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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