Monday, October 29, 2012

When the Marketing Tail Wags the Research Dog: More on Medtronic and InFuse

I have posted a number of times on the case of Medtronic, its payments (bribes) to spine surgeons, and its product BMP-2 or InFuse:

Our good friends at Health Care Renewal now inform us that the staff of the Senate Finance Committee has issued a report on this whole episode:

The Senate staff report itself can be found at:
I'd caution you that the entire report is over 2300 pages, of which 22 pages is the report itself and the rest is "exhibits." (More on that later.) I am not sufficiently dedicated to have read all 2300 pages so what follows is based on the HCRenewal summary plus the first 22 pages of the Report proper.

The committee, no doubt at the urging of Sen. Grassley of Iowa, demanded internal documents from Medtronic regarding its clinical trials of InFuse, which is a biological product that makes bone grow. The basic idea is that when a surgeon wants to do a spinal fusion, in which two vertebrae are more or less glued together to stabilize the back, you can do it in two ways. You can take a graft of bone from the patient's hip and use that to bridge the two vertebrae; or you can use InFuse, put into a special metal cage made for the purpose, and it causes bone to grow in the same area and fuses the vertebrae. The problem is when InFuse makes bone grow where you don't want it, or escapes from its cage, or causes a variety of untoward reactions. The earlier posts describe the problems with InFuse, Medtronic's initial efforts to hide the problems, and the exhorbitant sum it paid to spine surgeons who did its bidding; the later posts show how Medtronic has changed its tune and promised a full and neutral investigation.

Now enter the Senate Finance Committee. They plowed through all those documents and concluded that Medtronic exerted an undue influence over the clinical studies and the way they were reported in scientific journals. I'll focus here on one specific anecdote included in the report, that probably add the most to what we have long known about how Pharma allows its marketing apparatus to control the scientific branch.

One study compared the use of InFuse with the standard hip bone graft method. The authors of the study first reported, "12 months after surgery, the patients [sic] graft-site pain had resolved...and no patients complained about the graft-site appearance." Medtronic employee Neil Beals, assigned to manage marketing programs and initiatives for biologic products like InFuse, inserted a comment in the draft: "ALTHOUGH THE PATIENTS DID NOT COMPLAIN ABOUT THE APPEARANCE DIDN'T SOME STILL EXPERIENCE PAIN AT THE DONOR SITE? SEEMS LIKE RESIDUAL EFFECTS OF DONOR SITE SHOULD BE NOTED." The supposedly "scientific" authors then dutifully inserted a sentence: "...even at the 24-month follow-up assessment, some patients continued to experience residual pain at the donor site, and rated the appearance of the site as only fair."

This seems quite a blatant example--the clinician-scientists report that pain and appearance of the donor site are not a problem. The marketing dude back at the company, who probably never laid eyes on a single patient, says, that can't be right, we'll never sell a lot of product that way. So the scientists meekly buckle under and change their report to make it come out like the marketing guy wanted. When you read further that one of the authors of this study was paid $22M in so-called consulting fees by Medtronic between 1997 and 2010, you might hazard a guess as to why the authors were so malleable.

Now let me switch-hit and say a word for the other team. If indeed the Senate Finance staff plowed through 2300 pages of documents, and the worst dirt they could find against Medtronic was the few anecdotes in the brief report, then maybe things were not all that bad. (Except, if you read my previous posts, they were.) But as I say I am not just now about to read all 2300 pages for myself, so we'll just have to leave it there.

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