WASHINGTON -- It seemed like a great idea when a medicaldevice company peddled its expensive new silver-impregnatedcatheters to LDS Hospital of Salt Lake City. Urinarycatheterization is the leading cause of hospital-acquiredurinary and fatal blood stream infections, John Burke, chief ofinfectious diseases at LDS, told a congressional hearing on"Buying Medical Technology in the Dark," on Thursday. Theseside effects cost the nation $2 billion annually. And silver killsbacteria.
Nonetheless, Burke conducted his own large-scale study at LDSand found that the silver catheter actually increased infectionsand "bloated (patients') -- and our -- bills. It is unsafe at anyprice." Yet the catheter had already captured about 20 percentof the Salt Lake market.
Similar lost opportunities for superior treatment and costsavings abound. Rep. Ron Wyden, D-Ore., chairman of theSubcommittee on Regulation, Business Opportunities, andTechnology, which held the hearing on Thursday, has compiledseven other examples from the world of drugs and devices.Wyden is developing legislation that would motivate drug anddevice companies to compare their new technologies to existingones during premarket testing.
Meanwhile, four biotechnology companies -- Amgen Inc., Astra,Genentech Inc. and Ortho Biotech -- as well as sevenpharmaceutical companies, have sponsored development ofprinciples for conduct and publication of effectiveness, costeffectiveness and pharmacoeconomics research onbiotechnology and pharmaceutical products. This took place atthe University of Pennsylvania's Leonard Davis Institute ofHealth Economics, testified Alan Hillman, director of theinstitute's Center for Health Policy.
There is currently no federally mandated or federallysponsored research on comparative effectiveness or costeffectiveness, and the FDA, according to one witness, has littleinterest in doing it.
In addition, Hillman has written that pharmaceutical costeffectiveness analyses are often based on marketing devicesand not solid clinical research. That, said Burke, was true of themanufacturer's test of the silver catheters.
Even when compelling studies are available, doctors frequentlydon't find out about them. According to the Journal of theAmerican Medical Association, consensus conferences, at whichexperts spend several days at NIH defining the state of the art,have little influence on practice, said Wyden.
"Peer-reviewed journals impede the dissemination of validatedadvances," according to R.B. Haynes of McMaster University inOntario, whose research was cited by John Williamson.Williamson, who is professor of medicine and medicalinformatics at the University of Utah School of Medicine,recommended that advances, particularly in drugs and devices,should be disseminated via computerized expert systems.These are in early stages of development.
Furthermore, senior physicians who could influence the FDAhave little incentive to do so, testified Barry Marshall, professorof medicine at the University of Virginia. In the 1980s,Marshall discovered that ulcers have nothing to do with diet orstress, but are caused by a bacterium, Helicobacter pylori, andhe developed a treatment that cures 85 percent of ulcers veryquickly and inexpensively.
It took a long time for the treatment to be accepted in the U.S.,Marshall testified. FDA did little to help, and Marshall blamed"very conservative gastroenterologists," saying, "They probablyhave a vested interest in keeping all those ulcers ticking over."
Drug companies, said Marshall, "are terrified of upsetting theFDA; therefore, it does not get much constructive criticism."
Wyden received high praise for developing legislation thatwould motivate drug and device companies to compare theirnew technologies with existing ones during premarket testing.This, Wyden said, would ameliorate what he calls "the medical-technology information gap."
Incentives for companies would include:
-- Extended exclusivity for comparative study.
-- Extended exclusivity for special population studies withingeriatric, pediatric, or at-risk minority populations. FDAapproval of the study design would be required, and theagency would have 60 days for review.
If FDA deems a product superior that has not been approvedfor marketing, the agency would have to give the applicationpriority. Results of trials would be disseminated via electronicbulletin board and promulgated to health plans, said Wyden.
Brent James, executive director of the IHC Institute for HealthCare Delivery Research, described the research strategy atIntermountain Health Care, the 24-hospital system thatincludes LDS. Doctors compare their approaches and outcomes,then collaborate to develop the best strategy for treatment.This eliminates the gross variations in medical practice thatDartmouth University's John Wennberg first described morethan two decades ago. Highly accurate clinical trials can then beperformed within the hospital system.
The biotechnology/pharmaceutical task force had planned tocomplete its work next fall, but Wyden urged Hillman to finishearlier so that it could influence the health-care reformpackage, which is expected to be finalized next fall.
-- David C. Holzman Washington Editor
(c) 1997 American Health Consultants. All rights reserved.