In days of yore—say, eight or nine years ago—adverse events were the province of experts. Back in the day, the main question was, “Are we seeing a safety signal?” or “What will the FDA say?” Safety data, during clinical trials and after a drug’s approval, were carefully analyzed over a period of months or years. Small cadres of people specialized in the nuances. They combined esoteric statistical and medical expertise.

Today that world is gone. Today anyone can be an epidemiologist. All you need to do is watch the evening news. Each night brings a new drug safety problem affecting thousands of people. At this point, Cheerios could be slapped with a “black box” warning. Now, the operative drug safety questions are: “How long do we have before USA Today covers this?” and “Will any key opinion leaders support this drug?”

Lilly’s pain

Let’s get specific. There is fresh word of a tentative, $500 million settlement of 18,000 Zyprexa lawsuits against Eli Lilly. (We know the awards are decided according to complex formulas, but the simple average works out to a modest sum of $27,000 per case.) Zyprexa, an antipsychotic medication, is the subject of numerous state investigations and a series of sobering articles in the New York Times. Lilly has already spent $700 million to settle a few thousand other Zyprexa cases. The news stories don’t say whether the FDA is probing illegal promotion of Zyprexa. That’s interesting. Perhaps the FDA is still sorting out the facts.

In general, Zyprexa aside, the FDA is no longer a revered, Vatican-like authority on drug safety. Community physicians quietly discount what the FDA says. The days of Papal FDA power to guide physicians on drug safety are gone. It’s not that the agency and its European counterpart have done something wrong. It’s just that the multitude of voices within the FDA make it hard to discern when the agency is genuinely worried about a drug safety issue. Often, it appears that the FDA is as indecisive as the scientific community. The polls show that the FDA’s public image is being just as tarnished as the industry it regulates. That’s depressing but unlikely to change soon.

Wild guessing

Sadly, a disciplined appraisal of the risk-benefit ratio in any drug safety situation is usually missing. Instead, drug safety is now being adjudicated in an informal, nonscientific, seat-of-the-pants manner. With no central authority, chaos reigns. With every new controversy, each new FDA advisory panel, there is guesswork. Physicians and patients act on hunches about stents, anti-depressants, and many other biomedical products. There are private websites devoted to drug safety where physicians can compare notes and practice armchair epidemiology based on four patients they dimly remember seeing in the last nine years. This is no way to run a railroad.

In such a landscape, high-performance systems to correctly anticipate drug safety signals will be crucial tools. United Biosource, SAP and Cerner have recently invested in this sector; we would not be surprised to see heightened interest in the sector from large IT firms. Phase Forward could be the hardest firm to catch up with here, thanks to its prescient acquisition of Lincoln Technologies.

On another level, however, drug safety is a technological conundrum. In an era of multiple high-quality sources for drug safety data, both inside and outside government, from both pre- and post-approval sources, software should make discerning drug safety signals easier. That doesn’t seem to be the case. Indeed, there seems to be less clarity about when society should genuinely be worried—and when a possible safety signal really isn’t there.

The stakes

Just as 100 bazillion-cell spreadsheets haven’t enabled the U.S. government to spend money any more wisely than in the age of the abacus, all the pharmacovigilance software in the world has not been able to put our society’s messy drug safety house in order. Which is a pity, given the wealth of expertise on the topic in academia, government and industry.

The stakes of not fixing the drug safety mess are stratospheric. Think about the days when every month heralded a recall of an American car of one sort or another. Detroit’s auto industry was once plagued by years of recalls for poorly-made vehicles. This lead to a permanent credibility gap at GM, Ford and Chrysler. Companies in the life sciences should aggressively use the tools and resources at their disposal to avoid that fate.