40-44 As FDA Weighs its Options on Morcellation, Debate Erupts Over Harvard Device Study

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As FDA Weighs its Options on Morcellation, Debate Erupts Over Harvard Device Study

An interview with Amy Reed, formerly an anesthesiologist at Beth Israel Deaconess Medical Center, and Hooman Noorchashm, formerly a cardiothoracic surgeon at Brigham & Women’s Hospital.

Debate Over Brigham’s Containment Bag Study

FDA’s other option is to mandate creation of a post-market surveillance study combining power morcellators with a containment system or bag, which would be used to prevent the dissemination of any tissue, benign or malignant.

One such independent prospective study is underway at Brigham.

Titled “A Partners prospective study assessing the safety, feasibility and efficiency of morcellation in a containment system,” the study tests whether the bags would break or leak when used with a power morcellator.

“Indigo carmine dye will be used in a portion of the study population to assess leakage during the contained morcellation procedure, and is approved by the FDA to be used in laparascopic procedures,” according to a patient consent form for the trial obtained by The Cancer Letter.

About 400 women will take part in this research study, which is conducted at Brigham, Faulkner Hospital, Massachusetts General Hospital, and Newton-Wellesley Hospital.

“We expect to enroll approximately 100 women from each hospital,” the consent form reads.

The principal investigator of the study is Jon Einarsson, a minimally invasive gynecologic surgeon at Brigham. Site principal investigators include: Stephanie Morris, associate medical director at the Center for Minimally Invasive Gynecologic Surgery at Newton-Wellesley; Douglas Brown, director of the Center for Minimally Invasive Gynecology Surgery at MGH; and James Greenberg, chief of the division of gynecology at Faulkner.

Containment bags are cleared by FDA under the 510(k) for oncologic surgery—which removes malignant tissue intact—but not for specific use with power morcellators.

Brigham officials said that the study did not require applying for an Investigational Device Exemption with FDA for the express use of the bag with power morcellation of uterine tissue. The IDE is a process that allows potentially high-risk devices to be tested in patients. By inference, this would mean that the Partners HealthCare IRB had concluded the study to be of “minimal risk,” and therefore did not see the need for an IDE application.

Brigham officials said the study does not have industrial support or sponsors, and is conducted internally at Brigham. However, “sponsors” of the study are mentioned in the patient consent form numerous times, but are not identified.

The Storz Rotocut G1, a power morcellator manufactured by Karl Storz, is used in the study.

The German company had previously threatened Noorchashm with legal action if he did not end his campaign to ban power morcellation (The Cancer Letter, Aug. 27).

“Should we get to know further public statements from you that our device and/or management would be responsible for your wife’s or any other women’s uterine cancer, and/or any aggravation of their cancerous situations, we would not hesitate to take appropriate legal actions to protect our good name and our rights,” Storz wrote at the time in a letter to Noorchashm.

“We trust that you understand our position and conclude by wishing you and your wife that you win the battle against the shocking illness which, nevertheless, cannot be attributed to any of our devices or acts.”

Storz’s threats stem from its concern that possible FDA decisions would negatively impact their sales, now that Johnson & Johnson, their largest competitor, has withdrawn its devices from the market, Challoner said.

“Karl Storz’s issue is not with Hooman,” said Challoner. “Their issue is what the FDA is going to do, and their issue is that they simply want to continue to market their product.

“If you want to paraphrase it, it’s almost as if they said, ‘Your wife almost died when someone used our machine the same way everybody uses it. Machines don’t kill people, but doctors do.’

“I mean, what a great line that is, for God’s sake. So if doctors want to kill people with our machine, fine, keep your nose out of our business. It was really a bad line in that letter. I am simply appalled.”

At the FDA hearing in July, several experts said that training surgeons to morcellate uterine tissue within the confines of a bag would be an intensive process.

Visibility can be an issue, and surgical gynecologists would need to avoid perforating the bag with the morcellator’s spinning blades while removing strips of the patient’s tissue, which may contain undiagnosed malignancies.

In the committee’s summary focused on containment bags, panel chair Michael Diamond, professor and chair of the Department of Obstetrics and Gynecology and associate dean for research at Georgia Regents University, said:

“First of all, there are some techniques, such as vaginal surgery, when it’s possible, for the removal of an intact uterus—that would be a mitigation strategy that could be utilized. There is also concern with supracervical hysterectomy, and potentially cutting across a tumor. Multiple individuals mentioned the desire to avoid any kind of morcellation of tissues, and to remove the specimens intact.

“There was a lot of discussion about the use of bags, and while it was thought that, intuitively, that may have advantages in reducing dissemination of an unrecognized malignancy, the data to support that appears to be totally lacking at this point in time.

“Therefore, the conclusion is that we don’t know, through the use of the bags, to what extent, if any, we’re able to reduce the risk at this point.”

Challoner: Dye is not Cancer

According to Brigham officials, the study will enroll 400 patients to evaluate “a number of commercially available morcellators and bags.”

Challoner said he is skeptical about the investigators’ use of dye leakage as a measure for the dissemination of fibroid or sarcoma cells.

“My guess is that they are going to try and determine whether the dye leaks out of the bag in any way during the course of the procedure, as a clue to whether the bag could prevent any dissemination of morcellated fibroid, or sarcoma, in the worst case,” Challoner said. “It seems to me a pretty weak study.

“The carmine dye and bag are new to this usage. Under what kind of evidence that the combination of a morcellator and a containment bag gives you a 100 percent retrieval of morcellated tissue, I don’t know.

“To me, that is not an adequate study to see whether the bag captures the dye as a stalking horse for a fibroid or a sarcoma.”

The study will not change the risk that individual patients face with the power morcellator, Challoner said.

“Given that there are other alternatives to deal with the fundamental disease, which are not really any more traumatic or difficult than the use of the morcellator, and given the historic experience with the device—the risk in the use of the power morcellator at this moment, it seems to me, is not ethical to take.

“We should have every expectation—from what science is going to bring to this clinical equation over the next years—that we will be able to preoperatively make that diagnosis, and therefore make the use of morcellation and its marginal improvement in ease for the patient, a safe thing to do.

“We’ll know ahead of time who we can use it on and who we can’t. But right now, that’s not what we’ve got.”

In a statement to The Cancer Letter, Reed and Noorchashm wrote:

“In the end, this is very simple. A massive error in judgment, practice, design and ethics has killed a lot of women prematurely or unnecessarily for over two decades.

“What is tremendously and historically tragic is that almost the entire specialty of gynecology and its associated industry are defending this clear wrong and attempting to recover. Instead of humbly admitting a grave wrong and abandoning a hazardous practice, they are creating a controversy out of the incontrovertible.

“In medicine, we do not expose our patients to avoidable deadly harm. Morcellation is, indeed, an avoidable and potentially deadly harm that was adopted by gynecological surgeons for ease and vanity—patient safety and ethics seem to have been entirely abandoned.

“Nor is morcellation to be equated with minimally invasive surgery—morcellation is ‘maximally invasive’ surgery through small incisions. No other surgical subspecialty, except gynecology, accepts this practice as correct or safe.

“The only question that remains now is if, in the face of deadly peril and many victims, FDA and the United States Congress have the resolve, ethics and courage to act decisively to protect the minority subset of unsuspecting women whose cancers would be spread by morcellators.

“But perhaps our government will remain party to this travesty, choosing to adopt the ‘benefit of the majority argument’—after all, in politics and government, there are more dollars and more votes in that kind of argument.”

Study Investigators Applied for Patents on Bags

Jon Einarsson and James Greenberg, two principal investigators of the Brigham study, have applied for or own patents on containment bags that are intended for use with power morcellators.

Einarsson is listed as an inventor on a patent application filed March 5. The patent application is for a morcellating device comprising of a “containment mechanism including an aperture; the containment mechanism having an interior space.”

Einarsson and Greenberg do not have conflicts of interest that are specifically relevant to the study, and are not testing their own inventions in the study, Brigham officials said in a statement to The Cancer Letter.

“Dr. Einarsson’s patent is for a system and method for a laparoscopic morcellator,” officials said. “At the time this study was reviewed by the Institutional Review Board which governs research at BWH, Dr. Greenberg was listed as an inventor for a tissue extraction bag.

“While both of these technologies are generally relevant to the area of morcellation, neither of these patent/technologies are relevant to the specific study in question.

“The study does not involve, use, test or evaluate technologies under either the patent or invention. We are not aware that any of the other investigators have patents or financial interests that are relevant to the study.”

Einarsson was Erica Kaitz’s surgeon.

“There was unequivocally never a mention of morcellation until three days after Erica’s diagnosis,” Rick Kaitz said to The Cancer Letter. “In my meetings with the Brigham leadership, there was an acknowledgment of multiple things.

“One, that morcellation significantly harmed Erica. Two, that morcellation was not discussed or disclosed in any way, shape or form pre-surgery. And three, that the one in 10,000 risk number was used.”

Kaitz questions the ethical underpinnings of Brigham’s study.

“Einarsson has a patent,” Kaitz said. “He has a vested economic interest. They are trying to protect their turf, rather than asking front-end questions: ‘What type of harm are we causing,’ or ‘What’s the cost-benefit analysis of this device?’ That’s part one. Obviously, Erica’s story is instrumental to the whole thing.

“And part two is, unfortunately, the Harvard/Brigham position is in large part colored by institutional arrogance, because Hooman Noorchashm attacked them so publicly and so vociferously, that to continue their ban on power morcellation would be an admission of wrong-doing, which they would never do in the face of an insider attacking them like Hooman attacked them.

“That’s probably the biggest reason that the Brigham won’t do and hasn’t done the right thing.”

Brigham officials said that there was no need to disclose Einarsson’s patent or Greenberg’s invention in the patient consent form.

“The study was reviewed and approved by the Institutional Review Board which governs research at BWH,” officials said. “At the time of review, the IRB and the Partners Office for Interactions with Industry, which reviews researchers’ financial and other interests in connection with research studies and grants, were aware of the patent held by Drs. Einarsson and the invention of a containment bag by Dr. Greenberg.

“The Einarsson patent and the Greenberg invention were reviewed in connection with this study.

“It was determined that because neither Dr. Greenberg’s containment bag nor Dr. Einarsson’s morcellator is used, tested or evaluated in this study, neither the Einarsson patent nor the Greenberg invention are directly relevant to this study.

“Therefore, there was no requirement to disclose these technologies to the participants enrolling in this study.

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