Seth’s blog

I previously blogged about ICU checklists. Atul Gawande has written another excellent article about them, this time an editorial in the New York Times:

A year ago, researchers at Johns Hopkins University published the results of a program that instituted in nearly every intensive care unit in Michigan a simple five-step checklist designed to prevent certain hospital infections. It reminds doctors to make sure, for example, that before putting large intravenous lines into patients, they actually wash their hands and don a sterile gown and gloves.

The results were stunning. Within three months, the rate of bloodstream infections from these I.V. lines fell by two-thirds. The average I.C.U. cut its infection rate from 4 percent to zero. Over 18 months, the program saved more than 1,500 lives and nearly $200 million.

Yet this past month, the Office for Human Research Protections shut the program down. The agency issued notice to the researchers and the Michigan Health and Hospital Association that, by introducing a checklist and tracking the results without written, informed consent from each patient and health-care provider, they had violated scientific ethics regulations. Johns Hopkins had to halt not only the program in Michigan but also its plans to extend it to hospitals in New Jersey and Rhode Island.

The government’s decision was bizarre and dangerous. But there was a certain blinkered logic to it, which went like this: A checklist is an alteration in medical care no less than an experimental drug is. . . . A checklist may require even more stringent oversight [than drug tests], the [OHRP] ruled, because the data gathered in testing it could put not only the patients but also the doctors at risk — by exposing how poorly some of them follow basic infection-prevention procedures. . . .

A large body of evidence gathered in recent years has revealed a profound failure by health-care professionals to follow basic steps proven to stop infection and other major complications. We now know that hundreds of thousands of Americans suffer serious complications or die as a result. It’s not for lack of effort. People in health care work long, hard hours. They are struggling, however, to provide increasingly complex care in the absence of effective systematization.

Excellent clinical care is no longer possible without doctors and nurses routinely using checklists and other organizational strategies and studying their results. There need to be as few barriers to such efforts as possible. Instead, the endeavor itself is treated as the danger. . . . Scientific research regulations had previously exempted efforts to improve medical quality and public health — because they hadn’t been scientific. Now that the work is becoming more systematic (and effective), the authorities have stepped in. And they’re in danger of putting ethics bureaucracy in the way of actual ethical medical care.

Not “in danger of” — they have put “ethics bureaucracy” ahead of patient safety. In a big way.

Since the 1960s, this has been the standard conversation in dermatology offices:

PATIENT I think Food X causes acne. After I eat Food X, I break out.

DOCTOR There’s no link between food and acne, but if something bothers you, don’t eat it.

Here is Governor Huckabee campaigning for President:

“If you want to believe that you and your family came from apes, that’s fine,” Huckabee said after an early debate. “I’ll accept that. I just don’t happen to think that I did.”

The dermatologists made a mountain out of a molehill (the diet/acne question hadn’t been carefully studied). Huckabee made a molehill out of a mountain.

Many parents have said yes. David Healy, a Scottish psychiatrist, prompted by those stories, did a small experiment in which undepressed persons took anti-depressants. About 10% of them started having suicidal thoughts. Drug companies and the University of Toronto (where Healy had been offered a job) reacted very badly to this information, as Healy describes in Let Them Eat Prozac. An article in the latest issue of the American Journal of Psychiatry by David Leon, a biostatistician on the FDA oversight panel, describes why he voted to extend a warning about this from children (< 18 years old) to young adults (18-24 years old). This was the main data:

What’s shown is the odds ratio for a report of suicide ideation or behavior, comparing those who got anti-depressants with those who got placebos. An odds ratio of more than 1 means greater risk in those who got anti-depressants. The red bar is from a different study. When different ages are lumped together there is no increase in risk but that hides opposing tendencies at high and low ages.

The article contains this curious sentence: “The results did not provide definitive evidence of risk, yet they failed to demonstrate an absolute absence of risk.” No possible results could “demonstrate an absolute absence of risk” so it is unclear what Dr. Leon meant. Later he writes: “My vote to extend the black box warning to young adults was based on concern that risk of suicidality could not be ruled out and, given the widespread antidepressant use, even a small risk must not be ignored.” Yes, he has it backwards: The data do not “fail to rule out” suicide risk (no possible data could “rule out” such risk, i.e., show the risk is zero); they manage to overcome a barrier to show it’s there. And yes, he’s congratulating himself (”even a small risk must not be ignored”) for doing his job.

Uh-oh. That someone — a biostatistician, no less — in such a powerful regulatory position fails to understand basic concepts is bad enough; to make things worse, Dr. Leon has received money from three of the companies (Eli Lilly, Organon, and Pfizer) he oversees.

Related post by Andrew Gelman.

My dad has diabetes, and I casually got Amazon.com to send him the Shangri-La Diet book. I left him a message saying (still very casually) “I came across something that you might find interesting. The book is in the mail. Talk to you soon”.

A few weeks later he (casually) mentioned that he had started the oil, and was now physically incapable of overeating.

A few more weeks later, and he reports that he is unable to finish his breakfast in one sitting - he has to eat half, go work for a few hours, then finish his breakfast.

I’m elated.

My father has been compared to Homer Simpson. Both in the “get thrown out of Pizza Hut on all-you-can-eat night” and in the “awwww, my stomach hurts… I shouldn’t have eaten that packet of gravy that I found in the parking lot” departments.

From the SLD forums.

From Until Proven Innocent by Stuart Taylor and K. C. Johnson, about the Duke lacrosse case:

The Duke president addressed the [lacrosse] team for the first time since May a few weeks into its fall practice. . . . When Brodhead opened the floor for questions, Read Seligmann’s former roommate, Jay Jennison, spoke up. He said that all of the team had learned much from the case . . . “What have you and the administration learned?” Jennison asked Brodhead. . . . Brodhead responded, “What do you think I should have learned?”

Head of a prestigious institution of higher learning resistant to learning or at least admission of learning. Curious.

Tulane University.