Phil, here are some recent excerpts plus link to opinions on FDA controversial MBC drug rulings.
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Steven Walker on October 18, 2011 5:33 AM writes...
T-DM1 did not just get dusted off. It has been in human clinical testing for a quite a while, many experts think it is already proven to be better than herceptin alone, and FDA (meaning Dr. Pazdur) refused last year to agree to an Accelerated Approval pathway, which imposed at least a 2 year delay (nd probably longer) on its availability to women with Her-2 positive breast cancer. That action by FDA was part of the same ill-considered campaign by Pazdur to eliminate Accelerated Approval. I am often perplexed by the tendency among some to automatically think that everything happening in the cancer space is about nothing but greed. Our system is far from perfect on all sides of the process, but virtually all the drugs we have that actually do effectively treat cancer arrive as the result of major efforts by drug companies, regardless of whether they were originally conceived by the drug companies or others. Women with breast cancer need drugs like T-DM1 - which does not contain Taxotere and is much less toxic. The new results are from a trial that compared treatment with T-DM1 to treatment with a combination of Herceptin and Taxotere. T-DM1 - which is much less toxic, proved to be far more effective.
Why doesn't anyone on this blog ever seem to consider the undeniable fact that sometimes (actually fairly often) the FDA is screwing up by delaying or sometimes even denying, availability of new (and old) drugs that work to patients who need them. It happens a lot more than you might think. Do some real research on what has been happening with T-DM1 and you might find yourself wondering why this drug isn't already approved by the FDA.
Incidentally, the "shelved" drug referred to in the article isn't shelved at all. Taxotere is still very much approved, still used and still quite toxic. It is exactly the kind of drug researchers and Roche are trying to improve on, and Genentech/Roche developed a combination of Herceptin and DM1 to try to do that. T-DM1 is a good drugm, a fact now known for several years from well-run clinical trials. FDA has been sitting on it, requirirng more data and refusing to fast track it - which by the way drives up the development costs by hundreds of millions of dollars - which in turn drives up the cost of the drug after approval. Please check your facts. You are simply wrong on this one. Genentech/Roche are not the problem here. The FDA (yes, Dr. Pazdur again) is the problem.
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18. ex-Pfizerite on October 18, 2011 2:03 PM writes...
Steven, most commentators on this board are people who work in the pharma industry and although we may seem cynical it is because we have seen to many positive phase II clinical trials that were not replicable in a powered phase III clinical trial. After a while in the industry you only believe a fully powered clinical trial and then you believe that trial only after it has been confirmed with another fully powered clinical trial. I believe that anecdotal reports are only indicative of something to study more closely via cell based assay or an animal model before even beginning to think about a clinical trial.
I also think that most of the people who read and comment on this board, while they may have had projects that they feel were delayed by the FDA or felt that the FDA had moved the goal posts, would also agree that the FDA does a very difficult job in an exemplary manner and making personal attacks on a FDA official is uncalled for.
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19. Steven Walker on October 19, 2011 8:09 AM writes...
To ex-Pfizerite: I am well aware that exposing the warts of our drug development system from the real patient perspective is uncomfortable for people who work in it. Sorry to crash your club, but you can expect patients and their advocates to be doing a lot more of that. From where we sit, the system is a disaster. In my response above, I was adding factual information to the discussion because the person who posted didn't spend the extra ten minutes it would have taken to understand what T-DM1 really is, and to also understand that what Roche is doing is not based on greed, but rather on exactly what we want the drug compaies to be doing - trying to bring better, less toxic treatments for serious diseases to market. In the case of T-DM1, a great many people, including many in the industry and some former high-ranking FDAers were very troubled (some were outraged) by FDA's decision not to fast track the drug and grant it Accelerated Approval based on early trial data. I am perhaps the nation's most focused and heeded expert on Pazdur's policy missteps over the last ten years, and his delaying action for T-DM1 was part of his aggressive policy enforcement efforts. This is not about a personal attack on Pazdur, it is about educating the public regarding a powerful official's misguided policies and the enormous negative effects those policies have had on patients (my first and primary concern) and progress against cancer (a very close second). Pazdur aggressively sought the role of oncology czar, and he has executed that role as an effectively unsupervised regulator within CDER, but in reality separate from the management structure of CDER. Because of these facts, confirmed to me by senior officials in the agency, Pazdur and his senior staff are in fact the cause of the policy problems, policies which he has clearly explained as being "his policies." They are not the policies of some amorphous "FDA." So how would you have us, the patient community, explain what we think the problem is? Use the term "unnamed FDA official/" For us, this is real life and death stuff happening in real time, to us. So how would you have us explain it? The problem is in fact Dr. Pazdur and his senior staff. Sorry if that huirts his feelings, but a dying cancer patient doesn't have time for beating around the bush.
Again, sorry to crash your party, but when people post things that are simply wrong, or take strong positions in the public debate that run counter to the best interests of real patients who will be directly, adversely effected in real time - expect us to speak up.
We think we are very important stakeholders in this process, and with all due respect, we are tired of being told by the traditional insiders that we should just shut up."
http://pipeline.corante.com/archives...ast_cancer.php