Sunday, November 15, 2015

I told you so

There are a lot of terrible lessons that come from the sad case of Amy Reed and other women who have developed more widespread cancer as a result of morcellation of uterine growths.

Here's a comment from a pathologist friend:

I remember, when these morcellators first came out, saying to the gyn's that if a woman had an unexpected endometrial cancer, I would not be able to stage it because you can't tell how deep it went into the uterine wall when the uterus is in pieces. And yes, we were puzzled about the leiomyomas, too. We used to have a rule that you took so many microscopic sections per centimeter of leiomyoma (i.e. larger ones are more likely to be sarcoma) to look for sarcoma. But how could you tell how big it was or which one was which from pieces?

We were ignored of course. It all goes back to how new things are introduced - there is no vetting process at all.

Let's consider this deeply. Pathologists are highly trained MDs who specialize in the identification of anatomical and cellular abnormalities. They are the doctors upon whom other doctors rely for diagnosis of and phasing of cancer. In this case, they made it clear to the doctors who take care of women with potentially cancerous conditions that a piece of equipment and a technique employed by those gynecologists could eliminate diagnostic clarity. And yet, the technology was adopted.

This story represents an institutional failure of the highest order. Underlying that failure, I would assert, is the ongoing medical arms race. Manufacturers design a product that makes life easier for one segment of the medical world.  FDA approval with regard to safety is limited in scope. Because data emanating from usage of the device is inherently inaccurate or incomplete (i.e., a needle in a haystack level of precision), it remains in use notwithstanding harm that has been caused.

But doctors also need to consider the story and reflect on how their own behavior can be destructive.

The pattern. Stories start:

About ten years ago, reports started surfacing in the medical literature of women with severe pelvic pain or unexplained bleeding who all had something in common: they had undergone morcellation years prior. Doctors reported finding growths in the abdominal cavities that could be traced back to the fibroids and uteruses that had been removed. This was troubling enough in itself—it had been assumed that missed particles, without a blood supply, would simply be reabsorbed—but it also raised the possibility that cancer could be spread too.

Serious concerns emerge:

Between 2008 and 2010, case reports of disseminated leiomyosarcoma by researchers in New Delhi, Montreal, Boston and Osaka were published. In at least one instance, the new tumour growth was definitively linked to the original specimen. Other papers compared outcomes for women whose undetected LMS had been morcellated versus not morcellated, and they found that morcellating an LMS tumour made it more likely the cancer would spread, and, according to at least one paper, more likely that the woman would be dead within five years.

By 2011—two years before Reed’s surgery—morcellation had become a full-on conversation among cancer doctors. Jeong-Yeol Park, a gynecological oncologist at the Asan Medical Center in Seoul, Korea and the lead author on one of the morcellation comparison papers, presented his findings at the Annual Meeting on Women’s Cancer. In an Oncology Times article about the talk, Bobbie Gostout, chair of gynecology at the Mayo Clinic in Minnesota, commented: “I don’t think there’s an acceptable, safe morcellator out there ... We are exposing our patients to a risk that to me seems out of bounds.”

Nonetheless, inertia rules, as per what happened after a review of Amy's case and an impassioned plea from her surgeon husband Hooman Noorchashm:

By the end of the meeting, little had been achieved. The Brigham would not lead the world in banning morcellators or even curtail their use in its own operating rooms. A few days earlier, the hospital had circulated an internal memo acknowledging that the risk of accidentally morcellating a sarcoma might be much higher than previously thought. It suggested that all surgeons get informed consent from patients before using the device. With that, the hospital felt that the matter had been dealt with.

Likewise, across town:

Isaac Schiff, head of obstetrics and gynecology at Massachusetts General Hospital (MGH), another Harvard affiliate . . . recalled being alarmed by the case of a morcellated fibroid turning out to be a sarcoma and he brought it up at a faculty meeting on December 12, 2013. There, he and his colleagues changed the hospital’s informed consent procedures.

Meanwhile, the person trying to be the agent of change is himself attacked, as incumbents in the system started to eat their young:

Now, though, the Brigham moved to isolate Noorchashm. The day after the December meeting with CMO Ashley, senior hospital staff circulated an internal email instructing Noorchashm’s colleagues to not communicate with him directly but instead to go through official channels. His job also became a sticking point. 

His descent was steep and lonely. In a matter of weeks, Noorchashm had gone from being a Harvard-affiliated surgeon, a golden boy with a shining future, whose life and identity revolved around the operating room, who got up at 4:30 every morning and seldom made it home in time to kiss the kids goodnight, to someone whose major scheduled activities involved dropping his children off at school in the morning and listening for their buses in the afternoon.

Tragedy upon tragedy upon tragedy. And totally avoidable, if from the start, the thoughtful voices from the pathology profession had been taken into account. Rosemary Gibson (in The Wall of Silence) has written elegantly about the underlying problem, a problem the profession steadfastly refuses to address:

The people who provide health care to patients are organized in different tribes. . . . Virtually no training exists to help them learn how to work together, so instead of learning to understand and respect one another's role, there are chasms among the tribes.


Unknown said...

Excellent article.

Bob said...

What's unbelievable, just unbelievable, is that in two hospitals the immediate reaction was TO GET INFORMED CONSENT! Not look out for the patient, but look out for yourself and the institution. These guys should meet their colleagues at the U. of Illinois, they are of the same ilk morally and ethically. And behind it all is money and competition.

In the end, it's an ethical issue, and behind that, science. "That's what quality costs," I remember hearing. Right.

Carole said...

The cold blooded treatment they were shown after everything they had been through is cruel and sickening, their anguish is heart felt and their story should be told over and over and in the biggest and loudest way possible. If "they"will throw one of their own under the bus by not respecting them using their tragedy to help and make a positive difference for everyone's sake including the medical professionals then what does that mean for the rest of us?!? This is one story, there are hundreds more out there that people don't know about and should!! Where's our investigative journalist? make transparent the process behind the system that fails us all. Any of you who want to know the truth about the "so called flawed system" -Take a course in risk management, Go work or volunteer in all the places we file complaints to. Maybe then and only then you'll find out or realize the system isn't flawed after all, that it's been skillfully thought-out, created, designed, cleverly hidden and tucked away to serve a purpose that's successfully carried out and monetarily driven, and It is what it is, and it does what it does.
I think the not so wealthy malpractice lawyers who sincerely consider a harmed or dead patients "precious life value" not monetary value and if their worth (the money in advance) and the very very expensive time helping (proving what's already obvious, but pretend it's not) AND the incompetent error (only human) and honest mistake making (trained denial) professional rotten to the core, but saved and used apples- Are Best Friends...Just joking ! Trying to cover the hurt and anger this story triggers for me :( them hurt and worse betrayed, sad.

jeanX said...

Try The Journal of Minimally Invasive Gynecology, Jan 21 2015:
A Medical-Legal Review of Power Morcellation in the Face of the Recent FDA Warning and Litigation (probably written in August 2014)

The hospitals are really lawyering-up.
It's not the patients.

Anonymous said...

We talk about his story frequently. This is not only bad doctoring, more than anything it is bad admin. They are the ones who should pay more so than the doctors on this.

You should see a photo taken: all the admin AND GOVERNMENT together at a public meeting, against Hooman. It should be publicized in every major paper if they weren't as bought as politicians are.

Carole said...

JeanX and anonymous-
This story and everything that branches off of it, is a beast of corruption at its finest. Everybody should of heard and known about this, the fact they DONT speaks volumes. VOLUMES-
Those hospitals lawyered up because that's what the guilty who are taught and trained- denial and zero responsibility of wrong, DO.
I'm sorry I thought major newspapers were fearless, and could never be silenced, guess everyone has a price!! We're doomed, people!
Mr. Levy as always what you post and share with us is a gift that you keep on giving. It's like celebrating a birthday or holiday everyday.
Anon- where can we find the photo?
jeanX- that additional info. you guided us to was priceless, thanks.

Lori Nerbonne said...

Can we call this what it is? Medical narcissism at the highest end of the spectrum.

Anonymous said...

As a response to this, Hooman, Amy's husband, has had to leave Facebook because of the persecution from his own kind. There are photos of business leaders together with the govt entities on this mess. All set against doing what is right and ethical.

Carole said...

Everything about this story is outrageous and disturbing, always doing what's right and ethical should be praised, rewarded, and respected. When In this story are the good guys going to prevail, and the bad guys be exposed? Like really exposed? Being shady frauds and conniving so called professionals at this level "yes, your truly the bad guys" not the good guys we expect or trust you to be.
"The worse of the worst kind" to decent and righteous people- your no different than the common thugs on the streets who are out to hurt us and with no conscience, do. I'm struggling looking for words to express how completely sorry and saddened I am for this couple. Whatever any of us could say to them or for them will never ever be enough for what they've gone through and sacrificed to help others obviously trying to do the medically moral right thing, with ridiculous and unexceptable repercussions to their lives.

Thomas said...

Don't face the problem, don't care for the patient, just change the consent form to protect the hospital and perhaps the surgeon. Then walk away and let the suffering begin. Docs whining about taking away this "valuable" tool seem much more concerned with the income drop than the patients' outcomes.