Archive for Research
by Fred Fortin
January 18, 2008 at 12:31 pm · Filed under Uncategorized, Insurance, Industry Sector, Public Purchasers, Health Plan/Payer CEOs, Policy Makers, Business of Health, Medical Tourism, Retail healthcare, Electronic Medical Records, Research, Alternative Medicine
I don’t know if you’ve noticed but as we move into 2008 there’s a glut of papers, reports and predictions about what is going to happen in health care. Some have such a definitive tone, it makes you wonder if any have read Nassim Nicholas Taleb’s, The Black Swan, which engenders in the reader a humble appreciation and respect for role of high impact, improbable events in social affairs.
Anyway, I’ve taken the time to look through some of these pronouncements. Many are rehashes of the what I would call “more of the same” prognostications, others find us at various tipping points — unsustainability being a key concept here — in health care and forecast some, often vague, deep changes to come. Below are some of the bits and pieces of these various offerings of the future that caught my eye.
- Expect large institutions to make significant IT investments; RHIOs will still struggle with architecture and governance models; EMRs creep closer to reality, and health plans will continue to implement consumer-directed vendor partnerships. (Forrester)
- Doctors are using the Internet far more than their national averages, using email, obtaining professional information from online journals, attending courses and conferences, receiving professional updates and performing professional, administrative functions. . . In essence, in the short space of time that the Internet has been easily accessible through the Web, doctors have harnessed its power in both their personal and professional lives. All indications are that they will continue to do so. ( Masters)
- Two areas that are going to get a lot of play in the next year or two. There are a number of products in the telemedicine space that use IT not as a database or workflow tool, but as a telecommunication and management system, teleradiology is one prime example. The other is interoperable home-monitoring devices. There’s good value with keeping people out of nursing homes, and it’s getting a lot of attention right now from doctors, hospitals and health plans. (Brailer)
- Don’t see much of a business case for health 2.0 technologies, although personal health records as a concept has some validity, particularly as a service provided by health plans and employers. Still in a wait-and-see mode on PHRs. (Brailer)
- Medicare’s Hospital Insurance (HI) Trust Fund is already expected to pay out more in hospital benefits this year than it receives in taxes and other dedicated revenues. The growing annual deficit is projected to exhaust HI reserves in 2019. (Friedman)
- For the first time, a safe, effective and reversible hormonal male contraceptive appears to be within reach. Several formulations are expected to become commercially available within the near future. Men may soon have the options of a daily pill to be taken orally, a patch or gel to be applied to the skin, an injection given every three months or an implant placed under the skin every 12 months. (Schieszer)
- U.S. health care costs are growing at 8 percent per year, an unsustainable rate that will be forcing every employer to make a crossroads decision in the next 12 to 36 months: either continue to provide health care benefits to employees and become very aggressive about controlling expenses or exit the insurance market completely and let employees fend for themselves. (Deloite)
- Physician-hospital tensions will increase. Employer-health plan tensions will increase. The non-conventional provider movement (complementary and alternative medicine) will be pitted against the conventional. Off-shore resources will compete against high-cost domestics. The under-insureds will compete with employers for funding and services. Biologics developers will attempt to fend off traditional pharma to capture the high ground in diagnostics and therapeutics. Tension, anxiety, and turf battles for success will heat up, but so, too, will opportunities. (Deloite)
- In an environment where employers and consumers are demanding more for less, medical tourism, telemedicine, and other innovative disruptions offer attractive options for people who require expensive surgery and procedures but do not want to be limited by their health care insurance policies. (Deloite)
- Significant change is unlikely prior to 2010 and is apt to be gradual thereafter. Although urgency is still the operative word, the players involved have a healthy respect for the complexity of the problem and the runaway costs that will result if they get it wrong. Even if some changes emerge in the first year of the new administration, implementation would take at least a year. Bigger changes would probably follow, being phased in starting in 2011. (Booz Allen)
- A surge in the number of retail clinics will force states, payers, and policy makers to think about the right model for the delivery of primary care. (PWC)
- The market for individual health insurance could take off. (PWC)
- We envision the proliferation of “health infomediaries” (HIs) who help consumers navigate the insurance, channel and service options in care delivery. HIs will become a fixture in the landscape for both the well and the chronically ill, and for a much broader socioeconomic segment of the population. (IBM)
- The combination of the push for universal coverage, the erosion of employer-based insurance and the aging population is expected to drive this continued shift to individual and government-based coverage. (IBM)
by Scott MacStravic
January 9, 2008 at 10:03 am · Filed under Employer CEOs, Employee Health Management, Research, Health Management
It is highly likely that there is a “placebo effect” present in EHM interventions. They have been widely demonstrated in medical treatment and prescription drugs, where clinical trials consciously include the identification of the extent of this effect. There have even been studies that confirm the “nocebo” effect, where instead of patients’ belief in a given intervention, by itself, having a measurable positive effect on the patient’s condition, belief in a risk or side effect tends to have a negative impact, even when no real intervention is used.
Some of the placebo effect may be the optimism that seems to be hard-wired into our brains, as demonstrated by a study finding that students who were pessimistic about getting good grades were far less likely to do so than those who were optimistic, with no other scientific explanation for this effect. [S. Wang “Optimism Comes Standard in Humans” Wall. St. Journal Health Blog Nov 9, 2007] It has been more thoroughly and scientifically examined in a book by Esther Sternberg, M.D., Chief, Section on Neuro-Endocrine Immunology & Behavior, National Institute of Mental Health — The Balance Within: The Science Connecting Health and Emotions Freeman 2001, particularly her chapter “Can Belief Make You Well?”.
Doctors have readily admitted to taking advantage of the placebo effect in treating their patients for ills, with 45% of respondents to a recent survey saying they had done so during their clinical practice. [J. Steenhuysen “Doctors Say Placebo Use Common” Yahoo! News Jan 3, 2008 (news.yahoo.com)] The fact that placebos are generally known to work, while having no negative effects, can make them preferable to medications with known such effects.
Whenever treatments or medications are used in employee health management (EHM), or in managing the health of other populations for that matter (PHM), it seems likely that the placebo effect will be part of any measured impact health management interventions have on participants therein. In a recent study by Harvard psychologist Ellen Langer, hotel maids, who spend the majority of their days engaged in pushing equipment around, making beds, and other physical activity, were told that their work activity already exceeded the Surgeon General’s definition of an active lifestyle.
This was news to the majority of maids so informed, among whom 67% had reported themselves as “not exercising”. Half of the maids in the study were given the information about their current activity already meeting exercise standards, while half were not told, as “controls”. Among those told, there was a measured 10% drop in blood pressure, as well as reduced weight and waist/hip ratio. And there had been no indication that the maids had altered their routine in any way. Apparently, merely believing that their “exercise” would enable them to be healthier made it so. [A. Spiegel “Hotel Maids Challenge the Placebo Effect” National Public Radio Jan 4, 2008]
There is a much older demonstration of an equivalent placebo effect in a 1927 study of improving the lighting where workers performed at the Hawthorne Works of Western Electric Co. in Cicero, Illinois. IT found that “controls” improved their performance, despite having no changes at all made in their working conditions, as well as the “intervention group” improving theirs. This has been labeled the “Hawthorne Effect” and is normally analyzed in scientific, controlled studies of management interventions.
It is rare for any employer or even insurer to include controls in their studies of the effectiveness of EHM or PHM, but if participants in a given intervention know about the study, there may be some. It has never been clear precisely what causes the Hawthorne Effect. It may have been, for example, that workers were unconsciously or consciously affected by the fact that their performance was being measured, fearing that they might look bad if they did not make extra effort. Or merely knowing that their employer was doing something to improve rather than ignore their working conditions might have given them a more positive feeling about their employer, and caused an improvement in effort as a result.
Both such effects may well be present in EHM, where employees may have either or both reactions and responses to the measurement of their performance and their employers’ sponsorship of an effort to improve their health. It seems less likely to apply to insurer-sponsored PHM aimed at reducing healthcare use, since that is likely to be seen as self-serving for the insurer by participants, but I know of no studies investigating such an effect.
The amount of measured placebo effect is traditionally used to discount the effects of therapies and medications on patients in sickness care. If the placebo control group has a 43% improvement in some clinical measure, while the actual treatment group has a 75% improvement, the treatment is deemed to be responsible for only 75 minus 43 = 32% of the effect.
In EHM, however, where the effect is more likely, it makes sense to gladly accept the placebo effect as a positive and economically beneficial part of the intervention, especially since “controls” can rarely be given a true placebo, except in such cases as nicotine replacement therapy, where a placebo may help smokers quit, as well as the drug used. Rather, the placebo or Hawthorne effect, whichever applies, is a genuine part of the effect of the intervention in its broader sense.
Of course, the employer may choose to partially discount the results achieved by the EHM provider it hires for the job, if there are indications that a placebo/Hawthorne effect is present, since it is the employer, rather than the supplier that may be responsible for at least part of this effect, as sponsor of vs. provider of the intervention. There are also likely to be added effects caused by employees knowing about their health risks, even if they enroll in no intervention aimed at reducing them.
The HRA (health risk assessment) performed on most employees includes feedback to each who completes it, which may cause effects on its own, for employees (plus) dependents/retirees who get recommendations for improving their health, without any program participation. The data are unclear on this effect, with some studies indicating that HRA participants, by that act alone, have lower medical care costs than non-participants, while others indicate that HRA participants that do not follow up this act by engaging in an EHM intervention, end up with higher risks and lower productivity.
In any case, the placebo/Hawthorne/information effects in EHM can be readily identified by comparing those who do not participate in the HRA or an EHM intervention against those who do, on before vs. after healthcare, workers compensation, disability, and productivity impairment costs, compared to those who take the HRA but no intervention, and to those who take the intervention as well as the HRA.
This will enable identifying the probable inclusion of such effects in the results found, though the HRA and EHM participation effects can logically be accepted as true results of the intervention. And the economic benefits of such efforts are usually so much more than the costs thereof, that the credit can easily be shared between both the employer and the HRA plus EHM suppliers, where they are different.
by Scott MacStravic
December 14, 2007 at 2:46 pm · Filed under Insurance, Employer CEOs, Disease Management, Research, Health Management
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.
by Scott MacStravic
December 12, 2007 at 4:41 pm · Filed under Pharma, Value-based health care, Research
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.
by Nick Jacobs
December 6, 2007 at 9:40 am · Filed under Research
Before you hit exit without finishing this, let me ask you for your patience and petition you not to stop.
I’m at our eighth annual offsite with the United States Army for the Clinical Breast Care Project, in Gettysburg, PA. I’ll spare you the “Four score and seven years ago . . .” line because our scientists are speaking right now about fluidic stations, single nucleotide polymorphism, laser capture micro dissection, proteomics and genomics.
Don’t be confused by these terms. Really, hybridization, SNP files, chromosome locations, RNA integrity, gene expression arrays and all of the other scientific terms being thrown around here all relate to our breast cancer research. It reminds me of conversations I hear in physician meetings sometimes when the level of jargon reaches its highest peak. They often are not perceived to be speaking English. In fact, I just saw a study that revealed that speaking Japanese backwards sounds the same as speaking Dutch backwards. Who would have ever guessed?
I’m convinced that the average IQ in this room is somewhere above the minimum MENSA requirements and the maximum allowable human requirements. Admittedly, one of my greatest challenges today has been that of staying focused. You see, I tend to be a multi-tasking kind of guy and, consequently, I sometimes miss the current point of the speakers most recent comments . . . “High resolution scans are all dependent upon the selection and interrogation of the peptides.” Got that? “You’re going to need at least 200,000 cells for analysis.”
Seriously, we are learning about the progress made by our scientists this year in the somewhat public forum: the number of papers selected, posters picked, speeches made or to be made. My dream is to come here and hear about the number of people that we actually helped or cured as a result of our work, but patience is a virtue. We did hear today that going to the moon was simple compared to finding the source and possible eradication of breast cancers. Yeah, engineers vs. scientists?
We have been very careful to continue to inform everyone of the necessity to co-operate, share data and move forward with all of the different sites represented here. We have been very careful to explain over and over again that our work is progressing, our research is being consumed by other scientists, our findings are being shared.
One of the most rewarding presentations happened at the end of today’s sessions where a panel of our researchers spoke individually and collectively to the crowd: a clinical nurse, two biomedical informatics specialists, a proteomic scientist and a genomic scientist, it was a virtual ensemble, my dream, a multidisciplinary approach to translational medicine.
Unfortunately, we didn’t find any cures this year, but many of us are holding securely onto our dreams convinced that our day will come. This multidisciplinary approach is new, is bold and will work. We all need to keep sharing.
[Intended for publication several weeks ago.]
by Scott MacStravic
November 29, 2007 at 2:14 pm · Filed under Policy Makers, Research, Alternative Medicine
The “placebo effect”– i.e. the extent to which a person’s belief in the efficacy of a substance or therapy influences both the physiological and psychological effects thereof – is mainly familiar because of its use in clinical trials. Rigorous science often requires triple-blind studies, where the patients receiving treatment, the providers giving it, and the analysts evaluating it are not “biased” by knowledge of whether or not the treatment is a placebo, i.e. inert substance or sham treatment.
But there have been increasing arguments against thinking of the placebo effect as merely a “false” result. It clearly demonstrates the “mind-body” effect, i.e. the ability of the mind to influence the body’s responses, which accounts for both the negative and positive effects of stress, as well as the positive placebo and negative “nocebo” effects of treatment (where belief that the treatment will do harm produces harm even when the treatment is inert).
Many have argued that the placebo effect, and the nocebo effect for that matter, are both reflections of “enlisting the mind” in the pursuit of healing. Given the ability of this effect to add to as well as detract from the effects of substances and therapies, the effect, when positive, should include the total mind-body response to either, rather than discounting the effect as merely “humoring” patients into believing they are getting treatment when they really need none.
Since the placebo effect is often as much as or even above 50% of patient response noted, the acceptance or rejection of the effect can make a huge difference to the measured efficacy of a given treatment. In a recent book on the positive as well as negative effects of the mind on the body, its author made a strong case for recognizing the importance and value of the mind-body connection, which has been demonstrated in terms of objective physiological responses through the hypothalamus-pituitary-adrenal glands connection. [E. Sternberg The Balance Within: The Science Connecting Health and Emotions W.H. Freeman 2001]
The placebo effect seems to be particularly strong with respect to pain perceptions by people being treated – with almost anything. Since pain is primarily a subjective perception, rather than an objective metric, people who believe in the efficacy of a drug, herb, or therapy often report as much relief from the placebo as from what is supposed to be an “active” intervention. Sham acupuncture has yielded as much pain reduction as the real thing, for example.
The trouble is that the placebo effect can also be the foundation for immense profits by manufacturers and retailers of substances, and providers of therapies, that have no physiological effects at all, that may be dangerous to patients in either or both of two serious ways. They may cause damage, by being inherently inimical to health – or they may prevent or delay people from seeking and getting truly effective alternatives. They may even cause people to avoid or negatively affect what are proven treatments if people “tar them with the same brush” because of their similarity to unproven or proven-to-be-useless/harmful alternatives.
The general system of homeopathy, for example, has been under attack in the U.K. [B. Goldacre “The End of Homeopathy?” The Guardian Nov 16, 2007 (www.badscience.net)] People still swear by its remedies, because they say homeopathic pills make them feel better. But what if the entire impact of homeopathic medicine is “in the mind”, i.e. the placebo effect? A review of 110 homeopathic and 110 matched conventional medicine trials were compared, with both finding that smaller and lower-quality trials tended to find more benefit than did larger and higher quality, but the overall findings were compatible with the notion that homeopathic clinical effects were due to the placebo effect. [A. Shang, et al. “Are the Clinical Effects of Homeopathy Placebo Effects? The Lancet 366 2005 726-732]
In a recent series of stories, the major newspaper where I live describes a wide range of medical devices being manufactured, sold, and used as “energy” treatments. These machines relied on light, radio, electricity, or electromagnetic forces to “cure” diseases as serious as cancer. While such forces have been proven to have positive effects in a number of medical applications, the machines described in the reports had no demonstrable physiological effect, and certainly did not eliminate the conditions that their users claimed would be cured by them.
In most cases, these devices were used by untrained laypersons, though some physicians, chiropractors, and other health professionals, and at least one hospital also used them. [C. Willmsen & M. Berens “Miracle Machines: The 21st Century Snake Oil” Seattle Times Nov 18, 2007 A1, A10-13; “Public Never Warned About Dangerous Devices” Nov 19, 2007 A1, A8; and “A Patient’s Plea: Please God, No More” Nov 20, 2007 A1, A10] One example involved drawing a patient’s blood, treating it with “photo luminescence” light waves (ultraviolet light), then injecting the treated blood back into the patient. Infections at the injection site occurred, but cures did not. The provider was arrested for practicing medicine without a license, while the patient died the day after treatment. While claiming to be a naturopathic physician, the provider had no training, merely a degree from an unaccredited “diploma mill”.
Another device claimed to cure AIDS, cancer, and other life-threatening conditions with electromagnetic waves, and was being used in five states, including Washington, despite the foundation for its efficacy that “…goes beyond human knowledge” according to its inventor. It got around FDA regulations by claiming it was only being used in “clinical trials”, though providers profited from its use, which was not allowed in such trials. Machines had been sold to physicians, chiropractors, acupuncturists , naturopaths, and massage therapists, as well as people with no training at all, and used for desperately ill patients who feared or had already experiences severe side effects from conventional treatment of cancer, heart disease, ulcers, etc.
An out-of-work former mathematics instructor built a radiofrequency wave machine claimed to diagnose and treat everything from allergies to cancer, was forced by the FDA to leave the US, and now operates from Hungary. He has apparently sold over 10,000 of his devices in the U.S. alone. The idea of electric, light, sound, radio and microwaves being used to treat disease is over 100 years old, and has many proven applications, but probably far more unproven ones, with many dangerous, such as the use of electricity or electromagnetic waves in patients with implanted pacemakers, or simply dangerous machines.
Thanks to the placebo effect, almost any machine, nostrum, herb, or therapy may easily find dozens, hundreds, even thousands of patients who report being cured, or at least having pain diminished or disappeared. And these can be powerful testimonials in media advertising or word-of-mouth, viral and “buzz” marketing. Moreover, the placebo effects are real in many cases, though rarely as reliable or complete as truly efficacious alternatives. And given the profit motive, that can drive both professional clinicians and laypeople to purchase and use such machines, as well as sell them to patients, there are strong financial motivations, as well as gullibility that can drive widespread use.
Americans have not only the most expensive healthcare system in the world, but one of the most promising for quacks and charlatans, as well as misguided, well-meaning practitioners and marketers. The FDA has been criticized for years, charged with inadequate and biased regulation of medical treatments and prescription drugs. It has done far worse in the case of unproven (even as to causing harm) alternatives to these, and thousands of people suffer as a result.
At a minimum people who rely on the placebo effect alone are wasting their money where it could be better spent elsewhere, and at worst, they are delaying or avoiding proven alternatives, and dying as a result. The placebo effect is certainly valuable for those who experience it, but when there are alternatives with proven records for positive clinical effect as well, it a dangerous basis for patient choice, and an inadequate basis for generating profits.
by Nick Jacobs
November 28, 2007 at 2:19 pm · Filed under Policy Makers, International Best Practices, Research
According to Reuters today, Iceland overtook Norway as the world’s most desirable country in which to live in the world. Based upon an index blending figures relating to life expectancy, educational levels and real per capita income, the world’s countries were rated. Rich free-market countries dominate the top places, with Iceland, Norway, Australia, Canada and Ireland the first five, but the United States slipping to 12th place from eighth last year in the U.N. Human Development Index. The U.S. scores high on real per capita GDP, which at nearly $42,000 was second only to Luxembourg at a little over $60,000.
Here are a few statistics for your consideration . . .
We have 98,000 unnecessary deaths in our health system from medical errors each year, and we spend $10 a day more on average to imprison someone in the United States than we do for long term care.
Under the category “If I had known that I would live this long, I would have taken better care of myself” . . . If you are a 50 year old woman today, there is a 40% chance that you will live to be 100 years old. If you count all of the people in the history of the world who have ever reached 65 years of age, 65%of them are alive today. In 2012 five years from now, there will be more people in the United States as Social Security beneficiaries than there are working Americans to support them.
If you are a child today, there is a 30% chance that you will develop Type II diabetes. One third of all children today will be afflicted with Type II diabetes and the devastating impact of that disease.
Keep in mind that at least 30% of every health care dollar that is spent in the United States is spent on the last 30 days of life.
It’s also important to reflect on the fact that in 1993, 13.8% of the Gross Domestic Product was dedicated to health care, and by 2015, 20% of the United States GDP will be dedicated to health care. This year we spent $2.2 Trillion on health care and only 4% of that on preventative medicine.
We have 47 M uninsured and 43 M under insured citizens in the United States, and I’m not sure if that includes our illegal aliens.
Okay, how about passing this information on to our presidential candidates for their consideration because, my friends, it’s all about leadership, leadership at all levels.
by Scott MacStravic
September 26, 2007 at 10:50 pm · Filed under Hospital and Health System CEOs, Sickness care, Treatments and Therapies, Research, Alternative Medicine
It has often struck me as a writer, that once I initiate research into a given subject, complementary and alternative medicine (CAM) most recently (see my posting of Sep 24), I almost always run into a new story on that subject, often in a matter of days. This time it was: C. Johnson “Study: Acupuncture Works for Back Pain”, Washington Post Sep 24, 2007.
The article is an example of both scientific and economic reasons to consider at least the specific CAM treatment involved, namely acupuncture. Analysis by German researchers indicated that acupuncture works significantly better than conventional medications and other traditional Western treatments. Over 1100 patients were randomly assigned to 1) acupuncture; 2) sham acupuncture, or 3) conventional therapy. In the acupuncture group, 47% of patients improved, compared to only 27% in the conventional group.
One of the particularly interesting findings from this study was that sham acupuncture, i.e. where the treatment is “faked” by not inserting the needles as deeply as acupuncture requires, achieved almost as good results as the real thing, with 44% of patients getting the sham version improved. While Dr. James Young of Rush University Medical Center, who was involved in the research, says that we don’t know precisely why acupuncture works, and often treats his own patients that way, it is clear that it does work.
When dealing with pain, the patient often wills improvement, by believing there will be an effect, or where the sham treatment creates such a belief. This “placebo effect” is particularly strong in pain management, and if it occurs with sham treatment, it makes sense to use it as well. Apparently, in this research, at least, the conventional medical treatment did not produce nearly as great a placebo effect, or else its objective medical effect was so low that even with its placebo effect, improvement was still significantly less than for either sham or true acupuncture.
Dr. Heinz Endres of Ruhr University Bochum, in Bochum, Germany, reported in an e-mail that “patients experiences not only reduced pain intensity, but also reported improvements in the disability that often results from back pain, and therefore in their quality of life.” He noted that these findings are in line with a theory that pain signals to the brain can be blocked by competing stimuli, such as the needles used in both forms of acupuncture.
It could be, as Dr. Brian Berman at the University of Maryland’s center for complementary medicine suggested, that acupuncture changes the way the brain processes pain signals, or by releasing natural painkillers in the body. If this is the case, then there is a logical physiological, as well as psychological reason for the reported success.
The “conventional” treatment includes traditional prescription painkillers, injections, physical therapy, massage, heat therapy, or other treatments, with all patients in the study receiving about ten sessions lasting a half-hour each. Many include both massage and heat therapy in the CAM category, so even when these were included, the acupuncture as a specific therapy appears to work better, though no results specific to these therapies alone were reported.
Because CAM is such a “loose” category of solutions, and because there are so many different specific therapies and therapists that may offer and deliver treatments, this finding cannot be seen as proof that CAM, in general, works – either this treatment for all problems and all patients, or even for all patients with this problem. As has been demonstrated many times already, people’s genetic differences often create vastly different levels and types of response to traditional medications and treatments, so it should not be a surprise if the same is true for CAM in general, and for acupuncture treatment of back pain in particular.
Of course, to employers or insurers who are looking for the best and least expensive way to manage workers’ or covered members’ back pain, these findings may provide both a scientific and an economic reason to not only accept acupuncture for back pain, but even to recommend it over conventional treatment. In the spirit of competition, we should look forward to seeing conventional medicine fight back, perhaps by identifying one particular treatment that does better than acupuncture did in this case. The more we have rigorous science applied to questions of what works, as contrasted to the sophistry of both politics and the market, the better we will all be in the long run.
by Scott MacStravic
September 20, 2007 at 8:52 am · Filed under Employer CEOs, Disease Management, Research, Health Management
A recent article described an innovative approach to speeding innovation and sharing results of research more widely among people and organizations in the medical treatment business. [A. Marcus “Sharing Ideas Advance Cancer Research?” Wall Street Journal Sep 18, 2007, sub required] One effort involved the development of programs that offer million-dollar awards for the best ideas in cancer treatment, regardless of whether there have even been clinical trials. The intent is to promote the sharing of such ideas across researchers, rather than jealously guard them through the research, clinical testing and patenting period, merely in order to protect their economic value and publications potential for “publish or perish” faculty.
The other idea is being practiced by Oncology, a cancer journal, which is aimed at overcoming a long-established practice of researchers who fail never sharing that information with anyone. While it is perhaps understandable that researchers are reluctant to share such information, it can help others. For one thing, it can prevent others from duplicating efforts on treatments that don’t work. And for another, the basic concept in a treatment that failed may still be worth testing in some other way.
The reticence of organizations to share information about what they have found that does or does not work, or ideas that merely might work, is at least as common in the health management (HM) arena as it is in sickness treatment. And while we are constantly bombarded with studies by the federal government or university faculty showing that HM, or more often DM (disease management) does not work consistently, what we don’t know is precisely how successful and unsuccessful HM or DM providers went about shooting for success.
I have hundreds of articles in my files, for example, recounting the successes of particular HM and DM providers, clients, and organizations that do it themselves, often with what look to be exaggerated success. The exaggerations often arise from failure to account for regression to the mean and self-selection bias effects, but given the tendency for people to share good news much more than they share bad, the bias in published studies toward success is enormous.
While it is always easier for causes related to finding successful treatment for disease, particularly deadly ones, to raise money, there are good reasons for governments, large businesses, and private foundations to emulate examples such as the Value Investors Club, the Gotham Prize for Cancer Research, and Prize4Life by promoting the sharing of HM and DM “treatments”. Whether they work or not, the information would be valuable. Knowing that DM methods as a whole have yielded widely varying results is of little use, unless we also know how those with good results as well as those with bad went about it.
Were the problems related to the disease, for example, since DM programs aimed at congestive heart failure and diabetes often seem to save money, while those aimed at asthma and depression may not. One thing we do know is that programs aimed at employee populations can yield far greater savings, simply because the costs of health-related worker absence and presenteeism are usually much greater than healthcare costs alone, so savings from employee health improvement are far greater. [“Presenteeism Dwarfs Absenteeism as Cause of Employee Productivity Loss” HealthMedia.com Sep 17, 2007]
Moreover, there are surely a lot of people out there who have some ideas about how to make HM and DM more effective, but lack a forum for sharing the ideas or testing them in practice. I, myself, recently figured out a way to determine the participation rates needed for any particular return-on-investment (ROI) amount or ratio, but since I am retired, I have no way of testing it in practice, except with hypothetical numbers. HM and DM providers, once clearly separated, are becoming closer if not totally overlapped, as the market for proactive approaches to reducing the healthcare cost crisis expands dramatically.
The models that are emerging to promote sharing of information on HM and DM will clearly face the same hurdles as prevail in the search for sickness cures. But the value of earlier and more widespread sharing of information, insights and ideas about HM and DM could ultimately have far more value. The sooner we master the art and science of changing consumers’ health behaviors, and thereby reducing the incidence, prevalence and treatment costs of sickness, the better off all of us will be, with the possible exception of those dependent on sickness for their livelihoods.
by Nick Jacobs
September 17, 2007 at 4:59 pm · Filed under Insurance, Hospital and Health System CEOs, Business of Health, Research
Follow this scenario: a very well-trained, talented, experienced surgeon goes to the OR for a relatively straight forward surgery. The surgery goes very well except that, unbeknownst to the surgeon, he has inadvertently and unknowingly nicked another organ with his surgical tools. This of course results in a problem for the patient who, as soon as it is apparent, returns to have the problem corrected.
Two months later the medical records are collected by the law firm that will surely pursue a lawsuit, a lawsuit that, although the patient was inconvenienced, did not result in permanent damage or death. In this case the surgeon was totally committed to the patient and his family. He had done everything possible to ensure that the patient’s care was appropriate, but, as a human being from the planet earth, he has proven that, like the rest of us, perfection 100% of the time is not normal.
Was the patient wronged? Yes, of course he was. Was the patient and his family inconvenienced? Yes. Was it a malicious act of incompetence? No, it was not. Was it a stupid mistake that resulted from negligence, not really. It was just, as Forrest Gump once said, that “S - - - happens.”
I’ve mentioned in another post that, 15 years ago, as an assistant administrator, I had once done a personal investigation of a law suit over a carpal tunnel surgery that had not gone well. What I found was that, in the world of probability and statistics, if a surgeon performs 1000 of these surgeries, he or she is bound to have a problem at least once, and our physician had performed 995+ surgeries when this situation arose.
What is the answer? The prudent person rule used to be the guiding principle for every questionable situation that we faced. Did the person in charge do everything that was normal in that situation, everything that a prudent person could or would do? If the answer was, yes, then the verdict was “not guilty.”
Liability insurance is eating us alive in this profession, and attorneys and physicians have to make a living, but, is there not a better way to resolve these issues? In the past 10 years, we have spent over ten million dollars on liability insurance and have paid out such a low amount over those years that insurance companies actually compete for our business.
We attribute our low numbers of law suits to treating our patients with complete dignity, by being transparent, and by closely monitoring and helping our physicians to be the best that they can be. Unfortunately, we all face the reality of “sue happy” patients and attorneys every day.
My point? Can’t the prudent person rule once again become the norm as opposed to the exception? We always hear that health care in the United States is not competitive. Have we done the math on how much of those costs are generated from the lawsuits and insurances to protect us from the potential oblivion caused by those law suits? Now, that would be an interesting analysis.
Next entries »
