[Ip-health] Cancer Drug Shortages Are Placing Patients at Risk

Joana Ramos jdr at ramoslink.info
Sat Nov 20 19:58:21 PST 2010


Shortages are approaching crisis point

Zosia Chustecka
Medscape Medical News

> November 19, 2010 --- Across the United States, shortages of many 
> critical drugs, including several cancer drugs, are placing patients 
> at risk.
> "The oncology community is experiencing severe and worsening shortages 
> of many critical therapies, including but not limited to doxorubicin, 
> leucovorin, etoposide, nitrogen mustard, vincristine, propofol, and 
> morphine," the American Society of Clinical Oncology (ASCO) announced 
> this week.........

> "Factors we see contributing to these shortages, especially of older 
> parenteral products, include limited production capacity at the firms 
> making these products," said Captain Valerie Jensen, RPh, associate 
> director of the Center for Drug Evaluation and Research (CDER) Drug 
> Shortage Program at the FDA in the written statement. "We also see 
> fewer firms making these products each year since they are often 
> discontinued in favor of newer, more profitable products."

> However, she pointed out that the "FDA does not have the authority to 
> require a firm to increase production, nor can we stop a firm from 
> discontinuing a product. Firms are not required to report shortages or 
> discontinuations to the FDA, except in certain circumstances involving 
> sole-source products, and there is no penalty if a firm does not 
> report this information to us."
> *Lack of Financial Incentive? *
> Most of the cancer drugs that are in short supply are generic products 
> and are manufactured by a few companies. For example, cisplatin and 
> doxorubicin are manufactured by Teva, Bedford, and APP.
> The fact that they are generic products and not trademark-protected 
> drugs from large pharmaceutical companies is part of the problem, 
> according to Carlea Bauman, president of the patient advocate group 
> Colorectal Cancer Coalition <http://fightcolorectalcancer.org>. There 
> is no financial incentive to manufacture cheaper generic drugs, she 
> said: "In a free market, there is nothing to compel manufacturers to 
> make drugs that don't make them money; there is no hammer."


> *Recent Summit Meeting *
> The drug shortages were discussed at an invitation-only meeting held 
> November 5 in Bethesda, Maryland. This Drug Shortages Summit was 
> convened by several groups --- ASCO, the American Society of 
> Anesthesiologists, ASHP, and ISMP. Also invited were representatives 
> from pharmaceutical manufacturers, supply chain companies, and the FDA.
> "Significant drug shortages have occurred in every class of 
> medications, including some critical life-saving drugs," ASHP 
> executive vice president Henri Manasee Jr., PhD, ScD, noted after the 
> meeting. "We have a social responsibility to solve this serious threat 
> to our ability to safely and effectively care for our patients."


Joana Ramos, MSW
Cancer Resources&  Advocacy
Seattle WA USA

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