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Ep. 70 Industry-Sponsored Clinical Trials: An Insider’s View

Milton Packer, MD

Mention the phrase “industry-sponsored clinical trial” and many eyes will immediately roll back.  But is the reaction justified?  Are academic leaders who participate in phase 3 trials simply figureheads hired to rubber-stamp protocols designed by Pharma and spin the results in a positive way?

Our guest on this show has strong opinions on this question.  Dr. Milton Packer is an internationally recognized clinician, teacher, and scientist in the field of heart failure research.  He has served as Chief of Cardiology at Columbia University in New York City and, subsequently, as Chair of the Department of Clinical Science at the Southwestern Medical School in Dallas.  He is currently the Distinguished Scholar in Cardiovascular Science at Baylor University Medical Center.

Dr. Packer has received many teaching awards, mentored dozens of young clinical investigators, completed innumerable successful research projects, and served as a leader in many professional organizations.  He is now also well known and admired for his regular column on MedPage Today, “Revolution and Revelation,” in which he mixes wisdom and polemics to the delight of his many readers.

GUEST:

Milton Packer, MD. Professional web page

LINKS:

Milton Packer. Exactly What Does a Principal Investigator of a Clinical Trial Do? (on MedPage Today)

2 Comments

  1. David on 03/21/2019 at 2:43 AM

    Loved this episode. Good to hear the other side of the argument about drug company funding academic researchers to run their trials. One question though: when he talks about his “consulting fees” basically being his payment for doing the work to run the trial, isn’t he also being paid a full academic cardiologist’s salary on top of those fees? If I get an NIH grant so I can run a trial, the grant pays part of my academic salary, it’s not an extra bonus on top of an otherwise fully funded salary…

    I wish Michel had pushed a little harder on the real concerns people have with pharma funded trials: Packer focuses on criticisms that people call pharma trials corrupt or falsified. I don’t think that’s the issue most people have. Clearly that’s wrong and should be seen as criminal activity. I don’t doubt the integrity of Packer to stick to a trial protocol and publish the data, whether positive or negative. The bigger problem is design of trials with straw man comparators (see less than max dose enalapril), not-clinically-important endpoints (see “decrease in BNP”), and non-inferiority designs for drugs that cost a lot more.

    • Michel Accad on 03/26/2019 at 11:16 PM

      Thank you, David. Yes, I suspect consulting fees with industry supplement an academic’s salary, unlike grants, but I have no problem with that if the company that pays him is happy with the work he does and if the academic center that hires him is happy with the academic work he does. Also, he made it clear that he wasn’t talking about the clinical research with the problems that you’ve described. Perhaps we’ll address that on another episode. Michel

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