Category Archives: Activism & Advocacy

The Theranos Problem in One WSJ Graphic

Now that Theranos is allegedly/denying-trying to raise money, speculations continue as to whether it could survive the Wall Street Journal article, Hot Startup Theranos Has Struggled With Its Blood-Test Technology, or whether a big industry player may swoop down to acquire the company.

In terms of “who would be audacious (to use a polite word) enough to possibly merge/acquire Theranos”, I think a diagnostic company would be more a likely candidate… you know, one of the big players that Theranos was meant to “disrupt” the business of.

The short sighted assumption from many people thus far, is that Theranos was the only company that had the “foresight” to reduce sample volume required for blood based assays.

Can we actually believe that NONE of the big players NEVER considered the competitive advantage of reducing sample volume required from patients and human subjects? Are we saying that all these years no one had ever realized how many people hated needles, and the kind market leadership position one may gain if one creates an assay method that enables accurate sampling of mere drops of blood versus vials of blood?

When we look at Theranos’s “accuracy” compared with hospital results, most scientists familiar with the assay process can deduce the magnitude of what needs disrupting:

The best performance in the graphic from Theranos in terms of “accuracy” compared with a hospital result “standard”, is the glucose test.

This is nothing to be impressed about: getting the glucose reading right is no newer than the finger prick glucose draw available from today’s diabetes management devices. It only shows Theranos got their tech as right as what is already available in terms of a finger prick blood sugar test.

Perhaps someone can use current glucose monitoring technology, modify it so it could assay for Herpes (simplex type1), and see if the same “tech” transfers readily to accurately test for Herpes. This would offer an interesting data point to show just how novel the “Edison portfolio of technology” is.

This one graphic sums up the Theranos problem: the most accurate comparison is in a variable for which cheap and accessible diagnostic is available (glucose), and not for any variables for which wide clinical use are expected (liver function tests, which are critical for a variety of medications affecting liver function).

Theranos’s results are consistently “false positive” compared with hospital standard: if a clinician believes in the Theranos result, the clinician may order the patient to stop taking medications that the patient needed and was doing well on, but should no longer be taking because the results show that liver was being negatively affected, or the clinician could switch to another less effective medication for the patient out of concern for liver function. Either case, if the Theranos test was inaccurate, this would cause harm to the patient by unnecessarily disrupting treatment regimen that was otherwise appropriate.

This is not the kind of “disruption” healthcare providers want.

From a business perspective, Theranos’s FDA approved use for its product has a very narrow indication (Herpes), yet the test is commercially available without authorization from a licensed healthcare practitioner. This is great for the company’s bottom line, because the (federal) agency will have a tough time identifying which kits have been purchased for “approved” use and which kits are actually used “off-label”. The pricing advantage allows Theranos to reduce dependence on CMS reimbursement, by going straight to consumers. Liability becomes a matter of personal injury, which may be skirted when the consumers assume entire risk by “inappropriately using” the kit.

However, this is not great from a consumer protection standpoint.

We may subscribe to a conspiracy theory about major diagnostic and device companies colluding to keep an oligopoly on expensive assay machines and profit margins for assay kits, but from a business competition standpoint, the market dominance/leadership would be too attractive for a major player to ignore in the name of market oligopoly.

Dream and Nightmare of Web-Scale Pharmacovigilance

I’m not going to tap into fear-mongering of why Microsoft is involved in the study that pulls adverse event (side effect) data from the internet, but I’m wondering what’s taken people so long to figure out the vast pool of patient experiences available online. Oh wait, those of us involved in industry know about this, only we don’t want to know about it.

There is at least one valid reason: you need to have a full picture of what is involved behind a side effect, to say with some level of confidence that your reported side effect experience came from the drug you said you took, not the other drugs you’re conveniently not saying you’re taking (especially the not-so-legal kind), or that you have a drinking habit (alcohol has major interactions with every drug under the sun), or that you’re taking 20 supplements you got from the nutritional store, and some prescription med you got off the internet by some shady doctor who asked you a few questions before writing you the Rx…

But reality check. Web-scale pharmacovigilance is here, and needs to be here, and should be leveraged conscientiously and systematically.

2013-03-10 09.16 AM74

Some years ago I gave a talk at a DTC conference in New Jersey about the patients’ voice when it comes to safety information. I am not in the business of web-based pharmacovigilance, nor did I set out to collect this information, but patients started sharing their personal experiences with an antidepressant on my mental health website. Yes, there are paroxetine/Paxil-related reports, but for the most part patients talk about bupropion/Wellbutrin, and over the span of many years there are hundreds of patient reports that are consistent in terms of their side effect experience.

This all started with one reader asking a question about a particular side effect of bupropion, and whether there were any published studies about a particular side effect. I’m sure there are scores of data from the manufacturer, but like much of drug data, these are kept “proprietary” with the ever-present “data on file” label on clinical slide presentations that the manufacturer supplies to a well-selected public (doctors).

Industry shouldn’t fear it or revile it: pharmacovigilance is critical for gathering drug information over time as part of safety monitoring, and the FDA sucks at making this an easy task for anyone with the desire to report adverse events with bureaucracy.

Read NYT’s take on web-scale adverse event reporting and drug safety monitoring.

How People with disabilities May Find Gainful Employment?

A. Prioritize components of gainful employment.

Pick and choose / prioritize components from the “9 components of gainful employment (source: http://en.wikipedia.org/wiki/Gainful_employment). These include Variety of work, Safe working environment, Income, Feeling of Purpose, Friendship at work (among others.)

While we may desire all 9 components to feel “fulfilled”, we may not all rank these components the same. Thus, identify your personal ranking based on your self-knowledge and how you best thrive as a person.

B. Identify elements of gainful employment that, for you, requires some level of accommodation

For example, under the “Variety” component, you may desire variety but within certain parameters because of your special situation. The same may be said for “safe working environment” — we can use a very broad definition of “safe” to include safety from physical harm or harassment.

However, you may have additional considerations. For example, someone whose epilepsy may be triggered by certain kinds of lighting will need to look at a parameter that her peers may not think twice about, because of this special consideration.

C. Analyze the Risk/Benefit Ratio of accommodation.

This is truly the root of the matter. Employers want to behave in the most enlightened manner and they also must conduct some form of “risk/benefit” analysis when looking to include employees of all different abilities. This is where we can engage our creative muscles and look for a working solution.

For example, there are workers who need a certain level of “quiet” or they cannot function because they have such sensitive hearing it is painful to be in a regular workplace with ambient noise. Telecommuting may be a way to include workers like these. The limitation is that telecommuting requires other technologies like video or teleconferencing to “link” that worker to a work-hub. Telecommuting is also limited to work that can be done virtually, and does not require physical collaboration (for example, you cannot telecommute as a baker).

I suggest that you do the following:

  1. Go through A, B, C (prioritize, identify, analyze)
  2. Brainstorm various scenarios of “work environments” that can leverage your skills and talents
  3. Research where these work environments may exist, or what work environments lend well to becoming productive work environments for you, with some accommodations
  4. Sometimes you may do well by finding other with similar abilities and create a consortium or some type of a work group (I don’t have specific examples but just brainstorming this and throwing it out there for someone brilliant to have an ah-ha moment and add comments to this answer.)
  5. Sometimes you need to create your own job (and this is where looking at freelancing opportunities are needed, although I know this means you don’t get one of the most critical benefits of employment: healthcare benefits.)

I Believe in You!

Patient Hot Buttons in Pharma — Series with Casey Quinlan

Introduction: I met Casey Quinlan in October 2011 when we both presented at a Digital Pharma industry conference hosted by DTC Perspectives. Casey describes herself as a “rabble rouser”, and of course, I cannot resist. This is a series of conversations with Casey on various “Patient Hot Buttons in Pharma” that we will be relay-blogging.

Casey

Jane

Segments of this Series:

Absurd Advertising

Lack of Transparency

Behind the scenes manipulation we sense but can’t see

Lack of Presence

Cost

Pharma Companies that Can’t Handle Comments Should Get Off Facebook, Good Riddance!

Jonathan at Dose of Digital talks about pharma’s fear of Facebook pages centering around 2 issues that pharma thinks require 24/7 monitoring: Adverse Events and negative publicity.

I hear the same excuse on why pharma companies are so scared to look at patient comments on blogs: adverse events.

I’m sorry, but adverse events are happening whether pharma companies are monitoring or not, and this is different from monitoring whether someone’s posting something “bad” about your company (newsflash: not everyone’s going to like you, better to expect it and have rules to address it than bury your head in the sand).


Adverse events are crucial for patient adherence and avoiding Facebook comments for fear of posts on AE is a missed opportunity for pharma to engage with patients in an issue that they all care about.

Patients expect drugs to work — rarely will patients want to get on a pharma page to thank the company for making a product that works. You may have a cancer patient who will do this if the company has gone above and beyond the call of duty to help the patient gain access to the drug that the patient otherwise cannot afford. But for the most part, patients have a “love-hate” relationship with pharma companies that is more “hate” than “love”, and I can’t blame patients for feeling this way.

What patients gripe about, and fear, and dread, are the adverse events.

Adverse events chip away a patient’s hope of getting better.

Adverse events erode a patient’s quality of life.

Adverse events make patients wonder, “would I rather stay ill, or deal with this horrible side effect?”

Then they look at companies avoiding discussion about something that is so key to their treatment experience, they naturally assume “profits before patients”. Never mind the realities of bureaucracy in adverse event reporting, I know it’s a bitch… the FDA knows it too.

That’s how pharma companies come across in their being so scared about Facebook.

Funny… I rarely recall pharma companies coming across scared when some of their sales and marketing teams find creative ways to fly under the radar to promote off-label. Somehow these companies are fine with breaking the law to “expand” usage of their drugs, but now they’re claiming they can’t deal with lack of guidance where Facebook pages are concerned.

Better companies pull their pages off Facebook if they are hard-headed about not allowing comments. Leave those who are more enlightened to get those patients’ eyeballs and possibly gain some goodwill.

Companies who want to control the message and behave hypocritically are doing the right thing by leaving Facebook: they aren’t adding value on the social network anyway.