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 54thbirthday 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.