This is written in response to Ellen Pao’s article published September 15, which claims that Elizabeth Holmes’ is being singled out for prosecution because of her gender. As a woman, a former FDA employee and someone who has long been involved in laboratory testing regulation, I could not disagree more.
Ms. Holmes’ gender, in fact, allowed her to do what she did. Who else but a young, white, blond-haired, blue-eyed woman could have snookered all of these old white men? The singular nature of Theranos in its value and its leadership were what led to so much attention - Ms. Holmes was lauded by women’s magazines and financial magazines alike, garnering attention for her wardrobe and her vision. Her womanhood was part of her mystique -- she was one of few women who broke the venture capital glass ceiling. Her actions have had repercussions on all women in venture capital, who, according to the NYT, are regularly asked how their companies are not like Theranos. I would add, however, that we do not hear of men being asked how they are not like Bernie Madoff. I digress.
Theranos, as the world now knows, could never do what it claimed. The false claims around its performance were not only fraudulent but dangerous - allegations of false results leading to heart attacks, or being misdiagnosed with HIV are the result of shoddy Theranos testing. The effect of the fraud make it more than worthy of prosecution.
Elizabeth Holmes built Theranos, which was considered a “unicorn” in Silicon Valley - it was, at its peak, valued at $9 billion. She herself, at one point, was reportedly a billionaire. The sheer scale of the alleged fraud is staggering.
I would be remiss if I did not remind you that there are huge lapses in regulation of testing in the United States. I have long argued, both while I was at FDA and outside of the Agency, that FDA should play a larger role in ensuring the accuracy of tests. Currently, tens of thousands of tests are not FDA regulated, and their clinical and analytical validity is unknown by most users. Stronger FDA authority could have prevented at least some of these issues.
Another possible solution, which can be pursued concurrently, is to increase the diversity at venture capital firms. When people with different backgrounds, genders and races are represented, VC firms do better; they may also be more levelheaded about some proposals.
The extreme culture clash between Silicon Valley and the medical establishment is one that needs to be addressed carefully, especially as we continue applying technological solutions to the health field. We cannot “move fast and break things” when those “things” are people.