FDA Blocks Life-Saving Cancer Drug Rally

fullofbeans · 02-09-2012, 02:29 PM

Phil,

What regulations would like to campaign for exactly?

PS: petition signed.

fullofbeans · 02-09-2012, 04:17 PM

Being the devil's advocat: Another example that may be used although I do think that Tdm1 has much more proof..

..should there be new regulation for people that have exhausted standard therapy..or say third line therapy..

http://en.wikipedia.org/wiki/Gemtuzumab_ozogamicin

Gemtuzumab ozogamicin (marketed by Wyeth as Mylotarg) is a drug-linked monoclonal antibody that was used to treat acute myelogenous leukemia from 2000-2010. It was withdrawn from market in June 2010 when a clinical trial showed the drug increased patient death and added no benefit over conventional cancer therapies.

Gemtuzumab is a monoclonal antibody to CD33 linked to a cytotoxic agent from the class of calicheamicins. CD33 is expressed in most leukemic blast cells but also in normal hematopoietic cells, the intensity diminishing with maturation of stem cells. In the United States, it was approved under an accelerated-approval process by the FDA in 2000 for use in patients over the age of 60 with relapsed acute myelogenous leukemia (AML); or those who are not considered candidates for standard chemotherapy.[1]

phil · 02-12-2012, 06:51 PM

My primary focus roght now is to get t dm-1 approved. It would be " nice " if Genentechs top execs would give compassionate use to Stage IV Her2 pts in the meantime. They know what a powerful drug they have.
Then we can focus on changing The Crooked System. get rid of Dr. Pazdur and his top advisers. They are blind scientitists. So invested in being " scientiific " that they are " un-scientific ", so " rational " that they are " irrational ". T DM-1 will be their stumbling block. Science is known for its blunders as much as its successes.
I havent fully thought out systemic changes, but I would start w/ giving Stage IV pts Flexibility, expanded access at all Phase of testing , especialy Phase III , 14 day wash-outs to get in, flexible tx planning while your in the access program. , give extra time for counts to rebound, lower or raise doses , etc. Do your rigid trial testing with earler Stage pts., . Sign Informed Choice Consents. Take away some of This FDA's power to decide For Us " Benefits vs. Risks '. We Decide !
Then I would focus on this Racket called " Single Pt. Access, or so-called " compassionate use ". Right now its a Con, a Cop-out by This FDA. They wont talk w/ Pts, tell us " Have your doc contact the pharm. co, if the co. says ok, have them contact us ". Putting us at the mercy of Global For-Profit Companies ! And docs who are conservative by training, reluctant to take risks, relutant to challenge Big Pharma, or This FDA . They'll be black-listed from trials. Comp. use is a Fraud !
So, I say change the law, get an FDA that advocates for US, The People ! You will talk to us, and if we are Stage IV , you will approach the Global Mega Corporations for us !
As far as drugs like this G... whatever, I dont know what the pt. death rate was, I do know what the death rate for CML was not so many yrs ago, 100% or close to it ! many drugs have saved lives through accelerated approval, some have not worked. I go with what Lorraine said at the Rally " Give Us a Chance ", an informed chance !