Posted
February 27, 2006

Market-Driven Surgery and Quality of Care

The media has an endless fascination with stories out of Canada and Great Britain about long waits for basic health care services. Their national health care systems invariably get blamed. The stories generally revolve around anecdotes about elective surgery that many do not consider elective. The latest, in Sunday’s New York Times, revolves around a private Canadian clinic, operating outside the law, that replaces creaky knees and hips in seniors turned down by the national health care program.

The story suggests that in the wake of a recent Canadian court decision, its “slow motion” single-payer health care plan will inevitably be replaced by a two-tier system similar to our own that includes private insurance. Maybe so. But no one should mistake that for better health care. Let’s explore some issues the Times story left out.

Anyone who has suffered from the constant pain of crippled joints might have a second opinion about a determination that their operation can wait six to nine months. But how did the Canadian health authorities make that decision? It inevitably hinges on an evaluation of the health benefits of the operation, its cost, the number of people who might take advantage of the service if it were made freely available on demand, and the cost constraints on the entire health care delivery system, of which this is just one part.

How did they determine the benefits? While many joint replacement surgeries are needed, some are not. Some even make things worse for the recipients. Unfortunately, very little is known about who is most likely to benefit from these surgical procedures.

In the U.S., a December 2003 study by the Agency for Health Research and Quality found that Medicare in 2001 paid over $3.2 billion for joint replacements in nearly 200,000 seniors, two-thirds of whom were women and one-third of whom were obese. Despite these 200,000 operations every year, the AHRQ researchers could find virtually nothing in the medical literature that documented the results of these operations other than improved mobility for the group as a whole and greater benefits from those suffering from rheumatoid arthritis.

Did it improve outcomes for the obese? Did the severity of arthritis matter? How long did it take before another operation was required? “The current state of empirical work does not provide a strong basis for making clinical recommendations,” the report concluded. “As pressures mount for more discrimination in identifying subjects for elective surgery, better information will be needed.”

Unfortunately, better information is not easily obtainable. Compared to drug makers, device manufacturers have to meet much lower standards at the Food and Drug Administration before getting approval to sell new devices like artificial hips. Placebo-controlled trials are almost impossible since who would voluntarily sign on for an operation that might turn out to be a sham? Of course, extensive post-operative monitoring of the millions of people who have had these operations would tell researchers a lot. But the FDA rarely requires post-marketing studies and rarely enforces its mandate when it requires them. Moreover, what device manufacturer would voluntarily conduct such a study once it has already gained FDA approval? From its perspective, the study could only hurt sales.

Meanwhile, the cumulative cost of these popular operations are heading higher as more and more members of our graying and increasingly obese society opt to undergo the procedures. The result: public systems (the average age of patients in the AHRQ survey was 70, making Medicare the principal payer) will come under increasing financial stress without tools to discriminate among those who want the operation.

Governments could, of course, fund studies to show who really benefits the most from such operations. But manufacturers have been very adept at dissuading the authorities from conducting such studies. The Medicare Modernization Act’s budget for outcomes research was deliberately kept minuscule by a Republican Congress beholden to drug and device industry lobbyists.

While I don’t know the details, I am guessing that Canada decided, in the absence of research, to adopt a waiting period to sort out who really needed the operation. It’s probably the only choice they could make in the absence of good information.

But the result, in the wake of a recent court decision opening Canada’s provincial health care systems to competition, will be the worst of both worlds. Patients who have money or insurance will get their operations whether they need them or not. Meanwhile people who really need them but don’t have money or insurance will have to wait.

Rationing by price may be a good business decision for the knee and hip joint manufacturers and the osteopaths who install them. But it is lousy health care.