Cancer treatment drug shortages hit Western Massachusetts

By Patrick Donges

Pittsfield, MA – According to the U.S. Food and Drug Administration's website, in 2010 there were a record 178 reported drug shortages and this year the agency has seen that number rise.

Those shortages include anesthetics, drugs needed for emergency medicine, and cancer drugs, the latter of which can put patients and physicians in the situation of waiting for medication that has been established as necessary for a course of treatment. Dr. Richard Schilsky is a professor of medicine and chief of the section of Hematology and Oncology at the University of Chicago.

"There are shortages that are occurring sporadically all over the country. From what I can tell it's variable both with respect to where the shortages are and which drugs are in short supply, and it's somewhat cyclical as well with drugs coming in and out of supply."

In Western Massachusetts the shortages have affected the clinical decisions of some providers. Dr. James A. Stewart is Chief of Hematology and Oncology at Baystate Medical Center in Springfield.

"The shortage is real; it's a national event. We're dealing with it fairly here well at Baystate. We have had some situations where we need to change a patient's treatment plan using alternative treatments due to certain shortages, so we've seen that."

While using other drugs may be an option for patients dealing with some shortages, for others there is no alternative or the non-generic, brand name choice is cost prohibitive.

Josh White, nurse manager at Berkshire Hematology Oncology, which serves the county's three hospitals described one ongoing local shortage for which there are few viable alternatives.

"There are many shortages, mostly of generic drugs. Most notably leucovorin; which we haven't been able to give to colon cancer patients since October 2010."

Leucovorin, according to the National Institute of Health, is used to protect healthy cells from chemicals used in chemotherapy treatments. It is among those generic drugs that providers say pharmaceutical companies have little incentive to produce because their profit margin is so low, here's Schilsky.

"The generic manufacturers do not have much economic incentive to pursue the manufacture of generic cancer drugs, particularly if there's a manufacturing problem that develops."

"Most generic drug suppliers make all sorts of drugs, the cancer drugs they may make are probably only a small part of their portfolio, and most of the other drugs are much more widely used."

In the case of leucovorin, White said just as the first shortage hit, a new, brand name alternative was coming onto the market.

"There was a drug made by a company called Spectrum pharmaceuticals called Fusilev. It cost 38 times as much as leucovorin, but it didn't have an indication for colon cancer."

"It went on shortage again when they applied for that indication for the FDA. So now we're all wondering if we're ever going to see leucovorin again, and is there some kind of side deal, or something? Who knows what goes on behind closed doors?"

According to Paul Arndt, senior manager of investor relations at Nevada-based Spectrum Pharmaceuticals, while Fusilev received indication for use in colon cancer treatment April 29 of this year, the drug has been approved for use by the FDA for the treatment of another type of cancer since 2008.

Arndt said the company sold Fusilev to providers for colon cancer treatment per the FDA's request throughout three shortages since 2008, but that no cost adjustments were made to compensate for the increased price of the premium drug.

Providers and advocates agree that the issue currently has little traction in Washington amid debates on economic issues; Schilsky suggested one way providers may be able to advance the debate.

"If an oncologist shows up in their congressman's office with one of their patients who sits there, looks the congressman in the eye and says, 'I'm dying because I can't get the drugs that I need to keep me alive,' that would get the congressman's attention."