Medtronic’s tiny neurostimulator gets CE mark for multiple indications

Another tool for pain management and avoidance of opioid addiction. President Trump's announcement about the campaign against opioid addiction comes on the failed programs such as the War on Drugs.  Why are opioids so addicting ?  Because they are so . effective in blocking pain and allowing people to function in the face of chronic pain.  Success in decreasing opioid addiction will only come with a successful drug that manages pain as well as opioids, and proper management of pain with alternative treatments.  Medtronic's system may help with delivery of micro quantities to the spine and/or neurostimulation to block pain transmission from end receptors to pain centers in the CNS.

Medtronic’s Intellis platform grabbed a CE mark for peripheral nerve and spinal cord stimulation. With the nod, the device is now cleared to treat chronic, intractable pain of the trunk, posterior trunk and limbs.

The Intellis system, which earned the FDA green light in September, is the world’s smallest fully implantable spinal cord stimulation neurostimulator, the company said. The system includes the implant, a patient programmer and a recharger. A physician programs the therapy wirelessly, using a Samsung tablet.

The device is designed to help physicians make better treatment decisions. In addition to delivering pain-relieving neurostimulation, it records patient activity, such as their body position and how they self-administer their treatment, around the clock.

"Rather than rely on patient-reported data, the enhanced activity tracker of the Intellis platform provides real-time data that offers more visibility into quality of life changes," said Jean-Pierre Van Buyten of AZ Nikolaas Hospital in Belgium, where the first European patient received the implant. "Better understanding a patient's experience can lead to a more informed conversation that can help me maximize their pain relief.”

Non-opioid pain treatments are becoming increasingly important—the number of opioids prescribed and sold in the U.S. alone has quadrupled since 1999. While opioids used to be prescribed sparingly—after a surgery or injury, or for managing cancer-related pain—there has been a “dramatic increase” in their use for chronic, non-cancer pain, according to the CDC.

Stem Cell Therapy for TBI | UCSF

Stem Cell Therapy for TBI | UCSF

Due to technical details the formatting of this post is abnormal. I apologize for it.

Latest TBI Research Studies

A clinical trial is a research study designed to assess the safety and efficacy of a treatment or intervention. We are currently helping people see whether they are eligible for a clinical trial of modified stem cell therapy for TBI called STEMTRA (STEM cell therapy for TRAumatic brain injury).

STEMTRA Study

Stem cells are cells that have the potential to develop into different types of tissue within the body. The STEMTRA Study, a Phase II clinical trial, is working to understand whether stem cells taken from adult bone marrow can be used to help improve function after a TBI.

The STEMTRA Study is designed to test the safety and efficacy of a modified stem cell therapy that is administered directly to the injured brain through a neurosurgical procedure. Participants will have approximately seven follow-up visits for additional examinations, questionnaires, video recordings, and brain scans over the following 12 months.

Interested in participating? Take the TBI Survey to let us know. UCSF will review your survey information and if you qualify, we will help you get in contact with study personnel who can answer any questions you may have about the study and further pre-screening.

A New Impact on Public Health . Citing The Bible, The EPA Just Changed Its Rules For Science Advisers

The Environmental Protection Agency announced on Tuesday afternoon sweeping changes to who can advise the agency on its research and regulatory priorities, opening the door to more industry participation.

Effective immediately, scientists who receive EPA funding cannot serve on the agency's three major advisory groups. Some Republican lawmakers have been pushing for similar changes to the agency's advisory boards for years.

"We want to ensure that there’s integrity in the process and that the scientists that are advising us are doing so without any type of appearance of conflict of interest," EPA head Scott Pruitt said at a press conference announcing the directive.

Pruitt used a story from the Book of Joshua to help explain the new policy.

On the journey to the promised land, "Joshua says to the people of Israel: choose this day whom you are going to serve," Pruitt said. "This is sort of like the Joshua principle — that as it relates to grants from this agency, you are going to have to choose either service on the committee to provide counsel to us in an independent fashion or chose the grant. But you can’t do both. That’s the fair and great thing to do."

"Frankly, this directive is nuts," Al Teich of George Washington University wrote in an email to BuzzFeed News.

"There is an important role for citizen advisors who are not experts in a scientific field and who represent various constituencies on advisory committees," wrote Teich, a research professor of science, technology, and international affairs. "But they should complement, not replace the experts. Disqualifying the very people who know the most about a subject from serving as advisors makes no sense."

The change calls into question EPA's ability to protect the country, according to Rush Holt, chief executive officer of the American Association for the Advancement of Science. "We question whether the EPA can continue to pursue its core mission to protect human health and the environment," Holt said in a statement issued Tuesday.

Pruitt also announced the new chairs of EPA's advisory committees on Tuesday.

Michael Honeycutt, a controversial toxicologist from Texas, is the new head of EPA's Science Advisory Board, which provides scientific counsel to the agency's top official. Honeycutt once told Congress he didn't agree with the EPA's toxic evaluation for mercury, and he's argued against the agency's ozone standards, according to a 2014 investigation by InsideClimate News and the Center for Public Integrity.

Tony Cox is now the chair of EPA Clean Air Scientific Advisory Committee, which offers technical input on the nation's air standards. Cox is president of Cox Associates, a Denver-based risk analysis firm.

And Paul Gilman is the new leader of the Board of Scientific Counselors, which provides input on the EPA's research agenda. Gilman works at the waste management company Covanta Energy and served as an EPA assistant administrator during the Bush administration.

These three advisers attended today's EPA press conference and stood behind Pruitt as he signed the new directive.

Some lawmakers who have been highly critical of EPA regulations also attended the briefing.

"Today’s announcement shows that we have an administrator with common sense, commitment, and courage," Rep. Lamar Smith, a Texas Republican who chairs the House Science Committee, said at the press briefing.

Smith's committee passed a bill called the EPA Science Advisory Board Reform Act earlier this year that would have put in place some of these same restrictions on EPA advisers. The legislation has not yet passed both houses. The new policy enables "us to put the principles of this bill into practice," Smith said.

Citing The Bible, The EPA Just Changed Its Rules For Science Advisers

Are Payers the Leading Cause of Death in the United States? | Medpage Today

Are Payers the Leading Cause of Death in the United States? | Medpage Today

California's housing crunch is exacerbating a Public Health crisis -- a deadly hepatitis A outbreak among the homeless - The Washington Post

California's housing crunch is exacerbating a public health crisis -- a deadly hepatitis A outbreak among the homeless - The Washington Post

How is San Diego facing the challenges of Homelessness and Hepatitis A ?

Forum for Homelessness

The Outbreak of Hepatitis A

How to help the  Homeless .  Donate

AHF Offers Free Hepatitis A Vaccinations .  San Diego County

Your Local Health Department provides information about Hep A vaccinations. The free program is funded by the Federal Government via emergency funds through your local and/or state Dept of Health

Are Doctors wasting your precious time in their waiting room, and then rushing you through the examination?

A friend of a friend was quite upset about having to wait for prolonged periods of time in a physician's waiting room

As a physician , what I hear most is that patients  have to wait in the waiting room for etended waits, then in the exam room like our time doesn't matter, then the doctor pops in for a few minutes.  

What do you do while waiting? Read old magazines? (if your HMO doctor even has books or reading materials in the waiting room.}

Studies have shown 'health literacy' is a key ingredient for compliance, improved outcomes and understanding your health challenges. What better time than to have planned short courses, videos, and/or interactive augmented or virtual reality presentations for patients, which are entertaining as well as educational.  This  "empty" waiting room time is expensive and wasteful of patient's and doctor's time.  This time is ideal for guided education and can be modeled for precision medicine.  Precision medicine is not just high tech pharmacologic treatment. Precision medicine implies specific and accurate diagnosis and treatment.

2018 and Health 3.0 can provide this wealth of material quite . easily with electronic libraries available and synchronized by the electronic health record to select appropriate material for patients to read, or watch

Based upon diagnoses in your EHR educational monographs could automatically be printed for reading in the waiting room.

There exists the tools to overcome these deficiencies if recognized and addressed.  Are we applying technology where it is most needed?

This Infographic Shows How Only 10 Companies Own All The World’s Food Brands | GOOD Money

Just when you think there’s no end to the diversity of junk food lining supermarket aisles, an insanely detailed infographic comes along to set us all straight. Out of the hundreds of products at our disposal, only ten major corporations manufacture the bulk of what we toss in our shopping carts.

So whether you’re looking to stock up on anything from orange soda to latte-flavored potato chips, Mondelez, Kraft, Coca-Cola, Nestlé, PepsiCo, P&G, Johnson & Johnson, Mars, Danone, General Mills, Kellogg's, and Unilever own just about everything you could hope to buy. It seems that six degrees of separation theory has been proven after all, if only because we all drink Diet Coke every now and then.

Obviously, the horrors extend far beyond our own shattered daydreams. Massive corporations squash entrepreneurial diversity and make it nearly impossible for startups and small businesses to compete. According to Oxfam’s report, “The world’s largest food and beverage companies have a lot of power – but you have more. And because they’re not using theirs enough to help poor communities or the planet, you can use yours to change the way they do business.”

If you’re looking to avoid contributing to the Big 10 world takeover, try shopping at local farmers’ markets and maybe skip out on soda and highly processed foods altogether. Your body will thank you for it in the long run anyway.In order to visually elucidate that point, Oxfam International created a comprehensive infographic that reveals the extensive reach of the “Big 10” food and beverage companies. Unlikely ties between brands we largely don’t associate with one another show how easy it is to be misinformed about the American food system. For example, PepsiCo produces Quaker granola bars, and Nestlé makes Kit Kat bars but also frozen California Pizza Kitchen pies. To the surprise of many, Pineapple Fanta isn’t sourced straight from the mythical Fanta Islands, but canned right alongside Barq’s root beer at the Coca-Cola factory.

This Infographic Shows How Only 10 Companies Own All The World’s Food Brands | GOOD Money

Blood test can effectively rule out breast cancer, regardless of breast density:

 An important advancement in breast cancer detection in women with dense breast imaging.

Dense breast tissue: What it means to have dense breasts

Dense breast tissue is detected on a mammogram. Additional imaging tests are sometimes recommended for women with dense breasts.

By Mayo Clinic Staff

If a recent mammogram showed you have dense breast tissue, you may wonder what this means for your breast cancer risk. Doctors know dense breast tissue makes breast cancer screening more difficult and it may increase the risk of breast cancer.

In the United States, laws require doctors in some states to inform women when mammograms show they have dense breasts. But just what women should do in response isn't clear.

What is dense breast tissue?

Dense breast tissue refers to the appearance of breast tissue on a mammogram. It's a normal and common finding.

Breast tissue is composed of milk glands, milk ducts and supportive tissue (dense breast tissue), and fatty tissue (nondense breast tissue). When viewed on a mammogram, women with dense breasts have more dense tissue than fatty tissue.

On a mammogram, nondense breast tissue appears dark and transparent. Dense breast tissue appears as a solid white area on a mammogram, which makes it difficult to see through.

Ref:

Breast density does not impact the ability of Videssa® Breast to detect breast cancer in women under age 50

This information is intended only as general, and patients must confer with their physician for interpretation of images and followup testing and/or treamtent

Blood test can effectively rule out breast cancer, regardless of breast density: With over a 99 percent negative predictive value, a liquid biopsy test can help clinicians manage difficult-to-diagnose dense breast patients -- ScienceDaily

Is the free healthcare system in Canada ineffective?

Is the free healthcare system in Canada ineffective?

Steve Murdoch, worked at Sun Life Financial Canada (1996-2014)

I live in Canada.. The biggest misconception is that Canada has long wait times for life threatening events. This is not true at all. For most elective surgeries such as arthroscopy on your knee or even a full knee replacement etc., you will wait. If you are diagnosed with cancer and need surgery tomorrow, you will get it. If we are under age 65 we still pay for prescription drugs but rules differ by province.

Health care costs per capita in the US are more than 50% higher than anywhere else in the world (according to WHO). From my perspective, I blame insurance companies and the litigation lawyers that defend them for the high costs. An American citizen who needs a knee replacement, for example, can fly to Panama stay in a state of the art hospital run by USA trained doctors and pay less than half for their surgery.

The real problem the US has to grapple with is not how to give universal health care but how to deal with the blow to the economy from the removal of 300+ million health insurance policies and a bunch of unemployed lawyers.

Sometime, somewhere, somehow, someone will have to rip the band aid off.

(4/1) Home - Quora

A Woman Went Blind After Stem Cells Were Injected in Her Eyes

Color photgraph of Retina Following Stem Cell Transplant

Last year, a 77-year-old woman traveled to a clinic in Georgia to have stem cells injected in her eyes. She came in hope of a cure—or at least something that could help her macular degeneration, which causes a dark spot to appear in the center of vision.

The procedure was supposed to work like this: The clinic would take fat from her belly, separate out stem cells that naturally occur in fat, and inject them into her eyes to regenerate damaged tissue. The procedure cost $8,900. It had not been approved by the Food and Drug Administration and was not covered by insurance. To pay out of pocket, she had to raise money on a crowdfunding site.

Her vision did not get better. It got much worse. Within three months, her retinas—the eye’s layer of light-sensitive cells—had peeled away from the rest of her eyes. As a result, she can only make out hand motions in her right eye and light in the left, according to a recent case report. She could no longer walk on her own.

In March, eye doctors based primarily at the Bascom Palmer Eye Institute in Miami had published a widely covered report describing three eerily similar cases: Three elderly women with macular degeneration got stem cells derived from their own fat injected into their eyes at a different stem-cell clinic in Florida. The same thing happened: Their retinas became detached, and they went blind. The doctors ended up examining the 77-year-old woman too, which led to the recent case report describing her condition.

And there are likely even more cases. Since writing the first report, says Ajay Kuriyan, an author on the report and now a retinal specialist at the University of Rochester, eye doctors around the country have come forward with similar stories of stem-cell injections gone awry. They are now preparing an article describing the additional cases.

“It’s just not a professional thing to take an unproven intervention and inject it in both eyes.”

A precautionary note:

1. No competent ophthalmologist treats both eyes simultaneously, even with approved treatments.
2. All credible treatments have been studied with a verifiable, repeatable study approved by the FDA.

Always ask the treating physician for scientific peer reviewed articles.
Always ask for a written consent form.  It should list all possible side effects and complications. This is an accepted standard of care.  Absent this document the provider is guilty of malpractice, and it would be indefensible in court.

Always ask your physician for a referral to a local ophthalmologist, (BOARD CERTIFIED) for his opinion.

The FDA has drafted guidelines on how to oversee stem-cell clinics. The agency says stem cells do not have to be regulated as drugs as long as clinics follow certain standards, like if they only minimally manipulate the cells and don’t change their purpose in the body. For example, transferring fat from the belly to breasts would not fall under FDA purview because the fat is still acting as fat. But if stem cells are being separated from fat and then injected to treat a disease, then the FDA may have reason to step in.

Remember if it sounds too good to be true, it probably is not.

New York Times Article

The National Eye Institute and the National Institute for Health fund many of these studies.

Clinical Trials lists all current research and the phase of study.

1. Clinical Study of Subretinal Transplantation of Human Embryo Stem Cell Derived Retinal Pigment Epitheliums in Treatment of Macular Degeneration Diseases

2. Treatment of Dry Age Related Macular Degeneration Disease With Retinal Pigment Epithelium Derived From Human Embryonic Stem Cells

3. Study of Subretinal Implantation of Human Embryonic Stem Cell-Derived RPE Cells in Advanced Dry AMD

Stem cell treatments are successful for specific disease. It is not a generic or 'miracle' panacea.

Gary M. Levin is a Board Certified Ophthalmologist.  He blogs regularly on topics related to health issues, diseases and health reform. Comments are welcome.

The View from Here

The View from Here

One of my other lesser known blogs is "The View from Here".  My topics there are in a slightly different realm.  I was reviewing it last night and came across several germane topics for Health Train Express.

When the Doctor Doesn’t Look Like You (or me)

So, your doctor doesn't look like you ?  Don't sweat it !

For more than 50 years, international medical school 

graduates have filled the gaps in the physician work force

 in the United States. Currently, they make up fully 

one-quarter of all practicing physicians, and 

although a majority 

are foreign-born, approximately 20 percent are 

American citizens who have chosen to go abroad, most 

notably to the Caribbean, for medical school.

Regardless of whether they are United States citizens, 

all international graduates must go through an arduous 

regulatory process before practicing in this country, a 

process that includes verification of medical school 

diplomas and transcripts, residency training in 

American hospitals and the same national three-

part licensing exams and specialty tests that their 

medical school counterparts in this country take. 

Many go on to choose specialties or work in the rural 

and disadvantaged geographic locations that their 

American counterparts shun. International graduates, 

for example, now account for nearly 30 percent of all 

primary care doctors, a specialty that has had increasing 

difficulties attracting American medical 

students...........................

Now researchers from the Foundation for Advancement of

 International Medical Education and Research in 

Philadelphia have published the first study incorporating 

new research methods for evaluating the performance 

of large groups of physicians. And it turns out that contrary 

to certain individuals’ worst fears, accent or nationality 

did not affect patient outcomes. Rather, the main factor 

was being board-certified: completing a full residency at an 

accredited training program, passing written and, depending 

on the specialty, oral examinations, and having proof of 

experience with a defined set of clinical problems and technical 

procedures.

Foreign medical graduates also tend to 'cluster' choosing to practice in like minded communities, Asian, Phillipino, Latino, Jewish, and other minorities. These demographics also tend to refer internally when possible.

Racial prejudice exists even in health care.

Teaching Doctors the Art of Negotiation - The New York Times

Doctors negotiate every day, almost constantly — sometimes dramatically, often imperceptibly. They hold family meetings to resolve sensitive end-of-life issues. They address barriers to medication adherence. They encourage patients to receive uncomfortable screenings like colonoscopies and mammograms. They refuse treatments that are requested but not medically indicated. Yet they receive almost no formal instruction in how to do so.

Dealing with medical colleagues creates an additional layer of negotiating complexity—especially in busy academic centers with competing demands on specialists’ time. Medicine is increasingly a team sport. In 1970, only about 2.5 full-time clinical staff cared for the average hospital patient; today, that number is greater than 15.

Doctors consult other doctors many times a day to discuss potential treatment options and decide on the best course of action. They work closely with residents, students, nurses, physician assistants, care coordinators and others to implement those plans. At each interaction, opportunities for collegiality and efficiency — or rancor and resentment — abound. That can mean the difference between a timely or delayed blood draw, accepting or refusing a consult, or getting those biopsy results today versus tomorrow.

Recognizing the importance of negotiation, medical schools are starting to invest in communication training for students — and it seems to be paying off. Research suggests communication training can improve patient adherence, diagnostic accuracy and chronic disease management. But good communication, by itself, is only part of the solution. We need to teach doctors how to negotiate.

Negotiation, in this context, is not about winning or losing, or haggling over price or scare resources. It’s about exploring underlying interests and positions to bring parties together in a constructive way. It’s about creative, innovative thinking to create lasting value and forge strong professional relationships. It’s about investigating what is behind positions that may seem irrational at first to understand the problem behind the problem.

The medical profession is no longer one in which doctors dictate a given treatment course to patients, who are then expected to follow it. Rather, clinicians and patients deliberate about treatment options, weigh costs and benefits together, and determine the best course of action. This approach requires eliciting patient concerns and addressing underlying fears to arrive at the most effective strategy for maximizing health and well-being. As diseases like H.I.V. and some cancers that were once uniformly fatal become chronic conditions, and a greater diversity of treatment options becomes available, the ability to negotiate long-term care plans will only grow in importance.

Healthcare Stole the American Dream - Here’s How We Get it Back | Dave C..., Bay Area Cancer Patient.. 

Health Train Express   Remove Healthcare Stole the American Dream - Here’s How We Get it Back | Dave C... 17 hours ago  .  Save  .  Twitter  .  Facebook Healthcare Stole the American Dream - Here’s How We Get it Back |   TEDx TalkThanks to Rob Lambert M.D. a pioneer in direct primary care for bringing this to m.. Read More → Bay Area Cancer Patient Confronts and Embraces His Right to Die | State of Health | KQED News Something all patients should know if you live in California and five other states, Oregon,  District of Columbia,Vermont, Washington and California. It is an ..Read More → Best preventive care? Get vaccines, and don't smoke - 20 hours ago  .  Save  .  Twitter  .  Facebook Doctors giving regular checkups will get the most bang for their buck if they advise adults to quit smoking, convince teens to never start, and keep children