Joseph Biederman is Still at Harvard



And he has won several awards:


But there’s also this:


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

And there’s this:



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

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

Thanks to Alex Chernavsky.

Assorted Links

Thanks to Bryan Castañeda and Andy.

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

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.   Continue reading “End-of-Life Medicine: Enormous Lack of Informed Consent”

Assorted Links

Thanks to Patrick Vlaskovits.