publication date: Dec. 18, 2015
20151218 - Dec. 18, 2015
ISSUE 46 – DEC. 18, 2015PDF



How Medical Devices Do Harm

Friends call him The Hoomanator, a darkly comical conflation of his first name, Hooman, and morcellator, the medical device he has aggressively campaigned against.

Enemies—who are great in number—call him much worse.

Over the past two years, Hooman Noorchashm, a cardiac surgeon at Thomas Jefferson University Hospital, has been accused of launching a “campaign of distortions,” threatened with legal action, subjected to security searches and publicly chastised.

Over a two-year investigation, The Cancer Letter tracked Noorchashm and his wife, Amy Reed, as they challenged FDA, Congress, hospitals, the gynecology profession and manufacturers of medical devices. Their struggle began with a routine hysterectomy, during which a device called a power morcellator disseminated Reed’s undetected sarcoma. Today, as Amy’s aggressive disease spreads, the couple continues to draw public attention to the blind spots in the U.S. medical device regulatory system.

Two Docs Who Broke the Code

Hooman Noorchashm sends out several scathing emails each day.

Consider the subject lines of some recent emails that went to hospital administrators, with copies to members of Congress and the press: “Your ethical lapse and negligence.” “Outrageous!” “Your corruption.” “The Fouled Ethics of Your Specialty.” “Do read with care.”

“The time for diplomacy has passed,” Noorchashm said to The Cancer Letter. “I have no time to play politics. I have a wife with advanced cancer and six young children.”

His wife, Amy Reed, is battling advanced leiomyosarcoma. Since her undetected cancer was spread via power morcellation performed at Brigham & Women’s Hospital in October 2013, Reed has been in treatment for metastatic disease.

“Every time I see her go through these different phases and I think about the implications of it, it gives me a little bit more resolve to look at the root cause of this thing and hit it as hard as I can,” Noorchashm said.

The Root Causes of Harm From Medical Devices

The FDA Office of Criminal Investigations is being asked to determine why the agency has failed to detect the upstaging of cancers in women who had been operated on with a power morcellator.

These devices, widely used to shred uterine tissue in minimally invasive gynecological surgery, are now known to upstage undetected cancers that, according to FDA, occur in one of about 350 patients undergoing hysterectomies and myomectomies.

It took over two decades for the agency to realize that thousands of women may have died from metastatic uterine sarcoma upstaged by power morcellators, Rep. Mike Fitzpatrick (R-Pa.) wrote in a Dec. 18 letter to the agency.

Conversation with The Cancer Letter

Vodra: 510(k) Process Does Not Assess Risk; Needs to Be Broken Up Into Multiple Risk Groups

FDA’s Class II 510(k) clearance process for medium-risk devices—a category that includes the power morcellator—is inadequate, because it does not focus on risk assessment, according to Bill Vodra, a former associate chief counsel for drugs at FDA.

Instead, the 510(k) process relies on “substantial equivalence” to predicate devices, thereby allowing subsequent iterations of a device to introduce risk without active FDA surveillance.

“A huge variety of devices are now in Class II, and they pose extraordinarily different kinds of risk,” Vodra said. “The current test for clearance of a 510(k) is, ‘Is the proposed device substantially equivalent to another device (the predicate device or device chain) that has been marketed?’ “The answer may be yes, but that does not tell you much about risk of the proposed device or its predicates.”

Pilot: Don’t Change 510(k), Put More Money Into Enforcing Reporting Laws

Patients are being harmed because FDA doesn’t commit sufficient resources to enforce federal requirements for hospitals and manufacturers to report adverse outcomes caused by medical devices, according to Larry Pilot, one of the original authors of FDA’s 510(k) device clearance process.

There is no need to revamp the 510(k) process, Pilot said. The agency should instead enforce existing laws to make device manufacturers and user facilities report adverse outcomes.

“It’s a good system we have now, but FDA needs to allocate more resources to enforcement, especially for user facilities,” Pilot said. “That’s why FDA, with its authority, and this opportunity to put the emphasis on reporting to the user facility required by law, and then by specific regulation, should be going for money penalties for user facilities that do not abide by the reporting requirement.”

Daniel: FDA Does Not Have a Reliable Surveillance System for Medical Devices

Devices aren’t tracked with the same rigor as drugs, because FDA does not have a data system that can reliably track medical devices and identify potential safety problems, according to Gregory Daniel, fellow and managing director of the Center for Health Policy at Brookings Institution.

“Without having such a data system that can be used for active safety surveillance—i.e., safety monitoring that doesn’t rely on reporting of adverse events by providers or manufacturers—it is challenging to quickly identify potential safety issues with devices early on,” Daniel said.

Capitol Hill

Congress Passes $1.1 Trillion Omnibus Bill

Boosting NIH Budget by $2 Billion

Congress passed a $1.1 trillion government spending bill Friday morning, increasing the NIH budget by $2 billion. The measure now moves to the president’s desk for approval.

Editorial

The Year in Review

As the New Year approaches, we are preparing to revamp our website and launch an app. The work on it is almost done—a January launch seems likely.

In 2015, we got to report some cool stories, win national journalism awards and successfully deflect Amgen’s attack on our First Amendment rights.

In Brief

  • Raymond DuBois named dean of MUSC College of Medicine
  • John “Drew” Ridge elected medical staff president at Fox Chase – Temple Health
  • Bhramar Mukherjee appointed associate director for population science at University of Michigan Comprehensive Cancer Center
  • Joseph Smith Jr. awarded Huggins Medal from the Society of Urologic Oncology
  • Society of Toxicology honors award recipients, including Richard Adamson with the Founders Award
  • Albert Einstein Cancer Center awarded NIH grant
  • OHSU and Cancer Research UK to collaborate on early detection
  • St. Jude opens proton therapy center
  • IU Simon Cancer Center taking high school and college applicants for its Summer Research Program
  • HealthWell Foundation launches fund for underinsured multiple myeloma patients
Drugs and Targets

  • FDA approves Bendeka injection, a bendamustine formulation for infusion
  • Stem Cell Theranostics and CapellaBio launch collaboration on cardiotoxicity
  • Amgen enters into agreement with GSK to reclaim rights to Prolia, XGEVA, and Vectibix

 

The Cancer Letter will take a publishing break and return Jan. 8, 2016.

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