Archive for November, 2012

All Studies Are Not Created Equal

Monday, November 19, 2012 // Uncategorized

We are bombarded daily with medical news with often conflicting conclusions making it difficult to know what to do.  In medicine, we don’t weigh

 all studies equally.  There are different kinds as outlined in this recent articl from the San Antonio Express News by Dr. Steven Austad from the UTHSCSA.

 
 
 
 


Observational studies can lead to false conclusions

Steven Austad

Updated 3:24 p.m., Saturday, November 17, 2012

Page 1 of 1

People who eat diets rich in fruits and vegetables are healthier and live longer than people who don’t. Fruits and vegetables contain high levels of antioxidants, chemicals that neutralize damaging free radicals that our bodies produce. Therefore, consuming massive amounts of antioxidants to soak up the free radicals must be good for your health. From this logic, a lucrative industry was born — selling pills packed with the holy trinity of antioxidant vitamins, A, C, and E.

This scenario all made sense based on the sort of weak evidence that I’ve previously described — and on which most human health studies are based. That is, asking people questions, then following up what happens to them. People who take antioxidant vitamins are healthier and live longer than those who don’t. But is it the vitamins that do it or other lifestyle factors? We don’t have to depend only on weak evidence. Science has spent the last 500 years learning how to gather strong evidence. It’s called “doing experiments.” Experiments, if properly done (which is a whole other topic), are the gold standard of science.

Human health experiments are called clinical trials. They are pretty straightforward. Divide a group of people randomly into one part that gets the treatment (such as a daily supplement of antioxidant vitamins) and another part that doesn’t (the controls). Probably the most informative thing you can do when reading the health news is try to figure out whether the study was weak and observational (that is, it merely observed what happened to people), or strong and experimental, imposing a treatment on a randomly selected group of people and comparing them with who don’t get the treatment.

The advantage of experiments is that by randomly dividing people into groups, you are guarding against the possibility that the people you are studying differ in some systematic way that you weren’t aware of. People who take antioxidant vitamins, for instance, are likely to differ from people who don’t in lots of other health habits that no one asked about. If so, then the effect you thought was due to their antioxidants could be due to something else.

The strong evidence is now in on the holy trinity of antioxidants. It turned the weak evidence on its head. Taking massive amounts of vitamins A, C, or E has no obvious health benefits and in some cases may actually harm your health. Something similar happened with hormone replacement therapy for postmenopausal women. A large body of weak observational evidence indicated that HRT reduced heart disease by 40 percent to 50 percent. Yet when the Women’s Health Initiative experimentally tested one common type of HRT, it found quite the reverse: a slight increase in heart disease. Don’t take this to mean that you should avoid vitamins and postmenopausal hormones. Results of the studies I’ve mentioned are complex and depend on other factors that I don’t have room to discuss. I’ve focused on the unexpected results of these studies simply to illustrate that observational studies, even well-done ones, can sometimes lead to false conclusions.

 

Steven Austad is a professor and interim director for the Barshop Institute for Longevity & Aging Studies at the UT Health Science Center San Antonio. His column appears every other Sunday in S.A. Life.

[email protected]

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Meaningless Use Part Two

Sunday, November 18, 2012 // Uncategorized

Here is the checklist for the first stage of meaningful use.  While the goals may be worthwhile, achieving all of the first stage is what has practices pulling their collective hair and software companies overwhelmed with questions and complaints from their subscribers.

STAGE 1 MEANINGFUL USE CHECKLIST

 

Priority primary care providers (PPCPs) are physicians and health care professionals with prescriptive privileges. PPCPs

can be physicians, physician assistants, nurse practitioners, and nurse midwives. Primary care encompasses family

medicine, geriatrics, OB/GYN, general or internal medicine, adolescent medicine, and pediatrics.

 

I. Must meet 15 of the core meaningful use (MU) objectives:

 

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West Nile Virus Update

Saturday, November 17, 2012 // Uncategorized

A patient told me that a friend of his was hospitalized and in a coma due to West Nile Virus. Since the number of cases reported has peaked with cooler weather, this disease has not been in the news, but it is important to remember that it is still out there.  This has been a record year for the virus due to a variety of reasons which are outlined in the following interview with Dr. Lyle Peterson of the Center for Disease Control  in the November 14 issue of JAMA.

Medical News and Perspectives | November 14, 2012

Record Heat May Have Contributed to a Banner Year for West Nile Virus

Bridget M. Kuehn, MSJ
JAMA. 2012;308(18):1846-1848. doi:10.1001/jama.2012.13495.
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With nearly 4000 cases of West Nile virus reported to the US Centers for Disease Control and Prevention (CDC) as of early October, more than 5 times the number of cases reported in 2011, the 2012 West Nile virus season has been one of the worst since the virus emerged in the United States in 1999.

This surge in cases—which was concentrated in Texas, Mississippi, Michigan, South Dakota, Louisiana, Oklahoma, and California—likely resulted from a confluence of ecological factors, including higher-than-normal temperatures, that may have influenced mosquito and bird abundance, the replication of the virus in its host mosquitoes, and interactions of birds and mosquitoes in hard-hit areas, according to Lyle Petersen, MD, MPH, Director of the CDC’s Division of Vector-Borne Diseases. Petersen discussed this year’s resurgence of West Nile virus with JAMA.

 
 

Image not available.

Ecological changes likely led to outbreaks of West Nile virus infection in 2012, said Lyle Petersen, MD, MPH, Director of the Division of Vector-Borne Diseases at the Center for Disease Control and Prevention.

Higher temperatures and moist conditions can promote West Nile virus outbreaks by facilitating mosquito breeding and speeding viral replication.

JAMA:Was what happened this year unexpected?

Dr Petersen: Outbreaks of arboviruses, like West Nile virus, historically are very episodic in nature. When West Nile virus marched across the country, we didn’t really know what was going to happen, but St Louis encephalitis, a similar arbovirus tracked since the 1930s, is a good model of how West Nile virus may behave in the United States. In some years, there are very few cases of St Louis encephalitis, but it periodically causes focal or regional outbreaks big and small, including a huge epidemic in the Midwest in the 70s. People are still trying to figure out why. It’s very difficult to predict when and where arbovirus epidemics will occur.

JAMA:What trajectory has West Nile taken since it was introduced here?

Dr Petersen: From its 1999 discovery in New York City through 2001, West Nile virus spread across the eastern United States but caused relatively few human cases. Big outbreaks occurred in 2002 and 2003, when the virus spread into the Midwest and mountain states where all the birds were susceptible, sufficient water existed to breed many mosquitoes, and weather was warm. It was the perfect storm. The virus spread to the West Coast in 2003 and has become endemic nationwide. But in the last few years, West Nile virus seasons have been less active, so this year’s outbreak came as a surprise to those not familiar with the sporadic nature of arboviruses. The bottom line is that West Nile virus is here to stay and it will cause large and small outbreaks for years to come.

JAMA:Has West Nile virus behaved differently in the United States than in other regions where it is endemic?

Dr Petersen: West Nile virus is endemic in Africa. What is interesting is that big outbreaks only happen in more temperate climates, and the reasons for this aren’t clear. The big outbreaks haven’t been in equatorial Africa but have occurred in more temperate climates in South Africa, Europe, and now in the United States and southern Canada, which seem to have an environment that is particularly conducive to outbreaks. Similar to the situation in Africa, the virus has not caused outbreaks in tropical America.

JAMA:Why do you think we saw an uptick in cases this year?

Dr Petersen: We really don’t know. West Nile virus has a complicated ecological cycle between birds and mosquitoes. The number of susceptible birds, the number of vector mosquitoes, the rate of viral replication in mosquitoes, the average length of survival of mosquitoes, and the interaction of birds and mosquitoes are all important factors. All of these factors are influenced by weather. The first 8 months of 2012 were the hottest on record in the United States. That could have been an important factor in this year’s outbreak.

JAMA:Have previous outbreaks occurred in hot years?

Dr Petersen: The initial outbreak in New York City and the ones in 2002 and in 2003 were associated with warmer weather. Warmer-than-average weather does a couple of critical things. It increases viral replication in mosquitoes, making them more infectious. It also shortens the extrinsic incubation period—the time from when the mosquito takes an infectious blood meal to when the mosquito can become infectious by biting a person or bird. The shorter that period, the better it is for viral transmission. But high temperatures can also dry up mosquito breeding sites, reducing mosquito breeding. Temperature and rainfall patterns have a complicated relationship with mosquito breeding cycles.

JAMA:Why did we see an uptick only in certain states?

Dr Petersen: There was a huge swath of the country with high temperatures. But if you look at places with the big outbreaks, they mostly didn’t experience the severe drought other areas had. They had relatively normal rainfall. Most places with severe drought didn’t experience outbreaks. So it was probably a combination of enough rain to produce mosquitoes, along with a conducive temperature for West Nile virus transmission.

 
 

Image not available.

Ecological changes likely led to outbreaks of West Nile virus infection in 2012, said Lyle Petersen, MD, MPH, Director of the Division of Vector-Borne Diseases at the Center for Disease Control and Prevention.

Higher temperatures and moist conditions can promote West Nile virus outbreaks by facilitating mosquito breeding and speeding viral replication.

JAMA:Do we know if there were more neurologic cases this year?

Dr Petersen: Over all, about 1 in 150 to 250 persons who are infected will develop severe neurological disease. We have no reason to believe that this ratio has changed this year. Our surveillance data tell us that cases of West Nile virus neuroinvasive disease, particularly encephalitis, are related to increasing age and that people with kidney disease, diabetes, immunosuppressing conditions, and hypertension are also more likely to get neuroinvasive disease. Because people with neuroinvasive disease generally are hospitalized, the rate of testing for West Nile virus is very high. We believe that people with severe neuroinvasive disease are well captured in our surveillance, and that’s how we monitor the severity of a West Nile epidemic.

Among persons with West Nile fever, there’s quite a spectrum of illness, ranging from barely any symptoms to severely ill for weeks to months. Thus, many people don’t go to the doctor or, if they do, simply get sent home to rest, since we don’t recommend routine testing for these patients. The end result is only about 2% to 3% of West Nile fever cases are captured by our surveillance. So fever cases are grossly underestimated by surveillance.

JAMA:Is there any reason to believe that the outbreaks were caused by changes in the virus?

Dr Petersen: There is no reason now to believe that the virus’ virulence has changed, but we are looking to make sure that this isn’t the case. But the most likely explanation was that ecological conditions led to big outbreaks.

JAMA:Do you think cuts to public health and municipal services have contributed to the resurgence?

Dr Petersen: I don’t think they have necessarily contributed to the resurgence. But they have undoubtedly contributed to changes in the response to the resurgence.

We don’t collect data on local mosquito control, but anecdotally, we know a lot of jurisdictions have cut back on entomological services and don’t have sufficient response capability when an outbreak occurs. An effective response relies on a certain amount of expertise. Mosquito control activities and surveillance require experienced, well-trained people and special equipment. Once those capabilities erode, they can’t be easily regathered in the course of an epidemic. It takes a long-term perspective to maintain those services, and in this fiscal climate that is hard to do.

JAMA:What do we know about the long-term effects of West Nile virus infection?

Dr Petersen: We know many people with encephalitis will have long-term cognitive or neurological problems. Among people who develop West Nile virus paralysis, about one-third will have significant recovery, one-third will have some recovery, and one-third will have no recovery. People with meningitis generally do recover fully.

For those with West Nile fever, there is a huge spectrum of illness severity, but I think West Nile fever is an underappreciated source of morbidity. Many persons experience illness that may last for months, and a subgroup may have symptoms over the longer term.

JAMA:What can physicians do to prepare for West Nile outbreaks next year and beyond?

Dr Petersen: Physicians should have a high degree of suspicion for West Nile–related illness from late July through September. We know that even patients with classic symptoms are going unrecognized. The symptoms of West Nile fever include fever, headache, gastrointestinal disturbance, muscle aches, fatigue, sometimes a skin rash on the trunk and extremities, and swollen lymph nodes. Symptoms of neuroinvasive disease include headache, high fever, neck stiffness, stupor, disorientation, coma, tremors, convulsions, muscle weakness, and paralysis.

In terms of advice for patients, the name of the game is prevention. The best preventive measure is wearing mosquito repellent, particularly at dawn and dusk. But that is not so easy. There are repellents that work (DEET, oil of lemon eucalyptus, IR3535, and picaridin), but there are others that don’t. There are many myths about repellents, and physicians should steer patients toward products with these ingredients. Physicians should also be aware of what mosquito control is and isn’t. There is a lot of hype around municipal spraying, and patients may ask if they can be harmed by it. The bottom line is that for West Nile virus control, municipalities use ultralow volumes of pesticides sprayed by trucks or planes—less than an ounce per acre. With such a low amount, there are no known health effects. These pesticides are rapidly degraded and do not persist in the environment.

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Meaningful Use Part One

Thursday, November 15, 2012 // Uncategorized

EMRs (electronic medical records) = EHRs (electronic health records)

They are supposed to help improve the quality of medical care in this country.  To this end the federal government is giving financial incentives for their adoption.  This includes incentives to purchase and install the software and to use it.  The last bit entails “Meaningful Use”.  This is the term coined for the use of the software.  It has to be able to perform certain tasks.  All of this sounds laudible, but the road to hell in medicine, as in life, is paved with good intentions.  There is an extraordinary drop in productivity while physicians struggle to check the boxes.  Patients will notice that there doctor or his extenders is spending a lot  clicking on  these boxes so that they can get paid 1% more from Medicare.  Here is one of the original articles in the New England Journal.  Many of the ideas that became law seem to originate in Boston.  It’s a classic disconnect between the Ivory Tower and the real world and between the federal government and those in the frontline of patient care.

Perspective

The “Meaningful Use” Regulation for Electronic Health Records

David Blumenthal, M.D., M.P.P., and Marilyn Tavenner, R.N., M.H.A.

N Engl J Med 2010; 363:501-504August 5, 2010DOI: 10.1056/NEJMp1006114

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Citing Articles (129)

Letters

The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice.

But inevitability does not mean easy transition. We have years of professional agreement and bipartisan consensus regarding the potential value of EHRs. Yet we have not moved significantly to extend the availability of EHRs from a few large institutions to the smaller clinics and practices where most Americans receive their health care.

Last year, Congress and the Obama administration provided the health care community with a transformational opportunity to break through the barriers to progress. The Health Information Technology for Economic and Clinical Health Act (HITECH) authorized incentive payments through Medicare and Medicaid to clinicians and hospitals when they use EHRs privately and securely to achieve specified improvements in care delivery.

Through HITECH, the federal government will commit unprecedented resources to supporting the adoption and use of EHRs. It will make available incentive payments totaling up to $27 billion over 10 years, or as much as $44,000 (through Medicare) and $63,750 (through Medicaid) per clinician. This funding will provide important support to achieve liftoff for the creation of a nationwide system of EHRs.

Equally important, HITECH’s goal is not adoption alone but “meaningful use” of EHRs — that is, their use by providers to achieve significant improvements in care. The legislation ties payments specifically to the achievement of advances in health care processes and outcomes.

HITECH calls on the secretary of health and human services to develop specific “meaningful use” objectives. With the Centers for Medicare and Medicaid Services (CMS) in the lead, the Department of Health and Human Services (DHHS) has used an inclusive and open process to develop these criteria, providing an extensive opportunity for public and professional input. The department published proposed meaningful use requirements on January 16, 2010. The proposal prompted some 2000 comments. This week, the DHHS is releasing a final regulation for the first 2 years (2011 and 2012) of this multiyear incentive program. Subsequent rules will govern later phases.

Although the intent of our January proposals has been retained and indeed affirmed through the rule-making process, the final regulation also incorporates significant changes — a response to the comments and experience that diverse stakeholders shared with us. In particular, concerns about the pace and scope of implementation of meaningful use led us to adopt a two-track approach regarding the objectives that allow practices and hospitals to qualify for incentive payments in the first 2 years of the program.

The most important part of this regulation is what it says hospitals and clinicians must do with EHRs to be considered meaningful users in 2011 and 2012. In the original proposal, we identified a broad set of objectives, all of which would need to be met. This included 23 objectives for hospitals and 25 for clinicians. The DHHS received many comments that this approach was too demanding and inflexible, an all-or-nothing test that too few providers would be likely to pass.

In the final regulation, we have divided these elements into two groups: a set of core objectives that constitute an essential starting point for meaningful use of EHRs and a separate menu of additional important activities from which providers will choose several to implement in the first 2 years (see tableSummary Overview of Meaningful Use Objectives.).

Core objectives comprise basic functions that enable EHRs to support improved health care. As a start, these include the tasks essential to creating any medical record, including the entry of basic data: patients’ vital signs and demographics, active medications and allergies, up-to-date problem lists of current and active diagnoses, and smoking status.

Other core objectives include using several software applications that begin to realize the true potential of EHRs to improve the safety, quality, and efficiency of care. These features help clinicians to make better clinical decisions — and avoid preventable errors. To qualify for incentive payments, clinicians must start employing such clinical decision support tools. They must also start using the capability that undergirds much of the value of EHRs: using records to enter clinical orders and, in particular, medication prescriptions. Only when providers enter orders electronically can the computer help improve decisions by applying clinical logic to those choices in light of all the recorded patient data. And to begin extending the benefits of EHRs to patients themselves, the meaningful use requirements will include providing patients with electronic versions of their health information.

In addition to the core elements, the rule creates a second group: a menu of 10 additional tasks, from which providers can choose any 5 to implement in 2011–2012. This gives providers latitude to pick their own path toward full EHR implementation and meaningful use.

For example, the menu includes capacities to perform drug-formulary checks, incorporate clinical laboratory results into EHRs, provide reminders to patients for needed care, identify and provide patient-specific health education resources, and employ EHRs to support the patient’s transitions between care settings or personnel.

For most of the core and menu items, the regulation also specifies the rates at which providers will have to use particular functions to be considered meaningful users. Reflecting the views and experiences shared during the comment period, these rates will enable significant progress toward improving care — but are also achievable by average practices and providers in the early years.

The HITECH legislation further requires that meaningful use include electronic reporting of data on the quality of care. In the final regulation, we have simplified the January proposals for quality reporting, while still building toward a robust reporting capability that will inform providers about their own performance and will eventually inform the public as well. Clinicians will have to report data on three core quality measures in 2011 and 2012: blood-pressure level, tobacco status, and adult weight screening and follow-up (or alternates if these do not apply). Clinicians must also choose three other measures from lists of metrics that are ready for incorporation into electronic records.

The meaningful use rule is part of a coordinated set of regulations to help create a private and secure 21st-century electronic health information system. On June 18, 2010, the DHHS issued a rule that laid out a process for the certification of electronic health records, so that providers can be assured they are capable of meaningful use. The department has also issued still another regulation that lays out the standards and certification criteria that EHRs must meet in order to be certified. Finally, realizing that the privacy and security of EHRs are vital, the DHHS has been working hard to safeguard privacy and security by implementing new protections contained in the HITECH legislation.

The meaningful use rule strikes a balance between acknowledging the urgency of adopting EHRs to improve our health care system and recognizing the challenges that adoption will pose to health care providers. The regulation must be both ambitious and achievable. Like an escalator, HITECH attempts to move the health system upward toward improved quality and effectiveness in health care. But the speed of ascent must be calibrated to reflect both the capacities of providers who face a multitude of real-world challenges and the maturity of the technology itself.

As part of this process, the DHHS is establishing a nationwide network of Regional Extension Centers to assist providers in adopting qualified EHRs and making meaningful use of them. The DHHS is committed to the support, collaboration, and ongoing learning that will mark our progress toward electronically connected, information-driven medical care. We hope that providers and consumers will now join us in the effort to assure that we make the best possible use of our most precious health care resource: information about the patients we serve.

 

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

This article (10.1056/NEJMp1006114) was published on July 13, 2010, at NEJM.org.

Source Information

Dr. Blumenthal is the national coordinator for health information technology at the Department of Health and Human Services, and Ms. Tavenner is the principal deputy administrator of the Centers for Medicare and Medicaid Services — both in Washington, DC.

 

Citing Articles

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Electronic Health Records

N Engl J Med 2010; 363:2372-2374December 9, 2010DOI: 10.1056/NEJMc1010028

Article

To the Editor:

Health care entities compliant with the recent rules for “meaningful use” of electronic health records (EHRs) (Aug. 5 issue)1 will receive a share of billions in federal payments. EHRs can improve the quality of care, but the benefits provided will depend on the details of design and implementation. EHR-induced risks include use errors (an interaction between the user and the technology that is neither what the user expected nor what the designer intended), inefficiencies, miscommunication, and workarounds.2-5 Until there is a better understanding of the safety and usability of EHRs, their widespread promulgation is premature. The adverse consequences of the rush to EHR adoption — spurred by incentives — are many. Most health care entities, which do not have the knowledge or resources to properly evaluate EHRs, will make uninformed purchase decisions favoring products promoting the capture of “meaningful use” rather than usability or safety. Many will short change the local customization required to make EHRs efficient, usable, and safe. Pressure on clinicians to maximize “use” will lead to workarounds and faulty use reporting. Postmarket surveillance of adverse events related to health information technology will fail, since neither vendors nor health care entities have reporting incentives.

Current federal initiatives to address these issues amount to less than 1% of the planned incentives. The horse is out of the barn without a bridle or reins.

Matthew B. Weinger, M.D.
Vanderbilt University School of Medicine, Nashville, TN
[email protected]

No potential conflict of interest relevant to this letter was reported.

 

5 References

    1. 1Blumenthal D, Tavenner M. The “meaningful use” regulation for electronic health records. N Engl J Med 2010;363:501-504

    1. 2Weiner JP, Kfuri T, Chan K, Fowles JB. “e-Iatrogenesis”: the most critical unintended consequence of CPOE and other HIT. J Am Med Inform Assoc 2007;14:387-388

    1. 3Campbell EM, Sittig DF, Ash JS, Guappone KP, Dykstra RH. Types of unintended consequences related to computerized provider order entry. J Am Med Inform Assoc 2006;13:547-556

    1. 4Halbesleben JR, Wakefield DS, Wakefield BJ. Work-arounds in healthcare settings: literature review and research agenda. Health Care Manage Rev 2008;33:2-12

  1. 5Walker JM, Carayon P, Leveson N, et al. EHR safety: the way forward to safe and effective systems. J Am Med Inform Assoc 2008;15:272-277

To the Editor:

The article by Blumenthal and Tavenner highlights the large gulf separating decision makers in Washington from those of us on the front lines of health care reform. The authors rightly point out the still-unproved benefits of EHRs and their “meaningful use,” but they ignore the most important aspect of meaningful use as it relates to patient care: the sophistication of the software. Because of the enormous and immediate financial incentives available to implement this plan, hospitals are rushing to initiate programs that are far from user-friendly or safe, often requiring physicians to beta-test EHRs being written even as they are being installed (imagine running an iPhone on DOS). This might be forgivable if not for the serious risks EHRs pose to patients’ health and privacy, the very goals the authors laud. In the Wild West of commercial EHRs, there is virtually no regulation of program content or sophistication. The Centers for Medicare and Medicaid Services (CMS) need to commit resources to the development of high-quality software and to the certification of its safety for patients.

Robert F. Taylor, M.D.
Oncology Alliance, Milwaukee, WI

No potential conflict of interest relevant to this letter was reported.

 

To the Editor:

Blumenthal and Tavenner recognize the complexities of implementing EHRs. Among these complexities are massive costs and questions about the reliability and security of the information. Defined communication limits are inherent to competitive EHR systems, hindering information exchange in a large and mobile society. In addition, physicians are naive about commercial and technical aspects of EHR. These issues were recently reviewed in the Wall Street Journal.1

Fortunately, American taxpayers have already developed, paid for, tested, and used the world’s best EHR system: the Veterans Health Information Systems and Technology Architecture (VistA). Nearly 18.5 million veterans were enrolled by the spring of 2010, an accomplishment that is receiving belated recognition.2 To promote the public welfare, medical organizations should create a not-for-profit Joint Commission on Electronic Health Records that would provide VistA with the business and technical administration it needs to make this technology available to the entire U.S. population.

Grant V. Rodkey, M.D.
Veterans Affairs Boston Healthcare System, West Roxbury, MA
[email protected]

No potential conflict of interest relevant to this letter was reported.

 

2 References

    1. 1Johnson A. Doctors get dose of technology from insurers. Wall Street Journal. August 9, 2010.

  1. 2Longman P. Best care anywhere. 2nd ed. Sausalito, CA: PoliPoint Press, 2010.

Author/Editor Response

The “meaningful use” regulation developed by the Office of the National Coordinator for Health Information Technology (ONC) and the CMS offers the nation a blueprint for the development of an infrastructure for its health information technology. When effectively implemented, health information technology offers tremendous potential to improve the quality and efficiency of care.

Both Weinger and Taylor share concerns about the maturity of current EHR products. We believe that current records are fully capable of improving the quality and safety of health care. Furthermore, we believe that considerable innovation in the market for EHRs will result from the availability of stimulus funds. Existing systems are rapidly improving, and substantial new product offerings are being made available. Absent the “meaningful use” incentive program, we are certain that the innovation Weinger and Taylor deem necessary would be much slower in coming.

Weinger notes concerns about the safety of EHR products. The widespread implementation of EHRs will, in our opinion, improve the overall safety of care. However, the federal government and private actors have the responsibility to do everything possible to ensure that the implementation and use of EHRs are as safe as they can possibly be. The ONC is working on initiatives to promote this goal.

Rodkey offers the important perspective that there is much to learn from the experience of the Department of Veterans Affairs in its successful implementation of the VistA program and that physicians would benefit from technical assistance to successfully implement EHR systems. The federally supported Regional Extension Center program aims to distill the learning from effective implementations of this kind and provide critical support to those physicians who need it most.

The process of the nationwide implementation of health information technology will be challenging. Nonetheless, we believe that the evidence base and experience of most front line providers who have made the transition support the broad, safe adoption and meaningful use of EHRs, and we are working diligently toward this end.

David Blumenthal, M.D., M.P.P.
Marilyn Tavenner, R.N., M.H.A.
Department of Health and Human Services, Washington, DC

Since publication of their article, the authors report no further potential conflict of interest.

 

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What Is a Gene?

Tuesday, November 13, 2012 // Uncategorized

Gene therapy was supposed to revolutionize medicine.  That has yet to happen.  Why not?  Not surprisingly, the answer is that it is a lot more complicated than previously thought. 

 

 

New Studies Ask, “What Is a Gene?”

The ENCODE project has determined that 80% of the human genome is important for normal gene expression.

The early achievements of molecular biology researchers might have spoiled us. The first identified “molecular disease,” sickle cell anemia, involved a single mutation in the globin gene. Then came the central dogma of molecular biology: DNA makes messenger RNA (mRNA), and mRNA makes protein. Therefore, the DNA segment that coded for a protein was a gene. Diseases would result from structural abnormalities in genes.

However, we soon realized that, unlike sickle cell anemia, most diseases probably didn’t derive from a structural abnormality in a single gene, but from the combined effects of abnormalities in multiple genes. Members of the Human Genome Project set out to determine the sequence of every gene — every stretch of DNA that coded for a protein. The Project achieved that goal but also produced a rude surprise: Less than 2% of the human genome coded for proteins. What did the rest of the DNA do? At first, it was called “junk DNA” — the presumed detritus of evolution, with no role in current human biology.

More than 400 investigators working together as part of the ENCODE project have just published 30 papers that tell a very different story:

  • Disease can occur when structurally normal genes are not controlled properly (i.e., turned on or off or “expressed” correctly).
  • Eighty percent of human DNA is transcribed — not into mRNA that makes protein, but into small RNA segments that control gene expression.
  • Many stretches of DNA do not code for proteins but are landing zones for proteins that control gene expression.

Comment: The ENCODE project is a landmark event in human genetics. But its message is daunting: Human disease is a function not just of the structure of one or more genes but also of many different forces that control gene expression. Indeed, a gene might be better defined as a stretch of DNA that is transcribed at all — not just stretches of DNA that code for mRNA and, hence, protein. Or we could define a gene as the DNA that codes for a particular mRNA plus the other DNA that affects expression of that mRNA. Understanding the molecular pathology that leads to human diseases has become much more complicated than we once thought it would be.

Anthony L. Komaroff, MD

Published in Journal Watch General Medicine October 25, 2012

Citation(s):

Pennisi E. Genomics: ENCODE Project writes eulogy for junk DNA. Science 2012 Sep 7; 337:1159. (http://dx.doi.org/10.1126/science.337.6099.1159)

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Concierge Medicine

Thursday, November 8, 2012 // Uncategorized

    • HERE IS AN ARTICLE BY A RETIRED SAN ANTONIO PHYSICIAN, DR. JERALD WINAKUR THAT APPEARED IN A RECENT EDITION OF THE WALL STREET JOURNAL
    • OPINION
    • Updated October 29, 2012, 6:21 p.m. ET

    ‘Concierge’ Medicine, ObamaCare and the End of Empathy

    Traditional primary-care doctors are finding themselves, and their patients, squeezed by the government and the marketplace.

     

    By JERALD WINAKUR

    I call my cousin Irene regularly. She is 90, frail, living alone in New York in an apartment in Queens, and I worry about her. This time there is distress in her voice:

    “I just don’t know what I’m going to do. I got a letter from my doctor, the one I’ve been seeing for a long time. It said she was making some changes to her practice. I had to go to a reception at a hotel in Manhattan where the details would be explained. I have such a hard time getting into the city, so I called her office to see if someone couldn’t just tell me over the phone.”

    Irene was crying now. “No, they said, I needed to come to the reception. So I paid a car service to take me there and back.”

    What Irene learned was that her internist was converting her fee-for-service office into a “concierge practice.” For a yearly retainer of $2,200 (in addition to the usual charges that would still be billed through Medicare and supplemental insurance), Irene would receive “value-added” services. These include same-day appointments, electronic access to her medical records and lab reports, shortened waiting times, and other “frills” that Irene said her doctor always provided anyway.

    “Do you think I should do it?” Irene asked me, her younger cousin, the doctor in the family, the internist and geriatrician. “I don’t even own a computer.”

    My cousin, of course, is not alone. This same question is being asked by patients, many of them elderly, all over the country as more primary-care doctors opt for the concierge model.

    Meanwhile, companies are springing up to help doctors make the change. For a piece of the action, they help transform a struggling primary-care practice into a well-oiled profit center.

    As one such company, SignatureMD, advertises on its website: “It can be challenging for any physician to remain independent and profitable in the face of severe reimbursement cuts, increased regulation, and increased overhead. Our seasoned team of professionals have devoted years to developing a high reward, low risk concierge practice model. SignatureMD enables you to deliver the care that your patients desire while securing your financial independence.”

    Don’t get me wrong, for nearly 40 years I practiced as a primary-care internist and geriatrician, so I understand both sides of this issue. Primary-care doctors have been undervalued and under-reimbursed by Medicare since the inception of the program. There has not been a real increase in fees in the past decade, during which time costs have soared.

    “If you like this doctor, and you want to keep seeing her,” I said to Irene, “you won’t have a choice—you’ll have to join her concierge practice.”

    The Affordable Care Act, in theory, places more value on primary-care services. But so far this remains just theory. At the medical school where I teach, only a small minority of students are considering primary care as a career choice. That’s not unusual. Worse, in an era of burgeoning need, just 2% of young doctors in residency express any interest in geriatric medicine.

    Those of us who have spent our careers in the cottage industry of medical practice and working in America’s single-payer health-care system known as Medicare hear only this nowadays: “Get ready, changes are coming.” The talk is all wonky babble about “primary care medical homes,” “accountable care organizations,” “service bundling” and “resource-based relative value units.” Through the din, one thing is clear: The single practitioner will be unable to survive without joining some much larger entity, or by transforming into a concierge model.

    Medicare now looks the other way as the concierge-medicine movement grows. In times past, had physicians attempted to charge Medicare patients additional fees while still billing this agency for services rendered, all manner of fines and sanctions would have been imposed. No more. With the nation short 40,000 primary-care doctors—and that’s before 30 million more patients come on board in 2014 due to the Affordable Care Act—the policy gurus have looked around and concluded that they can’t afford to alienate the worker bees that still remain.

    Yet as financially tempting as a concierge practice might be, I could never have turned away a patient unable to come up with an annual retainer fee. I had a history with each and every one of them. They were my “family.” I tried to treat each of my patients equally and with the full measure of my time and concern. To do otherwise violates the basic justice principle of medical ethics that we teach medical students today.

    The last time I spoke to Irene, I asked her if she had been back to her internist since she had decided to pay the annual retainer. “I was in to see her last week,” she said. “Everything works the same way it did before—even though I’m paying all this extra money. . . . I just don’t feel the same about my doctor anymore.”

    I must ask: Are we witnessing the end of empathy in the practice of medicine?

    Dr. Winkaur practiced internal and geriatric medicine for 36 years. He is a clinical professor of medicine at the University of Texas Health Science Center at San Antonio, and the author of “Memory Lessons: A Doctor’s Story” (Hyperion, 2009).

    A version of this article appeared October 30, 2012, on page A23 in the U.S. edition of The Wall Street Journal, with the headline: ‘Concierge’ Medicine, ObamaCare and the End of Empathy.

  • HERE IS ONE OF MY FAVORITE COMMENTS:

  • 8 days ago
 

‘A good article almost until the end- when the author interjects his self-congratulatory “I could never have turned away a patient unable to come up with an annual retainer fee.” The author- like I- practiced during a different era. If he had to make ends meet, feed his family, pay for educating his kids and save for something that resembles a retirment in today’s healthcare economic reality he might well be singing a different tune. One will never know but without a doubt- he sure does not know what he’d have done if his practice realities were those of today’s doctors.

Not only does this ‘there but for the grace of God go I’ insertion smack of stories from non-combat troops opining about what they would have done had they been at the front line; but it serves to call into question the commitment of docs today who try to get the job done while paying off their student loans while at the same time listening to their future dictated by Obamanomics and Obamacare. Today’s doctors deserve better on a host of fronts- but particularly by the ‘old guard’ (including me) opining on their fate.

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Long Term Flu Vaccine?

Wednesday, November 7, 2012 // Uncategorized

 

A flu vaccine that gives long lasting protection against all strains of the flu and has to be given infrequently has long been the holy grail of flu researchers.  It appears to be getting closer to a reality. If the vaccine could then be mass produced with technology that did not involve growing the virus in eggs, that would be indeed  the holy grail.  This is a recent article from The New York Times.

Scientists Move Closer to a Lasting Flu Vaccine

By CARL ZIMMER
Published: October 29, 2012
 

As this year’s flu season gathers steam, doctors and pharmacists have a fresh stock of vaccines to offer their patients. The vaccines usually provide strong protection against the virus, but only for a while. Vaccines for other diseases typically work for years or decades. With the flu, though, next fall it will be time to get another dose.

 

Jacquelyn Martin/Associated Press

 

 

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“In the history of vaccinology, it’s the only one we update year to year,” said Gary J. Nabel, the director of the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases.

That has been the case ever since the flu vaccine was introduced in the 1950s. But a flurry of recent studies on the virus has brought some hope for a change. Dr. Nabel and other flu experts foresee a time when seasonal flu shots are a thing of the past, replaced by long-lasting vaccines.

“That’s the goal: two shots when you’re young, and then boosters later in life. That’s where we’d like to go,” Dr. Nabel said. He predicted that scientists would reach that goal before long — “in our lifetime, for sure, unless you’re 90 years old,” he said.

Such a vaccine would be a great help in the fight against seasonal flu outbreaks, which kill an estimated 500,000 people a year. But in a review to be published in the journal Influenza and Other Respiratory Viruses, Sarah Gilbert of Oxford University argues that they could potentially have an even greater benefit.

Periodically, a radically new type of flu has evolved and rapidly spread around the world. A pandemic in 1918 is estimated to have killed 50 million people.

With current technology, scientists would not have a vaccine for a new pandemic strain until the outbreak was well under way. An effective universal flu vaccine would already be able to fight it.

“Universal vaccination with universal vaccines would put an end to the threat of global disaster that pandemic influenza can cause,” Dr. Gilbert wrote.

Vaccines work by enhancing the protection the immune system already provides. In the battle against the flu, two sets of immune cells do most of the work.

One set, called B cells, makes antibodies that can latch onto free-floating viruses. Burdened by these antibodies, the viruses cannot enter cells.

Once flu viruses get into cells, the body resorts to a second line of defense. Infected cells gather some of the virus proteins and stick them on their surface. Immune cells known as T cells crawl past, and if their receptors latch onto the virus proteins, they recognize that the cell is infected; the T cells then release molecules that rip open the cells and kill them.

This defense mechanism works fairly well, allowing many people to fight off the virus without ever feeling sick. But it also has a built-in flaw: The immune system has to encounter a particular kind of flu virus to develop an effective response against it.

It takes time for B cells to develop tightfitting antibodies. T cells also need time to adjust their biochemistry to make receptors that can lock quickly onto a particular flu protein. While the immune system educates itself, an unfamiliar flu virus can explode into full-blown disease.

Today’s flu vaccines protect people from the virus by letting them make antibodies in advance. The vaccine contains fragments from the tip of a protein on the surface of the virus, called hemagglutinin. B cells that encounter the vaccine fragments learn how to make antibodies against them. When vaccinated people become infected, the B cells can quickly unleash their antibodies against the viruses.

Unfortunately, a traditional flu vaccine can protect against only flu viruses with a matching hemagglutinin protein. If a virus evolves a different shape, the antibodies cannot latch on, and it escapes destruction.

Influenza’s relentless evolution forces scientists to reconfigure the vaccine every year. A few months before flu season, they have to guess which strains will be dominant. Vaccine producers then combine protein fragments from those strains to create a new vaccine.

Scientists have long wondered whether they could escape this evolutionary cycle with a vaccine that could work against any type of influenza. This so-called universal flu vaccine would have to attack a part of the virus that changes little from year to year.

 

       Dr. Gilbert and her colleagues at Oxford are trying to build a T cell-based vaccine that could find such a target. When T cells learn to recognize proteins from one kind of virus, the scientists have found, they can attack many other kinds. It appears that the flu proteins that infected cells select to put on display evolve very little.

The scientists are testing a vaccine that prepares T cells to mount a strong attack against flu viruses. They engineered a virus that can infect cells but cannot replicate. As a result, infected cells put proteins on display, but people who receive the vaccine do not get sick.

In a clinical trial reported this summer, the scientists found that people who received the vaccine developed a strong response from their T cells. “We can bring them up to much higher levels with a single injection,” said Dr. Gilbert, the lead author of the study.

Once the scientists had vaccinated 11 subjects, they exposed them to the flu. Meanwhile, they also exposed 11 unvaccinated volunteers. Two vaccinated people became ill, while five unvaccinated ones did.

While the Oxford researchers focus on T cell vaccines, others are developing vaccines that can generate antibodies that are effective against many flu viruses — or perhaps all of them.

The first hint that such antibodies exist emerged in 1993. Japanese researchers infected mice with the flu virus H1N1. They extracted antibodies from the mice and injected them into other mice. The animals that received the antibodies turned out to be protected against a different kind of flu, H2N2. In hindsight, that discovery was hugely important. But at the time no one made much of it.

“By and large, people just said, ‘This is an oddity — so what?’ ” said Ian Wilson of the Scripps Research Institute.

Scientists did not appreciate its importance for more than 15 years, until Dr. Wilson and other researchers began isolating the antibodies that provided this kind of broad protection and showed how they worked.

The new antibodies turn out to attack different parts of the flu virus from the ones produced by today’s vaccines. Today’s vaccines cause B cells to make antibodies that clamp onto a broad region of the tip of the hemagglutinin protein. Recently, Dr. Wilson and his colleagues discovered a new antibody with a slender tendril. It can snake into a groove in the hemagglutinin tip.

Dr. Wilson and his colleagues found that this tendriled antibody can attach to a wide range of flu viruses. The results hint that the groove — which flu viruses use to attach to host cells — cannot work if its shape changes much.

The antibody is also impressively powerful, the scientists found. They infected mice with a lethal dose of the flu and then, after three days, injected the new antibody into them. The antibody stopped the virus so effectively that the mice recovered.

The hemagglutinin groove is not the only promising target for antibodies. Dr. Wilson and other scientists are discovering antibodies that attack the base of the protein. Influenza viruses can be broadly categorized into three types — A, B and C. Until now, scientists have found only antibodies that attack different versions of influenza A. Dr. Wilson and colleagues at Scripps and the Crucell Vaccine Institute in the Netherlands recently found a stem-attacking antibody that blocks influenzas A and B.

“The whole field is invigorated,” Dr. Wilson said. “It’s a great time.”

Building on these discoveries, Dr. Nabel and other scientists have recently developed vaccines that generate some of the new antibodies in humans. Now they are trying to figure out how to get the body to make a lot of the antibodies.

“Once you have an antibody that has all the properties you desire, how do you coax the immune system to make that?” Dr. Nabel said. “That’s the classic problem in immunology.”

 Conspiracy theorists would predict that the companies that produce annual flu vaccine might sabotage such research to avoid revenue loss.
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Shingles and Cancer

Thursday, November 1, 2012 // Uncategorized

Does having an episode of shingles mean that you might have cancer?  As someones who has had shingles recently, I took note of this recent article.  FYI, shingles is also known as varicella zoster and is caused by a recurrence of the same virus that causes chickenpox.  One’s immunity keeps it walled off in the spinal cord cells and then when the body’s immunity blinks it erupts in a blistering rash along a nerve  which can be painful.  Fortunately, in my case, it just itched.  It may be that the shingles vaccine, Zostavax, reduced the severity of the rash.  Shingles seems to be ubiquitous and for some reason,it is on the rise.

Does an Episode of Shingles Portend Cancer?

Cancer risk was not higher in a population-based study.

Clinicians have long debated whether an episode of shingles (herpes zoster) is a marker for underlying but not yet diagnosed cancer. In a retrospective cohort study, researchers in Taiwan used their national health insurance research database to address this question.

Shingles was diagnosed between 2000 and 2008 in nearly 36,000 adults with no history of cancer. During median follow-up of 4 years, cancer was diagnosed in 895 of these patients; this number of cancer events was virtually identical to the number predicted by national cancer registry data. No excess risk for cancer was found for any major cancer subgroup (head and neck, digestive, breast, lung, genitourinary, or hematologic).

Comment: A strength of this study is its population-based methodology. A search for occult cancer does not appear warranted in patients with recent episodes of shingles.

Allan S. Brett, MDt

Published in Journal Watch General Medicine September 27, 2012

Citation(s):

Wang Y-P et al. Risk of cancer among patients with herpes zoster infection: A population-based study. CMAJ 2012 Sep 17; [e-pub ahead of print]. (http://dx.doi.org/10.1503/cmaj.120518)

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