This article was written by guest authors Paul C. McAfee, M.D., MBA, Chief of Spinal Surgery University of Maryland St Joseph Medical Center; Jordan McAfee, a recent Syracuse University graduate, who is volunteering at NYU Hospital for Joint Disease and is in his final year of Post-Bac Medical studies at Fordham University Lincoln Center; and John P. (JP) McAfee, a cum laude graduate with honors from the University of Pennsylvania and a magna cum laude law school graduate from the University of Baltimore School of Law, was editor for the University of Baltimore Law Review, a Steven L. Snyder Litigation Fellow, and a member of the Heuisler Honor Society. Mr. McAfee clerked for the Honorable James R. Eyler in the Maryland Court of Special Appeals.
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Social media sites like Facebook and Twitter may well be more effective at spotting adverse events, drug failures or unintended drug, device, biologic or food consequences than the FDA, peer-reviewed journals or even implant registries.
So says John Tozzi, the author of a recent Bloomberg BusinessWeek article in which he described how technology companies are using sophisticated statistical analysis to mine social media sites like Facebook and Twitter to uncover possible drug adverse events (4, 401 to be exact) out of scanned Twitter posts (6.9 million, in his example).[1]
If such a social medial data mining effort can uncover early warning signs in pharmaceuticals, could it not also do the same for medical devices?
The annual number of medical device failures increased 97% from 2003 to 2012 says Steve Silverman, director of the FDA medical device center’s office of compliance, but the rate of device recalls lagged behind industry growth during the same period of time.
More device failures plus more patient data available on Facebook, Twitter and user forums, yet the lag period between device distribution and the 24-month follow-up required by many orthopedic publications such as Spine Journaland Journal of Bone and Joint Surgery remains unchanged.
2 Years and 8 Months
On October 1, 2005, Smucker et al., Shields et al., and Riew et al. presented three papers in a series at the 20th annual meeting of NASS (North American Spine Society) that discussed adverse events, swallowing difficulties and postoperative acute airway difficulties which were associated with applying Medtronic’s INFUSE in the cervical spine. Following additional patient case reports, the FDA issued a public health notification titled: “Life-threatening Complications Associated with Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion” – on July 1, 2008.
Two years and eight months. That’s how long it took the FDA to read the studies, evaluate the evidence, and take action.
Three companies, Epidemico, MedWatcher and Treato, now scan the Internet’s social media using data analytics to tease out the earliest warning signs of drug complications.
The Strange and Troubling Silence of Peer-Review Journals
So, we (the authors) took the social media sites out for a test drive.
On May 31, 2014, we searched several public social media sites and databases for adverse events and found on MedWatcher (www.medwatcher.com) an inordinate number of adverse event reports focused on Essure, a contraceptive device implanted in women, in a 19 to 1 ratio.
There is currently no FDA advisory on this device.
But the evidence on Facebook is substantial. A Facebook group entitled “Essure Problems” with over 6, 000 members is a wealth of information about patient’s complaints. Furthermore, activist Erin Brockovich started a website for women adversely affected by Essure (www.essureprocedure.net) and has generated a 7, 979 signature petition to recall Essure.
The FDA actually has a version of a social media site into which companies, hospitals and, presumably, physicians (not the general public) may post adverse events. It’s called MAUDE (Manufacturer and User Facility Device Experience). When we searched MAUDE regarding Essure we had 2, 270 search matches.
MedWatcher, Facebook and MAUDE. Literally tens of thousands of data points all pointing to problems with Essure. So where are the peer-review journals?
The peer-reviewed literature in obstetrics and gynecology remain silent.
In one study—McMartin, K:”Hysteroscopic Sterilization, An Evidenced-Based Analysis”, Ontario Health Technol Asses Ser, 13:(21);1 – 35, October 1, 2013—the authors conducted two systematic reviews covered 22 observational studies of hysteroscopic sterilization.
Only 1 (N = 93) of these 22 studies compared hysteroscopic sterilization to laparoscopic tubal ligation. The conclusions were that hysteroscopic sterilization is associated with:
- lower pregnancy rates compared to tubal ligation (GRADE very low);
- lower complication rates compared to tubal ligation (GRADE very low); and
- no significant improvement in patient satisfaction compared to tubal ligation (GRADE very low).
Despite thousands of these procedures being performed, the peer-reviewed specialty medical literature is graded as “Very Low” using the universal Kavanaugh criteria for judging the reliability of evidence–based medical data.
Clearly, there is a mismatch of worrisome complications in various social media sites and the specialty evidence-based medical literature.
Essure was approved for commercial sale in the U.S. by the FDA in 2002. On February 19, 2014 the FDA, in response to mounting social media and physician pressure officially updated its post-market surveillance data regarding Essure. According to the FDA, the most frequently reported adverse events were pain (606), hemorrhage (140), headache (130), menstrual irregularities (95), fatigue (88), and weight fluctuations (77). The most frequent device problems reported were the migration of the device or device component (116), patient device incompatibility (113) (e.g., possible nickel allergy), device operating differently than expected (73), malposition of the device (46), and device breakage (37).
The Social Media Accelerator
Consider the case of Dr. Amy Reed and minimally invasive uterine morcellation procedures.
Uterine morcellation is a minimally invasive technique for debulking and removing a uterine mass in the uterus via robot-assisted hysterectomy and myomectomy. The masses are presumed to be benign uterine fibroids, however in a small percentage of cases they turn out to be cancerous and the act of “morcellizing” the tumor can spread cancer cells.
Several companies provide devices for this procedure including ETHICON: Gynecare morcellator, Storz: Rotocut Morcellator, Richard Wolf Medical Instrumentation Company, LiNA: LiNA Xcise Cordless Laparoscopic Morcellator, Blue Endo MORE solution Tissue Morcellator, and Intuitive Surgical’ s Da Vinci Robot.
Amy Reed, a Harvard trained anesthesiologist and no stranger to the health care system, had a morcellation procedure to remove what was thought to be a benign uterine fibroid. In her case, however, it immediately converted into a stage IV metastatic leiomyosarcoma following the uterine morcellation (Figure 1).
In her view the morcellation procedure accelerated spread of her cancer. Reed started a petition on the website Change.org to call attention to morcellation’ s risks and garnered 9, 634 signatures in six months.
This time the FDA didn’t wait. On April 17, 2014 the agency issued a safety communication and “discouraged the use” of uterine morcellation—“If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival. For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”
This time the lag time from social media early warning to FDA action was six months.
Unfortunately, even in this dramatic case the medical peer-reviewed literature seems to be slow to detect and even slower to move. In a summary article in JAMA ;3111:905-906, March 5, 2014 Kho and Nezhat concluded:
“Evidence-based action is needed but requires prospective and reliable data. Examples of this approach exist in other specialties, such as the National Surgical Quality Improvement Program database developed by the American College of Surgeons. In gynecology, the Pelvic Floor Disorders Registry was established following an FDA-mandated requirement for surveillance after a similar debate about transvaginal mesh. A nationwide registry of gynecologic surgeries, including data on devices used (such as electric morcellators), quality of outcomes, and complications, would be a critical step toward this goal. Controversies about the role of new technologies are not new to gynecological surgery. However, the response to concerns about the risk of morcellation must include decisive, scientifically informed actions to better understand the risk and prevent complications among women for whom this procedure is considered.”
This is a call to action?
In the Amy Reed case, social media pre-empted scientific reports of device complications in evidence-based medicine.
Thirteen days following the FDA Safety Advisory, JNJ suspended worldwide sales of the following products—Gynecare Morcellex Tissue Morcellator, the Morcellex Sigma Tissue Morcellator System, and the Gynecare X-Tract Tissue Morcellator.
Social media wins out over peer-reviewed medical literature on prompting action.
And, most importantly, the FDA chopped its response time from 32 months in the Cervical INFUSE case to 6 months with uterine morcellation experience.
Metal-on-Metal Social Media Experience
The issues regarding metal-on-metal [MoM] hips have been exhaustively reported and investigated in the peer-reviewed orthopedic journals by Door et al., Jacobs et al., annual debates at CCJR [Current Conepts in Joint Replacement] by Seth Greenwald, by a DePuy Orthopaedics voluntary recall of its ASR XL Acetabular Hip System and DePuy ASR Hip Resurfacing System in August 2010 and on late night television by the client trolling law firms.
DePuy launched its 510(k) cleared metal-on-metal ASR in 2005. Between 2005 and DePuy’s voluntary recall in August 2010 approximately 8, 000 patients received the implant. To settle all patient claims arising from adverse events associated with the ASR, DePuy agreed to pay $2.4 billion (Bloomberg reported the settlement at $4 billion) to patients.
What U.S. registry implant data prompted the recall and formed the basis for the eventual settlement? None. In fact, the key piece of reliable data emerged from the National Joint Registry of the UK—554 hips implanted, mean follow up 2.2 years (range o to 5.12 years) 49 revisions, 8.8 %. The Kaplan-Meier survivorship curve predicted only a 63% survival estimate at 4.57 years post-operatively (Figure 2). This meant that the expected revision rate at 4.57 years would be an alarming 37%. There were similar findings in a registry from Australia.
The key FDA Safety Communication was issued on January 17, 2013—16 months later.
On January 17, 2013 the FDA also issued a formal “Proposed Order” requiring manufacturers of MoM total hip replacement systems to submit premarket approval (PMA) applications.
Social Media – the Plaintiff’s Friend
Social media proved to be an important plaintiff’s tool in the metal-on-metal lawsuits. Plaintiffs’ attorneys recruited clients using social media. Over 2, 000 patients eventually were organized as plaintiffs before the FDA issued its January 17, 2013 Safety Communication.
A typical plaintiff firm is Saiontz and Kirk. The firm set up direct patient enrollment on their website which seamlessly connected them to social media sites. As of June 1, 2014, 59 responses were posted from potential cases including 33 from email, 16 from Facebook, 3 from Stumbleupon, 5 from Twitter and 2 from Google plus.
Saiontz and Kirk’s longtime motto was: “If you have a phone, you have a lawyer.” Along the Amtrak corridor from Boston to Washington, that resonated with litigious patients. In this new era of social media, however, Saiontz and Kirk’s catchphrase is literally global: “If you have a phone or a computer, you have a lawyer”.
Next Week: Part Two: The Social Media Advantage for Post Market Device Performance Data
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[1]Tozzi, J. (n.d.). Searching Social Media for Drug Side Effects. Businessweek.com. Retrieved June 4, 2014, from http://www.businessweek.com/articles/2014-05-15/searching-social-media-for-drug-side-effects
