Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Friday, June 14, 2013

Boston Scientific follows product failure with belated $1 million clinical study



Vaginal Mesh Effectiveness Target of New Boston Scientific Study
By: Austin Kirk | Published: June 10th, 2013  (FiDA highlight)
Boston Scientific announced last week that it is working with the Pelvic Floor Disorders Network (PFDN) to study the effectiveness of treating uterine prolapse with vaginal mesh compared to traditional surgery.  
The company is contributing more than $1 million to the study, which will look at one form of pelvic organ prolapse (POP) and the available treatment options.
The announcement comes two years after the FDA found that there was no evidence that transvaginal mesh provides any additional benefits when compared to traditional surgery, yet it appears to carry a risk of serious complications.
Concerns about the safety of surgical mesh for treatment of pelvic organ prolapse and female stress urinary incontinence gained widespread attention in July 2011, when the FDA indicated that nearly 3,000 reports of problems with vaginal mesh were received by the agency between January 2008 and December 2010, including cases where the mesh eroded through the vagina, caused infections and other debilitating injuries.
In early 2012, the FDA sent a letter to several manufacturers of these products, ordering that they conduct additional studies and trials to evaluate the safety of transvaginal mesh products, looking for additional information to establish whether they pose an unreasonable risk of injury for women.
Concerns Over Safety and Effectiveness of Vaginal Mesh
The main manufacturers of vaginal mesh products sold in the United States are Boston Scientific, American Medical Systems (AMS), C.R. Bard, Johnson & Johnson’s Ethicon and Gynecare subsidiaries, Coloplast Corp. and Cook Medical.
Many of these products were approved through the FDA’s controversial 510(k) system, which allowed the manufacturers to begin selling the devices without conducting rigorous pre-market studies. Products were approved by the agency as long as the manufacturer could indicate that it was “substantially equivalent” to other products on the market.
As concerns have surfaced over the safety and effectiveness of vaginal mesh, many of the manufacturers have elected to cease marketing their products in an effort to avoid conducting the required studies.
The new study announced last week by Boston Scientific, the SUPeR clinical trial, is expected to enroll 180 women considering surgery to treat uterine prolapse who do not plan to have any more children. The women will either be implanted with the Boston Scientific Uphold LITE Vaginal Support System or they will be treated with more traditional surgery, including a vaginal hysterectomy.
The test subjects will be evaluated every six months for up to five years. Researchers will look at the safety, success, cost-effectiveness and other factors resulting from the surgery. The final results are expected in 2018.
Vaginal Mesh Lawsuits
About 20,000 women throughout the U.S. are currently pursuing a vaginal mesh lawsuit against the makers of these products, alleging that transvaginal surgical mesh is unreasonably dangerous and defective, carrying a severe risk of painful and debilitating health problems for women that outweighs any potential benefits.
The U.S. Judicial Panel on Multidistrict Litigation (JPML) has established separate consolidated proceedings in the federal court system for cases involving different manufacturers, with five Multidistrict Litigations (MDLs) centralized before U.S. District Judge Joseph Goodwin in the Southern District of West Virginia.
According to an updated case list (PDF) released on May 15, Judge Goodwin is currently presiding over at least 2,938 Bard Avaulta lawsuits, 6,028 AMS vaginal mesh lawsuits, 3,557 Boston Scientific pelvic mesh lawsuits, 5,763 Ethicon Gynecare mesh lawsuits and 320 Coloplast bladder slings lawsuits.
Several cases pending in state courts throughout the country have already gone to trial, with a California court awarding $5.5 million in damages to a woman who experienced complications with a Bard Avaulta mesh in July 2012, and a New Jersey state court jury awarded $11.1 million in damages in February, including both compensatory and punitive damages for problems with Ethicon’s Gynecare Prolift mesh.
In the federal court system, the first vaginal mesh trials are scheduled to begin next month, with a series of lawsuits involving the Bard Avaulta mesh set to begin on July 6. Later this year and early next year, a series of at least three additional trials will be held involving AMS mesh, Boston Scientific mesh and Ethicon mesh.
These early trial dates are designed to help the parties gauge how juries are likely to respond to certain evidence and testimony that may be offered throughout the vaginal mesh litigation. The preparation and any outcomes may help facilitate negotiations to reach vaginal mesh settlements in other cases.

Wednesday, June 12, 2013

Metal Allergy, Mother and Mystery: Joint Replacement Culprit


   

Journal of Participatory Medicine  (FiDA highlight)
Abstract
Summary: The author describes the detective work she did to find the reason for her mother’s unexplained deterioration and lack of muscular strength in hands and legs following joint replacement surgeries. A careful neurological workup ruled out ALS but did not result in a clear diagnosis. Her review of the medical literature suggested that metal toxicity might be causing inflammation that was destroying the muscle. She describes the numerous difficulties and eventual success she had interacting with a number of physicians as her mother’s advocate.

Keywords: Participatory medicine, patient engagement, inflammatory myopathy, metal allergies, joint replacements, muscle weakness.
Citation: Davis CC. Steel standing: metal meets muscle; a patient’s perspective. J Participat Med. 2013 Jun 5; 5:e23.
Published: June 5, 2013.
Competing Interests: The author has declared that no competing interests exist.
In 2008, my once active, vibrant, and energetic 68-year-old mother began to lose her ability to do things independently. Her body was succumbing to a debilitating weakness, and she was rapidly becoming unable to feed, dress, or care for herself without assistance.
She had played the piano since the age of 4, and been our church pianist for decades. Her upper body strength was tremendous. Then the gradual onset of her weakness escalated. I began noticing her difficulty in trying to pick up or hold a glass with both hands.
Previously, my mother had been examined by a hand specialist who strongly suspected carpal tunnel because of her history as a pianist and because her occupation before retiring included typing on a computer keyboard for the majority of her work time. The results of extensive testing and EEG were normal.
Within a few months of the onset of trouble with her hands, however, weakness developed in her legs. Her primary care physician referred her to a neurologist. The same tests and lab profiles were repeated, in addition to an MRI. Still no resolution or clue was offered. She appeared in good health with the exception of increasing muscle weakness, but again nothing significant was evident.
Unless one knew my mother’s daily behavior, actions, and habits, no one would have suspected she had troubling health issues. She was never one to complain or express personal difficulties. As her daughter, quickly becoming her primary caregiver, I also became her walking diary. It was my role as her spokesperson to communicate key information that my mother didn’t think to share with her physicians.
In a few weeks, she was referred to another neurologist with more clinical experience in a university (research) setting. He was young, eager, and very intrigued by my mother’s odd neuromuscular symptoms. After taking extra time to examine her carefully and listen to the information I was able to offer from observing her on a daily basis, he believed that she had ALS (Lou Gehrig’s disease). The next step was a muscle biopsy. My mother gladly agreed. She was extremely eager to learn what was happening with her body.
Within a few weeks she was diagnosed with a myopathy. However, the diagnosis brought more questions to mind, since a specific category of a myopathy or a potential cause was not found. That’s when I began my own research.
At this point, I questioned: “Why did the neurologist think mother had ALS and what were the symptoms he believed were so closely associated with myopathy?” In studying ALS, I quickly understood how the two conditions appeared closely related. Both started slowly. However, the origin and outcomes of the overall muscle weakness for each disease were quite different.
Hoping to learn which specific myopathy she may have acquired, I did more in-depth reading and spoke with close relatives about our family’s medical history. Based on this information, it appeared likely that my mother had inflammatory myopathy. That diagnosis was later confirmed by the neurologist who performed my mother’s muscle biopsy.
My next inquiry: “What could be inflaming her muscles and when did it begin?” Inflammatory myopathy had six geneses listed within its own category. There was only one that applied to my mother’s medical case. It was metal toxicity. My mother had had a hip replacement due to a fall in March 2006, followed by a knee replacement due to an injury 4 months later in July 2006.
After days of trying to connect her mysterious health issues, seemingly unassociated, I unearthed a 5-year timeline while doing my taxes. Scribbled beside my mother’s surgery in 2006, I had written, “Her hands became weak after her knee replacement.” This was a revelation!
Immediately, I acquired copies of her medical records going back to 2005. Then I gathered information in talking with her original orthopedic surgeon’s PA. If the metal in her knee was creating her weakness, then I needed valid research to connect the dots of how the initial reaction catapulted her once-healthy body into a spiral of decline. And now her weakness was spreading; she could no longer walk without assistance. I needed to link the research and present credible information and my theory to the neurologist, with whom she would meet again in a few days.
As I continued specific research on metal implants, I uncovered a wealth of medical information from European countries, with decades of clinical studies presenting cases identical to my mother’s.[1] More specifically, the same types of metals identified were also in my mother’s knee replacement; chromium, cobalt and nickel. In some patient cases, the hypersensitivity to these metals was linked to organ failure and possibly even cancer within five years.[2] Based on these reports, I became convinced that if my mother’s knee replacement were to be changed to a different type(s) of metal (we didn’t know at the time it was called a “revision”), then her muscles would recover or at least stop deteriorating. That was my theory.
In 2009, my idea was considered farfetched. To my surprise, the neurologist at the university medical center encouraged me to “go with your hunch.” He understood the premise of my thinking. He knew her muscle tissues were dying based on the appearance of her muscle biopsy. He urged us to seek her original orthopedist for further medical care.
After mentioning possible “metal toxicity” to the original orthopedic surgeon’s receptionist, we had an appointment the next day. I armed myself with copies of the case studies I had uncovered.
We arrived, fully equipped and ready to work with the orthopedist, believing he would welcome the data and help my mother. She was the last patient to be called before the office closed for lunch. The surgeon had always required an x-ray of my mother’s replacements before seeing her. This time, we were escorted directly to the exam room. The PA entered, leaving the door open.
The PA asked my mother why she was there. She shared her symptoms of severe weakness and a clicking noise that had just begun in her knee replacement. She stated that it felt loose when she walked and how sore her knee had become in the past few weeks. The PA made notes and exited.
In a few minutes, the surgeon entered, again leaving the door open. He also questioned why my mother was there to see him. She repeated her symptoms and he began an evaluation of her knee. I held off presenting my theory and the evidence until I heard his opinion.
He began his exam by pushing his thumb on the area where the replacement stem connected below her knee. She yelled, “OH that hurts!” My mother was never one to get above a normal voice tone, much less shriek with agony. She was obviously hurting. The surgeon continued to twist her knee from side to side. She again stated that he was hurting her leg. Upon completion, he sat down on a stool and while looking directly at my mother’s leg instead of her face, said, “I don’t think there is anything wrong with her knee replacement.”
He certainly didn’t believe her knee replacement and weakness were connected. He said it was normal to have some pain and discomfort after some replacements, and they are rarely pain-free. This was a stark contrast to their first discussion when he explained how her bone-to-bone degenerative pain would be relieved with a knee replacement. Since day one, she had pain with her knee replacement, sharing this repeatedly with the surgeon.
My mother’s expression showed her disappointment. She asked me to share my findings. I handed him several pages of medical journals and other information. Although he had never heard of metal allergies from a joint replacement, he seemed interested and appreciative as he flipped through the pages. Then he asked me, “What do you want me to do? What is the next step of action to take?” He was sincere, facing me as if I were a medical colleague with answers to this crisis. I suggested my mother go to a hospital for further testing as was done in the published studies. He pondered the idea. He said he was concerned about the CPT billing code conflict. He wasn’t sure how to admit her. He suggested we go to an ER, and have them call him. I was stunned with his reaction. He stated that he didn’t know of any labs in the South that could do metal allergy testing. He suggested the Mayo Clinic. I suggested a knee revision!
He asked for us to wait while he called a colleague and old college friend who did revisions. After almost an hour, he returned with the name and phone number of his colleague, hand printed on a sheet from his prescription pad.
We believed we were being referred to an orthopedic surgeon who was far more advanced in revision surgeries and metal allergies. He was not.
When I called to schedule an appointment, we were given the option of waiting either two days, or eight weeks. We chose two days. The nurse on the other end of the phone curtly demanded that we bring all of my mother’s medical records, x-rays, and any other test results.
We arrived hopeful for solutions. Within a short time my mother was called for a knee x-ray, after which we were escorted to an exam room. Within a few minutes, the nurse told my mother to get on the exam table and left her to perform this difficult task without any assistance.
The surgeon entered about one hour later. His demeanor was harsh, betraying skepticism before either of us said a word. My mother tried to answer his questions as best she could. He interrupted her remarks as if she were a witness for a prosecutor. It was obvious this was not going nearly as well as we had hoped.
Jerking the exam table away from a wall to get to her left knee, the surgeon pushed my mother down from a seated position without any warning. He began applying pressure in what was evidently a painful spot, while asking, “Is this where it hurts?” She screamed as tears began to form in her eyes. He moved her knee from side to side as if it were a piece of machinery and not connected to nerves, muscles, and bone. It was obvious she was in pain, trying to hold back her tears. He had never asked about any details or symptoms. It seemed he had already solved this medical mystery.
The surgeon finished his exam and sat down, never helping my mother back to a sitting position. I rose from my chair to help while she was struggling not to fall off the exam table. He proceeded to the sink as if he were literally washing his hands of the entire ordeal. At this point, my mother asked me to present my theory and evidence. Hesitantly, I began to show him the data, sharing extra copies. He grabbed the papers from my hands as if I had incriminating evidence. He asked me where I got my information. I answered, “On the internet.” He said that was not a reliable source.
He exited the room fuming. For the next few minutes, my mother and I quietly sat while waiting on his return. We looked at each other bewildered.
When he returned, he informed us that there was nothing wrong with my mother’s knee replacement. We didn’t try to convince him otherwise. We left, as my mother limped in pain while leaning on me.
We weren’t trying to blame anyone or seek legal action. My mother needed help and quickly. One of our cousins is a family practice physician. On the ride home, she called him to share her experience. Our usually calm and gentle cousin was outraged. He said he would make arrangements for her to see another orthopedic surgeon.
In a few days, she was again examined. This orthopedic surgeon, although also skeptical, was willing to consider a revision because of my mother’s apparent pain. He too denied any possibility that her knee replacement had anything to do with metal allergies.
To keep a check on her labs, my mother met again with her primary care physician. She shared her sorrowful experiences. He suggested another orthopedic surgeon in the area.
Two weeks later, we met yet another orthopedist, our fourth. This one was a subspecialist in adult joint replacements. He had trained in hip resurfacing in Birmingham, England. He took time to sit in the exam room with us as he read her medical records. He reviewed her x-rays and bone scan. He immediately understood her condition, the studies from Europe, and my theory. He said he was aware of metal allergies and had performed revision surgeries due to metal allergies before. He looked at my mother, asking one question, “When would you like to schedule a knee revision?”
The day of my mother’s knee revision arrived and she was taken to the operating room. Four hours later, the surgeon met with our family in a private room. He said, “It was a failed prosthesis. The metal never adhered to her bone and muscle. The top part fell out into my hands and the bottom part easily pulled out.” She had walked on a failed prosthesis for 37 months.
As her health began to stabilize after this exhausting journey, my mother returned to the neurologist at the university medical center for a followup visit.
In January 2011, he examined her physical strength and believed her muscles had stopped deteriorating.
In February 17, 2012, my mother returned for another followup. She passed the physical strength tests, showing tremendous and much unexpected improvement. The neurologist examined her left arm, where the original complicated muscle biopsy had left considerable weakness, discovering her muscle tissue had begun to regrow and get back to its baseline. He deemed her case a non-clinical (only known case) medical breakthrough. At her next appointment with the neurologist in January 2013, she greeted him with a bear-hug, picking him up. He was elated.
Today my mother is driving, doing household chores, active in social events, and plays the piano for community occasions. “Steel Standing” is her true story which I penned to share an unprecedented and compelling medical case, which correlates seemingly unassociated health issues directly to metal allergies.[3]
References
1.             Keegan, G.M., Learmonth, I.D. and Case, C.P. Orthopaedic metals and their potential toxicity in the arthroplasty patient: A review of current knowledge and future strategies. Bone & Joint Surg (Br) 2007; 89-B(5):567-573.
2.             Keegan GM, Learmonth ID, Case CP. A systematic comparison of the actual, potential, and theoretical health effects of cobalt and chromium exposures from industry and surgical implants. Crit Rev Toxicol. 2008;38(8):645-74. doi: 10.1080/10408440701845534.
3.             Davis CC. Steel Standing book website. Available at: http://www.steelstandingbook.com. Accessed June 3, 2013.
Copyright: © 2013 Christa Carmell Davis. Published here under license by The Journal of Participatory Medicine. Copyright for this article is retained by the author, with first publication rights granted to the Journal of Participatory Medicine. All journal content, except where otherwise noted, is licensed under a Creative Commons Attribution 3.0 License. By virtue of their appearance in this open-access journal, articles are free to use, with proper attribution, in educational and other non-commercial settings.

Comments


2 Responses to “Steel Standing: Metal Meets Muscle; A Patient’s Perspective”



.                 Stephanie Miller says: 
June 7, 2013 at 7:47 pmChrista, thank you sharing your mother’s story. It bought tears to my eyes. It’s a very powerful reminder of the importance of patient engagement and the role of carers. Kind regards, Stephanie

Reply
chad lehan says: 
June 10, 2013 at 9:39 amHello,
I have been battling the same issue with my wife. Only her metal toxicity is cause from 11 cironary stents that can’t be removed. Turns out if you can’t wear earrings because of a metal allergy, you shouldn’t get ANY metal installed. It’s amazing the amount of denial doctors possess. It’s not a new subject. Certainly WELL documented.

Monday, June 10, 2013

Patient Safety Impeded by Doctor Silence about Harm



Dallas Morning News - Danielle Ofri
Published: 07 June 2013 08:07 PM
Updated: 07 June 2013 08:09 PM

It was probably our eighth or ninth admission that day, but my intern and I had given up counting. I was midway through my medical residency, already a master of efficiency. You had to be, or you’d never keep up. This one was a classic eye-roller: a nursing home patient with dementia, sent to the emergency room for an altered mental status. When you were juggling patients with acute heart failure and rampant infections, it was hard to get worked up over a demented nonagenarian who was looking a little more demented.
The trick to surviving was to shuttle patients to another area of the hospital as quickly as possible. This patient was a perfect candidate for the intermediate care unit, a holding station for patients with no active medical issues who were awaiting discharge. First we just had to rule out any treatable medical conditions — get the labs, head CT scan and chest X-ray. But the docs at the intermediate ward left at 5 p.m., and it was 4:45. I quickly scanned through the labs, called the ward’s doctor and ran through the case — demented patient, still demented, return to nursing home tomorrow.
I remember the doctor’s voice so clearly: “You’re sure the labs and everything are normal?” Yes, yes, I said, everything is fine. She hesitated, then said OK. The intern and I high-fived each other and bolted back to our other admissions.
The next afternoon the doctor tracked me down. Without mincing words, she told me that she’d been called overnight by the radiologist; the patient’s head CT showed an intracranial bleed. The patient was now with the neurosurgeons, getting the blood drained from inside her skull.
My body turned to stone. An intracranial bleed? You couldn’t do much worse than miss an intracranial bleed.
How had I let my craze to decrease my patient load overtake proper medical care? I had failed to check the head CT! I was appalled at myself, mortified by my negligence. I stumbled through the rest of the day, an acrid mix of shame and guilt churning inside me.
I never told anyone about my lapse — not my intern, not my attending physician, certainly not the patient’s family. I tried to rationalize it: The radiologist had caught the bleeding, and no additional harm had come to the patient.
But what if I had discharged the patient? What if I had started her on a medication like aspirin that could have worsened the bleeding? My error could easily have led to a fatal outcome. The patient was simply lucky.
In hospital lingo, this was a near miss. But a near miss is still an error, just one in which backup systems, oversight or sheer luck prevent harm.
A near miss, like any error, is an opportunity to examine how mistakes are made and what changes might prevent them. Yet we have no idea how many near misses there are. Many experts feel that near-miss errors dwarf the number of known errors, a number that is already too high for comfort. (According to a 2006 report, medication errors alone injure an estimated 1.5 million patients a year.)
The instinct for most medical professionals is to keep these shameful mistakes to ourselves. For the past two years, I’ve been interviewing doctors about the emotional experiences that have molded them. Though I was interested in the full range of emotions, nearly every single one brought up a medical error that they had been party to during their careers; many of them had never spoken about it before. The shame of their errors — including the near misses — was potent, even decades later.
Much attention has been paid to reducing medical errors. Electronic prescriptions avoid penmanship mistakes. Bar codes on wristbands ensure that medications go to the right patient. Checklists and timeouts before surgeries help prevent common oversights. But we can stop only the errors we know about. There remains a black hole of near misses, of uncharted errors — a black hole of shame that prevents caregivers from coming forward.
Medical culture is less overtly punitive than it used to be, but the guilt and blame are internalized, often savagely, by its practitioners. How can we ease the shame and help doctors and nurses come forward with their near misses?
This is not the type of thing we can orchestrate with a quality-improvement initiative and a zippy slogan. It has to come from inside the medical world, and it helps to start at the top.
When the chief of medicine or the director of nursing stands up and talks about his or her biggest medical error, it will get noticed by the rank and file. Hearing how a person in authority handled the emotional fallout and the feelings of incompetence may give others the courage to come forward. Until we attend to the culture of shame that surrounds medical error, we will be only nipping at the edges of one of the greatest threats to our patients’ health.

Danielle Ofri, an associate professor at New York University School of Medicine, is the editor of the Bellevue Literary Review and the author of “What Doctors Feel: How Emotions Affect the Practice of Medicine.” Follow her on Twitter at @danielleofri.

Thursday, June 6, 2013

Consumer App for Reporting Adverse Events to FDA!


Reporting Adverse Events? There's an App for That, But Not for Industry--Yet
Latest News | Posted: 24 April 2013

Need to report an adverse event related to a medical device? Now patients are about to find there's an app for that, US regulators revealed yesterday.   https://medwatcher.org
Background
The US Food and Drug Administration (FDA) takes in an enormous number of adverse event reports each year through various systems, including MedWatch.
One issue, however, is that manufacturers, healthcare providers and patients are held to different standards. Medical device manufacturers, for example, are held to medical device reporting regulations that require them to report to MedWatch any adverse events they are made aware of, including for off-label uses.
Patients and healthcare providers, meanwhile, are able to report adverse events, but are not required to do so.
That difference has led to significant under-reporting of adverse events according to some estimates, posing a challenge for regulators in their attempts to transition more of the regulatory assessment process to postmarket settings. If, for example, a particularly dangerous adverse event is only seen in one out of every 10,000 patients, it might not be picked up by clinical testing. Once on the market, lax adverse event reporting practices by healthcare providers could delay the time at which the company and regulators become aware of that safety issue, potentially putting more consumers at risk for a dangerous event.
A New App
That's where FDA's new MedWatcher adverse event reporting application (iOS version) (Android version) comes in, said Bill Maisel, deputy director for science and the chief scientist at FDA's Center for Devices and Radiological Health (CDRH), in a statement.
"This app allows medical device users to easily report suspected or known problems with a device from their smartphone or tablet," he said. Users in this context include patients, caregivers, and healthcare professionals, FDA explained.
Maisel later said in an interview with the Wall Street Journal that the crux of the issue for FDA was: "How can we all find out earlier than we have been finding out?"
"We'll get access to better data more quickly now," he hypothesized.
The audience the application is not to be used by is worth noting in this context: Medical device manufacturers and healthcare providers. Maisel said that these two groups, "will continue to be required to report problems through the Medical Devices Reporting System and the Medical Product Safety Network."
Indicative of Future Changes?
But as Jeffery Shuren, director of CDRH, said at the Medical Device Manufacturers Association's (MDMA) annual meeting in April 2012, the system could be a harbinger of changes to come for industry.
According to MD+DI's Arundhati Parmar, Shuren said that the MedWatcher app "will push through adverse events into the database that will replace the Manufacturer and User Facility Device Experience (MAUDE) database. “It would make it easier for aggregating adverse event reporting.”
That functionality could eventually lead to device manufacturers being given the same reporting capabilities as consumers—an outcome that seems all the more likely given that the MedWatcher app is basically just a more user-friendly version of FDA's Form 3500, according to FDA.
"We're transforming this network into a modern system that uses electronic health information," William Maisel confirmed in an interview with the Wall Street Journal.
But the idea of an app hasn't received unanimous support. Paul Ivsin, a consulting director for clinical trials, argued last week that FDA would be better served by avoiding the use of apps entirely, and instead focus on "developing a robust set of Application Programming Interfaces (APIs) that can be used by the teams who are developing medical data apps." That would result in a wider array of more customizable options to meet the needs of hospitals, manufacturers and patients, he argued. In addition, they could link up with other databases, such as the Sentinel Initiative, giving users access to more information. That would also be in line with a 2012 White House directive ordering agencies to make more data open to the public via APIs.
For now, though, FDA can only wait and see whether consumers actually use the applications. As of the time of this article's publication, the app has been downloaded more than 10,000 times.