Barry Norris was relieved and encouraged when a chemotherapy drug called Doxil shrunk a painful, disabling cancerous lesion on his foot to half its size.
Shane Bevel, for USA TODAY
Thousands of Americans are being confronted with shortages of dozens of cancer medications that are forcing them into less-effective treatments or no treatment at all.
But when he arrived at the James Graham Brown Cancer Center in late August for the third of six treatments, he was told there was no more Doxil available because of a nationwide shortage and sent home.
"It's a kick in the head," said the 54-year-old Louisvillian, who has a cancer called Kaposi's sarcoma in several spots on his skin. "Am I going to have to spend the rest of my life with an open sore on the bottom of my foot when there's something that can be done about it?"
Across the country, thousands of Americans like Norris are being confronted with shortages of Doxil and dozens of other medications that are forcing them into less-effective treatments or no treatment at all. The U.S. Food and Drug Administration says the number of drug shortages has nearly tripled over the past six years, rising from 61 in 2005 to a record 178 last year.
The FDA cites several reasons, including a lack of raw materials, manufacturing and quality problems, increased demand and some companies' decisions to stop making older, less-profitable drugs. In the case of Doxil, which also treats ovarian cancer and multiple myeloma, drug makers give vague reasons regarding manufacturing that boil down to demand outstripping the ability to make the medication.
Experts say most shortages involve medicines given by injection or intravenously in the hospital, and include not only cancer drugs but anesthetics, electrolytes and other medications.
"Doxil is the latest example of therapeutic chemo agents that have been in short supply. It feels very urgent when it's a chemo drug," said Dr. Beth Riley, a medical oncologist and hematologist at the Brown Cancer Center. "There are situations when there's no alternative available. You compromise patient care in that situation."
Barbara Hagerman, a 75-year-old Louisville woman with recurrent ovarian cancer, said she's had four treatments with Doxil, which was successfully fighting her cancer, with few side effects. She was scheduled for four more treatments at Norton Cancer Institute when her doctor told her supplies had run out across the region and nation.
"Now I'm going to have to try something else, and it might not be as effective. —1/8 And there's nothing I can do about it," said Hagerman, whose cancer was first diagnosed in 2009 and came back about six months ago.
Cause of shortage(AT)
There's no generic equivalent for the drug, which is used by about 7,000 people at any one time and costs $3,234 for a cycle of treatment.
The shortage "is due to manufacturing issues at our third-party manufacturer," said Monica Neufang, a spokeswoman for Pennsylvania-based Janssen Pharmaceuticals, which sells Doxil. "Our No. 1 priority is patients. —1/8 We deeply regret the circumstances that have caused this shortage."
Neufang said Janssen first notified doctors about supply problems in late June, and set up a first-come, first-served waiting list that now contains about 1,000 patients nationwide.
Limited doses became available in early August and were allocated within two weeks, Neufang said, adding that she expects an intermittent supply over the coming months, with patients already on a course of therapy receiving first priority. Officials said they don't know when the shortage will end.
As the companies sort out these issues, local doctors and pharmacists are left with one less tool in their fight against cancer.
"We simply can't get it any longer," said Dr. Michael Kommor, an oncologist with the CBC Group Consulting in Blood Disorders & Cancer, part of Baptist Medical Associates. When a patient needs Doxil, "anyone in this practice is told you can't treat that person because we don't have the drug."
Patients' options few(AT)
Dr. David Doering, a gynecological oncologist at Norton Cancer Institute, said the Doxil shortage is particularly troubling since the medication is effective and generally causes less nausea and hair loss than other chemo drugs.
Also, he said, cancer sometimes grows resistant to the drugs used against it. So if Doxil is stopped and another drug started, the cancer may grow resistant to two drugs, giving doctors even fewer options.
"For some patients," Doering said, "they can get to the point where there aren't any more active drugs available for them."
Doctors said the long-term consequences of drug shortages are still unknown.
"We won't know the impact of changing therapy until down the road," Riley said.
Norris said he doesn't think his cancer will kill him, but fears his lesions will grow and keep him from ever getting around on his own and doing things as simple as walking his dogs. He likened that to "a very, very slow aging and death."
"It's frustrating to give up little parts of your life along the way," he said. "And it feels like nobody can do anything about it. —1/8 All you can do is remain hopeful."
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