Greetings all. I hope you are enjoying the appearance of red in the leaves and the chill in the air. This has been a tougher time for Mike and me as we wait for the look-see October 5th to confirm a likely re-occurence far too soon to bode well. So now I get to both research best options and fight for those drugs to be available. In the meantime, Mike’s brother and a great support to him is facing his own rapid decline as he was formally diagnosed with ALS the same day that my ca 125 jumped in August. What a happy little Oregon team we are. (Actually, we are fine. Just raw as well.)
I have written in other posts that it appears to me that the current chemo shortages are disproportionately affecting ovarian cancer, which is primarily an older woman’s disease. I was please to find this American Cancer Society article that confirms my position. Unfortunately the article skews the discussion a bit about what has caused the shortages by also quoting a large pharmaceutal distributor (McKesson) saying essentially it’s all the FDA’s fault. The spokesperson claims that FDA’s increased scrutiny on manufacturing processes and quality control have made certain drugs too low in profits to sustain production of those drugs. The article further states,”McKesson’s Chief Medical Officer Dr. Roy Beveridge, MD, says there is no economic incentive for manufacturers to make or distribute low-priced generic drugs, and that unless the baseline system changes, shortages are going to continue.”
J&J Headquarters designed by IM Pei
Ben Venue Labs, the manufacturer of Doxil, a critical treatment for recurrent ovarian cancer, for a subsidiary of Johnson & Johnson, claims that the problem is not one profit. An 9/22/11 article in courier-journal.com by Laura Ungar states:
Jason Kurtz, spokesman for the Ohio-based third-party maker, Ben Venue Laboratories, would only say “we’re facing capacity constraints” with a drug that is complex to make. He wouldn’t specify what type of constraints, but said examples of such problems include unplanned downtime because of machinery breakdowns and capital-improvement projects that limit manufacturing capacity.
However, Ben Venue Labs wants out of the Doxil business (and other contract manufacturing) to focus more on its business as Bedford Labs, a producer of generic injectables, and avoid all the problems that have caused bans from Canada and Europe of Ben Venue products. Like the WSJ said, it is all about manufacturing priorities. In the meantime, as Bedford Labs, the company has discontinued cisplatin and carboplatinand has significant shortages in production of Taxol. It appears to focus on commonly needed and presumably more profitable drugs such as those that treat migraine (generic Imitrix), indigestion (generic Zantac) and high blood pressure (generic Inderol).
With Ben Venue moving on to greener pastures, who will J&J find to manufacture Doxil and how hard will they try? Doxil reportedly represents less than 1% of Johnson & Johnson revenues. A few of my ovarian cancer sisters on inspire.com bulletin board noted that J&J makes a lot of money marketing to women, and in particular in women’s products. Here’s one list of products that J& J sells. Perhaps J&J needs to be reminded that they need to focus on Doxil as well, and quickly.
In addition, there are all the generic drug companies that have discontinued or have serious shortage in chemo drugs ovarian cancer patients need. For Taxol, they areAPP, Bedford, Hospira, Sandoz and Teva. For carboplatin, they are APP, Bedford, Sandoz and Teva. For cisplatin, they are APP, Bedford and Teva. And with Bedford, now out of the ovarian chemo business for the most part, more of the market power will consolidate in the handful of generic companies left, who will continue to make “allocation decisions” of their manufacturing capacity based on profit.
What can we do? Big Pharma would have us believe that the causes are all very complicated–increased reliance on outsourced ingredients, Medicare price controls, increased demand from all those pesky cancer patients, complicated manufacturing processes and lack of inspection capacity from the FDA. But we all know that it boils down to making sure that Big Pharma makes maximum profit, even when lives are at stake. This is unacceptable in a civilized society.
In my previous posts, I have encouraged people to write to Congress. A hearing was held on Friday September 23, 2011 in the House Energy and Commerce subcommittee on Health but the human voice of the affected cancer patient was sorely missing. We can continue to try to get our government to take some action in this area which they have been loath to regulate thus far. Or we can take our message to the streets and protest at the offices of the companies who will not manufacture the drugs we need. We could show up at J&J corporate offices (and the generic companies too) wearing scarves and teal arm bands, with our message that we are still here, we are still fighting and they have an obligation to get us the drugs that will keep us alive. Who’s up for a road trip to New Brunswick, New Jersey? by Maggie Heim