Out, out, brief candle! Life's but a walking shadow, a poor player That struts and frets his hour upon the stage And then is heard no more; it is a tale Told by an idiot, full of sound and fury, Signifying nothing.--Macbeth by Shakespeare
As similar drugs hit the market, the pundits race to see where the profits are likely to be highest. Case in point look no further then immuno-oncology drugs or other categories within personalized medicine.
"For now, sales are a useful metric fo starting and staying on a checkpoint (Inhibitor)"
I would argue that patient outcomes like "overall survival" will be the metric that delivers. We struggle to reconcile patient centered care with the aggregated data that leads to FDA approval. But meanwhile, premature media hype of early phase prognostic factors and clever pre-launch hype have become the harbors of safety investors have in the crosshairs.
My shareholders expect me to make the most profit. That's the ugly, dirty truth.--Martin Shkreli
I recognize discussion topics from the first pass on what loads on page 1 of an online search. What I don't hear is the granular discussions from well-designed trials that add a depth to pre-clinical decisions or moiety designs.
Attempts to vilify the pharmaceutical industry without transparency of health law, policy, and economics underlying the framework continue to be short sighted. In our big data lives, there are now infinite data libraries and resources for query and analyses. Was it Martin Luther King that warned us all, "Nothing in the world is more dangerous than a sincere ignorance and conscientious stupidity"?
The Southeastern Association of Law Schools 2018 conference featured a session on health law:
WORKSHOP ON HEALTH LAW
Healthcare in the Era of the Trump Administration
The 2016 election has already ushered forth dramatic changes to our healthcare system, in efforts to repeal and replace the Affordable Care Act, in deregulation, in executive orders that alter the effects of the ACA, and in numerous other ways. This panel will focus on the state of healthcare in America in the era of the Trump presidency. What are the enduring effects of the Trump presidency on the state of healthcare delivery and healthcare finance (both in private and public insurance programs) now and into the future?
Moderator: Professor Deborah Farringer, Belmont University College of Law
Speakers: Professor Jennifer Bard, University of Cincinnati College of Law; Professor Zack Buck, The University of Tennessee College of Law; Professor Nicole Huberfeld, Boston University School of Law; Professor Nicolas P. Terry, Indiana University, Robert H. McKinney School of Law
I recommend listening to This Week in Health Law podcast if you want to access a wide variety of legal scholar discussions outside of the typical journalistic soundbites and tantalizing ledes. These are a few of the graphics from the event. The broad discussions include the role of trade tariffs on the cost of medical equipment, the fight against global guidelines on livestock antibiotics, suggested bans on CDC employees using words like "evidence-based, science-based, vulnerable, entitlement, diversity, transgender, and fetus", the phrase "climate change", sexual discrimination and Title VII protections, use "religious liberty" to deny medical care, and on and on...
Harvard scientists say current and proposed environmental policies could lead to an extra 80,000 deaths per decade. Think of losing the entire audience from the MetLife Dome --where the New York Giants and Jets play--every decade because of changes in policies that impact our clean air and water. Requiring raw data from landmark cases to be released to the public or risk overturning of established science.
time to get our hands dirty...
Find more data--not just the data that supports our objectives, bottom line, or shareholder interests.