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ONYX Pharmaceuticals, AŞ Message Board

  • thegreycorner thegreycorner Jul 24, 2012 12:54 PM Flag

    I am calling BS on FDA approval

    Please note that trial design did not compare drug to anything - placebo or anything else.

    Please note that no QOL was shown - no survival or anything else.

    Please note that partial tumor reduction in 23% of patients doesn't necessarily translate to anything meaningful.

    Please note that FDA approval process is bogus and that is a societal problem. The combination of medical science and Wall Street smells bad and that is why I am calling it out as BS.

    Thank you.

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    • Carfilzomib is a salvage therapy for patients who've failed current standard of care and have nothing else to take. Subjecting them to a placebo control arm would be unethical. Moreover, the fact that carfilz has anti-cancer effects in patients refractory to other treatments is demonstration enough of efficacy and important clinical utility.

    • grey,

      Your beef on this board should be based on the ONXX trial. You have made many suspect statements about it here, such as your "only shrinks tumors a little bit comment", when the ORR is based on a 30% tumor shrinkage or greater. Approval of drugs based on uncontrolled trials are extremely rare, but your continuing screed makes it seem as if it is common place and SOP for the FDA. It isn't but rather it is quite rare. The FDA made the rules, and ONXX met the standards set out in those rules. Deal with it.

      You brought up the issue of finances affecting decisions. The decisions giving approval to Carfilzomib was made by the the FDA advisory board, and the FDA review board. If there was financial considerations that influenced the decisions, then you could have only meant the FDA. You claim to have suffered no negative financial consequences based on the Carfilzomib approval. Me thinks thou dost protest too much!

      Your concerns about patients dying on the Carfilzomib trial shows you don't understand how sick the patients were, and how limited their options were. The Carfilzomib study is going to be published so why not give it a read and then comment, rather than continuing your anti-FDA tirades.

    • Vin -

      I have no particular beef with ONXX - it is the overall 'early approval' process that I object to and that is why I call it out as BS.

      I did not say that the FDA makes their decisions based on finance (although you may find this article interesting ) -- but rather I was discussing the Advisory process. It is my opinion that human nature is such that it is greatly influenced by situations like the Advisory Panel process. Here you have people within an industry who have every career incentive to vote 'Yes' but very little incentive to vote 'No'.

      Re: the efficacy. I have seen many trials in which the ORR was met but ultimately that did not lead to ANYTHING of significance. My complaint is that the general public would never know ths. In other words, if you tell the patient that this drug has been FDA-approved for cancer then of course they will believe that there will be some real benefit. If you tell them that there is a 23% chance that their tumors will decrease by 30% they will naturally ask, "well, big deal, does that mean I will live longer or feel better?". They would be amazed to discover that this is not considered in the approval process. And furthermore, there might be a chance that they could die SOONER than without the drug -- again, this has not been tested.

      To say that other drugs have been approved in this way seems to be similar to allow bad legal decisions to be made simply because there is the cover of 'legal precedence'. Yes, that's how the court system works but that does not mean that a given decision is not necessarily BS.

      My beef has nothing to do with ONXX but the entire system. The clinical trials are far from rigorous and I believe that the desperate public is mislead by these drugs given FDA approval.

    • Desperation after shorts get burned really makes me laugh. Thanks. Keep posting as we all enjoy a laugh at your expense. It is clear you don't have a clue about the FDA, about Kyprolis, or how efficacious it is

      • 1 Reply to dr.vinmantoo
      • I'm glad that you are happy to laugh at me and to ascribe positions to me that I do not have. I do not own this stock and I have no intention of shorting it.

        I am simply pointing out the basic flaw of approving a drug before any meaningful testing is done. Any grade school student would easily understand this problem but you seem to have trouble grasping the concept.

        I do in fact understand the perverse way that the FDA works. However, you are right about one thing. I do not have any idea about the alleged efficacy of the drug. It is my contention that none of us can possibly have any idea about the efficacy of the drug because the trial did not attempt to determine any meaningful efficacy.

        I do not like misleading cancer patients by giving themm an FDA-approved medicine when nobody really knows if it does anything useful (other than sometimes reduce tumors a little bit). But it is good that you are able to laugh at this. To me, your laughter is false and you are in fact part of the problem.

    • It just ain't fair either.