Patients battle drug shortages for life-saving treatments
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On July 6, Betsy Neisner of Leverett went to Massachusetts General Hopsital in Boston for her monthly chemotherapy treatment for the ovarian cancer she has been fighting for nine years.
But on that day, she said, her doctor gave her some news. The hospital had only enough Doxil - the drug Neisner needs - to treat one person, and there were 12 patients waiting, Neisner said.
Neisner retraced her steps, driving several hours back to western Massachusetts without being treated - and not knowing when she'll get the drug she needs.
Her doctors and her care at Mass General are top-notch, Neisner says, and so she was not angry at them.
But something clearly was wrong.
"Why can't hospitals be put on notice if there's going to be a shortage?" she asks. "I don't understand that. I just want to know why this is happening."
Most cancer patients - who already feel they have so little control over their lives - are in no position, Neisner says, to navigate the thicket of bureaucratic, regulatory and economic forces that seem to be creating drug shortages around the country.
Patient and advocate
Neisner is still waiting to hear whether MGH will have enough Doxil - a drug that's used to treat ovarian cancer patients whose disease has progressed or recurred - on hand for her next treatment, scheduled for August.
Since starting on Doxil 15 months ago, she said, "I've been doing great."
Like other ovarian cancer patients around the country, she has looked into her options - in her case, a much more toxic drug that would have much harsher side effects.
But unlike most other cancer patients, she's also trying to take action as a consumer advocate. Neisner, 57, is the director of Cancer Connection, the Northampton-based, nonprofit organization that offers support programs to cancer patients and their families.
Other patients "don't have the time to pursue this," Neisner said during an interview last week at Cancer Connection. "And they don't want to be seen as complainers." But in her role as head of an organization that exists to serve those with cancer, Neisner says she feels she needs to figure out what's going on with Doxil and with other drugs that cancer patients need.
"I have to stay aware of it," she said.
Neisner is a former lawyer who quit practicing because of her illness. She has also served as a consumer advocate on government panels that review applications to fund ovarian cancer research.
Her hope, she said, is that by speaking out, she can help bring the issue to public attention.
Growing problem
It's a story that's becoming all too familiar.
In a survey released July 12, the American Hospital Association found that "hospitals across the country are feeling the strain of drug shortages on their resources, a situation that has serious consequences for patient care ..."
The AHA reported that 82 percent of the 820 hospitals it surveyed said they have had to delay treatment to some patients. Sixty-nine percent of the hospitals said they sometimes had to substitute less effective drugs - or had to purchase more expensive alternative drugs from other sources. And, they said, most hospitals said they don't get advance notice of pending shortages in the manufacturing or distribution pipeline, nor are they given clear reasons for the shortages. Though some of the drugs involved are for life-saving chemotherapy treatments, many others are used for other purposes.
Looking for answers
In her effort to find out when Doxil will be on the market again, Neisner last week made several calls to the company that manufactures it, Ben Venue Laboratories of Ohio.
She was told, she said, that the holdup was due to problems that had been noted by the Food and Drug Administration during a recent inspection. The problem, she was told, had nothing to do with the safety or efficacy of Doxil - and that, in fact, there are supplies of the drug sitting at distribution sites. But the supplies can't be released, she was told, until the paperwork currently traveling back and forth between the company and the FDA is complete.
Ben Venue makes Doxil for Janssen Pharmaceutical Companies of Pennsylvania, a division of Johnson & Johnson.
In a July 19 letter to health care providers, Janssen said it now estimates that supplies of Doxil won't be shipped until late August and "may be intermittently available in the weeks thereafter." In the meantime, the letter said, doctors shouldn't put any new patients on Doxil.
Neisner also wrote to her congressional representatives - U.S. Reps. John Olver, D-Amherst, and Richard Neal, D-Springfield, and Sens. John Kerry, a Democrat, and Scott Brown, a Republican.
In her emails, she said she wanted to make them aware that the shortages are affecting patients. She asked for their assessments of the causes of the shortages. And she asked them to review legislation already filed in Congress that would give the FDA authority to require early notification from drug companies of looming shortages and to let her know whether they support the legislation or not.
She also contacted the FDA in Washington and says she spoke to an officer there to see if importing drugs from overseas is an option in situations like this, and if so, to find out how it is done. She was told, she says, that the application takes about 30 days and that European countries are generally reluctant to let much of their own supplies leave for fear of creating shortages for themselves. She also learned, she said, that she couldn't file a Freedom of Information request about the Doxil shortage until the situation was resolved.
"All very fascinating," Neisner wrote in an email to an acquaintance who works in the health care field, "and here I sit, wondering whether my cancer cells care."
Complex issue
Contacted by the Gazette last week, Karen Nelson, vice president of clinical affairs at the Massachusetts Hospital Association, said the situation in the commonwealth mirrors the AHA's national survey.
"It's a very similar experience," she said. The shortages started showing up a year ago, she said, "and have been kind of snowballing since then."
To help track shortages, the American Society of Health-System Pharmacists is maintaining a list on its website. One item still on that list is cytarabine, a drug used to treat some forms of leukemia that received national media attention several months ago; according to the society, that shortage remains unresolved.
As to why the shortages are happening, Nelson said there are likely a host of contributing factors, among them the ongoing consolidation within the drug industry resulting in fewer, larger companies.
"As the companies get larger, there are fewer manufacturers of the same items," she said, and the remaining companies are less "nimble" about making changes in their product lines. Nelson said the lack of economic incentives to make older, less profitable generic drugs is also a factor.
Compounding those systemic problems are glitches in the "communication chain" that result in hospitals not being informed about production problems or delays. Companies are only required to inform the federal government's Food and Drug Administration of production problems if they're "the sole provider" of a drug, Nelson said.
Several news accounts of the shortages have also cited questions about whether federal government regulation and the red tape it entails are partly to blame for the delays - or whether government regulation is simply a convenient target for the pharmaceutical industry.
Whatever the causes, the shortages are creating numerous problems for hospitals, Nelson said.
Hospitals forced to find other sources can wind up paying "exorbitant costs," Nelson said, and the drugs they get may come in different formulations or concentrations - and that means time spent alerting staff to changes.
"It's not as simple as getting the simple round pill from somebody else," she said. "It's a huge burden across the system."
Dr. Michael Birrer, a professor at Harvard Medical School and director of gynecologic medical oncology at Mass General, says it's hard for doctors on the front lines of patient care to connect the murkier dots.
"I'm not really sure if this is a collision of rare events or something more systemic," he said in a telephone interview Friday.
In recent days, Birrer said, he has sent patients needing Doxil to hospitals in Maine, suburban New York, and Worcester because smaller hospitals are more likely to have supplies on hand. Birrer said it does seem, as the AHA survey found, that the shortages are becoming more frequent.
In Northampton, Cooley Dickinson Hospital spokeswoman Christina Trinchero said the hospital has experienced no shortages of chemo drugs yet.
Life on hold
Meanwhile, Betsy Neisner says she has contacted Dr. Richard Penson, her oncologist at Mass General, to talk about whether she should switch to what she calls the "dreaded," more toxic drug. And she's put her plans for a family vacation to Michigan in August on hold, she said, until she knows what her treatment will be, and when it will take place.
Last Friday, Neisner said she contacted Janssen Pharmaceuticals, but the spokesperson she reached had few specifics to add to July 19 letter posted on doxil.com that had cited production delays.
"We are deeply committed to ensuring that this treatment is readily available," the letter stated. "We will continue to work diligently with the supplier to help expedite production as soon as possible."
Suzanne Wilson can be reached at swilson@gazettenet.com.
