About this blog

CRIT is no longer adding posts or updating the CRITical Thinking blog.

CRITical Thinking is a blog written by staff, directors, and friends of the Collaboration for Research Integrity and Transparency (CRIT), a joint program of Yale Law School, Yale School of Public Health, and Yale School of Medicine. CRIT's mission is to promote health by improving the integrity and transparency of biomedical and clinical research.

This blog is published by and reflects the personal views of the individual authors, in their individual capacities. It does not purport to represent Yale University's institutional views, if any. No representation is made about the accuracy of the information, which solely constitutes the authors’ personal views on issues discussed. The information contained in this blog is provided only as general information and personal opinions, and blog topics may be updated after being initially posted.

 

CRITical Thinking Blog

Regulators Must Act In The Public Interest When Considering Real World Evidence: Examples from TB and HIV Treatments

October 16, 2017
By Marcus Low, Catherine Tomlinson

In general, fears about the potential harms of weakening evidentiary requirements through developments such as the 21st Century Cures Act in the US and so-called adaptive pathways in the EU, are warranted. These legal and regulatory changes increase the likelihood that the public will be exposed to unsafe and/or ineffective medicines. Unfortunately, the deregulation debate is more complicated than this, as shown by three examples relating to tuberculosis (TB) and HIV medicines, which highlight the need for regulatory approaches that allow for consideration of real world evidence when potential benefits outweigh harms.

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What Does a Pro-Patient, Pro-Public Health Regulatory Agency Look Like?

September 13, 2017
By Michael Carome

A pro-patient, pro-public health agenda for the regulation of medical products should, among other things: (a) ensure that these products are safe and effective for their intended uses; (b) maximize transparency regarding regulatory actions and the data used to support those actions; (c) spur the development of new treatments that truly meet the health needs of patients throughout the world; (d) minimize both industry bias in the development of medical products and industry influence on prescribing practices; and (e) ensure that medical products are affordable for all patients who need them and for society.

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Federal “Right to Try” Legislation – perpetuating a misguided skepticism towards the FDA

September 8, 2017
By Jeanie Kim

The “right to try” (RTT) movement presents a narrative that pits patients against the FDA. Supporters of RTT, powered by the libertarian Goldwater Institute, have pushed for laws that let terminally ill patients bypass regulators to access unapproved treatments.

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What is the State of the Evidence Base for Medical Products We Use Currently?

August 24, 2017
By Tom Jefferson

In June 2017, Yale CRIT hosted an international conference titled “Ensuring Safety, Efficacy, and Access to Medical Products in the Age of Global Deregulation.” The following blogpost is the third installment of a blog series with commentaries from the conference participants.

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