Obama says Congress must end deadlock on Zika funding

U.S. President Barack Obama talks to members of the media as he receives a briefing on the response to the Zika virus at the Oval Office in the in Washington, U.S., July 1, 2016.  REUTERS/Carlos Barria
U.S. President Barack Obama talks to members of the media as he receives a briefing on the response to the Zika virus at the Oval Office in the in Washington, U.S., July 1, 2016.

Reuters/Carlos Barria


U.S. President Barack Obama on Friday said Congress must end its deadlock on funding to combat the Zika virus before lawmakers head out to recess later this summer.

“The good news is we feel fairly confident that we can develop an effective vaccine for Zika,” Obama said after a meeting with U.S. health officials in the Oval Office. “The problem is right now that money is stuck in Congress.”


(Reporting by Ayesha Rascoe; Editing by Jeffrey Benkoe)


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Heart Disease Still America's Top Killer

Heart disease still leads among causes of death in the U.S. according to just-released final data by the Centers for Disease Control and Prevention for 2014, but a separate analysis suggested that progress in prevention is slowing.

The National Center for Health Statistics’ annual report based on death certificates from all 50 states and the District of Columbia showed that diseases of the heart accounted for 23.4% of all deaths in 2014, down from 23.5% in 2013, followed closely by cancer at 22.5% both years.

No differences in the rank order of the top 10 causes of death from 2013 to 2014 emerged in the full data released Thursday, although the total age-adjusted mortality rate was the lowest ever recorded, as reported in December from the initial data.

Despite the good news on overall mortality rates, analysis of trends in those top causes of death held some cause for concern, Stephen Sidney, MD, MPH, of Kaiser Permanente Northern California in Oakland, and colleagues reported online in JAMA Cardiology.

“During the first decade of the 21st century, heart disease mortality declined at a much greater rate than cancer mortality, and it appeared that cancer would overtake heart disease as the leading cause of death,” they wrote.

However, their analysis of the CDC’s Wide-Ranging Online Data for Epidemiologic Research data system showed that the rates of decline for cardiovascular, heart disease, and stroke mortality all “decelerated substantially” after 2011, whereas the rate for cancer remained fairly stable.

The annual rate of decline for all cardiovascular disease dropped from 3.79% in 2000-2011 to 0.65% in 2011-2014. For heart disease, the change was from 3.69% to 0.76%; whereas for cancer, the change was from 1.49% to 1.55%.

“If this trend continues, strategic goals for lowering the burden of cardiovascular disease set by the American Heart Association and the Million Hearts Initiative may not be reached,” Sidney’s group cautioned.

An accompanying invited commentary by Donald Lloyd-Jones, MD, of Northwestern University in Chicago, who has been heavily involved with the AHA and its prevention guidelines, agreed that target might be missed and explained the changing trends this way:

“Indeed, the inflection point in cardiovascular disease mortality rates in the U.S., when increases observed for the entire 20th century suddenly flipped to sustained declines, occurred in 1968, shortly after the U.S. Surgeon General’s first report on tobacco and coincident with the introduction of coronary care units for patients with acute myocardial infarction.

“However, while we celebrated these successes and appeared to be poised for victory, the seeds of our undoing were being planted. The largest population-wide epidemic of chronic disease in human history began to be evident in 1985. Since that time, we have seen relentless increases in the prevalence of obesity and trailing, but alarming, increases in the prevalence of diabetes affecting all ages and segments of the population. And right on schedule, about 25 years into the obesity epidemic, there appears to have been a sudden slowing in the progress of declining cardiovascular mortality rates, with now almost stagnant changes in age-adjusted cardiovascular disease mortality and actual increases in crude mortality rates and total cardiovascular deaths over the last few years as a result of population growth.”

To turn things around, society needs to get serious about primordial prevention from in utero well into middle age, Lloyd-Jones argued.

“For now, it appears we will be reaping what we have sown in the obesity epidemic over the last several decades. This bitter harvest can still be largely avoided if patients, physicians, public health officials, and politicians can finally create meaningful policies and pathways to enable a culture that prioritizes health and promotes prevention.”

The study was funded by the Cardiovascular Research Network through the National Heart, Lung, and Blood Institute and the American Recovery and Reinvestment Act of 2009 and by the National Cancer Institute–sponsored Cancer Research Network.

Sidney and Lloyd-Jones disclosed no relevant relationships with industry.

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Heart Disease Still America's Top Killer

Heart disease still leads among causes of death in the U.S. according to just-released final data by the Centers for Disease Control and Prevention for 2014, but a separate analysis suggested that progress in prevention is slowing.

The National Center for Health Statistics’ annual report based on death certificates from all 50 states and the District of Columbia showed that diseases of the heart accounted for 23.4% of all deaths in 2014, down from 23.5% in 2013, followed closely by cancer at 22.5% both years.

No differences in the rank order of the top 10 causes of death from 2013 to 2014 emerged in the full data released Thursday, although the total age-adjusted mortality rate was the lowest ever recorded, as reported in December from the initial data.

Despite the good news on overall mortality rates, analysis of trends in those top causes of death held some cause for concern, Stephen Sidney, MD, MPH, of Kaiser Permanente Northern California in Oakland, and colleagues reported online in JAMA Cardiology.

“During the first decade of the 21st century, heart disease mortality declined at a much greater rate than cancer mortality, and it appeared that cancer would overtake heart disease as the leading cause of death,” they wrote.

However, their analysis of the CDC’s Wide-Ranging Online Data for Epidemiologic Research data system showed that the rates of decline for cardiovascular, heart disease, and stroke mortality all “decelerated substantially” after 2011, whereas the rate for cancer remained fairly stable.

The annual rate of decline for all cardiovascular disease dropped from 3.79% in 2000-2011 to 0.65% in 2011-2014. For heart disease, the change was from 3.69% to 0.76%; whereas for cancer, the change was from 1.49% to 1.55%.

“If this trend continues, strategic goals for lowering the burden of cardiovascular disease set by the American Heart Association and the Million Hearts Initiative may not be reached,” Sidney’s group cautioned.

An accompanying invited commentary by Donald Lloyd-Jones, MD, of Northwestern University in Chicago, who has been heavily involved with the AHA and its prevention guidelines, agreed that target might be missed and explained the changing trends this way:

“Indeed, the inflection point in cardiovascular disease mortality rates in the U.S., when increases observed for the entire 20th century suddenly flipped to sustained declines, occurred in 1968, shortly after the U.S. Surgeon General’s first report on tobacco and coincident with the introduction of coronary care units for patients with acute myocardial infarction.

“However, while we celebrated these successes and appeared to be poised for victory, the seeds of our undoing were being planted. The largest population-wide epidemic of chronic disease in human history began to be evident in 1985. Since that time, we have seen relentless increases in the prevalence of obesity and trailing, but alarming, increases in the prevalence of diabetes affecting all ages and segments of the population. And right on schedule, about 25 years into the obesity epidemic, there appears to have been a sudden slowing in the progress of declining cardiovascular mortality rates, with now almost stagnant changes in age-adjusted cardiovascular disease mortality and actual increases in crude mortality rates and total cardiovascular deaths over the last few years as a result of population growth.”

To turn things around, society needs to get serious about primordial prevention from in utero well into middle age, Lloyd-Jones argued.

“For now, it appears we will be reaping what we have sown in the obesity epidemic over the last several decades. This bitter harvest can still be largely avoided if patients, physicians, public health officials, and politicians can finally create meaningful policies and pathways to enable a culture that prioritizes health and promotes prevention.”

The study was funded by the Cardiovascular Research Network through the National Heart, Lung, and Blood Institute and the American Recovery and Reinvestment Act of 2009 and by the National Cancer Institute–sponsored Cancer Research Network.

Sidney and Lloyd-Jones disclosed no relevant relationships with industry.

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Older Low-T Men Get Sex Boost Fom Testo Gel

Older men with low testosterone levels and low sex drive who used a testosterone gel were more likely to show interest in sex, and to have sex more often, than those on placebo in a randomized trial.

Researchers took 470 men, all ages 65 or older with testosterone levels below 275 ng/dL (mean 234 ng/dL, SD 63), and randomized them to receive either AndroGel or placebo gel for 1 year as part of the Testosterone Trials (TTrials); those using the testosterone gel reported significant improvements on 10 of 12 measures of sexual activity, such as how often they had intercourse and whether they anticipated sex.

In addition, increases in total and free testosterone was associated with improvements in sexual activities, but not erectile function, and there was no threshold effect seen for any of the outcomes measured, according to the investigators, who were led by Glenn Cunningham, MD, at the Baylor College of Medicine in Houston.

Cunningham and colleagues published their findings on Wednesday in the Journal of Clinical Endocrinology & Metabolism.

“To date, the sexual function trial of the TTrials is the largest placebo-controlled trial of the efficacy of testosterone on sexual function in older men with low libido and unequivocally low testosterone levels,” wrote the authors.

Most previous research has been of small groups, and only a few trials have included men with sexual symptoms, according to the authors, with some of those trials selecting men without any inclusion criteria for specific symptoms. Previous studies have generated conflicting results, and the TTrials comprise seven randomized trials to see how older men with low testosterone and symptoms respond.

AndroGel is currently approved for treating primary hypogonadism, on the basis of earlier studies involving men with serum testosterone levels below 300 ng/dL, but the product’s label indicates that “safety and efficacy … in men with ‘age-related hypogonadism’ have not been established.” The current study was funded by AndroGel’s manufacturer, AbbVie.

Cunningham and colleagues assessed sexual function at 3, 6, 9, and 12 months using 12 questions from an item on the PDQ survey. The survey asked about masturbation, having sexual daydreams, and other items like getting erections, ejaculating, and having orgasms. No significant improvements were seen in two of the measures: being flirted with by others and getting spontaneous erections during the day.

Patients were about 71 years old on average, and there were significantly more Hispanic patients and more married men in the treatment group than in the placebo group, which the authors said was was possibly due to chance despite P values of 0.02. Over 60% of the men in the study were obese, and about 33% had diabetes.

Of 27 baseline characteristics tested for, only alcohol use was related to post-treatment sexual activity and desire, as those in the treatment group who had more drinks saw a greater increase in sexual desire.

Patients started on a dose of 5 g each day with a target serum testosterone concentration range of 400-800 ng/dL that was later changed to 500-800 ng/dL after the early trial data showed that the median testosterone concentration of the men assigned to the treatment arm was 400-500 ng/dL, which was below the middle of the target range. Researchers tested compliance by weighing the patients’ pump bottles.

In some studies evaluating sexual function, depression can affect the outcomes, according to the authors, but the depression scores in this study were low and the treatment and control groups were balanced by randomization.

The findings might not be generalizable since the patients were required to be in a stable relationship with a partner, and the design of the study didn’t allow the authors to determine whether estradiol — which usually increases with testosterone treatment — had an independent effect on sexual function.

The study was funded by AbbVie (Androgel’s manufacturer) and by grants from the federal government.

The authors disclosed relationships with AbbVie, Apricus, Besins, Clarus Therapeutics, Endo Pharma, Ferring, Lilly, Pfizer, Repros Therapeutics, Ardana, Unimed, Sanofi, and Novartis, among others.

last updated 06.30.2016

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Older Low-T Men Get Sex Boost Fom Testo Gel

Older men with low testosterone levels and low sex drive who used a testosterone gel were more likely to show interest in sex, and to have sex more often, than those on placebo in a randomized trial.

Researchers took 470 men, all ages 65 or older with testosterone levels below 275 ng/dL (mean 234 ng/dL, SD 63), and randomized them to receive either AndroGel or placebo gel for 1 year as part of the Testosterone Trials (TTrials); those using the testosterone gel reported significant improvements on 10 of 12 measures of sexual activity, such as how often they had intercourse and whether they anticipated sex.

In addition, increases in total and free testosterone was associated with improvements in sexual activities, but not erectile function, and there was no threshold effect seen for any of the outcomes measured, according to the investigators, who were led by Glenn Cunningham, MD, at the Baylor College of Medicine in Houston.

Cunningham and colleagues published their findings on Wednesday in the Journal of Clinical Endocrinology & Metabolism.

“To date, the sexual function trial of the TTrials is the largest placebo-controlled trial of the efficacy of testosterone on sexual function in older men with low libido and unequivocally low testosterone levels,” wrote the authors.

Most previous research has been of small groups, and only a few trials have included men with sexual symptoms, according to the authors, with some of those trials selecting men without any inclusion criteria for specific symptoms. Previous studies have generated conflicting results, and the TTrials comprise seven randomized trials to see how older men with low testosterone and symptoms respond.

AndroGel is currently approved for treating primary hypogonadism, on the basis of earlier studies involving men with serum testosterone levels below 300 ng/dL, but the product’s label indicates that “safety and efficacy … in men with ‘age-related hypogonadism’ have not been established.” The current study was funded by AndroGel’s manufacturer, AbbVie.

Cunningham and colleagues assessed sexual function at 3, 6, 9, and 12 months using 12 questions from an item on the PDQ survey. The survey asked about masturbation, having sexual daydreams, and other items like getting erections, ejaculating, and having orgasms. No significant improvements were seen in two of the measures: being flirted with by others and getting spontaneous erections during the day.

Patients were about 71 years old on average, and there were significantly more Hispanic patients and more married men in the treatment group than in the placebo group, which the authors said was was possibly due to chance despite P values of 0.02. Over 60% of the men in the study were obese, and about 33% had diabetes.

Of 27 baseline characteristics tested for, only alcohol use was related to post-treatment sexual activity and desire, as those in the treatment group who had more drinks saw a greater increase in sexual desire.

Patients started on a dose of 5 g each day with a target serum testosterone concentration range of 400-800 ng/dL that was later changed to 500-800 ng/dL after the early trial data showed that the median testosterone concentration of the men assigned to the treatment arm was 400-500 ng/dL, which was below the middle of the target range. Researchers tested compliance by weighing the patients’ pump bottles.

In some studies evaluating sexual function, depression can affect the outcomes, according to the authors, but the depression scores in this study were low and the treatment and control groups were balanced by randomization.

The findings might not be generalizable since the patients were required to be in a stable relationship with a partner, and the design of the study didn’t allow the authors to determine whether estradiol — which usually increases with testosterone treatment — had an independent effect on sexual function.

The study was funded by AbbVie (Androgel’s manufacturer) and by grants from the federal government.

The authors disclosed relationships with AbbVie, Apricus, Besins, Clarus Therapeutics, Endo Pharma, Ferring, Lilly, Pfizer, Repros Therapeutics, Ardana, Unimed, Sanofi, and Novartis, among others.

last updated 06.30.2016

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CMS Releases Third Year of Open Payments Data

CMS Releases Third Year of Open Payments Data

June 30
by CMS

By Shantanu Agrawal, M.D., CMS Deputy Administrator for Program Integrity

On June 30, 2016, the Centers for Medicare & Medicaid Services (CMS) posted the Open Payments data for program year 2015, along with newly submitted and updated 2013 and 2014 records.  Open Payments (sometimes called the “Sunshine Act”) is a national program, required by the Affordable Care Act, that promotes CMS’ commitment to transparency by providing data on the financial relationships between the health care industry – including pharmaceutical and medical companies – and health care providers.

In program year 2015, health care industry manufacturers reported $7.52 billion in payments and ownership and investment interests to physicians and teaching hospitals.  This amount is comprised of 11.90 million total records attributable to 618,931 physicians and 1,116 teaching hospitals.  Payments in the three major reporting categories are:

  • $2.60 billion in general (i.e., non-research related) payments
  • $3.89 billion in research payments
  • $1.03 billion of ownership or investment interests held by physicians or their immediate family members

Over the course of the Open Payments program since 2014, we have published 28.22 million records, accounting for $16.77 billion in payments and ownership and investment interests.

Posting the Open Payments program 2015 year data is exciting not only because we’ve concluded the third reporting cycle for Open Payments, but also because we are now able to compare the data across years to identify trends.  We are also able to analyze payments related to covered drugs, devices, biologicals, and supplies.  For example, we were able to determine that for program year 2015, 2.26 percent (637,131 records) of all financial transactions between physicians and pharmaceutical companies was related to opioid medications.

The Open Payments program provides the public more information about the financial relationships between physicians and teaching hospitals and the health care industry. The Open Payments Program does not identify whether financial relationships are beneficial or may indicate conflicts of interest.  Rather, this transparency program was intended to shed light on the nature and extent of these relationships.

We found that while the totals by major reporting category remained relatively unchanged between 2014 and 2015, there were some shifts in who was paid and how the money was spent.  See Table 1 and Figure 1 below.  Transparency is empowering physicians to be purposeful about their financial relationships with companies, and there is a notable shift towards charitable contributions and away from other interactions such as honoraria and gifts. We also observed some shifts in the highest paid physician types that may be of interest to researchers and other stakeholders. Coming years will provide additional interesting trend information.

Table 1: Highest Paid Physician Types, 2014 and 2015

Open Payment Table

Figure 1: Percent Change of Total Dollar Value by Nature of Payment, 2014 – 2015

The graph below is the percent change of total dollar value by nature of payment, between Open Payment Program years 2014 and 2015. The charitable contribution increased 126.40%. Faculty for a non-accredited education program increased 24.68%. Royalty or license payments increased 13.8%. Food and beverage payments increased 1.18%. Travel and lodging increased 0.87%. Space rental or facility fees decreased 1.78%. Consulting fee payments decreased 1.98%. Grant payments decreased 2.75%. Ownership or investment interest payments decreased 3.71%. Services other than consulting decreased 15.31%. Entertainment payments decreased 20.75%. Faculty for an accredited education program decreased 21.41%. Education payments decreased 28.47%. Gift payments decreased 30.45%. Honoraria payments decreased 49.12%.

Health care industry manufacturers must report to the Open Payments program annually, while participation by physicians and teaching hospitals is voluntary and encouraged.  If physicians or teaching hospitals disagree with what’s been reported, they can initiate a data dispute against the record and work with the reporting entity to resolve the discrepancy before the data is published. This process helps verify the accuracy of the Open Payments data. Registered physicians and teaching hospitals disputed 0.13 percent of Open Payment records (16,653 disputed records) that were eligible for review and dispute, representing 1.95 percent of total value of the published records.  Additionally, 0.22 percent of records (28,955 records) were affirmed by physicians and teaching hospitals, accounting for 0.76 percent of total value of the published records. Registered physicians and teaching hospitals with data attributed to them in the Open Payments system account for 35.45 percent of the total value of their published data. This does not include research-related payments made to non-covered recipients that employed physician principal investigators, which accounted for 40.92 percent of the published payments value.

If disputes are not resolved by the end of the data correction period, those entries are published with a notation identifying them as “disputed.”  We encourage physicians to sign up for Open Payments and to actively monitor any financial data related to them that is being reported.

Open Payments is part of CMS’ ongoing effort to increase transparency and accountability in health care. Since last publication (June 30, 2015), Open Payments has been referenced over 2,600 times in broadcast placements, traditional print, and social media.  Open Payments has been highlighted as a resource for transparency and reporting in an industry with complex stakeholder relationships that traditionally have been difficult to quantify and qualify.

You can search the Open Payments data at: OpenPaymentsData.CMS.gov. We’re pleased that the public has searched Open Payments data more than 6.78 million times. If you’ve visited the Open Payments website in the past, you’ll notice that we’ve improved our data review tools and provided a number of ways to accommodate different users and their interests:

  • Search Tool: Site visitors can get immediate results using this standard search interface to find detailed information on individual physicians, teaching hospitals, or companies making payments. Search results will now be aggregated in alphabetical order by the company reporting the payment.
  • Data Explorer: You can select a dataset and customize the view using filters, sorts, and other actions to create your own, targeted views of the data along with visualizations, such as charts and graphs.
  • Data downloads: You can download the data in comma-separated values (.csv) format, which allows you to open and explore the data using your own software on your own computer. With this option, you must have robust data viewing software that allows for downloading and viewing data in large datasets.

Open Payments continues to be an important program for health care transparency and we look forward to its on-going contributions to dialogue on the policy and clinical communities. We also invite input on how to continue to improve this program. You can learn more about Open Payments by visiting CMS.gov/openpayments.

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Testosterone therapy improves sexual activity in older men

Older men with low libido and low testosterone levels showed more interest in sex and engaged in more sexual activity when they underwent testosterone therapy, according to a new study published in the Endocrine Society’s Journal of Clinical Endocrinology & Metabolism.

The study is the largest placebo-controlled trial in older men conducted on the subject to date. The sexual function study is part of the Testosterone Trials, a series of seven studies examining the effectiveness of hormone therapy in men who are 65 or older, who have low testosterone levels and are experiencing symptoms of testosterone deficiency. The research is supported primarily by the National Institutes of Health.

Testosterone is a key male sex hormone involved in maintaining sex drive, erectile function and sperm production. The Endocrine Society’s Clinical Practice Guideline recommends using testosterone therapy to treat men with symptoms of androgen deficiency and low levels of testosterone. Androgen deficiency occurs when a man has consistently low levels of testosterone and resulting symptoms such as sexual dysfunction.

In the past 15 years, use of testosterone therapy has rapidly expanded among men. Testosterone levels decline as men age, and some men develop low testosterone levels and symptoms. Since 2000, the number of men beginning testosterone therapy has almost quadrupled in the United States, according to a 2014 study published in The Journal of Clinical Endocrinology & Metabolism.

“Our findings indicate low testosterone is one cause contributing to reduced libido and erectile dysfunction in older men,” said the study’s first author, Glenn R. Cunningham, MD, of Baylor College of Medicine and Baylor St. Luke’s Medical Center in Houston, TX. “Men experiencing these symptoms should be evaluated for testosterone deficiency.”

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The study was designed to investigate the effectiveness of testosterone therapy. It was not large enough or long enough to address issues related to cardiovascular events or clinical prostate cancer.

The placebo-controlled, double-blinded trial examined the effect of testosterone therapy on sexual function in a group of 470 men. The men were enrolled in the study through 12 academic medical centers. The participants were at least 65 years old and had low testosterone levels, based on the average results of multiple tests. All of the men had a heterosexual partner.

During the year-long study, the men were assigned to receive either testosterone gel or a placebo applied to the skin. The participants answered questionnaires about sexual function at the outset and every three months during the 12-month study.

The men treated with testosterone therapy displayed consistent improvement in libido and in 10 of the 12 sexual activity measurements, including frequency of intercourse, masturbation and nighttime erections. In comparison, men who received the placebo did not change their questionnaire responses significantly over the course of the year-long study.

“For symptomatic older men with low testosterone levels, testosterone therapy led to consistent improvement in most types of sexual activity,” Cunningham said.

Source:

Endocrine Society

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