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FDA Reports On Association Of Breast Implants And A Rare Form Of Cancer

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*

Understanding Treatment: The Communication Disconnect Between Doctors And Patients

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*

Innovative Healthcare Cost Containment: The Economic Informed Consent

By George Lundberg, MD

georgelundbergJust 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

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