Column: Drug shortage: What can I do?

These are just some of the questions that I and the hundreds of thousands of others going through cancer treatment ponder on a daily basis. We know that these questions come with the territory, and we try to focus on staying positive and getting well. What we didn't anticipate was the truly life-threatening question we were hit with this summer — will our doctors be able to get the drugs we need to survive? As of now, this question remains unanswered.

As the Food and Drug Administration recently acknowledged, there is a serious shortage of lifesaving intravenous drugs needed to treat a variety of cancers in the USA. Though not all the drug shortages are for cancer treatment, the majority are. There are 197 drugs on a shortage list compiled by the American Society of Health-System Pharmacists in Bethesda, Md., a list that includes drugs that treat breast, ovarian, lung and colon cancers as well as various forms of leukemia and lymphoma. According to Cynthia Reilly, the director of ASHP's Practice Development Division, "There are cancer patients who will die because of this."

Shortage hits home

On May 13, the drug I depend upon was added to the list, a fact I became aware of the night before my ninth chemotherapy treatment. I was notified by my oncologist that his facility might not have any paclitaxel, the intravenous drug I need to cure my cancer. He told me to come in as planned and we would discuss our options as necessary. This was worrisome because, as far as I know, I don't have any options. Paclitaxel, the generic version of the drug Taxol, is the final part of a three-drug regimen that is the gold standard for treating the relatively rare type of breast cancer I was diagnosed with in March.

How could a shortage of such life-and-death drugs happen?

The FDA reported a record spike in drug shortages in 2010, a trend that continues this year and appears to be getting worse. A limit placed on the amount manufacturers can charge for generic drugs led to a significant drop in their profits. This caused many companies to stop making the drugs, a decision that served their bottom line but placed those of us who rely on them in danger.

There also is no regulatory requirement that manufacturers notify the FDA when they stop making a drug. So the agency had no idea the production of these critical drugs had stopped. In turn, this gave the FDA no opportunity to take action to prevent the shortage from occurring, and other manufacturers had no way of knowing they had an opportunity to pick up the slack.

The situation is exacerbated by the fact that intravenous chemotherapy drugs are very difficult to make, and their production is subject to strict quality-control measures. With the void left by the companies that got out of the business, any quality problems experienced by the remaining companies that interrupt production have an immediate negative impact on the overall supply.

A Solomon's decision

My treatment facility provides chemotherapy to approximately 150 patients per week. Now, the doctors must spend valuable time holding meetings to determine which of their patients should get the limited supply of lifesaving drugs that trickle in each week. Who can receive the drugs because they have a chance of being cured? Who cannot be cured but can have their life prolonged for a year or maybe more with the drugs? Which patients can receive an alternative treatment and survive, and which cannot?

After a sleepless night, I went in for my regularly scheduled appointment not knowing whether I would receive the drug. Based on the protocol the doctors had established, I was told I would receive one of the doses of paclitaxel they had left. At first, I felt an overwhelming sense of relief. But my relief was immediately replaced with guilt and sadness. I couldn't stop wondering, if I am getting the drug, who isn't?

All over the country, doctors are faced with these difficult decisions, patients are worried about the quality of their care and all of us are wondering when this issue will be resolved.

There are several ongoing efforts to alleviate the problem, including proposed legislation to require companies to report to the FDA well in advance a decision to stop manufacturing a drug. The FDA is also considering allowing some of the drugs to be imported from foreign sources that have not been approved in the U.S. But the agency, of course, must first ensure that the drugs meet its quality standards. While it is heartening that these efforts are underway, all these fixes will take time that many of us don't have.

What's the latest status on my cancer drug? Bedford Laboratories told ABC News that it expects to release more paclitaxel soon. But Teva Pharmaceuticals USA anticipated "constraints through the summer." In truth, nobody really knows.

So, we add to the list of questions we worry about on a daily basis: Will I be one of the "lucky" ones to receive my chemotherapy this week? Do I really deserve it more than someone else?