Dancing with the Dark Side, aka Industry

In July, columnist Kenneth Getz penned the piece: “Are Academia and NIH Bastions of Integrity?” It was in response to recent criticism by some in academia who claim that industry should have no involvement in clinical research. These same professionals insist that only those in academia can ensure high-quality clinical research and that such assurance is beyond the reach of industry.

Now, I get that there’s always been a quiet rift between academia and industry. This became clear to me after speaking with Mr. Getz last month about his July column. Apparently, although it’s let up a little, for years industry-funded research has been viewed negatively by the academic world. Investigators who decided to get involved with industry-funded trials were frowned upon and tagged as “sell-outs.” As Getz poignantly put it, “they [were] dancing with the dark side.”

But to suggest that industry should have no involvement in clinical research seems grossly unfair. Yes, industry has been involved with trials that have resulted in tragic consequences. Those include the 1996 Pfizer trials in Nigeria for its antibiotic Trovan that left 11 people dead and the Phase I trial by TeGenero (Wurzburg, Germany) 10 years later that sent six healthy male subjects into intensive care.

But academia is also no stranger to tragedy. In 1999, an 18-year-old boy died four days after receiving an injection as part of a Phase I trial run by the University of Pennsylvania. FDA reportedly found the scientists involved had broken several rules of conduct, including failure to report serious adverse effects in two other subjects. And a new ACRO report cites data from the Hastings Center that found “in the United States a higher number of deaths in trials with healthy volunteers have involved studies approved by academic rather than commercial IRBs.”

The point here isn’t to pit one side against the other based on their number of tragedies. It is, as was Ken’s in his July column, to show that neither side—academia nor industry—is above reproach. Both sides, after all, are made up of human beings who by their very nature are imperfect and sometimes fall prey to pressures that lead to bad decisions. And while the pressures faced are different (pressure to publish vs pressure to get a drug to market faster), corruption shows no favor.

One reader, Steven Steinbrueck, MPH, of Stonebridge GCP Consulting Inc., said it best in his written response to Ken’s column: “I have worked in health care (military, private, and academic) and industry for more than 35 years. The vast majority of my colleagues have been bright, hard working, ethical professionals who are primarily concerned with developing and/or providing interventions for the good of current or future patients. Unfortunately, avarice and hubris are independent of setting.”

Academia’s inability to admit this fact “[is] putting the clinical research enterprise at risk,” according to Ken, who says the consequences will be a loss of public trust. And you don’t have to work in academia or industry to know how fragile the “trust” situation is right now and has been for many years. Remember the April 2002 cover of Time magazine, which compared a female research participant to a rat in a cage?

In the fight for better medicine, more cures, and longer life spans for those we love, there’s no room for division within an enterprise that in reality is striving for the same goals, even if the nature of the research is different. So it’s high time those in academia who believe they’re above reproach got off their high horses and stopped saying things like “industry should have no involvement in clinical trials.” Continuing to hold such grudges does not improve patients’ lives. Which is what both sides are trying to do.