Robert McCoige

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Robert McCoige - WtUNESUAY, JULY 19, 1995 A9 THE INDIANAPOLIS...
WtUNESUAY, JULY 19, 1995 A9 THE INDIANAPOLIS S1AR Accelerating to new drugs By ROBERT W. McCOIGE ine years ago, I was diagnosed diagnosed with kidney cancer. If I hadn't been lucky enough to receive an experimental drug, I would be six feet under today. Instead, I'm working as an engineer engineer for the city of Goshen, playing playing tennis and competing in 10K races. So when people talk about reforming the Food and Drug Administration Administration in order to give patients patients access to new drugs sooner, this is not just an abstraction to me. It's a matter of life and death mine. In 1990, the latest year for which figures are available, the National Cancer Institute estimated estimated that about 149,000 Americans were living with kidney cancer. About 30,000 new cases of kidney cancer are diagnosed each year, according to the American Cancer Society, and the disease kills more than 10,000 people annually. When I was diagnosed with kidney kidney cancer in 1986, the prospects weren't bright. But after surgery I got included in a clinical trial of a new biotechnology medicine being conducted at the University of Chicago. The medicine was Inter-leukin Inter-leukin Inter-leukin II, which activates the body's own defenses against certain certain cancers. This drug doesn't work for everybody. everybody. In fact, it is estimated to help about one out of four kidney cancer patients. And it can produce produce some pretty severe side effects. effects. It's not a perfect drug, but it saved my life. I am now, knock on wood, cancer-free. cancer-free. cancer-free. Since I believed this drug should be more widely available, I testified testified in 1988 before a Food and Drug Administration panel considering considering its approval. The panel turned down the request even though the drug was already marketed marketed in nine European countries. Some three and a half years later, in May 1992, after another hearing hearing at which I testified again, the FDA approved the drug. In the interim, while committees met and papers were shuffled, many kidney cancer patients died who might have been saved. I was extremely lucky to be included in the clinical trial of the medicine. But not everyone is so lucky. You have to live in the right place, and have a physician who happens to know about the trial. There's a lot of just plain luck involved. Instead of relying on chance, we need to take positive actions to make sure patients have speedier the access for patients Eleanor Mill Illustration access to promising drugs. Because Because of agitation by AIDS patients, patients, drugs for this disease are put on a fast track at the FDA. This proves the FDA can review drugs faster if enough pressure is applied. But patients shouldn't have to go that route. We need to make legal, institutional changes. For a start, Congress can Instruct Instruct the FDA that its Job is. to help save lives by getting safe and effective new medicines to patients patients quickly, not just to guard the public against unsafe drugs. When the medicines in question are for potentially fatal diseases such as kidney cancer, the FDA shouldn't hold up a drug because of side effects. People with life-threatening life-threatening life-threatening diseases should be allowed allowed to make the decision that the risk of side effects is worth taking. A new medicine gave me my life back. But bureaucratic foot-dragging foot-dragging foot-dragging foot-dragging may have denied that chance to many other people with kidney cancer. We need to change the system to give all patients the chance I had. McCoige resides in Goshen. Time Savers Watch Repair. Since 1919, Windsor ha been repairing and maintaining fine watche. Saving people time and money. All Models Serviced Including Quartz Batteries Replaced While ton Wall. SOUTH OF THE CIRCLE AT 16 N. MERIDIAN 634-6736 634-6736 634-6736 MON. - FRI. 9-5, 9-5, 9-5, 6AT. 9:30-3 9:30-3 9:30-3

Clipped from The Indianapolis Star19 Jul 1995, Wed[First Editon]Page 8

The Indianapolis Star (Indianapolis, Indiana)19 Jul 1995, Wed[First Editon]Page 8
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