Category: Devices

Justifying EpiPen pricing, once again

published date
September 30th, 2016 by
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Back with more

I enjoyed Medical hackers create $30 DIY EpiPen in defiance of corporate greed over at inhabitat. The Four Thieves Vinegar collective cobbled together an “EpiPencil” from an auto injector for insulin, a hypodermic needle, and epinepherine. It’s a pretty cool trick but it proves nothing about EpiPen pricing nor does it help real patients.

Actually, it unwittingly reinforces the points I made in my very unpopular EpiPen may still be too cheap post, which is that the pricing of EpiPen has almost nothing to do with the cost of its parts.

Consider these caveats about the DIY EpiPencil from the inhabitat post:

However, it is worth mentioning that many experts have voiced concern about the EpiPencil and warned that it’s not advisable to try to create a piece of medical equipment at home – it can be difficult to ensure the correct dose is being administered, the epinephrine inside is delicate and might lose its effectiveness if stored this way, and of course, if someone were to create the device without paying close attention to hygiene, it could become contaminated. A miscalibration of the device could even cause the medicine to be injected into a vein, which can have dangerous side effects.

To recap, here’s what you’re paying for when you buy a real EpiPen:

  • The ability to send your kids to school, playdates, summer camp, hikes, and restaurants with reasonable confidence that they’ll survive an allergic reaction
  • An auto-injector that works. Remember, Twinject was rejected by the market for being clumsy, Auvi-Q was recalled because it could administer the wrong dose, and Teva’s autoinjector was rejected by FDA for “major deficiencies”
  • A device that many, many people know how to use: school nurses, babysitters, passers-by. That means someone is likely to be there to help you if you need it. Good luck with getting someone to learn how to use your EpiPencil in an emergency, even if somehow it worked as advertised

EpiPen’s maker, Mylan has done a lot of sleazy things, which I don’t defend, and as a result they may well deserve the opprobrium that is being directed at them. But I stand by my argument that EpiPen is not $2 of epinephrine and a syringe. Instead its a differentiated solution that provides plenty of value to users.

If someone can come up with something better and cheaper, please do!

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By healthcare business consultant David E. Williams, president of Health Business Group.

MedSentry: Adherence for complex drug regimens (podcast)

published date
September 16th, 2016 by

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Medication adherence is a tough challenge, especially for high-risk patients, whose complex drug regimens often feature more than a dozen pills. MedSentry is rolling out an end-to-end closed loop adherence system for this population. Although it’s not a large group, it is responsible for a disproportionate share of medical costs.

In this podcast interview, CEO Adam Wallen and I discuss the following:

    1. (0:11) Adherence is a big problem in healthcare. What does it mean? What’s the nature of the problem?
    2. (0:57) Are there multiple reasons for lack of adherence?
    3. (4:05) There are a number of adherence solutions in the market. How well do they work?
    4. (7:46) What is the MedSentry approach? How is it different?
    5. (11:57) What evidence is there that this approach is effective?
    6. (13:17) You have focused on the most complicated patients. Will that continue to be your niche as your commercialize?
    7. (14:55) Do you have a scale-up plan?

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By healthcare business consultant David E. Williams, president of Health Business Group.

Amazon Echo for healthcare

published date
June 2nd, 2016 by
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Alexa, what can you do for healthcare?

I bought an Amazon Echo this week and have been enjoying using it in the kitchen. I can ask, “Alexa, what time is it in Germany?” and it will tell me. Or I can say, “Alexa, play music by the Beatles,” or ask, “Alexa, how many ounces in a cup?” and it will let me know. It’s remarkably easy –and not at all frustrating– to use. The whole family is enjoying it.

Naturally I started almost immediately to think of healthcare uses, so I wasn’t at all surprised to pick up the Boston Globe yesterday and see that my friends from Boston Children’s Hospital are a step or two ahead. Chief Innovation Officer John Brownstein, PhD and clinical innovation director Michael Docktor, MD have launched a KidsMD app for the platform and are testing out uses for Echo in the OR, ICU and bedroom.

Although the article lays out some of the potential for Echo, overall I find it too dismissive, highlighting a software glitch, voice recognition problem, and asserting that “another layer of technology might frustrate staff.” The article ends with a quote from a Children’s engineer whose own kids aren’t interested in speaking with Alexa. None of this reflects my family’s experience.

What the article misses is that Echo represents the latest example of physicians bringing cutting edge consumer technology into the hospital and running circles around the standard tools offered by the IT department. In the real world, physicians are early and enthusiastic adopters of tools like the iPad and iPhone, and through the bring your own device (BYOD) movement they have upended the traditional, clunky hospital IT environment.

Here are some thoughts about what could make Echo so useful for healthcare:

  • It’s the rare tool that can be used equally well by doctors and patients
  • It’s a handsfree device, which makes it easy to use when one’s hands are occupied, dirty, or injured
  • The voice recognition is really good, and works just fine in a noisy environment
  • It enables continuity of care because a patient could use the same device at home that was used at the hospital
  • It gets smarter all the time as new intelligence and apps are added to the cloud
  • It can entertain as well as inform

I can foresee apps that help patients remember their customized care instructions, “Alexa, how often am I supposed to change my dressing?” or “Alexa, am I supposed to take my medication with food?”

I also think it will be useful for hospitalized patients who are trying to remember questions they want answered the next time their doctor or nurse comes around. There is a built in ability to say, “Alexa, add butter to my shopping list.” So there’s no reason it couldn’t compile a list of doctor questions as well.

These are the veritable tip of the iceberg, and I look forward to seeing a thousand (or more) flowers bloom as the healthcare field embraces Echo. “Alexa, I love you.”

By healthcare business consultant David E. Williams, president of Health Business Group.

 

Listen app: ResApp diagnoses respiratory ailments

published date
April 28th, 2016 by

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I’m intrigued by an Australian company, ResApp that has developed a smartphone app to diagnose respiratory diseases by analyzing the sound signatures of coughs. The company has just completed an oversubscribed fundraising round, so I guess I’m not the only one who finds it interesting.

I interviewed the CEO, Dr. Tony Keating via email, and his answers are below. Meanwhile, check out the demo for their consumer-facing product.
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What is ResApp? from ResApp Health on Vimeo.

Q1. What unmet need does ResApp serve? How big is the need?

ResApp is developing digital health solutions for the diagnosis and management of respiratory disease (e.g. pneumonia, bronchiolitis, asthma, COPD). We estimate that every year more than 700 million doctor visits result in the diagnosis of a respiratory disease within the OECD, in the US the number is 125 million visits. Pneumonia in particular costs the US hospital system $10.5 billion annually. The World Health Organization estimates that nearly 1 million children die of pneumonia in the developing world every year, with a large portion attributed to the lack of availability of a low cost diagnostic tool. 

Current diagnosis of these disease is costly and time consuming (consider that an x-ray for pneumonia diagnosis in the US costs more than $200 and can take up to an hour in an emergency department), and there are also many areas where current diagnostic tools are unavailable. Our initial focus is to provide an accurate remote diagnostic capability to telehealth where even the stethoscope is not available to physicians. 

Q2. How does the system work?

ResApp’s technology is based on the premise that cough and breathing sounds carry vital information on the state of the respiratory tract. We use machine learning algorithms that analyze the sound of a patient’s cough. Our algorithms are able to match signatures that are within a patient’s cough with a disease diagnosis. An analogy might be how speech recognition algorithms match speech to text, or how Shazam’s algorithms look for signatures in music to identify the artist and title. 

Q3. Who came up with the idea? How?

The technology was developed by Dr Udantha Abeyratne and his team at The University of Queensland. Dr Abeyratne and his team have been engaged in the R&D of the technology since 2009. They were initially funded by a grant from The Bill and Melinda Gates Foundation to investigate if mobile phones could be used to diagnose pneumonia in the developing world. The initial idea was to take the latest advances in speech recognition technology and couple them with physicians’ in-depth knowledge of cough and breathing sounds to develop a diagnostic test that could be delivered at low cost to patients in the developing world. 

Q4. You started as a telehealth app but are now looking to serve physicians for in-person visits, such as in the emergency room. Why?

Our focus remains on providing a remote diagnostic test to be used alongside a telehealth consultation. However we have seen great interest from physicians for use in in-person visits, such as in the ER. The potential of our technology to provide an instant and highly accurate differential diagnosis of respiratory disease is seen as a way to greatly improve the diagnosis and treatment of their patients. In addition, healthcare payers could potentially realize significant cost savings versus traditional diagnostic tests (such as chest x-ray). 

Q5. The app doesn’t require any additional hardware. Is a smartphone really good enough to serve as a medical device?

Our clinical study, run out of two major Australian hospitals, has demonstrated very high levels of accuracy (both sensitivity and specificity) in diagnosis from recordings taken using the microphone on the smartphone. We are simply using the smartphone as an efficient platform for delivering a clinical-quality medical diagnostic device. The FDA has approved over 100 mobile medical apps, including a number that diagnose a disease. 

Q6. Your initial focus is on diagnostics. Do you also plan to offer tools for ongoing management? 

Yes, our recent fundraising allows us to accelerate our plans to develop tools for ongoing management of the chronic respiratory diseases asthma and COPD. We see an opportunity to potentially measure the severity of these conditions on a more regular basis than what is done today. We also see the opportunity to deliver these management tools to all smartphone users who suffer from these conditions, without the need to purchase additional hardware (or perhaps also just as importantly, without the need to carry a second device). 

Q7. What geographic markets are you serving? Are you worried you are spreading yourself to thin?

Our focus is the US telehealth market, although our recent funding extends our US market into the in-person use by a physician. In both of these instances, we are still providing the diagnostic result to the physician, not directly to the patient, so our clinical studies and FDA submissions are essentially unchanged. We have recently seen growth in telehealth, in particular in Europe and Australia and will be working through the regulatory process in those regions in parallel to the US regulatory process.

Q8. What’s to prevent someone else from copying what you are doing?

The university has filed a patent application (which ResApp has a worldwide exclusive license to) describing the method and apparatus of respiratory disease diagnosis using sound. The machine learning algorithms that we use also require a significant amount of high quality clinical data, which we have generated from our multiple clinical studies. 

Q9. Anything else to add?

ResApp’s technology, originally developed by a world-class team at one of the world’s leading universities, provides an opportunity to deliver a clinical-quality medical diagnostic test for respiratory disease to everybody who has a smartphone in their pocket. While we’ve talked a lot about the opportunities in the US, Europe and Australia, we must remember that there are also billions of people in the developing world who do not have access to quality healthcare. We have recently partnered with a leading global humanitarian organization to help bring a high accuracy, low cost diagnostic test for pneumonia to those people and to try to reduce the number of children who die from pneumonia and other respiratory diseases every year in the developing world. 

By healthcare business consultant David E. Williams, president of Health Business Group.

How crazy is Ted Cruz's FDA reform proposal?

published date
January 4th, 2016 by

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I don’t think very highly of Senator and Republican Presidential candidate Ted Cruz, but his proposal to loosen the drug approval process is at least worth discussing. If you haven’t heard, Cruz’s RESULT Act proposal is as follows:

  • FDA to grant reciprocal approval of “life-saving” drugs and devices from regulatory agencies in developed countries including EU, Israel, Australia, Canada and Japan. FDA would have only 30 days to review and approve
  • Congress can override FDA decisions with a majority vote

Basically he is trying to make it easier to get drugs and devices on the market. There are a number of problems with this approach, which are pointed out by my most of the respectable analysts. Objections include:

  • FDA may just reject the applications anyway since 30 days is not a long enough time to review and they may object to procedures used elsewhere
  • Insertinbg Congress directly into the process undermines the scientific basis of the decision
  • Trial sponsors may seek the jurisdiction with the lowest standards or fastest review times, imperiling safety for Americans
  • It would hurt US economic development by shifting development resources overseas
  • We would be ceding our sovereignty to foreigners
  • FDA is already pretty fast and responsive and has programs for compassionate use and acceleration of the approval process when warranted

These are all reasonable, and yet I was struck by the fact that almost all the commentators use  the Thalidomide debacle as their one and only example.  See for example STAT, The FDA Group Blog, and Harvard Law Blog, which are the top articles that come up under a Google search for “Ted Cruz FDA proposal.”

Thalidomide was approved in Europe as a sleeping pill and for morning sickness but rejected in the US. It caused serious birth defects, with thousands of people affected in Europe but not the US. Great example but we’re talking 1956. Remember 1956? I don’t. But to give you some perspective it was just two years after food rationing was lifted in the UK and nine years before Medicare was established. Soviet troops rolled into Hungary to crush the uprising there.

I don’t hear people citing 1956 examples about anything else in healthcare.

A more serious discussion could be held on the balance between safety and efficacy in FDA approvals. Cruz’s impulses might be better directed to that debate. Maybe it’s ok for FDA to approve any product that’s safe, and not force sponsors to prove efficacy. Sponsors would still want to demonstrate efficacy, but they’d need to do so for healthcare payers, not the FDA.

That’s not as simple as it sounds either. Here are some of the challenges:

  • The biggest payers are Medicare and Medicaid, so even if you take FDA out of the business of judging efficacy the government is still involved
  • In many situations, safety is relative, not absolute. I might accept a modestly effective cancer drug that kills 1 percent of those who take it, while I wouldn’t accept a cure for toenail fungus with the same death rate. But it’s also important to protect cancer patients from dangerous drugs. A recent NYT article about the death from cancer of the wife of the FDA’s head of oncology included this important and under-appreciated point: “Cancer medicines not only often fail to save patients but can accelerate their deaths and make their last weeks far more painful”
  • Safety and efficacy are individualized. (Cruz seems to recognize this.) Some drugs will be effective for only a small population; similarly safety issues don’t always apply across the board. I would want access to a drug that could cure me even if it could kill someone else, especially if there were a companion diagnostic to sort out who will be helped and hurt

Overall I think the FDA is doing a good job of managing the conflicting pressures it faces. Some parts of FDA (such as the groups with responsibility for HIV and oncology) do a better job than others.

I really would like to see Cruz’s proposal spur a more productive debate and not simply be dismissed out of hand.

Image courtesy of vectorolie at FreeDigitalPhotos.net

By healthcare business consultant David E. Williams, president of Health Business Group.