Back in March 2016, one of the most prestigious academic medical journals in the nation published an article entitled "N-of-1 Policymaking — Tragedy, Trade-offs, and the Demise of Morcellation".

The New England Journal of Medicine's Dr. Lisa Rosenbaum suggested that the FDA action to discourage the use of power morcellation in women was based on one patient (i.e. Amy).

And Rosenbaum wrote that our public health campaign was being waged by "availability entrepreneurs" (i.e., us) based on this "emotional N-of-1."

That was surprising to us, because in addition to the FDA analysis, numerous independent studies have now shown that power morcellation — used to remove fibroids and the uterus — was upstaging potentially deadly cancers in up to one in 350 unsuspecting women. There are many faces and tremendous pain attached to this historic error in gynecological surgery.

We rebutted the NEJM's incorrect perspective, and the editors graciously published our letter. Our request that the NEJM editors retract the Rosenbaum paper remains unanswered to date.

But we realize Dr. Rosenbaum and her NEJM colleagues were correct about one issue. The FDA's Center for Devices and Radiological Health (CDRH) does makes dangerous public policy decisions using "Ns-of-1", based on the recommendation of experts, who often have financial interests in the products they develop.

Another example of failure at CDRH recently emerged. The agency has approved a containment system for use with power morcellators called a "Pneumoliner". This device is theoretically designed to limit the dissemination of morcellated bits of uterine tissue when the surgeon uses a power morcellator to mince up the uterus.

Sounds good. Until we read the fine print in the FDA's press release, which states that "We want to be clear that, although the device has been shown to successfully contain morcellated tissue, it has not been proven to reduce the risk of cancer spread during surgery."

To be clear, CDRH has approved a device for use on women to stop morcellators from spreading cancer — but the chief CDRH scientist admits that the agency is not sure that the "Pneumoliner" works.

Huh?

It feels like we are trapped in an episode of The Twilight Zone. The fact is that no rigorous clinical testing was demanded of the manufacturer of the "Pneumoliner" before the FDA approved it, this despite the agency's full knowledge of the oncological danger of morcellating uterine tumors.

Is this a case of the left hand not talking to the right hand at FDA? Or is it a case of "industry experts" influencing the process?

There is a silver lining for both CDRH and the NEJM here. Just last month the inventor of the "Pneumoliner" device, Dr. Timothy Shibley, published a true "N-of-1" maintaining that a single unsuspecting woman whose hidden cancer was "inadvertantly" morcellated using a "Pneumoliner" did just fine.

We are nearly certain that Dr. Rosenbaum and her colleagues will not give this "N-of-1 policy" the same scrutiny they have directed at our public health campaign to protect women from morcellation.

So, given the persistent threat posed to women's health by CDRH, we again felt compelled to act as physicians and public health advocates.

We recently filed a "Citizen Petition" to FDA commissioner Dr. Robert Califf, informing him of the CDRH's puzzling behavior on this device and requesting protective action for the sake of women's health.

In our petition, we also proposed a compromise to Dr. Califf: Given the high oncological risk of power morcellators, why not give regulatory jurisdiction over this device to the FDA's new Oncology Center of Excellence (OCE)?

The OCE was recently given real regulatory power over drugs and devices that help manage cancer as part of the Vice-President's Cancer Moonshot initiative. So, it would seem that Dr. Richard Pazdur, Acting Director of the OCE, is uniquely qualified and empowered to determine if the "Pneumoliner" device was appropriately assessed by CDRH.

Time will tell. But for now, one thing is certain. We are presenting NEJM and our public health leaders with an opportunity to earn their stripes in the patient advocacy world.


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