Archive for the 'undisclosed risks' Category

Joseph Biederman is Still at Harvard

Saturday, January 11th, 2014

Joseph Biederman is a professor of psychiatry at Harvard Medical School. It makes a certain sense. According to Wikipedia, in 2007 he was

the second highest producer of high-impact papers in psychiatry overall throughout the world with 235 papers cited a total of 7048 times over the past 10 years as determined by the Institute for Scientific Information.

And he has won several awards:

Biederman was the recipient of the 1998 NAMI Exemplary Psychiatrist award. He was also selected by the Massachusetts Psychiatric Society Awards committee as the recipient of the 2007 Outstanding Psychiatrist Award for Research. In 2007, Biederman received the Excellence in Research Award from the New England Council of Child and Adolescent Psychiatry. He was also awarded the Mentorship Award from the Department of Psychiatry at the Massachusetts General Hospital.

But there’s also this:

Biederman had pioneered the diagnosis of bipolar disorder in children and adolescents, a disorder previously thought to affect only adults. One of the world’s most influential child psychiatrists, Biederman’s work led to a 40-fold increase in pediatric bipolar disorder diagnoses and an accompanying expansion in the use of antipsychotic drugs – developed to treat schizophrenia and not originally approved for use in children – to treat the condition. However, Biederman and his colleagues Spencer and Wilens failed to accurately disclose the large consultancy fees they were receiving from pharmaceutical companies that make antipsychotics whilst conducting this research.

For which Biederman received a slap on the wrist from Harvard.

And there’s this:

Dr. Biederman pushed [Johnson & Johnson] to finance a research center at Massachusetts General Hospital, in Boston, with a goal to “move forward the commercial goals of J.& J” [said Biederman in an email]

In other words, he felt no shame in admitting that he considered the commercial goals of Johnson & Johnson more important than the health of children with severe problems. One of the few people who can really help these children — by doing good research — he preferred to help Johnson & Johnson.

Missing Data in Clinical Trials: FDA Officials Refuse to Set Limits

Sunday, December 29th, 2013

People who believe in “evidence-based medicine” say that double-blind clinical trials are the best form of evidence. Generally this is said by people who know very little about double-blind clinical trials. One reason they are not always the best form of evidence is that data may be missing. Nowadays more data is missing than in the past:

By [missing data] he [Thomas Marciniak] means participants who withdrew their consent to continue participating in the trial or went “missing” from the dataset and were not followed up to see what happened to them. Marciniak says that this has been getting worse in his 13 years as an FDA drug reviewer and is something that he has repeatedly clashed with his bosses about.

“They [his bosses] appear to believe that they can ignore missing and bad data, not mention them in the labels, and interpret the results just as if there was no missing or bad data,” he says, adding: “I have repeatedly asked them how much missing or bad data would lead them to distrust the results and they have consistently refused to answer that question.”

In one FDA presentation, he charted an increase in missing data in trials set up to measure cardiovascular outcomes.

“I actually plotted out what the missing data rates were in the various trials from 2001 on,” he adds. “It’s virtually an exponential curve.”

Another sort of missing data involves what is measured. In one study of whether a certain drug (losartan) increased cancer, lung cancer wasn’t counted as cancer. In another case, involving Avandia, a diabetes drug, “serious heart problems . . . were not counted in the study’s tally of adverse events.”

Here is a presentation by Marciniak. At one point, he asks the audience, Why should you believe me rather than the drug company (GSK)? His answer: “Neither my job nor (for me) $100,000,000’s are riding on the results.” It’s horrible, but true: Our health care system is almost entirely run by people who make more money (or make the same amount of money for less work) if they exaggerate its value — if they ignore missing data and bad side effects, for example. Why the rest of us put up with this in the face of overwhelming evidence of exaggeration (for example, tonsillectomies) is an interesting question.

Thanks to Alex Chernavsky.

Assorted Links

Monday, September 30th, 2013

Thanks to Alex Chernavsky.

Assorted Links

Saturday, May 18th, 2013

Thanks to Bryan Castañeda and Andy.

End-of-Life Medicine: Enormous Lack of Informed Consent

Friday, February 1st, 2013

A few weeks ago I blogged about undisclosed risks of medical treatments. Undisclosed risks are common. They might be the norm. The situation would be even worse — in some sense, much worse — if doctors knew of these risks and failed to tell their patients. It was unclear if doctors knew of the undisclosed risks I wrote about.

Recently Tyler Cowen quoted a newspaper story about Israeli doctors giving birth control injections to Ethiopian women immigrants ”without their knowledge or consent.” Every commenter thought this was repugnant.

The latest RadioLab podcast (“The Bitter End”) is about the dramatic difference between how doctors want to be treated when they are near death (they want no CPR, no ventilator, no dialysis, no surgery, no chemotherapy, no feeding tube, no antibiotics, nothing except pain medicine) and how the general public wants to be treated (most people want CPR, ventilator, dialysis, surgery, chemotherapy, feeding tube, antibiotics, and so on).

The RadioLab guys were puzzled by the difference.   (more…)

Assorted Links

Wednesday, January 16th, 2013

Thanks to Patrick Vlaskovits.