Dear Pizaazz Readers-Thanks for stopping by!

I haven’t had time post much lately because I’m head-down launching a startup called Wellcoin. It’s in the consumer health space, and it’s based on a tremendous concept. At least I think so!

For updates on Wellcoin, please check out wellcoin.com or follow us on Twitter. As for Pizaazz, I’ll be back at it one of these days!

Thanks, Glenn

Ladies and gents, I’m Glenn Laffel, the father of the bride. On behalf of my wife Lori and Mindy and Roy Kaufman, I welcome you to our celebration of Nikki & Ben’s wedding. Many of you have come a long way to join us. We’re honored and thankful that you came.

Off the bat, I want to say how proud I am to have accompanied Nikki today.

Nikki, I have never seen you more beautiful then you are right now. I am amazed at what you have achieved already. You were a 2-time state champion swimmer in high school. You got into Princeton when you were 16 years old. And you’ve managed a dozen different projects in a dozen different factories—on the ground, in China—to get the world’s coolest products to market, on time.

I look at your remarkable productivity, and what I see is your mother, who has had her share of success over the years, as well. I am proud that you take after her in areas that matter to me.

Every dad hopes his daughter will find a reliable, sensible, considerate partner and although you try not to interfere in their decisions, you do hope your children will make the right choices in life. Nikki chose Ben.

Nikki, in Ben you have found a perfect partner. He does the driving. He takes you shopping. He sets up your Wi-Fi and your iPhone. He even folds laundry, though he does put it on the couch where he just napped, buck naked!

Beginning today, Ben is the most important person in your life, Nikki. Mommy and I, your sisters, grammy and grampy, we are always here for you, but Ben is the last person you see before you close your eyes for sleep every night. So before you do that every night, Nik, look at this man. Remind yourself that he is Ben Kaufman, your husband and the most important person in your world. Now and forever.

And Ben, you are as amazing as your bride, and I admire you. You were named one of the nations’ top entrepreneurs under the age of 30, when you were barely 20! You sold a company to Carmelo Anthony. You were invited to the White House because of your success as an entrepreneur. You have lectured at Stanford, MIT and RISD, and there’s more where that came from.

So just one quick story. I said that Ben does all the driving with Nikki. So he and I have this little thing in which, whenever he and Nik go for a drive, and when it’s safe for him to do, Ben texts me to say that Nikki has fallen asleep in the car. It never takes Nikki more than 3 minutes to pass out when Ben is driving! I love getting this text from Ben because – first of all – Lori falls asleep like that in my car too, but more importantly, it comforts me to get that text from Ben. That’s because what he’s really saying is, he’s taking care of my daughter. Ben will always do that, I know. That’s a big reason why I’m so happy tonight.

OK so that’s it from me! Just please let me propose a toast to the new couple. Ben, Nikki, I wish you a lifetime of happiness together. May you fulfill all the hopes and dreams you have for yourselves and each other. And may your bond as a married couple gain strength, each and every day.

Martin Seligman is the originator of an increasingly mainstream theory of health and behavior known as Positive Health. His theory suggests that we should cultivate and maintain ‘positive health assets’ – things like optimism, connectedness, a stable marriage and so forth – because they contribute to a healthier, more fulfilling life and improved life expectancy as well.

In earlier posts on the matter, I reviewed 2 studies that support Seligman’s theory. In the first, Harvard scientists showed that emotional and cognitive well-being was associated with a reduced rate of coronary events.  In the second, University of Michigan scientists showed that optimism was an independent predictor of short term stroke risk.

While both studies suggest that the presence of certain positive health assets can be protective, they do not look at whether the absence of certain negative attributes can be similarly helpful.

Recently, scientists at the Karolinska Institutet undertook to study this aspect of Positive Health. Once again, the findings support Seligman’s concept.

As was the case for the first 2 studies, support for the new study was provided by the Robert Wood Johnson’s Pioneer Portfolio.

In the new study, Francisco Ortega and colleagues set-out to study the association between psychological well-being and cardiorespiratory fitness, and their combined effects on survival.

The scientists used data from the Aerobics Center Longitudinal Study (ACLS), a prospective epidemiologic investigation of more than 5,000 volunteers that began in 1988. At the time of enrollment, participants had a thorough clinical evaluation including a history, physical exam, blood chemistry tests and an exercise test. Participants ranged in age from 20-81. They were followed annually until they died or the study ended, in 2003.

In ACLS, psychological well-being was evaluated at the time of enrollment using negative and positive emotion subscales from the Center for Epidemiologic Studies depression (CES-D) test. Questions in this test asked about how frequently respondents experienced certain feelings in the preceding week. The negative emotion subscale included things like ‘my life had been a failure’, ‘not able to shake off the blues’, and ‘depressed’. The positive emotion subscale included things like ‘feeling as good as other people’, ‘happy’ and ‘hopeful’.

What Did They Find?
After adjusting for traditional cardiovascular risk factors, the scientists found that participants with low levels of negative emotion had a 34% lower risk of death than peers reporting high levels of negative emotion. The protective effect was localized to those with high levels of cardiorespiratory fitness (CRF): high levels of CRF were themselves associated with a 46% reduction in mortality risk, but in the subset of participants that had both high levels of CRF and low levels of negative emotion, there was a 63% lower mortality risk.

These associations were present across all age groups and both genders. They persisted after adjusting for the presence of underlying diseases and the impact of positive emotion. Interestingly, high levels of positive emotion were not associated with mortality.

What Do We Make of This?
Ortega’s study suggests that low levels of negative emotion and high levels of cardiorespiratory fitness are independent predictors of long-term survival. What is more, these two parameters exerted a strong combined effect such that participants having both low-level negative emotion and high CRF experienced a 63% lower mortality risk than those with high negative emotion and low CRF.

This study should be considered in light of several limitations, as noted by the authors. For example, although they controlled for many risk factors for premature mortality, it may be that uncontrolled factors like dietary habits could also have played a role. These data were not available to Ortega’s group.

In addition, nearly 98% of the ACLS participants were well-educated, white, and in middle or high socioeconomic strata. It remains to be determined whether these findings will hold up in populations with more varied ethnicity and socioeconomic status. Also, the ACLS provided only a baseline assessment of negative and positive emotion. Although the authors cite previous studies suggesting that measures of psychological well-being remain stable over time, this assertion doesn’t necessarily jive with my anecdotal experiences (!).

Finally, the beneficial effect of low-level negative emotion on survival was seen only in participants with high levels of cardiovascular fitness. It did not impact those with low or moderate CRF levels…a strange, inexplicable finding that bears further scrutiny.

These limitations mean it’s unwise to recommend at this time that health professionals should routinely assess psychological health of their patients during, say, an annual physical examination, or that providers should intervene to reduce negative emotions (if that’s possible) in addition to encouraging increased physical activity. That said, the current study suggests a lot is at stake. If the findings do hold up in follow-up investigations, we might well have another compelling way to help people maintain health.

It’s worth mentioning in closing that Ortega’s group found only a modest correlation between positive and negative emotion scores: people with high levels of positive emotion do not necessarily have low levels of negative emotion, and vice versa. The group concluded that positive and negative emotion are distinct from each other and can impact survival in their own, unique ways.

Way back in 1946, the chartering documents of a new UN agency—the World Health Organization—defined health as “a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity.”

We have made astounding progress in medicine and public health since the WHO charter was crafted, yet we have actualized only part of its comprehensive vision for health. What we call health care today is really just illness care. Even our disease prevention and health promotion programs focus on reducing risk factors for disease. It is the rare initiative indeed that encourages good health for its own sake.

New initiatives focused on the concept of Positive Health are changing that by helping us understand what it means to be healthy in a comprehensive sense, beyond the simple absence of symptoms and illnesses. The initiatives focus on health assets, which are biological, psychological, social and other characteristics that are associated with prolonged life, reduced morbidity and health care costs, and improved quality of life.

The initiatives have been triggered by the seminal contributions of Martin Seligman. Many are funded by the Robert Wood Johnson Foundation’s Pioneer Program. They have already produced provocative results, one of which I discussed last week.

In this post–the second in a continuing series–I review another initiative in the field of Positive Health. This one examines how optimism impacts the risk of stroke, the nation’s third leading cause of mortality and disability after heart disease and cancer.

The Study
The classic risk factors for cardiovascular disease (including stroke) include high blood pressure and cholesterol levels, cigarette smoking and diabetes. ‘Negative’ psychosocial factors like depression, anxiety, work stress, low socioeconomic status and poor social support also predict cardiovascular events. More recently, a few studies have filtered into the literature suggesting that health assets like life satisfaction are also predictive.

However, as the National Heart, Lung and Blood institute recently emphasized, essentially none of these factors are all that good at predicting near term (that is, 1-2 years) cardiovascular events, especially in asymptomatic adults. Furthermore, almost no studies have examined whether positive health assets can impact the risk of stroke, per se.

A study by Eric Kim, of the University of Michigan, and colleagues has addressed this opportunity. They concluded that optimism was in fact an independent predictor of short term stroke risk.

To reach this conclusion, Kim’s group looked at data from 6,044 adults with no prior history of cardiovascular or cerebrovascular disease. The subjects had participated in the Health and Retirement Study, a nationally representative, prospective study of Americans who were at least 50 years old.

The scientists assessed optimism using the Life Orientation Test, in which participants respond to 3 questions using a 6-point Likert scale. Kim’s group created an ‘optimism scale’ based on participants’ responses. The scale ranged from 3 (extremely pessimistic) to 18 (extremely optimistic).

It turned out across the entire survey population, each unit increase on the scale was associated with an age-adjusted 9% decrease in stroke-risk during the 2 year follow-up.

Negative psychological factors like anxiety, depression and neuroticism were also predictive of short-term risk for stroke, but optimism offset their impact.

Of note, the association between optimism and stroke risk persisted after controlling for cardiac disease and dozens of biological, behavioral and sociodemographic factors (including race/ethnicity, marital status, educational status, cigarette smoking history, exercise, alcohol use, diabetes, body mass index, blood pressure).

What Can We Make of This?
Kim’s study is the first to suggest that optimism may protect against stroke in older adults. It is consistent with other research which has shown that positive psychological factors like optimism are associated with a range of cardiovascular benefits, including a reduced risk of rehospitalization following bypass surgery, reduced  risk of coronary heart disease and even reduced cardiovascular mortality.

One potential flaw in Kim’s study is that stroke incidence was ascertained via self-reporting from participants, based on what they understood from their doctor or by proxy reports for participants that had died (many of the covariates were also self-reported in Kim’s study). According to Kim’s team however, self-reported stroke has been shown in several other studies to provide an accurate estimate of stoke incidence.

Why might optimism reduce stroke risk? Kim’s group mentioned several studies showing that high optimism is associated with health knowledge and the pursuit of healthy behaviors. They hypothesized that optimists might be more proactive about their health in general, perhaps by adopting a healthier lifestyle that minimizes health risks and increases health and well-being.

These theories make sense but require further validation, especially before we can comfortably recommend interventions designed to promote optimism in the effort to reduce the incidence of stroke.

For centuries, health providers have focused on the prevention, diagnosis and treatment of disease. This time-honored paradigm has generated phenomenal advances in medicine, especially during the last 60 years. It has also created an image problem for providers, because the paradigm encourages consumers to perceive health care as a negative good - that is, a product or a service that we use because we must, not because we want to. Recent trends towards empowered consumers are a symptom of this problem more than a solution to it, as I described here.

Recently, the concept of Positive Health has emerged as a possible antidote for the malaise.

Pioneered by University of Pennsylvania psychologist Martin Seligman, Positive Health encourages us to identify and promote positive health assets—which Seligman describes as strengths that contribute to a healthier, more fulfilling life and yes, improved life expectancy as well. According to Seligman, “people desire well-being in its own right and they desire it above and beyond the relief of their suffering.”

Proponents of Positive Health have proposed that several social and functional factors are positive health assets. These include optimism, connectedness, a stable marriage and so forth. Scientists, often supported by the Robert Wood Johnson’s Pioneer Program, have begun studying these proposals. Their results have been compelling to say the least.

This post is the first of a series on Positive Health. In each post, I’ll review scientific studies of the matter and as the series unfolds, I’ll  discuss the relationship between this emerging paradigm and the traditional disease-oriented paradigm favored by today’s health providers.

Heart Health Linked to Satisfaction with Life
Most people know that negative psychological states like stress, anxiety and depression are linked to poor health outcomes, including a slew of adverse cardiac outcomes. Does it follow that a state of emotional and cognitive well-being can have a protective effect on cardiovascular health?

To answer this question, Harvard’s Julia Boehm and colleagues reviewed data from the Whitehall II study, which involved nearly 8,000 British civil servants. As part of that study, each participant had assessed his or her satisfaction with several dimensions of life experience including leisure activities, standard of living, job, health, family life, sex life, marital or love relationships and overall feelings about themselves as a person. Participants also provided yes/no answers regarding negative aspects of their lives including the presence of depression, anxiety and so forth.

The Whitehall II study also collected information regarding age, gender and traditional cardiovascular risk factors like cigarette smoking, diabetes and hypertension,. It assessed the incidence of coronary heart disease using three measures, presence of angina, documented heart attacks, and deaths from coronary disease during a 5-year follow-up period after the information had been collected.

Boehm’s team examined these data and found a clear, indirect relationship between satisfaction with each life domain and the risk of coronary heart disease: people reporting higher satisfaction had lower cardiac risk. Specifically, subjects in the highest tertile of satisfaction had a 26% lower risk of coronary events, and those in the middle third had a 20% reduced risk compared with those reporting the lowest levels of life satisfaction.

These trends reached statistical significance in 4 of the 7 dimensions: satisfaction with job, family life, sex life and overall feelings about themselves, and they persisted after controlling for age, gender, health behaviors, blood pressure, and metabolic functioning.

What to Make of This?
The study provides strong, though narrowly focused support for Seligman’s theories about Positive Health. Being satisfied with specific life domains—especially the 4 mentioned above—is associated with lower risk of coronary heart disease, even after accounting for traditional cardiovascular risk factors. If these findings can be validated, scientists should follow-up with studies to determine whether interventions designed to enhance life satisfaction can reduce cardiovascular risk.

Of note, the beneficial effects in this study were localized to angina, one of 3 outcome measures examined by Boehm’s group. There was no association between life satisfaction and the so-called ‘hard’ cardiovascular outcomes like heart attacks and cardiovascular deaths. Reporting bias could explain these findings: people that have favorable feelings about their lives might be more likely to report favorably about their health or have a higher tolerance for pain.

On the other hand, subjects in the Whitehall II study were relatively young (mean age = 50). In the natural history of coronary artery disease, angina frequently becomes manifest before heart attacks and death from cardiovascular causes. Participants in the study were followed for a fairly short time, only 5 years. It’s possible that longer follow-up would have revealed higher incidence of ‘hard’ cardiovascular outcomes.

It’s also possible that–since nearly all patients who sustain heart attacks have coronary artery disease, but only some with atherosclerosis sustain a heart attack—life satisfaction might be associated with increased risk of atherosclerosis but not with the specific factors that predispose to thrombotic events, plaque rupture and other antecedent events to heart attacks.

Further studies are required to sort through these alternative explanations.

In recent weeks, several Democrats and some health reform advocates including the AMA have joined Republicans in calling for a repeal of provisions in the new health law that create the Independent Payment Advisory Board (IPAB). For these people, IPAB represents the worst aspects of the new law–an unelected, centralized planning authority empowered by government to make decisions about the peoples’ health care. Arbitrary cuts to providers, short-sighted decisions that stifle innovation and rationing of care are sure to follow, they claim.

While it’s true that the rules governing IPAB are flawed and should be fixed, eliminating IPAB altogether would be a mistake.

Created by the Affordable Care Act, IPAB is a fundamental part of the law’s plan to control health care cost escalations. The law contemplates that each of the Board’s 15 members would be appointed to a 6-year term by the president. Members are to include providers, health policy and public health experts, and consumer representatives. Each would have to be confirmed by Congress, much like Supreme Court justices. And unlike a frightening, wizard-like bureaucrat operating behind a curtain-as critics would have you believe-the IPAB chairperson would be required to appear before any committee of Congress that desires a hearing, just as the President’s cabinet members are required to do.

IPAB’s mandate would be to recommend ways to prevent excessive escalations in Medicare expenditures. Specifically, whenever these costs grow faster than targets established by the Affordable Care Act, IPAB would propose ways to reduce Medicare spending by up to 1.5%. When that happens, Congress can either approve those recommendations, develop alternatives with the same impact, or simply allow Medicare costs to accelerate. In the last instance, a 60% majority of the Senate would be required to overrule the IPAB recommendation.

Some sort of cost-governing approach is mandatory, because we want to offer comprehensive coverage to Medicare beneficiaries within some reasonable cost structure, and because Congress has shown no inclination to do so, for example by enacting quality- and efficiency-based payment models. As Jonathan Cohn points out, Congress is unlikely to do this going forward, because its members are heavily influenced by lobbyists whose job it is to maintain the lucrative status quo. IPAB members, shielded as they would be from such influences but still wholly accountable to Congress, may well succeed where lawmakers have not.

Some of those who are now calling for a repeal of IPAB predict it will release “treatment edicts” that prevent folks from gaining access to expensive procedures, cancer drugs and so forth. These predictions are unlikely. The Affordable Care Act prohibits IPAB from modifying Medicare benefit schemes or any other behavior that could be construed as “rationing.” It also prohibits IPAB from raising premiums, restricting benefits or modifying eligibility.

So What Will IPAB Do?
When medical research suggests that certain treatments are more effective, or cost-effective (I provide an example involving coronary stenting here), IPAB is authorized to recommend changing reimbursement rates under Medicare to promote such treatments. These recommendations do not ration care. Providers can practice medicine as they see fit. The new reimbursement scheme will incent providers, however, to heed the research sooner, and more comprehensively than would otherwise be the case.

Let’s not forget that all payers, private and public, already routinely decide what procedures to cover. In effect, IPAB can increase input by scientists and cuts down input by lobbyists when it comes to coverage decisions.

Critics have also charged that by cutting reimbursement to providers, IPAB might indirectly foster rationing. According to this argument, cash-strapped providers will begin turning-away Medicare beneficiaries if their payment is reduced too far. As Cohn points out however, these criticisms have never raised above the anecdotal stage. Most doctors still see Medicare patients; in fact they are more open to seeing such patients than to many of those insured through private carriers.

Is there room to improve current legislation governing IPAB? Yes, there is. According to Henry Aaron, IPAB can’t make recommendations governing acute and long-term care hospitals, psychiatric facilities and inpatient rehabilitation until 2020. It can’t do that for clinical labs until 2016. In their current form, IPAB rules also prevent recommendations that drive up costs in the short run, even though they might save money in the long run. These rules should be fixed, for obvious reasons. But repeal IPAB altogether? Heavens no!

It is ironic that the loudest critics of health reform–the ones who claimed it didn’t have enough teeth to control Medicare cost escalation–are the same ones who now demand that IPAB, a key element of the law’s cost-control strategy, be repealed.

If none of this is persuasive, consider the alternative proposed by Paul Ryan and supported by Republicans in the House. Rather than empowering a commission to improve Medicare efficiency, it severely reduces the scale of the entitlement program altogether. It offers seniors a voucher that provides less comprehensive coverage than today’s Medicare, and forces seniors to fend for themselves in the private insurance market, just as they did before LBJ created Medicare in the first place.

Few if any seniors want to revisit those days.

The Case
In 2009, administrators at St. Joseph Medical Center in Maryland wrote letters to the patients of Mark Midei, MD, informing them that its staff cardiologist may have subjected them to a coronary artery stenting procedure inappropriately. That communication prompted an article in a local newspaper, which triggered an investigation by the Senate Finance Committee.

The Committee subsequently released a report which asserted that Midei performed nearly 600 stenting procedures unnecessarily, and charged Medicare nearly $4m for these procedures. According to the report, all the procedures involved stents made by Abbott Labs. Abbott, in turn, had paid Midei $31,000, added him to its roster of top stent volume cardiologists, and feted him with a pig roast at his home to celebrate a prodigious day in which he implanted 30 stents (apparently a company record). Then, after St. Joseph’s dropped Midei from its roster, Abbott hired him to provide services in Japan and China. In the subsequent year, the number of patients who received stents at the hospital fell to 116 from 350 in the previous year.

Most recently, the Maryland Board of Physicians revoked Midei’s license to practice medicine after concluding that he inappropriately implanted stents into the coronary arteries of 4 patients. The Board also determined that he exaggerated the severity of coronary blockages and claimed incorrectly that they had unstable angina. Midei has denied the allegations and sued St. Joseph for damaging his career.

The Context
The Midei case is particularly egregious, but a recent study in the Journal of the American Medical Association suggests that many thousands of percutaneous coronary interventions (PCIs)—perhaps as many as 4% of all those performed each year in the US—are inappropriate.

The study was organized by Paul Chan of Saint Luke’s Mid America Heart and Vascular Institute. Chan’s team found that when PCIs were done for acute indications like an evolving myocardial infarction (heart attack), the overwhelming majority of cases (98.6%) were performed for appropriate indications. A remarkably low 1.1% were done inappropriately (in the other cases, the benefit was uncertain).

For elective procedures like the ones performed by Midei however, fully 11.6% of all PCIs were inappropriate, and an additional 38% were carried out for indications associated with unclear benefit. Most of the procedures deemed to be inappropriate were carried out on patients with no angina (54%), low-risk ischemia as determined by exercise testing (72%), or patients that were not receiving ‘maximal’ medical therapy (96%). Ninety-four percent of these patients also did not have ‘high risk’ coronary anatomical findings.

Chan’s group found enormous variation across hospitals in the rate of inappropriate elective PCIs, with the range being 0% to 55%. The best-performing quartile had 6% or fewer inappropriate PCIs, while the worst quartile had 17% or more.

To determine which PCIs were done for appropriate indications, Chan’s group used criteria released in 2009 by a task force which included representatives from the American College of Cardiology, the American Heart Association, the American Association for Thoracic Surgery, the Society for Cardiovascular Angiography and Interventions (SCAI), the American Society of Nuclear Cardiology and the Society of Thoracic Surgeons.

The scientists used data from the CathPCI registry which included information on more than 500,000 procedures performed at more than 1,000 US hospitals between July, 2009 and September, 2010.

Just over 70% of all procedures were done for acute indications, including ST-segment elevation MI (STEMI), non-STEMI, and certain high risk patients with unstable angina with high-risk features. The others were elective.

How Many Stents are Enough?
Nearly 600,000 percutaneous coronary interventions (PCIs) are performed per year in the US. Patients receiving the expensive procedure are exposed to procedural complications, and an increased risk of bleeding and stent thrombosis. Trials in patients with ‘stable’ cardiovascular disease reveal that PCI provides no better than modestly improved symptoms, when compared to medical therapy.

Given this, few cardiologists would be pleased to hear that one out of eight elective PCIs is performed for reasons deemed by experts to be inappropriate. My guess is that many of the inappropriate procedures can be traced upstream to earlier decisions to perform diagnostic catheterizations in the first place, perhaps motivated by a borderline result on an exercise tolerance test, or unwillingness by the patient or the physician to give medical therapy a full, fair trial. Once an invasive diagnostic procedure like this is undertaken, it can be awfully tempting to treat borderline lesions with PCI and stenting, even though these lesions are unlikely to be life-threatening anytime soon.

A second factor, cited by Chan’s group, is that Cardiologists don’t always agree with, or understand the guidelines crafted by their peers. In fairness, guidelines developers assume ‘average’ proficiency with the PCI procedure. For extremely talented clinicians, the risk-benefit ratios assumed by developers may not reflect results on the ground. Still, for Cardiologists who aren’t familiar with the guidelines, simple educational programs are likely to improve outcomes.

In part, this is why 38% of the elective PCIs in Chan’s study were done for ‘uncertain’ indications. Additional research is required understand how PCI can benefit certain patient populations, and how variable skill-levels among Cardiologists can affect recommendations.

And let’s not overlook the patients’ role in medical decision making, especially in areas deemed as uncertain by the experts. Some patients can tolerate and comply with complex medical regimens better than others. Some patients can more easily afford to pay for expensive, lifelong medical therapies. In Cardiology as in other disciplines, the practice of medicine is often not black and white. This is why clinical judgment and optimal physician-patient communication will always remain at the center of good medical care.

The Internet has transformed every aspect of health care. Online communities provide new forms of support for people with a thousand different medical conditions. Email has streamlined communication between stakeholders in the system. Electronic medical records and social networking sites hold a wealth of data that can be leveraged to study the effects of various treatments.

The most significant advance by far though, has been the ease with which people can access information about their health. As many as 74% of all people search for information about their symptoms and treatments online. Many of these information-empowered people now see physicians as guides to and interpreters of this information, a far cry from the era in which passive patients simply recounted their symptoms and relied on paternalistic physicians to act in their best interests.

There are problems with the new paradigm, just as there were with the one it replaced. In particular, online health information can be incomplete, biased, lacking for proper context or flat-out inaccurate…and not everyone can sort through these deficiencies in a way that assures they are properly informed.

A recent study by Alexander van Deursen and Jan van Dijk of the University of Twente has quantified these problems. The scientists used performance tests to assess health-related Internet search and other online skills in a representative sample of the people in the Netherlands.

Their tests focused on four types of skills:
Operational-These included basic internet skills like opening a health website, saving a PDF file and adding a website to a list of “favorites.”
Formal-These included navigating health-related menus and websites, and surfing a list of websites.
Finding Information-These included accessing specific information regarding medical conditions and answering specific questions like whether it is appropriate to begin a treatment after being infected with a particular germ.
Strategic-These included extracting information from different sources and making decisions based on the information. For example, “find out whether it is wise to give a 3-year-old boy Vitamin A and D.”

On average, study subjects successfully completed only 73% of the operational skill tasks and 73% of the formal skill tasks. They completed only 50% of the finding information tasks. An abysmal 35% used their findings strategically.

Only 28% of the subjects successfully completed all operational skills tasks, 39% completed all formal skills tasks, 13% successfully completed all information skills tasks, and 20% completed all the strategic skill tasks. There was substantial variation in the time required to complete any particular task successfully.

According to the scientists, age and educational level were strong predictors of success with operational and formal Internet skills. In the latter case, years of Internet experience was also somewhat predictive. When it came to information finding and strategic internet skills, educational level was the most important predictor of success.

What Should We Make of This?
The study, if it can be generalized, suggests that a surprisingly large fraction of the general population lacks basic Internet skills needed to keep pace with the explosion of online health information and services. Many more, including a surprisingly large number of younger folks, have problems finding information on the Internet and using it appropriately. In the latter group for example, subjects often failed to recognize that key information was missing, that the information they encountered was biased, and that claims made on certain sites were not based on scientific evidence. More pernicious problems included a tendency to focus on finding information quickly rather than information that answers specific questions. Frequently for example, subjects visited only the top-listed links (which are often sponsored) derived from a search.

What Should We Do?
First, we need to recognize there is a problem. I am just as bullish about the potential of the Internet as the next guy, but this potential will only be reached if we implement policies and procedures that improve Internet skills for the general population. Adult education and computer classes should be made available to teach operational and formal Internet skills, especially for older folks. Similar training in information finding and strategic Internet skills are required for people of all ages. It is dangerous and often flat-out wrong to assume that, just because the Internet has become ubiquitous, people know how to use it properly.

As for the age of the empowered e-patient, this study suggests that millions of people, perhaps tens or hundreds of millions, aren’t quite there yet. Even today, medical professionals must act as curators of credible information. They shouldn’t assume their patients can identify and use evidence-based information from the Internet. Minimally, their job is to steer patients away from the sponsored sites and ones touting miracle cures, and towards the ones which are reliable and free from bias.

I thought I read the final chapter in the tale of Pfizer’s shady marketing practices for Neurontin years ago. Sadly, there’s at least one more chapter to go.

Recall that in in 2008, leaked documents from a US District Court revealed that Pfizer had covered-up the results of a clinical trial which showed the drug didn’t work for chronic nerve pain, even as it promoted off-label use of the anti-seizure drug for that purpose. The next year, it was revealed that Parke-Davis (now a subsidiary of Pfizer) took advantage of lax disclosure policies by certain medical journals to publish 13 articles promoting off-label use of Neurontin that were ghostwritten and funded by the company without disclosing such arrangements.

Now, it has come to light that Parke Davis’ marketing department sponsored a seeding trial of Neurontin – that is, a trial portrayed deceptively as a patient study but whose real aim was to encourage prescribers to use the drug.

The trial was STEPS, the ‘Study of Neurontin: Titrate to Effect, Profile of Safety’ trial. More than 772 physician ‘investigators’ and 2800 patients participated in STEPS.

The stated objective of STEPS was to study the safety, efficacy and tolerability of Neurontin. However, after reviewing documents compiled for a pair of lawsuits against Pfizer and its subsidiaries, Joseph Ross and colleagues concluded that the actual objective was to increase prescribing rates by ‘investigators’ in the study. Neither the ‘investigators’ nor their patients were informed about the real purpose of STEPS.

The trial worked…from Parke-Davis’ point of view. Physician ‘investigators’ prescribed 38% more Neurontin as a result of their participation in the trial.

The drug company also leveraged the patient recruitment process to market Neurontin to ‘investigators,’ Ross’ group found. Company representatives asked ‘investigators’ to set-aside certain days on their schedule in which epilepsy patients comprised the bulk of the appointments, thereby permitting the reps to be present and promote Neurontin at the moment of truth. The reps even helped collect patient data for the trial.

The smoking gun was uncovered in the company’s marketing plans, which cited the trial itself – not its anticipated results – as central to the promotion of Neurontin. For example, a 1995 report listed STEPS as a deliverable under the strategy “Solidify Neurontin’s position with neurologists and select primary care physicians as the safe and easy add-on for refractory patients.” Another document stated that, “the rapid growth of Neurontin depends on the ability to influence the large population of community neurologists that see the majority of nonrefractory seizure patients. The STEPS trial…was a strong start to this…”

To be clear, Parke-Davis’ marketing department, not its clinical research department designed and conducted STEPS.

What’s Wrong with Seeding Trials?
Seeding trials are not illegal, but they are profoundly unethical. They don’t permit patients to make informed decisions about participating, since the real (marketing) objectives are not disclosed. Ross’ group reports that 11 patients died and 73 more experienced serious adverse events during STEPS, so they were exposed to considerable risk. Physician ‘investigators’ were also not informed that they, in fact, were the real study subjects in STEPS. Indeed, the very success of STEPS relied on deception; few physicians or patients would participate in studies with primary marketing objectives and little scientific value.

Remarkably, no one knows how many seeding trials have been carried out over the years, since their results are often not published (after all, the goal is to impact prescribing, not to contribute to medical knowledge). Other than Ross’ account of STEPS, the only other seeding trial to have been exposed in detail was Merck’s ADVANTAGE trial, which was designed to increase prescribing for Vioxx, a drug that was later pulled from the market after being linked to cardiovascular disease. As was the case in STEPS, a review of documents obtained during litigation was required to expose the problem.

What Can Be Done?
The FDA is largely powerless to prevent seeding trials. It only oversees trials designed to support new drug applications or to support label or advertising change requests. That leaves things up to the institutional review boards at individual institutions, which is not comforting since only one IRB (at Johns Hopkins) spotted problems with STEPS and failed to approve it.

It may finally be time to ramp-up government oversight of IRBs, therefore. Why not require all IRBs to register and become accredited, for example? Why not penalize institutions whose IRBs approve trials that are unethical, as was the case in STEPS? Why not proscribe commercial (as opposed to institutional) IRBs altogether, since they have intolerable conflicts of interest? Why not require that all research protocols be posted in a publicly available repository? At a minimum, this would make it easier to identify seeding trials—at least retrospectively. We wouldn’t have to wait for a lawsuit.

Even if all these recommendations were implemented however, clinical investigators and physicians themselves must ultimately step-up and accept their roles as ‘the last line of defense’ (as I mentioned here). It comes down to asking yourself this question: does the post-marketing study in which you have been invited to participate seem to have marketing objectives or actual science in mind?

It was nice while it lasted, but the brief surge in optimism surrounding debt-reduction negotiations died Sunday, when Speaker of the House John Boehner announced that his party wouldn’t swallow President Obama’s proposed $800 billion tax increase as part of a package designed to save $4 trillion.

If nothing else, the collapse of the negotiations made it clear that Republicans don’t care about the deficit per se. What they care about is cutting federal spending and taxes, and they’ll do that even if it means partially dismantling popular entitlement programs in the process.

One would think the GOP would have gotten the message that this was a bad idea when a reliably Republican district in upstate New York elected Democrat Kathy Hochul to fill a vacant House seat in a special election last month. Hochul’s entire campaign revolved around preserving Medicare and denouncing a plan by Republican Paul Ryan to transform it into a voucher program, cutting benefits in the process.

In fact the draconian spending cuts envisioned by GOP deficit hawks would impact the health of American citizens far more profoundly than the Ryan plan envisions.

That’s because, as I argued here and here, public health isn’t a medical problem at all. It is a socioeconomic one, and cuts to many programs other than those proposed for our health entitlement programs will affect national well-being and health as a result.

Take Canada for example. That country provides universal, free access to health services for all citizens. If poor access to health care (a problem that would be exacerbated by GOP cuts to health entitlement programs) was the only factor driving poor health outcomes, then we shouldn’t see poor, or less educated people experiencing poor outcomes in Canada. But these differences do exist, in spades. In a recent study of 15,000 Canadian adults for example, participants in the lowest income group were nearly 3 times more likely to die of any cause than those in the highest income group. They were also more likely to have diabetes, high blood pressure, cancer, cataracts and many other conditions. The study revealed similar disparities when participants were stratified by educational level.

In a recent editorial for the Journal of the American Medical Association, Steven Woolf of Virginia Commonwealth University describes how spending cuts for non-health related programs, particularly education, can affect the health of Americans as well. In 2007 for example, Woolf reports that adults who graduated a 4-year college were 4 times less likely than those who had not graduated high school to report their health as ‘fair’ or ‘poor.’ The latter group had more than twice the prevalence of diabetes, a risk of stroke that was 80% higher, and a life expectancy that was 5 years shorter than that for college graduates.

Many factors underlie the link between health disparities and educational status. Educational achievement is indirectly correlated to obesity and cigarette smoking, for example. It is also linked to jobs with better benefits (such as health insurance).

Income levels are also correlated with poor health. Poorer folks tend to skip exercise, eat unhealthy meals and forego medications in order to save money for other necessities. They must contend with pollution, pest infestations and crime (which increases stress and depression).

So What?
GOP deficit negotiators must remember that short-term plans in the name of fiscal discipline can create far larger budget problems in the long run, to the extent that they undermine the health and wellness of tens of millions of Americans. Health-related entitlement programs already consume 23% of the federal budget. Some of the cuts proposed by GOP budget hawks will cost people their jobs, cut their income and interfere with their right to pursue a good education. These cuts will increase the burden of illness for millions of people, possibly for generations. That will drive-up health spending and yes, raise the deficit to unimaginable levels before too long.

Many voters can’t see past the issue of short-term deficit reduction, but we elect officials to lead, especially when times are tough like they are now. For sure, it is hard for elected officials to make decisions that are in our nation’s long-term best interests, since they must please their constituencies in time for the next election cycle. Then again, that’s what leadership is all about.