Tuesday, September 29, 2015

Steven Brill's Brilliant Expose, America's Most Admired Lawbreaker: Pharma

Steven Brill's America's Most Admired Lawbreaker reveals the inside story of Johnson & Johnson's pharmaceutical marketing gone bad. His accounts of aggressive off-label marketing of its anti-psychotic drug Risperdal to children and elders, paying for steering and revising medical research and journal articles, and building partnerships to market off-label uses are electrifying.  
Here are the chapters of Brill's 15-day serialized series in Huffington Post.

Chapter 1. The Credo Company - J&J's evolution from its founder's credo of putting patients first to today, putting its management and shareholders first. 
Chapter 2. Blowing Past the Label - Marketing plan and SWAT team go off label.
Chapter 3. Sales Over Science - Risperdal legos. 46% of sales children, elders.
Chapter 4. Massaging the Data, Spreading the Word - Buying research.
Chapter 5. Three Card MonteHow to get away with data manipulation.
Chapter 6. Trouble - The Yo Yo Ma Brochure, and a Whistleblower emerges.
Chapter 7. A Multi-Front War - Cooking research findings for FDA, hiding weight gain and male breast development.
Chapter 8. Firing Blanks, Hunting for Smoking Guns - Gods, Doctors who would be Gods, Conflicts of Interest.
Chapter 9. Under Siege, Ducking and Weaving - Too Big to Nail, so the Game Plays On.
Chapter 10. Chess, at $1,000 an Hour - Playing Wizard's Chess with children's and elders' health at stake.
Chapter 11. Pleasing Wall Street - A plea to settle on illegal marketing to elders, in exchange for a skate on illegal marketing to children.
Chapter 12. Showdown, Almost - Unconscionable. How will candidates for President address this?
Chapter 13. Hardball - Thank goodness for David Kessler. Throw the book at pharma, devices and research crimes against humanity.
Chapter 14. The Good Soldier, The Good Mother, The Faded Star - Time to throw the moneychangers out of the temples of our bodies.
Chapter 15. The Verdict... And Moving On - Pulitzer Prize please. The best since Watergate. 

Thank you, Steven Brill, for an excellent narrative, cross, and summation. The honor system has become a dishonor system, and the sky's the limit. The FDA and U.S. Justice Dept. fiddle while American lives and health go up in flames. 

Reading this series is captivating, electrifying, and nauseating. What I find most troubling is that the US attorneys investigating would spend years and years developing evidence, rather than alerting FDA and taking swift action to protect the public. Think about that each time you consider taking a new drug, or installing a new medical device, that the time for the system to catch up with harm inflicted can take years or even decades.

The FDA drug approval system, which Steven Brill describes as an "honor system," clearly broke down and became a dishonor system. This is the system that Congress now wan
ts to fast track through the 21st Century Cures bill, which the House passed in July. Call your Senators and tell them to put patient safety first. 

We need a Precision Medicine and Precision Devices framework to ensure something is "right for you" before use. Patients vary and are not all average. Here is a petition for Medical and Dental Device Safety Urgent Reform: MEDDSURGE.

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