Sunday, March 04, 2007

Computer debacle: a Broken down process at the agency - or beyond?

A story in the WSJ has many familiar, recurrent themes to those who know the health IT sector well:

Report on FDA Blasts New Effort To Track Drugs; Four-Year Delay Is Said To Hinder Safety Work; Agency Disputes Claims

Anna Wilde Mathews. Wall Street Journal. Mar 3, 2007. pg. A.1

The Food and Drug Administration has bungled its effort to build a new system for detecting the side effects of medicines after they go on the market, delaying its implementation by at least four years, according to a report commissioned by the agency itself.

As a result, the agency must continue to rely on its existing "dysfunctional" computer system as a primary tool for tracking the safety of medications sold in the U.S., according to the November 2006 report, which hasn't been made public.

A dysfunctional computer system? Computer systems do exactly what they're designed to do. Perhaps its designers and implementers were the ones who were "dysfunctional?"

The situation is "frustrating and undermining . . . the post- marketing drug safety work" of its staff "because they lack some of the basic tools they need to perform their jobs, e.g. a computing system that meets their requirements," says the report. It was prepared by the Breckenridge Institute, a research and consulting firm in Breckenridge, Colo.

You'd think designing such a computer system were magic.

The FDA's drug-tracking system, called the Adverse Event Reporting System, consists of a database and other software and hardware that amass and help sift reports of potential side effects that have been filed by drug makers, doctors and others. The data are the FDA's main way to detect drug-related hazards, and can lead to changes in label warnings or even withdrawals of drugs from the market.

But, the report says, FDA safety experts waste time -- an average of 45 minutes per day -- dealing with the inefficiencies and snags caused by the current software. The Adverse Event Reporting System is overwhelmed by the growing volume of adverse-event reports, which exceeds 400,000 a year, the report says.

If that's an average, I wonder what the topside values are....considering the threats to the public and the drug industry from drug adverse events, one might think this would have been fixed by now...

Then again, there's stories like this that may help explain some of these problems ...

I recall an interview I had last year with the head of an adverse events department at Merck in a rehire situation. I came highly recommended by an Executive Director in the department, to whom I had shown my prior work. This included well-accepted, novel human-computer interaction designs I'd developed for use by busy biomedical researchers for a large clinical study in the Middle East , as well as my work modeling invasive cardiology and leading the development and implementation of a comprehensive information system to detect new device and treatment modality risks in a regional center performing more than 6,000 procedures/year. In addition, I'd worked with the wife of the Executive Director in years prior, when she ran the E.R. of the hospital where I was director of occupational medicine.

Despite all this in my favor, the Executive Director's boss, himself formerly one of the most senior FDA adverse events official in the Office of Drug Safety, dismissed me in five minutes as I was showing him the cardiology project, saying flatly "we don't need a medical informatics person here." I had driven 80 miles to Rahway for this interview to save the executive a trip to Pennsylvania, where I was originally scheduled to come for the interview, since the executive's father was ill in the hospital. In an instance of profound social ineptness, my effort was not even acknowledged. Perhaps he was in a bad frame of mind, but the dismissal under the circumstances was all the more disappointing.

(As an aside, this former FDA person who blew me off is a Hasidic Jew. Ironically, despite my being of the same basic tribe, I was treated better by the Saudi head of research during my locum at King Faisal Specialist Hospital & Research Centre in Dec 1995, who was polite and even took my colleagues and I out to dinner and to his family's shops although his own relative was sick and in the hospital at that time. How absolutely, positively perverse it was to be glibly dismissed by the former FDA official-now-at-Merck under these circumstances, I thought.)

... The FDA has sought to upgrade the technology used in its safety- tracking program for years. But efforts that date back at least to 2003 haven't produced the planned successor to the Adverse Event Reporting System, dubbed AERS II. Instead, the Breckenridge report says a new system isn't likely to be up and running until 2009 at the earliest, and that the FDA has wasted an estimated $25 million through its efforts.

Considering some of the failed health IT stories to appear in the news in recent years, we should perhaps be thankful it's only $25 million.

... A document prepared by FDA officials in response to the report, which is marked as a draft, said it is "riddled with editorial conclusions based on misleading or incorrect facts." Douglas Throckmorton, deputy director of the agency's drug center, said the current Adverse Event Reporting System "is a system that is working" despite "exploding" amounts of data. "Is it the best it can be? Of course not," he said. The FDA wants to develop a replacement "as quickly as anyone else does, but we want it to be done right."

Based on my own observations on health IT failure, blame-shifting and excuse-making, I'd place more credibility on the consultant's reports.

Echoing other recent outside examinations of the FDA, the Breckenridge analysts say the "root cause" of the problems can be found in the culture of the agency's drug regulators. More specifically, the report largely blames a "lack of effective leadership and management" by the center's Office of Information Technology, which it says mishandled the initiative through bureaucratic infighting, flawed planning and duplicative work performed by outside contractors.

Mark Bodnarczuk, executive director of the Breckenridge Institute, said he stands by the contents of the document. After it was completed, the FDA asked him to delete much of it, he said: "What they asked me to do was gut the report, and I refused to do it." The FDA's Dr. Throckmorton said he believes Breckenridge was asked by FDA to extend its work, at no cost, which would have "given us an opportunity to talk about those misunderstandings, those inaccuracies."

These themes are quite familiar to readers of HC Renewal. (Will the Breckenridge Institute get less federal work as a result of their refusal?)

FDA contracting practices, as well as the agency's handling of drug safety, are already the focus of congressional investigations. Senate Finance Committee Chairman Max Baucus, a Montana Democrat, and ranking Republican Charles Grassley of Iowa have sent a letter to the FDA about the computer-system issue. Mr. Baucus said the report raises "troubling questions," and Mr. Grassley said the report is evidence of a "broken-down process" at the agency. In the House Energy and Commerce Committee, Democrats John Dingell and Bart Stupak, both of Michigan, are also examining FDA contracting.

I believe it's more than a "broken down process at the agency." It's a "broken-down process" in the world of IT, i.e., the belief that IT is a homogeneous industry where expertise in business computing equips one to do all computing. I would be curious to know the backgrounds of those IT personnel who were involved in the leadership, planning and development of AERS II. I would bet most had a technical focus, and I would also bet none had expertise in medical informatics.

Perhaps one day the drug industry, including the FDA, will accept the IOM's recommendations on medical informatics.

-- SS

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