Dr. Leslie Busby of hematology and medical oncology at the Rocky Mountain Cancer Center (RMCC) in Boulder says he’s seen local shortages in generic prescription drugs, but so far no patients have been unable to get medicine they need to survive. But that may change soon.
Dr. Busby says he has only run out of two drugs completely. The first, leucovorin, helps a chemotherapy drug work better, he says, and the second, doxil, is a chemotherapy drug that is still unavailable due to a “manufacturing problem” that prompted a drug recall.
“It’s hard to find a lot of details on why or what happened,” he says of the doxil plant’s shutdown.
The thing is, one of his cancer patients may need it next week.
Martha Thomas, who underwent treatment for advanced ovarian cancer from December 2009 to May 2010, had a relapse five and a half months later, and she still has a 9.5-centimeter tumor. Doctors sent samples of the tumor to a lab in California to test what drugs would work best on it. If her scan scheduled this week shows no decrease in tumor size, doxil is one of the drugs that should be given to her as the next step, she says.
“That would impact me and other people who have ovarian cancer, and maybe other cancers as well,” Thomas says.
In most cases, Dr. Busby explains, there are alternate medicines that can be used when one drug runs out. But once, in the case of an extreme shortage in the leukemia drug cytarabine, doctors in his network had to decide which patients really needed that medicine the most, because there wasn’t enough to go around. No patients have suffered from the shortages yet, he says, due to “a lot of hard work in the background.”
He says the reimbursement to medical providers for certain generic drugs has been getting lower and lower, because fewer companies have been able to maintain their margins.
“They can’t make a profit on it, or profit is very slim,” Busby says. “So they don’t have a lot of motivation to make more than they need to make.”
A plant typically makes as much of a particular drug as manufacturers think they will need for the entire year, he explains. Then, when a plant is shut down by the Federal Drug Administration or the manufacturer, and there are only one or two others that have made that drug, demand suddenly skyrockets. Normally, when demand increases, prices go up, which should make it profitable for manufacturers. But thanks to The Medicare Prescription Drug, Improvement and Modernization Act of 2003, prices on certain generic drugs are capped, reducing manufacturers’ motivation to meet demand.
Busby agrees that it’s the manufacturers, not the “gray market” that Congress and President Barack Obama are so riled up about, that are driving the drug shortage.
“The gray market’s not the problem,” he says. “I’m not saying they’re wonderful people, either, but they’re not the problem, they’re just taking advantage of a situation that’s out there. They hoarded up some drug and then they’re trying to sell it at a huge profit.”
When asked about the federal government’s efforts to crack down on the drug shortage through measures like ensuring that manufacturers give six months’ notice of an anticipated shortage, Busby says, “I’m not sure what they’re talking about is going to fix it.”
The solution, he says, is encouraging manufacturers to make more generic drugs, possibly by amending the 2003 act to increase the allowable reimbursement rate above the current cost-plus-6-percent level for generics. Currently, the economics of Medicare encourage providers to prescribe expensive drugs because they get higher reimbursement, according to Busby.
Another idea, he says, is to take a hard look at whether any federal drug regulations can be cut back, since that is one of the factors that drives up costs and, as a result, prices. Busby adds that the FDA doesn’t have a good back-up plan if a drug supply is exhausted, such as looking to European suppliers.
When asked whether he would consider buying from the gray market if faced with a life or death situation and unable to find the necessary drug elsewhere, Busby replies, “That’s a good question.”
But even if medical providers buy an older generic drug from the gray market, they can only get reimbursed at the capped Medicare rate, so they have to eat that extra cost. Another budget-buster occurs when the generic version is unavailable and providers have to buy the expensive brand-name option. In theory, he says, significant drug shortages drive up health care expenses for insurance companies, which then increase their rates.
Busby agrees that the current assault on the gray market is, to some extent, political posturing.
“To me, it’s a great way to get political points — no one likes to see Grandma getting charged 100 times more than the drug is usually billed for,” he says. “That upsets everybody. But the gray market is not the problem, in my opinion. They’re a symptom of the problem. If you encourage companies to make lots of generic drugs and make it somewhat profitable for them, you’re not going to have a gray market, because they’ll always have drugs available.”
As for his patient Thomas, she agrees that “there does appear that there are a lot of politics between the FDA and the drug companies and the profit centers.”
She has heard of a cancer patient who was told she had 30 days to live by heavy hitters like MD Anderson, the Mayo Clinic and Sloan-Kettering. The patient moved to Brazil for the drugs she needed and is still alive, seven years later.
“Maybe I should go to Brazil,” Thomas says.