Where Are You Going My Darling Young One?

Bryan Vartabedian, MD writing at 33 Charts examines “When Push Comes to Shove: The Slow Death of the Medical Blog-o-sphere” at Dr. Wes blog. Vartabedian post is “The Implosion of the Medical Blogosphere” and from his view there are more physicians on-line but they are residing in communities specific to their needs. He agrees with Wes that “their presence is less about doctorly togetherness and more about personal presentation.” Life is one HUGE stage. Further Vartabedian points to the new world of video and microblogging as well as the fact most are not creating but curating.

He closes with this which I agree with

So while the blogosphere of the early-mid 2000’s may be part of history, I don’t think public doctors are going away.  We just share, create and relate differently.

So can we move those new relationships to patient engagement? 

Malpractice Reform is Not a Cure to Our Healthcare Mess

I’m gobsmacked at how Aaron Carroll find, reads, and comments on as much as he does and how he takes a deep dive so succinctly. This is one example “Some sober thoughts on malpractice reform“. He read a manuscript in Health Affairs “Let’s Make A Deal: Trading Malpractice Reform For Health Reform

In part he quotes the following

To obtain relief from malpractice liability, physicians may be willing to accept other policy changes that more directly improve access to care and reduce costs. For example, the American Medical Association might broker an agreement between health reform proponents and physicians to enact federal legislation that limits malpractice liability and simultaneously restructures fee-for-service payment, heightens transparency regarding the quality and cost of health care services, and expands practice privileges for other health professionals.

He further quotes from a key passage:

By contrast, decades of scholarship and empirical research suggest that malpractice liability acts only at the margin of health policy, where in relatively small ways it may both protect patients from negligent care and induce inefficient health care spending. (See the online Appendix for a more detailed summary of research on the malpractice system.) Physicians’ clinical decisions, on the other hand, are responsible for roughly two-thirds of total health spending. Physicians determine the quantity and quality of medical services and heavily influence the price paid for them. Research has revealed that far more of this spending is wasteful than can reasonably be attributed to liability pressure alone.

Check out Aaron Carroll, MD look at this topic, The Incidential Economist. He recommends reading the full article. It’s behind a pay wall and I am a cheap dude right now. But more importantly this is a new way to look at malpractice. A rather interesting and important step in this tort reform insanity. 

The Good Old Days of Marketing and Advertising: Re-Modeled for Big Data

The best marketer, strategist, advertising thinker online DigitalTonto offers up his take on where advertising and marketing need to go in todays big data love fest. His post “Why Most Marketers Will Fail In The Era Of Big Data“. Walks us through the heyday advertising Leo Burnett to big data.

Leo Burnett and Marlboro is a success story built on the back of guts and instinct. Those of us from the day know this story and even though it is for poison the reality is clear you can move from “worst to first”.

Greg reminds us of New Coke and what that ended up being. F L O P Yet it was tested with over 200,000 consumers who voted it a winner. (Reminds me of a brand manager who said he didn’t want us to use green on an ad because his wife didn’t like green.) Well the truth was no one wanted ‘real’ Coke taken away.

Lest we forget planners, those in the agency who would research the shit out of the consumer to enhance the creative product. They offered up the likes of ‘professional men’, ‘young aspires’, etc. As Greg shares planners suffered confirmation bias. So much for the human condition and data.

Today we are moving toward simulation marketing where data is analyzed by machines. It is the application of BIG data into marketing decisions to identify what to do, say, pitch, at various segments. Greg points out that we are no longer Leo Burnett’s but (a new word for me) growth hackers. But the following is where he sees this marketing world and us inhabiting it:

In fact, he points [Andrew McAfee] to research which shows that rather than trying to use data to inform our judgment, we would do much better by putting our energy into building better models, but taking their answers at face value.  Applying our own subjective judgment after the fact is much more likely to worsen results than it is to improve them.

I am not so sure that we have to do that, you know close our eyes fall back and trust someone will catch us. I am not a Luddite and I believe that we can take what the machines tell us and massage meaning and color and shading and messaging and strategy and a headline and a graphic from it. We need to work in parallel with the machines and the big data. To this point a good trusted and very smart friend had this response to Greg’s post:

So essentially no one has to actually think anymore, no one has to exercise judgment or insight or perception, they just have to be able to push the “start” button.  Hitchhiker’s Guide to the Galaxy: the answer is 42.  Perfect for today’s crop of spoiled, insolent, lazy-minded students.  The computer nerds win.  Civilization is totally, totally fracked.

Makes you glad we’re old and useless, rather than young and useless which is what we would be today, where the mantra is do not think, force not accommodate, and make war not love.

My take on this, my friend is right we can not surrender at least those of us who think and have experience. We can be Leo with the help of the machines. Perhaps even better but the issue is those to control the creative product in advertising and marketing are not creatives but that is whole long rant. 

Virtual Patient: Real Learning for Medical Students in Primary Care

Salminen, Zary, et. al submitted an original paper in JMIR “Virtual Patients (VP) in Primary Care: Developing a Reusable Model That Fosters Reflective Practice and Clinical Reasoning“. 

The authors were looking to create a virtual patient model for the primary care setting that would drive reflective practice and clinical reasoning. The virtual patient they sought to create included embedded process skills applicable to the primary care setting. 

Using virtual patients in medical education is not new. It has been used in all stages of a medical students learning to teach communication skills, patient focus, clinical reasoning, and reflective learning. What the authors note as lacking are reports on how to design and use VP within the primary care setting. 

The model the authors build they embedded ways to promote meaningful learning such as reflection, clinical reason, and in depth subject knowledge. This was accomplished with open-ended questions and free-text answers as well video clips. Students worked these cases independently without help from teachers it is self-directed and at their own pace. 

What struck me about this study is how they authors approached this. They built the VP around adult learning and not how can we cram as much knowledge as possible into a student and how do we do this around primary care. Using adult learning theory primarily Kolb and Schon’s reflection and change they found unsurprisingly students responded  positively and were able to apply new knowledge to their understanding of medicine. 

It would be interesting to see how a VP can be build around current epatients and their behavior as active learners and participants in their healthcare. Can a VP be used to demonstrate how to engage patients better and improve communications skills of those physicians well past medical school. 

Caregiving: Take a Tablet and E-Mail My Family

Jennifer Hicks a contributor at Forbes wrote a piece on simple tablet/technology for in home caregivers. It is called the Betty Care Tablet. This is a point-of-care system to help in home caregivers focus on patients and not paper work. Yup yup and more yup the world and in particular the US has a bolus of rapidly aging individuals with an estimated world population of 65+ to be 523 million in mid 2010.

Hicks shares the implementation of The Betty Care Tablet by Caring Senior Service. There goal is to reduce or eliminate abuse, neglect, and theft of the in-home care industry. This will be done at no cost.

The Betty Care Tablet designed for private duty home care agencies. The caregiver uses the tablet in the home setting for tasks such as scheduling, daily logs, and alerts with the office without paperwork. Families with internet access can log in from any mobil device for real-time updates.

Betty Care identifies the ability to easily update care plans based on need and goals. Changes are pushed to the tablet without delay all the while tracking real time activity feeds with weekly and monthly reports so the family is up to date.

On the Betty Care site they address the salient point of the idea, differentiation from other in-home caregiving organizations. Information can be collected, with notes and forms with checkboxes with easy to publish to the corporate portal.

I like the idea and would be interested in knowing levels of satisfaction from family members as well as if reports are sent to the PCP for chart update?

One other point to consider. Austin Frakt writing at The Incidental Economist stepped back to look at health insurance in America in an excellent piece “Stop rearranging deck chairs and focus on the engine room“. His primary point we need to examine healthcare delivery where 80 cents of each dollar ends up in the delivery system. Is Betty Care improving delivery? I think it is and I think this point to new business ideas across the spectrum of our healthcare system. 

Twenty Years Later We Wonder if Harm Was Done? Huh?

Bill Gardner writing on The Incidental Economist examines an article in the NY Times “A.D.H.D. Experts Re-evaluate Study’s Zeal for Drugs”. The study completed twenty years ago was named Multimodal Treatment of Attention Deficit Hyperactivity Disorder. It was free of pharmaceutical money, fully funded by NIMH and well controlled. It compared community care, high quality behavioral treatment, medication following evidence-based guideline, or behavioral treatment and medication. It ran for 14 months. But it became the single most important paper to support the pharmaceutical management of ADHD.

The conclusion of the researchers was:

Combined behavioral intervention and stimulant medication—multimodal treatment, the current criterion standard for ADHD interventions—yielded no significantly greater benefits than medication management for core ADHD symptoms; this parallels findings reported by others.

Today the authors of the MTA study question if their validation of medication-only may have harmed children in the long run. 

This study was not done in the 50’s and these researchers are well regarded leaders in the medical community. Could they have considered what they are seeing now. Or more likely, they are seeing the reality of their work played out over time as demonstrated in an investigative piece by the NY Times “The Selling of Attention Deficit Disorder“. What will be our collective 20/20 hindsight in 2033? Or perhaps with the Internet and more and more open access to data we are seeing a change. We are all getting collectively smarter and more attuned to our healthcare footprint. 

Coming Out of the Closet: The Pharmaceutical Sample Closet

Evans, Steven, Brown, and Smetana published the following research in Journal of the American Board of Family Medicine (JABFM) “Sample Closet Medications Are Neither Novel Nor Useful”  PDF is here. No need to read further the headline does a great job. Well allow me to capture some of the more damning points.

  • In 2009 80% of cardiologists, 70% of family physicians, and 67% of internists reported receiving samples
  • Samples get handed out in 20% of office encounters
  • 12% of all Americans receive drug samples yearly
  • Physicians and their staff frequently use sample drugs. (Bank CEOs get helicopters HCP get samples)
  • 82% of patients being given sample were insured for the year and had income 200% above federal poverty line (So much for samples helping the poor)
  • Samples skip EMR and the pharmacist which mean no potential for counseling
  • Physicians using samples bypass preferred drug choice

 

Drug samples are “almost never time worn and well-tested drugs … and usually comprise the newest drugs on the market.” Many new drugs on the market are “me too” drugs, a new drug within an existing class of medications that offers minimal additional therapeutic benefit. In addition, the long-term safety of newly approved drugs is often unknown.

Newly approved drugs, including those most likely to be found in samples closets, are often not novel or useful. For example, in one analysis of new drugs approved by the US Food and Drug Administration (FDA) in 2008, not a single new drug was both novel and relevant to primary care. Many newly approved drugs are heavily marketed as samples.

Need we continue? Okay

  • Only 5 of the 23 medications are first in a new class. Can you say me too?
  • Most sampled medications are not useful (20 of 23 sample closet medications had no studies demonstrating superior patient outcomes)
  • Safety and tolerability data was only found for 26% of the sample closet drugs
  • The closet samples are not first line agents in published guidelines
  • As if you need to ask these samples are more expensive when compared to generics
  • Finally, when the free sample are gone patients continue with the same medication at a higher cost.

This is a small sample but is the first of its kind. Bravo. The authors note that the number of physicians accepting sample was 64% in 2009 down from 78% in 2004. 

The strategy has worked for pharma and perpetuates the use of name brand drugs over generics and uses the physician to be the detail person with the patient. This research shows this strategy works. What can be done by pharma to make the sample closet a truly productive and valuable place for helping those in financial need. Coupons may not fair any better. 

Marketing vs.R&D in Pharma: As if It’s a Fair Fight

John LaMattina a contributor at Forbes caught my attention with the following headline “Should The Marketing Division Set Strategy For Pharmaceutical R&D?” He presents a fair and balanced look at this idea starting with a quote from George W. Merck 

“We try never to forget that medicine is for the people. It is not for the profits. The profits follow, and if we have remembered that, they have never failed to appear. The better we have remembered it, the larger they have been.” (taken from “Built to Last, James C. Collins and Jerry I. Porras, 1994)

And he presents the reality that back in the olden days it was simpler to go from idea to market and cheaper too. Okay I’ll buy into that. And he ends with the need for a strong bond between scientists and the commercial dudes. Mom and apple pie. Somewhere in the middle he makes the case for the long-term testing in patients for safety, efficacy, and differentiation from current standard of care. 

He lost me here. Differentiation means, at least to me, you compare the compound to a competitor. Nearly all drug trials are comparing to placebo and rarely compare to the leading standard of care drug in the category and for good reason. If I’d had spend $100s of millions to get here why risk it in a head to head comparative trial. As in the link below.

But that is changing and we will be seeing more and more of this: “Glaxo’s diabetes drug fails to beat Takeda’s Actos in head-to-head study” If you want to claim superiority head-to-head will be required. 

CDC Recommends Ladder Safety App: That Beats Apple’s 5 Star Rating

FALL INJURIES PREVENTION IN THE WORKPLACE
The CDC is recommending apps to help workers identify ladder selection, positioning, accessorizing, and safe use. The data seems clear

Falls are a persistent hazard found in all occupational settings. A fall can occur during the simple acts of walking or climbing a ladder to change a light fixture or as a result of a complex series of events affecting an ironworker 80 feet above the ground. According to the 2009 data from the Bureau of Labor Statistics, 605 workers were killed and an estimated 212,760 workers were seriously injured by falls to the same or lower level.

I wonder if the app maker is sending users notifications to rate this app? You know rate this app now.

GlaxoSmithKline Not to Pay Physicians for Endorsements: Meh

James Hamblin writing at The Atlantic has a short piece on the announcement by GlaxoSmithKline to Stop Paying Doctors for Endorsements. Hamblin’s primary point is that GSK will not pay physicians to “give speeches about their products at medical conferences”. And further down Hamblin writes

Doctors still have to learn about new medications somewhere, of course. It is in everyone’s interest that doctors are made aware of the newest pharmaceutical developments. We are most likely to trust that information when it comes through the filter of respected colleagues. How many such doctors would misinform their peers just to get paid?

A couple of points I believe are missing from this piece. If you refer to the NYT article that had the original announcement a second change was being made, pharmaceutical sales people will no longer be paid in part based on number of Rx written. That tied with physician payments may have a more positive effect. 

Physician speakers/lecturers/KOL’s at medical meetings are not out and out hocking drugs like barkers in a side show. These national and state medical meetings are run by medical societies and associations like the American Heart Association, ASCO, American Academy of Dermatology, etc. Pharma gets to side show their products in the exhibit halls. The lectures are primarily CME programs and as such are under very strict and managed rules dictating bias, fair balance, and disclosure of speakers conflicts of interest, identified needs assessment, etc. And most, if not all, of these lectures are the product of third party educational companies or medical societies etc. They are not executed by pharma nor are they dictated by pharma. Pharma will give grants to companies who identify topics, speakers, needs, etc all to solve a clinical issue. So we do not know if GSK will stop supporting CME through medical education companies and societies. The Sunshine Act allows speakers paid by a medical education company or a medical society not to have to disclose that fee for speaking was from pharma since it was from a third party. Kind of money laundering? 

Truth be told pharma does hold and pay for non-CME promotional education. There is no hiding pharma sponsored education. Those who attend these meetings come to learn about the drug straight from the horses mouth. Of course we all know studies that were even slightly negative about the drug never get into the monograph.Good luck in critical appraisal without full disclosure. So at these promotional education activities GSK won’t be paying physicians. I doubt if they will be abandoned all together. The speakers may be in house physicians. But physicians will be paid for CME just not directly from phama. And these CME lectures will have balance and transparency and address a clinical need. 

It is also important to note that those physicians who are speaking at the CME events are most likely investigators on the clinical trials and are very knowledgeable about the therapeutic area and disease. That is why they are speaking and are trusted. So directly paying physicians to lecture on a drug/disease will not amount to much. We will have CME doing the lions share of the educational work. But there is much to not known right now and we will have to wait and see how GSK executes this portion of their announcement. 

Pharmaceutical sales people not having income linked to Rx is big. I have seen this question asked in other places, how will GSK know who is producing? I imagine management will know because pharma will never surrender knowing the number of Rx each physician is writing. The issue is going to be, GSK can’t fire the underproducing sales person based on Rx since they are not being paid for that. So what will be the measure? How well educated on a disease or drug topic is the physician, does knowledge translate into Rx, is the sales persons physicians satisfied with GSK, etc? Also this may change that whole I don’t want to see a pharma rep attitude of physicians. Since the rep is not being paid for Rx perhaps the physician would be willing to spend more time or even speak with them. Nah the sales person is a GSK shill. Will the sales person still stock the sample closet? 

There are some bigger issues here that are not addressed by this window dressing. First and foremost is the product monograph. When a drug is approved by the FDA based on clinical trials it has a single product monograph identifying all known knowledge about the drug, the disease, side effects, etc. We now know trials that impact the drug negatively do not make it into the monograph. We need full disclosure to the FDA during the approval phase so that all data is known. This is important so a physician can truly perform a critical appraisal. 

I am not fooling myself, most physicians are busy wire to wire day in and day out. They do not have the time or inclination to deconstruct a monograph or a sales aid in order to make a critical appraisal of the drug. They trust that the FDA has done its job when it approved a drug for sale for an indication. And consider that most practices are made up of different types of patients some with a plethora of issues that need to be weighed against the drug. That is where the pharma company sales person, promotional materials etc help the busy physician. By identifying the salient issues and science. Of course truth in advertising and selling is similar to the Easter Bunny. And pharma is rated in trustworthiness at the bottom of the trust barrel. So how do we return pharma to a trusted place? While helping the overworked physician to make head or tails out of promotional material. 

I would like to think that GSK would want to provide a series of educational programs CME or otherwise to teach HCPs how to perform critical appraisal on clinical trial data. Make the HCP the gate keeper not of Rx alone but of how to access and use knowledge. Give them the tools to reject, accept, or apply appropriately where drug xyz can be used and on whom. A wise man once said a pharma should not seek a 100% share of a market but a 100% share of those patients who will benefit the most and most appropriately from the drug. Differentiation in a crowded marketplace will come from educating your audience to see the value and designing the drug and its clinical trial to show that value.

I just saw this post on The Healthcare Marketer Blog “Should Physicians Disclose Potential Conflicts of Interest to Patients?“. The simple answer is yes. And it fits with the discussion above the more the patient knows the better he or she can align their values to their physician. This drives the physician to improve their knowledge and care since the patient is facing them asking questions. This post introduces the Who’s My Doctor a movement promoting and driving transparency on the part of the physician. 

Check out the Total Transparency Manifesto for Dr. Leana Wen to see what real transparency looks like. 

There are a lot of moving parts in this discussion and finding the right balance is going to be a long fought battle. We are seeing more and more patients raising questions about their care and making demands to know and understand treatment. Patient engagement is at the heart of this change and will continue to drive it. Perhaps we have a bright future in our healthcare system to spite current events. And GSK has drawn a line in the sand that we will see if others cross.