Phase 3 Study Begins Using Target e*CTR as eSource and Associated Risk-Based Monitoring

 

A meeting was held with FDA on 19 July 2012 to discuss our approach to the paperless clinical trial and Risk-Based Monitoring and no obstacles were identified. Minutes of the meeting, redacted, are available by request. Since that time, Target Health is pleased to announce that a fully paperless Phase 3 clinical trial has begun. In terms of software:

 

  1. Target e*CRF®is being used for EDC (24 approvals to date). In addition to the standard functionality of EDC, Target e*CRF includes:
    1. Real-Time Direct Data Entry (RT-DDE) at the time of the office visit using Target e*CTR™ as the eSource software
    2. Target Encoder® for medication and AE coding
    3. Target Monitoring Reports™ for Qualification, Initiation, Interim (central and onsite) and Closeout Visits
    4. Target e*Pharmacovigilance to generate Form 3500A and CIOMS1 forms
  2. Target Document® for the eTMF
  3. Target e*CTMS for study startup and project management

 

In addition, Risk-Based Monitoring has been implemented using the Clinical Data Monitoring Plan (CDMoP).

 

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

 

Schizophrenia Research: A Path to the Brain Through the Nose

 

Photo Source: FLICKR.com

 

 

A significant obstacle to progress in understanding psychiatric disorders is the difficulty in obtaining living 1) ___ tissue for study so that disease processes can be studied directly. Recent advances in basic cellular neuroscience now suggest that, for some purposes, cultured neural 2) ___ cells may be studied in order to research psychiatric disease mechanisms. But where can one obtain these cells outside of the brain?

 

Increasingly, schizophrenia research is turning to the nose. Strange as it may seem, the idea makes sense because the olfactory mucosa, the sense organ of smell in the 3) ___, is continually regenerating new sensory neurons from “adult” stem cells. These neurons are among the very few nerve 4) ___ outside of the skull that connect directly to nerve cells in the brain. Over several decades, researchers found that these cells can be collected directly by obtaining a small tissue sample, called a 5) ___. By taking small pieces of olfactory tissue from the nose, researchers of this new study were able to gain access to the stem cells from patients with schizophrenia and compare them to cells from healthy individuals.

 

“We have discovered that patient cells proliferate faster — they are running with a faster speed to their clock controlling the cell cycle — and we have identified some of the molecules that are responsible,” explained Dr. Alan Mackay-Sim from the National Centre for Adult Stem Cell Research in Brisbane, Australia, an author of the study. The findings clearly indicate that the natural cell 6) ___ is dysregulated in individuals diagnosed with schizophrenia. “This is a first insight into real differences in patient cells that could lead to slightly altered brain development,” Mackay-Sim added. This is an important finding, as scientists are already aware of many developmental abnormalities in the ‘7) ___ brain’.

 

Dr. John Krystal, editor of Biological Psychiatry, commented: “The current findings are particularly interesting because when we look closely at the clues to the neurobiology of 8) ___ disorders, we find new and often unexpected mechanisms implicated.”

 

ANSWERS: 1) brain; 2) stem; 3) nose; 4) cells; 5) biopsy; 6) cycle; 7) schizophrenia; 8) psychiatric

 

Neuroscience

Joyce Hays and Jules Mitchel, of Target Health Inc. were attendees of the University of New Mexico Neuroscience Music and the Brain symposium held this past August 2012 in Santa Fe, NM.

 

Statue of Egyptian Physician, Imhotep

 

Imhotep is credited with being the founder of medicine. He was the author of a medical treatise remarkable for being devoid of magical thinking; the so-called Edwin Smith papyrus.

 

Descriptions of Imhotep:

 

“In priestly wisdom, in magic, in the formulation of wise proverbs; in medicine and architecture; this remarkable figure of Zoser’s reign left so notable a reputation that his name was never forgotten. He was the patron spirit of the later scribes, to whom they regularly poured out a libation from the water-jug of their writing outfit before beginning their work.”

 

‘Imhotep was portrayed as a priest with a shaven head, seated and holding a papyrus roll. Occasionally he was shown clothed in the archaic costume of a priest.’

‘Of the details of his life, very little has survived though numerous statues and statuettes of him have been found. Some show him as an ordinary man who is dressed in plain attire. Others show him as a sage who is seated on a chair with a roll of papyrus on his knees or under his arm. Later, his statuettes show him with a god like beard, standing, and carrying the ankh and a scepter.’

‘He is represented seated with a papyrus scroll across his knees, wearing a skullcap and a long linen kilt. We can interpret the papyrus as suggesting the sources of knowledge kept by scribes in the “House of Life”. The headgear identifies Imhotep with Ptah, and his priestly linen garment symbolizes his religious purity.’

 

The brain was not always held in high regard. The Greek philosopher, Aristotle, thought the heart, not the brain, was the location of intelligence and thought. The ancient Egyptians also did not think much of the brain. In fact, when creating a mummy, the Egyptians scooped out the brain through the nostrils and threw it away. However, the heart and other internal organs were removed carefully and preserved. These organs were then placed back into the body or into jars that were set next to the body.

 

Hieroglyphic for “Brain”

 

The papyrus is a description of 48 cases that were written by an Egyptian surgeon thousands of years ago. The papyrus is about 4.68 meters (15 ft., 3.5 in.) long and 32.5 to 33 cm (13 in.) wide. Because some of the document is missing, the original papyrus was probably at least 5 meters long. Several cases are important to neuroscience because they discuss the brain, meninges (coverings of the brain), spinal cord, and cerebrospinal fluid for the first time in recorded history.

The surgical papyrus is named after Edwin Smith, an American Egyptologist who was born in 1822 and died in 1906. On January 20, 1862 in the city of Luxor, Smith bought the surgical papyrus from a dealer named Mustapha Aga. After Smith died, his daughter, Leonora Smith, gave the papyrus to The New York Historical Society. In 1920, James Henry Breasted, founder of the Oriental Institute of Chicago, was asked to translate the papyrus. Finally, in 1930, Dr. Breasted published the English translation for The New York Historical Society (University of Chicago Press.) According to Arlene Shaner, reference librarian of historical collections at The New York Academy of Medicine, the papyrus was sent to the Brooklyn Museum in 1938. Ten years later, the Museum purchased most of the Egyptian artifacts from the Society. At that time, however, the directors of the Society and of the Museum decided that the papyrus really belonged at The New York Academy of Medicine. The papyrus has been part of The New York Academy of Medicine collections since December 2, 1948.

 

The 48 cases contained within the Edwin Smith Surgical Papyrus concern:

  • 27 head injuries (cases #1-27)
  • 6 throat and neck injuries (cases #28-33)
  • 2 injuries to the clavicle (collarbone) (cases #34-35)
  • 3 injuries to the arm (cases #36-38)
  • 8 injuries to the sternum (breastbone) and ribs (cases #39-46)
  • 1 injury to the shoulder(case #47)
  • 1 injury to the spine (case #48)

It is likely that the patients described in the 48 cases were injured by falls (maybe from working on monuments or buildings) or were victims of battle (many wounds appear to be caused by spears, clubs or daggers.) The brain is mentioned 7 times throughout the papyrus. However, there is no use of the word “nerve.” Scholars of medical history have been impressed with the rational, scientific approach to diagnosing and treating the 48 patients. The methods used are based on rational observation and practical treatment and are for the most part, free of “magic” and superstition.

 

Each case is presented in a logical manner:

 

  1. Title: the type of injury and its location are described.
  2. Examination: the case and the manner in which the patient should be examined are described. The examination may include sensory testing, probing of the wound and movement of the affected body part. Some patients were examined more than once. The examination section of the papyrus always starts as:

“If thou examinest a man having…”

  1. Diagnosis:the doctor has three choices and will say one of the following about the condition:
    1. “An ailment which I will treat” – this is used for injuries that most likely will be cured.
    2. “An ailment with which I will contend” – this is used for difficult, but not impossible cases. The doctor will try to treat the condition, but the outcome is uncertain.
    3. “An ailment not to be treated” – in these cases, the condition cannot be treated at all because the injury is thought to be incurable.

 

The diagnosis section of the papyrus always starts as:

“Thou shouldst say concerning him…”

  1. Treatment: these include bandages, plasters, stitching, cauterization (heating of a wound), and splints. Surgical dressings included honey, grease and lint.
  2. The treatment section of the papyrus always starts as:

 

“Thou shouldst …”

 

  1. Glosses: these are short dictionaries of terms. Not all of the cases have a gloss.

 

The following are some of the cases in the Edwin Smith Surgical Papyrus that concern the nervous system.

 

Case 6

A gaping wound in the head, fracture of the skull and opening of the meninges. This case describes the:

 

  1. Convolutions of the brain – the author of the papyrus describes these “like those corrugations which form molten copper.” This most likely refers to the wrinkled appearance of the brain created by the gyri and sulci of the brain.

 

“Corrugations” of the Brain

 

  1. Meninges (coverings of the brain) – described as the membrane enveloping the brain.

 

“Membrane” enveloping the Brain

 

 

  1. Cerebrospinal fluid – described as the fluid in the interior of the head.

 

“Fluid” in the Interior of the Head

 

Case 6 was “An ailment not to be treated.”

 

Case 8: Fracture of the skull with no visible external injury. Apparently this patient injured his head, but the skin remained somewhat undamaged. This case is important because it describes which side of the body is affected by a head injury. In this patient, there was abnormal eye movement and paralysis of the arm and leg on the side of the body that was the same as the head injury. Because the right side of the brain controls the left side of the body and the left side of the brain controls the right side of the body, it is thought that the damage to the brain was caused by a contracoup injury. A contracoup occurs when impact to one side of the head pushes the brain within the skull such that the brain hits the opposite side of the skull. This results in brain damage on the side opposite to the side receiving the impact. The description of this case indicates that the Egyptian surgeon may have known that the brain controlled movement.

Case 8 was “An ailment not to be treated.”

 

Case 22: Fracture of the temporal bone (of the skull). This patient could not speak and this case is thought to be the first to document aphasia. If this is a description of aphasia, it would pre-date the famous work on aphasia by Paul Broca (1861) by thousands of years!

Case 22 was “An ailment not to be treated.”

 

Case 31: Dislocation of cervical vertebra; Case 33: Crushed cervical vertebra. Both cases describe paralysis and sensory problems caused by injuries to the backbone.

Cases 31 and 33 were both classified as “An ailment not to be treated.”

 

Case 48 is the last case and describes a sprain in the spinal vertebra. When the patient was asked to move his legs, the surgeon noted that this caused pain. The text of case 48 comes to an unexpected stop in the middle of a sentence. This suggests that there may have been more cases in the original papyrus.

Case 48 was “An ailment which I will treat.”

 

Our understanding of the brain has come a long way since 3000 BC. Now, through brain imaging techniques such as positron emission tomography (PET) and magnetic resonance imaging scientists can “look” at how the brain works. Neuroscientists also know what many parts of the brain do, what brain cells look like and how drugs affect the nervous system. However, many mysteries of the mind still remain:

 

  1. How are memories formed and lost?
  2. What are the causes and cures for Alzheimer’s disease, Parkinson’s disease, Autism and Schizophrenia?
  3. Why do we sleep?
  4. Why do we dream?
  5. What is consciousness?

 

 

Plates vi & vii of the Edwin Smith Papyrus at the Rare Book Room, New York Academy of Medicine

UROLOGY

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Quality-of-Life Effects of Prostate-Specific Antigen Screening

 

The quality-adjusted life year (QALY) is a measure of disease burden, including both the quality and the quantity of life lived. It is used in assessing the value for money of a medical intervention. The QALY model requires utility independent, risk neutral, and constant proportional tradeoff behavior. The QALY is based on the number of years of life that would be added by the intervention. Each year in perfect health is assigned the value of 1.0 down to a value of 0.0 for death. If the extra years would not be lived in full health, for example if the patient would lose a limb, or be blind or have to use a wheelchair, then the extra life-years are given a value between 0 and 1 to account for this. Under certain methods, such as the EQ-5D, QALY can be negative number.

 

After 11 years of follow-up, the European Randomized Study of Screening for Prostate Cancer (ERSPC) reported a 29% reduction in prostate-cancer mortality among men who underwent screening for prostate-specific antigen (PSA) levels. However, it is not known whether the side effects resulting from unnecessary procedures based on the overdiagnosis of prostate cancer counterbalance the benefit of the reduced mortality. As a result, a study published in the New England Journal of Medicine (2012;367:595-605), used Microsimulation Screening Analysis (MISCAN) to predict the number of prostate cancers, treatments, deaths, and quality-adjusted life-years (QALYs) gained after the introduction of PSA screening. Based on the data, various screening strategies, efficacies, and quality-of-life assumptions were modeled.

 

Results showed that per 1,000 men of all ages who were followed for their entire life span, annual screening of men between the ages of 55 and 69 years would result in nine fewer deaths from prostate cancer (28% reduction), 14 fewer men receiving palliative therapy (35% reduction), and a total of 73 life-years gained (average, 8.4 years per prostate-cancer death avoided). The number of QALYs that were gained was 56 (range, – 21 to 97), a reduction of 23% from unadjusted life-years gained. To prevent one prostate-cancer death, 98 men would need to be screened and 5 cancers would need to be detected. Screening of all men between the ages of 55 and 74 would result in more life-years gained (82) but the same number of QALYs (56).

 

According to the authors, the benefit of PSA screening was diminished by loss of QALYs owing to post-diagnosis long-term effects and that longer follow-up data from both the ERSPC and quality-of-life analyses are essential before universal recommendations regarding screening can be made.

Tropical Diseases: The New Plague of Poverty

 

At a tropical disease clinic outside Houston where patients show up every Friday, just last month, the clinic’s director has treated a young woman with cutaneous leishmaniasis, three people with brain lesions from cysticercosis and a middle-aged man with Chagas disease.

 

The following is based on an article publish in the New York Times (18 August 2012) by Peter J. Hotez, MD, PhD,, Dean of the National School of Tropical Medicine at Baylor College of Medicine and the President and Director of the Sabin Vaccine Institute and Texas Children’s Hospital Center for Vaccine Development.

 

Dr. Jules T. Mitchel, President of Target Health, taught Tropical Medicine at the Cornell School of Medicine, and worked in the area of mosquito control, for malaria prevention. In 2012, Target Health has met with FDA to discuss the development of a drug to treat a neglected tropical diseases currently impacting the US.

 

In the US, 2.8 million children are living in households with incomes of less than $2 per person per day, a benchmark more often applied to developing countries and an additional 20 million Americans live in extreme poverty. In the Gulf Coast states of Louisiana, Mississippi and Alabama, poverty rates are near 20% and in some of the poorer counties of Texas, where the author lives, rates often approach 30%.

 

Poverty takes many tolls, but in America, one of the most tragic has been its tight link with a group of infections known as the neglected tropical diseases, which we ordinarily think of as confined to developing countries. Outbreaks of dengue fever, a mosquito-transmitted viral infection that is endemic to Mexico and Central America, have been reported in South Texas. Then there is cysticercosis, a parasitic infection caused by a larval pork tapeworm that leads to seizures and epilepsy; toxocariasis, another parasitic infection that causes asthma and neurological problems; cutaneous leishmaniasis, a disfiguring skin infection transmitted by sand flies; and murine typhus, a bacterial infection transmitted by fleas and often linked to rodent infestations.

 

In addition, among the more frightening is Chagas disease. Transmitted by a “kissing bug” that resembles a cockroach but with the ability to feed on human blood, it is a leading cause of heart failure and sudden death throughout Latin America. It is an especially virulent scourge among pregnant women, who can pass the disease on to their babies. Just last month, the first case of congenital Chagas disease in the United States was reported. A boy born two years ago has become the first known child to acquire Chagas disease, dubbed the “new AIDS of America,” from his mother. The mother, a 31-year-old immigrant from Bolivia, delivered the baby by Cesarean section in Virginia in August 2010, according to the July 6 issue of CDC’s Morbidity and Mortality Weekly Report. Two weeks after the birth, the mother admitted that she had been previously diagnosed with Chagas disease, prompting doctors to test to the boy, who showed signs of being infected by Trypanosoma cruzi, the parasite that causes the disease.

 

These are, most likely, the most important diseases you’ve never heard of and they disproportionately affect Americans living in poverty, and especially minorities, including up to 2.8 million African-Americans with toxocariasis and 300,000 or more people, mostly Hispanic Americans, with Chagas disease. The neglected tropical diseases thrive in the poorer South’s warm climate, especially in areas where people live in dilapidated housing or can’t afford air-conditioning and sleep with the windows open to disease-transmitting insects. They thrive wherever there is poor street drainage, plumbing, sanitation and garbage collection, and in areas with neglected swimming pools. Most troubling of all, they can even increase the levels of poverty in these areas by slowing the growth and intellectual development of children and impeding productivity in the work force. They are the forgotten diseases of forgotten people, and Texas is emerging as an epicenter. Just this past week, headlines are carrying frightening news of West Nile virus outbreaks, north of Dallas, TX, beginning to resemble an epidemic. Americans need to be more vigilant about their own health and the health of the larger group of citizens all around.

Tobacco Use in 3 Billion Individuals from 16 Countries: an Analysis of Nationally Representative Cross-Sectional Household Surveys

 

Despite the high global burden of diseases caused by tobacco, valid and comparable prevalence data for patterns of adult tobacco use and factors influencing use are absent for many low-income and middle-income countries. As a result, a study published in The Lancet (2012; 380:668-679), was performed to assess these patterns through analysis of data from the Global Adult Tobacco Survey (GATS).

 

GATS used nationally representative household surveys, collected between 1 October 2008 and 15 March 2010, to obtain relevant information from individuals aged 15 years or older in 14 low-income and middle-income countries (Bangladesh, Brazil, China, Egypt, India, Mexico, Philippines, Poland, Russia, Thailand, Turkey, Ukraine, Uruguay, and Vietnam). The study compared weighted point estimates of tobacco use between these 14 countries and with data from the 2008 UK General Lifestyle Survey and the 2006-2007 US Tobacco Use Supplement to the Current Population Survey. All these surveys had cross-sectional study designs.

 

Results showed that in countries participating in GATS, 48.6% of men and 11.3% of women were tobacco users. 40.7% of men (ranging from 21.6% in Brazil to 60.2% in Russia) and 5.0% of women (0.5% in Egypt to 24.4% in Poland) in GATS countries smoked a tobacco product. Manufactured cigarettes were favored by most smokers (82%) overall, but smokeless tobacco and bidis. Bidis are small, thin hand-rolled cigarettes imported to the United States primarily from India and other Southeast Asian countries. For individuals who had ever smoked daily, women aged 55-64 years at the time of the survey began smoking at an older age than did equivalently aged men in most GATS countries. However, those individuals who had ever smoked daily and were aged 25-34-years when surveyed started to do so at much the same age in both sexes. Quit ratios were very low (<20% overall) in China, India, Russia, Egypt, and Bangladesh.

 

According to the authors, the first wave of GATS showed high rates of smoking in men, early initiation of smoking in women, and low quit ratios, reinforcing the view that efforts to prevent initiation and promote cessation of tobacco use are needed to reduce associated morbidity and mortality.

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

 

Sharp Dip in US Drug Approvals is Forecasted

 

According to World News (27 July 2012), a study published by from Fitch Ratings has predicted that the FDA will approve fewer novel drugs in 2012 than it did last year. Despite a strong first quarter, with eight New Molecular Entities (NMEs) approved, the total of 14 new approvals in first-half 2012 lags behind the 18 new approvals in the same period of 2011.

 

2011’s unusually high number of registrations is now nearing fruition, with 13 NMEs currently under review at the US FDA or the European Medicines Agency (EMA), with expectations of full marketing approval over the next few quarters.

 

Filings with the FDA and/or EMA are planned this year for the following 12 NMEs:

 

  1. Bayer’s alpharadin for bone metastases in prostate cancer and regorafenib for metastatic colorectal cancer;
  2. GlaxoSmithKline’s IPX066 for Parkinson’s disease and Revolair for chronic obstructive pulmonary disease;
  3. Johnson & Johnson’s canagliflozin for type 1 diabetes;
  4. Merck & Co’s Bridion for reversal of neuromuscular blockade and suvorexant for insomnia;
  5. Pfizer’s Aprela for relief of menopausal symptoms;
  6. Roche’s trastuzumab-DMI for metastatic breast cancer; and
  7. Sanofi’s Kynamro (mipomersen) for familial hypercholesterolemia, iniparib for breast cancer and Lyxumia (lixisenatide) for diabetes.

Tuna Sauce

 
We first had the classic Italian dish, tuna sauce over veal, at Giovanni VentiCinque (23 East 83rd Street) in Manhattan and loved it. This past summer we discovered an unbelievable gourmet Italian restaurant, Trattoria Nostrani, on Johnson Street in Santa Fe, NM, where they served us a refreshingly delicious salad of tuna sauce over endive and our mouths did cartwheels of joy.

 

In trying to duplicate the wonderful recipe of tuna sauce, we discovered that not only is it fabulous with a large number of options to serve it over, but it’s extraordinarily simple, once we experimented with getting the right flavors and accurate measurements. The one splurge in this recipe is the Kraft mayonnaise, but otherwise, the ingredients are healthy. You could experiment further with vegan mayonnaise.  The biggest experiment was finding the right thickener.

 

This tuna sauce can be served over endive, and any other salad greens you care to try it with. It’s good over steamed or roasted veggies, and delicious with any kind of pasta, rice, or new potatoes. The original Italian dish is tuna sauce over veal, but it’s also delicious over, turkey, chicken, and a tuna steak. We haven’t tried it over a lighter fish like Dover or Gray Sole, but here’s betting that would be good too.

 

So, for not very much work, whip up some of this tuna sauce and everything you serve it over will be transformed.  We’re still drinking the light delicious Italian white wine, Orvieto, made icy in the freezer and in chilled wine glasses.

 

 

Tuna Sauce Over Endive

 

Ingredients

 

Allow for 1 endive per person

 

1can (7 oz) tuna fish in oil

1 Tablespoon anchovy paste

1 Tablespoon capers

2 Tablespoons fresh lemon, juice

1/4 cup extra-virgin olive oil

3 Tablespoons Kraft mayonnaise

Pinch black pepper

Flat leaf parsley, chopped, for garnish

1 to 2 teaspoons, powdered Agar-Agar (add slowly to thicken the sauce)

 

Should be enough tuna sauce for 2-4 people

 

Directions

 

  • Figure on one endive per person
  • Wash the endive and drain it.
  • Cut the endive, with a knife, (don’t break) into 2” to 3” pieces; make them spear-shaped
  • Keep the endive in the refrigerator until ready to serve with the tuna sauce

 

  • Put the tuna fish in a food processor.
  • Add the anchovy paste, capers, lemon juice, oil and add ½ teaspoon of the agar agar.. Start the food processor and turn the ingredients into a very fine, smooth paste.
  • Transfer the mix to a bowl and stir in the mayonnaise.
  • Now, determine if your sauce is too thick or too thin, or just right.  If too thin, add another

½ teaspoon of the agar agar, wait a few minutes, and determine if you have the right

thickness for your sauce.

  • Only add additional agar-agar very very slowly, if the sauce needs to be thicker.  Use your judgement re: thickness of the sauce.  We don’t like it too thin, but too thick and it’s not a lovely sauce, but a paste.  If, at this point, the sauce is too thick, slowly add tiny amounts of olive oil until you get it to your taste.  You could also add small amounts of chicken broth as thinner.
  • Serve 3 or 4 Tablespoons of the tuna sauce over the pieces of endive on individual salad plates and garnish with chopped parsley

 

 

Let the Debates Begin

 

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

 

Whatever one’s political leanings, the selection of Representative Paul Ryan has the potential to be a ‘game changer’ in the campaign rhetoric. Happily, and once again irrespective of any individuals’ political views and absent gross negligence by the media, the impact will almost certainly be controversial, which is a positive, because it’s a driver of political discussion everywhere. We are already seeing the evidence.

 

With alacrity the news reports, Op-Ed pieces, Editorials, and commentary have begun to focus not solely on the ‘gaff’s de jour’: e.g., college transcripts, fancy horse steps, off-shore accounts, birth certificates, & generally silly comments, and instead to pay at least modest attention to the actual content of the candidates’ policy proposals. More specifically and importantly, the focus is on entitlements. Initially the attention is on the politically immensely sensitive Medicare program, but potentially (and hopefully) Social Security and Medicaid will follow. These discussions are timely, critical and cannot help but be salutary for our republic if even close to properly managed.

 

The key challenge is for the media. The debate will need to be chaperoned both to keep it reasonably civil, and more importantly, to assure that it is maximally instructive. Exaggeration and outright misrepresentation will doubtless occur, especially in campaign commercials, but if the media is responsible and does its job competently we can have a substantive discussion.

 

At present, the most detail regarding the divergent approaches exists for the Medicare program, so the campaigns will initially focus there. The parties clearly differ in their approaches to stabilizing the program and keeping it solvent as it absorbs the coming wave of retiring baby-boomers. However, the health care discussion is complex and will be expanded in scope by the impact of the Affordable Care Act which links changes in the Medicare Program to overall health system reform. Republicans appear committed to repealing the Act which necessarily raises issues of covering the uninsured and those with preexisting conditions, and mitigating lifetime payment caps. What are their practical alternative solutions?

 

These discussions will engage the public, broaden the debate, and if properly managed focus attention on proposals (or lack thereof) to solve critical problems addressed by the ACA.

 

So, irrespective of anyone’s feelings about Representative Ryan and his controversial voting record, like a lightening rod, his selection will create a substantive debate on issues impacting not just health care, but also national solvency. The country will in large measure rely upon our media to meet the challenge, appreciate the gravity of the situation, and seize this opportunity to educate the public. Paraphrasing NY Senator Daniel Moynihan’s much quoted observation “Everyone is entitled to his own opinion, but not his own facts”; the media is best positioned to assure that the coming debate is factually based, that numbers and figures are used to clarify and not obfuscate, and that parroted, rehearsed “talking points” designed to oversimplify and create public anxiety are effectively challenged.

 

If this challenge is met, the decision in November can reflect the considered decision of an informed public; that’s probably not what most expect but why not be an optimist? So, “Let the Debates Begin.”