The Role of Healthcare Professionals in Clinical Trials

by Molly McGuane

No matter how severe the cancer diagnosis, patients and their families look towards their doctors and healthcare providers to lead them down a path towards treating the disease. Typically, cancer is treated in three ways: with chemotherapy, radiation therapy or, in some cases, surgery. The best treatment options are based on a variety of factors including the type of cancer, the progression of the disease and a patient’s medical history.

Aside from the more common forms of treatments, there are healthcare professionals that are striving towards coming up with new treatments and breakthroughs in the field of cancer. These doctors and researchers are helping care for their patients in the present and working towards the future of cancer treatment. For cancers with a devastating prognosis, or cancers that are not responding well to other forms of treatment, those in the clinical trial field are a ray of hope. Though the road can often be long, the end result is often life changing for patients and their families.

What is a Clinical Trial?

Working with doctors and scientists, patients can participate in clinical trials in order to treat their cancer, manage symptoms, or prevent cancer from forming. Clinical trials are essentially the last step in a research study where data, patterns, new drugs and devices are implemented in real time. Any drug or new technology must be tested in a clinical trial before being approved by the FDA, which is an important step in moving medicine and cancer treatment forward. Although clinical trials can be used at any stage of cancer, they are commonly sought out by patients with difficult diagnoses and those who are not reacting favorably to common treatments.

While treatments like these are in fact “trials,” there are thousands of people who are benefitting by taking part every year, and there are even more who could benefit by testing what types of treatment work for them and what doesn’t. Not every clinical trial is a guaranteed success, but trials are required to go through several steps before making it to the patient stage, including cell and animal studies. Currently, there are several different types of emerging treatments being tested at the leading hospitals across the country, many of which specifically focus on cancer patients.

Immunotherapy

As the name suggests, immunotherapy targets the immune system in order to strengthen or suppress the body’s defenses in order to fight cancer cells or give certain treatments the environment to succeed. Cancer cells effectively harm our organs due to their ability to avoid immune cells, and certain types of immunotherapies can help find and mark the debilitating cancer cells.

Depending on the type of therapy decided on with one’s doctor, immunotherapy drugs can be taken orally, through an IV, through an ointment or cream or in some cases intravesically. As with many forms of treatment, there can still be side effects such as swelling, soreness, congestion and various flu-like symptoms. In the past few years, immunotherapy treatment has been useful for a number of different cancer diagnoses, including lymphoma and lung cancer. 

Gene Therapy

In recent years, gene therapy has been among the most promising treatments to emerge in cancer trials. Our genes are sets of code that help our body and health progress, so manipulating certain genes can help prevent and treat cancer. In gene therapy, doctors can replace faulty genes with functional genes, fix mutated genetic material or strengthen genes to better fight disease. The treatment is generally injected or given intravenously, and has shown progress for patients not only with cancer, but also for those with genetic diseases like muscular dystrophy and cystic fibrosis.

A specific type of gene therapy that has been successful in trials is known as p53 therapy. The p53 gene is responsible for coding proteins that facilitate proper cell function. Doctors have noticed that the p53 is mutated in several different types of cancer, pinpointing that gene as a hinge in cancer treatment. Restoring that specific gene to its correct function can help slow the growth of cancer and potentially help patients improve their prognosis. While the restoration of gene p53 is not eradicating the cancer, it can help slow down the growth of fast moving cancers. For example, these trials would be useful for treating mesothelioma patients, since mesothelioma is an aggressive cancer with an average prognosis of only 6-18 months. So far, doctors have seen a reduction in tumor size and an extended life expectancy for mesothelioma patients in phase 1 clinical trials.

Virotherapy

An effective emerging treatment for cancer patients, virotherapy utilizes viruses to target and eliminate cancer cells in the body using oncolytic viruses–which are viruses that specifically kill cancer cells. The goal of these oncolytic viruses is to find and destroy cancer cells without causing damage to functioning cells or an infection. This is another therapy that is often used in patients with a poor prognosis or those who have advanced stages of cancer.

Virotherapy is often administered in conjunction with other treatments like chemotherapy and immunotherapy. This branch of medicine is a good option for cancer patients because there are few side effects and little to no risk of affecting the mutation of other cells. Oncolytic virotherapy can also be used at any point in the treatment process and is an emerging option for those looking into participating in a clinical trial.

The Importance of Physicians in Trials

Becoming involved in a trial or study that pushes towards a cure for cancer can be extremely exciting and fulfilling for those in the field of science and health. The role of the physician in a clinical trial is more than just a patient’s doctor. These professionals are the bridge between pharmaceutical companies and those in the trenches of a cancer diagnosis. While there are a number of positions and researchers involved in trial, physicians are those who are best equipped to comment on what drugs and therapies will be most useful in practice.

Physicians wear a number of hats, but first and foremost, most doctors desire to serve their patients and seek out miracles in medicine. Those who have a passion for unlocking issues at the forefront of cancer care should not shy away from a role in a clinical trial. For families, friends, and patients who are dealing with a difficult or rare diagnosis, trials and alternative treatments are what provide hope for those fighting for strength and precious time with their loved ones.

 

About the author: Molly McGuane is a Communications Specialist at the MAA Center.

Top 10 Professions of the Future in Healthcare

Experts believe that by 2030, these new branches and specialties will be in demand.

Experts believe that by 2030, hospitals will be a thing of the past, and people will be more engaged in self-treatment and prevention. At the same time in medicine, there will be new branches and specialties that will be in demand.

This article presents a selection of future health care professions.

  1. Mechanic for companion robots

Companion robots will accompany the elderly. They will help in domestic affairs, make it easier to move around the house, control the medication and entertain with conversations. If the robot breaks down, the owner will call a mechanic who understands precisely this kind of robots. You can invite an expert at any time of the day or night.

  1. Expert in deep learning

Algorithms in the future will take on the task of organizing all work processes. That is why experts will be in demand who can teach algorithms new skills. They will “feed” neural networks with training data and monitor the results.

  1. AI Chatbots Developers

Medical chatbots now advise patients around the world. Soon they will be available in every smartphone. With a migraine attack, the patient will turn to the bot, who will find the cause of the ailment and tell you the appropriate treatment method. Chatbots will appear not only in the field of medicine but also in other industries. One example is the DoNotPay chatbot advocate, who challenged 160,000 fines.

  1. Lifestyle strategist

By 2020, the world will sell 245 million wearable devices. Lifestyle strategists will create individual programs with a daily routine for their clients, as well as help with the selection of wearable gadgets and advise on health insurance.

  1. Telesurgery

According to calculations, by 2020, sales of surgeon robots will double and amount to $6.4 billion. Robots, of course, will not be able to work on their own – surgeons-supervisors will monitor their activities. Courses on telesurgery and operations with the help of robots will appear in the world’s leading universities, and the accuracy of surgical procedures will be improved significantly.

  1. A lobbyist for robotic surgeons

The main task of lobbyists is to promote robotics in medical institutions. Especially often, they will act in cases of medical error. Lobbyists use these cases to their advantage to prove the superiority of robots over humans.

  1. Routers for medical drones

Experts will be engaged in developing optimal routes for the delivery of medicines, medical equipment, donated blood and organs to patients in remote regions. This work will require knowledge of engineering and topology.

  1. Drone mechanic

The drone will become an assistant who monitors the status of its owner. Robocars equipped with biometric sensors, will analyze the condition of the person and inform him or her about the problems found. In case of breakdown, a professional mechanic for robots can restore the electronics.

  1. Cryopreservation Specialist

The general idea is that with time one can bring a body back to life. There is the Michigan Institute of Cryonics where they keep bodies at 384, 8 °F. Cryopreservation can also be used to help patients who have been shot or injured in an accident.

  1. Bodies developers

The ability to create organs from the patient’s stem cells will solve the problem of organ donation and its lack. Owners of knowledge in the field of molecular biology, 3D printing and medicine will be able to design and develop organs for transplantation.

 

About the author: Melisa Marzett is an expert in the area of writing who is currently performing tasks for Professional writers – penessays.com and enjoying a healthy lifestyle. She does morning exercise, jogging, and practicing meditation since recently and reads motivation books. “If you believe, you can achieve,” is her life motto.

7 Ways to Make the Most of Your Holiday Nursing Shift

by Deborah Swanson

Ask any nurse working a holiday shift if they’d rather be home with their friends and family and they’ll likely say “yes.” However, patient needs don’t stop for the holidays, and most every nurse has to work at least a couple of holidays each year. That being said, working on a holiday doesn’t mean that your shift has to be completely lacking in seasonal cheer. With the winter holidays coming up, here are seven ideas to help you make the most of a holiday nursing shift, from seasonal scrubs to cookie swaps..

Decorate the lounge.

Get permission to decorate the lounge or nurses’ station, and then let your inner interior decorator out. It’s easy to get cheap, seasonal decor at party goods or home decor stores, and you can of course make your own DIY decorations if you’re feeling especially crafty. You can theme the decorations to match your setting—for example, stringing tinsel on the walls to look like an EKG reading—or you can keep things strictly holiday-focused with classic decorations. Out of respect for coworkers and patients, either keep the decorations nonreligious or try to represent winter holidays of various cultures (Chinese New Year, Christmas, Hanukkah, Kwanzaa, etc.).

Create a common Christmas tree.

If you have room in the lounge or reception area, put up a small fake Christmas tree (real ones can trigger allergies in some people) and ask each nurse in your unit to bring in an ornament to decorate it. The ornaments can be funny, personal, sentimental—whatever they choose to bring in! If you want to get really elaborate, you can decide on a theme for the tree—for example, everyone has to bring a nursing-inspired ornament—or you can keep things eclectic and simply see what everyone brings. Or you can forgo the ornaments altogether and simply make a tree from scratch using surgical gloves instead.

Wear holiday-themed scrubs.

You can carry the holiday cheer with you wherever you go by dressing for the season. There are many (many, many) printed scrub tops with holiday designs available, with styles ranging from tasteful to the best kind of tacky. If you prefer a more subtle look, you can always combine red and green solid scrubs or wear holiday-themed compression socks under your pants. Of course, don’t forget accessories such as stethoscope charms, badge holders, lanyards and small jewelry items such as stud earrings. As always, prioritize safety first and make sure none of your holiday accessories dangle in such a way that they can snag on something or get pulled on by patients.

Holiday Nursing Shift_2

Coordinate a potluck.

Besides gifts, delicious food is a major staple of holiday celebrations around the world. Rather than picking at hospital cafeteria food for the umpteenth time, get your coworkers together and host a holiday potluck. Have each person sign up to bring a certain type of dish (main course, side dish, dessert, drinks, etc.) and encourage them to make food from their religious or cultural background if they would like to share with the group. Nurses are already stressed enough around the holidays, so if some people in your unit would rather not cook, encourage them to bring a store-bought dish instead. After all, even pre-made mashed potatoes from the grocery store will probably taste better than whatever the cafeteria is offering.

Do a cookie swap.

If a potluck sounds like too much effort or you don’t have a lot of cooks in your unit, you can always coordinate a cookie swap instead. Invite each person to make or buy their favorite type of cookie (again, it’s a good idea to have a sign-up sheet of some sort so you don’t end up with too many duplicates) and then line the cookies up on the counter in the nurses’ lounge and let people grab them as they can. Even if people don’t have time for a full potluck meal, they probably will have time to eat a cookie or two! Definitely make sure the cookies are stored in airtight containers so they won’t get stale. If stored properly, the cookies will stay fresh for several days, which means that nurses across several shifts will get to partake in the cookie swap.

Holiday Nursing Shift_3

Host an office Secret Santa exchange.

You should know who is working the holiday shift with you in advance, which gives you all a chance to plan a Secret Santa exchange. Have people randomly draw the name of someone else who will be working the holiday shift, and then set a monetary limit for gift purchases. If you want to keep things low key, you can just exchange one gift on the day of the holiday. However, if all the nurses in your unit are really close, you can spread multiple small gifts out over the course of several weeks to keep the holiday cheer going all season long.

Make the most of your breaks.

Working on a holiday can be even more tough emotionally than a regular nursing shift. If your break is long enough, use the time to call or FaceTime your family so you feel like you got to connect with them on the holiday itself, however briefly. If it will cheer you up, you can ask your family members to send you pictures of the celebrations so you feel included. However, if that will just make you feel what you’re missing out on even more acutely, put your phone down and use your break to catch up with coworkers you like instead. Even if all you do is commiserate about having to work the holiday, as least you’ll be getting in some social time. Plus, talking to people face-to-face releases the hormone oxytocin, which boosts your mood.

No nurse really wants to work a holiday—but someone has to do it–so you might as well have fun while you’re at it. Try one or all of these seven ideas to inject a little cheer into your holiday nursing shift (pun definitely not intended).


Deborah Swanson is a Coordinator for the Real Caregivers Program at allheart.com. A site dedicated to celebrating medical professionals and their journeys. She keeps busy interviewing caregivers and writing about them and loves gardening.

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

Thailand Medical Tourism, 2018: Reviewed

by Darren Lyons

It continues to be another busy year for Thailand’s private hospitals, clinics and dental facilities, with the seemingly endless arrival of international patients from across the globe. Whilst the volume begins to subside a little as the year comes to a close, the team at MyMediTravel put together their analysis from a sample of 1,000 of their English-speaking, non-Thai based customers and made some interesting discoveries.

It’s no surprise that the Aussies make up nearly a fifth of all arrivals, given its relative proximity to Thailand, but what is surprising is that Americans make up the largest group at 20% – the country with by far the biggest medical tourism market in the world! Our neighbour, Singapore, understandably provides 10% of arrivals – Thailand is much cheaper after all and a 1.5-hour long flight can cost as little as 2,500 THB, return. It is worth noting that Chinese and other non-English speaking medical tourists have not been included in this survey, as they tend to travel with a local facilitator who can provide around the clock assistance.

Almost two-thirds opt for a medical facility in Bangkok, most likely due to the abundant supply of competing facilities who bring the prices down when compared to the other cities and regions. Heavily weighted in favour of females, no wonder given that the second most popular procedure is Breast Augmentation! But notice the ‘very-2018’ addition of a third gender, Trans. Gender is no longer a binary option, with 3% identifying themselves as neither male or female.

CoolSculpting, ever heard of it? Click the link for more information, but in a nutshell, it’s a non-invasive alternative to liposuction where the fat cells are frozen and slowly die off, with the body excreting them naturally over the following weeks. The procedure is ideal for those who have smaller more stubborn fat in areas like the ‘muffin top’ or the ‘love handles’. The rest of the top-10 procedures are mostly different types of cosmetic surgery with, of course, Gender Reassignment and also the Hair Transplant among them.

Finally, analysing the popular facilities, we see the undisputed champion of Thai medical facilities, Bumrungrad at the top, with the Sikarin Hospital not far behind – offering almost as many procedures and services, but at a fraction of the cost. KTOP Clinic and Yanhee Hospital are fast gaining a reputation for being up with the best cosmetic surgery facilities in the region.

 


Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

Thailand, Third Biggest Medical Tourism Destination in the World

Thailand is edging out South Korea to become the world’s prime destination for cosmetic surgeries and treatments. What is driving this Global Medical Tourism market?

by Darren Lyons

Source: Articles.MyMediTravel.com

In the process of shrugging off its reputation for cheap back-alley plastic surgeries, Thailand is quickly catching up to South Korea as the world’s prime destination for cosmetic surgeries and treatments. Home to 64 JCI-accredited medical facilities – three times more than Singapore and 6 times more than Malaysia.

JCI is the industry standard in global healthcare, where facilities are benchmarked against US standards and practices.

In an industry of massively over-inflated figures, it’s difficult to really gauge the size of the Global Medical Tourism market or even the Thai market. According to the TAT, a whopping 9% of Thailand’s 35m annual visitors are ‘Medical Tourists’, but it’s believed this figure doesn’t account for tourists who happen to visit a medical facility during their stay and it doesn’t disregard multiple visits or expats. A more honest assessment by the International Medical Travel Journal suggests the global market is worth around $13bn, with Thailand being the joint third biggest beneficiary, taking $600m in revenue each year.

The top 25 medical travel destinations by value:

Thailand_Ranking

Source: International Medical Travel Journal

But what is Medical Tourism and why is Thailand so popular? A loose definition of a Medical Tourist would be someone who travels to another country with the primary purpose of undertaking some form of medical, cosmetic or dental procedure. Common procedure types, include plastic surgery, dental procedures, tertiary medical care and fertility procedures.

It’s estimated that Thailand receives 350,000 dedicated Medical Tourists each year, spending an average of $1,700 in hospitals and clinics across the country, with Bangkok seeing the majority of this money. South Korea still leads the way, but for how much longer?

Darren Lyons of MyMediTravel, a Singapore based Medical Tourism information and referrals platform (best comparison being, the Booking.com of global Medical Tourism), states that half of their requests are for cosmetic procedures in Thailand. Darren explains:

“We work with hospitals and clinics in 43 countries across the world and yet 48% of all enquiries are for Thai facilities, with the vast majority of these being cosmetic procedures. Breast Augmentation procedures in Thailand are by far the most common, but other more ‘modern’ procedures are on the rise, for example CoolSculpting, the Brazilian Butt Lift and the Labiaplasty.”

We asked Darren why he thinks Thailand is such a popular choice for Medical Tourists:

“Reputation. Thailand invested so heavily over the last 20 years, it’s now reaping the benefits of having 60-plus gold standard facilities and hundreds of smaller but well-established clinics. And a huge amount of the surgeons are internationally trained with many years of experience. Gone are the days of everyone sniggering at Thailand for its botched plastic surgeries. Of course, there’ll always be ill-informed people who still say this, but with so much information and first-hand accounts and reviews available online, such ignorance is being disregarded now.

“And cost is an important factor. Outside of the major hospitals, Thailand is so competitive, not just in the region, but globally. Other more affordable hospitals are quickly gaining ground, for example Sikarin Hospital and Bangpakok 9 International Hospital. Smaller, more niche clinics like KTOP Clinic are gaining a reputation for the ‘Korean Style’ facial plastic surgeries, attracting patients who’d previously only ever considered South Korea as a viable destination.

“Finally, no waiting times. Prospective patients will say ‘I want my procedure done on this day’, and nine times out of ten, that’s when it’s booked in for. Failing that, it’ll be the following day.”

Darren went on to explain how emerging nations like Thailand were able to undercut hospitals in Western / developed countries, and it comes down to simple economics. Where the cost to build, run and maintain a multi-disciplinary hospital and pay the staff is much lower, and this huge saving is passed onto the consumer.

Price comparison of some popular procedures:

Procedure US Singapore Thailand
Coronary Angioplasty $28,200 $13,500 $4,200
Heart Bypass $123,000 $17,200 $15,000
Hip Replacement $40,300 $12,000 $17,000
Gastric Bypass $25,000 $13,700 $16,800
Hysterectomy $15,400 $10,400 $3,650
LASIK $4,000 $3,800 $2,310
Dental Implant $2,500 $2,700 $1,720
Breast Augmentation $6,400 $8,400 $3,500

Source: medicaltourism.com

 


Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

Aging in Place

Aging in place is a dream for many seniors. We’ve compiled a great list of helpful resources that will help you understand how to assess the needs of a disabled senior.

by Jennifer McGregor

Aging in place is a dream for many seniors. Of course, the older we get, the more likely we are to be living with some form of a physical disability, meaning our homes will likely need some changes in order to allow us to remain there for as long as possible.

But don’t worry: we’ve compiled a great list of helpful resources that will help you understand how to assess the needs of disabled seniors, and create a financial plan and make modifications accordingly.

Guide to Room-by-Room Repairs for Easy Accessibility for Disabled Loved Ones – This handy guide will help you make an accessibility plan for your bathrooms, kitchen and yard – three of the most treacherous places for individuals with disabilities.

11 Low-Cost Aging in Place Modifications You Can Do Yourself – Fortunately, not every safety upgrade requires an arm and a leg, and many can be done DIY!

Senior’s Guide to Paying for At-Home Long-Term Care: How Your Home Can be a Great Asset – Your home can actually be a great tool for paying for any needed accessibility modifications – without having to sell it! This guide offers seniors ideas for funding options their home can provide to pay for both minor and major updates.

How to Make & Pay for Home Modifications to Enable Aging in Place – In addition to your actual home, there are more options than you might be aware of to fund safety upgrades. This guide offers lots of helpful tips and links to other resources for helping you fund your home modifications.

This list only scratches the surface of this topic, of course, and as an advocate for people of all ages with disabilities, we’re here to help. If you have questions on how to make a home safe for patients in their Golden Years, please contact us.

Jennifer co-created Public Health Library to write about health and wellness topics and to create a forum for sharing reputable health and medical information.

 

Heart Drug Spotlights Troubling Trends In Drug Marketing

Headlines proclaimed a potential game changer in treating cardiovascular disease—Vascepa—and company shares quickly soared, but the study behind the claim remains a mystery.

Shefali Luthra, Kaiser Health News

At the end of September, Amarin Corp. teased some early findings for Vascepa, its preventive medicine for people at risk of heart disease. The claim was astounding: a 25 percent relative risk reduction for deaths related to heart attacks, strokes and other conditions. Headlines proclaimed a potential game changer in treating cardiovascular disease. And company shares quickly soared, from $3 a share to about $20.

Vascepa is Amarin’s only product. The company wants to turn its pill made of purified fish oil into a cash cow, allowing it to staff up both in the United States and abroad so it can sell doctors and millions of consumers on its medical benefits. Although the product has been on the market for more than five years, its first TV ad campaign rolled out this summer in anticipation of the study findings.

Except there is one problem. The particulars of the scientific study on which this claim was based remain a mystery.

Amarin’s preliminary announcement came via a news release on Sept. 24. The company plans to release detailed findings in November at the national American Heart Association conference. Then early next year, it plans to seek Food and Drug Administration approval to use the drug as a preventive for a range of heart conditions, beyond its current role targeting high triglyceride levels.

In the interim, a battle is brewing among physicians, cardiovascular experts and pharma watchers who say Vascepa brings to the foreground troubling trends in the marketing and advertising of new drugs. Companies sometimes promote new products, but withhold the detailed findings until much later. The consequences for both consumers and the health system are vast.

“Until all the data is available for review by the public and medical community, it’s really premature to see some of the cheerleading that’s being done,” said Dr. Eric Strong, a hospitalist and clinical assistant professor at Stanford School of Medicine. “It’s harder to change people’s minds once you have these rosy pictures.”

John Thero, Amarin’s CEO, argued that the imminent release of the drug’s complete picture should alleviate those concerns.

In unveiling topline findings in a news release, he said, the company’s playbook doesn’t diverge from that of other pharmaceutical makers, and provides a necessary level of disclosure for shareholders.

But it’s the specifics in the data — for instance, which patients benefited, by how much, their absolute risk reduction and which precise conditions saw improvement — that illustrate whether a product is cost-effective, said medical and drug experts.

That’s especially true in the case of Vascepa, whose manufacturer is working hard to convince people the product is clinically superior to ordinary fish oil supplements. Fish oil, which can retail for a few dollars a bottle, has long been promoted as a preventive for heart disease. But the substance has never held up in clinical trials as a way to systematically lower disease risk, said experts.

That’s where Amarin’s product is superior, Thero said.

The manufacturer has tried to limit competition by seeking to block other fish oil products —arguing to the U.S. International Trade Commission that omega-3 supplements aren’t equivalents, and calling on the FDA to block a chemical component of fish oil, known as EPA and marketed by a number of supplement companies, from being sold as a dietary supplement. Amarin hasn’t yet prevailed.

Preston Mason, a biologist who consults for Amarin and has advocated on its behalf, argued that ordinary fish oil supplements carry risks because they are not regulated or approved by the FDA, which does oversee prescription drugs like Vascepa.

How Vascepa performs against regular fish oil remains unknown. Amarin’s trial compared the drug against a placebo, not over-the-counter supplements.

Vascepa itself isn’t new. It was approved in 2012 as a remedy for extremely high triglyceride levels, which can put patients at risk for pancreatic problems. But reducing that fat hadn’t been conclusively tied to, say, lowering the risk of heart attacks, or other major cardiac problems.

That link, ostensibly, is what Amarin is trying now to assert. And there’s plenty of money to be made if it succeeds.

As of last December, Vascepa retailed for about $280 for a month-long supply, a list price increase of 43 percent over five years, though the company says its net sale price has stayed the same. (That difference would come if Amarin increased the size of rebates, or discounts it provides, commensurate with price hikes.)

Now, citing the drug’s potentially increased value, Amarin has declined to say whether it will change the price again — though Thero said he sees greater profit potential if the company increases sales volume rather than price.

This gets at the crux of this debate. If a company makes available the technical details of a product, but only after hyping the findings, and if the details undercut some of that buzz — is it too late?

Dr. Khurram Nasir, a Yale cardiologist, acknowledged that it’s unclear how effective Vascepa really is, but maintained those ambiguities will be cleared up soon enough.

“As the findings reveal themselves, there will be a lot of discussion around cost effectiveness, and whether this is worth the spend,” Nasir said.

Mason, the Amarin scientist, said FDA scrutiny can also alleviate concerns about overhype.

But others worry the perception of Vascepa’s effectiveness is now set.

“People are weighing in with really strong language, without enough information,” said Dr. Lisa Schwartz, who co-directs the Dartmouth Institute’s Center for Medicine and Media and studies effective scientific communication.

That has both clinical and financial consequences, she added. Doctors are more likely to prescribe a product that’s been heavily promoted, even if subsequent discussion indicates the drug isn’t as powerful as initially implied. And manufacturers can cash in, whether through increased company stock market value or by charging higher list prices.

For Vascepa, the central question is which specific heart conditions saw risk reduction, she and others said. In its news release, Amarin noted a “composite outcome” — that is, the 25 percent relative improvement encompassed all conditions for which the researchers tested.

“People are saying, Wow, it reduced heart attack, stroke and blah, blah, blah — when it may just reduce the least important one,” said Dr. Steven Woloshin, Schwartz’s research partner.

Another issue: The Vascepa trial focused on a specific population — patients with high triglyceride levels plus elevated risk of cardiovascular disease or diabetes who were already taking a daily statin. That means any proof of benefit is limited to that group.

Woloshin and Schwartz both suggested that nuance could get lost in translation. “It is this much narrower, high-risk population,” Schwartz said.

Woloshin added, “The fear is [the message] would generalize to anyone with high triglycerides.”

This concern is amplified by a 2016 court settlement in which the FDA permitted Amarin to market Vascepa to audiences for whom it hasn’t been specifically approved — so long as the company doesn’t say anything untrue about the drug.

Thero said Amarin’s marketing of Vascepa has stayed, and will remain, consistent with what is factual and relevant.

“We are proceeding consistently with what the FDA has guided,” he said.

But, some experts said, the 2016 settlement could unlock the door to wider marketing of Vascepa’s off-label use, implying the pill benefits more people than it actually does.

“They’ll take pains to show how different this is from everything out there … and its results in these populations,” said Dr. Ameet Sarpatwari, an epidemiologist and lawyer at Harvard Medical School, who studies the pharmaceutical industry. “What they can’t do is say it will be beneficial to these other populations. But they can hint at that.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

New Opioid Approved by FDA, Mere Days After Trump Signs Opioid Bill

On October 24th, President Trump signed a package of bills designed to confront and combat the nation’s opioid epidemic. On November 2nd, the FDA approved Dsuvia.

On October 24th, President Donald Trump signed a package of bills designed to confront and combat the nation’s opioid epidemic. On November 2nd, the FDA approved Dsuvia, an opioid painkiller 1,000 times stronger than morphine.

Dsuvia is restricted to limited use, only available in health care settings, such as hospitals, surgery centers and emergency rooms. However, critics worry the opioid will add fuel to an already ugly epidemic.

The FDA seemed to be expecting the backlash, and following the approval of the drug, FDA Commissioner Scott Gottlieb, M.D., issued the following statement:

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s approval of Dsuvia and the FDA’s future consideration of new opioids

The crisis of opioid addiction is an issue of great concern for our nation. Addressing it is a public health priority for the FDA. The agency is taking new steps to more actively confront this crisis, while also paying careful attention to the needs of patients and physicians managing pain. As part of these considerations, there’s been an important and robust public debate leading up to the regulatory decision on Dsuvia that merits a response. I want to take this opportunity to address some of the concerns that were raised, and more broadly, how I believe the FDA should consider the approval of new opioid pain medications that can help fill targeted medical needs.

Looking beyond this particular drug approval, I believe that we should consider whether we should be doing more to evaluate each candidate opioid, not just as an independent review decision, but rather also to consider each novel opioid drug in the context of the overall therapeutic armamentarium that’s available to patients and providers. As we look at the public health implications of each new approval, we should evaluate whether we need to take additional steps to systematically consider new opioids relative to the comparative benefit and risks of other opioids already on the market. We should consider whether we could do more in weighing approvals to ensure that new opioids are sufficiently better than existing drugs to justify their addition to the market in the context of the current crisis of abuse.

In this particular case, Dsuvia is a sublingual (under the tongue) formulation of sufentanil that’s delivered through a disposable, pre-filled, single-dose applicator. The medicine is restricted to use in certified medically-supervised health care settings ‒ such as hospitals, surgical centers and emergency departments ‒ for administration by a health care professional. Dsuvia, which was previously approved by the European Medicines Agency in July under the brand name Dzuveo, has some unique features in that the drug is delivered in a stable form that makes it ideally suited for certain special circumstances where patients may not be able to swallow oral medication, and where access to intravenous pain relief is not possible. This includes potential uses on the battlefield. For this reason, the Department of Defense (DoD) worked closely with the sponsor on the development of this new medicine. This opioid formulation, along with Dsuvia’s unique delivery device, was a priority medical product for the Pentagon because it fills a specific and important, but limited, unmet medical need in treating our nation’s soldiers on the battlefield. The involvement and needs of the DoD in treating soldiers on the battlefield were discussed by the advisory committee.

There are very tight restrictions being placed on the distribution and use of this product. We’ve learned much from the harmful impact that other oral opioid products can have in the context of the opioid crisis. We’ve applied those hard lessons as part of the steps we’re taking to address safety concerns for Dsuvia, including requiring a Risk Evaluation and Mitigation Strategy (REMS) to accompany this drug. The REMS reflects the potential risks associated with this product and will tightly control its distribution and use. Importantly, the distribution system will restrict Dsuvia’s use to certified medically-supervised health care settings, an important step to help prevent misuse and abuse of Dsuvia. The FDA will continue to carefully monitor the implementation of the REMS associated with Dsuvia and compliance with its requirements, and we’ll work to quickly make regulatory adjustments if problems arise.

But underlying the debate surrounding this approval is a broader issue that must be addressed head on: why do we need an oral formulation of sufentanil – a more potent form of fentanyl that’s been approved for intravenous and epidural use in the U.S. since 1984 – on the market?

This question is especially critical in the context of the crisis of opioid addiction and evidence that opioids continue to be inappropriately prescribed, marketed, diverted and abused. Given this context, we need to address the question that I believe underlies the criticism raised in advance of this approval: to what extent should we evaluate each opioid solely on its own merits, and how should we also consider, within the broader context of our public health mission including the overall therapeutic armamentarium that we have available for addressing pain, the other opioid analgesics that are already on the market, the epidemic of opioid misuse and abuse that’s gripping our nation and the risk for illicit diversion and abuse?

I’m committed to considering these key questions as part of a comprehensive process that the FDA has underway to develop a formal benefit and risk framework for how the agency evaluates the safety and efficacy of opioid medicines.

Currently, in applying our statute and regulations, we generally consider each new drug approval – and each new opioid drug approval – largely on its own merits. As part of our review, we ask whether the individual drug meets the standard for safety and effectiveness, and whether additional controls are needed to ensure safe use of that specific drug.

But opioids are a unique class of medicines. Congress recently directed us to think differently about opioids as a drug class in enacting novel and specific authorities that enable the FDA to, among other things, require post-market studies to evaluate efficacy of opioids if we have concerns that these products may not be as effective as previously thought; to consider the risks associated with the misuse and abuse of opioids as a factor in how we make pre- and post-market regulatory decisions; to require opioids to be sold in unit dose packaging; and to require that certain opioids be dispensed with packaging or systems that enable the drugs to be safely disposed.

The FDA has already begun implementing these new authorities. And, even before Congress granted the FDA these new authorities, we have started to take a different approach to the benefit-risk evaluation of opioids. In the post-market setting, we’ve taken strong actions where appropriate, such as requesting the withdrawal of reformulated Opana ER from the market. In the pre-market setting, we routinely seek advisory committee input on new opioid product approvals. For example, at an October 2018 meeting of the Anesthetic and Analgesic Drug Products Advisory Committee, the committee recommended 10-3 that Dsuvia be approved. Committee members in attendance for the meeting included experts on pain management, medication safety, human factors and critical care nursing, who are anesthesiologists, pain specialists and pharmacists.

We’re also re-evaluating how we consider both the individual and public health impacts of new opioids as they are reviewed for approval. To that end, I’ve asked the professional staff at the FDA to evaluate a new framework for opioid analgesic approvals; one that provides a transparent process to delineate clearly, eventually in new guidance, how we intend to consider the benefits and risks of these products in the context of this crisis. As part of this process, we need to closely consider how we evaluate questions such as:

  • How does the availability of an additional opioid drug benefit the public health through its ability to, for example, provide therapeutic differentiation, promote more appropriate access, or advance safer use of these medicines?
  • Does the approval of an additional opioid drug create added risks for diversion, accidental overdose, abuse and misuse, or other concerns?
  • If the approval of an additional opioid will create such added risks, will the new drug provide sufficient clinical differentiation that can benefit certain groups of patients, or offer other important clinical benefit, such that the benefits to patients of introducing the additional opioid outweigh the risks? And can the implementation of REMS help mitigate some of these risks?

Such a framework also would need to address the potential hurdles to product innovation. So, if we develop such a framework that takes into closer consideration the overall therapeutic armamentarium as we consider new opioid product approvals, and weighs new opioid approvals against the benefits and risks of existing drugs for the treatment of pain; then we’d also need to describe how we intend to characterize the benefits and risks of opioids, and what we believe the unmet medical needs are. In this way, innovators would know up front where the opportunities are for developing new drugs that meet the FDA’s standards for safety and effectiveness.

As part of the effort to consider and apply a more holistic approach, I will also be taking these questions, and a consideration of such a framework, to my Opioid Policy Steering Committee to evaluate what additional steps we may want to take within our own authority to consider these goals and the development of such a framework. There could also be other places where we would seek additional input, as well as help from Congress. We know now that our evaluation of opioids is different than how we assess drugs in other therapeutic classes. And Congress agreed with us that opioids are different. I believe that there are population-based considerations when it comes to drugs that are subject to such widespread abuse and misuse that warrant us considering each approval within a broad public health context.

This brings us back to discussion around today’s approval.

I believe that the unique aspects of Dsuvia, including those that make this drug a high priority for the Pentagon, differentiate this new formulation of sufentanil from other sufentanil products in a way that is consistent with population-based considerations for how it fits into the overall drug armamentarium. The FDA has made it a high priority to make sure our soldiers have access to treatments that meet the unique needs of the battlefield, including when intravenous administration is not possible for the treatment of acute pain related to battlefield wounds. The military application for this new medicine was carefully considered in this case. We understand the concerns about the availability of a high potency formulation of sufentanil and the associated risks. The FDA has implemented a REMS that reflects the potential risks associated with this product and mandates that Dsuvia will only be made available for use in a certified medically-supervised heath care setting, including its use on the battlefield.

To address concerns about the potential risks associated with Dsuvia, this product will have strong limitations on its use. It can’t be dispensed to patients for home use and should not be used for more than 72 hours. And it should only be administered by a health care provider using a single-dose applicator. That means it won’t be available at retail pharmacies for patients to take home. These measures to restrict the use of this product only within a supervised health care setting, and not for home use, are important steps to help prevent misuse and abuse of Dsuvia, as well reduce the potential for diversion. Because of the risks of addiction, abuse and misuse with opioids; Dsuvia is also to be reserved for use in patients for whom alternative pain treatment options have not been tolerated, or are not expected to be tolerated, where existing treatment options have not provided adequate analgesia, or where these alternatives are not expected to provide adequate analgesia. Like all opioids, Dsuvia will also carry a boxed warning about the serious risks of misuse and abuse, which can lead to addiction, overdose and death. It also includes a boxed warning about the serious risks, including extreme sleepiness, respiratory depression, coma and death, side effects that may be potentiated by the combined use with central nervous system depressants such as drugs called benzodiazepines. Common side effects of Dsuvia include nausea, headache, vomiting, dizziness and hypotension.

But I recognize that the debate goes beyond the characteristics of this particular product or the actions that we’re taking to mitigate this drug’s risks and preserve its differentiated benefits. We won’t sidestep what I believe is the real underlying source of discontent among the critics of this approval – the question of whether or not America needs another powerful opioid while in the throes of a massive crisis of addiction.

It’s an important question that has surfaced in past approval decisions and will come up again in the future. As a public health agency, we have an obligation to address this question openly and directly. As a physician and regulator, I won’t bypass legitimate questions and concerns related to our role in addressing the opioid crisis.

We owe an answer to those who support us in these decisions, and to those who may disagree. We owe an answer to patients with medical pain, and the innovators who take risks to develop products to help address their needs. We owe it to Americans who want the FDA to do our part to help end one of the biggest addiction crises of modern times, while we carefully balance these grave risks against patient needs.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

Breaking Down MIPS for PTs, OTs, and SLPs

2019 is coming, and so is Medicare’s Merit-Based Incentive Payment System. Here’s an easy-to-follow breakdown of what PTs, OTs, and SLPs need to know.

from WebPT

Medicare’s Merit-Based Incentive Payment System (MIPS)—the forthcoming payment mechanism that will provide annual updates, based on performance in quality, resource use, clinical practice improvement activities, and meaningful use of an electronic health record system—has two main questions that surround it for therapy professionals: whether or not all physical, occupational, and speech therapists need to report, and if there is a penalty, how to avoid it. Heidi Jannenga, PT, DPT, ATC, over at WebPT breaks down what you can actually expect in terms of MIPS, without any over-dramatization or scare tactics.

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Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

Holiday Gift Guide for Children with SPD

The holidays can be hard on children with sensory processing disorders. Here is a guide of sensory-friendly items your patients’ families might want to add to their lists this year.

The holidays can be hard on children with sensory processing disorders—everything from being surrounded by strangers at holiday dinners to sitting on Santa’s lap can be hurdles for your patients and their families to climb, or events for them to flat out avoid—but as awareness of SPD grows, more and more options are available to help children better enjoy the gifting aspects of the upcoming holiday season. Below is a guide of well-reviewed, sensory-friendly items your patients families might want to add to their lists this year.


Photo credit: Amazon.com

Abilitations Teacher’s Pet Weighted Lap Dog

Featured Review:
“This was perfect in every way for my son with autism and sensory processing disorder.”



Photo credit: Amazon.com

Educational Insights Playfoam Pals Wild Animals 6-Pack

Featured Review:
“These are great special treats that are a wonderful alternative to a traditional “surprize egg”. You get the initial excitement of “what toy did I get” coupled with the long term sensory play of the foam!”



Photo credit: Amazon.com

Educational Insights Playfoam Combo 8-Pack

Featured Review:
“I work with kids who have autism, and this a great alternative to Playdoh.”



Photo credit: Amazon.com

CoolSand 3D Sandbox – Dino Discovery Edition

Featured Review:
“Great sensory play toy for my 2 and 5 year old boys. This helps them to calm down and play together nicely.”



Photo credit: Amazon.com

BizyBeez MagStix Sensory Magnetic STEM Toys Building Set for Kids

Featured Review:
“I like all of the different pieces: straight, curved, balls, half spheres, and wheels. I also appreciate the different textures of the items for my son with sensory processing.”


Please note: HealthJobsNationwide.com receives no compensation for recommending these items and makes no warranties regarding their safety. Items listed above should be evaluated individually for potential risks and hazards.

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.