Searching for Medical Jobs: Going Where the Money Is

Despite the modern workforce wanting more than just good pay and benefits, there is no getting around the fact that people want to be paid what they feel they are worth. Healthcare workers are not an exception to the rule. It is with that in mind that looking at the top job markets for healthcare workers gets interesting. Some markets definitely pay more than others.

 Becker’s Hospital Review recently released a list of the highest paying job markets for healthcare workers in the U.S., based on data from the Bureau of Labor and Statistics (BLS). Most of what the data shows isn’t surprising. But there are a few hidden gems in the numbers.

 It is reasonable to assume that job seekers on the hunt for medical jobs might consider salary and benefits first. After that, they might look at things like location and work environment. Moreover, it could be that the majority of American workers do not necessarily want to pick up and move just to make more money.

 Top Locations for Nurses

 The first category examined by Becker’s was registered nurses (RNs). We already know that RNs are in high demand across the country. But where do they earn the most money? Apparently, it’s in California. All the top spots on the Becker’s list are found in the Golden State. Here they are:

  •  San Jose – $155,230
  • San Francisco – $151,640
  • Vallejo-Fairfield – $146,360
  • Santa Rosa – $141,440
  • Napa – $139,680.

 California seems like the place to be if you are a registered nurse hoping to maximize your paycheck. That’s curious, considering that supply and demand heavily influences salary and benefits. What is it about California that appears to make it more difficult to recruit registered nurses there?

 Advanced Practice Nurses

 Becker’s Hospital Review took the approach of dividing advanced practice nurses into two categories: nurse practitioners and physician assistants. That could be due to the fact that the top paying locations for both are different. NPs are paid most in four of the same five cities listed in the RN category. For the fifth city, just remove Santa Rosa and insert Yuba City. San Jose keeps the top spot at $197,870.

 PAs apparently make the most in the joint cities of Portsmouth, NH and Portsmouth, ME. There, they earn roughly $167,240. The remaining four of the top five cities for PAs are:

  •  Panama City, FL – $165,000
  • San Francisco – $164,150
  • San Jose – $163,720
  • Vallejo-Fairfield, CA – $162,030.
  •  California still commands three of the top five spots for physician assistants. So far, the Golden State appears to be the destination of choice for high paying medical jobs.

 Top Locations for Pharmacists

 Last on the list for Becker’s are pharmacists. If you are guessing that California jobs pay the most, you are spot on. Here are the numbers:

  •  San Jose – $168,640
  • San Francisco – $163,840
  • Santa Rosa – $158,420
  • Vallejo-Fairfield – $156,850
  • Santa Cruz – $152,770.

 It is clear that medical jobs pay extremely well in California. We just don’t quite know why. We cannot discount supply and demand but getting a clear picture would also require looking at things like median income, cost of living, and so forth. Just because healthcare workers make more money in California doesn’t mean they enjoy a higher standard of living. Things cost more on the West coast as well.

 At any rate, if you are in the hunt for medical jobs, California has plenty to offer. So do most other states. Take a good look around our job board and see what you can find. With so many jobs available in nearly every healthcare sector, you’re bound to find something that suits you.


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.

The Greatest Difficulties that Can Arise When Studying Medicine Abroad

Much like any other profession, you can master medical specializations while studying abroad. And people do it despite the difficulties of getting into such programs. In the US, for example, 3% of medical students come from other countries.

 

However, studying medicine abroad is as difficult as finding a program that will fit you in. International students can face many challenges, which are not easy to overcome.

 

What challenges?

 

Take a look.

1.   Language Barrier

Studying medicine doesn’t only mean being good at biology, chemistry, physics, and math. It is also about your ability to operate very specific terminology. And, if your knowledge of the language of the country where you’re going to is shaky, consider improving it first.

 

The reason is simple – you won’t have enough time to learn the language when your classes start. You will spend so much time studying for lectures and seminars that you will hardly have time to sleep. But such is the life of a medical student.

 

So, before you make any plans to study abroad, make sure you master the language. The best way to do it is to get yourself a native speaker. It’s not that expensive – for example, on Preply, you can find Portuguese tutors for as low as $5 an hour:

 

Why should you go for a native speaker?

 

You need someone who doesn’t just know the language and culture very well, but who also understands the medical and educational systems of the country you’re going to. This way, you will have a connection to keep in contact with if you encounter misunderstandings.

2.   No Shadowing Period

A shadowing period is a time you get at a potential workplace to go around observing doctors, nurses, and other medical staff and gaining valuable knowledge from it. Shadowing is essential in any job that requires a learning curve.

 

Unfortunately, not all medical programs can provide that. For instance, in the 2017 research, surveyed medical students in the UK shared that the lack of a shadowing period was one of the disadvantages of becoming a medical practitioner there.

 

So, before you apply for a program, do your research. Find whether you’ll have access to internships with shadowing periods and other opportunities to apply your knowledge in practice.

3.   Pressure During Exam Weeks

Medical school is stressful. A study that surveyed medical students around the Middle East has revealed most of them experienced severe stress and even considered leaving the studies altogether.

 

Since you will be responsible for saving people’s lives, you can’t take your education carelessly. The exam weeks will be the most challenging – even to get a simple pass, you will have to study tirelessly.

 

The worst part is that you will hardly have any support system. So, if you’re not ready for such stress, reconsider your choice of studying medicine. Or, think about going to a local college or university.

4.   Expensive Courses

Some colleges and universities abroad offer additional courses to students who want to further their education. Such courses aren’t necessary to attend to get a diploma, but they can be really helpful in your future career.

 

For instance, a workshop about AI in healthcare can give you valuable knowledge and advance your career path, especially if you want to be a surgeon. Adding such qualifications to your CV will help you stand out in the job market.

 

That said, such courses can be very expensive. For instance, a course on AI in healthcare services at MIT costs $2,800. So, consider such expenses before enrolling in a medical school and put some money aside to be able to get extra skills and expand your knowledge.

Over to You

These are only a few examples of difficulties a medical student can encounter when studying abroad. Of course, there are other problems, like difficulties to adapt, ethical differences, etc. You need to be mentally and emotionally ready for the lack of moral support as well, as your parents and friends will be far away from you.

 

But no worries, all these challenges are manageable. Every college and university has a department helping international students adjust and get everything they need to keep up with the studies. So, it would be wise to contact this department before you set off to start your studies – they will help you prepare everything you need to start your first semester stress-free.

 

Article written by Ryan Pell

Ryan is a passionate blogger and writer who likes sharing his thoughts. He works as a content editor and internet researcher and likes to travel and explore new countries.

 


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.

Helping Behind the Scenes: 5 Advantages to Being a Medical Lab Professional

If you’re looking for a career in healthcare behind the scenes, being a medical lab professional could be a great option.

Physicians and other clinicians rely heavily on lab testing to help care for patients. That means the medical lab professionals who conduct those tests are vitally important. As the volume of testing grows and new types of testing emerge, medical lab professionals will continue to be in great demand.

If you’d like to play an active, hands-on role in the healthcare field but aren’t necessarily drawn to working directly with patients, becoming a medical lab professional could be a great fit for you.

Below, I’ll describe five advantages to being a medical lab professional. But first, let’s take a closer look at the professions I’m talking about.

 

Understanding the roles of medical lab professionals

There are two types of medical lab professionals who commonly perform testing. They vary in the education required and in the kinds of responsibilities they typically have.

1. Medical lab technicians

Medical lab technicians generally work in clinics and other healthcare facilities that provide lab services. They use specialized medical instruments and automated technology to conduct a variety of testing and analysis on specimens taken from patients.

Although they may occasionally have direct patient contact, most of their tasks are conducted within the lab.

A common path to becoming a medical lab technician involves completing a two-year associate degree program. Note that a medical lab technician can pursue further education to become a medical lab scientist (see directly below).

2. Medical lab scientists

Medical lab scientists commonly perform more advanced hands-on lab tests in hospitals and large clinics. These procedures often go beyond the more automated processes that a medical lab technician is likely to perform. In addition, medical lab scientists often take on lab leadership roles.

Working as a medical lab scientist requires at least a bachelor’s degree. Note that there are a number of options you can take to obtain that degree, including a bachelor’s degree completion program.

Let’s now turn to the advantages of a career as a medical lab professional.

1. Become a healthcare professional within a shorter amount of time

If you’re interested in a healthcare career but are concerned about the time and expense it can take to earn an advanced professional degree, pursuing a career as a medical lab professional could be an excellent option.

For example, you could be working full-time in a medical lab environment in as little as two years by earning the appropriate associate degree. In fact, if you have transferable credits, that time could be even shorter. (See How to Become a Medical Laboratory Technician for more information.)

And with approximately another two years of education, you can obtain a bachelor’s degree in medical laboratory science. This can open up additional opportunities for taking on leadership positions and conducting more advanced lab procedures. (See How to Become a Medical Laboratory Scientist for more information.)

2. Choose a profession with a bright future

Although there are no guarantees when it comes to obtaining employment, you should know the current — and expected — demand for medical lab professions is high.

According to the Centers for Disease Control and Prevention (CDC), “70% of today’s medical decisions depend on laboratory test results.” In fact, the COVID-19 pandemic has served to underscore just how crucial medical lab professionals are.

Another encouraging indicator is from the Bureau of Labor Statistics (BLS), which projects a positive job growth rate for medical lab professionals over the next decade. (Note: The BLS uses the terms clinical laboratory technicians for medical lab technicians and clinical laboratory technologists for medical lab scientists.)

3. Channel a science background into a valued healthcare profession

If you obtain a medical lab degree, you’re going to have a specific healthcare profession to enter upon graduation. This isn’t necessarily the case if, for example, you major in a subject like biology.

In fact, people who are drawn to medical lab education programs may already have college science credits and even job experience. But what they lack are the credentials to establish a specific career in healthcare.

An associate degree in medical lab technology or a bachelor’s degree in medical lab science can change that.

4. Enjoy a schedule that fits with your lifestyle

Medical lab technicians are typically employed at clinics. That means they generally work steady weekday shifts, during regular daytime hours, with occasional weekend rotations. Also, medical laboratory technicians usually have plenty of opportunities for part-time positions.

Medical lab scientists, who often have positions at hospitals, may work daytime shifts as well as evenings, weekends, and holidays. Note that working non-daytime shifts often comes with additional pay on top of the base hourly wage.

In either case, as a medical lab professional you’ll likely be able to find a schedule that fits well with your lifestyle and your responsibilities outside of work.

5. Play a key role in helping care for patients

Although you may not have a lot of direct interaction with patients, as a medical lab professional you still play a vital part in caring for them. And that can be incredibly rewarding.

On a daily basis, you’ll be using specialized medical instruments and cutting-edge technology to conduct a variety of testing and analyses on specimens taken from patients.

The resulting information helps physicians and other healthcare providers make critical decisions in the prevention, diagnosis, monitoring, or treatment of illnesses and diseases.

 

Take the next step and start exploring programs

Becoming a medical lab professional gives you the opportunity to join the exciting and ever-expanding field of healthcare — while also working behind the scenes without extensive patient interaction.

If that sounds appealing to you, I strongly suggest you take the next step and begin researching medical lab programs.

 


Jessica Hoernemann, MS, MLS(ASCP), is an assistant professor and the program chair for the Medical Laboratory Technology and Medical Laboratory Science programs at Northwestern Health Sciences University.

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.

Americans Rank Pharma Industry as Least Favorable

According to a new poll, even the U.S. federal government is more well-liked by Americans than the pharmaceutical industry.

Even the U.S. federal government is more well-liked by Americans than the pharmaceutical industry, or so the findings of a recent Gallup poll indicate.

The poll, which asked Americans to say whether their overall view of 20 different industries was very positive, somewhat positive, neutral, somewhat negative, or very negative, ranked the pharmaceutical industry in dead last, unseating the federal government from the position they held from 2011 to 2018.

According to the findings, only 27% of Americans polled viewed the pharmaceutical industry positively, while 58% of Americans held a negative view of the industry. It is the lowest ranked the pharmaceutical industry has been since Gallup began polling Americans on their opinions of the industry in 2001.

“The new low in the pharmaceutical industry’s U.S. image comes amid a range of criticisms of industry norms, from generating the highest drug costs in the world to spending massive amounts in lobbying politicians to the industry’s role in the U.S. opioid crisis. Several Democratic candidates have called out the industry in their party’s presidential debates,” Gallup said as part of the findings.

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.

Oklahoma’s ‘Precedent-Setting’ Suit Puts Opioid Drugmakers On Trial

All eyes were on Oklahoma last week, when the first case in a flood of litigation against opioid drug manufacturers began Tuesday.

Jackie Fortier, StateImpact Oklahoma

All eyes were on Oklahoma last week, when the first case in a flood of litigation against opioid drug manufacturers began Tuesday.

Oklahoma Attorney General Mike Hunter’s suit alleges Johnson & Johnson, the nation’s largest drugmaker, helped ignite a public health crisis that has killed thousands of state residents.

With just two days to go before the trial, one of the remaining defendants, Teva Pharmaceutical Industries of Jerusalem, announced an $85 million settlement with the state on Sunday. The money will be used for litigation costs and an undisclosed amount will be allocated “to abate the opioid crisis in Oklahoma,” according to a press release from Hunter’s office.

In its own statement, Teva said the settlement does not establish any wrongdoing on the part of the company, adding Teva “has not contributed to the abuse of opioids in Oklahoma in any way.”

That leaves Johnson & Johnson as the sole defendant.

Court filings accuse the company of overstating the benefits of opioids and understating their risks in marketing campaigns that duped doctors into prescribing the drugs for ailments not approved by regulators.

The bench trial — with a judge and no jury — is poised to be the first of its kind to play out in court.

Nora Freeman Engstrom, a professor at Stanford Law school, said lawyers in the other cases and the general public are eager to see what proof Hunter’s office offers the court.

“We’ll all be seeing what evidence is available, what evidence isn’t available and just how convincing that evidence is,” she said.

Most states and more than 1,600 local and tribal governments are suing drugmakers and distributors. They are trying to recoup billions of dollars spent on addressing the fallout tied to opioid addiction.

Initially, Hunter’s lawsuit included Purdue Pharma, the maker of OxyContin. In March, Purdue Pharma settled with the state for $270 million. Soon after, Hunter dropped all but one of the civil claims, including fraud, against the remaining defendants. Teva settled for $85 million in May, leaving Johnson & Johnson as the only opioid manufacturer willing to go to trial with the state.

But he still thinks the case is strong.

“We have looked at literally millions of documents, taken hundreds of depositions, and we are even more convinced that these companies are the proximate cause for the epidemic in our state and in our country,” Hunter said.

Precedent-Setting Case

The companies involved have a broad concern about what their liability might be, said University of Kentucky law professor Richard Ausness.

“This case will set a precedent,” he said. “If Oklahoma loses, of course they’ll appeal if they lose, but the defendants may have to reconsider their strategy.”

With hundreds of similar cases pending — especially a mammoth case pending in Ohio — Oklahoma’s strategy will be closely watched.

“And of course lurking in the background is the multi-state litigation in Cleveland, where there will ultimately be a settlement in all likelihood, but the size of the settlement and the terms of the settlement may be influenced by Oklahoma,” Ausness said.

‘There’s Nothing Wrong with Producing Opioids”

The legal case is complicated. Unlike tobacco, where states won a landmark settlement, Ausness pointed out that opioids serve a medical purpose.

“There’s nothing wrong with producing opioids. It’s regulated and approved by the Federal Drug Administration, the sale is overseen by the Drug Enforcement Administration, so there’s a great deal of regulation in the production and distribution and sale of opioid products,” Ausness said. “They are useful products, so this is not a situation where the product is defective in some way.”

It’s an argument that has found some traction in court. Recently, a North Dakota judge dismissed all of that state’s claims against Purdue, a big court win for the company. In a written ruling that the state says it will appeal, Judge James Hill questioned the idea of blaming a company that makes a legal product for opioid-related deaths. “Purdue cannot control how doctors prescribe its products and it certainly cannot control how individual patients use and respond to its products,” the judge wrote, “regardless of any warning or instruction Purdue may give.”

Now the Oklahoma case rests entirely on a claim of public nuisance, which refers to actions that harm members of the public, including injury to public health.

“It’s sexy you know, ‘public nuisance’ makes it sound like the defendants are really bad,” Ausness said.

If the state’s claim prevails, Big Pharma could be forced to spend billions of dollars in Oklahoma helping ease the epidemic. “It doesn’t diminish the amount of damages we believe we’ll be able to justify to the judge,” Hunter said, estimating a final payout could run into the “billions of dollars.”

Hunter’s decision to go it alone and not join with a larger consolidated case could mean a quicker resolution for the state, Ausness said.

“Particularly when we’re talking about [attorneys general], who are politicians, who want to be able to tell the people, ‘Gee this is what I’ve done for you.’ They are not interested in waiting two or three years [for a settlement], they want it now,” he said. “Of course, the risk of that is you may lose.”

Looking For Treatment

Oklahoma has the second-highest uninsured rate in the nation and little money for public health. The state is trying to win money from the drug companies to pay for treatment for people like Greg, who is afraid he’ll lose his job if we use his last name.

Greg and his wife, Judy, said they haven’t been able to find the integrated treatment that Greg needs for both his opioid addiction and his bipolar disorder. It’s either one or the other.

“They don’t give you … a treatment plan for both,” Judy said. “They just say ‘Here, you can talk to this person.’ They don’t recognize that it’s like self-medicating.”

The couple live in Guthrie, Okla., about an hour north of the courthouse where the opioid trial will take place. Greg said he has been addicted to opioids for 11 years. People with prescriptions sell him their pills — sometimes Greg binges and takes 400 milligrams of morphine at once, a huge dose.

Of the $270 million Purdue settlement, $200 million is earmarked for an addiction research and treatment center in Tulsa, though no details have been released. An undisclosed amount of the $85 million Teva settlement will also go to abating the crisis. Judy said she hopes the treatment center will eventually help Greg.

“I wish he would stop using [opioids], but I love him. I’ll always be here,” she said.


This story is part of a partnership that includes StateImpact Oklahoma, NPR and Kaiser Health News.

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.

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.

Global Pricing Plan Added To Trump’s Attack On Drug Prices, But Doubts Persist

The proposal would have Medicare base what it pays for some expensive drugs on the average prices in other industrialized countries.

Sarah Jane Tribble, Kaiser Health News

President Donald Trump’s new pledge to crack down on “the global freeloading” in prescription drugs had a sense of déjà vu.

Five months ago, Trump unveiled a blueprint to address prohibitive drug prices, and his administration has been feverishly rolling out ideas ranging from posting drug prices on television ads to changing the rebates that flow between drugmakers and industry middlemen.

Thursday, Trump proposed having Medicare base what it pays for some expensive drugs on the average prices in other industrialized countries, such as France and Germany, where prices are much lower. The proposal is in the early stages of rule-making and awaiting public comments.

The U.S., Trump said, will “confront one of the most unfair practices, almost unimaginable that it hasn’t been taken care of long before this.”

The proposal was met with hope and skepticism, with several experts saying they were happy the administration was taking on Medicare Part B’s rising drug prices but questioning its approach.

Walid Gellad, director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh, said in an online post that the administration’s proposed solutions were unclear. And, he said, they would “face insurmountable challenges.”

While some industry watchers pointed to the announcement as a political move, Wells Fargo pharmaceutical analyst David Maris said that this is a broader effort by the president and his administration to attack the root causes of high drug prices.

“The reality is he could very easily not take this on and do what other administrations have done and let the prices keep rising.”

Trump, too, promised more to come and said he will soon announce “some things that will really be tremendous.” On Friday, Health and Human Services Secretary Alex Azar said that, as promised in the blueprint, there would be more changes to Medicare Part D, which covers most prescriptions. Ian Spatz, a public policy expert and senior adviser at Manatt Health, said the overall blueprint was “unprecedented in terms of how many different ideas and areas of ideas that it contained.”

Nothing would happen overnight. The proposal to require drug prices in TV ads could be delayed by litigation and notably, if implemented, does not include any penalties for companies who fail to post their prices.

The proposed rebate rule was delivered to the Office of Management and Budget in July. Matt Brow, president of industry consulting firm Avalere Health, said he expects the administration to publish the rule for comment by year’s end.

Trump’s international pricing plan is not as far along as the rebate proposal. Rather, it is an “advanced notice of proposed rule-making.” The proposed rule could come in spring 2019, and Azar said the new model could begin in late 2019 or early 2020.

Yet, on Friday, Azar signaled the proposal could change, telling an audience at the Brookings Institution that the administration is “open to any number of alternative ideas.”

Avalere’s Brow said there is a good chance the proposal will change significantly.

“The sweeping nature of the proposal makes the stakes higher and makes it harder to implement,” Brow said.

If the administration moves forward, it would bypass Congress and implement a pilot under the Center for Medicare & Medicaid Innovation’s purview. The pilot would phase in over five years and apply to 50 percent of the country. Azar said there would be no changes to Medicare benefits and no restrictions on patient access.

The proposal focuses on drugs covered under Medicare Part B, which are administered in hospitals, clinics and doctors’ offices. It also would alter the reimbursement formula for doctors and providers and would allow private-sector vendors to purchase drugs and then sell them to doctors and hospitals. Medicare would reimburse those vendors at the international pricing level.

Currently, doctors and hospitals administering Part B drugs are reimbursed the average price of a drug plus 6 percent. President Barack Obama’s administration attempted to alter Part B as well but drew intense lobbying opposition and eventually withdrew a proposed pilot project.

Allan Coukell, senior director for health programs at Pew Charitable Trusts, said removing incentives that reward doctors for purchasing costlier drugs and bringing in a new way to control prices “makes a lot of sense.” Drug spending within Medicare Part B reached $22 billion in 2015, and drug costs have increased by an average of 8.6 percent annually since 2007.

Stephen Ubl, president of the industry trade group Pharmaceutical Research and Manufacturers of America, or PhRMA, said imposing foreign price controls from countries with socialized health care systems would harm patients and hinder drug discovery and development.

Azar, a former executive at pharmaceutical manufacturer Eli Lilly, told reporters Thursday that “you may hear the tired talking points” that this will affect innovation. He disputed that idea, concluding that “less than 1 percent of pharma [research and development] could potentially be impacted by this change.”

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

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 Drug to Treat the Flu Approved by FDA

The new drug, Xofluza, is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years.

Alison Hunt, FDA.gov

Today, the U.S. Food and Drug Administration approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza (flu) in patients 12 years of age and older who have been symptomatic for no more than 48 hours.

“This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years. With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical. This novel drug provides an important, additional treatment option,” said FDA Commissioner Scott Gottlieb, M.D. “While there are several FDA-approved antiviral drugs to treat flu, they’re not a substitute for yearly vaccination. Flu season is already well underway, and the U.S. Centers for Disease Control and Prevention recommends getting vaccinated by the end of October, as seasonal flu vaccine is one of the most effective and safest ways to protect yourself, your family and your community from the flu and serious flu-related complications, which can result in hospitalizations. Yearly vaccination is the primary means of preventing and controlling flu outbreaks.”

Flu is a contagious respiratory illness caused by influenza viruses. When patients with the flu are treated within 48 hours of becoming sick, antiviral drugs can reduce symptoms and duration of the illness.

“When treatment is started within 48 hours of becoming sick with flu symptoms, antiviral drugs can lessen symptoms and shorten the time patients feel sick,” said Debra Birnkrant, M.D., director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research. “Having more treatment options that work in different ways to attack the virus is important because flu viruses can become resistant to antiviral drugs.”

The safety and efficacy of Xofluza, an antiviral drug taken as a single oral dose, was demonstrated in two randomized controlled clinical trials of 1,832 patients where participants were assigned to receive either Xofluza, a placebo, or another antiviral flu treatment within 48 hours of experiencing flu symptoms. In both trials, patients treated with Xofluza had a shorter time to alleviation of symptoms compared with patients who took the placebo. In the second trial, there was no difference in the time to alleviation of symptoms between subjects who received Xofluza and those who received the other flu treatment.

The most common adverse reactions in patients taking Xofluza included diarrhea and bronchitis.

Xofluza was granted Priority Review under which the FDA’s goal is to take action on an application within an expedited time frame where the agency determines that the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition.

The FDA granted approval of Xofluza to Shionogi & Co., Ltd.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also 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.

Large Number of Influencers on the “Health Care 50” are in Biopharma

Of the fifty most influential people innovating healthcare named by Time Magazine, those with ties to biopharma make up a large percentage.

Time Magazine released their inaugural list of the fifty most influential people in healthcare—dubbed the Health Care 50—and a solid portion of those recognized for transforming healthcare have ties to the biopharma space.

To select the fifty most influential people, among them physicians, scientists, and business and political leaders, Time Magazine’s health editors and reporters made nominations, which were then evaluated for their work on key factors, including originality, impact, and quality.

Notable honorees who are innovating healthcare through biopharma include:

  • Bill and Melinda Gates, Philanthropists and Founders of the Bill and Melinda Gates Foundation
  • Scott Gottlieb, Commissioner of the U.S. Food and Drug Administration
  • James P. Allison and Tasuku Honjo, Recipients of the 2018 Nobel Prize in Medicine
  • David Sinclair, Professor of Genetics in the Department of Genetics at Harvard Medical School
  • Anne Wojcicki, CEO of 23andMe

To view the full list of influencers, please click here.

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.