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325 East Sonterra Blvd.

Clinic: Suite 120

Administrative Office: Suite 220

San Antonio, TX 78258

Phone: (210) 614-5100 / Fax (210) 614-5103

San Antonio Orthopaedic Specialists

Potentially Harmful

Regulations and Guidelines

Before a discussion of dishonest guidelines, a brief discussion on the "how" and "why" of guidelines. The concept behind guidelines is good. Gather together a team of physicians and scientists who are recognized experts in their field in order to make recommendations for diagnosis and/or treatment of a particular problem or patient population. The physician is the supposed to extract from these guidelines that which fits his patient--one patient at a time.

Problems arise from two directions. First, one would hope that physicians and scientists involved in the creation of the guidelines are honest and caring individuals. Unfortunately, the money involved too often corrupts, and the conclusions benefit the sponsors. Even so, most guidelines are reasonable. The second issue arises when these guidelines become codified into regulations. Increasingly, pharmaceutical companies and other interests lobby the legislators to pass new regulations that favor their products. Guidelines are designed for "groups" and, whileoit sounds overly simplistic, as "guides" on how to treat an individual patient. When guidelines become regulatlons, compliance with the regulation becomes a requirement for every patient. An individual patient may not fit the "group" well and hence, compliance with these regulations may not be in the patient's best interest.

A good example nationally has to do with the guidelines for skin scrub before surgers. The literature is replete with studies that show chlorhexadine to be superiyor to betadine. However, these studies routinely compare chlorhexadine and alcohol to betadine. The conclusion that chlorhexadine is superior ignores the contribution of the alcohol. It turns out that the alcohol is the real difference. However, a company out of California, CareFusion, paid more than $11 million dollars to Dr. Charles Denham, co-chair of the National Quality Forum. Chlorhexadine became the government's prefered pre-surgical scrub. Despite a $40 million dollar settlement imposed by the Justice Department on CareFusion, chlorhexadine remains the government's preferred surgical prep.

A good example here in Texas of pharmaceutical companies using legislation to promote their products involves the vaccine against cervical cancer. The vaccine actually protects against many, but not all cervical warts. Only one company makes the vaccine. While probably a great step forward, there is not yet proof that the protection afforded by the vaccine lasts indefinitely, and efficacy beyond 4 years is being questioned. However, in 2007, Governor Perry mandated by executive order, bypassing the legislature, that girls entering 6th grade be vaccinated. These are girls 11 and 12 years old.  One would hope that they’d not be sexually active until they might need their first booster.

My personal pet peeve has to do with the recommendations for preventing abnormal blood clots after orthopaedic surgery. Those who have generated these guidelines from the mid 1980s until 2011 have had multiple financial and intellectual conflicts of interest. A critical reading of the guidelines easily identifies multiple errors, all in favor of using the drugs preferred by the editors. (if you would like more details on this one, please send me an e-mail.) Only in 2014 have the government's guidelines changed to at least allow, if not prefer, treatments actually based on solid science.