It is deeply troubling to learn that Congress is considering not completing the fiscal year 2017 budget appropriations process. Because of the normal political fighting that we still see in Washington, Congress is now considering passing a short-term or even long-term budget continuing resolution instead of the negotiated budget resolution they have worked so hard [...]
The cost of Enzalutamide (Xtandi) in the United States is being challenged by Knowledge Ecology International (KEI), a public interest advocacy group. The average US wholesale price of Xtandi in 2015 was $88 per capsule. That can add up to $129,000 annual cost per man. There are significant issues related to high costs of treatment. [...]
We have some good news, the United States Congress has passed the Omnibus spending package. The package will fund the U.S. Government through fiscal 2016. We should take note that this bill includes a $2 billion increase for the National Institute of Health (NIH), a 5% increase for the National Cancer Institute (NCI) and the [...]
Yes, it is true, many clinical trial results are not published, especially negative results. This is even true for FDA approved drugs and treatments! Failing to publish, or actually hiding negative results and harmful side effects that occur in clinical trials is too common and jeopardizes each and everyone of us, including survivors of advanced [...]
Malecare will be holding a free teleconference this Tuesday, April 30 at 6.m. I will be speaking with Dr. James Gulley who is the Deputy Chief of the Laboratory of Tumor Immunology and Biology at the National Cancer Institute and the Director of the Clinical Trials Group. He also serves as a Senior Investigator within [...]
It is truly amazing and very shocking, from 1996 to 1999, the U.S. food and Drug Administration (FDA) approved 157 new drugs. Compared to the period of 2006 to 2009 the FDA approved 74 drugs. However, NOT one of these approved drugs provided a cure for any serious illness! Diseases that destroy lives, diseases like [...]
President Barack Obama has nominated Harold E. Varmus, M.D., the Nobel Prize-winning scientist for studies showing how certain normal genes could cause cancer when they went awry; to serve as the 14th director of the National Cancer Institute (NCI). Dr. Varmus served as director of the National Institutes of Health in the 1990s, a period [...]
In yesterday’s post, Provenge, Its Future & A Clinical Trail Alternative for Men with Hormone Dependent Prostate Cancer, I said that I attempted to get into a vaccine trial, but was rejected because I have a history of an autoimmune disease and I have had evidence of some lymph node involvement (stage D1). I want [...]
The FDA did introduce its Critical Path initiative in 2004. But, even these expedited processes have become bogged down. The FDA has responded to the political winds and become cautious after the negative publicity it received from the withdrawals of drugs like Rezulin and Vioxx. The best and most recent delay in the prostate cancer [...]
Senator Arlen Specter (D-PA) introduced S. 914, the Cures Acceleration Network and National Institutes of Health Reauthorization Act of 2009. The bill has three main components: 1. Establishes a new, independent federal agency, to be known as the “Cures Acceleration Network” (CAN), which would award grants and contracts to accelerate the development of cures and [...]
