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Archive for December, 2007

Wishing You All Aloha and A Global Happy New Year .

by Fred Fortin

As we suffer through assassinations, earthquakes, censorship and all forms of political and electoral mayhem, let’s just take one moment to celebrate, together, the incoming new year. The new year brings with it a renewal of hope that things will change for the better, and a re-commitment to pursue that change, to make it happen. So from the middle of the Pacific Ocean to all of you, Aloha and best wishes in the coming year.

More Integrated Systems Investing In EHM

by Scott MacStravic

Employee health management (EHM) has always been a logical arena for investment by healthcare organizations (HCOs) of all kinds, since they are employers facing a constant and worsening labor shortage and high labor costs. By protecting and improving the health of their workforces, HCOs can not only reduce their health, workers compensation, and disability insurance costs, but increase worker productivity and performance. And as more of their revenue becomes dependent on their overall performance, the more they can improve their workforce performance, the better their revenue situation will be, in addition to their cost situation.

There is, of course, the problem that EHM derives part of the savings it generates by reducing the incidence and prevalence of disease and injury, and thereby, the use and expenditures for “sickcare”, upon which HCOs depend for the vast majority of their revenue. So while offering EHM to their own employees makes eminently good sense, offering it to other employers would seem to be directly counter to HCOs’ financial interests.

But there are many, and an increasing number of HCOs whose missions and visions for their future recognize that preventing disease and injury is in the best interests of the communities they serve, and may be in their best long-range interests, as well. With all payers for sickcare services looking for ways to dramatically reduce their payment obligations, it is clear that sickcare is not in the “best of health” as a future market, while healthcare, in its truest sense, certainly is. If HCOs do not join in the general move to proactive management of health, it will likely become only a bystander and victim of others doing so.

It is certain that in the most optimistic of scenarios for the future, sickcare will continue to be needed. But if the volume and intensity of sickcare utilization and expenditures can be significantly reduced, then payers will be able to afford being at least about as generous as they are now in paying for it. If not, and particularly if payers become widespread and heavy purchasers of healthcare instead, HCOs that depend solely on sickcare revenue may be in serious trouble. Already prestigious HCOs such as the Mayo Clinic are significantly engaged in EHM, with Mayo serving 70 or so employers in the US with its proactive health management services.

Sutter Health, an integrated health system of 26 hospitals plus medical practice affiliates such as the Palo Alto Medical Foundation, has been engaged in EHM for both its own 41,000 employees and employers in its markets, beginning in 2001. More recently, it developed Sutter Health Partners as a separate division responsible for employer-focused EHM services as both a revenue-generating and employer relationship management (ERM) strategy. It offers a “Live Well for Life” program to employers in the Northern California market where it operates, using the same double entendre meaning of “for life” as I did as the Chief Marketing Officer for Provenant Health Partners in Denver, where we developed the tagline “Your Partner for Life.”

Sutter offers customized turnkey EHM programs to area employers, based on onsite convenience. The programs include onsite biometric screening tests to assess and evaluate progress among participating employees, in addition to an online health risk assessment survey. Personal coaching, including a personal meeting with the coach assigned to each participant, and ongoing meetings at least quarterly thereafter, are offered along with wellness topic and exercise classes at the worksite for participants’ convenience, as well as the high personalization possible through face meetings.

Coaching, support and monitoring communications are also carried out online and by phone to supplement onsite meetings. Based on an average annual employee compensation of $40,000 a year, fairly low among employers who invest in EHM, including Sutter, itself, Towers Perrin has predicted first-year savings for employers of almost $1000 per participant in the EHM program, of which over three-quarters are in absenteeism, disability and presenteeism cost reductions, with less than one-quarter in medical/sickcare costs. [“What LIVE WELL FOR LIFE Can Do for You” SutterHealthPartners.com (downloaded Oct 2007)]

Moreover, these savings are predicted to increase each year thereafter, from $1000 to $1700 per participant per year, adjusted for inflation. Cumulative savings per participant over that period would be over $3500 per participant including medical costs, absenteeism and presenteeism. For employers with higher average annual compensation per employee, or where the value of employees is greater than their annual compensation, total positive economic impact would be that much greater.

The Sutter program combines assessment, coaching interventions that motivate and support employee health behavior change, with measurement of results and return on investment. Sutter has reported results such as:

* Moving 25% of workers from high- to low-risk status with respect to blood pressure readings, with a Towers Perrin estimated cost savings of $706 for each employee affected
* Moving 27% of workers from high- to low-risk for cholesterol level, with estimated savings of $492 per worker
* Sedentary Lifestyle risk down by 16%, with savings of $738 per affected worker
* Body Mass Index risk down 11%, with estimated savings of $1295 per worker.

Instead of estimating productivity impacts based on employee self-reports of their own productivity levels, Sutter uses research-generated correlations between specific types and numbers of health risk reductions and productivity levels. Combined with biometric verification of changes in risks, this enables an objective basis for gauging productivity improvements, rather than the often overstated levels of productivity impairment and improvement that employees have been known to report. [G. Pransky, et al. “Performance Decrements Resulting from Illness in the Workplace” JOEM 47:1 Jan 2005 34-40]

While onsite coaching adds to EHM costs, Sutter Health Partners’ CEO and Sutter VP for New Product Development, Margaret Sabin argues that it is more effective as well. She reports that participants who have been involved in other kinds of EHM communications say that other methods are nowhere near as beneficial and effective. Participants cite the coaching 10% more often than they do the up to $500 per year incentives available as the reason they have changed to healthier behaviors. (phone interview on Oct 29, 2007)

Like most EHM programs, Sutter’s Live Well for Life efforts focus mainly on weight, stress, and risk management, along with physical activity and nutrition as key elements in a healthier lifestyle. They empower each participant to formulate reasonable and sustainable personal health goals, and support them with coaching via personal onsite visits, as well as online and phone interactions, combined into at least six 20-minute contacts over five months, in addition to participants’ self-directed learning and behaviors.

Sutter charges for its HRA and biometric assessment efforts on a per employee basis, then for its coaching and classes on a per participant basis. This minimizes the cascading effect of per employee charges, which multiply costs per employee by the inverse of the participation rate, e.g. doubling them at 50% participation, quintupling them at 20%. Sutter also reports that its clients achieve from 60 to 80% participation, meaning they get far more out of the program than do employers who only achieve 10-30%, which is more like the average for employee participation in wellness programs.

In addition to saving employers money on total labor costs, the Sutter program helps strengthen, and even initiate good employer relations, with examples of new business for Sutter Health medical and hospital care arising thanks to relationships begun with Sutter Health Partners relationships. And Sutter has been offering its own employees the same program for many years, realizing savings similar to those its employer clients enjoy. While there will always be a degree of conflict between the financial interests of sickcare services and EHM, there are equally solid common interests in terms of both internal EHM applications and the improved relationships with employers it makes possible.

China Sees Dramatic Increase in Blogs in 2007 — Important Development for Health Care

by Fred Fortin

The China Internet Network Information Center(CNNIC) reports that by the end of November 2007, China had almost 73 million blog “spaces” and 47 million bloggers. “By the end of 2006, the number of blog writers was 17.5 million, and within one year the increase reached nearly 30 million, indicating the large-scale growth in number of the blog writer group,” according to the CNNIC report.

While health care is not specifically mentioned, the report goes on to say that blogs cover “almost all the areas of people’s daily life, including the cultural, military, economic, tourist, living areas, etc.” and has become an “important channel for people to obtain information.”

We know that in the West internet use to obtain health information is major activity, with blogs becoming a serious source of consumer information and empowerment. Blogs, especially bridge blogs (those that translate information from one language to another), are critical entry points in developing countries where people can gain access to health information on a global scale. Just as important is that the reverse is also possible; the growth of these blogs also gives the West an opportunity to connect and interact with what I would call ‘local communication and health care leadership’.

Now there’s a great idea: Could a blog or internet service aggregate connections to those local blogs in such a way as to facilitate health care communications directly between East and West? Sort of a ‘Global Voices’ for health care? Consumers to consumers? Doctors to doctors?

China to Rank Physician Ethical Behavior

by Fred Fortin

From a China Digital Times post translated from the China News Service:

China’s Ministry of Health and Chinese Medicine Administration have jointly issued a regulation that aims to set up a evaluation system to tally the medical ethics of doctors in various hospitals and other health care providers in the country. There are three components in the evaluation regime: self-assessment, departmental assessment and institutional assessment. A filing system will also be set up to store the records, in an effort to link the ethics scores with the doctor’s compensations and promotions. But there is one thing missing, as some commentaries point out: opinions from the patients and their families.

If I were a physician in China, this new initiative would make me extremely uncomfortable for a couple reasons. First, physicians working in a health care system characterized typically by a heavy top-down management style, and absent a strong peer advocacy group, are at a distinct disadvantage when it comes to disagreements about professional behavior. And second, political intolerance of dissent and social action is often framed as action against ethical misconduct. I do recognize that medical leaders and institutions do have responsibilities when it comes to the ethical behavior of those whom they oversee. But it is the cultural and political context that surrounds this new ranking approach that makes me uncomfortable.

As far as the absence of the public ranking of physicians in this new scheme, that, my friends, is simply a matter of time.

Genentech and ophtalmologists come to terms on Avastin

by David Williams

As reported extensively on the Health Business Blog (see here, here, here, here, here, here, and here ) Genentech has undergone a contentious period with the American Academy of Ophthalmology (AAO) and American Society of Retina Specialists (ASRS). Compounding pharmacies have been repackaging Avastin into small doses, which eye doctors then use in place of Lucentis, a very similar drug from Genentech that is indicated for ocular use. This has been a real headache for Genentech, because repackaged Avastin sells for about $40 compared to Lucentis, which is $2000. The latest controversy was triggered when Genentech announced its intention to stop distributing Avastin to compounding pharmacies.

Now the parties seem to have come to terms. The way I read the statements (see below) from Genentech and AAO/ASRS, physicians have essentially gotten what they wanted.

A number of fascinating issues are raised by this controversy, including:

  • Is Genentech selling a product or a solution to a problem? Obviously the manufacturing cost of Avastin/Lucentis is low relative to the sales price. If Genentech can make a real impact on wet Age Related Macular Degeneration they probably deserve more than $40 for it. Think of it like software: Microsoft licenses a home version of Office for much less than the commercial version. The product is the same, but it’s licensed for a different use at a different price. This strikes me as fair. Perhaps we will see indication or value-based models like this emerge in the future.
  • What role should the FDA play in regulating the quality of a product once it’s left the manufacturing facility? FDA is very strict about manufacturing plant quality and inspections. Yet once a product leaves the dock standards are much looser. This is true for all sorts of products, not just injectables. It’s an issue in traditional pharmacies, compounding pharmacies, doctors’ offices and patients’ medicine cabinets. I still don’t know how safe repackaged Avastin is.
  • When Genentech decided to develop Lucentis, it must not have expected Avastin to cannibalize the market so dramatically. In similar situations in the future, will companies go to the trouble and expense of developing and registering a new product or simply fall back on off-label use?

First, the statement from Genentech:

Genentech, in collaboration with the American Academy of Ophthalmology (AAO) and the American Society of Retina Specialists (ASRS), is pleased to provide an update on our joint efforts to address physician questions about access to Avastin® (bevacizumab) after Genentech’s January 1, 2008 change to the distribution of the product.

Since October, when Genentech announced it would no longer allow compounding pharmacies to purchase Avastin directly from authorized wholesale distributors, we have partnered with the AAO and ASRS to understand physicians’ needs related to their ongoing access to Avastin.

We are pleased with our collaboration and progress to date. Working together, we have determined that physicians can prescribe Avastin and purchase it directly from authorized wholesale distributors and wholesalers can ship to the destination of the physician’s choice, including to hospital pharmacies, compounding pharmacies or directly to the physician’s office. This process is one that the AAO and ASRS believe addresses the needs of their members. It is a significant step forward, reflecting the collaborative approach of Genentech and AAO and ASRS leadership.

Genentech continues to believe LUCENTIS® (ranibizumab injection) is the most appropriate treatment for patients with wet age-related macular degeneration (AMD) because it was specifically designed, formally studied, approved by the U.S. Food and Drug Administration (FDA) and manufactured for intraocular delivery for the treatment of wet AMD. At the same time, Genentech does not interfere with physicians’ prescribing choices and believes that physicians should be able to prescribe the treatment they believe is most appropriate for their patients.

We also remain committed to ensuring that eligible patients have access to Lucentis regardless of their ability to pay. Therefore, Genentech, the AAO and ASRS are working together to develop additional programs that will more efficiently facilitate and expedite patient access and physician reimbursement for Lucentis. Updates on our progress will be provided in early 2008. In the meantime, physicians or patients who have questions related to access and reimbursement services offered by Genentech can call 1-866-724-9394.

We would like to thank the AAO and ASRS for their leadership and collaboration over the past several months. We are encouraged by our progress to date and look forward to continuing our efforts with the common goal of helping patients with potentially blinding diseases.

Second, the statement from the American Academy of Ophthalmology and American Society of Retina Specialists:

Solution to Avastin Access Found through a Joint Effort by the Academy, ASRS and Genentech

The American Academy of Ophthalmology and the American Society of Retina Specialists (ASRS) are pleased to report that a solution has been found that addresses Genentech’s decision to no longer allow compounding pharmacies to purchase Avastin® (bevacizumab) directly from authorized wholesale distributors. The Academy and ASRS believed that this change in distribution could have impacted access to Avastin for some physicians and patients.

Since October, when Genentech made its announcement, the Academy and ASRS have been in discussions with the company to determine how physicians and their patients can maintain their access to Avastin. Working together, we have determined that physicians can prescribe Avastin and purchase it directly from authorized wholesale distributors and wholesalers can ship to the destination of the physician’s choice, including to hospital pharmacies, compounding pharmacies or directly to their office. This process is one that the Academy and ASRS believe addresses the needs of most of their members. It is a significant step forward.

Because laws differ from state to state, the implementation of this solution may vary. The Academy and ASRS recommend that physicians check with their legal advisors when considering this new option.

Genentech also remains committed to ensuring that eligible patients have access to Lucentis® regardless of their ability to pay. Therefore, Genentech, the Academy and ASRS are working together to develop additional programs that will more efficiently facilitate and expedite patient access and physician reimbursement for Lucentis. Updates on our progress will be provided in early 2008. In the meantime, physicians or patients who have questions related to access and reimbursement services offered by Genentech can call Genentech’s Lucentis Commitment™ helpline at 1-866-724-9394.

For questions about Genentech’s authorized wholesale distributors, please contact Genentech at 1-800-551-2231 or csordermgmnt-d@gene.com.

Some Reflections on the WHIT 3.0 Conference

by Fred Fortin

As I’ve had some time now to think about the presentations at the recent WHIT 3.0 conference, a couple comments are in order.

The conference was almost totally focused on what was happening in U.S. health care. This made it exciting and relevant to us. But I can’t help thinking that we still need to better integrate a global perspective on health care. As I’ve talked about a number of times, our public discourse in health care is often too insular, too self-serving and thus irrelevant when it comes to the rest of the world; that the world, and health care with it, is changing in dramatic ways. And we are not paying enough attention to the above two points.

Health care is a complicated business. The seemingly intractable problems in health care are not all due to recalcitrance, ignorance or incompetence — or even the dominance of special interests. As much as I recognize that innovations in technology and consumerism are incredibly important to fixing health care, traditionally conservative health institutions have evolved their nature due to deeply embedded aspects of human nature and how we collectively define who we are and our responsibilities to each other. Information technology innovators still have to develop a more nuanced appreciation of these dynamics. We can build it, but they might not come. The true difficulty of fundamental change in health care should not be underestimated since it involves changes in mass behavior and culture. The social cost of these changes and the propensity of things to go very wrong should instill a certain caution in our thinking.

Risks to Health: Does the Type of Risk Matter, or Only the Number?

by Scott MacStravic

In managing the health of populations, there is emerging a growing consensus that managing diseases is only part of the “solution” for controlling healthcare costs. Managing the population’s overall health and reducing their risks can be far more rewarding in the long run at least. Moreover, when the population is a workforce, managing not merely risks but “productivity/performance-impairment factors” can end up saving employers far more in labor costs than they can realize in healthcare costs alone, when employee health management (EHM) is provided.

When addressing health risks, there is a substantial body of research that suggests that by reducing the sheer number of risks that members of the population of the population have can significantly reduce both healthcare costs and productivity/performance impairment. I have 33 articles in my EHM files on the subject that report either the cost impact of the numbers of risks or the benefit of reducing them, sometimes both. And I have at least three examples, all from the same source, reflecting the productivity impairment levels associated with both numbers of health risks and numbers of diseases affecting employee populations, and reporting both the costs of having them and the benefits of reducing them.

Unfortunately, there is little uniformity in: 1) deciding what health risks will be included in research; 2) choosing how many risks constitute a “low”, “medium” and “high” risk status; or 3) choosing which and how many costs of risks will be included in research. As a result, there are limited opportunities to compare results from different studies, or determine anything like average results across multiple studies.

For example, dollar costs for various individual risks, and for the numbers of risks affecting individuals, vary from a few hundred to one or two thousand dollars per person affected per year, in healthcare costs alone. In general, the costs per risk added, when only the numbers of risks were counted, usually range in the one to a few hundred dollars each, though the addition of risks tends to increase total costs per person affected more when the numbers are above five or six than when only zero to three.

The vast majority of “risks” measured have been conditions or behaviors that increase the probability of a particular chronic disease, e.g. high blood pressure and cholesterol as risks for heart disease, stroke, etc. and high blood sugar as a risk for diabetes. Obesity is a risk factor for all these diseases, as well as for arthritis and other diseases. But as a growing number of health risk assessments focus on employee populations, vs. insured lives, and on labor costs and contributions, vs. just healthcare costs, a whole new set of “productivity impairment factors” and costs associated therewith are being measured.

Productivity impairment typically identifies conditions such as high stress, emotional disorders, lack of fitness, and obesity as impairment factors, not merely disease risks. And smoking, for example, as well as poor nutrition and lack of physical activity, are behaviors that are linked to reduced productivity. Smoking, for example, is linked to the immediate loss of work time as smokers take frequent smoke breaks away from their work station and often outside their workplace, entirely. Stress is also a major impairment factor, as are emotional disorders, such as depressed and anxious feelings (mostly undiagnosed and untreated).

The costs of individual risks or impairment factors are almost impossible to determine, because people almost always have more than one affecting them simultaneously, and only the total effect of all of them, on health care costs or productivity, can be calculated or estimated. For this reason, counting the costs or impairment across a population by the number of risks is helpful, since every individual has just one number of risks, so multiple counting of separate risks is avoided.

The impact of the number of risks on both expenses and productivity can be calculated quite easily, though these are often counted separately, with employers or insurers counting expenses, based on claims costs, and EHM providers estimating impairment, based on employee self-reporting. After all, employees would be very reluctant to report their impairment to their employer, lest they be penalized for it. By contrast, such reports are kept confidential relative to individuals, with only overall impairment totals and improvements gauged by providers.

One EHM provider that has reported the productivity impairment of over 200,000 employees in its database is HealthMedia® ,Inc. Ann Arbor, Michigan. It does not have the healthcare/disability/WC costs of these employees, however, so its data understate the total costs of the chronic diseases and risk conditions, as well as risk behaviors of those in its database. And while it reports the total impairment costs associated with individual diseases and risks, it also has reported the amount of impairment linked to specific numbers of each, avoiding double counting except among those who have both chronic conditions and other impairment factors.

Its most recent report notes that the productivity impairment linked to different numbers of the seven impairment conditions analyzed ranged from an average of 6.03% for the 14.01% of the population who had less than three risks, to 8.33% for the 26.47% with three, and 11.53% for the 59.53% with four or more. Across the seven chronic risk and disease conditions analyzed, impairment started at a low of 8.2% among those with no chronic condition (they would still have impairment factors, of course), then 10.19% for those with one, 12.4% for those with two, 12.10% for those with three, 17.95% for those with four, 19.95% for those with five, and 24.63% for those with six (though only 0.22% of those in the database, roughly 440 employees, had six).

This certainly suggests that chronic risk and disease conditions are more significant impairment factors for those who are affected, but with only a minority of employees having even one chronic condition, and an even smaller minority (6.25%) having three or more, the impact of the two kinds of impairment factors was far greater for numbers of health risks, since the entire population was included in that count. The total impairment for all employees based on their impairment factors was 9.66% for example, while that linked to chronic conditions alone was only 8.51%, when the effect was spread over the entire population, since only a minority had one or more. But the average impairment of those who had at least one condition was 11.73%, where the average for those who had at least one impairment factor was only 9.50%.

Individual risk factors varied widely in their individual “effects”, i.e. the amount of impairment reported by those who reported having them, along with any others they also had. Impairment due to coronary disease, asthma and diabetes were all in the 14-15% range, while high blood pressure and cholesterol, were 11-12%, and congestive heart failure was 20.71%. Those who were obese reported 11.3% impairment, while those extremely obese reported 16.35%. Smokers were 11.86% impaired, compared to non-smokers’ 9.35%. Those troubled by high stress “fairly often” reported impairment of 14.01%, while those troubled “very often” reported 19.74%.

Among workers who reported being troubled by depressed feelings “sometimes”, impairment was 13.63%; if “occasionally”, 17.99%; if most of the time 22.78%. Even those who did not answer this question, 7.82% of the population had impairment of 19.02%.Those who slept six hours per night or less had impairment of 12.03%, while those who slept nine or more hours, and those who failed to answer the question averaged 12.23%. Those with low nutrition scores ranted from 10.32% to 18.20% as their scores got worse, while those with less than recommended levels of physical activity ranted from as little as 6% to as much as 13.54%.

Because HealthMedia only reported the number of impairment factors across a range of zero to four+, there is no real way to determine how much the addition of a single risk factor added to the impairment linked to employees with different numbers. The impairment linked to number of factors did not topped the overall average impairment of the entire population of 9.56% until the number reached four, and while impairment most likely increased from there up to seven, if anyone had all seven, the only thing reported was that with four or more such factors, average impairment was 11.53%. In any case, the key to assessing the problems for investment decisions is which impairment factors or chronic conditions, once managed, yielded the greatest overall impact.

The sheer number of conditions and factors offers some insights for use in planning EHM investments. But it is the prevalence of particular conditions and factors, together with the predicted improvement potential of each, in terms of reduced healthcare, workers compensation, and disability expenses, plus improved productivity, which should guide investment decisions. Neither the number nor the type of risks is an accurate or reliable basis for fully understanding the problem or predicting potential gains, nor even the two together.

Tripling Up Clinical Trials

by Scott MacStravic

Scientific research into alternative treatments and new drugs are commonly “doubled up” by the combination of looking at two alternatives simultaneously, and by “blinding” both patients and providers as to which patients are getting which of the alternatives.

This serves to minimize bias due to the “placebo effect”. If patients and providers knew which patients were getting the real drug, both might be moved to perceive effects that are not there, or that are due to the “mind-body connection”, rather than the effects of the drug, per se. With “controls” getting placebos, the effect of “pure belief” in the efficacy of the drug would be uniform for all cases, and can be subtracted from the total effect of treatment to calculate the impact of the drug alone.

Comparisons of specific therapies that do not involve drugs are normally between the “usual treatment” and the specific therapy under study. These are more difficult to “double blind”, since the provider of the treatment will certainly know whether the patient is getting the usual treatment or the studied alternative. The patient may not know what the usual treatment is, of course, so that “placebo bias” may not be present, or a “sham” version of the therapy may be used as an actual placebo. It is often difficult to “fool” the patient, however, unless the “sham treatment” is perceived as the real thing.

But there are new reasons for adding a third option – “no treatment” to the usual vs. new therapy alternatives or drugs are being studied. For one thing, only the addition of “no treatment” will enable what is the equivalent of a placebo to treatment trials, since usual treatment involves a treatment rather than a placebo. And when comparing drugs, only the no-drug option will be totally devoid of the placebo effect, and provide the basis for learning whether either treatment is as cost-effective as “watchful waiting” for example. This should only be done when ethically acceptable, of course, and when patients are informed.

Moreover, since treatments often have negative side effects, only the no treatment option should be devoid of these, and permit a full and balanced comparison of the logical options. While placebo drugs should have no side effects, usual care may have some, and the net positive vs. negative effects of treatments should be compared to no treatment, where feasible and acceptable, to enable greater learning about what is the best option.

When no treatment is used, there should be no placebo effect for patients who get none. However, the total effects of both real and sham treatment should be included for comparison with no treatment, since the placebo effect is a real benefit to the patient, even if not due to a particular treatment, but to the patients’ belief in its efficacy. Subtracting the placebo effect would eliminate what may be a major portion of the actual benefits patients gain from being treated compared to not.

As we enter the era of “value-based medicine”, and “value-based” purchasing and payment thereof, it makes sense to look at the no treatment option in most cases where it is ethically permissible. Certainly consumers should know how proposed treatments differ in outcomes, including side effects, from both usual care and any new alternative, and so should providers. It is already far too common for providers to use or refer patients to the alternatives with which they are most familiar and comfortable, and perhaps the ones that generate volume and revenue for their practices, as well.

By including a third option of no treatment, and perhaps comparisons to complementary and alternative medicine (CAM) options as well, both consumers and providers, and hopefully payers as well, will have a more complete picture of the full range of options available. Since there are often multiple CAM alternatives as well as multiple options in traditional medicine, all options will probably not be included in any given trial, but multiple trials can cover all reasonable options, while comparing all to each other and the no treatment alternative to all.

For similar reasons, “triple blinding” such studies also makes sense. There has been too much evidence already that the sponsorship of a given study tends to bias the results reported by those who analyze the data. Only if those who perform the analysis are blind as to both which patients got the no treatment option, the usual care, or the alternative being studied, whether a drug or a particular therapy is involved, — and ideally as to who is sponsoring the study — will such bias likely be eliminated.

Bias may be as likely to arise from unconscious optimism or leanings on the part of analysts as from a deliberate attempt to “fudge the data”, but whether conscious or not, analyst bias should be eliminated as well as patient or provider bias. By combining triple options with triple blinding, though this may require higher expenditures for the studies affected, the reliability and validity of results would at least be improved or protected, and we would learn that much more from each study reported.

This might also promote far greater reporting of results that do not promote the interests of the study sponsors. If those who perform the study are separated from sponsors entirely, not only will bias potential be reduced, but we will all gain from the reporting of far more study results than seems to be the case today under current clinical trial methods, where sponsors control which and whether results are reported.

There is a fourth approach that would also add greatly to the public good in regard to clinical trials, of course. That would be the willingness of the media to avoid writing and publishing sensationalist and premature stories about the latest “wonder drug” or treatment. As was pointed out in two books, the first for medicine [SK Sarnoff Sanctified Snake Oil: The Effects of Junk Science on Public Policy Praeger 2001] and the second for CAM [RB Bausell Snake Oil Science: The Truth About Complementary and Alternative Medicine Oxford 2007], the “science” on drugs and treatments is often anything but.

The media tend to publish whatever medical care reports will interest the public, while either not understanding or not caring enough about the validity and reliability of the science behind it. But at least one journalist has recently taken a vow to report anything that is not based on: “… large, randomized, placebo-controlled, and double-blind clinical trials published in high-quality, peer-reviewed medical journals.” [J. Adler “A Big Dose of Skepticism” Newsweek Dec 1, 2007]

He reported being “shamed into” such a vow by reading the Bausell book that described the kind of statistical analysis that journalists should demand to see before writing their reports of findings. When compared to placebos, far too many treatments fail to offer any added benefit, and publishing stories about them, while promoting placebo effects, enables too many people to either make or pay money for useless treatments and nostrums. While this could go too far if popular media only published studies that meet scientific standards and journalists understand the science behind them, given the average statistical acumen of journalists, it could prevent a lot of “snake oil” from doing harm to and wasting money of consumers.

WHIT 3.0 Conference: Comments on Day Three

by Fred Fortin

Today, was the third and last day of the WHIT. 3.0 Conference in Washington, D.C.. It was the day that some of the heavy hitters of the technology industry — Tim Berners-Lee, Steve Case, and Adam Bosworth, came to give their take on health care and innovation.

The fast talking Berners-Lee (inventor of the world wide web) gave a short and speedy history of the thinking that led to the early development of the web, and a view into his current work on the semantic web. He tried to show the relevance of the semantic web for health care and broadly encouraged a “just do it” approach to identifying and building the necessary ontologies relevant to the health care system. Berners-Lee then cajoled his audience on everything from adhering to the “golden rule of one web” to giving all things their unique URI, to demanding data in RDF/SPARQL.

Steve Case (Co-Founder America Online (AOL) Chairman & CEO Revolution Health) gave his considered opinion on the state of the U.S. health care system, then proceeding then to make eight predictions:

  • Consumers are going to take control of health care big time;
  • Centralized approaches to controlling information in health care will breakdown with access becoming more open and distributed;
  • There will be less not more government regulation of health care because the pace of innovation will demand it;
  • There will be a torrent of innovation relevant to health care with the inevitable, but short term chaos, to follow;
  • There will be more emphasis on being healthy and taking more individual responsibility;
  • The personalization of health care will proceed with the development of consumer technology tools; and finally,
  • The “killer app” for health care is, and will be. . . (drum role) . . . “community”. Facebook, IM, Chat — social media, and the people aspect of health care technology — will be the key driver of any progress.

I was really looking forward to Adam Bosworth (Chief Executive Officer, Keas, Inc.; Former Vice President Google, Inc.) in order to get an idea of where he was heading with his new start-up company, Keas, Inc. But alas, unless we could read between the lines in his speech, he gave no clue even under direct questioning.

What he did deliver to the crowd was an eloquent and impassioned rant on just how broken the health care system is. This was probably old news to this audience, but one always likes to hear a good thrashing of the idiots, incompetents, and evil doers that victimize the hapless patient. While not very nuanced about what to do about the multiple catch-22s inherent in health care, it was a fine speech.

Bosworth did make several important points worth noting. He, like many others in the information technology industry, have a hard time empowering consumers as a result of privacy rules. Consumers need to gain control of their health care information. “Giving patients control over their own data is what we need to do,” says Bosworth emphatically. But the government denies us that ability. Government is “trading off the deaths of hundreds of thousands of people to prevent the exposure of very few” with these laws against ” possible and rare risks to privacy.”

Bosworth also wants a new health consumer bill or rights (No mention of President’s Clinton’s Patient Bill of Rights and Responsibilities circa 1998 — no matter) that will make sure consumers have access to their data electronically from all the players in health care. This is critically important if consumers are going to be able to use the information intelligently.

On another front, Bosworth wants to get physicians participating in online communities talking about health care. Most are fearful and reluctant to do so due to a host of good financial and legal reasons. He wants protections and financial reimbursements to promote this kind of critical exchange with consumers.

This years’ WHIT Conference was thick with energy, excitement and vision. People are starting to see future possibilities in how the health care system could change. You could hear consensus being built, and how innovative technology along with new business models, can strengthen the political will to take action. Grant Harrison (VP, Integrated Consumer Experience, Humana Inc.) in his presentation on learning what health means to people — “not a state but a skill” — said ” that when we say people are not engaged in their health it just means we don’t understand how they are engaged in their health. ” The path to that understanding is being blazed as we speak.

WHIT 3.0 Conference: Comments on Day Two

by Fred Fortin

The WHIT 3.0 conference in Washington, D.C. continues to steam along with some great presentations. I particularly liked David Lansky (Senior Director Health Program, Markle Foundation) and his work on the public interest when it comes personal health records (PHR). His thinking involves the creation of a “ecosystem” which is sympathetic to PHRs. Soon, he argues, we will have an ecosystem which sees three main actors: the 21st century consumer, global internet companies, such as Google and Microsoft, and traditional health care institutions. Three separate and clashing cultures now define these actors. You can envision the aggressive consumer, who wants fully what health 2.0 has to offer, tangling with global entities, unregulated and operating on a huge scale, and both of these confronting conservative, slow and paternalistic, traditional health care institutions. He offers some strategies that involve cooperation on data liquidity, building a national privacy and security framework, and evolving a PHR business model that makes PHRs available to all.

But the presentation that I’ve been trying to get my head around was trotted out by Roy Schoenberg (Chief Executive Officer, American Well Systems) and what they are doing in his shop. Roy boasts, — and I tend to think he’s really on to something — that he is developing the “killer app” in health care. His plan is to offer to consumers online access to health care — not just information — 24 hour, 7 days a week, 365 days a year. This ‘access on demand’ to doctors and specialist integrates a host of complex technologies, and unique relationships with health plans and providers to offer real time health care. It brings these services online to a convenient place (the home) where consumers can be comfortable and for less cost.

This is the very definition of a disruptive innovation.

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