Bedford, Ohio manufacturer, Ben Venue Laboratories Inc., hopes to be allowed to resume production of a crucial cancer drug, Doxil and Johnson and Johnson has filed applications with the FDA that they hope will be approved. Doxil is used in chemotherapy to treat recurring or advanced ovarian cancer. Production of the drug was discontinued last year when Ben Venue voluntarily suspended its manufacturing operations when a batch of Doxil was found to be tainted with metal. Further Ben Venue was found to be in violation of many FDA regulations. Ben Venue was cited for the lack of routine preventative maintenance activities and the discovery of a 10-gallon can in a storage area containing an "unknown liquid" that was found to include urine.
Ben Venue is the sole supplier of Doxil in the United States.
As reported in the Cleveland Plain Dealer; "To ease the shortage of critical cancer drugs, the FDA in February began importing drugs from India. Lipodox, which is made in India and distributed in the United States by a Detroit-based Company, has the same active ingredients as Doxil. The agency also began allowing several U.S. companies to step in to make other drugs made by Ben Venue to treat other various diseases.
Lipodox is considered a "reasonable substitute" for Doxil, but whether or not it is as effective remains to be seen, said Dr. Robert DeBernardo, a gynecologic oncologist at University Hospitals Case Medical Center."
What I find most upsetting about this whole thing is that Ben Venue has been shut down since last year and no one has been making Doxil. Hospitals are rationing the supply they do have. Women are sick and dying. So my question is; why is no one else making this drug? Is Ben Venue the only manufacturer that can make it? No. They are not. Johnson and Johnson's long term solution is to have the drug made by other manufacturers if Ben Venue is not reinstated by the FDA. It seems really awful to me that women with cancer are having this drug rationed while J&J wait it out and offer a drug referred to as a "reasonable substitute". And if I had guess why; I'd guess it's because it's not cost effective to start manufacturing at a new facility. Having lost several people that I love to cancer, this really touched a nerve.
What do you think? Is a "reasonable substitute" good enough when treating cancer?
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This is abhorrent to me! If I am sick, I do not want a 'reasonable substitute'. I want the real thing. To ration a life saving drug because of a manufacturing stoppage is ridiculous, considering our many resources.
Can you imagine going to a woman who has just been diagnosed with ovarian cancer and she is told that there is a drug protocal that could save her life, but unfortunately they cannot administer it. Instead lets put you on a 'suitable substitute'. Also HOW is it rationed? Do you not receive it if you are too old? Too young? A mother? Not a mother? History of other illnesses? Pre-existing conditions? Who makes the determination? This is very dangerous water we are treading.
I think that either Ben Venue needs to be reinstated OR the formula should be given to another laboratory to create.
I am with you sister. My jaw hit the ground when I read this. I had to post it. There is more to this story too. There are many other drugs they are the sole distributer for. All of which are not being produced at this point. Not sure what the ration protocol is, but I will try and find out.
Most likely Ben Venue is the one that holds the patent on the drug, which is why no one else is allowed to make it. If Ben Venue won't release the patent or agree to allow someone else ot make it, then there is nothing that can be done.
And I am sure it's not cost effective to being producing a drug at a new facility by a new company. But that's what comes with a business, if something isn't cost effective, it isn't necessarily done.