Lessons about Labs - Theranos, Buzzy, and the Grail of Painless Phlebotomy

In 2014, Elizabeth Holmes and I both shared a San Francisco TEDMED stage for the same reason – we were inspired to decrease the pain and fear of needles. She feared needles, and I feared a world where a phobia's shame kept people from healthcare.  My solution was to block the pain signal using cold and vibration to jam the transmission, with the theoretical benefit of vibration vasodilating to make blood collection easier. Hers was to change the way blood tests were processed, so a tiny drop from a fingertip could supplant a tube or two taken from a vein.  While subsequent developments show Holmes' approach may not be ready for prime time, Buzzy has now been used by over a quarter million people who aren't fond of needles.

The Wall Street Journal recently shed light on differences found with Theranos’ “Edison Techonology” of running labs from fingerstick collection compared to standard blood collection. Jean-Louis Gassée, in a detailed personal example, found differences of 35% and 7% comparing Theranos’ tests and Stanford’s. In his case, the differences could have meant the difference between needing an urgent blood reduction and “business as usual”. But how much of a difference matters for most people, and what are the lessons learned from Theranos’ lack of published trials?

First, some lab science: the two most common labs drawn are complete blood cell counts (CBC), and chemistries. A CBC counts and categorizes the different types of cells making up a sample. It specifies subtypes of infection fighting white blood cells, the number of platelets for clotting, and details about the red cells – how much hemoglobin is packed in the cells, how much variety in size (indicating stressed new cell production), and how big the cells are on average. Chemistries, on the other hand, measure elements like sodium, potassium, chloride, and molecules like bicarbonate and glucose. Cellular tests can be affected by excess cold or tourniquet application, chemistry tests can be affected by trauma, tourniquet time, and skin preparation.

It doesn’t take much to change the values of some tests. The normal ranges hospitals use were established using a tourniquet to block the free flow of blood for no more than one minute. When blood is “dammed up” with a tourniquet, over time potassium will leak out of blood cells (artificially increasing the value), hemoglobin from red cells backs up against the dam and can appear more plentiful than it is, etc. These changes are well known – when a critically high potassium number comes back, clinicians automatically ask if it was a fingerstick sample (trauma from squeezing the finger breaks down cells) or a difficult draw. Because squeezing blood out affects lab values, the concept of Theranos’ fingerstick draws was curious. In addition, because the fingertips have the most nerve endings of any place except for the lips, it was surprising that the fingerstick mechanism was inspired by a desire to decrease pain. What is most amazing, though, is that a 9B valuation validated the market need to reduce needle fear.

One big lesson is that the market loudly recognized what people seldom discuss: a dislike of medical pain—and the fear of needles—has skyrocketed. Since 1995 when Hamilton quantified the condition at 10% of adults and 25% of children, needle fear has increased 252%. Recent work by France et al proves that fear relates to the willingness of blood donors to return, to the likelihood of reacting to the blood draw, and is a significant proportion of even would-be donors. Finding solutions to make blood draws more comfortable without changing critical medical information is critical for personal and public health, and Theranos capitalized on this.

One important lesson from Theranos is probably to give interviews freely and promptly when the WSJ asks. The other is to have data, and publish it (see Appendix below). In addition, Theranos highlights just how much people are willing to fund, and desire to believe in technology inspired by pain reduction. While as a society we value strength and bravery, the value of a company that helps avoid a vein stick raised billions. No doubt Theranos will pour the needed money in to verify which of their tests do, or do not, alter lab values. Beyond whether their technology stands up to the light of scrutiny, though, shedding light on why Theranos was valuable to people is valuable in itself. 

 

[Buzzy is 510K cleared to control needle pain. Two studies have specifically noted improvement in the success of lab draw collection.  Over 18 clinical trials proving decreased pain used Buzzy for phlebotomy.]

Appendix: Buzzy and Tourniquet Lab Values compared to free flow blood collection:

In laboratory quality control, multiple analyses of the same sample are run and compared to a reference database for optimal minimum differences, which are not generally achieved in the clinical laboratory setting.(1) These differences are much smaller than the allowable number that signifies potentially important changes between two results, classically named “critical difference” (2) and today called Reference Change Value (RCV). This number would come when two different labs sampled the same person, as in the Gassée situation.

Lab results from draws with Buzzy, tourniquets, and free flowing blood have been published using the more stringent reference database equations. These results compared an experimental free flow collection device versus both a tourniquet and Buzzy. Both the tourniquet and Buzzy were left in place for the amount of time demonstrated to maximally change both chemistry and cellular values. Even using the more stringent same-sample lab equations, the differences for most results are negligible, with both Buzzy and the tourniquet samples measuring at most 3% over free flow. As Buzzy and the tourniquet both “dam up” blood, their results showed the same differences reflecting prolonged application. 

 1) Ricos C, Alvarez V, Cava F. Biologic Variation and Desirable Specifications for QC. In: Westgard J, editor. Westgard QC2009.

2) Ricos C, Perich C, Minchinela J, Alvarez V, Simon M, Biosca C, et al. Application of biological variation – a review. Biochemia medica : casopis Hrvatskoga drustva medicinskih biokemicara / HDMB. 2009;19(3):250-9.

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