Vizient Inc. Retracts “Innovation Award” to Olympus For its New Power Morcellator — Corporate Ethics, Alive!
Last week, I wrote an article about a misguided “innovation” award a prominent healthcare marketing corporation named Vizient, Inc. had given to Olympus — the maker of a new power morcellator device marketed under the trade name “Pneumoliner”.
You can read this article HERE.
I followed up with Vizient’s Chief Executive Officer, Mr. Curt Nonomaque, in an email, also CC’d to the company’s Chief Legal Officer, Mr. David Berry. My email read as follows:
“Dear Mr. Curt Nonomaque,
This email is to inform you that your corporation is participating in the unsafe and false marketing of a medical device manufactured and distributed by Olympus:
https://medium.com/@noorchashm/deceptive-marketing-in-healthcare-women-beware-2d8902806526
It is my recommendation, in the interest of maintaining your corporation’s public trust, that Vizient immediately retract its endorsement of the untested and oncologically unsafe medical device known as the “Pneumoliner”.
I’d be happy to discuss this serious error in your corporation’s marketing of this device with you, if you wish.
Sincerely,
Hooman Noorchashm MD, PhD”
To my total surprise, I received a very prompt and polite response from Mr. Berry. His email read:
“Dear Dr. Noorchashm,
Thank you for your email and bringing your concerns to our attention. Vizient takes patient safety very seriously, and we are looking into this matter immediately. We would welcome any additional data and information that you can share that would assist in our analysis.
We look forward to hearing from you.
Sincerely,
David”
This was encouraging. So in a response to Mr. Berry, I elaborated on the reasons why Vizient executives, like Olympus’, were making a serious error involving their company with a product that is proven to cause a mortality risk to unsuspecting women. I sent the following response to Mr. Berry, Vizient’s Chief Legal Officer:
“Dear Mr. Berry,
Your prompt attention to my communication is appreciated.
Please note that FDA placed a black box warning on power morcellators in November 2014, contraindicating the use of this device in the “vast majority of women”. I am certain that you will look into the large press that was generated surrounding this FDA decision and discovery of the danger associated with the use of power morcellators in women.
The Pneumoliner power morcellator device, now manufactured and marketed by Olympus, was subsequently granted FDA clearance through the 510(k) loophole without any preclinical large animal or clinical safety trials. Certainly performing human experimentation using this device, given that its core component (i.e., the power morcellator), itself, causes a severe cancer risk to women, is ethically prohibitive.
In fact, the University of North Carolina, upon learning about the serious safety, ethics and liability risks inherent to human experimentation with Pneumoliner has suspended its clinical trial of this medical device, after serious concerns were raised. The Vice Chancellor for Clinical Research at UNC, Dr. Robin Cyr, is CC’d here and can confirm that UNC suspended this trial of the Pneumoliner based on the stated concerns.
I suspect and hope, that in recognizing this device with an “innovation” award, your corporation was unaware that this medical device has not been safety tested, and that the FDA’s 510(k) process used to attain FDA clearance for Pneumoliner, is a loophole that enables medical device companies to avoid adequate preclinical safety testing. I cannot imagine Vizient having been aware that this product has not been safety tested in a setting where a well-known and deadly cancer risk is intrinsic to its design, and yet granted it an innovation award as a “safe” and trail-blazing tool. I hope you are able to see your company’s error with clarity.
As background, in case you are unfamiliar, FDA’s Center for Devices and Radiological Health (CDRH), passed the Pneumoliner through its 510(k) process in April 2016, despite the fact that the core technology underlying the Pneumoliner (i.e., the power morcellator) itself causes the upstaging of gynecological cancer — as has been the case in hundreds, if not thousands, of unsuspecting women across the the US and abroad for nearly 20 years. CDRH did so under tremendous pressure from industry advocates — and without any real guarantee of oncological safety, as their chief scientist admitted and warned in the FDA press release of April 2016:
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm494650.htm
The question of pertinence to your corporation, now, is if you and Vizient’s executives are willing to stake your company’s reputation on a product whose safety is unproven — and if anything relies on a core element that causes a deadly risk of cancer upstaging in the Gynecology space.
My respectful suggestion is that Vizient immediately retract this “Innovation Award” you’ve given to Olympus and divest yourselves from this dangerous product. This technology, and the harm it has caused along with its untested (and ethically untestable) new version from Olympus, will only represent liability to your company’s reputation as a leader in promoting and marketing safe medical products. Additionally, several power morcellator companies are undergoing active litigation in courts across the nation for having caused deadly cancers to spread in unsuspecting women. I suspect Olympus will soon join their ranks.
Please accept this communication and warning as that of a friend to your corporation’s mission of improving and enhancing America’s public health. I will look forward to hearing that Vizient has divested itself from this dangerous and untested medical device by retracting the innovation award you’ve publicly presented to Olympus. I assure you that it would be the correct decision on your part.
Sincerely,
HN.”
The following day and to my total astonishment, given the spat of disturbing corporate misbehavior I’ve been used to in the campaign against morcellation in gynecology, I got this email from Mr. Berry:
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“Dr. Noorchashm,
Thank you for sharing your concerns related to the Olympus morcellator. After investigating this matter further, we have decided to discontinue our association with this product and will be withdrawing our innovative technology designation.
Again, thank you for reaching out to us.
Sincerely,
David”
Now, this response to me demonstrates that our corporate leaders are capable of listening to and acting upon safety and liability signals from the marketplace. And they are able to do so efficiently and ethically….when they choose to.
I responded to Mr. Berry, as follows:
“Dear Mr. Berry,
If you would send me a link to Vizient’s press release regarding this retraction, I’d like to include it in an update to the large community of patient safety advocates, activists and citizens aware of the public health battle against morcellation in gynecology — as a clear example of a corporate healthcare entity finding itself well capable of standing unequivocally on the side of patient safety and medical ethics when any doubt at all exists.
Again, please convey my sincere thanks to your corporate leadership for standing on the side of women’s health with little hesitation on this issue. It was an unexpected, unconventional and welcome response in an arena where most have behaved in a defensive and protectionist manner
Thank you again,
Hooman.”
He agains responded:
“Good afternoon, Dr. Noorchashm,
Thank you for your most recent email, and I want to respond to your request. Per our normal business practice, we did not issue a press release announcing the innovation designation for the morcellator product produced by Olympus. The press release that you sent us in your initial email was issued by Olympus. At our request, Olympus has agreed to take down their press release.
Thank you for sharing your concerns and expertise on this important issue.
Sincerely,
David”
And, in fact, Olympus has removed the press-release announcing Vizient’s innovation award from their website. If you click on THE LINK, it will come up as “Access Denied”.
I responded to Mr. Berry as follows:
“Dear Mr. Berry,
Excellent.
Thank you Mr. Berry.
I’ve noted that the press release has been deleted by Olympus (i.e., “access denied”):
Now, if only the executives at Olympus recognized that it is not acceptable to market and distribute a medical device that has not undergone any clinical safety testing, and where its core component is known to spread cancer and has been banned from use in the “vast majority of women” by FDA….
Perhaps from a liability and publicity perspective Vizient can take a leadership role in convincing Olympus’ executives to drop this potentially deadly and avoidable product from its line up.
All reasonable persons know that it is better to be safe than sorry….The totally avoidable spread of cancer in unsuspecting women is no small matter. Very certainly the notion that a corporation would allow unsuspecting women to be used as “experimental” subjects, when the known mortality risk is cancer upstaging caused by the device itself, is totally egregious.
I ask for your continued friendship to public health by convincing your colleagues at Olympus to withdraw this dangerous product from the market urgently.
Sincerely,
Hooman.”
Now it remains to be seen if one instance of strong and ethical corporate behavior by Vizient, Inc. will rub off on their clients at Olympus. After all, I am sure Vizient executives looked at the problem I elucidated for them and agreed that this product is way too unsafe, untested and controversial to bet on.
For now, Olympus seems full steam ahead with marketing a product that FDA has essentially banned from use in the vast majority of women, The University of North Carolina as suspended a clinical trial of for ethical and safety concerns, and Vizient has retracted as an innovative invention.
Perhaps Olympus executives are ok with making a few dollars and passing the buck on ensuring patient safety and ethics to others — I suspect such an orientation will eventually get them and their insurers into hot water. And I am glad to finally see an instance of corporate courage: Vizient’s retraction of Pneumoliner’s “innovation” award was a strong move and demonstrated that that company’s leaders have their priorities straight.
If you are one of Olympus’ executives reading this article, please consider that your primary concern and goal ought to be the safety and ethics of your products — Pneumoliner has not undergone clinical safety testing (and cannot, from an ethics perspective). Your decision to manufacture, market and distribute this dangerous product remains, dead wrong!
