Daniel Schultz, MD, acting director of the FDA's Center for Devices and Radiological Health (CDRH) since April, last month had the "acting" term removed from his title by acting FDA Commissioner Lester Crawford. In announcing the appointment of Schultz to head CDRH, the agency's medical device unit, Crawford said he "brings to our medical device program the ideal combination of skills, experience and temperament to ensure that FDA's medical device program is second to none. He is just the man to usher in the new era of medical device

user fees and to see to it that safe and effective medical devices continue to reach patients who need them." Schultz takes the position left vacant by David Feigal, MD, who resigned from FDA last spring to take a position in the private sector.

Schultz joined the FDA in April 1994 as a medical officer in the General Surgery Branch of CDRH. He went on to become chief medical officer in the Division of Reproductive, Abdominal and Radiological Devices. He later served as division director and then as deputy director and director of the Office of Device Evaluation in CDRH.

The selection was praised by Mark Brager, director of communications for the Advanced Medical Technology Association (AdvaMed; Washington). Brager said Schultz "brings a lot of experience, being a 10-year veteran of CDRH. He has good perspective to the regulatory process." Like Crawford, he cited as one of Schultz's key responsibilities the device user fee program, a program which was put in place with the encouragement and assistance of AdvaMed.

Brager added: "He knows about the allocation of resources and knows what it takes to do a product review. We hope to work with him to make sure the user fee program is successfully implemented and any other programs CDRH is working on." Among these other programs, he noted, is the critical path initiative intended to speed the regulatory process for devices. "We're working to see what kind of mileage we can get out of that effort, and [Schultz] is someone familiar with that program," Brager said.

Schultz also got a positive review from Mark Leahy, director of the Medical Device Manufacturers Association (MDMA; Washington). He too cited Schultz's experience with the agency and the need for oversight of the user fee programs. Schultz, he said, has "an understanding of the issues to move the center forward in the years ahead. He has a closeness to the medical device user fee program and some of the concerns the industry has relating to escalating user fees and the issues relating to enhancing the center's performance." Leahy especially praised Schultz for having an "open-door policy" and a willingness to listen to industry concerns, "especially of the smaller, innovative companies" that make up MDMA's membership. He added, "We're not always going to agree on the issues, but he offers the opportunity for open and fair dialogue."

Before his employment at the FDA, Schultz entered the Commissioned Corps of the U.S. Public Health Service and served a three-year assignment as a general medical officer and clinical director of the Tuba City Indian Hospital on the Navajo reservation in Arizona. He then completed a general surgical residency at the Public Health Service Hospital in San Francisco, California. In 1981, Schultz moved to Denver, Colorado, where he did a fellowship in pediatric surgery and completed his general surgery training. He is board-certified in general surgery and family practice and is a fellow of the American College of Surgeons (Chicago, Illinois).

A native of New York City, Schultz graduated from City College of New York with a BA in political science. He received his MD degree from the University of Pittsburgh (Pittsburgh, Pennsylvania) in 1974 and completed a combined internship in pediatrics and medicine at the University of New Mexico (Albuquerque, New Mexico).

CMS looks at TMR, PMR

Proactive and not reactive. That seemed to be the effort the Centers for Medicare & Medicaid Services (CMS; Baltimore, Maryland) was undertaking when it convened a meeting of its Medicare Coverage Advisory Committee (MCAC) last month. The committee was charged with discussing and making recommendations concerning the quality of the evidence and other issues related to the use of transmyocardial revascularization (TMR) and percutaneous myocardial revascularization (PMR) for treatment of severe angina. CMS often is criticized for being too bureaucratic and not very transparent.

Ronald David, MD, director for the Center for Health Promotion and Disease Prevention for the Henry Ford Health System (Detroit, Michigan) and chairperson for the proceedings, said that though MCAC has not met often up until now, that would change. He called it a "renewed effort to be proactive rather than reactive" to the marketplace. "We will be having more meetings to evaluate and discuss products and review materials that have not reached coverage yet," David said.

In that spirit, the meeting was not to hold a definitive vote to continue coverage of TMR or to decide on coverage for PMR, as much as an effort by CMS to take the pulse of where the technology stands today and review current data. Present to make their cases for the technology were the Society of Thoracic Surgeons (STS; Chicago, Illinois); Cardiogenesis (Foothill Ranch, California), a developer of both TMR and PMR technology; and PLC Systems (Franklin, Massachusetts) and Edwards Lifesciences (Irvine, California), which work together to manufacture and market TMR technology.

TMR is a surgical technique that uses a laser to bore holes through the myocardium of the heart in an attempt to restore perfusion to areas of the heart not being reached due to diseased or clogged arteries. The procedure is believed to trigger angiogenesis or the creation of new blood vessels in the heart to relieve the often crippling chest pain caused by angina. CMS cleared TMR and adjunctive TMR – TMR plus coronary artery bypass grafting (CABG) – for reimbursement in 1999. Though TMR alone was approved by the FDA in 1998, TMR in conjunction with CABG has yet to be approved. Also not yet FDA-approved or approved for reimbursement by CMS, PMR is a less-invasive, catheter-based version of TMR technology. It is intended to be used as a late or last resort to relieve symptoms of severe angina in patients suffering ischemic heart disease who are unable to undergo direct coronary revascularization interventions such as angioplasty, stenting or bypass. PMR has been approved in other markets, such as Europe, Canada and Australia.

Since the introduction of the procedures, skeptics of TMR and PMR have criticized the technology, saying that despite perceived and documented benefits, there is a placebo or sham effect associated with the technology and that mechanisms of actions have yet to be identified. "We don't know what the mechanisms are [for both TMR and PMR or] why they work," said guest panelist John Cooper, MD, of Washington University (St. Louis, Missouri). "Despite [producing] improvement in quality of life, in my mind, there is still a lot of doubt."

On the other side of the issue was Keith Horvath, MD, associate professor of cardiothoracic surgery at Northwestern University's Feinberg School of Medicine (Chicago, Illinois), who told the panel: "Diffuse coronary disease is a significant and growing problem, particularly applying to the Medicare population." Horvath has performed TMR for 15 years and has performed extensive research on TMR technology. In response to the panel's queries regarding a sham effect and mechanisms of action for TMR, Horvath said he had no reservations. "I have been asked before if I believe in TMR, but I do not think this is a faith-based initiative. I know TMR works," he said. "There is improvement in quality of life that cannot be denied, which goes beyond any placebo effect, as the five-year data demonstrate."

Robert Guyton, MD, recent past president of STS and professor and chief of cardiothoracic surgery at Emory University (Atlanta, Georgia), said that symptom relief is the upside to the treatment. He acknowledged that this obviously is not a cure, but that there is significant mortality difference at one year with adjunctive TMR. Data, however, did show that mortality benefits fall off at the five-year mark. "I confess that that I was a skeptic. I told companies again and again, come back and talk to me when you have five-year data," Guyton said. "About a year ago, when I saw the five-year data, it was pretty persuasive."

He said that TMR has shown "remarkable improvement" in aiding those suffering from angina, adding that CMS coverage needs to continue because TMR serves "an unmet need" in a subset of severely disabled patients. "For me, TMR finally does make intuitive physiologic sense – controlled injury leading to angiogenesis," Guyton said. "It is low-risk with considerable benefit, and with CABG there is no additional risk compared to cardio bypass alone. It has a statistically significant benefit with long-term symptom relief."

Present during the meeting were patients that have undergone TMR surgery. One such patient, a 74-year-old Medicare beneficiary, was perhaps the most impressive. She has had three heart attacks, angioplasty and several open-heart bypass surgeries. She said she could not walk from her bedroom to the kitchen without having to sit down because of the intense pain and was finally told she needed a heart transplant operation, but that she was too old for the procedure and so should "go home and pray."

After obtaining a second opinion, she was recommended for TMR. Following the procedure in 1996, she reported a quicker recovery time than any of her other cardiac procedures, continued stamina and almost no pain. "This saved my life," she said. "I have been on hikes in Alaska, whitewater rafting and continue to travel." She said she plans to go skydiving with her grandson on his 17th birthday next year.

When asked to rate the overall benefit of TMR and TMR and CABG, the panel members were cautiously optimistic. They acknowledged the improvement in quality of life and safety of the procedure, but some still had doubts regarding a possible placebo effect and the procedure's mechanism of action. "What's the bottom line here, though?" asked committee member Lishan Aklog, MD, of the department of thoracic surgery at Mount Sinai Medical Center (New York). "This is a therapy for people who need as many options as possible, and we have seen the benefit."

The committee, however, did advise that there should be more studies for TMR plus CABG, and for PMR. More than one committee member called the results "encouraging," but the consensus was that more data was needed.

Closing gap in healthcare practice, research

Healthcare researchers, academics and clinicians gathered at the Washington Convention Center last month for a three-day conference focusing on bringing healthcare discovery into everyday practice.

A presentation on research-based quality improvement was featured during a breakout session on IT and Translating Research into Practice, highlighting research conducted by Baptist Hospital (Nashville, Tennessee) and diagnostics manufacturer Biosite (San Diego, California).

Speaking on behalf of Biosite, Cynthia Cadwell, RN, said that Baptist Hospital was looking for a way to improve the flow of patients with chest pain through the emergency department (ED). In 2002, 10% of all visits to Baptist's ED in 2002 were for chest pain. The hospital decided to create a chest pain center with a chest pain evaluation unit as an accelerated care pathway, using Biosite's Triage Cardiac Panel.

The product performs a blood test that measures certain chemical levels to provide a more rapid insight into the cause of the patient's chest pain. According to Cadwell, Baptist Hospital was the first facility in the state to gain approval from the FDA to conduct point-of-care cardiac marker testing at the bedside. Physicians worked with the new technology and laboratory technicians to refine the diagnostic accuracy and create a chest pain protocol designed to optimize patient outcomes.

The result had immediate care and financial impact, Cadwell said. Lengths of stay in the ED dropped, producing annual savings of $74,000. Unnecessary admissions also were reduced because of more accurate and timely diagnostic capability, she said. More accurate diagnosis also resulted in more efficient bed use, which translated into an annual savings of $196,000 for the hospital. Inpatient length of stay also was reduced for most cardiac admit patients, according to the results outlined during the presentation. In total, roughly $344,000 a year was saved.

The hospital and Biosite estimate that nearly $1 million a year could be saved once the process is improved and refined, and consistency among physicians is achieved. Baptist Hospital also plans to roll out the program to sister facilities to ensure consistency in care.

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