Wednesday, November 19, 2008

Look Who's In The Operating Room

At an article today entitled "Medtronic Says Device for Spine Faces Probe" (Wall St. Journal, Nov. 19, 2008, subscription required) the WSJ reports another major medical device manufacturer, Medtronic, faces a probe for promoting unapproved uses of its technologies, which is improper:

Doctors can deploy FDA-approved drugs and products any way they see fit, but companies aren't permitted to promote off-label applications or to pay doctors inducements to do so.

"While the law establishes that doctors can prescribe any approved treatment, but off-label promotion by manufacturers is not allowed, there's growing concern that the line is being crossed, and a Justice Department review is the right kind of response to those questions," said Sen. Charles Grassley (R., Iowa) who has been looking into whether inducements by Medtronic have led doctors to use its products off-label.

This type of story is common at Healthcare Renewal, and the blog leaves quite a rich trail of search engine-available information, since the healthcare blogs are relatively immune to the anechoic effect. I see numerous hits from governmental agencies in the U.S. and overseas, for example, on search engine queries regarding malfeasance or incompetence at specific companies and organizations. I will not comment on the ethics of the Medtronic/nonapproved promotion issue any further here.

I do want to comment, however, on an item in the WSJ article that caught my eye:

Depositions in a malpractice lawsuit brought by Laurie DeNeui, of Rushmore, Minn., focused on off-label Infuse use and Medtronic salesman Curt Messler's relationship to her spinal surgeon, Bryan J. Wellman of Sioux Falls, S.D. Mr. Messler said in his depositions in the case that he was with Dr. Wellman in the operating room "a lot" when he used Infuse. He also said he considered Dr. Wellman a friend and said the men saw each other socially.

... About four days after her October 2005 operation to fuse cervical vertebrae, Ms. DeNeui said in an interview, her neck swelled up, she had trouble swallowing and she started choking on food. Soon, she said, she started having difficulty breathing. Ms, DeNeui, 46, said the problems prevented her from returning to work as a teacher and baffled several specialists. Steroid treatment helped ease the breathing and gagging problems, but caused her to gain weight and contract diabetes.

Dr. Wellman denies any malpractice. In a deposition, he said Mr. Messler encouraged him to use Infuse in cervical spine operations, and that he has done more than 100 such procedures with the product. Dr. Wellman said he discussed with Mr. Messler the right dosage of the Infuse material to use in the surgeries but determined the dosage on his own.

Mr. Messler, who isn't a physician, has a degree in criminal justice, and his prior work history included owning a bar and jobs with New York Life Insurance Co. and Procter & Gamble Co. In his depositions, Mr. Messler denied encouraging Dr. Wellman to use Infuse for unapproved applications or discussing how much to use.

This is the typical I said-he said scenario. That issue's adjudication will also not be discussed here. While the article also states this patient signed a consent to permit Medtronic representatives to be in the operating room, I have several questions of a very fundamental nature.

In background to these questions, when I was fifteen years old I attended the summer NSF-funded Advanced Preceptorship Training Program (ATP) at Hahnemann Medical College and Hospital back in the early 1970's. It was a program designed to introduce high school students to biomedicine (ironically Hahnemann's former medical college is now part of Drexel University, where I teach healthcare informatics). I was assigned back then to watch surgery under the surgical team of Drs. Pearce, Ulin and Weinstein, permitted to scrub in and hold retractors, and in one case to actually saw through a femur in a leg amputation for diabetes-related gangrene. I also made rounds with the surgical team. While today this practice would probably not be permitted on privacy and malpractice concerns, I can honesty admit I offered no advice on surgical procedures or other interventions. I simply didn't have the background.

In the Medtronics situation of reps in the O.R., I thus ask the following questions:

  • Were patients and others in the O.R. aware of the lack of the Medtronic sales representative's medical credentials?
  • Are such consents sought and signed routinely for allowance of medical device company reps in the operating theater?
  • What, exactly, was the purpose of having a nonmedical person in the O.R.? What, exactly, could such a person contribute?
  • Why would any patient want a nonmedical person in the O.R. with the potential for that person to give advice or affect the procedure in some manner?
  • What were patients told to convince them to sign the consent?
  • If advice was given of any kind to any clinician the O.R., would that not constitute the practice of medicine without a license?
  • What were the rep's obligations if they witnessed anything they thought could be misuse of the device, or any other practice they thought improper?
  • Did the rep follow the surgical team around in postop care?
  • Why couldn't Medtronic actually hire people with medical backgrounds for such roles, instead of a former bar owner and P&G sales rep? Could such people be afforded?
  • Might people with medical credentials and experience actually be better suited to make valid scientific observations in the O.R. setting?

These are just some of the questions that come to mind in the seemingly inexhaustible cornucopia of nonmedical people either leading healthcare organizations or performing roles perhaps better performed by people who actually have a medical background, and actually know at a very detailed level what they're doing.

-- SS


Anonymous said...

This is an old issue. As noted by the information below reps have been in surgery, often directing or in some cases performing the surgery itself for some time. What I find disturbing is that there is a general outcry about the lunacy of this situation, only to see it repeated at a future date.

The presence of sales representatives in the OR

AORN Journal,  April, 2001  by Ellen K. Murphy

In 1997, a highly publicized ambulatory surgery incident occurred involving the use of a new piece of equipment, the presence of a sales representative in the OR, and a patient death. This incident renewed attention to the need for hospital and ambulatory surgery units to revisit, revise, or, in some cases, formulate policies that address the presence, preparation, and expected behavior of sales representatives during surgical procedures.

Steve Lucas

MedInformaticsMD said...

Steve Lucas wrote:

What I find disturbing is that there is a general outcry about the lunacy of this situation, only to see it repeated at a future date.

ref: "Anechoic Effect" at link in my post!

-- SS

Anonymous said...

Excellent questions asked in this post.

The problem, I believe, is that others do not ask such questions, which likely are void of appropriate answers.

MedInformaticsMD said...

Anonymous wrote:

The problem, I believe, is that others do not ask such questions, which likely are void of appropriate answers.

They are void of defensible answers, at least to anyone who abides by the core values of medicine.

-- SS

Anonymous said...

This IS my story. All that happened was unethical-- and wrong.

Anonymous said...

I was first to sue and lost in federal court-- (Confidential with medronics) - now the suing is working---and it has stopped being used. Unfortunately- I am still disabled after 13 years and always will be. Now- no one cares. Except, maybe, me.