The situation has worsened to the extent that, in addition to keeping oncologists from being able to begin or complete the most effective treatment protocols for some patients, a number of clinical trials have been halted on new cancer drugs (which are being compared to or tested alongside mainstream treatments that are in shortage).?The federal government is investigating drug resellers who appear to be price gouging on cancer drugs sold to hospitals.
Cancer treatment products currently experiencing delays include Doxil (doxorubicin liposomal), a treatment for multiple myeloma, ovarian cancer, and Kaposi?s sarcoma, as well as non-liposomal doxorubicin, a generic chemotherapy medication used to treat a large number of cancers including breast cancer and Hodgkin?s lymphoma. Another generic chemo drug used for multiple cancer types, paclitaxel (trade name Taxol), is also in short supply, along with leukemia drug cytarabine, leucovorin for colon cancer, and cisplatin for testicular cancer.
Doxil is sold by Johnson & Johnson, but it is apparently in short supply because J&J?s contract manufacturer Ben Venue Labs (owned by another drugmaker Boehringer Ingelheim) is experiencing capacity constraints, and J&J is working to find a new manufacturing provider that can produce the drug.
But generic manufacturers are responsible for producing the bulk of the cancer drugs in shortage. These producers, including Teva, Hospira, APP Pharmaceuticals, Sandoz, and Bedford Labs?(a unit of Ben Venue),?are all experiencing supply constraints either due to manufacturing troubles (Teva, for instance, has produced lower volumes of several drugs after it had to shut down a plant to meet quality standards), insufficient raw materials, and supply chain delays.
In some cases the drugmakers are having trouble keeping up with increased product demand caused by another manufacturer?s plant troubles. Oncology therapeutics is not the only medicinal area facing outpaced demand, though it appears to be the worst; the FDA is also seeing a rise in shortages of injectable pharmaceuticals in areas including intensive care nutrition and pain management.
Unfortunately, in addition to manufacturing difficulties, these shortages are also sometimes caused by the ever increasing race to make the biggest profit. When generic or low cost medicines become too expensive to produce, for instance, a drugmaker isn?t going to go out of its way to keep producing it. And industry consolidation has made it so that there?s not always a competitor ready to step in and fulfill the entire product demand.
While some of these drugs can be effectively replaced with alternative chemotherapy agents and support medicines, others have no direct substitute. Meanwhile, the FDA (and I imagine hospitals, patients, and physicians) is putting pressure on drugmakers to bring supplies up to par.
And while it is amazing that hospitals and doctors in developed countries still face such dilemmas, this is not the first time that manufacturers? problems have impacted the quality of care in the US and other nations. Clearly something has gone wrong in how these medicines are produced, as well as how they are paid for. Meanwhile, for the immediate future, no end to the current shortage is in sight.
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