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Health Care Leaders Call Drug Shortages 'Major Threat' to Patients
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Health Care Leaders Call Drug Shortages 'Major Threat' to Patients
February 14, 2012

(The New York Times News Service) -- A renowned Boston oncologist, Dr. Sidney Farber, pioneered a treatment in the late 1940s to beat a childhood cancer long thought to be incurable.

Today, however, children diagnosed with the disease, acute lymphoblastic leukemia, face another threat: a shortage of one of the drugs Farber used to cure it.

A plant that made much of the country's supply of preservative-free methotrexate -- which Al Patterson, pharmacy director at Children's Hospital Boston, called the "cornerstone" of Farber's treatment plan -- closed last year. Patterson said Monday that the supply at his hospital may last just 10 days and that hospitals across the country are facing similar shortages.

"There is no light at the end of the tunnel, yet, that we see," he said.

Patterson was among about a dozen health care leaders who testified before the Legislature's Joint Committee on Public Health Monday about the growing problem of drug shortages linked to manufacturing problems and the rise of what the speakers described as a "gray market," in which drug suppliers stockpile medications, then sell them at inflated prices.

The shortages are particularly severe among drugs that are injected intravenously, because they require more complex manufacturing facilities to maintain sterility. They have affected many aspects of medical care, including cancer treatment, anaesthesia, psychiatric care, and the administration of intravenous nutrition. In a survey last year by the American Hospital Association of 820 acute-care hospitals, nearly all reported drug shortages. Eight-two percent said they had delayed patient care as a result, and 69 percent said patients had received a less effective drug.

"The situation has devolved into a public health crisis that threatens our ability not only to provide routine and timely medical care to patients in need, but also to save the lives of people suffering from what should be preventable, treatable, and curable health conditions," said Representative Jeffrey S?nchez, a Democrat from Jamaica Plain and chairman of the committee.

The list of medically necessary drugs in short supply has grown from 61 in 2005 to about 250 last year, said Dr. Sandra Kweder of the US Food and Drug Administration Center for Drug Evaluation and Research.

Particularly among injectable drugs, the problem is largely rooted in manufacturing troubles, Kweder said.

Last year, Ben Venue Laboratories closed an Ohio plant that made about half of the country's supply of methotrexate, which is also used to treat rheumatoid arthritis, systemic lupus, and bone tumors, among other illnesses. The plant had been under scrutiny for what Kweder said were significant quality-control problems. The plant also was a major producer of Doxil, a drug used to treat ovarian cancer.

"Science and industry created a successful drug, but industry let it disappear," Betsy Neisner, diagnosed with ovarian cancer in 2002, said during her testimony.

Doxil kept the cancer in check after she relapsed from initial treatments, and it has given her a high quality of life, Neisner said. There is no similarly effective alternative. Neisner has been able to remain on the drug during the shortage. But, she said, she aches for those less fortunate and worries that her access will be cut off.

"Rationing is going on for cancer patients today, not because of government, but because of companies" that have disrupted drug supplies, said Dr. David Frank, chairman of the pharmacy and therapeutics committee at Dana-Farber Cancer Institute, named in part for Sidney Farber.

Hospitals are forced to swap out the drugs they typically use for others that may be less effective or more expensive and often come in different doses than doctors and nurses are accustomed to. Adding variables to care creates "a major threat" to patient safety, Frank said.

Several pharmacists said that they receive regular faxes from companies offering drugs in short supply for exorbitant prices.

She said her office is pushing for Congress to make it mandatory for more drug manufacturers to report anticipated disruptions in production before they happen and to take other measures to create a cushion in the case of shutdowns like the one in Ohio. No bills have been submitted in Massachusetts, but Sanchez said the state needs to take a role in addressing the problem.

A dozen health care leaders testified before the Joint Committee on Public Health yesterday about the effects of the growing problem of drug shortages linked to manufacturing problems and the rise of a "grey market," in which they said drug suppliers stockpile medications and then sell them at inflated prices. The shortages are particularly severe among drugs that are injected intravenously, including one to treat childhood leukemia, because they require more complex manufacturing facilities to maintain sterility.

Copyright 2012 The New York Times News Service. All rights reserved.

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