AHRP Letter to Editor re: ARDS published NEJM

AHRP Letter to Editor re: ARDS published NEJM

Fri, 11 Jul 2003

A truncated version of a Letter to the editor submitted by John H. Noble, Jr., PhD and Vera Sharav appears in the current July 10, 2003, issue of The New England Journal of Medicine.

Note: On April 3, 2003 the NEJM published several articles relating to controversial clinical trials that have raised concerns about the ethics of non-consensual human experiments in which patients are put at risk of harm. An editorial in the NEJM supported a multi-site, clinical trial that was suspended by the federal oversight agency, the Office of Human Research Protections.

The trial was sponsored by the National Heart, Lung, and Blood Institute (NHLBI), one of the institutes of NIH, but came under criticism because it failed to compare an experimental method against a control group using standard of care. Instead, non-consenting, critically- ill, incapacitated human beings with acute respiratory distress syndrome (ARDS) were subjected to one of two rarely used experimental methods that increased mortality risk for the subjects compared to ARDS patients treated in routine practice at the same participating research centers.

On April 10 AHRP submitted a letter to the editor. See:

When asked by the NEJM to shorten it to 175 words, we did. However, contrary to assurance that 4 reference notes were acceptable, the published letter was sanitized – the reference note citing documented cases of ethical violations at NIH was deleted.**

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http://content.nejm.org/cgi/content/extract/349/2/188
July 10, 2003. Correspondence NEJM. Volume 349:188-192 Number 2

Protection of Research Subjects

To the Editor: Drazen takes great pains to lay out the seemingly meticulous process of design, review, and approval of clinical trials that would appear to validate whatever decisions the National Institutes of Health (NIH) make about the direct conduct or funding of such trials. His strong suggestion that the OHRP should back off from questioning an ARDS study sponsored by the National Heart, Lung, and Blood Institute is nothing short of astonishing. The historical and recent records demonstrate that clinical trials approved by the NIH have not always satisfied the tenets of medical ethics and, therefore, are very much in need of independent monitoring and supervision.[1] Checks and balances are at the heart of the U.S. system of governance. If the OHRP’s independent oversight authority[2,3] were to be disregarded, how could citizens participating – consciously or unconsciously – in biomedical research feel secure about their lives and safety?

John H. Noble, Jr., Ph.D.
Vera H. Sharav, M.L.S.
Alliance for Human Research Protection
New York, NY 10023

References

  1. Marshall E. NIMH to screen studies for science and human risks. Science 1999;283:464-465.[Full Text]

  2. Department of Health and Human Services, Health Resources and Services Administration. Delegation of authority. Fed Regist 2000;65:37136-37136.

  3. Department of Health and Human Services. Amendment of statement of organization, functions, and delegations of authority for the Office of Human Research Protections. Fed Regist 2002;67:10216-10216.

** Deleted reference note: Recent NIH research lapses in medical ethics include: (1) 29 clinical trials suspended in 1999 by the director of the National Institute of Mental Health for failure to meet ethical and/or scientific standards. (See Marshall, E. NIMH to screen studies for science and human risks. Science 283;1999:464-5); (2) An experiment involving 193 children in violation of federal protections was suspended by the National Institute of Child and Human Development in November 2002 (See OHRP letter of determination at: http://ohrp.osophs.dhhs.gov/detrm_letrs/nov00a.pdf ); (3) As determined by the OHRP, 23 ARDS Network sites failed to describe adequately the reasonably foreseeable risks and discomforts of the research (See Carome, M. Letter at: http://www.ahrp.org/ethical/CaromeARDS082802.php ). (4) NIH sponsored genetic experiments conducted by Harvard in rural China were criticized for human rights violations. (See OHRP letters:
1. http://ohrp.osophs.dhhs.gov/detrm_letrs/YR02/mar02a.pdf
2. http://ohrp.osophs.dhhs.gov/detrm_letrs/YR02/mar02b.pdf
3. http://ohrp.osophs.dhhs.gov/detrm_letrs/YR02/mar02c.pdf

Two other letters critical of the editorial and Dr. Drazen’s reply are on our website: http://www.ahrp.org/ahrpspeaks/ARDSletterNEJ071003.php

***On July 3, 2003, OHRP issued its letter of determination to the ARDSNetwork determined that the risks to subjects was unjustifiable and the informed consent process invalid as the risks–including increased risk of death– were not disclosed to subjects or surrogates. OHRP calls for a complete reevaluation process, requiring detailed comparison data of routine practice outcomes with experimental intervention–and full justification in writing to OHRP by any any center that considers resuming the ARDS trial. See: http://ohrp.osophs.dhhs.gov/detrm_letrs/YR03/jul03a.pdf

Additional documents available on the AHRP website: http://www.ahrp.org

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