Seth’s blog

Two years ago, a University of California Berkeley undergraduate was a subject in an MRI experiment at the Henry H. Wheeler, Jr. Brain Imaging Center on the UC Berkeley campus. She did it for the money: It paid $200 for two two-hour sessions, during which you lie motionless inside a large loud machine. During the first session, the persons monitoring the experiment could see that something was seriously wrong: The subject had a large mass in her brain. Clearly her life was at risk. But they didn’t tell her immediately what they had seen. (Later they claimed they “couldn’t” have told her, for legal reasons. A friend of hers who was present at the experiment was threatened with serious legal action if he told her.) Instead, they sought outside opinion about what the mass was and what to do about it. A few weeks later, they told her about it. “Sometimes unusual things show up on these scans” she was told. This was incorrect: Nothing like this had happened before at UC Berkeley.

In a way, the story has a happy ending. The large mass turned out to be benign (but at the time of the experiment they had no way of knowing that). It was removed. A year and a half after the operation, there are no signs of reoccurrence.

The experimenters not only (a) withheld what might have been life-saving information, (b) they persisted in this behavior after having time to think about it; and (c) they threatened someone who wanted to do the right thing. This is no momentary lapse in judgment. The experimenters — including the professor in charge and who knows what other powerful people at UC Berkeley — actively did the wrong thing. They carefully decided not to tell her info that might have saved her life.

More. After I wrote this post, I learned that the person in charge of the Wheeler Brain Imaging Center at the time was Professor Mark D’Esposito. By email I asked him if he disputed any of the facts in this post and if the Center had done anything to keep such a thing from happening again. He didn’t reply.

From Inside Higher Ed:

T. Hayden Barnes opposed his university’s plan to build two large parking garages with $30 million from students’ mandatory fees. So last spring, he did what any student activist would do: He posted fliers criticizing the plan, wrote mass e-mails to students, sent letters to administrators and wrote a letter to the editor of the campus newspaper. While that kind of campaign might be enough to annoy university officials, Barnes never thought it would get him expelled.

Rather than ignore him or set up a meeting with concerned students, Valdosta State University, in Georgia, informed Barnes, then a sophomore, that he had been “administratively withdrawn” effective May 7, 2007. In a letter apparently slipped under his dorm room door, Ronald Zaccari, the university’s president, wrote that he “present[ed] a clear and present danger to this campus” and referred to the “attached threatening document,” a printout of an image from an album on Barnes’s Facebook profile. The collage featured a picture of a parking garage, a photo of Zaccari, a bulldozer, the words “No Blood for Oil” and the title “S.A.V.E.-Zaccari Memorial Parking Garage,” a reference to a campus environmental group and Barnes’s contention that the president sought to make the structures part of his legacy at the university.

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.