Science Weekly podcast: How blogs are changing science

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From Science Online 2011, we take an extended look at the world of blogging and its role in modern science

Event at Mt. Sinai on Social Media For Healthcare

Target Health is pleased to announce that the Fundamentals of the Bioscience Industry Program (FOBIP) Alumni Executive Committee (Veronica Dudu, PhD., VP Industry Relations) is organizing a second event, on the “Opportunities, Challenges, Best Practices, and Value of Social Media for Healthcare.”  Drs. Glen Park and Mark Horn of Target Health Inc. participated in the first event, which focused on comparative effectiveness.

Location: The Mount Sinai School of Medicine, Icahn Medical Institute, 1425 Madison Avenue (at 98th St.), 1st Floor Seminar Room

Time and date: 6:30-8:30 pm; January 31, 2011

The invited confirmed speakers are:

– Michelle Hoffmann, PhD, Senior Research Manager, Deloitte Research
– Diane Zuckerman, RPh, CEO, Evidence-Based Solutions
– Louise Clemens, JD, Consultant on Digital Strategy for the Healthcare Industry
– Sandra Holtzman, President and Founder, Holtzman Communications
– Bradley Jobling, MBA, Social Media Consultant, Dept. of Surgery, Columbia U. Medical Center
– Sarah Webb, PhD, Journalist, Science Writer and Editor, Webb of Science

Please find more information here:


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. Target Health’s software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website at

FDA Plans New Limits on Prescription Painkillers

Percocet 10/650 mg

Vicodin 5/500 mg

Tylenol-Codeine #4 300/60 mg

The government announced last week, that it would sharply restrict some of the nation’s most popular prescription painkillers, saying they are causing many patients to poison themselves with overdoses of the drug 1) ___.

The decision fell short of the total ban on pills like Percocet and Vicodin that had been recommended by an advisory panel in 2009. Instead, manufacturers of these drugs, which combine 2) ___ with acetaminophen, have three years to reformulate them or stop making them altogether.

Under the new limit, the pills may contain no more than 325 milligrams of acetaminophen – less than half the amount found in many of them now. The problem, the FDA said, is that many patients, unaware of the pills’ acetaminophen content, continue to take over-the-counter acetaminophen 3) ___ like Tylenol. The agency will also require more explicit warning labels about the risk of overdosing with acetaminophen.

Acetaminophen, which relieves pain and 4) __, is one of the world’s most popular medicines. In 2005, American consumers bought 28 billion doses of remedies that contained it. And drugs that combine acetaminophen with opioids like codeine, oxycodone and hydrocodone are prescribed more than 200 million times each year. But even recommended doses of acetaminophen can cause 5) ___ damage in some people. More than 400 people die and 42,000 are hospitalized every year in the United States from overdoses. Often the 6) ___ results when a patient takes, for instance, one acetaminophen-based medicine for back pain, another for migraines and perhaps a third for cough and cold symptoms.

Federal drug regulators have been trying for decades to cut down on acetaminophen’s toll, but little has changed until now. In June 2009 a committee of experts convened by the F.D.A. voted by a bare majority to call for a 7) ___ on drugs that combine acetaminophen with narcotics. The amount of acetaminophen in these products has gradually crept up over the 8) ___.

Half of all acetaminophen overdoses occur in patients taking prescription medicines, but agency officials said they might someday take action concerning Extra Strength Tylenol and similar over-the-counter pills that contain more than 325 milligrams of acetaminophen. Indeed, over-the-counter medicines will soon contain more acetaminophen than 9) ___ pills. The agency has delayed action against the over-the-counter remedies, which would require a far more time-consuming and burdensome regulatory process than the one for prescription pills.

ANSWERS: 1) acetaminophen; 2) narcotics; 3) painkillers; 4) fever; 5) liver; 6) overdose; 7) ban; 8) years; 9) prescription

(Founding Fathers) Congress Mandates Health Insurance in 1798

President John Adams – Image via Wikipedia

In July of 1798, Congress passed – and President John Adams signed – “An Act for The Relief of Sick and Disabled Seamen”. We encourage you to read the law as, in those days, legislation was short, to the point and fairly easy to understand.

The law authorized the creation of a government operated marine hospital service and mandated that privately employed sailors be required to purchase health care insurance. The reason is that during the early years of America, our nation’s leaders realized that foreign trade would be essential to create a viable economy. To make foreign trade work, there was a major reliance on the nation’s private merchant ships. The problem was that a merchant mariner’s job was a difficult and dangerous undertaking as sailors were constantly hurting themselves, picking up weird diseases, etc.

The reductions in manpower caused by back strains, twisted ankles and strange diseases often left a ship’s captain without enough sailors to get underway – a problem both bad for business and a strain on the nation’s economy. As a result, Congress and the President resolved to do something about it by passing the first healthcare act.

First, the Act created the Marine Hospital Service, a series of hospitals built and operated by the federal government to treat injured and ailing privately employed sailors. This government provided healthcare service was to be paid for by a mandatory tax on the maritime sailors (a little more than 1% of a sailor’s wages), the same to be withheld from a sailor’s pay and turned over to the government by the ship’s owner. The payment of this tax for health care was not optional. If a sailor wanted to work, he had to pay up.

The law was not only the first time the United States created a socialized medical program, but it was also the first to mandate that privately employed citizens be legally required to make payments to pay for health care services. Upon passage of the law, ships were no longer permitted to sail in and out of our ports if the health care tax had not been collected by the ship owners and paid over to the government – thus the creation of the first payroll tax in our nation’s history.

When a sick or injured sailor needed medical assistance, the government would confirm that his payments had been collected and turned over by his employer. The government would then give the sailor a voucher entitling him to admission to the hospital for treatment. While a few of the healthcare facilities accepting the government voucher were privately operated, the majority of the treatment was given out at the federal maritime hospitals that were built and operated by the government in the nation’s largest ports.

As the nation grew and expanded, the system was also expanded to cover sailors working the private vessels sailing the Mississippi and Ohio rivers. The program eventually became the Public Health Service, a government operated health service that exists to this day under the supervision of the Surgeon General. So much for the claim that “The Constitution nowhere authorizes the United States to mandate, either directly or under threat of penalty….”

As for Congress’ understanding of the limits of the Constitution at the time the Act was passed, it is worth noting that Thomas Jefferson was the President of the Senate during the 5th Congress while Jonathan Dayton, the youngest man to sign the United States Constitution, was the Speaker of the House.

What is different today from 1798? Yes, the law at that time required only merchant sailors to purchase health care coverage. Thus, one could argue that nobody was forcing anyone to become a merchant sailor and, therefore, they were not required to purchase health care coverage unless they chose to pursue a career at sea. However, this is no different than what we are looking at today. It would have been impractical for a man seeking employment as a merchant sailor in 1798 to turn down a job on a ship because he would be required by law to purchase health care coverage. For more on this, go to: Source:, The Policy Page Blog at Forbes , by Rick Ungar.


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Gene Variants Predict Treatment Success for Alcoholism Medication

Severe drinking can cause serious morbidity and death. Because the serotonin transporter (5-HTT) is an important regulator of neuronal 5-HT function, allelic differences at that gene may modulate the severity of alcohol consumption and predict therapeutic response to 5-HT3 (serotonin) receptor antagonists. As a result, a study published online in the American Journal of Psychiatry (19 January 2011), evaluated the effectiveness of ondansetron treatment for alcoholism. Ondansetron, a 5-HT3 receptor antagonist, is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy and surgery. According to NIAAA Acting Director Kenneth R. Warren, Ph.D., “This study represents an important milestone in the search for personalized treatments for alcohol dependence.”

The study randomized 283 alcoholics by genotype in the 5’-regulatory region of the 5-HTT gene (LL/LS/SS), with additional genotyping for another functional single-nucleotide polymorphism (T/G), rs1042173, in the 3’-untranslated region. Participants received either ondansetron (4 µg/kg twice daily) or placebo for 11 weeks, plus standardized cognitive-behavioral therapy.

Results showed that for subjects with the LL genotype, those receiving ondansetron reduced their average number of daily drinks to less than five, while those receiving placebo continued to have five or more drinks per day. LL subjects who received ondansetron also had significantly more days of abstinence, relative to those who received placebo. Ondansetron’s effects were even more pronounced among individuals who possessed both the LL and TT gene variants, while subjects who lacked the LL variant showed no improvement with ondansetron.

According to the authors, by being able to do genetic screening beforehand, clinicians can eliminate a great deal of the trial and error approach to prescribing medicine and that personalized medicine allows for the better prediction a successful treatment option.

New Technology Peeks Deeply Into the Brain Using Time-Lapse Techniques To Assess Addiction and Brain Tumors

According to an article published online in Nature Medicine (16 January 2011), changes within deep regions of the brain can now be visualized at the cellular level. The study, performed in mice, used a groundbreaking technique to explore cellular-level changes over a period of weeks within deep brain regions, providing a level of detail not possible with previously available methods.

The study used time-lapse fluorescence microendoscopy, a technique that uses miniature probes to directly visualize specific cells over a period of time, to explore structural changes that occur in neurons as a result of tumor formation and increased stimulation in the mouse brain. Hopefully, this technique could lead to greater information on how the brain adapts to changing situations, including repeated drug exposure.

The study focused on two brain regions, the hippocampus and striatum. The striatum, a brain region important for motor function and habit formation, is also a major target for abused drugs. Some scientists believe that a shift in activity within the striatum is at least partly responsible for the progression from voluntary drug-taking to addiction.

The study introduced cellular-level time-lapse imaging deep within the live mammalian brain by one- and two-photon fluorescence microendoscopy over multiple weeks. Bilateral imaging sites allowed longitudinal comparisons within individual subjects, including of normal and diseased tissues. Using this approach, CA1 hippocampal pyramidal neuron dendrites were tracked in adult mice, revealing these dendrites’ extreme stability and rare examples of their structural alterations. To illustrate disease studies, the study tracked deep lying gliomas by observing tumor growth, visualizing three-dimensional vasculature structure and determining microcirculatory speeds. Results showed that average erythrocyte speeds in gliomas declined markedly as the disease advanced, notwithstanding significant increases in capillary diameters.

According to the authors, time-lapse microendoscopy will be applicable to studies of numerous disorders, including neurovascular, neurological, cancerous and trauma-induced conditions, and should also allow for a better understanding of how these processes occur at the cellular level, leading to insights into mechanisms underlying addictive behaviors. The authors added that the results should now allow neuroscientists to track longitudinally in the living brain the effects of drugs of abuse at the levels of neural circuitry, the individual neuron, and neuronal dendrites.

Association of Plasma β-Amyloid Level and Cognitive Reserve with Subsequent Cognitive Decline

Lower plasma β-amyloid 42 and 42/40 levels have been associated with incident dementia, but results are conflicting and few have investigated cognitive decline among elders without dementia. As a result, a study published in the Journal of the American Medical Association (2011;305:261-266) was performed to determine if plasma β-amyloid is associated with cognitive decline and if this association is modified by measures of cognitive reserve.

The study evaluated 997 black and white community-dwelling older adults from Memphis, Tennessee, and Pittsburgh, Pennsylvania, who were enrolled in the Health ABC Study, a prospective observational study begun in 1997-1998 with 10-year follow-up in 2006-2007. Participant mean age was 74.0 (SD, 3.0) years; 55.2% (n = 550) were female; and 54.0% (n = 538) were black.

The main outcome measure was the association of near-baseline plasma β-amyloid levels (42 and 42/40 measured in 2010) and repeatedly measured Modified Mini-Mental State Examination (3MS) results.

Results showed that low β-amyloid 42/40 level was associated with greater 9-year 3MS cognitive decline. Results were similar after multivariate adjustment for age, race, education, diabetes, smoking, and apolipoprotein E [APOE ] e4 status and after excluding the 72 participants with incident dementia. Measures of cognitive reserve modified this association whereby among those with high reserve (at least a high school diploma, higher than sixth-grade literacy, or no APOE e4 allele), β-amyloid 42/40 was less associated with multivariate adjusted 9-year decline. For example, among participants with less than a high school diploma, the 3MS score decline was −8.94 for the lowest tertile compared with −4.45 for the highest tertile, but for those with at least a high school diploma, 3MS score decline was −4.60 for the lowest tertile and −2.88 for the highest tertile (P = .004 for interaction). Interactions were also observed for literacy (P = .005) and for APOE e4 allele (P = .02).

According to the authors, lower plasma β-amyloid 42/40 is associated with greater cognitive decline among elderly persons without dementia over 9 years, and this association is stronger among those with low measures of cognitive reserve.

TARGET HEALTH excels in Regulatory Affairs and Public Policy issues. Each week we highlight new information in these challenging areas.

From Tragedy to Opportunity?

We have, once again, been tragically reminded of the difficulties in assuring proper care for individuals with serious psychiatric disorders. The key dilemma remains what it has always been. It is simply unrealistic to expect individuals suffering from major thought disorders to appreciate their need for care, let alone to expect that they will have the necessary personal and familial resources required to seek and secure it.

That a problem is vexing does not diminish the need to address it. The catastrophic events in Tucson, which dramatically demonstrated the inadequacy of current approaches, should focus our attention on taking full advantage of the concurrent implementation of the Affordable Care Act to assure we miss no opportunities, as benefits packages are defined, to address some longstanding problems.

The Act itself, fortunately, has already helped bring younger people, especially vulnerable to certain psychiatric disorders, into the system by expanding coverage and guaranteeing insurability irrespective of pre-existing conditions. Once the Act is fully implemented, older adults will be afforded similar protections. The combined impact of eliminating key exclusions and expanding insurance coverage means fewer individuals will “fall through the coverage cracks”. This, plus an expectation (perhaps hope) that benefits packages will be designed to enhance ongoing efforts to secure Mental Health Parity offers hope that patients with mental illness will fare better in a redesigned health system. As we have seen, society overall, as well as individuals, will be the beneficiaries.

Despite the Affordable Care Act, however; major problems remain. Many of these transcend health system design and coverage solutions. The incongruity of expecting someone with severe mental illness to recognize and act upon their need for care has been widely acknowledged. If repeat episodes of what recently happened in Tucson & Virginia Tech (to name just two recent examples) are to be avoided, we must develop more effective mechanisms to assure that citizens manifesting symptoms and signs of mental illness engage the system, secure appropriate care, and receive proper follow-up. Their health and our safety depend on it.

Expansion of coverage is a positive step, serving as a catalyst for care by assuring access for many formerly uninsured and vulnerable patients. Couple that step with properly designed benefits packages and serious reassessment of the (currently inadequate) mechanisms assuring that “at risk” individuals are, at minimum, evaluated by an adequate supply of properly trained mental health professionals, and real progress is possible. (Mark L. Horn, MD, MPH, CMO Target Health Inc.)

For more information about our expertise in Medical Affairs, contact Dr. Mark L. Horn. For Regulatory Affairs, please contact Dr. Jules T. Mitchel or Dr. Glen Park.