Episode 46 - Pill of Sale

Drug prices, shortages, and barriers to access are out of control, prompting hospitals to join forces to make their own, and spurring the emergence of inventors hoping to chart a future in which life-saving drugs can be made cheaply at home. To lock in high prices, drugmakers have learned to game the American patent system to extend their monopolies, and block generic alternatives for essential medicines. Additionally, pharmaceutical companies have for years withheld data from important clinical trials, skewed the data that is published, and put the health and safety of clinical trial participants at risk. In this episode, we will examine these trends, as well as the historical quirks of drug approval in the United States that have led us down this sick path.

Full Transcript Available

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This is part two of a three part series on the American healthcare system:

  1. Episode 45 - Bill of Health
  2. Episode 46 - Pill of Sale
  3. Episode 47 - painKiller

Chapters

  • 01:51 Drug prices out of control
  • 08:08 Case story: Inhalers
  • 10:38 The process of drug approval
  • 14:41 American drug patent system and the games companies play
  • 20:23 Behind the scenes: clinical trial results manipulation
  • 22:06 Behind the scenes: clinical trial human guinea pigs
  • 27:58 Behind the scenes: clinical trial oversight
  • 31:21 Are drugmakers even making the medicines we need?
  • 36:24 The evils of socialized medicine
  • 38:10 Going forward: alternative systems

Recommended Reading

On the humans involved in clinical trial test:

An American Sickness by Elizabeth Rosenthal

Four Thieves Vinegar Collective

Webpage: fourthievesvinegar.org

Motherboard article, Meet the Anarchists Making Their Own Medicine

From the episode:


Corrections

@ [5:27], we said "CEO of valeant Martin shkreli also had another investment company that bought up an important generic antiparasite drug and then raise the price from just $13 to 750."

Correction offered by Fredex8:

A small correction:

Martin Shkreli was not the CEO of Valeant. He was the CEO of Turing Pharmaceuticals. At the time of this Valeant fuckery J. Michael Pearson was the CEO. Both of them hiked prices and exploited the system but Pearson was not held accountable besides being removed from the company.

I assume the mistake comes from the poorly worded headline that comes up first when searching for Martin Shkreli and Valeant:

Martin Shkreli, Valeant CEO face Congress - Business Insider


Sources

@misc{Abelson_2018a, title={Merger of Cigna and Express Scripts Gets Approval From Justice Dept.}, url={https://www.nytimes.com/2018/09/17/health/cigna-express-scripts-merger.html}, journal={The New York Times}, author={Abelson, Reed}, year={2018}, month={Sep} }

@misc{Abelson_2018b, title={CVS Health and Aetna $69 Billion Merger Is Approved With Conditions}, url={https://www.nytimes.com/2018/10/10/health/cvs-aetna-merger.html}, journal={The New York Times}, author={Abelson, Reed}, year={2018}, month={Oct} }

@misc{Abelson_Thomas_2018, title={Fed Up With Drug Companies, Hospitals Decide to Start Their Own}, url={https://www.nytimes.com/2018/01/18/health/drug-prices-hospitals.html}, journal={The New York Times}, author={Abelson, Reed and Thomas, Katie}, year={2018}, month={Jul} }

@misc{Alison Kodjak_2018, title={Hospitals Prepare To Launch Their Own Drug Company To Fight High Prices And Shortages}, url={https://www.npr.org/sections/health-shots/2018/09/06/644935958/hospitals-prepare-to-launch-their-own-drug-company-to-fight-high-prices-and-shor}, journal={NPR.org}, author={Alison Kodjak}, year={2018}, month={Sep} }

@misc{Aric Jenkins_2017, title={Mylan’s Massive Recall of Faulty EpiPens Spreads to the U.S.}, url={http://fortune.com/2017/04/01/mylan-epipen-us-recall/}, journal={Fortune}, author={Aric Jenkins}, year={2017}, month={Apr} }

@misc{CBC Radio_2018, title={Clinical drug trials: The strange world of human guinea pigs}, url={https://www.cbc.ca/radio/ondrugs/clinical-drug-trials-the-strange-world-of-human-guinea-pigs-1.4573983}, journal={CBC}, author={CBC Radio}, year={2018}, month={Mar} }

@article{Couzin-Frankel_2014, title={A lonely crusade}, volume={344}, ISSN={0036-8075, 1095-9203}, DOI={10.1126/science.344.6186.793}, number={6186}, journal={Science}, author={Couzin-Frankel, Jennifer}, year={2014}, month={May}, pages={793–797} }

@misc{DeNeen Brown_2017, title={‘You’ve got bad blood’: The horror of the Tuskegee syphilis experiment}, url={https://www.washingtonpost.com/news/retropolis/wp/2017/05/16/youve-got-bad-blood-the-horror-of-the-tuskegee-syphilis-experiment/}, journal={Washington Post}, author={DeNeen Brown}, year={2017}, month={May} }

@misc{Drugs dot com_2018a, title={Colcrys Prices, Coupons & Patient Assistance Programs}, url={https://www.drugs.com/price-guide/colcrys}, journal={Drugs.com}, author={Drugs dot com}, year={2018}, month={Oct} }

@misc{Drugs dot com_2018b, title={EpiPen 2-Pak Prices, Coupons & Patient Assistance Programs}, url={https://www.drugs.com/price-guide/epipen-2-pak}, journal={Drugs.com}, author={Drugs dot com}, year={2018}, month={Oct} }

@misc{Elliott_2007, title={Guinea-pigging}, url={https://www.newyorker.com/magazine/2008/01/07/guinea-pigging}, journal={The New Yorker}, author={Elliott, Carl}, year={2007}, month={Dec} }

@misc{Elliott_2014, title={Is Big Pharma Testing Your Meds on Homeless People?}, url={https://medium.com/matter/did-big-pharma-test-your-meds-on-homeless-people-a6d8d3fc7dfe}, journal={Medium}, author={Elliott, Carl}, year={2014}, month={Jul} }

@article{Elliott_2017, title={Institutional Pathology and the Death of Dan Markingson}, volume={24}, ISSN={0898-9621}, DOI={10.1080/08989621.2016.1246969}, number={2}, journal={Accountability in Research}, author={Elliott, Carl}, year={2017}, month={Feb}, pages={65–79} }

@article{Goldacre_2017, title={The WHO joint statement from funders on trials transparency}, volume={357}, ISSN={0959-8138, 1756-1833}, DOI={10.1136/bmj.j2816}, journal={BMJ}, author={Goldacre, Ben}, year={2017}, month={Jun}, pages={j2816} }

@misc{Hakim_2018, title={Humira’s Best-Selling Drug Formula: Start at a High Price. Go Higher.}, url={https://www.nytimes.com/2018/01/06/business/humira-drug-prices.html}, journal={The New York Times}, author={Hakim, Danny}, year={2018}, month={Jan} }

@book{Hari_2018, title={Lost Connections: Uncovering the Real Causes of Depression and the Unexpected Solutions}, ISBN={978-1-63286-832-9}, note={Google-Books-ID: dWAzDwAAQBAJ}, publisher={Bloomsbury Publishing USA}, author={Hari, Johann}, year={2018}, month={Jan} }

@misc{Harvard_2012, title={Carl Elliott - Exploiting Homeless Schizophrenic Subjects in Clinical Trials}, url={https://ethics.harvard.edu/exploiting-homeless-schizophrenic-subjects-clinical-trials}, journal={Harvard}, author={Harvard}, year={2012}, month={Mar} }

@misc{Jessa Crispin_2018, title={Beyond Goop and Evil | Jessa Crispin}, url={https://thebaffler.com/salvos/beyond-goop-and-evil-crispin}, journal={The Baffler}, author={Jessa Crispin}, year={2018}, month={Sep} }

@misc{Kevin Campbell_2018, title={Insulin Costs Are Skyrocketing. This Is Why.}, url={https://health.usnews.com/health-care/for-better/articles/2018-06-29/whats-behind-the-rising-costs-of-insulin}, journal={US News & World Report}, author={Kevin Campbell}, year={2018}, month={Jun} }

@misc{Kevin Drum_2013, title={Here’s why your asthma inhaler costs so damn much}, url={https://www.motherjones.com/kevin-drum/2013/10/heres-why-your-asthma-inhaler-costs-so-damn-much/}, journal={Mother Jones}, author={Kevin Drum}, year={2013}, month={Oct} }

@misc{Kim_2018, title={Goldman asks: “Is curing patients a sustainable business model?”}, url={https://www.cnbc.com/2018/04/11/goldman-asks-is-curing-patients-a-sustainable-business-model.html}, abstractNote={Goldman Sachs warns sales from the most successful disease treatments are difficult to maintain.}, journal={CNBC}, author={Kim, Tae}, year={2018}, month={Apr} }

@book{Kirsch_2010, title={The Emperor’s New Drugs: Exploding the Antidepressant Myth}, ISBN={978-0-465-02104-8}, url={https://books.google.com/books?id=wk-OxcTKyi4C&vq=twenty+seven&source=gbs_navlinks_s}, publisher={Basic Books}, author={Kirsch, Irving}, year={2010}, month={Jan} }

@misc{Lewis_2016, title={How I designed a “DIY” closed loop artificial pancreas}, url={https://diyps.org/2016/05/12/how-i-designed-a-diy-closed-loop-artificial-pancreas/}, journal={DIYPS.org}, author={Lewis, Dana}, year={2016}, month={May} }

@misc{Michael Smith_David Evans_2005, title={Miami Test Center Lures Poor Immigrants as Human Guinea Pigs}, url={https://www.bloomberg.com/news/articles/2005-11-02/drug-industry-human-testing-masks-death-injury-compliant-fda}, journal={Bloomberg}, author={Michael Smith and David Evans}, year={2005}, month={Nov} }

@misc{Oberhaus_2018, title={Meet the Anarchists Making Their Own Medicine}, url={https://motherboard.vice.com/en_us/article/43pngb/how-to-make-your-own-medicine-four-thieves-vinegar-collective}, journal={Motherboard}, author={Oberhaus, Daniel}, year={2018}, month={Jul} }

@misc{Peter Loftus_Denise Roland_2018, title={By Adding Patents, Drugmaker Keeps Cheaper Humira Copies Out of U.S.}, url={https://www.wsj.com/articles/biosimilar-humira-goes-on-sale-in-europe-widening-gap-with-u-s-1539687603}, journal={WSJ}, author={Peter Loftus and Denise Roland}, year={2018}, month={Oct} }

@misc{Pollack_2017, title={Drug Prices Soar, Prompting Calls for Justification}, url={https://www.nytimes.com/2015/07/23/business/drug-companies-pushed-from-far-and-wide-to-explain-high-prices.html}, journal={The New York Times}, author={Pollack, Andrew}, year={2017}, month={Dec} }

@misc{Pollack_Tavernise_2018, title={Valeant’s Drug Price Strategy Enriches It, but Infuriates Patients and Lawmakers}, url={https://www.nytimes.com/2015/10/05/business/valeants-drug-price-strategy-enriches-it-but-infuriates-patients-and-lawmakers.html}, journal={The New York Times}, author={Pollack, Andrew and Tavernise, Sabrina}, year={2018}, month={Jan} }

@misc{Rabin_2018, title={Consumers Struggle to Find EpiPens}, url={https://www.nytimes.com/2018/05/10/well/live/epipen-shortage-allergies.html}, journal={The New York Times}, author={Rabin, Roni Caryn}, year={2018}, month={May} }

@misc{Rae Ellen Bichell_2016, title={Professional “Guinea Pigs” Can Make A Living Testing Drugs}, url={https://www.npr.org/sections/health-shots/2016/05/08/476797735/professional-guinea-pigs-can-make-a-living-testing-drugs}, journal={NPR.org}, author={Rae Ellen Bichell}, year={2016}, month={May} }

@misc{Ragan_2018, title={Medicine Ignored This Insulin Problem. Hackers Solved It.}, url={https://medium.com/neodotlife/dana-lewis-open-aps-hack-artificial-pancreas-af6ef23a997f}, journal={Medium}, author={Ragan, Sean Michael}, year={2018}, month={Aug} }

@misc{Repouliou_2015, title={Exploitation and Coercion of Prisoners in Clinical Drug Trials}, url={https://pjb.mycpanel2.princeton.edu/wp/index.php/2015/11/26/exploitation-and-coercion-of-prisoners-in-clinical-drug-trials/}, journal={Princeton Journal of Bioethics}, author={Repouliou, Anastasia}, year={2015}, month={Nov} }

@book{Rosenthal_2017, title={An American Sickness: How Healthcare Became Big Business and how You Can Take it Back}, ISBN={978-1-59420-675-7}, publisher={Penguin}, author={Rosenthal, Elisabeth}, year={2017} }

@misc{Sarah Jane Tribble_2018, title={Drugmakers Play The Patent Game To Lock In Prices, Block Competitors}, url={https://www.npr.org/sections/health-shots/2018/09/28/652546095/drugmakers-play-the-patent-game-to-lock-in-prices-block-competitors}, journal={NPR.org}, author={Sarah Jane Tribble}, year={2018}, month={Sep} }

@misc{Stein_2010, title={U.S. apologizes for newly revealed syphilis experiments done in Guatemala}, url={http://www.washingtonpost.com/wp-dyn/content/article/2010/10/01/AR2010100104457.html}, journal={Washington Post}, author={Stein, Rob}, year={2010}, month={Oct} }

@misc{Thomas_2017, title={F.D.A. Accuses EpiPen Maker of Failing to Investigate Malfunctions}, url={https://www.nytimes.com/2017/09/07/health/epipen-fda-malfunction.html}, journal={The New York Times}, author={Thomas, Katie}, year={2017}, month={Dec} }

@misc{Thomas_2016, title={My Life As a Full-Time Human Guinea Pig}, url={https://www.vice.com/sv/article/xd7naw/my-life-as-a-full-time-human-guinea-pig-58477fdc068ed4026770ef67}, journal={Vice}, author={Thomas, Sophie Saint}, year={2016}, month={Apr} }

@misc{Tori Marsh_2018, title={Here’s Why Asthma Inhalers Are So Expensive}, url={https://www.goodrx.com/blog/heres-why-asthma-inhalers-are-so-expensive/}, journal={GoodRx}, author={Tori Marsh}, year={2018}, month={Apr} }

@misc{Zhang_2018, title={The Surgeon Who Experimented on Slaves}, url={https://www.theatlantic.com/health/archive/2018/04/j-marion-sims/558248/}, journal={The Atlantic}, author={Zhang, Sarah}, year={2018}, month={Apr} }

See the specific page numbers for the sources below:

Lost Connections, by Johann Hari: pages 22-24

The Emperor's New Drugs: Exploding the Antidepressant Myth by Irving Kirsch: pages 41-44

Published 18-10-2018 00:22