The New York Times continues to be the best and brightest remaining light for good national journalism. I can’t speak to your politics; I’m impressed with the depth and breadth of the medical writing. I don’t see that as political.
I first wrote about the possibilities of a new, fast track style FDA experimental approval policy two weeks ago:
Check-out this good news as reported by Reuters/msnbc.com yesterday:
Earlier this month, I wrote a short post about the Food and Drug Administration (FDA). Let’s take another look:
FDA Begins Process to Remove Breast Cancer Indication From Avastin Label
From FDA Press Release. 2010 Dec 16
I have written several articles about the chemotherapy drug, Avastin, this year: Avastin Proving To Be Versatile–Although Sometimes Controversial Chemotherapy Drug, and this article from the ASCO meetings in June – Avastin Extends Progression-Free Survival By 39% In Women With Previously Untreated Ovarian Cancer.
I am interested in this story for several reasons. One, keeping drug company claims and hipe under control is important. It is only human and corporate nature for pharmaceutical companies to get excited and push their products. But in the medical world, the FDA is very tough on over promising. You can understand why!
Here is the first part of an article titled, Trial aims to shave years off cancer drug development by GREG FREIHERR, which appeared May 13, 2010 on Cancer Network.com:
Here is an excerpt from an article we found in the Wall Street Journal, “Push to Cure Rare Diseases, by Amy Docker Marcus:
FDA Approves Lymphoma Drug Developed at Memorial Sloan-Kettering
Just in case some of you don’t read comments after the previous day’s posts, I thought I would share Betsy’s comment about yesterday’s article with you:
Clinical trials must follow a specific protocol in order to gain approval by the FDA. Phase I: Dose-seeking trials to identify side effects
Phase II: Determine response rates for a particular disease
Phase III: Compares new treatment to current standard of care
Here is a thought-provoking article that originally ran in February about a large number of clinical trials now being conducted outside the United States. Note my comments at the end of the post about how we, as patients, are losing our opportunity to receive cutting edge medical care at little or no cost:
Now the good news! Yes, newly diagnosed cancer cases are way up in the United States each year. But patients are living longer once they are diagnosed. Yesterday I shared my opinion we are losing the war against cancer. I was critical of the short-sighted, profit driven motivation of privately owned drug companies. It all depends how you spin it! This is definitely a glass half empty/half full situation. Everyday there is a press release announcing a newly approved cancer drug or drug combination. That is the new thing, you know. Using existing drugs in combination to slow the growth of the cancer. And it is working! A year here, a few months there – Last time I checked that adds up to a longer life for millions of cancer patients!
Baby steps. By taking this approach, drug companies and researchers get positive reinforcement. Anytime a new drug is approved by the FDA that company’s stock shoots up. And the FDA is approving more and more new drugs all of the time. Thankfully, the bar for approval has been re-set very low for cancer related therapies. Show any significant improvement, even if the study is small and documented improvements are only for a month or two, and the FDA fast-tracks the chemotherapy approvals and allows drug companies to use expanded studies and then get the drug to market relatively quickly. In tomorrow’s third and final installment, I will share my theory about why this is working and where cancer research is headed in the near future. See, the glass is half-full after all!
Feel good and keep smiling- Pat