“Sell You Everything” – Buzzcocks

Goop, the lifestyle company owned by Gwyneth Paltrow that started as a newsletter in 2008, is valued at over $250 million today. Goop sells a variety of items including the $85 Goop Medicine Bag for healing and balancing the chakra system (¯\_(ツ)_/¯) and a $66 rock called the jade egg which should be placed into your vagina for hours at a time to improve your sex life, balance your menstrual cycle, and “intensify feminine energy.”

Why are people taken in by pseudoscience and the accompanying “scientific” jargon that gives a false impression that claims are backed by laboratory research and facts? Why have scientists like me gone from being viewed as god-like, having put mankind on the moon, to nimrods who’re in the pocket of big pharma? And most of all, how is it that I had not heard of Timothy Caulfield before the 2018 Advancing Ethical Research Conference (AER18)?

Caulfield, a keynote speaker at AER18, is the author of The Cure for Everything: Untangling the Twisted Messages about Health, Fitness and Happiness (Penguin 2012) and Is Gwyneth Paltrow Wrong About Everything?: When Celebrity Culture and Science Clash (Penguin 2015) as well as the host and co-producer of the Netflix television show, A User’s Guide to Cheating Death, a documentary series that provides information on dubious techniques that are being used by people to improve their health, and the doctors and businesses, like Goop, that are thrilled to take their money. Disappointingly, Ms. Paltrow is currently in talks with the same network to host a show focusing on wellness and homeopathic traditions—and this leads me to another question: why has it become acceptable to give equal air time to both scientific experts and individuals with marginal, contradictory opinions?

“We’ve Got a Bigger Problem Now” – Dead Kennedys

I think it all comes down to an issue of critical thinking. Critical thinking has been roughly defined as: “Disciplined thinking that is clear, rational, open-minded, and informed by evidence.” And, to an extent, I think this concept has broken down in practice in recent years. The average person receives vast amounts of information on a daily basis, from sources of varying credibility, and it seems sometimes that crucial step of critical analysis is missing—which, in some cases, can be very detrimental.

One of the best examples of how an inability to critically analyze data leads to significant healthcare concerns surrounds the advocacy for and tolerance of the anti-vaxxer agenda. The 1998 publication of a fraudulent research paper by Andrew Wakefield linked autism spectrum disorders to the MMR vaccine. Sadly, “PhDs” from the University of Google—people with no real understanding of or interest in the science of vaccination and herd immunity—continue to stress this unproven link and advocate for forgoing vaccination. This has led to outbreaks and exposures in areas with decreased vaccination rates. Fourteen years after the eradication of measles in the United States, almost 700 cases of the disease were reported in 2014! A remarkable increase compared to the 50 cases diagnosed in 2012.

“Now Is the Time” – Black Flag

As ethics-minded research administration and oversight personnel, critical thinking about issues in clinical research is a skill that we use almost daily; yet, it is not taught or assessed in education programs for health professionals.

In a clinical setting, personnel need to consider diagnoses, diagnostic tests, inclusion/exclusion criteria, what adverse events to anticipate, and how to communicate with a subject, their family, or other healthcare personnel. In an IRB setting, critical thinking skills are applied every day with every review. Is the described study research? Is the study exempt? What level of review is necessary? Is subject selection equitable? Are potential risks minimized and benefits maximized? Does the consent process minimize the possibility of coercion or undue influence?

Meanwhile, with the rise of pseudoscientific beliefs there’s also been a rise in IRB reviews of scientifically dubious clinical studies. Will 100 supplements cure Alzheimer’s Disease? Will chiropractic care effectively treat a concussion? Will fresh plasma from young healthy donors enhance immune responses in elderly individuals?

It might be easiest to just discount some of these questions/studies as purely absurd. But the use of our best critical thinking skills often leads us to a familiar answer for IRB professionals: “it depends.” When the answer is “it depends”, collaboration with colleagues is essential to ensure that research review is thorough, regulations are applied appropriately, and medical review is been comprehensive. I think we, therefore, need to do better to build pathways for connecting with each other and facilitating collaboration to discuss and answer these questions, and to support each other. As a PRIM&R member and an employee of a small AAHRPP accredited IRB, I am shocked at how difficult it still is to connect and share with other IRB professionals; I’ve had a difficult time logging into the IRB Forum or getting advice though LinkedIn.

So, to answer Caulfield’s book title, yes, Gwyneth Paltrow is wrong about everything. But, what can we do as research professionals to encourage a conscious uncoupling of disinformation from established scientific fact? I think a good first step is for us to collaborate and share information as much as possible.

So, to that end, what are your favorite online resources or professional networking forums? And what have you learned from your peers at the AER Conference and similar events? Comment below.

Gretchen Parker, PhD, RAC, CIP, serves as co-chair for Pearl IRB and provides regulatory and clinical research support services for clients. Throughout her career, she has been deeply involved in regulatory affairs, clinical research, and medical writing for the pharmaceutical and medical device industries.  She led the AAHRPP accreditation efforts at Pearl IRB and has assisted FDA inspectors on site. She is currently leading the efforts to update Pearl IRB institutional policies and procedures to comply with the revised Common Rule.

Dr. Parker began her career as a Regulatory and Compliance Analyst at a consulting firm, where she worked with clients, ranging from biotech start-ups to Fortune 500 companies, to plan and implement regulatory strategies, submissions, and research protocols.  Her duties engaged her with several US governmental agencies, including FDA, USDA and EPA.

Dr. Parker received a PhD in Molecular Endocrinology and Biochemistry from Purdue University, and completed her Post-Doctoral Fellowship in Biochemistry and Molecular Biology at the Indiana University School of Medicine Center for Diabetes Research.  She has authored and published dozens of scientific articles in major peer-reviewed journals, holds a patent for a diagnostic assay, and is a member of PRIM&R. She is Regulatory Affairs Certified (RAC) and a Certified IRB Professional (CIP).

Members of PRIM&R’s Blog Squad and other guest contributors are valued members of our community willing to share their insights. The views expressed in their posts do not necessarily reflect those of PRIM&R or its employees.

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PRIM&R’s next AER Conference (AER19) takes place November 18-20, 2019 in Boston, MA; you also have the option attend either the AER19 Preconference Programs or our biennial SBER Conference on November 17.  Visit primr.org/boston19 to explore this year’s conference agendas and register!