In the wake of 9/11 and a rush of funding directed toward bioterror defense technologies, the ongoing critical needs in life science funding shouldn't be abandoned. That was a major message delivered last month during a Capitol Hill luncheon for cancer researchers, the event sponsored by the National Dialogue on Cancer and featuring 11 companies and physicians, plus representatives of the National Cancer Institute (Bethesda, Maryland), MD Anderson Cancer Center (Houston, Texas) and the National Academy of Sciences (Washington). The attendees were an attentive choir since the medical technology community has been preaching the same message rather loudly in recent years.
Helping to make the pitch was Sen. Edward Kennedy (D-Massachusetts), who said that device and drug manufacturers and researchers looking for government funding had better ask Congress for more monies soon because there's just one of the "last of the great spenders" left, a gibe directed squarely at himself. "This is the age of the life sciences," Kennedy said, and the overall tone of the meeting centered on the critical role that breakthrough technology has played in oncology.
Underlying the need for more funding, Sen. Dianne Feinstein (D-California) used the meeting to urge Kennedy to join her as a co-sponsor of the National Cancer Act, which currently lists 28 sponsors in its caucus, including Sen. Sam Brownback (R-Kansas), another luncheon speaker. Passage of the new act, she said, would focus on research grants and bring the percentage of dollars going to research from the current 28% to 40% — "a figure the National Cancer Institute has said is ideal for cancer," Feinstein said. The previous National Cancer Act, passed in 1971, needed revision because it was from a bygone era, she said.
Imaging and scanning device technologies were hailed by Ted Kennedy Jr., a former cancer patient himself, who credited experimental technology with saving his life. "There are amazing things happening right now in device technology, and access to that technology should be available to all, not just those in clinical trials," he said.
The resistance to accepting new devices, diagnostics and pharmaceuticals for treating cancer can be likened to the debates surrounding the use of DNA not so many years ago, noted the senior Kennedy. "The controversy over such an experimental technology — which people now see the clear benefit of — is similar to the controversy now surrounding the device and diagnostics industry, but you should also view it as an opportunity. We need your help to work with the FDA and [the Department of] Health and Human Services to get fast-track approval for what I consider breakthrough science," he said.
Richard Klausner, MD, senior fellow and special advisor to the president's counterterrorism council at the National Academy of Sciences, told the audience that these innovations were part of a new age of medicine in the post-genomics era. "The completion of the human genome showed us that there are three applications to molecular medicine for new drugs and technology." Those divisions are molecular profiling, molecular targeting and molecular monitoring. The molecular approach, Klausner said, "will alter the need for clinical trials in the future by giving us real-time feedback on obtaining the maximum available dosage and move to a more predictive level of medicine."
James Cox, MD, professor and chair of radiation oncology at MD Anderson Cancer Center, focused on current treatment options available for prostate cancer patients at his facility, with emphasis on new developments in imaging as the key to the fight. "Thanks to you here today, there's never been a more exciting time in radiological imaging," Cox said. He described his practice of treating prostate patients 35 years ago as involving a "monstrous machine that was two stories high" but having limited precision. Compared to that he described the evolution of today's methods for finding a tumor's exact location and focusing the radiology only to the afflicted area.
Med-tech firms exhibiting at the luncheon were Ethicon Endo-Surgery (Cincinnati, Ohio), Radionics (Burlington, Massachusetts), Siemens Medical Solutions USA (Iselin, New Jersey), Baxter Fenwal (Deerfield, Illinois) and Varian Medical Systems (Palo Alto, California).
MDMA proposes FDA task force
The Medical Device Manufacturers Association (MDMA; Washington) last month proposed the formation of an industry task force focused on helping to alleviate some of the funding constraints that the FDA currently works under and to help bolster its expertise. The task force proposed by MDMA would be a joint effort between it, the Advanced Medical Technology Association (AdvaMed; also Washington) and the National Electrical Manufacturers Association (NEMA; Rosslyn, Virginia), Larry Holden, president of MDMA, told The BBI Newsletter's sister publication, Medical Device Daily. Holden said that he has sent letters presenting the idea to the other two groups but has yet to receive a response.
"This wouldn't be just an effort of associations throwing money at a problem, but actually looking at the agency and determining where the money could best be applied to update an antiquated system," Holden said. The task force won't require any funding from member groups initially. Rather, it will first determine the needs of the agency, the funding required to fill those needs and how to obtain that funding. "What the task force will do is sit down to determine how best to accomplish that goal," he added.
As proposed by MDMA, the group would consist of members from the boards of the three associations, plus staff at the FDA, noted Holden. The group's initial task will be to get the Medical Device Amendments (House Resolution 3580) of 2001 passed through Congress, he added. After that, he said, the task force will need "to determine how to assess the needs within the FDA."
The FDA, it turns out, already is working with MDMA in terms of getting the task force up and running. "So far, [CDRH director David] Feigal has been cooperative in getting data and information to us in a timely manner," Holden said. An in-depth assessment next will help determine exactly where funding is needed. "The level of expertise within the FDA is getting depleted rapidly, and that could be one area where the additional funds would help — to get some expertise back in the agency," he added. Holden said that one of the most obvious areas of need is agency computers, many of which he termed "outdated." Some of its computers "aren't even Y2K-compliant."
Specifically, H.R. 3580, which was referred to a subcommittee within the House Energy and Commerce Committee, would make improvements in how medical devices are regulated. It is sponsored by Rep. James Greenwood (R-Pennsylvania) and co-sponsored by Rep. Anna Eshoo (D-California). The bill, known as the Medical Device Amendments of 2001, would amend the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to establish within the office of the FDA commissioner the Office of Combination Products and Product Jurisdiction. The intent is to designate the component of the FDA with primary or exclusive responsibility for the premarket and postmarket regulation of drugs, devices and biological products. It also would authorize the commissioner to establish a fellowship program to augment the scientific expertise of the agency component responsible for regulating devices. The bill also would revise or set forth requirements concerning a list of 14 regulatory issues, from facility inspection by non-government inspectors to electronic labeling.
Holden emphasized the need for device manufacturers concerned about allocating resources to a federal agency to get involved. "I understand there's concern out there about how the FDA currently spends money," he said, "but once everyone is at the same table, including the FDA, we'll be able to look at the data and understand exactly where the money would be going."
CDC focuses on antimicrobial resistance
The Centers for Disease Control and Prevention (CDC; Atlanta, Georgia) last month announced during the International Conference on Emerging Infectious Diseases in Atlanta, a campaign aimed at clinicians to prevent antimicrobial resistance in healthcare settings. Titled "Prevent Antimicrobial Resistance," the campaign will center on four key strategies in health care settings: Preventing infection, diagnosing and treating infection effectively, using antimicrobials wisely, and preventing transmission of drug-resistant pathogens. Within these strategies are 12 specific action steps derived from evidenced-based guidelines and recommendations already developed by the CDC and other organizations that clinicians can take now to prevent antimicrobial resistance in hospitalized adults. The CDC said it will announce at some future time similar action steps for clinicians who care for dialysis patients, emergency room patients, obstetrical patients, critical care patients, patients in long-term care facilities and pediatric patients.
"Clinicians are always on the go and are bombarded with lots of information about preventing infections. The CDC is trying to simplify things by presenting the best practices in simple terms that easily can be recalled and followed by fronting clinicians to protect patients and prevent antimicrobial resistance in health care settings," said Julie Gerberding, MD, director of the agency's program to promote health care quality.
Each year in the U.S. an estimated 2 million hospitalized people acquire infections that result in more than 90,000 deaths, according to CDC estimates. More than half of these infections are caused by bacteria that are resistant to at least one of the antimicrobial commonly used to treat those infections, the agency says. "We are confident that this campaign will help prevent the emergence and spread of antimicrobial resistance in healthcare settings and make health care in the U.S. even safer than it is today," Gerberding said.
The action steps for clinicians who provide care for hospitalized adults range from increasing influenza vaccinations among at-risk patients to greater consultation with infectious disease experts, from stopping antimicrobial treatment when infection is unlikely to greater emphasis on clean hands.
The CDC is partnering with organizations including the Infectious Diseases Society of America, the American Society for Microbiology, the National Foundation for Infectious Diseases, national medical centers and other health care institutions to evaluate and distribute campaign materials.