Artificial pancreas could be 'holy grail' for Type 1 diabetics

Artificial pancreas could be 'holy grail' for Type 1 diabetics - CNN.com

By Saundra Young, CNN Medical Senior Producer
updated 8:31 AM EST, Sat November 26, 2011

A trial patient for the Juvenile Diabetes Research Foundation’s Artificial Pancreas Project tests the device.

(CNN) — Kerry Morgan was just 3 years old when she participated in her first clinical trial for type 1 diabetes prevention. She didn’t have the disease, but her 7-year old sister did and there was concern that she might develop it, too. During the trial she was given one shot of insulin a day in the hope that it would stave off the disease, but a year later, she was officially diagnosed.

“I remember a lot of things changed.” Morgan said. “I went from having juice every day and M&Ms to not having sugar at all. I remember getting shots every day, finger pricks, my parents had to hold me down.”

School, she says was difficult. “You had to let teachers know what was going on. You had a special relationship with the nurse because she had to check your blood sugar every day before going to lunch.”

At 14 she entered a second trial, this one at the University of Virginia, for a continuous glucose monitoring system called The Navigator. It was at UVA that she first learned about the artificial pancreas. A high school senior at 18 now, she has participated in four clinical trials and two have involved artificial pancreas systems.

“It was awesome. I’ve never done anything quite like it before. For the two days that I was on the artificial pancreas I experienced normalcy. I wasn’t checking myself every five seconds and giving myself insulin because it was doing it for me.”

In type 1 diabetics, the pancreas makes very little or no insulin, a hormone that controls glucose levels, or the amount of sugar in your blood. Patients must constantly check their levels throughout the day, determine how much insulin they need to lower their blood sugar and administer the proper amount using a pump or syringe. Drops or spikes in blood sugar can be extremely dangerous. If the level is too low — a condition called hypoglycemia — patients can experience shakiness, confusion, trouble speaking, seizures, even coma and death. A level that is too high — hyperglycemia — can cause excessive thirst, frequent urination and cardiac arrhythmia. Left untreated, hyperglycemia can lead to a number of serious complications including vision loss and nerve damage.

An artificial pancreas mimics the glucose regulating function of a healthy pancreas. The automated device features a sensor that’s placed under the skin that measures blood sugar. Information from this continuous glucose monitor is sent to a receiver and an insulin pump delivers insulin in controlled amounts. A glucose meter calibrates the sensor. Sophisticated software checks the blood sugar in the body and automatically provides the correct dose of insulin needed at the right time.

“When you have diabetes, every second you’re thinking about your blood sugar,” says Morgan. “You’re wondering if you’re high, if you’re low, if you’re OK, if you’re giving yourself enough insulin, if you’re not giving yourself enough insulin. With the artificial pancreas it takes that worry away because it’s doing it for you. It lets you know if something’s wrong. That way you’re not always worrying about your blood sugar.”

The device has not yet been approved by the U.S. Food and Drug Administration. In June the agency issued a draft guidance seeking input from the industry and researchers on an early version of the artificial pancreas, called the low glucose suspend system. It’s a backup for diabetics experiencing hypoglycemia. Patients still have to monitor their levels and give themselves insulin if necessary, but the low glucose suspend system temporarily reduces or stops the insulin flow in the event of an episode.

There are two types: A reactive low glucose suspend system that stops insulin infusion when a predetermined level has been reached, and a predictive low glucose suspend system that anticipates a hypoglycemic event based on the current blood sugar level and how fast those levels are falling.

Dr. Charles Zimliki chairs the FDA’s Artificial Pancreas Critical Path Initiative and he is a type 1 diabetic. Testifying before a Senate committee in June, he said the FDA is committed to seeing the device come to market but is proceeding with caution.

“While the potential benefits are enormous, an artificial pancreas system is considered a significant-risk device, meaning it presents a potential for serious risk to the health, safety or welfare of a patient. If not properly designed, use of an artificial pancreas device in an outpatient setting can place patients at significant risk, because the device controls the administration of insulin without the oversight of health care professionals.”

The FDA is expected to release new guidance for future generations of the artificial pancreas systems on December 1. The Juvenile Diabetes Research Foundation has been working closely with the FDA on the artificial pancreas. It says low glucose suspend systems have been in use in more than 40 countries for the last 2½ years and the process in the United States is taking much too long.

“Here in the U.S. we’re now almost three years behind and the first study to test these systems is just going to launch in the next month, which means it’s going to be another year or so before patients even have access,” said Aaron Kowalski, assistant vice president of treatment therapies for the foundation. “What JDRF is advocating for is to ensure that people here in the U.S. have access to these tools in a timely manner.”

The FDA says other countries have different regulatory systems in place that do not require the same safety and effectiveness data for a product of this level of risk.

Tom Brobson, a 51-year-old Christmas tree farmer and the national director for donor relations at JDRF was diagnosed eight years ago with type 1 diabetes. “I think they’re getting hung up on better when good enough can do the job. You can’t get better until it’s out there being used. We know that technology isn’t perfect, but what we’re talking about are significant improvements and enhancements over what we have today that can significantly reduce the daily burden of living with this disease, improve quality of lives and save lives.”

Brobson has been participating in artificial pancreas clinical trials at UVA since 2007. “It’s been awesome, fantastic, frankly everything I could ever imagine it to be and then some,” he says. “The open question for me was could a computer system using off-the-shelf technologies do a better job of controlling my blood sugar than I was already doing for myself and the answer turned out to be overwhelmingly yes.”

Without it, Brobson says he has to spend every minute managing his diabetes. “I have to be my own pancreas 24 hours a day. Last thing at night, first thing in the morning and often in the middle of the night. When the artificial pancreas took over, that was a real power moment. It kept me perfect from 8 p.m. to 8 a.m. When the artificial pancreas took over moment to moment when it was actively assisting me in the management of my disease, it was a life changing moment and it was life changing because I didn’t have to think about my diabetes every moment of the day.”

Dr. Michelle Magee is an endocrinologist and director of the MedStar Diabetes Institute at Washington Hospital Center in Washington, D.C. “The data from other countries showed that the system could be used safely and effectively. It’s been somewhat disappointing that it has taken so long to get approval here.”

She says the long awaited system offers hope to patients. “For people with type 1 diabetes, the artificial pancreas has been kind of the holy grail of technology to support self management of diabetes. It’s not going to cure it, but it’s going to be a huge step in the right direction. Once it’s approved and can be used it will be fantastic.”

According to the Juvenile Diabetes Research Foundation, about 80 people a day are diagnosed with type 1 diabetes. Approximately 3 million Americans are living with the disease. Most of them only have healthy blood sugars 30% of the day. The foundation says it has spent $1.5 billion on diabetes research, $40 million of that on research on artificial pancreas systems.

“Our goal is to drive the development of artificial pancreas systems,” Kowalski said. “This could not only improve tremendously glucose control, and help reduce the risk of these terrible diabetes complications, it could also help people with diabetes live easier. The bottom line is diabetes is a 24 hour a day, 7 day a week, 365 day a year job and if we can make some of that easier that would be a huge step forward.”

Morgan agrees. “I think it’s superimportant, I think next to having a cure for diabetes it’s the big thing. Because it’s such an instrumental piece of equipment it can allow you to live closer to what we consider normal than anything that we have now.”



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How about a wireless pacemaker?

Next-Gen Cardiac Care Includes Wireless Pacemakers:
scientificamerican.com





WiCS: In the new pacemaker called the Wireless Cardiac Stimulation (WiCS) system, a wireless electrode replaces one or more leads. A conventional pacemaker is implanted just below the collarbone in the left side of the chest and sends out a signal through a lead running into the heart’s right side. The WiCS unit, implanted near the heart, wirelessly senses the pacemaker’s pulse via this lead; it then sends an ultrasonic signal to the wireless electrode on the left side, which converts the sonic energy into electrical energy to pace the left ventricle synchronously with the right. Image: Courtesy of Cambridge Consultants

Millions of pacemakers have been successfully implanted in the past half century to regulate erratic heartbeats, but the electrical leads, which connect the device to the heart, complicate the surgery and increase infection risks. The heart’s continuous and vigorous beating also creates strain on the leads and can damage them over time.

Now researchers seek to go wireless. In a new pacemaker called the Wireless Cardiac Stimulation (WiCS) system, a wireless electrode replaces one or more leads. California start-up EBR Systems, working with English technology-development firm Cambridge Consultants, recently announced their system was successfully implanted in 100 patients needing cardiac resynchronization therapy (CRT) during a series of human clinical trials in Europe. (Wireless signaling is not entirely new to pacemakers—doctors have for the past few years been able to communicate with them via the Internet or even smart phones.) CRT patients suffer from a type of chronic heart failure requiring both the left and right ventricles to be paced. Normally, such devices require the implantation of three leads, the trickiest of which is threaded through a complex route running from the right atrium, into the coronary sinus on the outside surface of the heart, and then to the left ventricle. In the new device, a small electrode inserted in the left side of the heart replaces one or more of the leads. In the system, a conventional pacemaker, implanted just below the collarbone in the left side of the chest, sends out a signal through a lead running into the heart’s right side. The WiCS unit, implanted near the heart, wirelessly senses the pacemaker’s pulse via this lead; it then sends an ultrasonic signal to the wireless electrode on the left side, which converts the sonic energy into electrical energy to pace the left ventricle synchronously with the right. Advances in low-power microelectronics and improved digital signal processing at high speed and low power enabled the system, says Andrew Diston, Cambridge’s director of global medical technology. The ultimate goal is to eliminate all wire leads, making the pacemaker easier to implant. Another goal is to integrate the functions of the conventional pacemaker and the WiCS into a single device. Wireless technology is notoriously tough on battery life. Diston says that most of the pacemaker’s battery—generally lasting seven or eight years before needing to be replaced—is still dedicated to monitoring the heart and deciding when to pace. The WiCS system has its own battery, and no modification to existing pacemakers is required, he added. Diston is hesitant to set a time frame for the system’s availability to the general public. WiCS continues to be tested in human clinical trials in Europe and will first be available there. Before it is made available in the U.S., it will need successful clinical trials here and approval from the U.S. Food and Drug Administration.

WiCS is potentially a disruptive technology, says Bruce Wilkoff, director of cardiac pacing and tachyarrhythmia devices at the Cleveland Clinic, who was not involved with the research. It is still immature, he adds, because it requires other components to coordinate the stimulation. Given that wireless technology is typically not as reliable as its wired counterpart, the largest concern involves the signal—whether the ultrasound will penetrate the heart muscle consistently and efficiently transfer energy to the wireless lead, Wilkoff says. Still, he adds, “I don’t think that there is any concern about safety.”

Pacemakers in general require patients to take certain safety precautions, such as not placing cell phones directly against the chest and avoiding strong electric or magnetic fields. Whereas some newer pacemakers are not affected by magnetic resonance imaging (MRI) scans, patients should consult their physicians before undergoing such tests. The addition of wireless to a pacemaker does not change the need to take these precautions.

Some experiments to “hack” into pacemakers capable of communicating wirelessly with computers and smart phones have been demonstrated by security researchers, but there have been no reported incidents of wireless pacemaker data being tampered with to the detriment of a patient. Still, researchers from the Massachusetts Institute of Technology and the University of Massachusetts Amherst say they are developing a jamming device that could be used to shield pacemakers from cyber attackers.

EBR and Cambridge are not only ones working on wireless pacemakers. Minneapolis-based Medtronic, Inc., last year introduced plans for a small, self-contained and fully leadless pacemaker the company hopes to market within three or four years. The Medtronic titanium-encased device will have a circuit board, an oscillator to generate current, a capacitor to store and rapidly dispense charge, memory to store data, and a telemetry system to wirelessly transfer that data to a computer or smart phone.

Unlike WiCS, however, Medtronic’s bullet-shaped pacemaker, about the size of an antibiotic pill, would be delivered directly into a patient’s right ventricle through a catheter, without surgery. Unfortunately, as currently designed, the Medtronic device could not be repositioned or retrieved from the heart after its seven-year battery failed. It would remain in the heart to be replaced by a new miniature pacemaker.


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How about getting an EKG with your iPhone?

From Red Ferret


It seems that almost every day I’m amazed by what smartphones can do. Sure, making calls, sending emails and checking the weather are cool, but some companies are really making the most of these devices. Take, for instance, this iPhone ECG that is currently being developed.

This ECG is a case that will attach to your iPhone, and provide you with an accurate ECG reading, with nothing more than a phone. It can be used either in your hands, or against the chest to take a reading. The results can be stored both locally, and uploaded elsewhere via WiFi. You can perform breathing exercises for relaxation, and use the ECG to see how your heartbeat corresponds to the relaxation. The device is still awaiting approval by the government as a proven medical instrument, so it may still be a little while before we see these on the market. There is also an Android version in the works.

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Lab created blood used in transfusion

For the First Time, Lab-Grown Blood Is Pumped Into a Human's Veins | Popular Science popsci.com
By Sean Kane Posted 11.11.2011 at 2:57 pm






Artificial blood may become a common reality, thanks to the first successful transfusion of lab-grown blood into a human. Luc Douay, of Pierre and Marie Curie University, Paris, extracted hematopoietic stem cells from a volunteer’s bone marrow, and encouraged these cells to grow into red blood cells with a cocktail of growth factors. Douay’s team labeled these cultured cells for tracing, and injected 10 billion of them (equalling 2 milliliters of blood) back into the marrow donor’s body.

After five days, 94 to 100 percent of the blood cells remained circulating in the body. After 26 days, 41 to 63 percent remained, which is a normal survival rate for naturally produced blood cells. The cells functioned just like normal blood cells, effectively carrying oxygen around the body. “He showed that these cells do not have two tails or three horns and survive normally in the body,” said Anna Rita Migliaccio of Mount Sinai Medical Center in New York.

This is great news for international health care. “The results show promise that an unlimited blood reserve is within reach,” says Douay. The world is in dire need of a blood reserve, even with the rising donor numbers in the developed world. This need is even higher in parts of the world with high HIV infection rates, which have even lower reserves of donor-worthy blood.

Other attempts to synthesize blood have focused on creating an artificial blood substitute, rather than growing natural blood with artificial means. For example, Chris Cooper of the University of Essex in Colchester, UK, is working on a hemoglobin-based blood substitute that is less toxic than the protein in its unbound state. Artificial blood substitutes present a solution for transfusions after natural disasters and in remote areas. The artificial substitutes do not require refrigeration, unlike fresh and stem cell-grown blood.

The stem cell method has its own pros, though. “The advantage of stem cell technology is that the product will much more closely resemble a red cell transfusion, alleviating some of the safety concerns that continue around the use of the current generations of artificial products,” says Cooper.

While Douay’s results, published in the medical journal Blood, are a major step forward, mass-produced artificial blood is still a long way away. A patient in need of a blood transfusion would require 200 times the 10 billion cells that Douay and his colleagues used in the test. Robert Lanza, one of the first people to grow red blood cells in a lab on a large scale, suggests using embryonic stem cells, which could generate 10 times the amount grown by Douay.


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Location:Georgetown TX,United States

$0.99 iPad 2 app does vital signs

App Measures Vital Signs Using iPad Camera | Gadget Lab | Wired.com
Wired | by Charlie Sorrel on November 17, 2011




Doctor iPad is in the house

Amazingly, it’s possible to count your heart rate just by observing tiny changes in the color of your skin, caused by the movement of blood through the body. Even more amazingly, it’s possible to detect these changes using the terrible camera in the iPad 2.

The app that performs this double-rainbow of technological magic is Philips Vital Signs Camera. It uses the front-facing camera of the iPad to both track the rising and falling of your chest to determine breathing rate, and the small changes in skin color to track heart rate.

Incredibly, it actually seems to work.

I downloaded the app and tried it out. You need to sit still in a well-lit area and make sure your face and chest are in the correct parts of the screen (there are colored rectangular guides to help). That’s it. The default settings stop when a measurement has been determined, and you can just read them or inflict them on your friends via Facebook or Twitter.

It’s certainly no replacement for a proper doctor, but as a technological demonstration, it’s surprisingly impressive. The app is available now, for $1.
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Location:Georgetown TX,United States

A New Small Cardiac Assist Device

Devices - The Future of Medicine



Cardiac Assist Device

Let’s consider some other devices that can be helpful for patients with heart problems, in particular, patients with heart failure. I will illustrate with the story of Ron Caspian, a fifty-nine-year-old analyst with one of the think tanks that surround Washington, DC. In the fall of 2002, he developed some chest discomfort one Saturday morning. His wife and daughter were out shopping, so he drove himself to the nearby emergency room where it was quickly confirmed that he was having a heart attack.

Indeed, his heart rapidly began to fail, and he was rushed to the cardiac catheterization laboratory where an angioplasty was performed. This opened up the major blocked artery, but his heart muscle was dangerously weak. His cardiologist telephoned a cardiac surgeon at the hospital where I worked and asked if he could transfer the patient while adding, “But I’m not sure you’ll be willing to accept him.”

The surgeon, never one to give up easily, asked, “Why not?” “Well, because despite the angioplasty, his pulse is very rapid, his blood pressure is zip, his kidneys are not making much urine, and his blood flow is so limited he is semi-comatose.” “Send him quick,” said the surgeon, who geared up to insert a cardiac assist device. The idea is to let the heart rest while a mechanical device does much of the pumping for the heart. It is hoped that after a few days the heart may regain some of its function and be able to carry on its role once again.

So Mr. Caspian was transferred, and the cardiac assist device was installed. It is about the size of your fist and fits around a portion of the heart and through a pneumatic system helps the heart pump blood to the body. The large pneumatic driver that powers the assist device is housed in a small suitcase-like affair that the patient must keep next to him all the time.

I saw this gentleman when I came to work on Monday morning, and he certainly did not look well-although the surgeon was quite pleased. By Wednesday, Mr. Caspian was sitting up and really looking pretty good. This was remarkable because there is no question he would have died on Saturday afternoon if not for the quick work of the cardiologist in doing an emergency angioplasty and the cardiac surgeon in implanting the cardiac assist device.

After a few more days, however, it became evident that Mr. Caspian’s heart was just not going to recoup and that he would need a heart transplant to survive. But a heart for transplantation becomes available only every so often, and in fact, most patients die before a heart is ever available.

What to do? The cardiac surgeon decided-with the advice and consent of both the patient and his wife-to try a new device. It is about the size of a D battery, like the one you use in your flashlight, with a little electric turbine inside; yet it can move blood, not quite in the amounts that a normal heart can pump, but still enough to keep the body functioning at a fair level of activity.

The surgeons tell me it is quite easy-for a skilled surgeon-to insert, but the description I am about to give you may not sound all that simple. First, the chest is opened, and then the tip end (apex) of the heart is opened, and this battery-sized device is inserted and sewn into place. Coming out from the heart is a tube about an inch in diameter, which goes to the aorta, that large artery that sends blood to the rest of the body. Also a wire from the little turbine comes out through the chest and hooks onto a battery about the size of a cell phone that can be hooked to your belt. The chest is sewn up. Using electricity from the battery, the turbine moves the blood from the heart out through the tube up to the aorta and into the body.

This device is much smaller than the larger assist device that Mr. Caspian first had installed; it can be left in place for quite some time, and it runs on batteries. Indeed, some even think that this may prove to be a long-term alternative to a heart transplant, a “destination” device if you will. This was placed into Mr. Caspian’s chest, and he did great. He was shortly up and about and after a time went home.

Then about three months later, a heart became available and he had a cardiac transplant. I saw him one day in the hospital coffee shop, and he said that he was going to retire. “I’ve been eligible for three years now and frequently thought about it, but after 9-11 there was so much work to be done at our organization that I just couldn’t leave. But now I know I need to avoid the stress and take care of myself. I have a new lease on life, and I want to make good use of it.”

That all sounded pretty logical to me, but when I saw him again six months later he said, “Well, I just started back to work. They made me an offer I couldn’t refuse. I really need to get out of the house and do some constructive things. But I will be careful. I feel really good, but I do know I need to not get overstressed.”


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How Steve Jobs mentored a physician and changed health care

How Steve Jobs mentored a physician and changed health care



Published on October 6th, 2011kevinmd.com
How Steve Jobs mentored a physician and changed health care

I’ve been reading A Game Plan for Life: The Power of Mentoring written by famed UCLA basketball coach John Wooden. Wooden spends half of his book thanking the people who had a powerful influence on his life, coaching, philosophy, and outlook on life. Important people included his father, coaches, President Abraham Lincoln, and Mother Theresa.

Yes, President Abraham Lincoln and Mother Theresa.

Though clearly he could have never met the former and didn’t have the opportunity to meet the latter, Wooden correctly points out that as individuals we can be mentored by the writings, words, and thoughts of people we have never and will likely never meet.

Which seems like the most opportune time to thank one of my mentors, founder and former CEO of Apple, Steve Jobs.

Now, I have never met nor will I ever meet Steve Jobs. Lest you think I’m a devoted Apple fan, I never bought anything from Apple until the spring of 2010. Their products though beautifully designed were always too expensive. I’m just a little too frugal. I know technology well enough that people mistaken me for actually knowing what to do when a computer freezes or crashes. Yet, the value proposition was never compelling enough until the release of the first generation iPad. Then the iPhone 4. Finally the Macbook Air last Christmas.

No, thanking Steve Jobs isn’t about the amazing magical products that have changed my life as well as millions of others. It’s more than that. What he has mentored me on is vision, perspective, persistence, and leadership. Nowhere is this more important than the world I operate in, the world of medicine. Increasingly health care is fragmented, confusing, and frustrating for patients. As Dr. Atul Gawande noted in his commencement to Harvard Medical School:

Everyone has just a piece of patient care. We’re all specialists now—even primary-care doctors. A structure that prioritizes the independence of all those specialists will have enormous difficulty achieving great care.

We don’t have to look far for evidence. Two million patients pick up infections in American hospitals, most because someone didn’t follow basic antiseptic precautions. Forty per cent of coronary-disease patients and sixty per cent of asthma patients receive incomplete or inappropriate care. And half of major surgical complications are avoidable with existing knowledge. It’s like no one’s in charge—because no one is. The public’s experience is that we have amazing clinicians and technologies but little consistent sense that they come together to provide an actual system of care, from start to finish, for people.

We don’t have an actual system of care. A majority of doctors still use paper charts and prescription pads which can be difficult to access or decipher (doctors have poor penmanship?) and communicate with colleagues via letters, faxes, and phone calls. In an industry which is information driven, this seems too antiquated to be true. Hospitals each have their own unique system of care and their is little standardization which means both patients and doctors need to learn new rules with each new hospital. Patients cannot invest in long term relationships with their doctors because they change jobs, their company or their doctors dropped their previous insurance plan.

What we have is a potpourri of doctors, hospitals, pharmacies, and health insurers cobbled together to form a “health care system”. For a patient, the number of combinations is staggering. Each experience varies depending on who they see, what insurance coverage they have, and the type of (or lack of) information technology their doctors have. Many doctors today still bristle at the possibility that they actually need to email their patients and as a result don’t offer that as a way of communication or education.

In the end, what patients and doctors really want sits at the intersection of humanity and technology. Patients want doctors who know them as individuals, use medical technology thoughtfully, and a system that is highly reliable, safe, and focused on them to stay well or get them better. Doctors want patients who are partners in their care, technology that enables them to get the accurate information they need real-time, and a system that is streamlined to allow doctors to be healers.

In other words, we need a better health care system for both parties.

As a practicing primary care doctor, his words inspire me to help work towards creating a system which “simply works” for both doctors and patients. Some of the most important quotes that has shaped my thinking include:

“Innovation has nothing to do with how many R&D dollars you have. When Apple came up with the Mac, IBM was spending at least 100 times more on R&D. It’s not about money. It’s about the people you have, how you’re led, and how much you get it.”
— Fortune, Nov. 9, 1998

“It’s really hard to design products by focus groups. A lot of times, people don’t know what they want until you show it to them.”
— BusinessWeek, May 25 1998

“It comes from saying no to 1,000 things to make sure we don’t get on the wrong track or try to do too much.”
— BusinessWeek Online, Oct. 12, 2004

“Do you want to spend the rest of your life selling sugared water or do you want a chance to change the world?”
— The line he used to lure John Sculley as Apple’s CEO, according toOdyssey: Pepsi to Apple, by John Sculley and John Byrne

“So you can’t go out and ask people, you know, what the next big [thing.] There’s a great quote by Henry Ford, right? He said, ‘If I’d have asked my customers what they wanted, they would have told me “A faster horse.” ‘ ” – CNN / Money

“My job is to not be easy on people. My job is to make them better. My job is to pull things together from different parts of the company and clear the ways and get the resources for the key projects. And to take these great people we have and to push them and make them even better, coming up with more aggressive visions of how it could be.” – CNN / Money

“Your time is limited, so don’t waste it living someone else’s life. Don’t be trapped by dogma — which is living with the results of other people’s thinking. Don’t let the noise of others’ opinions drown out your own inner voice. And most important, have the courage to follow your heart and intuition. They somehow already know what you truly want to become. Everything else is secondary.” – Stanford 2005 commencement address


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Personalized medicine, really?

The Revolution of Personalized Medicine | ParisTech Review
paristechreview.com

From risk profiling to gene therapy and molecular diagnostics, personalized medicine opens new, exciting fields to medical research. Not only is it good news for the patients: considerable improvements are at stake, both for health systems and pharmaceutical firms now struggling to reinvent themselves. But the road ahead is still full of obstacles.

The concept of personalized medicine was introduced two decades ago by the Swiss company Roche. The initial concept was based on a simple reality in medical practice: the same drug may induce different reactions according to patients, and for a given patient, some drugs work while others don’t. With the introduction of a treatment of breast cancer in the 1990’s, Roche demonstrated that it was possible to anticipate which patients would or would not benefit from the treatment.

It became therefore possible to personalize treatments, that is to administer a drug only to those patients who would react positively to it. The impact of this new approach is huge: a better efficiency, less side-effects, and no more waste of time and resources spent on a treatment that does not work.

Five new approaches
This first form of personalized medicine opened the way to five different approaches.

Stratified medicine is the approach developped by Roche for its treatment of breast cancer, Herceptin: it consists in dividing patients in four groups, depending on their reaction to a drug regarding efficiency and side-effects. The drug is given only to the group who reacts positively and does not display side-effects.

Oncological vaccination is another form of personalized medicine whereby the patient’s immune system is “trained” to destroy tumor cells. This result is obtained by re-injecting a sample of a patient’s own cells after an external treatment. The treated cells are designed to stimulate the patient’s immune system specifically against tumor cells.

Tissue reconstruction is a promising new area. It can be done by implanting cells that have the capacity to grow on a damaged tissue and repair it. The cells can either come from the patient himself after an external treatment, or they can be stem cells donated by others.

Gene therapy aims at changing the genome of a patient, in order to remove the mutation at the origin of a disease. Gene therapy can be divided into persistent DNA transfection, transient DNAA transfection, and RNA therapy. Persistent DNA therapy has been almost abandoned today: changing permanently the genome of somebody can have implications in the long term, even after the patient’s death, since genome modifications are transferred to his offspring. It also often has consequences on other biological processes that cannot be predicted. Current research is now concentrating on the other two approaches, which have the benefit of being reversible. The first drugs are now reaching the market, an interesting example being Glybera, the first effective treatment of LPLD, a rare disease where patients have a deficiency in a protein called LPL, which induces diabetes and cardiovascular diseases.

Risk profiling is probably the most publicized form of personalized medicine: by sequencing a patient’s genome, it becomes now possible to measure the risk that a person develops a disease in the future. As the total cost of sequencing the entire genome of a person goes down every year, it will soon be possible for everyone to obtain his own genome sequence, and therefore his risk profile for a number of diseases. Besides, some other, more accurate forms of risk profiling exist: in cardiology for example, by measuring the concentration level of a certain protein in the blood, it becomes possible to accurately predict the risk for a patient to have a cardiovascular accident (stroke, heart failure) in the coming months or years.

Risk profiling is a particularly important aspect of personalized medicine, since it opens the way to prevention, a huge potential source of well-being for people and cost-savings for healthcare systems.

To understand why and how the whole healthcare industry is now turning to personalized medicine, one has to take a look at the scientific revolution that triggered this paradigm shift.

Molecular diagnostics: the underlying driver
For the last 10 years, improving R&D productivity has been one of the key challenges for pharmaceutical companies. With most of their top-selling drugs going off-patent between 2004 and 2012 and not enough new products coming up to compensate for the loss, this wealthy industry has been facing an increasing pressure for more innovation.

Streamlining management of R&D projects, forming alliances, building long-term agreements with academic or biotech research teams, licensing-in research projects with sophisticated deal structures have been typical and sometimes very effective responses to this challenge. However, none of these approaches have really addressed the central problem of pharmaceutical R&D today. To find new drugs tomorrow, scientists will need to better understand the molecular processes that govern diseases, and how genetic diversity of patients influences treatment outcomes.

In parallel, the industrialization of molecular biology techniques has led to significant progress in the detection and analysis of molecules of ever-increasing complexity such as long DNA/RNA fragments, proteins, or even entire cells. These techniques have allowed scientists to gain a much more accurate understanding of the molecular processes which are at the origin of many diseases. The potential of what is now called molecular diagnostics is immense, not only in R&D, but in daily medical practice as well.

At the other end of the spectrum, healthcare systems in most countries are under high pressure. They are no longer reimbursing “me-too” drugs that do not add any medical value on top of existing treatments; and they are now also, in some cases, paying only if the treatment outcome is positive. A growing number of healthcare systems admit the need for return on investment – once a taboo.

Molecular diagnostics are providing the scientific answer to both of these challenges: not only are they improving R&D productivity, but they are also providing clinicians with powerful tools to better understand what they are doing and how effective their treatment decisions are. Hence in the end, they treat their patients better, at a lower cost.

Molecular diagnostics and biomarkers: a few definitions
Molecular diagnostics detect and measure specific molecular targets using selective probes; they are always associated with a visualization method. The value of these targets – called biomarkers – is that they correlate with a disease, or sometimes even are the root cause of it. Biomarkers can be of very different nature, ranging from simple small molecules (like metabolites) to complex structures such as proteins, nucleic acids, or even entire cells.

Finding the right biomarker that will enable clinicians to understand and accurately track the progression of the disease – or the response to a therapy – is one of the key challenges of pharmaceutical research today. Indeed, there is often no direct causality between a biomarker and the disease/response. Some biomarkers may be representative of several diseases and conversely, it might be necessary to detect several biomarkers to identify a disease.

Detection and amplification technologies have made huge progress in recent years and have become the main drivers in the development of molecular diagnostic tools. The most well-known methodology is Polymerase Chain Reaction (PCR), but others such as Micro-Arrays, Fluorescent In-Situ Hybridization (FISH), immunohistochemistry, Fluorescence-Activated Cell Sorting (FACS) and many others have now reached maturity.

The role of biomarkers in the pharmaceutical value chain
Biomarkers play an important role at all levels of the pharmaceutical value chain: very early in the discovery process, during product development, and also at the patient’s level, for prevention, treatment monitoring and disease management.

Biomarkers can be sorted in three categories; their role depends on where they are used in the value chain.

Discovery biomarkers are molecular entities that are usually identified during the early discovery process of a new drug. These biomarkers are related to the biological target, and are used to validate disease mechanisms, probe potential toxicological effects or anticipate potential genetic variations in drug response. The hope of many pharma R&D executives is that they will help reach proof of concept in humans quicker: the idea is to be able to perform clinical trials safely, with very low doses, on a few patients much earlier, before even the full pre-clinical package has been completed. Drugs that are shown not to work in these early trials would then be eliminated earlier, which in turn would allow more substances to be tested.

Later in the process, development biomarkers can also be very useful. Usually the same as those identified during the discovery process, they are used in clinical trials to provide early information about the drug’s efficacy and safety, before any clinical parameter can be measured. Because they are able to provide information that is not accessible to conventional clinical monitoring, they can sometimes contribute to significantly accelerate the development process. In a nutshell, in order to measure the efficacy of a new drug, simple blood tests can now (in some cases) replace months or even years of clinical observation.

And finally, the commercial biomarkers. By “commercial” we mean biomarkers that have been officially recognized by the regulatory authorities as tools that bring useful information on a patient’s state and that can be used to make clinical decisions; diagnostic tools using these biomarkers can also be reimbursed by the healthcare system. This type of biomarker is not new. To mention two examples, glucose has been recognized as a biomarker of diabetes since the XIXth century (now it has been replaced by HbA1c), and PSA (Prostate Specific Antigen) since the 80’s for prostate cancer.

Although biomarkers have been used for a long time, the development of molecular biology, bioinformatics and innovative detection methods has hugely increased the possibilities, and a new type of tool has emerged: “molecular” diagnostics. The first emblematic examples of these new powerful techniques are the so-called “companion diagnostics”, which have been introduced in cancer (first with Herceptin, mentioned earlier) and more recently HIV, where the prescription of some expensive treatments has been conditioned by the patient responding to a specific genetic test. Other well-known examples are routine screening tests for infectious diseases (HIV) that have a very high degree of specificity and sensitivity.

Molecular diagnostics are the tools of modern medicine. They enable clinicians to identify early signs of diseases, to select the right treatment based on genetic profiles (companion diagnostics), to monitor treatments’ efficacy and to make much better informed decisions based on each patient’s particular profile and reaction to previous treatments. They also have an economic role, because they may lead in some cases to significant savings in treatment costs.

The road ahead: when will personalized medicine become common practice?
It seems, then that an ideal world is ahead where all diseases would be diagnosed before it is too late, would receive personalized treatments that would be cured immediately, without side-effects and relapses… There are, however, some barriers on the road.

Firstly, for healthcare manufacturers: the use of biomarkers may in some cases not accelerate, but slow down research and development: as genetic profiling of patients becomes possible, the temptation is high to demand that patients be divided into more groups, according to their genetic profile, which in turn increases the amount of tests to be performed and data to be analyzed, and may also slow down patient recruitment.

Secondly, and this is the biggest challenge, the regulatory and economic framework that should favor the development of molecular diagnostics is not in place yet. Molecular diagnostics is an emerging field, and healthcare is a highly regulated environment. For drugs in most countries today, the regulatory process that leads to the marketing authorization is well structured, as well as the “market access” process that leads to the reimbursement of the drug by healthcare systems. It is, however, not yet the case for molecular diagnostics. The first reason is that the field of molecular diagnostics is new; the second, more important reason is that the nature of what they bring, information, is something that healthcare professionals are not yet used to value.

Be it in Europe, in the United States or elsewhere, a new molecular diagnostic tool will always have to prove that the biomarker it is supposed to monitor has both clinical relevance AND economic value in the overall management of the patient. In contrast with drugs where clinical performance (vs. standard of care) is always the most important criteria, what payers will look for in a diagnostic tool is most often how much can be saved. The medical information brought by a molecular diagnostic tool can save or prolong lives, avoid pain, secure the patient, help a physician make the right decision: payers however, especially in Europe, are not prepared to pay for this information – yet. Introducing the principle of “value-based pricing” in future reimbursement negotiations is tomorrow’s main challenge for the diagnostic industry.

The time has not come where molecular diagnostics will be used systematically for every patient in every country, in prevention programs, before any treatment decision is taken, and after each treatment phase. It is also not yet entirely clear when and how payers will recognize the value of the information they bring.

However, there is little doubt that in the end, because the information they bring is so valuable to physicians – and eventually to payers as well – they will become the main tools of tomorrow’s medicine, personalized medicine.

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The gene responsible for cystic fibrosis brings new treatments closer

Cystic Fibrosis Drugs on Horizon - WSJ.com
online.wsj.com
By JONATHAN D. ROCKOFF

More than two decades after scientists identified the gene responsible for cystic fibrosis, drug makers are finally edging closer to new treatments—a long journey that underscores the challenges of translating genetic discoveries into actual drugs.

Vertex Pharmaceuticals Inc., Pfizer Inc. and PTC Therapeutics Inc. are among the companies working on drugs that aim to arrest the disease’s destructive march through the lungs and airways by targeting its cellular underpinnings. Furthest along is a pill from Vertex, which on Wednesday filed for regulatory approval of its drug Kalydeco. The drug is for only a small fraction of cystic fibrosis patients with a specific genetic mutation, but in 48 weeks of clinical testing, Kalydeco improved the lung function of patients by 17%, while cutting their risk of getting intermittent sicknesses by 55%.

“We really believe with these new drugs that we should be able to add decades to the lives of patients in a very short period of time,” said Robert Beall, chief executive of the Cystic Fibrosis Foundation, which has given or committed $315 million to companies for drug research.

The new wave of drugs in the pipeline could cost as much as $200,000 a year per patient, according to one Wall Street analyst, and sales for the category could peak at $5.5 billion world-wide despite a small market.

Cystic fibrosis is an inherited, life-threatening disease that clogs airways with thick mucus, inviting bacterial infections and progressively robbing patients of their ability to breathe. The condition affects some 30,000 patients in the U.S. and a total of 100,000 world-wide.

To date, treatment has been limited. Sufferers can take drugs that address symptoms, such as antibiotics to tackle the infections, and they typically wear a mechanical vest for several hours each day that vibrates to dislodge the mucus.

Aggressive use of treatments has raised median life spans dramatically, but patients still can’t expect to survive much past their 30s or 40s. Hence patients’ interest in treatments ever since researchers identified the responsible gene in 1989.

That it’s taken two decades for the first drug to near approval provides some “important lessons” on the need to speed the development of genetic advances into treatments so that what turn out to be the nonviable compounds can be weeded out earlier on, said Francis Collins, a co-discoverer of the cystic fibrosis gene who now heads the National Institutes of Health. “It shouldn’t have to take that long in the future.”

After discovery of the cystic fibrosis gene, it took several years for scientists to develop a hypothesis explaining how a defective gene results in the disease. The gene makes the channels that carry chloride in cells up to airways, where it’s needed for clearing mucus that builds up, some scientists believe. Mutations impede the flow of chloride, causing the mucus to accumulate and impeding the hair-like particles called cilia from beating back and forth to clear out the mucus.

Researchers spent years at first on gene therapy—aiming to replace the mutated gene with a healthy substitute. But it proved difficult to introduce a healthy gene in patients without their immune systems thwarting the effort. Eventually researchers turned to drugs that could correct for the cellular hitches caused by the mutations and enable chloride to get into airways.

At Vertex, it took all of 2003 to find a way to test promising compounds. Company scientists wanted to test drug prospects on the lung cells of cystic fibrosis patients, but the donated lungs were too contaminated with mucus. Vertex scientists had to use tweezers to extract the mucus, then isolated the cells for use in testing, said Fred Van Goor, who led the project.


Ten days after she was born, 2-year-old Gwendolynn Hughes was diagnosed with cystic fibrosis. Her mother Elisa shares what life is like for the little girl and her family. Plus, how new drugs are offering new hope for CF patients.

With the test in place, the researchers could quickly see through their microscopes the compound that became Kalydeco having an impact: fluid containing chloride was on the surface of the cells and cilia had resumed beating back and forth. “You could actually see the restoration of the cellular defect. That’s when the organization started to believe that we really [had] something here,” Dr. Van Goor said.

In Kalydeco’s pivotal trial, patients experienced improved breathing and fewer of the illnesses associated with cystic fibrosis. Patients, who are typically underweight, gained an average of seven pounds.

Since joining the trial in 2009, cystic fibrosis patient Capri Faulk has added 24 pounds to her 49-pound frame, and can play outside with her brother and sister without getting exhausted. Her mother, Nicole Faulk, of Oklahoma City, Okla., says she now talks with the 8-year-old about one day having a family.

“I had hopes and dreams for her, and I was scared they would be robbed from her and from me” until the new drug came along, Ms. Faulk said.

The pill has limitations. It targets a mutation, called G551d, affecting just 4% of patients. Nor has the drug been shown to reverse the effects of the disease. So far, results haven’t been as strong for other compounds from Vertex and others that are further behind in development.

“It says we’re not quite there yet, but it suggests maybe we’re not too far off,” said Michael Welsh, a cystic fibrosis researcher at the University of Iowa and Howard Hughes Medical Institute.

PTC Therapeutics, a 13-year-old biotech that has received $100 million from Genzyme, is conducting a phase III trial of its compound, ataluren, in cystic fibrosis patients with a so-called nonsense mutation. Novartis AG has a compound in phase 1 clinical trials, a spokeswoman said. And Pfizer has begun screening for potential cystic fibrosis drugs, said Ed Mascioli, head of the drug giant’s orphan and genetic diseases unit.


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Breakthrough in treatment of heart disease

Medical breakthrough for heart repair
latestmedicaltechnology.net

In a medical breakthrough a man’s heart was saved through the use of a breakthrough medical technology. The man, John Christy, is the first person in the United States to undergo this procedure. The new procedure utilizes stem cells in helping repair the arteries all throughout a person’s body.
Christy was suffering from coronary artery disease at a very advanced stage. What was done to him was to insert his own specific stem cells into his body during a CABG surgery. The stem cells are used to grow new blood vessels in the heart. This is a revolutionary procedure that can save millions of lives when it is further developed and become widely available.


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Taking Your Blood Pressure Drugs at Bedtime May Cut Heart Risk

Blood Pressure Drugs at Bedtime May Cut Heart Risk

Study Suggests Benefits to Taking Blood Pressure Drugs Before Going to Sleep

By Kathleen Doheny
WebMD Health News
Reviewed by Laura J. Martin, MD

Oct. 27, 2011 — Taking at least one blood pressure medicine at bedtime cuts the risk of heart problems, according to new research.

The study also shows that participants taking at least one blood pressure pill at bedtime had lower blood pressure while asleep.

Earlier studies have suggested that bedtime dosing of at least one blood pressure medication may help control blood pressure. But the new study is believed to be the first to look at whether the timing makes a difference in terms of heart attacks, strokes, and death.

Ramon C. Hermida, PhD, director of the bioengineering and chronobiology labs at the University of Vigo in Spain, studied 661 people with both high blood pressure and chronic kidney disease.

“Taking blood-pressure-lowering medication at bedtime, compared to [taking] all medication upon awakening, not only improved blood pressure control, but significantly reduced the risk of cardiovascular events,” Hermida says in a news release.

The research appears in the Journal of the American Society of Nephrology.

Timing of Blood Pressure Medicines

Hermida’s team asked half of the men and women to take all their blood pressure medicine when they got up in the morning. On average, each person took two medicines. Many took more than three.

The researchers asked the other half to take at least one of their blood pressure medicines at bedtime.

They measured blood pressure by using 48-hour ambulatory monitoring at the start of the study — not just a single daytime measurement used in most earlier studies. They also measured blood pressure three months after any treatment changes or, at the least, every year.

The researchers followed the men and women for about five and a half years. They looked to see which heart problems developed. They tracked death from any cause and from heart disease or stroke.They also tracked heart attack, angina, heart failure, and other problems.

More than half of those with chronic kidney disease also have high blood pressure, according to the National Kidney Foundation. High blood pressure increases the risk of the kidney disease worsening. Overall, one in three U.S. adults has high blood pressure, according to the researchers.

Bedtime Dosing of Blood Pressure Medicine

Those who took at least one blood pressure medicine at bedtime had lower nighttime blood pressure while asleep. They were also more likely to have overall good control of their blood pressure.

The bedtime group was one-third as likely to have heart and blood vessel problems such as heart attack, stroke, or heart failure, the researchers found.

Improved overnight blood pressure with bedtime dosing had a real benefit. Each 5-point drop in sleep-time blood pressure was linked with a 14% reduction in risk for heart attack, stroke, or heart failure.

“Cardiovascular event rates in patients with hypertension can be reduced by more than 50% with a zero-cost strategy of administering blood pressure-lowering medications at bedtime rather than in the morning,” Hermida says in a news release.


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How does cancer know its cancer? The answer leads to a new approach to treatment.

TED is a great site. The site says TED Ideas Worth Spreading. This video is a great example. It is titled How Does Cancer Know It Cancer? It looks at the cure of Cancer in a new light.

http://www.ted.com/talks/jay_bradner_open_source_cancer_research.html

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Vampire like bacteria may become antibiotic

Vampire-like Predatory Bacteria Could Become A Living Antibiotic
| 80beats | Discover Magazine blogs.discovermagazine.com | by Douglas Main





The bacterium Micavibrio aeruginosavorus (yellow), leeching
on a Pseudomonas aeruginosa bacterium (purple).
What’s the news: If bacteria had blood, the predatory microbe Micavibrio aeruginosavorus would essentially be a vampire: it subsists by hunting down other bugs, attaching to them, and sucking their life out. For the first time, researchers have sequenced the genome of this strange microorganism, which was first identified decades ago in sewage water. The sequence will help better understand the unique bacterium, which has potential to be used as a “living antibiotic” due to its ability to attack drug-resistant biofilms and its apparent fondness for dining on pathogens.
Anatomy of a Vampire:
The bacterium has an interesting multi-stage life history. During its migratory phase it sprouts a single flagellum and goes hunting for prey. Once it find a delectable morsel of bacterium, it attacks and irreversibly attaches to the surface, and sucks out all of the good stuff: carbohydrates, amino acids, proteins, DNA, etc.
Sated, the cell divides in two via binary fission, and the now-depleted host is left for dead.
Hungry for Pathogens:
M. aeruginosavorus cannot be grown by itself; it must be cultured along with another bacteria to feed upon. A 2006 study found that it only grew upon three bacterial species, all of which can cause pneumonia-like disease in humans. A more recent study showed that it can prey upon a wider variety of microbes, most of them potentially pathogenic, like E. coli.
These studies also found that M. aeruginosavorus has a knack for disrupting biofilms, the dense collection of bacteria that cause harmful plagues on teeth and medical implants alike, and can be up to 1,000 more resistant to antibiotics than free-swimming bugs.
The bacteria can also swim through viscous fluids like mucous and kills Pseudomonas aeruginosa, the bacterium that can colonize lungs of cystic fibrosis patients and form a glue-like film.
These qualities have caught the eye of researchers who think it could be used as a living antibiotic to treat biofilms and various types of drug-resistant bacteria, which are a growing problem in medicine. Sequencing the organism’s genome is an important step in understanding its biochemistry and how it preys on other microbes.
Clues From the Vampire Code:
The new study found that each phase of life involves the use (or expression) of different sets of genes. The migratory/hunting phase involves many segments that code for flagellum formation and genes involved in quorum sensing. The attachment phase involves a wide variety of secreted chemicals and enzymes that facilitate the flow of materials from the host.
Micavibrio aeruginosavorus possesses no genes for amino acid transporters, a rather rare trait only seen in a few other bacterial species that depend heavily upon their host to help them shuttle these vital protein building-blocks. This absence helps explain the bacterium’s dependence on a narrow range of prey, from which it directly steals amino acids. Although it remains unclear exactly how the microbe attaches to and infiltrates other cells.
The Future Holds:
The range of microbes upon which Micavibrio aeruginosavorus can survive is expanding; after being kept in laboratory conditions for years it has apparently evolved a more diverse diet. If this expansion continues, that could be a real problem for its use as an antibiotic; it could begin to eat beneficial gut bacteria, for example.
Researchers claim it is harmless to friendly gut microbes, but it hasn’t been tested on all the varieties of bacteria present in humans.
Several important steps must be taken before testing in people, like learning more about what traits makes another bacteria tasty to Micavibrio aeruginosavorus. Researchers speculate the bacterium may need to be genetically altered in order to go after specific pathogens, or to reduce the risk of it causing unforeseen complications.
Reference: Zhang Wang, Daniel E Kadouri, Martin Wu. Genomic insights into an obligate epibiotic bacterial predator: Micavibrio aeruginosavorus ARL-13. BMC Genomics, 2011; 12 (1): 453 DOI: 10.1186/1471-2164-12-453
Image credit: University of Virginia
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November 2nd, 2011 2:07 PM Tags: antibiotic resistance, antibiotics, bacteria, genome sequence, genomics, Pseudomonas aeruginosa
by Douglas Main in Environment, Health & Medicine, Living World, Top Posts | 7 comments | RSS feed | Trackback >



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A potential new bio marker for heart attack

From online WSJ

Cardiac biomarker: A protein that regulates heart-muscle contractions may help to diagnose heart attacks in the 60% to 70% of patients admitted to the hospital with undetermined chest pain, according to a U.S.-led study in the Journal of Molecular and Cellular Cardiology. Cardiac biomarkers are proteins released into the bloodstream that signal a heart attack has occurred and its severity. The most widely used biomarker, cardiac troponin-I, takes up to six hours to be detected, and elevated levels also can indicate severe infections and other conditions.

Experiments on rats and human blood samples found that cardiac myosin binding protein-C (cMyBP-C), a large protein that plays a key role in stabilizing the heart, is a potentially faster, more precise cardiac biomarker than troponin-I, researchers said. Initial experiments showed significantly higher levels of cMyBP-C in rats with induced heart attack compared with control animals.

Further experiments found greater concentrations of cMyBP-C than cardiac troponin-I in blood samples from 16 heart attack patients compared with 11 healthy controls. Laboratory tests showed cMyBP-C is released quickly and can be detected up to 12 hours following a heart attack.

Caveat: It isn’t known if cMyBP-C is released from ischemic, dying or injured cells, or a combination of the three. The research was carried out in rats and a small number of blood samples from humans.


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Breakthroughs in Mobile Technology for Medicine - WSJ.com

Breakthroughs in Mobile Technology for Medicine - WSJ.com
online.wsj.com
By STEPHANIE SIMON

Eric Topol felt a twinge of nostalgia when he stopped carrying around his trusty stethoscope.

It didn’t last long.

Dr. Topol, a cardiologist in San Diego, carries with him instead a portable ultrasound device roughly the size of a cellphone. When he puts it to a patient’s chest, the device allows him to peer directly into the heart. The patient looks, too; together, they check out the muscle, the valves, the rhythm, the blood flow.

“Why would I listen to ‘lub dub’ when I can see everything?” Dr. Topol says.

The $8,000 device—called the Vscan, made by GE Healthcare, a unit of General Electric Co.—is just one entry in the booming field of mobile-health technology. In an era where many medical schools hand out iPods along with dissection kits, Dr. Topol, the chief academic officer for Scripps Health, a San Diego-based nonprofit health-care network, says smartphone apps, wireless sensors and other innovative tools hold “transformative potential.”

He and other physicians say the technology can not only improve diagnoses and treatment, but also revolutionize how doctors and patients think about health care. Mobile tools allow physicians to monitor vital signs, note changes in activity levels and verify that medications have been taken, without ever seeing a patient face to face.

That means fewer office visits—and fewer hospitalizations, since even very ill patients can be monitored from afar. For their part, patients can monitor their health in real time, gaining access to an unprecedented amount of data that will allow them to “take charge of their own health care,” Dr. Topol says.

Kelly Morris, a mother in Union Grove, Ala., sees the potential most clearly in a red plastic tag she clips to her daughter’s shirt each morning. One side of the tag reads: “In Case of Emergency.” The other instructs responders to text a unique PIN to the number 51020. Anyone who does so will receive a text offering detailed instructions for 13-year-old Michaela’s care. They’ll learn, for instance, that her particular form of epilepsy does not respond well to the most common seizure drugs and that certain medications make her manic.

“These are things I would like an emergency team to know,” Ms. Morris says. “It gives me the ability to say what I want to say, even if I’m not there.”

Another feature of the $10-a-year service allows trained medics, who are given special access codes, to pull up a preprogrammed list of the patient’s emergency contacts. The medic can swiftly notify them all—by automated text, email or phone call—that the patient is being taken to a specific hospital.

The technology, called “invisible bracelet,” was developed by Docvia LLC of Tulsa, Okla. In addition to the red plastic tags, the company sells key fobs and stickers that can be attached to ID cards and that carry the same instructions about texting a PIN in case of emergency.

Eyes on the Road

Emergency responders are also on the front line of another innovation: a wireless ambulance-monitoring system developed by GlobalMedia Group LLC, a developer of telemedicine hardware and software based in Scottsdale, Ariz.

The TransportAV system, which costs about $30,000, uses a small video camera, digital stethoscope and microphone mounted on a stretcher to transmit live images of the patient to the treatment team waiting in the hospital emergency room. Paramedics and nurses in the ambulance can send close-up images of wounds, real-time video of the patient’s response to various treatments, and audio of heartbeats and respiration.

Such monitoring isn’t all that crucial for short ambulance rides. But specialized facilities like Cincinnati Children’s Hospital Medical Center often pick up patients in other states, four or five hours away. Hamilton Schwartz, an ER physician at Cincinnati Children’s, says the system lets him see the patient for himself, instead of having to rely on an ambulance nurse to describe symptoms by cellphone. Dr. Schwartz can then order treatments en route, brief the ER team or prepare a surgical suite for the ambulance’s arrival.

Dr. Schwartz has been using the system on a trial basis for several months and says his “gut feeling is that it’s great.” He has launched a formal study to determine whether doctors who use this technology order different treatments from those who simply hear the patient’s symptoms described.

IPhone Diagnostics

When the patient is in the hospital and the physician is on the road, a different type of long-distance monitoring is needed. The Mobile MIM system, approved last month by the Food and Drug Administration, lets doctors use their iPhones to view images from sophisticated hospital tests such as MRIs and CT scans. Developed by MIM Software Inc., of Cleveland, the program reproduces the scans with enough clarity and fidelity that physicians can make diagnoses via smartphone.

Yuko D’Ambrosia, a Denver obstetrician, uses an iPhone for another purpose—keeping track of her patients’ labor.

Nurses on the labor and delivery floor routinely use sensors to monitor the fetal heart rate and the mother’s contraction patterns and oxygen levels. In days past, Dr. D’Ambrosia would call the hospital every hour or two to ask a nurse to describe the data being spit out by the sensors.

“Everyone uses different terminology,” she says. “I would have to spend a few minutes trying to tease out what that heartbeat looks like.” If she wasn’t satisfied with the nurse’s description, she’d drive to the hospital to look at the graphs and charts in person.

Now, however, Dr. D’Ambrosia uses an application called AirStrip OB to pull up that information on her iPhone. With a couple of taps, she can view, in real-time, all the data from the sensors strapped to her patient’s belly. If she spots danger signs, she can order a Caesarian section by phone, so the patient will be prepped and ready for surgery by the time she gets to the hospital.

Hundreds of hospitals nationwide use the system, developed by Airstrip Technologies of San Antonio, Texas.

The California Hospital Medical Center in Los Angeles has adopted a more elaborate patient monitoring system, EverOn, for critically ill patients.

The system consists of a sensor-studded mat that is placed under a patient’s mattress. Nurses program the device to alert them if any of the patient’s vital signs drop to a level that they deem worrisome for that individual.

If that happens, the EverOn wirelessly transmits an alarm that goes off at the main nursing station on the floor, in the patient’s room, and on nurses’ smartphones or pagers.

“We’ve had a lot of saves on close calls,” says Jamie Terrence, the hospital’s director of risk management. “The nurse gets in there before we have to call code blue for cardiac arrest.”

The mat, made by EarlySense Ltd. of Dedham, Mass., can also be set to send nurses reminders at predetermined intervals, so they don’t forget, for instance, to turn a patient regularly to prevent bed sores. Installing the system throughout a typical 30-bed hospital unit costs about $230,000, with annual maintenance costs of about $50,000.

Other monitoring devices abound.

Sotera Wireless Inc. in San Diego is developing a wristband sensor that tracks vital signs—including blood pressure, cardiac rhythm, even activity level—and sends wireless alerts to the doctor at the first sign of trouble.

AT&T Inc. is developing “smart slippers” with pressure sensors to detect any changes in the wearer’s gait that may signal a health issue or increased risk of falling. If such changes are detected, a transmitter is supposed to notify the patient’s doctor.

And myriad smartphone applications promise to help patients do everything from monitoring their blood glucose to taking their pills on time.

So much information, so readily available, can have a downside. “We could create a whole culture of cyberchondriacs,” says Dr. Topol, the cardiologist in San Diego.

He acknowledges, too, that something will be lost when most face-to-face visits with physicians are replaced by wireless exchange of data. “We’re getting virtual touch, rather than actual touch,” he says.

But Dr. Topol says in his own practice, he’s found that many patients are more willing to make lifestyle changes that keep them healthy when they can monitor the consequences of their actions in real time. A doctor can talk “until he’s blue in the face,” he says, but it sometimes takes cold, hard data to motivate a patient.


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The eulogy of the great innovator

I know this seems a bit out of character but it is a great comment about the person greatly responsible for the growth of the Tech Savvy Patient

A Sister’s Eulogy for Steve Jobs

By MONA SIMPSON

Published: October 30, 2011
I grew up as an only child, with a single mother. Because we were poor and because I knew my father had emigrated from Syria, I imagined he looked like Omar Sharif. I hoped he would be rich and kind and would come into our lives (and our not yet furnished apartment) and help us. Later, after I’d met my father, I tried to believe he’d changed his number and left no forwarding address because he was an idealistic revolutionary, plotting a new world for the Arab people.

Even as a feminist, my whole life I’d been waiting for a man to love, who could love me. For decades, I’d thought that man would be my father. When I was 25, I met that man and he was my brother.

By then, I lived in New York, where I was trying to write my first novel. I had a job at a small magazine in an office the size of a closet, with three other aspiring writers. When one day a lawyer called me — me, the middle-class girl from California who hassled the boss to buy us health insurance — and said his client was rich and famous and was my long-lost brother, the young editors went wild. This was 1985 and we worked at a cutting-edge literary magazine, but I’d fallen into the plot of a Dickens novel and really, we all loved those best. The lawyer refused to tell me my brother’s name and my colleagues started a betting pool. The leading candidate: John Travolta. I secretly hoped for a literary descendant of Henry James — someone more talented than I, someone brilliant without even trying.

When I met Steve, he was a guy my age in jeans, Arab- or Jewish-looking and handsomer than Omar Sharif.

We took a long walk — something, it happened, that we both liked to do. I don’t remember much of what we said that first day, only that he felt like someone I’d pick to be a friend. He explained that he worked in computers.

I didn’t know much about computers. I still worked on a manual Olivetti typewriter.

I told Steve I’d recently considered my first purchase of a computer: something called the Cromemco.

Steve told me it was a good thing I’d waited. He said he was making something that was going to be insanely beautiful.

I want to tell you a few things I learned from Steve, during three distinct periods, over the 27 years I knew him. They’re not periods of years, but of states of being. His full life. His illness. His dying.

Steve worked at what he loved. He worked really hard. Every day.

That’s incredibly simple, but true.

He was the opposite of absent-minded.

He was never embarrassed about working hard, even if the results were failures. If someone as smart as Steve wasn’t ashamed to admit trying, maybe I didn’t have to be.

When he got kicked out of Apple, things were painful. He told me about a dinner at which 500 Silicon Valley leaders met the then-sitting president. Steve hadn’t been invited.

He was hurt but he still went to work at Next. Every single day.

Novelty was not Steve’s highest value. Beauty was.

For an innovator, Steve was remarkably loyal. If he loved a shirt, he’d order 10 or 100 of them. In the Palo Alto house, there are probably enough black cotton turtlenecks for everyone in this church.

He didn’t favor trends or gimmicks. He liked people his own age.

His philosophy of aesthetics reminds me of a quote that went something like this: “Fashion is what seems beautiful now but looks ugly later; art can be ugly at first but it becomes beautiful later.”

Steve always aspired to make beautiful later.

He was willing to be misunderstood.

Uninvited to the ball, he drove the third or fourth iteration of his same black sports car to Next, where he and his team were quietly inventing the platform on which Tim Berners-Lee would write the program for the World Wide Web.

Steve was like a girl in the amount of time he spent talking about love. Love was his supreme virtue, his god of gods. He tracked and worried about the romantic lives of the people working with him.

Whenever he saw a man he thought a woman might find dashing, he called out, “Hey are you single? Do you wanna come to dinner with my sister?”

I remember when he phoned the day he met Laurene. “There’s this beautiful woman and she’s really smart and she has this dog and I’m going to marry her.”

When Reed was born, he began gushing and never stopped. He was a physical dad, with each of his children. He fretted over Lisa’s boyfriends and Erin’s travel and skirt lengths and Eve’s safety around the horses she adored.

None of us who attended Reed’s graduation party will ever forget the scene of Reed and Steve slow dancing.

His abiding love for Laurene sustained him. He believed that love happened all the time, everywhere. In that most important way, Steve was never ironic, never cynical, never pessimistic. I try to learn from that, still.

Steve had been successful at a young age, and he felt that had isolated him. Most of the choices he made from the time I knew him were designed to dissolve the walls around him. A middle-class boy from Los Altos, he fell in love with a middle-class girl from New Jersey. It was important to both of them to raise Lisa, Reed, Erin and Eve as grounded, normal children. Their house didn’t intimidate with art or polish; in fact, for many of the first years I knew Steve and Lo together, dinner was served on the grass, and sometimes consisted of just one vegetable. Lots of that one vegetable. But one. Broccoli. In season. Simply prepared. With just the right, recently snipped, herb.

Even as a young millionaire, Steve always picked me up at the airport. He’d be standing there in his jeans.

When a family member called him at work, his secretary Linetta answered, “Your dad’s in a meeting. Would you like me to interrupt him?”

When Reed insisted on dressing up as a witch every Halloween, Steve, Laurene, Erin and Eve all went wiccan.

They once embarked on a kitchen remodel; it took years. They cooked on a hotplate in the garage. The Pixar building, under construction during the same period, finished in half the time. And that was it for the Palo Alto house. The bathrooms stayed old. But — and this was a crucial distinction — it had been a great house to start with; Steve saw to that.

This is not to say that he didn’t enjoy his success: he enjoyed his success a lot, just minus a few zeros. He told me how much he loved going to the Palo Alto bike store and gleefully realizing he could afford to buy the best bike there.

And he did.

Steve was humble. Steve liked to keep learning.

Once, he told me if he’d grown up differently, he might have become a mathematician. He spoke reverently about colleges and loved walking around the Stanford campus. In the last year of his life, he studied a book of paintings by Mark Rothko, an artist he hadn’t known about before, thinking of what could inspire people on the walls of a future Apple campus.

Steve cultivated whimsy. What other C.E.O. knows the history of English and Chinese tea roses and has a favorite David Austin rose?

He had surprises tucked in all his pockets. I’ll venture that Laurene will discover treats — songs he loved, a poem he cut out and put in a drawer — even after 20 years of an exceptionally close marriage. I spoke to him every other day or so, but when I opened The New York Times and saw a feature on the company’s patents, I was still surprised and delighted to see a sketch for a perfect staircase.

With his four children, with his wife, with all of us, Steve had a lot of fun.

He treasured happiness.

Then, Steve became ill and we watched his life compress into a smaller circle. Once, he’d loved walking through Paris. He’d discovered a small handmade soba shop in Kyoto. He downhill skied gracefully. He cross-country skied clumsily. No more.

Eventually, even ordinary pleasures, like a good peach, no longer appealed to him.

Yet, what amazed me, and what I learned from his illness, was how much was still left after so much had been taken away.

I remember my brother learning to walk again, with a chair. After his liver transplant, once a day he would get up on legs that seemed too thin to bear him, arms pitched to the chair back. He’d push that chair down the Memphis hospital corridor towards the nursing station and then he’d sit down on the chair, rest, turn around and walk back again. He counted his steps and, each day, pressed a little farther.

Laurene got down on her knees and looked into his eyes.

“You can do this, Steve,” she said. His eyes widened. His lips pressed into each other.

He tried. He always, always tried, and always with love at the core of that effort. He was an intensely emotional man.

I realized during that terrifying time that Steve was not enduring the pain for himself. He set destinations: his son Reed’s graduation from high school, his daughter Erin’s trip to Kyoto, the launching of a boat he was building on which he planned to take his family around the world and where he hoped he and Laurene would someday retire.

Even ill, his taste, his discrimination and his judgment held. He went through 67 nurses before finding kindred spirits and then he completely trusted the three who stayed with him to the end. Tracy. Arturo. Elham.

One time when Steve had contracted a tenacious pneumonia his doctor forbid everything — even ice. We were in a standard I.C.U. unit. Steve, who generally disliked cutting in line or dropping his own name, confessed that this once, he’d like to be treated a little specially.

I told him: Steve, this is special treatment.

He leaned over to me, and said: “I want it to be a little more special.”

Intubated, when he couldn’t talk, he asked for a notepad. He sketched devices to hold an iPad in a hospital bed. He designed new fluid monitors and x-ray equipment. He redrew that not-quite-special-enough hospital unit. And every time his wife walked into the room, I watched his smile remake itself on his face.

For the really big, big things, you have to trust me, he wrote on his sketchpad. He looked up. You have to.

By that, he meant that we should disobey the doctors and give him a piece of ice.

None of us knows for certain how long we’ll be here. On Steve’s better days, even in the last year, he embarked upon projects and elicited promises from his friends at Apple to finish them. Some boat builders in the Netherlands have a gorgeous stainless steel hull ready to be covered with the finishing wood. His three daughters remain unmarried, his two youngest still girls, and he’d wanted to walk them down the aisle as he’d walked me the day of my wedding.

We all — in the end — die in medias res. In the middle of a story. Of many stories.

I suppose it’s not quite accurate to call the death of someone who lived with cancer for years unexpected, but Steve’s death was unexpected for us.

What I learned from my brother’s death was that character is essential: What he was, was how he died.

Tuesday morning, he called me to ask me to hurry up to Palo Alto. His tone was affectionate, dear, loving, but like someone whose luggage was already strapped onto the vehicle, who was already on the beginning of his journey, even as he was sorry, truly deeply sorry, to be leaving us.

He started his farewell and I stopped him. I said, “Wait. I’m coming. I’m in a taxi to the airport. I’ll be there.”

“I’m telling you now because I’m afraid you won’t make it on time, honey.”

When I arrived, he and his Laurene were joking together like partners who’d lived and worked together every day of their lives. He looked into his children’s eyes as if he couldn’t unlock his gaze.

Until about 2 in the afternoon, his wife could rouse him, to talk to his friends from Apple.

Then, after awhile, it was clear that he would no longer wake to us.

His breathing changed. It became severe, deliberate, purposeful. I could feel him counting his steps again, pushing farther than before.

This is what I learned: he was working at this, too. Death didn’t happen to Steve, he achieved it.

He told me, when he was saying goodbye and telling me he was sorry, so sorry we wouldn’t be able to be old together as we’d always planned, that he was going to a better place.

Dr. Fischer gave him a 50/50 chance of making it through the night.

He made it through the night, Laurene next to him on the bed sometimes jerked up when there was a longer pause between his breaths. She and I looked at each other, then he would heave a deep breath and begin again.

This had to be done. Even now, he had a stern, still handsome profile, the profile of an absolutist, a romantic. His breath indicated an arduous journey, some steep path, altitude.

He seemed to be climbing.

But with that will, that work ethic, that strength, there was also sweet Steve’s capacity for wonderment, the artist’s belief in the ideal, the still more beautiful later.

Steve’s final words, hours earlier, were monosyllables, repeated three times.

Before embarking, he’d looked at his sister Patty, then for a long time at his children, then at his life’s partner, Laurene, and then over their shoulders past them.

Steve’s final words were:

OH WOW. OH WOW. OH WOW.


- Posted from my iPad2

Location:Georgetown, TX,United States