This is part of an occasional series that recalls some of the stories reported 10 years ago in the News section of the Journal.
In the July 15, 1992 issue of the Journal, the News announced the creation of the Office of Alternative Medicine (OAM)now the National Center for Complementary and Alternative Medicine (NCCAM)at the National Institutes of Health to evaluate and determine the effectiveness of alternative treatments for cancer and other diseases.
The OAM was a response to a government report showing that many patients with cancer were turning to alternative treatments without any information about the safety and effectiveness of these treatments.
Despite the need for such research, there was a great deal of skepticism among the scientific community, recalled Stephen C. Groft, Pharm.D., first acting director of the OAM and current director of the NIH Office of Rare Diseases. Many researchers were simply unfamiliar with complementary and alternative medicine, he said. The public was equally skeptical, arguing that the government should focus its money on more "important" research.
However, there was also a good deal of excitement. "There was a recognition that this was something that would be worthwhile to follow up and to evaluate, and it wasnt any different than any other area of science," said Groft.
The OAM began with a $2 million grant from Congress, which was not a lot of money at the time, Groft admitted, but it was enough to lay the groundwork. "I think it forced us into doing some planning and looking at, What were the opportunities? What should we evaluate? How can we evaluate?" he said.
The planning paid off. In 1998, Congress elevated the status of OAM to an NIH Center, renamed it NCCAM, and gave it a budget of $50 million. "The creation of NCAAM not only created the authority to give grants but allowed us the resources to give grants that are appropriate to answer given questions," said Stephen E. Straus, M.D., director of NCCAM.
This year, the NCCAM has a budget of over $106 million. The center funds 16 Centers of Research on Alternative Medicine, each with a specific research focus. Two centers are looking specifically at alternative treatments for cancerthe Center for Cancer Complementary Medicine at Johns Hopkins University in Baltimore, Maryland, and the Specialized Center of Research in Hyperbaric Oxygen Therapy at the University of Pennsylvania in Philadelphia.
NCCAM also works with other NIH centers and institutes, including the National Cancer Institute, which houses the Office of Cancer Complementary and Alternative Medicine. Two ongoing studiesa phase III trial of the effect of a nutritional program on advanced pancreatic cancer and a study of shark cartilage for the treatment of lung cancerare funded by NCCAM and coordinated by the NCI.
NCAAM is also interested in the basic mechanisms and biology of complementary and alternative medicine, said Straus. Studies are ongoing to understand the pharmacology of certain herbal products that may have efficacy in some diseases. Other studies will explore the variability of ingredients in herbal products.
The center is also taking advantage of resources on the NIH campus. Last year, the center initiated an intramural research program, and their first research laboratory is now up and running.
A lot has changed in 10 years, but there is still a long way to go. "Were only 10 years out now, and thats not a long time in the field," said Groft.
PSA Debate Still Unsettled
Although a decade can bring many changes, some things are slow to change.
In the Dec. 16, 1992, issue of the Journal, the News discussed the debate over screening for prostate cancer with prostate-specific antigen (PSA). At the time, prostate cancer experts could not agree on how, when, or whether to use PSA testing to detect early prostate cancer.
Compared with other cancers, prostate cancer is a relatively slow growing tumor, and there was concern that screening could lead to overdiagnosis, or the detection of cancers that otherwise would not have been detected within the patients lifetime. Therefore, not only would treatment be of no benefit, it could cause harm.
Recent estimates indicated that as many as 29% of white men and 44% of black men with prostate cancer are overdiagnosed, and would otherwise never have been affected by the disease.
In May, preliminary results from the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial suggested that an annual PSA test may not be helpful in many men if a PSA of 4 ng/ml or more is used as the trigger for further tests. Researchers found that men who have PSA levels of less than 1 ng/ml have a very small chance of having a PSA of at least 4 ng/ml over the next 5 years. However, this still leaves the question of whether routine screening with PSA has a net benefit for men, the researchers concluded.
Despite the increasing reservations about the use of PSA testing, most men with prostate cancer still support the test, concluded a study in the October 5 issue of the British Medical Journal. However, these same men had received little information about screening beforehand. In contrast, the study found that men who were informed of the risks and benefits of PSA screening were more likely to oppose the test.
Grace Lu-Yao, Ph.D., an expert in PSA screening at HealthStat in Princeton, N.J., pointed out that when the public assumes that PSA testing is effective, it could compromise the results of a randomized trial (two of which are under way) to evaluate the effectiveness of the PSA test in reducing deaths from prostate cancer.
"If people start to believe that PSA screening will work, and [people in] the control arm ... go have their PSA screening, you can imagine what will happen with the trial," said Lu-Yao. "At the end, we may not get the answer." She said that it is important to get the message out that we still do not know whether the PSA test works. The control arm of the PLCO will be monitored to determine whether PSA testing outside of the clinical trial had any effect on the overall results.
And even if one assumes that the PSA test is a good measure of the presence of prostate cancer, the test cannot tell a doctor what type of prostate cancer it is. "What we really need is something that will tell us whether one man is going to die of aggressive prostate cancer versus the other man who will have such a slow growing tumor that you really dont need to have much intervention," said Lu-Yao.
That may not be too far away. Researchers at the U.S. Food and Drug Administration and the NCI are working on a test to identify specific protein patterns in blood that can help distinguish between prostate cancer and benign conditions. In a study in the October 16 issue of the Journal, the test correctly predicted 36 of 38 patients with prostate cancer, whereas 177 of 228 patients were correctly identified as having benign conditions.
While techniques like these mature, Lu-Yao stressed the importance of patient education. She pointed out that patients who start out supporting PSA testing, when informed about the risks and benefits of the procedure, will often change their mind.
Split Societies
In the Dec. 2, 1992, issue of the Journal, the News announced the "trial separation" of the American Association for Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO) annual meetings, which at the time were back-to-back and spanned almost a week.
Some researchers were concerned that the separation of the meetings would create a gap between basic and clinical research and, as a result, not encourage translational research.
"But the effect of that was not as much as I thought it would be, and the effect in some ways is good because it disseminated the national meetings," said Emil Frei, M.D., physician-in-chief emeritus at the Dana Farber Cancer Institute, Harvard Medical School, and past president of both societies.
He explained that, in addition to their annual meetings, both ASCO and AACR hold smaller, more focused, meetings throughout the year. In that form, basic scientists and clinical oncologists within a specific area of research can interact, Frei said.
Margaret Foti, Ph.D., chief executive officer of AACR, pointed out that the two societies also continue to collaborate on activities such as an annual clinical trials workshop to teach young physicianscientists how to design clinical trials. The societies have also discussed collaborating on a workshop to train researchers in other countries how to conduct clinical trials. These researchers would in turn train researchers in their respective countries.
Many researchers felt the separation was necessary because of the sheer length of the meeting. "I was glad for the split because it enabled me to attend more of both meetings than I was [when they were combined]," said Charles M. Balch, M.D., executive vice president and chief executive officer of ASCO.
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Today, the AACR, which has more of an emphasis on basic and translational research, holds a 5-day meeting in April. And ASCO, which places its emphasis on translational and clinical research, holds its 4-day meeting in May. The membership and meeting attendance of both societies have more than doubled since the separation.
"I think thats a statement that by separating and by focusing a little bit better on the somewhat different but overlapping groups that weve been able to serve the oncology community better," said Balch.
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