ED: Mine canary for numerous health issues

Men experience erectile dysfunction commonly due to stress and health problems. The condition can also intensify the stress and negatively affect someone’s self-confidence and relationship.

Now, a new study provides more information on how erectile dysfunction causes changes in the body. Researchers also explored how many people to date are experiencing problems with their sexual activities.

Erectile dysfunction happens when a man has an inability to start or maintain an erection. It has long been linked to some medical conditions, such as high blood pressure or obesity, according to Medical News Today.

But the latest study, published in the journal BJU International, shows the link between the lost capability to have an erection, cardiovascular disease and mortality. It also provides detailed information on the prevalence of the condition.

In the U.S., the annual spending to treat the condition reached $330 million in 2000, a significant increase from $185 million in 1994, according to the researchers. The team said the increase was associated with the aging population and more cases of obesity and related conditions.

The findings come from the analysis of data from 41 previous studies that examined erectile dysfunction and how it affects other conditions.

Erection Problem And Health Risks

There is a “wealth of evidence” for the link between erectile dysfunction and cardiovascular disease, the researchers said. The problem with erection has been found common in men with hypertension, stroke, myocardial infarction, angina, arteriosclerosis, ischemic heart disease and peripheral vascular disease.

Men with erectile dysfunction also showed higher risk of death compared to men without the condition. The researchers said patients “had an increased risk of all-cause mortality.”

More Men May Be Suffering

The researchers said there are problems with current methods to assess erectile dysfunction. Common methods use the two questionnaire-based tools, the International Index of Erectile Function and one that was designed for the Massachusetts Male Aging Study.

The study states most assessments using the tools are subjective. Some doctors use other methods, which also led to different conclusions.

Erectile Dysfunction Per Region

The researchers also reviewed data from earlier studies to see the prevalence of the condition across regions. They found that age, obesity, diabetes, depression, heavy alcohol consumption and smoking are the most common risk factors for erectile dysfunction across the world.

• Europe: 10-76.5 percent
• Asia: 8-71.2 percent
• Oceania: 40.3-60.69 percent
• Africa: 24-58.9 percent
• North America: 20.7-57.8 percent
• South America: 14-55.2 percent

“The global prevalence of [erectile dysfunction] is high and represents a significant burden on the [quality of life] of men and their partners,” the researchers said. “Physicians should consider screening for [erectile dysfunction] in at-risk patients, as information may not be volunteered.”

https://www.medicaldaily.com/erectile-dysfunction-facts-your-doctor-does-not-tell-you-438432

Cortexyme To Present Data at Alzheimer’s Association

Cortexyme, Inc. (CRTX), today announced that its work to pioneer a novel disease-modifying therapeutic approach to treat a key underlying cause of Alzheimer’s and other degenerative diseases will be discussed in two research abstracts at the Alzheimer’s Association International Conference^® 2019 (AAIC^®). The conference, which is the largest international meeting dedicated to advancing dementia science, will be held July 14-18, 2019 in Los Angeles.

In a Developing Topics poster (P4-663), researchers will detail the rationale for and design of the GAIN trial, the recently initiated Phase 2/3 study of Cortexyme’s lead gingipain inhibitor, COR388, in subjects with mild to moderate Alzheimer’s disease (AD). The GAIN trial is based on growing evidence that points to a key role for Porphyromonas gingivalis, the bacterium most commonly associated with chronic periodontal disease, in the development of AD, based on the identification of the bacteria in the brain of AD patients and its ability to cause neurodegeneration, inflammation, and other pathology associated with Alzheimer’s in animal models.

“We’re in a critical moment for Alzheimer’s drug development, and patients deserve new approaches driven by solid science,” said Casey Lynch, Cortexyme’s chief executive officer, chair, and co-founder. “The researchers at Cortexyme, along with our academic and industry collaborators, look forward to the opportunity to share the latest updates on our work to evaluate the gingipain hypothesis, which represents a wholly new, potentially disease-modifying approach to a disease that affects millions of patients and their families globally.”

A second Developing Topics poster (P4-542) will examine the utility of a speech-based digital biomarker for tracking disease progression and treatment response to COR388. This tool, developed by Winterlight Labs, was deployed in Cortexyme’s Phase 1b clinical trial of COR388 and is also being used as an exploratory endpoint in the GAIN trial.

https://finance.yahoo.com/news/cortexyme-announces-upcoming-data-presentations-120000767.html

AAIC19: Lifestyle Interventions and Alzheimer’s Risk

One of the big topics presented at the Alzheimer’s Association International Conference (AAIC) 2019 in Los Angeles was the effect of lifestyle on the risk of Alzheimer’s disease.

One of the studies presented on Sunday evaluated data from 196,383 adults of European ancestry who were 60 years of age or older. The data was pulled from the UK Biobank. The researchers found 1,769 cases of dementia over a median follow-up period of eight years.

The team then sorted the participants into high, intermediate and low genetic risk for dementia, as well as favorable, intermediate and unfavorable lifestyles based on diet, physical activity, smoking and alcohol consumption.

“We included four healthy lifestyle factors in our lifestyle score: no current smoking, regular physical activity, moderate alcohol consumption and healthy diet,” Elzbieta Kuzma, a researcher at the University of Exeter Medical School and a visiting academic at the University of Medical Center Hamburg-Eppendorf and the Albertinen-Haus Centre for Geriatrics and Gerontology, Scientific Department at the University of Hamburg in Hamburg, Germany, told BioSpace.

Kuzma and the research group utilized a polygenic risk score (PRS) based on Alzheimer’s disease genome-wide association studies statistics that have already been published. This PRS included all mutations linked to Alzheimer’s. Then the genetic risk factor was weighted according to how closely associated it was with the disease.

“Genetic risk and lifestyle factors were independently associated with risk of dementia, meaning that living a healthy lifestyle was associated with a reduced dementia risk, regardless of genetic risk,” Kuzma said. “When we investigated dementia risk within genetic risk categories, healthy lifestyle was associated with a 32% reduced risk of dementia in those with high genetic risk.”

The bottom line is that people with a high genetic risk of Alzheimer’s and an “unfavorable lifestyle,” are nearly three times more likely to develop dementia than people with a low genetic risk and a favorable lifestyle. Even if a person has a high genetic risk, a healthy lifestyle, meaning not smoking, regular exercise, limited alcohol intake and a healthy diet, could decrease the risk of dementia by a third.

“Many people are worried about developing dementia,” Kuzma told BioSpace. “Our findings are very exciting as they show that living a healthy lifestyle is associated with a reduced risk of dementia even in those with high genetic risk for dementia. This strengthens the need for healthy lifestyle interventions that may help to prevent or delay dementia.”

This study was led by the University of Exeter Medical School.

At least four other lifestyle-related studies were also presented at the AAIC 2019 meeting on Sunday. Researchers at Rush University Medical Center in Chicago used data from the Chicago Health and Aging Project and the Rush Memory and Aging Project to study healthy lifestyles and Alzheimer’s. This research focused on five low-risk lifestyle factors including a healthy diet, at least 150 minutes per week of moderate to vigorous physical activity, no smoking, light to moderate alcohol intake and cognitively stimulating activities.

In their study, they found that patients who adopted four out of five of the low-risk factors had about 60% lower risk of Alzheimer’s dementia compared to patients who didn’t follow any or only one of the low-risk factors. But patients who adopted one or more low-risk lifestyle factors, regardless of current behaviors, decreased their risk by 22%.

Another presentation, by Diana Younan, a senior research associate at the University of Southern California, looked at women aged 65 to 79 years from the Women’s Health Initiative Memory Study who did not have dementia at the time of enrollment. They evaluated whether exposure to outdoor air pollution changed the risk of Alzheimer’s. Their research confirmed that high air pollution increased the risk for Alzheimer’s and other dementias, and that older women with a higher cognitive reserve had a 21% increased risk compared to 113% for women with lower cognitive reserve. Cognitive reserve refers to the brain’s capacity to deal with the negative impact of brain damage on cognition.

A similar study presented by Amber Bahorik, a postdoctoral researcher at the University of California, San Francisco (UCSF), and the team led by Kristine Yaffe, the principal investigator, evaluated the risk cigarette smoking may have on cognitive function in mid-life. The investigation looked at patients over 25 years to determine the connection between smoking and cognitive function.

They found that compared to non-smokers, “heavy stable” smokers were 1.5 to 2.2 times more likely to have cognitive impairment. People who quit or who were classified as “minimal stable” did not have an increased risk. Cognitive impairment among smokers was observed as early as their 40s.

Bahorik and Yaffe also presented research on alcohol use disorder (AUD) among female military personnel over the age of 55. They studied 2,207 female veterans without AUD over the age of 55 at Veterans Health Administration medical centers from October 2004 to September 2015—all were free of dementia at baseline. They found that an average of 3.6 years of follow up, 4% of female veterans with AUD developed dementia compared to only 1% in the control, non-AUD group. Essentially, women with AUD have a greater than a threefold increased risk of developing dementia.

https://www.biospace.com/article/aaic19-lifestyle-interventions-and-alzheimer-s-risk-/

ORYZON to Present Data From ETHERAL Phase IIa Trial at Alzheimer’s Association

Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a public clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, announced today that the company will present data from the ongoing Phase IIa clinical trial with vafidemstat in Alzheimer’s disease (AD) named ETHERAL (Epigenetic THERapy in ALzheimer’s Disease) at the 2019 Alzheimer’s Association International Conference (AAIC-2019) to be held in Los Angeles (USA) on July 14-18.

Dr. Roger Bullock, Oryzon’s Medical Director, and Dr. Michael Ropacki, Oryzon’s Vice-President of Clinical Development, will attend the Conference. Dr. Bullock will present a written communication in the form of a Poster entitled “P#31419. Safety Evaluation of Vafidemstat on Mild to Moderate Alzheimer’s Subjects” at the session “Therapeutics: Clinical” to be held on Monday, July 15, 2019, 9:30 AM – 4:15 PM, at the Los Angeles Convention Center, South Hall GH. Safety data from the first 90 patients will be presented and the evolution of some relevant (blinded) functional parameters on the 33 first patients that have finished the first 6 months of treatment will be also discussed.

https://www.globenewswire.com/news-release/2019/07/10/1880766/0/en/ORYZON-to-Present-Data-From-ETHERAL-Phase-IIa-Trial-at-the-2019-Alzheimer-s-Association-International-Conference-in-Los-Angeles.html

GSK in talks to name HSBC’s Symonds as its next chairman

GlaxoSmithKline Plc (GSK.L) is in talks to name HSBC’s deputy chairman Jonathan Symonds as the next chairman of the British drugmaker, Bloomberg reported on Sunday, citing a person familiar with the matter.

Symonds’ appointment still needs to be finalised and is subject to approval from banking regulators, Bloomberg reported bloom.bg/2jSPkal.

In January, the company said Chairman Philip Hampton would step down after more than three and a half years in the role.

Citing people familiar with the talks, Bloomberg said the appointment could happen in the coming weeks.

https://www.reuters.com/article/us-gsk-chairman/gsk-in-talks-to-name-hsbcs-symonds-as-its-next-chairman-bloomberg-idUSKCN1U90K3

How Trump Is Reforming Medicare, Part 2

As we wrote recently, the Trump administration is making fundamental changes to the Medicare program, and the changes initiated so far may be just the beginning. In this post we look at new rules requiring hospital price transparency, drug advertising price transparency, paperwork reduction, the advent of concierge medicine, and the administration’s effort to eliminate drug rebates and gag clauses.

Hospital Price Transparency. When customers pay for goods and services out of their own pockets, price transparency is never a problem. This is just as true in health care as it is in any other market. For cosmetic surgery or Lasik surgery, for example, patients are never unsure what the cost will be. Similarly, in the market for medical tourism, patients are almost always given an upfront package price, or a reasonably good estimate. When Canadians come to the United States for joint replacements, for example, they not only know the price, they usually pay in advance.

For ordinary Americans, however, the U.S. hospital sector is completely dominated by third party payment. As a result, hospitals don’t compete for patients on price. And has been previously argued, when providers don’t compete on price, they don’t compete on quality either. Hospital competition is mainly competition on amenities.

The Trump administration would like to change that. As of January 1 of this year, every hospital in the United States is required to post its standard price for the procedures it performs. Unfortunately, that may not help patients as much as might be hoped. It appears that many hospitals are meeting this requirement from the Centers for Medicare and Medicaid Services (CMS) by posting their charge master numbers. These are like list prices that no one actually pays. Also, some hospitals are posting services in technical language that most patients won’t understand. For example, Vanderbilt University Medical Center lists a charge of $42,569 for a cardiology procedure described as “HC PTC CLOS PAT DUCT ART.”

Partly in reaction to these developments, last month the President signed an additional executive order directing federal agencies to find ways of requiring hospitals to reveal their “actual charges,” including amounts that patients can expect to pay.

If hospitals start doing that, patients will soon discover something health policy analysts already know:  what people are paying for the same service varies widely, even for facilities that are within a few blocks of each other.

To what extent can patients usefully take advantage of price information to lower their costs of care? One study, cited by the Council of Economic Advisers in its 2019 Annual Report, found that 73 percent of the 100 highest-spending hospital procedures were “shoppable.” That means patients can reasonably be expected to compare prices and make choices.  Among outpatient procedures, 90 percent of the 300 highest-spending categories were shoppable.

Drug Price Transparency. Last month the Trump administration finalized another regulation on price transparency. This one requires pharmaceutical companies to make visible their list prices in all direct-to-consumer drug advertising. The most important impact will be on television advertising. As in the case of the hospitals, pharmaceutical companies argue that list prices aren’t meaningful since almost no one pays them. The industry wants instead to post information on how consumers can find out how much they will pay as individual patients. However, the administration rejected that idea on the grounds that it puts too much burden on the consumer.

As of this writing the regulation is in limbo. The drug manufacturers sued and just hours before the regulation was to take effect, a federal judge blocked it – ruling that the administration has exceeded its regulatory authority.

Ending Rebates and Gag Clauses for Drugs. At the risk of oversimplification, the market for prescription drugs can best be understood as two separate markets. About 85% of all prescriptions in the United States are for generic drugs and Americans pay some of the lowest prices in the world for most of them. Lower than in Europe or in Canada, for example.

That outcome has been recently helped along by the Food and Drug Administration’s approval of a record number of generic drugs  last year, saving consumers an estimated $26 billion. Pharmacy Benefits Managers (PBMs), who work on behalf of insurance companies,  do a very good job negotiating price discounts for these drugs and consumers gain as a result.

The other market is the market for more expensive, brand name drugs. It is in this market that Americans pay the highest drug prices in the world. Consumers often don’t benefit from PBM discounts. All too often they pay more than they should at the local pharmacy.

According to a University of Southern California study, in almost one-fourth of all prescription transactions patients are likely paying more in health insurance copays than the cash price of the drug they are buying. Gag clauses often prohibit pharmacists from telling patients about more affordable options.

Under PBM contracts for these drugs, most of the discounts go to the PBM itself in the form of a rebate. In return, the PBM is induced to place an expensive drug on its formulary so that patients are induced to choose it over a less expensive drug.

In general, all parties have perverse incentives in this system. The pharmaceutical companies have an incentive to raise prices, because the higher the price the larger the rebate for the PBMs. High rebates give the PBMs an incentive to structure their formularies in way that induce patients to choose the more expensive drugs.

Under the legislation that created the Part D Medicare drug benefit, the PBMs get a safe harbor from federal anti-kickback laws that would otherwise prohibit such arrangements.

To promote needed reforms, the president has signed two pieces of legislation to ban pharmacy gag clauses and a new HHS rule will classify PBM rebates as illegal kickbacks unless the benefits are passed on to the consumer. A study by Milliman estimates that this policy change could reduce federal spending on government programs by between $78 and $98 billion over the next ten years, and reduce costs to seniors in the Part D program by as much as 18 percent.

The administration admits uncertainty over these effects, and its own internal analysis predicted that ending the rebates could cost the federal government $200 billion over ten years. (Casey Mulligan gives a brief explanation at his blog.) Perhaps for this reason, the administration reversed course on the rebates just yesterday (Thursday).

Although these changes affect Medicare and Medicaid patients only, UnitedHealthcare has already announced a new policy under which it will pass along rebates to the patients in its private sector plans – perhaps in anticipation of the administration’s new initiative. Many private employer plans are also beginning to share the rebates with their employees.

Paperwork Deregulation. CMS has launched a major initiative to do something most doctors probably think is long overdue. Based on input from thousands of practitioners, the agency has made changes it estimates will eliminate 53 million hours of burden, costing an estimated $5.2 billion, over the first five years. Despite some complaints, these changes have been generally well received

Concierge doctors. Direct primary care is coming to Medicare. This is a variation on what ordinary observers might be tempted to call “concierge care.” Under the arrangement, Medicare would pay a fixed monthly fee to a physician or physical group instead of the traditional fee-for-service payment. In return, the physicians would provide virtually all primary care. The fees will be from $90 to $120 a month, depending on patient’s age and medical complexity.

As of March 2018, there were 790 direct primary care practices in the United States. In general, they provide 24/7 access to a physician and they involve communication by phone, email and Skype. These practices have a number of attractive features: They improve access to care, improve the quality of care, reduce overall health care spending and report high levels of patient satisfaction.

The emergence of direct primary care has the potential to radically transform the way medicine is practiced in the United States. But it may not be available for Medicare patients as quickly as the administration hopes. The reason: most primary care doctors have opted out of all third-party insurance arrangements, including Medicare. But these doctors cannot contract with a Medicare patient unless they are in Medicare. Further, once in Medicare, they won’t be free to engage in the type of innovation that makes direct contracting so successful.

This Catch 22 could be eliminated by Congress. Half the country gets a tax break when they buy goods and services from providers who aren’t governed by Medicare rules. The elderly and the disabled should be able to do the same thing.

Conclusion. The Trump administration is clearly pushing the envelope – in many cases acting to fill a void left by Congress. These changes will result in a very different health care system. It will be one that is shaped more by individual choice and market forces than by rules and regulations.

https://www.forbes.com/sites/johngoodman/2019/07/12/how-trump-is-reforming-medicare-part-ii/#1a794e4b2c30

Shifting goals in Alzheimer’s disease to focus on prevention

After more than 100 years of research on Alzheimer’s disease, scientists are beginning to believe that a cure is not achievable.

“The idea that there is going to be one drug that fixes all this seems more and more unlikely. It is a multifactorial disease,” said Margaret Gatz, professor of psychology at USC Dornsife College of Letters, Arts and Sciences.

Although sticky amyloid plaques and tangles in the brain are an obvious Alzheimer’s hallmark, they are not the sole factors behind the memory-erasing illness, which affects more than 5 million Americans.

The search for solutions is urgent amid an aging baby boomer population. U.S. annual costs associated with Alzheimer’s disease are projected to increase from $307 billion to $1.5 trillion by 2050, according to research by the USC Schaeffer Center for Health Policy and Economics and USC Leonard Davis School of Gerontology.

Researchers at USC Dornsife have identified a host of factors that raise the risk for the disease that could be potential targets for treatment or prevention. Many are presenting their latest findings July 14–18 at the Alzheimer’s Association International Conference in Los Angeles.

“USC’s angle on this is that we need to incorporate things other than just amyloid and tau, such as vascular and inflammatory contributors,” said Daniel Nation, associate professor of psychology at USC Dornsife. “And that treatment may need to target, more generally, how to sustain brain health and how to stop neurodegeneration.”

A broad approach to treatment requires an interdisciplinary approach to research. At USC, Alzheimer’s research involves a cross-collaboration of scientists from biological and computational sciences, economics, environmental science, genetics, gerontology, medicine, neuroscience, psychology and policy. Together, they may have the right amount of fire power to curb Alzheimer’s disease.

One disease, many contributors

Working with data from the Swedish Twin Registry and other large data sets, Gatz has found  anxietyappears to raise risk for the disease. In addition, she has found that someone who develops type 2 diabetes in middle age also has a significant risk factor for Alzheimer’s disease.

Meanwhile, Caleb Finch, University Professor at USC Leonard Davis School of Gerontology and USC Dornsife, has found that pollution exposure raises the risk of developing Alzheimer’s, particularly among older women.

Several USC Dornsife researchers are focused on gender differences. Women are at greater risk of developing Alzheimer’s than men because of their longer lifespans, Gatz said, but other factors may also be in effect. To answer this question, Christopher Beam, assistant professor of psychology and gerontology, is studying whether certain levels of hormones, or early life exposure to them, may protect some women from developing the disease.

Many countries including the United States have large studies that track aging populations. However, some of the studies stop short of identifying whether or not someone has dementia or Alzheimer’s, even though the data sets include cognitive and memory results that could serve as a marker for who is likely to have the disease.

Susan Luczak, a research professor of psychology at USC Dornsife, is working with Beam and Gatz to develop a score that would indicate, based on a constellation of symptoms, whether or not dementia is developing and, if so, its severity. Ultimately, having such a proxy for all of these studies would help scientists compare the different data sets on the basis of memory, cognitive abilities and the participants’ ability to function in everyday life.

Genetic risks

Certain genes — including the ApoE4 gene — can significantly raise the risk. For instance, Gatz noted that someone with the ApoE4 gene and cardiovascular disease has a significant risk of developing Alzheimer’s disease. However, another gene, TOMM40, may be even more influential than ApoE4 in memory loss, according to work by Carol Prescott, professor of psychology and gerontology at USC Dornsife, and T. Em Arpawong of USC Leonard Davis School.

However, genes are not the only reason someone may develop a disease or become immune to it. The location of someone’s home, their line of work, years of schooling, or even their own mental health may affect whether or not Alzheimer’s is in the cards.

Titus Galama, an associate professor of economics at USC Dornsife’s Center for Economic and Social Research, is studying the intersection of genetic risks with environmental factors, such as the work environment, that may affect whether or not someone develops Alzheimer’s disease. He and his colleagues use large social-science datasets that follow aging Americans over time, such as the national Health and Retirement Survey. Many of these studies in recent years have collected genetic information, too.

“An important focus of our work is on the ‘use it or lose it’ hypothesis,” said Galama. “We know what kind of work these individuals are in, and we can tell whether these are cognitively, physically, or socially demanding, to see whether certain jobs protect them from cognitive decline. We then want to see if, for example, cognitively demanding jobs can delay the onset of Alzheimer’s for genetically-at-risk individuals.”

Gatz has found indications that the type of job matters for whether a patient develops Alzheimer’s disease. Positions that involve managing, mentoring or organizing seem to be protective.

Keeping Alzheimer’s at bay

On the preventive side, scientists believe that there are potential opportunities in drug therapies that are already on the market for treating other ailments.

Recently, Nation found that people receiving treatment for diabetes have a lower risk for Alzheimer’s than those who have diabetes but aren’t on any prescription drugs to manage it.

Nation has been exploring how signs of Alzheimer’s may first appear in the brain’s vast system of capillaries, which are essential to the brain’s protective blood-brain barrier, the “pathway” that determines which nutrients and other items may pass through.

Lately, Nation said, he has been delving into “senolytics” — the use of drugs to help clear the body of aging cells that may be toxic.

Regardless of how his tactics compare to those of other researchers, they are on the hunt for the same trophy — more lives saved.

“Treating earlier and treating all of these pathologies may not be realistic, but if we can come up with ways to boost brain function, then that will benefit the brain in the face of many other diseases,” Nation said.

https://dornsife.usc.edu/news/stories/3044/usc-dornsife-researchers-focus-on-prevention-for-alzheimers/