Letter from the Publisher

Theranos Lab Testing: Easier, Less Expensive

The past holiday season was a great time to catch up on one’s reading. I thought I would glean the latest and greatest perusing the journals – but the most eye-popping read was not in JAMA, New England Journal of Medicine, or Lancet. Instead, it was to be found in a New Yorker article in the Dec. 15, 2014, issue by Ken Auletta writing about Elizabeth Holmes, a 30-year old who is seeking to upend commercial laboratory testing. Fluent in Mandarin by the time she completed high school, Holmes was able to participate in a graduate-level chemical engineering program at Stanford. At 19 years of age, she dropped out of the university to found Theranos, a Silicon Valley company now in its 10th year. Holmes’s work with her engineering group led her to rethink how medicine approaches laboratory testing. She had always had a fear whenever she was in the doctor’s office and a lab test was required, and she recalled how other family members fainted when their blood was drawn. Wasn’t there a better way?

Holmes believes that a laboratory test does not need multiple specimens of blood removed by venipuncture. Instead, a simple finger stick is sufficient for completing a lab panel. What’s more, Holmes’s laboratory model offers testing stations to be conveniently located in pharmacies operating seven days per week, throughout the day, making lab testing as convenient as a trip to the supermarket. The laboratory technique depends on a proprietary method known as “lab-on-a-chip.” Rather than using the large equipment manufactured by Roche Diagnostics and Siemens, lab testing is done on machinery designed by Holmes’s company, Theranos. Its equipment is much smaller and presumably more efficient in assessing a lab result with minimal blood. Theranos has perfected the assessment of dozens of laboratory tests all done with a simple lancing of the blood performed in less than 2 minutes. It offers the testing at a fraction of the cost of its competitors – below the amount approved by Medicare. The lab testing is CLIA approved, but it has not been subject to medical peer review – it doesn’t have to, because the instrumentation and testing methodology have been developed in house (the FDA does not require peer review for in-house testing, but this may change in 2015.)

Holmes, who owns 50% of the stock of Theranos, has an impressive team of statesmen and CEOs for her board of directors because of her friendship with Palo Alto neighbor former Secretary of State and Treasury George Shultz. Working on the board with Holmes is Bill Frist, a cardiac surgeon and former Senate Republican majority leader. Other board members include former Secretary of State Henry Kissinger; Sam Nunn, former Democratic senator; William Perry, former defense secretary; and William Foege, MD, former director of the CDC. Holmes has convinced Cleveland Clinic president and CEO Dr. Delos Cosgrove that her testing will not only upend lab science but will also be a “major change in how we deliver health care.” Currently, a Walgreens store in Palo Alto as well as 30 Walgreens stores in Phoenix offer Theranos testing. Individuals are required to have a physician prescription to have testing done. Holmes hopes to get lab testing available at all 8400 Walgreen stores in the future as well as at competitor pharmacies. Couriers pick up lab specimens several times daily and are shipped to the Palo Alto laboratory for processing.

Quest argues against Holmes’s claim that it continues to use the technology of the 1940s – the company’s instrumentation and testing methodology have greatly reduced the volume of blood required for testing. Further, Quest’s senior scientist, Nigel Clarke, disputes that the lab assessment from a capillary finger stick is the same as a venous specimen. Laksmann Ramamurthy, former associate director of the FDA, is concerned that the technology does not have peer review. Although Theranos has applied for FDA approval, it has never received any official response from the agency. Some critics worry that patients will not be able to understand laboratory test results without physician oversight. Holmes counters, how difficult could it be to interpret a cholesterol score or a blood count?

Craig Venter, PhD

Perhaps the most intriguing speaker at the A4M December meeting at the Venetian Hotel in Las Vegas was J. Craig Venter, PhD. Venter is one of the first to sequence the human genome. He is the first to transfect (introduce DNA or RNA into) a cell with a synthetic genome. As an example a bacteriophage is a virus capable of infecting a bacterial cell causing bacterial cell lysis. Venter’s group analyzed and sequenced the genome for Phi X 574 bacteriophage that kills E. coli. When the synthesized genomic material was implanted in E. coli, viral particles accumulated and the bacteria were lysed. The phage was able to further infect adjoining E. coli bacteria. Venter thinks of the phage transfecting process as viral software that enables it to build its own hardware. He sees the process of synthesizing artificial genomes, DNA assembly tools, as the process by which one can convert one species into a different species. Venter explains that the donor genome encodes restriction enzymes that degrade the recipient cell’s genome. Once the synthetic DNA is implanted the activity of the DNA in the recipient cell is changed permanently.

In 2010 his group was successful in creating the first synthetic life form. Venter thinks that transfected organisms with implanted DNA will be the key to developing new vaccines, medicines, biofuels, waste remediation technologies, and other scientific advances. When Venter began his work gene sequencing required massive computers and hours of time to sequence hundreds of DNA/RNA pairs. Now the technology is available with lab bench instrumentation that is capable of sequencing 10,000 pairs in a similar period of time. The speed of the genomic sequencing with these portable instruments means that medical workers could sequence an emerging virus in a jungle environment and with the synthesis of small fragments of the viral genome proceed to create vaccines. Effectively this would enable vaccines to be made in “real time” as new viruses are encountered. Venter discusses the role of synthesizing phages for difficult to control hospital bacterial infections; for example, a phage could be synthesized for resistant pseudomonas in hospital burn units. He sees a role for synthetic genomic sequencing in transplantation work. Lung transplants have been extremely expensive and difficult. He thinks that we can “humanize” pig cells for organ transplantation. If pigs could go through genomic editing, pig cells would be available for lung transplantation. Venter sees the application of portable genomic sequencing in space exploration for life; genomic sequencing can be made of a suspected Martian life form and the sequencing can be messaged to earth, then the genomic sequencing can be synthesized here.

Venter’s most ambitious project to date is his joint venture Human Longevity Inc. The company was formed in March 2014 with the goal of expanding quality human life expectancy. Venter’s group intends to use “big data” from genomics, microbiomics, metabolomics, and proteomics to determine how best to use stem cell therapy and other treatments for life extension. Venter is the author of a book telling his personal story, A Life Decoded. Venter reviews his work and predictions for the future of science in Life at the Speed of Light: Double Helix to the Dawn of Digital Life.

Best of Naturopathic Medicine Competition 2015

Our February/March 2015 issue publishes the winners of our “Best of Naturopathic Medicine” competition held every two years. This year we have three naturopathic physicians sharing the first-place prize: Jonathan Prousky, ND; Steven Sandberg-Lewis, ND; and Allison Siebecker, ND. Dr. Prousky is the chief naturopathic medical officer and professor at the Canadian College of Naturopathic Medicine. Dr. Sandberg-Lewis is a professor at the National College of Naturopathic Medicine and cofounder of the SIBO Center. Dr. Siebecker is an instructor at the National College of Naturopathic Medicine and co-founder and medical director of the SIBO Center.

Jonathan Prousky has spent more than 16 years treating patients with mental disorders. He has employed orthomolecular medicine and naturopathic treatment in managing patients with anxiety, depression, bipolar disorder, and schizophrenia. As editor of the Journal of Orthomolecular Medicine, he has examined and reviewed the work of Abram Hoffer, MD; Linus Pauling, PhD; and others, incorporating their work in his practice. His paper on assessing vitamin B12 published in the February/March 2011 issue of the Townsend Letter offers a well-documented rationale for administering high doses of B12 in managing mental disorders. Prousky’s paper in this issue examines the triggers of mental breakdown and the need for the patient to have effective resilience to cope with stress. Prousky argues that the majority of psychiatric medications not only fail to reverse mental disorders but render the patient less motivated and capable to actively seek strategies that restore wellness and mental health. The psychosocial support that patients need include effective counseling, proper shelter, regular meals, employment, exercise, connection to nature, religious/spiritual practice, sufficient sleep, and orthomolecular interventions.

Steven Sandberg-Lewis has devoted his academic work to teaching gastroenterology; he is the coauthor of Functional Gastroenterology. Sandberg-Lewis and Allison Siebecker have founded a clinical center in Portland, Oregon, to treat dysbiosis and irritable bowel syndrome. They have conceptualized dysbiosis as small intestinal bacterial overgrowth (SIBO) – an abnormally high number of microorganisms typically found in the large colon populating the small intestine. These commensal bacteria include E. coli, Bacteroides, Clostridium, Streptococcus, Enterococcus, and Campylobacter. Because carbohydrates and fats are not fully digested until passing through the small intestine, bacteria ferment the carbohydrates, yielding vast quantities of hydrogen, hydrogen sulfide, and methane. Sandberg-Lewis and Siebecker contend that it is only by measuring the gas production that one may make a diagnosis of SIBO and advise an appropriate treatment strategy. They differentiate IBS symptoms of diarrhea and constipation based on the predominant gas production; excess methane leads to constipation and excess hydrogen leads to diarrhea. The treatment of SIBO includes a carbohydrate-restrictive diet, antibiotics, herbal antibiotic alternatives, and biofilm disruptors. Prevention of SIBO relapse includes a modification of the restrictive diet, a “prokinetic” agent to mobilize the intestine, and further supplementation. Sandberg-Lewis and Siebecker offer strategies to prevent treatment failures.

Jonathan Collin, MD