Article

From: “VERACARE”
To: “Dr. Bart Campbell”
Subject: RE: AHRP Response to criticism re: fatal ARDS lung experiment
Date: Tue, 1 Jul 2003

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
http://www.ahrp.org/ARDSpages/ARDSindex.php

Indeed, OHRP’s letter to AHRP (Aug. 28, 2002) states: “In reviewing the above letters, you will note that in all cases OHRP found that the informed consent documents approved by the institutional review boards (IRBs) for the research failed to describe adequately the reasonably foreseeable risks and discomforts of the research.” See: http://www.ahrp.org/ethical/CaromeARDS082802.php

As we note in our testimonies, in some cases grossly inaccurate information was provided in the informed consent document, misleading subjects and surrogates with false statements such as: “…both treatment groups have been extensively tested and been associated with a four-fold increase in survival for patients with severe lung disease.” See AHRP testimonies:
“>http://ahrp.org//testimonypresentations/ARDSNet0603/noble.html
http://ahrp.org//testimonypresentations/ARDSNet0603/nass.html

As noted by OHRP the ARDSNet consent process was coercive in nature. See: http://www.ahrp.org/ARDSpages/ARDSindex.php

Fifth, you state, “Society is greatly benefited by this study and the ARDSNet.”

AHRP response: How could society benefit from a trial that increased mortality rates? How could society benefit from a human experiment that provided no useful information to guide clinicians in selecting the safest method of ventilating the lungs of ARDS patients?

The researchers, who were using human subjects, had an obligation to design the trial in such a way that the controls were assigned the best alternative treatment, and had a legal and ethical obligation to obtain proper informed consent. It was not their role to decide that the laws governing human subject research should be changed for the good of society, and thus act accordingly.

Finally, AHRP agrees with your statement, “We must take great care to serve well those who put their trust in us.” AHRP believes that performing research on human subjects is a privilege and requires the highest ethical and medical standards. In this particular case, both appeared to be lacking.

Meryl Nass, MD, board member

Vera Sharav, President

John H. Noble, Jr., Ph.D, board member

—–Original Message sent to AHRP—

From: Dr. Bart Campbell
Sent: Friday, June 27, 2003
Subject: AHRP Testimonies re: Fatal ARDS lung experiment

AHRP provides a service to humankind by offering alternative viewpoints in research and bioethics. However, as a practicing cardiologist with extensive experience in caring for parients afflicted with acute respiratory distress syndrome (since it was described and named by my mentors, Tom Petty and David Ashbaugh), I must object to AHRP’s vilification of the ARDSNet report in the May 4,’00 NEJM. Several AHRP allegations are totally devoid of veracity. The trial did not, as alleged, ” test two extreme, rarely used methods of mechanical lung ventillation” but compared instead (and for sound reasons) the traditional (and most widely used) method of ventillation in these extremely ill people to a lower ventillatory volume method. The question; “how many o f the subjects who died might have lived had they continued to receive standard, individualized care” suggests the study resulted in adverse outcomes when in reality, mortality in the group that did not receive “standard” care had a mortality strikingly lower that any of the five trials in the Eichacker et al post hoc meta-analysis. The conclusion that “the published ARDSNet findings in The New England Journal of Medicine could potentially jeprodize the lives of future patients” could not be further from the truth. This was a necessary and landmark trial that is likely to significantly lessen mortality in a catestrophic condition that has for many years claimed an extremely high mortality. These “subjects were (indeed) fighting for their lives” and were fortunate to be in a trial that clearly lessened mortality in the treatment group.

Regarding the allegation that the trial was ethically flawed, AHRP is technically correct that some patients did not have “legally valid informed consent”. As IRB chair in a State that does not provide a law validating surrogate consent, I have had great concern about patients who are too ill to give consent for trials that might provide significant benefits. Prior to OHRP’s decision that there was no way to include these patients, surrogate consent was commonly accepted in such States (just as it was in providing standard care for potentially life-saving therapies in those whose loved ones gave surrogate consent). Unfortunately, until a law is in place providing access, these people cannot participate even when their caregivers (and loved ones) realize they are, in some cases, being denied access to potentially life saving therapies. Is this ethically appropiate? The allegation by AHRP that “informed consent was largely nonexistent” and “Neither the known nor foreseeable risks were disclosed to any of the patients or their surrogates is simply not true and is inflammatory. Surrogates of these desparately ill people were informed of the risks of ARDS and of the high liklihood of not surviving. They are fortunate to have the study available to them.

The ARDS investigators are to be congratulated, not castigated. Society is greatly benefitted by this study and the ARDSNet. We must support them and urge them to get on with the business of reducing mortality in this dread disease. AHRP is right to ask us to think carefully about the ethical nature and validity of research. We must take great care to serve well those who put their trust in us. In this instance however, AHRP has sadly missed the mark.

W. Barton Campbell