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GM recalls are bad. Medical device recalls are worse.

August 8, 2014 by Mighty Casey Leave a Comment

USPTO image of morcellator

It’s bad enough when your GM SUV turns into a rolling fire hazard.

Imagine needing, and getting, a hysterectomy, only to discover that the surgical procedure itself turned you into an advanced stage cancer patient?

USPTO image of morcellator
Giant sucking sound. And cancer risk.

That’s exactly what’s been going on since power morcellators became common in laparoscopic uterine surgery to remove fibroids. In morcellation, the fibroid tissue, and/or the entire uterus, is ground up prior to being sucked out of the abdominal cavity. I’m sure that you, and I, can do the biological math on this question, “What if that fibroid is cancerous?” Yep, that would mean that previously encapsulated cancer cells would be set free to run rampant through the aircraft – the patient’s body – spreading its metastatic self far and wide.

Why didn’t anyone at the FDA do that bio-math? Turns out that when these devices were approved in the late ’90s, since other similar devices were already on the market, no clinical trials were ever done. Here’s a graf from the NY Times back in April, talking about this very thing:

“Morcellators were allowed onto the market in the 1990s without the usual clinical trials in patients because they were similar to other devices that had already been approved — a process that critics of the agency say can lead to safety problems like the one that has now been recognized.”

I’ve known about morcellators for only about 10 months – which is surprising, considering my interest in medical quality and patient safety – but my eyes were opened by my buddy Gilles Frydman, the man who started the Association of Cancer Online Resources (ACOR), which gets credit for helping some friends of mine, including ePatient Dave himself, save their own lives by giving them the information they needed to fully participate in their own care. Gilles is also behind SmartPatients.com, but I digress. Gilles tipped me off to the morcellation controversy when we were both at a meeting at a major pharma company – irony! – and asked me to add my voice to the “Morcellator, begone!” chorus. Which I did.

I was delighted to see stories in Medscape and the Wall Street Journal about the FDA warning. But I was not delighted at the fact that it was simply a warning, and an end to sales, not a full-on recall. Because that means that morcellators are still out there in surgical suites and ORs across the globe, putting women’s lives at risk.

One bright spot in this morcellated mess arrived in my inbox last Monday (Aug. 4, 2014) from American Recall Center. I saw the send address, and wondered if my car was getting recalled again. When I opened the email, I discovered that American Recall Center is all and only about medical device and pharma recalls – what a great idea, and how double-delighted I am to learn of its existence.

Here are the facts about morcellation, and its unintended outcome in gynecological surgery:

  • Hysterectomy is the 2nd most common surgery among women in the United States
  • By age 70, one out of three American women will have had a hysterectomy
  • 90% of these surgeries are done to remove fibroids (non-cancerous tumors found in the uterus)
  • The average life span following accidental morcellation of sarcoma is only 24-36 months (editor’s note: WHOA)
  • Only 15% of women who have leiomyosarcoma (LMS) that has spread (stage 4) will be alive after 5 years
  • Women with sarcoma who are morcellated are about 4 times more likely to die from sarcoma than if they had not been morcellated

If you’d like to know more, visit the ARC’s power morcellator page. If you’ve had a hysterectomy or myomectomy where a morcellator was used, you can get a claim review, gratis, from ARC.

Add your voice to the “Morcellator, begone!” chorus – let’s not leave it at “warning,” let’s get these power tools from hell removed from medical practice, shall we?

Addendum: Turns out there’s a page on the ARC site that actually talks about GM recalls. So my opening comment turns out to be not *just* snarky.

Filed Under: Business, Healthcare, Storytelling, Technology Tagged With: e-patients, health care, health literacy, Healthcare, hysterectomy, mighty casey media, morcellator, myomectomy, patient safety, politics, power morcellator, PR, sarcoma

Stetho-Snopes: Time for some rigorous myth-busting in healthcare?

June 23, 2013 by Mighty Casey 22 Comments

stetho-snopes image

It was recently revealed that an Excel error contributed to the European fiscal crisis, and a continuing global economic recession/depression. Paul Krugman called the revelation the Excel Depression in the NY Times.  Certainly lives are at stake when the success or failure of large economies are at risk, but not nearly as many lives as are at stake every day given the lack of transparency (and even, in some cases, plain truth) in bioscience research and medical outcomes reporting.

Ben Goldacre gave a barn-burning TED talk, “Battling Bad Science,” in 2011. He gave another one in 2012 in which he called the data manipulation in scientific research the “cancer at the core of evidence-based medicine.” His point? We cannot make a meaningful decision in the absence of ALL the data.

Tim Berners-Lee, the man who invented the actually-useful-to-humans WWW part of the Internet, has consistently called for raw data – ALL the raw data – NOW.

Paul Levy, the former CEO of Beth Israel Deaconess Hospital, recently blogged about the failure of the Journal of Pediatric Surgery to reveal, in a report on a surgery for sunken-chest deformity, a widely-reported death of a teenage boy after said surgery, even though that boy’s case is used as an example of avoidable medical error in safety bootcamps for medical interns and residents. Boggles the mind, doesn’t it?

Even if the data is fully reported, the PR geeks who write up the announcement of results might get that report 100% wrong. Witness the recent contretemps over a University of Chicago study on patient engagement, shared decision-making, and healthcare cost control. A full outline of that mess, by ePatient Dave deBronkart in Forbes, will give you 411 on that story. The Cliff’s Notes: it was a post-discharge survey, not a full study; it measured attitudes, not outcomes; and the press release was sent out on a holiday weekend, ensuring both pick up (slow news cycle) and lack of follow up.

Given the general public’s lack of understanding of science, the scarcity of journos who can interpret same for said general public, and the scale-thumbing going on in bioscience research, what’s to be done to reverse this disease-mongering and full-on prevarication (look it up) trend?

stetho-snopes image
Stetho-Snopes

How about a Snopes.com for medicine? We could call it … Stetho-Snopes. There’s certainly enough interest in the subject on the part of people and organizations. The challenge is to take all the small villages of interest across the globe and give them a repository for what they find, and what they can debunk.

Ben Goldacre is walking his own talk with an effort called AllTrials, a petition that’s demanding open data from all sources of medical research. Organizations like the Robert Wood Johnson Foundation are working on making medicine and healthcare more transparent and accessible for patients. The Society for Participatory Medicine‘s membership is committed to the same mission: transparency and collaboration across the continuum of care.

How about we all band together and make RAW DATA NOW a reality in medicine? GIMME MY DaM DATA. Now.

Filed Under: Business, Find the funny, Healthcare, Media commentary, Politics, Storytelling, Technology Tagged With: data access, e-patients, health care, health care reform, Healthcare, media, medical research, mighty casey media, myth-busting, politics, PR, science, scientific research, Social media, Storytelling, technology

Medical Monopoly: Medicine has a major image problem

February 12, 2013 by Mighty Casey 2 Comments

medical monopoly image
image credit: Alec

When you hear the word “monopoly,” does it fill you with a warm and fuzzy feeling? (Unless you’re Hasbro, you really should say no, unless you’re a cyborg.)

Healthcare is a monopoly. We can’t DIY cancer treatment, or surgically repair a broken hip for ourselves, so we have to go to the medical-industrial complex to regain our health if we wander into the weeds, health-wise. We also have deep difficulty accessing pricing information. I’ve talked about that here and in even more depth on the Cancer for Christmas blog over the last few years. Maybe not a monopoly in the financial-reg sense of the word, but it sure is mighty like a game of Monopoly.

This “chaos behind a veil of secrecy” (all credit for that phrase belongs to healthcare economist Uwe Reinhart) has created the impression in healthcare customers that there’s no way to tell what something will cost before you buy it. You checks the box and takes yer chances. No Get Out of the Hospital Free cards. No pass-the-admissions-counter-collect-$200 option. That’s a rotten way to run a railroad (one of the original monopoly industries in US history), and an even worse way to run a hospital.

Dan Munro wrote about this, and the star-chamber cabal that actually sets the prices in healthcare, the RUC, on Forbes.com yesterday. I’ve talked about the RUC myself. And the search for price transparency, which seemed such an outlier activity just a couple of years ago, is now popping up in the Well blog on the New York Times site, as well as on Reuters. The Reuters piece has the addition bonus of quotes from my buddy Jeanne Pinder, founder of ClearHealthCosts.com. (Yesterday was a big day in medical price transparency.)

This is the central reason I registered the hashtag #howmuchisthat with Symplur, the healthcare hashtag registry. We all have to start demanding that prices be visible, and that the RUC stop cabal-ing around with our lives and our wallets. As more and more people are finding themselves with high-deductible health insurance, asking how much things cost before you make a healthcare decision will become the norm. If a healthcare provider can’t answer that question, s/he will find that s/he’s seeing the patient panel sinking fast, along with practice revenue.

Get with it, medicine. Remake your image, and your brand, to be clear as glass and user-friendly. Outcome metrics along with pricing would be really nice, too.

Filed Under: Business, Healthcare, Media commentary, Politics, PR, Social media, Storytelling, Technology Tagged With: brand, branding, e-patients, health care, health care reform, health insurance, Healthcare, healthcare economics, media, medical monopoly, medicine, PR, price transparency, Social media, Storytelling, technology

athenahealth CEO Jonathan Bush on EHR & HIE (e-i-e-i-o)

October 8, 2012 by Mighty Casey Leave a Comment

Jonathan Bush of athenahealth has long been a provocateur in health IT. His take on EHR tech, and the build-out of health information exchanges, is worth a listen. He stops short of talking about any open API or open source, though, which means that EHR tech is still in legacy-IT-thinking mode to a degree. Perhaps a big degree?

Res ipsa loquitor:

Filed Under: Find the funny, Healthcare, PR, Storytelling, Technology Tagged With: athenahealth, e-patients, ehr, health care, health care reform, health insurance, Healthcare, hie, jonathan bush, media, PR, Storytelling, technology

Paranoia: American as apple pie. And gunpowder.

April 3, 2012 by Mighty Casey Leave a Comment

strip search

Yesterday (Monday, April 2, 2012) the US Supreme Court handed down a 5-4 decision on the legality of strip searches in jails and prisons.

strip searchThe news is not good for anyone who gets arrested – guilty or not – and proves that the precept of “innocent until proven guilty” is sinking beneath the surf of paranoia that has marked the last decade, and has been a dark underbelly of the American character since Columbus landed all those moons ago.

Which leads me to reflect on the fact that it appears that the more open and social global society becomes, the more paranoid some sectors of society in turn become.

Look at the George Zimmerman/Trayvon Martin incident in Sanford, Florida. Would Martin have been in danger of being pursued and shot by a self-appointed neighborhood watch volunteer if it were not for some serious societal paranoia that drove Zimmerman to feel that he needed to wander the streets strapped with a 9 mil?

Full disclosure: I’m a gun owner. Additional full disclosure: if someone breaks into my house when I’m there, they run a risk of getting a face-full of lead. However, I don’t walk in paranoia when walking the streets of the city where I live. And I didn’t on the streets of New York City for the 27 years I walked there, even though I often found myself in dangerous places because of my work in TV news.

The Kinks song “Destroyer” says it all:

Silly boy you got so much to live for
So much to aim for, so much to try for
You blowing it all with paranoia
You’re so insecure you self-destroyer

Paranoia, the destroyer
Paranoia, the destroyer

As a culture, I think we need to take a long hard look at how we view our fellow citizens, and how we react to their presence in our vicinity. How do you tell if someone “belongs” in your community? Is it based on clothing, demeanor, skin color, language, the car they drive, what?

If your negative-perception radar is pinged simply because someone looks different than you, or different from what your definition of “normal” is, what does that mean about you? Does it mean you’ll shoot a dwarf who walks down your street because s/he is different?

Think about it. Your behavior could lead to a strip search … of you.

That’s my story, and I’m stickin’ to it …

Filed Under: Media commentary, Storytelling Tagged With: branding, casey quinlan, media, mighty casey media, politics, PR, Social media, Storytelling

FDA paranoia – who knew?

January 31, 2012 by Mighty Casey Leave a Comment

fda titanic

In its rigorous search for food & drug safety, the FDA added searching through the personal emails of agency employees who questioned FDA decisions.

That would be an oops – for both sides of that story.

fda titanic
(c) PBS | Frontline

Here’s the lowdown: on Sunday (Jan. 29, 2012) the Washington Post reported that the FDA was being sued by staffers – scientists and doctors charged with testing medical devices – for harassment and wrongful dismissal as a result of the agency’s surveillance of their personal email accounts. That email surveillance revealed that the FDA staffers were contacting Congressional staff with whistle-blower complaints about FDA approval of devices that the scientists and docs thought were a risk to patients.

Hue and cry! Bad FDA!

Actually, I agree that the snoopy surveilling of personal email accounts is creepy, even wrong.

However, here’s the rub: the FDA staffers were accessing their personal email using computers at work. At the FDA. Within the Federal government IT infrastructure. You know, the people that oversee other stuff like Echelon. And the Pentagon. Gee, FDA guys plotting whistle-blower campaigns on work computers – stupid much?

On the FDA side of the story, we have creepy fascist tactics deployed by an agency that should be all about making sure that no pharmaceutical, no medical device, no food product makes anyone sick. Or worse, dead.

The record there? Not so stellar. Can you say Vioxx?

On the outraged-former-employee side of the story, we have some folks who thought they were veryvery smart (scientists and MDs always think that, trust me), but who played veryvery stupid on the interwebz.

Accessing personal email on a computer that belongs to your employer is pretty dumb if you’re doing or saying anything that casts a shadow on the hand that feeds you. Yes, that means you become the bad dog, and that’s not a great role to play. Because “no-no-bad-dog!” translates to “your ass is fired” in this scenario.

Even if you’re on your own computer, and you’re using your employer’s network or VPN, you have no reasonable expectation of privacy.

It boils down to this: just like anything else on the web, don’t put anything on it/through it unless you’re willing to either have it on page 1, above the fold, of the WaPo or the New York Times. Or your boss’s desktop.

The saddest part of this story is that the FDA really does need a total tear-down. It’s become too obstructionist to what could really improve public health, and too easy-peasy for big-money players who want to make the system work for Citizen Corporate, not Mr./Ms. Every-patient.

This lawsuit could become quite the precedent-setter, if it gets past the lower courts with its plaintiffs intact.

Stay tuned for further developments. I sure will.

That’s my story, and I’m stickin’ to it …

Filed Under: Crisis communications, Find the funny, Healthcare, Politics, PR Tagged With: branding, Business, casey quinlan, e-patients, FDA, health care, Healthcare, pharma, politics, PR, Storytelling

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