The FDA's Cancer Czar Says He Can't Approve New Drugs Fast Enough
Maybe more than any other person alive, Richard Pazdur, the director of the Food and Drug Administration's Office of Oncology and Hematology Products, personifies the tension between the need to get new drugs to patients fast and the competing desire to make sure they are safe and effective first.
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#1 Jun 23, 2013
If it has "mab" in the name, it's an antibody, and thus made it through toxicity tests, but may have little effect if any. It however may work. In either case, if it has little side effects, anything helps, especially with cancer.
If its gene therapy, the problem is not the inserted gene's contents, but rather the vector. Usually its either on an RNA or DNA with attached proteins such as integrase, transposons, or associated insertion insertion machinery, and using a virus coat aprticle or just raw circular or linar RNA/DNA with attached proteins. The problem is the proteins that insert the gene's are by and large "random", thta is they insert the corrected gene at sites that may or may not cause a problem, such as also causing a different cancer. Most of these play a statistical game, where if I give a patient X amount of the gene therapy, the odds are I will not cause a different cancer trying to cure the origional one, or origional genetic disease. As the proteins involved are valid, I would also tell all patent holders to develope targetted delivery systems that insert the gene at one specific site, which can be done realitivly quickly now. I would still believe that in the case of a 100% or even 80% life threatening disease however, the initial vectors/therapy should also be allowed as a 1-5% chance of a different cancer is a much better survival rate than 100% death from the initial disease. I think in this aspect, the recomendation or telling them they have to develope targeted site delivery is warrented and should be routine. However, I do realize how many companies right now would go under having to back-track 8 years in drug development, when they already have the actual protein for the cure, but would have to develope over 3 months a target specific insertion protein, and then spend the money to move these through the process. If however people are not made aware of the risks of cancer from random insertion in the first place, you will see a very large backlash from patients reguardless, and mostly loose the companies in the mean time you wish to promote and allow to aquire money and provide jobs as well as products.
#2 Jun 24, 2013
Thats why Pharmaceuticals maim and kill consumers, because FDA quickly approves them. Oh but could it be that allowing Big Pharma to use unknowing test subjects AKA: The public to act as lab rats, Pharma saves money on real safety studies and gets to see how faulty their latest miracle drug is?
Since: Mar 12
#3 Jun 25, 2013
When it comes to cancer drugs, even the tested and approved ones aren't all safe. Many die, they say from the cancer but it's the drugs (like chemo). The only thing approval insures is it's not going to kill most people outright. Cancer is a very challenging and resilient disease and so the drug treatment is in proportion to that.
i think we just have to go with whatever is available at the time. When people have cancer they have it now, not when some super all promising drug/therapy becomes available. Chances are it's not altogether safe or effective but it's an optional alternative to dying.
#4 Sep 23, 2013
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