Some of the other LadyDocs and I invite you to join us for an exciting event, the March for Science in Washington DC on April 22nd, Earth Day. Becoming active, vocal, and engaged with our communities about the value of science is one way we work to counter long-standing social and economic causes of poor health.
Injury prevention research is one reason I march for science. My son was two years old when he pulled a gun out of a relative’s purse, which was lying on a coffee table at my home during a family event. I quickly but calmly took it from him and informed my relative to remove the gun from my house. Of course I was relieved, but shaken that my son managed to be holding the gun at all, while I was watching him the whole time!
Around the time of this incident, I was working as a preventive medicine physician on injury-prevention projects at the Centers for Disease Control and Prevention in Atlanta. When Congress stopped funding CDC’s gun safety research in the late 1990’s, I was stunned. Because of injury prevention science, pediatricians now routinely counsel families about bike helmets and firearms safety, but that’s not enough. Today, research demonstrates that the state of Georgia has one of the highest death rates due to toddlers’ access to guns in their homes. On April 22, I will march for science to make the importance of injury-prevention research more widely understood by policymakers.
Another reason I will march for science is to improve drug safety regulations. Currently I am a private physician-consultant for drug development companies, using the knowledge I gained after seven years serving as a Medical Officer at the FDA.
In my new role, I joined my company’s team to speak to a group of executives from a small biopharmaceutical company that was a potential client. We knew they did not have any products on the market yet and had been negatively impacted by a recent FDA determination about the safety of their leading product. Although FDA had found their investigational drug to be effective in the first 1,000 patients studied, about 2.5% of these had experienced transient increases in liver enzymes. None of these had developed jaundice, which would indicate the potential for impending liver failure, or had died or required a liver transplant as a result of taking the drug.
Nevertheless, according to FDA’s published guidance (2007) the future risk of severe liver toxicity could not be safely predicted with only the 1,000 patients studied to date. The FDA therefore informed my client that another 2,000 patients must be evaluated in a rigorous clinical trial before bringing the product to market, plus an additional 7,000 patients should be followed closely immediately after the product was on the market, if approved. At that disappointing news, the executives felt they had no choice but to lay off all but 30% of the their employees to support the continuing evaluating their promising new drug.
My delicate task on the team was to inform our potential client that despite promising research on biomarkers to predict and reduce the risk of drug-induced liver toxicity, no better method was available than to proceed with the expensive and time-consuming testing in many more patients. One of the executives became so angry; he turned his back on me, although he later apologized!
Today, I would say to him that lowering FDA standards as proposed is not a good solution, because in the long-run, regulations based on solid science give patients and consumers confidence in the rapidly changing marketplace of healthcare products. In 2010, when I was an FDA pediatric medical officer, the Agency first defined Regulatory Science as the science of “developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products.” Congress heard FDA’s message in 2010. For example, FDA awarded $25 million to fund a wide range of regulatory science projects (www.fda.gov) in 2017.
I will march on April 22 to support increased funding for drug-safety science that supports our economy and more importantly, protects public health. By the way, my company did win the bid to conduct our client’s clinical research because we presented the best strategy to move forward with the necessary research.
We look forward to seeing you on April 22 and reading about your perspectives on science and health here!