Apparently sensing the directional winds, the Advanced Medical Technology Association (AdvaMed; Washington) in early December adopted a statement of principles supporting increased transparency in healthcare cost and quality, positioning itself to be one of the key voices that may put together any comprehensive program to address the issue. AdvaMed said it supports building a "transparent value-driven" healthcare system to improve the quality and reduce spending.

Stephen Ubl, AdvaMed president/CEO of AdvaMed, said that support of the statement of principles by the organization board is based on the understanding that greater transparency will help to ensure continued patient access to available technologies. "Everyone is a healthcare consumer. Greater transparency is a win for patients and the delivery of health care overall. Transparency supports increased consumer and provider awareness about the quality and costs associated with healthcare." He added: "Escalating healthcare costs have led employers to seek new ways to reduce costs in order to remain competitive in the global marketplace," Ubl added.

Adoption of the stand on transparency comes in response to an executive order from President George Bush requiring four government agencies to implement quality measurement programs awaits implementation in January. Additionally, the initiative dovetails with the plan by Mike Leavitt, secretary of U.S. Health and Human Services to connect the healthcare system through better use of information technology, including electronic health records; measuring and publishing information regarding the quality of healthcare, with a focus on patient outcomes from care; measuring and publishing prices for episodes of care; and creating positive incentives by implementing contractual arrangements that reward those who offer and purchase high-quality, competitively-priced healthcare.

AdvaMed said its principles underscore the need to provide consumers with tools to make informed decisions about their healthcare, based on "accurate, timely and robust measures which reflect the complexity of the procedures and services available." The group said that such initiatives should incorporate comprehensive definitions of the benefits and costs of healthcare services, including consideration of recovery times, lost productivity from days absent from work, and other factors contributing to the overall value of the healthcare provided.

The AdvaMed board recommended that quality and cost measures should be tied to well-established clinical guidelines developed by appropriate physician specialty societies. The organization did not suggest, however, that its members should have to provide data on the cost of their products to the public. Indeed many medical device companies have jealously guarded that information and it appears unlikely that outside of a government mandate, that will change any time soon. Rather, the board said that cost measures should be based on the resources needed to deliver a group of services, or entire episode of care. The resources, it said, should be identified from "well-established clinical guidelines."

The group also stressed that greater transparency must support technological innovation as well as innovation in healthcare delivery. Any transparency requirements, they noted "should not discourage vigorous competition within the healthcare system and should also ensure continued patient access to the full array of available technologies."

Disability in elderly tailing off

As administrators at the Centers for Medicare & Medicaid Services work to rein in spending, various stakeholders continue to offer evidence that while there is no free lunch, the budget lunch sometimes is a worse deal than going with something pricier than the blue plate special. A recent report on the functioning of Medicare enrollees by the Center for Demographic Studies at Duke University (Durham, North Carolina) suggests that investments in long-term care eventually save the taxpayer a dollar or two, a notion that echoes an earlier, privately funded study on power wheelchair use (Medical Device Daily, Nov. 9, 2006).

On the other hand, the growing numbers of the "older old" — and the impact that 79 million Baby Boomers will have on this population — demand that improvements in the status of the disabled be sustained to keep the federal ledger in balance.

Kenneth Manton, PhD, director of research at the Center for Demographic Studies, and the rest of the team reviewed data obtained in the National Long-Term Care Survey (NLTCS) documented that the percentage of Medicare eligibles who were disabled fell to 19% in 2004/05 from 22.5% in 1982, the first year of data available for the analysis. Those with one disability only dropped from 5.7% in that first year to 2.4% in the final year, and those who were institutionalized due to their disabilities fell from 7.5% to 4% during that same time span.

The definition of disability is based on "the difficulty of performing both activities of daily living," which includes basic personal care such as eating, grooming and bathing, and so-called instrumental activities of daily living, a list that includes meal preparation and budget maintenance.

When broken down by age, the ratio of the disabled between the ages of 65 and 74 fell from 14.2% in 1982 to 8.1% in 2004/05. For those aged 75-84, those numbers went from 20.7% to 11.9% and for those older than 85, the disability drop was from 62.1% to 49.7%.

The authors noted, however, that if federal healthcare expenditures are to "decline at the projected rate because of a per annum decline of 1.5% in chronic disability, future disability declines will have to occur at increasingly older ages." This improvement in those above the age of 85 "must occur to maintain the current rate of improvement in the fiscal status of Medicare and Medicaid to 2050, the year by which the last of the post-World War II" cohort has reached that age.

The article noted that the "rate of decline in chronic disability prevalence accelerates from 1982 to 2004/2005, starting at 0.6% per annum in 1982-1984 and increasing to almost four times that level (2.2%) by 1999-2004/2005." The authors stated a correlation with "a change in the management of severely disabled persons, especially in long-term institutional care." Prior to the 1980s, institutional long-term care was "primarily conceived of as residential and housing services and maintenance care, which was not well developed medically or for rehabilitation." Among subsequent institutional changes were the push from acute-care hospitals to skilled nursing facilities (SNFs) and the increased use of post-acute care due to the 100-day limit on Medicare payment for SNFs.

While the authors are reluctant to project the impact of the recent increases to the NIH budget, from slightly more than $10 billion in 2003 to a projected $28 billion in 2007, on disabilities in those aged 65 and older, they nonetheless comment that "investments in biomedical research and the production of innovative and more effective therapeutic and preventive medical care are possible explanations," as are "behavioral risk factor changes such as smoking cessation and moderation of alcohol consumption."

The impact of all this on the budget for Medicare and Medicaid is of no small consequence. The article put the potential savings at $73 billion, "or 17% of all Medicare expenditures expected for the elderly … if declines in chronic disability prevalence continue at their 1982-1999 rate."

Manto told Medical Device Daily that cardiovascular and cerebrovascular diseases are most closely tied to the observed drop in disability. "The biggest source of the decline in cardiovascular disease is reductions in disease risk and treatment after the event occurs," he stated. On the other side of the coin sits a series of neurological disorders, such as Alzheimer's disease. However, the prevalence of Alzheimer's and other neurological condions is somewhat linked to other elements of health status.

Alzheimer's has "a lot of circulatory disease underlying it," Manto remarked, and by some projections, the prevalence numbers "get huge." However, he insisted that "[t]he numbers are not as overwhelming as they're sometimes portrayed," adding that some Americans are fearful that they will inevitably succumb to Alzheimer's. He said such fears are somewhat overblown.

Getting after disabilities in the extremely elderly sounds particularly difficult, a notion Manto did not refute. On the other hand, early intervention makes a difference here, too. "If you reduce disability in the "young old, it cuts down on disability in the older old," Manto said.

"The relative rate of improvement has been higher in those 80 and older," he observed, but Manto said that the link between disease and age-related decline is blurry. "A lot of what we see is identifiable as disease syndromes that are separate from the other thing that we call senescence," but there is some interplay, often leading to a chicken-or-egg dilemma where differential diagnoses are concerned.

As for the Woodstock crowd that partied heartily with substances that were much less popular or even unavailable prior to the Sixties, Manto said that the effects of drug abuse on the prevalence of cognitive disability are difficult to pin down. "I don't know that it comes through in the numbers, but I'm sure that's a factor in a small percentage of people," he said.

"I have a feeling that recreational drug use is a bit like alcohol consumption in that other problems go along with it, and it's not clear that your life expectancy will be as high."

Too little 'nano' knowledge a big problem?

Two recent polls of the public indicate a host of positives in attitudes concerning nanotechnology but this doesn't translate to continued and guaranteed success for this emerging sector, according to one analyst and commentator on the field.

Neal Lane, a former science advisor to President Bill Clinton, has warned that the good public relations nanotechnology is experiencing now may not last, since the "warm and fuzzy" public attitudes toward the sector don't eminate from a good understanding of the science. This, he says, could result in considerable misunderstanding when critical questions and negative headlines inevitably come along.

"Nanoscale science and engineering promise to be as important as the steam engine, the transistor, and the Internet, and have the potential to revolutionize all other technologies" Lane said, in remarks made at a Project on Emerging Nanotechnologies event at the Woodrow Wilson International Center for Scholars. The program marked the release of an article in the December 2006 issue of Nature Nanotechnology.

Lane cited a recent poll by the Project on Emerging Nanotechnologies indicated awareness of nanotechnology is increasing. But it also showed, he said, that 69% of Americans have heard little or nothing about nanotechnology, said Lane and that "more young people are seeing nanotechnology in advertisements for MP3 players than are learning about nanotechnology in schools."

Another survey, called the largest and most comprehensive survey on the subject, recently tested public perceptions of nanotechnology. It found that U.S. consumers are willing to use specific nano-containing products — even if there are health and safety risks — when the potential benefits are high. And it found that U.S. consumers rate nanotechnology as less risky than everyday technologies like herbicides, chemical disinfectants, handguns and food preservatives. The study was conducted by researchers at the Center for Biological and Environmental Nanotechnology (CBEN) at Rice University, University College London (UCL) and the London Business School.

Lane is a co-author of that study, and he said the public is likely to become more aware of nanotechnology's risks as environmental health and safety research is completed and as nanomaterials find their way into more products. But he said that the survey also appears to indicate that the public may not be able to discriminate between real nanotech and what is misrepresented as nanotechnology.

"A major environmental, medical or safety problem — real or bogus-with a product or application that's labeled 'nanotechnology' — whether it actually is nanotechnology or not — could dampen public confidence and financial investment in nanotechnology's future, and could even lead to unwise regulation. We should not let this happen," Lane said.

To ward off this possibility, Lane emphasized a major educational effort " to investigate nanotechnology's possible environmental, health, and safety risks." A second educational effort should be pursued in schools. He compared such an effort to the Sputnik-generated interest in science, and he said America's "children and workforce need that same level of national commitment to lead and keep them competitive in the Nano Age."

Finally, Lane called for "a deliberate effort to provide the public with balanced and easily understood information about nanotechnology's potential benefits and its possible risks and for more public engagement" — led by government, industry and the science and engineering community working together.

Lane proposed that the UK's Royal Society and the US's National Academies set up interagency clearinghouses to coordinate public education and synthesize the latest scientific findings. Transmitting the latest information about both risks and benefits, in a timely, thorough and transparent way, will minimize the likelihood of a polarized public debate that turns on rumor and supposition."

Shear forces key to lubrication

Taking a cue from machines that gently flex patients' knees to help them recover faster from joint surgery, bioengineering researchers at University of California San Diego (USCD) have shown that sliding forces applied to cartilage surfaces prompt cells in that tissue to produce molecules that lubricate and protect joints. The results, reported in Osteoarthritis and Cartilage, are important in the ongoing efforts of the group led by Robert Sah, a Howard Hughes Medical Institute (HHMI) professor at UCSD's Jacobs School of Engineering, to grow cartilage in the laboratory that can be used to replace patients' injured or diseased joint surfaces.

"We have shown that shear forces on cartilage prompt chondrocyte cells in it to produce proteoglycan-4," said Sah. "This is an important step toward our goal of eventually growing joint tissue for transplantation." Proteoglycan, a name that reflects its protein and polysaccharide components, is a basic building block of connective tissue throughout the body. The chondrocyte cells of cartilage make several forms of proteoglycans, including several that build up in cartilage and contribute to its stiffness. However, proteoglycan-4 is primarily secreted into the joint fluid where it coats and lubricates cartilage surfaces.

Unfortunately, the smooth surface of the articular cartilage at the ends of bones located at joints often deteriorates with aging, becoming increasingly roughened and eroded. Those joints become painful and progress to osteoarthritis. Surgeons can replace damaged and diseased joints with artificial joints, but they would like to be able to simply resurface patients' existing joints with cartilage.

In a series of experiments, Sah's team attached bovine stifle joints, which are similar to human knee joints, to a bio-reactor that provided continuous irrigation with sterile nutritional fluids under normal physiological conditions. Immobile joints were compared to joints that were flexed 24 hours in a way that mimicked walking motions. The flexing was provided by a specially designed continuous passive motion device.

The team measured up to a three-fold increase in chondrocytes secreting proteoglycan 4 in continuously flexed joints compared to immobile controls. The flexing motion caused cartilage on the surfaces of opposing bones to slide against each other, creating so-called shear forces. In one large surface region of continuously sliding cartilage, 40 percent of the chondrocytes were secreting proteoglycan 4, whereas in the same areas of cartilage in immobilized joints only 13 percent of the chondrocytes were secreting proteoglycan 4. In areas of the joints exposed to only intermittent cartilage sliding, the effect on proteoglycan 4 production was intermediate between continuously sliding and immobilized regions of the joints.

"A challenge for us is to create large tissue grafts for transplantation," said Sah. "We are systematically addressing the technical challenges to maintain and grow healthy fragments of bone and cartilage in the laboratory and now we can use nature's self-regulating system, whereby application of shear forces to this tissue increases its synthesis of proteoglycan 4."

Senators back diabetes screening

Nineteen senators have sent a letter to Mike Leavitt, secretary of U.S. Health and Human Serivces, requesting that he "make diabetes screening and prevention for Medicare beneficiaries a top priority."

According to the letter, findings from a recent study in the journal Diabetes Care show that 61% of Medicare beneficiaries — 21 million of an estimated 32 million seniors — have either diabetes or pre-diabetes. Of those, 14 million beneficiaries are believed to have undiagnosed pre-diabetes.

"Please include in your FY 2008 budget proposal an aggressive collaborative effort between the CDC, [CMS], and other key agencies to find and screen" those beneficiaries who have not yet been diagnosed, the letter states.

The senators, including John Cornyn (R-Texas) and Charles Schumer (D-N.Y.), noted that a clinical trial conducted by NIH found that "modest" changes to diet and exercise prevented diabetes in 58% of participants considered to be at high risk of contracting diabetes. The trial also found that such changes prevented the onset of diabetes in participants over age 60 by 71%. The trial "shows that such an initiative will save lives and money" the letter states.

Weyden lays out universal insurance plan

Sen. Ron Wyden (D-Oregon) in late December said that early this year he will introduce legislation that would guarantee health insurance for all U.S. residents. According to Wyden, his plan would call for private health insurers would provide coverage to individuals directly, rather than through employers, and employers would initially shift funds currently used to pay for coverage to employee wages. Over time, employers would to pay the federal government a health insurance contribution.

The legislation would require individuals to use the funds contributed by employers to purchase through state purchasing pools private health insurance, which would provide coverage at the same level as the BlueCross BlueShield Standard Plan offered to federal employees. Individuals would not have to pay higher income taxes as a result of the funds they receive from their employers. Additionally, state agencies would be established to give advice on the acquisition of private health insurance converage.

The uninsured also would have to purchase health insurance, but the federal government would subsidize premiums for those in low-income categories and partially subsidize premiums for middle-income individuals. Similar to the protocol for auto insurance, those failing to buy a health insurance plan would be fined. The federal government would collect premiums paid by individuals and contributions from employers through the tax system and distribute the funds to health insurers. The legislation would apply to individuals until they reach retirement and would not apply to Medicare beneficiaries. In addition, the legislation would not apply to those who receive health insurance through the military.

Wyden cited comments from business leaders who previously have said that the reform of healthcare would be too costly. He said that now those business leaders are saying "We can't afford not to reform health care."

Steve Burd, CEO of Safeway Supermarkets, joined Burd in announcing the legislation and said that "dramatic change" is needed to keep the American worker from becoming "less competitive."

The legislation is intended to extend coverage to the estimated 47 million in the U.S. not insured and limit employer exposure to cost increases for healthcare coverate. Experts in this field said, however, that the legilsation is unlikely to pass without being championed by a chief executive committed to seeing it — or a similar plan — adopted.

IHI unveils safety plan

The Institute for Healthcare Improvement (IHI; ) Cambridge, Massachusetts), a non-profit organization, late last year launched a campaign to cut the number of patient injuries in hospitals by 5 million over the next two years. IHI said that there are between 40 and 50 "incidents of harm" for every 100 hospital patients in the U.S., meaning that about 15 million harm events occur each year.

IHI's plan includes calls for improved bedding and hand hygiene, better treatment of congestive heart failure and thorough disinfection of rooms where previous patients have had antibiotic-resistant infections. The plan calls for random audits of patient charts as a tool to determine the source of preventable accident.

IHI in 2004 launched a campaign to prevent 100,000 deaths as a result of what it termed hospital "failures."