worth sharing

Samuel, Rana Rana.Samuel at VA.GOV
Tue Aug 13 17:50:27 UTC 2019

2 articles that I received through 2 separate newsfeeds this week:

1) This article won an award for excellence in healthcare journalism. It is well worth the read:

                Reporter Heidi Ledford wrote this November story about how social media and patient-advisory groups have given clinical-trial participants unprecedented   power in how experiments are run<https://nature.us17.list-manage.com/track/click?u=2c6057c528fdc6f73fa196d9d&id=036dcb8393&e=d97fc80a84> - sometimes threatening the integrity of the research. <https://nature.us17.list-manage.com/track/click?u=2c6057c528fdc6f73fa196d9d&id=b06829f662&e=d97fc80a84> (17 min read<https://nature.us17.list-manage.com/track/click?u=2c6057c528fdc6f73fa196d9d&id=8b59ddb254&e=d97fc80a84>)

2)           Undisclosed financial conflicts of interest among authors of American ...<%20%20%20%20%20%20%20%20%20Undisclosed%20financial%20conflicts%20of%20interest%20among%20authors%20of%20American%20...%0dhttps:/onlinelibrary.wiley.com/doi/pdf/10.1002/cncr.32408%0d>

Buried in the first (clinical trials and social media) article I found the following:

"An evaluation of 30 patient advisory boards found that many were making recommendations about the convenience and feasibility of study visits, and the schedule of procedures performed (A. Anderson and K. A. Getz Ther. Innov. Regul. Sci. 52, 469-473; 2018<https://doi.org/10.1177/2168479017720475>). The advisory boards have good cause to push back. Getz says that as many as one-third of procedures - such as blood tests or biopsies - performed during clinical trials are not crucial to the applications for drug approval." (highlighting added my me).

I have personal experience of this as well, and have reached out to have a lab test removed from a study protocol (evaluating post-operative rates of Myocardial Infarction under 2 different study conditions) because it was a redundant test (CK-MB) that provided no additional information over another test (Cardiac Troponin) that was (appropriately) included in the test protocol. Doing the CK-MB would have added cost to the study but provided no benefit, and may have resulted in harm, if the results conflicted with the Troponin results..

                2.  The second may help to explain the variability and lack of consistency among guidelines, supposedly all evidence based, that address the same topic (eg: 'blood transfusion' or 'Cervical cancer screening').

Q for this group (improved Dx): I think of clinical trials and guideline development as highly scrutinized activities. If unnecessary tests are common in clinical trials, and safeguards against bias are flouted or watered down in groups developing guidelines, how can we expect to prevent unnecessary tests and bias at the (relatively unscrutinized) individual practitioner level?

Rana Samuel, MD, FCAP
Chief, Pathology and Laboratory Medicine Service (PALMS, 113)
Medical Review Officer, Federal Drug Free Workplace Program (DFWP)
VA western New York Healthcare System (VAWNYHS)
3495 Bailey Avenue, Buffalo, NY 14215

Lead pathologist - VISN 2
Regional Commissioner, Region 2, National Enforcement Office

Ph:    716-862-8701
Fax:  716-862-7824
Rana.samuel at va.gov

Moderator: David Meyers, Board Member, Society to Improve Diagnosis in Medicine

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