HIFU Article

Here's a link to a good article on HIFU in the Miami Herald.

If posting links is against the rules, I apologize and admins, please delete.

http://www.miamiherald.com/living/health-fitness/article68452672.html

It is my understanding that the FDA granted approval to HIFU for "prostate tissue ablation". It is NOT approved for treatment of PCa. Sonacare, the company named in that article, and which George Suarez has significant monies tied to it, failed miserably last year to get approval, smacked down by the FDA panel because of poor data and failure to follow the proper guidelines for submission.
Thus, if I am correct, it is misleading for any practitioner to advertise or suggest that HIFU is approved to treat prostate cancer. Such approval is a much larger hurdle to clear in order to be approved. The data they submitted failed to show the panel HIFU was any better, more successful, or demonstrated similiar or less complications than current approved treatment modalities.
One would also be wise to be cautious when seeking advice from a physician so closely tied to the company whose products he is undoubtedly going to be handsomely rewarded for using.

JimmyDukes said...
The data they submitted failed to show the panel HIFU was any better, more successful, or demonstrated similiar or less complications than current approved treatment modalities.

All that is true, but one of the arguments that was made to the FDA is that neither surgery nor radiation, which can be considered ancient and grandfathered treatments for PCa, ever had to prove their effectiveness in the protocols that the HIFU manufacturers were being subject to. So, to acknowledge that hurdle, the approval was of HIFU being a surgical instrument, analogous to a knife. A knife is dependent on the skill of the surgeon. HIFU is now allowed to have the same playing field.

Not saying that I am a HIFU advocate, but they never would have received any clearance, given the original burden placed on them.

My surgeon stated that HIFU was an option. He routinely makes trips to Mexico to perform the procedure. But he never directly recommend it. In fact he would never commit or suggest any procedure over the other, including radiation. I ended up using him for surgery because of his experience, over 700 RP's, and I liked his personality, (not a good reason, but I needed it). However, it was interesting that when I went to MD Anderson for my second interviews, I was told very firmly that HIFU would be a BAD decision and should NOT be considered as an option in my situation. I'm still a bit disturbed that my surgeon would even discuss an option that is so clearly not appropriate me. Could it be the $30K vs. the $3.5K from BCBS?