Rich66
06-08-2011, 11:54 AM
http://www.reuters.com/article/2011/06/07/us-cancer-drugs-shortages-idUSTRE75653V20110607
"These are chestnuts. These are not old-fashioned drugs. They remain incredibly important drugs which serve as the backbone for treating many of the most common and treatable cancers," said Dr. Robert Mayer of the Dana-Farber Cancer Institute in Boston and a past president of American Society of Clinical Oncology (ASCO) which held its annual meeting in Chicago this week.
Cisplatin is used to treat testicular, bladder and ovarian cancers that have spread. The drug, also used to treat lung cancers, is sold under multiple brand names, originally by Bristol-Myers Squibb. A generic form is sold by Teva Pharmaceutical Industries Ltd, among others.
Doxorubicin, also available under multiple brands and as a generic from Teva and others, is used to treat non-Hodgkin's lymphoma, multiple myeloma, acute leukemias and other cancers.
Cytarabine, produced by Hospira Inc and others, is used to treat certain types of leukemia. Leucovorin, also sold by Teva, is used along with certain chemotherapy drugs to treat colorectal, head and neck and other cancers.
Dr. Michael Link, a pediatric oncologist at the Mayo Clinic and current ASCO president, called it a disheartening crisis.
"Here we have highly effective drugs, they've been shown they work and to think we don't have them available is almost unconscionable," Link said. "We don't see an end in sight."
In some cases, doctors can substitute another drug for one that is in short supply.
"It's still uncomfortable to say that this is ideally what we'd like to do, but unfortunately we don't have it," Link said. "You can imagine the conversation and I'm sure they're going on all over -- doctors have to tell their patients or their patients' parents that we can't give them the proven drug because we don't have it."
Dr. Richard Schilsky, cancer specialist at the University of Chicago and a past ASCO president, said the shortages have been going on for about nine months with no sign of abating.
"When you talk to the drug companies, they say there are manufacturing problems or they are taking plants offline and then it takes a while to get them back up," he said.
"They point the finger at the FDA (Food and Drug Administration), saying the FDA is under-resourced and they can't get plants inspected to allow resumption of drug production. The drug suppliers are in the middle of this as well," he said.
But underlying all of this, he said, is a dearth of financial incentive to make the lower-cost cancer drugs, especially when new cancer drugs command huge premium prices.
"The return on investment of manufacturing generic drugs is pretty low. If something goes wrong, it may be that some manufacturers decide to pull out rather than fix the problem."
Hospira spokesman Dan Rosenberg said shortages arise for many reasons -- capacity constraints, commodity shortfalls, or when a competitor withdraws its product for some reason or when competitors have shortfalls. It is not always possible for Hospira to ramp up production that quickly, Rosenberg said.
"We are doing everything we can to ensure access to these products for clinicians and patients," he said. "Often, we continue manufacturing products at a loss because we realize there is a critical medical need and we are the only company that provides the medication."
"These are chestnuts. These are not old-fashioned drugs. They remain incredibly important drugs which serve as the backbone for treating many of the most common and treatable cancers," said Dr. Robert Mayer of the Dana-Farber Cancer Institute in Boston and a past president of American Society of Clinical Oncology (ASCO) which held its annual meeting in Chicago this week.
Cisplatin is used to treat testicular, bladder and ovarian cancers that have spread. The drug, also used to treat lung cancers, is sold under multiple brand names, originally by Bristol-Myers Squibb. A generic form is sold by Teva Pharmaceutical Industries Ltd, among others.
Doxorubicin, also available under multiple brands and as a generic from Teva and others, is used to treat non-Hodgkin's lymphoma, multiple myeloma, acute leukemias and other cancers.
Cytarabine, produced by Hospira Inc and others, is used to treat certain types of leukemia. Leucovorin, also sold by Teva, is used along with certain chemotherapy drugs to treat colorectal, head and neck and other cancers.
Dr. Michael Link, a pediatric oncologist at the Mayo Clinic and current ASCO president, called it a disheartening crisis.
"Here we have highly effective drugs, they've been shown they work and to think we don't have them available is almost unconscionable," Link said. "We don't see an end in sight."
In some cases, doctors can substitute another drug for one that is in short supply.
"It's still uncomfortable to say that this is ideally what we'd like to do, but unfortunately we don't have it," Link said. "You can imagine the conversation and I'm sure they're going on all over -- doctors have to tell their patients or their patients' parents that we can't give them the proven drug because we don't have it."
Dr. Richard Schilsky, cancer specialist at the University of Chicago and a past ASCO president, said the shortages have been going on for about nine months with no sign of abating.
"When you talk to the drug companies, they say there are manufacturing problems or they are taking plants offline and then it takes a while to get them back up," he said.
"They point the finger at the FDA (Food and Drug Administration), saying the FDA is under-resourced and they can't get plants inspected to allow resumption of drug production. The drug suppliers are in the middle of this as well," he said.
But underlying all of this, he said, is a dearth of financial incentive to make the lower-cost cancer drugs, especially when new cancer drugs command huge premium prices.
"The return on investment of manufacturing generic drugs is pretty low. If something goes wrong, it may be that some manufacturers decide to pull out rather than fix the problem."
Hospira spokesman Dan Rosenberg said shortages arise for many reasons -- capacity constraints, commodity shortfalls, or when a competitor withdraws its product for some reason or when competitors have shortfalls. It is not always possible for Hospira to ramp up production that quickly, Rosenberg said.
"We are doing everything we can to ensure access to these products for clinicians and patients," he said. "Often, we continue manufacturing products at a loss because we realize there is a critical medical need and we are the only company that provides the medication."