Cancer drug shortage threatens patients / Defeat Osteosarcoma

By Julian Spector ? | ? February 27, 2012

A recent cancer drug shortage is threatening the prognosis of many pediatric cancer patients with acute lymphoblastic leukemia. Injectable preservative-free methotrexate, a drug that treats acute lymphoblastic leukemia as well as rheumatoid arthritis, has been in short supply since November, when a principle manufacturer?Ben Venue Laboratories in Bedford, Ohio?shut down production. Since then, care providers around the country have scrambled to stock up on the drug, which plays a key role in fighting leukemia, lymphoma and osteosarcoma. Patients at Duke University Hospital have not been affected so far, said Dr. Daniel Wechsler, chief of pediatric oncology and hematology at Duke Hospital and associate professor of pediatrics. The shortage, however, demonstrates continuing flaws in the system of cancer drug production and distribution, which have caused regular shortages in the past several years. ?The thing that is different about methotrexate is that it is curative, and there is no substitute,? said Duke oncologist Dr. Louis Diehl. ?Imagine telling a child that you simply don?t have the medicine that can cure them. You never want to do that.? The Food and Drug Administration expedited its review process and approved a new manufacturer?APP Pharmaceuticals?for a preservative-free methotrexate, according to a FDA press release Feb. 21. Methotrexate forms part of the drug regimen for treating acute lymphoblastic leukemia?the most common cancer found in children that accounts for one quarter of all pediatric cancer cases, Wechsler said. With the development of this and other drugs, the survival rates for acute lymphoblastic leukemia rose from 10 percent in the 1960s to approximately 85 percent currently. **Economic pressures** The effectiveness of the drug does not excuse it from the dictates of supply and demand among drug manufacturers. Of the approximately 1.7 million new cases of cancer diagnosed each year, only 12,000 to 15,000 of them involve children under 15 years of age, Wechsler noted. This limits the opportunity to profit from manufacturing pediatric cancer drugs. ?Because of the relatively small number of pediatric cancer cases in this country, there is not a big economic incentive for drug companies to spend a lot of resources making drugs that affect a relatively small numbers of patients,? he said. Methotrexate is a generic drug with a limited number of American producers. This leads to supply problems if one of those manufacturers has to stop production, such as when the FDA finds manufacturing problems at a facility, said Paul Bush, chief pharmacy officer at Duke Hospital. If the remaining producers cannot increase production to make up for the deficit when another closes, then shortages may follow. Questions remain about what role the government should play in moderating pharmaceutical supply crunches. ?The government should be involved in terms of regulating because you don?t want lousy products hurting patients,? Wechsler noted. ?But can the government force a company to produce something?? One proposal is to create a government oversight body that would communicate with drug manufacturers and compel them to alert the body of imminent shortages or planned halts in production, Wechsler noted. With this information, the government could then offer incentives to drug companies to maintain safe levels of supply for American patients. ?[The system] is flawed on a big level because for a given drug company, they?re under no obligation to say, ?We?re stopping production of this drug in a month.? And if they are the only one that makes it, we?re out of luck,? he said. ?There?s no regulatory body that says every month, ?You need to tell us what your supplies are and what your plans are.? That would be the ideal.? Bush noted that proposed legislation compelling companies to report their supplies more frequently could help, but ultimately a market-driven solution is required. ?It?s been a free market for years?the drug companies manufacture products that sell,? Bush said. ?The better government can?t mandate that a company make a product. All they can do is provide some sort of incentive to make the product, like a tax break.? **Who gets what?** The recent drop in methotrexate supplies is only the latest in a series of 20 to 25 drug shortages that have required the Duke medical community make allocation priority decisions in the past 14 months, said Dr. Philip Rosoff, director of clinical ethics at Duke Hospital and professor of pediatrics and medicine. This has forced Duke Hospital to determine how to prioritize medical supplies in the event that they lack sufficient drugs to serve the patients in need. Rosoff led the deliberations of a committee of oncologists, pharmacists, ethicists and other relevant stakeholders Feb. 6 to apply the existing policy to the current preservative-free methotrexate shortage. ?[We asked,] ?who can benefit the most from the remaining stock??? Rosoff recalled. ?Let?s say we have 100 grams of methotrexate, and we have enough patients in those situations where it can be used for a cure, but cumulatively they need more than 100 grams. Which of those patients get it?? The committee came to a consensus that the top priority patients should be those for whom there is the greatest evidence of the drug?s efficacy, which in this case means children with acute lymphoblastic leukemia and certain types of bone cancer, he said. Next, priority goes to patients in the midst of treatment over those who have not started and then to patients for whom the drug is less likely to be effective. Within those bounds of comparable medical situations, Rosoff said, all patients are equal. ?Patients are patients irrespective of other characteristics about them,? he noted. ?There?s no VIPs that can jump ahead of people, and no less important people that we can bump to the back.? Although the policy is in place, there has not been cause to implement it yet at Duke. ?We are lucky in that we [at Duke] have yet to have be faced with having to make a tragic choice between two or more people who could realistically benefit from receiving a scarce medicine when there is not enough to treat all of them,? Rosoff said. ?But if we keep on having shortages like this, then this will come up some time.?

Source: http://defeatosteosarcoma.org/2012/03/cancer-drug-shortage-threatens-patients/

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