Harvard Psychiatrist Joseph Biederman and Parents: “Should Be Left in a Room Together”

Joseph Biederman is a professor of psychiatry at Harvard. He recently received a far-too-mild sanction for behavior that included this:

Biederman was then placed in charge of the institute and began a study of 40 children between 4 and 6 years old who were given Risperdal [made by Johnson & Johnson] and Lilly’s Zyprexa, another antipsychotic. At the time, Harvard and MGH [Massachusetts General Hospital] rules forbid researchers from running trials with [drugs] if they receive more than $10,000 from a company that makes the drug.

It was eventually revealed that Biederman had received at least $1.6 million from drug companies, including far more than $10,000 from Johnson & Johnson and far more than $10,000 from Lilly. One comment on the quoted article made the excellent point that bipolar disorder had a usual onset age of onset of 18 years or more and had never been found in young teenagers (e.g., 14-year-olds). Yet Biederman suddenly claimed it appeared in 6-year-olds. In a good expression of how I feel about Biederman’s behavior, another comment said he should “be left alone in a room with the parents of the children [he] treated”.

Google Yes, Wikipedia Yes, Aaron Swartz No?

We praise Google and Wikipedia for making knowledge more available — consider them two of the best innovations of the last 50 years — but after Aaron Swartz, a friend of mine, apparently tried to do the same thing he was charged with wire and computer fraud and faces up to 35 years in jail and a $1 million fine.

The prosecutor, U.S. Attorney Carmen Ortiz, made an interesting statement:

Stealing is stealing, whether you use a computer command or a crowbar, and whether you take documents, data or dollars. It is equally harmful to the victim whether you sell what you have stolen or give it away.

In my experience, tautological statements such as “stealing is stealing” or “correlation is not causation” do not bode well for that side of the argument. As Thorstein Veblen might say, the reason for the tautology was the need for it.

Ortiz’s statement shows that she, like the rest of us, thinks that what matters is amount of harm. Harm is hard to find here. The only clear harm is that MIT access to JSTOR was shut down for a few days. This is so minor that JSTOR’s statement about the case (which includes “it was the government’s decision whether to prosecute, not JSTOR’s. . . . We [have] no interest in this becoming an ongoing legal matter”) doesn’t mention it. I don’t think many people will agree that this amount of harm justifies the charges that Ortiz has brought.

Sign a petition supporting Aaron.

Welcome to the Sausage Factory: Multiple Fraud in a Paxil Study

Dr. Jay Amsterdam, a professor of psychiatry at the University of Pennsylvania, recently lodged a very interesting complaint against five authors of a 2001 study that compared Paxil to another drug and placebo for treatment of bipolar disorder. The paper reports research paid for by SmithGlaxoKline, the makers of Paxil. For a subgroup of patients, it says, Paxil worked better than the other drug and better than placebo. Paxil supposedly had fewer side effects than the comparison drug. Amsterdam accuses the five academic authors of plagiarism — meaning they put their names on a paper they didn’t write (like a student who buys a paper). He also says the paper grossly misrepresents the results (because the subgroup analysis was completely ad hoc and the side effects description utterly wrong). So if they did write it . . .

The paper has been cited hundreds of times. Given the actual results — Paxil had worse side effects than the other drug, and the subgroup result means little — this is no small matter.

As Spy magazine has said, if you cheat your customers, don’t fire anyone. Email included with Amsterdam’s complaint suggests he was upset because he was not an author on the paper. Why? Well, the study was done at many sites and there could be only one author per site — according perhaps to SmithGlaxoKline. At Penn, the work (enrolling subjects) was first given to a junior faculty member named Laszlo Gyulai. However, Gyulai couldn’t enroll enough subjects. Amsterdam was asked to help and paid for doing so. He ended up enrolling more subjects (12) than Gyulai (7). Yet Gyulai was an author and he was not! This greatly bothered him. He considered it “misappropriation” of his data, said Gyulai had engaged in “the theft and publication of a professor’s data”, and wanted Gyulai censured. Perhaps Gyulai had considered Amsterdam’s non-authorship okay because many professors who contributed subjects were not authors. Whatever the reason, it appears that authorship was determined by the firm that did the ghostwriting, Scientific Therapeutics Information, presumably following orders from SmithGlaxoKline.

I don’t know why Amsterdam waited ten years to complain. Since 2001, however, the ghostwriting problem has become much clearer. In 2001, Amsterdam complained to his department chair, Dr. Dwight Evans, about the situation. In 2010, Amsterdam learned that Evans had benefited from ghostwriting. That’s how common it was.

There’s also this:

POGO [Project on Government Oversight], in a letter to President Obama [related to Amsterdam’s complaint], asked that he remove Amy Gutmann, president of the University of Pennsylvania, from her position as chairman of the Presidential Commission for the Study of Bioethical Issues, until the two cases involving Dr. Evans are fully investigated and resolved.

Chairman! Another indication how common and tolerated ghostwriting is. It is as if an obesity expert, appointed head of the most important obesity committee in the country, charged with recommending how to stop the obesity epidemic . . . is fat.

Perhaps British journalistic phone-hacking has been more common than misrepresentation of results by med school professors but the latter, I’m sure, has done more damage.

Attachments to the Amsterdam complaint. Pharmalot weighs in. Some of the accused defend themselves.

Morning Faces Therapy for Bipolar Disorder: Follow-Up Questions

In May I posted a friend’s story about how he used my morning-faces discovery to improve his life. It helped enormously (“It felt like a giant headache was just lifted off me”). I asked him some follow-up questions.

What time of day do you look at your face in a mirror? For how long?

I look at my face in a mirror for an hour starting at about 6:20am (Daylight Saving Time). It doesn’t feel weird or vain to me. I usually listen to C-SPAN, Comedy Central, or music during the therapy.

You wrote: “I’m able to enjoy life and relate to others in ways that I never could my entire life.” Could you elaborate?

In my letter I said that my initial reaction to the face therapy was that it felt like a giant headache was just lifted off of me. That “headache” was the weight of depression and anxiety on my mind. My whole life I have been burdened by that weight, under its shadow to one degree or another. Another angle on this: Your initial reaction was “I felt great – cheerful and calm, yet full of energy”. I am quite certain that before the therapy I was never in that state of mind. But I’m not just talking about typical enjoyment—hearing the music, conversing and laughing, a fine meal, etc. In The Simpsons episode “Barting Over”, Homer is twirling slowly high in the air on a skateboard, and a novel idea pops into his head: if he buys two kinds of nuts separately, he can combine them at home to get “mixed nuts”. That sensation of weightlessness, with little solutions to little problems just popping up, is new to me. When you add up hundreds of those solutions, you find life itself less burdensome. You make more room for appreciation, gratitude, friendship, and so on. You begin to get an inkling of what a full human life could be.

People “automatically reject the idea”, you wrote. What happens?

“That’s the most ridiculous thing I’ve ever heard” was the comment of a woman in the bipolar support group. Some in the group of the if-it-sounds-crazy-enough-I-believe-it persuasion would nod their support. My sister theorized that it was all just meditation (!) and finished by saying, “I get enough faces at work.” My dental hygienist was somewhat persuaded by the fact that a newborn can recognize its mother’s face within hours of birth.

Do you continue to see a psychiatrist and/or a psychologist? If so, are they curious about how well you are doing without meds? If they’re not curious, how do they explain it?

My psychiatrist and psychotherapist are glad that I’m doing well, but they are not curious about the face therapy, the bright lights, or the fish oil. They are skeptical toward alternative treatments. I gather they think that my improvement is due to remission, or an upswing in the illness’s cycle, or the accumulated years of talk therapy. Or they abandon reason altogether, saying, “Whatever works for you.”

Why do you need to go to bed “early”? What happens if you don’t? What makes it difficult or discipline-requiring to go to bed “early”?

If I go to bed late, I need to take an hour nap the next day, which is a drag. At 10pm I’m almost never tired enough, plus I usually feel that I haven’t accomplished enough for the day. At your suggestion, I am trying to reset my circadian rhythm by getting 2 hours of morning light from approximately 7:30am to 9:30am.

What effect does the early morning bright light therapy have? How do you do it (e.g., equipment, time of day)? Why did you start it?

As I recall, the lights helped me to wake up early, fairly rested and alert. I started in 1997 at your suggestion with a bank of four GE F40SP65-ECO tubes, 40 watts each, 48 inches long. I now cover half of the bank to reduce the intensity. I get thirty minutes of exposure starting at about 6:50 am (Daylight Saving Time).

In 1997, what made you decide to try the faces?

I was primed for the idea that a big change might help. Six months prior, I had made a somewhat beneficial switch to Depakote after taking lithium for 11 years. Also, you claimed that you already had good experimental results with several people, and that Andrew Gelman at Columbia University was impressed with your work.

“I hadn’t needed Moban since 1999,” you write. Why not?

From 1999 to 2003, the face therapy was so effective that I didn’t need an antipsychotic (e.g. Moban). From 2003 to 2006, when I didn’t use the face therapy, I kept certain habits that I had adopted during that therapy: keeping a fairly normal sleep schedule, avoiding fluorescent lights at night, and getting a decent amount of social interaction.

With the benefit of hindsight, why do you think it did not keep you out of the hospital in 2003?

When I told my psychiatrist in 1999 that I was going to use the face therapy instead of medications, he exclaimed, “That’s like taking off a cast and trying to walk right away!” Indeed, for 12 years my mind had been numbed with psychiatric drugs. Although the face therapy was seemingly miraculous, it couldn’t restore all that was lost. Yet with little support from others I was trying to “walk”: I had the goals of getting a job and a social circle; I had a dream of leading the way for all depressed people. It was unrealistic to expect that I could do much more than crawl through life. By 2003, I needed the hospital because I was in over my head.

Why did back pain and stress put you back in the hospital? Why did they lead to a suicide attempt?

My mental state deteriorated because of lack of sleep, which in turn was due to back pain and stress. Both back pain and stress are manageable—given enough time and attention. Unfortunately, at the time I was overwhelmed with many new problems and many lingering old problems. I had just moved. The house had far more traffic noise and housemates than I was accustomed to. I didn’t have the money or strength to move again; I was falling out with an old friend; my wrists and feet were injured. If I went back to the mental health system, I would be more handicapped than ever. The situation seemed hopeless.

Why did publicity related to The Shangri-La Diet make you try this again?

I actually thought that Diane Sawyer might call me after saying to herself, “Wow, what else has Professor Roberts discovered?” So I wanted to shape up my mood fast! I assumed that the Shangri-la Diet in its way must be about as great as the face therapy. I didn’t suspect that the media would treat your diet like any other—as an offbeat fad.

You wrote: “In August of 2010, dissatisfied with my low energy level, I decided to go off medications completely again. What did you do?

I had been “stabilized” on 250 mg of Depakote, which is a sedating anti-manic drug, and 20mg of Prozac, which is an antidepressant that can induce mania. About once a month, I got rid of the sedation by skipping the Depakote for a few days. On one occasion, when I tried to skip the Depakote for 9 successive days, I became slightly hypomanic and had trouble sleeping. Over the course of several months, I reduced the Prozac to 10mg, and even to 5mg, but still I couldn’t stay off the Depakote for more than about 7days without problems.

You wrote: “Getting off just the two drugs was tricky, because of the difference in half-lives.” What was “tricky” about it?

I was boxed in by the difference in the drugs’ half-lives. Prozac has a plasma half-life of about 10 days, while Depakote has a half-life on the order of only 10 hours. I considered splitting the enteric-coated Depakote, but never did. I decided that the only way out was to stop taking the Prozac, but continue taking the Depakote for 10 days until the Prozac was out of my system. So I tolerated being depressed and sedated until I could stop the Depakote, too.

 

 

The Value of a Diagnosis of Asperger’s

In a recent post I said Marcia Angell was too hard on psychiatric diagnosis. Long before perfection, diagnoses can be useful. For example, Alexandra Carmichael recently found out she has something close to Asperger’s Syndrome (note that she has not been diagnosed by a doctor). She explained why:

I feel like at least I’m on the *path* to a much smoother life now – whether I’m there or not can be debated. :) Learning about Asperger’s has illuminated sensory and social sensitivities that I didn’t realize other people *didn’t* have. It was understandably confusing to live in a world where I thought I was defective because I couldn’t do what other people were doing as easily. Knowing that there is a subset of people who experience the world the way I do has been liberating, and seeing how other “aspies” modify their lives and routines to suffer less has helped me make helpful structural changes in my life, too.
For example, right now I am wearing my Bose QC 15 headphones on a flight from Boston to San Francisco, because I know that too much sound in a day can make me incredibly weak the next day. I’ve arranged to do 90% of my work by email and chat these days, with the occasional in-person meeting, because I know that my auditory processing is not great for phone calls, and it takes me days to prepare for and recover from a social meeting/event. I say no to most things I get invited to (conferences, dinners, etc), because I prefer to contribute my thinking/organizing/connecting talents online and reserve social energy for one-on-one time with close friends. I’ve also become aware that my ability to listen and empathize with people is powerful and something I enjoy, maybe in part because I build such intricate models of everyone I meet, so my purpose in life has become to listen and help where I can. I only wear comfortable clothes, because my mood will suffer terribly if I have jeans or high heels on. I give and receive lots of hugs, because these are very calming for me. I have a very detailed daily routine that I follow, which reduces cognitive load used to consider options every day and feels comfortable for me. I’m much more aware of my weaknesses, especially regarding relationships, and am very careful about communicating clearly and non-violently, making sure I have a good understanding of both my needs and the needs of people around me – so that I can help, or at least not harm them.
So things like this have all come about because of trying on the Asperger’s hat for a while, and the increased self-awareness that came with it. After a certain point, you can drop the label and integrate what you’ve learned into your identity. But for me, having the label for a while was a guide and a relief, helping me realize that it’s really ok to be myself.

Worse Than Placebo? Forest Laboratories’s Shameful Marketing


While Forest [Laboratories] applied to the FDA for pediatric use of Celexa [the anti-depressant] and was eventually denied, the company admitted it had marketed the drug to doctors by hiring speakers to tout its benefits for young patients. Forest also admitted it had suppressed the negative results of research in Europe that found Celexa was no more effective in treating depressed children and adolescents than a sugar pill. Fourteen young patients in that study attempted suicide or contemplated suicide, compared with five in the placebo group, court records show.

From this article. Is Forest Laboratories worse than other big drug companies? Probably not. What’s horrible is how this sort of thing — suppression of negative results — keeps happening. It suggests that the evaluation of drugs should be taken entirely out of the hands of drug companies.

Percentile Feedback Update

In March I discovered that looking at a graph of my productivity (for the current day, with a percentile attached) was a big help. My “efficiency” — the time spent working that day divided by the time available to work — jumped as soon as the new feedback started (as this graph shows). The percentile score, which I can get at any moment during the day, indicates how my current efficiency score ranks according to scores from previous days within one hour of the same time. For example, a score of 50 at 1 p.m. means that half of the previous days’ scores from noon to 2 p.m. were better, half worse. The time available to work starts when I get up. For example, if I got up at 4 a.m., at 6 a.m. there were 2 hours available to work. The measurement period usually stops at dinner time or in the early evening.

This graph shows the results so far. It shows efficiency scores at the end of each day. (Now and then I take a day off.) One interesting fact is I’ve kept doing it. The data collection isn’t automated; I shift to R to collect it, typing “work.start” or “work.stop” or “work.switch” when I start, stop, or switch tasks. This is the third or fourth time I’ve tried some sort of work tracking system and the first time I have persisted this long. Another interesting fact is the slow improvement, shown by the positive slopes of the fitted lines. Apparently I am slowly developing better work habits.

The behavioral engineering is more complicated than you might think. My daily activities naturally divide into three categories: 1. things I want to do but have to push myself to do. This helps with that, obviously. 2. things I don’t want to do a lot of but have to push myself away from (e.g., web surfing). 3. things I want to do and have no trouble doing. But the recording system is binary. What do I do with activities in the third category? Eventually I decided to put the short-duration examples (e.g., standing on one foot, lasts 10 minutes) in the first category (counts as work), keeping the long-duration examples (e.g., walking, might last one hour) in the second category (doesn’t count as work).

Before I started this I thought of a dozen reasons why it wouldn’t work, but it has. In line with my belief that it is better to do than to think.

Phone Hacking and Jane Jacobs

I am fascinated by the British phone hacking scandal. Jane Jacobs has helped me understand it.

Should police officers be paid per arrest? Most people think this is a bad idea, I imagine, but the larger point (what can we learn from this?) isn’t clear. In Systems of Survival, Jacobs tried to spell out the larger point. She wrote about two sets of moral rules. One set (“guardian syndrome”) applied to warriors, government officials, and religious leaders. It prizes loyalty and obedience, for example. The other set (“commercial syndrome”) applied to merchants. It prizes honesty, avoidance of force, and industriousness, for example. The two syndromes correspond to two ways of making a living: taking and trading. The syndromes reached the form they have today because they worked — different jobs need different rules. When people in one sort of work (e.g., guardian) follow the rules of the other, things turn out badly. Ayn Rand glorified the commercial syndrome. When Alan Greenspan, one of her acolytes, became a governor, he did a poor job.

What about journalists? As a journalistic business becomes more powerful, it becomes more guardian-like. A powerful newspaper isn’t inherently bad; we want a powerful newspaper to keep other powerful institutions (government, large businesses) in check. Murdoch’s News International, of course, has became very powerful. Yet Murdoch newsrooms retained commercial norms, especially an emphasis on selling many copies. Reporters in Murdoch newsrooms were under intense pressure to produce — like policemen paid per arrest. Other journalists, with guardian norms (e.g., at the New York Times), didn’t like the commercial norms of Murdoch newspapers. The mixture of commercial values and guardian power led to the phone hacking scandal. Friends of mine blame Murdoch himself — but commercial norms are not unique to Murdoch. The problem is their mixture with great power.

When newspapers are small, they are not powerful, not guardians, and must adopt commercial norms — they must try to sell more copies or they will be crushed. When a small newspaper becomes large and powerful, however, its norms must change to guardian ones or things will turn out badly. This suggests that the phone-hacking scandal happened because Murdoch became very powerful too fast — too fast for a shift in values to accompany much greater power.

 

 

 

 

 

 

 

 

 

 

Assorted Links