healthcare technology

So far the internet of things hasn’t made much headway into patient care in the medical setting, but consumers are buying wellness devices for a variety of reasons. Will the medical world embrace that data?

The intersection of healthcare and connected devices was thrown into high relief these last few weeks as both Apple and Samsung unveiled ecosystems to take consumer health data and turn it into actionable intelligence.

But this week’s guests at the Weekly podacst at GigaOm are confident that as advanced as consumer-grade consumer grade health devices get, they won’t become something doctors are hot on for years to come — if ever.

In this week’s podcast Stacey Higginbotham discusses medical connected devices and where it may meet the consumer with Rick Valencia from Qualcomm Life. Will doctor’s prescribe our apps or devices? 

“If you’re dealing with a disease like cancer that can be arrived at by multiple pathways, it makes sense that you’re not going to find that each patient has taken the same path” - John McDonald, a professor in the School of Biology at the Georgia Institute of Technology in Atlanta.

If a driver is traveling to New York City, I-95 might be their route of choice. But they could also take I-78, I-87 or any number of alternate routes. Most cancers begin similarly, with many possible routes to the same disease. A new study found evidence that assessing the route to cancer on a case-by-case basis might make more sense than basing a patient’s cancer treatment on commonly disrupted genes and pathways.

The study found little or no overlap in the most prominent genetic malfunction associated with each individual patient’s disease compared to malfunctions shared among the group of cancer patients as a whole.
“This paper argues for the importance of personalized medicine, where we treat each person by looking for the etiology of the disease in patients individually,” said McDonald, 

“The findings have ramifications on how we might best optimize cancer treatments as we enter the era of targeted gene therapy.”

The research was published February 11 online in the journal PANCREAS and was funded by the Georgia Tech Foundation and the St. Joseph’s Mercy Foundation.

In the study, researchers collected cancer and normal tissue samples from four patients with pancreatic cancer and also analyzed data from eight other pancreatic cancer patients that had been previously reported in the scientific literature by a separate research group.

McDonald’s team compiled a list of the most aberrantly expressed genes in the cancer tissues isolated from these patients relative to adjacent normal pancreatic tissue.

The study found that collectively 287 genes displayed significant differences in expression in the cancers vs normal tissues. Twenty-two cellular pathways were enriched in cancer samples, with more than half related to the body’s immune response. The researchers ran statistical analyses to determine if the genes most significantly abnormally expressed on an individual patient basis were the same as those identified as most abnormally expressed across the entire group of patients.

The researchers found that the molecular profile of each individual cancer patient was unique in terms of the most significantly disrupted genes and pathways.

more at http://www.news.gatech.edu/2014/02/24/personalized-medicine-best-way-treat-cancer-study-argues

We are all encouraged to live a healthy lifestyle to avoid potentially life-threatening diseases. Exercising and good dietary habits make a big difference in maintaining our health.

However, for some diseases, our cells carry important information that can alter this equation. It is estimated that the cells in our body have about 30 thousand genes. The information they encode tells each cell how to behave within our body.

For example, a particular gene might determine the eye color of a person; another gene might tell a cell that it should become heart tissue; and yet another could be in charge of producing insulin in our body. However, sometimes these genes can be mutated, causing the gene to be either nonfunctional or functioning with a different behavior. These mutations have been found to cause some of the most challenging diseases.

Patient engagement, defined as the process of placing patients at the center and in control of their own healthcare, is becoming a chief healthcare priority

Concurrently, a number of national information infrastructure initiatives are targeting increased patient engagement and the design of health information systems that improve the availability of health information and integrate it in meaningful ways for patients.  So far, these technology goals have been advanced primarily through the design of personal health records (PHRs), patient portals, electronic health records (EHRs), and health information exchanges (HIEs).  However, we remain far from achieving the goal of truly engaging patients in their care.

Generation and exchange of health data with patients is a requirement for Stage 3 EHR meaningful use incentives. Patients are entitled to an electronically generated copy of the record of their encounters with providers. 

Sharing provider-generated data with patients is expected to promote patient engagement and accountability, but our own experiences suggest that the data that are being shared are currently a mixed blessing.  For example, one encounter report took the form of a 6-page document in which the vast majority of information was copied and pasted from previous encounters and in which there were several factual errors. The errors will be discussed with the provider during the next visit.

Certainly the report got our attention; whether empowerment will result remains an open question.  On another occasion, although the visit itself had included making decisions about future treatment, the plan was not mentioned in the document, leaving the patient to rely on her own memory and notes.

Personalized medicine, or the ability for the medical profession to tailor therapy to particular individuals’ genetic characteristics, has been a long desired but ever elusive goal for the life sciences.  However, the prospects for personalized medicine appear to be improving in recent years.  These changes come in the wake of a variety of medical advances, including human genomic testing and cancer drugs targeted for individuals with specific genetic profiles.

As public attention to understanding the human genome has increased, the topic has garnered substantial controversy and regulation in this sector is poised to increase.  The Food and Drug Administration (FDA) has already indicated its intent to regulate—most recently in a report clarifying its future role in personalized medicine and in warning letters to direct-to-consumer genetic testing companies.

The FDA maintains it has the authority to regulate personal genetic data because it defines that data as a medical device under Section 201(h) of the Food Drug & Cosmetics Act.  The agency also points to its role as the federal body charged with providing guidance on medical device claims and protecting consumers.

Some health scholars and consumers have weighed in on the propriety of regulation.  In a study of consumer attitudes toward regulating direct-to-consumer genetic testing, researchers found many consumers wanted unfettered access to genetics testing services without government regulation, but favored oversight to ensure that the information provided was high quality.

You’re one of a kind. Wouldn’t it be nice if treatments and preventive care could be designed just for you, matched to your unique set of genes?

The story of personalized medicine begins with the unique set of genes you inherited from your parents. Genes are stretches of DNA that serve as a sort of instruction manual telling your body how to make the proteins and perform the other tasks that your body needs. These genetic instructions are written in varying patterns of only 4 different chemical “letters,” or bases.

The same genes often differ slightly between people. Bases may be switched, missing, or added here and there. Most of these variations have no effect on your health. But some can create unusual proteins that might boost your risk for certain diseases. Some variants can affect how well a medicine works in your body. Or they might cause a medicine to have different side effects in you than in someone else.

The study of how genes affect the way medicines work in your body is called pharmacogenomics. 

“If doctors know your genes, they can predict drug response and incorporate this information into the medical decisions they make,” says Dr. Rochelle Long, a pharmacogenomics expert at NIH.

It’s becoming more common for doctors to test for gene variants before prescribing certain drugs. For example, children with leukemia might get the TPMT gene test to help doctors choose the right dosage of medicine to prevent toxic side effects. Some HIV-infected patients are severely allergic to treatment drugs, and genetic tests can help identify who can safely take the medicines. 

“By screening to know who shouldn’t get certain drugs, we can prevent life-threatening side effects,” Long says. 

Pharmacogenomics is also being used for cancer treatment. Some breast cancer drugs only work in women with particular genetic variations. If testing shows patients with advanced melanoma (skin cancer) have certain variants, 2 new approved drugs can treat them. 

New tools for analyzing genes are allowing doctors to personalize treatment for some lung cancer patients.

Imagine your doctor being able to scan your DNA from a biopsy and pinpoint the medicine that will work best for you. This type of high-tech approach is a clinical reality for advanced lung cancer at The Ohio State Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James).

The technology, known as next generation "multiplex" gene sequencing, analyzes 50-plus genes in DNA extracted from a tumor biopsy for particular genetic mutations.

Knowing which mutations are present in lung tumors can help doctors tailor a patient's treatment to the unique genetic features present in his or her cancer cells.

The knowledge can also help in the development of new drugs that target previously unrecognized gene mutations in lung tumors. I often compare these genes to the gas pedal in a car — when activated, these genes make the cancer grow. By breaking the linkage between the gas pedal and the motor (or interfering with these "driver" mutations) with specific targeted drugs, doctors can stop this growth and often make the cancer shrink.

That's especially important in lung cancer because the majority of patients with this disease are diagnosed in the later stages, meaning it's important to start effective therapies quickly.

For example, a patient could be given a standard chemotherapy and expect a 25- to 30- percent response rate/shrinkage of a tumor. But if the treatment team knows that a patient has a mutation in a gene called EGFR, we can offer him or her a pill (erlotinib and afatinib are approved for this use in the United States), which has a 75-percent response rate and fewer side effects.

Gene sequencing is now considered the standard of care for stage-4 lung cancer patients at The OSUCCC – James and a handful of other centers across the United States — and several clinical trials evaluating molecular targeted therapies for patients with stage-3 lung cancers will soon start at The OSUCCC – James.

Personalized medicine is the tailoring of a medical treatment to the individual characteristics, needs and preferences of a patient. Many recent advances involve using a patient's genetic information to guide his or her treatment.

Developing a truly personalized approach to patient care will require fundamental advances in the understanding of the biological, anatomical and physiological mechanisms that underlie disease, and how they are affected by environmental, genetic, social and cultural factors.

To describe its unique responsibilities and its efforts in facilitating the advancement of personalized medicine, the Food and Drug Administration (FDA) has released a new report entitled "Paving the Way for Personalized Medicine: FDA's Role in a New Era of Medical Product Development