Seth's Blog

In an undergraduate poetry class, Joe Newbury writes,

The first assignment [was] to write a one-page description of our influences and what they meant to us. I submitted a tongue-in-cheek, but graphic and flamboyantly described list: Jeffrey Dahmer, Ted Bundy, [and] a woman I’d slept with who had a giant mole on her rear end.

After this, his teachers forwarded all his work to the university administration, without telling him (and later denying it). Somehow this forwarded work showed he was dangerous. Eventually a cop told him,

“I believe you are a threat to yourself and to the people around you. If the University is not going to do anything about it, I will.’ She then announced that she was contacting Social Services to have my daughter taken away.

Because of something he wrote in poetry class.

From Claudia Adkison, Emory University dean, to Charles Nemeroff, Emory University professor of psychiatry, in a 2006 memo:

I have been grateful that the reporter was not sophisticated enough to ask all the right questions.

Grateful. She was grateful. Ugh. Double ugh. Professor Nemeroff, you’ll recall, took vast sums of money to advocate the prescription of dangerous drugs to millions of people and hid this fact, even after several warnings. Dean Adkison was grateful, let me repeat, that a reporter didn’t ask “all the right questions” to expose this.

This is why New York Times reporter John Schwartz’s lack of understanding matters.

I am visiting Philadelphia. Yesterday I learned that if you want to do human subjects research at Drexel University you must:

1. Include indemnification language in the consent form. The subject must promise to not sue Drexel no matter what happens. This is a bluff: You cannot sign away your ability to sue. Of course this requirement leaves subjects more vulnerable, not less, the usual purpose of consent forms. Shades of twisted skepticism.

2. Never contact subjects via email.

3. Never advertise your research on the web.

4. Never contact subjects who have been in a previous experiment.

The Drexel IRB (Institutional Review Board) will never approve any study that involves giving any drug to a non-patient. This means the very important studies by David Healy that involved giving Prozac to ordinary (non-depressed) people — some of whom became suicidal — wouldn’t be possible.

I suppose it’s no surprise that Drexel IRB members, such as literature professors, criticize research designs. In an NPR piece, a former IRB member boasted about the accomplishments of her membership, which included correcting faulty designs. At UC Berkeley a few years ago, I submitted to the animal research IRB a proposal to test with rats a key observation behind the Shangri-La Diet: Drinking sugar water caused me to lose weight. The proposal was turned down: It couldn’t possibly be true that sugar water can cause weight loss, said the IRB. Testing this idea was a waste of time.

IRB Watch. Earlier post about IRBs.

The following letter is from a Swedish professor who was president of the European Society of Pediatric Allergy and Clinical Immunology. Background about Ranjit Chandra.

Lerum, March 16^th 2008

Dear Prof Roberts,

The correspondence/letters I have found or remembered are as follows.

1. In 1993, The European Society of Pediatric Allergy and Immunology, ESPACI) intended to publish a position paper on Cow’s milk allergy(1). In my position as secretary of ESPACI, I wrote that paper in collaboration with the authors listed. We had intense discussions on whether or not we should cite Prof Chandra, whom we all knew, but did not trust, mainly since we found his inclusion criteria and symptoms curious and not according to scientific knowledge at that time. We also opposed, since he had not performed any blinded oral provocation tests and several authors, e.g. Arne Host(2) have found that less than 50 % of those reporting symptoms at exposure had cow’s milk allergy at scheduled blinded oral provocation testing. I wrote a letter to the dean of the university of St John asking whether or not the rumors about Prof Chandra, that his nurse/secretary(?) had produced the results without the involvement of patients, were true. The reply was: ”Since the allegations against Prof. Chandra have not been proven or disproven, he is still in office”. I do not find that letter in my files.
2. In 1997 Ranjit Chandra published a 5 yrs follow up study on his cow’s milk allergic children(3). This paper included DBPCFC. Then some of my colleagues drew the conclusion that everything was in order.
3. In 1998 we published a second position paper together with the European Society on Pediatric Gastroenterology and Nutrition, ESPGAN, on cow’s milk allergy(4). At that time we accepted the Chandra paper, according to point 2.
4. In 2003 we were writing up three papers later published in PAI(5-7). These publications were based on papers read during the ESPACI/Section on Pediatrics meeting in Padua, Italy on Dietary prevention of Allergy. Since at that time I was President of ESPACI and Chairman of the Section on Pediatrics within EAACI and organizer of the meeting, I wrote (in collaboration with the speakers) paper I and II and Arne Host and Susanne Halken paper III. Since I was still skeptical of the data by Chandra, I wrote a letter on Feb 15 2003 to the dean of St John’s (enclosed), without any response. The three papers were published in 2004.
5. January 19 2006 I wrote once again to St John since I never got any response from the dean, correspondence enclosed.
6. On February 16 2006 I got a response from St John from Prof Strawbridge and responded. On February 20 2006 I got another response and again responded to Prof Strawbridge, Dean of St John, enclosed.
7. On Feb 24 I got a copy from German Friends and on March 3^rd another one from Arne Host on the (enclosed) TV series in CBC on January 29^th2006 and later

The rest you know much better than I do.

Actually, I don’t know whether my correspondence has any value on a website. But maybe you can use it for your documentation.

1. Businco L, Dreborg S, Einarsson R, Giampietro PG, Host A, Keller KM, et al. Hydrolysed cow’s milk formulae. Allergenicity and use in treatment and prevention. An ESPACI position paper. European Society of Pediatric Allergy and Clinical Immunology. Pediatr Allergy Immunol 1993 Aug;4(3):101-11.
2. Host A. Cow’s milk protein allergy and intolerance in infancy. Some clinical, epidemiological and immunological aspects. Pediatr Allergy Immunol 1994;5(5 Suppl):1-36.
3. Chandra RK. Five-year follow-up of high-risk infants with family history of allergy who were exclusively breast-fed or fed partial whey hydrolysate, soy, and conventional cow’s milk formulas. J Pediatr Gastroenterol Nutr 1997 Apr;24(4):380-8.
4. Host A, Koletzko B, Dreborg S, Muraro A, Wahn U, Aggett P, et al. Dietary products used in infants for treatment and prevention of food allergy. Joint Statement of the European Society for Paediatric Allergology and Clinical Immunology (ESPACI) Committee on Hypoallergenic Formulas and the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) Committee on Nutrition. Arch Dis Child 1999 Jul;81(1):80-4.
5. Muraro A, Dreborg S, Halken S, Host A, Niggemann B, Aalberse R, et al. Dietary prevention of allergic diseases in infants and small children. Part III: Critical review of published peer-reviewed observational and interventional studies and final recommendations. Pediatr Allergy Immunol 2004 Aug;15(4):291-307.
6. Muraro A, Dreborg S, Haken S, Host A, Niggemann B, Aalberse R, et al. Dietary prevention of allergic diseases in infants and small children. Part II. Evaluation of methods in allergy prevention studies and sensitization markers. Definitions and diagnostic criteria of allergic diseases. Pediatr Allergy Immunol 2004 Jun;15(3):196-205.
7. Muraro A, Dreborg S, Halken S, Host A, Niggemann B, Aalberse R, et al. Dietary prevention of allergic diseases in infants and small children. Part I: immunologic background and criteria for hypoallergenicity. Pediatr Allergy Immunol 2004 Apr;15(2):103-11.

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.

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.

A few weeks ago, the manager of a New Orleans art gallery told me a story that I wish had surprised me.

When he was a senior at Tulane University, he took a Political Science class about the British Political System. For his term paper he wrote about the functions of the British Cabinet. The night before the final he got a phone call. It was from the Tulane honor board: He was charged with plagiarism. He was devastated, and did badly on the final.

The next semester a hearing took place. At the hearing, he listened to a tape of his professor’s testimony. The professor recommended that he be expelled: Not only had he plagiarized, the professor said, he had flunked the final. The supposed plagiarism was that he had listed ten functions of the British Cabinet without giving a source. He had believed that this was common knowledge, such as saying the sky is blue, and thus did not need a source. He had not copied word for word — he had paraphrased his source. The honor board gave him an WF for the course — withdrawal with an F.

The charge of plagiarism is absurd. It isn’t even obvious that the student did anything wrong — he is correct that you don’t need to reference “the sky is blue.” The telling part of this story is not that an individual professor was cruel and stupid — it is that a committee of professors backed him up.

Another case — this time at Memorial University of Newfoundland — where a committee of professors did exactly the wrong thing with awful consequences for an innocent person. The current Memorial administration now defends this!

A website about how IRBs (institutional review boards) abuse their power. IRBs are university-wide committees that oversee research. They consist mostly of professors.

So you can see why I wasn’t really surprised.