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Reporter runs into wall requesting FDA's public records of financial disclosures Date: 02/16/11

Editor's note: AHCJ and its Right to Know Committee have been advocating for better and faster access to information and experts in the federal government. One agency – the FDA – has repeatedly been a focus of our efforts.

Just this week, we wrote to the FDA urging it to abandon an unusual and troubling approach to embargoes. Along with 10 other journalists' organizations, in 2009 we called on the FDA's Task Force on Transparency to end constraints on newsgathering. Last year, we published an account of the FDA's refusal to answer a reporter's questions even as it was quietly preparing a public statement to appear online.

Here, John Fauber of the Milwaukee Journal Sentinel describes another disturbing incident: his months of fruitless efforts to obtain public records from the FDA.

By John Fauber

How extensive were the financial conflicts of interest among researchers of Medtronic's back surgery product known as bone morphogenetic protein-2?

The Food and Drug Administration knows the answer. Maybe it is time they let patients and doctors know too.

But after nine months of trying to get those records, I'm not holding my breath.

Throughout 2010 I had a great deal of contact with the FDA while researching stories on BMP-2, a biological agent used to promote bone growth in spinal fusion surgery.

My interest in those records stemmed from the Journal Sentinel's ongoing reporting about conflicts of interest in medicine.

As it turned out, several of the doctors involved in the BMP-2 clinical trial had financial relationships with Medtronic. Their results with the product were considerably better than doctors in the trial who had no conflict of interest. The FDA approved the device in 2002.

In many ways, the BMP-2 story epitomizes an important, on-going controversy in medicine: Should doctors who have a financial stake in a drug or medical device company be allowed to experiment with its product on people?

Today, about 85 percent of BMP-2 use is off-label, meaning it is being implanted in applications for which it was not originally tested and approved.

There have been reports of serious complications in those off-label uses.

In the case of the BMP-2 clinical trial that led to the FDA approval, my Freedom of Information Act request was simple.

I wanted to see the financial disclosure statements of all the investigators. In particular, I wanted to examine whether doctors receiving money from Medtronic reported greater success with the product in clinical trials than those who didn't.

The agency had redacted the financial disclosure statements prior to approving the product.

I was told by the FDA that it has a policy of keeping those names confidential until a product gets approved. After approval, that kind of information is supposed to become public.

But I ran into a byzantine process run by an agency that seemed ill-equipped or unwilling to do its job.

In a letter responding to my initial FOIA request (May 2010), I was first told the records did not exist.

A couple months later, I was told by FDA personnel that the records did exist, but they were in a warehouse in Maryland and it would be difficult to locate them. Then they said the records were available electronically, but it would take time to find them.

They did provide one record that contained some of the information I was looking for, though no names or financial disclosure statements. I give the FDA credit for eventually acknowledging that they erred in initially saying the information did not exist.

But that didn't seem to matter much when it came to actually producing the rest of the records.

The names of the clinical investigators with financial ties to Medtronic continue to be kept confidential.

Why is that important?

Last year, Medtronic began listing payments to doctors on a public website.

Dozens of physicians around the country are pulling in six- and seven-figure annual payments in royalties from the company.

How many of them were involved in the BMP-2 clinical trial or other published research involving the product?

My last contact with the FDA was in a series of e-mails that ended with this statement on Dec. 8 from a public affairs person:

"John, Your request is still pending. As you know, FOIA requests are first in and first out. They are also handled based upon their complexity. Yours is complex and require a page by page review of thousands of pages. Based on the backload, CDRH will not be able to get to your request for many months but you can be assured, they WILL get to it. I'm sorry."

John Fauber is a medical reporter at the Milwaukee Journal Sentinel. His stories also appear in MedPage Today as part of a partnership with the medical news web site. His ongoing series, "Side Effects," examines conflicts of interest in medicine.