The University of North Carolina’s IRB Approves an Unethical and Flawed Clinical Trial in Women: The Power Morcellator, Risen.

Hooman Noorchashm
Jul 25, 2017 · 9 min read

Recently the University of North Carolina (UNC)announced the start of a very concerning clinical trial on women with symptomatic uterine fibroid tumors.

The title of this clinical trial is: “Safety and Efficacy of Using PK Morcellator With Pneumoliner Containment Hysterectomy” (ClinicalTrials.gov Identifier: NCT03216772). You can find a description of this clinical trial, here.

This trial is led by Erin Carey, MD, a UNC gynecologist and member of the American Association of Gynecologic Laparoscopists (AAGL). The study appears to have been approved by UNC’s Institutional Review Board (IRB) and is funded by the medical device company Olympus.

All sounds very legit until one takes the time to explore the specifics. As with all thing “the devil is in the details”.

Unfortunately, there is a serious ethical violation and dangerous surgical error lurking in the proposed clinical trial, which could compromise the lives of the unsuspecting women who will be consented to participate in this trial by the investigators. The purpose of this article is to inform the public and the responsible professionals, academics and regulators of the facts that prohibit performing the proposed experiment on any women with symptomatic fibroids.

Erin Carey MD, Principal Investigator on UNC’s new clinical trial of the new Olympus Morcellator

The Pneumoliner containment system was specifically promoted and marketed following a 2014 FDA action eliminating the use of power morcellators in the vast majority of women with symptomatic uterine fibroids . This warning came specifically because of a deadly adverse event associated with the use of this device in one in 200–400 women susceptible to spread or upstaging of their occult or missed uterine cancer when undergoing morcellation.

Timothy Shibley MD, inventor of Olympus’ new Pneumoliner morcellator

In fact, the designer of this device, Dr. Timothy Shibley, was present at the FDA hearing of July 2014, which focused on the perils of morcellation and has led to its virtual demise in Gynecology. But Dr. Shibley and his venture capitalist and AAGL colleagues, with the FDA’s blessings, elected to use this session as a forum to defend morcellation and to advertise their “safer” verison of the power morcellator: the Pneumoliner. This was not only a distasteful choice for the FDA to allow in the face of the many families who had lost a loved one to a morcellator, it was also telling of the AAGL’s goal of keeping this revenue-rich, flagship procedure alive in gynecology.

The FDA subsequently approved this untested and dangerous device for marketing in the United States without any input from the FDA’s Cancer section, the OCE. But in a profoundly shocking statement at the time of this approval, the FDA’s chief scientist in the medical device section said that “we want to be clear that, although the device has been shown to successfully contain morcellated tissue, it has not been proven to reduce the risk of cancer spread during surgery.” Undeterred and ignorant of their elementary error and ethical confusion, Dr. Shibley and his colleagues, later boasted about a single patient whose dangerous high grade cancer had been morcellated using this invention and who reportedly did not experience spread of her cancer at 2 years post-op — this, as evidence that his invention must be safe. Of course, no self-respecting clinician would ever accept an “N-of-1” as demonstration of safety — especially when it comes to a mortality risk like that caused by the mechanical spread and upstaging of an occult cancer.

Olympus’ new Pneumoliner morcellation device for use in gynecology

So, the true purpose of the Pneumoliner device, and the new UNC study’s objective now, is to defend and retain the practice of morcellating women’s uterine tumors using a power morcellator in gynecology. The AAGL and its practitioners hope they can point to a study and say to their patients (and, possibly, to judge and jury), “here, this thing is safe. We studied it. We proved it was safe.” So Ms. Smith, “don’t worry, you don’t have cancer and if you do this thing will protect you”. And Ms. Jone, whose cancer was upstaged, “Sorry, you are incredibly unlucky, but this device is proven safe in a clinical trial”.

All sounds good.

Except, of course, morcellation of women’s uterine fibroids has not only harmed and killed many unsuspecting women, it is also a dangerous violation of a time tested surgical principle: That resecting tumors with malignant potential must always be done in one piece and with reasonable margins. Gynecological morcellation is a direct violation of this proven safety principle in surgery. But because the vast majority of GYN surgeons assume that fibroid tumors are benign, the women whose fibroids are not benign end up susceptible to their cancers being upstaged by their gynecologists — well meaning, but surgically ignorant.

That brings us to the UNC trial, which is very troubling, indeed. It is frankly shocking that an academic institution of UNC’s caliber and its IRB, ethics board and risk managers would ever buy into such flawed and unethical experimentation on women. Very likely, this approval was either farmed out to a third party IRB like Western IRB for a rubber stamp, or the in-house IRB was not informed of the actual details or didn’t care to ask. So. here, I am providing them with the background and analysis for the record.

First, the trial’s stated design is highly misleading in that it does not explicitly state its cancer-related objective, instead stating the goal to be quantification of “disruption of the isolation bag (using dye leak testing) or visible tissue dissemination”. This is deceptive marketing at its worst, because it fails to announce the true purpose of the study to those participating.

Secondly, it is impossible to perform this study, whose main goal is to prevent the spread of occult or missed cancers of the gynecological tract, with any degree of ethical integrity, statistical power and without the medical center incurring a substantial burden of liability. This makes it all the more shocking that UNC’s IRB and lawyers were convinced to undertake the risk of such a clinical trial. Perhaps they should drink more coffee and stay awake during their board meetings.

But let me be very specific. Here is a point-by-point critique of Dr. Carey’s clinical trial of the Peneumoliner morcellator at UNC — and why the institution ought to immediately abandon it:

1) In order to specifically demonstrate oncological safety (i.e., the ability of the pneumoliner device to prevent upstaging), the study subjects will have to be women with uterine cancers undergoing morcellation using the pneumoliner device. Of course, everyone understands that such a study would be ethically unacceptable and negligent to perform, irrespective of whether a patient with an already diagnosed cancer might be willing to consent to such an experiment. So, the trial appropriately excludes women with a suspected or known gynecologic malignancy. But without such a study population, it is not possible to definitively demonstrate oncological safety, because it is ethically incorrect to use the necessary study population to conduct the experiment.

2) Assuming that at least one of the subjects enrolled in this study does have an unsuspected, missed or occult gynecologic malignancy, and irrespective of her having consented to participating in the experiment, that subject would be inevitably placed in deadly harm’s way from cancer upstaging by the investigators — and by UNC. The ramification of such a devastating complication in a subject would be devastating to the subject and, very likely, to UNC’s insurers. It is important to consider carefully that neither such a patient, nor the investigators, expect her to have had a malignancy because if they did then she would have been excluded from the study — but if she does harbor an occult or missed cancer, specifically given the unknown oncological safety of the pneumoliner device, as stated by the FDA, the subject will have been exposed to an avoidable, irreversible, well-established and deadly oncological risk.

3) The informed consent process for this experiment, no matter how carefully crafted, will inevitably lack in integrity. Because the study’s principal investigator does not believe the subject to whom she offers the experimental procedure to have cancer, but if she happens to have an undiagnosed missed or occult cancer there is an unknown risk of cancer upstaging with potentially deadly consequences. Who would consent to such a study? And how does such a consent protect the patient with an unsuspected malignancy from spread or upstaging? The answer is that the informed consent in this study is virtually impossible to obtain without compromising the safety of the subject —any reasonable clinician and ethicist understants that knowing this possibility at the outset of a study contraindicates initiating the experiment. The simple fact is that uterine fibroids carry a risk of malignancy that cannot be definitively ruled out — and morcellation violates a universal oncological safety principle. These two facts should prohibit morcellation, in general. Of course, this is a basic calculus that was lost on the vast majority of GYNs until 2013. But, I am, frankly, shocked at how any reasonable IRB/Institutional ethics board could possibly approve such a consent with all the information that exists now about the perils of morcellation and power morcellators? I am certain that none of the UNC general surgeons weighed in on the safety of this study — because surgeons know better than to mince up a tumor with malignant potential inside a human body cavity. Very certainly UNC’s risk managers and lawyers ought to carefully consider the legal ramifications of such a dangerous and unethical study design and its consent process — especially given the serious liability incurred at the present time when a gynecologist upstages an occult gynecological cancer. The UNC risk managers may not be aware that there are literally hundreds of lawsuits ongoing around the nation, against gynecologists and device manufacturers who have harmed (and killed) women using power morcellators. Do UNC and its risk managers really want to incur the financial and professional liability involved with this public health hazard? I suppose we shall see.

4) Even assuming the UNC ethicists and risk managers can somehow be silenced or convinced by Dr. Carey and her colleagues in Gynecology that this study is important enough to perform at their institution, it is still seriously deficient in its design. With an occult cancer risk of one in 200–400 in women with symptomatic fibroids, the proposed 140 subjects would lead to an impressively underpowered study to assess the true oncological safety of the Pneumoliner device. Literally thousands of women would have to be morcellated in this experiment in order to determine, with statistical significance, if the one in 200–400 with occult cancers are truly protected from the spread of cancer by this device. Therefore, even granting that both UNC’s ethicists and risk managers somehow erroneously approve such a dangerous and ethically impossible study, the design itself is critically flawed. It would be impossible to demonstrate oncological safety in the proposed 140 women with potential occult or missed uterine cancers whose symptomatic fibroids lead to their enrollment in this experiment.

The primary purpose of this article is to warn any women considering participation in this study against it. Moreover, it is hoped that the University of North Carolina medical center’s IRB, ethics board, risk managers and academic faculty are able to see that the proposed study is critically flawed in its ethics and design.

Also, executives and liability managers at the Olympus corporation ought to study the power morcellator hazard in women’s health and learn from the large liability being imposed on their compatriots at J&J and STORZ, who are in the morcellation business. Though it is likely that Olympus bought into Shibley’s Pneumoliner invention with the intention of capitalizing on a patient safety deficit marketed by the AAGL — the company’s executives have clearly not studied the deadly danger of morcellation and the massive liability it will impose on the corporation, with any degree of clarity.

In summary, the new study from UNC poses a serious and irreversible danger to unsuspecting women with occult or missed cancers undergoing experimentation by the UNC gynecologists. And the study poses a very serious legal liability to UNC and its insurers, because even if one out the 140 proposed subjects has an occult or missed cancer, the unknown oncological safety of the pneumoliner device is a potentially deadly risk to that patient.

It is my sincere hope that the academics and risk managers at UNC will immediately move to suspend this impossible-to-perform clinical trial — and consider that there is no ethical or scientifically sound way in which to perform the proposed experiment to prove the oncological safety of the penumoliner device. Certainly, one would hope that Olympus would learn from the liability cost being paid by J&J, STORZ and the other device companies that caused the deaths of many unsuspecting women.

Hooman Noorchashm

Written by

Hooman Noorchashm MD, PhD is a physician-scientist. He is an advocate for ethics, patient safety and women’s health. He and his 6 children live in Pennsylvania.

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