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Media ignore impact of unsafe medical devices — unless the company CEO is a celebrity billionaire like Elizabeth Holmes

Elizabeth Holmes Fortune coverJames Stewart’s recent New York Times story about Elizabeth Holmes, the rising star in the high-tech galaxy turned media celeb, raises an important press question in this time of the 21st Century Cures Act.

Are the media interested in covering problematic and potentially unsafe drugs, devices, and other medical products only when celebrity is involved?

The Cures Act, you may recall, weakens already weak regulation of new medical technologies — which include the kinds of products that Holmes’s company Theranos is introducing to make it easier to draw blood from squeamish patients. (Theranos has claimed it does not need FDA approval for its blood tests even though the FDA has asserted its authority over them.) And as I’ve repeatedly noted, media coverage of the Act moving rapidly through Congress has been sorely lacking.

Not so in the case of Theranos and its new methods for testing and analyzing blood. Stewart wrote: “The attention lavished on Ms. Holmes has been effusive… but that so many eminent authorities…appear to have embraced Theranos with minimal scrutiny is a testament to the ageless power of a great story.” Michael Cherny, an analyst at an investment bank and early skeptic of Theranos’s claims, told Stewart. “It all fit together perfectly: the college dropout, the fear of needles, the humanitarian mission. She checked all the boxes.” The money box was checked, too. The company has raised more than $400 million in venture capital and has been valued at $9 billion. Holmes’s stake is worth half of that.

Her story fit together so perfectly that she has been the subject of two profiles: one in the New Yorker and one in Fortune, and she snagged an interview with Charlie Rose. Glamour named her one of its women of the year. ReCode, a tech news and analysis site, ranked her five news cover appearances for Fortune, Forbes, Inc., T: The New York Times Style Magazine, and finally the Wall Street Journal whose not-so-flattering expose popped her bubble. (ReCode ranked that one number one.) Even after the Journal  brought to light many problems with Thernaos and its blood-testing method, the press seemed reluctant to let go of a good story. New York Magazine used this headline — “Silicon Valley’s Most Inspiring Company May Be a Fraud” — to note the company’s troubles. The Washington Post framed its gentle Q and A as a “Comprehensive guide to Theranos’s troubles and what it means for you.”

What’s wrong with framing such stories about life and death devices and drugs around the glamour of celebrity? It leaves out too much crucial information. Elizabeth Holmes’s brief career at Stanford and her net worth substitute for real reporting that warns patients about harmful products. No one appears to have died or been injured from the Theranos way of testing blood, but that’s not the case with dozens of other devices, some of which are still on the market. I didn’t see any explainer Q and As after two Reuters reporters exposed financial scams involving another questionable device, the pelvic mesh. The mesh has been the subject of some 100,000 lawsuits and has resulted in women incurring thousands of dollars in medical costs to have the mesh removed and repair damage it may have caused. There was no celebrity in this story about mostly poor women now drowning in debt to fix a problem caused by a device they were told was safe.

Celebrity also leaves out discussion of the systemic questions—how a device got approved, how it has been regulated, are the manufacturers following the rules? Two days before Stewart’s story appeared New York Times staffer Andrew Pollack reported on FDA inspection reports that flagged gaps in the company’s quality assurance procedures and documentation. Pollack noted that for the 12 months ending in September 2014, the agency had issued nearly 1,000 post-inspection reports to medical device companies. There were 251 cases in which the agency said a device company lacked adequate procedures for handling customer complaints. That number alone invites reportorial scrutiny. (To its credit, NBC Nightly News did report on inspection reports and warnings in its September segment on the Bard recovery filter.) But don’t look for such revelations when celebrity frames the story.

This focus obscures a more basic question: are the devices made or promoted by today’s media stars really the right ones for Americans? Do they encourage overuse plus the additional cost to the healthcare system that such overuse brings? The lengthy Twitter chat between ProPublica’s Charles Ornstein and Dallas Mavericks owner Mark Cuban, who also stars as a “shark” investor on Shark Tank, is a case in point. Last spring Cuban tweeted that those who could afford it should have their blood tested for everything every quarter to create a baseline for their own personal health. Ornstein countered that Cuban’s advice was a recipe for false positive results and unnecessary treatments that could cause harm, and the chat went back and forth from there. Putting the chat in context of what’s happened to Theranos, one wonders if a test that makes drawing blood a snap feeds right into advice like Cuban’s. In other words, sales and celebrity go hand in hand, and making more sales is what the soon-to-be-newly-shaped FDA rules are designed to encourage.

Do deaths and harm from unsafe medical products matter? At one time in our journalist past, deaths caused by unsafe drugs and devices did make headlines precisely because they were unsafe. Reporters didn’t rely on celebrities and pretty CEOs as reasons to examine drugs and devices and the companies that made them. As the saga of Theranos shows, waiting for a celeb to emerge can lead the public—patients, investors, and the medical profession itself—down the wrong path. But in this age of Dancing with the Stars and Shark Tank, no one seems to care. The celebrities matter more.


Trudy Lieberman is a veteran health care journalist who often writes about consumer safety protections and the media’s role in upholding those protections. She tweets as @Trudy_Lieberman.

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Comments (5)

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Sarah

November 20, 2015 at 1:38 am

So very true. We have been campaigning for two years to ban the surgical power tool, the
Power Morcellator, used by GYN’s on unsuspecting women with problematic fibroids who are scheduled for hysterectomies or myomectomies. The Power Morcellator has been “black boxed” by the FDA, as 1:350 women undergoing surgery will harbor a hidden aggressive deadly cancer called Leiomyosarcoma. (LMS).. Use of the Morcellator, grinds up the tumor (to be removed through a small cosmetic incision) spreading the cancer, leading to premature death. The Power Morcellator as well as other faulty medical devices were cleared by FDA’s antiquated 510k legislation. . Please visit, sign our move.on petition and like our page. https://www.facebook.com/campaignagainstmorcellation/

Joleen Chambers

November 20, 2015 at 7:46 am

Trudy Lieberman, you are following this story and reporting on it. Thank you! I will like and share and Tweet your work to my friends and followers! Eroding the power of the medical device industry is necessary to call attention to the real culprit: their blindness to PREVENTABLE patient harm and total focus on profit. Our government is allowing these profitable enterprises to exploit its’ citizens.

Ken Rubenstein

November 20, 2015 at 1:34 pm

The FDA has become some bete noir keeping patients from getting cured. That could not be further from the truth; the agency has been hamstrung by an on-the-take congress in multiple ways from protecting us against stuff that plain doesn’t work.

Laura Henze Russell

November 20, 2015 at 9:00 pm

Join the call for Medical and Dental Device Safety Urgent Reform #MEDDSURGE: http://www.petition2congress.com/18325/medical-dental-device-safety-urgent-reform-meddsurge.

Nonie Wideman

November 24, 2015 at 12:41 am

As one of the hundreds of thousands of women harmed by mesh, trying to get the media’s attention about the devastating aftermath of mesh rejection and the high rate of autoimmune problems post mesh complications seems an impossible task. The FDA has betrayed the trust we gave. Thank you for highlighting the issues with media indifference to the non celebrity championed patients suffering from preventable harm. Polypropylene meshes hurt a significant cohort of patients who have them implanted in their bodies for hernia repair, prolapse repair and incontinence repair surgeries. With a complication rate over 25% for this type of implant material one would think these mesh products would have to face a higher level of scrutiny and at least face the requirements of level 3 testing. The FDA appears to be protecting the manufacturers who have means and money to defend their actions while leaving injured patients abandoned. It is a shame that lawsuit advertising is more effective at warning women about mesh than is the FDA.