Why Elizabeth Holmes’ Sentencing Matters for BioPharma

  • November 08, 2022
  • by Daniel J. Rehal
  • Pharmaceutical Technology,Technology

Why do “snake oil” salespeople still exist within rare, but visible pockets of the BioPharma industry? People with questionable ethics have swindled patients, put people’s health at risk, and have garnered hundreds of millions of dollars in profits, only to leave many patients desperate, feeling ripped-off, and angry at an entire community that is committed to bettering humankind.

Frankly, I’m sick and tired of it.

A few years ago, I was called to a meeting in New York City to discuss how to help a BioPharma company get off the ground. It was a very exciting time for Vision2Voice because our team is dedicated to helping companies deliver healthcare education to assist in improving patient lives. I slowly learned that these borderline strategy and planning sessions were being led by a man who knew nothing about healthcare. Martin Shkreli had little regard for patients when he purchased a life-saving product for sepsis and increased the price from $12.50/tablet to $750/tablet. Deraprim had been on the market for 70 years and was long generic. Yet Shkreli, founder of three hedge funds, came from the Wall Street world to seek his financial fortune in healthcare. Admittedly, I look back and that experience seemed like it happened in slow motion—it took me too long to understand what kind of leader he was.

In BioPharma, future leaders are selected based on their good intentions. During my career at Merck and Takeda, I never needed to question someone’s commitment to the greater cause. This time, I walked away from an opportunity because it just didn’t feel right. Years later, Shkreli was convicted of securities fraud and was sentenced to prison.

Now with the recent scenario surrounding Elizabeth Holmes, those old memories came flooding back. Holmes was a biotech entrepreneur who dropped out of Stanford to found Theranos, a blood-testing start-up. The company soared to billions in valuation after she claimed to have revolutionized blood testing by developing methods that could take small volumes of blood to run over 250 different biomarker tests. She lied—Theranos had only received approval for one test. Imagine being one of the patients who didn’t know that their blood sugar test was inaccurate, or the woman whose breast cancer test appeared negative, but who actually had the disease. The extent of Holmes’ damage to human lives will never be fully known.

Holmes’ bad practices were discovered because John Carreyrou, a reporter for The Wall Street Journal, initiated a secret, months-long investigation of Theranos after he received a tip from a medical expert who thought that the company’s Edison blood testing device seemed suspicious. Carreyrou spoke to former-employee whistleblowers and obtained company documents. Despite Holmes’ attempted threats and intimidation of Carreyrou, The Wall Street Journal published his bombshell article that detailed how the Edison device gave inaccurate results and revealed that the company had been using commercially available machines manufactured by other companies for most of its testing.1  

She has since been convicted on four counts of fraud with each carrying a maximum of 20 years in prison. As we await her sentencing, we’ve all watched in horror how her recklessness has adversely affected thousands of patients, the key opinion leaders who backed her, and Theranos investors.

Last month, I, along with several members of ourDan Rehal and John Carreyrou Vision2Voice team, met with Mr. Carreyrou while attending an event that focused on the commitment toward ensuring ethics and integrity in our work. When I asked him about his thoughts on the pervasiveness of fraud in our industry, he responded:

“So with the merging of tech and healthcare industries, missions changed in this situation. As Silicon Valley and healthcare come closer together and as more and more people in Silicon Valley come [together] to solve healthcare challenges, they need to bear in mind that stakes are higher. Healthcare, however, is peer-reviewed with scientific publications and that has always been the way that discoveries and innovations are aired out, and there is a reason we have things like clinical trials and peer reviews before publications in top journals.”

The rigors of our processes used in healthcare cannot be understated. Double-blinding our trials, randomizing patients, stratifying results, placebo controls, ensuring statistical significance, and differentiating between the way the statistics pan out and the way patients are clinically assessed are all rigors of measuring the effectiveness for new discoveries in healthcare. Ultimately, we have an environment where people within the scientific community must agree and show that their results are replicable. 

Holmes could not have succeeded in the long-term in the pharma industry. She was praised for being the first female “Steve Jobs,” and the media projected her as the shiny new leader who would change the world. However, she didn’t match the mission and values of our industry and her malpractice was uncovered.

So why do these people still exist in our industry? Well, we live in a capitalistic society and greed can overtake morals. Capitalism, however, is the best economic model in the world in my opinion because it leads to extraordinary innovation and opportunity. We must, however, utilize our checks and balances by following the scientific methods we’ve built and hold one another accountable for the promises that we each make.

So, the next time someone greedy and amoral lurches into BioPharma, be assured that it is only a matter of time before a healthcare reporter, or an inside whistle-blower, or ultimately, the lack of product efficacy is exposed. In the meantime, we must remain committed to choosing integrity. Let’s never forget that our common goal is to improve patient care.

  1. Carreyrou J.  Hot startup Theranos has struggled with its blood-test technology. October 21, 2015. The Wall Street Journal. https://www.wsj.com/articles/theranos-has-struggled-with-blood-tests-1444881901.

About the Author

Daniel J. Rehal, President of Vision2Voice, thoroughly understands the pharmaceutical industry from the ground floor up. By ascending the ranks at Merck to his global responsibilities at Takeda, Dan has significant experience in both marketing and sales roles supporting a multitude of pharmaceutical brands as an award-winning Sales Representative, Training Manager, District Manager, Senior Product Manager, and Marketing Director.

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