In the last couple of weeks there were two interesting articles in the New York Times about patient-physicians communications.

Value of Empathy
In the first  piece, Dr. Pauline Chen discusses an academic article that explored the way physicians communicate empathy to their patients who have serious and life threatening illnesses.  The conclusion of the research, (which looked at the experience of people who had lung cancer), was that physicians miss 90% of the opportunities to connect empathetically with their patients.

The researchers speculated that physicians don’t engage patients empathetically because they are concerned that this would take too much time. However, according to Dr. Chen, the researchers found that “empathy, expressed throughout the patient-doctor encounter, may actually help alleviate problems with time.”  This occured because when empathy was not acknowledged at the beginning of the visit, patients would to try to elicit that type of support from the physician, which could actually extend the time of the visit.

Patients Make a List
The second article was from Jane Brody – a wonderfully gifted health writer – who wrote about ways patients can improve their communications and interactions with clinicians.  Her list had two parts: 6 things to keep written down and bring to your doctor appointments, and 4 tips on how to interact with clinicians.  Her list of 6 things you should keep written down is a good one, and in essence [with my annotations] it is:

1. Questions for the doctor
2. Diary of symptoms
3. List of medicines, supplements and vitamins you take - with name, dosage and how frequently you take them. [Also, please tell your doctor if you are not taking the medicines as instructed for any reason, including if you are having a problem affording any of them.]
4. Your understanding of how you are supposed to be treating your medical problems [Doctors may think that because they told you something at your last visit that you both understood what they said and are following their guidance.]
5. Medical history for yourself and your immediate family
6. Your use of alcohol, tobacco and any drugs not included in #3

The other 4 items on Jane Brody’s list are also valuable:

1. “Be willing to see a physician’s assistant or nurse practitioner for routine care.”  [They will likely be able to spend more time with you on preventive and wellness care issues.]
2. Ask if the doctor uses email for non-urgent issues and questions.   [Some physicians do and some don’t – possibly because they don’t get reimbursed for communicating with patients via email or over the phone.]
3. If the doctor tells you to go to the Emergency Room because of your symptoms, don’t wait.  [Go right away.  Don’t wait for your TV show to be over, for the laundry to finish, or to put on makeup or shave.]
4. If you are told you have a life threatening condition or you need surgery, get a second opinion.

Physicians Use Lists Too
Lists are clearly good things to use so that important things are not forgotten.  People involved with critical, safety-conscious activities like flying airplanes have used lists to make sure that everything is set before takeoff and landing.  After what has probably been too long, such lists are making their way into modern medicine in a more standardized way.

Last December, Atul Gawande wrote in The New Yorker about how such lists are being used to improve the quality of care and save live (and money) in Intensive Care Units.  The first standardized and studied checklist was for putting in a central intravenous line.  The results were remarkable – lowering infection rates in lines that had been in patients for 10 day from 11% to essentially zero.  Peter Pronovost and his collaborators have since developed many other such checklists, (or protocols as they may sometimes be called), and their use has expanded to many, but still probably not most hospitals.

While these lists are clearly beneficial and valuable, like many medical advances, they are first developed and used for the most critically ill patients in hospitals.  This makes sense, because for hospitalized patients a mistake - or action not taken - can mean the difference between life and death.  And hospitals are also places where systematic changes can be implemented and the results measured.

More Use of List by Physicians
Physicians treating patients outside of hospitals often have lists too, but they are often incomplete and are certainly not standardized.  For example, the charts for most patients have problem lists, which list the individual’s medical problems.  However, it is up to the physicians to refer to them, otherwise, the only problem that may be addressed by the clinician will be the one that brought the patient to the office that day – so any needed preventive or wellness care (like an annual eye exam for someone with diabetes) might be overlooked. This is one reason why the list recommended by Jane Brody is so important.

So while physicians may have their own lists, and they know the reason why each patient has come to see them that day, they might be better served by making a list for each patient’s visit so they can make sure to cover all the things that are needed for that individual patient – and of course, that list should also include a reminder to connect empathetically to the patient.  (This is the same concept as having an agenda before any business meeting that not only lists the topics to be covered, but also states an overall objective and concludes with a wrap-up of actions to be taken – a practice I try to follow and force others to do when I’m invited to a meeting.)

Optimism for the Future
In the future, more diagnostic and treatment protocols and guidelines will be developed and configured into standardized checklists to be used in the outpatient setting.  Integrating these into electronic medical records (EMRs) – which include prioritized problem lists with links to recommended preventative exams and monitoring tests – will certainly help improve the quality of care and control the growth in costs.  Of course, this is predicated upon the development of EMRs that can provide such information in ways that are easily used by physicians and their associates.  (This too might be an area where the medical IT industry can learn from those designing airplane information systems.)

While physicians have railed in the past about guidelines and protocols forcing them to practice cookbook medicine, I hope that in the coming years they will welcome them as a way to standardize and simplify their practices so that they can actually work to individualize care for every patient, and connect empathically with them as individuals.  In decades past, that was one of the primary functions of the local doctor, and perhaps if that function again rises in prominence, the interpersonal rewards of practicing primary care medicine will help it grow in popularity with graduating medical students and residents.

The cover of this week’s Economist magazine caught my eye because this weekend I was talking with people about stem cell issues in the context of the Presidential election.

Part of our discussion was how the selection of Sarah Palin as John McCain’s Vice Presidential nominee will effect the Republican ticket’s position on stem cell research.

Doing a quick search on the internet, it appears that John McCain is refining in his position to support research on adult stem cells, while maintaining a foundation that doesn’t alienate the conservative base of his party.  Specifically, the only reference to stem cell research that I could find on the campaign’s web-site is:

Addressing the Moral Concerns of Advanced Technology

Stem cell research offers tremendous hope for those suffering from a variety of deadly diseases - hope for both cures and life-extending treatments. However, the compassion to relieve suffering and to cure deadly disease cannot erode moral and ethical principles.

For this reason, John McCain opposes the intentional creation of human embryos for research purposes. To that end, Senator McCain voted to ban the practice of “fetal farming,” making it a federal crime for researchers to use cells or fetal tissue from an embryo created for research purposes. Furthermore, he voted to ban attempts to use or obtain human cells gestated in animals. Finally, John McCain strongly opposes human cloning and voted to ban the practice, and any related experimentation, under federal law.

As president, John McCain will strongly support funding for promising research programs, including amniotic fluid and adult stem cell research and other types of scientific study that do not involve the use of human embryos.

Where federal funds are used for stem cell research, Senator McCain believes clear lines should be drawn that reflect a refusal to sacrifice moral values and ethical principles for the sake of scientific progress, and that any such research should be subject to strict federal guidelines.

I also found other articles and analyses concerning his earlier positions on stem cell research which seem less equivocal than his current campaign position.

Q: Would you expand federal funding of embryonic stem cell research?

A: I believe that we need to fund this. This is a tough issue for those of us in the pro-life community. I would remind you that these stem cells are either going to be discarded or perpetually frozen. We need to do what we can to relieve human suffering. It’s a tough issue. I support federal funding.

Retrieved from http://www.ontheissues.org/Social/John_McCain_Abortion.htm

Source: 2007 GOP primary debate, at Reagan library, hosted by MSNBC May 3, 2007

New Ad
Our weekend discussion also turned out to be a bit prescient, since my internet search turned up information about a new radio ad the McCain-Palin campaign is running that touts all the benefits of stem cell research without making any qualifications about what types of research would be allowed, or any of the moral issues raised on his campaign’s web-site.

Stem Cells Probably Not a Defining Campaign Issue
While stem cell research is certainly a sub-issue of the abortion/choice debate, and would not likely be a deciding factor for many voters, it is an issue of particular interest for biomedical researchers and some patient groups concerned with the development of better treatments and cures for cancers, (as discussed in the Economist), and degenerative diseases like Parkinson’s and Alzheimer’s.  It will be interesting to see how this issue plays out in the next few weeks and if it is raised during any of the debates…. Stay tuned.

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.

Cost containment is becoming an increasingly powerful force in shaping the environment for life sciences companies - as well as other parts of the healthcare system.  In addition, more sophisticated tools for analyzing and demonstrating the clinical and economic value of medical treatments are making it more challenging for life sciences companies to communicate the value of their new products to all types of audiences, including clinicians, payers, patients and regulators.

These new tools and the changing environment are requiring life sciences companies to think about developing more sophisticated messages to reach these audiences. I recently recorded a short 6 minute discussion about these topics with Jeff Sandman, CEO of Hyde Park Communications - where I am also a Senior Counselor.  Click on the icon-link below to listen to our discussion.

And as always - if you have any comments on this topic - please feel free to share them.

An article in the July/August Health Affairs about Massachusetts health plans implementing Pay-for-Performance (P4P) incentives for physicians raised more questions than it answered.

The study found that P4P programs from 5 private sector payers “wasn’t associated with greater improvement in quality” compared to the overall upward trend in the factors measured.  But the study didn’t address some overarching questions and basic realities about P4P, such as:

• How the payers P4P incentives to the physician groups was actually translated into incentives for the individual physicians - or smaller groups of physicians inside the larger groups?
• How the P4P incentives compared to the other financial incentives the physicians are facing?  For example, seeing more patients or doing more procedures could increase their income more than meeting the P4P standards. (The Health Affairs article states that P4P incentives for Massachusetts physician groups averaged 2.2% of their income.)
• The quality measures used in the study were all performance based, rather than actual outcomes, e.g. cholesterol screening rates rather than patients’ actual cholesterol levels, HbA1C screening rates in diabetics rather than their actual HbA1C levels, or asthma medication use for children ages 5-17, rather than ER visits or hospitalizations for these same children.  What impact does that has on physicians’ behavior, and the value of changing their actions to meet these process standards?  Would physicians be more responsive to incentives tied to clinical outcomes?

Making Incentive Programs Successful:
While the study concluded that the P4P incentives program instituted in 2002 may not have produced dramatic changes in the HEDIS process measures, that does not mean  they were ineffective or that P4P is not a useful tool.

First, while collecting process measures data is easier, since clinical outcomes are what patients (and their physicians) should really care about, shouldn’t P4P incentives be based upon actual clinical outcomes? Process measures are easier to monitor by using billing data, but as the prevalence of quality electronic medical records systems grows, collecting and analyzing data about clinical outcomes will become much easier.  In addition, measuring a small set of any factors – process or outcome – presents the pitfall of driving physicians to focus on those diseases and measures to the exclusion of other important things.  For example, in the Health Affairs study, there are a number of preventive services in the process measures, but what about flu vaccinations, colonoscopies or smoking cessation?  This “managing what is being measured” behavior is why the number of factors used for P4P incentives should be as broad as possible.  (But this does not mean that they all have to be measured at every interval, or for every compensation period.)

Second, as any psychologist (or parent) will attest, the time between the actions and the reward (or penalty) is very important for changing behaviors. The Health Affairs article indicates that the bonuses are paid to the physicians groups annually.  Having the incentives paid annually, (or even quarterly), would be unlikely to provide adequate feedback to physicians to prompt them to change their behaviors.  An alternative blended methodology would be to provide physicians feedback on their actual performance against many of the possible measures on a weekly or bi-weekly basis, while making the P4P payments on a monthly or quarterly basis.

Third, many large companies structure their bonuses for their senior managers around a minimum of 20% of compensation.  If incentives for P4P programs only represent a small percentage of physicians’ income, then it would be unlikely to change their behaviors – particularly if they can make up for any lost income by increasing volume.  However, if physicians are being paid a fixed (capitated) amount per month to provide a certain set of services to a patient group – either primary or specialty care – then the volume part of the equation disappears, and P4P programs could be much more effective, even at a lower fraction of their potential income.

And lastly, and most simply, the insurers would not be spending time and money developing and implementing these programs if they didn’t think they provided some benefit – even if it is only financial - so they must be getting some benefits, or at least learning some things to make these programs beneficial in the future.

Conclusions:
18 years ago I wrote a book chapter that focused on structuring incentives for physicians.  Since then it has been hard to move payers and clinicians toward using more focused financial incentive systems.  But the P4P concepts are important, and to be successful they need to be implemented in a way that works for payers, physicians, and patients.  Unless these and other stakeholder groups buy-in to the purpose and practice of such incentives systems, they are unlikely to have the desired effects.  And the result will be more of the same – rising costs, variable quality, and limited access for many patients.

In talking to people about the problems with the US healthcare system, two fundamental truths have become apparent.

First, people really want the type of healthcare that is envisioned in science fiction such as Star Trek, where almost any ailment is treated with a single injection or pill, or a few waves of a healing wand. Unfortunately, medical science hasn’t accomplished that, except in a few instances – antibiotics for a bacterial infection, or perhaps relocating a dislocated finger or shoulder (and those still require weeks to heal and therapy to regain strength and mobility).

And second, the ongoing problem of healthcare literacy and communications may be getting worse as the complexity of medical treatments increases.  Literacy and communications problems impair good healthcare when patients don’t understand what their doctors are telling them, how to take their medicines, or what disease they have.  When this happens  patients have much greater difficulty properly taking care of themselves.  A few examples and data:

• The American Academy of Family Physicians has a Literacy Toolkit which they promote with the twin facts that only 50% of “patients take medications as directed,” and “nearly 90 million American adults have difficulty understanding and using health information.”
• A July 9^th ABC news story reported about an Annals of Emergency Medicine article showing that 78% of Emergency Room patients had some misunderstanding of their doctor’s instructions, but only 20% realized that they didn’t fully understand the instructions.
• More patients are misusing medicines in dangerous ways. The actor Heath Ledger’s accidental overdose was the most recent high profile example of this. And CNN reported Monday about an Archives of Internal Medicine study showing that deaths of this type have increased 700% in 20 years.

Star Trek directly addressed communications challenges in a Next Generation episode, (Darmok and Jilad at Tanagra), where the crew of the Enterprise encounters an alien race whose words are understandable, but none of it makes any sense. It turns out that the alien’s language is based upon metaphors, and since the Enterprise’s crew doesn’t understand the context for the metaphors – the mythology and stories behind the metaphors – communications is nearly impossible….. until of course Captain Picard figures it all out in 60 TV minutes.

Unfortunately clinicians and patients aren’t able to resolve communications challenges like TV characters. When clinicians use words and concepts that their patients don’t understand, patients can’t correctly follow their instructions, and end up relying on what they think they heard or understand.

A classic example of this is that many people think taking antibiotics makes them resistant to antibiotics.  While it is true that antibiotic resistance is an issue of concern, it is the bacteria that become resistant to the medicines – not the patients. But patients who believe that they will become resistant may not take the full dosages of their antibiotics, or for as long as the doctor has prescribed – inactions that can actually increase the rate of bacterial resistance and not adequately treat the patient’s infection – bad outcomes for both society and the individual.

This is just one example of how misunderstanding a disease or a treatment can produce adverse consequences. Similar misunderstandings about diseases like diabetes and high blood pressure also lead to inadequate treatments and poor outcomes. For example, many patients believe they can tell when their blood pressure is high – and only then do they take their medicine. But high blood pressure (or hypertension) is called the “silent killer” because people can’t feel high blood pressure – except sometimes when it is dangerously high.

Which brings us back to Star Trek. One of the great things about the one-dose cure is that the patient doesn’t have to understand their disease or remember to take their medicines for the treatment to be effective, so literacy and communications problems are less of an issue for quality of care.

Lessons for Healthcare Reform
The lessons here for health reform are twofold: First, producing one-shot cures will require a lot more research and development – which needs to occur at the same time as we are improving the healthcare delivery system. And second, a fundamental area for improving healthcare delivery is communications and literacy. If patients don’t understand their disease, how to take their medicines, or modify their lifestyle, etc., then that is not their fault – that is the fault of the healthcare delivery system, and we should be able to find ways to fix it because this is not a new problem.

The leadership of HHS had a tele-conference on Monday to highlight the new Medicare incentives for physicians to adopt e-prescribing systems.  What the Washington Post and Kaiser Family Foundation reported about this press briefing that wasn’t in the HHS press release was that the Acting Administrator of CMS said that the per physician cost of e-prescribing systems is about $3,000 up front, and then $80-400/month for operation and maintenance.

These numbers caught my eye, because with the incentives in the Medicare bill, the break-even point for physicians is as follows:

First, let’s assume that the per month cost is $240 (the mid-point between $80 and $400), or $2,800 per year. Since the Medicare incentives for e-prescribing are a net 2% of Medicare reimbursements, that means to break-even the physician has to have $144,000/year in Medicare reimbursements – just for the operation and maintenance costs.  Additionally if the up front costs are spread over two years ($1,500/year), that raises the break-even point another $75,000, to $219,000/year.

For some clinicians, this amount of revenues from Medicare might be low, and therefore, it would make sense to get an e-prescribing system. However, if the doctor only sees a minority of Medicare patients, then the incentives could be a penalty.  Which is exactly what Congress expects the financial effects of the e-prescribing incentives to be. According to the Congressional Budget Office, “CBO estimates that the net budgetary effect of the electronic prescribing provision will be to reduce Medicare spending by $0.2 billion over the 2008-2013 period and $2.1 billion over the 2008-2018 period.”

Of course, if other insurers were to match (or exceed) Medicare’s incentive payments for having e-prescribing systems, then obviously the break-even point for physicians would come down, since the calculations wouldn’t balance solely on Medicare revenues.  However, I’m not aware that other insurers are rushing to provide financial incentives for physicians to use e-prescribing systems.

Additional Points
There are additional important points about e-prescribing that need to be made.  First, e-prescribing can have additional costs for physicians’ offices in the form of training time and lost productivity, and unlike electronic medical records, e-prescribing itself is unlikely to improve the office’s billing accuracy and revenues.  Second, e-prescribing can certainly provide clinical benefits by reducing medical errors with better communications about individual prescriptions.  I wrote about these issues a couple of weeks ago (see “Challenges to Making E-Prescribing Increase Efficiency and Improve Quality”), but want to reinforce one point here: Going from paper to computer communications can also introduce new opportunities for medical errors – particularly if people rely on the computer generated information while they might question the legibility or accuracy of a hand-written prescription. That is, technology is great, but its appropriate role needs to be understood by the users, who also have to use it correctly for it to provide real value.

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.

One of my interests in health communications is how the findings from scientific research are presented to various stakeholder audiences.  Because of this, I was interested to see how the titles of several reports about one study of an investigational compound highlighted different perspectives.

The compound being investigated in this research was resveratrol, which has been shown to replicate the life-span extending effects of dietary restriction in lower animals.  (Resveratrol is also the component of red wine that is believed to provide various health benefits.)  The new study looked at the effects of resveratrol in mice.  The titles of the journal article of the study’s findings, the NIH’s press release and the company’s press release were:

• “Resveratrol Delays Age-Related Deterioration and Mimics Transcriptional Aspects of Dietary Restriction without Extending Life Span” (From Cell Metabolism’s web-site)
• “Resveratrol Found to Improve Health, But Not Longevity in Aging Mice on Standard Diet” (From National Institute of Aging’s web-site)
• “Long-Term Study of Middle-Aged Mice Shows Resveratrol Improves Health and Mimics Some Benefits of Dietary Restriction” (From Sitris’ web-site)

Looking at these titles it is interesting to note that the scientific journal only includes a general statement about life-span.  Conversely, the NIH’s press release specifies the study found that only the mice on the standard diet did not see any great life span.  And lastly, the title of the company’s press release doesn’t mention life-span changes and only points to the positive effects in biochemical markers of disease. However, the text of the company’s press release states, “The study also found a significant increase in lifespan in both the resveratrol treated group on a high-calorie diet and the resveratrol treated group on a calorie restriction diet, but the treatments did not extend lifespan of mice on a standard diet when started at one year of age.” But, looking at the study’s data tables, it appears that the research only found an extended life-span in the calorie restricted mice if they were given a lower dose of resveratrol, this extended life span was only significantly greater than the mice given a standard diet, and it wasnot significantly greater than the life span of the calorie restricted mice given either a higher dose of resveratrol or none at all - see supplemental table S3.

The differences in these titles isn’t surprising considering their sources, but they do illustrate the challenge facing reporters trying to communicate the results from scientific research to the general public. That is why I focused on the life-span results, since that would have the most public interest and “news worthiness.”  Thus, in this case, if reporters relied on the company’s press release, they could end up writing a story slanted one way, whereas if they relied on the NIH’s press release their article could tilt another way.  And of course, a more fundamental challenge is how many reporters have the time and scientific background to read and understand the actual journal publication.

Anyone have other perspectives or examples on this topic?

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.