Cancer Drug Shortages Concern Doctors and Patients
Article date: September 7, 2011
By Stacy Simon
A couple of dozen generic chemotherapy drugs used to treat cancer are currently in short supply. Some of them are commonly used, older, tried-and-true medications. The shortage is causing some doctors to delay treatments or substitute drugs, and forcing some patients to travel to a less convenient treatment center. And it is interfering with clinical trials for research into new treatments.
Reasons Behind the Shortage
The Food and Drug Administration (FDA) says drug shortages in 2010 – not just cancer drugs – hit a record high. And the shortages have only increased in 2011. Reasons include manufacturing and quality problems, delays, and discontinuations.
About 10% to 11% of the drugs on the shortage list are for treating cancer, says Donald Harvey, PharmD, director of the Emory Winship Cancer Institute’s Phase I Clinical Trials section in Atlanta.
Most of them are older sterile injectable drugs. According to the FDA, sometimes manufacturers stop making the older drugs in favor of newer, more profitable drugs.
For example, one of the drugs on the FDA’s shortage list is cisplatin, which is used to treat testicular, bladder, and ovarian cancers that have spread. It also can be used to treat several other cancers, such as lung cancer.
According to the American Society of Health-System Pharmacists (ASHSP) Web site, Bedford Laboratories discontinued cisplatin in May to concentrate on the manufacturing of other products. A Bedford company spokesman says when the decision was made 2 years ago to discontinue making cisplatin, at least 3 other companies were manufacturing and selling it. Now only 2 companies still make the drug, and both of them have it on backorder. A spokeswoman from Teva Pharmaceuticals, one of the companies, says Teva is working with the FDA to ramp up production of injectable drugs and create redundancies in the system. She says Teva’s focus is on life-saving drugs that are on the drug shortage list.
Healthcare company McKesson Specialty Care Solutions is the largest pharmaceutical distributer in North America. Roger Anderson, Dr.PH., Chief Pharmacy Officer, says the FDA’s increased scrutiny on the drug manufacturing process may have contributed to the problem. Anderson says he applauds the FDA for protecting the drug system, but the increased oversight has helped shrink the profit margin so significantly in the last 3 years that some manufacturers have had to shut down plants.
McKesson’s Chief Medical Officer Dr. Roy Beveridge, MD, says there is no economic incentive for manufacturers to make or distribute low-priced generic drugs, and that unless the baseline system changes, shortages are going to continue.
“This is a very serious problem for hospital-based, community-based and academic-based physicians and their patients all over the country,” Beveridge says.
Anderson says treatment centers must be proactive in increasing their stock levels without hoarding, by anticipating the needs of patients and purchasing their supplies from multiple companies, instead of awarding contracts to just one.
The Impact on Patients
The shortages have been going on for at least 9 months to a year, according to Emory’s Donald Harvey, and it’s getting worse. He says Emory has not had a lot of shortages that directly affected patient care, but the problem is worse at smaller hospitals, which may not have the buying power of larger hospitals and treatment centers. That means patients in small towns may end up having to drive to bigger cities to get the drugs they need.
Dr. Harvey says shortages of drugs like paclitaxel, fluorouracil, doxorubicin, and bleomycin are disproportionately affecting patients with lung, breast, and ovarian cancers, as well as some less common cancers. Unlike, for example, an antibiotic, Dr. Harvey says switching to a different cancer drug often means making a sacrifice. The substitute could be less effective, cause more side effects, or not be covered by medical insurance.
This has some patients frustrated and angry. Amy Chen, MD, American Cancer Society Director of Health Services Research, says the shortages are affecting about 10% of the patients in her clinical practice. She treats patients with head and neck cancer at Emory Winship Cancer Institute. When they can’t get the drugs they need to treat their cancer, some patients blame her. And she’s not alone. Dr. Beveridge says when generic drugs aren’t available, patients can relapse. “It doesn’t feel good. The patient then blames you. You must not be very smart or very good. People blame their doctor.”
Dr. Chen recommends patients work together cordially with their doctors to come up with options like using a different drug or a different combination of drugs, waiting until the drug is available, or traveling to an alternate treatment center.
Clinical Trials Affected
The shortage of some cancer drugs is not just affecting patients currently in treatment, but may also have a long term effect on research. Emory Winship Director Walter Curran, MD, says a lot of national high priority clinical trials are being significantly compromised. He is a chairman for the Radiation Therapy Oncology Group, which has 42 studies open. Seven of them are affected because of a shortage of just 1 drug. “If a patient is not on a clinical trial, you can change the drug, with some sacrifices. But if they are on clinical trial, changing the drug affects the integrity of the whole trial.”
Pending Federal Legislation
Legislation has been introduced to the Senate that would require a prescription drug manufacturer to notify the FDA 6 months before it stops making a drug, if that would likely result in a shortage. The idea is that advanced notification will enable the FDA to better track and manage drug shortages, and possibly even use its regulatory powers to help prevent some shortages in the future.
The American Cancer Society’s advocacy affiliate, the American Cancer Society Cancer Action Network (ACS CAN) is supporting this legislation, titled “Preserving Access to Life-Saving Medications Act” (S.296).
American Cancer Society Chief Medical Officer Otis W. Brawley, M.D. says, “The availability of cancer drugs can mean the difference between life and death for many cancer patients. As the nation’s leading cancer organization, the American Cancer Society and ACS CAN are aware and very concerned about the accessibility of prescription drugs, especially chemotherapy agents, and the implications for cancer patients. This is an issue that the organizations continue to follow with great interest.
“The Society and ACS CAN will continue to actively pursue avenues to address drug shortages to improve the treatment of cancer patients across the country.”
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