“For as long as my spouse continues to be an employee of Arnold & Porter Kaye Scholer LLP firm, I will not participate personally and substantially in any particular matter that to my knowledge will have a direct and predictable effect on my spouse’s compensation or employment with that organization.”—Jeffrey Shuren, FDA Director, Center for Devices and Radiological Health, excerpt from memorandum to Dr. Scott Gottlieb, FDA Commissioner
She, the shrewd and indefatigable corporate attorney willing to go to the wall and beyond for her multinational, multibillion-dollar clients.
He, the public servant entrusted with a nation’s health—except when it interfered with the interests of his wife’s financially formidable patrons.
And together, they made the most devastating 1-2 punch since Bonnie and Clyde.
Jeffrey Shuren, the FDA director of the Center for Devices and Radiological Health, and Allison Shuren, attorney with the powerful Arnold & Porter law firm, enjoyed an alliance of mutual back-scratching for years until Jeffrey’s announced retirement earlier this summer.
As first reported by Freedom in 2016 and picked up by The New York Times eight years later, the pair were the epitome of conflict of interest, bestowing—through their joint efforts—great profit to the corporate behemoths, with little accountability from the FDA and highly questionable benefit to the public.
Thousands, perhaps millions of individuals, have been harmed by the high-risk medical devices Jeffrey Shuren allowed to skate through FDA approval with no evidence of their safety and efficacy. Millions, perhaps billions of dollars were made by Allison Shuren’s corporate clients as a result of her spouse’s apparent practice of winking them through the FDA’s requirements.
Case in point: the electroconvulsive therapy (ECT) machine, a device the FDA circled in red in 1976 as potentially dangerous. Those unlucky souls who have been victimized by the psychiatric practice of zapping electricity through the brain describe the experience variously as a grenade going off in your body or as a 40-pound cinder block dropped seven and a half feet onto your head.
Health reform advocates and former electroshock victims were rightly outraged.
The more succinct description of ECT is “torture,” to quote the United Nations, a Mother Jones report, and a judge ruling in favor of a victim of brain and burn injuries and cognitive impairment who received these gifts courtesy of this “therapy.”
Yet the 5.4-billion-dollar ECT industry has yet to provide proof of its contraption’s safety and efficacy, as theoretically required by the FDA. The General Accounting Office gave the FDA an eight-month deadline to get US-based manufacturers of ECT machines, among other high-risk devices, to furnish such evidence. That was in 2009.
The result: Crickets.
The FDA: “Meh.”
How could such egregious negligence be allowed? Enter Jeffrey and Allison. Her high-powered law firm represents medical device makers and Jeffrey, meanwhile, from his FDA position, was responsible for regulating high-risk medical devices in the interest of public health and safety.
That “interest” exited swiftly. Helping to kick it out the door was the continued pressure exerted on the FDA over nearly half a century by the American Psychiatric Association (APA)—ECT torture’s biggest fan. With the Jeffrey-Allison-APA three-way taking place in the background, in late 2015, the FDA issued a “proposed order” to downgrade ECT machines from high-risk to low-risk, in spite of their demonstrably dangerous effects on human subjects. And shockingly, though classified as “high-risk,” the ECT contraption had never even made it to the science-based clinical trials required to earn that designation. If there was a classification worse than “high-risk” the ECT device was in that category when the FDA proposed its “low-risk” designation.
Health reform advocates and former electroshock victims were rightly outraged.
“It would be unprecedented for the agency to declare a device safe without any submission of safety data from its manufacturers, but the FDA has always treated shock machines differently from all other medical devices because of the power of the APA,” said the National Association of Rights Protection and Advocacy, an organization that informs and mentors individuals to make their own treatment choices after being diagnosed with a mental illness by a psychiatrist.
But that was only Mr. and Ms. Shuren warming up. Behold a sample-size version of their résumé:
- LASIK corrective eye surgery: Jeff proposed stronger warnings regarding the procedure’s risks, including dry eye, distorted vision and pain. Two of Allison’s clients said we don’t want that. The warnings were never issued.
- Theranos (the healthcare tech start-up that was later dissolved and liquidated, with its founder convicted of conspiracy and wire fraud): Allison’s law firm represented the company in court and demanded the FDA halt an inspection at its sites in California. Though Jeff says he wasn’t involved in the Theranos lawsuit, court records suggest that he was.
- Allergan (manufacturers of Botox and other pharmaceuticals): Allison’s law firm was helping a client acquire the $63 billion company, whose breast implants were tied to a rare form of lymphoma. At an FDA hearing in March 2019, a mastectomy survivor testified that, after receiving the Allergan implants, she developed the rare cancer. “Please, please make the right moral decision to ban these implants like the other 30-plus countries and hold Allergan accountable,” she pleaded to applause.
But when faced with the obvious in-the-public-interest decision of recalling the dangerous implants, Jeffrey announced the FDA wouldn’t. The following month, Allison’s client announced it was purchasing Allergan.
Device-related injuries on Jeffrey’s watch hit 190,000 in 2012, then skyrocketed over the ensuing decade to 900,000 in 2023. In the same period, recalls of devices that cause severe injury or death more than tripled.
Standing up for their guy in the face of criticism and outrage, the FDA proclaimed it “is proud of Dr. Shuren’s commitment and integrity in serving the American public throughout the course of his extensive government career and stands by his science-based public health decisions.”
The American Medical Association (AMA) disagreed, raising “serious safety concerns” about questionable medical devices that had been approved and about the secrecy surrounding the injuries those devices caused. The AMA also expressed concern about the many devices approved by the FDA with little or no testing of them on actual humans.
Dr. Hooman Noorchashm, a Harvard-trained cardiothoracic surgeon, also has issues with Jeff. “Essentially,” he said, “he’s pumping medical products into the US marketplace, outside of an evidence-based paradigm.” Dr. Noorchashm’s wife died of a cancer spread by a “power morcellator”—another gadget rushed to approval by the director.
In announcing his retirement, Jeffrey Shuren’s tenure with the FDA was described by that agency as “remarkable.”
Health advocates, ECT victims and concerned observers might also use the same word, but in a less warm and fuzzy context.
Infamously cozy with the $500-billion medical device industry—and with no apparent concern for the lives ruined by ECT machines and other dangerous devices he approved—Jeffrey Shuren’s legacy was best summed up by former FDA associate commissioner Dr. Peter Lurie. Regarding Shuren’s successor, Lurie mused, in what amounts to a colossal understatement: “Somebody who would better protect consumer interests would be welcome.”
