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Why I Left My Pharma-Sponsored Academic Research Gig

flying cadeuciiNot long back, I departed a pharma-sponsored research project. I based my decision to leave in something I occasioned over a decade ago. I thought it was time to share the episode and the lessons learned given the attention being paid to physician conflict of interest nowadays (as well as the annual Open Payments review and dispute period approaching).

When I finished training, very few docs practiced hospital medicine—or even knew what the term hospitalist meant. Several forward-thinking medical centers hitched their wagons to the hospitalist model, as did some astute information technology and staffing companies.

However, few healthcare players embraced the hospitalist movement in a serious fashion like the pharmaceutical industry. They realized hospitalists prescribed a narrow band of products, in big lots, within a centralized location. The higher ups in the pharma sector saw the benefits in directing reps our way.

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The Joint Commission Pain Standards: Five Misconceptions

Baker_David_275In the environment of today’s prescription opioid epidemic, everyone is looking for someone to blame. Often, The Joint Commission’s pain standards take that blame. We are encouraging our critics to look at our exact standards, along with the historical context of our standards, to fully understand what our accredited organizations are required to do with regard to pain.

The Joint Commission first established standards for pain assessment and treatment in 2001 in response to the national outcry about the widespread problem of undertreatment of pain. The Joint Commission’s current standards require that organizations establish policies regarding pain assessment and treatment and conduct educational efforts to ensure compliance. The standards DO NOT require the use of drugs to manage a patient’s pain; and when a drug is appropriate, the standards do not specify which drug should be prescribed.

Our foundational standards are quite simple. They are:

  • The hospital educates all licensed independent practitioners on assessing and managing pain.
  • The hospital respects the patient’s right to pain management.
  • The hospital assesses and manages the patient’s pain.

Requirements for what should be addressed in organizations’ policies include: 

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Beyond the Valley of Hype and the Plateau of Despair

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I can’t get Dan Lyons out of my head.

Lyons is the author of Disrupted, the buzzy new book about what happens when a curmudgeonly fifty-ish tech writer gets unceremoniously dumped from a plum role at Newsweek and takes a job as a “content generator” at Hubspot, a white-hot Boston startup selling marketing software.

Best known for creating a “Fake Steve Jobs” blog, and more recently for his work on the writing team for HBO’s achingly funny Silicon Valley, Lyons has a taste for the absurd, and his prologue (excerpt here)–describing his initial experience at Hubspot–is a laugh-out-loud takedown of tech startup culture.

The fun only lasts a few chapters, however (captured perfectly in this review by Erin Griffith), as Lyons hopes to convey a more serious point (conveniently summarized in an op-ed in today’s New York Times): that the excitement around technology companies is largely empty hype, enthusiasm used to sucker naïve young adults to work for peanuts (and candy), and to enrich savvy founders and venture capital investors, and the investment bankers who enable them, at the expense of the gullible mom and pop investors who buy shares of these fast-growing but often profitless companies after they go public.Continue reading…

How a Physician Can Work With a Not Yet Approved Drug Through Compassionate Use

Screen Shot 2016-04-18 at 8.05.22 AMIn a time when evidence-based prescribing and clinical guidelines are hot topics in medicine, trying to access a not-yet-approved drug to use in a patient can feel like navigating uncharted waters. Many physicians are unaware that the US Food and Drug Administration (FDA) allows the use of unapproved drugs outside of clinical trials and — even if they did know it is possible — have no idea how to access such investigational drugs for their patients.

This knowledge is largely sequestered into certain clinical specialties, such as oncology or rare disease, and it is not taught in medical school or during residency: instead, is largely self-taught. Thus, while some physicians have become very accustomed to requesting pre-approval access to drugs, the majority lack this knowledge. In this essay, I use a fictional case to trace the process for requesting access to an unapproved drug. I hope to explode several myths about the process, such as the notion that the FDA is the primary actor in granting access to unapproved drugs and the belief that physicians must spend 100 hours or more completing paperwork for pre-approval access.

Imagine you are a physician, and you have a pregnant patient who has tested positive for Zika. While she is only mildly ill, she’s terrified that her unborn child may be impacted by the virus, which has been provisionally linked with microcephaly and other abnormalities. She’s so concerned that she is contemplating an abortion, even though she and her husband have been trying to have a child and were overjoyed to learn she was pregnant.

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Your Personal Healthcare System in the Year 2030

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Against your better judgment, you’ve just checked your contact lens-enabled news feed. You’re annoyed, because President Meghan McCain has just used the Trump Doctrine to “fire” Medicare’s lead administrator over the botched roll-out of the Agency’s block-chain claims payment system.  The mild spike in sweat stress chemicals detected by your clothing sensors prompts a boost in the transcutaneous dosing of the blood pressure pharmaceuticals from the networked skin patch on your thigh.

It’s the year 2030, and personalized “eDxTx” (ecosystems of Diagnosis and Treatment) has arrived for a lucky few who are able to afford it. That has created political headaches for the President and her campaign promise to bring Medicare out of the 20th century. Your decision to opt out of “Medicare for All” (a.k.a “TrumpCare”) has been expensive, but worth it because your Geico insurance plan includes eHealth as a covered benefit.  Geico’s ability to automate all underwriting and claims handling means high service standards and keeping costs down. Plus, those video ads are still cool.

Thanks to ubiquitous wireless connectivity, cloud-based machine intelligence and mass-personalized medicine, you and your private doctor’s team were able to configure a suite of customizable off-the-shelf apps that meet your goals for living well as well as long.  The first step was your $2 psychometric, biomic and genetic testing (the expense of a mitochondrial analysis was offset with an agreement with the laboratory, Theranos, to pool your data with other customers) that spotlighted the optimum mix of nutrition and pharmaceuticals to blunt your risk of Type 15 Hypertension and GAB15a-linked gastrointestinal cancer.

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The Pharma = Evil Narrative

flying cadeucii“People hate pharma,” my Forbes colleague Matthew Herper observed recently–and at times I can understand why. There’s not much to admire about executives like Martin Shkreli, or businesses like Valeant.

But I’ve started to worry that the “pharma = evil” narrative has become so ingrained that it’s taking on a life of its own, as readers instinctively anticipate this storyline, and journalists reflexively provide it. Coverage of a recently announced innovative training collaboration between Johns Hopkins and MedImmune (a subsidiary of AstraZeneca ), for instance, focused primarily on potential conflicts of interest.

(Disclosure/reminder: I work at DNAnexus, a health data management company in Silicon Valley and Boston; our partners include universities, government agencies and private companies.)

This narrow view, however, not only fails to capture the urgent need for effective, new therapies, it overlooks entirely the vital role played by companies in translating fragile but promising scientific ideas into robust medicines for patients.

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Check Your 2015 Open Payments Data

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The Centers for Medicare & Medicaid Services’ continues to publish data from applicable manufacturers and group purchasing organizations (GPOs) about payments they make to physicians and teaching hospitals on its website. We’re pleased that the public has searched Open Payments data more than 6.3 million times. Doctors, teaching hospitals and others receiving payments or other transfers of value that are sent to us from reporting entities, should take steps to ensure that this information about you, your related research, ownership, and other financial concerns are accurate.

Doctors and teaching hospitals have the chance to review and dispute the information shared about them before we post the new and updated Open Payments data on June 30, 2016. The data we post on June 30th is now available for review through May 15, 2016. Since April 1, this is the only chance for these health care providers to dispute inaccurate or incomplete data before we post it. After that they only have until the end of the year that this financial data is published to review and dispute any payment records and how it was attributed from GPOs, drug and device manufacturers.

Any doctor or teaching hospital that wants to look at the financial information reported on them by manufacturers and GPOs can register on the Open Payments website to create an account or log if they already have an account. Visit our website for instructions and quick tips.

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Stephen Curry’s Health Care Plan

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The 3 point shot has revolutionized basketball and turned the NBA upside down. The smartphone has revolutionized health care and turned the doctor-patient relationship upside down.

Let’s examine those two statements.

In a recent Wall Street Journal article, Martin Johnson describes the dramatic changes that the creation of the 3 point shot has created. The prior era in was dominated by a dominating big man-  Bill Russell, Wilt Chamberlin, and Kareem Abdul Jabbar.  As Johnson writes, “This made intuitive sense: The better a team is at protecting its basket, the better its defense should be.”

Suddenly, the rules changed and the 3 point shot was created.

With new rules, new values.

With new rules, new math, new economics for the NBA.

What had been valuable- the dominant big center to defend the basket- is no longer as valuable.

What had not been as valuable- a small, quick, long distance shooting guard, and those best suited to defend against them- now are a valued resource.

The evidence of this ‘transformative innovation’ is everywhere; from Stephen Curry, a small nimble, excellent shooting guard, winning the NBA MVP award to the NBA finals between the Cavaliers and the Warriors- where the defense is as fierce at the 3 point line as it is right under the basket.

So the  new rule establishing the 3 point line has turned the game inside out, shifting the focus from the ‘big man’ to a new type of player – as John Hollinger, the Memphis Grizzlies vice president of basketball operations, states in the Journal, “It has completely changed the way players are valued on the market.  Now we put a premium on length and basketball IQ.”

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Design Encompasses the Whole of Health Care at HxRefactored Conference

downloadHxRefactored, the conference put on jointly by Health 2.0 & Mad*Pow about technology & design in health care, draws a relatively small crowd–participants numbered in the hundreds, not the tens of thousands found at some health conferences. So I asked a leading health IT expert, Shahid Shah, why he invests so much effort in coming and make presentations to HxRefactored each year. He answered, “This is the only health IT event that covers not just the digital aspects, but the entire healthcare experience, focused on developers and designers who are building solutions. It goes beyond platitudes, cheerleading, and hand waving and gets into actionable advice that engineers need to know to build complex systems that will actually get used.”

And that really shows the key influence provided by design, broadly defined. You can get as “meta” as you want and stay within the field of design:

  • Worried whether your staff will adapt to and use a new IT system? Success with that is a design goal.
  • Determined not to let an IT system “get in the way,” but to ensure it enhances relationship-building with patients? Definitely a matter of design.
  • Eager to make innovation a standard kind of thinking throughout your institution? Designers with the proper combination of support and independence can get you there.

Reflecting the sweep of design itself, sessions at HxRefactored varied from chronicling the path to successful designs, to describing the contributions technologies make, to recommending strategies for getting designs adopted.

Design as a way of Life

A hoary shibboleth of design is that practitioners must seek out users and collaborate tightly with them. A more pointed statement of that principle is to turn all users into designers. This means not flying in to do a design, collecting your pay, and taking off again. Instead, designers hang out in the hallways to meet people, cajole users into joining creativity workshops, and–with teeth gritted–attend committee meetings.

Comprehensive engagement came up from the start of the conference, as when Adam Connor in his keynote pointed out that isolated researcher can’t transfer their insights automatically to others in the organization–everyone in the organization must participate in user research. He also pointed out that no system makes sense except when one views the larger environment of which it is a part.

The CTO of HHS, Susannah Fox, in her inspiring keynote, said “Technology is a Trojan Horse for change…We say interoperability and open data, but we mean culture change.” Design, for her, must recognize people without power, which currently includes most patients and their caregivers.

Fox championed Maker-style innovation at the grassroots, such as promoted in the famous work of Eric von Hippel at MIT. Hundreds of people are making custom prosthetics, for instance. She also mentioned that a very useful sleeve to keep an IV firmly in a child’s skin was designed by a parent. Similarly, patients could improve their medical devices, but manufacturers deny patients access to their own device-generated information, and prohibit patients from making changes. Patients who lack access to research labs and academic libraries are finding the information online to improve their experiences. Fox didn’t describe the risks and downsides of these practices, but I found that acceptable because the risks and downsides are cited all too often to throw up barriers to competition and innovation.

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Climate Change and the Migration of Infectious Disease

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Zika is all over the news. Zika is surely dangerous, but it has its limitations and is likely to be well contained. However, its greater significance extends beyond any current spread. Instead, it exemplifies the crucial emerging trend of a novel infectious agent that has swiftly become a global threat.

The common phrase, ‘this time is different’, is almost always wrong. Yet, our modern circumstances are distinctly unlike any previous era. Humans possess a unique ability for rapid travel and we choose to journey with our favorite pets and plants. This unprecedented degree of mobility extends across every planetary habitat. Further yet, it now occurs during a phase of a rapidly shifting climate. Certainly, species migration or global climate change are not new but it is only in this present moment that these factors can amplify through instantaneous global travel in a singular manner.

In fact, the results of this unusual conjunction are already apparent. For example, Zika’s advance across Europe and to the Americas has been extremely rapid. This is such an extraordinary event that at the beginning of this year, the World Health Organization declared Zika a global emergency in recognition of its rapid spread from continent to continent. Its rising incidence mirrors our prior concerns about the global scope of other recent epidemics such as Ebola or SARS.

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