Dr. Amy Reed Dies at Age 44, Mother of 6 Children and Advocate for Safe Medical Devices

Amy Reed, Doctor Who Fought a Risky Medical Procedure, Dies at 44

By DENISE GRADY

MAY 24, 2017  (FiDA highlight)

Dr. Amy J. Reed, a physician and cancer patient who turned a personal calamity into a crusade to spare other women from the medical procedure that harmed her, died on Wednesday night at home in Yardley, Pa. She was 44.

Dr. Amy J. Reed and her husband, Dr. Hooman Noorchashm, in 2014. (MATTHEW CAVANAUGH FOR THE NEW YORK TIMES)

Her husband, Dr. Hooman Noorchashm, said the cause was leiomyosarcoma of the uterus, a type of cancer.

Dr. Reed and her husband fought for years to ban the use of a surgical tool called a power morcellator, which has a spinning blade that slices up tissue so it can be extracted through small incisions. Though the device is regarded as a great boon to minimally invasive surgery, if a patient has cancer, as Dr. Reed did, morcellation can spread the disease.

Dr. Reed and Dr. Noorchashm (pronounced NOOR-chasm) won some notable victories. Because of their efforts, the Food and Drug Administration studied morcellation and in 2014 recommended that it not be used in the “the vast majority” of women having surgery for uterine fibroids, a common tumor that is usually benign but that can hide a dangerous type of cancer.

Some insurers began declining coverage for morcellation, and one major manufacturer took its morcellators off the market. Use of the technique dropped.

Dr. Reed, an anesthesiologist and the mother of six children, underwent surgery involving morcellation in 2013, when, at 40, she had her uterus removed because of fibroids. The operation was performed at Brigham and Women’s Hospital in Boston, which is affiliated with Harvard Medical School, where both Dr. Reed and Dr. Noorchashm had teaching positions. A biopsy after the operation found that Dr. Reed had a hidden leiomyosarcoma, an aggressive type of cancer.

Only then were Dr. Reed and her husband told that her surgeon had used a power morcellator to slice up her uterus. The device allows doctors to work through small slits rather than big, open incisions, so that patients can heal faster and run less risk of bleeding and infection.

At that time, morcellation was performed on 50,000 women a year in the United States to help remove fibroids, or to remove the entire uterus.

The device had sprayed malignant cells around inside Dr. Reed’s abdomen, leaving her with an advanced, Stage 4 cancer.

As physicians, Dr. Reed and Dr. Noorchashm knew at the time that her morcellation procedure could be a death sentence. As a surgeon himself, Dr. 

Dr. Reed quickly embarked on a series of aggressive treatments, but she still suffered one recurrence after another, in her abdomen, lungs and spine. She had several major operations and received arduous courses of chemotherapy, radiation, immunotherapy and experimental treatment.

The couple fought the medical establishment as fiercely as they did the cancer, seeking to ban morcellation. They sent thousands of emails to the F.D.A., device makers, hospitals, legislators, professional societies and individual doctors, and they reached out to news organizations to publicize their cause.

Dr. Noorchashm also collected the names and histories of women whose cancer had spread after morcellation, enlisting them, or their survivors, in the crusade.

Dr. Amy Reed with her husband, Dr. Hooman Noorchashm, and their children in their backyard in Yardley, Pa., in the summer of 2015.

JENNIFER CAPOZZOLA

Their activism, alienating some colleagues and aggravating administrators, came at a price. Dr. Noorchashm had been a rising star in cardiothoracic surgery at Brigham and Women’s, where his wife had the operation, but as he continued to criticize its gynecology department, his career there began to stall.

He and Dr. Reed were both hired by the University of Pennsylvania, and moved there in 2014. Both had extended family in and around Philadelphia.

They had apparently burned their bridges at Harvard. At one point, when Dr. Reed needed to return to Brigham and Women’s for a medical procedure, she and Dr. Noorchashm were stunned to find that the hospital had assigned a guard to inspect their bags and escort them at all times, for security reasons. Dr. Noorchashm called a lawyer. A judge put a stop to the escort, issuing a restraining order against the hospital.

The gynecology profession also fought back against Dr. Noorchashm and Dr. Reed, insisting that leiomyosarcoma was so rare that the benefit of morcellation — the ability to have minimally invasive surgery — far outweighed any risk.

Before 2013, the F.D.A. had received no reports of uterine cancers being spread by morcellators. But after Dr. Reed and her husband went public — interviewed by newspapers, magazines and TV news shows — reports began to pour in. Dr. Reed, with her hair gone and her youngest child sometimes climbing onto her lap during interviews, was a sympathetic figure.

The couple’s efforts gained traction. The F.D.A. responded by studying published and unpublished medical data on morcellation. Before then, estimates of how many women with fibroids would have undiagnosed leiomyosarcomas or other uterine sarcomas were based on studies of varying reliability, and ranged from 1 in 10,000 to in 1 in 500. But the F.D.A. concluded in April 2014 that hidden sarcomas were more common than earlier estimates had stated — and probably occurred in about one in 350 women with fibroids. The tumors are extremely difficult to detect without surgery.

Soon after the F.D.A. issued its findings, one maker of morcellators, Johnson & Johnson, pulled its devices off the market. But others remained.

In November 2014, the F.D.A. went further, recommending that power morcellators not be used in the vast majority of women having fibroid surgery. Using the device in women with undetected sarcomas, it said, “may spread cancer and decrease the long-term survival of patients.” The F.D.A. portrayed the statement as a “safety communication,” not as an announcement of a new regulation.

Morcellator use dropped significantly, but many gynecologists still favored it, and the devices remained available. Dr. Noorchashm and Dr. Reed would not settle for less than a complete ban, and continued to agitate. They prodded legislators to ask the Government Accountability Office to investigate morcellation.

In a report issued in February, the G.A.O. criticized the F.D.A.’s method of collecting data on problems stemming from morcellation, noting that the system was dependent on voluntary reports from doctors, who frequently fail to report bad outcomes.

The F.D.A. said it agreed that it needed a better system to detect harm to patients. By September 2016, the agency had received 285 reports of uterine cancer being spread by morcellation.

Amy Josephine Reed was born on March 22, 1973, in Bristol, Pa. Her mother, the former Joann Tunis, was a pharmacist and executive at the drug company Pfizer. Her father, William Reed, was a health insurance consultant.

Dr. Reed graduated from Pennsylvania State University in 1995 and went on to the University of Pennsylvania, where she earned a Ph.D. in immunology and a degree in medicine. She specialized in anesthesia and critical-care medicine.

She and Dr. Noorchashm met as graduate students and married in 2001. In 2011, both were offered teaching posts at the Harvard Medical School and clinical positions at its affiliated hospitals — Dr. Noorchashm at Brigham and Women’s and Dr. Reed at Beth Israel Deaconess. She treated victims of the Boston Marathon bombing in 2013, as well as the surviving bomber.

Besides Dr. Noorchashm, Dr. Reed is survived by her parents; her daughters, Nadia and Ava; her sons, Joseph, Joshua, Luke and Ryan; and seven siblings: Alison Perate, Andrea Kealy, Amber Trainer, Matthew Reed, Justin Reed, Daniel Trainer and Sarah Trainer.

https://mobile.nytimes.com/2017/05/24/us/amy-reed-died-cancer-patient-who-fought-morcellation-procedure.html?_r=0&referer=http%3A%2F%2Fm.facebook.com

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.

Righteous Indignation!

Righteous indignation is typically a reactive emotion of anger over perceived mistreatment, insult, or malice. It is akin to what is called the sense of injustice. In some Christian doctrines, righteous indignation is considered the only form of anger that is not sinful.

ReginaHolliday, the Walking Gallery, just completed this amazing jacket for my brother, Steven Baker.  "Don't Tell Me To Zip It!" 

 What you see in our eyes is not disappointment, but righteous indignation!

The righteous indignation stems from research (my blog is an aggregate of that research) that easily uncovers a continuing systemic abuse of our government by elements of the entitled implanted medical device industry.  The indicators are patient harm (mutilation, torture) and futile class action lawsuits that do not stop the perpetrators from exploiting others. 

This morning the Senate Medical Technology Caucus was briefed  (with the FDA/CDRH) about the new “Medical Device Innovation Consortium” an unnecessary and redundant platform for the industry to influence regulators and legislators.

Patients are the primary stakeholders.  Patient engagement is a term that is not being honored.  I am witness as a patient advocate who has dedicated much of my life the last 5 years to following protocol to determine why my brother’s elbow implant failed and to get him the care that he needs.   It is clear to me that our government (FDA) is unable to assure that implants are safe and effective and subsequently unable to provide justice/assistance to correct the system so this does not happen to others. 

The cost of this failure to U.S. healthcare consumers is staggering, but the profit of the device industry is driving exploitive legislation and status quo medical practice.  Public education and public indignation is coming.  Ethical CEO’s must get out in front and lead the US medical device industry to embrace patient adverse event reports as an essential, timely mechanism to improve product. 

Dear MDIC founders,

 "Maura Donovan, PhD" <maura.donovan@medtronic.com>  

Dale Wahlstrom <dwahlstrom@biobusinessalliance.org>

Please accept this as my application for MDIC membership.  Please waive the $5000 annual fee.  I represent patients harmed by failed implants with the goal of making implants safer and more effective.  FDA/OSHI has interviewed me, I attended a FDA Patient Representative workshop and testified at 2 CDRH Town Hall meetings and the first MDUFA meeting 1/2011.  I understand that MDIC is interested in inclusion of all stakeholders in this new 501(c)3 nonprofit partnership.  I look forward to working with you.

http://www.washingtonpost.com/business/technology/fda-pledges-to-work-with-medical-device-industry-consortium-to-speed-up-product-approvals/2012/12/03/0c9e4c10-3d64-11e2-8a5c-473797be602c_story.html

FDA pledges to work with medical device industryconsortium to speed up product approvals

           

By Associated Press, Updated: Monday, December 3, 10:11 AM

WASHINGTON — The Food and Drug Administration says it will collaborate with medical device manufacturers on a public-private partnership designed to speed up the development of new medical technology.

The agency says it hopes to offer guidance to the Medical Device Innovation Consortium, a new industry-backed group that aims to simplify the design and testing of medical devices.

Medical device makers have criticized the FDA for an overly burdensome review process, which they claim slows down development of important new therapies. Congressional Republicans have held several hearings to scrutinize the agency’s system.

Faced with criticism from industry and Capitol Hill, the FDA has been highlighting efforts to slash red tape and accelerate review times.

The new consortium was created by LifeScience Alley, a Minnesota-based industry group that includes leading manufacturer Medtronic Inc.

Gratitude for Blog interview by 'Confident Voices' Beth Boynton

Rehab Counselor’s MissionWhen Brother’s Surgery Failed? Campaign for Surgeon & ManufacturerAccountability

November 7, 2012 By Beth Boynton

“Escape Fire” is a documentary film that explains how broken our healthcare system is in some big ways and inspires focus on people who are working to make it safer, kinder, and more cost-effective.  We can do amazing things in USA healthcare, but not always.  And when things go wrong, patients, families, and even healthcare professionals suffer terribly. As tragic as such eye-opening experiences can be, some people respond by trying to understand what went wrong and why and then work to prevent similar problems from happening to others.  In today’s post, I interview Joleen Chambers, who’s brother, Steven had elbow replacement surgery at the Mayo Clinic.  The replacement elbow failed, leaving him with more suffering and a healthcare system that is unresponsive and unaccountable.

Tell us a little bit about your background.

I grew up in small town Minnesota in a family of three children. I am the middle child and my brother is younger than me by 4 years.   After college I married and completed my education with a MS in Rehabilitation Counseling in Chicago.  I have enjoyed living on the east coast and the last two decades in Dallas, TX.  I am active in support of the arts locally and of women’s leadership programs statewide and nationally.

What led your brother to seeking a right elbow replacement at the Mayo Clinic?

My brother is a life-long Minnesotan, Air Force veteran and father of two young adults.  For seven years he attempted to overcome a severe work injury by having 7 surgeries of plates and screws to hold his elbow together.  Maintaining employment as a millwright (a 20 year-long job that he loved) became impossible.  Finally, his surgeon in Minneapolis, MN told him about the Mayo Clinic option to have an elbow replacement. 

What happened after the surgery and how is he doing now?

Steven was quite confident immediately after the 5/19/2008 elbow replacement that he would have significantly less pain and more functionality, but at just 4 months, he felt and heard the elbow “pop” and the pain began.  My advocacy began one morning when I called Steven and he was in so much pain he could not speak/think clearly.  His arm was yellow, green, blue, purple & black.  I phoned his surgeon/Tornier device designer, Shawn O’Driscoll and Steven was told to return to the Mayo Clinic.  On 9/29/2008 the elbow was “revised”.  When Steven read the clinical records he learned that two components were removed.  Steven asked that the surgeon report the elbow to the FDA MedWatch because a revision of a joint replacement is considered an adverse event.  The surgeon refused (and is not legally required to report unless there is a fatality).  Steven reported as #5009052.  I became his ‘scribe’ because of his injury and the amount of correspondence that was required.

How did the Mayo Clinic respond to concerns about the elbow and your brother’s persistent problems?

 There was an astonishing disconnect between the marketing (patient-centered care) and the reality of care for this harmed patient.  A registered/certified letter I wrote to the Mayo Trustees went unanswered.   Steven and I met with Mayo Clinic Patient Affairs to no effect.  Steven was referred to surgeons with less experience than the original surgeon (trained by Tornier and only on cadavers!).  July 10, 2010 Steven received a letter stating that Mayo Clinic would provide only federally mandated emergency care because of ‘communication and trust difficulties’ with no notice and no appeal. This summer I applied and competed for a scholarship to the Mayo Clinic Social Media Summit and I was ‘unselected’. 

What are your concerns about the surgeon, the medical device, (elbow replacement) and the medical device company?

I believe that the surgeon/designer is conflicted by his profitable business association with the medical device company.   His elbow (which is an innovation on the more traditional Morrey elbow) had not been proven to be safe and effective.  It was FDA approved through FDA 510(k) process that does not require clinical testing.  The Institute of Medicine  7/29/2011 report states that 510(k) is flawed legislatively.  In Canada, the elbow had been recalled.

What are your concerns about the judicial system in situations where medical devices fail and or cause problems for patients?

Lawsuits (especially class action, i.e. metal-on-metal hips, surgical mesh, ICD, etc.) highlight that current regulation of implanted medical devices is in disarray and does not protect patients.  Patient harm from implants is catastrophic and cannot be compensated in a court of law.  It is too little, too late! 

Tort reform limits the cases that injury lawyers can afford to take and Supreme Court Riegel v Medtronic gives the medical device industry preemption from state courts.  The system is corrupted because there is no feedback to/accountability by the medical device industry that prompts responsiveness to reduce/eliminate patient harm. 

What are you doing to make healthcare safer?

I use social media to join with other patient advocates, consumer organizations and activist legislators to support

their efforts and to stay current with progress towards:

•             Medical device registry accessible to patients,

•             Unique device identifiers (UDI),

•             Product warranty,

•              FDA Patient Representative stakeholders with full voting rights,

•             Rescind/reduce medical device industry judicial entitlements.

Do you and/or Steven have anything you would like to ask Dr. O’Driscoll?

I would ask him, if he believes that his treatment of my brother fulfills the Hippocratic Oath he took and to please explain.

Steven would ask Dr. O’Driscoll two questions:

1. How do you justify continuing to implant Tornier elbows when the patient harm is so catastrophic and the failure rate is undetermined?

2.  What was it about my communications that prompted you to request of Mayo Clinic that I be medically abandoned by the entire institution without appeal?

Thanks Joleen,  for all of your work to help create safer kinder healthcare.  You can reach Joleen Chambers at  jjrk_ch@swbell.net.

I wonder how tricky boundaries we face in healthcare sometimes and ask how we have create systems that respond to patients when we think we can help them but shut down when we fail.

To understand more about our struggling healthcare system and get involved, watch the movie, “Escape Fire” on Itunes or through  “Escape Fire” Website.  The trailer itself is full of talking points!