Category Archives: Ethics

5 Myths about our ailing Health Care System

Washington Post’s Sunday edition had an opinion piece on our health care system. Nicely done as far as it goes.

The Post’s myths, with medicynical comments:

1. “America Has the best Health Care in the World”–

” We rank near the bottom of countries in the Organization for Economic Cooperation and Development , just ahead of Cuba and way behind Japan, France, Italy, Sweden and Canada, countries whose governments (gasp!) pay for the lion’s share of health care.”

Medicynic: This appears to be an accepted truth, except perhaps for the very wealthy, for whom cost and access are not issues.

2. “Someone else is paying for your health insurance”

“Rising health-care costs are partly to blame for stagnant wages. Over the past five years, health insurance premiums have risen 5.5 times faster on average than inflation, 2.3 times faster than business income and four times faster than worker’s earnings.”

Medicynic: This also seems to be understood. What’s missing is the fact that we all are paying one way or another for those who are uninsured and need care.

Also, as we move away from employer based coverage to a more rationale arrangement the question whether the money used to pay for insurance is employee salary or employer profit will need to be settled–watch this issue carefully.

3. “We could save a lot if we could cut the administrative waste of private insurance”

“For one thing, some administrative costs are not only necessary but beneficial. Following heart-attack or cancer patients to see which interventions work best is an administrative cost, but it’s also invaluable if you want to improve care. Tracking the rate of heart attacks from drugs such as Avandia is key to ensuring safe pharmaceuticals.”

“Let’s just say that we could wave a magic wand and cut private insurers’ overhead by half, to what the Canadian government spends on administering its health-care system — 15 percent. How much would we save?”

Medicynic: The authors include monitoring for toxicity and evaluating a drug’s or procedure’s effectiveness as administrative costs and as noted above seem to posit that private insurers routinely do such work. Others count this a drug or procedure development expenses and while administrative are not what insurers do or what they count as an insurer’s administrative cost.

However, even with these non-typical costs included as administrative expenses, they believe that as much as 125 billion dollars can be saved–not chump change. Medicynic thinks the numbers are conservative as most other countries spend far less than the 15% suggested overhead. Medicare for example spends less than 10% on such expenses.

4. Health Care reform is going to cost a bundle

“Even moderate reform of the delivery system would improve care and save money. The Lewin Group’s analysis shows that a bill proposed by Sen. Ron Wyden , an Oregon Democrat, calling for a more comprehensive overhaul of the health-care system than either McCain ‘s plan or Obama ‘s could actually insure everyone and save $1.4 trillion over 10 years. More reform is cheaper.”

Medicynic: Health care reform will be costly but probably no more than our current system that excludes 50 million people. Omitted in the article’s analysis is the major problem of conflicts of interest in the system, and the need to control the costs of developing new technology. See this for more on cost saving strategies for health reform.

5. Americans are not ready for a major overhaul of the health-care system

“A recent study published in the New England Journal of Medicine found that only 7 percent of Americans rate our health-care system excellent. Nearly 40 percent consider it poor. A whopping 70 percent believe it needs major changes, if not a complete overhaul.”

Medicynic: Medical expenses are one of the major causes of bankruptcy in our country. The system is toxic and and people are dying from their lack of reliable affordable access to care. It’s time to heal ourselves.

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More Conflicts of Interest in health care–The Health Care Bubble demands attention

The report that Dr. Frederick Goodwin has received financial support (money) from a drug company for touting their products is not shocking or for that matter the most onerous of conflicts of interest in our health care system. Consider practitioner’s tendency to do procedures for which they benefit financially; insurers declining to cover services thereby increasing profits; deceptive advertising that doesn’t fully reveal the risks benefits and costs of a product; technological innovators (drug companies included) who tout marginal advances and then charge a fortune for them.

In regard to Dr. Goodwin, we’re not talking small amounts of money. He is reported to have received $329,000 for promoting the drug Lamictal and probably more for his “other” valuable services. The article also noted that “Dr. Charles B. Nemeroff of Emory University, an influential psychiatric researcher, earned more than $2.8 million in consulting arrangements with drug makers from 2000 to 2007, failed to report at least $1.2 million of that income to his university and violated federal research rules.” Guess who pays?

Using the analogy of our current financial mess, we have a bubble in health care caused by the deregulation. Each player in the health care system is corrupted (i.e.has a major conflict of interest). Deceptive practices promote ridiculously priced products, often with marginal efficacy, that the health care non system cannot afford. These conflicts of interest drive utilization and inefficiency without significantly improving outcomes. Pricing of products and services have increased exponentially while health care statistics, compared to other industrialized countries, are mediocre. The goal of the health care industrial complex appears to be to assure profit, not wide access to quality affordable health care.

In summary, the industry has lost interest in prudent management, value and efficiency in order to increase short term profits. Sound familiar?

We need more than disclosure of conflicts of interest to correct the system.

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Wide Variation in cost of Treating Colon Cancer

This article in the American Journal of Managed Care only tells half the story. It reports on the costs of chemotherapy for colon cancer using conventional chemotherapeutic agents. As reported common regimens costs are:

Total Cost of 6 Cycles of Commonly Prescribed Treatment Regimens

Chemotherapy Regimen Total Cost of Treatment ($)
5FU/LV (5-flurouracil plus leucovorin) 1,028
IFL/FOLFIRI (flurouracil/leucovorin/irinotecan) 38,027
FOLFOX (fluorouracil/leucovorin/oxaliplatin) 17,584
Irinotecan 25,287
CapeOx (capcitebine/irinotecan/oxaliplatin) 34,744
Oxaliplatin 11,593

Part of the wider variation in cost is the need for leukocyte stimulating factor (GCSF) and erythropoietin with the more aggressive regimens. Given the large difference in cost to the system one wonders why a historical comparison of the effectiveness of the various regimens was not included.

The study was completed in 2005 and the cost variation may be worse now:

“This variation is likely to be even bigger now that monoclonal antibodies, such as cetuximab (Erbitux) and bevacizumab (Avastin), have been accepted as standard therapies to be added onto chemotherapy regimens. The study finished at the end of 2005, and so did not assess the impact of these new products, Dr. Lyman explained. It focused on chemotherapy regimens and found enormous variations in cost. “As bad as it looked then,” Dr. Lyman commented in an interview, “I would guess it is even worse now.”

Cetuximab and bevacizumab may increase costs by as much as $10,000/month and only improve the outcome by a modest amount.

The larger question is whether physicians and institutions should factor in cost to the treatment equation. It’s been our practice to ignore cost when considering treatment alternatives but as the expenditures for health care increase exponentially it may be time to consider another approach.

It is difficult for individual physicians to do all the work on this. In UK there is an agency, the Nation Institute for Health and Clinical Excellence (NICE), that produces studies and make recommendations to their National Health Service. A similar non-biased source of cost/effectness evaluation in our system should be welcomed by all practitioners. For what it’s worth the FDA is prohibited from including cost in their evaluations of new drugs.

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The rosuvastatin (Crestor) Jupiter study–Watch your wallet

This week we were inundated with reports of a major study with near miraculous results. Just under 18,000 participants in the Jupiter study either received rosuvastatin (Crestor) or placebo. Patients were chosen to participate if they had low LDL cholesterol (under 130 mg/deciliter) and elevated C-reactive protein (above 2 mg/liter). The results, as summarized, in a accompanying editorial :

The trial of nearly 18,000 patients was stopped, with only 1.9 of its proposed 4 years of follow-up concluded, when the data and safety monitoring board noted a significant reduction in the primary end point among participants assigned to receive rosuvastatin (142 primary events, vs. 251 in the placebo group; hazard ratio, 0.56; 95% confidence interval [CI], 0.46 to 0.69). There was a similar reduction in a combination of the more important hard outcomes: myocardial infarction, stroke, or death from cardiovascular causes (83 events in the rosuvastatin group vs. 157 in the placebo group; hazard ratio, 0.53; 95% CI, 0.40 to 0.69).

The study also reported virtually no extra side effects among the study patients. “Total numbers of reported serious adverse events were similar in the rosuvastatin and placebo groups (1352 and 1377, respectively; P=0.60) Nineteen myopathic events were reported (in 10 subjects receiving rosuvastatin and 9 receiving placebo, P=0.82)” There was one case of major muscle lysis problems (rhabdomylysis) in a 90 year old man after the study was completed. Virtually all other toxicity was equivalent between drug and placebo.

Medicynical note: As noted above the finding that there was no difference in side-effects between the drug and placebo is at least a little strange. That the reported side effects occurred much less frequently even than the incidence in the FDA drug insert also is remarkable. It could indicate patient selection or bias from in this drug company sponsored trial. Interestingly 25% of patients were reported not taking the drug at the end of the study. Why? That’s left to the imagination.

From the drug insert:

In clinical studies of 10,275 patients, 3.7% were discontinued due to adverse experiences attributable to rosuvastatin. The most frequent adverse events thought to be related to rosuvastatin were myalgia, constipation, asthenia, abdominal pain, and nausea.”

Uncomplicated myalgia has been reported in rosuvastatin-treated patients (see Creatine kinase (CK) elevations (>10 times upper limit of normal) occurred in 0.2% to 0.4% of patients taking rosuvastatin at doses up to 40 mg in clinical studies. Treatment-related myopathy, defined as muscle aches or muscle weakness in conjunction with increases in CK values >10 times upper limit of normal, was reported in up to 0.1% of patients

The NEJM editorial about the study also noted:

On the other side of the balance, of concern are the significantly higher glycated hemoglobin levels and incidence of diabetes in the rosuvastatin group in JUPITER (3.0%, vs. 2.4% in the placebo group; P=0.01). There are also no data on the long-term safety of lowering LDL cholesterol to the level of 55 mg per deciliter (1.4 mmol per liter), as was attained with rosuvastatin in JUPITER, which is lower than in previously reported trials. Long-term safety is clearly important in considering committing low-risk subjects without clinical disease to 20 years or more of drug treatment.”

An additional concern is cost.

“The proportion of participants with hard cardiac events in JUPITER was reduced from 1.8% (157 of 8901 subjects) in the placebo group to 0.9% (83 of the 8901 subjects) in the rosuvastatin group; thus, 120 participants were treated for 1.9 (Medicynical note: 693 days) years to prevent one event.

At a cost of $3.45/day treating 120 patients for 693 days is a total of almost $300,000 spent to prevent one event. This is far above any reasonable cost/effective intervention. It’s obvious why this information was not included in this drug company sponsored study. It is, however, one of the major concerns we all should have in this time of crisis in health care.

Having patients commit to take a medication for the duration of their lives to prevent serious medical problems is the dream of drug companies. But in order to seriously consider such an intervention, it must be very effective, have low toxicity and be affordable both for the patient and the health care system. Use of rosuvastatin to prevent cardiovascular disease doesn’t fully meet these criteria and as such, the report should be viewed as an interesting approach that merits further study, not wholesale adoption.

In the press I noted comment that other statins that are available as generics may have the same beneficial effect at lower cost. It’s unlikely however, that drug company sponsored studies of these low cost alternatives will ever be done.

Placebos, Much ado about nothing, literally

For years we’ve been hearing of the “benefits” of such interventions as homeopathy, mega-vitamin therapy, coffee enemas, detoxification, cranial sacral therapy, weekly chiropractic therapy and a multitude of other alternative remedies.  People swear they help and spend billions.   Yet there is precious little evidence that show’s benefit such as decreased chronic illnesses or improved longevity.

So it’s not surprising that a study of routine medical practices reveals that doctors candidly believe some of the practices no better than placebo.  I used to tell patients with colds that without treatment it would take seven long days for the problem to resolve.  With antibiotics it would take just one week–yet that is what they wanted.  I was told that if I didn’t treat them they’d find someone else to do so and a number of patients did so.

It’s as simple as that, people believe an intervention anyone, even lacking in evidence, is better for them than none.  How else to explain the “efficacy” of homeopathic remedies which contain no active ingredient and is diluted to the the point of having no medicinal value.  Yet patients swear by it because they think they are being treated and they do get better.  It should be pointed out that the great majority of what a family doc sees each day would also better, just as quickly and completely, without any intervention.  Patients seek  reassurance but also in many cases insist on something being “done.”

That’s the essence of placebos and as long as patients want to believe it works it will in most instances–just a week rather than 7 long days.

But it is a costly game.