 3 people in them. The FDA is negligent. It’s a crime.
Jim Wright said
So why does the FDA force men in this country to have radiation treatments for prostate cancer when they know insurance companies won’t pay for HIFU? The only logical reason the FDA has not approved HIFU after all these years of positive results in the rest of the worlds is because somebody is making $billions in this country using radiation. For example, my brother’s prostate radiation treatments alone last year cost over $40,000.