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MONDAY, June 4 (HealthDay News) -- John Mahan, a 58-year-old Nashville firefighter battling a gastrointestinal cancer, couldn't believe what he was hearing last July.
His doctor had just told him that his clinic had run out of injectable fluorouracil (5-FU), the generic chemotherapy Mahan needed to keep his tumor at bay.
"My initial reaction was, 'you've got to be kidding, right?'" he said.
Unfortunately, the news was all too real. Mahan was switched to another drug, capecitabine. Taken in pill form, it had the same anti-cancer effectiveness as 5-FU but with more onerous side effects.
"It made me feel bad, weak," Mahan said, "just run down, feeling tired all of the time, loss of appetite."
At a Monday news briefing at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Mahan spoke on behalf of the thousands of cancer patients who have been hit hard by the recent nationwide shortages of generic, injectable cancer drugs.
The crisis peaked earlier this year when children with a leading form of childhood cancer, acute lymphoblastic leukemia (ALL), were faced with a looming shortage of a lifesaving drug, methotrexate. Quick action on the part of the U.S. Food and Drug Administration, the pharmaceutical industry and others averted that shortage, but deficits in this and other cancer medicines are still possible, experts warn.
"The good news has been that the frequency of the drug shortages has begun to decline for a variety of reasons," Dr. Richard Schilsky, chair of ASCO's government relations committee, told reporters. "But there is still an unpredictable availability of many drugs and we are never sure exactly when a generic drug is suddenly going to go out of supply. That creates a tremendous amount of uncertainty -- anxiety for our patients and great difficulty in planning if you're a physician."
Overall, 22 crucial oncology therapies have recently been in short supply, noted ASCO President Dr. Michael Link. Of most concern right now, he said, are shortages of a handful of medicines:
"Hearing from our members, we are learning that the shortages are most acute among community practices where the majority of adult patients are cared for," Link added. Smaller centers may not have the buying clout that larger, academic medical centers might have, leaving them more vulnerable to shortages, he explained.
These drug shortages typically occur among sterile injectable cancer medications that have gone to cheaper, generic status. The experts gathered at the meeting noted that the world's supply of generic medications is now concentrated in only about six companies that may produce dozens or hundreds of drugs.
"So, for example if one company makes 30 products and they have a problem, suddenly 30 products are at risk of a shortage," explained Dr. Sandra Kweder, deputy director of the Office of New Drugs at the FDA. Producing highly sophisticated, sterile injectables is a particularly complicated process, she said, and quality issues can arise that cause plants to be temporarily shut down while the issue is resolved.
In many cases, these safety issues are not minor ones, Kweder noted, and can include "particles of glass or metal shavings" found in vials that, of course, pose safety issues for patients.
But, why the shortages now? According to Kweder, it's not that new, tougher quality-control rules have come into place recently. Instead, a host of popular drugs have recently gone off-patent and "what we've seen is great growth in the generic world," she said. As more generics get produced at more production facilities, "we are just seeing more in terms of problems in that manufacturing," Kweder said. Many companies are now modernizing their production facilities, she said, but that will take time.
According to Kweder, the FDA, in close consultation with drug companies, has already prevented about 150 drug shortages since October of last year, when President Barack Obama signed a special Executive Order demanding action on the issue. As companies gave FDA early warning of looming problems, the agency and the pharmaceutical industry worked together to find alternate sources of supply, including imports from abroad, Kweder said.
Methotrexate, the drug needed by children with leukemia, "continues to be very carefully monitored," Kweder said. "We expect the [shortage of] the injectable that has been difficult for some practices to obtain to be resolved within the next month completely."
Progress is taking place at the Congressional level as well, the experts said, as a bill makes its way through the House and Senate that would mandate that generic drug makers give the FDA six months advance notice of any possible production problems.
The bill, which has the full support of ASCO, also includes a provision that generics makers would pay the FDA a user fee, aimed at speeding oversight and approval for new generics.
All of this gives some comfort to Mahan, whose cancer has progressed but is being held in check by a new course of therapy. Still, he worries about other patients who may be facing the same dilemmas he did.
"Until this impacts you personally," he said, "most people aren't even aware that there's even a shortage going on."
Find out more about the shortage of cancer medications at the U.S. Food and Drug Administration.
SOURCES: June 4, 2012, press briefing, annual meeting of the American Society of Clinical Oncology (ASCO), Chicago, with: John Mahan, Nashville; Richard Schilsky, M.D., chair, government relations committee, ASCO, and chief, hematology/oncology, University of Chicago School of Medicine; Michael Link, M.D., president, ASCO, Stanford University School of Medicine and Lucile Packard Children's Hospital, Stanford, Calif.; Rear Admiral Sandra Kweder, M.D., deputy director, Office of New Drugs, U.S. Food and Drug Administration
Copyright © 2012 HealthDay. All rights reserved.
Thu Jun 07, 2012 03:16 PM
I too have been faced with this dilemma. I have been undergoing treatments since Dec. 2009 for Ovarian Cancer and twice already have been hit with shortages. The first of Taxol wasn't so bad, but just recently I was at the half-way mark of six rounds of Gemzar & Carbo when there was a Gemzar shortage. When I was placed on the Gemzar regimen, the Dr. had actually wanted to put me on Doxil/Carbo, but at that time there was a shortage of the Doxil. Well, with the shortage of Gemzar, the Doxil had become available and I'm now on Doxil/Carbo. The shortages and change in treatment extended the treatments.
Cancer patients have enough to worry about without having to worry whether their meds are going to be available. I think a lot of this has to do with $$$. Sometimes I think about just skipping the treatments - at least I might feel better for awhile, even though I might not live as long.
Who knows maybe some of the bigger Cancer Centers is working up a deal with the suppliers so that we all have to go to their facilities. Just one more thing to worry about - and they tell cancer patients to worry and get stressed out?????
Fri Jun 08, 2012 05:51 AM
I am also being treated for Breast Conservation treatment.. I have prescribed Letrozol. In the starting I did not have any problem and I am taking this medicine since 2 years. But now my Left hand has been effected. I have lots of problem I cannot move my hand backwards. Upright and I have lots of paid the day long. Can some one hlep me in this matter.
Fri Jun 08, 2012 02:28 PM
It's all M&M's...Math and Money. When Pharmacy Giants 'Do their Math', they find that they are losing their Money. The technologgy is there for better Disease Management for many types of Cancer. The new meds that I will be starting is made by a Pharmacy in Switzerland
Sat Jun 09, 2012 05:36 PM
I have CLL Leukemia I was faced with this situation until I began making and ingesting Hemp Oil with THC for my Leukemia. The Hemp oil seems to be lowering my WBC on a monthly basis. It is now at 43,000 and is stage 0.
I found that there is no shortage of Hemp Oil with THC with which to make my medicine. I also had a spot of Bowens Squamish Cell Carcinoma and put it on the skin cancer and covered it with a bandage. In four days it was almost all gone and after re applying it again in ten days the liesion was completely gone and after six months there has not been a recourrance. If any do re-occur, I will treat it again with Hemp Oil with THC as seen on the phoenixtears video "Run From The Cure" I saw on YouTube.
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