Spending for clinical trials could reach the $4.5 billion mark this year, according to a new report from CenterWatch (Boston, Massachusetts), a sister publication to The BBI Newsletter, with 80% of that amount coming from medical device, biotech and pharmaceutical companies. "The results of our analysis show a very robust market that is growing 18% annually," said Annick de Bruin, research manager for the publication that focuses on the clinical trial sector. Not unexpectedly, she said that the "lion's share" of the health care total is spent by pharmaceutical firms. Additionally, "Only about 20 cents of every clinical grant dollar is spent by the government for clinical trials involving human subject participation," de Bruin said.
CenterWatch said overall spending on medical device trials is growing by 25% annually. This yearly rate is nine percentage points higher than clinical spending levels for drug trials. CenterWatch estimates that medical device manufacturers spent $250 million on clinical grants to investigators in 1999, about 7% of the estimated $3.86 billion spent on studies that year. The figures include historical data on spending levels by industry and by the National Institutes of Health (Bethesda, Maryland). The analysis also includes revised 1999 estimates of the market distribution for clinical trial services by academic institutions and independent for-profit investigative sites.
CDRH unveils scientific dispute panel
A new panel given the task of handling scientific disputes between medical device manufacturers and the FDA's Center for Devices and Radiologic Health (CDRH) was introduced last month.
The Medical Device Dispute Resolution Panel of the Medical Devices Advisory Committee has no disputes on its agenda thus far, according to CDRH Ombudsman Les Weinstein, but that may be because he has been handling some of the inevitable conflicts himself over the past seven months as the first ombudsman for the center.
The panelists include:
Harold Sox, MD, chair of the new group. He is a practicing internist who is a professor and chair of the department of medicine of the Dartmouth Medical School's Dartmouth-Hitchcock Medical Center (Lebanon, New Hampshire).
Mark Carlson, MD, an internist on the staff of University Hospital of Cleveland (Cleveland, Ohio) and associate professor of medicine at Case Western Reserve University (also Cleveland).
Scott Ramsey, MD, PhD, a staff physician at the University of Washington Medical Center (Seattle, Washington) and an assistant professor in the university's department of health services.
Hector Gonzalez, PhD, the consumer representative, a professor and chairman emeritus of the department of nursing education at San Antonio College (San Antonio, Texas) and chief executive officer of the San Antonio Chapter of the National Association of Hispanic Nurses.
Judy Gordon, DVM, the industry representative, a regulatory consultant with ClinReg Consulting Services (Irvine, California).
Weinstein said the focus of the group, as conceived by the FDA Modernization Act, is not to deal with every dispute but only those that cannot be resolved by working through the regular channels at the CDRH. Its focus, he said, will be conflicts concerning scientific evidence and the type of evidence used when actions are taken against a company or when a company disagrees with a product decision.
Study: breast implants don't cause cancer
The National Cancer Institute (Bethesda, Maryland) last month issued results of a major study of breast implants, the results indicat that the implants do not increase the risk of breast cancer.
The study is being called one of the largest of its kind since it followed more than 13,000 women who had the implants, with average length of implantation more than 12 years. Additionally, the study is independent of any industry influence, since it was authorized by Congress, funded by the government and carried out by the government agency. Its focus is the attempt to resolve issues which emerged in the early 1990s concerning the health risks of gel implants – a scare which resulted in them being pulled from the market. Since that time, there have been numerous studies – and even more lawsuits – to determine whether implants were linked to a wide variety of other diseases such as rheumatoid arthritis, lupus, migraines and memory loss.
Louise Brinton, chief of the environmental epidemiology branch of the cancer institute and author of the study, called the research the first to follow women with the implants for more than 10 years. It included 13,500 women who had implant surgery for cosmetic reasons between 1962 and 1989. The average length of follow-up for the women who had implants was almost 13 years.
The institute now will do a follow-up study looking at connections between implants and other types of cancer, as well as connective tissue diseases, lupus and rheumatoid arthritis.