“Letting the data lead” is a term used to describe the act of a judgement-free approach to letting results be the basis of one’s decisions. This concept exists in mathematics – think big data and the Bayesian approach companies take. Bayesian inference is a method of statistical inference in which Bayes‘ theorem is used to update the probability for a hypothesis as more evidence or information becomes available.
Within the pharmaceutical industry, letting the data lead has resulted in the development of blockbuster drugs, generating billions of dollars in sales. More importantly, these drugs have improved the lives of people around the world.
A great example of letting the data lead was in the discovery of Viagra – the first treatment for erectile dysfunction. Pfizer originally introduced the chemical slatternly, the active drug in Viagra, as a heart medication. While clinical trials proved Viagra was ineffective for heart conditions, the data led Pfizer to discover that the little blue pill worked for something much different. Viagra recorded $1.6 billion in global sales for 2016, and Pfizer is likely still relishing in their success of letting the data lead.
Insulin is another innovation from letting the data lead. In 1889, two Parisian doctors attempting to understand how the pancreas affects digestion removed the organ from a healthy dog. Days later, they noticed flies swarming around the dog’s urine, which was unusual and unanticipated. They tested the urine, and after finding sugar in it, realized they gave the dog diabetes. However, it wasn’t until the early 1900’s that researchers were able to figure out that what the pancreas produced actually regulated blood sugar. The researchers were able to isolate a pancreatic secretion that they called insulin, a discovery that would win them the Nobel Peace Prize. The pharmaceutical giant Eli Lilly went on to realize the value of insulin and began selling it within a year after the discovery.
The ability of these companies to improve the lives of millions is truly a result of letting the data lead. As Founder and CEO of the bio-science company LifeStory Health Inc. (“LSH”), I have seen firsthand how letting the data lead has resulted in truly groundbreaking discoveries that will play a significant role in the future of women’s health.
LifeStory Health is the first company to recognize that menstrual blood (“MB”) may contain vital and unique clinical information and is not a waste product. LSH focuses on significant women’s health diseases unveiling the opportunity for macro and micro applications related to precision medicine. On the macro level, women represent 51% of the population and, as a result of letting the data lead, LSH has uncovered a method of differentiating females from other females. The implications are treatments and diagnostics designed specifically for women that will significantly improve patient outcomes. The discoveries are also proving beneficial giving LSH the ability to stratify women into subgroups to improve prospects of gender neutral clinical trials. On a micro level, identification of potential new biomarkers in MB to develop targeted diagnostics and therapeutics for subgroups is underway, with the LSH initiating three new studies on specific proteins of interest in 2018.
Letting the data lead also means focusing on gaps in scientific research and identifying new opportunities brought on by new data. A shift in protocol is occurring and there is real time interest in women’s health. The FDA is beginning to retroactively change dosing standards, based on sex specific research, for current medications that have been on the market for over 20 years. The sleep aid Ambien is the case study for this increased attention of female pharmaceutical interactions.
For LifeStory Health, letting the data lead has allowed us to discover more about female biology. It has also initiated surprising opportunities and has allowed LSH to impact a much larger patient population than originally thought. Unexpected sources of revenue have come to fruition, a rapid path to market is on the horizon, and inclusion in global standards of LSH’s practice of sex specific research is a reality.