Tucson, U.S.A. — The United States is forfeiting a half century of leadership in medical care and medical research and development, writes orthopaedic surgeon Lee Hieb, M.D., in an article in the winter issue of the Journal of American Physicians and Surgeons.

“We are rapidly throwing it all away as we spiral ever downward into a “vampire economy”—an economy so overtaxed and overregulated that it is sucking the lifeblood out of its productive citizens, she writes.

Hieb undertakes a diagnostic examination of the medical economy, and features the following findings:

• There are 140,000 pages of regulations pertaining to Medicare, compared with a “mere” 82,000 in an impossibly complex tax code.
• Today, 49 cents out of every dollar is spent by government. In 1920, only 10 cents was spent by government, and 90 cents privately. Even in 1947, after World War II and the Marshall Plan, only 20 cents of every dollar was spent by government.
• Businesses are organized into cartels. Some are favored by government, so that profits are retained privately, but losses are shared by taxpayers.

The diagnosis, Hieb writes, according to the Austrian school of economics, is that we have a classic fascist economy. According to Lwewellyn Rockwell, “Fascism is the system of government that cartelizes the private sector, centrally plans the economy to subsidize producers, exalts the police state as the source of order, denies fundamental rights and liberties to individuals, and makes the executive state the unlimited master of society.”

Hieb’s description of the economy comes from the title of Guenther Reimann’s 1938 book, The Vampire Economy: Doing Business Under Fascism.

“The frontispiece of Reimann’s book is a pictorial representation of what it took a car manufacturer to get 5,000 tires for his autos. After 6 months and numerous encounters with boards, chambers, secretaries, ministers, councils, and commissars, the company received 1,000 rubber tires and 4,000 ersatz tires, at a 200% increase in price.”

Hieb compares this with the U.S. Food and Drug Administration (FDA), although the FDA takes 15 years to approve a drug, not just 6 months.

When F.A. Hayek wrote The Road to Serfdom in 1928, 55 percent of the German economy was controlled by the government, and their military expenditure was 10 percent of their budget. Today in America it is estimated that 45 percent of our economy is controlled by the government, and our military consumes 21 percent of the national budget.

Hieb explores the moral hazards of dependency on government money, and warns physicians: “We must never put ourselves in such financial dependency on the government that we are willing to compromise Hippocratic principles of ethical patient care.” Independence, she writes, is the “garlic necklace.”

The Association of American Physicians and Surgeons (AAPS), a national organization representing physicians in all specialties, founded in 1943, publishes the Journal of American Physicians and Surgeons.

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Pennsylvania, U.S.A. — Department of Health Secretary Dr. Eli N. presented on August 21 nearly $4 million in Commonwealth Universal Research Enhancement Program, or CURE, grants to support two research projects focused on esophageal cancer treatment and advancing detection of abdominal aortic aneurysms.

The CURE program funds health research with the purpose of discovering new scientific knowledge to help improve the health of all Pennsylvanians.

These competitive grants focus on specific research priorities established and reviewed by the Department of Health in conjunction with the Health Research Advisory Committee, a panel made up of universities and research institutes.

The funds, allocated in the 2011-12 fiscal year, focus on projects that translate the information found within the human genome and support research that commercializes and brings to market new, proven cancer diagnostics or therapeutics.

Twelve projects statewide are receiving CURE grant awards totaling $15.3 million. Since the grant program’s inception, Geisinger Clinic has received nearly $5.2 million in CURE funding, part of the more than $750 million in total CURE awards.

“This is an exciting time in health research and we are confident this research will improve public health and help Pennsylvanians to live longer, healthier lives,” said Avila.

More information about the CURE program is found at the Department of Health’s website at www.health.state.pa.us/cure.

Overview of the funded projects and awards announced on August 21:

• Geisinger Clinic: Utility of Genomic Data in Population Screening for Abdominal Aortic Aneurysm ($2,909,969):

The project is using knowledge of genetic risk factors to improve screening for abdominal aortic aneurysm (AAA), the 13th leading cause of death in the United States.

• Geisinger Clinic: Diagnostic-Prognostic Testing in Patients at High Risk for Esophageal Cancer ($1 million):

The project is developing a test that predicts the risk of developing esophageal cancer in patients with chronic gastro-esophageal reflux disease (GERD) and Barrett’s Esophagus.

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Vancouver, Canada — With FDA approval of a brain amyloid imaging compound in early 2012 and the expected start in 2012 and 2013 of three clinical trials in people with pre-symptomatic Alzheimer’s disease, issues around disclosure of dementia risk status are becoming more urgent. Several research efforts have been reported at the Alzheimer’s Association International Conference describing the creation and evaluation of new risk disclosure methods, and the examination of related ethical issues.

Alzheimer’s is a devastating, progressive, and fatal illness. There is a movement in the Alzheimer’s research field to detect and treat the disease earlier – even before there are outward symptoms – so that people do not have to suffer from the debilitating memory and thinking problems that lead to loss of normal daily activities and independence, and eventually death.

A number of Alzheimer’s prevention trials are in the planning stages. They will be conducted in people without memory or thinking symptoms who are considered at-risk for Alzheimer’s on the basis of genetic and/or biomarker positivity.

A biomarker is something in the body that can be measured as an indicator of normal biological processes, disease processes, or changes in response to therapy. For example, cholesterol levels are a biomarker for heart disease. A variety of imaging and fluid biomarkers are under investigation in Alzheimer’s disease. Biomarkers allow investigators and clinicians to detect Alzheimer’s-related changes in the brain and other body systems prior to the onset of dementia symptoms due to Alzheimer’s.

“Biomarkers are being increasingly used in clinical practice and research trials to provide risk information for Alzheimer’s. The goal is to develop evidence-based methods for communicating this risk in effective and supportive ways,” said J. Scott Roberts, Ph.D., of the University of Michigan, School of Public Health. Dr. Roberts is chair of an AAIC 2012 featured research session where new research on disclosing risk information will be reported and discussed.

One of the most promising biomarkers is brain imaging using positron emission tomography (PET) scans that can show whether a person has deposits of an abnormal protein called beta amyloid, which is one of the hallmarks of Alzheimer’s disease. There also are well-established genetic risk factors, such as the APOE Alzheimer’s risk gene.

Based on current knowledge, APOE-e4 is the gene with strongest impact on Alzheimer’s risk. APOE-e4 is one of three forms of the APOE gene; the others are APOE-e2 and APOE-e3. Everyone inherits a copy of APOE from each parent. Those who inherit one copy of APOE-e4 have an increased risk of developing Alzheimer’s. Those who inherit two copies have an even higher risk, but not a certainty. Scientists estimate that APOE-e4 is implicated in about 20 to 25 percent of Alzheimer’s cases. APOE-e2 may provide some protection against Alzheimer’s.

Until recently, the presence of brain amyloid could only be confirmed by autopsy. Now it is possible to look for the protein in living brains using a special type of dye during a PET scan. These PET scans may help determine whether or not a person who is experiencing memory loss has Alzheimer’s disease.

“People with memory loss who test negative on a PET scan using the newly-approved dye do not have Alzheimer’s disease,” said William Thies, Ph.D., Alzheimer’s Association Chief Medical and Scientific Officer. “Their symptoms are caused by something else. If they test positive, the cause is likely Alzheimer’s, but that is not 100% certain because the presence of amyloid can be detected in other diseases besides Alzheimer’s. We do not yet know what the test means in people without symptoms. The predictive value of the test is uncertain.”

“The disclosure of test results to cognitively normal older people raises some important ethical issues because researchers and clinicians do not yet know how to interpret them. How will this biomarker information be gathered? When, how, and to whom will it be disclosed? How do we disclose it accurately while minimizing any potential negative impact? These are issues that must be addressed by the research and healthcare communities, with crucial input from Alzheimer’s families and other stakeholders,” Thies added.

The Alzheimer’s Association currently is working with the Society of Nuclear Medicine to develop guidelines for when an amyloid PET scan is appropriate and how it should be interpreted.

Disclosing Alzheimer’s disease genetic risk to people with MCI

The Risk Evaluation and Education for Alzheimer’s Disease Study (REVEAL) is a multi-center randomized clinical trial enrolling people with mild cognitive impairment (MCI) to investigate the impact of disclosing “imminent” Alzheimer’s disease risk information – specifically, the probability of progressing to Alzheimer’s within the next three years. The trial tests different methods for disclosing this information, including a method where genetic testing is used to refine the risk estimates given to study participants.

“We hope to learn how people with MCI and their study partners respond to health education and learning risk information,” said Robert C. Green, M.D., MPH, of Brigham and Women’s Hospital and Harvard Medical School. “We continue to evaluate how well participants understand the Alzheimer’s risk assessment and what they do with the information. We’re monitoring how the people with MCI and their care partners adjust psychologically and what health related and behavioral changes they make in response to the new information.”

Green and colleagues designed and are implementing an evidence-based procedure for risk estimation and an experimental trial of APOE genotype disclosure in people age 55 to 90 with MCI and their study partners recruited at four university medical centers (Harvard, Univ. of Michigan, Univ. of Pennsylvania, and Howard). Participants receive risk estimates for their chance of progressing to Alzheimer’s disease that are based on their age, MCI diagnosis and APOE genotype (intervention arm) or age and MCI diagnosis alone (control arm). Risks disclosed to participants range from 8-57% in the intervention arm and 25-44% in the control arm.

The research team developed graphics and language to facilitate communication of APOE genotype and numerical risk estimate. Both participants with MCI and their study partners are followed up to 6 months following risk disclosure to determine its impact on caregiver distress, health behavior, and insurance/lifestyle changes. To inform further development of educational materials, researchers will also evaluate how well participants understood the information that was provided to them.

“This is the first study to examine the impact of disclosing Alzheimer’s genetic risk information to individuals with MCI,” Green said. “We believe the findings from REVEAL will have important implications for clinicians and policy makers in informing the future practice of educating and treating people at risk for Alzheimer’s.”

Disclosing brain amyloid imaging results to people with MCI and their families

Brain amyloid imaging is increasingly recognized as a powerful tool for predicting whether people with MCI will transition to Alzheimer’s disease.  As this technology moves from the research setting into clinical practice, an emerging concern is that people with MCI may have difficulty comprehending their test results.

Given the lack of research on disclosing this information to people with cognitive impairments, Jennifer Lingler, Ph.D., of the University of Pittsburgh, Pennsylvania, and colleagues conducted a study to develop a standardized procedure for effectively communicating amyloid imaging results in the context of MCI, which is often described as an intermediate state between normal cognitive aging and Alzheimer’s.

Based on previous research and insights from a panel of experts in neuroimaging, neuropsychology, risk communication, regulatory affairs, and bioethics, Lingler developed scripts and visual aids that guide clinical researchers in disclosing positive, negative, or inconclusive amyloid scan results. Ten people with MCI and 10 of their family members participated in mock results disclosure sessions and provided feedback on the procedure.

The researchers found that:

• The great majority of participants reported that the session was “easy to follow,” (19 of 20) “included just about the right level of detail,” (17 of 20) and was “just about right” in length (17 of 20).
• All 20 participants rated the information as “clearly presented.”
• Eight of the 10 family members and seven of the 10 people with MCI correctly repeated their mock results back to an interviewer after the session.
• Analysis of interview data from the five participants with questionable comprehension suggested that (a) cognitive factors may explain problems with comprehension among those with MCI, while (b) emotional factors may underlie problems with comprehension among family members.

“Our study demonstrates that it is possible to provide people with MCI and family members with highly comprehensible and acceptable information about their brain imaging results of Alzheimer’s risk,” Lingler said. “However, since some of the participants had some difficulty, we recommend that a family member or friend be present, and that emotional support be provided, when imaging results are discussed.”

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Ann Arbor, U.S.A. – A new free app developed at the University of Michigan Health System allows users to create a photographic baseline of their skin and photograph suspicious moles or other skin lesions, walking users step-by-step through a skin self-exam. The app, UMSkinCheck, sends automatic reminders so users can monitor changes to a skin lesion over time, and provides pictures of various types of skin cancers for comparisons. The app is designed for iPhone and iPad and is available to download on iTunes.

“Whole body photography is a well-established resource for following patients at risk for melanoma. However, it requires a professional photographer, is not always covered by insurance, and can be an inconvenience. Now that many people have digital cameras on their phones, it’s more feasible to do this at home,” says Michael Sabel, M.D., associate professor of surgery at the U-M Medical School, who was the lead physician involved in developing the app.

More than 2 million Americans are diagnosed with skin cancer each year, and some 50,000 will be diagnosed with melanoma, the most serious kind. Regular skin checks can help people discover melanoma in its earliest stages.

The app, a collaboration of the University of Michigan’s technology and clinical expertise, guides users through a series of 23 photos, covering the body from head to toe. Photos are stored within the app and serve as a baseline for future comparisons. The app will create a reminder to repeat a skin self-exam on a regular basis.

If a mole appears to be changing or growing, the photos can then be shared with a dermatologist to help determine whether a biopsy is necessary.

“We recommend skin self-exams for everyone in order to detect skin cancer at the earliest stages, when treatment is less invasive and more successful. If you have fair skin or burn easily, have had sunburns in the past or used tanning beds, or have a family history of melanoma, you are considered high-risk, and so it’s even more important,” Sabel says.

Not sure if you’re at high risk of skin cancer? The app includes a risk calculator that allows you to input your personal data to calculate your individual risk.

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Menlo Park, California, U.S.A. — The Department of Defense (DoD) has awarded SRI International a one-year grant to develop a novel therapy for multiple sclerosis (MS), an autoimmune nervous system disease that affects about 400,000 people in the United States and more than two million people worldwide. There is currently no cure for this disorder, which can impair vision and movement.

The grant, funded through DoD’s Congressionally Directed Medical Research Programs, will support the development of an oral drug that targets miR-326, a molecule recently found to stimulate the production of immune system mediators known as T-helper 17 (Th17) cells. Patients with MS have high levels of miR-326, and Th17 is thought to play a critical role in causing MS and other autoimmune diseases.

The new therapy will inhibit miR-326 and block the production of Th17 cells. The novel, orally administered drug will be more convenient for patients than currently available treatments. MS treatments today often require frequent hospital visits for injections or intravenous infusions.

The new drug could also help patients who do not respond to existing medications, or who experience significant side effects as a result of taking them. ”New and more convenient and effective therapeutics for multiple sclerosis are greatly needed,” saidJennifer Lam, Ph.D., a research scientist in SRI’s Biosciences Division who is spearheading the project. “Our research is directed toward the development of a novel oral therapeutic as well as a deeper understanding of the mechanisms that contribute to MS.”

Innovations from SRI International have created new industries, billions of dollars of marketplace value, and lasting benefits to society—touching our lives every day.

The project described was supported by Award Numbers W81XWH-11-1-0736 from the U.S. Army Medical Research Acquisition Activity. The content of the information does not necessarily reflect the position or the policy of the Government, and no official endorsement should be inferred

For more information about SRI International please visit www.sri.com

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“Progress in preventing HIV in the United States will be set back, while little will be done to provide additional care and treatment to people already living with HIV/AIDS in our country,” said Carl Schmid, Deputy Executive Director of The AIDS Institute, commenting on the final Fiscal Year 2012 spending bill to be voted on by Congress on December 16.

“This is especially disappointing in light of the optimism expressed by national and global leaders just two weeks ago on World AIDS Day,” he continued.

At the insistence of the House of Representatives, the bill would reinstate a federal funding ban of syringe exchange programs, a scientifically proven method to prevent HIV and other blood borne infections, while not increasing drug use. Additionally, the bill would resurrect failed abstinence-only-until-marriage programs, but only at a minimal level of $5 million.

Despite an estimated 50,000 new HIV infections each year and over 240,000 people unaware of their infection, funding for HIV prevention at the Centers for Disease Control and Prevention (CDC) would be cut by $10 million. Surprisingly, this cut would be to its school health HIV program. The CDC reports that young people aged 13–29 accounted for 39% of all new HIV infections in 2009.

The bill flat funds the Ryan White HIV/AIDS Program except for a $15 million increase, originally proposed by the Senate, for the AIDS Drug Assistance Program (ADAP). The Ryan White Program provides care and treatment to over 550,000 low-income people with HIV/AIDS. According to NASTAD, there are currently 4,155 people in 12 states on ADAP waiting lists and over 445 people in six states who have been disenrolled from the program due to budget constraints and growing enrollment.

On World AIDS Day, President Obama, recognizing the need for additional funding for both care and treatment for low income people with HIV/AIDS in the U.S., announced $50 million in additional funds for the Ryan White Program. As part of that announcement, ADAP would receive an additional $35 million. While it is not known yet how the funds will be distributed, taken together, the $50 million in new ADAP money could eliminate the ADAP wait lists if it is distributed to the wait list states.

“We are extremely grateful to both President Obama and the Congress for continuing to recognize the importance of providing medications to people with HIV/AIDS and the serious funding gap for ADAP,” commented Michael Ruppal, Executive Director of The AIDS Institute. “While it is far from enough to meet the growing need, these increases are a very positive development.”

According to HRSA data, the number of ADAP clients served nationally has grown an astounding 40 percent from FY07-CY10. Under the bill, funding for medical research at the National Institutes of Health would increase by $299 million.

The final bill, which is a product of negotiation between the House and the Senate, is far better than the one introduced earlier this year by House Labor, HHS, Education and Related Agencies Appropriations Subcommittee Chairman Denny Rehberg.

That bill would have decimated the Teen Pregnancy Prevention Program by cutting its budget from $105 million to $20 million, eliminate all Title X spending, and the entire Prevention and Public Health Fund. Additionally it would have prevented implementation of much of the Affordable Care Act. The bill also includes an across the board 0.189 percent cut, meaning all programs are subject to being cut even further

Jose Gil / Shutterstock.com

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