Theranos- a lesson in innovation and integrity.

The 2014 New Yorker feature on CEO Ms. Elizabeth Holmes of the rising biotechnology company, Theranos, was an exciting and promising piece. In an uncertain time for scientists looking to commercialize their research, Theranos was proving that research was both practical and feasible for the digital age. Fast forward a few years later and we now have a case study on the importance of scientific vigilance and fact-checking. The discipline of biotechnology, as with any stream within the sciences, is rooted in experimentation. Concepts and theories are useful for comprehension and important for understanding the mechanics of the system to be studied, but very little can be accomplished if there is no actual labour done. Graduate school and technical lab research positions offer the opportunity to test out a hypothesis, analyze a mechanism and try out all of the possible “what if” scenarios.

However, from my own experiences and those of my colleagues, research is never straightforward and failure is a common factor in any experimental work. This may be the disconnect we face when science is commercialized or a technique adopted for mass production, there is no perfect formula for ensuring that research will be successful. In fact, it may not produce anything substantial, and therein lies the issue, the success of scientific research can never be guaranteed, neither can it be quantified. Simply, all research (good or bad) is important. Another consideration to take note of is the amount of time it takes to validate findings.  Changing research systems from a molecular to a patient-based setting has its own considerations and requirements (i.e., experimental conditions, variables, laboratory techniques, scaling, controls).

Take for example CRISPR-Cas9, the gene editing mechanism, it has taken almost two decades to decipher this complex mechanism first discovered in bacteria and prepare it to be used within human cells. Only now are we ready to see if the mechanism is capable of editing out mutated genes in humans, potentially providing gene therapy to patients with a hereditary disease. These timelines should come as no surprise, when dealing with humans and complex molecular models that cannot be controlled, expect long and deliberate efforts. When Theranos claimed to have developed a blood testing technology that could diagnose patients with merely a fingerprick amount of blood, in a relatively short amount of time and with no publications documented,  red flags should have been raised prior to the ensuing sensational media storm.  Unlike some of the other technologies and applications developed for entertainment or leisure that are shrouded in secrecy, applications developed for patients should not be treated the same way. An error during mass deployment is not a bug, it becomes an adverse event and an adverse event could mean anything from a serious side effect to a life-threatening condition, there can be no room for error.

Following the Wall Street Journal’s investigative analysis, Theranos was found to have exaggerated the technology, misleading its investors and regulatory bodies with the number of blood tests the device could analyze. The failure of Theranos and its technology, although ambitious, is not a surprise, countless biotech companies with revolutionary ideas and therapeutic mechanisms start off with promise, as any hypothesis does, but fail to achieve the desired result and this type of failure should not be shunned. Integrity in research, however, should be upheld in all situations and if we are to continue with developing innovation in healthcare, we as a community need to establish clear guidelines for product commercialization and consumption. Innovation is important for the advancement of our societies and industries but it must be done with awareness on the public’s part and vigilance on the experts.

 

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