Update of Phase 3 Clinical Trial Using eSource (Target e*CTR)


A phase 3 clinical trial started in August this year is using Target e*CTR™ (eClinical Trial Record), fully integrated with Target e*CRF, in lieu of paper source documents. Subject data are being entered at the time of the office visit in real team, thus the name eClinical Trial Record. Clearly, being alerted in real time when a subject signs informed consent, seeing data in real time, and being able to query almost immediately after entry, has revolutionized the way we now monitor our clinical trials. We met with FDA and shared our approach at a Type C Meeting under an IND. Interestingly, the sites are making very few errors. The majority of the database changes have to do with modifications of form properties based on requests from the sites, changes of online edit check specifications, and yes, “over-zealous” monitoring. Once we modified the Target e*CRF EDC application and retrained the monitors, query rates dropped.


Here are some metrics:


A. Query Rates

  1. At the time when 2,291 forms were entered the query rate was 8.3%. A week later, when 3,432 forms were entered, the query rate dropped to 7.6%.
  2. When there were 190 queries, 62% came from just 2 forms. A week later when there were 260 queries, those 2 forms represented 59% of total queries (sites retrained, EDC tweaked)
  3. Just 29 online edit checks fired from 2291 entered pages (forms) for a rate of 1.3%. This rate has stayed stable (1.4% a week later)
  4. Of the 29 edit checks, 15 were from one edit check which was modified. A week later when the edit check was modified, of the 49 edit check firing, there were still 15 from that edit check indicating that the problem was solved


B. Form Review: From the time of the office visit, of the entered forms:


  1. 1.     50% were reviewed in 4 hours
  2. 2.     75% were reviewed in 23 hours (<1 day)
  3. 3.     90% were reviewed in 45 hours (<2 days)
  4. 4.     95% were reviewed in 66 hours (<3 days)


Goodbye Binders


Goodbye Paper: Time to go to the shredder


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

Not Socialized Medicine/New Medical Care Networks Show Savings



A new model for delivering medical care, one promoted by the federal health care law, holds promise for slowing the 1) ___ of treating the sickest, most expensive patients, according to a new study. The sweeping law, enacted in 2010 and upheld by the Supreme Court this summer, encourages the creation of “accountable care organizations” — networks of 2) ___, doctors’ groups and other health care providers that collaborate to keep a defined group of patients healthier. The groups share in the savings if they meet quality and cost targets. The study, which was published Wednesday in The Journal of the American Medical Association, found that a predecessor to accountable care organizations achieved particular savings in caring for patients eligible for both Medicare and 3) ___.


Many of those patients have multiple, severe 4) ___ conditions and are especially expensive: The nation’s nine million “dual eligibles,” as they are known, make up 15% of the Medicaid population but account for 39% of the program’s spending. In the predecessor program, a Medicare experiment that ran from 2005 to 2010, 10 doctors groups from around the country received bonus 5) ___ if they met quality targets and achieved lower cost growth compared with Medicare spending on other patients in their region. The study, conducted by researchers from the Dartmouth Institute for Health Policy and Clinical Practice, found that the growth in spending per “dual eligible” 6) ___ slowed by $532 a year, or 5%, after doctors groups joined the demonstration program.


Over all, 7) ___ on dual eligibles in the program grew at only 60% of the rate of the control group. “The fact that they saved any money at all is a pretty significant finding,” said Carrie H. Colla, the study’s lead author. “It shows promise in that they did significantly improve 8) ___ while modestly improving spending.” The study found that for dual eligibles, the savings came largely from reducing hospital stays. Savings for the overall patient population in the experiment was more modest: Spending per patient slowed by $114 a year after the 10 doctors groups joined the demonstration program. The groups varied significantly in how much they spent per patient and how much they slowed the growth of spending over 9) ___. The doctors group that spent the most before joining the program – the University of Michigan Faculty Group Practice, based in Ann Arbor – also saved the most, an average of $2,499 per dual eligible patient annually. But the group that spent the least on such patients before entering the program – Marshfield Clinic, in Wisconsin – also achieved notable savings, the study found, slowing the growth of spending per dual eligible patient by an average of $987 per year.


The findings come as accountable care organizations are forming around the country. According to the Department of Health and Human Services, more than 150 such groups now serve about 2.4 million Medicare patients. In the predecessor program, the Medicare Physician Group Practice Demonstration, participating 10) ___ groups were eligible for up to 80% of any savings they generated if they could also show improvement on 32 quality measures. In addition, The Institute of Medicine report – its research led by 18 best-of-class clinicians, policy experts and business leaders – details how the American medical system wastes an estimated $750 billion a year while failing to deliver reliable, top-notch 11) ___. That is roughly equivalent to the annual cost of health coverage for 150 million workers, or the budget of the Defense Department, or the 2008 bank bailout.


The American medical system squanders 30 cents of every dollar spent on health care, according to new calculations by the respected Institute of Medicine. But in all that waste and misuse, policy experts and economists see a significant opportunity – a way to curb runaway health spending, to improve 12) ___ outcomes and even to put the economy on sounder footing. The institute’s analysis of 2009 data shows $210 billion spent on unnecessary services, like repeated 13) ___, and $130 billion spent on inefficiently delivered services, like a scan performed in a hospital rather than an outpatient center. It also shows the health care 14) ___ wasting $75 billion a year on fraud, $55 billion on missed prevention opportunities and a whopping $190 billion on paperwork and unnecessary administrative costs. The Institute of Medicine is an independent adviser to the government and the public, and part of the National Academy of Sciences. Sources: JAMA, The New York Times by Abby Goodnough


ANSWERS: 1) cost; 2) hospitals; 3) Medicaid; 4) health; 5) payments; 6) patient; 7) spending; 8) quality; 9) time; 10) doctor; 11) care; 12) medical; 13) tests; 14) system

What Killed Vladimir Ilyich Lenin (1870-1924)



Vladimir Ilyich Lenin who died at 54 years of age in 1924, is remembered as one of the most seminal political figures of the 20th century. The cause of his last difficult years of health problems has been debated ever since – did Lenin, the founder and first head of the Soviet Union, suffer from syphilis? What caused the massive stroke that killed him just as the Communist nation he envisioned was taking shape? Now, more than 20 years after the Soviet Union fell, doctors are using modern medical knowledge and techniques to examine the medical mystery behind Lenin’s suffering and eventual death. Lenin is the subject of this year’s annual Historical Clinicopathological Conference (CPC) sponsored by the University of Maryland School of Medicine and the Veterans Affairs (VA) Maryland Health Care System. The conference is devoted to the modern medical diagnosis of disorders that affected prominent historical figures.


The physician considering Lenin’s case is noted neurologist and neuropathologist Harry Vinters, MD, professor of neurology and neuropathology and chief of neuropathology in the David Geffen School of Medicine at the University of California, Los Angeles. Each year at the conference, a medical expert is joined by a historian who summarizes the life and historical impact of the figure in question. This year’s guest speaker is Lev Lurie, PhD, a St. Petersburg-based expert in Russian history and politics. Vinters began his work by considering Lenin’s clinical history and autopsy report, the latter translated from the original Russian. In the report, Vinters found evidence of at least two strokes – a major stroke on the left side of his brain that would have left him unable to speak and paralyzed on one side of his body, and a smaller stroke on the right.


It is likely that Lenin suffered the effects of this larger stroke for some time before dying. According to Lurie, history shows that Lenin’s health began to decline in late 1921. The Communists had won the Civil War, but turmoil was still abundant. Lenin began to suffer from chronic headaches, insomnia, and fainting spells. Over time, Lenin’s condition worsened. In November 1921, Lenin faltered during a major speech, forgetting the words and snapping his fingers as he tried to remember. Later on, aphasia – the inability to speak – and agraphia – the inability to write – continued to develop, at times slightly lessening. But finally he could hardly walk. His right side was paralyzed. He had to learn to speak anew and to write with his left hand. He suffered in his estate before dying on Jan. 24, 1924. “What happened to Lenin is not a mystery,” Vinters says. “The autopsy findings and history are classic of stroke. But our question is, what was the cause of those strokes in a relatively young and otherwise healthy man?”


Lenin is somewhat of a puzzle. It is evident that the basal vessels in his brain were extremely hardened – this hardening of the blood vessels is known as atherosclerosis – but Lenin did not have many of the classic risk factors for this condition. “The interesting thing is why he would develop atherosclerosis at such an early age,” Vinters says. Lenin was not a smoker, a leading risk factor for atherosclerosis. In fact, he abhorred the habit and forbade smoking in his presence, a rarity considering how common smoking was among Russians during his lifetime. His autopsy also showed no signs of high blood pressure, another major risk factor. High blood pressure often causes an enlarged heart or kidney damage, neither of which were reported in Lenin’s body. He was not elderly, did not suffer from diabetes and was not obese – all also significant risk factors for atherosclerosis.


Vinters notes, however, Lenin’s family history. His father died at 54 – the identical age as Lenin himself. He also may have had a very strong predisposition to atherosclerosis. Stress is another risk factor, and there is no question Lenin dealt with it. “He led an extremely stressful life,” says Vinters. “People were always trying to assassinate him, for example. We all know what stress is, but everyone reacts to it differently. It is not clear how it affected him.” The specific cause of his cerebrovascular disease is still unclear, though the long-discussed possibility of syphilis is ruled out by the autopsy report even though syphilis was quite common in those days and was hard to treat. Meningovascular syphilis has distinct characteristics in the brain. The infarcts, or strokes, are usually very small in syphilis. Vinters stated that he did not see evidence of that. The other vessel that is usually affected by syphilis is the aorta, and that characteristic is not described in the autopsy either. It is therefore very unlikely that he would have had syphilis.


Strokes are historically common among political leaders. U.S. President Dwight Eisenhower suffered several while serving, as did British Prime Minister Winston Churchill. “Maybe what is most interesting is to speculate about what would have happened if Lenin had survived,” he says. “He could have been the leader of the Soviet Union well into his 70s and even 80s. How would that have changed history?”


“Though scientists and doctors of his time lacked even the terminology to describe cerebrovascular disease, certainly Lenin could have been diagnosed and treated had he lived in modern times,” says Philip Mackowiak, MD, MBA, professor and vice chair of the Department of Medicine at the University of Maryland School of Medicine and chief of the Medical Care Clinical Center at the VA Maryland Health Care System.

Long-Term Cardiovascular Risk of NSAID Use Post MI


The cardiovascular risk after the first myocardial infarction (MI) declines rapidly during the first year. As a result, an article published online in Circulation (10 Sept 2012), was performed to evaluate whether the cardiovascular risk associated with using nonsteroidal anti-inflammatory drugs (NSAIDs) was associated with the time elapsed following first-time MI.


The study identified patients aged 30 years or older admitted with first-time MI in 1997-2009 and subsequent NSAID use by individual-level linkage of nationwide registries of hospitalization and drug dispensing from pharmacies in Denmark. The study calculated the incidence rates of death and a composite endpoint of coronary death or nonfatal recurrent MIs associated with NSAID use in 1-year time intervals up to 5 years after inclusion. Results showed that of the 99,187 patients included, 43,608 (44%) were prescribed NSAIDs after the index MI. There were 36,747 deaths and 28,693 coronary deaths or nonfatal recurrent MIs during the 5 years of follow-up. Relative to non-current treatment with NSAIDs, the use of any NSAID in the years following MI was persistently associated with an increased risk of death (hazard ratio (HR) 1.59 after 1 year, and HR 1.63 after 5 years, and coronary death or nonfatal recurrent MI (HR 1.30) and HR 1.41.


According to the authors, the use of NSAIDs is associated with persistently increased coronary risk regardless of time elapsed after first-time MI and they advise long-term caution in using NSAIDs for patients after MI.

Cell Therapy for the Treatment of Chronic Venous Leg Ulcers


Spray-Applied Cell Therapy with Human Allogeneic Fibroblasts and Keratinocytes for the Treatment of Chronic Venous Leg Ulcers


Many patients with venous leg ulcers do not heal with standard care. HP802-247 is a novel spray-applied cell therapy containing growth-arrested allogeneic neonatal keratinocytes and fibroblasts. A study, published online in The Lancet (3 August 2012), compared different cell concentrations and dosing frequencies of HP802-247 when applied to chronic venous leg ulcers.


The investigation was a double-blind, randomized study which enrolled adult outpatients from 28 centers in the USA and Canada. Subject had to have up to three ulcers, venous reflux confirmed by doppler ultrasonography, and adequate arterial flow. At least one ulcer had to measure 2-12 cm2 in area and to have persisted for 6-104 weeks. Patients were randomly assigned to either 5.0×106 cells per mL every 7 days or every 14 days, or 0.5× x106 cells per mL every 7 days or every 14 days, or to vehicle alone every 7 days. All five groups received four-layer compression bandages. The trial sponsor, trial monitors, statisticians, investigators, center personnel, and patients were masked to treatment allocation. The primary endpoint was mean percentage change in wound area at the end of 12 weeks. Analyses were by intention to treat, excluding one patient who died of unrelated causes before first treatment.


At study initiation, 45 patients were assigned to 5.0 x106 cells per mL every 7 days, 44 to 5.0 x106 cells per mL every 14 days, 43 to 05 x106 cells per mL every 7 days, 46 to 0.5 x106 cells per mL every 14 days, and 50 to vehicle alone. All required visits were completed by 205 patients. The primary outcome analysis showed significantly greater mean reduction in wound area associated with active treatment compared with vehicle (p=0.0446), with the dose of 0.5 x106 cells/mL every 14 days showing the largest improvement compared with vehicle (15.98%, p=0.0028). Adverse events were similar across all groups, with only new skin ulcers and cellulitis occurring in more than 5% of patients.


According to the authors, venous leg ulcers can be healed with a spray formulation of allogeneic neonatal keratinocytes and fibroblasts without the need for tissue engineering, at an optimum dose of 0.5 x106 cells per mL every 14 days.

Children’s Immune Systems Restored Using Gene Therapy


Gene therapy is an experimental method for treating patients with genetic diseases. It is intended to integrate functioning genes among those naturally existing in the cells of the body to make up for faulty genes. While rare, severe combined immunodeficiency (SCID) became widely known because of the remarkable boy-in-the-bubble story of the 1970s. The story was based in part on a boy named David Vetter, who lived for 13 years in a plastic isolation unit to protect him from infections. He died following an unsuccessful bone marrow transplant that doctors had hoped would repair his immune system. This rare condition blocks the normal development of a newborn’s immune system, leaving the child susceptible to every passing microbe. Children with SCID experience chronic infections, which usually triggers the diagnosis. Their lifespan is two years if doctors cannot restore their immunity.


SCID has many causes. In one type, a gene that produces the adenosine deaminase (ADA) enzyme becomes mutated and fails to produce the normal enzyme. Without ADA, a chemically altered form of adenosine, one of DNA’s building blocks, accumulates in rapidly dividing bone marrow cells, killing them and destroying the immune system in the process. Normal bone marrow makes healthy white blood cells, or lymphocytes, which are the key players in the immune response that reacts against harmful bacteria and destroys cells infected by viruses. ADA deficiency accounts for some 15% of SCID cases. If there is a sibling available whose blood is compatible with the patient’s blood, doctors can perform a bone marrow transplant. If not, a form of the enzyme has to be administered by injection regularly to maintain the child’s immune system.


According to an article published online in the journal Blood (11 September 2012), it has demonstrated that a refined gene therapy approach safely restores the immune systems of some children with SCID. In the 11-year study, the authors tested a combination of techniques for gene therapy, arriving at one that produced normal levels of immune function for three patients.


“Doctors who treat patients with SCID have had limited treatment options for too long,” said Dan Kastner, M.D., Ph.D., scientific director of the National Human Genome Research Institute (NHGRI), part of the NIH. “The research teams and the patients who have participated in the studies have together achieved an impressive advance toward a cure that is welcome news for both the scientific and patient communities.”


Researchers seek to cure the disease by inserting a healthy copy of the ADA gene into continuously dividing bone marrow cells called stem cells. Bone marrow stem cells give rise to all other blood cells, including oxygen-carrying red cells and the white cells of the immune system. The healthy ADA gene would then produce enough enzyme to prevent immune-destroying toxicity. Getting a healthy, working ADA gene into bone marrow stem cells has proved difficult. Until now, the success of gene therapy for ADA-deficient SCID has been limited to about 10 children in Europe. Now, after 11 years of research, three children who received an optimized form of gene therapy in this U.S. clinical trial have experienced improved health for up to five years and have not required the enzyme-replacement injections.


The authors conducted a gene-therapy trial in 10 patients with ADA-deficient SCID. They used two slightly different DNA insertion vehicles, called retroviral vectors, to deliver the healthy ADA gene into the bone marrow cells of the patients. Retroviruses have the specialized ability to become a permanent part of host cells. Their genome consists of RNA that can be transcribed into DNA, delivering the corrected genetic material to the host cell. The authors reported the favorable performance of one of the vectors, which will be used from now on. Four of the patients remained on enzyme-replacement therapy throughout the procedure. The patients experienced no adverse effects, but did not experience a gain of ADA function. The authors suggest that enzyme replacement therapy may dilute the numbers of corrected lymphocytes in the patients’ immune systems, diminishing the treatment’s effect.


For six additional patients, the authors modified their gene therapy approach, stopping enzyme-replacement therapy beforehand and treating patients with a low dose of a chemotherapy that depletes stem cells in the bone marrow, making space for the gene-corrected stem cells that had been given the new gene in the laboratory and then returned to the patient’s body.


An additional eight children, most of whom are 1 year old or younger, have been added to a second phase of the study. The younger patients are showing even more favorable response rates to the therapy.

TARGET HEALTH excels in Regulatory Affairs. Each week we highlight new information in this challenging area


FDA Approves Production of Imaging Agent that Helps Detect Prostate Cancer


The FDA has approved the production and use of Choline C 11 Injection, a Positron Emission Tomography (PET) imaging agent used to help detect recurrent prostate cancer. Choline C 11 Injection is administered intravenously to produce an image that helps to locate specific body sites for follow-up tissue sampling and testing in men with recurrent prostate cancer.


PET imaging with Choline C 11 Injection is performed in patients whose blood prostate specific antigen (PSA) levels are increasing after earlier treatment for prostate cancer. An elevated PSA result suggests that prostate cancer may have returned, even though conventional imaging tests, such as computerized tomography (CT), have not shown any signs of cancer. PET imaging is not a replacement for tissue sampling and testing.


Choline C 11 Injection must be produced in a specialized facility and administered to patients shortly after its production. While PET imaging with Choline C 11 Injection has been performed at a few facilities over the past several years, none of these facilities were approved by the FDA to manufacture the agent. The Food and Drug Administration Modernization Act directed the agency to establish appropriate approval procedures and current good manufacturing practice requirements for all PET products marketed and used in the United States. The Mayo Clinic is now the first FDA-approved facility to produce Choline C 11 Injection.


The safety and effectiveness of Choline C 11 Injection were verified by a systematic review of published study reports. Four independent studies examined a total of 98 patients with elevated blood PSA levels but no sign of recurrent prostate cancer on conventional imaging. After PET imaging with Choline C 11, the patients underwent tissue sampling of the abnormalities detected on the PET scans. In each of the four studies, at least half the patients who had abnormalities detected on PET scans also had recurrent prostate cancer confirmed by tissue sampling of the abnormal areas. PET scan errors also were reported. Depending on the study, falsely positive PET scans were observed in 15% to 47% of the patients. These findings underscore the need for confirmatory tissue sampling of abnormalities detected with Choline C 11 Injection PET scans.


Aside from an uncommon, mild skin reaction at the injection site, no side effects to Choline C 11 Injection were reported.


Choline C 11 Injection is manufactured and distributed by the Mayo Clinic PET Radiochemistry Facility in Rochester, Minn.

Fresh Figs Stuffed & Baked with Cheese


Last Saturday, we had dinner (Manhattan) at our favorite Italian restaurant on the upper Eastside.. It’s fig season now, so to start, we were served the most delicious dish of fresh figs stuffed with gorgonzola cheese. Who knew how quick and easy this delectable appetizer would be to make. We want to share this fig recipe with our readers. We had our old favorite Italian white, Orvieto, icy from the freezer and served in chilled glasses, along with chunks of warm Italian bread, just out of the oven, which we drizzled with olive oil. The Italians sure know what they’re doing.  MMMmmmm!!




  • 12 fresh Figs
  • High-quality balsamic vinegar
  • Pinch Kosher salt (or none at all)
  • 8 ounces Gorgonzola Dolce, at room temperature
  • 1/2 cup walnuts, quartered and toasted


  • Preheat the oven to 350°F.
  • Slice the figs in half lengthwise, place them on a baking sheet, and dig a little hole in the middle with your finger. Drizzle the fig halves with 2 or 3 drops of balsamic vinegar and a pinch of salt or forget the salt not a big deal.
  • Fill each fig with the Gorgonzola and top with a quarter of a walnut. Bake for 5 minutes or until the cheese is melted and bubbly.
  • Serve on some thinly sliced fresh fennel. Use a mandolin to slice the fennel very very thin. Serve with some icy Orvieto wine in chilled wine glasses and chunks of warm Italian bread.

Where Cows Are Happy and Food Is Healthy


This article is from The New York Times, September 12, 2012, by Nicholas D. Kristof



Miraculously, here is a happy column about food! It’s about a farmer who names all his 230 milk cows, along with his 200 heifers and calves, and loves them like children.


Bob Bansen is a high school buddy of Nicholas Kristof who is a third-generation dairyman raising Jersey cows on lovely green pastures in Oregon beside the Yamhill River. Bob, 53, a lanky, self-deprecating man with an easy laugh, is an example of a farmer who has figured out how to make a good living running a farm that is efficient but also has soul. Bob has had names for every one of his “girls,” as he calls his cows. Walk through the pasture with him, and he’ll introduce you to them. “I spend every day with these girls,” Bob explained. “I know most of my cows both by the head and by the udder. You learn to recognize them from both directions.”


“This is Hosta,” he began, and then started pointing out the others nearby. “Jill. Sophia. This is Kimona. Edie would be the spotted one lying there. Pesto is the black one standing up. In front of her is Clare. Next to her is Pasta, who is Pesto’s daughter.” Bob was asked about Jill, and Bob then rattled off her specs. She is now producing about eight gallons a day, with particularly high protein and butterfat content. Jill’s mother was Jolly, a favorite of Bob’s. When Jolly grew old and unproductive, he traded her to a small family farm in exchange for a ham so she could live out her retirement with dignity.


As a farm-kid, Kristof grew up with Bob on the rolling green hills of Yamhill, where the Willamette Valley meets the coastal range. Just this year, Kristof has written about hens jammed in cages, with dead birds left to rot beside the survivors, and about industrial farms that try to gain a financial edge by pumping chickens full of arsenic, antibiotics, Tylenol and even Prozac. Yet all is not lost. Family farms can still thrive, while caring for animals and producing safe and healthy food. For Bob, a crucial step came when he switched to organic production eight years ago. A Stanford study has cast doubt on whether organic food is more nutritious, but it affirms that organic food does contain fewer pesticides and antibiotic-resistant bacteria. Bob’s big worry in switching to organic production was whether cows would stay healthy without routine use of antibiotics because pharmaceutical salesmen were always pushing them as essential. Indeed, about 80% of antibiotics in the United States go to farm animals – leading to the risk of more antibiotic-resistant microbes, which already cause infections that kill some 100,000 Americans annually.


Bob began to experiment by withholding antibiotics. To his astonishment, the cows didn’t get infections; on the contrary, their health improved. He realized that by inserting antibiotics, he may have been introducing pathogens into the udder. As long as cows are kept clean and are given pasture rather than cooped up in filthy barns, there’s no need to shower them with antibiotics and other pharmaceuticals, he says. Many cows in America now live out their lives in huge dairy barns, eating grain and hay and pumping out milk. But evidence is growing that cows don’t do well when locked up, so now many dairies are reverting to the traditional approach of sending cows out to pasture on grass.


This isn’t to say that Bob’s farm is a charity hostel. When cows age and their milk production drops, farmers slaughter them. Bob has always found that part of dairying tough, so, increasingly, he uses the older cows to suckle steers. That way the geriatric cows bring in revenue to cover their expenses and their day of reckoning can be postponed – indefinitely, in the case of his favorite cows.


Like many farmers, Bob frets about regulations and reporting requirements, but he also sympathizes with recent animal rights laws meant to improve the treatment of livestock and poultry. “You hate to have it go to legislation, but we need to protect the animals,” he said. “They’re living things, and you have to treat them right.” Granted, such a humane attitude may be easier to apply to dairying than to poultry. It’s tough for cage-free poultry farms to compete economically with huge industrial operations that raise millions of birds jammed into cages, and healthy food that is good for humans and animals in some cases will cost more. Moreover, we’re never going to revert to the kind of agriculture that existed a century ago. Bob’s 600 acres used to be farmed by five different families, and that consolidation won’t be undone. But neither is it inevitable that consolidation will continue indefinitely so that America’s farms end up as vast, industrial, soulless food factories.


I loved growing up on a sheep and cherry farm, even if that did mean getting up at 3 a.m. in the winter to check for newborn lambs, and I hope medium-size family farms remain a pillar of rural America. As Bob’s dairy shows, food need not come at the cost of animal or human health and welfare. We need not wince when we contemplate where our food comes from.


The next time you drink an Organic Valley glass of milk, it may have come from one of Bob’s cows. If so, you can bet it was a happy cow. And it has a name.



Editor’s Note: We winced to learn that 80% of antibiotics in the United States go to farm animals.  


Bob Bansen raises Jersey cows on his Yamhill, Ore., organic farm. To him, they’re more than milk cows. They’re his girls. Photo: Susan Seubert for The New York Times

Mycobacteria, MRSA, et al.; Target Rich Environments (seemingly) without Magic Bullets


By Mark L. Horn, MD, MPH, Chief Medical Officer, Target Health Inc.



A long and sad article in last weekend’s Wall Street Journal (A Woman’s Drug Resistant TB Echoes Around the World, by Geeta Anand, Saturday/Sunday September 8-9, 2012), told the tale of an Indian woman infected with resistant tuberculosis. There were an array of impressions and lessons, both overt and subtle, in this lengthy saga. Foremost was the suffering of the patient, but additionally impactful were the extraordinary willingness of her family to sacrifice virtually everything to secure the best care, the lengthy journeys to see yet another physician with yet another new treatment plan, and with respect to these the likely profound public health consequences of a woman with resistant tuberculosis taking long rides on crowded trains across vast distances. How many others were likely exposed and infected by these journeys; what are the global implications of these exposures and infections for the evolution of additional resistant strains which will inevitably spread beyond national borders?


Sometime after reading the story, I began to wonder about the apparently limited, but potentially important role of the global pharmaceutical industry in this story, not limited to resistant tuberculosis, but including methicillin resistant staphylococcus (MERSA) and the growing problem of bacterial resistance overall. Much is known about how these organisms function, so at least hypothetically (and here I confess to limited microbiologic knowledge) there are likely identifiable targets for drug discovery. Yet, it seems that essentially all of the attention is focused on behavioral change for patients directed towards maintaining adherence to increasingly complex and toxic therapeutic regimens and concurrently restricting their mobility. These are certainly rational strategies given current options, but at the same time wouldn’t it be desirable to augment the global response with an enhanced medical arsenal e.g., improve the biologic weaponry?


Perhaps this is a matter of economics rather than science; the profitability is higher for medicines directed against diseases plaguing developed nations, and the focus of the industry has consequently shifted to higher margin medicines directed against cancers, immunologic disorders (including HIV/AIDS where resistance seems to be anticipated and aggressively addressed), and Alzheimer’s Disease. Yet, a growing number of pathogens that my generation of physicians considered serious yet eminently treatable seem to be emerging as global threats. Despite vigorous efforts at containment, (some mentioned in the WSJ piece), given the mobility of individuals in our age, it is dangerous to rely solely on efforts to identify and quarantine infected patients; ultimately we shall need new medicines, and potentially new economic models to support their discovery and development.


Creative policies to augment the economic viability of new antibiotics developed in the private sector seem worth exploring; it is not only solar power and electric vehicles that cry out for more effective public-private collaboration.