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Target Health In The Public Domain

 

Manuscript:

 

Target Health is pleased to announce that The Drug Information Journal has accepted a manuscript for publication entitled “Cost-Effective Approach to Managing Laboratory Reference Ranges for Local Laboratories in Clinical Research.” Our good friend and colleague Vadim Tantsyura, MS, MA, DrPH (c) is lead author, with co-authorship by Imogene Grimes, (Sr. Director, Otsuka Pharmaceutical Company); Jules Mitchel, PhD MBA (President, Target Health); Sergiy Sirichenko, MS (Principal Data Scientist, Pinacle21/OpenCDISC); Jim Crowe, MS (President, JT Crowe Consulting); and Deborah Viola MBA PhD (Associate Professor of Public Health Practice, New York Medical College).

 

Feature in Science Careers:

 

Target Health is also pleased to announce that Dr. Jules T. Mitchel was featured by Dr. Cliff Mintz in Science Careers (9 March 2012), in an article entitled Biotech Training Programs Expand Employment Options. In the article, the Fundamentals of the Bioscience (FBS) Industry Program is described where Dr. Mitchel is a Course Director.

 

DIA Presentation:

 

Lastly, on Tuesday, June 26, 2012 (1:30 pm-3:00 pm), at the 48th Annual Meeting of the DIA, Dr. Mitchel will participate in a Forum entitled “Effective and Efficient Monitoring as a Component of Quality Assurance in the Conduct of Clinical Trials.” The forum will present data collected from the Clinical Trials Transformation Initiative (CTTI) survey on clinical trial monitoring and auditing practices used by organizations to address regulatory requirements, provide a rationale for the re-evaluation of these practices, and summarize new industry trends in the areas of monitoring and auditing of clinical trials.

 

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

Primary Progressive Aphasia

 

 

Primary progressive aphasia (PPA) is a rare 1) ___ syndrome that impairs language capabilities. PPA is a type of frontotemporal lobar degeneration, a cluster of related disorders that all originate in the frontal or temporal lobes of the 2) ___. People with PPA may have trouble naming objects or may misuse word endings, verb tenses, conjunctions and pronouns. Symptoms begin gradually, sometimes before the age of 65, and tend to worsen over time. People can become mute and may eventually lose the ability to understand written or spoken language. People with the disease usually continue caring for themselves, working and maintaining their interests, sometimes for many years after the disorder’s onset.

 

Signs and Symptoms: Sign and symptoms may vary by individual, depending on which portion of the brain’s 3) ___ center is involved and may include:

 

  • Word-finding pauses in speech
  • Difficulty in naming objects
  • Difficulty with comprehension of spoken and written language
  • Misuse of word endings, verb tenses, conjunctions and pronouns
  • Inability to comprehend word meanings
  • Prominent spelling errors

 

Signs and symptoms may also vary depending on the speaking situation. For example, a person may need to pause frequently to find 4) ___ during a conversation requiring a high level of precision, but then have no pauses when exchanging small talk. Some people may have less trouble with written language than with spoken language.

 

Causes: PPA is caused by a shrinking (atrophy) of the central portion of the brain’s left hemisphere which is the language center. Scar tissue and abnormal proteins may also be present, and brain activity is often reduced.

 

Risk Factors: Risk factors for primary progressive aphasia include:

 

  • Having learning disabilities. People with learning disabilities, particularly 5) ___, are at higher risk of PPA, perhaps because both conditions involve using and understanding language.
  • Having certain gene mutations. Rare gene mutations have been linked to the disorder. If several other members of your family have had PPA, you may be more likely to develop it, too, but a genetic form of PPA is extremely rare.

 

Complications: People with PPA can become mute and may eventually lose the ability to understand written and spoken language. This generally happens within 10 years of diagnosis. As the disease progresses, other mental skills may become impaired. If this occurs, the affected person eventually will need help with day-to-day care. And 6) ___ is common in people who have PPA.

 

Communication Tests: Written and verbal tests pose questions that measure cognitive functions for attention, learning, recall and language. But because these tests depend primarily on language skills, their usefulness declines as the symptoms of primary progressive 7) ___ worsen.

 

Blood Tests: Doctors may order blood tests to check for other factors that can cause memory loss, such as infections, vitamin deficiencies, anemia, medication levels, and disorders of the thyroid, liver or kidneys.

 

Brain Scans: MRI or CT scans can detect strokes, tumors or other conditions that may affect brain function. SPECT or PET scans can be helpful if other scans do not show any abnormalities.

Treatments and drugs

 

Medications: There are no 8) ___ that specifically treat PPA. Some doctors have tried Alzheimer’s drugs but no studies have proved these drugs are effective. Experimental therapies will be available with increasing frequency in upcoming years.

 

Therapy: Speech and language therapy, focusing primarily on efforts to compensate for eroding language skills, can be helpful. If speaking and writing skills become limited, examples of alternate communication strategies include:

 

  • A series of cards that display specific messages, such as common requests
  • A word book, used by pointing to the words that can’t be articulated
  • Laptop computers containing digitally stored words and phrases or pictures

 

ANSWERS: 1) neurological; 2) brain; 3) language; 4) words; 5) dyslexia; 6) depression; 7) aphasia; 8) drugs

Primary Progressive Aphasia

 

Image of a Migraine painted in 1998 by Anne Adams, who was drawn to structure and repetition. She had a rare disease that changes connections between parts of the brain.

 

 

When Anne Adams completed Unravelling Bolero in 1994, her brain was starting to be affected by a neurodegenerative condition called primary progressive aphasia. It later robbed Adams of speech, and eventually took her life. In its early stages, however, the condition seemed to unleash a flowering of neural development in a brain area that integrated information from different senses. In part, Unravelling Bolero may be a beautiful symptom of a terrible disease. This is the view of a group of neurologists led by William Seeley and Bruce Miller of the University of California, San Francisco.

 

And here’s the jaw-dropper: Ravel is thought to have suffered from the same condition, which may have drawn him towards repetitive patterns such as the themes that cycle through Bolero. Adams was unaware of this, and of her own condition, while working on her painting. Trained in mathematics, chemistry and biology, Dr. Adams left her career as a teacher and bench scientist in 1986 to take care of a son who had been seriously injured in a car accident and was not expected to live. But the young man made a miraculous recovery. After seven weeks, he threw away his crutches and went back to school. According her husband, Robert, Dr. Adams then decided to abandon science and take up art. She had dabbled with drawing when young, he said in a recent telephone interview, but now she had an intense all-or-nothing drive to paint.

 

In 1994, Dr. Adams became fascinated with the music of the composer Maurice Ravel, her husband recalled. At age 53, she painted “Unravelling Bolero” a work that translated the famous musical score into visual form.

 

Unravelling Bolero, painted in 1994 by Anne Adams

 

 

Unbeknown to her, Ravel also suffered from a brain disease whose symptoms were identical to those observed in Dr. Adams, said Dr. Bruce Miller, a neurologist and the director of the Memory and Aging Center at the University of California, San Francisco. Ravel composed “Bolero” in 1928, when he was 53 and began showing signs of his illness with spelling errors in musical scores and letters. Bolero alternates between two main melodic themes, repeating the pair eight times over 340 bars with increasing volume and layers of instruments. At the same time, the score holds methodically to two simple, alternating staccato bass lines.

 

Bolero is an exercise in compulsivity, structure and perseveration,” Dr. Miller said. It builds without a key change until the 326th bar. Then it accelerates into a collapsing finale. Dr. Adams, who was also drawn to themes of repetition, painted one upright rectangular figure for each bar of Bolero. The figures are arranged in an orderly manner like the music, countered by a zigzag winding scheme, Dr. Miller said. The transformation of sound to visual form is clear and structured. Height corresponds to volume, shape to note quality and color to pitch. The colors remain unified until the surprise key change in bar 326 that is marked with a run of orange and pink figures that herald the conclusion.

 

Ravel and Dr. Adams were in the early stages of a rare disease called FTD, or frontotemporal dementia, when they were working, Ravel on Bolero and Dr. Adams on her painting of Bolero, Dr. Miller said. The disease apparently altered circuits in their brains, changing the connections between the front and back parts and resulting in a torrent of creativity.

 

“We used to think dementias hit the brain diffusely,” Dr. Miller said. “Nothing was anatomically specific. That is wrong. We now realize that when specific, dominant circuits are injured or disintegrate, they may release or disinhibit activity in other areas. In other words, if one part of the brain is compromised, another part can remodel and become stronger.” Thus some patients with FTD develop artistic abilities when frontal brain areas decline and posterior regions take over, Dr. Miller said. An article by Dr. Miller and colleagues describing how FTD can release new artistic talents was published online in December 2007 by the journal Brain. FTD refers to a group of diseases often misdiagnosed as Alzheimer’s disease, in that patients become increasingly demented, Dr. Miller said. But the course and behavioral manifestations of FTD are different. In the most common variant, patients undergo gradual personality changes. They grow apathetic, become slovenly and typically gain 20 pounds. They behave like 3-year-olds in public, asking embarrassing questions in a loud voice. All along, they deny anything is wrong. Two other variants of FTD involve loss of language. In one, patients have trouble finding words, Dr. Miller said. When someone says to the patients, “Pass the broccoli,” they might reply, “What is broccoli?” In another, PPA or primary progressive aphasia, the spoken-language network disintegrates. Patients lose the ability to speak.

 

All three variants share the same underlying pathology. The disease, which has no cure, can progress quickly or, as in the case of Senator Pete V. Domenici, Republican of New Mexico, who announced his retirement last fall because of an FTD diagnosis, over many years. Dr. Adams and Ravel had the PPA variant, Dr. Miller said. From 1997 until her death 10 years later, Dr. Adams underwent periodic brain scans that gave her physicians remarkable insights to the changes in her brain. “In 2000, she suddenly had a little trouble finding words,” her husband said. “Although she was gifted in mathematics, she could no longer add single digit numbers. She was aware of what was happening to her. She would stamp her foot in frustration.” By then, the circuits in Dr. Adams’s brain had reorganized. Her left frontal language areas showed atrophy. Meanwhile, areas in the back of her brain on the right side, devoted to visual and spatial processing, appeared to have thickened.

 

When artists suffer damage to the right posterior brain, they lose the ability to be creative, Dr. Miller said. Dr. Adams’s story is the opposite. Her case and others suggest that artists in general exhibit more right posterior brain dominance. In a healthy brain, these areas help integrate multisensory perception. Colors, sounds, touch and space are intertwined in novel ways. But these posterior regions are usually inhibited by the dominant frontal cortex, he said. When they are released, creativity emerges. Dr. Miller has witnessed FTD patients become gifted in landscape design, piano playing, painting and other creative arts as their disease progressed. Dr. Adams continued to paint until 2004, when she could no longer hold a brush. Her art, including “An ABC Book of Invertebrates,” a rendering of the mathematical ratio pi, an image of a migraine aura and other works, is at two Web sites: members.shaw.ca/adms and memory.ucsf.edu/Art/gallery.htm. Sources: The New York Times, and New Scientist

 

Pi………..by Anne Adams.

The Effect of Rosuvastatin (Crestor) on Incident Pneumonia

 

Evidence from observational studies has raised the possibility that statin treatment reduces the incidence of certain bacterial infections, particularly pneumonia. As a result, a study published on line in the Canadian Medical Association Journal (19 March 2012), analyzed data from a randomized controlled trial of rosuvastatin calcium (Crestor) to examine this hypothesis.

 

For the study, data were analyzed from the randomized, double-blind, placebo-controlled JUPITER trial (Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin). In the trial, 17,802 healthy participants (men 50 years and older and women 60 and older) with a low-density lipoprotein (LDL) cholesterol level below 130mg/dL (3.4mmol/L) and a high-sensitivity C-reactive protein level of 2.0mg/L or greater, were randomly assigned to receive either rosuvastatin or placebo. The incidence of pneumonia was evaluated on an intention-to-treat basis by reviewing reports of adverse events from the study investigators, who were unaware of the treatment assignments.

 

Results showed that among 17,802 trial participants followed for a median of 1.9 years, incident pneumonia was reported as an adverse event in 214 participants in the rosuvastatin group and 257 in the placebo group (hazard ratio [HR] 0.83). In analyses restricted to events occurring before a cardiovascular event, pneumonia occurred in 203 participants given rosuvastatin and 250 given placebo (HR 0.81). Inclusion of recurrent pneumonia events did not modify this effect (HR 0.81), nor did adjustment for age, gender, smoking, metabolic syndrome, lipid levels and C-reactive protein level.

 

According to the authors, data from this randomized controlled trial support the hypothesis that statin treatment may modestly reduce the incidence of pneumonia.

Burn Size and Survival Probability in Pediatric Patients in Modern Burn Care

 

While patient survival after severe burn injury is largely determined by burn size, modern developments in burn care have greatly improved survival and outcomes. However, no large analysis of outcomes in pediatric burn patients with present treatment regimens exists. As a result, a study published in The Lancet, (2012;379:1013-1021), was designed to identify the burn size associated with significant increases in morbidity and mortality in pediatric patients.

 

The investigation was a single-center prospective observational cohort study using clinical data for pediatric patients with burns of at least 30% of their total body surface area (TBSA). Patients were stratified by burn size in 10% increments, ranging from 30% to 100% TBSA, with a secondary assignment made according to the outcome of a receiver operating characteristic (ROC) analysis.

 

Between 1998 and 2008, 952 severely burned pediatric patients were admitted to the center. All groups were comparable in age (mean 7.3 years, ranging from 6.1 years in the 30-39% TBSA group to 9.6 years in the 90-100% TBSA group). Gender distribution was 66% boys, ranging from 59% in the 60-69% TBSA group to 82% in the 90-100% TBSA group.

 

Results showed that burn size of 62% TBSA was a crucial threshold for mortality (odds ratio 10.07; p<0.00001).

 

According to the authors, in a modern pediatric burn care setting, a burn size of roughly 60% TBSA is a crucial threshold for postburn morbidity and mortality and that on the basis of these findings, it is recommended that pediatric patients with greater than 60% TBSA burns be immediately transferred to a specialized burn center. The authors added that at the burn center, patients should be treated with increased vigilance and improved therapies, in view of the increased risk of poor outcome associated with this burn size.

ONCOLOGY

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Viruses Recruited as Killers of Tumors

 

The following was abstracted from an article by Rachel Nuwer, Published 19 March 2012 in the NY Times based on research performed by Dr. Robert Martuza, Harvard Medical School; Dr. Bernard Roizman, University of Chicago; Dr. Ian Mohr, New York University.

 

In the early 1900s, not much could be done for cancer patients unless surgeons could excise the tumor. But in dozens of published cases over the years, it was observed that cancer patients sometimes enjoyed a brief reprieve from their malignancies when they caught a viral infection. For example, in 1951, after a 4-year-old boy with leukemia contracted chickenpox, his liver and spleen, swollen by the cancer, soon returned to normal, and his elevated blood cell count fell to normal. His doctors at the Laboratory of Experimental Oncology in San Francisco were thrilled by his sudden remission, but his leukemia eventually returned and progressed rapidly.

 

Researchers discovered that this was not a coincidence and that common viruses could sometimes attack tumor cells. For decades, scientists tried to harness this phenomenon, to transform it into a cancer treatment. Now, after a long string of failures, they are nearing success with viruses engineered to kill cancer. “It’s a very exciting time,” said Dr. Robert Martuza, chief neurosurgeon at the Massachusetts General Hospital and professor of neuroscience at Harvard Medical School. “I think it will work out in some tumor, with some virus.” Candidates are already in advanced trials, he noted.

 

Cancer cells are able to replicate wildly, but there’s a trade-off: They cannot ward off infection as effectively as healthy cells. So scientists have been looking for ways to create viruses that are too weak to damage healthy cells yet strong enough to invade and destroy tumor cells. Researchers started down this road in 1904, when they discovered that women with cervical cancer temporarily recovered when given a rabies vaccination. By midcentury, physicians were administering live viruses to cancer patients, infecting terminally ill children with polio and adenovirus and injecting patients with concoctions from the feces of normal children, from sick chickens, and from “feline spleen suspension” of rural kittens infected with “cat plague.” These experiments proved ill fated. The cancer returned, or in the worst cases, according to a 1964 American Journal of Pathology report the injections themselves caused “the development of lethal infection in the host.”

 

The field was abandoned for a time. But in 1991, Dr. Martuza seized upon the idea of using the herpes simplex virus (HSV-1) as a cancer-fighter. The genome of HSV-1 is comparatively large and can accommodate a number of mutations and deletions. Dr. Martuza weakened the virus by removing some of its genes. The modified virus was injected into mice with brain cancer, and it did bring about remission. But most of the mice died of encephalitis. In 1990, Bernard Roizman, a virologist at the University of Chicago, found a “master gene” in the herpes virus. When this gene is removed, the virus no longer has the strength to overcome healthy cells’ defenses. As it turned out, the modified virus was so crippled that it could only slow tumor growth.

 

Then, in 1996, Dr. Ian Mohr, a virologist at New York University, stumbled on a way of further altering Dr. Roizman’s crippled virus. He exposed it repeatedly to cancer cells until a new viral mutant evolved with the ability to replicate in those cells. Dr. Mohr and a doctoral student, Matt Mulvey, then engineered a way for their virus to evade the immune system, making it an even more potent cancer-killing agent.

 

Unlike chemotherapy, which can diminish in effectiveness over time, oncolytic viruses multiply in the body and gain strength as the infection becomes established. In addition to attacking cancer cells directly, some also produce an immune response that targets tumors.

 

Today, several potential cancer-fighting viruses are in trials, including two in Phase 3 trials. An engineered form of vaccinia the viral agent that helped eradicate smallpox – is being tested against advanced liver cancer, the third leading cause of cancer deaths globally. In a recent trial, survival for patients treated with high doses of the virus, called JX-594, doubled to 14 months from 7, compared with that of patients treated with low doses. “To see that kind of response in a randomized trial is simply unheard of,” said Tony Reid, the director of clinical investigation at the Moores Cancer Center of the University of California, San Diego.

 

A herpes virus based on Dr. Mohr’s original discovery is in advanced trials against melanoma; initial data showed a 26% response rate in patient regression and survival. A reovirus is being tested against head and neck cancers, often difficult to treat. According to the researchers, the side effects of treatment with these viruses are minimal, and include nausea, fatigue and aches. “In comparison to what happens with standard chemotherapy, flulike symptoms are very manageable,” said Dr. Reid, who has treated hundreds of patients with oncolytic viruses. Dr. Mulvey now heads a firm in Baltimore testing viruses to fight melanoma and bladder cancer.

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

 

 

FDA Is Ordered to Restrict Use of Antibiotics in Livestock

 

 

 

A vast majority of antibiotics used in the United States still goes to treat animals, not humans. Meanwhile, outbreaks of illnesses from antibiotic-resistant bacteria have grown in number and severity.

 

A federal magistrate judge has ordered the Obama administration to alert drug makers that the government may soon ban the common agricultural use of popular antibiotics in animals because the practice may encourage the proliferation of dangerous infections and imperil public health.

 

The order, issued by Judge Theodore H. Katz of the Southern District of New York, has the effect of restarting a process that the FDA began 35 years ago in hopes of preventing penicillin and tetracycline, two of the nation’s most popular antibiotics, from losing their effectiveness in humans because of their widespread use in animal feed to promote growth in livestock like chickens, pigs and cattle. The order comes two months after the Obama administration announced restrictions on agricultural uses of cephalosporins, a critical class of antibiotics that includes drugs like Cefzil and Keflex, which are commonly used to treat pneumonia, strep throat and skin and urinary tract infections.

 

The FDA is expected to issue within days draft rules that would bar the use of penicillin and tetracycline – highly popular in agricultural settings – in animal feed to further growth, the same issue tackled by Judge Katz. A decade ago, the FDA banned indiscriminate agricultural use of a powerful class of antibiotics, called fluoroquinolones, that includes the medicine Cipro. The judge’s order may accelerate the FDA’s incremental efforts to restrict common agricultural practices that are viewed by microbiologists and other medical researchers as leading to the growth of bacteria that are resistant to common antibiotic treatments, a development that many doctors say has cost thousands of lives.

 

Antibiotics were the wonder drugs of the 20th century, and their initial uses in both humans and animals were indiscriminate. Farmers were impressed by the effects of penicillin and tetracycline on the robustness of cattle, chickens and pigs, and added the drugs in bulk to feed and water, with no prescriptions or sign of sickness in the animals. By the 1970s, public health officials had become worried that overuse was leading to the development of killer infections resistant to treatment. In 1977, the FDA announced that it would begin the process of banning these uses. But the powerful House and Senate appropriations committees passed resolutions urging the FDA not to follow through on these efforts, and the agency retreated.

 

Environmental and health groups petitioned the FDA in 1999 and 2005 to restart the process to ban the drugs from being overused on farms. In January, the Natural Resources Defense Council, the Center for Science in the Public Interest, the Food Animal Concerns Trust, Public Citizen and the Union of Concerned Scientists filed suit against the FDA On Thursday, Judge Katz ruled that these groups had won their case without need for a trial.

 

Judge Katz ordered the FDA to alert drug manufacturers of its intention to end its approval for popular uses of penicillin and tetracycline to promote growth in animals. The manufacturers can request a hearing to present evidence that these uses are safe. If the companies have such evidence, the drugs can continue to be used as they are in agriculture

 The New York Times, March 23, 2012, by Gardiner Harris

The Affordable Care Act

 

The following is an article by Linda Greenhouse, published in The New York Times, March 23, 2012. You be the judge

 

 

Never  Before

 

Free of convention, and fresh from reading the main briefs in the case to be argued before the Supreme Court next week, I’m here to tell you: that belief is simply wrong. The constitutional challenge to the law’s requirement for people to buy health insurance – specifically, the argument that the mandate exceeds Congress’s power under the Commerce Clause – is rhetorically powerful but analytically so weak that it dissolves on close inspection. Maybe the court will agree with that assessment, and maybe it won’t. I think it will, by a wide margin, but that isn’t my point; the justices will do what they will do. Going into as dramatic a week at the Supreme Court as I can recall (the argument in Bush v. Gore was over in 90 minutes, compared with the six hours the justices have allocated to the Affordable Care Act), my concern is that the three-day marathon may leave people muddled and confused about something that is really quite simple and clear. So I want to unpack the challengers’ Commerce Clause argument for what it is: just words.

 

Basically just one word, in fact: “unprecedented.” Did you know that the individual mandate is unprecedented? You will after you read the brief filed by the redoubtable Paul D. Clement, the former solicitor general, on behalf of the 26 states that filed suit to challenge the law. The brief uses the word “unprecedented” 10 times. Unprecedented is a description, not an analysis. What’s unprecedented is the singular determination of the Republicans both on Capitol Hill and in the statehouses to deprive President Obama of his major domestic achievement. Republican officeholders in all 26 states joined together in the case now known as United States Department of Health and Human Services v. State of Florida. In 22 of those states, the officeholder was the attorney general. In four states with Democratic attorneys general (Nevada, Wyoming, Iowa and Mississippi), Republican governors filed in their own names. Ironically, not so long ago, the individual mandate was an idea conceived of and promoted by conservative policy wonks to counter more fundamental reform sought by the Clinton administration.

 

The countless unprecedented things that Congress has done over the centuries were not, for that reason, unconstitutional. Social Security, Medicare, the Employee Retirement Income Security Act (Erisa), and the Emergency Medical Treatment and Labor Act, the 1986 law passed to prevent hospitals from refusing to care for uninsured patients in acute distress, all come to mind. (From the perspective of today’s toxic politics, it’s a miracle that any of these laws actually got passed, but that’s a separate issue.) So there must be some problem with the Affordable Care Act other than “never before.” As I said, the rhetoric is powerful: “The Constitution protects and promotes individual liberty, while the mandate’s threat to liberty is obvious.” How so? “It is a revolution in the relationship between the central government and the governed.” In what respect? Beyond regulating commerce, a power explicitly granted to Congress by Article I of the Constitution, the Affordable Care Act gives Congress “the power to compel individuals to enter into commerce” – a “fundamental” distinction with “breathtaking” implications.

 

This is the argument that persuaded the two members of the three-judge panel of the Atlanta-based United States Court of Appeals for the 11th Circuit who voted to invalidate the mandate. The government argues that, to the contrary, the “uncompensated consumption of health care” by those who are willfully or helplessly uninsured is itself an enormous economic activity. The uninsured don’t exist apart from commerce. To the contrary, their medical care results in some $43 billion of uncovered health care costs annually and, through cost-shifting, adds $1,000 a year to the average cost of a family insurance policy. People who don’t want to buy broccoli or a new car can eat brussels sprouts or take the bus, but those without health insurance are in commerce whether they like it or not.

 

Just like their opponents, the government lawyers are not above using repetition to hammer home their main points. The government brief repeatedly cites a 2005 Supreme Court decision, Gonzales v. Raich, which upheld Congress’s authority to criminalize the private, non-commercial cultivation of marijuana for medicinal purposes. Justice Antonin Scalia wrote a concurring opinion in that case. Neither Chief Justice John G. Roberts Jr. nor Justice Samuel A. Alito Jr. was on the court then. But two years ago, they both voted with the majority in another case the government cites repeatedly, United States v. Comstock. That decision, a robust interpretation of Congress’s authority to pass legislation it deems “necessary and proper,” upheld a federal law imposing extended confinement on dangerous sexual predators who have completed their criminal sentences.

 

One of the more depressing news items I’ve seen lately was the report of a Bloomberg News national poll indicating that 75% of people expect that the Supreme Court’s health care decision will be influenced by the justices’ politics. Only 17% predicted that the case would be decided “solely on legal merits.” Now it’s up to the court to prove them wrong.

 

The Affordable Care Act – Supreme Conflict

 

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

 

It is more than proper that ON TARGET acknowledge the momentous argument scheduled this week in the Supreme Court.

 

Virtually all engaged in health care are aware that constitutional challenges to the Affordable Care Act are about to be argued before the Court which has devoted an almost unprecedented amount of time for oral arguments. I am therefore, honored and flattered that the editors of ON TARGET have asked me to comment on the matter, a task I approach with the upmost humility.

 

First, I am not a constitutional lawyer, and individuals with that background have commented on both sides of this issue which has been argued for months in both the Medical and Lay press (I cannot speak for Legal journals which I don’t read, but suspect the arguments have been even more intense there). From my medical perspective there are elements of the Act that I find congenial, (among them interestingly enough, the quite controversial individual mandate) and some I view with at least modest concern, (among these are the cost control mechanisms, the expansion of Medicaid, and the first dollar coverage for ‘preventive care’). However, when I think of the questions before the Court, I’ve decided that none of these views matter, compared to the importance of supporting and passing the ACA.

 

Whether any of us supports, or dislikes, specific elements in the Act, is, I have come to believe, tangential to the larger question which is, of course, is the Act constitutionally sound? As noted, on this matter, many much more expert than I (including Federal judges) have opined without consensus, so the matter is clearly a proper one for the Supreme Court. That said, it is important for citizens to weigh in with their expectations for how the Court handles the issue.

 

The Affordable Care Act was born amid great controversy and remains, if the polls are to be believed, politically unpopular. Due to the polarization in our politics, it is evidently among the rare (perhaps only) pieces of major social legislation passed on a strictly partisan basis, e.g., there was no minority support. Given that, it is important for the reputation of the judiciary and fundamental faith in our system that Americans believe that the Court approaches this issue in an apolitical and non-partisan fashion. Since (again, my perception only) it seems that many believe the conservative justices will oppose, and the liberal justices will support the Act, one reassuring outcome (again, for this observer) would be unanticipated votes from either group.

 

In this instance, confidence of the citizenry in the process may be as important as whether people are pleased with the outcome. Due to the polarity of our polity the Justices will be criticized and accused of politicization irrespective of their decision – the true vote will be the historical judgment, which by definition will take time. This verdict will become a historic part of Supreme Court jurisprudence; as citizens we can only hope that the Justices appreciate the gravity of both their decision and how they are perceived to reach it, overcome the political pressures and their individual prejudices, and wisely apply the law – Americans deserve no less.

Risk-Based Monitoring and Direct Data Entry

 

Target Health Inc. is pleased to announce that it has initiated 3 clinical trials using direct data entry, central monitoring and risk-based source document verification (SDV). One study has already been completed and 2 are ongoing. The following are some of the outcomes of this paradigm shift:

 

1. Onsite monitoring reduced by 60%

2. Screening errors picked up early

3. Real time monitoring at the time of data entry

4. No need to do additional subject recruitment

5. EDC edit checks modified early in the game

6. Compliance issues identified in real time

7. Real-time transparency of safety issues

8. Site saved 70 hours of data entry time

 

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

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