The Top Gun of Health Train Express Blogs for 2016 (so far)

Our readership fluctuates quite a bit, averaging a paltry 200-300 users/day. Most of the readership is from the U.S. and the U.K.

This year we had several posts that went well above 1000 readers/day.  Like most internet publications readership depends heavily upon Google searchs.  Readership continues for days, weeks months and even years.  We network our contributions on facebook, twitter Newsana, Digg, Redditr and a list of email subscribers. We have an RSS  feed as well.

Top Gun Posts:

11 TOP PATIENT QUESTIONS ABOUT TELEHEALTH Affordable Care Act causing more mega=-mergers Sleep is not an Option Revised Food and Drug Labels New Hope for Stroke Patients The Senior Learning Network The Five Percent in Health Curing Cancer MentalHealth, Behavioral Health, and Neuroscience. Patients Cannot Always Access Complete Medical Records There were many others receiving between 750 and 950 readers/day.  Our readership continues to grow consistently...thanks for  your interest.

A Shot in the Arm for Obama’s Precision Medicine Initiative

.Precision medicine is a big idea. Tailoring drugs and therapies to a patient’s individual disease, lifestyle, environment, and genes could touch off a health-care revolution, or so the thinking goes. But first there is much we need to learn about what that all means to a person’s health. That’s why the Obama administration announced Wednesday evening that it is devoting $55 million this year to the creation of a public database containing detailed health information about a million or more volunteers. It’s also why it’s trying to figure out how to better regulate the fast-growing genetic testing market.

Precision medicine is not wihout high risk, as the molecules have powerful effects, and side effects that are potentially lethal.  Hence the need for clinical trials.

Called the Precision Medicine Cohort, the database will be the “largest, most ambitious research project of this sort ever undertaken,” said Francis Collins, director of the National Institutes of Health, during a call with reporters. It will contain medical records, sequenced genomes, blood and urine tests, and even data from mobile health tracking devices and applications. Collins stressed that the database will represent people from all races, ethnicities, and socioeconomic classes, and said it will track participants over many years.

In a separate but related project, also announced Wednesday, the U.S. Food and Drug Administration published draft guidance documentson how it might police the exploding field of genetic testing. The agency is concerned that a new generation of genetic tests could risk patient safety. The technology underlying these tests can quickly and inexpensively sequence an entire genome and identify millions of genetic abnormalities at a time. But interpreting the results is still a work in progress.

Many of the tests purport to tell patients whether they have or are at risk for certain diseases and even direct them toward targeted therapies. The whole area has been largely unregulated, but the FDA aims to use its regulatory power to assess how accurate and clinically useful the tests really are.

Advanced tests like these are “pivotal to the future promise of the Precision Medicine Initiative,” said Robert Califf, the FDA’s commissioner, but that promise is only “as good as the tests that guide diagnosis and treatment.” Califf wouldn’t say when the new regulations would be finalized, but the new information should clarify some of the regulatory uncertainty facing companies that develop such tests.

                                                                     (figure 1) retina of a patient with retinitis pigmentosa:

Patients with currently untreatable neurologic diseases may benefit from novel therapies such as Retinitis Pigmentosa, Schizophrenia and Parkinson's disease.

 (figure 2) Normal retina

VC companies are investing in companies such as  Retro-sense to develop novel methods using injectables directly into the eye.

The current clinical trial is now recruiting it's initial patient cohort. To learn more about the study, it is published at Clinicaltrials.gov  

RST-001 is a gene therapy given as an injection into the eye and delivers a gene encoding a photo switch, channelrhodopsin-2, (optogenetics) to cells in the retina of the eye. When expressed, the channelrhodopsin-2 protein can depolarize in response to light thus generating a signal that is transmitted to the brain.

The study is composed of two parts. An initial dose-ranging study (part 1) is proposed whereby three dose levels of RST-001 will be studied in three separate groups of adult patients with advanced disease. This first part of the study is aimed at determining a single dose of the experimental agent which is safe and well tolerated, to further evaluate in a fourth group of patients. The second part of the study is aimed at obtaining additional safety data at the highest tolerated dose and providing important additional clinical data to guide the design of future efficacy studies.)

A Shot in the Arm for Obama’s Precision Medicine Initiative

Mobile Health App Scams

The U.S. Food and Drug Administration has released guidelines for mobile health apps, and soon will have enforcement power to eliminate scams such as this one.

Smartphone and tablet users should be wary of mobile health apps whether they are on iOS or Android. The potential marketplace is enormous globally.  Euro regulators will also be surveying offerings from vendors as well.

If you’re worried about melanoma, head to the doctor — not the app store. On Monday, the Federal Trade Commission announced it has cracked down on two companies that charged customers up to $4.99 for apps that claimed to help them detect early signs of melanoma.

You get the idea. According to the FTC, the app makers had no evidence to provide support for their apps’ claims that they could assist consumers detect melanoma, which is a form of skin cancer.

The Mole Detective app first appeared in 2012 and was marketed by a U.S. company while MelApp appeared in 2011 from a U.K. firm. The apps sold from $1.99 to $4.99 in the Apple and Google app stores.

A search of Apple’s app store shows both apps have now disappeared, and a search for “melanoma” turned up no results.

The scheme is so far-fetched that the best way to explain it is through these pictures from the FTC, which show how the apps — named MelApp and Mole Detective — claimed to use smartphone cameras to assess skin conditions:

FTC to regulate sales of mhealth apps

In an announcement Monday, the FTC states marketers of MelApp and Mole Detective acted deceptively in claiming the apps can detect melanoma symptoms based on photographs a consumer uploads to the app. Two of the four companies involved with the apps have agreed to stop making unsupported and unsubstantiated claims.

"Truth in advertising laws apply in the mobile marketplace," said Jessica Rich, director of the FTC's Bureau of Consumer Protection, in the announcement. "App developers and marketers must have scientific evidence to support any health or disease claims that they make for their apps."

The settlement with New Consumer Solutions prohibits the vendor from claiming an app can detect or diagnose melanoma unless the claim is supported by "competent and reliable scientific evidence in the form of human clinical testing of the device." It prohibits the company from making misleading or unsubstantiated health claims about a product or service, and includes a $3,930 fine. The FTC is pursuing a litigated judgment against non-settling defendants Lasarow and his company.

In regard to MelApp, marketing began online in 2011 by Health Discovery, which sold the app for $1.99. The FTC settlement bars the company from the same stipulations cited for New Consumer Solutions. The settlement prohibits Health Discovery from making any other misleading or unsubstantiated claims about a device's health benefits or efficacy, and includes a fine of $17,963.

The FTC decisions were split votes, with a dissenting vote issued by Commissioner Maureen Ohlhausen in both cases.

For more information:
- read the FTC announcement
- read the commissioners' statement in favor of the decision
- read the dissenting commissioner statement

Potential buyers must be aware of scams in mobile health apps.  General health information apps have no regulatory oversite. However remote monitoring and wearable technology will require  certification by the FDA, FTC and other agencies as yet unknown.

The mhealth industry has to deal with  Blurred Lines during this relatively early period of development.

Before the Federal Trade Commission or Food and Drug Administration tackle another mobile health technology investigation, the two federal agencies--both of which are charged with protecting consumers--need to huddle up in a conference room, lock the door and not come out until they produce a clear map of what they're responsible for when it comes to oversight and regulating such tools.

Why? Because right now it's getting quite difficult to figure out who's keeping on eye on the shallow end of the mobile health technology pool and who's watching the deep end. And anyone who's had a pool or spent time at a public pool know that a lack of supervision at either end can lead to potential disaster.

the FTC describes itself as working "for consumers to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them." The FDA, for its part, describes its focus as being "responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation."

That may be all well and good, but it really doesn't answer the big question: Is the FTC going to be the one and only lifeguard when it comes to the mHealth technology pool. Additionally, what role, if at all, will the FDA play as more mHealth cases come to light?

Health Affairs:FDA and Primary Care

Health Affairs briefing at the National Press Club in Washington, DC,

The clinical and economic virtues of provider consolidation have long been recognized by policy experts, but in recent years, research has shown that large provider organizations may use market power to obtain relatively high prices from payers without necessarily delivering superior quality. On May 19, Health Affairs will release a package of "Web First" papers examining questions regarding provider consolidation.

Follow live Tweets from the briefing at @HA_Events, and join in the conversation with #HA_ProviderConsolidation.  We invite you to a Health Affairs briefing at the National Press Club in Washington, DC, where the authors will present their findings and engage in a discussion with a panel of expert responders and the audience. The papers and the briefing are supported by a generous grant from The Commonwealth Fund.

WHEN:	Monday, May 19, 2014 9:00 a.m. - 10:30 a.m.
WHERE:	National Press Club 529 14th Street NW Washington, DC 13th Floor (Metro Center)

FDA  Fast-track for new drug development

Physicians and Pharma have long complained about the length of time for new drug approval by the FDA for clinical use.  Pharma is required to perform Clinical Trials, I, II, and III to test for toxicity, effectiveness, and possible side-effects. Various amounts are quoted for the process of approval.  These add significantly to the costs of biochemical and pharmacological production. Health Affairs and the Robert Wood Johnson Foundation describes a new expedited drug development pathway designed to speed up the Food and Drug Administration's (FDA's) premarketing approval process for drugs and devices that treat serious or life-threatening conditions. Created under a 2012 law, the Food and Drug Administration Safety and Innovation Act (FDASIA), a drug may be designated a "breakthrough therapy" if it shows far more promise over comparable treatments already on the market. At that point, the FDA will initiate a special rapid approval process. The pharmaceutical industry has responded positively to this law, and as of last month the FDA has received 178 requests for this designation. The law, whose full impact will not be known for several years, carries significant implications for approaches to clinical development, patient access to new drugs, and the drug regulations process itself.

Social Media Response to Release of Medicare Payments to specific Physicians

Josh Seidman discusses the implications of the social media response to the release of information on Medicare payment to specific physicians. This is the first time physician reimbursement amounts have been released to the public.

Primary care physicians are suffering "agenda overload"

ABOUT HEALTH AFFAIRS:

Health Affairs, published by Project HOPE, is the leading journal of health policy. The peer-reviewed journal appears each month in print, with additional Web First papers published weekly at www.healthaffairs.org.

Laudable but excessive prevention and public health initiatives have been added to the work load of primary physicians who are already hard-pressed to comply with a multitude of bureaucratic requirements. These additonal requirements may have a negative effect on primary care duties.

Receive new Health Affairs article alerts in your choice of format:

• E-mail alerts of new articles and tables of contents from Health Affairs.
• RSS feed for new article headlines delivered to your Web site or reader.
• Sunday UpDate: a weekly e-mail summary of what's new in Health Affairs.
• Follow Health Affairs updates on Twitter.

Meningitis Outbreak .....A Near Miss

I doubt if the family's and students at UCSB or Princeton who had Type B meningitis don't feel it was a "near miss"  For them regardless of the low risk of contracting the type B strain when it occurs to you statistics mean nothing.

Meningitis is a particularly challenging illness to diagnose and treat early.  It often presents as a mild sore throat which quickly escalates into a high fever, mental changes, stiff neck and rash.  Unless intervention occurs early loss of limbs, and other severe complications can arise.  Sore throats and headaches and fever are ubiquitous at any school in the fall and winter.

Meningitis  can be caused by multiple etiologies, (fungal,parasites, viral, and bacterial).  Multi-valent and univalent vaccines have been developed.

Nearly 2,000 Princeton University students lined up for shots Monday as the New Jersey school began offering an emergency vaccine aimed at halting an outbreak of potentially deadly meningitis that has sickened eight since March, health officials said.

That's about one-third of the estimated 6,000 students and others expected to get injections this week of an imported drug approved in Europe, Australia and Canada, but not in the U.S. It protects against the B strain of meningitis — the bug behind the illnesses — which isn’t covered by the vaccines that most college students already receive.

Statistics can prove almost anything. Logic and probability are terms that 'QUANTS" use.  Quants are the statisticians that develop and consult algo's (algorithms) .  Algorithms have always been important in the insurance world, engineering, weather forecasting and much more.

Algorithms have not so quietly slipped into the mainstream of medicine in terms of managed care, cost,risk factors for disease and in basic research. Most of us remember the 'P' factor as the liklihood something would happen by chance in an experiment.  It indicated how many times the event would occur by chance if repeated 100 or1000 times

The non-availability of Meningitis type B vaccine was due to one of those algorithms that determined it was NOT COST EFFECTIVE to import Bexsero into the  U.S.  It was deemed by decision makers that it would be too expensive to run through the U.S. FDA investigative new drug application process.  For most really new drugs this can be one or more years.

The drug manufacturer, of Bexsero, a vaccine licensed only in Europe and Australia that protects against meningitis B, a strain not covered by the shots recommended for college students in the U.S.   had to apply to the FDA to initiate the process (started in October 12-13  at about the same time as the first cases at Princeton and UCSB were diagnosed.

The first doses were given at Princeton  December 9, 2013.  The process obviously was fast-tracked but it required  two months because of the arduous bureaucracy.

The take-aways here are:
   
1. Many preventive measures are calculated on the basis of similar algorithms
2..A centralized authority such as the Affordable Care Act and the proposed IPABs  establish many         procedures and/or treatments that are acceptable, not recommended, or 'not covered' by the affordable   care act as a standardized practice, all based upon statistical algorithms.
3. Diverting from a standard practice, or an emergency practice can be delayed considerably by these processes.

Inevitably the physician has the moral and the ethical responsibility for the decision.  The patient's welfare is the ultimate arbiter.

Our health system is becoming dangeously close to interfering with a physician's hippocratic oath.

mHealth----More Necessary Regulations

Much of the big news in health IT this year came out of the Office of the National Coordinator for Health IT. ONC -- along with CMS -- is in charge of overseeing the widespread adoption of EHRs through the meaningful use program. After years in the works, the first phase of that program is wrapping up right now.

The past several years were almost frantic for HIT and ONC, with meaningful use standards, interoperability standards, incentive funding and a succession of creative and dynamic national coordinators, each with their own focus on what needed to be accomplished.

Unlike other Executive departments, Medicine has been fortunate to have a clear path, relatively clear goals, and minimal political divisiveness......all to the benefit of our patients.

mHealth has had an explosive growth in mobile applications for iOS and Android.  The hardware form factors are multiple with stiff competition and new hardware offerings almost monthly.

Growth and competition are plentiful and numerous manufacturers (Nokia, Windows, Google, Motorola,iPhone) in smartphone or pc tablet form.  In many cases EHR vendors have rapidly developed a mobile app portal.  The acceptance rate has been high for those who are tech savy.  Despite the potential vulnerability to a security breech and all that HIPAA stands by on the sidelines ready to pounce with a hefty penalty. The plain truth is that these applications and hardware offer so much to efficiency a way needs to be found quickly to certify HIPAA compliance for each application and device.

Not withstanding this urgent need there have been several attempts to regulate this market. FDA, FTC, FCC,  and HHS have all been mentioned. Suffice it to say that regulatory agencies are pressed to stay current with new hardware and devices.

Why, How and Which  Mobile Health applications need regulation?

In an article (blog post) in June 20012 I discussed  Five Reasons Why Digital Health Technologies Need FDA Oversight   Now the FDA is in the process of forming a mobile health division to study, certify and authenticate applications.  A new workgroup in HHS has been formed,

According to mobiHealthNews;

"The workgroup’s efforts will likely end up affecting the regulation of mobile health and health IT. According to HHS, FDASIA requires Sibelius, with the ONC and the FCC, to “develop a report that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework for health IT, including medical mobile applications, that promotes innovation, protects patient safety, and avoids regulatory duplication.”  The new workgroup’s input will feed into that report.

According to Brian Ahier,

"As a general matter FDA regulates all medical devices and FCC regulates devices that utilize electromagnetic spectrum - i.e. broadcast devices. So with regard to mobile health devices - sensors, applications, systems - FDA regulates any given device as a medical device while FCC regulates the device as a communications device. 

Recognizing the potentially overlapping jurisdiction in digital health, in 2010 the agencies entered into a Memorandum of Understanding "to promote collaboration and ultimately to improve the efficiency of the regulatory processes applicable to broadband and wireless enabled medical devices."

Last month FCC announced its mobile body area network (MBAN) proposal, which would allocate electromagnetic spectrum for personal medical devices (see link below). The allocated spectrum would be used to form a personal wireless network, within which data from numerous body sensors could be aggregated and transmitted in real time."

Representative Marsha Blackburn (R-TN) and others introduced The Software Act.which will act to build a cohesive multi-agency over view of mHealth.