a pill in place of a model globe

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet SarpatwariBeatrice Brown, Neeraj Patel, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of August. The selections feature topics ranging from a commentary on the need for rigorous scientific evaluation of COVID-19 vaccine candidates in the face of political and economic pressures, to an evaluation of patients’ and pharmacists’ experiences with pill appearance changes, to an examination of the extent and cost of potentially inappropriate prescription drug prescriptions for older adults. A full posting of abstracts/summaries of these articles may be found on our website.

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Woman surfing.

#MedBikini and Social Media Peer Review

By Louise P. King

Recently, #MedTwitter was awash with pictures of medical professionals in bikinis as a unique and effective protest to a flawed, and now retracted, journal article.

Those posting objected to the methods used and implicit bias contained in a recently published article in the Journal of Vascular Surgery. The authors replicated the methods and conclusions of a prior 2014 study, which did not garner the same attention at the time.

In both studies, various authors from different branches of surgery created fake accounts on social media and then used Accreditation Council for Graduate Medical Education (ACGME) lists of residents to scrutinize their public profiles for evidence of “unprofessional” conduct. Each of these studies was presented at a national meeting.

But having men create fake accounts to then secretly monitor residents’ social media profiles for what they personally find objectionable is not scientifically rigorous, and itself represents unprofessional behavior.

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a covid 19 swab test being inserted into a vile

Maintaining Healthy Skepticism About Reported COVID-19 Findings

By Andy Podgurski and Sharona Hoffman

The COVID-19 pandemic presents special challenges to even well-informed and well-intentioned promulgators and consumers of medical research findings, including the legal community.

The stakes in the debate about handling the pandemic are extremely high in terms of lives, jobs, wealth, and political power. In addition, there are tremendous opportunities for researchers to receive attention and notoriety for influencing the debate.

All this means that perverse incentives exist to publicize initial scientific findings that are dubious, poorly vetted, and possibly dangerous to public welfare. The risk of promulgating false or misleading scientific claims is substantial, even when they are made by well-respected scientists affiliated with prestigious institutions. Government authorities must be extremely cautious about basing public policy decisions on inadequately vetted findings, no matter how much hype they get.

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Good news for many South African HIV patients—with a big glitch

On Wednesday, South African Health Minister Aaron Motsoaledi announced that, as of January 2015, HIV-positive patients in the country would start receiving free antiretroviral treatment once their CD4 count fell below 500, instead of current threshold of less than 350. Some patient groups would start receiving antiretrovirals immediately upon being diagnosed with HIV infection, regardless of their clinical stage.

Last month, Till Bärnighausen, Dan Wikler and I predicted in PLoS Medicine that sub-Saharan nations would move in the direction that South Africa is now moving, and pointed out a big complication. This policy change might make several gigantic trials of so-called treatment-as-prevention in sub-Saharan Africa impossible to complete successfully. As we explained, these trials remain important for assessing the potential of treatment-as-prevention to curb the spread of HIV in general populations (with many different relationship types and different levels of care delivery and support).

In treatment-as-prevention, antiretrovirals are offered to patients immediately upon their diagnosis with HIV. The hope is that very early treatment would be better for these patients and prevent them from infecting others. We also offered some ways out of this mess, but they involve untraditional approaches to research conduct and to policy. Our piece was featured in the June issue of UNAIDS’ HIV This Month.

Legal Scales: An Empirical Methods Question

By Scott Burris

The most important topic we did NOT address in our PHLR methods book was valid methods for rating laws for characteristics like “stringency.”  I am not aware of any general work on this.  Nonetheless, it is not uncommon for researchers to create scales purporting to measure the distribution of some characteristic(s) over a group of laws. It seems often to be done by some facially plausible means (e.g., penalties) or through a Delphi or similar expert process.  For example, Woodruff and colleagues1 developed a stringency scale for tanning laws that distributes characteristics of laws (age covered, standards for eye protection) on 2-5 point scales based on a priori judgments.  Chriqui and colleagues used an expert advisory committee to rate the strength of clean indoor air laws.2 For alcohol control policies, Nelson et al used a Delphi method.3  As a field, however, I can’t see that we have much consensus on how to create and validate such scales. So to start a discussion, some thoughts on a basic typology of scales, with some possible measures and examples off the top of my head:

 

Approach Possible Measures Examples
Assessment based on apparent features of the legal text Magnitude of penalty Fine; imprisonment
Comprehensiveness of coverage of categories of actors engaged in the regulated activity Distracted driving: all drivers, novice drivers, bus drivers
Comprehensiveness of coverage of specific behaviors constituting or relating to the regulated activity Distracted driving: all device use; manual use; texting
Procedural efficiency Number of distinct steps required to enforce or comply with law
Legal assessments Consistency with other requirements (constitutionality or preemption, for example)
Qualitative assessments “Clarity” or “specificity” of rule
Assessment based on evidence, expert knowledge or prediction of the implementation of the law by legal agents Incentives for enforcement Resources, required reporting of enforcement actions/outcomes
Social marketing investment MADD social marketing against drunk driving
“Technical” feasibility of enforcement Consistency with mechanisms/methods already in use, cost, procedural complexity
“Social” feasibility of enforcement Normative consistency with current practices or values,* political constraints
“Legal” feasibility of enforcement Probability of legal challenge, procedural complexity
Qualitative assessments “Clarity” or “specificity” of rule as perceived by enforcers
Assessment based on evidence, expert knowledge or prediction of the reaction to the law of regulated parties Likelihood that regulated parties will learn of the law Social marketing, publicity, high enforcement levels
Consistency with general theories of compliance Deterrence, legitimacy, procedural fairness, expected utility of compliance
Social support for compliance Consistency of required behavior with current norms*
Feasibility of compliance Availability of technology,
Qualitative assessments “Clarity” or “specificity” of rule as perceived by regulated parties
Hybrid methods

* The normativity of the required behavior or enforcement mechanism would not be a stable measure, since we would expect passage and enforcement of the law to change norms over time (e.g., drunk driving)

 

Has my admittedly quick search for methods guidance on this missed some good sources? How does this rough typology and examples strike you?  I’d be very happy to get some comments and suggestions.

 

1.            Woodruff SI, Pichon LC, Hoerster KD, Forster JL, Gilmer T, Mayer JA. Measuring the stringency of states’ indoor tanning regulations: Instrument development and outcomes. Journal of the American Academy of Dermatology. 2007;56(5):774-780.

2.            Chriqui JF, Frosh M, Brownson RC, et al. Application of a rating system to state clean indoor air laws (USA). Tob Control. Mar 2002;11(1):26-34.

3.            Nelson TF, Xuan Z, Babor TF, et al. Efficacy and the Strength of Evidence of U.S. Alcohol Control Policies. American Journal of Preventive Medicine. 2013;45(1):19-28.