Replies to post #40010 on Ariad Pharmaceuticals Inc fka ARIA

[grandma_of_jbraika]

jq1234 & iandy, if the FDA hadn't changed AE definition, there wouldn't have been the enormous gulf between the 2 SAE rates (the doctors' 4% vs. the FDA's 24%). The Oct. 9 CC transcripts may also help people find clues and figure it out.

I have reported Fraud to the Office of Inspector General, US Dept. of Health & Human Services. Do you think I am patently silly as Dew thinks??

Following are the contents of what I reported to HHS OIG:
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Please inquire into an evolving situation regarding Ariad Pharmaceuticals, a Biotech company based in Cambridge, MA, and the FDA. The FDA forced Ariad to ‘voluntarily’ withdraw Iclusig, a life-saving drug, due to SAE's.

Are all the SAE's (Serious Adverse Events) drug-related? It seems that the clinical trial doctors differentiate the Iclusig-related SAE's from the ones that are not Iclusig-related while the FDA count all the AE's as Iclusig-related SAE's, which is probably the root cause of the enormous gulf between the 2 heart SAE rates (the doctors' 4% vs. the FDA's 24%).

Whose methodology is more scientific, the doctors' or the FDA officials'? Who treat and examine the patients physically? Who know about the safety/toxicity of Iclusig better, the doctors or the FDA officials?

The 2-Year FACE Trial Follow-Up of the Ariad drug by 25 doctors from many countries concludes that "Pancreatitis was the most common DRUG-RELATED serious AE (5%); it occurred early and was primarily managed with dose modification, 1 pt discontinued. Serious cardiovascular, cerebrovascular, and peripheral vascular AEs occurred in 6%, 3%, and 2% of pts (DRUG-RELATED: 2%, 1%, 1%)."

Link: https://ash.confex.com/ash/2013/webprogram/Paper59380.html
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Doctors and patients across the country obviously disagree with the FDA as 23 leukemia specialists and 3 patient advocacy groups immediately sent the FDA a letter saying they were concerned right after the FDA withdrew the life-saving drug Iclusig.

“Without this medication, they won’t have long to live. My patients are panicked. I have patients right now who are benefiting from this medication with very few side effects.” said Dr. Brian Druker, the director of the Knight Cancer Institute at Oregon Health and Science University.

“What we don’t want to have happen is for a good drug, ponatinib, to be killed and not given to patients,” said Dr. Javid Moslehi, a co-director of the cardio-oncology program at the Dana-Farber Cancer Institute and Brigham and Women’s Hospital in Boston.

Link: http://www.nytimes.com/2013/11/02/health/doctors-fear-losing-leukemia-drug-deemed-risky.html?pagewanted=1&_r=4&partner=rssnyt&emc=rss&adxnnlx=1384675370-qFR2pICcxyo2PSRUr7j9Pw