Tuesday, January 29, 2013

The Future of Medicine Is Now - DNA Sequencing for Routine Checkups

DNA Sequencing for Routine Checkups
Amy Dockser Marcus - The Wall Street Journal

At a genetics conference in November, Oxford Nanopore Technologies unveiled the first of a generation of tiny DNA sequencing devices that many predict will eventually be as ubiquitous as cellphones—it's already the size of one.

Since the first sequencing of the human genome was completed in 2003 at a price tag of over $2 billion, the speed, price and accuracy of the technology have all improved. Illumina Inc. ILMN -1.19% has dropped its price for individual readouts to $5,000; earlier this year, Life Technologies introduced a sequencer it says can map the human genome for $1,000. The smallest machine is now desktop-size.

But nanopore sequencing devices, which are designed to be even smaller and more affordable, could speed efforts to make gene sequencing a routine part of a visit to the doctor's office. DNA molecules are exceedingly long and complicated; that makes them hard to read. Nanopore technology measures changes in the molecules' electrical current as the DNA is threaded in a single strand through tiny holes called "nanopores" created in a membrane.

So far, U.K.-based Oxford has released the results of sequencing a virus genome with this technique. The company hasn't provided data, however, showing that the sequencers can analyze the much larger human genome. A spokeswoman for Oxford says the company is working hard toward being able to sell devices, including one that is expected to cost under $1,000, though it doesn't yet have a launch date.

Amit Meller—an associate professor at Boston University, a scientific adviser at Oxford and the co-founder of Noblegen Biosciences—is at work on another nanopore device that he says would use fluorescent signals to read the DNA information. His company is still a number of years away from a prototype, but Dr. Meller says the goal is to speed up sequencing even more—with results in a few hours, not the current weeks or days, at a cost of less than $100.

A version of this article appeared December 29, 2012, on page C2 in the U.S. edition of The Wall Street Journal
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Monday, January 28, 2013

And this is supposed to make health insurance less expensive?

BUSINESSJanuary 25, 2013, 6:35 p.m. ET
Device Makers Add Fees to Cover Health Tax


Some medical-device companies faced with a new tax meant to help finance the health law are hoping someone else will pick up the tab: their hospital customers.

Companies including feeding-tube supplier Applied Medical Technology Inc. and respiratory-valve maker Hans Rudolph Inc. quietly added new surcharges or warned hospitals of price increases to cover the new 2.3% tax on device sales that went into effect Jan. 1, according to letters and invoices from nine manufacturers sent to hospitals that were reviewed by The Wall Street Journal.

"As a result of this law, we will be forced to charge the 2.3% federal medical device excise tax to you," said a letter to hospitals from Cardica Inc., CRDC +1.28% a maker of heart-surgery tools. A senior Cardica executive declined to comment.

Hospitals executives say they are also footing the bill for the tax as they sign new contracts with higher prices and as companies discontinue older, inexpensive products in favor of more costly models. Executives for Applied Medical declined to comment. Hans Rudolph and other device makers didn't respond to requests for comment.

The device tax adds to manufacturers' costs in an era when hospitals have become more sophisticated negotiators and have driven prices down—and as demand for medical devices has softened after economic conditions slowed the growth in use of health services.

"It's kind of a triple whammy [for device makers], and it could come back to bite us," said Adam Robinson, contract manager at Beth Israel Deaconess Medical Center in Boston. Mr. Robinson said Beth Israel noticed a new 2.3% surcharge—labeled as a "medical device adjustment"—in a bill for radiology supplies sold by a small company. Procurement officials say they have seen the charges appended to commodity items sold by "mom-and-pop" outfitters.

Most devices are purchased under contract or through group-purchasing organizations, however, which could help hospitals push back against the charges.

Larger companies, such as Medtronic Inc. MDT 0.00% and General Electric Co.'s GE 0.00% GE Healthcare, haven't explicitly tacked on surcharges, said Mr. Robinson, who manages a $150 million supply budget, and other hospital supply-chain managers. He said he expects that, as contracts end, bigger vendors will seek to "bake it in to the contract renewals."

Medtronic said it expected the tax to cost $125 million to $175 million annually and said it would take funding away from other possible investments. GE said it plans to "manage the impact of this new expense just like any other expense."

As health-care businesses—and employers that cover workers' health costs—grapple with the new law, many are seeking ways to divvy out new costs stemming from the law. Device companies in particular have argued that their new tax, which applies to sales rather than profits, is unfair. Hospitals and drug companies face new costs, but in exchange will get a swath of newly insured patients, while device lobbyists argue that most of the patients who need devices are older and already covered by Medicare.

"This theory that there's going to be a windfall [of new patients for device makers] just doesn't hold water," said JC Scott, chief lobbyist for device group AdvaMed. The group has been pushing for repeal of the tax and hopes a new measure to end it will be introduced in Congress in the next few weeks.

Meanwhile, hospitals have argued that, because they had already agreed to give up $155 billion in the form of Medicare-payment cuts over 10 years to help pay for the health law, other sectors should also cough up their own share. "We're disappointed," said Mike Rock, senior associate director for federal affairs at the American Hospital Association. The group is lobbying the Internal Revenue Service to draft rules preventing device makers from foisting the tax on to their members.

Publicly passing on costs companies attribute to the health-care overhaul has become a rallying cry for some health-law opponents in other industries, too. Papa John's International Inc. CEO John Schnatter said at a shareholders meeting last summer that the health law would boost pizza prices by 11 cents to 14 cents per pie. And, a Denny's franchise owner in Florida threatened a 5% health-law surcharge to customers before public pressure, including from Denny's Corp.'s corporate offices, quashed the plan.

Insurers, too, have attributed premium increases paid by their customers to the health law. Aetna Inc. AET 0.00% Chief Executive Mark Bertolini said in December that premiums for a subset of small business customers could "go up as much as 100 percent."

Though the device surcharges noted on hospital invoices are sometimes tiny, the device tax could add up to big dollar amounts. Tampa General Hospital received a bill this month tacking $5.73 on to the cost of a $249 throat device to cover the tax. But, the 1,000-bed hospital buys about $114 million worth of taxable items a year, estimates Mark Campbell, vice president of materials management. The tax will generate $29 billion for the government's health-care overhaul by 2022, congressional budget forecasters estimate.

It might be harder for hospitals to spot cases where device companies raise prices to cover the tax, without explaining it on bills. Nevertheless, companies seen baking in the cost of the tax would feel "a very swift and vocal objection in the marketplace," said Pete Allen, senior vice president of sourcing operations at the hospital-owned group-purchasing organization Novation.

Device makers have also said they would cut costs with layoffs or reductions in research spending to help offset the impact of the tax. In November 2011, for instance, Stryker Corp., SYK 0.00% a maker of hip and knee implants, said it would lay off 1,000 employees in part to brace for the tax. Stryker didn't respond to a request for comment.

Some hospitals are warning device vendors that they won't budge on price, citing multiyear contracts that include fixed prices. "If out of nowhere, you come back with a 2.5% price increase, we're just not going to honor it," said Bill Matthews, vice president of supply chain at Lehigh Valley Health Network in Allentown, Pa.

—Jon Kamp contributed to this article.
Write to Christopher Weaver at christopher.weaver@wsj.com

A version of this article appeared January 26, 2013, on page B3 in the U.S. edition of The Wall Street Journal, with the headline: Device Makers Add Fees to Cover Health Tax.

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Brotherly Love Prompts Young Entrepreneur’s Autism App

Brotherly Love Prompts Young Entrepreneur’s Autism App
Ina Fried
JANUARY 28, 2013 AT 4:00 AM PT

When Jonathan Izak looks at AutisMate, he wishes something similar had existed when his brother was younger.

The iPad app, which Izak and colleagues have spent the last 18 months creating, is designed for autistic children — kids like Izak’s brother.

“I think it definitely would have helped him [with his] acquisition of language,” Izak said.

In recent years, the iPad has been a hotbed for apps designed to help those with autism and other special needs, so AutisMate will have plenty of company when it hits the App Store later this week.

Some apps, such as Proloquo2go, replicate a staple of the autism field — the sentence builder that kids can use to build sentences using symbols and basic concepts such as “I want.” Such devices have long existed as standalone machines that can cost thousands of dollars. Other autism apps mimic the kinds of flash cards that can be used to visually represent things that one has trouble verbalizing.

AutisMate aims to handle those kinds of functions, but doesn’t stop there. One of its key features is designed to help kids even before they are able to piece together sentences that explain their desires. The scene-builder module uses pictures of the child’s own settings, such as their bedroom, work room, living room and kitchen.
Support for GPS allows the child to see one set of rooms, for example, at home and another set of scenes when at school.
The scene builder can also incorporate a variety of licensed videos to help with other settings, such as visits to the dentist or barber shop, as well as to help educate on concepts such as how to make it clear when they need a break.

Another portion of the app breaks tasks up into different components and time frames, tying completing the activity to a reward, such as a cookie.
At $150, AutisMate is certainly pricier than the average app, but it’s in the same ballpark as Proloquo2go and other comprehensive software for those with special needs.
“It’s generally in the range of apps out there,” Izak said. That said, there are other apps — including free and low-cost apps — for specific functions. There’s even an app, Autism Apps, that is a guide to other autism-related mobile apps.

Izak left his role at the University of Pennsylvania’s linguistics department to start work on AutisMate. Initially, he did the hands-on programming, but now he serves as CEO of the 10-person New York startup behind the app.
Eventually, Izak hopes to build his tiny company into a larger educational software firm.

“Really, the vision when I started this whole thing was pretty broad — to use modern technology to help those with a variety of special needs,” Izak said. “I started with autism because it was very close to home, and close to my heart.”

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Wednesday, January 23, 2013

How do you connect the dots between CAT scan and your cell phone?

From the Georgetown Advocate
The Tech Savvy Patient
Webster Russell

First a little relevant trivia. Unless you are my age or a fan of history, the chance that you would recognize the name William Shockley is remote. Without Mr. Shockley, it would be unlikely that the likes of Apple, Microsoft, Dell, or Intel would exist. If they didn't exist one wonders if CAT scans, MRI'S, Cancer radiation therapies, or pocket diabetic monitoring devices would exist. For that matter, it seems unlikely there would be the internet, Direct TV, Dish, cable companies, cell phones, or your flat screen TV. You see he invented the transistor, the component that today's electronics are based on.

Enough trivia, now to the question I posed two weeks ago. On January 10, 2007 Steve Jobs walked out on San Francisco's Moscone Center stage and announced the creation and release of the iPhone. Starting on June 29, 2007 you could not only have a revolutionary phone but you could also carry a fully functional computer in your hand or pocket, whose software did its thing with a touch of your finger on the screen.

Think about it for a minute. Prior to that June date access to the Internet was limited to your home or the library. With the advent of the smartphone internet access and information gathering was now only limited to the signal strength of your carrier.

Then of course came the invention of the “app”. Prior to the “app”, software was in the $25 to $100 range. Now smart phone software cost between $0.99 to $10.00. Those “apps” made it possible to do word processing, spread sheet utilization, storing of webpages, and of course games on a device that fits in your pocket. Add to that it had a camera and the ability to work with your home wifi system. The world was now literally at your fingertips.

Then on January 28, 2010 Mr. Jobs turned the PC industry upside down with the introduction of the IPad tablet. It had more memory and a much bigger screen than the iPhone, it was faster, and it ran the same apps as the iPhone.

I go through all this history, not to bore you with dweeb like facts, but to outline the changes that were, in part, responsible for the birth of what I call the Tech Savvy Patient. This individual is better informed and prepared to partner with their physician in the management of their Healthcare and that fact changed the patient/physician relationship in profound ways.

Now having introduced you to the Tech Savvy Patient I thought I would ask you to ponder how a priest, the Internet, and Alzheimer's created a tech savvy patient? Stay tuned.

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Location:Klondike Dr,Georgetown,United States

Wednesday, January 16, 2013

The future of Medicine is now - Matching a Tumor to a Drug

Matching a Tumor to a Drug
Ron Winslow - The Wall Street Journal

Our growing understanding of the workings of the human genome is posing a new challenge: How to use that data to change the course of disease. Consider cancer. As seen through a gene-sequencing machine, some cancers can appear as at least a dozen different genetic diseases, some of which have been shown to respond uniquely to a specific drug. But how do cancer doctors quickly match a patient’s tumor with a drug that targets it?

One answer is a test developed by Foundation Medicine Inc., a Cambridge, Mass., startup whose scientific founders include one of the leaders of the Human Genome Project. The test, officially launched last June, enables doctors to test a tumor sample for 280 different genetic mutations suspected of driving tumor growth.

This changes “everything in terms of how we approach patients with cancer,” says David Spigel, director of lung-cancer research at the Sarah Cannon Research Institute in Nashville, Tenn. He used the test in one patient with advanced disease and few apparent options. She turned out positive for an alteration in a gene targeted by several drugs currently in development. She was signed up for one of the studies. A short time later, “she’s like a new person,” he says. “She’s off pain medicines. She gained her weight back.”

Michael Pellini, Foundation’s chief executive officer, says that more than 600 oncologists have requested the test, which lists for $5,800. So far, he says, about 70% of cases have turned up a mutation that is potentially targeted by a drug on the market or in a clinical trial.

In one recent case, Dr. Pellini says, a sample from a woman with advanced pancreatic cancer yielded a response for “her2,” an alteration associated with a certain form of breast cancer. She was treated and her cancer responded to the breast-cancer drug Herceptin. Few oncologists would think to look for her2 in a patient with pancreatic cancer, he says.

A version of this article appeared December 29, 2012, on page C2 in the U.S. edition of The Wall Street Journal

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Location:Georgetown Tx

Monday, January 14, 2013

The Future of Medicine is Now - Letting Your Body Fight Cancer

Letting Your Body Fight Cancer
Ron Winslow - The Wall Street Journal

Few advances in cancer care are generating more enthusiasm than harnessing the power of the immune system to fight the disease.

Tom Stutz is one reason why. Last April, the 72-year-old retired lawyer was confined to a wheelchair, struggling for every breath, and required help with simple tasks such as eating, all because of a previously diagnosed skin cancer that had spread to his lungs and liver. “I was ready to check out, to be honest,” he says.

That month, he began taking an experimental drug known as MK3475. Six weeks later, he started feeling better. Today, Mr. Stutz has jettisoned the wheelchair and regularly walks a 3.5-mile loop near his home in Los Angeles. “I feel terrific,” says Mr. Stutz, who learned after a checkup in the fall that his tumors had shrunk by about 65% so far.

For decades, cancer researchers have wondered why the immune system typically doesn’t treat tumor cells as invaders and target them. Part of the mystery was recently solved: Tumors protect themselves by hijacking the body’s natural brake for the immune system.

MK3475, being developed by Merck & Co., is among a new category of drugs that release the brake, unleashing an army of immune cells to hunt down the cancer. A recent report from a trial in which Mr. Stutz participated said that of 85 patients who took the drug, 51% saw their tumors significantly shrink; in eight cases, the tumors couldn’t be detected on imaging tests.

Still, not everyone was helped. And unleashing the immune system can put normal cells in harm’s way: In studies of MK3745 and similar drugs, some patients developed serious side effects related to immune-system response, including a small number who died.

But interest in the approach is strong. Bristol-Myers Squibb Corp.’s drug Yervoy, approved by the Food and Drug Administration in 2011, is the first of its kind to reach the market. The company has others in development. GlaxoSmithKline PLC and AstraZeneca’s MedImmune are among others exploring ways to activate the immune system against cancer.

One reason for the excitement is that most “solid” tumors—colon, lung, breast, prostate—use the same or a similar mechanism to hide from the immune system. Obstructing that mechanism may have a broad impact across a variety of malignancies.

A version of this article appeared December 29, 2012, on page C2 in the U.S. edition of The Wall Street Journal

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Location:Georgetown Tx

Saturday, January 12, 2013

The Future of Medicine is Now - Rejigging Your Genes

Rejigging Your Genes

After years of controversy, gene therapy is poised to become a viable option for a variety of often life-threatening medical conditions, especially those resulting from a single defective gene. Last month, the European Union approved Glybera for treatment of a rare genetic disease, making it the first gene-therapy medicine approved in the Western world. The approval comes amid a flurry of research showing broader promise for the approach in a range of disorders, from a rare form of blindness to hemophilia to heart failure.

Though outright cures are still elusive, gene therapy "is beginning to emerge as a meaningful clinical" strategy, says Stephen J. Russell, director of molecular medicine at the Mayo Clinic in Rochester, Minn.

Gene therapy's tantalizing attraction is that a single treatment has the potential to cure lethal diseases by enabling normal genes to take over for defective ones. The treatment involves loading a functional gene onto a fragment of a deactivated virus that transports the gene to a cell's nucleus, where it is intended to take over.

The idea suffered major setbacks in 1999 when a U.S. teenager died in a gene-therapy trial and again soon after when several children in Europe developed leukemia after receiving gene therapy.

The episodes prompted criticism that researchers had moved too quickly. Scientists returned to the laboratory, hoping to develop better delivery vehicles and to improve both the safety and efficacy of the treatments.

Bluebird Bio, a Cambridge, Mass., gene-therapy startup, expects to launch studies next year for two rare genetic diseases: childhood adrenoleukodystrophy, or ALD, an inherited and lethal neurological disorder; and beta thallasemia, which causes the destruction of red blood cells and leads to life-threatening anemia. Its technique involves extracting a patient's own bone-marrow cells, isolating certain stem cells, and delivering the gene therapy before returning the cells to the body.

Four boys in Paris with ALD have been successfully treated, says Nick Leschly, Bluebird's president and chief executive officer, including two treated nearly six years ago. They are now in their teens and would otherwise likely have died before age 10, he says.

Other gene-therapy efforts include Novartis SA's NOVN.VX -0.43% partnership with the University of Pennsylvania on a treatment for cancer, GlaxoSmithKline's alliance with Italian scientists for a range of disorders, and Celedon Corp.'s clinical trial of a gene therapy in patients with advanced heart failure.

—Ron Winslow
A version of this article appeared December 29, 2012, on page C2 in the U.S. edition of The Wall Street Journal

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Tuesday, January 8, 2013

The Future of Medicine Is Now - growing a Heart

Growing a Heart
Ron Winslow - Wall Street Journal

Surgeons at Boston Children’s Hospital have developed a way to help children born with half a heart to essentially grow a whole one—by marshaling the body’s natural capacity to heal and develop.

About 1,000 babies are born in the U.S. each year with a condition called hypoplastic left-heart syndrome, the result of a genetic anomaly that leaves them without a functioning left ventricle, the heart’s main pumping chamber. Without a surgical repair, the defect is almost always fatal.

A new surgical strategy helped 9-year-old Alexa Rand’s body to essentially grow half a heart into a whole one.

The standard treatment is a series of three open-heart operations to reroute circulation so that the right ventricle can take over pumping blood to the body’s organs and extremities. But the right ventricle “is meant to handle low-pressure blood flow to the lungs,” says Sitaram Emani, the surgeon heading the effort on the new approach. “Now you’re asking it to do the work of a high-pressure system and to do that work for many years. Eventually it fails.” That’s one reason why 30% of patients or more don’t survive to adulthood.

Dr. Emani and his colleagues devised a complex strategy to open obstructed valves and repair other malformations to direct blood flow to the left ventricle instead of away from it. That triggers biological processes that promote the heart’s growth.

Last month, after using the approach on 34 carefully selected patients over the past decade, the doctors reported in the Journal of the American College of Cardiology that 12 now have two working ventricles. One of them, 9-year-old Alexa Rand of Kings Park, N.Y., whose treatments began in utero, is thriving. She sings, dances and surprises doctors with how long she can walk on a treadmill, says her mother, Rosamaria Rand.

The main drawback: The strategy requires one more surgical procedure, on average, and significantly more days in the hospital than the conventional surgery. The hope is, Dr. Emani says, that the long-term benefits will outweigh the extra hospital time.

A version of this article appeared December 29, 2012, on page C2 in the U.S. edition of The Wall Street Journal

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