US drug supplies run short, endangering patients
Monika McBride has acute myeloid leukemia, a life-threatening blood cancer that requires six months of intensive chemotherapy. Three days before her third treatment, however, a nurse called to cancel her appointment: Her doctor had run out of the drug.
Doctors, hospitals and patients across the U.S. are grappling with a record number of drug shortages, causing them to delay treatment, postpone surgery or make do with costlier and less effective substitutes.
"I thought, 'Maybe this is it. I'm done. I won't have any more chemo,'" says McBride, 55, of Victor, Idaho. "I didn't want to stress about it, because I believe stress could make the cancer worse. I thought, 'I'm just going to give it up to God.'"
So far this year, 180 drugs have been in short supply - more than in all of 2010, says the FDA. Virtually all U.S. hospitals say they've been affected, and 82 percent say the problem has delayed care for patients, says the American Hospital Association. Although drugmakers say they're doing everything they can to relieve the shortages, some health care experts say they see no end in sight.
"It's a crisis situation," says Joseph Hill of the American Society of Health-System Pharmacists.
The shortage delayed McBride's third treatment by nearly two weeks. She doesn't know how that will affect her chance of being cured. In general, patients with this kind of cancer have a 30 percent chance of survival, says the Leukemia & Lymphoma Society. "When you are diagnosed with an acute leukemia, you need to be treated now," says McBride, a nurse who has been unable to work since January. "If you are not treated, you can die within weeks."
She says she feels lucky she was able to find a supply of the drug, cytarabine, in Salt Lake City. She and her husband had to drive 4.5 hours each way - and find money for him to stay in a hotel during her week-long hospitalization. After one treatment in Utah, she was able to return to Idaho and complete her full course of therapy, which ended last month.
Although McBride is now in remission, she worries that other patients may not be so lucky.
Drug shortages are also driving up prices, forcing hospitals to spend 10 times the usual amount, says Allen Vaida, executive vice president at the Institute for Safe Medication Practices.
Michael Link, president of the American Society of Clinical Oncology, specializes in treating children with cancer. The prospect of being unable to get the drugs they need to survive, he says, is "heartbreaking and unconscionable."
The causes of the shortages are complex, and there's no one source of blame, says Deborah Banker, vice president of research at the Leukemia & Lymphoma Society. And while some patients might wonder if the shortages are due to health care reform, Banker says they have nothing to do with the Affordable Care Act, passed last year to provide health care to more people.
Instead, Banker says, the shortages stem from changes in the ways drugs are made and regulated. Most hard-to-find medications are liquid, injectable drugs that need to be kept sterile, according to the FDA. These drugs are more complicated to manufacture, store and ship than pills or tablets, FDA spokeswoman Shelly Burgess says.
In several cases, manufacturers have had to pull drugs because of "severe quality issues," such as particles or crystals in liquid medications. Most of the drugs in short supply are older, generic therapies, for which profits are much smaller than those of more expensive, brand-name drugs, Link says.
"If a drug is on patent and expensive and there is a big profit margin, then companies have an incentive to make sure there is an adequate supply," Link says. "If there's a problem, there is an incentive to correct it in a hurry. If there's not much profit, the incentives to rapidly fix problems aren't there."
About 80 percent of the raw materials for drugs are imported, says Vaida. That provides more opportunities for shipments to be delayed. Consolidation in the generic drug business has left fewer companies making each drug, he says.
In some cases, only one or two companies may make an individual drug, says Dan Rosenberg, spokesman for Illinois-based generic drugmaker Hospira. If one company has a breakdown, "there is no backup," Banker says.
Rosenberg says his company understands "the impact of these shortages and we are aggressively pursuing solutions. ... 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."
Drug companies aren't required to notify the FDA or other regulators about shortages or delays, says John Santa, a physician and director of the Consumer Reports Health Ratings Center. Drugmakers are required only to alert the FDA if they plan to discontinue a "medically necessary" drug for which they are the only supplier, Burgess says. And while the FDA asks companies to voluntarily provide as much information as possible, drug makers don't have to reveal the cause of the delay, or when they expect to resume production.
Makers of generic drugs say they're trying to help. Illinois-based APP Pharmaceuticals, for example, plans to expand its manufacturing site in the state of New York, says spokeswoman Debra Lynn Ross. APP has ramped up production of several cancer drugs, including the one McBride needed. It also has begun shipping directly to hospitals to discourage middle men from stockpiling drugs, APP said in a statement.
The Generic Pharmaceutical Association suggests that Congress provide incentives, such as tax credits, to companies that agree to begin making "medically necessary" drugs, or those in short supply. And just as the government stockpiles vaccines and other emergency supplies, it should consider stockpiling raw materials and active ingredients for drugs, the group says.
The FDA can't force a company to make a money-losing drug, even if thousands of patients' lives depend on it, Link says. It's possible that the only maker of a lifesaving drug could one day decide to just shut down production. "That's our great anxiety," he says.
FDA officials say they were able to head off 38 potential shortages last year by taking measures such as asking companies to ramp up production when a competitor can't, Burgess says. The FDA also tries to help these companies by quickly approving new production lines or raw materials, she says.
And last year, the FDA cleared the way to import propofol, a common anesthesia drug. This year, the FDA is allowing the importation of drugs to treat cancer, AIDS complications and low blood pressure.
Yet some say the FDA also has contributed to the problem. It recently began requiring makers of medications approved before 1938 to submit new drug applications, Vaida says. Some generic drugmakers say it's cheaper to stop making a drug than submit a new application, Vaida says. That has led some cancer patients to hunt for their own medications.
Tom Kornberg, 62, was diagnosed two years ago with lymphoma, which requires six months of therapy with four drugs. When his doctor warned him that one might not be available, Kornberg, a biochemist, began calling doctor friends until he found someone who had it. "This treatment is not something that you can interrupt at any time and assume the outcome is going to be the same," says Kornberg, a professor at the University of California at San Francisco. "My oncologist told me, 'I'm used to rationing hospital beds, but I've never had to ration drugs.'"
Legislation introduced in both the Senate and House of Representatives could help, by requiring a drugmaker to alert the FDA when it anticipates a shortage. That could give it time to ask others to make up for the shortfall.
The Generic Pharmaceutical Association says requirements could force companies to reveal proprietary information. But drugmaker Hospira supports the legislation and is acting on many of its requirements, Rosenberg says. Yet giving notice of a coming shortage could have drawbacks, Link says. "Once the word is out, there is going to be hoarding and price gouging," he says. Banker adds the legislation may be a tough sell at a time when money is tight.
Without some sort of intervention, the problem could get worse. "I don't think we really know the scope of the problem," Kornberg says, "except that it's large and alarming and growing."
(c) 2011, USA Today.
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