Scientists at the National Institutes of Health know Samantha Seinfeld’s body down to its cellular makeup. Every few months, she shows up at NIH’s leafy Bethesda campus to get a CT scan and be injected with an experimental vaccine. Made from a live fowlpox virus pumped up with genes, the vaccine is intended to boost Seinfeld’s immune system. Later, at home, she gives herself injections of a drug that stimulates the growth of white blood cells. Seinfeld, a 35-year-old former solar energy marketer, endures this in the hopes of staving off a recurrence of Stage IV breast cancer — but she is also contributing to scientific research. For three years Seinfeld has been a participant in one of NIH’s clinical trials, or medical studies conducted on humans. This one is testing whether a vaccine called PANVAC and its follow-up boosters will keep breast cancer, which first showed up in Seinfeld’s breastbone five years ago, from coming back. It’s risky, uncertain and exhausting at times — and not necessarily foolproof.
Despite all that, Seinfeld is extremely grateful. “Clinical trials are not for everyone,” she said. “My faith has been in science. I find it more comforting to look at numbers, statistics and research. Cancer is not a death sentence in this day and age. So much is being done in research.” Seinfeld, who no longer works, devotes much of her day to learning everything she can about her disease.
NIH is conducting nearly 1,500 trials at its Clinical Center and is budgeted to spend about $10 billion on clinical research this year, with about $3 billion of that specifically for trials. The center is the largest hospital in the world dedicated to these human studies. Their topics range from obesity to rare blood diseases to cerebral palsy, and they represent only a small fraction of the trials conducted in the United States. Still, they are unique because many of the diseases being studied are too rare, or the treatment is too much of a gamble, for pharmaceutical companies, biotech firms or universities to pursue.
“It is the only way to know if a new drug or device will work,” said John Gallin, director of NIH’s Clinical Center. “As such, [a clinical trial] is the future of medicine.”
A new drug or device cannot get the okay from the Food and Drug Administration unless it has gone through three phases of clinical trials. It was here that scientists discovered that fluoride can prevent cavities, that lithium can bring relief to people with bipolar disorders, that AZT can prolong the life of people with AIDS and that an MRI scan can assess the risk of a heart attack in patients with chest pain.
Reasons are varied
The government created the Clinical Center in 1953. Initially NIH scientists relied on word of mouth among doctors around the country to find patients to participate in research. Today, many people learn about trials through the Internet at Clinicaltrials.gov and the center’s own site, and the numbers hoping to get into a trial has ballooned.
About 400,000 patients have participated in NIH-sponsored clinical trials, and they come for a variety of reasons: a last-ditch effort at a cure; a rare disease no one else understands or can treat further; a new approach to a disease; or a desire to further medical knowledge.
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