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

The American Health System is Shameful

Guest Post from Quora

What do foreigners admire about the U.S. healthcare system? What part of their healthcare do they wish was more like the United States’?

Steve Grocott, Political insider /investor / businessman

Answered 21h ago

I am a American who largely lives outside of the US, I split my time between New Zealand, Australia and the US. I buy travellers health insurance when going home for a few months each year. I have used the universal healthcare in about 5 countries over the years. Even as a tourist it is usually free or heavily subsidised and of good quality. I have come to think the concept of a user pays healthcare system is about as useful as a user pays police system. The benefits to the economy, society and community of free healthcare far outweighs the profit system used in America.

I can’t imagine any country that looks at the American healthcare system, and thinks “we should only offer drugs and surgery to those than can afford it, we should send debt collectors after victims of accidents we have treated while they are still recovering “ it boils down to what kind of society you wish to live in. Millions of tourists each year are put off by the requirement to purchase additional Healthcare on top of flights and accommodation when visiting America. The only reason to keep the system is the huge profits made by drug companies, hospitals and insurance companies.

The Revised Declaration of Geneva: The Modern-Day Physician’s Pledge

A newly revised version of the Declaration of Geneva was adopted by the World Medical Association (WMA) General Assembly on October 14, 2017, in Chicago.

As the contemporary successor to the 2500-year-old Hippocratic Oath, the Declaration of Geneva, which was adopted by the World Medical Association (WMA) at its second General Assembly in 1948,¹ outlines in concise terms the professional duties of physicians and affirms the ethical principles of the global medical profession. The current version of the Declaration, which had to this point been amended only minimally in the nearly 70 years since its adoption, addresses a number of key ethical parameters relating to the patient-physician relationship, medical confidentiality, respect for teachers and colleagues, and other issues. A newly revised version adopted by the WMA General Assembly on October 14, 2017, includes several important changes and additions (Supplement).

• AS A MEMBER OF THE MEDICAL PROFESSION:
• I SOLEMNLY PLEDGE to dedicate my life to the service of humanity;
• THE HEALTH AND WELL-BEING OF MY PATIENT will be my first consideration;
• I WILL RESPECT the autonomy and dignity of my patient;
• I WILL MAINTAIN the utmost respect for human life;
• I WILL NOT PERMIT considerations of age, disease or disability, creed, ethnic origin, gender, nationality, political affiliation, race, sexual orientation, social standing, or any other factor to intervene between my duty and my patient;
• I WILL RESPECT the secrets that are confided in me, even after the patient has died;
• I WILL PRACTISE my profession with conscience and dignity and in accordance with good medical practice;
• I WILL FOSTER the honour and noble traditions of the medical profession;
• I WILL GIVE to my teachers, colleagues, and students the respect and gratitude that is their due;
• I WILL SHARE my medical knowledge for the benefit of the patient and the advancement of healthcare;
• I WILL ATTEND TO my own health, well-being, and abilities in order to provide care of the highest standard;
• I WILL NOT USE my medical knowledge to violate human rights and civil liberties, even under threat;
• I MAKE THESE PROMISES solemnly, freely, and upon my honour.

For 2500 years The Hippocratic Oath has been referenced as the 'gold standard' of medical ethics.  

HIPPOCRATIC OATH: MODERN VERSION

I swear to fulfill, to the best of my ability and judgment, this covenant:

I will respect the hard-won scientific gains of those physicians in whose steps I walk, and gladly share such knowledge as is mine with those who are to follow.

I will apply, for the benefit of the sick, all measures [that] are required, avoiding those twin traps of overtreatment and therapeutic nihilism.

I will remember that there is art to medicine as well as science, and that warmth, sympathy, and understanding may outweigh the surgeon's knife or the chemist's drug.

I will not be ashamed to say "I know not," nor will I fail to call in my colleagues when the skills of another are needed for a patient's recovery.

I will respect the privacy of my patients, for their problems are not disclosed to me that the world may know. Most especially must I tread with care in matters of life and death. If it is given me to save a life, all thanks. But it may also be within my power to take a life; this awesome responsibility must be faced with great humbleness and awareness of my own frailty. Above all, I must not play at God.

I will remember that I do not treat a fever chart, a cancerous growth, but a sick human being, whose illness may affect the person's family and economic stability. My responsibility includes these related problems, if I am to care adequately for the sick.

I will prevent disease whenever I can, for prevention is preferable to cure.

I will remember that I remain a member of society, with special obligations to all my fellow human beings, those sound of mind and body as well as the infirm.

If I do not violate this oath, may I enjoy life and art, respected while I live and remembered with affection thereafter. May I always act so as to preserve the finest traditions of my calling and may I long experience the joy of healing those who seek my help.

—Written in 1964 by Louis Lasagna, Academic Dean of the School of Medicine at Tufts University, and used in many medical schools today.

Ethical Principles for Medical Research

The Revised Declaration of Geneva: The Modern-Day Physician’s Pledge | Law and Medicine | JAMA | The JAMA Network

Predict Asthma Conditions using an App

Propeller launches API that predicts local asthma conditions

“Smart inhaler” player Propeller Health is rolling out an application programming interface (API) that provides information on local asthma conditions.

The service, dubbed Air, uses machine learning to analyze millions of days of anonymized asthma-related data to forecast the potential effects of the local environment on people’s breathing, Propeller said in a statement. These data include when people have asthma symptoms and the environmental conditions at the locations and times they have symptoms.

Propeller markets a sensor that attaches to an inhaler and tracks where a patient uses his or her inhaler. The sensor then transmits this data via Bluetooth to a smartphone, where an app analyzes where, when and why a patient took his or her medication.

GlaxoSmithKline and Propeller Health are expanding their R&D partnership, inked in 2015, into a commercial one, under which both companies will be able to commercialize Propeller’s digital respiratory health management system for use with Glaxo’s Ellipta inhaler.

Propeller’s platform includes a sensor that attaches to various inhalers and tracks when patients take their medication. These data are sent via Bluetooth to a smartphone app, which uses machine learning to help patients and physicians better understand what may be causing asthma or COPD symptoms.

In December 2015, Propeller signed on to create a custom sensor for GSK’s Ellipta inhaler, to be used in clinical studies of asthma and COPD. A year later, the company notched an FDA clearance for the use of its platform with Ellipta, its eighth FDA clearance.

RELATED: Propeller Health's latest smart inhaler deal: Novartis' Breezhaler

"We are excited to be working closely with GSK to make the sensor for the Ellipta inhaler available in our commercial programs, and for the first time, as part of commercial pilots with GSK outside the US," said Propeller CEO David Van Sickle in a statement. "Companion digital experiences simplify and personalize the management of chronic respiratory disease, and help ensure individuals and their physicians realize the benefits of inhaled medicines."

Revolutionizing the Delivery of Care for ED Patients

In the 7 years since the passage of the Affordable Care Act, the number of Emergency Department (ED) visits has steadily increased while the number of EDs has fallen —  resulting in increased pressure on hospitals. Consequently, health care systems find themselves challenged to develop innovative ways of accommodating this growing volume while still providing high-quality and efficient medical care. The surge in smartphone use, combined with the advancement of provider-focused telehealth capabilities, has created an opportunity for systems to leverage technology in service of these goals. Today, the American Telemedicine Association reports that there are currently 200 active telemedicine networks, with over half of U.S. hospitals now using some form of telemedicine.

This is the context in which NewYork-Presbyterian (NYP) and Weill Cornell Medicine jointly launched their cutting-edge Emergency Department Telehealth Express Care Service (ECS). This innovative program has enabled us to provide a much better experience for low-acuity patients presenting to the EDs at NewYork-Presbyterian/Weill Cornell Medical Center and NewYork-Presbyterian/Lower Manhattan Hospital. Building upon this success, NYP has recently expanded ECS to the Columbia-affiliated NewYork-Presbyterian/Columbia University Medical Center and NewYork-Presbyterian/Allen Hospital campuses, and similar expansions at the NYP regional hospitals are expected in the coming months.

NYP OnDemand ED Express Care Service

This was the context in which we conceived and launched the ED Telehealth Express Care Service for low-acuity patients presenting to the ED. To operationalize this program, we first identified the conditions that would be amenable to treatment via telehealth, including minor rashes, sprains and contusions, upper respiratory infections, wound checks, suture removals, and tetanus immunizations. Next, we developed our workflow: after an initial RN triage and medical screening exam by a physician assistant or nurse practitioner, qualifying ED patients are offered a real-time video visit with one of our board-certified Emergency Medicine faculty physicians.

This ECS consultation is conducted in a private patient room with comfortable lounge chairs and a monitor, and the patient is connected to a physician located in a separate room. Patients are interviewed by the physicians remotely while they are in the private room and then directly discharged from the room. Discharge paperwork is printed directly in the room and prescriptions are called in electronically to the patient’s pharmacy. Importantly, the remote physician covers both Express Care sites, offering us economies of scale by having a single “server” for multiple queues.

This has been a pilot program at NYP and is undergoing evaluation for effectiveness, cost and reimbursement issues.  At this time the visit is billed as an ED event, which reimburses greater than a telemedicine or office visit.

This usage of telehealth is a unique application of telemedicine.  A single telehealth physician could evaluate patients from many different EDs.

The Future of the Neurologic Examination | Medical Education and Training | JAMA Neurology | The JAMA Network

Has the development of high tech obsoleted the neurologic physical examination?  

Michael J. Aminoff, MD, DSc, FRCP¹

Author Affiliations

JAMA Neurol. Published online October 2, 2017. doi:10.1001/jamaneurol.2017.2500

The development of precision medicine, gene therapies, advanced imaging techniques, novel monitoring systems, ingestible or injectable sensors, and remote medical care (telemedicine) is leading to remarkable changes in health care. But the increasing ability to deliver care remotely will also reduce physical interactions between physicians and patients, with implications that have barely been explored.

There is no doubt that the art of the neurologic examination is already being lost, as some of these advances come to supplant rather than complement the clinical examination. Indeed, the modern trainee neurologist can perhaps be pardoned for wondering about the place of the clinical examination when, for example, magnetic resonance imaging or computed tomography can detect, localize, and provide prognostic information about a central lesion in just a few minutes and genetic studies can diagnose certain disorders regardless of the clinical findings. The neurologic examination requires time, patience, effort, and expertise and may have to be performed in difficult or unpleasant circumstances, whereas an imaging or laboratory study simply requires completion of a request form and the responsibility is passed to a colleague. Why, then, examine the patient?

This gradual technical change will cause a paradigm shift for authorization of high cost imaging studies which have for to with required an A-OK from insurance companies. It makes sense when it comes to accuracy and the speed of correct diagnosis.

Implantable Vagus Nerve Stimulation for Epilepsy

This is also true of other organ systems, where imaging and/or genetic testing are used.

The Future of the Neurologic Examination | Medical Education and Training | JAMA Neurology | The JAMA Network