Still, I wonder what the problem with KLH is because it's relatively non-toxic, as with other things going on in Europe: Synergo, EMDA and Hexvix, 3 more relatively non-toxic tx and dx alternatives. We also use more radiation and brachytherapy for blc than the USA does, with good results.
While in the US, chemos are given rather indiscriminately much of the time, Germany offers many alternative tx's that are covered by insurance, but I don't know much about alternatives in Germany aside from KLH for blc.
One thing the FDA is quite generous with granting approval with is chemo drugs, while chemo-sensitivity testing assays have never been in mainstream use. I had my breast tumor tested in '99 for chemo-sensitivity/, sent it to England as the tests were not available in the Netherlands (maybe that's changed)
I noticed that a chemo has just been FDA approved for intravesical Ta/T1 blc, after it had been taken off the market due to impurities. The question was how it ever got approved in the first place given the bad response rates, below 20%. Valstar, it's a form of doxorubicin. Indicated for use with CIS after BCG fails, as a bladder sparing protocol.
Doxorubicin/Adriamycin has been the first line chemo for breast cancer for many years. Recently it was learned that only 8% of women will ever respond to it, yet it has been the most popular treatment for 15 yrs or so? Boy, I'm glad I refused it when my chemosensitivity assay said I was not responsive to it! My sister's breast cancer did not respond to doxorubicin in huge, high dose chemo trials (which BTW were never popular in Europe).
I have a high regard for the EORTC's guidelines and innovations as well as for the NCI's. I only wish chemo-sensitivity testing would become more popular, everywhere.
For those who want a reference about that breast cancer stat:
"Only 8% of breast cancer patients have the genetic makeup [over-expressed Toppol-2] that make them responsive to the drug [adriamycin/doxorubicin-a very toxic chemo]."(Dr. Dennis Slamon, chief of oncology at UCLA, at a ASCO closed meeting, June 2007, Chicago)
Really...who are these top uro's?
Also having been in the pharmaceutical industry myself and my father who was a PharmMD and head of a large division of a major pharmaceutical giant ..growing up all i ever heard was how the FDA drags their feet...its not a conspiracy.....there are not enough FDA agents out there....our restrictions for testing are extremely complex and its a complaint of the pharmaceutical industry as well as the consumer or the doctors. And i won't even go into the millions spent on research because you need to blame someone and what i say ain't goina make a difference.......Pat
I don't know if there is conspiracy or not. However the doctor who recomended this medicine to my father believes there is. This doctor is a highly regarded american urologist.According to the doctor this medicine will not be aproved any time soon.
The FDA will drag it's feet as long as it can. I know this might sound wild, but considering who said it... I thought that I will get a lot of" thank you "
e-mails or postings for the information I have posted. Instead I got something else.
I understand, people are sceptical, they don't know me etc.That's why I am posting this last piece.Top urologists in the USA recomend to their family members to go to Europe to get treated with this medicine, Hello-oo.
About the FDA not approving this treatment in the USA, I think it's probably more a problem of having enough data from clinical trials, and not necessarily corruption. I'm not a big believer in any conspiracy keeping effective treatments from the market.
Maybe patients advocating for this treatment would help make it more available. We should start asking why it's not.
My father gets treatment in Bulgaria because is much cheaper to live there than in Western Europe. The medicine did not cost him much. I think about 2500Euros.He paid cash. However the farmaceutical company might increase the price in the future.Germany has one of the strictest requiriments for aproving medicines in Europe. I understand they are going to aprove it very soon, the process is in the last stage.Most of the information that I was refering to is on german language sites. The studies and all.Why The FDA did not approve this medicine yet is beyond me. It doesn't look like it will be aproved in the near future.I think FDA is either too bureaucratic or is corrupted by BIg Farma to keep the status quo.