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Doctor fights antibiotics regulations in court

Neurosurgeon Dr. David McKalip says the state guidelines take too much freedom away from physicians.

Published June 4, 2005

ST. PETERSBURG - As a neurosurgeon, Dr. David McKalip treats patients with the worst brain injuries - victims of car crashes, strokes and tumors.

And he doesn't want the government telling him how to do it.

As the national patient safety movement spreads across the country, with its emphasis on standardizing medical treatment and publicizing hospital performance, McKalip is one of the few fighting it.

McKalip, of St. Petersburg, is challenging new state rules to make hospitals report how surgeons use antibiotics to prevent infections. The rules are meant to make patients safer, but McKalip argues they do just the opposite.

"I don't want the state telling patients what kind of medical care they can get," he said. "They're not practicing medicine. They don't have to face that patient."

Advocates for the new rules say they will help cut surgical infections. But ultimately, the debate is about more than antibiotics.

McKalip attacks the core of a national movement that seeks to improve patient safety by promoting guidelines to give more uniform treatments to all patients.

Patient safety advocates point to an influential federal report issued five years ago saying that up to 98,000 patients die every year because of medical errors. McKalip and other critics say that number was extrapolated from two small studies and is grossly exaggerated.

Some standards, such as methods to prevent the wrong doses of medicines from being administered, would be an improvement, McKalip said. But others dictate to doctors.

"I don't call it a patient safety movement," he said. "I call it a socialized medicine movement."

McKalip, 39, is on staff at five Pinellas County hospitals, including Bayfront Medical Center and St. Anthony's Hospital. He is on the board of the Florida Neurological Society and has held various positions with the Florida Medical Association. He's now on the group's Patient Safety Task Force.

In the past, McKalip has seen new state rules and grumbled. This time, he decided to do something. He sued to stop the rules, acting as his own lawyer and gathering a thick stack of legal documents in his office.

"I have a lot more respect for lawyers now," McKalip joked.

But McKalip has a more serious purpose. The move toward guidelines and rules, he said, is "cookbook medicine," and he views it as a threat to his patients and his future.

"If things continue the way they're going, I'll have to get out of medicine in five to 10 years," he said.

Although he's acting on his own, McKalip has won some allies. The FMA had its attorney testify in favor of McKalip at a court hearing. McKalip's case is scheduled to go back to court next week.

The rules that McKalip opposes are widely backed by the government, hospitals and safety groups.

"The evidence shows the more they follow those measures, the lower the infections are," said Alan Levine, secretary of the Agency for Health Care Administration, which is proposing the rules.

Besides, Levine said, the public has a right to know "which hospitals do a good job of preventing infections."

Antibiotics kill bacteria that can infect a surgical wound and cause deadly infection, and it's standard practice to give them to a patient just before surgery to prevent such infections.

But doctors also worry that using too many antibiotics can kill off healthy bacteria normally found in the body and also encourages dangerous bacteria to resist antibiotics - an issue that's constantly becoming a greater worry.

That's why the agency that funds Medicare, patient safety groups and others recommend that preventive antibiotics be stopped after 24 hours.

"There are abundant studies showing that 24 hours or less, even one dose, is enough," said Dr. Don Goldmann, a Harvard Medical School professor who also is medical director of infection control at Children's Hospital Boston. "There's no evidence other than that works just fine. There's plenty of evidence that antibiotic resistance is becoming a huge, potentially insoluble problem."

Goldmann also is senior vice president of the Institute for Healthcare Improvement, a safety group that has signed up more than 2,000 U.S. hospitals for its 100,000 Lives Campaign, which asks hospitals to try to cut patient deaths by following steps, including 24-hour antibiotics.

But McKalip and some other doctors say 24 hours isn't always enough for complicated surgeries and vulnerable patients. The FMA says that doctors often will believe it "is not medically necessary or appropriate" to follow the proposed rules.

"It seems to me there's an attempt to make one size fit all," said Dr. John Sinnott, director of the Florida Infectious Disease Institute at the University of South Florida. "Is it truly correct that, for surgeries that last 12 hours ... that you only need 24 hours (of antibiotics?) It seems to be a little simplistic to me."

But regulators know that not every case will fit, Levine and Goldmann said. The solution is simple: Doctors should note in a patient's chart why they didn't follow the guideline. The case doesn't count against a hospital, and the doctor weighs the benefits of the guidelines.

That's not good enough, McKalip said. The 24-hour clock could run out on one patient while he's operating on another.

"We shouldn't have to explain to the government why we want to do something different than what they want," he said. "It's just more bureaucracy."

[Last modified June 4, 2005, 06:14:28]

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