Did Mrs. Jones receive her off-label failed spinal implant via excellent informatics data, or via a surgeon's visit to a prostitute?

In a story that leaves me at a loss for what has become of medical ethics, I read that Medtronic stands accused of, among other marketing tactics, inducing surgeons to use its spinal implant devices via kickbacks and outings to a now-closed Memphis strip club whose owners pleaded guilty to dancers engaging in acts of prostitution.

Apparently the devices were being used extensively for off-label uses, resulting in unexpected adverse events, some quite serious in nature.

I could not have made up this rather sordid story if I tried:

Wall Street Journal
Sept. 25, 2008

Lawsuit Says Medtronic Gave Doctors Array of Perks

(subscription required)

A lawsuit brought by a former Medtronic Inc. lawyer alleges the big medical-device maker gave surgeons a variety of incentives to use its products, including regular entertainment at a Memphis strip club, trips to Alaska and patent royalties on inventions they played no part in. The previously undisclosed allegations involve Medtronic's spinal-devices unit, which has $3 billion in annual revenue. The unit's business relationships with doctors who use its spinal-repair implants are being investigated by Sen. Charles Grassley and have been the focus of lawsuits by other former employees.

Sen. Grassley has been looking into whether inducements for doctors, like those alleged in the lawyer's suit, have led to what surgeons say is widespread off-label use of Medtronic spine products.

... Ms Kelley's [whistleblower Ami P. Kelley, a former senior legal counsel for the spine unit] lawsuit says kickbacks were "pervasive" and "the culture and way of doing business" at Medtronic. Sales staff, she said, "routinely took physicians" visiting the spine unit's Memphis headquarters to the Platinum Plus strip club, and picked up the tab for the dancers' services during "VIP visits." In 2007, Platinum Plus's owner pleaded guilty to charges related to dancers engaging in acts of prostitution, and the club has closed.

Ms. Kelley's lawsuit sought to recoup damages for the federal government, which prohibits companies from giving doctors inducements to use products covered by Medicare or Medicaid.

Her lawsuit and a separate one that also accused the spine unit of paying illegal kickbacks to doctors were the basis for a $40 million settlement deal between Medtronic and the government in 2006, according to the settlement document.

"VIP Strip Club" visits for orthopedic surgeons and neurosurgeons? I'm certain that only the most advanced scientific discussions between company and client occurred at such venues.

My questions are:

• Why would any physician allow themself to be taken by a vendor to a strip club? This is a questionable and unprofessional activity on its face, but in the context of vendor marketing to surgeons (presumably male), it is even more appalling. I personally would have rejected such an invitation out of hand as being sleazy and tawdry by its nature.
• Was there a genuine data-driven attempt to evaluate the off-label uses?
• What datasets were being collected by the company and the surgeons to support non-FDA-approved uses of the spinal implant devices?
  
• Who designed those datasets?

Not to mention:

• Did the wives and families of the surgeons know where their husbands and fathers were being taken on their "business trips to Medtronic?"
  

The names of the involved physicians are currently a closely-guarded secret:

The former Medtronic lawyer's allegations are contained in a 2002 suit filed in U.S. District Court in Memphis against Minneapolis-based Medtronic and 10 doctors. The lawsuit and other filings in the case remain sealed, except for a heavily redacted copy of the complaint, which contains none of the doctors' names nor specifics of the allegations.

Medtronic has refused repeated requests from the Senate Finance Committee's staff for an unredacted version. Sen. Grassley, an Iowa Republican, is the panel's ranking minority member.

... The Kelley lawsuit names several top spinal surgeons among the 10 doctor defendants and lists several others as receiving inducements.

The complaint clearly comes from the typical "disgruntled employee":

Ms. Kelley, who now works at another company, alleges she was dismissed by Medtronic after challenging improper payments.

One surgeon's name was apparently made available to the WSJ:

The suit says surgeon Jeffrey Wang, now director of the University of California at Los Angeles's Comprehensive Spine Center, "liked to be taken" to Platinum Plus and emailed Medtronic sales official Brad Hancock saying he was "looking forward to going" to the club with him.

Of course, UCLA has an air-tight explanation for this:

A UCLA spokeswoman said Dr. Wang, who isn't named as a defendant in the suit, "denies ever being entertained by Medtronic at the Platinum club" and doesn't recall sending any such email. If he did send it, she said, "it would have been done so in jest."

In jest? They mean to say, a top surgeon who claims he never went to the club, doesn't recall sending the email --- but if he did actually send it and simply forgot (meaning he would have known a vendor takes doctors on "VIP visits" to strip clubs / houses of prostitution but refused to go himself) then it was just a joke?

On the MedInformaticsMD scale of credibility, that rates about a 0.3 out of 10. It's not even good spin.

All is better now:

Medtronic declined to comment on the lawsuit's allegations. It said it has changed many business practices since the suit was filed, and is "committed to reform and transparency in the industry."

How reassuring.

Actually, not, considering the posts about Medtronic's practices on this blog here, here, here and here, among others.

Also not reassuring was the simplest Google news search on "spinal implant problem medtronic" which returns items like this:

Medtronic Will Settle Accusations on Kickbacks
New York Times - Jul 19, 2006
Medtronic was the subject of two lawsuits filed in Federal District Court in Memphis by whistle-blowers on the actions of its spinal-implant division, ...
All 14 related - Related web pages

Medtronic to settle with doctor over spinal implant invention.
Free with registration - Saint Paul Pioneer Press - AccessMyLibrary.com - Apr 23, 2005
Spinal implant devices are part of a division that accounted for 20 percent of Medtronic's $9.09 billion in total sales last year. In 1999, Medtronic paid ...
Medtronic to Pay $1.35 Bln to End Spinal Doctor... - Bloomberg
Medtronic to buy spine patents, ends legal battle - USA Today
Forbes - San Diego Union Tribune - All 22 related - Related web pages

Medtronic Sofamor Danek's Patent Infringement Lawsuit Begins.
Free with registration - Commercial Appeal - AccessMyLibrary.com - Jun 4, 2004
Medtronic Sofamor Danek and Dr. Gary Michelson are disputing patent rights over the Los Angeles surgeon's inventions in spinal implants, instruments and ...
All 2 related - Related web pages

Medtronic Must Pay Inventor $109 Million, Jury Says (Update3)
Bloomberg - Sep 28, 2004
28 (Bloomberg) -- A US jury told Medtronic Inc., the world's biggest maker of spinal implants, to pay at least $109 million to an inventor for violating ...
Medtronic Must Pay Inventor $109 Million, Jury... - Bloomberg
Memphis, Tenn., jury awards surgeon $110 million... - Commercial Appeal - AccessMyLibrary.com (Free with registration)
All 12 related - Related web pages

Medtronic Must Pay Surgeon $400 Mln Punitive Damages (Update2)
Bloomberg - Oct 12, 2004
Minneapolis-based Medtronic doesn't break out sales of spinal implants. The unit that includes spinal products, as well as ear-nose-and-throat devices, ...
Medtronic ordered to pay $400 million to Los... - Saint Paul Pioneer Press - AccessMyLibrary.com (Free with registration)
$400 Million Judgment Against Medtronic - New York Times
Los Angeles Times - Star Tribune - All 11 related - Related web pages

I'm not even going to attempt to dig any deeper. I fear I may lose my breakfast as a result.

However, hopefully Sen. Grassley and his staff will dig deeper.

A lot deeper.

It's hard for Medical Informaticists and others to help usher in an era of data-driven healthcare when we are competing with strippers and prostitutes for the affection of our surgeons.

-- SS

Addendum:

I am increasingly coming to believe the executive resistance I faced to development of an advanced, very fine-grained, still-used Invasive Cardiology Clinical Database (ICCD) at a major heart center in Delaware late last decade was not based on scientific issues.

This information system could show whether a new device or treatment was effective or not in short order, affecting valuable orders for devices. In fact, in its first year it saved almost $1 million in expense through just that means.

Interestingly, the resistance was from administration and IT, not the doctors, who were the true cheerleaders of the system. Reading the increasingly common stories about the way business is conducted by such companies, I do wonder if cardiac device companies could have been in bed with administration in some way.

Additional addendum 9/28/08:

UC leadership is certainly aware of this issue as well as this posting, after reading it via a Google search on the terms "Medtronic" and "stripper." From the HCRenewal tracking logs:

Domain Name: ucsf.edu ? (Educational)
IP Address: 169.230.242.# (University of California San Francisco)
ISP: University of California, Office of the President
Operating System: Macintosh MacOSX
Browser: Firefox
Time of Visit: Sep 28 2008 6:35:33 pm
Last Page View: Sep 28 2008 6:35:33 pm
Referring URL: http://www.google.co...r&btnG=Google Search
Search Engine: google.com
Search Words: medtronic stripper
Visit Entry Page: http://hcrenewal.blo...eive-her-failed.html
Visit Exit Page: http://hcrenewal.blo...eive-her-failed.html