After writing last week about Pitney Bowes’ experience in creating positive financial returns by providing quality health benefits for their employees, I attended a panel of alumni and faculty from the Yale School of Management that discussed the topic “Do Consumers Make Rational Healthcare Decisions?” (I’m told a video podcast will be available soon.)  While their consensus on this question was no, their discussion and Q&A included employer provided health benefits.

Professor Fiona Scott Morton noted that the value employers get from providing health benefits depends upon their industry - specifically whether the company retains employees or has a high turn-over rate.  This makes sense, since it would take time for employers to have a positive return on investing in employees’ health.  Professor Scott Morton also pointed me to a very interesting research article by professors at Duke and NYU that looked at this issue by analyzing data bases that included individuals occupations.*  By comparing workers in high and low turn-over industries they found several interesting things, including:

• Employers in low turn-over industries provide better health benefits
• Employees in low turn-over industries use more health care services while working
• Employees in high turn-over industries use more health care services when retired

This paper had many other interesting conclusions, and I’ll confess to not being able to fully assess all its conclusions because of some of the mathematical modeling used and the manner in which they presented their quantitative findings.  However, from what they said, I do wonder if much of the effect they observed could be due to higher wages in the lower turn-over industries.  This makes simple economic sense to me, because the researchers used average vocational preparation for the employees in the industry as a proxy for turnover (see footnote), and companies that depend on higher skilled workers would likely pay them more - which would also lead these companies to retaining their employees.   In addition, companies with lower skilled workers might also be less likely to provide paid sick leave as an additional form of compensation - which could account for the lower rate of doctor visits and preventive care the researchers found for the employees in the high turn-over industries.

What this means for health reform - and the future of employer-based insurance in the US - is that for some employers and employees the current situation works well, and seems to benefit society overall since retirees from higher skilled/low-turnover companies are less of a financial burden on Medicare.  However, for employees and employers in industries with high turn-over rates, the  employer-based insurance situation in its current form may not be working so well - although I’m still concerned about how much of the researchers conclusions are related to income -  either directly or as a proxy for less generous health benefits.  In any case, the findings from their paper point out some of the areas where our health system is working and others where it needs some fixing.  Hopefully reform initiatives in the coming months and years will address those realities.

* The researchers used the average Specific Vocational Preparation (SVP) - a Department of Labor categorization system used in the databases -  for each industry as a proxy for employee turn-over since other researchers have found an inverse relationship between average SVP and employee turn-over.

One of the challenges for improving the healthcare system is creating a vision for what is achievable in a timeframe of months or years.  The first step for creating such a realistic vision is to understand how progress has been made in the past.

A microcosm of such progress was described in a recent article in The Economist.  This article describes advances in our understanding of stomach ailments – one of my favorite areas of biomedical progress because in the last several decades dramatic changes have occurred in our basic knowledge about this area, and so many people can relate to stomach problems.

The most significant change occurred in 1982 when two Australian scientists disproved the dogma that because of its very acidic pH the stomach was sterile.  They showed that the H. pylori bacteria could live in the stomach and cause the stomach inflammation associated with an upset stomach.  Subsequent research showed that H. pylori could be the cause of ulcers and stomach cancer. Following those discoveries, medicines were developed to change the pH of the stomach to treat the stomach inflammation and eliminate the H. pylori.

While lowering the acidity of the stomach with medicines would often improve symptoms, it also raised the question about what bacteria might be able to live in the stomach under less acidic conditions?  This question is more intriguing because it has been observed that when people taking medicines to lower their stomach’s acidity stopped taking these medicines, they have a resurgence in their symptoms.  This could be because their stomach had become accustomed to the less acidic conditions and then reacts to the renewed acidity; Or it could be because the bacteria that were living in the less acidic stomach are not happy with the greater acidity; Or perhaps the H. pylori that had been struggling in the less acidic stomach multiply very happily with the return of the acidic conditions.

H. pylori – Obesity and Asthma
The Economist article discusses some even more interesting ideas about the role of H. pylori in the stomach.  For example, they cite researchers who speculate that the elimination of H. pylori from the stomach may be linked to rising rates of obesity and cancer in the esophagus. These researchers at NYU School of Medicine also found that children who had not been infected with H. pylori were more likely to have asthma.  The article summarizes these observations with the speculation from NYU’s Dr. Blaser that perhaps H. pylori should be viewed not as a pathogen, but rather as a symbiotic organism “that is sometimes helpful and sometimes harmful.”

One of Dr. Blaser’s key observation is that H. pylori appears to not just be a passive resident of the stomach, but may actually regulate the stomach’s acid levels to keep the stomach’s pH in a range the bacteria prefer.  However, the substance that H. pylori secretes to get the stomach to produce less acid may be toxic to the stomach and result in ulcers and local cancers.  Thus, while eliminating the H. pylori would eliminate the toxic source of ulcers and cancers, it can also allow the stomach to produce too much acid – which can lead to cancer of the esophagus, as well as “acid reflux disease,” a.k.a. “heartburn.”

The H. pylori-obesity link is based upon the possibility that the bacteria modify the secretion of certain hormones effecting how people feel hungry, and the H. pylori-asthma link is based upon the effects the bacteria may have on children’s developing immune system.  (See The Economist article for more information about these areas.)

Conclusions
These findings lead to the conclusions that perhaps treating stomach ailments and preparing peoples’ stomachs for healthy lives should be based upon their genetic makeup, and seeding children with strains of H. pylori that don’t produce the toxins that can lead to ulcers and stomach cancer, could benefit them without doing harm in the long run.

Overall, this is a great example of how once more knowledge is obtained about a disease and the relevant human physiology, scalpel-like treatment and prevention strategies can be developed and implemented.  Of course, educating clinicians, patients, payers and others about these advancements – and why they are important – are also important challenges, because improving health care treatments and our healthcare system involves not just determining what should be done, but also how to actually accomplish those things.

I couldn’t resist witting something about this when I saw today’s press release from HHS which announced that Terry Cline, Ph.D., the administrator of HHS’ Substance Abuse and Mental Health Services Administration is leaving that post, and starting August 31st he will be the HHS Health Attaché and representative at the U.S. Embassy in Baghdad, Iraq.

On the serious side, I’m sure he will do good things to help improve the healthcare system in Iraq.  But on the less serious side, someone (maybe Jon Stewart?), needs to ask how did this happen?  How bad did he step on someone’s toes to get moved from Rockville, MD to Bagdad? Or was he just doing intensive and personal research into abusing substances, which led him to believe that Bagdad would be a nice place to be for a while?

While I certainly hope that Dr. Cline has a safe and productive time in Iraq…. but while he’s over there, given his expertise in substance abuse, maybe he can get over to Afghanistan too, since I understand they have a bit of an issue with poppies and heroin.

What’s the point of vacations?  As a consultant that’s something I often ask myself since with the internet, cell phones, etc., it seems almost impossible to really “get away” and not be connected to work.

So what’s the value of vacations?  I think I’ve found the answer at the poker table.  As Ricky Ricardo used to tell Lucy, “Lemme splain!”

The point of vacations is to recharge by being in a different environment that presents a new context for viewing our normal “reality.”  A great practitioner of this principle was Teddy Roosevelt.  He would travel to the wildest and most dangerous parts of the world, and hunt the largest of animals. After these experiences he probably came back to Washington DC and the political world, and said to himself, “Hey, this jungle and these animals really aren’t so bad or ferocious.”

As a consultant, I often find my vacations are pieced together days, (or pieces of days), that often include work “time-outs.”  For example during a recent 5 day trip to visit family in Seattle, aside from the many emails, I had two 8 am conference calls, and a 6 am telephone presentation.  Trips like this have forced me to schedule “vacation” time like I schedule exercise time – in 2-6 hour chunks.  The challenge is making these mini intra-day vacations count.

Which brings me to the poker table.  I had gone with some friends to play at a local casino a few months back, and we all had a good time.  I also found that while playing I could completely focus on the game, and not keep drifting back to ongoing work projects.  I later realized that this was a mini-vacation which provided a refreshing break from the work mindset – a cranial reset if you will.

But there is more to it than just a diversion, because a good movie provides that same 2 hours of alternative focus.  What the poker table provides is an intellectual and rather fast-paced set of interpersonal interactions.  This is when I realized the two connections between poker and clinical medicine:

First, playing cards for many years has helped me learn how to read people – an essential skill in poker, and very useful in clinical medicine where non-verbal communications are a big part of the clinician-patient relationship.  This is similar to teaching medical students about art as a way to improve their observational-diagnostic skills.

And second, while playing poker I get the most gratification not from winning a hand, but from tossing down a hand I had started to play but then decided was probably not going to win.  This latter “skill” is essential to playing good poker, and is also related to good diagnostic skills.  Lemme splain.

In clinical medicine, the diagnostic process starts with gathering the first round of information – by talking to the patient, reviewing their chart, and doing a physical exam.  (This is like looking at the first cards you are dealt.)  Then, as more testing and inquiry are done, you and the patient learn more about their medical problem.  (In poker this information comes in the additional cards in the hand.) And then, as the patient tries different treatments, even more is learned about their condition and how best to treat them.  (This is similar to what happens with the betting in poker – each bet tells you something about the other players and their cards.)

Thus, by seeing the cards as they are dealt and the other players’ bets, (and their responses to my bets), I learn about how my cards stack up against theirs.  And with this additional information I can make a better diagnosis – and decide whether or not my cards are likely to win.  By correctly folding my cards in the middle of a hand, I have in essence made the right diagnosis – which is the ultimate goal of any clinician.  It is an essential step for helping patients – and at the poker table, for limiting losses from that hand.  Conversely, winning or losing a hand – no matter how big the pot – doesn’t carry the same thrill since the intellectual options have been exhausted and all that’s left is to get ready for the next hand – or get back to work.

The clinical analogy to staying in until the end of the hand is that the patient has no more options; every test has been done and treatment considered, and either a treatable or controllable condition has been diagnosed – or not. Medical research strives to expand these options by providing patients and clinicians with more and better diagnostic tests and treatments.  Successful research gives patients the opportunity to draw more cards and play more hands.  And just to come full circle here, medical research is very much like poker in that the skill to correctly fold research spending on an experimental compound or diagnostic test is very valuable – hundreds of millions of dollars valuable.

With two notable government actions in the last couple of weeks there has been significant movement towards increasing the use of e-prescribing.

DEA Proposed Rule
The Drug Enforcement Agency (DEA), proposed regulations on June 27th that would make it possible for controlled substances to be prescribed electronically. Interestingly, this was released right after a National Journal article on this topic.

The DEA’s proposed rule is very important, because while it is appropriate to place stronger safeguards on medicines that are likely to be abused (which is the criteria for being a DEA scheduled medicine), having controlled medicines prescribed by pen and paper while all other medicines are e-prescribed would be a logistical problem and obviate many of the potential benefits of e-prescribing.  And technologically, if banks and others can provide secure login systems and other security measures, I would think that e-prescribing systems could be similarly secure to make sure that unauthorized people aren’t electronically writing themselves prescriptions for thousands of narcotics pills using a legitimate doctor’s DEA number.  (See more about this in the e-quackery section below.)

Medicare Bill Contains Carrots and Sticks for E-Prescribing
The Medicare bill which passed Congress yesterday included a provision to increase the incentives for physicians to use e-prescribing technologies.  These incentives are a small percentage add-on to allowed Medicare charges for physicians who are e-prescribing starting in 2009, and a cut to payments for allowed Medicare charges starting in 2011 for physicians who are not e-prescribing.

Movement in a Good Direction
Together these actions move the US healthcare system towards greater e-prescribing, something that if done right, should increase efficiency (with lower administrative costs), and improve quality of care and patient safety by creating a better system for detecting and preventing adverse drug reactions from known drug allergies and drug-drug interactions.  The use of computerized prescription order systems for patients in hospitals has been shown to accomplish both of these improvements, but how e-prescribing will work in the outpatient world remains to be seen.

Challenges to Making E-Prescribing Increase Efficiency and Improve Quality
There are many challenges for e-prescribing in clinicians’ offices.  Like electronic medical records, they have to buy and install the systems, learn how to use them, and then keep them updated – since new prescriptions keep getting approved etc.  Because of these challenges, it is estimated that only about 6-7% of physicians’ offices are currently using e-prescribing systems.

Optimally e-prescribing systems should be an integrated part of the office’s electronic medical records system so that it could identify potential problems with drug allergies, or the need to alter dosages for patients with impaired kidney or liver function.  And at a minimum, a free standing e-prescribing system should be able to keep track of each patient’s prescriptions to flag drug-drug interactions, otherwise it may become nothing more than a sophisticated fax machine – which some could argue (but I wouldn’t) is a rudimentary form of e-prescribing.

While, e-prescribing systems should provide alerts about drug-drug interactions,  potential allergic reactions, and the need for dosing adjustments, systems that constantly flash up reminders for such things when they’re not relevant, leads users to ignore them altogether. I take a lesson about this hazard from my brother who works on designing aircraft information systems. Clearly pilots need to know certain things at the right time, but I doubt any pilot would fly better or more safely if they kept getting an alert about it being unsafe to land the airplane because the wheels were up – even with the plane at 30,000 feet.  OK – that may be a bit of an extreme example, but if the e-prescribing system doesn’t know anything about the patient, it may send similarly useless alerts and lead those using it to ignore all alerts – which could be worse than having no alerts at all, since it having them pop-up and be ignored could provide a false sense of security.

This illustrates what most people involved with healthcare reform recognize - improving the quality and efficiency of healthcare in the US requires making the systems work better since our practitioners are generally already pretty good.  But giving these good people flawed systems won’t help them, their patients (i.e. us), or our overall healthcare system.

This brings me to one last point.  How many e-prescribing systems will each clinician’s office need?  I certainly hope that every pharmacy chain/group won’t require their own version of an e-prescribing system, nor will each payer, insurer or regulator require a different electronic or paper output of the prescription information for reimbursement or quality auditing purposes.  If that becomes the case, then e-prescribing will face even greater hurdles.

Since they do good work in this area, I also want to include the eHealth Initiative’s  summary of the challenges for e-prescribing systems:

• Financial burdens – Physician practices face varying financial burdens related to e-prescribing, including covering the implementation, training and maintenance costs.
• Workflow changes and change management – Although e-prescribing efficiencies and time savings are gained in the long run, introducing e-prescribing, and electronic health records (EHRs), can be difficult, time consuming, and requires adequate planning, training, and support, particularly in the beginning.
• Continued needs for greater connectivity – The infrastructure exists for connectivity among pharmacies, physician practices, payers and pharmacy benefit managers (PBMs), but some pharmacies, payers/PBMs and mail order pharmacies are not yet connected.
• Medication history – Although e-prescribing is an improvement over relying on paper medical records and patients’ memories, the information that is available may not always be comprehensive or accurate and therefore tools to adequately reconcile medication histories from multiple sources are needed.

E-Dispensing – Bad!!  And E-Quackery – Bad Too!!!
One of the other challenges for e-prescribing may be the practical and policy interactions between physicians’ e-prescribing and internet sites that sell medicines directly to a patient without a prescription.  While e-prescribing potentially can improve efficiency and quality, e-dispensing can lead to bad fiscal and clinical outcomes from patients getting fake, adulterated or dangerous pills and potions.

Information on the worst examples of e-dispensing is in a recent report from Columbia’s National Center on Addiction and Substance Abuse (CASA).  Their recent annual report found that the number of web-sites selling controlled medicines without a prescription has decreased from the start of 2007 to the start of 2008 - from 581 to 365.  The CASA report also found, “Of those sites not requiring prescriptions, 42 percent explicitly stated that no prescription was needed, 45 percent offered an “online consultation,” and 13 percent made no mention of a prescription.”

I’m not sure if anyone knows what the total number of patients using these sites is, or the number of prescriptions they are filling, so it’s unclear if this reduction represents a real decline in the “industry,” or just its consolidation and maturation.  What CASA also found - and that I find especially worrisome - is “an emerging practice of Internet sites selling prescriptions for controlled drugs that can be filled at local pharmacies. The report also found sites selling online “medical consultations” which enable Internet users to get controlled drugs online without a proper prescription.”  I call this e-quackery, because this is physicians acting inappropriately, or non-physicians acting in the role of a physician and practicing medicine without a license by writing prescriptions.

Other notable findings from the CASA report include:

• Of the few sites that require prescriptions, half permit the prescription to be faxed, allowing significant opportunity for fraud.
• Benzodiazepines (like Xanax and Valium) continue to be the most frequently offered drugs for sale with 90 percent of sites selling them; followed by opioids (like Vicodin and OxyContin) at 57 percent of sites, and stimulants (like Ritalin and Adderall) at 27 percent of sites.
• According to DEA estimates, in 2007 eleven percent of prescriptions filled by traditional pharmacies were for controlled substances compared to 80 percent of prescriptions filled by Internet pharmacies.
• There are no controls blocking access to these sites by children and teens.

Conclusions
Just to bring things full circle – clearly e-dispensing and e-quackery are bad, so perhaps the greater use of legitimate and appropriate e-prescribing will help to clamp down on these illegal and dangerous activities.  And from a personal perspective, I can also only hope that it will reduce the ongoing flow of spam emails for on-line medicines - and the similar onslaught of spam blog comments to this blog that you never see because I delete them, but which like spam emails, just chew up time from every day.

p.s. Sorry about the long post – but this is an important and complicated topic.

According to my calculations, sometime this month research and development spending in the United States by pharmaceutical companies will pass the $100 million per day mark.

The $100 million/day figure assumes R&D spending seven days a week, and it doesn’t include R&D spending outside the US, or spending by smaller biotech, medical device, diagnostic, or health IT firms.  By comparison, the National Institutes of Health spends about $79 million a day.

With all the reports about the slowdown in the industry’s output, higher barriers for FDA approval of new medicines, and the criticism of the industry and the FDA, I hope that the industry’s ongoing R&D investments do produce new medicines that are valuable to individual patients and society overall.

A couple of months ago I wrote about how one percent of adults in the US get free government health care.  While the statistics in the February Pew study were very interesting (and somewhat shocking), I saw a report in a local Connecticut newspaper (The Day, June 26th) that put a face on these statistics.

The Day’s story was about Jihad Abdulshaheed, a 36-year-old man who had been incarcerated since November 2007.  The judge was prepared to sentence to a one year sentence, and since he had already served at least 50% of his time, under the Department of Corrections guidelines for nonviolent prisoners he could have been released the next day.

However, this is where the story gets very interesting.  The man asked the Judge to hold off his sentencing “because he is waiting for the Department of Correction to schedule his surgery for a groin hernia.”  The newspaper also noted that the DOC’s health care budget for its 23,000 prisoners was $99.3 million.  This works out to a little more than $4,300 per prison.  It seems that finding a way to release this man, and still pay for his hernia surgery would make more sense than keeping him locked up until the DOC can pay for the surgery……. I also wonder about his follow-up care? Where will he get it - in prison or outside?  And how will that be paid for?

This man’s situation and the Pew study illustrates how communicating the essence of a healthcare story can involve statistics, analyses, and anecdotes.  The first two provides a framework if the issue, and the anecdote puts a face on that skeleton.  Each one can be powerful, but together they create a remarkable picture that can change policies, attitudes and actions.

A long-standing debate in the life sciences has been the role of nature versus nurture in determining individual characteristics. For example, how much of an individual’s height is determined by their genes and how much by their nutrition – both in childhood and prenatally?

In the last few decades advances in our understanding of genetics has shifted this dichotomy to describe it in terms of genetics versus environmental factors, and expanded our appreciation for the role nature/genetics play in causing all manner of human diseases. For example, it was discovered that genetically determined slow serotonin transporters in the brain can predispose individuals to developing depression. However, the more we learn about genetics, similarly exciting discoveries are being made into how environmental factors influence the activity of genes, and thus affect an individual’s health.

Thus - like many things with multifactorial causes - the pendulum swings one way and then the other, i.e. between nature/genetics and nurture/environment.

But what has also become clear is that genetics and environmental influences are not  separable - they interact in important ways, and both can cause health problems and be routes to solutions too.

What recently caught my eye in the nature versus nurture debate were two studies about smoking cessation that came out in the last couple of weeks. The first, by Nicholas Christakis published in the New England Journal of Medicine (and reported in the May 22nd New York Times) describes the importance of social factors for people trying to quit smoking. This study demonstrates how an individual’s social environment plays a dramatic role in their ability to stop smoking, and how people can help each other stop smoking as a collective activity.

On the nature side of the equation, NIH researcher George Uhl led a study that shows how genetic markers can predict which of two smoking cessation treatments will be more likely to work for an individual. From these two studies it is also possible to postulate that individuals may have genetic predispositions that effect the ability of social networks to help them to stop smoking – or possibly to start smoking in the first place. (Didn’t we call this peer-pressure in junior high?)

I find both these studies very interesting because for years smoking has often been described in terms of individual choice (or weakness), and as such something that is completely separate from genetic or environmental factors. These studies refute that popular myth, and more generally illustrate the fundamental point that most illnesses and healthcare problems are complex, and that the solutions to these problems need to be similarly sophisticated. This also reminds me why I cringe a bit when someone says to fix a healthcare problem, “all we need to do is…….”

What are your favorite examples of interacting genetic and environmental factors, or where simple solutions have gone awry when used for complex problems?

Today’s Boston Globe had another report about the delayed opening of the Level 4 research lab at Boston University.  Since it was first proposed and funded, this lab has raised controversy - primarily from those in the community who were concerned about the safety of research involving the most dangerous of organisms occurring in their urban neighborhood. While substantive process (and EPA) concerns have been raised during the building and certification of the lab, the problem really appears to have started from the beginning, with BU seeming to believe that all things biotech-science related are golden, and that their new lab would be welcomed into the neighborhood. What happened instead was they got hit with a NIMBY (Not In My Back Yard) protest.

Too often positive biomedical/healthcare initiatives can get derailed or delayed because the developers or innovators don’t get input and buy-in from the various stakeholders while developing their program or plan. This seems to have happened at BU, and they have been paying the price in dealing with many community protests and objections, and delays in actually opening the lab.

Does anyone have similar situations they would like to share?