Category Archives: Ethics

Bloomberg has an interesting article on the limited medical benefit of spinal fusion to patients–but big financial benefits to doctors, medical practices and suppliers (Medtronic). The article documents at least the appearance of, if not actual, conflicts of interest; high costs $135,000 for the surgery (yes on one patient); $800,000/year incomes for the orthopedists–three times that of pediatricians.

The possibility that many of these and other surgeries are needless has gotten little attention in the debate over U.S. health care costs, which rose 6 percent last year to $2.47 trillion. Unnecessary surgeries cost at least $150 billion a year, according to John Birkmeyer, director of the Center for Healthcare Outcomes & Policy at the University of Michigan.

“It’s amazing how much evidence there is that fusions don’t work, yet surgeons do them anyway,” said Sohail Mirza, a spine surgeon who chairs the Department of Orthopaedics at Dartmouth Medical School in Hanover, New Hampshire. “The only one who isn’t benefitting from the equation is the patient.”

There’s lots to this article including evidence that fusion is no better than physical therapy for disc related pain in several studies–only a 47% success rate for surgery in one U.S. study;  high complication rates for surgery;  direct payments from the medical supplier (Medtronic) in the form of royalties and consulting fees to doctors (as high as $440,000/year to an individual doctor and 1.75 million to a practice in Minneapolis).

Medicynical note: Not a pretty picture of American medicine. Costly, open conflicts of interest, use of aggressive expensive unproven procedures over more conservative approaches–with the same or worse outcomes.  Is it any wonder that our costs are one and half to two times that of other industrialized countries.

The “free market” encourages entrepreneurs to find ways to take advantage of markets, sometimes that leads to better outcomes and more efficiency but in medicine it seems to encourage waste, high cost and over-utilization.

The Washington Times presents a tortured argument against promoting more efficient care in the most expensive health care non-system in the world.

Think of it, a centralized, federal database tracking your every visit to a health care provider – where you went, who you saw, what was diagnosed and what care was provided. Chilling.  Medicynical note: as if private insurers oversight that  controls and limits treatment given is less intrusive, or as if the data will have patient identifiers.

The Times takes issue with the notion of efficiency in health care.  To them, apparently,   spending 50% more per capita on health care than any other nation in the world and 17% of GDP, and increasing yearly, is acceptable:

There is no telling what metrics will be used to define the efficiencies, but it is clear who will bear the brunt of these decisions. Those suffering the infirmities of age, surely, and also the physically and mentally disabled, whose health costs are great and whose ability to work productively in the future are low. And how will premature babies fare under the utilitarian gaze of Washington’s health efficiency experts? Will our severely wounded warriors be forced to forgo treatments and therapies based on their inability to be as productive as they once might have been? And will the love between a parent and child have a column on the health bureaucrats’ spreadsheets?

The Times then goes on to compare cost efficacy measures with the nazis.

Medicynical note: Nothing surprising here. Until we show some will to control  costs our non-system caring for an aging increasingly health care needy population will continue to spend our nation’s wealth.

Our republican friends have been amazingly quiet about their solutions. Their “free market” rhetoric leads one to assume they would put an increasingly large burden of expense on individuals–their form of individual mandate. They would then let the costs of health care assure economic rationing. For those who can’t afford care, I suppose their solution for patients is that of 18th century France and will let them eat cake.

Conflicts of interest affect outcomes as noted in this article on “new hips.”

Wright paid tens of thousands of dollars to a foundation Keggi helps run and gave him a trip to a conference in the Bahamas. Keggi recommended the ceramic device over the kinds of implants used in 97 percent of cases.

The ceramic joint made by Wright Medical Group Inc. shattered, leading to an infection and four more surgeries that left Hirschbeck permanently sidelined.

And costs:

The companies increased doctor compensation for 2008 to about $300 million, according to the data compiled by Bloomberg from reports posted on the device makers’ websites. Fees for 2008 were delivered in 2009, the surgeons say.

More on costs:

The financial ties between device makers and surgeons help explain why health-care costs in the U.S. rose at 2.5 times the rate of inflation in the past 10 years and account for a sixth of the economy. The $300 million works out to $300 for each of the 1 million hips and knees implanted in Americans in 2008.

In the U.S. in 2010, the average price of a primary artificial hip was $7,200, more than four times the $1,600 in Germany, says Melissa Hussey, a senior analyst on the orthopedic team at Millennium Research Group, based in Toronto. In Germany and other countries, she says, sales representatives have restricted access to surgeons.

Medicynical Note: So much for the “free market” system. Without regulation and limits companies will work endlessly to manipulate markets to their financial benefit. Are we fools or what?

It’s in vogue in medicine to market drugs offering slight benefit to desperately ill patients at cost of between $50,000 and $100,000/year.

What’s the real cost of these “advances.”

In a hypothetical (but typical) situation lets say the drug is used in 100 patients and compared with another group of 100 patients receiving placebo (or standard therapy).

As one would hope the group of patients receiving the study drug appears to have some response. In the distant past a response was defined as a decrease in tumor bulk of 50%. In recent years that definition has been broadened, some would say undermined, to mean that there was no evidence of tumor progression during treatment. Since we are in “modern” times lets use the definition of response being no progression.

We do our study and find in the group of patients receiving placebo (or standard therapy) 25% showed no progression. While in the study group receiving the new drug of 100 patients 40% showed no progression.

Drug companies take such data as evidence of the drug’s efficacy and try to get FDA approval. Note there is no evidence at this point of extension of life.

The real cost of this advance is interesting to contemplate. Consider treating 100 patients with a $100,000 drug–that’s 10 million dollars. Consider that just 40% get a “benefit” with the drug and 25% had the same “benefit” with placebo (or standard therapy)–and a marginal “benefit” at that. That means that 6 million dollars was spent on patient who got no “benefit” at all from the drug (the 60 of 100 patients without “benefit”). 2.5 million dollars on the 25 patients who would have shown no progression with placebo (or standard therapy). The incremental “benefit” of the drug over placebo or conventional therapy was therefore a total of 15 patients.

That means in our hypothetical but somewhat typical new drug situation 85 out of 100 patients will be treated with the $100,000/year drug and get nothing from it. 15 patients get a limited improvements. The cost/patient that improved is $100,000 X 100 patients treated/15 patients who get the improvement=$666,666 expended for each patient who improved. It should be noted that this is a cost per year figure for a single drug.

How much is a reasonable amount for the system to spend for an improvement. It’s been thought in the literature that between $50,000 and $150,000 per year of life gained was an affordable sum. It’s never been clear to me where these numbers came from but in the cost efficacy literature they seem to be the most used figures.

In our hypothetical situation our outcome was no progression of disease during the treatment period. But for the sake of our discussion lets say the study continues and the study patients (the 15% with benefit) lived a median of 2,3,4,5, or 6 months longer. For what it’s worth except for the very rare super effective new agent (Gleevec for example) most new biological agent’s improvement of survival is in the 2-6 month range.

If the median improvement is 2 months then the cost of a 12 month survival would be 6 X $666,666 (the cost/patient who benefitted) or about $4,000,000 to buy a total of a year’s survival time for patients who benefit from the treatment.

If the improvement is 6 months then the cost of 12 months survival would be 2 X $666,666 or in the range of 1.33 million dollars.

Neither would be considered cost effective by any of our current measures.

Medicynical Note: You won’t find the drug companies funding cost efficacy studies nor touting their results as cost efficient. Instead our hypothetical study would be touted as showing a 60% improvement in response rates between placebo and study group. (40% response rate with drug/25% with placebo or conventional Rx X 100=160%) It won’t be easy to find out that the difference between a “response” to placebo and the study drug was 15% (40% vs 25%) or that the benefit was just 2-6 months, if that. That the American way of drug marketing.

In case you think the above is exaggerated consider these from real life NEJM 355:2542-2550

The median survival was 12.3 months in the group assigned to chemotherapy plus bevacizumab, as compared with 10.3 months in the chemotherapy-alone group (hazard ratio for death, 0.79; P=0.003). The median progression-free survival in the two groups was 6.2 and 4.5 months, respectively (hazard ratio for disease progression, 0.66; P<0.001), with corresponding response rates of 35% and 15% (P<0.001). Rates of clinically significant bleeding were 4.4% and 0.7%, respectively (P<0.001). There were 15 treatment-related deaths in the chemotherapy-plus-bevacizumab group, including 5 from pulmonary hemorrhage.

Or this from today’s (April 25, 2010) Seattle Times:

Dendreon’s case rests largely on a study of more than 500 men with an advanced form of prostate cancer that spread to other parts of their bodies. Of the men who got Provenge, nearly a third were still alive in three years, compared with less than a quarter of those who got placebos. (medicynical emphasis) The vaccine boosted median survival time by 4 months, from 22 months in the placebo group to 26 months in the Provenge group.

How much difference is there between nearly a third and less than a quarter? I wonder who provided this verbiage? I figure an 8% benefit. Affordable?

Elective surgery, particularly when it has a cosmetic or convenience rationale, should be completely safe and effective.

It now appears that LASIK (laser assisted in situ keratomileusis) has problems and the industry is being criticized for not be fully honest about risks. This in Salon notes:

Last spring, the FDA inspected about 50 Lasik facilities and found that many had no system in place for collecting and transmitting data to the FDA on patients’ reports of post-surgical “adverse events.”

And in August, Consumer Reports Health released the results of a survey, which found that 55 percent of Americans who’ve had laser vision correction surgeries are still wearing glasses or contacts some of the time. Fifty-three percent experienced at least one side effect within the first four weeks of the surgery; 22 percent of patients experienced them six months after surgery, especially dry eyes, halos, glare and starbursts around lights.

Lasik surgery, which can cost up to $5,000, has a 95.4 percent patient satisfaction rate, based on an analysis of research worldwide from 1996 to 2008,

Medicynical note; There are two problems here. The first is the push for revenue by LASIK providers. The more they do, the more they make. With such incentives providers tend to minimize risk and extend their indications for the procedure. The second is the patient wanting (for some reason desperately wanting) surgery assuming they have no to minimal risk or that the other person is more likely to get the complications.

This powerful drive for medical services and the tendency to ignor risk (and cost) is part of our system wide problem.