014. Regulation

A discussion about the maze and the pathway

  1. What is the mandate of our current medical enterprise?

  2. What should the role of the (federal) government be with regards to your personal health?

  3. A classic example of a consequence of the FDA’s slow regulatory process was its delay in allowing beta-blockers to be prescribed in America. In 1965, beta-blockers (specifically, propranolol), were approved for use in the treatment of cardiovascular disease in Europe. The FDA would wait until 1978 to approve the same drugs for the same treatment. To what extent is the FDA culpable in the preventable deaths that occur between 1965-1978? What consequences should there be for regulatory bodies that “fail to do their job”?

  4. What are some differences seen in and between various regulatory environments? For example, how does the United States and European regulatory markets differ? Which do you prefer? Why?

  5. When does the “randomness” necessary for good experimental trials pose sufficient probably harm to a subject as to be dangerous? How should regulatory bodies approach these two necessary but often conflicting factors?

  6. In May 2014 Colorado became the first state to pass “right-to-try laws” – state laws that allow terminally ill patients to try experimental therapies (drugs, devices, biologics, etc.) that have completed Phase 1 testing, but have not been approved by the FDA. As of March 2018, 39 states have enacted such laws. Why do you think there has been such an uptick in this kind of legislation?

  7. Right-to-try laws have been criticized as exploiting the vulnerable and have been heralded as a pinnacle of biomedical liberty. Where do you think the balance lies?

  8. What do you make of the first case of thalidomide embryopathy being a girl born Christmas day of 1956? Are there legitimate omens in this world?

  9. An aside: To what degree are we congenitally predestined? [Re: “Tim’s disability has never prevented him from achieving his goals. His profession as a Genetics Counsellor at McMaster University Medical Centre is close to his heart. Here, he helps families dealing with congenital anomalies and genetic disorders.”]

  10. Why should activities in medical environments be regulated? Who should do such regulated? How should they wield such powers / bear such responsibilities?


Essays of possible interest

  1. Thalidomide retrospective: what did we learn?
  2. Improving medical device regulation: the United States and Europe in perspective
  3. Ethics, regulation, and comparative effectiveness research