CDRH unveils its "patient power" initiative at the same time that a third patients' group rallies against the Center's medical device safety review process.
The New Year broke amid an unusually acrimonious election season characterized by a heightened sense of public dissatisfaction with Washington—and among patient advocacy groups that definitely included FDA, especially its devices Center.
By the second week of January, CDRH had picked up on this with the publication of an ambitious manifesto, 2016-2017 Strategic Priorities, that put patient power front and center even as a new group of injured patients was joining others who have recently found new ways of attacking the way the Center protects them.
In a personal email to CDRH director Jeffrey Shuren, Nonie Wideman, advocate for thousands of women who claim to have been injured by allergic adverse reactions to transvaginal surgical mesh, demanded the recall of all such meshes, not only the pelvic organ prolapse (POP) meshes that FDA had just ordered reclassified into Class III because of inadequate assurance of safety.
The women complain of excruciating pain from mesh erosion, degradation, migration, nerve damage, and chronic inflammation leading to autoimmune problems and lasting loss of sexual relations and even physical mobility. “We are aghast that you would not include [stress urinary incontinence] mesh” in the POP reclassification, Wideman told Shuren.
Her approach constitutes the third injured patients’ group (all women) to surface publicly in three months and take up direct attacks on Shuren, CDRH, and the way medical device safety is reviewed and monitored at FDA, especially via the 510(k) process, after power morcellators and the Essure permanent birth control device (PMA), previously reported here.
The mesh patients’ complaints made the same basic point that the other two did: Just because a non-essential device helps a majority of its patients (in this case, about 70% based on published studies), why should its risks be visited upon the minority who can’t be identified until it’s too late and the implants are in place? Device explantation does not restore quality of life, Wideman says.
In each case, FDA’s unarticulated answer seems to be: Because manufacturers and practitioners want to continue making money from these devices.
High-sounding strategy documents have issued from FDA for years, only to be largely forgotten under the weight of the agency’s other business, and CDRH’s “patient power” 2016-2017 Strategic Priorities document is likely to be no different.
“We believe that if CDRH is to successfully achieve a mission and vision in the service of patients, we must interact with patients as partners and work together to advance the development and evaluation of innovative devices, and monitor the performance of marketed devices.” So proclaims the Partner with Patients chapter, in extra-large type.
Calling patients “our most important customer,” the document vows to “establish a foundation to facilitate the development of more patient-friendly information, promote more patient-centric clinical trials, advance benefit-risk assessments that are informed by patient perspectives, promote the use of patient-reported outcome data, and foster access to new devices that meet patients’ needs.”
From there, it gets bolder and bolder:
GOAL: PROMOTE A CULTURE OF MEANINGFUL PATIENT ENGAGEMENT BY FACILITATING CDRH INTERACTION WITH PATIENTS
• By December 31, 2016, establish one or more new mechanisms for CDRH employees to obtain patient input on key pre- and postmarket issues facing CDRH and foster participation of 10 patient groups to participate.
• By December 31, 2017, foster participation of 20 patient groups to participate in these mechanisms.
• By December 31, 2016, 50 percent of CDRH employees will interact with patients as part of their job duties.
• By December 31, 2017, 90 percent of CDRH employees will interact with patients as part of their job duties.
GOAL: INCREASE USE AND TRANSPARENCY OF PATIENT INPUT AS EVIDENCE IN OUR DECISION MAKING
• By September 30, 2016, 50 percent of PMA, de novo and HDE decisions will include a public summary of available and relevant patient perspective data considered.
• By September 30, 2017, 100 percent of PMA, de novo and HDE decisions will include a public summary of available and relevant patient perspective data considered.
• By September 30, 2017, increase the number of patient perspective studies (e.g., evaluating patient reported outcomes or patient preferences) used in support of premarket and postmarket regulatory decisions. (compared to FY 2015 baseline)
To accomplish these goals, CDRH will take several steps including the following:
• Resources permitting, establish in CDRH a patient-focused program responsible for the strategic development and coordination of CDRH’s initiatives to advance patient engagement and the science of patient input throughout the total product lifecycle.
• Convene the Patient Engagement Advisory Committee to discuss high priority topics regarding patient input in the total product lifecycle.
• Identify/define the various pre- and postmarket regulatory uses of patient reported outcome measures (PROMs) and issue a report summarizing current PROM regulatory usage patterns and gaps.
• Work with members of the medical device ecosystem to develop a framework for patient input to inform clinical study design and conduct, with a goal of reducing barriers to patient participation and facilitating recruitment and retention.
• Develop education and training for CDRH staff and industry on the development and use of the science of measuring and communicating patient input throughout the total product lifecycle.
What if, as is highly likely, all this is a bridge too far and CDRH simply can’t do it?
The Center, despite its flowery words in the strategies document, is an ordinary government bureaucracy that hides its real motives whenever it can, especially when user fees are hanging over its head.
For example, when I asked FDA devices press officer Deborah Kotz why the agency had proceeded to reclassify less-common pelvic organ prolapse surgical mesh but exempt identical yet more-common stress urgency incontinence mesh from the same order, she replied: “FDA believes that Class II (general and special controls) provides a reasonable assurance of safety and effectiveness for mesh to treat SUI.”
When I responded, “This isn’t explicit enough. On what does FDA base its belief that Class II provides a reasonable assurance of safety when Wideman has presented literature-based evidence that the adverse effects are the same as for POP mesh?” Kotz fell silent.
Research on the regulations.gov website for this rule revealed a possible answer. During the 2014 gestational process for FDA’s order, the Society of Gynecologic Surgeons had submitted a comment that
“because of widespread confusion among the lay population which has attended the previous FDA advisories, we ask that the FDA further clarify and highlight that use of type 1 monofilament polypropylene surgical mesh for surgical treatment of stress urinary incontinence (i.e., mid-urethral slings) and abdominal pelvic organ repair (i.e., sacral colpopexy) has become the standard of care, that these therapies are not the subject of the advisory letter, and that these products are not being reclassified. This will help to minimize these potential points of confusion for patients, patient advocacy groups and gynecologic surgeons.”
It appears that FDA has followed this advice. Wideman, who runs a website for mesh-injured women at meshproblems.weebly.com that she says has logged over 6,000 hits, told me that many of the surgical society’s leaders have been and still are preceptors for the mesh manufacturers. FDA’s acquiescence to the society would be a pragmatic trade-off engendering mutual cooperation into the future.
Which makes me wonder, what a wonderful integration could result if industry-affiliated patient networks melded with the pie-in-the-sky vision illuminated in CDRH’s 2016-2017 Strategic Priorities?
Looked at another way, what influence then might an injured minority of patients exert on an agency that doesn’t heed them now?
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Jim Dickinson is MD+DI's contributing editor.
[Image courtesy of STOCKIMAGES/FREEDIGITALPHOTOS.NET]