CAMLAW: Complementary and Alternative Medicine Law Blog

CAM and Conventional Medicine: A 'Double Standard' for Proof of Safety and Efficacy?

Some may find support for the claim that CAM and conventional care are subjected to a "double standard" for proof of safety and efficacy in a new Minnesota report that 20 people died and four people were seriously disabled in 99 different hospital incidents in 15-month period.

The full article by JOHN MYERS, "Hospitals report 20 deaths from mistakes" (Duluth News Tribune, Jan. 19, 2005), looked at the Minnesota data in the context of the new state reporting requirement regarding medical errors.

The article reported that:

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"The Minnesota Department of Health on Wednesday released -- for the first time ever -- data from the state's 145 hospitals showing the number of medical mistakes that led to ``adverse health events.''

In all, 20 people died and four people were seriously disabled in 99 different hospital incidents from July 2003 through Oct. 6, 2004.

It was the first such reporting period under a new state law approved in 2003.....

The new law, called by one healthcare official as a ``distinct shift in the culture of healthcare'' is considered a first look in the previously shrouded world mistakes and accidents in the health care industry -- problems that often had been resolved in internal reviews or civil lawsuits where the results are not made public.

Minnesota hospitals now are required to report incidents in 27 different medical categories, including falls in the hospital, foreign objects left in the patient after surgery, improper medication, operating on the wrong part of the body, operating on the wrong patient, newborns sent home with the wrong parents, pressure sores, malfunctions of medical products or devices and more.

Minnesota is the first state to require hospitals not only to report the mistakes but to make much of the information public. And because this is the first year of data within the state, there's no track record against which the numbers can be compared."

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Ideally such reporting will lead to increased vigilance and risk management within the hospitals systems.

At a time when the safety of dietary supplements is being rigorously questioned in the CAM world, the number of adverse events in conventional medicine may be surprising.

The article reported that "of the 99 serious problems reported in the state, more than half -- 52 -- occurred during surgery. The most common surgical problem was a foreign object, such as a sponge or needle, being left inside a patient after surgery. The 31 problems in the next most common category were associated with care management, including medication mistakes, newborn deaths and more."

The report observed that government officials and analysts were explaining that the "problem is the complex system of healthcare, not poor training or incompetent staff." It is difficult to say whether these statements are valid interpretations of the data, or hopeful disclaimers of possible malpractice lawsuits.

The report cites the 1999 report by the Institute of Medicine that showed an estimated 44,000 to 98,000 patients annually may have been dying in U.S. hospitals each year because of preventable mistakes within the hospital (drug errors accounting for 7,000).

The report noted the hospitals were looking into implementing changes to help reduce risks of patient injuries resulting from unnecessary medical errors.

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