Archives Decides At Last Minute Not to Publish a Scheduled Paper

Here’s something I’ve never seen: 12 minutes before the scheduled publication of a paper the journal publishing the paper announced that it had “made the decision not to publish” the paper. Here’s what happened:

Last Thursday the JAMA/Archives media team issued a press package to  accredited media about several articles scheduled for publication in Archives of Internal Medicine on Monday (today) at 4 PM ET. The package included a press release (see below) about an article, “Stress Reduction in the Secondary Prevention of Cardiovascular Disease: A Randomized Controlled Trial of Transcendental Meditation and Health Education in African Americans.” The first author was Robert Schneider, MD, from the Maharishi University of Management, Maharishi Vedic City, Iowa. Co-authors from the same institution were: Maxwell Rainforth PhD, Sanford Nidich. EdD, Carolyn Gaylord-King, PhD, John Salerno, PhD, and Charles Alexander, PhD. Two other authors, Clarence Grim and Theodore Kotchen are from the Medical College of Wisconsin in Milwaukee.

Today (Monday), at 3:48 PM ET, 12 minutes before the scheduled publication of the paper, the following message appeared in my inbox:

Subject: Important Notice from Archives of Internal Medicine — Please Open Immediately!

The editorial office of the Archives of Internal Medicine has made the decision not to publish,  “Stress Reduction in the Secondary Prevention of Cardiovascular Disease: A Randomized Controlled Trial of Transcendental Meditation and Health Education in African Americans,” by Schneider et al, and the accompanying Commentary by Mehta and Bairey Merz that was to post Online First at 3 PM central time today.

The decision is to allow time for review and statistical analysis of additional data not included in the original paper that the authors provided less than 24 hours before posting. We apologize for the short notice, but hope you will understand and not run your stories on this study today.

Sincerely,

JAMA/Archives Media Relations

Without more information it’s difficult to comment at this point, but I strongly suspect that we will hear more about this story in the future. It should be noted that the study was funded by the NHLBI. In addition, the same study was presented at the AHA Scientific Sessions in 2009. The first author, Robert Schneider, is the Dean of the College of Maharishi Consciousness Based Health Care at Maharishi University of Management and Director of the Institute for Natural Medicine and Prevention, which is funded by the NIH’s National Center for Complementary and Alternative Medicine. “Schneider is a specialist in clinical hypertension and has published extensively, including papers in the American Journal of Cardiology, Stroke, and Hypertension.

[Update: the NCCAM has written to inform me that it “does not currently fund research at Maharishi University of Management; we last provided grant funding to the institution in FY 2004.” The information in the article was taken directly from the website linked above.]

For more on this story see my next post.

Here is the press release that was issued by JAMA/Archives last Thursday:

Stress Reduction Approach May Help Reduce Risk of Cardiovascular Events in African-American Patients With Cardiovascular Disease

CHICAGO – A stress reduction approach using meditation techniques in African-American patients who have coronary heart disease (CHD) appears to reduce the risk of death, myocardial infarction (heart attack) and stroke, and also is associated with reduced blood pressure and stress levels, according to a report published Online First today in Archives of Internal Medicine, one of the JAMA/Archives journals.

According to background information in the article, cardiovascular disease (CVD) is the leading cause of death in the United States and worldwide. The authors note that African Americans have higher rates of CVD-related illness and death, and that psychosocial stress might be a contributing factor. “The disparity in CVD in African Americans may be related, at least in part, to high levels of psychosocial and environmental stress,” they write.

Robert H. Schneider, M.D., from the Maharishi University of Management, Maharishi Vedic City, Iowa, and colleagues investigated the effect of stress reduction with the Transcendental Meditation (TM) program, in 201 African American patients with CHD. The clinical portion of the study was conducted at the Medical College of Wisconsin, Milwaukee. The researchers theorized that the effects of a stress reduction intervention would help reduce CVD risk factors and perhaps prevent CVD-related morbidity and mortality. Between 1998 and 2007, study participants either engaged in meditation techniques for 20 minutes twice per day, or spent the same amount of time practicing other heart-healthy lifestyle behaviors that they were taught in a cardiovascular health education program.

The researchers found that the group practicing meditation had a lower risk, compared with the control group, of experiencing the combined endpoint of cardiovascular events that included myocardial infarction or stroke, or death. This group also experienced a reduction in systolic blood pressure of, on average, 4.9 mm Hg (millimeters of mercury) more than the control group. Participants who entered the study with high blood pressure or high stress levels were more likely to have a lower risk of CVD-related illness and death if they were in the meditation group, versus the health education group.

The authors point out that in addition to a reduction in clinical endpoints, participants who practiced meditation techniques were more likely to experience less stress and anger. Those who adhered most closely to the protocol for meditation frequency and length had greater risk reduction. “The results of this trial placed in the context of other studies in the field suggest that the TM program is feasible and efficacious to clinically implement in patients with CHD for prevention of CVD clinical events and associated risk factors,” the researchers conclude. “These clinical data along with cost-effectiveness data have implications for the role of behavioral intervention in prevention-oriented cardiovascular practice and policy.”
(Arch Intern Med. Published online June 27, 2011. doi:10.1001/archinternmed.2011.310. Available pre-embargo to the media at www.jamamedia.org.)

Editor’s Note: This study was funded by a grant from the National Institutes of Health, National Heart, Lung and Blood Institute. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Commentary: Stressing Stress Relief

An accompanying commentary discusses the role that psychosocial stress may play in CVD, and the relevance of the findings from the study by Schneider and colleagues. Besides aggravating the effects of other pathophysiologic risk factors, the article states, psychosocial stress may contribute to injury of the lining of the blood vessel wall and to early atherosclerosis. “Accordingly, interventions that address psychosocial stress offer new therapeutic opportunities to ameliorate CHD morbidity and mortality,” write Puja K. Mehta, M.D. and C. Noel Bairey Merz, M.D., both from Cedars-Sinai Medical Center in Los Angeles.

Although the study by Schneider and colleagues improved some measures of stress and anger in the intervention group, they point out, it did not seem to affect other measures. For example, the level of depression was not significantly different between the treatment and control groups. This, apparently, is in concordance with other research which has not shown that stress reduction can reduce major adverse events by mitigating depression, isolation and lack of social support.

Still, Mehta and Bairey Merz note, the meditation practice studied by Schneider and colleagues appeared to benefit patients with CHD, offering “new hope for the beleaguered area of psychosocial stress intervention for improving health outcomes in our over 13 million women and men with established CHD in the United States.” They urge further research into how these methods can best help patients. “Secondary prevention guidelines should include psychosocial stress interventions demonstrated to reduce morbidity and mortality,” they add. “Cardiac rehabilitation programs should reinvigorate their psychosocial screening and treatment options.”
(Arch Intern Med. Published online June 27, 2011. 2011;doi:10.1001/archinternmed.2011.300. Available pre-embargo to the media at www.jamamedia.org.)

Editor’s Note: This work was supported by the National Center for Complementary and Alternative Medicine, the National Institutes of Health General Clinical Research Center, the National Center for Research Resources, the Women’s Guild of Cedars-Sinai Medical Center, the Edythe L. Broad Women’s Heart Research Fellowship and the Barbra Streisand Women’s Cardiovascular Research and Education Program at Cedars-Sinai Medical Center. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

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