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Tags: FDA | Standard | Standardized

Standardized Care Will Harm, Not Help Patients

Richard Amerling By Monday, 08 February 2016 02:59 PM EST Current | Bio | Archive

One of the first things I learned in medical school is that there are no diseases, only sick patients. This is a lesson many need to relearn.

A disease is an intellectual construct based on careful observation of sick patients. Patterns of symptoms and signs, observed over years and in different patients leads to the utilitarian concept of a disease state.

This construct allows physicians to make predictions about the course of an illness, based on historical information.

It is almost impossible to make specific prognostic statements about individual patients.

The concept of “standard of care” is mostly legal, and is intentionally vague. It applies to approaches to treatment, and shies away from specific therapeutic remedies.

A practice with a high standard of care is one that sees patients promptly, addresses patients’ concerns, practices good communication, responds to abnormal findings appropriately, and in general, respects the patients’ time and autonomy. Departures from the standard of care might constitute negligence under malpractice law.

“Standardized care,” is something altogether different. It suggests there are specific treatments, lionized by “evidence-based medicine,” or by “best practices,” that should be prescribed to everyone with a given diagnosis.

These treatments are put forth in practice guidelines, published mostly by medical specialty societies, but financed largely by grants from industry. All such documents begin with a similar disclaimer, that guidelines should not be a substitute for the clinical judgment of practitioners.

Since, with the exception of identical twins, we are all genetically unique, it makes sense that we will all experience a given ailment in a unique way. Likewise, we should all be able to agree that a “one-size-fits-all” approach to treatment is a non-starter.

Yet, that is what current policies are promoting. Proponents of centrally controlled medical care decry variations in practice patterns. We should be celebrating the variations!

The various forms of “payment for quality” or “payment for performance” will reward physicians and organizations for adhering to standardized care, as promoted via practice guidelines.

Financial rewards (or the absence of penalties, more likely) will be offered to practices achieving clinical “targets,” such as blood pressure, LDL cholesterol, or blood sugar (estimated by glycosylated hemoglobin or HbA1c) below certain levels.

These treatment algorithms will be inserted into the electronic medical record, which will literally force practitioners to follow them.

Even the most naïve will recognize the major positive impact this practice model will have on pharmaceutical sales. The problem is that adherence to standardized care will harm patients for whom the targets are inappropriate.

Aggressive blood sugar control in Type 2 diabetes often leads to the use of insulin and sulfonylureas, with attendant large weight gain. This worsens the underlying metabolic syndrome and increases mortality (ACCORD Trial).

Overzealous treatment of blood pressure, especially in the elderly, produces major symptoms such as dizziness and an alarming incidence of kidney failure.

The vast majority of patients taking statins for cholesterol has no chance of receiving any benefit, but is exposed to toxicity.

Marcia Angell, former editor of the New England Journal of Medicine, has written eloquently about the problem of the outsized influence the pharmaceutical industry has on medical practice. She says, “Over the past two decades the pharmaceutical industry has moved very far from its original high purpose of discovering and producing useful new drugs.

Now primarily a marketing machine to sell drugs of dubious benefit, this industry uses its wealth and power to co-opt every institution that might stand in its way, including the U.S. Congress, the FDA, academic medical centers, and the medical profession itself.”

Doctors must retain their independence in order to treat patients as the individuals they are. Maintain a high standard of care by rejecting standardized care.

Dr. Amerling is board certified by the American Board of Internal Medicine for Internal Medicine and Nephrology. He also is also immediate past president of the Association of American Physicians and Surgeons. For more of his reports, Go Here Now.


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Doctors must retain their independence in order to treat patients as the individuals they are. Maintain a high standard of care by rejecting standardized care.
FDA, Standard, Standardized
Monday, 08 February 2016 02:59 PM
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