Meanwhile, some medical device manufacturers and physicians have been taking advantage of America’s distraction over the unethical practices of drug companies. But with the cost of implant and other devices seriously hurting hospitals, patients, and payers, device makers may be about to share the harsh spotlight.

Perhaps the US has its restrictions in the wrong places. Free-market medicine is widening the access-to-care gap in the United States, partly by redefining “to deserve” as “to be wealthy.” But on the other hand, entrepreneurial, nurse-staffed clinics in supermarkets and pharmacies are showing the healthcare industry how primary care should be done. Hospitals and physicians who don’t take this trend seriously stand to lose opportunities and patients to those who do.

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Clinical trials will be dramatically accelerated and improved when we put IT and networking to full use, as they were recently in an international collaborative research project in which researchers in Australia performed real-time cell surgery in California, over the Internet.

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At a recent conference jointly organized by the University of Tokyo and the private Nomura Research Institute discuss what products might be desirable — and available — in 2055. The conference aimed in part to stimulate Japanese researchers to focus more on basic sciences (in which they tend to be weak) instead of just on developing applications of scientific breakthroughs made elsewhere.

Among the items proposed by researchers at the conference were robotic private tutors for children, and sand that detects and absorbs the shocks of an earthquake.

Indian Ethics and Modern Medical Research

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President Bush’s restrictions on federal financing for stem cell research, laid down in 2001, “provoked joy” in India, said an Indian journalist writing in the New York Times. “The weekly newsmagazine India Today, read mostly by the country’s ambitious middle class, spoke of a ‘new pot of gold’ for Indian science and businesses [and said that] ‘If Indians are smart,’ American qualms about stem cell research ‘can open an opportunity to march ahead.’ Just four years later, this seems to have occurred.”

He cites studies showing “tenfold” growth in Indian biotechnology companies over the next five years and more than 10,000 highly trained and cheaply available scientists as evidence. He also provides some specific examples, such as Reliance Life Sciences, which is trying to devise new treatments for diabetes and Parkinson’s and Alzheimer’s diseases, and create human skin, blood and replacement organs genetically matched to their intended recipients.

But most of the article is devoted to a comparison of Asian versus Western ethics, and it appears that Asian religions offer no more solid ethical guidance regarding cloning and embryonic stem cells than Western religions do. However, with no religiously motivated and opinionated political leadership to restrain it, the Indian biotech industry is forging ahead.

Technology Costs and Corruption

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A Louisiana State University Health Sciences Center surgeon has been fined US$10,000 for favoring Sulzer’s artificial knee in return for $175,000 a year in “consulting” contracts with the company. Six-figure consulting agreements, royalties on new devices, expenses-paid educational conferences, sponsored fellowships, and unrestricted grants are not uncommon and are partly responsible for a 40 percent ($4 billion) rise in Medicare payments for implant surgery over the past two years. Hospitals, consumers, and other insurers besides Medicare are all hurt by the practice.

Medical device companies are less subject to scrutiny than drug companies and can work in greater secrecy. “One large device company, Guidant,” reports the New York Times, “has even sued two hospital consultants because they divulged pricing information to competing hospitals.” Keeping pricing secret leaves hospitals vulnerable to overcharging and “impotent to negotiate a better price.”

As well, hospitals often don’t know of their doctors’ relationships with the device companies or the details of those arrangements. Needless to say, the device companies’ trade association, AdvaMed, claims the practices are legitimate, and points to its voluntary code of ethics that limits the value of gifts to under $100 and recommends hiring consulting doctors for their expertise rather than for bringing in business. The association’s members have been “aggressive” in implementing its code of ethics, a spokesperson told the Times.

Not, apparently, aggressive enough. In March, the US attorney in Newark, New Jersey issued subpoenas to five orthopedic implant companies, asking them about their consulting agreements and other arrangements with doctors in connection with a number of investigations under way.

Meanwhile, “Prices are soaring. A defibrillator now runs as much as $35,000; the price of the latest artificial knee approaches $10,000. A single screw used in spinal surgery can cost as much as $1,600,” reports the Times. Little wonder that device companies garnered net profits of nearly 20 percent at the end of 2003, more than twice the average for the S&P 500; and little wonder that in the past two years spending on implant surgeries by Medicare increased twice as fast as Medicare spending over all.

Price is not the only contributor to increasing costs. Hospitals are also hurt by the constant introduction of more expensive models that are not so much innovations than cosmetic makeovers of existing products. In addition, implants are sometimes unnecessarily sophisticated for the patients who get them. Case in point: The “bells and whistles” on an enhanced single chamber defibrillator costing $5,000 to $8,000 more than a basic model are simply not needed by the average patient, according to one physician.

“A rebellion,” says the Times, “has begun on several fronts.” First, some hospitals are trying to “align their interests more closely with those of their doctors” — i.e., they want a piece of the action so as to bring their costs down. Second, some hospitals are hiring consultants to provide information about what other hospitals are paying, to give them negotiating leverage. Guidant has responded by suing two such consultants for sharing confidential price information.

Healthcare Disparity Grows

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Baltimore’s Pinnacle Care International advises families on which doctors and hospitals provide the best care. It will then make appointments, do the paperwork, and even accompany patients. “From time to time,” says a reporter for the Baltimore Sun, “it coordinates with a member’s chef on healthful menus and with his personal trainer on an exercise plan.” Membership fees range from US$10-30,000 for joining and from $5-25,000 annual renewal, depending on the level of service desired. Except for periodic “executive physicals,” any actual treatment is extra.

Such “concierge” or “boutique” medicine is spreading. Johns Hopkins offers “executive physicals” at about $2,000 each, “with specialists lined up for back-to-back tune-ups of the busy patient,” says the article. A few mass-market patient advocacy companies take phone calls to help patients sort through a problem, for a few dollars a month. Some doctors have launched “advocacy practices” that don’t treat patients but instead advise them and coordinate with other providers. Florida’s MDVIP helps doctors set up concierge practices. Nurses and social workers are getting into the business as well.

At the same time as the US healthcare system grows even more Byzantine, it puts greater onus on patients to manage their own care and navigate the labyrinth alone. That practically forces anyone who can afford it into the arms of the concierges. And at such prices, fewer and fewer people can afford it, resulting in a further widening of the unconscionable access gap for American citizens.

Pinnacle’s chairman told the Sun that he decided such service was “not only something VIPs and princes and kings deserved, but that everybody deserved, at least if you can afford it.”* Pinnacle’s founders told the Sun “they don’t believe that by getting extra care for some, they are reducing care for others,” and one said that pushing for better care “brings the game up for the entire system.”

* This editor feels morally bound to protest that the implied definition of “deserve” here is corrupt. The dictionary definition is: “To earn by service; to be worthy of (something due, either good or evil); to merit; to be entitled to; as, the laborer deserves his wages; a work of value deserves praise.” If society allows self-serving re-definitions of basic values to pass unchallenged, society will indeed deserve what it gets.

March of the MinuteClinics

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“Americans,” says an article in the Pittsburgh Post-Gazette, “can increasingly get basic medical care in the same place they buy toothpaste and light bulbs” — which is to say, pharmacy and retail chain stores. In-store health clinics offer people speed, convenience, and (especially for the tens of millions without insurance) relatively low cost. Several CVS and Target stores already have such clinics, and three more chains — Rite Aid, Brooks Eckerd Pharmacy, and Osco Drug — plan to introduce them. America’s largest pharmacy chain, Walgreen’s, is thinking about it, and the biggest retailer in the world — Wal-Mart — is preparing to open clinics in several states.

Some doctors feel threatened, and some question the quality of care the nurse-practitioner-staffed clinics offer. But patients themselves seem to appreciate the convenience, and many of the clinics have built networks of local physicians who are available by phone if the nurse practitioner needs help with a diagnosis, and to whom the clinics can direct referrals where necessary. Clinic services are restricted to about 30 basic services and diagnoses, ranging from athlete’s foot to tetanus shots. The nurse practitioners do not prescribe drugs for health situations that require continuing care such as antidepressants, birth control, or heart medications.

Health insurers see savings — under US$60 for a store clinic visit versus $110 for a typical physician office visit and versus hundreds of dollars for a hospital emergency room visit (e.g., $300 for a strep throat test at the emergency room) — and some are actively encouraging patients to use the clinics by lowering the co-pay.

The clinics make heavy use of two things the healthcare industry does not: Information technology, and lessons from other industries. Software is used to help with diagnosis. The patient’s record is computerized and available to (and maintained by) the nurses on handheld wireless devices, as well as to a primary-care physician if the patient is referred. Prescriptions are transmitted electronically to the store pharmacy, or another pharmacy.

IT Can Speed Up Clinical Trials

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To fix the current “broken” model of clinical trials, writes a Siemens executive in Hospitals & Health Networks Most Wired magazine, we must find a more efficient way than media campaigns and chart reviews to identify patients appropriate for a trial, and we must find better methods to safely and efficiently process patient data during its course.

With regard to identifying trial candidates, “innovative software [is or will soon be available] to read the clinical notes in a chart [and] match patients to criteria thousands of times faster than through traditional methods.”

And with regard to managing trial data: “Most of the data needed for clinical trials automation already exists within hospital and clinic information systems. The next step is to use computerized systems to create, modify, maintain, archive, retrieve, transform or transmit the clinical data that is required by the FDA in a much more efficient and secure way.”

The US National Cancer Institute’s cancer Biomedical Informatics Grid (caBIG) — an open-source, open-access, voluntary network sharing cancer research tools, standards, data, applications, and technologies — will also help to speed clinical trials and hence speed the delivery of new treatments for cancer, by providing a means to manage the explosion of information.

Laser Telesurgery

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By controlling a laser scissor-and-tweezers technology called RoboLase over the Internet, scientists at the University of Queensland in Australia burned surgical holes in cells at the University of California, with the same speed and precision as if they were actually in the California lab. The Australian scientists were also able to “optically trap” swimming sperm in the California lab by operating optical-laser tweezers remotely, which was doubly significant because it required 1 gigabyte/second of bandwidth.

The experiment opens the door for researchers to become directly immersed in experiments around the world without having to travel, and to have access to technologies (like the RoboLase ) that they might not be able to afford at home.