Compounding the Problem?

healthcare crisisHere’s a question to get you thinking this Friday morning.  What has been called the “worst public health crisis” in the US in decades?  Is it:

(a)  HIV

(b)  Obesity

(c)  Healthcare.gov

(d)  Heart Disease

(e)  None of the above

fungal meningitisWhile there’s no doubt options (a) through (d) challenge our healthcare system, the correct answer is in fact (e). What’s more, this public health crisis may have gone unnoticed by many. What we’re referring to is the fungal meningitis outbreak that was traced to the New England Compounding Center. So far, there have 751 reported cases, including 64 deaths.

fungal meningitis case-counts-960px-2013-10-23Indeed, most Americans had never heard of compounding pharmacies until the now-shuttered New England Compounding Center was blamed for making tainted steroid injections that killed and sickened people in 20 states.

Since then, the FDA has issued more than 60 reports of compounding pharmacies that had one or more quality or sterility issues. Five compounding pharmacy testing labs received similar reports.

Now, after months of negotiating, the US Senate has finally passed legislation that was drafted in the wake of the scandal.  The Drug Quality and Security Bill will give the FDA greater oversight of compounding pharmacies and also creates a national system for tracking prescription medicines from factory to pharmacy. The bill, which was already passed by the US House, is designed to bolster the pharmaceutical supply chain, and now goes to President Obama for his signature

The bill will create a new class of compounding pharmacies, as suggested by the FDA. The agency believes that traditional compounders – those who mix or alter ingredients for individual patients on an as-needed basis, should be distinguished from ‘non-traditional’ compounders – those that sell high volumes and ship out of state because these activities may pose a higher risk.

We know more from a barcode on a gallon of milk than we do from a barcode on a bottle of prescription drugs, which could mean the difference between life and death,” says US Senator Michael Bennet. “Whether it’s a stronger drug supply chain or better oversight for compounded drugs, this commonsense bill will help restore confidence in our prescription drugs and protect our families from potential health risks.”

compoundingThe bill also creates a voluntary category for so-called office compounding of sterile medications. These operations would voluntarily register with the FDA and submit to GMP, or good manufacturing practices, compliance and pay fees in exchange for the right to ship product without a prescription. But there is no criteria concerning interstate shipping or the percentage of production involved.

The legislation “leaves regulation of this vital and long-accepted practice by independent community pharmacies to state boards of pharmacy, where it should be,” says the National Community Pharmacists Association.

But not everyone agrees.

Rosa DeLauro, a Democratic Congresswoman from Connecticut, says the “voluntary approach will continue to expose patients to potentially unsafe, mass-produced compounded drugs that are not approved or evaluated by the FDA.”

NECC steroidsSimilarly, the International Academy of Compounding Pharmacists released a statement saying that “a voluntary category of outsourcing facilities is not the answer” and warned that another potentially deadly New England Compounding Center type of scandal could still occur.

Some health policy experts have even said they fear the new bill will make drugs, less, rather than more, safe.

Critics say that by giving compounding pharmacies the option whether or not to register with the Food and Drug Administration and adhere to stricter guidelines for testing, quality and sterility, does not go far enough.

It makes what is now illegal legal,” said Dr. Michael Carome, who directs the health research group at Public Citizen, a think tank.

Carome said he opposes the bill because it allows large scale compounding without individual prescriptions and with no requirement to follow the strictest quality and sterility guidelines that drug manufacturers must adhere to.

It makes no sense to have two different tiers of drug manufacturers – one that has to meet all the manufacturing guidelines and one that only has to meet some of them. We believe in a level playing field.”

What do you think of this legislation?  Has it gone far enough?  We’d love to hear from you.

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A Blinding Pill to Swallow?

woman eyesOn Monday we brought you news about the health benefits of sex. Today the news is not so good….and for many women will be extremely concerning.

Research presented earlier this week at the American Academy of Ophthalmology annual meeting, showed that women who have taken oral contraceptive pills for three or more years are twice as likely to suffer from glaucoma.

Glaucoma is one of the leading causes of blindness affecting nearly 60 million worldwide.

glaucomaThe researchers caution gynecologists and ophthalmologists to be aware of the role oral contraceptives might play in glaucomatous diseases, and inform patients to have their eyes screened for glaucoma if they also have other risk factors.

The study – conducted by researchers at University of California, San Francisco, Duke University School of Medicine and Third Affiliated Hospital of Nanchang University, Nanchang, China – is the first to establish such increased risk.

The researchers utilized 2005-2008 data from the National Health and Nutrition Examination Survey (NHANES). The study group included 3,406 US women aged 40 years or older who completed the survey’s vision and reproductive health questionnaire and underwent eye exams. They found that females who had used oral contraceptives, no matter which kind, for longer than three years are 2.05 times more likely to report that they have glaucoma.

aao posterAlthough the results of the study do not speak directly to the causative effect of oral contraceptives on the development of glaucoma, they indicate that long-term use of oral contraceptives might be a potential risk factor for glaucoma. Certainly, “the pill” needs to , be considered as part of the risk profile. Other risk factor include:  African American- ethnicity, family history of glaucoma, history of increased eye pressure or existing visual field defects. Previous studies in the field have shown that estrogen may play a significant role in the pathogenesis of glaucoma.

This study should be an impetus for future research to prove the cause and effect of oral contraceptives and glaucoma,” said Shan Lin, M.D., lead researcher and professor of clinical ophthalmology at the University of California San Francisco. “At this point, women who have taken oral contraceptives for three or more years should be screened for glaucoma and followed closely by an ophthalmologist, especially if they have any other existing risk factors.”

Given the fact that 28% of all sexually active women in the US are on the pill, that’s a lot of glaucoma screening. You may want to call your ophthalmologist or optometrist now and get a jump on the line. Alternately, you may want to reconsider your birth control.

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Side Effects of Sex

monday-morning-blues--large-prf-1124686656It’s Monday morning, it’s cold and the holidays are still too far away to be a reality for most of us.  Not a lot to be cheerful about?  Right!

Never fear, SRxA’s Word on Health is here to help start your week off right with some health news that may just bring a smile to your face.

While many people associate a healthy lifestyle with grueling workouts, strict dieting and general deprivation and misery  – this is a misconception.

According to Dr Joseph Mercola, an osteopathic physician, web entrepreneur and New York Times best selling author, healthy habits can be among the most rewarding.  Take sex. It counts as moderately intense exercise plus it boosts numerous aspects of both physical and mental health. As long as you’re engaging in safe-sex practices, increasing your sexual activity is a surefire strategy to better health!

benefits of sexMercola suggests regular sex can reduce stress, bolster self-esteem and foster feelings of intimacy and bonding between partners.  Better still, a healthy sex life can result in a longer, healthier and, most would agree, more enjoyable life.

In case that’s not enough – here’s 10 more healthy side effects of sex:

1. Improved Immunity

People who have sex frequently have significantly higher levels of immunoglobulin A (IgA). IgA is part of the immune system that forms your body’s first line of defense. Its job is to fight off invading organisms at their entry points, reducing or even eliminating the need for activation of your body’s immune system. This may explain why people who have sex frequently also take fewer sick days.

2. Heart Health

According to one study, men who made love regularly (at least twice a week) are 45% less likely to develop heart disease than those who did so once a month or less.

Sexual activity not only provides many of the same benefits to your heart as exercise but also keeps levels of estrogen and testosterone in balance, which is important for heart health.

3. Lower Blood Pressure

Sexual activity, and specifically intercourse, is linked to better stress response and lower blood pressure.

4. It’s a Form of Exercise

Sex helps to boost your heart rate, burn calories and strengthen muscles, just like exercise. In fact, research recently revealed that sex burns about 4 calories a minute for men and 3 for women, making it (at times) a ‘significant’ form of exercise. It can even help you to maintain your flexibility and balance.

5. Pain Relief

Sexual activity releases pain-reducing hormones and has been found to help reduce or block back and leg pain, as well as pain from menstrual cramps, arthritis and headaches. One study even found that sexual activity can lead to partial or complete relief of headache in some migraine and cluster-headache patients.

6. Help to Reduce Risk of Prostate Cancer

Research has shown that men who ejaculate at least 21 times a month (during sex or masturbation) have a lower risk of prostate cancer.

sex and sleep7. Improve Sleep

After sex, the relaxation-inducing hormone prolactin is released, which may help you to nod off more quickly. The “love hormone” oxytocin, released during orgasm, also promotes sleep.

8. Stress Relief

Sex triggers your body to release it’s natural feel-good chemicals, helping to ease stress and boost pleasure, calm and self-esteem. Research also shows that those who have sexual intercourse responded better when subjected to stressful situations like speaking in public.

9. Boost Your Libido

The more often you have sex, the more likely you are to want to keep doing it. There’s a mental connection there but also a physical one, particularly for women. More frequent sex helps to increase vaginal lubrication, blood flow and elasticity, which in turn make sexual activity more enjoyable.

10. Improved Bladder Control in Women

Intercourse helps to strengthen pelvic floor muscles, which contract during orgasm. This can help women improve their bladder control and avoid incontinence.

Happy Monday!

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Anaphylaxis Legislation gets Presidential Seal of Approval

HowtoUseYourEpiPen644x356-process-sc644x356-t1338817363SRxA is delighted to announce that earlier this week President Obama signed into law the School Access to Emergency Epinephrine Act.  During a week in which Obama and his new healthcare.gov website have made headlines for all the wrong reasons, we thought it only fair to commend him on this important anaphylaxis initiative.

The School Access to Emergency Epinephrine Act is legislation that will help to protect schoolchildren who experience life-threatening anaphylaxis.

This legislation is a significant milestone for food, venom and latex allergy safety in our nation’s schools,” says Tonya Winders, chief operating officer of Allergy & Asthma Network Mothers of Asthmatics (AANMA). “It will help save lives of children who experience an anaphylactic reaction for the first time or don’t have epinephrine auto-injectors readily available when anaphylaxis occurs.”

Think Fast Allergy Symptoms PicThe measure provides a funding incentive to states that enact laws allowing school personnel to stock and administer emergency supplies of epinephrine auto-injectors. Epinephrine is the first line of treatment for anaphylaxis.

The School Access to Emergency Epinephrine Act was bipartisan legislation, first passing the U.S. House of Representatives on July 30, 2013, and then the U.S. Senate on Oct. 31, 2013, before heading to the President’s desk.

Allergic reactions to foods are the most common cause of anaphylaxis in community settings, according to the U.S. Centers for Disease Control and Prevention (CDC). Studies show that 16-18% of schoolchildren with food allergies have had a reaction from accidentally ingesting food allergens. In addition, 25% of anaphylaxis cases reported at schools happened in children with no prior history of food allergy.

USAnaphylaxis_10_14_13As of today, 28 states have passed emergency stock epinephrine legislation and six have bills pending.  Let’s hope this legislation will spur the remaining states to follow as soon as possible.

Green states that have passed stock epinephrine laws or regulations:

AlaskaArkansasArizonaCaliforniaColoradoFloridaGeorgiaIllinoisKansasKentuckyLouisiana,MarylandMassachusettsMinnesotaMissouriMontanaNebraskaNevadaNorth DakotaOklahoma,OregonSouth CarolinaTennesseeUtahVirginiaVermontWashington, and West Virginia

Yellow states have pending stock epinephrine bills:
MichiganNew JerseyNew YorkNorth CarolinaOhio and Pennsylvania

Red states that have no stock epinephrine bills: 
AlabamaConnecticutDelawareHawaiiIdahoIndianaIowaMaineMississippiNew HampshireNew MexicoRhode IslandSouth DakotaTexasWisconsin, and Wyoming

To find out more about anaphylaxis in schools please visit http://www.epipen4schools.com/ and https://www.anaphylaxis101.com/Resource-Library/Anaphylaxis-in-Schools.asp

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Does Double Dutch Delay Dementia?

Multilingual-HELLO1G’day, Zao shang hao, Bonjour, Kalimera, Boker tov, God morgen, Buon giomo, Bom dia, Zdravstvuyitye, Buenos dias!

Or if you prefer – Good Morning!

No it’s not one of those guess the country viral Facebook quizzes (although we will print the answers at the bottom of this post for those of you who want to play along).  No, the reason for today’s multilingual greetings is because a new study has shown that speaking more than one language can delay the onset of, not one, not two…but three types of dementia.

In the largest study on the topic to date, published this week in the online issue of Neurology, researchers found that people who spoke two languages developed dementia four and a half years later than people who only spoke one language.

Our study is the first to report an advantage of speaking two languages in people who are unable to read, suggesting that a person’s level of education is not a sufficient explanation for this difference,” said study author Suvarna Alladi. “Speaking more than one language is thought to lead to better development of the areas of the brain that handle executive functions and attention tasks, which may help protect from the onset of dementia.”

dementiaFor the study, 648 people from India with an average age of 66 who were diagnosed with dementia were evaluated. Of those, 391 spoke two or more languages. A total of 240 had Alzheimer’s disease, 189 had vascular dementia and 116 had frontotemporal dementia, with the remainder having dementia with Lewy bodies and mixed dementia. Fourteen percent were illiterate.

People who spoke two languages had a later onset of Alzheimer’s disease, frontotemporal dementia and vascular dementia than people who spoke only one language. The difference was also found in those who could not read. There was no additional benefit in speaking more than two languages.

The two-language effect on age of dementia onset was shown separately of other factors such as education, gender, occupation and whether participants lived in the city or country.

These results offer strong evidence for the protective effect of bilingualism against dementia in a population very different from those studied so far in terms of its ethnicity, culture and patterns of language use,” Alladi said.

Thanks languageWhile the study didn’t show any additional benefit in speaking more than two languages, we don’t think it hurts to try.

How many languages do you speak?

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Answers:

G’day [Australia] Zao shang hao [China], Bonjour [France] Kalimera [Greece] Boker tov [Israel] ,God morgen [Denmark], Buon giomo [Italy], Bom dia [Portugal], Zdravstvuyitye [Russia], Buenos dias [Spain]

Honoring the Health Sacrifices of Our Veterans

VETERANS-DAY-poster-2012On Veterans Day, America pauses to honor every service member who has ever worn one of our Nation’s uniforms. Each time our country has come under attack, they have risen in her defense. Each time our freedoms have come under assault, they have responded with resolve. Through the generations, their courage and sacrifice have allowed our Republic to flourish. And today, a Nation acknowledges its profound debt of gratitude to the patriots who have kept it whole.

As we pay tribute to our veterans, we are mindful that no ceremony or parade can fully repay that debt. We remember that our obligations endure long after the battle ends, and we make it our mission to give them the respect and care they have earned. “

These two paragraphs are taken directly from the 2013 Veterans Day Presidential Proclamation.

But getting Veterans the care they deserve is not always easy.  The wounds of war can go far beyond what meets the eye. From mental health issues to pain and illness that persist long after they’ve left the battlefield, veterans face a multitude of health troubles either unique to their service or more frequent among them than the general population.

Folks returning from combat have a constellation of health concerns, including physical issues, psychological issues and psychosocial issues concerning things like work and family,” said Dr. Stephen Hunt, national director of the U.S. Department of Veterans Affairs Post Deployment Integrative Care Initiative.

Some of the most common physical complaints of returning soldiers cannot be classified into a single disorder. They include nonspecific symptoms such as fatigue, pain and cognitive disturbances such as memory and concentration problems.

Here are seven of the most commonly seen health conditions confronting veterans:

vetsparade-79576Musculoskeletal injuries and pain

Just over half of all veterans’ post-deployment health visits address lingering pain in their backs, necks, knees or shoulders.  According to a study in the Journal of Pain, about 100,000 veterans of the Gulf War nearly 20 years ago have reported chronic muscle pain.

Mental health issues

PTSDWhile post-traumatic stress disorder (PTSD) among soldiers has been well publicized, other mental woes can also result from the trauma of war. A study in the journal Archives of General Psychiatry [now JAMA Psychiatry] found that one in 10 Iraq war vets develop serious mental problems, including violent behavior, depression and alcohol abuse. The study found that PTSD or depression seriously impaired daily functioning in 8.5 – 14% of these vets.  Disabling on its own, PTSD is also linked to the development of physical illnesses for veterans as years pass. Researchers from Walter Reed Army Medical Center reported that 54% of veterans with PTSD also had sleep apnea, compared with 20%of PTSD patients in the general population. PTSD in vets is also associated with a greater risk of developing dementia.

Chemical exposure

syria1Research by the American Heart Association found that exposure to nerve agents such as sarin – which can trigger convulsions and death on the battlefield – may cause long-term heart damage in Gulf War veterans. The damage can include an enlarged left ventricle, heart rhythm abnormalities or a reduction in the pumping strength of the heart.

Infectious diseases

Although all military personnel are given routine vaccinations before deployment, veterans suffer disproportionately from certain infections that civilians almost never experience.  They include bacterial infections such as brucellosis, which may persist for years; campylobacter jejuni, which causes abdominal pain, fever and diarrhea; and Coxiella burnetii, which in chronic cases can inflame the heart.

Leishmaniasis, a parasitic disease caused by the bite of a sand fly native to the Middle East, is a particularly brutal condition veterans experience. Those infected suffer weight loss, fevers, headaches, muscle pain and weakness, anemia, and enlargement of the spleen and liver. It can be fatal if untreated, according to the VA..

army-mil-2007-06-28-113715Traumatic Brain Injury (TBI)

TBI, often brought on by a blow or jolt to the head, disrupts brain function and has been called the signature wound of the fighting in Iraq and Afghanistan, according to the National Academy of Sciences. Blast exposures and other combat-related activities put service members at greater risk for sustaining a TBI compared to their civilian counterparts, according to the Defense and Veterans Brain Injury Center.

Common effects of TBIs include cognitive issues such as shorter attention span, language disabilities, and an inability to process information. Vets can also suffer from lack of motivation, irritability, anxiety and depression, headaches, memory loss and PTSD.

However, you choose to mark Veteran’s Day 2013, please remember the sacrifices made by all of our vets and be mindful of the long-term health problems they face. Ladies and Gentleman of the military, we thank you for your service.

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Working Out to Ward Off Depression

depression-and-exercisePhysical activity is being increasingly recognized as an effective tool to treat depression. But now researchers have taken the connection one step further.  In a review published in the October issue of the American Journal of Preventive Medicine, George Mammen has demonstrated that moderate exercise can actually prevent episodes of depression.

This is the first longitudinal review to focus exclusively on the role that exercise plays in maintaining good mental health and preventing the onset of depression later in life.

Mammen analyzed over 26 years’ worth of research findings to discover that even low levels of physical activity (walking and gardening for 20-30 minutes a day) can ward off depression in people of all age groups.

Mammen’s findings come at a time when mental health experts want to expand their approach beyond treating depression with costly prescription medication. “We need a prevention strategy now more than ever,” he says. “Our health system is taxed. We need to shift focus and look for ways to fend off depression from the start.”

ladyexerciseMammen acknowledges that other factors influence a person’s likelihood of experiencing depression, including their genetic makeup. But he says that the scope of research he assessed demonstrates that regardless of individual predispositions, there’s a clear take-away for everyone. “It’s definitely worth taking note that if you’re currently active, you should sustain it. If you’re not physically active, you should initiate the habit. This review shows promising evidence that the impact of being active goes far beyond the physical.”

Let’s hope so.  Now that I’m back in the gym six days a week maybe all the push-ups and perspiration will keep the Prozac at bay!

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Condom Homework Increases Compliance, Comfort and Consistency

condomsA new and successful strategy for combating the spread of sexually transmitted diseases such as HIV was revealed today at the American Public Health Association’s annual meeting in Boston.

The idea is based upon the decades old premise that practice makes perfect!.

In the study entitled “A novel, self-guided, home-based intervention to improve condom use among young men who have sex with men.  The men were given a “ditty bag” full of eight different types of condoms and five different types of  lubricants, taught how to apply the condoms correctly, and then assigned homework. The men were expected to try out at least six condoms solo, paying particular attention to their own pleasure and which condoms they liked best.

The purpose of this study was to test of feasibility and efficacy of this intervention and to promote positive condom attitudes and to reduce risk behaviors.

30 volunteer subjects were recruited from a Midwestern University and its surrounding community. A pre-test questionnaire was administered.  A post-test questionnaire was given at Day 15 and an additional follow-up questionnaire at Day 45.

condom-safe-sexIt’s such a simple idea, but nobody has every structured an approach like this,” said William L. Yarber, professor in the Indiana University School of Public-Health. “These are pilot studies. But even with small samples, the results are really good. Men become more motivated to use condoms; they use them more correctly and consistently. They also appreciate learning that there are different condoms available.”

A pilot study, published in the Journal of Men’s Health in 2011, focused on heterosexual men. The new study, focuses on young men who have sex with men, or MSM.  It will be published in the Journal of American College Health, MSM aged 18 – 29 are diagnosed with HIV more than any other group, according to the Centers for Disease Control and Prevention. In fact, half of all new HIV infections in the U.S. are among MSM between the ages of 13 and 24 years. College-aged MSM are more likely than older MSM and men who only have sex with women to be infected with HIV.

This is an important group of men to reach,” says  Roberta Emetu, who coordinated the research project.  “The men who experienced this intervention became better in their condom use. They not only used them more often but used them correctly. We saw an increase in motivation to use them.”

condom_thumbs_upWhen pre-test and post-test responses were compared, significant post-intervention improvements were found for beliefs and application of condoms, self-efficacy, condom attitude, motivation to use condoms, and consistency of condom use for insertive penile-anal intercourse.

Yarber and his colleagues have documented for more than 10 years how merely wearing a condom is not enough to provide effective protection against STDs and unwanted pregnancies. Condoms need to be used correctly, yet fit-and-feel issues can result in erection difficulty, loss of sensation, removal of condoms before the intercourse episode ends, and other problems that can interfere with their correct use.

These findings suggest that this intervention could be applicable to college-aged MSM, and could be a great resource or model for other public health condom interventions.

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Spit It Out! How saliva may provide the key to sports-related concussion

concussionSRxA’s Word on Health has reported several times on the problems of concussion among football players and cheerleaders. So we couldn’t help but sit up and take notice of an article in our local newspaper about some cutting edge research taking place yards from our front door.

The third floor of Bull Run Hall on George Mason University’s Prince William campus plays host to plenty of mind-bending science projects – laser capture microdissection, protein electronics and high-resolution mass spectrometry to name but a few.

Yet the most complex and potentially influential findings to emerge from the school’s College of Science might come down to a kid spitting in a cup after football practice.

Once a week athletic trainers collect saliva samples from the 12- and 13-year-old kids playing for the Jets, an A-League football team in the Central Loudoun Youth Football League. Then they send them to Dr. Shane Caswell, a George Mason professor and pioneer of the world’s first salivary biobank designed for concussion research in athletes.

Caswell stores the saliva in a freezer he dubs the “spit repository.” He eventually extracts the samples and runs them through sophisticated machinery to determine changes in protein variance. By comparing each kid’s spit samples to previous submissions, he hopes to uncover a handful of proteins that can detect concussions.

George Mason scientistsWorking alongside Caswell is Dr. Chip Petricoin. Long accustomed to studying protein biomarkers for cancer research, Petricoin never imagined he’d wind up plying his trade for studies on traumatic brain injury and concussions.  But the seed was planted six years ago, when he was called up to Fort Detrick to conduct a site review for a company that had been given a grant from the army to do concussion research. Petricoin admired their efforts, but he realized that his own work with cancer biomarkers could reap significant benefits for the concussion research that remained in its nascent stages.

A year later he found himself working in the same building as Caswell, whose extensive background in athletic training was getting him increasingly involved with concussion research. The two discussed their respective endeavors and quickly realized they could join forces.

The university’s College of Science and College of Education and Human Development began funding their efforts last year. Since then, Caswell and Petricoin have begun to explore the vast quantities of information stored in athletes’ salivary biomarkers.

Think about the biomarker content of a sample like an iceberg,” said Petricoin, co-director of the university’s Center for Applied Proteomics and Molecular Medicine. “The concept of what you see is only the tip of the iceberg? That’s kind of like biomarker research. Things that have been seen before are just the tip of what really is there. If we could go all the way down and see everything, you’d see a whole new iceberg. So we’re kind of going a mile deep now in the iceberg biomarker research.”

athlete spittingIndeed, the depth of these largely uncharted waters became apparent when the duo began their work with the Jets this fall using eight saliva samples. A few weeks after collecting those baseline samples, they used the nanotechnology at their disposal to examine new samples from four of the same kids who had recently suffered concussions. After compiling a list of proteins, they found that 60% of their list featured proteins that had never been described.

The process generates an information archive that’s larger than anyone’s ever seen before in saliva,” Petricoin said.

Caswell and Petricoin are currently working on 37 concussion cases, a total that increases every week with new samples arriving from different sources. They’re collaborating with Prince William County Public Schools, as well as intercollegiate athletics at Marymount University and George Mason.

The Jets’ head coach, Rob Scola, says his team has so far adapted nicely to the study. George Mason sends a certified athletic trainer to the field to provide care and to collect data on hits the players endure. The trainer tapes every game and practice, something that allows coaches to see what they’re doing right and wrong in their efforts to teach proper heads-up tackling techniques. Players also wear helmets with sensors that detect the force and location of impacts sustained in practices and games.

It’s all part of an effort to determine what measures coaches should take to minimize players’ risk of head trauma on the football field, where the rate of brain injuries is higher than in any other youth sport.

It’s very hard to get information from a very small team in a very small league and then extrapolate that,” Scola said. “I think that as Mason starts to expand the study, I think there will be some really interesting pieces of information that come from that, which I believe can be helpful to the league and football as a whole. I think it’s a phenomenal first step.”

Part of the project’s appeal lies in its lack of hassle. Biomarker work has traditionally come from blood and spinal fluid samples, which are rooted in far more invasive processes than simply spitting in a cup.

If I were to go out on the field and say, ‘Hold on a second. I want to take your child’s blood or their cerebral spinal fluid.’ That’s game over. We can’t move forward,” Caswell said. “This is a non-invasive tool that is rapidly deployable. There’s no threat of infection, it’s easily done and it provides a great deal of information.”

Caswell and Petricoin’s work with the Jets has opened the door to broader studies that extend to the entire lifespan of an athlete’s career. The hope is that parents will have their children give samples when they begin participating in youth football, ice hockey, soccer, or whatever sport they choose to play. They can then follow that up by giving more samples as they pursue the sport in high school, college and beyond.

“You are then able to track at various time points throughout someone’s career and identify how their marker is changing and then maybe one day compare it to a database that could help inform decisions about whether or not that individual should retire from play, whether that individual is suffering any adverse consequences from their participation,” Caswell said.

blue mouthgardEven more ambitious is their ultimate goal of implementing the biomarkers into a clinical diagnostic device. Petricoin envisions a mouthguard that turns from clear to blue when a concussion is detected. The technology, he says, is there – impregnating the nanoparticles into the mouth guard, binding the biomarkers and producing a color shift are concepts that have already been engineered.

The hard part is nailing down the biomarkers. For the moment, all Caswell and Petricoin are trying to do is identify what’s in the saliva. As the data mounts, they hope to reveal protein distribution patterns that coincide with repeated head trauma.

Caswell, a former hockey player who once returned to the ice minutes after suffering a concussion only to realize minutes later that he wasn’t carrying his stick, believes those patterns will come and that his team is well-positioned to make meaningful discoveries that could impact concussion policies on a greater scale.

If and when they do, we’ll be sure to let you know.

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FDA ups the Ante on Pharma Ads

bad ad cme courseAs the feds continue to crack down on pharma marketing infractions the FDA has upped its own stake in making sure advertisers play by the rules. The agency has just launched an e-learning course aimed at healthcare providers to teach them how to spot and report misleading or untruthful drug ads, or promotional activities.

The multi-module, multi-media  course, launched in conjunction with MedScape, uses case studies to help HCP’s “become more discerning readers of drug promotional information,” according to Thomas Abrams, director of the FDA’s Office of Prescription Drug Promotion.

bad ad course screen shotThe course is part of Bad Ad, a program the agency designed in 2010 to educate doctors about their role in ensuring advertising stays honest. And to incentivize doctors to take the course they are offering Continuing Medical Education (CME) credit for physicians and Continuing Education (CE) credit for other HCPs.

The FDA estimates that there are more than 80,000 unique new pieces of promotional literature produced each year, including journal ads, sales aids and e-detailing pieces.  In addition, there are approximately 80,000 pharmaceutical sales reps working in the field. Assuming each one makes 8-10 calls per day and presents 1-3 products during every call, that adds up to between 166 and 624 million opportunities to breach promotional guidelines.

Over the past decade, drug-makers have agreed to pay close to $14 billion in penance for off-label and safety-related claims. Click on the links below for details of the biggest 11 settlements in recent years:

Back when the FDA was rolling out the Bad Ad program, the agency drew fire from marketing execs for encouraging physicians and other providers to report false advertising  – and for allowing them to do so anonymously. They accused the agency of deputizing doctors rather than hiring the staff necessary to review advertising internally.

Even so, many states have taken their own steps to combat misleading materials through “academic detailing,” where physicians, pharmacists, nurses and other trained medical reps spread info about prescription drugs. The goal is to improve quality of care and reduce healthcare spending. Advocates of academic detailing say that educating prescribers about all treatment options – not just the new, expensive ones – could help them make informed decisions that could, in turn, bring down drug costs.

Bad Ad brochure Pharma sales and marketing folks take note.  Between these federal and state initiatives, the potential for falling foul of the guidance just increased.

And yes, in case you’re wondering I did take, and pass, the course as part of my research for this blog post.

Contact us today, to find out how SRxA can help you with compliant pharma promotion.

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