Daniel Schultz, MD, acting director of the FDA's Center for Devices and Radiological Health (CDRH) since April, has had the "acting" term taken from the title. Schultz was named last month by acting FDA Commissioner Lester Crawford to head CDRH, the agency's medical device unit. In announcing the appointment, Crawford said that Schultz "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." Crawford added that Schultz "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 the 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). Schultz, Brager said, "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," which make up most of 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."
Schultz, before his employment at the FDA, 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 October 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 an MD 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).
AMA seeks all-trial database
An initiative launched last month by the American Medical Association (AMA; Chicago, Illinois) to create a national clinical trials registry – for both medical devices and drugs – appears to be gaining momentum around Washington. It started in late June when the AMA's House of Delegates approved a proposal calling for the Department of Health and Human Services to establish a new registry that would ensure that all trials, whether with negative or positive results, would be made publicly available. The AMA also called for institutional review boards to require companies to register in the database as a condition of approval for all trials, an AMA statement said.
Since release of the proposal, several lawmakers reportedly have jumped on the bandwagon by asking the National Institutes of Health (NIH; Bethesda, Maryland) and the FDA to provide guidance as to what can be done to improve such a database, which is currently available under the FDA Modernization Act (FDAMA) of 1997. The law requires companies and other organization to make public studies of experimental treatments for serious or life-threatening diseases, but the FDA reportedly does not enforce the regulation.
Indeed, the AMA took up the issue out of concern that negative or null trial results were not being published. Joseph Heyman, an AMA trustee, said the association believes that that pattern of non-publication distorts the medical literature, affecting the validity and findings of systematic reviews, the decisions of the funding agency and, ultimately, the best practice of medicine. Also, the AMA said it believes investigators and authors are reluctant to submit poor trial results because they don't believe the medical journals will publish them. Journals are more interested in publishing studies that are likely to affect clinical practice, and as a result, confirmatory trials with negative results and trials that show no significant result are less likely to be published, the AMA said.
Asthma, COPD more closely linked
New research shows that adults with asthma may have an increased risk of developing chronic obstructive pulmonary disease (COPD). According to a 20-year study published in the July issue of Chest, the journal of the American College of Chest Physicians (ACCP; Northbrook, Illinois), patients with asthma were 12 times more likely than non-asthmatics to develop COPD later in life.
The article's lead author, Graciela Silva, MPH, of the University of Arizona College of Medicine (Tucson, Arizona), said, "For many years, asthma and COPD have been regarded as distinct conditions, with separate clinical courses. However, over time, the two diseases may develop features that are quite similar. Our study shows a strong link between asthma diagnosis and the development of COPD, which suggests they may share a common background. It is possible that factors such as smoking and repeated episodes of acute bronchitis may facilitate the evolution of asthma into COPD, but the process by which asthma and COPD become co-morbid conditions is not clear."
COPD is a collective name for a group of chronic lung diseases, including emphysema and chronic bronchitis, characterized by irreversible airflow limitation and permanent lung damage. Asthma is a chronic disease in which the airways become inflamed, causing airflow obstruction and difficulty breathing. Unlike COPD, it is thought that asthma does not lead to permanent lung damage, and symptoms can usually be relieved spontaneously or with medication.
University of Arizona researchers assessed whether an active asthma diagnosis is a predictor of a future diagnosis of emphysema, chronic bronchitis, or COPD (emphysema and/or chronic bronchitis and pulmonary function test results less than 80 percent of predicted). Researchers analyzed survey data obtained from 3,099 Caucasian community subjects enrolled in the Tucson Epidemiologic Study of Airway Obstructive Disease between 1972 and 1973. Patients at least 20 years of age upon enrollment were initially assessed for asthma, allergies, and potential confounders, including age, sex, and smoking status. Of the patients, 192 currently had asthma (active asthma), 156 were previously diagnosed with asthma but no longer experienced symptoms (inactive asthma), and the remaining patients did not have asthma.
All patients had negative findings for chronic bronchitis and emphysema at initial survey. Over the next 20 years, 12 periodic follow-up surveys and lung function tests were administered. Study results showed that patients with active asthma were 10 times more likely to acquire symptoms of chronic bronchitis, 17 times more likely to receive a diagnosis of emphysema, and 12.5 times more likely to develop COPD than patients without asthma. No association was found between inactive asthma and the lung conditions. Age and current smoking were significantly associated with an increased risk of acquiring COPD, emphysema, or chronic bronchitis.
"Although most people living with COPD have a history of smoking, the majority of smokers do not develop COPD later in life, suggesting that other factors, such as genetic, occupational, or environmental conditions, convey significant risks," said Silva. "For people with asthma, minimizing exposure to risk factors like tobacco smoke and air pollution may delay disease progression to COPD. Effective antiinflammatory therapy at the onset of asthma may also decrease the likelihood of COPD developing years later," added article co-author Robert Barbee, MD. Researchers caution that more research is needed to understand risk factors for onset and progression of COPD.
No significant associations were found between childhood and adulthood asthma onset and risk of acquiring chronic bronchitis, emphysema, or COPD. Similarly, no significant association was found between asthma duration and risk for lung disease. Overall, patients with active asthma died at a younger age and had significantly fewer follow-up years than those with inactive or no asthma. In addition, male subjects were more likely to acquire emphysema and die at a younger age than women.
"Although there is no cure for COPD, early detection is critical in slowing disease progression," said Richard Irwin, MD, president of the American College of Chest Physicians. "Understanding the relationship between COPD and other chronic lung diseases, such as asthma, may lead to early disease detection, as well as more effective treatments for patients with COPD." ACCP represents more than 15,700 members who provide clinical respiratory, critical care and cardiothoracic patient care in the U.S. and throughout the world.