Embracing Transparency

Electricity is “value neutral.” What do I mean by that? Well, we all know about the potential benefits of electricity, modern society’s been living with them for a century now. We light our homes, our offices, our streets and we replace many formerly muscle-powered tasks with machines. On the other hand, lightning strikes kill people every year and wiring faults are responsible for thousands of fires that produce considerable damage? As a consequence, we must conclude that electricity is neither inherently good nor bad; it’s a force that can produce either effect depending upon how it’s used.

Why is this relevant? In parts of the research-based biopharmaceutical industry “transparency” is the new catch-phrase. Let me suggest that transparency is a lot like electricity – it’s value neutral and can be a force that either benefits or harms the industry depending upon how it’s used. Senior executives in biopharmaceutical companies need to think through not just the tactical, but the strategic considerations as well when they respond to calls for transparency of clinical data.

We all know that paper is still the primary means of collecting clinical trials data. By some reports, 70 percent of all clinical studies are still documented manually. We also know that this adds considerable time and expense to a process that consumes a great deal of both and is usually the rate-limiting step for delivering new products to the market. Automating these processes, especially if they could be seamlessly integrated with the emerging medical electronic infrastructure to document and manage medical care (e.g. electronic medical records and information exchanges) could be very useful. It would also likely make data far more accessible, which would assist the industry in answering the growing chorus of voices calling for public disclosure of such information.

There is another side to the story however. More accessible data generally means that more people will access it. Some, perhaps many, of those people may conduct their own analyses of this information using statistical tools that are also electronic and readily available. The results of such analyses may reach conclusions very differently from those of the biopharma firms that are the sources of the original data. It was the American author Mark Twain who said, “There are lies, damn lies, and statistics.” We live in an era when industry is under a microscope for questions related to the safety and the comparative effectiveness of its products. Being able to present a positive but data driven picture of products is vital to success of any company, so the potential loss of control presented by a world of data transparency is threatening. The natural tendency in such stressful times is to fall back on traditional models of trying to control information flow. Unfortunately, that only reinforces the negative stereotype of an industry with something to hide.

So, what’s an industry executive to do when faced with this potentially troubling tradeoff? Firstly, it’s important to recognize that the proverbial genie is out of the bottle, and nothing the industry can do is likely to put him back inside again. The global pressures on health care spending are driving the calls for greater use of electronic clinical tools and these are unlikely to abate anytime soon. These same pressures will continue to fuel calls for industry disclosure of information. Second, we must recognize that once a product leaves the cloistered environment of clinical trials, providers and payers and even regulators will be using these same electronic tools to collect and analyze data on new products. These entities will use (some are already using) such data to make decisions about the safety, efficacy, and relative value of products. Most of this data will be invisible to biopharmaceutical companies unless they take active steps to embrace the new digital world and seek access to it themselves.

Even though change is always somewhat threatening, and the biopharmaceutical industry is inherently conservative, this is a situation that calls for proactive measures. Embrace transparency, and get a first-mover advantage by experimenting with the emerging digital tools. Get a seat at the table as policy discussions are conducted about how data should be collected and shared. Above all, be part of the solution rather than part of the problem. That is the path with the highest likelihood of success in the tumultuous world the industry faces today.

About the author

Kim D. Slocum is President of KDS Consulting, LLC, an organization devoted to helping health care organizations understand the broader environment in which they operate and assisting them in finding strategic, sustainable solutions to the business challenges they face.