This is part of an occasional series that will recall some of the stories reported 10 years ago in the News section of the Journal. This article looks at the first 4 months of 1989.
The National Cancer Institute began 1989 with a nearly $1.6 billion budget under a new director, Samuel Broder, M.D., who tapped cancer prevention and early diagnosis as his top priorities.
"Investigator-initiated research will remain the major priority of NCI," Broder told the Journal. "We have to assess and implement the results of clinical and basic research with as much speed and focus as possible, so that research results can be made quickly available to physicians, and to the public at large."
Ten years later with a budget estimated at $2.8 billion the tasks Broder set as priorities remain high on NCI's list, but with a more established infrastructure for accomplishing them. And in 1996, NCI defined four "extraordinary opportunities for investment" to add to that list: cancer genetics, preclinical models of cancer, imaging technologies for diagnosis, and defining the signature of cells.
Basic Research
The News reported on Jan. 18, 1989, about advances in the molecular and genetic understanding of cancer in its article "Perspective: What Makes a Cell Run Wild?" The new technology at the time included genetic analysis of individual organisms using restriction fragment length polymorphisms, cloning genes using recombinant DNA technology, and production of multiple copies of DNA sequences by means of polymerase chain reaction.
"Now that we are coming to understand the causes of cancer on a molecular level, we have for the first time a rational basis for designing cancer therapies," said Robert A. Weinberg, Ph.D., of the Whitehead Institute for Biomedical Research. "I think this understanding is likely to lead to entirely new and, hopefully, more effective treatments within the next decade."
Since then, technology has improved and genetics research has offered some new insights into the molecular causes of cancer, but the basic understanding of how genes change as cancer progresses remains unknown.
In 1997, the NCI launched the Cancer Genome Anatomy Project to answer some of these questions. The project has begun creating an index of tumor genes that will be accessed and analyzed for future clinical application. From this, researchers will be able to track a normal cell as it progresses to a cancer cell.
Gene Therapy
The first proposal for gene transfer into humans was approved in late 1988, and the Journal reported the approval in the Feb. 15, 1989, issue. "Ultimately, the scientists hope to use the transfer technique for cancer therapy," the article reported. "They hope to enhance the effectiveness of TILs (tumor-infiltrating lymphocytes) by inserting into them genes with therapeutic potential."
That trial began in May 1989, and showed that gene insertion into TILs can be performed using retroviruses. NCI scientists reported the findings in The New England Journal of Medicine on Aug. 30, 1990, and that landmark research paper has since been cited 533 times.
The first treatment trials for gene therapy began in late 1990, and in 1995, Michael Blaese, M.D., Steven Rosenberg, M.D., and W. French Anderson, M.D. all then at the National Institutes of Health were named as co-inventors on a patent issued to the NIH for gene therapy technology. Today there are more than 150 gene transfer protocols approved for cancer, although it still remains an experimental treatment.
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In February 1989, the Institute of Medicine released a report, "Resources for Clinical Investigation," that concluded that third-party payers should pay the patient care costs for beneficiaries enrolled in approved clinical trials. At the time, the Journal reported, Medicare regulations prohibited Medicare beneficiaries from receiving payment for care for experimental or investigational therapies.
The issue of insurance coverage for clinical trials has been a long and difficult battle, but some progress has been made. A 1996 agreement between NCI and the Department of Defense provides TRICARE/CHAMPUS insurance holders with coverage for NCI-sponsored phase II and phase III clinical trials, and a 1997 agreement with the Department of Veterans Affairs covers eligible veterans who participate in clinical trials. In addition, several health plans in Wisconsin and Minnesota agreed in 1997 to cover patients who participate in NCI-sponsored Cooperative Group clinical trials.
A bill was introduced in Congress in January 1999 to provide Medicare reimbursement for patients who enroll in clinical trials.
Also, the American Association of Health Plans, the trade group of the managed care industry, recently reached an agreement with the National Institutes of Health to pay for patients' clinical trial costs. The National Academy of Sciences is expected to release a report in October of this year on whether Medicare, whose policy on clinical trials remains unchanged, should cover the costs of experimental treatments.
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