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.

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Work Locally, Coordinate Globally

February 22, 2018

By Joel Lexchin

I think that there are a number of problems that are common in all parts of the world. Among these are: the political and economic power of the pharmaceutical industry, the way that intellectual property rights interfere with access and affordability of medicines, the poor evidentiary base for the safety and effectiveness of many medicines and the increasing ties between regulators and industry, that result in the weakening of regulatory standards.

What Would a Pro-Patient, Pro-Public Health Regulatory System Look Like?

February 13, 2018

By Els Torreele

While we get many new products we don't need, major public health needs remain unmet.

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.

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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