A government advisory panel has concluded that the U.S. should replace more than 1,000 irradiation machines used in hospitals and research facilities because terrorists could use the radioactive materials inside them to make "dirty" bombs. "Any one of these 1,000-plus sources could shut down 25 square kilometers, anywhere in the United States, for 40-plus years," according to the Defense Science Board, a panel of retired military and CIA officials and defense industry experts.

The machines are in relatively unprotected locations, such as hospitals and research facilities all over the country, and they may be tempting sources of radioactive materials for terrorists who want to make bombs that can disperse radioactive debris over large areas, rendering them uninhabitable, the board said.

The irradiators contain cesium-137, one of the most dangerous and long-lasting radioactive materials. They are used for radiation therapy and to sterilize blood and food. Replacing the cesium irradiators with X-ray machines or irradiators that use other materials would cost about $200 million over five years, but it would take the most accessible sources of dangerous radioactive material inside the United States "off the table" for terrorists, the panel says.

The recommendation is part of an as-yet-unreleased Defense Science Board report that describes how unfriendly nations or terrorist groups could attack the U.S. with radiological or biological weapons or blackmail the U.S. government with a threat of a nuclear detonation, all while manipulating world opinion against the country in the news media and on the Internet.

The board's report is expected to be released later this year.


Review: Evidence lacking for key treatments of osteoarthritis

A new scientific review released by the Department of Health & Human Services' (HHS) Agencyfor Healthcare Research and Quality (AHRQ) concludes that evidence of benefit is lacking for many common ways of treating osteoarthritis of the knee, including popular dietary supplement ingredients, a common surgical procedure and injected preparations.

The review found that glucosamine and chondroitin, over-the-counter dietary supplement ingredients that are used widely because of purported benefits to relieve knee pain caused by osteoarthritis and improve physical functioning, appear to be no more effective than placebos.

The review, requested and funded by HHS' Centers for Disease Control and Prevention, also failed to find convincing evidence of benefit from arthroscopic surgery to clean the knee joint with or without removal of debris and loose cartilage.

Published studies generally report that injections with hyaluronan preparations (substances that are intended to improve lubrication of the knee joint) improve scores on patient questionnaires used to measure pain and function. However, the evidence is uncertain because of variation in study quality and difficulty determining whether changes in scores translate into real clinical improvements for patients.

"Millions of Americans seek relief from the pain and reduced mobility caused by osteoarthritis of the knee," said Carolyn Clancy, MD, director of AHRQ. "However, they should work with their clinicians to decide the best course of treatment for them based on what has and has not been proven to work."

Osteoarthritis wears away the cartilage cushioning the knee joint, causing pain and reducing mobility. Arthritic diseases, which include osteoarthritis, affect an estimated 46 million people in the U,S., and at age 64 and older, one in 10 Americans is estimated to have osteoarthritis of the knee. Osteoarthritis and related arthritic conditions cost more than $81 billion a year in medical care, lost wages, and other expenses.

According to authors of the review, better quality randomized clinical trials are needed to clarify whether these treatments are beneficial.

The review scrutinized individual studies concerned with these treatments' effects as well as meta-analyses that analyzed the combined evidence of groups of studies.


CMS draws back from move to tighten up trials policy

The Centers for Medicare & Medicaid Services last month reported that it has decided not to change national coverage determination for clinical trial policy instead of imposing further conditions for coverage.

According to a statement issued last month, the agency said it conducted "a thorough review and consideration of comments from the public, and the enactment of the Food and Drug Administration Amendments Act of 2007."

CMS said it came to the conclusion that Medicare contractors had been paying for beneficiary participation in clinical trials that were outside the terms of the previous iteration of clinical trial policy, issued in 2000. But that version apparently did not mandate that CMS pay for beneficiary participation in clinical trials for off-label device use or in trials that sought to enhance surgical procedures.

The preliminary version of the new policy, published in April, did nothing to clarify the matter and, despite the fact that there was little indication that CMS had previously been stingy about coverage, hospitals and device makers saw the new policy as an opening for coverage denial.

The agency floated a series of additional standards in July in an attempt to clarify the issue, but it said it again "received numerous comments from the public with regard to the authority of CMS to establish standards and provide limitations to coverage within research studies." Those comments indicated that "the proposed policy was confusing, and that CMS should use notice and comment rulemaking to provide a longer transition period for clinical trials to prepare for these changes."

Among the comments received by CMS was one from the American Medical Association (AMA; Washington), which said that the policy of non-coverage of services, that would be covered had the beneficiary not been enrolled in the trial, would be "punitive to beneficiaries and is not consistent with the statutory language" that requires coverage of services deemed reasonable and necessary.

AMA urged CMS to "revise this policy in the final decision memorandum."

Alexandra Clyde, VP for health policy and payment at Medtronic (Minneapolis, Minnesota), wrote that "without the requested clarifications to the NCD, it is likely that Medicare beneficiaries will have to be informed that their coverage may be withdrawn if they participate in certified clinical studies." Clyde said that such a scenario "would have a chilling effect on Medicare beneficiaries' participation in clinical studies, particularly when they can receive the same covered items and services outside of the study without risk of non-coverage."

CMS said that after "careful consideration of the public comments and this new legislation, the agency has decided that a change to the July 9, 2007, NCD would be inappropriate at this time."


Study: CT colonography, colonoscopy similar in results

A study comparing computed tomography colonography (CTC) and traditional optical colonoscopy (OC) using an endoscope for colorectal cancer screening may put the argument over whether CTC is useful as a screening tool to rest — or perhaps not. The study, published in the Oct. 4 edition of the New England Journal of Medicine, concluded that "primary CTC and OC screening strategies resulted in similar detection rates for advanced neoplasia, although the numbers of polypectomies and complications were considerably smaller in the CTC group."

One of the researchers at the University of Wisconsin School of Medicine and Public Health (Madison), Perry Pickardt, MD, told Biomedical Business & Technology that this study goes beyond validation of the technology. OC is performed by a gastroenterologist who snakes an endoscope into the rectum and through the colon. CTCs and the images they produce are analyzed by radiologists, much like any other diagnostic imaging procedure. Both CTC and OC require bowel cleansing prior to the procedures, which is one aspect of either procedure that most patients do not like.

Gastroenterologists say that OC is both diagnostic and therapeutic, since polyps, whether benign or pre-cancerous, can be removed during the procedure, potentially preventing colon cancer from ever occurring by removing such polyps before they can turn into the disease.

The study compared primary CTC screening in 3,120 adults (mean age 57) with primary OC screening in 3,163 adults (mean age 58.1). According to the study, "The main outcome measures included the detection of advanced neoplasia (advanced adenomas and carcinomas) and the total number of harvested polyps."

In the study, the researchers report advanced neoplasia was confirmed in 100 of the CTC group, or 3.2%, and in 107 of the patients in the OC group, or 3.4%, "not including 158 patients with 193 unresected CTC-detected polyps of 6 mm to 9 mm who were undergoing surveillance."

While 561 polyps were removed in the CTC group, 2,434 were removed in the OC group. According to the study, there were seven "colonic perforations" in the OC group and none in the CTC group. Perforation of the colon with the endoscope used by gastroenterologists is one of the potential problems associated with traditional colonoscopy.

"Important outcome measures included detection rates for advanced adenomas and adenocarcinomas for various categories of polyp size and overall polpectomy rates. "Those observations provided an assessment of CTC as a selective filter for therapeutic OC in the detection of advanced neoplasia," the study reported.

Pickhardt said the University of Wisconsin study, along with a study completed by the American College of Radiology Imaging Network (ACRIN; Philadelphia) reported in late September, should erase any remaining doubt about CTC's usefulness.

The results of the two studies may convince the federal government that CTC should be reimbursed by the Centers for Medicare & Medicaid Services (CMS). Lack of reimbursement has been one of the primary stumbling blocks to greater adoption by radiologists, Pickhardt said.

For example, Viatronix's (Stony Brook, New York) device for CTC, which was used in the University of Wisconsin study, was approved by the FDA in April 2004.

Federal recommendation and coverage of CTC as a screening tool for colorectal cancer would have to be passed via legislation in the U.S. House and Senate, he said, and there are efforts under way to make that happen.

As a result of the ACRIN study, MGT Capital Investments issued a statement as the parent company of Medicsight (London), a company providing computer-aided detection (CAD) and image analysis software, including ColonCAD.

Commenting on the ACRIN study, Medicsight CEO David Sumner said it confirmed "that CT colonography is a genuine and robust option in the armamentarium that physicians have at their disposal when screening for colorectal cancer. "This is likely to lead to a material increase in the use of CT colonography for screening populations aged 50 or more who are most at risk of developing this devastating condition," Sumner said.

Meanwhile, the American College of Gastroenterology (Bethesda, Maryland), which represents gastroenterologists who conduct the traditional optical colonoscopy, issued comments offering their own perspective on the results of the University of Wisconsin researchers' CTC study, not unexpectedly putting an emphasis on caution.

"While all of us on the front lines of battling colorectal cancer will welcome effective and clinically proven new tools, the evidence needs to be closely evaluated, and patients need to recognize that a virtual test is not without significant potential risks in its own right," said David Johnson, MD, president of the ACG. He also said that the organization saw a "major limitation" in the fact that the study was nonrandomized.

Johnson noted that in the Wisconsin study, about 8% of CTC screenings resulted in referrals for OC for removal of suspicious polyps. He also noted that the total numbers of polypectomies in the CTC and OC groups were 561 and 2,434, respectively, so "far more potentially cancerous polyps were removed by colonoscopy."

The ACG said that an "important reality" of CT colonography is that patients most likely will need a follow-up with a traditional colonoscopy, and that the organization has concerns about the "economic impact to the healthcare system of separate diagnostic and therapeutic exams."


AHRQ reports hospital CV mortality declining

The Agency for Healthcare Research and Quality (AHRQ; Washington) has published a statistical brief on hospital mortality for a series of diagnoses as part of its Healthcare Cost and Utilization Project (HCUP), the numbers indicating that hospitals have made substantial inroads on mortality associated with cardiovascular disease.

According to the HCUP statistical brief, covering data from community hospitals between 1994 and 2004, hospital mortality for acute myocardial infarction (AMI) "had the largest [absolute] reduction in hospital deaths per 1,000 admissions" for all the procedures tracked in the survey, "with 43 fewer in-hospital deaths per 1,000 admission" in 2004 compared to 1994. The drop was from 125 deaths per 1,000 to 82 for AMI.

Hospital mortality rates for abdominal aortic aneurysm also demonstrated substantial reductions in mortality, dropping from 103 to 74 deaths per 1,000 admissions for a net reduction of 29. Congestive heart failure deaths per 1,000 admissions fell from 67 to 38 deaths per 1,000, whereas mortality from stroke fell 138 to 105 deaths per 1,000. Pneumonia mortality also fell by more than 30 per 1,000, from 106 to 70.

Some other conditions — not quite so deadly to begin with — offered less opportunity for improvement.

Neurosurgical procedures requiring craniotomy (removal and replacement of skull) declined by 15, from 83 to 68 deaths per 1,000, and carotid endartectomy, the removal of stenotic tissue from the carotid artery, dropped by only five per 1,000. But the mortality rate in 1994 for this procedure was only 12 per 1,000, a reduction of nearly 40%, a figure much higher than for the other procedures


CMS ready to roll out P4P demo home healthcare project

Pay for performance (P4P), is growing in the hospital sector, and the Centers for Medicare and Medicaid Services said it will roll out a P4P demonstration program for home healthcare providers as well. However, as is the case with some hospitals, some home healthcare agencies (HHAs) may find that it costs more to participate than they earn in performance bonuses. The statement described the P4P program as "an important new step in its drive to become a more effective purchaser of quality healthcare."

The agency last month reported that it will begin solicitations of home healthcare agencies this quarter and will have some of the projects rolled out on Jan. 1. The agency will set up demonstration sites for two years in seven states and will measure the incidence of acute care hospitalization, the incidence of emergent care, and improvement in the status of surgical wounds. Other measures will include improvements in oral medication management and in the patient's ability to walk under his or her own power.

The demonstration project will operate essentially as a randomized, controlled clinical trial, with home health agencies assigned either to a study group, with patients monitored over the two years, or a control group, comprised of HHAs that will continue their care practices for the duration of the study.

The demonstration will attempt to recruit a group of HHAs that are collectively representative of HHAs across the nation by selecting specific geographic targets. In the Northeastern U.S., CMS will select HHAs operating in Connecticut and Massachusetts and for the South, operations in Alabama, Georgia and Tennessee. Illinois HHAs will represent the Midwest, and California is the site of demonstration projects representing the West Coast.

HHAs will be eligible for payments under the demonstration only if their quality improvements "result in the highest performance levels or significant improvement in outcomes." CMS said that while no participating HHAs will experience a loss of revenue but that payments "will depend on whether or not the demonstration results in improvements in the quality of care and the actual savings to the Medicare program overall — not just for home health services provided to the patients served under the demonstration."

Mary St. Pierre, VP of regulatory affairs for the National Association for Home Care & Hospice (NAHC; Washington), told Biomedical Business & Technology that the association's members are "very excited" about the program and that CMS "adopted a lot of our recommendations" for the program. "We're looking forward to seeing how this progresses."

Some hospitals that have participated in a P4P project found that their costs negated the bonuses received, and St. Pierre said the same scenario could play out in the home healthcare setting. She said that some providers have seen acute care hospitalization rates fall from 32% to 24% under quality initiatives.

"It could cost [more], but could benefit patients in the long run" if all home healthcare providers adopted higher quality standards, she said.


New U.S. patent application continuation rules now in force

The U.S. Patent and Trademark Office (PTO) has notified med-tech and other firms that its rules regarding patent application went into force Nov. 1. The agency issued the final rule in September after floating the proposed rule the previous month.

According to PTO's statement, the final rule allows a transitional "one-more" continuing application provision for any applications that were the subjects of two continuations or continuations-in-part applications prior to Aug. 21.

Applicants can file a "one-more" continuation after Nov. 1 with no petition if they can show that no other patents have been filed that "claims the benefit of the prior-filed applications."

In the case of pending continuation-in-part applications, PTO is also waiving the requirement that "an applicant must identify the claim or claims in the continuation-in-part application for which the subject matter is disclosed" per 35 USC 112.

In that passage, the United States Code says that the specifications of a patent must "contain a written description of the invention, and of the manner and process of making and using it," but also stipulates that "a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed."

The new rule allows an in-part continuation to go forward despite having initially not referenced the prior claims so long as the applicant can show "where a prior application provides support...for the invention as defined in the claims of an application." However, this refers only to those continuation-in-part claims that are the subject of an action-on-the-merits letter from PTO dated before Nov. 1. Any in-part continuation claims referenced later than that date will have to make reference to the prior claim.

Among the other provisions of the final is a provision dealing with the agency's waiver of a two-month provision codified in the Code of Federal Regulations for applications having a common owner and at least one common inventor.

In keeping with the tortured use of language inherent in regulations, PTO also clarified the use of the term "examined" in reference to the scope of an application. Any application for U.S. patent that does not clear an international search may nonetheless be filed and "examined" for a divisional application for U.S. purposes.


NIH to fold bioengineering, physical science group into NIBIB

The National Institutes of Health reported that it will fold the Division of Bioengineering and Physical Science (DBEPS) into an intramural research program at the National Institute of Biomedical Imaging and Bioengineering (NIBIB).

Formerly part of the NIH Office of Research Services, DBEPS' work was already geared toward support of the NIBIB mission in that the branch "specializes in the development and application of new technologies, based on engineering, mathematics, and the physical sciences, for the solution of problems in biology and medicine," according to the Oct. 4 statement.

The NIH said that these efforts should mesh well with NIBIB's emphasis on "cutting-edge technologies operating at scales ranging from near-atomic resolution to intact organisms."

Rod Pettigrew, PhD, director of NIBIB, said that his institute is "excited about the transfer of this exceptional cadre of researchers to the NIBIB Intramural Research Program," due to the "exceptional fit with the mission of the institute ... ."