FDA permits marketing of a medical device for treatment of ADHD

The U.S. Food and Drug Administration today permitted marketing of the first medical device to treat attention deficit hyperactivity disorder (ADHD). The prescription-only device, called the Monarch external Trigeminal Nerve Stimulation (eTNS) System, is indicated for patients ages 7 to12 years old who are not currently taking prescription ADHD medication and is the first non-drug treatment for ADHD granted marketing authorization by the FDA.

“This new device offers a safe, non-drug option for treatment of ADHD in pediatric patients through the use of mild nerve stimulation, a first of its kind,” said Carlos Peña, Ph.D., director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health. “Today’s action reflects our deep commitment to working with device manufacturers to advance the development of pediatric medical devices so that children have access to innovative, safe and effective medical devices that meet their unique needs.”

The device known as a transneuronal stimulator is not new on the market. It has previously been approved for the treatment of other disorders.

A diagram of it's the mechanism of action for a transneuronal stimulator

Trigeminal Nerve Stimulation for Comorbid Posttraumatic Stress Disorder and Major Depressive Disorder.
An eight-week,  study of trigeminal nerve stimulation in youth with attention-deficit/hyperactivity  
The potential use of trigeminal nerve stimulation in the treatment of epilepsy.
Central mechanisms of cranial nerve stimulation for epilepsy.

ADHD is a common disorder that begins in childhood. Symptoms include difficulty staying focused and paying attention, difficulty controlling behavior and very high levels of activity. The diagnosis of ADHD requires a comprehensive evaluation by a health care professional. For a person to receive a diagnosis of ADHD, the symptoms of inattention and/or hyperactivity-impulsivity must be chronic or long-lasting, impair the person’s functioning and cause the person to fall behind normal development for his or her age.

The Monarch eTNS System is intended to be used in the home under the supervision of a caregiver. The cell-phone-sized device generates a low-level electrical pulse and connects via a wire to a small patch that adheres to a patient's forehead, just above the eyebrows, and should feel like a tingling sensation on the skin. The system delivers the low-level electrical stimulation to the branches of the trigeminal nerve, which sends therapeutic signals to the parts of the brain thought to be involved in ADHD. While the exact mechanism of eTNS is not yet known, neuroimaging studies have shown that eTNS increases activity in the brain regions that are known to be important in regulating attention, emotion, and behavior.

The stimulation should feel like a tingling sensation on the skin, and the device should be used in the home under the supervision of a caregiver during periods of sleep. Clinical trials suggest that a response to eTNS may take up to 4 weeks to become evident. Patients should consult with their health care professional after four weeks of use to assess treatment effects.

The Monarch eTNS System’s efficacy in treating ADHD was shown in a clinical trial that compared eTNS as the sole treatment, or monotherapy, to a placebo device. A total of 62 children with moderate to severe ADHD were enrolled in the trial and used either the eTNS therapy each night or a placebo device at home for four weeks. The trial's primary endpoint was an improvement on a clinician-administered ADHD Rating Scale, ADHD-RS.  ADHD-RS scales are used to monitor the severity and frequency of ADHD symptoms. A higher score is indicative of worsening symptoms. The ADHD-RS uses questions about the patient’s behavior, such as whether they have difficulty paying attention or regularly interrupt others. The trial showed that subjects using the eTNS device had statistically significant improvement in their ADHD symptoms compared with the placebo group. At the end of week four, the average ADHD-RS score in the active group decreased from 34.1 points at baseline to 23.4 points, versus a decrease from 33.7 to 27.5 points in the placebo group.

The most common side effects observed with eTNS use are drowsiness, an increase in appetite, trouble sleeping, teeth clenching, headache and fatigue. No serious adverse events were associated with use of the device.

The Monarch eTNS System should not be used in children under seven years of age. It should not be used in patients with an active implantable pacemaker or with active implantable neurostimulators. Patients with body-worn devices such as insulin pumps should not use this device. The eTNS System should not be used in the presence of radio frequency energy such as magnetic resonance imaging (MRI), because it has not been tested in an MRI machine, or cell phones, because the phone’s low levels of electromagnetic energy may interrupt the therapy.

The FDA reviewed the Monarch eTNS System through the de novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.

The FDA granted marketing authorization of the Monarch eTNS System to NeuroSigma. 

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, 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.

This is not a recommendation for treatment.  See your physician for diagnosis and treatment.

Press Announcements > FDA permits marketing of first medical device for treatment of ADHD: FDA permits marketing of first medical device for treatment of ADHD

The 2020 Final Payment Notice, Part 1: Insurer and Exchange Provisions

On April 18, 2019, the Centers for Medicare and Medicaid Services (CMS) released its final 2020 Notice of Benefit and Payment Parameters rule. The final rule was accompanied by a fact sheet, the final letter to insurers in the federal marketplace, and key dates for the calendar year 2019.

This is the latest that a payment rule has ever been finalized. From here, insurers can develop their products for 2020 and get these products reviewed and approved by state regulators or CMS.

The complexity of rules changes requires almost one year to process. The process if nothing else traces a route through providers, hospitals, and patients.  There is a public commentary period.

Overall, CMS made very few major changes from its proposed rule, which was released on January 17. Where the final rule deviates from the proposed rule, CMS mostly opted not to implement certain proposed changes. The final rule does not, for instance, require the sale of “mirror” abortion plans, adopt many significant changes to prescription drug standards, or allow navigators and other assisters to use web broker websites. In terms of significant changes that were adopted, the final rule allows insurers to adopt accumulator adjustment programs in limited circumstances and maintains an increase in the 2020 premium adjustment percentage as proposed. The latter is described as a “technical” change to the methodology that will result in higher consumer costs, reduced access to premium tax credits, and more uninsured people.

There were more than 26,000 comments on the proposed rule, about 500 of which were unique. Most of the remaining 25,000 comments were like one of eight different letters and focused on the rule’s abortion coverage proposal. This post addresses final changes in plan benefits, eligibility, and enrollment changes. A second post will consider the final changes to the risk adjustment program.

The “payment notice” is issued on an annual basis to adopt a variety of major changes that CMS intends to implement for the next plan year in areas such as the marketplaces, the risk adjustment program, and the market reforms. Historically, the payment rule has been issued in early fall and finalized in early spring (typically late February or early March) to give insurers, states, and other stakeholders time to understand the rules for the next year as new products are developed and approved for sale. 

This is the latest that a payment rule has been finalized and reduces the window of time for insurers and state regulators or CMS to develop, adjust, review, and approve plans for 2020. This delay notwithstanding, CMS did not alter its timeline for qualified health plan (QHP) certification for 2020: insurers must submit their 2020 QHPs  to CMS by June 19, 2019, for approval. CMS has already released its final rate filing timeline for 2020.

Much of the rule is devoted to changes regarding direct enrollment and risk adjustment, but the 401-page final rule addresses the following topics:

Changes in plan benefits and qualified health plan provisions;
Eligibility and enrollment changes, such as a new special enrollment period, changes to navigator requirements, and new standards for direct enrollment;
The 2020 payment parameters, such as the federal exchange user fee, annual limits on cost-sharing, and a new way of determining premium growth; and
Changes to the risk adjustment program.

In 2018 large increases were prevented by "silver loading" premiums.  How 'silver-loading' helped save the ACA's exchanges in 2018

In contrast to the 2019 payment rule, CMS proposes very few changes regarding the essential health benefits (EHB) and plan design. For 2019, CMS allowed states to choose from among many more EHB-benchmark plan options on an annual basis, deferred additional responsibility to state regulators, and eliminated standardized plan options and meaningful difference standards, among other changes. The 2020 final rule maintains these changes and makes no additional changes beyond laying out new timelines and providing additional background on discriminatory benefit design.

Toll-Free Hotline for SHOPs
The final rule includes a very minor change to the SHOP program. This is because the 2019 payment rule (and guidance before that) essentially wound down the SHOP exchanges after CMS concluded it is no longer cost-effective for the federal government to maintain a SHOP website and functionality. Thus, small employers no longer enroll using the SHOP platform and, instead, enroll through a SHOP-registered agent or broker or directly with an insurer.

CMS did, however, retain some SHOP standards, including a requirement that SHOPs continue to provide a call center to answer SHOP-related questions. Noting that SHOP call center volume has been extremely low, CMS will allow “leaner” SHOPs to operate a toll-free hotline in lieu of a call center. (CMS explained the difference between a hotline and a call center in the 2017 payment rule.) The toll-free hotline must allow for automated messages, pre-recorded responses to common questions, ways to reach local agents and brokers, and the option to leave a message.






















http://tinyurl.com/y6a6wxed

Doctors Wasting Over Two-Thirds Of Their Time Doing Paperwork

The issue of increasing medical bureaucracy is at a critical juncture. All of the well-intentioned technical additions for healthcare administration, such as electronic health records are having a paradoxical effect on the quality of care, and also decreases efficiency due to its poor design. 

Electronic health records are superb at capturing and saving critical medical information. It serves bureaucrats, support personnel, and payers well. However, the first and last link in the equation are physicians who are reduced to data entry clerks.

Paperwork for many doctors has become overwhelming. While initiatives have tried to convert paperwork into electronic paperwork, are the new systems actually designed to make doctors' lives easier? (Photo by Joe Raedle/Getty Images)

If medical school curricula were based on what a recent study says many doctors actually do with their time, more than half of medical school would be on how to do paperwork. Medical school admissions essays would be on "why I really want to do paperwork when I grow up." Required classes would be "Introduction to Filling Out Forms" and "Advanced Form-filling." Indeed, a recently published study in the Annals of Internal Medicine found that for every hour physicians were seeing patients, they were spending nearly two additional hours on paperwork. Is this really the best use of doctors' training and ability? Isn't this like telling LeBron James to spend the majority of his time manning the Cleveland Cavaliers ticket windows and phone lines? And isn't this also wasting the time of patients, who came for the doctor's medical expertise, not paperwork expertise?

Medical interns spend over 43% of their day on EHR use, study finds
Medical Educators realize this problem

Physicians who were already peaked out prior to the adoption of the electronic health records, and the additional impact of CMS rules, MIPS, new ICD 10 codes, requirements for MOC (maintenance of competence) recertification by specialty boards and more are burning out
Physicians are also talking about their 'moral dilemma' as they are required to follow insurance company rules in order to be reimbursed.

Studies have shown that physician dissatisfaction affects patient care and thus patient satisfaction. For instance, a study in the Journal of General Internal Medicine of 11 general internal medicine practices in the greater-Boston area demonstrated that patients of more satisfied physicians also were more satisfied with their health care.  Makes sense. Just like you don't want to have a pissed-off chef, lawyer or airplane pilot.

Something has to change. Hire people to help with paperwork, develop better technology to complete the paperwork, give physicians more time to see fewer patients or get rid of paperwork. Despite concerns having been raised, what is really being done? There needs to be real action. Otherwise, doctors will just have less and less time to actually examine and treat patients. And this will hurt everyone and eventually the entire system will hit a breaking point. After all, no patient wants to hear the following words in a waiting room, "the doctor will see your paperwork now."

Doctors Wasting Over Two-Thirds Of Their Time Doing Paperwork: Tune in the next epidisode of the ABC Network drama series, "Grey's Anatomy," when Dr. Meredith Grey, (played by Ellen Pompeo) does paperwork. (Photo by Amy Sussman/Invision/AP)

Ten Steps To Prepare For Life At 100 Or More In An Exponential Future And How to Live Near a Black Hole

Living longer seems to be a mixed feature of our generation. There are already existing exponential changes, a relative decrease in young and working people to support a growing aging population.  Less opportunity to fund retirement plans to support living after retirement, and a longer period of what we now call retirement.

If it feels like technological change is happening faster than it used to, that’s because it is.

It took around 12,000 years to move from the agrarian to the industrial revolution but only a couple of hundred years to go from the industrial to the information revolution that’s now propelling us in a short number of decades into the artificial intelligence revolution. Each technological transformation enables the next as the time between these quantum leaps become shorter.

That’s why if you are looking backward to get a sense of how quickly the world around you will change, you won’t realize how quickly our radically different future is approaching. But although this can sometimes feel frightening, there’s a lot we can do now to help make sure we ride this wave of radical change rather than get drowned by it.

1. Do what you can to preserve your youth
2. 
   Scientists are discovering new ways to slow the biological process of aging. It won’t be too long before doctors start prescribing pills, gene therapies, and other treatments to manage getting old as a partly curable disease. Because most of the terrible afflictions we now fear are correlated with age, medically treating aging will push off the date when we might have otherwise developed cancers, heart disease, dementia, and other killers. To maximally benefit from the new treatments for aging tomorrow, we all, no matter what our current age, need to do what we can to take care of our bodies today. That means exercising around 45 minutes a day, eating a healthy and mostly plant-based diet, trying to sleep at least seven hours a night, avoiding too much sun, not smoking, building and maintaining strong communities and support networks, and living a purposeful life. The healthier you are when the anti-age treatments arrive, the longer you’ll be able to maintain your vitality into your later years.
3. 
   
4. Quantify and monitor your health
5. 
   You can’t monitor what you can’t measure. If you want to maintain optimal health, you need a way to regularly assess if you are on the right track. Monitoring your health through regular broad-spectrum blood and stool tests, constant feedback about your heart rate and sleep patterns from devices like your Apple Watch or Fitbit, having your genome sequenced, getting a full body MRI, and having a regular colonoscopy may seem like overkill to most people. But waiting until you have a symptom to start assessing your health status is like waiting until your car is careening down a hill to check if the brakes are in order. Some smart people worry that this kind of monitoring of “healthy” people will waste money, overwhelm our already overburdened healthcare system, and cause people unnecessary anxiety. But even the healthiest among us are in the early stages of developing one disease or another. Society will inevitably shift from a model of responsive sick care of people already in trouble to the predictive healthcare trying to keep people out of it. Do you want to be a dinosaur-like victim of the old model or a proactive pioneer of the new one?
6. 
   
7. Freeze your essential biological materials
8. 
   Our bodies are a treasure trove of biological materials that could save us in the future, but every morning we still flush gold down the toilet. That gold, our stool, could potentially be frozen so we could repopulate our essential gut bacteria if our microbiome were to take a dangerous hit from antibiotics or illness. Skin cells could be transformed into potentially life-saving stem cells and stored for future use to help rejuvenate various types of aging cells. If our future treatments will be personalized using our own biological materials, but we’ll need to have stored these materials earlier in life to receive the full benefit of these advances. We put money in the bank to ensure our financial security, so why wouldn’t we put some of our biological materials in a bio-bank to have our youngest possible rescue cells waiting for us when we need them and help secure our physiological security?
9. 
   
10. If you plan on ever having children, freeze your eggs or your sperm
11. 
    More people will soon shift from conceiving children through sex to conceiving them through IVF and embryo selection. The preliminary driver of this will be parents’ increasing recognition that they can reduce the roughly 3% chance their future children will be born with dangerous genetic mutations by having their embryos screened in a lab prior to implantation in the mother. This may seem less exciting than making babies in the back seat of a car, but the health and longevity benefits of screening embryos will ultimately overpower conception by sex kind of like how vaccinating our children has (mostly) overpowered the far more natural option of not doing so. If you are likely to conceive via IVF and embryo selection, why not freeze your eggs, sperm, or embryos when you are at your biological peak and when the chance of passing on genetic abnormalities is lower than it may be later in life?
12. 
    
13. Manage your public identity
14. 
    The days of living incognito are over. No matter how aggressively some of us may try to avoid it, our lives leave massive digital footprints that are becoming an essential part of our very identities. The authoritarian government in China is planning to give “social credit“ scores evaluating the digitally monitored behavior of each citizen in a creepy and frightening way. But even in more liberal societies we will all be increasingly judged at work, at home, and in our commercial interactions based on our aggregated digital identities. These identities will be based on what we buy, what we post, what we seek, and how and with whom we interact online. Some societies and individuals are smartly trying to exert a level of control over the collection and use of this personal data, but even this won’t change the new reality that our digital identities will significantly influence what options are available to us in life and represent us after we die. Given this, and perhaps sadly, we all need to protect our privacy but also think of our public selves as brands, managing our digitally recorded activity from early on to present ourselves to the world the way we consciously want the world to know us.
15. 
    
16. Learn the language of code
17. 
    Our lives will be increasingly manipulated by algorithms few of us understand. Most people who were once good at finding their way now just use their GPS-guided smart phones to get where they need to go. As algorithms touching many different aspects of our lives get better, we will increasingly rely on them to make plans, purchasing decisions, and even significant life choices for us. Pretty much every job we might do and many other aspects of our lives will be guided by artificial intelligence and big data analytics. Fully understanding every detail of how each of these algorithms function may be impossible, but we’ll be even more at their mercy if we don’t each acquire at least a rudimentary understanding of what code is and how it works. If you can read one book about code, that’s a start. Learning the fundamental of coding will do even more to help you navigate the fast arriving algorithmic world.
18. 
    
19. Become multicultural
20. 
    Pretty much wherever you were in the 18th century, you needed to understand Europe to operate effectively because European power then defined so many parts of the world. The same was true for understanding United States in the 20th century understanding America was imperative for most people living outside of the United States because US actions influenced so many aspects of their lives. For many people living in 20th century America, understanding the rest of the world was merely interesting. As China rises and Global power decentralizes in the 21st-century, we’ll all need to learn more about China, India, and other new power, population, and culture centers than ever before. This won’t just help you become a more well-rounded person, it will give you a far greater chance of success in most anything you’ll be doing. Although machine translation will make communicating across languages pretty seamless, you’ll need a cultural fluidity and fluency to succeed in the 21stcentury world. The good news is that people motivated to learn about other groups and societies now have more resources than ever before to do so. If you want to be ready for our multicultural, multinational future, you’d better start doing all you can to learn about other cultures and societies now.
21. 
    
22. Become an obsessive learner
23. 
    Technological change has been a constant throughout human history, but the pace of change is today accelerating far more rapidly than ever before. As innovations across the spectrum of science and technology empower, inspire, and reinforce each other, multiple technological transformations are converging into a revolutionary whole far greater than the sum of its parts. This unprecedented rate of change will mean that much of your knowledge will start becoming obsolete as soon as you acquire it. To keep up in your career and life, you’ll need to dedicate yourself to a lifetime of never-ending, aggressive, continuous, and creativity-driven learning. The only skill worth having in an exponential world will be knowing how to learn and a passion for doing it. Call me an old-fashioned futurist, but this learning process must include reading lots of books to help you understand where we have come from and how the disparate pieces of information fit together to create a larger story. This type of knowledge will be an essential foundation of the wisdom we’ll each and all need to navigate our fast-changing world.
24. 
    
25. Invest in physical community
26. 
    
27. We, humans, are social species. A primary reason we rose to the top of the food chain and built civilization is that our brains are optimized for collaborating with those around us. When we bond with our partners and friends, we realize one of our essential cord needs as humans. That’s why people in solitary confinement tend to go a bit crazy. But although our progression from feeling our sense of connection, belonging, and community has expanded from the level of clan to village to city to country to, in some ways, the world, we are still not virtual beings. We may get a little dopamine hit whenever someone likes our tweet or Facebook post, but most of us still need a connected physical community around us in order to be happy and to realize our best potential. With all of the virtual options that will surround us – chatbots engaging us in witty repartee, virtual assistants managing our schedules, and even friends messaging from faraway lands among them – our virtual future must remain grounded in our physical world. To build your essential community of flesh and blood people, you must invest in deep and meaningful relationships with the people physically around you.
28. 
    
29.   Don’t get stuck in today 
30. 
    
31. The olden days were, at least in most peoples’ minds, always better. We used to have better values, a better work ethic, better communities. We used to walk to school uphill in both directions! But while we do need to hold on to the best of the past, we also need to march boldly into the future. Because the coming world will feel like science fiction, will all need to be like science fiction writers imagining the world ahead and positioning ourselves to shape it for the better. The technologies of the future will be radically new but we’ll need to draw on the best of our ancient value systems to use them wisely. The exponential future is coming faster than most of us appreciate or are ready for. Like it or not, we are now all futurists.

If you feel as if we are entering a black hole, you could be correct.

And most important, teach this to your children.

Ten steps to prepare for an exponential future | TechCrunch: Ten steps to prepare for an exponential future

Newt Gingrich: How much is health care really worth? Patients, not bureaucrats, should decide |

When I met with several Republican senators this week, it was clear that they recognize Americans’ desire to have practical solutions for the cost of health care. The combination of pressure from constituents and a direct challenge from President Trump is focusing their attention on immediate reforms which could be enacted – even with a Democratic House.  Republicans also realize their alternative to “Medicare for All” must be built on a larger, positive vision. It is clear that fixing health care may be the biggest issue in the 2020 election.

WHY TRUMP ABANDONED HIS PLAN TO REPLACE OBAMACARE

The second is to fix the underlying structural problems in the health care system which are at the root of the health inflation problem.

On this latter priority, it is important that we define the problem that must be fixed. In fact, our most fundamental challenge is not that we pay too much for health care – but that we have no idea how much health care is worth.

In a normal marketplace, as Edward Deming wrote, innovators create products and customers define value. An innovator may create something they think is impressive, but it is the customer who gets to decide how much they are willing to pay for it. They make this decision based on how much they value the product over other ways to spend their money. It is this interplay between innovators creating new products and customers defining their value, which makes the magic of the marketplace work. It is why in most free markets with sound intellectual property protections, we get a continuing virtuous cycle of innovation which leads to higher quality and lower cost.

Health care, however, is not a normal market.

It is not normal because the consumer of the product, the patient, is not the one purchasing the health care (deductibles, co-insurance, and co-pays notwithstanding). Instead, the purchaser is the insurer, employer, or the government from whom the patient receives health coverage.

So, in health care, who is the customer – the payer or the patient? And who should determine value?

I believe, and I think most Americans would agree, that the patient’s voice should be more important than the payer’s. This is especially true because the patient is usually directly or indirectly the source of money for the payer. Since the patient is the one receiving the health care, we want the patient defining value.

That’s why I advocate eliminating third-party payments in health care as much as possible. The rise of direct primary care practices, for example, is a promising development which liberates doctors to be accountable directly to their patients by replacing third-party payers with direct payment by patients.

Still, the unpredictable nature of life requires some sort of health insurance for unexpected, large medical expenses. This means that for a significant portion of the health marketplace, the third-party payment model is unavoidable.

The question then becomes: How do we make this third-party payment system as accountable as possible to the patients, so they can define value even though a third-party is paying?

The answer is by making that interplay between the patient, payer, and provider as simple and transparent as possible. Establishing this right to know begins to improve the value of the system.

Unfortunately, for the past 40 years, most health reforms in Washington have taken the opposite approach. They have led to more middlemen, more opacity, and more complexity in the system. It is no surprise then that as the patient’s ability to determine value was submerged in a mountain of bureaucracy, that the health inflation problem became worse, not better.

Author's comments:

Newt Gingrich has hit the nail on the head. Health care economics has never been an elastic model. Supply and demand have little relationship.  The demand for health care approaches infinity. Rising costs do not eliminate or lessen the need for treatment of disease, except perhaps for cosmetic procedures which obey the normal rules since they are a cash commodity.

Our health system needs to be simplified.  Universal Payer is advocated by many.  It's success will be in the details and several questions need to be addressed going forward.  Universal payer does not address who the payer is. Will it be government, will it be framed around medicare?

There is no necessity that it be 'run' by the government.  In the U.K. a National Trust was formed and it became the administrative body for health care.  It is tightly regulated and one step removed from 'government' although most call it socialized medicine.  The true meaning of socialism is the government owns the assets.  

In the United States, there is a polyglot system of hospital and provider ownership, private, federal, state, government and large health systems.  There is a network of VA hospitals, Military hospitals, and non-profit hospitals.

With a universal payer system, are we talking about just payments or ownership? Patients' fear is rationing care, procedures lack of choice, and little control of what they desire.

Undoubtedly this will be a top priority during the 2020 elections. I expect to see little progress in such a divided and polarized Congress, which emphasizes byte sized slogans.

Novel, 'Non-habit Forming' Medication May Reduce Low Back Pain

An over the counter (OTC) precursor of testosterone, cholesterol, and cortisone has been studied in a controlled clinical trial for the relief of back pain.  The study was performed in a cohort of Iraq and Afghanistan soldiers also with a comorbid condition of PTSD (post-traumatic stress disorder) The study was not conducted in patients without PTSD (non-military personel. There the study cannot be applied to other cohorts (civilians without PTSD)

While pregnenolone is available over the counter, the researchers used a pharmaceutical-grade tablet formulation for the study. This development comes at a time when opioid addiction has become an epidemic.

Some other benefits for pregnenolone have been proposed, 

Pregnenolone is also used to sharpen memory, reduce stress, stimulate the immune system, promote detox, prevent heart disease, and slow the aging process. It has been marketed as a means of improving memory.

A search is ongoing for a non-addicting analgesic for chronic pain. Nature provided the opium poppy plant from which opium can be concentrated.  Dependence on the drug develops very quickly and a course of opioids can become addicting in a relatively short time.  Much of this occurs accidentally during a course of treatment following surgery.

Chronic pain from arthritis, neuropathy is also mismanaged by prescribing opioids. Oxycodone has been the most frequently abused drug. 

Pharmaceutical companies have been implicated in incentive programs by some companies. Purdue Pharmaceuticals is facing serious accusations of profiteering from their manufacturing of oxycodone.  They have agreed to a legal settlement with the state of Oklahoma for victims of opioid addiction

Purdue Pharmaceuticals knew how addicting Oxycodone was over 20 years ago. Yet their marketing materials such as this video would say otherwise. (The video is from 1998)

There are many precautions about using pregnenolone, 

Side Effects & Safety

There isn't enough information to know if pregnenolone is safe when taken by mouth. It might cause some steroid-like side effects including overstimulation, insomnia, irritability, anger, anxiety, acne, headache, negative mood changes, facial hair growth, hair loss, and irregular heart rhythm.

Special Precautions & Warnings:

Pregnancy and breast-feeding: Not enough is known about the use of pregnenolone during pregnancy and breastfeeding. Stay on the safe side and avoid use.

Hormone-sensitive condition such as breast cancer, uterine cancer, ovarian cancer, endometriosis, or uterine fibroids: Pregnenolone is converted by the body to estrogen. If you have any condition that might be made worse by exposure to estrogen, don’t take supplemental pregnenolone.

Be cautious with this combination

!

• Estrogens interacts with PREGNENOLONE
• Pregnenolone is used in the body to make hormones including estrogen. Taking estrogen along with pregnenolone might cause too much estrogen to be in the body.
  
  Some estrogen pills include conjugated equine estrogens (Premarin), ethinyl estradiol, estradiol, and others.
• Progestin interacts with PREGNENOLONE
• Progestins are a group of hormones. Taking other hormones along with progesterone pills might cause too much hormones in the body. This could increase the effects and side effects of hormone pills.
• Testosterone interacts with PREGNENOLONE
  The body changes pregnenolone into testosterone. Taking pregnenolone along with a testosterone pill might cause too much testosterone in the body. This might increase the chance of testosterone side effects.
• NONE OF THIS INFORMATION IS TO BE USED AS A RECOMMENDATION FOR TREATMENT.  ALWAYS CONSULT WITH YOUR TREATING PHYSICIAN BEFORE TAKING PREGNENOLONE

Bibliography

The potential role of allopregnanolone for a safe and effective therapy of neuropathic pain.

Balancing steroidal hormone cascade in treatment-resistant veteran soldiers with PTSD using a fermented soy product (FSWW08): a pilot study.


Author's note:  The literature is very scant on the use of pregnenolone for pain management








Novel, 'Non-habit Forming' Medication May Reduce Low Back Pain: Randomized controlled trial findings suggest possible benefits for a pharmaceutical-grade formulation of the neurosteroid pregnenolone as a "non-habit-forming" treatment for chronic low back pain.

Measles - NYC Health Special Edition

Recent Infections in Brooklyn and Queens

As of April 8, 2019, there have been 285 confirmed cases of measles in Brooklyn and Queens since October. Most of these cases have involved members of the Orthodox Jewish community.

The initial child with measles was unvaccinated and acquired measles on a visit to Israel, where a large outbreak of the disease is occurring. Since then, there have been additional people from Brooklyn and Queens who were unvaccinated and acquired measles while in Israel. People who did not travel were also infected in Brooklyn or Rockland County.

The neighborhoods that are affected include:

• Bensonhurst: 1 confirmed measles case (no additional cases since November 2018)
• Borough Park: 49 confirmed measles cases (no additional cases in the past week)
• Brighton Beach: 1 travel-related case
• Crown Heights: 1 (no additional cases in the past week)
• Midwood/Marine Park: 3 confirmed measles cases (no additional cases in the past week)
• Williamsburg: 228 confirmed measles cases (26 additional cases in the past week)
• Flushing: 2 confirmed cases (no additional cases in the past week)

Vaccination Requirement

On April 9, the Health Commissioner ordered (PDF) every adult and child who lives, works or resides in Williamsburg and has not received the measles-mumps-rubella (MMR) vaccine to be vaccinated. People who demonstrate they are immune from measles or should be medically exempt from this requirement will not need to get vaccinated.

If the Health Department identifies a person with measles or an unvaccinated child exposed to measles in Williamsburg, that individual or their parent or guardian could be fined $1,000.

Measles is a virus that causes fever and a rash. It is highly contagious and anyone who is not vaccinated against the virus can get it at any age.

Although measles is rare in the United States because of high vaccination rates, it is still common in other parts of the world. Measles is common in some countries in Europe, Asia, and Africa and is occasionally brought into the Unites States by unvaccinated travelers who return with measles infection.

Measles is spread through the air when an infected person sneezes or coughs. A person will start being contagious four days before a rash appears. They will stop being contagious four days after the rash appears.

The virus remains active and contagious on surfaces for up to two hours.

Symptoms

Symptoms usually appear 10 to 12 days after exposure to the virus. In some cases, symptoms may start as early as seven days or as late as 21 days.

 Early symptoms include:

• Fever
• Cough
• Runny nose
• Red, watery eyes

Three to five days after initial symptoms, a rash of red spots appears on the face that then spreads over the entire body.

Anyone can become infected with measles, but the virus is more severe in infants, pregnant women and people whose immune systems are weak. Complications of measles include:

• Diarrhea
• Ear infections
• Pneumonia (infection of the lungs)
• Encephalitis (swelling of the brain)
• Premature birth or low-birth-weight in pregnancy
• Death

Prevention

Vaccination is the best way to prevent measles. Anyone who has received two doses of a measles-containing vaccine is highly unlikely to get measles.

MMR Vaccine

A child should get a measles vaccine on or after their first birthday. The vaccine is combined with mumps and rubella vaccines into one vaccine called MMR (measles, mumps, rubella). A second dose of MMR vaccine is recommended before children enter school at 4 to 6 years of age. Infants ages 6 to 11 months should also receive MMR vaccine before travelling internationally.

Anyone born after January 1, 1957, who has not received two doses of a measles-containing vaccine, or who does not have a blood test proving that they are already immune to measles, should receive two doses of the MMR vaccine.

For information on where you or your child can get vaccinated, call 311.

Measles - NYC Health

Jim Jordan And Mark Meadows Warn Drug Companies Not To Cooperate With Congressional Investigation

Drug prices have soared and as Congress begins to investigate, Congressman Jim Jordan and Mark Meadows warn drug companies not to cooperate with a congressional investigation.

Congressional Hearings on Drug Pricing

L-Congressman Jordan R-Congressman Cummings (chair)

The House Oversight Committee is attempting to study how drug companies set prescription drug prices, but Republicans have warned the industry that it may be better for them not to cooperate. 

Republicans on the House Oversight Committee sent letters to a dozen CEOs of major drug companies warning that information they provide to the committee could be leaked to the public by Democratic chair Elijah Cummings in an effort to tank their stock prices.

Cummings requested information from 12 drug companies such as Pfizer Inc., Johnson & Johnson, and Novartis AG in January as part of a broad investigation into how the industry sets prescription drug prices.

“Rep. Jordan is on the absolute wrong side here,” Cummings said in a statement  “He would rather protect drug company ‘stock prices’ than the interests of the American people.”

Cummings seems to be bragging about an “astronomical” impact on drug company stocks. In the context of his statements before and after, he seems to be saying the “astronomical” impact is on taxpayer savings, which justify giving his committee more resources. A minute later he says: “Whatever you all give us, we will give it back in savings by rooting out fraud, waste, and abuse.”

There is no doubt that Pharma stock prices are going to be affected by cost containment measures. PBMs (pharmacy benefit managers) have had a paradoxical effect on drug prices. The PBMs interact with large health plans and hold a large market share of prescription drugs.  Patients most affected by rising drug prices are those without insurance coverage.

The Health 202: Pharmacy middlemen are under scrutiny for pushing up drug prices

The middlemen who negotiate the prices paid by consumers at the pharmacy counter — known as pharmacy benefit managers — face their own Senate grilling tomorrow over the role they play in making drugs more expensive in the United States than anywhere else. 

The story of U.S. drug costs is a hugely complicated one and its villain shifts depending on which part of the drug supply chain is telling the tale. When pharmaceutical executives had their turn at the Senate Finance Committee in February, they characterized the PBMs as the bad guys, complaining that these third-party negotiators don’t pass drug discounts along to consumers but pocket them instead. Yet here’s an important piece of context to keep in mind, one that PBMs are likely to share with senators tomorrow: It’s the pharmaceutical makers who pocket by far the largest share of gross revenue from drug sales. Two-thirds of U.S. spending on pharmaceutical drugs in 2016 were captured by drug companies, while just 4 percent were captured by PBMs.

None of this is new, as we depict another hearing from years ago

Senator Everett Dirksen drug price hearing (circa 1960)

Dirksen, center holding glasses

Republicans Jim Jordan And Mark Meadows Warn Drug Companies Not To Cooperate With Congressional Investigation: