For research companies in search of human guinea pigs to test new drugs or conduct other research, L.A. is a very attractive place.
The dense and diverse population here is a tantalizing pool for industry and institutional sponsors. In fact, the National Institute of Health Web site lists 380 research studies now recruiting in Los Angeles.
Almost all major pharmaceutical and biotech companies, most of which are based on the East Coast, back clinical trials in L.A. In addition, research is done by the U.S. Department of Defense and the Department of Veteran Affairs, along with smaller for-profit groups like California Clinical Trials Medical Group Inc. and Alpha Therapeutics Corp.
The work includes a slew of local medical centers, including facilities at UCLA and USC, and other facilities like Cedars-Sinai Medical Center and Kaiser Foundation Hospital.
“Everybody wants a piece of what they see as a growing pie,” said Marie Clarke, spokeswoman for the nonprofit Health Research Association, which is based at USC and is said to be the largest clinical research site in the country.
Founded in 1947, HRA manages around 300 research studies each year for the USC School of Medicine. The company acts as an intermediary between the industry sponsors of a trial and USC medical researchers. Among other things, it finds USC physicians to conduct the research, hires support staff, purchases equipment and helps with patient recruitment.
HRA’s list of current industry sponsors reads like a who’s who of pharmaceutical and biotech players. Amgen Inc., Bristol-Myers Squibb Co., Merck & Co. and Warner-Lambert Co. are among the nearly 60 companies tapping HRA for clinical trials. The volume of genetic research, in particular, has exploded.
“Genetic research is making it possible to tailor a drug to you and your DNA,” Clarke explained. “That is phenomenal and foreign territory. There is a tremendous amount of interest in the field and a tremendous number of clinical trials.”
Subjects wanted
Finding the right people to participate in the research can be a major challenge. For example, HRA was recently asked by a drug company to recruit Japanese women born in Japan who have lived in the U.S. for 10 years and are infertile.
While Clarke said those women “don’t grow on trees,” she is confident HRA can find women in L.A. that meet the criteria.
Indeed, efforts to find the right people can be intense. The NIH Web site (www.clinicaltrials.gov) is a virtual shopping mall for clinical trials of all kinds. Meanwhile, newspaper, radio, television, billboard and Internet ads compete to lure qualified patients for trials for everything from experimental cancer drugs to new forms of eye surgery.
A billboard on La Cienega and Venice boulevards is designed to recruit people for a trial that aims to correct age-related macular degeneration. The trial is backed by a Florida-based biotech company that’s using the Retina-Vitreous Association in Beverly Hills as its research center.
Companies operating without any NIH connection sometimes pay small amounts to participating subjects, and they often cover the costs of medical care connected with a trial. Patients recruited for major studies by biomed giants often participate for free in exchange for the chance to be treated by renowned specialists at major facilities.
Once enlisted, subjects can be in for a rough ride. The majority of experimental drugs being tested don’t work, so the hopes of subjects for a cure or relief can be dashed. Also, many of the trials are blind studies, meaning that at least some of the patients are given placebos and experience no change whatsoever in their condition.
Protecting patients
The government has strict guidelines and safeguards to protect patients. Every trial in the U.S. must be approved and monitored by an Institutional Review Board, an independent committee of physicians and others that makes sure a trial is ethical and that the rights of patients are protected according to FDA standards.
For some studies, finding a sufficient number of qualified subjects is not difficult. Some institutions, like the nonprofit John Wayne Cancer Institute at St. John’s Hospital in Santa Monica, are so renowned that patients come from all over the U.S. to take part.
“John Wayne,” as it’s known, is one of 30 centers worldwide participating in trials for a federally funded melanoma skin cancer vaccine. Many of the 60 enrolled patients participating in L.A. came from across the country because of the outstanding reputation of Dr. Donald Morton, medical director and surgeon-in-chief at John Wayne. (The John Wayne Cancer Institute was named after the celebrated actor, who died of stomach cancer in 1979. Wayne was treated by Dr. Morton.)
Morton, who is the study’s “principal investigator,” is a pioneering researcher and has the patent rights to the cell lines from which the vaccine is made.
Most trials for cancer drugs and therapies are conducted at nonprofit centers and universities, said Dr. Guy Gammon, the John Wayne physician overseeing the melanoma vaccine trials.
While it is possible that researchers at for-profit centers may receive monetary incentives such as stock deals with drug companies, most trials are based on more altruistic and scientific motives, Gammon said.
“Melanoma is such a deadly disease and there are very few treatments, so physicians are eager to join,” Gammon said.
Sponsors typically pay $5,000 to $10,000 per patient for trials conducted at John Wayne, but none of that funding ends up in the pockets of physicians. Instead, physicians bill their patients’ insurers for their time, Gammon said.
HRA collects about the same amount per patient from sponsors. The funds that HRA then distributes to physicians are for research-related activities only, said HRA chief financial officer Kenneth Kang.
“There is no financial incentive for our physicians,” Kang said. “They are faculty and they do it for the research aspect.”
