Behaviors Couldn't Get Any Worse

At the 2006 Regulatory Affairs Professional Society (RAPS) conference in Boston I attended a discussion session on Algorithmic Diagnostic Devices, a topic I knew nothing about, and therefore could observe impartially. These devices simultaneously take several medical readings (e.g., heart rate, blood pressure, skin pallor) and quantitatively combine the readings into a single digital conclusion for the physician (e.g., good, bad, need more data). Illustratively, if your blood pressure’s high it can be offset in the calculation of the heart rate, or skin pallor. My anti-quant antenna was up. I entered the session my mind filled with questions about false generalization+, the three-body+ problem, and the challenge of combining three or more measurements that by themselves often have wide ranges of acceptable readings.

This was a session on proposed regulations for these devices. The speakers included a representative from industry, a consultant for industry and a representative from the FDA. I went into the meeting expecting to gain insights on the uses and misuses of these devices. Instead I chanced into witnessing one of the worst public displays of arrogance and disrespect ever seen at a ‘professional’ society meeting. This single meeting encapsulated all that is wrong with industry – FDA relations.

The speaker from the FDA argued physicians should have access to the underlying data: that a single digital readout, like a thermometer, may in certain cases be misleading. Physicians needed to know both the individual readings and needed some guidance on how those readings summed up into the overall conclusion reached by the device. Although the devices themselves could be perfectly calibrated for ideal situations and well-defined patient cases, often you can have one disease masquerading as another and only by digging into the specifics of the measurements can you have a chance of unmasking these cases.

Both speakers from industry went on the attack. It was an ad hominem attack, accusing the FDA official of not understanding the technology, of denigrating the strict controls that are built into the manufacturing process to avoid false readings, of holding back significant advances in diagnostic technologies, of reneging on past promises, etc. They held that giving the physician access to the underlying data would only confuse the diagnosis; that physicians wouldn’t understand the extremely complex calculations that went into the algorithms; that adding additional readouts would only complicate the devices and make them less useful, etc. The attack was personal, visceral, histrionic and most inexplicably, public.

I was amazed. I would never have believed my colleagues in the industry could be so blind in their understanding of interpersonal relationships. At the conclusion of the session, Dr. G. from the FDA rushed out without acknowledging a single audience member: he had a very visible storm-cloud brewing over his head. Woe to you if you were from industry and later had to go to Dr. G asking for directions to the nearest Starbucks, let alone anything industry-related.

I approached the industry personnel after the session and pointed out that I had attended a fabulous session on bargaining with the FDA and that they would do good to attend it. I admonished them on the inappropriateness of their attack and how they had just poisoned the well for any future industry-FDA conversations, and not just with Dr. G. They looked at me as though I was from another planet. “Dr. G reneged on our earlier agreements. He was supposed to say he was in favor of not presenting detailed data to the physicians. We had every right to do what we did! We know about bargaining session and Dr. G should attend it, not us.”

Dr. G if you’re reading this, I apologize on behalf of the industry. The behavior of its representatives in this session was horrific; you were fully in the right to be suspicious of any blinding of the underlying data. Physicians are trained and paid not to be confused and befuddled by having more information rather than less. We don’t need simplistic devices that reduce diagnoses to a single number: we need physicians trained in systematically ruling out bad diagnoses in their search for the right one. What was clear from this session was that the FDA is often besieged by unscrupulous players from the industry whose only object is money, and FDA personnel are often right in setting up the rules having the worst-case individuals in mind.