Don’t Count Out Theranos

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The past few weeks haven’t been easy for Theranos, the pioneer hoping to make blood diagnostics a whole lot easier.

A scathing account by The Wall Street Journal, followed by some troubling documents released by the FDA, armed critics of the upstart start-up. The company clearly needs to counter these charges and demonstrate efficacy of its tests and the soundness of its business model.

However, change isn’t easy even in an industry like blood testing, which must be disrupted. We are literally still drawing vials and vials of blood for laboratory tests. This procedure seems only a shade better than the days of medical bloodletting with leeches. Also, these tests are notoriously expensive and have slow turnaround times.

What if Theranos CEO Elizabeth Holmes is on to something here?

What if her vision of easier, faster and cheaper blood testing is really possible? Wouldn’t we all like to see that? Blood testing is a very fundamental aspect of medicine and improving the current antiquated process has the potential to truly transform health care in a big way. Imagine how many more people might be compliant with their blood tests with this type of testing. Imagine how much faster we’d get results in critical situations, and how many lives might be saved. Imagine how much we could save our very wasteful and expensive health care system by making this process cheaper.

Before you say it’s impossible, let’s remember that the FDA did approve one of Theranos’ tests via its nanotainer technology, a test for the herpes simplex virus (HSV). That is an impressive feat, and quite frankly, I’d really like to see what other tests Theranos has been able to do via its tiny nanotainers. According to Holmes, the firm has something on the order of 120 tests submitted for approval with the FDA. Squash them now and the world may never know.

The media frenzy circling Theranos is unfortunate, and we should all hope it won’t kill off something that could really transform health care for the better. We shouldn’t be trying to protect the status quo in our dysfunctional health care system. Instead, we should be less hasty to judge Theranos.

Let’s keep in mind when we read media reports that there are a lot of stakeholders embedded in the health care industry – from equipment makers to laboratories to walk-in clinics and pharmacies – that might like to see Elizabeth Holmes fail. Some of these players currently own the market. That means they dictate the availability, the turnaround times, and yes, the price of these tests. Sure, maybe they could innovate also, but there’s inherently less motivation when you’re already a market leader. How about we introduce some competition to drive prices down and introduce more motivation to innovate?

Theranos, admittedly, has a lot of work to do. It is trying to disrupt the entire laboratory industry, while currently having just one FDA-approved test. I’m hoping more of its technology will meet FDA approval. In the meantime, it makes business sense to offer venous blood draws. If the company wants to capture enough of the market, it needs to offer the full spectrum of services to customers, be it using its proprietary technology or the industry standard.

As for Holmes, I can’t blame her for being protective of her nascent company. Unfortunately, people tend to be suspicious of things they don’t know much about, so that approach is not going to work anymore. Her challenge in the coming months will be how to effectively share more information with the media and increase transparency, now that she and Theranos are much more in the public eye.

There’s reason for optimism, not paranoia, about Theranos. Let’s allow some room for its visionary leader to carry out her ambitions. Maybe, just maybe, she’s on to something that can change health care, and the world, for the better.

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Conflict-of-interest disclosure:

I have no financial or other ties to Theranos or Elizabeth Holmes. My biases include wanting to see positive health care change and more women leaders. The opinions I’ve expressed here are my own and not those of any of my employers or affiliates.

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This article was originally published at www.digitalhealthcaresummit.com.

Precision Medicine: Pros & Cons

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23 chromosomes (image from Scientific American)

This past week, President Obama announced a $215 million proposed genetic research plan, called the Precision Medicine Initiative.  According to the plan,  the NIH would receive $130 million towards a project to map the DNA of 1 million people, the National Cancer Institute would receive $70 million to research the genetic causes of cancer, the FDA would receive $10 million to evaluate new diagnostic drugs and devices, and finally, $5 million would be spent on tech infrastructure to analyze and safely store this data.

Not surprisingly, this announcement sparked some online controversy.  If internet pundits are to be believed, this plan is going to prevent you from ever finding a mate, an employer, get health insurance, cause us all to become part of a giant genetic experiment to tailor human beings, and will also put us into crippling debt and line the pockets of Big Pharma.  I’m not even sure I covered it all…The complaints ranged from reasonable to ridiculous.  The most amusing are the conspiracy theorists who are certain that Obama must be plotting a genetic apocalypse.

But, in all seriousness, I have to admit I have concerns as well, despite being mostly optimistic about this news.

Here are some of the exciting positives offered by the precision medicine plan:

  • New diagnoses:  We may finally be able to identify genetic causes of diseases that were previously unknown.
  • Prevention vs. disease management:  Knowing genetic risks ahead of time can help us to focus more on preventing disease rather than reacting after-the-fact, once the disease occurs.
  • Early diagnosis:  We may be able to detect diseases earlier and at a more treatable stage.
  • Protective genes:  Some people have certain genes that protect them against diseases or prevent them from “expressing” their bad genes.  Studying these differences may help us to learn how to protect ourselves against those diseases.
  • Drug development:  Therapies can be developed in a faster and more efficient way by targeting certain genetic problems, rather than using the traditional trial-and-error method.
  • Personalized treatments:  Treatments can be tailored to a patient’s unique genetic aberration and we can avoid giving treatments to patients that we know may cause adverse reactions or that will fail to work.
  • Population health:  We can study genetic patterns in populations of patients to find out causes of diseases, develop treatments, and find ways to prevent disease.
  • Healthcare costs:  There’s a potential to reduce healthcare costs if focus changes to prevention rather than treatment of disease and also if we can streamline drug development.

But, let’s also look at the potential downsides:

  • Data storage:  We already know that gene sequencing of an individual produces MASSIVE amounts of data.  The sequencing of a million people is going to produce unimaginable amounts of data.  How will we store all this big data and analyze it to make any sense of it?
  • Privacy/Security:  Is there anything more personal and vulnerable to cyber-attack than your genetic information?  I wonder if the $5 million allotted to this effort will really be enough.
  • Data relevance:  According to Obama, the data will be collected from 1 million volunteers.  That’s not a random cross-section of people in the US and may not represent the population adequately in order to make population health recommendations.  I’d argue that only certain types of people would sign up and other types won’t.  Would we miss certain disorders? Would we see too much of another disorder in a population of volunteers for this project?
  • Culture:  How do we prevent people from abusing this information and not using it to screen potential partners, deny insurance coverage, denying jobs?  How will this affect culture?  Will we be cultivating a different kind of racism, on a genetic basis?  Are we on the path to a real-life version of the movie Gattaca?
  • Ownership:  Who will claim ownership of this data?  Will it be the government?  I’d argue that this data should be owned by the individuals from whom it comes, but the experience of the genetic sequencing (now genetic ancestry) company 23 & Me is worrisome.  For the time being, the FDA has blocked the company from allowing individuals from having access to their own genetic information.  Will this change as part of the new initiative or not?
  • Drug/device industry:  Genetic research and development of treatments has been very promising and productive in the private sector.  How will government involvement affect research?  Will our governmental agencies work cooperatively with them or competitively?  Again, if the experience of 23 & Me is any indication, this is a real concern.
  • Healthcare Costs:  Yes, there’s potential to decrease costs, but there’s also potential in greatly increasing costs.  It’s no small feat to genetically map a population, analyze the information, store it safely and securely, and develop recommendations and treatments.

Part of me is excited about the potential and I think that it probably does take a huge governmental initiative to tackle and impact population health, but another part of me is concerned about government invading a space that is so personal and private and I wonder if it could slow down progress in developing life-saving therapies in the private sector.

What do you think?  Are you excited or nervous about President Obama’s Precision Medicine Initiative?