January 28th, 2011 by Elaine Schattner, M.D. in News, Opinion
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The FDA [has] issued an alert about a possible link between breast implants — saline or silicone — and a rare form of lymphoma called anaplastic large cell lymphoma (ALCL). These lymphoma cases are exceedingly rare, but the association appears to be significant.
The FDA identified a total of approximately 60 ALCL cases in association with implants, worldwide. Of these, 34 were identified by review of published medical literature from 1997 to May, 2010; the others were reported by implant manufacturers and other sources. The agency estimates the number of women worldwide with breast implants is between five and 10 million. These numbers translate to between six and 12 ALCL cases in the breast, per million women with breast implants, assessed over 13 years or so.
In women who don’t have implants, ALCL is an infrequent tumor, affecting approximately one in 500,000 women is the U.S. per year. This form of lymphoma — a malignancy of lymphocytes, a kind of white blood cell — can arise almost anywhere in the body. But ALCL cases arising in the breast are unusual. The FDA reports that roughly three in 100,000,000 women are diagnosed with ALCL in the breast per year in the U.S.
These are very small numbers. Still, the finding of ALCL tumors by the implant capsules is highly suggestive. Almost all of the implant-associated ALCL cases were T-cell type, whereas most breast lymphomas are of B-cell type. The lymphomas arose in women with both silicone and saline-type implants, and in women with implants placed for purposes or augmentation and for reconstruction after mastectomy. Read more »
*This blog post was originally published at Medical Lessons*
November 30th, 2010 by Elaine Schattner, M.D. in Better Health Network, Health Policy, News, Opinion, Research
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Over the long weekend I caught up on some reading. One article* stands out. It’s on informed consent, and the stunning disconnect between physicians’ and patients’ understanding of a procedure’s value.
The study, published in the Sept 7th Annals of Internal Medicine, used survey methods to evaluate 153 cardiology patients’ understanding of the potential benefit of percutaneous coronary intervention (PCI or angioplasty). The investigators, at Baystate Medical Center in Massachusetts, compared patients’ responses to those of cardiologists who obtained consent and who performed the procedure. As outlined in the article’s introduction, PCI reduces heart attacks in patients with acute coronary syndrome — a more unstable situation than is chronic stable angina, in which case PCI relieves pain and improves quality of life but has no benefit in terms of recurrent myocardial infarction (MI) or survival.
The main result was that, after discussing the procedure with a cardiologist and signing the form, 88 percent of the patients, who almost all had chronic stable angina, believed that PCI would reduce their personal risk for having a heart attack. Only 17 percent of the cardiologists, who completed surveys about these particular patients and the potential benefit of PCI for patients facing similar scenarios, indicated that PCI would reduce the likelihood of MI.
This striking difference in patients’ and doctors’ perceptions is all the more significant because 96 percent of the patients “felt that they knew why they might undergo PCI, and more than half stated that they were actively involved in the decision-making.” Read more »
*This blog post was originally published at Medical Lessons*
August 17th, 2009 by admin in Better Health Network, Health Policy, Opinion
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By George Lundberg, MD
Just as “all politics is local”, so is all medical care personal. One patient; one physician; one moment; one decision. And in this era of balanced physician and patient autonomy, that decision often is an informed joint decision. Many patients now make serious efforts to learn about their conditions both before and after visits to their physicians. Many physicians welcome such informed patients and willingly discuss comparative effectiveness of the available diagnostic and therapeutic options. However, a frank discussion about the comparative costs and charges for the options, whether they be to the insurance company, Medicare, Medicaid or out-of-pocket for the patient, is usually missing.
Many health economists insist that the medical marketplace does not behave like other markets and believe it is fruitless to expect market principles to usefully inform the medical arena. That bias is true in emergencies,
operating rooms or intensive care units, and with patients who are mentally disabled.
Such behavior does not have to persist in an outpatient setting. In my book Severed Trust: Why American Medicine Hasn’t Been Fixed (Basic Books, 2000, paperback 2002), I presented the concept of “the economic informed consent.”
I believe that every patient who is mentally competent and in a non-emergency situation should be informed of the cost of a proposed diagnostic or therapeutic procedure or product, before it is “ordered.” This includes referral to another (often more specialized and costly) physician, no matter who pays the bill. The costs should all be discussed IN ADVANCE decision. This discussion should include whether it is worth it and
whether there a less expensive good alternative.
A recent NPR/KFF/HSPH survey reported that 55% of Americans believe that their insurance company should have to pay for an expensive treatment, even if has not been proven to be more effective than a less expensive
treatment. This attitude underlies the ruling convention, “if insurance will cover it, do it,” that lies at the root of our problem of health care cost inflation. No one is held accountable.
If we as a country could widely apply the “economic informed consent,” physicians and patients would become educated together. They could both become wiser shoppers for the most cost-effective diagnostic tests,
prescribed drugs, and specialists.
With an “economic informed consent,” physicians and patients can reset attitudes toward a healthy concern for the total costs or charges, stifling the usual knee-jerk response, “if the insurance covers it, do it.” No one
knows whether this approach, diligently applied, would actually cut down on wasteful spending, such as choices that drive huge geographic variations, but we do know that pricing an automobile, an airplane ticket, a dinner or a bottle of wine does affect consumer decisions. Why not try it for medical charges as well? Current sweeping proposals for health system reform all state that there must be “cost control” but offer little likelihood of delivering real cost savings.
Now is the time for the US Health Information Technology Initiative to create inter-operative systems that would provide the data to support widespread use of the “economic informed consent” in a timely fashion and
let the medical marketplace speak. Knowing the cost of a medical decision in advance should become a part of a new “Patient’s Bill of Rights”. In a medical care decision, it is the right of a patient to know “who pays whom
how much for what.” All of us in health care laud “transparency”–let that include economic transparency.
George D. Lundberg MD
President and Board Chair, www.lundberginstitute.org
