MB Civic

By Jerry Fensterman | August 3, 2006 | The Boston Globe

I AM BATTLING an incurable cancer. I’m alive, thanks to a clinical trial drug. News of cancer breakthroughs captures my attention nearly daily as new drugs — and redeployed old ones — slow, stop, reverse, and even cure previously fatal cancers. Will a miracle come in time for me or for those like me?

Since only 5 percent of cancer patients participate in clinical trials, it takes three to five years to gauge a new therapy’s effectiveness. According to a former director of the National Cancer Institute, this could be shortened to just one if 10 percent of patients would participate in clinical trials.

Doubling participants should be easy.

A Harris Interactive survey of 6,000 cancer patients conducted in 2000 reported that 85 percent of the respondents “were unaware that participating in a clinical trial was a treatment option.” That seems to be why only 5 percent of patients participate in clinical trials. Attracting another 5 percent should be a breeze, especially since all parties want better drugs faster. Why is there a problem? My experience may reveal some answers.

When my cancer became incurable, my only hope lay in clinical trials. I expected to find a well-organized system to help me learn about and enroll in appropriate trials. This is hardly what I found. I learned of good trials not because of an organized and equitable system but because my oncologist is a leader in kidney cancer. I’d only leaped the first hurdle.

I planned to call trial doctors in my hometown of Boston, Chicago, and New York to see if their trials were right for me. But to be taken seriously, I was told, I would have to visit. Doctors are busy, and phone calls don’t demonstrate sincere commitment. I told myself I’d go anywhere to save my life. But my one trip to Chicago demonstrated just how hard it would be to fly there twice per week and continue those trips indefinitely if the drug worked.

Expenses mount fast. Travel is costly. My employer paid my salary despite time missed. How many other people would be so fortunate?

There may also be variable costs to participate. Two of my trials required only a co-pay. One, however, amassed bills of $7,000 in less than two months. Such costs are a hardship in any circumstances, but more so now since I have gone onto long-term disability and my income is down 60 percent.

Most trial drugs are free. Mine was until it received Food and Drug Administration approval. Because I’m well insured, I only pay 1 percent of the $4,300 monthly bill. Imagine the person who successfully navigates the trial system but lacks health insurance.

I’m lucky. I live close to major research centers. My doctor leads many trials and knows of others. My employer was unusually supportive. I possess sufficient moxie to advocate for myself. And I do have that insurance. Missing even one of these characteristics might doom my chances.

Improving the system won’t be easy. Human experimentation demands extraordinary caution, well-organized administration, and oversight. Achieving cost efficiencies is easier in larger systems. Yet we have to do more to help the many people who don’t share my advantages.

Given the vast profits of the pharmaceutical companies and the public good at stake, it doesn’t seem too much to ask all interested parties to partner in improving this system, making it easier for sick or dying patients to participate in clinical trials without regard to where they live or how much money they have. That includes not having to pay one penny for the right to be a guinea pig. After all, you may one day live a better life because of the vomiting I did — certainly on my behalf but possibly also on yours.

Powerful national and global interests are served by making better drugs faster. More private and public funding would make a big difference. So, too, would demystifying and improving the clinical trial system. It seems an important and solvable challenge. Drug discovery is supposed to be the hard part, right?

Jerry Fensterman was the director of development for Fenway Community Health until he was disabled by kidney cancer.