Some 20 million to 25 million Americans are currently living with some sort of medical implant, according to Judith Weertman, DSc, professor of materials science and engineering at Northwestern University (Evanston, Illinois). Weertman offered that estimate at a National Institutes of Health (NIH; Bethesda, Maryland) Technology Assessment Conference on medical implants held in mid-January. But despite these numbers, representing somewhat over 10% of the population – and magnified by the number of families this fact impacts – there is strikingly little information about the long-term impact of device implantation. Specifically, there is no systematic method for the retrieval and analysis to create any sort of reliable database on the issue. Sponsored by the NIH Office of Medical Applications of Research and the National Heart, Lung and Blood Institute, the conference brought together a non-federal group of 14 experts to discuss the possibilities of establishing a national implant database. The consensus of the panel was that the lack of a national implant database offers a critical impediment to research in this sector. Most research done on retrieved implants is voluntary, non-uniform, and independent, without the establishment of core data elements or standards. "Even our best reporting is probably inadequately informed," said D. Glenn Pennington, MD, chair of cardiothoracic surgery at Wake Forest School of Medicine (Winston-Salem, North Carolina). "There is no multi-institutional way of looking at products once they are on the market."

By retrieving and analyzing implants, data could be collected on complications, design defects, average device lifetimes, and clinical endpoints, among other areas. Other countries, such as Japan, Sweden, and the United Kingdom, have some types of implant databases, kept either by device manufacturers or government agencies. In the U.K., six databases track different types of devices. The largest, a national database of pacemakers, has more than 250,000 registrants. The information collected varies with the registry, although all collect core information, said Andrew Crosbie, section head of the Implants and Materials Section in the U.K.'s Medical Devices Agency.

In the U.S. today, "The expectation is that there will be full scientific disclosure of how a device should work," said Robert Baier, PhD, professor and executive director of the Industry/University Center for Biosurfaces at the State University of New York-Buffalo (Buffalo, New York).

That lack of systematic data-gathering "hampers decision-making," said Larry Kessler, ScD, director of the FDA's Office of Surveillance and Biometrics. Current FDA regulations require tracking of some medical devices, but not for the purpose of explanation and follow-up. Tracking is required in case of device recall, so manufacturers can ensure all patients are contacted. "I do not consider it within FDA authority to use the tracking regulation to ask for explant analysis," Kessler said.

Industry opinions leaned toward the idea that a mandated, standardized implant retrieval and analysis system would not be worth the time, effort and cost. Robert Gussin, PhD, vice president for science and technology at Johnson & Johnson (New Brunswick, New Jersey), said that "the key is to work with the clinicians that use your product. I don't think we can easily attack this on a global basis. I think it needs to be done device by device."

In its conclusions, the panel noted the emergence of tissue engineering as a new and promising area of medical implant science, and it recommended that the U.S. government begin active preparation and planning to construct regulatory protocols for this class of implants. In addition, the panel called on NIH to develop an aggressive R&D program to ensure continuing advances in medical implant science.

Over the past 20 years, several conferences have addressed implant retrieval, and an obvious question must be asked: Will this one produce results? "Time will tell," said panel member Phyllis Greenberger, MSW, executive director of the Society for Women's Health. "There are lots of conferences and lots of recommendations. Some never see the light of day, but we hope most of ours will be put into action."

Transplant centers form coalition

Fifteen U.S. transplant centers which perform a total of more than one-sixth of all organ transplants in the country last month formed the Coalition of Major Transplant Centers (MTC) to speak out on what they termed "the critical issues facing patients at the start of the 21st century." The new organization further said in a statement that its intent is to express a "real consensus" on transplant policy issues. The coalition is comprised of programs that perform a minimum of 150 kidney, pancreas, liver, heart, lung and intestine transplants each year. Member centers include four of the eight largest transplant programs in the country, and they provided transplants for more than 3,700 patients in 1998. Hans Sollinger, MD, of the University of Wisconsin (Madison, Wisconsin), said that because of the diversity of the transplant programs provided and patients served by these programs. "We also believe that most of the major transplant programs across our country have a similar perspective on the critical issues facing transplantation, but this perspective has been overshadowed by the loud voices of a couple of large centers with a different agenda." Approximately 40 of the more than 270 accredited transplant programs in the United States would be eligible for membership in the MTC. These centers performed more than 40% of the 21,000 organ transplants for U.S. patients in 1998.

Founding members of the coalition are the University of Alabama at Birmingham (Birmingham, Alabama); University of Wisconsin; Fairview-University Medical Center (Minneapolis, Minnesota); University of Michigan (Ann Arbor, Michigan); Ohio State University (Columbus, Ohio); Washington University (St. Louis, Missouri); St. Barnabas Health Care System (Toms River, New Jersey; the Health Alliance of Greater Cincinnati and Children's Hospital (Cincinnati, Ohio); Medical University of South Carolina (Charleston, South Carolina); University of Colorado (Boulder, Colorado); Clarian Transplant Center (Indianapolis, Indiana); University of Tennessee (Knoxville, Tennessee); Froedtert Memorial Lutheran Hospital (Milwaukee, Wisconsin); Vanderbilt University (Nashville, Tennessee); and the University of Texas Health Sciences Center (Houston, Texas).

U.K. cancer survival still lagging

"Every year for the past 12 years, we have seen [cancer] cure rates increase by 1%, so there is every reason that by 2050 we can achieve a 90% cure rate," said Gordon McVie, director of the U.K. Cancer Research Campaign (London). One in three men and two in five women who develop cancer live beyond five years at the moment. A quarter of a century ago, it was one in five men and one in three women. The greatest improvements have been made with skin cancers, and cancers of the testes, bone, bladder and colon, in which a patient now has a 20% better chance of surviving than he or she did 25 years ago, according to McVie. He cited two principal reasons why British survival rates lag well behind those in the U.S., where physicians are twice as successful at treating lung and prostate cancer. The first is the money available to pay for the drugs and specialist care, the second the relative lack of investment in gene therapy in Britain.

The good news about cure rates is tempered by statistics showing that the chances of getting cancer are also increasing as people live longer. In Britain, 40% of people can now expect to develop the disease in their lifetime, compared to 33% of the U.K. population 20 years ago. Sixty-five percent of all new cancers occur after pensionable age. The real crisis point in cancer treatment in Britain will therefore come in 15 years' time, when the baby boom generation reaches that point. Income levels and private health insurance also play a key role in beating cancer, with a 5% better survival rate for higher income groups.

This translates to 2,500 deaths which could be prevented each year in poorer people, McVie said. "None of the key cancer drugs we know work are available [in the UK National Health Service] in every case. The only sure bet is if you are a private patient."

California med-tech to keep growing

Already producing a large portion of the country's health care R&D, California will continue its heady expansion over the next 10 years, according to a report produced by the California Healthcare Institute (CHI; La Jolla, California). The report indicates that 81% of the state's biomedical firms foresee increased R&D efforts over the next two years and 90% plan to expand R&D facilities in California. "Direct employment in the industry, now accounting for more than 212,000 jobs in California, is expected to increase by almost 30% in the coming decade," according to a report summary.

Other report highlights:

2,500 companies and 75 university and private research institutions are currently pursuing biomedical R&D and manufacturing in California.

In 1998, the biomedical industry paid $13.7 billion in wages and salaries. Californians employed within the industry earned an average salary of $64,300 – an estimated 85% higher than the average industry earnings in the state.

Biomedical R&D now accounts for more than 212,000 California jobs, and the total number directly employed in 2010 is projected to top 220,000.

California exports more than $4.2 billion in health care technology product sales annually.

In 1998, California's leading biomedical companies invested $6.1 billion in the development of new products for unmet medical needs. The average California biomedical company invests 42% of operating expenditures into R&D.

All signs point to boom in e-health

Whether or not Forrester Research (Cambridge, Massachusetts) issued its new report on health care e-commerce to coincide with last month's Chase H&Q investor conference, its conclusions were the same as those drawn by many H&Q conference presenters: Internet health is a boom that will continue and not a passing trend. Forrester's new report estimates that health care on-line transactions will reach $370 billion by 2004. And it predicts that 32% of online consumers already are shopping for health products on the web, with 8% of all retail health sales – about $22 billion – moving to the Internet by 2004. The remaining $348 billion will come in the business-to-business category, according to Forrester, or about 17% of total industry expenditures.