Endocrine Ethics Blog

This month, everyone has started talking about the “declaration” of Helsinki — surprising remarks made on July 16, 2018 by President Trump at his recent historic summit in Helsinki. But before this month, the only professionals who talked frequently about the Declaration of Helsinki, were those involved in biomedical research. That’s because the Declaration of Helsinki refers to the World Medical Association’s ethics guidelines for medical research with human subjects, originally published in 1964 (See: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/). It is this document that established the need for Institutional/Ethical Review Boards (in its 1975 revision) for research protocol oversight. It’s been revised several times since 1975.

Prior to the Declaration of Helsinki, the only other guiding international document for research ethics with human subjects was the Nuremberg Code, created in 1947 (See: https://history.nih.gov/research/downloads/nuremberg.pdf).

The Declaration of Helsinki largely echoed the Nuremberg Code, but helped to define distinctions between therapeutic and nontherapeutic clinical research. It was first announced on July 18, 1964 in the British Medical Journal, and just had its 54^thbirthday this month.

On July 16, 2018 – yes, the same day as that Helsinki summit — another shocking event took place in the U.S. that should concern the World Medical Association. The U.S. Department of Health and Human Services eliminated years of medical knowledge by removing a critical website that housed hundreds of clinical practice guidelines. (See: https://www.msn.com/en-us/news/us/hhs-plans-to-delete-20-years-of-critical-medical-guidelines-next-week/ar-AAzXUJC?ocid=se).  That means all of the clinical practice guidelines you rely on, and used to be able to get at the URL www.ahrq.gov/gam are now gone. Many of the guidelines published by the Endocrine Society or the American Thyroid Association –  intended for a range of primary care practitioners or other specialists — are no longer readily available through the National Guideline Clearinghouse, known for housing bias-free clinical practice guidelines. The National Guideline clearinghouse was created in the 1990s to help ensure that evidence-based medicine was more accessible to the practitioner. The clearinghouse practice guidelines database was maintained by the Agency for Healthcare Research and Quality (AHRQ), on its “Guidelines and Measures” site. Now when you go there, you’ll get the sad message: “Funding to support AHRQ’s National Guideline Clearinghouse (NGC) ended on July 16, 2018.”

The New York Times had this to say:

“The sheer volume of medical information now within a few clicks’ reach can make it difficult, even for doctors, to separate wheat from chaff. Clinical guidelines based on careful consideration and solid impartial research can be difficult to tell apart from those based on weak data, or rooted in a clear conflict of interest (usually a financial stake in whatever treatment they are promoting). The clearinghouse, which not only vets countless sources of medical information but also makes its results easily searchable, is regarded as the most dependable repository of its kind in the world… On [July 16, 2018], the Department of Health and Human Services took it offline, the latest casualty in an administration determined to eliminate science from the government’s agenda….The official explanation is maddening enough: a budget shortfall that roughly equals the amount Tom Price  spent on travel during his brief tenure as department secretary. The site costs just $1.2 million a year to operate, and is maintained by an agency with a budget of more than $300 million. (See:https://www.nytimes.com/2018/07/19/opinion/trump-medicine-data-hhs-ahrq.html)

The World Medical Association’s Declaration of Helsinki was groundbreaking in 1964. It would be a natural extension of this body to take up the task of housing not just the U.S. database of clinical practice guidelines discarded this month by the Trump Administration, but the world’s medical association guidelines so that they are never again vulnerable to the whims of politicians.

January, 2017 has been arguably one of the most chaotic months in the democratic history of the United States, with many Americans wondering if the country has devolved into an autocracy or dictatorship. Anyone trying to keep up with the news has probably become exhausted. There are many issues that have begun to dominate the science news, including a Scientists’ March on Washington. But that’s the not the subject for this month’s blog. Instead, it is the Executive Order issued January 27^th, which is the travel ban on 7 Muslim-majority countries (the word “ban” is the President’s words), which affected even permanent residents of the U.S. (something that is currently being potentially corrected or evaluated on a “case by case” basis), as well as people who have dual citizenship in one of the banned countries as well as another country, such as Canada. The ban has had immediate and dire ramifications for the scientific and medical communities. Several universities have issued statements, and in a rare instance, The Endocrine Society has now weighed in. Here is the official Press Release:

https://www.endocrine.org/news-room/current-press-releases/endocrine-society-responds-to-trumps-executive-order-on-immigration

In individual letters sent to members, it made these statements (bold added for emphasis):

“We are currently working with the broader research and medical communities on supporting legal efforts to overturn the order… [And] we have already heard concerns from colleagues in targeted countries about missing ENDO this spring. We also recognize that as a result of this order there are physicians and scientists training in the US who are now unsure of their status and patients from targeted countries blocked from participating in studies.”

There are clearly research and clinical ethical consequences to such orders from President Trump that were likely not considered, which may violate basic bioethics principles.

But the travel ban has had an unprecedented detrimental global impact on the U.S.’ relationships with other countries. Notwithstanding harsh criticism from various European countries, Britain, as well as Iran and Iraq, the President of the European Union made the statement today that the U.S. is now being considered a global threat to Europe on par with Russia. See: http://www.cnn.com/2017/01/31/politics/european-union-trump/

When the Acting Attorney General of the United States, Sally Yates, declared that she could not defend this travel ban in court because she was not convinced it was lawful, she was demonstrating moral courage. (See: https://www.nytimes.com/interactive/2017/01/30/us/document-Letter-From-Sally-Yates.html?_r=0). As is sometimes the case when speaking out against something that compromises professional and moral integrity, she was fired and called a “betrayer” by the White House. (See: https://www.nytimes.com/2017/01/30/us/politics/trump-immigration-ban-memo.html). Such an action recalled the “Saturday Night Massacre” of the Watergate era when former President Nixon fired then Attorney General, Elliot Richardson and his Deputy Attorney General for refusing to fire Archibald Cox, the Independent Prosecutor investigating the President.

All Endocrine Society Members should applaud the Endocrine Society’s moral courage in speaking out on this ethically and legally problematic ban. Future Society meetings may be best held in Canada, which has spoken out against the ban and can offer a safe travel situation for all Endocrine Society Members. (See: http://www.theglobeandmail.com/news/world/us-politics/trumps-travel-ban-on-citizens-from-muslim-majority-countries-causes-anger-chaos-in-us-andabroad/article33818462/).

The history of science and medicine is filled with refugee scientists’ accomplishments. What would have happened had we banned Albert Einstein from entering the U.S. in 1933, prior to the infamous and unfortunate banning of Jewish refugees who tried to flee later (See: https://www.theatlantic.com/politics/archive/2017/01/jewish-refugees-in-the-us/514742/)? Who knows what scientific discovery was on the ship we turned away, and how much science was lost to the ashes of the Holocaust? It is all the more ironic that this new Executive Order was signed on Holocaust Memorial Day. It’s worth noting that the influx of Jewish refugees who did get into the United States led to a 31% increase in patents. (See: http://news.stanford.edu/news/2014/august/german-jewish-inventors-081114.html)

Academics around the country have initiated petitions about this travel ban, such as this one: https://notoimmigrationban.com . We do not yet know the complete toll this ban has had on the academic medical community or patients. Stay tuned.