The Sunday before last, the Star Tribune published a front-page story laying out how Medtronic, one the area’s highest profile corporations, “misfiled” a report on adverse reactions to the company’s lucrative but problematic bone fusion device, Infuse.
Reported by Jim Spencer, Joe Carlson and Mary Jo Webster, and edited by Thom Kupper of the paper’s business section, the piece, “a Question of Risk,” drew an immediate and predictable response from Medtronic, which the Strib published, asserting among other things that, “The article makes insinuations that are false, and fails to include important information regarding the [retrospective chart review] RCR and Medtronic’s actions. Medtronic provided the Star Tribune an extensive account of what transpired around the RCR, both in person and in writing, which was largely omitted from the article.”
Public reaction, judging from the (relatively modest) 35 comments attached to the story and my conversations with people about the story, was all over the map.
Medtronic was a great company under attack from the scurrilous press!
The Star Tribune had stepped up big time by going after a major player like Medtronic!
The real villains were at Medtronic’s orthopedics acquisition in Memphis not here in Minnesota!
Doctors performed surgeries beyond Infuse’s approved parameters!
Whatever your takeaway, and mine was and is that story played fair with Medtronic — and did so while delivering new, broadly relevant information — it was very much an example of the type of investigative journalism large mainstream newsrooms need to regularly produce and the public needs to read. To its credit, the Strib has produced several solid, long investigative pieces in the last couple of years. But the willingness to go after an influential local corporate giant like Medtronic sends a more provocative signal than tales of appalling injustice, or even government malfeasance: that the most prominent, well-funded, best-lawyered characters on the local scene will not operate with immunity from inquiry.
Medtronic of course earned itself a special place on the public’s watchlist with its infamous U.S. tax avoidance move, the 2014 “inversion” establishing itself as an Irish company. (Despite the real estate here in Minnesota, Medtronic is now, officially, Ireland’s largest company, by a factor of five.) Not that tax dodging alone was a valid reason to find something — anything — on Medtronic. Nor would, as some have suggested, an anti-capitalist agenda by a bunch of closet socialist reporters out of step with the realities international commerce.
If there’s a different standard at all to be applied to multinational corporations, including those employing thousands in your hometown, it’s that they have a larger than usual obligation to honest citizenhood. Maybe especially if they’ve made a point in skipping out on hundreds of millions of taxes.
Taking the attitude that a story like “Question of Risk” deserves a lifespan longer than a single news cycle, I contacted the story’s editor, Kupper, with a few questions that I had after digesting both the story and Medtronic’s response. (It helps if you’ve read both.)
MinnPost: Can you say what piece of information sparked this effort?
Thom Kupper: We got started on this story after our reporter Jim Spencer learned about the existence of the Medtronic study — or chart review, as they call it — that we described in the article. Then we spent a lot of time trying to verify the information, some of which gradually came out through the FDA. Last fall, we started asking Medtronic what had happened, and we met with a team of their people and received extensive written comments from them. During this exchange, they explained that the material had been misfiled – “not tagged appropriately” was how they described it. They also acknowledged that they should have reported the adverse events they found to the FDA as soon as they learned about them.
MP: As is often the case, Medtronic insists it provided all the information and access you needed (and by implication asked for). Do you refute that? Where if anywhere did you ask for more access/documentation and were denied?
TK: We asked for the 76-page table that they say details the adverse events they found, and they did not provide it. We wanted to speak to the spine and biologics division vice president who was in charge of regulatory and clinical affairs at the time the study was shut down in 2008, but Medtronic declined to make him available. We also asked who was in charge of the chart review and who the company communicated with at the FDA concerning the chart review, and they did not disclose that information.
MP: Was, as they charge, anything of significance omitted from the published piece? Can you even speculate on what they might be talking about?
TK: We’ve reviewed the news release they issued after the story appeared, and we carefully considered all the written materials they provided us in the course of our reporting. Our article includes everything that we considered significant.
MP: In that context, Medtronic seems to be on (more) solid ground when it says that it in fact documented the 1,039 adverse cases. On that point again, the FDA seems to be the problem. Is that the impression you meant to leave? Did you specifically ask Medtronic to release the 76-page table, and did they directly refuse?
TK: We specifically asked for the 76page table, and Medtronic did not provide it.
MP: Medtronic argues that problems with rhBMP2/Infuse were well documented by the time it “discovered” the RCR in 2013, which you state. There certainly has been ample coverage of Infuse’s medical and legal issues. With your story are you in effect suggesting that the product’s usage should/would have been reduced had Medtronic handled the 2008 RCR in an ideal, timely fashion?
TK: No, it’s impossible to say what might have happened if there had been prompt public disclosure of the adverse events when Medtronic first conducted the chart review. What we know is that such disclosure didn’t happen, as Medtronic acknowledges.
Medtronic did not return a call seeking further discussion of the story.
J. David Prince, the emeritus professor at Mitchell Hamline quoted in the Strib piece (because of his career litigating product liability cases) had no complaints with the finished piece, a story he realized was getting special legal attention when reporter Spencer called him back to read him the seriously lawyered, precise quotes that were making the final cut. “It signaled to me,” he said, “they were taking this very seriously.”
“I think the paper handled it pretty well,” Prince added. “Frankly, I’m surprised anything like this gets done outside of The New York Times.”
Though he was struck by the FDA’s behavior in the tale, his final takeaway on the agency’s role — which I thought could have been brought up to a level nearly equal to Medtronic’s — was more sympathetic than mine.
“The FDA’s role still seems odd to me,” says Prince, who is on the board of Fairview Hospital’s Human Subjects Protection Committee. “I get to see firsthand how the FDA works, and the fact is they don’t have an abundance of staff or money to handle everything they’re responsible for, and I don’t see that changing in the current anti-regulatory, anti-government climate we’ve got going on.”
Two essential problems, typical of so much government regulation, he says, is that so much depends on voluntary reporting. That is coupled with the relatively small sample sizes products such as Infuse go through in the three levels of trials prior to approval. To some extent, that argument bolsters Medtronic’s — that the number of adverse reactions is still small compared to the number of successful treatments.
The one question Kupper passed on was whether he suspected revolving door cronyism between the FDA and Medtronic, accounting for the appearance of protecting Medtronic from prying reporters. “I suppose that’s possible,” said Prince. “Or it could be as simple as the FDA screwed up and they were just hoping it’d all go away.”
Chris Ison’s career as an investigative reporter for the Strib (and a Pulitzer-winner at that) may not make him the most objective judge on the journalistic merits of “Question of Risk.” But the fact that he now has to stand up in front a class of smart kids at the University of Minnesota and defend his thinking gives him fair cred. “I told my students I thought it was a good, important story and a good example of digging out information despite the efforts of a big company to keep it hidden.”
“I thought it was very well reported,” Ison continued. “It made the case that several times when Medtronic’s internal study would have seemed to be relevant and could have been provided to people or agencies that wanted just that kind of information, the company failed to disclose it. The explanation that they simply misfiled the study seems strained. But even if that’s true, it seems like pretty questionable management. The reporting also provided plenty of experts explaining why the undisclosed data could be important. I liked that they linked online to many government records so that readers could see them for themselves. You have to give the reporters credit for sticking with their public records request to the FDA. It kind of shows that you can’t give up when the first answer is ‘no.’ And the FDA looks terrible for dragging its feet and denying access to those records. It’s trendy to say that the news media doesn’t go as deep as it used to. This kind of story shows again that those criticisms tend to be way overstated. There’s lots of very good, in-depth journalism going on out there. You just have to look.”
Like pretty much everything in the public eye, journalism is a competitive game. MPR and others committing themselves to the investigative form could do worse than look at “A Question of Risk” as setting a bar to beat.