How Conflict Of Interest Harms Patients: The Case Of FDA’s Dr. Jeffrey E. Shuren
By
Leonard Zwelling
https://www.nytimes.com/2024/08/20/health/fda-medical-devices-ethics.html?searchResultPosition=1
If I am not mistaken, I met Dr. Shuren once at the tail-end of my time in DC when I visited the FDA campus in Maryland. He must have just taken over the regulation of medical devices for the agency in the Obama Administration. He has just retired from that role.
In this absolutely chilling article on the front page of The New York Times on August 21, Christina Jewett documents the flagrant conflict of interest between Dr. Shuren who oversees the approval of new medical devices and his wife, Allison W. Shuren, an attorney for Arnold and Porter, a firm representing these very device manufacturers.
Here’s the gist:
- Shuren signed ethics agreements aimed at “walling him off” from business with his wife’s law firm. Enforcement was very lax.
- Shuren’s firm represented Theranos, the phony blood testing company headed by now felon Elizabeth Holmes. Dr. Shuren remained involved in the oversight of Theranos’ interactions with the FDA when his wife’s firm represented Theranos.
- The law firm also represented breast implant maker Allergan. Many countries in Europe had recalled these implants whose use was associated with a rare local lymphoma. Dr. Shuren declined to recall the implants. His wife’s firm was engineering the $63 billion acquisition of Allergan.
- Similar conflict occurred surrounding another client of Ms. Shuren involving LASIK surgery.
- “During the decade and a half of overlapping career trajectories, Dr. Shuren has not requested, nor has he received any waiver or agency authorization to participate in any particular matter relating to his wife’s employment or any of her clients,” an FDA spokesman said
- During these years, Dr. Shuren made $400,000 annually. His wife made between $1-5 million.
- Shuren was initially criticized for being slow to approve new devices. Under pressure from Congress, and the device industry. Shuren picked up the pace. Device-related injury reports went from 190,000 in 2012 to 900,000 in 2023. Shuren bragged that initial world approval of devices in the US went from 25 in 2009 to 125 in 2023. Device approval had accelerated.
- In 2012 Dr. Shuren founded a non-profit called the Medical Device Innovation Consortium with a former Medtronic (prominent device maker) executive. He got a waiver from agency ethics rules (not to serve on non-profit boards) to do this.
- It was during Dr. Shuren’s tenure that the birth control implant Essure caused harm to numerous women. The power morcellator used to eliminate uterine growths, but which disseminated malignant cells leading to patient deaths, was approved under Shuren’s watch.
- Shuren started the National Evaluation System for Health Technology (NEST) to have the FDA act on new device safety concerns. This too was led by industry personnel.
- Both the FDA and Arnold and Porter claim to have processes in place to prevent conflicts of interest. They were ineffective. They were so ineffective that when one of the leaders of Theranos went on trial, Dr. Shuren was shown to have been involved in the regulation of Theranos in 91 documents. Dr. Shuren was deposed but the transcript is under protective order.
The article goes into even furtherdetails on a number of devices that have harmed patients and whose makers Ms. Shuren represented.
That such a flagrant conflict of interest should go on for fifteen years in a critical federal regulatory agency is outrageous. This is why conflicts cannot be managed. They must be eliminated. When they aren’t, people get hurt.
Recently the blog noted that really smart people don’t seem to be able to grasp the concept of conflict of interest. Here’s a great example.
I expect the Shurens to retire with their millions despite having entered into a conflict which resulted in the deaths of some patients. If you want to read a horror story, read this article.
