The FDA’s recent acknowledgement that it has a problem keeping up with the accelerating introduction of new devices is a start at resolving the issue, but one wonders if a resolution is achievable. The flood of new devices and treatments may be unmanageable even with the best of intentions and all the scientific review in the world. The intentions are certainly suspect when an FDA official arbitrarily rejects the findings of his staff’s scientific review.

The murk at the FDA would make good hunting for New York ace attorney general Eliot Spitzer, but he will have other things to do if elected governor. Specifically, he will be busy making stem cell research the centerpiece of his healthcare policy. With the national Republican administration putting politics over science and failing the country on this issue, states have to step in, he said.

States are already stepping in, though we suspect not in the way Spitzer intended, with a flurry of bills seeking to protect “conscientious objector” healthcare workers. Maybe such legislation is a good idea, provided there is equal protection for conscientious proponents. If one nurse can refuse to participate in an abortion procedure on grounds of conscience, why should not another be allowed to participate on precisely the same grounds?

* * *

A pundit calls for spending “billions” to train more doctors to fill a projected massive shortage in the US. Like many such projections, this one makes no reference whatsoever to healthcare innovation and its accompanying storm surge of cures, preventatives, and home disease/disability management technologies. It is time to take the issue of acceleration of healthcare innovation seriously and to stop giving policymakers the easy, expensive, and very likely false way out.

And we are happy to report that some have begun to do that.

First: Even for healthcare services with the highest projected rates of growth among the baby boomers, aging is “a much less important factor than local population trends and changing practice patterns attributable to advancing medical technology,” say three researchers in a highly credible study that recognizes and tries to account for the impacts of technology on demand for hospital inpatient services. The study should give pause not only to administrators planning for a boom more likely to resemble a whimper, but also to policy analysts making potentially significant over-estimates of future shortfalls in physicians and nurses.

Second: Further evidence that the future painted by Baby Boom doomsayers ain’t what it used to be is available from as credible an authority on population trends as one could wish for: The US Census Bureau.

Third: Adding to the optimism is a scholar who has calculated that the age of retirement will be 85 by the year 2050, based on technology’s ability to increase the average lifespan by one year every year between 2010 and 2030. We don’t know why he stops at 2030.

All this assumes that the costs of the so-called “War on Terror” and other contributors to the burgeoning US budget deficit won’t drain the coffers of the funds needed to research and develop the technologies that will keep us healthier, longer.

* * *

Science is developing the ability not only to read your mind, but also to predict what you are about to do or say as a result of what you are thinking about. A question Europeans are asking is: Given the extraordinary powers we are acquiring to both look into and manipulate what goes on in people’s brains, shouldn’t we be thinking about regulating those powers much more carefully?

Source article

Resurfacing of arthritic hips is a common procedure in Europe. It is long-lasting, less invasive than traditional hip replacement, and it works. Instead of removing the top of the femur, the surgeon smoothes the damaged ball joint and covers it with a metal cap, “much as a dentist would cap a damaged tooth,” writes News & Observer reporter Jean Fisher. Should the implant eventually wear out and the patient opt for a hip replacement later, “the surgeon [still] has plenty of bone to work with.”

Yet it is only now being tested in clinical trials at a handful of US hospitals. So what is a US citizen with an arthritic hip to do? Why, go abroad for the procedure, of course. Fisher cites as an example a couple who used their frequent-flyer miles to fly to India, where the wife’s hip was resurfaced for US$5,600, including all hospital fees. It would have cost more than $40,000 in the US, as an experimental procedure not covered by insurance.

Multiply that anecdote by at least 72,000 hip replacement surgeries (20 percent of the total), and that is the size of the potential loss to US healthcare providers if hip resurfacing remains hard to find and expensive here. And word does get around: the couple that went to India have since helped other sufferers go there. The Indian surgeon who operated on them said he resurfaces up to 15 American hips a month.

Monitoring Medical Devices

Source article

Following the death of a patient from a implantable cardioverter defibrillator (ICD), the US Food and Drug Administration’s Center for Devices and Radiological Health has promised to do a better job of monitoring the performance of devices it approves after they are put on the market. The ICD’s maker, Guidant Corp., knew but did not tell physicians and patients that it could malfunction in a small number of cases. Guidant later recalled 300,000 ICDs and pacemakers.

Dr. Daniel Schultz, director of the Center for Devices and Radiological Health, said the Center is challenged by the size and growth of the device industry, the complexity of devices, increased home use of devices and the tension between safety and approving cutting-edge technology that could improve people’s lives, but promised to be “even more vigilant” in future. “Our priority for the next year, or however long it takes, is to try to make sure that we have a postmarket safety net that is equal to our premarket review process,” Schultz said.

FDA Credibility Under Suspicion Again

Source article

Last year Dr. Daniel G. Schultz, director of the US Food and Drug Administration’s Center for Devices and Radiological Health, overruled the unanimous opinion of his scientific staff and approved Cyberonics’ implantable vagus nerve stimulator to treat persistent depression, despite evidence that it was not effective for depression, though it was effective against epilepsy.

Spitzer Wants Stem Cell Research in NY

Source article

New York attorney general Eliot Spitzer has said he will seek a US$1 billion bond to pay for stem cell and other medical research, if he is elected governor. Significantly, in our view, he said this would be the “centerpiece” of his health care policy, which he contrasted with the Bush administration’s propensity “Time and time again [to] put politics over science.”

His fellow democratic gubernatorial contender Thomas R. Suozzi, a Roman Catholic, declined to speak with the New York Times about his position on stem cell research, which some Catholics oppose.

Ethics & Acceleration

Source article

At least 18 states are considering 36 bills “to protect health workers who do not want to provide care that conflicts with their personal beliefs,” writes Rob Stein in the Washington Post . He is talking about pharmacists who refuse to fill prescriptions for birth control and morning-after pills because they believe the drugs cause abortions, and about doctors, nurses, aides, technicians or other employee who object to any therapy on some or other religious ground, or even on mere “conscientious objector” grounds. “That might include in-vitro fertilization, physician-assisted suicide, embryonic stem cells, and perhaps even providing treatment to gays and lesbians,” he notes.

“This goes to the core of what it means to be an American,” said David Stevens, executive director of the Christian Medical & Dental Associations, thereby dismissively disenfranchising a sizeable number of folks who thought they were Americans. “We are moving into a brave new world of cloning, cyborgs, sex selection, genetic testing of embryos,” he said, and I’d be the last to argue with that. And while I would further agree wholeheartedly with his opinion that “Conscience is the most sacred of all property,” the question is to what degree society, or an institution, should be held hostage to his, or my, or any individual or small group’s conscience.

Staffing Shortage

Source article

“The healthcare staffing shortage is like a Category 5 hurricane looming on the horizon,” trumpets a pundit in HealthLeaders . “Everyone can see it coming, but no one knows how to stop it.” She cites a currently projected deficit of 200,000 physicians and 800,000 nurses in the US by the year 2020.

“So far,” she writes, “U.S. healthcare organizations have been able to cope with staffing shortages by demanding longer hours from staff, loading more patients on existing staff, and contracting with temporary healthcare professionals,” but this can’t go on forever. Already, “The increasingly limited access to healthcare workers leaves little or no room for surges in the demand for healthcare services.”

So what do “Hospitals, healthcare providers, policy analysts, academics, and the healthcare staffing industry” need to do about it? “Coalesce and become more vocal …, [raise the] cap on the number of medical residency programs funded through CMS” even if it takes “millions–or even billions–of dollars to increase the number of trained physicians.” And that’s in addition to the money that will be needed to expand training programs for nurses and other healthcare workers.

“There is no doubt the storm is coming,” she says.

Technology vs. Aging

Source: Health Affairs 25 (2006): w141–w149 (published online 28 March 2006; 10.1377/hlthaff.25.w141)

Rather than our usual practice of summarizing and paraphrasing an article, in this case it is worth quoting directly from the source article:

Although aging will likely have an important impact on spending, its magnitude will be dwarfed by the impact of advances in technology and other factors that affect medical practice patterns. To see this, consider coronary artery bypass graft (CABG) surgery and percutaneous transluminal coronary angioplasty (PTCA). Between 1993 and 2002, if nothing had changed other than the age distribution of the population, use of each of these procedures would have increased 0.6 percent per year. However, the actual rates of growth for these two procedures were strikingly divergent: The number of patients who received PTCA during an inpatient stay grew a total of 83.4 percent, or 7 percent per year, from 1993 to 2002, while the number of patients on which CABG was performed grew a total of 1.4 percent, or 0.2 percent per year.

…Although having a large elderly population could influence priorities in industries that develop new medical technologies, [the] historical record suggests that advances in technology not responsive to health system developments will probably dwarf this incentive. Some have maintained that those in the baby-boom generation culturally are inclined to make greater demands on the medical care system than their parents and grandparents did, but we find it difficult to ever validate this, when baby boomers have dramatically expanded possibilities to draw from than did those a generation or two older.

…In general, the effect of aging effect on use of inpatient services will be small, but it will have a larger impact on use by patients with certain types of medical conditions that are more concentrated among the elderly. But for many of the conditions highlighted in this analysis, changing technology is a much larger factor in changes in treatment than population aging. In local geographic areas, forecasts of population growth will probably be more important for planning than forecasts of aging will be. Indeed, site-visit analyses in the Community Tracking Study (CTS) show sharp contrasts between areas like Phoenix, in which population growth is so high that risks of too much expansion of capacity are negligible, and areas like Syracuse, with stagnant or declining populations, which need to exercise much more care in forecasting demand.

Of course, hospitals must plan for capacity for ancillary services that will serve both inpatients and outpatients. But projecting demand for outpatient services is particularly difficult now because of recently developing trends of investment in outpatient facilities owned by physicians. These facilities’ competitive threat to hospitals could not have been foreseen a few years ago, which makes its importance five years into the future very difficult to predict.

US Census Bureau: Boom Does Not Mean Bust

Source article

Reporting on a recent US Census Bureau report, New York Times writer Rick Lyman notes that “the economic and social impact of this baby boomer sunset may be gentler than had been feared.” The report showed that today’s older Americans are more prosperous, better educated, and healthier than previous generations, and those attributes will improve further by 2011, when the first boomers reach retirement age. Lyman quotes the director of the National Institute on Aging, on whose behalf the study was conducted, as saying that “Older Americans, when compared to older Americans even 20 years ago, are showing substantially less disability,” suggesting that disability will happen increasingly later in life.

Salient statistics:

• The percentage of those over 65 who had what the report described as “a substantial limitation in a major life activity” due to disability fell from 26.2 percent in 1982 to 19.7 percent in 1999.
• In 1900, there were 120,000 Americans — about 0.1 percent of the population — over age 85. Today there are more than four million, about 1 percent.
• In 2003, there were 35.9 million Americans over the age of 65, about 12 percent of the population. By 2030, there will be 72 million — about 20 percent of Americans.
• In 1959, 35 percent of people over 65 lived in poverty. By 2003, that figure had dropped to 10 percent.
• The proportion of older Americans with a high school diploma rose to 71.5 percent in 2003 from 17 percent in 1950.

“The report was not all good news,” writes Lyman — it also showed that divorce is rising among older Americans, leading to concerns that broken families combined with low birth rates among baby boomers may result in fewer family caregivers. Also, the drop in poverty is only an average: “There are subgroups among the old who still have fairly high levels of poverty, including older women, and especially those who live alone,” said a Census Bureau official said, noting also that poverty hit blacks and Hispanics, especially women, harder than whites. While 10 percent of older white women lived in poverty in 2003, 21.4 percent of older Hispanic women and 27.4 percent of older black women did.

Anti-Aging and Retirement at 85

Source article

The age of retirement should rise to 85 by 2050 because of trends in life expectancy, a leading biologist has said. A Stanford University biologist told the American Association for the Advancement of Science annual meeting that because anti-aging technologies will increase longevity over the next two decades, the age of retirement should be 85 by the year 2050. But he questioned whether individuals, institutions, and society will be ready for the change.

His projections show anti-aging technologies will add one year per year to the average lifespan between 2010 and 2030. In the US, that would mean the cost of social security and medical care would almost double if people still retired at 65, whereas an increase in the retirement age to 85 would bring costs down to today’s levels.

US Medical Research Funding Crisis

Source article

In the 1980s, writes Regina McEnery in the Cleveland Plain Dealer , scientific researchers in the US won their first government grant by their early 30s. Today, the average age is 42. The delay may be driving some scientists to pursue other professions. The Bush administration’s goal to freeze the budget of the National Institutes of Health, and even to cut funding for cardiac and cancer research, will not help.

“The fear,” says McEnery, “is it will slow the pace of medical breakthroughs and force more collaborations with private companies where the potential for bias is greater.”

Googling the Brain

Source article

Scientists have monitored the memory process in the brain to predict what a person will think of next. While their brains were being scanned, test subjects watched computer images of famous people, famous places, and everyday objects. The images were removed as the subjects’ brains continued to be scanned, and the subjects were asked to recall as many of the images as they could. After analyzing the “before and after” patterns of brain activity associated with each picture, the researchers were able to tell over five seconds (on average) before the people could voice their memory, whether they were about to name one of the celebrities, places, or everyday objects.

In an earlier, similar experiment, researchers were able to predict where a patient would move his hand based on brain activity the instant prior. Whether such capabilities, as well as memory-enhancing drugs, should be regulated or even banned is a question under debate via the King Baudouin Foundation’s “Meeting of minds” project, a 126-member European citizens’ panel considering the ethical dilemmas emerging from brain science research. Their remit includes technologies such as deep brain stimulation, which is used to treat Parkinson’s but can also have an effect on mood and behavior.

Among the “big questions” to be answered, one of the participants told New Scientist , are: “Do we really want cognitive enhancement via surgery or medication, and if so how do we regulate it? It is already possible to detect a person’s intention or perceptions regardless of whether they are aware of them, and even if they try to cover them up. How will we deal with issues such as privacy and responsibility?” Others include defining what it is to be normal — “working out where creativity or eccentricity end and illness begins.”