March Madness? Harvard profs take shots at controversial studies, request retractions

harvardIn the wake of Harvard’s gritty performance in the NCAA men’s basketball tournament — they were eliminated Saturday — a pair of faculty members at the Ivy League institution are calling foul on two controversial journal articles that have already been corrected.

Walter Willett, an oft-quoted Harvard nutrition expert, is calling for the retraction of an eyebrow-raising article earlier this month challenging the relative health benefits of fats from fish and vegetables over those in meat and butter.

The article, which appeared in the Annals of Internal Medicine, quickly came under fire and the researchers — from the University of Cambridge — ended up making several corrections. Despite the changes, the authors have stood by their work, according to a piece this week in Science.

But that hasn’t stopped Willett from urging a retraction. Per Science:

“They have done a huge amount of damage,” says Walter Willett, chair of the nutrition department at the Harvard School of Public Health in Boston. “I think a retraction with similar press promotion should be considered.”

And, to bring the point home:

Willett says correcting the paper isn’t enough. “It is good that they fixed it for the record, but it has caused massive confusion and the public hasn’t heard about the correction.” The paper should be withdrawn, he argues.

Now, we certainly agree with Willett that journals ought to handle retractions with as much fanfare as they treat the original studies. But the rest of his argument is one that seems up for debate. Do scientific journals have the responsibility to correct everything downstream of the studies they publish? If the authors made appropriate corrections and satisfied the editors’ concerns, they have met their duty and the paper should stand, yes? Willett himself seems to acknowledge this by admitting that the authors “fixed it for the record.”

Speaking of downstream effects of studies, in 2012, the Brigham and Women’s Hospital retracted statements in a press release about a study by Willett and co-authors in the American Journal of Clinical Nutrition about aspartame and cancer.

And Willett isn’t a stranger for calling for a purging of the record of data with which he disagrees. In 2011, he demanded the retraction of a press release from a Dutch university that, he claimed, had greatly misrepresented findings from a study of milk intake and heart disease. He subsequently retracted that demand.

Maybe something’s in the water up in Boston, because today another Harvard physician, Abraham Morgentaler, director of Men’s Health Boston, has released a letter to JAMA calling on the journal to retract a November 2013 article linking testosterone therapy to greater risk of cardiovascular illness and death.

According to Morgentaler, the paper which garnered the attention of the New York Times editorial page, is fatally flawed, with egregious errors including misstated numbers of patients and, incredibly, the inclusion of women in a cohort purportedly limited to men. A March 5 online correction backs him up:

Incorrect Number of Excluded Patients Reported in the Text and Figure: In the Original Investigation entitled “Association of Testosterone Therapy With Mortality, Myocardial Infarction, and Stroke in Men With Low Testosterone Levels” published in the November 16, 2013, issue of JAMA (2013;310[17]:1829-1836. doi:10.1001/jama.2013.280386), incorrect data appeared. The second paragraph of the Results section should have read, “We excluded the following patients from this cohort: 2798 patients who had initiated testosterone prior to coronary angiography; 1301 patients who had missing coronary anatomy data or whose coronary anatomy was categorized as other; 128 patients who had testosterone prescribed after MI because treatment decisions after an event were likely to be different and because coronary anatomy data to assess coronary disease severity were not uniformly available; 112 patients who had started testosterone prior to having a testosterone level checked; 100 patients who were women; 17 patients with hematocrit levels higher than 50%; 12 patients with PSA levels of 4.0 ng/mL or higher; and 9996 patients who had total testosterone levels of 300 ng/dL or higher.” Figure 1 should have included “1301 Missing coronary anatomy,” “128 Had testosterone therapy prescribed after myocardial infarction or stroke,” and “100Women” in the box listing excluded patients. This article has been corrected online.

The letter to JAMA is signed by 125 experts, among them:

8 emeritus professors, 51 additional full professors, 6 journal editors, and 10 presidents of medical societies.

A number of those experts have received funding from Abbvie, which makes Androgel, and other drug manufacturers.

Like Retraction Watch? Consider supporting our growth. You can also follow us on Twitter, like us on Facebook, add us to your RSS reader, and sign up on our homepage for an email every time there’s a new post.

7 thoughts on “March Madness? Harvard profs take shots at controversial studies, request retractions”

  1. “A number of those experts have received funding from Abbvie, which makes Androgel, and other drug manufacturers.”


  2. Last week I saw commercials from a law firm intending to start a class-action lawsuit for those that had heart problems after testosterone therapy. Obviously the financial stakes are high.
    Looking at the numbers though, from the abstract’s results section, you’ll see that of the 7486 patient not receiving testosterone treatment, 1587 (21%) either died, had an infarction, or a stroke. Of the 1223 receiving testosterone treatment only 123 (10%) died, had a infarction or stroke. That seems to show a strongly reduced risk for the testosterone treated group. Obviously all kind of corrections in the analysis led to the paper’s conclusion of a higher risk for the testosterone treated group. That points to the fact that the treated and non-treated groups characteristics were too dissimilar for a direct comparison, and that this study is meaningless. The authors obviously did not clearly state that their study was meaningless, but reviewers should not have let this pass in my opinion.

    1. this is a case of made up disease to sell a drug to people (under the cover of an actual disease that few of them have). the quintessential problem is: the drug companies aren’t going to do a real, prospective, unbiased study of men in the 50s getting testosterone because they are tired/not as sexually active/want bigger muscles. pretty much the same reasons that men in their 20s use testosterone. one is doping, the other is sanctioned because of a made up disease. I suffer from clinical small biceps, should i get a prescription for testosterone? So, drug companies won’t do a study that reflects the population being prescribed the drug…. but what self respecting physician is going to say “Ok. I should do a clinical trial for a drug that probably has serious health risks…. where no GOOD clinical trial has ever been done for the patients being prescribed the drug in clinics… for a “disease” whose existence is not just highly questioned but completely undefined and probably non-existent.”

      Hi, I’m Dr. So and So, you probably don’t have a disease, but I’m going to randomly assign you to one of two groups… and possibly give you something that could kill you… or might make you have a little more energy. Why not just do a clinical trial of cocaine for “low T?” Have less energy than you used to? Have trouble waking up in the morning? Can’t go clubbing until 6 am? Nothing a bump can’t cure!

      Point being: The paper might be poorly done, but so is everything else out there on this “drug” and “disease.” The group calling for the retraction just has a crap-load of money to blow.

      1. Wow! That was great! Yes, the full perspective. There are made up diseases. Made Up Disease Watch? Also the risk analysis methodology is incredibly problematic. We’re using it to do things it can’t do. And it serves as a way for MDs with zero scientific understanding to get in on the research game. Plus “Nutrition” is not real biology. If we had a magic wand that would remove all the med science papers that are not scientifically valid due to slovenliness, fraud, bogus or wrong methodology for the subject matter or about not real things, the volume would shrink by like 90%. Something to think on.

        1. A few years back there was a push to pathologize picky eating as a psychiatric disorder based on a new phenomenon of people refusing to eat foods they considered ‘unclean.’ It was the perfect merger of bad, misinterpreted nutritional information, of the sort shared by Dr. Oz and his ilk on TV and through the Internet every day, getting into the hands of people with underlying psych problems and limited critical thinking ability. Instead of recognizing the social context for modern information overload triggering new expressions of existing, already known psych conditions (obsessive-compulsive problems, eating disorders, excessive self-focus, etc.) a new disorder was created. No doubt existing off-patent drugs will be largely ineffective to treat the scourge of ‘Picky Eating Disorder’ and a new, very expensive drug will need to be developed.

          To be clear, I don’t doubt that there are individuals very impaired by obsessive concerns about food. I just highly doubt it is a brand new, discrete disorder. This is another issue with pathologizing normal life and mild behavioral quirks. It manages to trivialize real problems by lumping them in with the largely self-imposed concerns of the worried well.

          I think it’s time we recognize ‘Gullibility about Disorders Disorder,’ or GADD, as a serious and very expensive western health problem. Not sure what the cure is, but I hypothesize that an RCT would demonstrate that a simple, very inexpensive slap upside the head might be quite effective.

  3. “Another Harvard physician, Abraham Morgentaler, director of Men’s Health Boston, has released a letter to JAMA calling on the journal to retract a November 2013 article linking testosterone therapy to greater risk of cardiovascular illness and death.”
    Any bets on whether Morgentaler has any conflicts of interest related to testosterone therapy?


      Sounds like a pretty big conflict of interest… considering his business is essentially based on this being a real disease. “There are now data from a number of scientific studies (some performed at Men’s Health Boston) that low T is associated with an increased risk of diabetes or cardiovascular disease, and that treatment can be effective in restoring sexual function, improving mood and energy.”

Leave a Reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.