13 Foods You’re Better Off Avoiding Before Having Sex

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While most of us are aware of the foods that act as aphrodisiacs, only a handful are aware of the foods we should avoid at all costs. Not only will these make you feel bloated, unsexy and lethargic, they are likely to prevent you from getting it on!

#1. French fries

As tempting as reaching for those French fries are at all times fried foods (including the likes of pizza) are disastrous for your libido. They lower your testosterone levels, decrease blood circulation, and reduce your chances of maintaining strong erections.

#2. Hot dogs

Thinking of chomping on a hot dog towards the end of your grand night out before heading back for a raunchy session under the sheets? Although this super popular snack is great when paired with beer while watching your favorite sport it’s loaded with the kind of saturated fat that can clog the arteries that improve blood flow to your sexual organs. 

#3. Processed foods

Whether it is the aforementioned hot dog or the savory cupcake, the trans fat and sugars in processed food items can weigh down your digestion and slow your blood flow; hampering your sex drive.  Over time this can cause a loss of muscle mass, increase in fat and a dip in your testosterone levels.

#4. Canned or packaged foods

Canned or packaged foods are loaded with crippling levels of sodium. When we say crippling we mean that it can elevate your blood pressure to unfavorable levels and blockade the flow of blood to certain parts your body, like your genitals, leaving your limp.  

#5. Beer

If your night out entails having sex, later on, make sure it doesn’t include cracking open pints of beer in the build-up to it. Although it might give you the buzz you seek the phytoestrogens present in beer stand a good chance to alter the hormones that tamper with your libido. 

#6. Energy drinks

These bottled up potions of liquid give you instant energy due to the caffeine and sugar they are loaded with, but they do just the opposite to your sexual stamina. Once the caffeine and sugar burn off in your system they leave you with lesser energy than you had before. Studies also suggest that it lowers the level of the hormone serotonin that impacts your mood.

#7. Tonic water

 

Although this makes for a perfect combination with gin it doesn’t fair that well with your testosterone levels. The chemical quinine present in the water not only kills your sex drive and lowers your sperm count but it also can cause gas and bloating. 

#8. All sorts of beans

 

Love your rice and beans? Science has it that beans contain oligosaccharides (sugar molecules that the body cannot fully breakdown), which create gas and excessive cramping. And these are the last two things you want to be feeling down there when you’re setting yourself to get it on.

#9. Cruciferous vegetables

 

Sometimes the healthiest of vegetables can be just what you need to avoid in certain situations. Cruciferous vegetables like cabbage, broccoli and cauliflower create a lot of gas since our body cannot digest the natural sugars found in them. The methane, carbon dioxide and hydrogen produced by your body, as a result, can really stink up your surroundings.

#10. Tofu

Tofu has earned its name as one of the healthier options of protein for vegetarians and non-vegetarians as well, but not so much before a sexual encounter. Soy laden products increase your estrogen levels that have shown to decrease the estrogen levels in both sexes.

#11. Onions and garlic

If your food is loaded with onions and garlic, like most of our food is, try to avoid them in your meal prep before you engage in coitus. These pungent vegetables can affect your body odor for the worse; similar to how spices do. 

#12. Red meats

 

If you’re big on eating meats like lamb, pork or beef, especially on night outs where you’re looking forward to a romp in the sack, later on, swap it with seafood instead. Red meat is associated with the production of foul-smelling gas that can be downright offensive in nature!

#13. Cream-based sauces

Avoid cream-based sauces, such as the ones they use to make pasta in some restaurants; their heavy nature will put your system into a slump. The cream can upset your stomach and cause gas if you’re lactose intolerant dampening your elevated spirits.

 

Written By: REGI GEORGE JENARIUS

Article Source: http://www.indiatimes.com/health/healthyliving/13-foods-you-re-better-off-avoiding-before-having-sex-329846.html

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Testosterone therapy improves sexual, urinary function in men

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Men with hypogonadism treated long-term with testosterone therapy experience improvements in sexual and urinary function compared with men who are not treated, according to findings published in The Journal of Urology.

Abdulmaged M. Traish, PhD, of the department of biochemistry and department of urology at Boston University School of Medicine, and colleagues evaluated data on men with total testosterone levels of 12.1 nmol/L or less and symptoms of hypogonadism assigned to parenteral testosterone undecanoate 1,000 mg for 12 weeks (n = 360; mean age, 57.4 years) or no testosterone (n = 296; mean age, 64.8 years) for up to 10 years to determine the effect of long-term testosterone therapy on urinary and sexual functions and quality of life. Follow-up was a mean of 6.5 years.

Total testosterone levels were restored to the physiological range (500 ng/dL) in the treated group during the first year and the levels remained stable through follow-up; however, mean testosterone levels remained less than 300 ng/dL in the untreated group.

The untreated group experienced increases in the international prostate symptom score during follow-up compared with decreases in the treated group. At baseline, 50% of the treated group reported mild symptoms and 50% reported moderate symptoms, and 91.5% of the untreated group reported mild symptoms and 8.5% reported moderate symptoms. At the last visit, all the treated group had mild symptoms, and 61% of the untreated group reported mild symptoms and 39% reported moderate symptoms.

Post-voiding bladder volume and score on the Aging Males’ Symptoms scale decreased in the treated group but increased in the untreated group.

Among the treated group, 17.1% had no erectile dysfunction, 30.5% had mild erectile dysfunction, 20.7% mild to moderate, 25.6% moderate and 6.1% severe. At the last visit, the proportion of treated participants without erectile dysfunction increased to 74.4%, 17.1% had mild, 7.3% had mild to moderate and 1.2% had moderate. Among the untreated group, 1.2% had no erectile dysfunction, 31.7% had mild, 52.4% had mild to moderate and 14.6% had moderate. The severity of erectile dysfunction increased in the untreated group through follow-up to 51.2% having moderate and 48.8% having severe.

Prostate volume remained stable in the untreated group but increased from 31.4 mL to 33.2 mL in the treated group.

 

Article Source: https://www.healio.com/endocrinology/hormone-therapy/news/in-the-journals/%7B0c2f828d-0812-42fa-8f66-181eb9a8ee0f%7D/testosterone-therapy-improves-sexual-urinary-function-in-men

 

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Hair loss warning: THIS popular medication could trigger erectile dysfunction

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HAIR loss – or alopecia – affects half of men over the age of 30 in the UK, but using certain medications to counteract it could cause erectile dysfunction – which is the inability of a man to get and maintain an erection.

By the time they reach their fifties, over 50 per cent of men will experience some degree of baldness, according to the NHS.

The most common type of hair loss is male-pattern baldness, where sufferers often experience a receding hairline followed by thinning of hair on the crown and temples.

However, there are now a number of treatment options, and the Alopecia Treatment Market Size is set to see sustained growth between now and 2022.

These include hair transplants and medications, but experts are warning of the risks involved.

Doctors at the International Andrology London have warned that men undergoing a hair transplant could suffer erectile dysfunction as a result.

They are raising awareness of a condition called post-Finasteride Syndrome which is caused by a drug called 5-alpha reductase type II enzyme inhibitor or Finasteride.

The medication works by halting hair loss in men with thinning hair.

It also assists hair transplant treatment by stopping the body from rejecting new hair.

However, it can cause some worrying side-effects.

These include neurological and physical symptoms such as muscle atrophy, chronic fatigue and depression.

Such is their prevalence that the Post-Finasteride Syndrome Foundation has been created to boost awareness.

Dr Amr Raheem at International Andrology said: “Erectile dysfunction, loss of libido, reduction of semen creation and curvature of the penis (known as Peyronie’s) are all part of this disturbing reaction.

“Hair transplant clinics are aware of the issue and have an obligation to explain the risks to patients while the drug itself is becoming more clearly labelled.

“However, understand that investment into finding alternatives to this drug, which can provide results without compromising patients’ health, are ongoing.

“At International Andrology London, we encourage men who are developing a serious hair condition such as alopecia and know that they will need hair replacement to make a pre-emptive move, seeking out treatment for erectile dysfunction, such as shockwave therapy, before they experience the problem.

“This builds up muscle resistance and manages the condition through the hair treatment.

“An alternative option is to take Minoxidil spray which improves the circulation to the scalp and has been proven to help without the same side effects.”

Written By LAUREN CLARK

Article Source: http://www.express.co.uk/life-style/health/841366/hair-loss-erectile-dysfunction-transplant-treatment-medication-finasteride-alopecia-bald

 

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The Benefits of High Cholesterol

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People with high cholesterol live the longest.

This statement seems so incredible that it takes a long time to clear one´s brainwashed mind to fully understand its importance.

Yet the fact that people with high cholesterol live the longest emerges clearly from many scientific papers.

Consider the finding of Dr. Harlan Krumholz of the Department of Cardiovascular Medicine at Yale University, who reported in 1994 that old people with low cholesterol died twice as often from a heart attack as did old people with a high cholesterol.

Supporters of the cholesterol campaign consistently ignore his observation, or consider it as a rare exception, produced by chance among a huge number of studies finding the opposite.

But it is not an exception; there are now a large number of findings that contradict the lipid hypothesis.

To be more specific, most studies of old people have shown that high cholesterol is not a risk factor for coronary heart disease.

This was the result of my search in the Medline database for studies addressing that question.

Eleven studies of old people came up with that result, and a further seven studies found that high cholesterol did not predict all-cause mortality either.

Now consider that more than 90 % of all cardiovascular disease is seen in people above age 60 and that almost all studies have found that high cholesterol is not a risk factor for women.

This means that high cholesterol is only a risk factor for less than 5 % of those who die from a heart attack.

But there is more comfort for those who have high cholesterol; six of the studies found that total mortality was inversely associated with either total or LDL-cholesterol, or both.

This means that it is actually much better to have high than to have low cholesterol if you want to live to be very old.

High Cholesterol Protects Against Infection

Many studies have found that low cholesterol is in certain respects worse than high cholesterol.

For instance, in 19 large studies of more than 68,000 deaths, reviewed by Professor David R. Jacobs and his co-workers from the Division of Epidemiology at the University of Minnesota, low cholesterol predicted an increased risk of dying from gastrointestinal and respiratory diseases.

Most gastrointestinal and respiratory diseases have an infectious origin.

Therefore, a relevant question is whether it is the infection that lowers cholesterol or the low cholesterol that predisposes to infection?

To answer this question Professor Jacobs and his group, together with Dr. Carlos Iribarren, followed more than 100,000 healthy individuals in the San Francisco area for fifteen years.

At the end of the study those who had low cholesterol at the start of the study had more often been admitted to the hospital because of an infectious disease.

This finding cannot be explained away with the argument that the infection had caused cholesterol to go down, because how could low cholesterol, recorded when these people were without any evidence of infection, be caused by a disease they had not yet encountered?

Isn´t it more likely that low cholesterol in some way made them more vulnerable to infection, or that high cholesterol protected those who did not become infected? Much evidence exists to support that interpretation.

Written By: Uffe Ravnskov, MD, PhD

Article Source: https://www.functionalmedicineuniversity.com/public/924.cfm

 

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Ben Stiller Wants Men to Test for Prostate Cancer

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Actor Ben Stiller was as surprised as anyone when he heard these words: “So yeah, it’s cancer.”

After all, he was only 48 and had no real reason to suspect that he had cancer, especially prostate cancer, which many people think of as an older man’s disease.

“I have no history of prostate cancer in my family and I’m not in the high-risk group,” he wrote in a public posting detailing his experience. “I had no symptoms.”

So how did the star of movies including There’s Something About MaryMeet the Parents, and Zoolander end up getting diagnosed in the first place? And what does his case have to say about the way we diagnose and treat prostate cancer in the United States?

Stiller’s story began two years before the day in June 2014 when he was diagnosed with prostate cancer. This is when his doctor, a “thoughtful internist”, gave him a simple and inexpensive PSA screening test. This was the first of many PSA tests over the next few years.

A one-time modest elevation of PSA blood levels can be explained by several factors that are often correctable. So the best course of action is to have follow-up PSA tests to monitor what direction the PSA is moving in.

As follow-up PSA tests were performed, Ben Stiller’s doctor noted a gradual rise in Stiller’s PSA over his earlier baseline. These rising levels triggered a referral to a urologist, who did further testing, including a digital rectal exam, an MRI, and finally a biopsy that confirmed the diagnosis.

Three months after his diagnosis, Stiller had undergone treatment—in his case a robotic-assisted laparoscopic radical prostatectomy, or removal of his prostate gland during a minimally invasive surgery—and was cancer free. That could have been the end of it, but after doing his research into prostate cancer screening and diagnosis, Stiller realized he couldn’t be silent about his experience. He’s been spreading the same message ever since: “Taking the PSA test saved my life.”

This might not seem like a controversial statement—after all, it might seem hard to argue against a simple blood test that can identify prostate cancer early enough to treat it before it spreads and without major side effects. But in fact, due to recent chaos in the official recommendations for PSA blood testing, tens of thousands of American men are skipping the very test that possibly saved Stiller’s life on the advice of their doctors and with potentially devastating consequences.

History of Screening Recommendations

The PSA test is used to measure prostate-specific antigen, a protein that is produced by the prostate gland.

PSA levels rise in aging men and can be the first signal of underlying prostate cancer. So the PSA blood test is used to identify men who may have prostate malignancy and need further evaluation.

This simple blood test was approved by the FDA in 1994, allowing men to begin monitoring their PSA levels and identify possible tumors long before they become dangerous.1

Since PSA testing was introduced, the risk of dying from prostate cancer among men who were regularly screened declined by as much as 42%.2,3

Despite this drop, widespread PSA screening remained controversial in the medical community.

Prostate cancer is typically a slow-growing cancer, and the current biopsy and treatment methods, including the kind of less-invasive surgical removal that Stiller underwent, carry risks such as pain, incontinence and impotence. Some doctors worried that the PSA test, which can detect very slight increases in PSA levels, might be causing men with low-risk cancers to undergo biopsies and possibly unnecessary treatment.

Based on these concerns, in 2012, the US Preventive Service Task Force (USPSTF) issued a stunning update to prostate screening recommendations. Drawing its conclusions from the results of a $400 million federal study, the USPSTF advised against PSA screening for healthy men, saying that PSA screening has “no net benefit.”4-6 The American Cancer Society soon revised its recommendations, steering healthy, average-risk men away from PSA screening until age 50, with revised recommendations for men with a family history of prostate cancer.7

These guidelines caused immediate uproar in the medical community, including rebuttals from Life Extension® urging men over age 40 to continue having annual PSA blood tests. By 2016, the USPSTF announced it was reconsidering its prior recommendations against PSA screening.

In 2017, a new draft recommendation was released for public input. This time, the USPSTF slightly backtracked, saying that the risks and benefits of PSA screening are “closely balanced” in men between the ages of 55 and 69 and they should seek their doctor’s advice on PSA screening. Men aged 54 and under and those over the age of 70 would still be counseled to avoid PSA screening. These new, slightly softer guidelines were still not finalized as of May 2017, and the agency was soliciting public input.8

In Stiller’s case, following even the updated guidelines might have meant disaster—he was still too young to be screened according to the USPSTF (United States Preventive Service Task Force).

“If he [Ben Stiller’s doctor] had waited, as the American Cancer Society recommends, until I was 50, I would not have known I had a growing tumor until two years after I got treated,” he wrote. “If he [Ben Stiller’s doctor] had followed the US Preventive Service Task Force guidelines, I would never have gotten tested at all, and not have known I had cancer until it was way too late to treat successfully.”

The USPSTF’s original recommendations against screening were partly based on the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial. This huge trial assigned 76,685 men aged 55 – 74 years to one of two study arms. The first group (38,340 men) underwent annual PSA testing for 6 years and an annual digital rectal exam for 4 years. The control group (38,345 men) underwent normal care, with occasional “opportunistic screening” but no regular PSA monitoring. At the end of the 13-year follow-up period, researchers announced there was “no evidence of a mortality benefit” for annual PSA screening.9 The USPSTF recommendation against PSA screening soon followed.

Life Extension, which has long supported PSA screening, issued a detailed rebuttal challenging the findings of this study. In fact, the study was deeply flawed thanks to widespread “contamination” of the control arm.

While Life Extension was early in identifying the obvious flaws with this study, it wasn’t long until astute research groups began to catch up. In early 2016, a group of urologists from the New York Presbyterian Hospital and Weill Cornell Medical College in New York published a letter in the New England Journal of Medicine confirming what Life Extension suspected.10

The shocking truth was that more than 80% of the men in the control group—which was supposed to only receive “occasional” PSA screening—reported at least one PSA test during the trial. In fact, by some measures, the men in the control group received more PSA screening than men in the PSA screeningarm!10

Their conclusion? “We’re going to have to reconsider this issue.”11

Further support for this position was published in another large study, this one called the European Randomized Study of Screening for Prostate Cancer. This study randomized 182,000 men aged 50 to 74 to a “usual care” control group or a group with PSA screening every two to seven years. Spread across seven research centers in Europe, the group tracked prostate cancer mortality in both study arms. At the median follow-up of nine years, researchers reported that PSA screening resulted in a 20% reduction in prostate cancer mortality!12

A study from the Göteborg center, one of the seven participating centers in this study, found that men aged 50 to 64 years of age who had a PSA screening every other year had a 44% reduced mortality risk from prostate cancer. The center used a PSA cutoff of 2.5 ng/mL to 3.0 ng/mL. Men with these cutoff PSA levels and higher were referred for additional testing, including a digital rectal exam, transrectal ultrasound, and prostate biopsy.13

Although it’s too late to help the tens of thousands of men who likely skipped PSA screening, we are grateful the USPSTF is slowly grappling with the well-documented issues in its original guidelines by issuing the new draft recommendations.14

The issue was further complicated by results from a study published in the New England Journal of Medicinein 2016. This trial followed 1,643 men for a decade, each with prostate cancer that was first detected by PSA screening, to see which of the most popular treatment techniques was most effective, including “active waiting” and monitoring the disease, surgery to remove the prostate gland, or external radiation beam therapy to treat the cancer. While the prostate-cancer-specific survival rate was high (>98%) in all three groups, researchers found that men in the “active waiting” group were more likely to progress to metastatic disease, and about half of them needed surgery or radiation therapy within the 10-year study period.15

These results suggest that men benefit from early detection and early treatment of prostate cancer.

Please note that Life Extension does not recommend “watchful or active waiting” in the presence of high PSA and/or low-grade prostate cancer. We instead advise men to follow an aggressive “active surveillance” program that involves an anticancer diet along with specific drugs and nutrients that may enable early-stage disease to be contained.

Rise in Metastatic Cancer Rates

While various agencies continue to issue contradictory and confusing advice, men across the country have paid the price. In late 2016, a research group from Northwestern Medicine released a stunning and tragic finding: diagnoses of metastatic prostate cancer, the worst type, climbed an unbelievable 72% between 2004 and 2013.16

To reach these findings, the group studied a database of more than three-quarters of a million men in the National Cancer Data Base. What they found should alarm any man who skips his PSA screening.

“The fact that men in 2013 who presented with metastatic disease had much higher PSAs than similar men in 2004 hints that more aggressive disease is on the rise,”17 said study author Dr. Edward Schaeffer, chair of urology at Northwestern University Feinberg School of Medicine and Northwestern Medicine.

“One hypothesis is the disease has become more aggressive, regardless of the change in screening,” said Dr. Schaeffer. “The other idea is since screening guidelines have become more lax, when men do get diagnosed, it’s at a more advanced stage of disease. Probably both are true. We don’t know for sure but this is the focus of our current work.”17

This makes treatment more difficult, and it’s exactly the situation Ben Stiller would have faced if his forward-thinking doctor hadn’t established a PSA baseline early on and tracked it, allowing him to discover Stiller’s troubling increase in PSA levels over time and recommend the movie star for further evaluation and surgery.

It’s important to note that the increase in metastatic, aggressive prostate cancer almost perfectly aligns with the trend away from PSA screening that culminated with the USPSTF 2012 recommendation against any PSA screening.

Prostate Cancer Survivors Due to Early Detection

Name Year Successfully Treated
Robert De Niro 2003 at age 60
John Kerry 2003 at age 60
Rudy Giuliani 2000 at age 56
Robert Goulet 1993 at age 60
Colin Powell 2003 at age 66
Michael Milken 1993 at age 46

Stiller’s Happy Ending

The main concern with PSA screening is the potential for overdiagnosis and unnecessary treatment. These are real concerns—PSA screening frequently returns “false positives,” which are stressful for the patients involved and result in unnecessary biopsies and additional tests.18

We recommends regular, inexpensive PSA screening to establish a baseline and follow PSA numbers over time. If your PSA level rises above 1.0 ng/mL, there are natural and safe measures you can take to reduce it. Further evaluation may be necessary if your PSA continues to rise over time.

In fact, this is exactly the course Stiller followed, and today he’s alive and grateful for it.

“The bottom line for me: I was lucky enough to have a doctor who gave me what they call a ‘baseline’ PSA test when I was about 46,” he wrote in Medium, a popular blogging platform. “My doctor watched my PSA tests rise for over a year and a half, testing me every six months…I think men over the age of 40 should have the opportunity to discuss the test with their doctor and learn about it, so they can have the chance to be screened.”19

More recently, two years after his diagnosis and treatment, Stiller went public with his experience with an interview with Matt Lauer on the Today show, alongside Dr. Schaeffer. While reporting that he wasn’t experiencing any of the major complications of prostate surgery, Stiller gave a simple reason for going public. He wanted to educate as many men as possible about their options when it came to PSA screening.

“It’s a whole new world,” Stiller said. “You need to educate yourself.”

We at Life Extension commend Bernard M. Kruger, M.D. for having the foresight to test Ben Stiller’s PSA blood levels despite conventional “authorities” advising against PSA screening.

Written By Jon Vanzile

Article Source: http://www.lifeextension.com/Magazine/2017/9/Ben-Stiller-Advocates-Prostate-Cancer-Screening/Page-01

 

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Low Plasma Testosterone Is Associated With Elevated Cardiovascular Disease Biomarkers

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BACKGROUND:

The relation between testosterone (T) plasma concentration and cardiovascular (CV) risk is unclear, with evidence supporting increased risk in men with low and high T levels. Few studies have assessed CV risk as a function of plasma T levels using objective biomarkers.

AIM:

To determine the relation between T levels and high-sensitivity CV risk biomarkers.

METHODS:

Ten thousand forty-one male patients were identified in the database of a commercial clinical laboratory performing biomarker testing. Patients were grouped by total T concentration and associations with the following biomarkers were determined: cardiac troponin I (cTnI), endothelin-1 (ET-1), interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), interleukin-17A, N-terminal pro-B-type natriuretic peptide (NTproBNP), high-density lipoprotein (HDL) cholesterol, high-sensitivity C-reactive protein (hs-CRP), hemoglobin A1c (HbA1c), and leptin.

OUTCOMES:

Association of CV risk markers with levels of T in men.

RESULTS:

The median age of the cohort was 58 years (interquartile range = 48-68), and the median plasma T level was 420 ng/dL (interquartile range = 304-565); T levels did not vary with patient age. An inverse relation between plasma T levels and CV risk was observed for 9 of 10 CV markers: cTnI, ET-1, IL-6, TNF-α, NTproBNP, HDL cholesterol, hs-CRP, HbA1c, and leptin. Even after adjusting for age, body mass index, HbA1c, hs-CRP, and HDL cholesterol levels, the CV markers IL-6, ET-1, NTproBNP, and leptin were significantly associated with a T level lower than 250 ng/dL.

CLINICAL IMPLICATIONS:

Men with low T levels could be at increased risk for increased CV disease as seen by increased CV risk markers.

STRENGTH AND LIMITATIONS:

This study was performed in a group of 10,041 men and is the first study to examine CV risk associated with circulating T levels using a large panel of 10 objective biomarkers. This study is limited by an absence of clinical data indicating whether men had pre-existing CV disease or other CV risk factors.

CONCLUSION:

Men with low plasma T levels exhibit increases in CV risk markers, consistent with a potential increased risk of CV disease. Pastuszak AW, Kohn TP, Estis J, Lipshultz LI. Low Plasma Testosterone Is Associated With Elevated Cardiovascular Disease Biomarkers. J Sex Med 2017;XX:XXX-XXX.

Article Source: https://www.ncbi.nlm.nih.gov/pubmed/28757119

 

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The Myth of Drug Expiration Dates

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Hospitals and pharmacies are required to toss expired drugs, no matter how expensive or vital. Meanwhile the FDA has long known that many remain safe and potent for years longer.

The box of prescription drugs had been forgotten in a back closet of a retail pharmacy for so long that some of the pills predated the 1969 moon landing. Most were 30 to 40 years past their expiration dates — possibly toxic, probably worthless.

But to Lee Cantrell, who helps run the California Poison Control System, the cache was an opportunity to answer an enduring question about the actual shelf life of drugs: Could these drugs from the bell-bottom era still be potent?

Cantrell called Roy Gerona, a University of California, San Francisco, researcher who specializes in analyzing chemicals. Gerona had grown up in the Philippines and had seen people recover from sickness by taking expired drugs with no apparent ill effects.

“This was very cool,” Gerona says. “Who gets the chance of analyzing drugs that have been in storage for more than 30 years?”

The age of the drugs might have been bizarre, but the question the researchers wanted to answer wasn’t. Pharmacies across the country — in major medical centers and in neighborhood strip malls — routinely toss out tons of scarce and potentially valuable prescription drugs when they hit their expiration dates.

Gerona and Cantrell, a pharmacist and toxicologist, knew that the term “expiration date” was a misnomer. The dates on drug labels are simply the point up to which the Food and Drug Administration and pharmaceutical companies guarantee their effectiveness, typically at two or three years. But the dates don’t necessarily mean they’re ineffective immediately after they “expire” — just that there’s no incentive for drugmakers to study whether they could still be usable.

ProPublica has been researching why the U.S. health care system is the most expensive in the world. One answer, broadly, is waste — some of it buried in practices that the medical establishment and the rest of us take for granted.  We’ve documented how hospitals often discard pricey new supplies, how nursing homes trash valuable medications after patients pass away or move out, and how drug companies create expensive combinations of cheap drugs. Experts estimate such squandering eats up about $765 billion a year — as much as a quarter of all the country’s health care spending.

What if the system is destroying drugs that are technically “expired” but could still be safely used?

In his lab, Gerona ran tests on the decades-old drugs, including some now defunct brands such as the diet pills Obocell (once pitched to doctors with a portly figurine called “Mr. Obocell”) and Bamadex. Overall, the bottles contained 14 different compounds, including antihistamines, pain relievers and stimulants. All the drugs tested were in their original sealed containers.

The findings surprised both researchers: A dozen of the 14 compounds were still as potent as they were when they were manufactured, some at almost 100 percent of their labeled concentrations.

“Lo and behold,” Cantrell says, “The active ingredients are pretty darn stable.”

Cantrell and Gerona knew their findings had big implications. Perhaps no area of health care has provoked as much anger in recent years as prescription drugs. The news media is rife with stories of medications priced out of reach or of shortages of crucial drugs, sometimes because producing them is no longer profitable.

Tossing such drugs when they expire is doubly hard. One pharmacist at Newton-Wellesley Hospital outside Boston says the 240-bed facility is able to return some expired drugs for credit, but had to destroy about $200,000 worth last year. A commentary in the journal Mayo Clinic Proceedings cited similar losses at the nearby Tufts Medical Center. Play that out at hospitals across the country and the tab is significant: about $800 million per year. And that doesn’t include the costs of expired drugs at long-term care pharmacies, retail pharmacies and in consumer medicine cabinets.

After Cantrell and Gerona published their findings in Archives of Internal Medicine in 2012, some readers accused them of being irresponsible and advising patients that it was OK to take expired drugs. Cantrell says they weren’t recommending the use of expired medication, just reviewing the arbitrary way the dates are set.

“Refining our prescription drug dating process could save billions,” he says.

But after a brief burst of attention, the response to their study faded. That raises an even bigger question: If some drugs remain effective well beyond the date on their labels, why hasn’t there been a push to extend their expiration dates?

It turns out that the FDA, the agency that helps set the dates, has long known the shelf life of some drugs can be extended, sometimes by years.

In fact, the federal government has saved a fortune by doing this.


For decades, the federal government has stockpiled massive stashes of medication, antidotes and vaccines in secure locations throughout the country. The drugs are worth tens of billions of dollars and would provide a first line of defense in case of a large-scale emergency.

Maintaining these stockpiles is expensive. The drugs have to be kept secure and at the proper humidity and temperature so they don’t degrade. Luckily, the country has rarely needed to tap into many of the drugs, but this means they often reach their expiration dates. Though the government requires pharmacies to throw away expired drugs, it doesn’t always follow these instructions itself. Instead, for more than 30 years, it has pulled some medicines and tested their quality.

The idea that drugs expire on specified dates goes back at least a half-century, when the FDA began requiring manufacturers to add this information to the label. The time limits allow the agency to ensure medications work safely and effectively for patients. To determine a new drug’s shelf life, its maker zaps it with intense heat and soaks it with moisture to see how it degrades under stress. It also checks how it breaks down over time. The drug company then proposes an expiration date to the FDA, which reviews the data to ensure it supports the date and approves it. Despite the difference in drugs’ makeup, most “expire” after two or three years.

Once a drug is launched, the makers run tests to ensure it continues to be effective up to its labeled expiration date. Since they are not required to check beyond it, most don’t, largely because regulations make it expensive and time-consuming for manufacturers to extend expiration dates, says Yan Wu, an analytical chemist who is part of a focus group at the American Association of Pharmaceutical Scientists that looks at the long-term stability of drugs. Most companies, she says, would rather sell new drugs and develop additional products.

Pharmacists and researchers say there is no economic “win” for drug companies to investigate further. They ring up more sales when medications are tossed as “expired” by hospitals, retail pharmacies and consumers despite retaining their safety and effectiveness.

Industry officials say patient safety is their highest priority. Olivia Shopshear, director of science and regulatory advocacy for the drug industry trade group Pharmaceutical Research and Manufacturers of America, or PhRMA, says expiration dates are chosen “based on the period of time when any given lot will maintain its identity, potency and purity, which translates into safety for the patient.”

That being said, it’s an open secret among medical professionals that many drugs maintain their ability to combat ailments well after their labels say they don’t. One pharmacist says he sometimes takes home expired over-the-counter medicine from his pharmacy so he and his family can use it.

The federal agencies that stockpile drugs — including the military, the Centers for Disease Control and Prevention and the Department of Veterans Affairs — have long realized the savings in revisiting expiration dates.

In 1986, the Air Force, hoping to save on replacement costs, asked the FDA if certain drugs’ expiration dates could be extended. In response, the FDA and Defense Department created the Shelf Life Extension Program.

Each year, drugs from the stockpiles are selected based on their value and pending expiration and analyzed in batches to determine whether their end dates could be safely extended. For several decades, the program has found that the actual shelf life of many drugs is well beyond the original expiration dates.

A 2006 study of 122 drugs tested by the program showed that two-thirds of the expired medications were stable every time a lot was tested. Each of them had their expiration dates extended, on average, by more than four years, according to research published in the Journal of Pharmaceutical Sciences.

Some that failed to hold their potency include the common asthma inhalant albuterol, the topical rash spray diphenhydramine, and a local anesthetic made from lidocaine and epinephrine, the study said. But neither Cantrell nor Dr. Cathleen Clancy, associate medical director of National Capital Poison Center, a nonprofit organization affiliated with the George Washington University Medical Center, had heard of anyone being harmed by any expired drugs. Cantrell says there has been no recorded instance of such harm in medical literature.

Marc Young, a pharmacist who helped run the extension program from 2006 to 2009, says it has had a “ridiculous” return on investment. Each year the federal government saved $600 million to $800 million because it did not have to replace expired medication, he says.

An official with the Department of Defense, which maintains about $13.6 billion worth of drugs in its stockpile, says that in 2016 it cost $3.1 million to run the extension program, but it saved the department from replacing $2.1 billion in expired drugs. To put the magnitude of that return on investment into everyday terms: It’s like spending a dollar to save $677.

“We didn’t have any idea that some of the products would be so damn stable — so robustly stable beyond the shelf life,” says Ajaz Hussain, one of the scientists who formerly helped oversee the extension program.

Hussain is now president of the National Institute for Pharmaceutical Technology and Education, an organization of 17 universities that’s working to reduce the cost of pharmaceutical development. He says the high price of drugs and shortages make it time to reexamine drug expiration dates in the commercial market.

“It’s a shame to throw away good drugs,” Hussain says.

Some medical providers have pushed for a changed approach to drug expiration dates — with no success. In 2000, the American Medical Association, foretelling the current prescription drug crisis, adopted a resolution urging action. The shelf life of many drugs, it wrote, seems to be “considerably longer” than their expiration dates, leading to “unnecessary waste, higher pharmaceutical costs, and possibly reduced access to necessary drugs for some patients.”

Citing the federal government’s extension program, the AMA sent letters to the FDA, the U.S. Pharmacopeial Convention, which sets standards for drugs, and PhRMA asking for a re-examination of expiration dates.

No one remembers the details — just that the effort fell flat.

“Nothing happened, but we tried,” says rheumatologist Roy Altman, now 80, who helped write the AMA report. “I’m glad the subject is being brought up again. I think there’s considerable waste.”

At Newton-Wellesley Hospital, outside Boston, pharmacist David Berkowitz yearns for something to change.

On a recent weekday, Berkowitz sorted through bins and boxes of medication in a back hallway of the hospital’s pharmacy, peering at expiration dates. As the pharmacy’s assistant director, he carefully manages how the facility orders and dispenses drugs to patients. Running a pharmacy is like working in a restaurant because everything is perishable, he says, “but without the free food.”

Federal and state laws prohibit pharmacists from dispensing expired drugs and The Joint Commission, which accredits thousands of health care organizations, requires facilities to remove expired medication from their supply. So at Newton-Wellesley, outdated drugs are shunted to shelves in the back of the pharmacy and marked with a sign that says: “Do Not Dispense.” The piles grow for weeks until they are hauled away by a third-party company that has them destroyed. And then the bins fill again.

“I question the expiration dates on most of these drugs,” Berkowitz says.

One of the plastic boxes is piled with EpiPens — devices that automatically inject epinephrine to treat severe allergic reactions. They run almost $300 each. These are from emergency kits that are rarely used, which means they often expire. Berkowitz counts them, tossing each one with a clatter into a separate container, “… that’s 45, 46, 47 …” He finishes at 50. That’s almost $15,000 in wasted EpiPens alone.

In May, Cantrell and Gerona published a study that examined 40 EpiPens and EpiPen Jrs., a smaller version, that had been expired for between one and 50 months. The devices had been donated by consumers, which meant they could have been stored in conditions that would cause them to break down, like a car’s glove box or a steamy bathroom. The EpiPens also contain liquid medicine, which tends to be less stable than solid medications.

Testing showed 24 of the 40 expired devices contained at least 90 percent of their stated amount of epinephrine, enough to be considered as potent as when they were made. All of them contained at least 80 percent of their labeled concentration of medication. The takeaway? Even EpiPens stored in less than ideal conditions may last longer than their labels say they do, and if there’s no other option, an expired EpiPen may be better than nothing, Cantrell says.

At Newton-Wellesley, Berkowitz keeps a spreadsheet of every outdated drug he throws away. The pharmacy sends what it can back for credit, but it doesn’t come close to replacing what the hospital paid.

Then there’s the added angst of tossing drugs that are in short supply. Berkowitz picks up a box of sodium bicarbonate, which is crucial for heart surgery and to treat certain overdoses. It’s being rationed because there’s so little available. He holds up a purple box of atropine, which gives patients a boost when they have low heart rates. It’s also in short supply. In the federal government’s stockpile, the expiration dates of both drugs have been extended, but they have to be thrown away by Berkowitz and other hospital pharmacists.

The 2006 FDA study of the extension program also said it pushed back the expiration date on lots of mannitol, a diuretic, for an average of five years. Berkowitz has to toss his out. Expired naloxone? The drug reverses narcotic overdoses in an emergency and is currently in wide use in the opioid epidemic. The FDA extended its use-by date for the stockpiled drugs, but Berkowitz has to trash it.

On rare occasions, a pharmaceutical company will extend the expiration dates of its own products because of shortages. That’s what happened in June, when the FDA posted extended expiration dates from Pfizer for batches of its injectable atropine, dextrose, epinephrine and sodium bicarbonate. The agency notice included the lot numbers of the batches being extended and added six months to a year to their expiration dates.

The news sent Berkowitz running to his expired drugs to see if any could be put back into his supply. His team rescued four boxes of the syringes from destruction, including 75 atropine, 15 dextrose, 164 epinephrine and 22 sodium bicarbonate. Total value: $7,500. In a blink, “expired” drugs that were in the trash heap were put back into the pharmacy supply.

Berkowitz says he appreciated Pfizer’s action, but feels it should be standard to make sure drugs that are still effective aren’t thrown away.

“The question is: Should the FDA be doing more stability testing?” Berkowitz says. “Could they come up with a safe and systematic way to cut down on the drugs being wasted in hospitals?”

Four scientists who worked on the FDA extension program told ProPublica something like that could work for drugs stored in hospital pharmacies, where conditions are carefully controlled.

Greg Burel, director of the CDC’s stockpile, says he worries that if drugmakers were forced to extend their expiration dates it could backfire, making it unprofitable to produce certain drugs and thereby reducing access or increasing prices.

The 2015 commentary in Mayo Clinic Proceedings, called “Extending Shelf Life Just Makes Sense,” also suggested that drugmakers could be required to set a preliminary expiration date and then update it after long-term testing. An independent organization could also do testing similar to that done by the FDA extension program, or data from the extension program could be applied to properly stored medications.

ProPublica asked the FDA whether it could expand its extension program, or something like it, to hospital pharmacies, where drugs are stored in stable conditions similar to the national stockpile.

“The Agency does not have a position on the concept you have proposed,” an official wrote back in an email.

Whatever the solution, the drug industry will need to be spurred in order to change, says Hussain, the former FDA scientist. “The FDA will have to take the lead for a solution to emerge,” he says. “We are throwing away products that are certainly stable, and we need to do something about it.”

This story was co-published with NPR’s Shots blog. Written BY: Marshall Allen

Article Source: https://www.propublica.org/article/the-myth-of-drug-expiration-dates

 

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