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SAN DIEGO—Last year, the New York Times asked if the hype about new technology is getting ahead of the science. In an article focusing on balloon sinuplasty, the newspaper questioned whether this new technology had been rushed too quickly into clinical practice, without more scientific evidence that it worked.
An article in the April 5, 2007 issue of the New England Journal of Medicine implied that another technology—image-guided mammography—may have not been tested thoroughly in advance. Data from 222,135 patients showed that the accuracy of diagnosis was reduced and the rate of biopsy increased with image-guided mammography. In addition, the change in the cancer detection rate was not significant.
These issues and others regarding new medical technology were the inspiration for an April 26 panel discussion during the American Rhinologic Society’s program at the Combined Otolaryngology Spring Meeting.
A ‘Medical Arms Race’
“We appear to be in a medical arms race and there are a number of drivers for this,” said panel organizer Marvin P. Fried, MD, Professor and University Chair in the Department of Otorhinolaryngology–Head and Neck Surgery at Montefiore Medical Center and Albert Einstein College of Medicine in New York.
Noting that health care providers and the public are always looking for better-quality, more effective treatment, he added that “sometimes, the new technology may overshoot the needs of patients. How many ways are there to do the same procedure?”
While the main concepts in technology assessment are need, safety, and cost, Dr. Fried said there is often a lack of published results from clinical trials. “However, randomization is not always feasible,” he said, illustrating his point with a humorous article in the British Medical Journal that described a supposed randomized testing of parachutes. The control group was to jump without this “new” device.
“There are times when withholding a device from the patient would not be ethical,” he commented.
Although all the panelists at the ARS program were involved in one way or another with the introduction of balloon sinuplasty, Dr. Fried urged them to use that experience only as a point of reference and focus their comments on the broader issues of the initial investigator’s point of view, the rationale and methods behind corporate development, and tips on how physicians should assess new technology.
From Concept to Testing
William E. Bolger, MD, an otolaryngologist with the Maryland Sinus Center in Bethesda, who was involved in balloon sinuplasty clinical trials, described how an idea is taken from concept into testing.
“Often, the effective use of the device is already known,” he said. Whereas drugs have a very involved process of multiphase clinical trials, the testing of devices is primarily to determine safety and effectiveness. “The FDA recognizes that with devices, the product developer and the end user—physicians—have to communicate. This is not just for innovation, but also to make devices safer and maximally effective for best medical practices.”
Dr. Bolger noted that since 1980 and the Bayh-Dole Act (in which innovation was stimulated as universities were allowed to commercialize their inventions without the loss of federal funding), corporate contributions to university research budgets increased from a little over $20 million to $2.3 billion in 2000. “Today, 60 percent of all clinical trials in the United States are funded by the biotech and pharmaceutical industries. We have to recognize that many patients have benefited from industry’s involvement,” he said.
However, when industry finances a study, there are financial biases that must be addressed through disclosure, he said, adding that physicians should also be aware of additional sources of bias including politics, personal beliefs, rivalries, and academic passions.
Dr. Bolger ended his remarks by noting that he has often been approached by salespeople from companies. “I would like to see a process where otolaryngology colleagues can show me real testing data. Subject it to publication and peer review,” he said. “And we would like to have the people with the most experience with the technology participate in its evaluation.”
Corporate Point of View
Representing the corporate viewpoint was panelist William M. Facteau, President and CEO of Acclarent, Inc., the Menlo Park, CA, company that makes the device used in balloon sinuplasty™.
“When a salesperson approaches you,” he told the audience, “be assured that the company has gone through a tremendous amount of work and effort in navigating through the entire development process.”
Mr. Facteau noted that safety is the most important thing a medical device company needs to take into consideration before launching a new technology. “That is our biggest challenge and our direction. When is the right time to move from a bench model or to a cadaver, or to animals and then, finally, into humans?”
Regarding his own company, Mr. Facteau said that once they are confident of the safety profile, they must have a value proposition for whom they call “the triangle of influence”—physicians, hospital administrators, and the Centers for Medicare and Medicaid Services (CMS) and other payers.
Physicians will have many questions ask about safety, effectiveness, training, patient benefit, reimbursement, and economic benefit. Hospital administrators will be interested in increasing revenue, reducing costs, and enhancing patient care. Payers will want to see, via clinical evidence, that the technology can have a positive societal impact.
It’s a tough business,” Mr. Facteau said. “It’s not like the 1980s when we had a lot of toys and physicians were just using technology because they could.”
Regarding payers, Mr. Facteau said a company must be aware of the multiple requirements of CMS and private payers in terms of reimbursement. “There is a significant amount of data and criteria we have to provide in order to get adequate reimbursement,” he said.
The final panelist was Donald C. Lanza, MD, a former ARS president who is an otolaryngologist with the Sinus & Nasal Institute of Florida in St. Petersburg. During the introduction of balloon sinuplasty, Dr. Lanza criticized the lack of safety and effectiveness data supplied to physicians. In the panel discussion, Dr. Lanza discussed ethics in general, and guidelines from the American Academy of Otolaryngology in particular. For example, the AAO Code of Ethics notes:
In all circumstances, the best interest of the patient must be foremost.
- The patient must be treated with competence, respect for dignity, and honesty. Confidences shall be kept private except as otherwise required by law.
- The physician must maintain proficiency and competence through continuing study, and be diligent in the administration of patient care.
- Fees must be commensurate with the service rendered and the ability of the patient to pay.
- The impaired physician must withdraw from that part of the practice which is affected by the impairment.
- Academy members should assist their colleagues in complying with these principles.
“With regard to commercial interest,” Dr. Lanza said, “physician commercial or financial interests should never be placed ahead of the welfare of patients. Conflicts of interest undermine the trust that patients place in their physician.” He further commented that financial interests should not influence prescribing patterns for drugs, devices, appliances, or treatment.
“Regarding patents, those issued after 1996 may not be lawfully enforced against physicians or their affiliated health care institution,” Dr. Lanza continued. “This law is consistent with established principles of medical ethics. Unrestricted access to medical knowledge is one of the defining characteristics of the medical and surgical profession.”
When it comes to technology assessment, Dr. Lanza noted, “the Committee on Choices in Health Care in the Netherlands has been quoted as saying that everything that is technologically possible should not be introduced into the health system. Technology assessment should be performed on all major new technology.”
Dr. Lanza urged audience members to take responsibility regarding new technology and to question the scientific, economic, ethical, legal, and social implications.
In conclusion, panel moderator Dr. Fried said, “As innovators attempt to push the envelope, it is the clinicians, you folks in the room, who must resist the initial enthusiasm for new technology while they determine if the new technology is effective or dangerous. It behooves all of us to take that step back and assess the technology.”
©2007 The Triological Society