Selling Miracles: The Danger of Unproven Medical ClaimsSelling Miracles: The Danger of Unproven Medical Claims

This week in Pedersen's POV, our senior editor calls for stricter regulations on how unproven treatments are marketed and the need for global standards to close jurisdictional loopholes.

Amanda Pedersen

January 27, 2025

2 Min Read
Graphic featuring headshot of the author and a pull-quote from the op-ed piece
Pedersen's POV is a weekly opinion column that addresses various aspects of the medtech industry, including the good, the bad, and the controversial.

An investigative report by The New York Times recounts the harrowing journey of Kim and David Hudlow, a couple who flew to the Caribbean island of Antigua last year in search of a last-ditch treatment for David’s late-stage esophageal cancer. Promised a revolutionary blood-filtering therapy, they arrived on the island filled with optimism but returned home on a chartered plane, with Kim adjusting the valves on David’s oxygen tank as he struggled to breathe.

The story, reported by Pulitzer Prize-winning journalist John Carreyrou (best known for breaking the Theranos story), exposes a disturbing trend: marketing unproven treatments that prey on the vulnerabilities of the terminally ill. These “miracle cures” usually come at a steep price—not just in dollars, but in the physical and emotional toll they take on patients and their families.

In this case, the device in question is the Seraph 100 blood purification device developed by Martinez, CA-based ExThera Medical. Once praised for its role in saving lives during the COVID-19 pandemic, the device is apparently now being used for experimental cancer treatments offshore. According to The Times report, ExThera sold thousands of its devices to Alan Quasha’s private equity firm, Quadrant Management, which began using them early last year on late-stage cancer patients at a small clinic in Antigua. Patients, including the Hudlows, were charged $45,000 per treatment and encouraged to forgo chemotherapy while returning for regular sessions of the blood filtering therapy.

Related:Tackling the Most Burning EU MDR Questions

The justification for this so-called miracle treatment? A Croatian study involving just 12 patients—which is way too small to draw any credible conclusions. While the clinic in Antigua is beyond FDA's reach, The Times obtained phone recordings indicating that ExThera executives promoted the device to the Hudlows while on U.S. soil. This raises serious questions about whether the company violated federal regulations by marketing its device beyond its authorized indication. At the very least, the company put profits over patient welfare, a practice we’ve seen all too often in medtech.

Stories like these can erode public trust in the entire medical device industry, even for companies that adhere to rigorous clinical testing and regulatory pathways. When the line between innovation and exploitation is blurred, it becomes harder for patients to discern which treatments are truly evidence-based.

The Hudlows’ story is a tragic reminder of the need for strict regulations for how unproven treatments are marketed, even offshore. Global standards and international collaboration are needed to close jurisdictional loopholes to make it harder for companies to prey on the vulnerabilities of terminally ill patients and their families. Public awareness would also go a long way toward education about the importance of evidence-based treatments and the red flags to watch out for.

Related:Medtech Implementation of FDA’s Updated QMSR

Watching a loved one slowly lose their battle with cancer is heartbreaking enough without companies trying to commodify hope with unproven miracle cures.

About the Author

Amanda Pedersen

Amanda Pedersen is a veteran journalist and award-winning columnist with a passion for helping medical device professionals connect the dots between the medtech news of the day and the bigger picture. She has been covering the medtech industry since 2006.

Sign up for the QMED & MD+DI Daily newsletter.

You May Also Like