Clinical Trial

Last week's news that a medical researcher studying zinc lozenges owns stock in the Doylestown company that sells the cold-remedy product might have raised eyebrows among the general public, but it's not an unusual event in today's commercial world of science. Researchers increasingly have financial interests in the medicines, devices and treatments they test before they're sold to the public - so much so that the Food and Drug Administration says there needs to be a financial-disclosure rule for all scientists who conduct clinical trials, to identify potential bias.

The recent votes to legalize marijuana for medical use in California and Arizona, and the Clinton administration's threats of sanctions for physicians who prescribe pot, beg the larger question: Is marijuana good medicine? The answer is: No one knows for sure. And until scientists can conduct tightly controlled, clinical trials, no one will know. So instead of taking punitive measures, the Clinton administration should have the guts to authorize and fund serious research, to serve as a basis for sound public policy on this emotional issue.

Leo Lyons of Indian Mills, Burlington County, knew he had a mild case of high blood pressure, but did not take medication for his ailment. However, when he heard a radio announcement that a Jenkintown clinic wanted volunteers for a hypertension research project, he leaped at the chance to receive free care. "I had lost my medical insurance at the time, and anything to do with high blood pressure caught my attention," said Lyons, a 58-year-old ostrich farmer and former computer engineer.

About 250 Burlington County residents are expected to gather tomorrow at Haines Elementary School to participate in a federally approved study of an experimental vaccine to ward off Lyme disease. Sponsors said the initiative was the first study to evaluate the effectiveness of a Lyme vaccine on humans. Clinical trials on the vaccine will be held beginning tomorrow in five states with a total of 8,000 volunteers. In addition to New Jersey, where 2,000 people are expected to participate, trials will be conducted in New York, Connecticut, Wisconsin and Massachusetts.

Michele Feiner found a lump in her breast and stepped on the roller-coaster no woman wants to ride. A surgeon told her she had non-invasive cancer, but nonetheless her breast would have to be removed. Jefferson breast cancer specialist Gordon Schwartz offered something different. "He said that I didn't need surgery, but I'd be married to him. He would examine me four times a year and I'd get an annual mammogram," said Feiner, of Plymouth Meeting. "I was 31 when this happened.

Less than three years ago, Estelle Meyding was a college teacher and serious runner who played tennis three times a week. Suddenly and painfully, large areas of her skin began to tighten, thicken and harden so much that, within months, she no longer could extend her arms. She had to resign as a reading specialist at Valley Forge Junior College. Sports were out of the question. "Doctors describe the pain as pins and needles," she said. "I describe it as knives and forks. " The diagnosis: a rapidly escalating case of scleroderma, a mysterious disease that, in its most severe form, turns the skin and other organs rigid and kills 80 percent of its victims, mostly women, in less than 10 years.

People with AIDS infection are eligible to participate in 30 different clinical trials in Philadelphia hospitals, according to a directory to be published today. Eighteen of the trials, including four for children, are of drugs designed to combat the AIDS virus itself. The 12 others will test various therapies for HIV-related conditions and opportunistic infections. At Graduate Hospital, for example, physicians are examining the drug omegasyn's effectiveness in combating severe fatigue.

In his Aug. 14 opinion column, "AIDS victims: Potential cures kept unavailable," Stephen Chapman defines a "double blind" trial as one in which "for every patient getting the (potentially useful) drug, another one must be given a worthless placebo. " This is not correct, and may give readers an alarming impression of clinical trials. To deny patients a known effective treatment violates a physician's ethics. If it becomes apparent during the course of a clinical trial that an experimental treatment is clearly effective, patients can be moved out of the "ineffective" groups so they can receive the new treatment.