In 2010, Bill Hawkins, then head of Medtronic, declared the end of the “Surgeon Champion Era.”
Gary Michelson, M.D.The pronouncement came three years after federal prosecutors levied massive fines against the major orthopedic device companies and put in place a new set of rules for companies who pay surgeon/scientists to be consultants or trainers or to receive royalties for inventions manufactured and sold by those companies.
Gary Michelson, M.D., if you count patents filed and payments received, is the single most successful surgeon/inventor/scientist of that era. In his own words, he told OTW that in the early ‘90s, many surgeons who were receiving money from implant suppliers and being called consultants were actually doing almost nothing other than influencing their colleagues to use that same supplier’s products.
Recent allegations by peer review journal editors that royalty payments and consulting fees have tainted clinical research have once again brought the issue of the relationship between surgeons and industry to the public conscious.
OTW asked Dr. Michelson, who has received more in corporate payments than any other living surgeon, about these issues of corporate payments to surgeons and the integrity of clinical research and, indeed, the broader state of spine care and orthopedics in the U.S.
Surgeon Champion
OTW: What was a “Surgeon Champion?”
Dr. Michelson: A product champion was to a surgeon what a Michael Jordan was to a basketball fan. They are in a position to directly influence a tremendous amount of sales because they have the minds of the people who are the consumers on behalf of the patients.
When the surgeons wrote so-called monographs, the reader would get the impression that they were the creators of this technology. At the bottom of the monographs they had what was called a ‘Pearl.’ That was actually the word that was used.
And the ‘Pearl’ was: “When I do this, I use BMP, ” or some other product in conjunction with this product.
OTW: Would this include off-label use?
Dr. Michelson: That’s not the doctor’s concern because there are not the same FDA ramifications of off-label use by a doctor. That is only for a medical device manufacturer or drug manufacturer. But these physicians had financial relationships with those entities. I don’t think this will come as big news to anybody in the orthopedic field, but you know Congress has been looking into this for a very long time.
This has become a bit of a game reminiscent of the Spy vs. Spy comic strip from the old MAD Magazines. As soon as Congress gets on to one thing, the players just change the game to achieve the same purpose in another way.
The real discussion should be; should doctors be paid for influencing other doctors to use products for medical device companies. I guess that’s the right discussion and if all the doctors say yes, that’s good and Congress says, that’s good, then there’s nothing left to discuss. But where there is a lack of transparency, where it happens in the dark, that is suspect and then the question is, ‘Is that really ethical?’
A Transparent Relationship
OTW: Devices aren’t like drugs. You’re not going to develop those in the lab. So, there is a requirement for a marriage between the physician and the industry engineer. How do you properly structure an ethical and transparent relationship there?
Dr. Michelson: It’s an intriguing question. There are all different things that lead to invention. If you read Land, the man who invented the Polaroid process, he said the difficult part was simply to define the problem and then the solution is much easier.
The surgeon is in the best position to recognize how the state of the art is insufficient. He’s very aware of what it does, but is also in a position to understand what is still needed.
So, perhaps he comes up with what he thinks is a solution to what he needs and he goes to a device manufacturer and says, ‘You’re in this area, here’s the problem. How can this be solved?’ In that situation, maybe he really is working as a consultant.
In which case, his remuneration should probably be proportionate to his contribution. So, maybe the surgeon makes an average of $300 an hour or $500 an hour when you take his total hours work versus income.
You know, under the old model that was going on in the early ‘90s, people were just getting a lot of money being called consultants and doing almost nothing except influencing other surgeons to use the products.
And either the medical device company, be it spine or hips or anything else, was simply buying the purchasing value of that particular surgeon because he used a lot of stuff. Or, what’s worse, that person was in a position to influence a lot of other doctors to magnify the benefit back to the device manufacturer.
And then, the person in that position wasn’t saying, ‘Listen, I’m hawking or I’m shilling for such and such a medical device company.’ This was happening even under rules of various medical societies and journals, where he, as a physician, was required at a minimum, to disclose his financial ties and the sheer magnitude of their remuneration to a manufacturer. The bad actors had those undisclosed relationships.
Fraud
OTW: Some of the most vocal critics of surgeon consulting fees have claimed that this lack of transparency was tantamount to fraud.
Dr. Michelson: If one were to look at the definition of ‘fraud, ’ you would find that is where a person is induced to make a purchase where the seller either makes statements that he knows to be false; or, withholds from the purchaser important information, which had he known, he would not have made the purchase.
The physicians who had the financial relationships with the maker of these products, which were either undisclosed or the magnitude of the financial value of those relationships were undisclosed, and who misled other physicians (the intermediary purchasing decision-maker on behalf of the patient) such that they were induced to purchase those products, are in my opinion guilty of fraud.
While this statement may seem incendiary, it is not. There are a lot of conditional prepositions (ifs) in that statement, such that if the shoe does not fit, then no one needs to be offended. If, on the other hand, someone wants to stand up and say that statement applies to me so I am offended, then I stand by the statement.
OTW: Where are the problems?
Dr. Michelson: The number one problem and I don’t mean in terms of importance, but just in order is, transparency.
Number two, were they even being honest? If they were to say, ‘Look, I do have a relationship with company X. I get money and this is what this product does. Here are the good parts or the bad parts, ’ then at least they are being honest. I think what’s now causing the fall-out in the recent BMP issue, is the question about whether the researcher paper’s authors and physician promoters were being honest. They were representing that they were academicians when they were being salespeople.
If what someone is doing is shilling for people who are giving them a lot of money for doing it, that’s probably a crime. And if it’s not, it should be.
Not One Piece of Evidence
OTW: When then federal prosecutor Christopher Christie reached the deferred prosecution agreements with device companies, he said he had evidence that surgeons were taking money to use the product. To this day, not one piece of evidence has been made public nor has one surgeon has been prosecuted.
Dr. Michelson: That’s because I think government has looked at this as if the surgeons were the Johns. We are going to take the hookers off the street rather than going after the Johns. It wasn’t for lack of evidence.
So they had a day of ‘mea culpas.’ They had admissions where the companies just said ‘Yeah we did that, we had to do that because it was the playing field.’ In the end the companies were not denying it and not saying that never happened.
Then they said, ‘We’re for new governance, we’ll go forward, we’ll clean up our act.’
That was up to government whether to go after the physicians. But apparently they figured they could clean up the situation and move on. That was their decision.
OTW: When Christie testified in front of Congress, he said had he brought prosecutions forward, the big device companies would’ve fallen because they would all have lost their Medicare and Medicaid certification.
Dr. Michelson: The Medicare business is particularly important to those companies whose primary source of income are total joints because that’s the demographic of people who are getting total knees and total hips, they are the people covered by Medicare.
Restoring Trust
OTW: Do you have any thoughts on how research, particularly involving the FDA, can be more trustworthy?
Dr. Michelson: Maybe what is needed is for the academicians who are involved in this and the FDA to sit down and figure out some other way to do this. Maybe there needs to be a third party that says, ‘Okay, we’ll go out and conduct the research.’ But that third party is getting paid regardless of the result of the research.
But you know, of course, what happens now simply does not work. That’s the problem.
Note: Over the next few weeks, OTW will bring readers more of our interview with Dr. Michelson as he discusses the state of the science of orthopedics and his work with patent reform, medical research, animal advocacy, rainforest preservation and the 20 Million Minds Foundation to bring free textbooks to college students.
