Update – eSource Pivotal Trial – WOW!!!
Target Health has begun to eliminate the use of paper records in the clinical trials it is managing. Target e*CTR (eClinical Trial Record; patent issued)™ is now being offered as part of our EDC and paperless clinical trial offering. And yes, it is compatible with any “modern” EDC system and does not change any of the interfaces or behavior of EDC systems. The following are contracted studies:
- 2 Phase I/II studies completed (IND Project 1)
- 2 Phase I studies to be completed December 2012 (IND Project 1)
- 1 Phase III pivotal study (n=200; 20 sites) to be completed Q1 2013; NDA to be submitted Q2 2013 (IND Project 1)
- 1 Phase IIIb open-label extension study to be completed Q4 2013 (IND Project 1)
- 1 Phase II study (n=120; 6 sites) to be completed December 2012 (IND Project 2)
- 1 Phase I study to be initiated January 2013 (IND Project 3)
- 5-year followup of a PMA device study
RESULTS: An analysis was performed of 10,458 pages entered in the first 3 months of an ongoing Phase 3 clinical trial using Target e*CTR and direct data entry at the time of the office visit. What is unique is that it is possible to review all monitoring metrics in real time and implement changes within hours of any real time observation.
- Of the 2,283 pages that were source document verified (SDV) because there were paper records in the patient’s chart, there were just 16 (0.7%) changes made to the database; 4 of the changes were 4 minor medical histories for 1 subject that was found by the CRA in the chart. None of the findings were critical.
- Initial form review from the time of data entry, which occurred in real time at the office visit:
- 50% of pages were reviewed within 11 hours
- 75% of pages were reviewed within 25 hours
- 90% of pages were reviewed within 54 hours
- 95% of pages were reviewed within 92 hours
- Just 4.2% of pages were queried
- Just 1.4% of pages had queries that were generated as a result of online edit checks (auto queries)
- Just 1.6% of pages were modified post query.
- Of those pages that were changed, at least 62% were non-significant changes to baseline medications and medical history.
- There were no changes made to the database that would have affected patient safety or the outcome of the trial.
|# Pages Entered||# Pages With Queries||# Pages Modified Post Query|
|10,458||435 (4.2%)||164 (1.6%)|
For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website at www.targethealth.com
Genome Hunters Go After Martian DNA
Hot place: Some biologists want to send a DNA sequencing machine to Mars to search for life.
NASA – courtesy of nasaimages.org
J. Craig Venter may have just started a race to discover alien life on the Red Planet. Two high-profile entrepreneurs say they want to put a DNA sequencing machine on the surface of Mars in a bid to prove the existence of 1) ___ life. In what could become a race for the first extraterrestrial genome, researcher J. Craig Venter said Tuesday that his Maryland academic institute and his company, Synthetic Genomics, would develop a machine capable of sequencing and beaming back 2) ___ data from the planet. Separately, Jonathan Rothberg, founder of Ion Torrent, a DNA sequencing company, is collaborating on an effort to equip his company’s “Personal Genome Machine” for a similar task. “We want to make sure an Ion Torrent goes to 3) ___,” Rothberg told MIT Technology Review.
Although neither team yet has a berth on a Mars rocket, their plans reflect the belief that the simplest way to prove there is 4) ___ on Mars is to send a DNA sequencing machine. “There will be DNA life forms there,” Venter predicted Tuesday in New York, where he was speaking at the Wired Health Conference. Venter said researchers working with him have already begun tests at a Mars-like site in the Mojave Desert. Their goal, he said, is to demonstrate a machine capable of autonomously isolating microbes from soil, 5) ___ their DNA, and then transmitting the information to a remote computer, as would be required on an unmanned Mars mission.
Meanwhile, Rothberg’s Personal Genome Machine is being adapted for Martian conditions as part of a NASA-funded project at Harvard and MIT called SET-G, or “the search for extraterrestrial genomes.” Christopher Carr, an MIT research scientist involved in the effort, says his lab is working to shrink Ion Torrent’s machine from 30 kilograms down to just three kilograms so that it can fit on a NASA 6) ___. Other tests, already conducted, have determined how well the device can withstand the heavy radiation it would encounter on the way to Mars.
NASA, whose Curiosity rover landed on Mars in August, won’t send another rover mission to the planet before at least 2018 (see “The Mars Rover Curiosity Marks a Technological Triumph“), and there’s no guarantee a DNA sequencing device would go aboard. “The hard thing about getting to Mars is hitting the NASA specifications,” says George Church, a Harvard University researcher and a senior member of the SET-G team. “[Venter] isn’t ahead of anyone else.”
Many scientists are lobbying NASA for what’s called a “sample return” mission–one that would make a round trip, bringing back soil and rocks for analysis. However, taking a DNA sequencing 7) ___ to Mars could be a better way to search for life. “The reason to take a device all the way to Mars and not bring back the sample is because of contamination. No one would believe you,” says Tessi Kanavarioti, a chemist who carried out early theoretical work on Martian biology and was involved in studying rocks brought back from the moon in the 1970s. Sequencing machines are so sensitive that if a single Earth germ landed on the sample returned from Mars, it might ruin the experiment.
Martian chronicler: A microfluidic device developed at MIT is designed to automatically run DNA experiments on other planets. Credit: Christopher Carr – MIT
Looking for DNA on Mars won’t be easy. A 8) ___ would have to scoop up soil and prepare a sample automatically. The sequencing machine would need to work in cold temperatures and in a very thin atmosphere made mostly of carbon dioxide. Martian genes might also be different from those in the bodies of terrestrial animals, perhaps being made up of different chemical building blocks. “This will work only if the DNA on Mars is exactly the same in its fundamental structure as on 9) ___,” says Steven Benner, president of the Foundation for Applied Molecular Evolution in Gainesville, Florida. He says he’s skeptical that will be the case: “It is very unlikely that Terran DNA is the only structure able to support Darwinian evolution.”
Discovering and sequencing extraterrestrial life would be an immense scientific prize. Sequencing could reveal whether life evolved in similar ways on both Earth and Mars or, perhaps, moved between the 10) ___. During a series of massive space collisions around four billion years ago, the two bodies exchanged about a billion tons of rocks and debris. So far, NASA researchers have searched Mars for traces of 11) ___—a prerequisite for life as we know it—as well as indirect signs that life might have existed there many eons ago. Since DNA molecules don’t survive more than a million years, even on Earth, anyone sending a DNA sequencer to Mars has to believe that living microorganisms will be found there now.
Life probably can’t survive the 12) ___ on the Martian surface, but it could exist under a meter or more of soil, where it would be protected. On Earth, for instance, living microorganisms are found several kilometers beneath the ground. Carr calls sending a DNA sequencer to Mars a “high-risk, high-payoff” experiment. It might very well find nothing, but if DNA were discovered, that would provide nearly irrefutable proof of extraterrestrial life. The slim odds apparently appeal to both Venter and Rothberg, two of biotechnology’s biggest showmen. A decade ago, Venter gave academic researchers heartburn with his privately financed effort to sequence the 13) ___ genome. Rothberg, also a media celebrity, has made news by sequencing the DNA of notables like James Watson, as well as of Neanderthals.
Venter said it might be feasible in the future to reconstruct Martian organisms in a super-secure laboratory on Earth, using just their DNA sequence. The idea would be to use the DNA data to rebuild their 14) ___ and then inject those into an artificial cell of some kind. It’s an idea he calls the “biological teleporter.” “People are worried about the Andromeda strain,” says Venter. “We can rebuild the Martians in a P-4 spacesuit lab instead of having them land in the ocean.” Source: MIT Technology Review, October 2012
ANSWERS: 1) extraterrestrial; 2) DNA; 3) Mars; 4) life; 5) sequencing; 6) rover; 7) machine; 8) robot; 9) Earth; 10) planets; 11) water; 12) radiation; 13) human; 14) genomes
J. Craig Venter (1946 to present)
John Craig Venter (born October 14, 1946) is an American biologist and entrepreneur and is known for being one of the first to sequence the human genome and for creating the first cell with a synthetic genome. Venter founded Celera Genomics, The Institute for Genomic Research (TIGR) and the J. Craig Venter Institute (JCVI), and is now working at JCVI to create synthetic biological organisms. The British magazine New Statesman listed Craig Venter at 14th in the list of “The World’s 50 Most Influential Figures 2010”.
Venter was born in Salt Lake City, Utah. In his youth, he did not take his education seriously, preferring to spend his time on the water in boats or surfing. According to his biography, A Life Decoded, he was said to never be a terribly engaged student, having Cs and Ds on his eighth-grade report cards. Venter himself recognized his own ADHD behavior in his adolescence, and later found ADHD-linked genes in his own DNA.
Venter graduated from Mills High School and began his college career at a community college, College of San Mateo in California. He received his B.S. degree in biochemistry in 1972, and his Ph.D. degree in physiology and pharmacology in 1975, both from the University of California, San Diego. At UCSD, he studied under biochemist Nathan O. Kaplan. After working as an associate professor, and later as full professor, at the State University of New York at Buffalo, he joined the National Institutes of Health in 1984.
While at the NIH, Venter learned of a technique for rapidly identifying all of the mRNAs present in a cell and began to use it to identify human brain genes. The short cDNA sequence fragments discovered by this method are called expressed sequence tags (ESTs), a name coined by Anthony Kerlavage at The Institute for Genomic Research. The NIH initially led an effort to patent these gene fragments, in which Venter coincidentally and controversially became involved. The NIH later withdrew the patent applications, following public outcry. Subsequent court cases declared that ESTs were not directly patentable.
Venter was passionate about the power of genomics to radically transform healthcare. Venter believed that shotgun sequencing was the fastest and most effective way to get useful human genome data. The method was controversial, however, since some geneticists felt it would not be accurate enough for a genome as complicated as that of humans. Frustrated with what Venter viewed as the slow pace of progress in the Human Genome project, and unable to get funds for his ideas, he sought funding from the private sector to fund Celera Genomics. The goal of the company was to sequence the entire human genome and release it into the public domain for non-commercial use in much less time and for much less cost than the public human genome project. The company planned to monetize their work by creating a value-added database of genomic data to which users could subscribe for a fee. The goal consequently put pressure on the public genome program and spurred several groups to redouble their efforts to produce the full sequence. DNA from five demographically different individuals was used by Celera to generate the sequence of the human genome; one of the individuals was Venter himself. In 2000, Venter and Francis Collins of the National Institutes of Health and U.S. Public Genome Project jointly made the announcement of the mapping of the human genome, a full three years ahead of the expected end of the Public Genome Program.
The announcement was made along with US President Bill Clinton, and U.K. Prime Minister Tony Blair. Venter and Collins thus shared an award for “Biography of the Year” from A&E Network. On the 15 February 2001, the Human Genome Project consortium published the first Human Genome in the journal Nature, and was followed, one day later, by a Celera publication in Science. Despite some claims that shotgun sequencing was in some ways less accurate than the clone-by-clone method chosen by the Human Genome Project, the technique became widely accepted by the scientific community and is still the de facto standard used today.
Although Celera was originally set to sequence a composite of DNA samples, partway through the sequencing, Venter switched the samples for his own DNA. After contributing to the Human Genome, and its release into the public domain, Venter was fired by Celera in early 2002. According to his biography, Venter was ready to leave Celera, and was fired due to conflict with the main investor, Tony White, that had existed since day one of the project. Venter writes that his main goal was always to accelerate science and thereby discovery, and he only sought help from the corporate world when he couldn’t find funding in the public sector.
The Global Ocean Sampling Expedition (GOS) is an ocean exploration genome project with the goal of assessing the genetic diversity in marine microbial communities and to understand their role in nature’s fundamental processes. Begun as a Sargasso Sea pilot sampling project in August 2003, Craig Venter announced the full Expedition on 4 March 2004. The project, which used Craig Venter’s personal yacht, Sorcerer II, started in Halifax, Canada, circumnavigated the globe and returned to the U.S. in January 2006.
Venter is currently the president of the J. Craig Venter Institute, which conducts research in synthetic biology. In June 2005, he co-founded Synthetic Genomics, a firm dedicated to using modified microorganisms to produce clean fuels and biochemicals. In July 2009, ExxonMobil announced a $600 million collaboration with Synthetic Genomics to research and develop next-generation biofuels.
In May 2010, a team of scientists led by Venter became the first to successfully create what was described as “synthetic life”. This was done by synthesizing a very long DNA molecule containing an entire bacterium genome, and introducing this into another cell, analogous to the accomplishment of Eckard Wimmer’s group, who synthesized and ligated an RNA virus genome and “booted” it in cell lysate. The single-celled organism contains four “watermarks” written into its DNA to identify it as synthetic and to help trace its descendants. The watermarks include:
- Code table for entire alphabet with punctuations
- Names of 46 contributing scientists
- Three quotations
- The web address for the cell.
On September 4, 2007, a team led by Sam Levy published the first complete (six-billion-letter) genome of an individual human-Venter’s own DNA sequence. Some of the sequences in Venter’s genome are associated with wet earwax, increased risk of antisocial behavior, Alzheimer’s and cardiovascular diseases. This publication was especially interesting since it contained a diploid instead of a haploid genome and shows promise for personalized medicine via genotyping. This genome, dubbed HuRef by Levy and others, was a landmark accomplishment and as of mid-2010 is probably the highest quality personal genome sequence yet completed.
Associations Between Conventional Cardiovascular Risk Factors and Risk of Peripheral Artery Disease in Men
Previous studies have examined the associations of individual clinical risk factors with risk of peripheral artery disease (PAD), but the combined effects of these risk factors are largely unknown. As a result, a study published in the Journal of the American Medical Association (2012;308:1660-1667) was performed to estimate the degree to which the 4 conventional cardiovascular risk factors of smoking, hypertension, hypercholesterolemia, and type 2 diabetes are associated with the risk of PAD among men.
The investigation was a prospective study of 44,985 men in the US without a history of cardiovascular disease at baseline in 1986. These participants in the Health Professionals Follow-up Study were followed up for 25 years until January 2011. The presence of risk factors was updated biennially during follow-up.
The main outcome measure was clinically significant PAD defined as limb amputation or revascularization, angiogram reporting vascular obstruction of 50% or greater, ankle-brachial index of less than 0.90, or physician-diagnosed PAD.
Results showed that during a median follow-up of 24.2 years, there were 537 cases of incident PAD. Each risk factor was significantly and independently associated with a higher risk of PAD after adjustment for the other 3 risk factors and confounders. The age-adjusted incidence rates were:
- 9 for 0 risk factors
- 23 for 1 risk factor
- 47 for 2 risk factors
- 92 for 3 risk factors, and
- 186 for 4 risk factors.
According to the authors, among men in this cohort, smoking, hypertension, hypercholesterolemia, and type 2 diabetes account for the majority of risk associated with development of clinically significant PAD.
Dying for the Weekend – Association Between Day of Hospital Presentation and the Quality and Safety of Stroke Care
Sickness knows not the time of day or the day of the week.
According to an article published in the Archives of Neurology (2012;69:1296-1302), a study was performed to examine the association between day of admission and measures of the quality and safety of the care received by patients with stroke.
The investigation was a retrospective cohort study of patients admitted to English National Health Service public hospitals with stroke (codes I60-I64 from the International Statistical Classification of Diseases and Related Health Problems, Tenth Version) from April 1, 2009, through March 31, 2010. The main outcome measures were quality and safety measurements using 6 indicators spanning the hospital care pathway, from timely brain scans to emergency readmissions after discharge.
There were 93,621 admissions during the study period. Performance across 5 of the 6 measures was significantly lower on weekends (confidence level, 99%). One of the largest disparities was seen in rates of same-day brain scans, which were 43.1% on weekends compared with 47.6% on weekdays. In particular, the rate of 7-day in-hospital mortality for Sunday admissions was 11.0% (with Monday used as a reference) compared with a mean of 8.9% for weekday admissions.
According to the authors, strong evidence suggests that, nationally, stroke patients admitted on weekends are less likely to receive urgent treatments and have worse outcomes across a range of indicators. The authors assed that although the results were adjusted for case mix, it was not possible to rule out some of the effect being due to unmeasured differences in patients admitted on weekends compared with weekdays. The findings suggest that approximately 350 in-hospital deaths each year within 7 days are potentially avoidable, and an additional 650 people could be discharged to their usual place of residence within 56 days if the performance seen on weekdays was replicated on weekends.
NIH Establishes Down Syndrome Patient Registry
Down syndrome most frequently results from an extra copy of chromosome 21 (Trisomy 21). Infants with Down syndrome are likely to have certain physical characteristics, such as short stature and distinctive facial features, as well as health conditions like hearing loss, heart malformations, digestive problems, and vision disorders. Although Down syndrome most commonly results in mild to moderate intellectual disability, the condition occasionally involves severe intellectual disability. In addition, some individuals with Down syndrome age prematurely and may experience dementia, memory loss, or impaired judgment similar to that experienced by individuals with Alzheimer disease.
People with Down syndrome or their family members will now be able to enter contact information and health history in an online, secure, confidential database. Registry participants will be able to customize their profile, update it online, and choose which information they would like to display, including reminders about their own medical care and general information about Down syndrome. They also will be able to compare their own medical information to that of other registrants in a confidential and anonymous manner.
If a participant gives permission to be contacted, clinicians and researchers who are authorized to access the database will be able to contact these individuals to see if they are interested in participating in a research study. Ultimately, the registry will be able to link to biorepositories of tissue samples and other resources, with the goal of making it easier for patients to take part in clinical studies for new medications and other treatments for Down syndrome.
Development of a patient registry was a leading recommendation in the 2007 NIH Down Syndrome Research Plan, which sets goals and objectives for the Down syndrome research field. Together with the Global Down Syndrome Foundation, the NICHD sponsored the Down syndrome National Conference on Patient Registries, Research Databases, and Biobanks to solicit the advice of a number of experts from the advocacy community, federal agencies, industry, and the clinical and research communities on how best to establish a Down syndrome registry.
The plan for the registry was supported by the public-private Down Syndrome Consortium which was established by the NIH in 2011 to foster the exchange of information on Down syndrome research, and to implement and update the Research Plan. Membership on the Consortium includes individuals with Down syndrome and family members, representatives from prominent Down syndrome and pediatric organizations, and members of the NIH Down Syndrome Working group, an internal NIH group that coordinates NIH-supported Down syndrome research.
TARGET HEALTH excels in Regulatory Affairs. Each week we highlight new information in this challenging area
FDA Approves Synribo for Chronic Myelogenous Leukemia (CML)
According to the National Institutes of Health, an estimated 5,430 people will be diagnosed with chronic myelogenous leukemia (CML) in 2012.
The FDA has approved Synribo (omacetaxine mepesuccinate) to treat adults with chronic myelogenous leukemia (CML), a blood and bone marrow disease. Synribo blocks certain proteins that promote the development of cancerous cells.
Synribo is intended to be used in patients whose cancer progressed after treatment with at least two drugs from a class called tyrosine kinase inhibitors (TKIs), also used to treat CML. Synribo blocks certain proteins that promote the development of cancerous cells. It is injected just under the skin (subcutaneously) twice daily for 14 consecutive days over a 28-day cycle until white blood cell counts normalize (hematologic response). Synribo is then administered twice daily for seven consecutive days over a 28-day cycle as long as patients continue to clinically benefit from therapy.
Synribo is the second drug approved to treat CML in the past two months. On 4 September 2012, the FDA approved Bosulif (bosutinib) to treat patients with chronic, accelerated or blast phase Philadelphia chromosome positive CML who are resistant to or who cannot tolerate other therapies.
Synribo was approved under the FDA’s accelerated approval program, which allows the agency to approve a drug to treat a serious disease based on clinical data showing that the drug has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients. This program provides earlier patient access to promising new drugs while the company conducts additional clinical studies to confirm the drug’s clinical benefit and safe use. Synribo also received orphan-product designation by the FDA because it is intended to treat a rare disease or condition.
The effectiveness of Synribo was evaluated using a combined cohort of patients whose cancer progressed after previous treatment with two or more TKIs. All participants were treated with Synribo. The drug’s effectiveness in chronic phase CML was demonstrated by a reduction in the percentage of cells expressing the Philadelphia chromosome genetic mutation found in most CML patients. Fourteen out of 76 patients (18.4%) achieved a reduction in an average time of 3.5 months. The median length of the reduction was 12.5 months.
In accelerated phase CML, Synribo’s effectiveness was determined by the number of patients who experienced a normalization of white blood cell counts or had no evidence of leukemia (major hematologic response, or MaHR). Results showed five out of 35 patients (14.3%) achieved MaHR in an average time of 2.3 months. The median duration of MaHR in these patients was 4.7 months.
The most common side effects reported during clinical studies include a low level of platelets in the blood (thrombocytopenia), low red blood cell count (anemia), a decrease in infection-fighting white blood cells (neutropenia) which may lead to infection and fever (febrile neutropenia), diarrhea, nausea, weakness and fatigue, injection site reaction, and a decrease in the number of lymphocytes in the blood (lymphopenia).
Synribo is marketed by Frazer, Pa.-based Teva Pharmaceuticals. Bosulif is marketed by New York City-based Pfizer.
Fig Galette ala Glen Park
This space has printed several luscious recipes for fresh figs, which help to transition from summer to fall. Here is yet another delicious dish to pleasure your palette
A recipe by Glen Park, Senior Clinical Director at Target Health Inc.
Fresh figs are a great delight for late summer, whether raw or cooked as in this fig galette. This recipe is based on a recipe from Bon Appetit magazine October 1998. A galette is basically a rustic tart where the sides of the tart are free form.
- 1 1/3 cups all-purpose flour
- 1/2 teaspoon salt
- 1/3 cup chilled solid vegetable shortening, cut into small pieces
- 5 tablespoons chilled unsalted butter, cut into small pieces
- 2 tablespoons (about) ice water
- 1 pound fresh ripe figs (about 10), quartered
- 2 tablespoons raspberry jam
- 1 tablespoon Chambord liqueur
- 1 large egg yolk beaten to blend with 1 teaspoon water (for glaze)
- Demerara (or other natural brown sugar) for sprinkling
Mix flour and salt in processor. Add shortening and butter. Using on/off turns, process until mixture resembles coarse meal. Mix in water 1 tablespoon at a time just until moist clumps form. Gather dough into ball; flatten into disk. Wrap in plastic and refrigerate 30 minutes.
Preheat oven to 425°F. Roll out dough between 2 layers of plastic wrap to 12-inch round. Remove top layer of plastic. Invert dough onto unrimmed baking sheet. Remove top layer of plastic.
Heat raspberry jam in a small saucepan with the Chambord. Bring to a boil for 5 minutes or until thickened. Let the jam cool to room temperature and spread onto the dough on the baking sheet, leaving a 2-inch border around edges. Arrange figs in concentric rows over the jam. Fold dough border over fruit, pleating loosely and pinching to seal any cracks. Brush dough border with egg mixture. Sprinkle border with sugar.
Bake galette until crust is brown and filling bubbles, about 35 minutes. Transfer baking sheet to rack and cool galette slightly, about 20 minutes. Slide spatula under all sides of crust to free galette from baking sheet. Using large tart pan bottom as aid, transfer galette to platter. Serve warm or at room temperature.
To serve with this galette we suggest your favorite coffee or tea.
To Glen’s recipe we add one more and then say goodbye to figs until the end of next summer or early fall
Easy Poached Figs
Here’s another fig recipe, that’s quick and easy to put together, if you can still find some fresh figs. The season is slipping by.
Poached Figs With Blackberries
For an easy dessert, try poaching figs in the slow cooker. The figs simmer in a strained blackberry puree, turning them a pretty purple. You could also use a blueberry puree. To make a fresh fruit puree, simply wash and then dry your fresh fruit with paper towel, put into a food processor and pulse. Scoop the fruit out of the food processor and into your slow-cooker. You can add a little port wine or your favorite liqueur (to your taste) to the puree and stir. Then poach the figs slowly for about 30 to 45 minutes. Serve warm with a dollop of crème fraiche or vanilla ice cream and use the sauce to spoon over the dessert either before or after you add the crème fraiche or vanilla ice cream.
Because figs go so well with cheese, another serving option is, once the figs are poached, place all of the figs in an oven-proof serving dish. Now add a generous amount of brie over the figs, with the sauce spooned over, and put into a preheated oven (350) for a few minutes until the brie has started to ooze over the figs. Serve warm at once.
Serve with your favorite coffee or tea. You might enjoy some amaretto liqueur and biscotti
Can we “Keep” our Health Care? A Requiem for Small Practices
By Mark L. Horn, MD, MPH, Chief Medical Officer, Target Health Inc.
Editor’s note: While we may be seeing an end of an era, there may be advantages to go[J1] to a group practice, where all specialties are represented in “one building”; so if needed, a consult could occur at the time of the office visit. This happened recently during an eye examination in a multi-specialty eye care medical practice. At a moment’s request, a cornea expert consulted with a retina expert where a non-issue was resolved in 10 minutes.
While preparing a lecture reviewing Medical Homes and Accountable Care Organizations for a class of public health graduate students, a thought intruded which, in retrospect, was self-evident, but nevertheless troubling. Under many, if not most, of the proposed innovative medical models receiving serious attention it is sadly (at least for me) hard to envision the survival of the individual and small group practices that have been fundamental models of care during virtually my entire professional life.
The forces compelling a change in the system of healthcare delivery are profound and compelling. These forces predate the passage of the Affordable Care Act and will remain drivers of health system change irrespective of any changes to the ACA as a consequence of the upcoming election. For our ON TARGET audience it is unnecessary to review the cost pressures, quality challenges, and the widening sense of dissatisfaction among multiple constituencies with the current US healthcare system; these are long standing, intensely analyzed, and chronically unsolved. Physicians, other provider groups, government and private payers, and patients and their advocates, despite their varied views about what should be done, seem aligned around the need for major system change. Of note, the still widely used and liked (by many physicians) “fee-for-service” reimbursement system seems a favored target as a driver of both uncontrollable costs and suboptimal quality. It is therefore a major target for reform.
It is not the intent today to review, assess, and opine on payment systems; the goal this week is less quantitative and more philosophical.
As I researched my lecture for the students, several themes emerged as drivers of most reform initiatives. These include the need for enhanced and more convenient access, improved coordination among multiple specialties, thoughtful utilization of teams including multiple types of providers, sophisticated tracking and reporting of costs, results, and patient outcomes, and finally, the alignment of financial incentives and sharing of risk across the entire system. These are critically Important and necessary goals.
Unfortunately for the extant solo and small group practices, it is hard to see how they can access the capital and expertise required to meet the needs for expanded information technology infrastructure, sophisticated ancillary personnel, and increased financial flexibility (e.g. the assumption and management of risk). Participation in Medical Home models and evolving Accountable Care Organizations will require capabilities characteristic of large organizations but not readily available to small practices.
Does the potential disappearance of solo and small practices matter? In a time of transformational change, are these models necessary casualties? Perhaps this is the case.
Still, for those of us of a certain age, the small, intimate private practice was the model of our mentors. There was a profound personal satisfaction that accrued to physicians adopting this style of practice. This threatened “small business model” had a genuine appeal for the doctors and, I suspect, worked well for many patients. As we move towards what will seemingly be larger, more complex, and (sorry for the charged word) “corporate like” structures, we should endeavor to identify and retain the best of the past.
An epidemic of age-related dementia looms
MIT Technology Review, October 25, 2012, by Gary Small — Every 68 seconds, another American is diagnosed with Alzheimer’s disease. The coming wave of older people with dementia will place an unprecedented emotional and economic burden on society (see “The Dementia Plague“). We’re living longer thanks in part to advances in medical technology, but we’re not necessarily living better.
Approximately 80 million baby boomers are beginning to approach the years when symptoms of Alzheimer’s disease emerge.
The risk for those 65 and older is 10 percent, and it nears 50 percent by age 85. A report on the global economic impact of dementia by Alzheimer’s Disease International estimated the 2010 costs of care at $604 billion.
We are wholly unprepared for this crisis. Despite decades of research, we have no cure, nor even any drug that can reverse or stave off symptoms more than temporarily. Considerable effort has targeted the plaques of amyloid protein that form in the brains of Alzheimer’s patients, but none of the latest clinical trials have succeeded. Though we must continue to explore amyloid’s contribution, we also need to research more widely, because there is more to Alzheimer’s disease.
We are wholly unprepared for this crisis.
Efforts need to be made to investigate treatments that target other potential mechanisms, such as abnormal accumulation of brain tau protein and inflammation of neurons. Resources need to be found for work on drugs or vaccines that protect a healthy brain before it becomes damaged. Many research groups, including my own, have developed brain scans and other tests that can detect the disease years before dementia develops.
We cannot afford to wait for new treatments, with their long development times. We should act now on compelling evidence that lifestyle choices such as diet and cardiovascular conditioning can forestall dementia symptoms. For example, two key Alzheimer’s prevention strategies, diet and exercise, are known to prevent type 2 diabetes, which doubles the probability of developing Alzheimer’s dementia.
If society is to avoid being overwhelmed by the cost of the Alzheimer’s epidemic, the disease must become an international health priority. Yet we have not invested as much in fighting it as we have in combating other diseases. Recent findings from the U.K. support increasing Alzheimer’s research funding by a factor of 30 to reach parity with cancer research. Making such an investment to catch up will pay off by saving millions of lives and, eventually, trillions of dollars.
Gary Small is director of the University of California, Los Angeles, Longevity Center.
FACTS of Vitamin D and Cognition (from MIT Technology Review)
– FACT: Cognitive decline is associated with low vitamin D levels. 19X more likely if < 10 ng of vitamin D
– FACT: Alzheimer’s Disease is associated with low vitamin D levels. 4X less likely if less likely if high vitamin D
– FACT: Every single risk factor listed for Alzheimer’s Disease is also a risk factor for low vitamin D levels
– FACT: Elderly cognition gets worse as the elderly vitamin D levels get even lower (while in senior homes)
– OBSERVATION: Reports of increased vitamin D levels result in improved cognition
– OBSERVATION: Alzheimer’s Disease has been seen to halt when vitamin D was added.
– OBSERVATION: Ten vitamin D INTERVENTION clinical trials are underway to prove the above
– OBSERVATION: Several studies have shown a strong association of Alzheimer’s Disease with a gene mutation which reduces vitamin D effectiveness
– OBSERVATION: 2 Meta-analysis in 2012 agree that Alzheimer’s Disease. associated with low vitamin D