Monday, March 7, 2016

No. 147: Medical Education of Resident Physicians—A Shocking Scandal Relating to a Pair of Clinical Trials

Public Citizen is a public interest organization that Ralph Nader and Dr. Sidney Wolfe founded in 1971. For many years, Dr. Wolfe headed Health Research Group (HRG), a unit of Public Citizen. I have long admired the important service HRG renders to the public.

HRG Press Release
On November 19, 2015, HRG issued a 19-paragraph press release entitled "Unethical Trials Force Hundreds of Resident Doctors Nationwide to Work Dangerously Long Shifts, Placing Them and Their Patients at Risk of Serious Harm," and subtitled "Public Citizen and American Medical Student Association [AMSA] Call on Federal Regulators to Investigate and Immediately Stop Research, Urge Accrediting Body to Reinstate Work-Hour Limits for All Resident Doctors." The fifth paragraph of the press release reads:
The primary goal of the two trials is to determine whether the rates of death and serious complications for the patients unwittingly enrolled in the trials at the hospitals where first-year residents are forced to work significantly longer work shifts (28 or more hours) than permitted under current ACGME [Accreditation Council for Graduate Medical Education] rules (the experimental group) are higher than the rates of death and serious complications in patients enrolled at hospitals where residents' work shifts comply with the ACGME limit of 16 consecutive hours (the control group). The investigators have not obtained the voluntary informed consent of the medical residents or their patients.
On the same day, HRG and AMSA sent a four-page letter to ACGME. They sent copies of the letter to senior officials in the U.S. Department of Health and Human Services (DHHS).  They also sent the DHHS officials lengthy letters elaborating on the concerns. HRG and AMSA strongly urged ACGME "to immediately rescind the organization's waivers of most of its 2011 duty-hour standards for internal medicine and general surgery training programs randomly assigned to the experimental groups" in one ongoing trial and one recently completed trial. The final substantive paragraph of the HRG/AMSA letter reads:
In closing, it is imperative that the ACGME immediately rescind the waivers of most of its 2011 duty-hour standards for the internal medicine and general surgery residency training programs randomly assigned to the experimental groups in the [two trials]. Furthermore, in light of all the concerns highlighted above and in our letters to [DHHS], an independent body needs to investigate the process that allowed these inappropriate waivers to be granted in the first place, in the face of the strong evidence of resident and patient harm that caused ACGME to issue the duty-hour standards in 2011.
On December 7, 2015, ACGME sent a nine-paragraph letter to HRG and AMSA. The first two and last two paragraphs of the letter read:
This letter is in response to your November 19, 2015 correspondence regarding the [two] trials. The [ACGME] is committed to ongoing assessments of our requirements based on the most up-to-date evidence to foster a safe learning environment serving the best interests of patients, residents, and fellows.
The ACGME's support of the two large, multicenter clinical trials to investigate the impact of duty hour standards on patient safety and resident education will be elements of the ACGME's scheduled five-year review of whether the Institutional and Program Requirements are achieving their intended goals to foster a safe learning environment.
The ACGME was not involved in the design and implementation of the [two] trials beyond the waiver requirements, and will not be involved in the interpretation of their results. Nevertheless, the ACGME understands that both duty hour study protocols were reviewed by the Institutional Review Board (IRB) of the institution affiliated with each principal investigator. The ACGME also understands that the [second] trial was funded by the National Institutes of Health (NIH).
The ACGME is committed to the highest quality of patient care and resident/fellow learning. Wherever possible, the ACGME will continue to support and facilitate well designed, IRB-reviewed, multicenter educational trials with aims to scientifically test elements of the educational process that have the potential to enhance the quality and effectiveness of graduate medical education programs, and the safety and quality of care rendered to our patients today, and tomorrow.
HRG/AMSA Follow-up Letter to DHHS
On February 11, 2016, HRG and AMSA sent a ten-page follow-up letter to DHHS. The final substantive paragraph of the letter reads:
Finally, we are troubled by [the DHHS] failure so far to take these requested actions. It has now been 12 weeks since our initial complaint letter was submitted to your office. Resident and unwitting patient subjects continue to be forced to participate in greater-than-minimal-risk research without their voluntary informed consent. Your continued inaction makes [DHHS] a culpable party in this unethical research.
General Observations
A combination of three aspects of the scandal prompted me to write about it. First, it is outrageous that residents and patients included in the trials are not given an opportunity to provide voluntary informed consent to their inclusion in the trials. Carrying out such trials without the voluntary informed consent of the residents and patients violates fundamental rules governing the use of human subjects in research.

Second, what purported to be a response from ACGME was not a response. ACGME merely brushed off the serious concerns expressed by HRG and AMSA.

Third, the absence of major media coverage of the scandal is disappointing. The story warrants prominent coverage by outlets such as The New York Times, The Wall Street Journal, The Washington Post, Bloomberg News, and the major television networks.

Available Material
I am making available a complimentary 20-page PDF consisting of the HRG press release (it contains links providing access to other documents, such as the lengthy HRG/AMSA letters to DHHS officials and the lists of the many hospitals engaged in the trials), the HRG/AMSA letter to ACGME, the ACGME purported response to HRG/AMSA, and the HRG/AMSA follow-up letter to DHHS officials. Email and ask for the HRG/AMSA March 2016 package.

Blogger's Notes
Readers of this blog and my other writings may think this post is outside my areas of interest. They are right. However, I was so outraged by the scandal HRG has exposed that I decided to write about it anyway.

Also, in the interest of full disclosure, I am deeply indebted to Public Citizen Litigation Group (PCLG), another unit of Public Citizen. PCLG represented me on a pro bono basis several times over the years. Three important examples of PCLG's work on my behalf are discussed in chapters 5, 7, and 23 of my 2015 book, The Insurance Forum: A Memoir. The book is available from Amazon. It is also available from us; ordering instructions are on our website at, and I will autograph it upon request.