Last week, there had been an inundation of coverage regarding Theranos, and the validity of the blood testing company, citing Founder Elizabeth Holmes as "an engineer with rudimentary training and no medical background"; the Stanford dropout who founded the company at the urging of one of her Professors and since then came into the media spotlight just two years ago. Criticisms about Theranos reveal that the company is still partly, in stealth mode with no peer reviewed papers on the biotech company, infuriating the medical and scientific communities.
However, if we take a closer look into her Board of Directors, we can see clearly that there is something going on under the surface of what is transpiring at her company.
Theranos Board of Directors
A former US Secretary of State (Henry Kissinger)
A former director of the Center for Disease Control (William H. Foege MD, MPH)
A former Wells Fargo chairman (Richard Kovacevich)
A US Marine Corp General (James Mattis)
Two US Senators (Samuel Nunn Jr., William H. Frist MD)
A former US Secretary of Defense (William Perry, PhD)
A U.S. Admiral in the U.S. Defense Community (Gary Roughead)
A former Marine Corps officer and Chairman at the Energy Task Force at the Hoover Foundation and former US Secretary of State and Secretary of Labor (George Pratt Shultz, PhD)
and a Chairman of the Bechtel Corporation, who won the contract to rebuild the infrastructure of Iraq for the US Agency of International Development (Riley Bechtel).
Reading the Board of Directors of Theranos is akin to reading the Who's Who of the US Defense Community. Last year at the World Economic Forum, the charismatic Jack Ma said in a talk that:
"You can fall in love with the government, but don't marry them." -Jack Ma, Founder of Alibaba
Clearly, Elizabeth Holmes is not only married to the government, but her Board of Directors is the Government. So why would the FDA and the US Government now want to suppress their own technology to prevent people from accessing this new blood testing method?
Although much of Theranos technology is in stealth mode, and they are reported to be working with the US Military (surprise, surprise) on undisclosed projects, we can take a glimpse into what they are developing by reading their patents.
"An aspect of the invention is directed a method of evaluating a biological sample collected from a subject, said method comprising: (a) receiving data transmitted from a device placed in or on the subject or at a retailer site, wherein the device is configured to process the biological sample by: (i) receiving the biological sample; (ii) preparing the biological sample for a subsequent qualitative and/or quantitative evaluation, to yield data necessary for the subsequent qualitative and/or quantitative evaluation of said biological sample; and (iii) transmitting electronically the data to an authorized analytical facility and/or an affiliate thereof for performance of said subsequent qualitative and/or quantitative evaluation; and (b) analyzing the data transmitted from the device, at the authorized analytical facility and/or the affiliate thereof, to provide said qualitative and/or quantitative evaluation of said biological sample."
According to the patents they have listed, they are going far beyond mere blood testing. Traditional laboratory blood testing is done by taking vials of blood, sent to a lab where a sample of the blood is tested for substances by how it reacts with certain chemicals, bacterium and substances. The blood testing methodology that Theranos has developed uses a nanocontainer, and records in-real-time (and I hypothesize most likely also analyses all the DNA components of the blood) and transmits that wirelessly onto a remote computer interface.
The reason why the US Military would want this technology is self-explanatory. One of the advantages is that anyone can be accurately identified, in addition to knowing all the proclivities of a person's DNA, and the exact makeup of the chemical composition of each blood sample before it is altered by transport (blood coagulates fairly quickly so vials must be immediately tested before it loses its accuracy). The Theranos patent PCT Application No. PCT/US11/53189, filed Sep. 25, 2011 cites the inaccuracy and drawbacks of traditional lab tests:
"Traditional systems and methods also affect the integrity and quality of a clinical test due to degradation of a sample that often occurs while transporting such sample from the site of collection to the place where actual analysis of the sample is performed. For examples, analytes decay at a certain rate, and the time delay for analysis can result in loss of the sample integrity. Different laboratories also work with different qualities which can result in varying degrees of error. Each laboratory can have its own set of references that further introduce a wide range of variability in coefficients of variation. Additionally, preparation of samples by hand permit upfront human error to occur from various sample collection sites."
Another unicorn biotech company, 23andme, only needs a minor saliva sample (eg, a wad of spit) and not any stem cells, spinal fluid, hair or blood samples as people did in the past, before it can be said to determine your entire genetic history and identify all the nearby relatives in any geolocation.
Thus far, we have relied on the outdated methodology of blood testing via the traditional laboratory which we assume is the most accurate, but in reality, how many people have taken a laboratory blood test which came out abnormal unless they were on the verge of dying?
The Wall Street Journal reported a case study in which Theranos reported an abnormally high calicum level in two women, whilst their traditional lab reports said their levels were normal. The journalist at the Wall Street Journal immediately made the assumption that since the Theranos results were different from the traditional lab testing results, that the former and not the latter must be inaccurate. The Wall Street Journal reported that Theranos must've diluted samples of their blood to use on Siemens machines. However, to my knowledge, when blood samples are diluted, the results are they appear lower in tested content. However, in the Theranos result, there was an elevated calcium level result, whereas the traditional lab result showed normal results. This is inconsistent with blood dilution techniques.
The Wall Street Journal reported last week that the Theranos blood diagnostics sample had a higher calcium blood level which is actually inconsistent with blood dilution techniques that the Wall Street Journal alleges Theranos is guilty of.
We would like to think laboratories do not dilute samples, but the fact is, all traditional laboratories dilute samples. Unless the blood sample is analysed immediately after it is taken, most laboratories use heparin and dilute the sample to prevent the blood sample from coagulation. That is why it takes between 1-3 weeks before you receive the results of your blood test- during that time, your blood sample has been diluted and sitting in a laboratory somewhere. The problem with heparin is that calcium ions bind to heparin- therefore, the result is that the blood serum sample appears to havelower calcium levels than if the sample was analysed undiluted. In the case that the Wall Street Journal cited above, the Theranos sample showed a higher level of calcium in the blood. Again, this is inconsistent with blood dilution techniques that the Wall Street Journal alleges Theranos is guilty of.
In addition, Theranos probably uses the Siemens diagnostics system to handle a high workload environment. It is unclear which Siemens diagnostics tool Theranos used, but their patents do not use traditional laboratory blood testing methodologies, and it could be they use the Siemens diagnostics to record the blood analyses from their relationship with Walgreens since they are still going through the process of FDA approval of all their diagnostics equipment.
In relation to the difference between the two results that the Wall Street Journal cited, I extrapolate that the Theranos sample was probably the more accurate result for the reasons I listed above and also for the following reason:
An elevated, high calcium level (hypercalcemia) in the blood are potentially indicative of at least two disease conditions:
1) heart disease 2) osteoperosis
Heart disease is a cumulative effect when there is excess calcium in the bloodstream that leads to plaque buildup in the arteries. At optimal calcium levels, calcium stays in the bones; however, when the body has a problem with calcium absorption (from a lack of Vitamin D, Vitamin K2, Magnesium), calcium is leeched from the bones into the bloodstream, creating an environment for heart disease and osteoperosis. Ironically, calcium supplementation further progresses this disease state, as the body is not able to absorb the calcium into the bones, and instead creates an excess in the bloodstream. For optimal calcium absorption, the body needs more Vitamin D, Magnesium and Vitamin K2 or CoEnzyme Q10 (which works in a similar way to Vitamin K in the body).
Elizabeth Holmes said that she wanted people to have access to early detection of their disease states. The medical community often finds disease states in advanced stages, such as cardiovascular disease and diabetes and typically attempts to treat the disease state with harmful drugs, such as statins, beta blockers and calcium channel blockers, which have been found to have adverse side effects that can lead to premature death, myocardial infarction, memory loss, brain damage and stroke.
If Elizabeth Holmes is successful in early detection of these disease states, then there is a possibility that people could reverse their condition without the need for these adverse drugs through a change in diet and exercise. Diet and exercise will most likely only have a minimal effect in advanced cases of the disease state. However, that is not necessarily good news for the FDA nor the global pharmaceutical market that has increased 230%+ in the last 10 years to nearly $1 trillion and projected to grow at a similar rate into 2025 as more people are treated in the late stages of their disease states.
It is reported that Elizabeth Holmes owns 50% of Theranos, making her the majority shareholder of the company. She is also the Chairwoman, Founder and CEO, effectively making her the ultimate decision maker in what she chooses to do with her technology.
The problem remains though that the US Government has a long history of usurping technology from Founders and keeping them in stealth mode whilst working on their secret projects. This has been the subject of books such as Ayn Rand's Atlas Shrugged, in which she critiques the US Government and holds them responsible for the disappearance of all the innovative Founders of her era, and the suppression of their discoveries that would never see the light of day; and in such popular Hollywood films, such as The Bourne Legacy, in which scientists are prevented from publishing their findings whilst working under non-disclosure agreements on government projects.
But fiction aside, the fact remains that dethroning the medical and scientific communities is not an easy task, where there are many disillusioned scientists of all levels, who sometimes plagiarise from each other, publish under pressure and pushed towards using inconclusive results to further their research grants. It isn't easy being a scientist nor a medical doctor. It probably isn't easy being a salesman for pharma drugs either. The fact is, what Elizabeth Holmes has accomplished is still an incredible feat, whether or not she is merely the figurehead of the organisation that is Theranos, or whether she was the creative brainchild who had devised the blueprint of these technologies whilst working with the world-class British biochemist, University of Cambridge alumni and scientist Ian Gibbons, to create the patents that are now being actively utilised by the US Military.
The US Military has reasons why they want to keep Theranos' technology under wraps and not be released to the public. Elizabeth Holmes has a different idea.
By Sierra Choi
[disclaimer: this post is not intended to diagnose any diseases nor a criticism of the FDA, nor the medical and global pharmaceutical industries]