A Little Knowledge is a Dangerous Thing

An article entitled “A Comprehensive Care Management Program to Prevent Chronic Obstructive Pulmonary Disease Hospitalizations: A Randomized, Controlled Trial” from the VA cooperative studies program was recently published in the Annals of Internal Medicine (1).  This article describes the BREATH trial mentioned in a previous editorial (2). BREATH was a randomized, controlled, multi-center trial performed at 20 VA medical centers comparing an educational comprehensive care management program to guideline-based usual care for patients with chronic obstructive pulmonary disease (COPD). The intervention included COPD education during 4 individual and 1 group sessions, an action plan for identification and treatment of exacerbations, and scheduled proactive telephone calls for case management. After enrolling 426 (44%) of the planned total of 960 the trial was stopped because there were 28 deaths from all causes in the intervention group versus 10 in the usual care group (hazard ratio, 3.00; 95% CI, 1.46 to 6.17; p = 0.002). Deaths due to COPD accounted for the largest difference (10 deaths in the intervention group versus 3 in usual care; hazard ratio, 3.60; 95% CI, 0.99 to 13.08). This trial led us to perform a meta-analysis of educational interventions in COPD (3). In this meta-analysis of 2476 subjects we found no difference in mortality between intervention and usual care groups and that the recent Annals study was heterogenous compared to the other studies.

Should the recent VA study have been stopped early? Several reports demonstrate that studies stopped early usually overestimate treatment effects (4-7). Some have even suggested that stopping trials early is unethical (7). A number of articles suggest that trials should only be stopped if predetermined statistical parameters are exceeded, with the p value for stopping set at a very low level (4-7).  There was no planned interim analysis for any outcome in the recent VA trial. The rationale for stopping a study for an adverse effect when there is no a priori reasonable link between the intervention and the adverse effect is missing in this instance.  It seems unlikely that education would actually lead to increased deaths in COPD patients.  Any effect should logically have impacted the COPD related mortality, yet there was no significant increase for COPD related deaths in the intervention group. An accompanying editorial by Stuart Pocock makes most of these points and suggests that chance was the most likely cause of the excess deaths (8).

The VA Coop Trials coordinating center told the investigators that the reason for stopping the trial was that there were “significant adverse events” in the intervention group. Inquires regarding what adverse events went unanswered. This would seem to be a breakdown in VA research oversight. The information provided to both investigators and research subjects was incomplete and would seem to be a violation of the informed consent, which states the subject would be notified of any new information that significantly altered their risk.

Lastly, investigators were repeatedly warned by the VA coordinating center that “all communications with the media should occur through your facility Public Affairs office”. It seems very unlikely that personnel in any public affairs office have sufficient research training to answer any medical, statistical or ethical inquiries into the conduct of this study.

In our meta-analysis we have shown that self-management education is associated with a reduction in hospital admissions with no indication for detrimental effects in other outcome parameters. This would seem sufficient to justify a recommendation of self-management education in COPD. However, due to variability in interventions, study populations, follow-up time, and outcome measures, data are still insufficient to formulate clear recommendations regarding the form and content of self-management education programs in COPD.

Richard A. Robbins, M.D.*

Editor, Southwest Journal of Pulmonary

   and Critical Care

References

1. Fan VS, Gaziano JM, Lew R, et al. A comprehensive care management program to prevent chronic obstructive pulmonary disease hospitalizations: a randomized, controlled trial. Ann Intern Med 2012;156:673-683.
2. Robbins RA. COPD, COOP and BREATH at the VA. Southwest J Pulm Crit Care 2011;2:27-28.
3. Hurley J, Gerkin R, Fahy B, Robbins RA. Meta-analysis of self-management education for patients with chronic obstructive pulmonary disease. Southwest J Pulm Crit Care 2012;4:?-?.
4. Pocock SJ, Hughes MD. Practical problems in interim analyses, with particular regard to estimation.Control Clin Trials 1989;10:209S-221S.
5. Montori VM, Devereaux PJ, Adhikari NK, et al. Randomized trials stopped early for benefit: a systematic review. JAMA 2005;294:2203-9.
6. Bassler D, Briel M, Montori VM, et al. Stopping randomized trials early for benefit and estimation of treatment effects: systematic review and meta-regression analysis. JAMA 2010;303:1180-7.
7. Mueller PS, Montori VM, Bassler D, Koenig BA, Guyatt GH. Ethical issues in stopping randomized trials early because of apparent benefit. Ann Intern Med. 2007;146:878-81.
8. Pocock SJ. Ethical dilemmas and malfunctions in clinical trials research. Ann Intern Med 2012;156:746-747.

*Dr. Robbins was an investigator and one of the co-authors of the Annals of Internal Medicine manuscript (reference #1).

Reference as: Robbins RA. A little knowledge is a dangerous thing. Southwest J Pulm Crit Care 2012;4:203-4. (Click here for a PDF version of the editorial) 

VA Administrators Gaming the System

On 4-23-12 the Department of Veterans Affairs (VA) Office of Inspector General (OIG) issued a report of the accuracy of the Veterans Healthcare Administration (VHA) wait times for mental health services. The report found that “VHA does not have a reliable and accurate method of determining whether they are providing patients timely access to mental health care services. VHA did not provide first-time patients with timely mental health evaluations and existing patients often waited more than 14 days past their desired date of care for their treatment appointment. As a result, performance measures used to report patient’s access to mental health care do not depict the true picture of a patient’s waiting time to see a mental health provider.” (1). The OIG made several recommendations and the VA administration quickly concurred with these recommendations. Only four days earlier the VA announced plans to hire 1900 new mental health staff (2).

This sounded familiar and so a quick search on the internet revealed that about a year ago the United States Court of Appeals for the Ninth Circuit issued a scathing ruling saying that the VA had failed to provide adequate mental health services to Veterans (3). A quick review of the Office of Inspector General’s website revealed multiple instances of similar findings dating back to at least 2002 (4-7). In each instance, unreliable data regarding wait times was cited, VA administration agreed, and no or inadequate action was taken.

Inadequate Numbers of Providers

One of the problems is that inadequate numbers of clinical physicians and nurses are employed by the VA to care for the patients. In his “Prescription for Change”, Dr. Ken Kizer, then VA Undersecretary for Health, made bold changes to the VA system in the mid 1990’s (8). Kizer cut the numbers of hospitals but also the numbers of clinicians while the numbers of patients increased (9). The result was a marked drop in the number of physicians and nurses per VA enrollee (Figure 1).

Figure 1. Nurses (squares) and physicians (diamonds) per 1000 VA enrollees for selected years (10,11).

This data is consistent with a 2011 VA survey that asked VA mental health professionals whether their medical center had adequate mental health staff to meet current veteran demands for care; 71 percent responded no. According to the OIG, VHA’s greatest challenge has been to hire psychiatrists (1). Three of the four sites visited by the OIG had vacant psychiatry positions. One site was trying to replace three psychiatrists who left in the past year. This despite psychiatrists being one of the lowest paid of the medical specialties (12). The VA already has about 1,500 vacancies in mental-health specialties. This prompted Sen. Patty Murray, Chairman of the Senate Committee on Veterans Affairs to ask about the new positions, "How are you going to ensure that 1,600 positions ... don't become 1,600 vacancies?" (13).

Administrative Bonuses

A second problem not identified by the OIG is administrative bonuses. Since 1996, wait times have been one of the hospital administrators’ performance measures on which administrative bonuses are based. According to the OIG these numbers are unreliable and frequently “gamed” (1,4-7). This includes directions from VA supervisors to enter incorrect data shortening wait times (4-7).

At a hearing before the Senate Committee on Veterans' Affairs Linda Halliday from the VA OIG said "They need a culture change. They need to hold facility directors accountable for integrity of the data." (13). VA "greatly distorted" the waiting time for appointments, Halliday said, enabling the department to claim that 95 percent of first-time patients received an evaluation within 14 days when, in reality, fewer than half were seen in that time. Nicholas Tolentino, a former mental-health administrative officer at the VA Medical Center in Manchester, N.H., told the committee that managers pressed the staff to see as many veterans as possible while providing the most minimal services possible. "Ultimately, I could not continue to work at a facility where the well-being of our patients seemed secondary to making the numbers look good," he said.

Although falsifying wait times has been known for years, there has been inadequate action to correct the practice according to the VA OIG. Sen. Murray said the findings show a "rampant gaming of the system." (13). This should not be surprising. Clerical personnel who file the data have their evaluations, and in many cases pay, determined by supervisors who financially benefit from a report of shorter wait times. There appears no apparent penalty for filing falsified data. If penalties did exist, it seems likely that the clerks or clinicians would be the ones to shoulder the blame.

The Current System is Ineffective

A repeated pattern of the OIG being called to look at wait times, stating they are false, making recommendations, the VA concurring, and nothing being done has been going on for years (1, 3-7). Based on these previous experiences, the VA will likely be unable to hire the numbers of clinicians needed and wait times will continue to be unacceptably long but will be “gamed” to “make the numbers look good”. Pressure will be placed on the remaining clinicians to do more with less. Some will become frustrated and leave the VA. The administrators will continue to receive bonuses for inaccurate short wait times. If past events hold true, in 2-5 years another VA OIG report will be requested. It will restate that the VA falsified the wait times. This will be followed by a brief outcry, but nothing will be done.

The VA OIG apparently has no real power and the VA administrators have no real oversight. The VA OIG continues to make recommendations regarding additional administrative oversight which smacks of putting the fox in charge of the hen house. Furthermore, the ever increasing numbers of administrators likely rob the clinical resources necessary to care for the patients. Decreased clinical expenses have been shown to increase standardized mortality rates, in other words, hiring more administrators at the expense of clinicians likely contributes to excess deaths (14). Although this might seem obvious, when the decrease of physicians and nurses in the VA began in the mid 1990’s there seemed little questioning that the reduction was an “improvement” in care.

Traditional measures such as mortality, morbidity, etc. are slow to change and difficult to measure. In order to demonstrate an “improvement” in care what was done was to replace outcome measures with process measures. Process measures assess the frequency that an intervention is performed.  The problem appears that poor process measures were chosen. The measures included many ineffective measures such as vaccination with the 23 polyvalent pneumococcal vaccine in adult patients and discharge instructions including advice to quit smoking at hospital discharge (15). Many were based on opinion or poorly done trials, and when closely examined, were not associated with better outcomes. Most of the “improvement” appeared to occur in performance of these ineffective measures. However, these measures appeared to be quite popular with the administrators who were paid bonuses for their performance.

Root Causes of the Problems

The root causes go back to Kizer’s Prescription for Change. The VA decreased the numbers of clinicians, but especially specialists, while increasing the numbers of administrators and patients. The result has been what we observe now. Specialists such as psychiatrists are in short supply. They were often replaced by a cadre of physician extenders more intent on satisfying a checklist of ineffective process measures rather than providing real help to the patient. Waiting times lengthened and the administrative solution was cover up the problem by lying about the data.

VA medical centers are now usually run by administrators with no real medical experience. From the director down through their administrative chain of command, many are insufficiently medically trained to supervise a medical center. These administrators could not be expected to make good administrative decisions especially when clinicians have no meaningful input (10).

The present system is not transparent. My colleagues and I had to go through a FOIA request to obtain data on the numbers of physicians and nurses presented above. Even when data is known, the integrity of the data may be called into question as illustrated by the data with the wait times. 

The falsification of the wait times illustrates the lack of effective oversight. VA administration appears to be the problem and hiring more administrators who report to the same administrators will not solve the problem as suggested by the VA OIG (3-7). What is needed is a system where problems such as alteration of wait times can be identified on the local level and quickly corrected.

Solutions to the Problems

The first and most important solution is to provide meaningful oversight by at the local level by someone knowledgeable in healthcare. Currently, no system is in place to assure that administrators are accountable.  Despite concurring with the multitude of VA OIG’s recommendations, VA central office and the Veterans Integrated Service Networks have not been effective at correcting the problem of falsified data. In fact, their bonuses also depend on the data looking good. Locally, there exists a system of patient advocates and compliance officers but they report to the same administrators that they should be overseeing. The present system is not working. Therefore, I propose a new solution, the concept of the physician ombudsman. The ombudsman would be answerable to the VA OIG’s office. The various compliance officers, patient advocates, etc. should be reassigned to work for the ombudsman and not for the very people that they should be scrutinizing.

The physician ombudsman should be a part-time clinician, say 20% at a minimum. The latter is important in maintaining local clinical knowledge and identifying falsified clinical data. One of the faults of the present VA OIG system is that when they look at a complaint, they seem to have difficulty in identifying the source of the problem (16). Local knowledge would likely help and clinical experience would be invaluable. For example, it would be hard to say waiting times are short when the clinician ombudsman has difficulty referring a patient to a specialist at the VA or even booking a new or returning patient into their own clinic.

The overseeing ombudsman needs to have real oversight power, otherwise we have a repeat of the present system where problems are identified but nothing is done. Administrators should be privileged similar to clinicians. Administrators should undergo credentialing and review. This should be done by the physician ombudsman’s office.  Furthermore, the physician ombudsman should have the capacity to suspend administrative privileges and decisions that are potentially dangerous. For example, cutting the nursing staffing to dangerous levels in order to balance a budget might be an example of a situation where an ombudsman could rescind the action.

The paying of administrative bonuses for clinical work done by clinicians should stop. Administrators do not have the necessary medical training to supervise clinicians, and furthermore, do nothing to improve efficiency or clinically benefit Veterans (14). The present system only encourages further expansion of an already bloated administration (17). Administrators hire more administrators to reduce their workload. However, since they now supervise more people, they argue for an increase in pay. If a bonus must be paid, why not pay for something over which the administrators have real control, such as administrative efficiency (18). Perhaps this will stop the spiraling administrative costs that have been occurring in healthcare (17).

These suggestions are only some of the steps that could be taken to improve the chronic falsification of data by administrators with a financial conflict of interest. The present system appears to be ineffective and unlikely to change in the absence of action outside the VA. Otherwise, the repeating cycle of the OIG being called to look at wait times, noting that they are gamed, and nothing being done will continue.

Richard A. Robbins, M.D.*

Editor, Southwest Journal of Pulmonary

            and Critical Care

References

1. http://www.va.gov/oig/pubs/VAOIG-12-00900-168.pdf  (accessed 4-26-12).
2. http://www.va.gov/opa/pressrel/pressrelease.cfm?id=2302 (accessed 4-26-12).
3. http://www.ca9.uscourts.gov/datastore/opinions/2011/07/12/08-16728.pdf (accessed 4-26-12).
4. http://www.va.gov/oig/52/reports/2003/VAOIG-02-02129-95.pdf (accessed 4-26-12).
5. http://www.va.gov/oig/54/reports/VAOIG-05-03028-145.pdf (accessed 4-26-12).
6. http://www.va.gov/oig/54/reports/VAOIG-05-03028-145.pdf (accessed 4-26-12).
7. http://www.va.gov/oig/52/reports/2007/VAOIG-07-00616-199.pdf (accessed 4-26-12).
8. www.va.gov/HEALTHPOLICYPLANNING/rxweb.pdf (accessed 4-26-12).
9. http://veterans.house.gov/107th-congress-hearing-archives (accessed 3/18/2012).
10. Robbins RA. Profiles in medical courage: of mice, maggots and Steve Klotz. Southwest J Pulm Crit Care 2012;4:71-7.
11. Robbins RA. Unpublished observations obtained from the Department of Veterans Affairs by FOIA request.
12. http://www.medscape.com/features/slideshow/compensation/2012/psychiatry (accessed 4-26-12).
13. http://seattletimes.nwsource.com/html/localnews/2018071724_mentalhealth26.html (accessed 4-26-12).
14. Robbins RA, Gerkin R, Singarajah CU. Correlation between patient outcomes and clinical costs in the VA healthcare system. Southwest J Pulm Crit Care 2012;4:94-100.
15. Robbins RA, Klotz SA. Quality of care in U.S. hospitals. N Engl J Med 2005;353:1860-1 [letter].
16. Robbins RA. Mismanagement at the VA: where's the problem? Southwest J Pulm Crit Care 2011;3:151-3.
17. Woolhandler S, Campbell T, Himmelstein DU. Health care administration in the United States and Canada: micromanagement, macro costs. Int J Health Serv 2004;34:65-78.
18. Gao J, Moran E, Almenoff PL, Render ML, Campbell J, Jha AK. Variations in efficiency and the relationship to quality of care in the Veterans health system. Health Aff (Millwood) 2011;30:655-63.

*The author is a former VA physician who retired July 2, 2011 after 31 years.

The opinions expressed in this editorial are the opinions of the author and not necessarily the opinions of the Southwest Journal of Pulmonary and Critical Care or the Arizona Thoracic Society.

Reference as: Robbins RA. VA administrators gaming the system. Southwest J Pulm Crit Care 2012;4:149-54. (Click here for a PDF version of the editorial)

Will Fewer Tests Improve Healthcare or Profits?

Earlier this month, the American Board of Internal Medicine (ABIM) Foundation, in partnership with Consumer Reports, announced an educational initiative called Choosing Wisely (1). Nine medical organizations were asked to name five things physicians and patients should question. The initiative lists specific, evidence-based recommendations physicians and patients should discuss to make wise decisions on their individual situation. The list of tests and procedures Choosing Wisely advises against include common procedures and treatments such as EKGs done routinely during a physical examination, routine MRI’s for back pain, antibiotics for mild sinusitis, and routine EKG and chest X-rays preoperatively. Some experts estimate that up to one-third of the $2 trillion of annual health care costs in the United States each year is spent on unnecessary hospitalizations and tests, unproven treatments, ineffective new drugs and medical devices, and futile care at the end of life (2). We at the Southwest Journal of Pulmonary and Critical Care (SWJPCC) applaud the use of evidence-based medicine in determining testing and treatment. Any information that can inform medical decision making is welcome.

With most of the Choosing Wisely recommendations there is solid evidence that the procedures do not improve patient outcomes (1). Nevertheless several previous efforts to limit testing have failed and even provoked backlashes. For example, in November 2009, new mammography guidelines issued by the U.S. Preventive Services Task Force advised women to be screened less frequently for breast cancer, stoking fear among patients about increasing government control over personal health care decisions and the rationing of treatment (2). An area of further concern is that the Choosing Wisely recommendations will be used not just to make informed decisions, but by payers to limit decisions that a patient and physician can make. This is especially true since the motivation for these recommendations may not be to improve care but to decrease expenses and increase profits by insurers and other payers.

Several of the quality improvement and training organizations affiliated with the ABIM have recommendations and guidelines that are either non- or weakly-evidence based and have not been shown to improve patient outcomes. Surely, these should also be questioned. These include most of the hospital performance measures for acute myocardial infarction, congestive heart failure, pneumonia and surgical process of care, the ventilator-associated pneumonia guidelines, and the central line associated bloodstream infection guidelines (3-5).  Furthermore, in examining the requirements for recertification by the ABIM, the parent organization that sponsored the Choosing Wisely initiative, the evidence basis for the ever increasing frequency of examinations for ever increasing fees and the quality improvement initiative in individual practices is unclear (6).

The recommendations number only 5 from each society (with several overlapping) and come from only 9 of the over 50 medical societies, organizations and boards affiliated with the ABIM. Why recommendations from other medical societies including pulmonary and critical care organizations such as the American Thoracic Society (ATS)* and the American College of Chest Physicians (ACCP) were not included was not stated. In order to help the ABIM, ATS and ACCP, we list some procedures and treatments below that pulmonary and critical care physicians might consider for inclusion in the Choosing Wisely recommendations:

1. Pneumococcal vaccination with the 23 polyvalent vaccine in adults
2. Chest X-ray after bronchoscopy or needle biopsy in the absence of symptoms
3. Routine use of heparin for deep venous thrombosis prophylaxis 
4. Routine chest X-ray in the absence of clinical suspicion of intrathoracic pathology
5. Pulmonary consultation for bronchoscopy for nonobstructive atelectasis
6. Ordering blood troponin levels in the absence of a clinical suspicion of myocardial infarction
7. Admission of a patient to the ICU who has chosen not to be resuscitated (DNR) and without clear goals of what is be accomplished in the ICU
8. Provision of powered mobility devices where there is not a clear medical necessity. 
9. Diagnosis and management of  COPD without spirometry
10. Developing and calling guidelines “evidence-based” when they are opinion or developed from nonrandomized trials.

Overall, the Choosing Wisely recommendations are a welcome start provided they are put to the use intended by the ABIM and contributing organizations. These should be expanded by contributions from other specialty groups and societies, but only if the evidence basis for each recommendation is clearly stated and based on adequate trials. Efforts to use these recommendations to control physician practice by proxy for financial gain are unethical and should be prominently noted and publicized if found to occur.

Richard A. Robbins, MD

Allen R. Thomas, MD

References

1. http://choosingwisely.org/?page_id=13
2. http://www.nytimes.com/2012/04/04/health/doctor-panels-urge-fewer-routine-tests.html?_r=1&permid=67
3. Robbins RA, Gerkin R, Singarajah CU. Relationship between the Veterans Healthcare Administration hospital performance measures and outcomes. Southwest J Pulm Crit Care 2011;3:92-133.
4. Padrnos L, Bui T, Pattee JJ, Whitmore EJ, Iqbal M, Lee S, Singarajah CU, Robbins RA. Analysis of overall level of evidence behind the Institute of Healthcare Improvement ventilator-associated pneumonia guidelines. Southwest J Pulm Crit Care 2011;3:40-8.
5. Hurley J, Garciaorr R, Leudy H et al. Correlation of compliance with central line associated blood stream infection guidelines and outcomes: a review of the evidence. (Submitted)
6. http://www.abim.org/research/seminal-bibliography/certification.aspx

*The Southwest Journal of Pulmonary and Critical Care is the official publication of the Arizona Thoracic Society which is the Arizona state affiliate of the  American Thoracic Society.

The opinions expressed in this editorial are the opinions of the authors and not necessarily the opinions of the Southwest Journal of Pulmonary and Critical Care or the Arizona Thoracic Society.

Reference as: Robbins RA, Thomas AR. Will fewer tests improve healthcare or profits? Southwest J Pulm Crit Care 2012;4:111-3. (Click here for a PDF version of the editorial)

Identification of a Biomarker of Sleep Deficiency—Are We Tilting Windmills?

The amount of time spent asleep by adults in the United States and other developing countries is decreasing. It is estimated that over 40 years ago, adults slept in excess of 8 hours per night, but now sleep barely 7 hours per night (1) During this time frame, there has been a corresponding increase in obesity and diabetes mellitus which in part has been attributed to a reduction in time sleeping (2). In addition, sleep deficiency and other sleep disorders have been implicated as risk factors for hypertension, cardiovascular disease and cancer (3-5). Consequently, billions of excess health care dollars are spent on medical conditions associated with sleep deficiency or sleep disorders (6,7). Their impact also include substantial costs resulting from lost productivity as well as increased absenteeism, presenteeism and motor vehicle or industrial accidents (6,7).  Thus, sleep disorders and sleep deficiency are significant threats to public health and productivity in the United States and worldwide and no evidence of a decline is on the horizon. One barrier to reducing their impact is the difficulty in identifying on a societal and personal level the major consequence of sleep deficiency, sleepiness.

Despite the extraordinary progress made by sleep and circadian science in recent years, developing an accurate and easy to use biomarker for sleepiness and/or sleep deficiency has been elusive. Currently used objective assessments of sleepiness such as the multiple sleep latency test or the psychomotor vigilance test are either difficult to use outside the laboratory environment or do not evaluate all domains of sleep deficiency. Subjective assessments of sleepiness are unreliable because many individuals cannot recognize their impairment (8) and in some occupational scenarios (e.g., truck drivers, railroad engineers); there is personal incentive to deny its presence because of the fear of losing employment or income (9).

If developed, there would be several uses for a sleepiness or sleep deficiency biomarker. These include:

• Research: especially in field studies of the impact of sleep deficiency and/or sleepiness in both small and large size cohorts;
• Fitness for duty: in clinical and occupational settings (e.g., operating a motor vehicle, aircraft pilot) where objective assessment of sleepiness would be important in determining whether an individual could perform their job;
• Personal health: such testing might ultimately provide a means for an individual to determine his/her level of sleepiness and allow self adjustment of medication or positive airway pressure in the case of obstructive sleep apnea patients, analogous to currently used home glucose testing in persons with diabetes mellitus;
• Disease risk stratification: level of sleep deficiency might identify individuals with a greater likelihood of developing other medical conditions such as cardiovascular disease or diabetes.

In an attempt to “jumpstart” interest and research into developing a sleepiness or sleep deficiency biomarker, the Division of Sleep Medicine at Harvard Medical School hosted a conference on September 21-22, 2010 supported by the National Heart, Lung and Blood Institute and commercial entities entitled “Finding a Research Path for the Identification of Biomarkers of Sleepiness” (10). A number of prominent national and international speakers presented possible approaches to achieving this goal including behavioral, physiologic, genomic and proteomic solutions. This conference was followed by a panel discussion on this same topic at the annual Sleep 2011 international conference. Despite these high profile public discourses, there has been little progress in finding a sleepiness/sleep deficiency biomarker. A brief search of PubMed identified only one paper published since the conference directly relevant to this area (11).

Why has there been so little progress? I would propose the major reason is lack of a public “outcry”. Despite high profile incidences such as the crash of Colgan Air Flight #3407 (12) and the grounding of the Exxon Valdez (13), and a report from the Institute of Medicine (6) the general public has not adopted sleep issues as a major public health concern. In contrast, cancer, heart disease, obesity and diabetes, all of which may in part be consequences of sleep deficiency or a sleep disorder, are higher in the public consciousness. As a result, it is unlikely that funding initiatives such as a RFA on research into sleepiness or sleep deficiency biomarkers from the National Institutes of Health will be forthcoming.

What can be done? It should be the mission of all of us who are involved in sleep research and clinical Sleep Medicine to promote to the public the importance of sleep deficiency and sleep disorders in adversely impacting public health. Until there is a ground swell of public support, I fear attempts to identify biomarkers for sleepiness or sleep deficiency may be similar to “tilting at windmills.”

Stuart F. Quan, M.D.

Division of Sleep Medicine,

Brigham and Women’s Hospital and Harvard Medical School

401 Park Dr., 2^nd Floor East

Boston, MA 02215

Voice: 617-998-8842

Fax: 617-998-8823

Email: Stuart_Quan@hms.harvard.edu

References

1. McAllister EJ, Dhurandhar NV, Keith SW, et al. Ten putative contributors to the obesity epidemic. Crit Rev Food Sci Nutr 2009;49:868-913.
2. Spiegel K, Tasali E, Leproult R, Van Cauter E. Effects of poor and short sleep on glucose metabolism and obesity risk. Nat Rev Endocrinol 2009;5:253-261.
3. Budhiraja R, Sharief I, Quan SF. Sleep disordered breathing and hypertension. J Clin Sleep Med 2005; 1:401-4.
4. Kakizaki M, Kuriyama S, Sone T, et al. Sleep duration and the risk of breast cancer: the Ohsaki Cohort Study. Br J Cancer 2008; 99:1502-5.
5. Quan SF. Sleep Disturbances and their Relationship to Cardiovascular Disease. Am J Lifestyle Med 2009; 3:55s-59s.
6. Colten HR, Altevogt BM, Institute of Medicine. Committee on Sleep Medicine and Research. Sleep disorders and sleep deprivation: an unmet public health problem. Washington, DC: Institute of Medicine: National Academies Press, 2006; 404.
7. Anonymous. The Price of Fatigue: the surprising economic costs of unmanaged sleep apnea. 2010. https://sleep.med.harvard.edu/what-we-do/public-policy-research
8. Durmer JS, Dinges DF. Neurocognitive consequences of sleep deprivation. Semin Neurol 2005;25:117-129.
9. Smith B, Phillips BA. Truckers drive their own assessment for obstructive sleep apnea: a collaborative approach to online self-assessment for obstructive sleep apnea. J Clin Sleep Med 2011;7:241-245.
10. Anonymous. Harvard Biomarkers of Sleepiness Conference. 2011. https://sleep.med.harvard.edu/what-we-do/biomarkers-conference
11. Goel N, Banks S, Lin L, Mignot E, Dinges DF. Catechol-O-methyltransferase Val158Met polymorphism associates with individual differences in sleep physiologic responses to chronic sleep loss. PLoS One 2011;6:e29283.
12. Anonymous. Colgan Air Flight 3407. 2012. http://en.wikipedia.org/wiki/Colgan_Air_Flight_3407#cite_note-ntsb.2Faar-10.2F01-20
13. Anonymous. Details about the Accident SPILL: The wreck of the Exxon Valdez Final Report, Alaska Oil Spill Commission. 1990. http://www.evostc.state.ak.us/facts/details.cfm

Reference as: Quan SF. Identification of a biomarker of sleep deficiency-Are we tilting windmills? Southwest J Pulm Crit Care 2012;4:58-60. (Click here for a PDF version of the editorial) 

Competition or Cooperation?

One of our local institutions, the Mayo Clinic Arizona, was mentioned in a recent op-ed in the New York Times. The editorial entitled, “It Costs More, but Is It Worth More?” by Ezekiel J. Emanuel and Steven D. Pearson (1), criticizes the Mayo Clinic in Rochester and Arizona for building two new proton beam treatment facilities at a cost of more than $180 million dollars each.  It accuses the Mayo Clinic of participating in “…a medical arms race for proton beam machines, which could cost taxpayers billions of dollars for a treatment that, in many cases, appears to be no better than cheaper alternatives”. The editorial states that except for a handful of rare pediatric cancers, the evidence is lacking for treatment of other types of cancer such as lung, esophageal, breast, head and neck, and prostate cancers.

John Noseworthy MD, President and Chief Executive of the Mayo Clinic, replied that the Mayo Clinic “will carefully study proton therapy and other new therapies, compare clinical outcomes and offer high-quality, cost-effective, proven and safer treatments for patients”. In another letter to the Minneapolis StarTribune, Nosewothy goes on to say, “Mayo Clinic takes serious issue with the authors' use of Mayo Clinic and its programs in this manner. As a not-for-profit institution, we are motivated by the best interests of our patients, not ‘profit’ or competitiveness. With the facility costs, start-up expenses and the extensive training required to offer this therapy, we do not expect to break even, much less earn a ‘profit,’ on our proton therapy program for years”.

I am not an expert in either cancer treatment or proton beam therapy, but a weekend search of the medical literature largely confirms that the therapy is unproven for most cancers, although there was no evidence that proton beam is inferior to more traditional means of delivering radiation therapy. Second, the cost of proton beam therapy is high. Costs are about $55,000 plus $15,000 in physician fees per patient for the therapy alone, twice as much as a linear accelerator. This sounds like a lot of money but you still need an estimated volume of about 2,000-3,500 patients per year to cover an investment of over $180 million investment.

So why are the Mayo Clinic and others constructing these centers since they are expensive; mostly of unproven superiority over existing therapies; and reimbursement, although generous, may not cover the cost of the facility? The answer is likely competition. Competition for patients largely drives tertiary referral centers. Locally, there is a small war going on between the Mayo Clinic Arizona and the new Banner MD Anderson Cancer Center. Mayo Clinic is concerned about MD Anderson having greater name recognition and losing its patients to the new center. Banner in partnership with MD Anderson sees an opportunity to compete in a large metropolitan center without a strong university medical center. Mayo Clinic Arizona undoubtedly feels that new technologies such as proton beam are necessary to compete with MD Anderson, especially since MD Anderson has a proton beam therapy unit in Houston.  

All this is probably not good for patients and illustrates that competition in medicine does not necessarily lead to cheaper, more effective care. Patients will be easily persuaded to receive the latest and greatest therapy when their life is on the line, especially when the bulk of the cost is covered by a third party. Whether proton beam therapy is the latest and greatest is fairly difficult to determine at this time, given the absence of well designed, randomized studies. The Center for Medicare and Medicaid Services (CMS) process of determining reimbursement costs is largely a mystery but needs to show some restraint. Large reimbursements for unproven therapies such as proton beam while underfunding areas with well demonstrated benefits is not in the best public interest. Furthermore, instead of directly or indirectly encouraging competition, CMS needs to foster cooperation. Perhaps requiring hospitals to work together to study the effectiveness of proton beam to get reimbursed would be a good first step. As Franklin D. Roosevelt said, “Competition has been shown to be useful up to a certain point and no further, but cooperation, which is the thing we must strive for today, begins where competition leaves off” (5).

Richard A. Robbins, MD

Editor, Southwest Journal of Pulmonary and Critical Care

References

1. Emanuel EJ, Pearson SD. It costs more, but is it worth it? New York Times. http://opinionator.blogs.nytimes.com/tag/proton-beam-therapy/ (accessed 1-23-12).
2. Noseworthy J. Mayo clinic’s investment. New York Times. http://www.nytimes.com/2012/01/06/opinion/mayo-clinics-investment.html (accessed 1-23-12).
3. Nosewothy J.  Mayo CEO defends use of proton beam therapy. Minneapolis StarTribune http://www.startribune.com/opinion/otherviews/136758278.html (accessed 1-23-12).
4. Clark C. What would super committee say about $430m proton beam center war? http://www.healthleadersmedia.com/page-1/QUA-272912/What-Would-Super-Committee-Say-About-430M-Proton-Beam-Center-War (accessed 1-23-12).
5. http://www.brainyquote.com/quotes/authors/f/franklin_d_roosevelt.html (accessed 1-23-12).

Reference as: Robbins RA. Competition or cooperation? Southwest J Pulm Crit Care 2012;4:30-1. (Click here for a PDF version of the editorial)