Despite well-documented benefits to thousands of arthritis sufferers, the drug Vioxx was withdrawn from the market in September 2004 because of certain side effects that could have been prevented or avoided if doctors had followed the warning labels. To judge from the split decisions in product-liability cases tried so far, there's reasonable doubt that Vioxx should have been withdrawn.

 

Safety will always be an issue. It’s an important issue, but it should never be the only issue. We must all be wary of safety measures which arbitrarily end otherwise successful programs, slow down research and encourage destructive lawsuits. No drug is 100 percent safe for all patients all the time. All drugs have risks as well as benefits. 

 

Our system of drug regulation involves a careful balancing of drug benefits and risks based on the best possible scientific information that can be discovered about a new drug’s safety profile. Reform is needed, but careful and considered reform that advances our understanding of safety in the context the individual patient – not hasty measures that grab headlines and do harm to the public health by slowing down the availability of new and better medicines.

 

Pharmaceutical companies should seek out, monitor and report adverse events in new ways, especially for drugs that are widely prescribed off-label. But hasty regulatory concepts that allow dictatorial shutoffs and demonize the pharmaceutical industry are just as likely to slow the pace of medical progress.

 

We must work for reform that makes drugs safer, but avoid those that might unintentionally slow down the flow of new medicines, or worse, discourage the creation of them altogether. Safety is always an issue, but patients with life threatening diseases also have a right to timely access to advances in medicine.

 

Genetic screening is playing an increasingly important role safety. Progress is being made using DNA testing to identify "responders" and "non-responders" prior to dispensation of medicines. While such programs are still in their infancy, they are already helping doctors to reduce the risk of adverse side effects, and avoid medications that can do nothing for patients with certain genetic characteristics.

 

There’s no simple solution. Universal disclosure of all large clinical trials or creating detailed risk management plans to uncover and control any safety problems that arise after a drug is approved won’t do it. That is, as my 15-year old might say “so 20th Century.” What we need is legislation, funding, and collegiality that kicks into hyperdrive development of the FDA’s modernization initiatives known as Critical Path.

All concerned parties should embrace the following five key “Pillars of Safety” that are critical to reforms at the FDA, to safety, and to 21st century healthcare:

 

 

FDA Commissioner Andrew von Eschenbach describes 21st century medicine as having to be “personalized, predictive, and participatory.” The same can be said for the FDA. The agency must become more personalized in the sense that it can no longer operate under a “one-size fits all” mentality to regulation — particularly as relates to safety. 21st century safety demands 21st century tools to become more predictive.

As for participatory, the 21st century FDA must both engage and lead. The agency’s recent rope-a-dope communications strategy has resulted in falling public confidence, increased media scrutiny, more intense and self-serving political posturing, and an internal crisis of confidence.

Dr. von Eschenbach often speaks about “FDA Evolution” — that a caterpillar is going to morph into a butterfly — and there’s nothing it can do to prevent that change. So too will the FDA change into something. But, unlike the caterpillar, the FDA can decide what it wants to become and choose how it wants to evolve. But evolve it must. And that process must be a collaborative effort. FDA can neither work nor change in a vacuum. Our elected officials should remain mindful of these concerns when they consider how best to continue to provide the resources and oversight that make our drug approval system the world’s gold standard.