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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Your Risk Of Erectile Dysfunction More Than Triples If You Have This Health Condition

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High blood sugar can make it hard to get hard: Men with diabetes are significantly more likely to have erectile dysfunction that those with normal blood sugar readings, new research in the journal Diabetic Medicine concludes. That’s a problem, since diabetes cases have increased four-fold since 1980.

After crunching the numbers from 145 studies including over 88,000 men who averaged 56 years old, the researchers determined that those with diabetes were more than three times as likely to have erectile dysfunction than healthy guys were. In fact, 59 percent of men with diabetes had ED.

What’s more, men with diabetes tended to develop their erectile dysfunction 10 to 15 years earlier than those without the condition did, according to the study. (Want to keep your penis healthy for life?

So how can high blood sugar sink you in the bedroom?

Diabetes can damage your blood vessels and your nerves—both of which are needed for healthy erectile functioning, says Sean Skeldon, M.D., who has previously researched ED and diabetes, but was not involved in this study.

Another important point: Erectile dysfunction is often considered a harbinger of heart disease. That’s because the blood vessel issues that cause ED—say, like plaque buildup—can also affect your heart, too. They just manifest first with problems in the bedroom, since your blood vessels in your penis are smaller than the ones that carry blood to your heart. (Here are 8 other weird facts you never knew about your heart.)

The good news, though, is that many of the risk factors for diabetes are under your control—meaning your penis and your heart could benefit from some prevention strategies. One easy one? Eat three servings of legumes a week. That can cut your risk of diabetes by 35 percent, as we recently reported, possibly because their fiber can help prevent blood sugar spikes.

Written by: CHRISTA SGOBBA

Article Source: http://www.menshealth.com/health/diabetes-raises-erectile-dysfunction-risk?

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Infertility in men could point to more serious health problems later in life

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Poor sperm quality affects about one in ten men and may lead to fertility problems. These men also have an increased risk of developing testicular cancer, which is the most common malignant disease of young males. And, even if they don’t develop testicular cancer, men with poor sperm quality tend to die younger than men who don’t have fertility problems.

Couples who can’t achieve pregnancy usually go to fertility clinics for treatment. At these clinics, emphasis is put on deciding whether the couple needs assisted reproduction or not, and, if so, to choose between different methods (such as IVF, IUI, or ICSI) for doing this. In most cases, these treatments lead to pregnancy and a live birth. So the problem seems to be solved. But if infertility is an early symptom of an underlying disease in the man, fertility clinics won’t pick it up.

Missed opportunity

Testicular cancer is easy to detect. In men seeking treatment for fertility problems, a simple ultrasound scan of the testes can reveal early cancer, so a life-threatening tumour can be prevented. If detected, 95% of all cases can be cured. But, unfortunately, testicular ultrasound scans are rarely performed at fertility clinics as the focus tends to be on sperm numbers and which method of assisted reproduction to use.

And testicular cancer is not the only threat to young infertile men’s health. Serious health problems, such as metabolic syndrome (high blood pressure, high blood sugar and obesity), type 2 diabetes and loss of bone mass are also much more common conditions among infertile men. These disorders are possible to prevent, but if left untreated often lead to premature death.

A possible culprit

At Lund University in Malmö, Sweden, we have – together with other research groups – made a number of studies focusing on the link between male fertility problems and subsequent risk of serious diseases. We cannot yet explain the causes, but testosterone deficiency is a strong candidate. My research team found that 30% of all men with impaired semen quality have low testosterone levels. And men totally lacking the hormone have early signs of diabetes and bone loss.

We recently conducted a study in which we investigated almost 4,000 men below the age of 50 and who had had their testosterone measured 25 years ago. We found that the risk of dying at a young age was doubled among those with low testosterone levels compared with men with normal levels of this hormone.

Although testosterone treatment may not necessarily be the best preventive measure, these findings makes it possible to identify men at high risk so that they can be advised about lifestyle changes, such as losing weight or quitting smoking – lifestyle changes that will help reduce the risk of developing type 2 diabetes, cardiovascular disease and osteoporosis.

A relatively high proportion of men get in touch with their doctor about infertility problems and, as they represent a high-risk group for some of the most common diseases occurring later in life, perhaps it is time to change the routines for managing them. With the knowledge we now have regarding these men’s health, the least we can demand from doctors is to identify those who are at risk of serious diseases after they have become fathers. This is cheap and only requires simple tests. It is no longer enough to just evaluate the number of sperm.

 

Written by:  Aleksander Giwercman And Yvonne Lundberg Giwercman, The Conversation

Article Source: https://medicalxpress.com/news/2017-05-infertility-men-health-problems-life.html

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Jerking Off Cuts Prostate Cancer Risk By 33 Percent: Male Orgasm Flushes Out Harmful Toxins, Theory Says

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Many men know a healthy diet and lifestyle provides some protection against prostate cancer. Eating less red meat, animal fats, and dairy fats and adding more fruits and vegetables promote good health, but science suggests men can also give their prostate a helping hand, literally. A study published in European Urology found having sex or jerking off can lower the risk of prostate cancer via the male orgasm.

There’s a link between how much men masturbate and their likelihood of developing prostate cancer. A total of 21 orgasms a month, either by having lots of sex or jerking off, can reduce the risk of disease by 33 percent.

“These findings provide additional evidence of a beneficial role of more frequent ejaculation throughout adult life in the etiology of PCa [prostate cancer], particularly for low-risk disease,” wrote the researchers from Harvard T.H. Chan School of Public Health, in the study.

However, it remains unclear why having this many orgams per month is good for the prostate.

One theory is that ejaculation flushes out harmful toxins and bacteria in the prostate gland that could cause inflammation. The prostate works by providing a fluid into semen during ejaculation that activates sperm, and prevents them from sticking together. High concentrations of potassium, zinc, fructose, and citric acid are drawn from the bloodstream.

Previous research has shown carcinogens found in cigarette smoke, like 3-methylcholanthrene, are also found in the prostate. This means carcinogens can build up over time, especially if men ejaculate less, which is known as the prostatic stagnation hypothesis. In theory, the more a man “flushes out” the ducts, the fewer carcinogens that are likely to linger around and damage the cells that line them.

Another theory proposed is ejaculation can lead the prostate glands to mature fully, which makes them less susceptible to carcinogens.

Approximately 32,000 men were surveyed on their number of orgasms as researchers tracked  those who developed prostate cancer over the course of decades. The study was a 10-year follow-up on questions answered on ejaculation frequency in 1992 and followed through to 2010. Average monthly ejaculation frequency was assessed during three periods: age 20–29; age 40–49; and the year before the questionnaire was distributed.

The researchers concluded daily masturbation throughout adulthood had a protective effect against prostate cancer. These findings echo results from a 2008 Harvard study that found there was no increased risk of prostate cancer related to age of ejaculation, but benefits increased as men aged. Yet, other studies have found men experience a reduced risk of prostate cancer if they frequently masturbated during young adulthood.

Jerking off as an effective preventative measure for prostate cancer remains murky. These studies suggest there is a connection between the two, but its effects seem to fluctuate depending on a man’s age. This warrants further research to determine what age group can reap the most benefits from daily masturbation for prostate health.

Prostate cancer mainly affects men over 50, and risk increases with age. About six in 10 cases of prostate cancer are found in men older than 65, according to the American Cancer Society. Other risk factors include race, genetics, weight, physical activity, diet, height, and chemical exposure.

The exact causes of prostate cancer remain unknown, but sticking to a healthy diet and lifestyle could offer protection. Perhaps men who give themselves a helping hand in the bedroom can also improve their prostate health. After all, relaxing and reducing stress can help increase longevity, and decrease the onset of disease.

Source: Rider JR, Wilson KM, Sinnott JA et al. Ejaculation Frequency and Risk of Prostate Cancer: Updated Results with an Additional Decade of Follow-up. European Urology. 2016.

Written By Lizette Borreli 

Article Source: http://www.medicaldaily.com/jerking-cuts-prostate-cancer-risk-33-percent-male-orgasm-flushes-out-harmful-419783

 

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Dangerous Combinations

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Five things you need to know about food and drug interactions

You are diligent about taking your medication each day. But did you ever think that the bologna sandwich, grapefruit or glass of milk you have with it could be making your medicine less effective, or even dangerous? Read on for five facts you need to know about food and drug interactions.

1. Beware of grapefruit.

This popular breakfast fruit interacts with a variety of medications, including blood pressure medications, statins, HIV medications and organ transplant medications, says Charlie Twilley, Pharm.D., a pharmacist at Johns Hopkins Bayview Medical Center. The culprits are furanocoumarins, compounds found in grapefruit that block the enzymes in the intestines responsible for breaking down these drugs. This can make the drugs more potent, and raise the level of drug in your bloodstream. If you are a big grapefruit fan, talk to your doctor or pharmacist to find out whether it is safe to eat with the medications you are taking.

2. Dairy diminishes antibiotics’ infection-fighting powers.

Twilley warns that the calcium in milk, yogurt, cheese, ice cream and antacids can interact with tetracycline and the tetracycline group of antibiotics used to treat a number of bacterial infections. To make sure you are getting the full benefit of your antibiotic, take it one hour before, or two hours after you eat anything containing calcium.

3. Leafy greens cancel the effects of warfarin.

The vitamin K in spinach, collards, kale and broccoli can lessen the effectiveness of warfarin, a blood thinner used to prevent blood clots and stroke. The darker green the vegetable is, the more vitamin K it has. “You don’t want to eliminate leafy greens from your diet, because they do have many health benefits,” says Twilley. The key is to be consistent with the amount you eat. If you plan to drastically change the amount of these veggies in your diet, talk to your doctor or pharmacist first.

4. Beer, red wine and chocolate are dangerous to mix with some antidepressants.

These popular indulgences may be a nice way to relax in the evening, but they contain tyramine, a naturally occurring amino acid that can cause an unsafe spike in blood pressure when mixed with MAO inhibitors. Tyramine also is found in processed meat, avocados and some cheeses. “This is a significant, dangerous interaction,” says Twilley. If you take MAO inhibitors for depression, talk to your doctor or pharmacist before eating anything with tyramine. Alternative therapy may be considered.

5. Think before you crush medication in applesauce.

Many people who have trouble swallowing pills like to crush them up and mix them with applesauce or pudding. Always ask your doctor or pharmacist before you crush or take apart medication. “This method can dump too much of the drug into your system at once, or change the way the drug works,” says Twilley.

Also keep in mind that some medications are affected by whether or not you eat with them. Before you start any new drug, talk to your doctor or pharmacist about whether it is affected by food. “They can help you come up with a schedule that’s good for the drug and convenient for you,” says Twilley. Even over-the-counter medications and supplements can have food interactions.

Article Source: http://www.hopkinsmedicine.org/news/publications/jh_bayview_news/fall_2014/dangerous_combinations

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