By JR on Sunday, February 19, 2012
Obama's FDA is doing all it can to make life difficult for drug companies -- meaning that it is now uneconomic or even impossible for them to produce some drugs
SHORTAGES of life-saving cancer drugs are putting thousands of Australian patients at risk. Drugs used to treat childhood cancers, breast and ovarian cancer, the deadly skin cancer melanoma and blood cancer have either run out or are in short supply because of manufacturing problems in the US.
The American drug regulator, the powerful Food and Drug Administration, ordered the upgrade of equipment at several drug manufacturing facilities in the US late last year. While there have been no findings that the drugs are unsafe, the Australian shortage is a direct result of pressure this action has put on the global supply chain.
Australian doctors are now worried they might have to ration supplies, delay treatment or use other medicines that are less effective and can result in serious side effects.
One of the "Rolls Royce" chemotherapy drugs - Caelyx, which is used for ovarian and breast cancer - has already run out and is not expected to be back in supply until 2013. Already national clinical trials using Caelyx to improve patient care in Australia have had to be cancelled.
Oncologists around the country are alarmed and are compiling an urgent submission to the Federal Government to devise a national strategy to secure supply.
The drug shortages have also sparked concerns about medication errors. Since the problem began in the US, one in four doctors have reported medication errors occurring in hospitals. Many of these were because of inexperience with alternative products. Some of the errors involved overdoses.
Clinical Oncology Society of Australia pharmacy chair Dan Mellor said the society had been notified that a number of chemotherapy drugs were out of stock. "Over the past 12 months there has been an increasing number of drugs that have become unavailable, particularly in the US. These are vital anti-cancer drugs," he said.
"The American drug regulator has been inspecting drug manufacturing facilities and towards the end of last year they closed down a number of them because they didn't meet standards. "Those factories were the worldwide solo producers of a number of chemotherapy drugs that are now no longer being produced until the factories can be brought up to scratch."