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Patients’ FDA Act

April 26, 2012 By Leave a Comment

Sens. Richard Burr (R., N.C.) and Tom Coburn (R., Okla.) recently rolled out a new bill designed to significantly improve the regulation of drugs and medical devices at the FDA. The bill, called the “PATIENTS’ FDA Act” is “a bill to help make sure that the FDA fulfills its mission to ensure that patients have access to cutting-edge, life-saving drugs and devices as quickly as possible.”

The basic premise behind this piece of legislation — as expressed by Senators Burr and Coburn — is that the FDA needs to be subject to a great deal more Congressional oversight if it is to fulfill its public health mission in a predictable and timely manner and to keep medical innovation and job creation (related to the development of new drugs, diagnostics, and medical devices) from going overseas.

I found Forbes take on the bill interesting.

Avik Roy states “A lot of the Burr-Coburn plan involves requiring the FDA to do things it’s already supposed to be doing. But there are areas where Congressional action would be especially useful: in improving the accountability and transparency of FDA decisions; in modernizing the FDA’s use of information technology, given the enormous amount of clinical data it must track; reforming the agency’s clumsy conflict-of-interest rules; and making sure the agency is always thinking about the costs, as well as the benefits, of retarding innovation.

The basic problem with the FDA is its perverse incentives. The agency gets punished by Congress and the public when an approved product runs into safety problems, whereas nobody complains about the patients who are harmed when an important new medicine is stalled by the agency. As former FDA Commissioner Andrew von Eschenbach recently put it in the Wall Street Journal, “Until FDA reviewers can be scientifically confident of the benefits and risks of a new technology, it is their duty is to stop it—and stop it they will.””

The entire legislation is 55 pages in length, although the summary is a mere 7 pages.  Something to keep on your bedside table to lull you to sleep at night…

 

 

 

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Happy Anniversary Medical Device Tax

March 26, 2012 By Leave a Comment

It has been two years since the controversial 2.3% medical device tax was signed into law as part of the Affordable Care Act. Set to go into effect in January 2013, the medical device tax has been at the center of a heated national debate that only seems to escalate as the industry’s doomsday approaches. In addition to concerted efforts to repeal the tax, the medical device industry and its supporters have emphasized the serious potential consequences associated with implementation of the tax. Among them are large-scale layoffs, relocation of operations out of the country, barriers to innovation, and prices being passed on to consumers—an outcome that negates the purpose of the bill.

Will all the gloom and doom come to fruition?  Only time will tell. A fair portion of medtech professionals continue to hold out hope. In fact, in an online poll conducted last month on mddionline.com, optimists edged out pessimists with 55% of respondents saying that they thought that the tax would be repealed.

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Any Room Can Be an OR

March 23, 2012 By Leave a Comment

A new product called Arc Sterile from IMEX brings purified, surgical quality air to just about any environment.  The portable system can be easily wheeled and quickly setup over a surgical table, turning any room into an OR.  It features HEPA filters to clean the air and fans that sweep the environment free of unwanted particles.

I’ve talked before about my favorite medical drama, Grey’s Anatomy.  In the show, there always seems to be a shortage of operating rooms. This leaves the doctors having to wait until a room opens up, every minute that passes putting their patient in grave danger of not making it, and thus adding to the drama.  If real life hospital situations are anything like this show, an Arc Sterile would come in handy as doctors trapped in a stuck elevator attempt to bravely save their dying patient by doing a heart surgery with nothing to work with but their bare hands and a couple of tools that the other doctors are able to slip through a small crack between the elevator doors which they have managed to pry open. (That is, provided someone had the foresight to strategically store an Arc Sterile in a secret compartment in the elevator ahead of time.)  OK- well hopefully reality would be a bit more realistic.  Nonetheless, it is still a valuable idea.

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Insulin Pump Hacking

March 14, 2012 By Leave a Comment

This is something I never would have considered possible, but it certainly does make you stop and think…

With a radio device, Barnaby Jack, a researcher with McAfee Inc, showed how a common insulin pump — which is implanted inside the body of a diabetic patient to deliver prescribed doses of the chemical into the bloodstream — can be hacked to deliver doses higher than required, triggering fatal consequences.

Although this may seem like fodder for the latest thriller novel, it is in reality rather frightening. It goes to show you that although innovation is great, with it comes greater responsibility.

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Clean Hands, Warm Computer

February 24, 2012 By Leave a Comment

Recently, a group of psychologists from Germany and the United Kingdom evaluated whether a web-based intervention could affect the frequency of hand-washing in the home.  The team of psychologists concluded strong evidence now exists that web-based interventions could be an effective way to promote hand hygiene in the home.  It was determined that the intervention had “positive indirect effects on change in hand-washing via intentions”.

Does this mean that if I were to send my child messages about washing his hands on the web, he would be more likely to soap up than he is when I constantly nag him about it? What about other things, like cleaning his room or doing his math? Could there be “positive indirect effects” on with web-based intervention in these areas also?  Well, it’s certainly something to consider…

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Cockroaches Produce Electricity

February 9, 2012 By Leave a Comment

Researchers at Case Western Reserve University managed to generate electricity from naturally occurring chemicals within the abdomen of the false death’s head cockroach. How does this help us, you might ask?  The thought is that if we can learn to harvest energy from within the human body, we may spur the development of a new generation of implantable devices that can work as long as the patient is alive, and therefore producing electricity, without requiring bulky batteries, a typical stumbling block for biomedical engineers.

I’m all for advances in technology, but I can’t seem to wrap my mind around this one.  Part of the problem is probably that I am a cockroachaphobe.  I don’t mind most bugs (except spiders), but I am having troubles getting over the fact that I find cockroaches creepy, ugly, and disgusting. Why couldn’t a cute bug, like a lady bug, have chemicals capable of producing electricity in its belly?

 

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Fashion Sense

February 8, 2012 By Leave a Comment

Post image for AutoSense wearable sensors and smartphone app helping to manage health effects of stress

 

The effects of stress on health have been a main focus area for public health research, but progress has been limited due to a lack of wearable sensors that can be worn effectively in the field, until now. Researchers at Ohio State University recently analyzed wireless, wearable sensors that are a part of a system developed by AutoSense.  The system’s sensors effectively collect and processes cardiovascular, respiratory, and thermoregularity measurements that can inform about the general stress state of test subjects in their natural environment.

Will this change the way stress is analyzed in the future?  Perhaps.  However, I’d like to see it in a nice girl-cut t-shirt.  I always say “A woman should never sacrifice  fashion for comfort”, or in this case, stress management.

 

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Be Still My Heart

February 6, 2012 By Leave a Comment

It defies explanation that an artificial heart that doesn’t actually beat would be functional.  Even more amazing, one of these beatless hearts was actually implanted in a man who was dying from amyloidosis and had no other options.  The operation saved his life, although by current medical criterion (he had no heartbeat) afterwards he was dead.

This short film titled “Heart Stop Beating” is truly amazing.

 

 

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Don’t be Afraid

January 11, 2012 By Leave a Comment

Are you afraid of heights, or do you break out in a cold sweat every time you have to get on a plane? Perhaps you can’t stand to be shut in a small space or you run screaming from the room if a spider is present.  You are not alone.  Phobias are the most common psychiatric problems. Traditional treatment consists of psychotherapy, specifically exposure to the stimulus with attempts to control the response. Now, a new offering from Self-Study Apps purports a similar approach in the comfort of your own home.

The best part is, not only do you get in-home convenience, but the app is much less expensive than a visit to your friendly neighborhood therapist.  The app goes for $2.99 and has different sections for dealing with dentists, spiders, and flying.  So, for those of you who have a phobia of therapists, or a shallow wallet, this is the perfect solution for you.

 

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It’s the End of the World as We Know It

November 4, 2011 By Leave a Comment

Two researchers from University of California, San Francisco and University of Oslo are reporting that inhaled anesthetics significantly contribute to the destruction of the ozone layer and add to the overall global warming gas content in the atmosphere.

As if we don’t have enough to worry about already… Now, as we are already dealing with the stress over any upcoming medical procedures we may have, we have to be concerned that we may be contributing to the end of the world as well.

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Military Tents Help Prevent Infection

October 21, 2011 By Leave a Comment

The following is an innovative idea that I never would have considered:

DHS Systems, a company that manufactures military tents, has unveiled a new feature for their products that may help prevent the spread of pathogens.  XYTEX 500, as the technology is called, is used to modify the inside fabric of the tent to make the surface be full of nano sized spikes that can rapture cell walls.  Bacterial pathogens flying around the tent, a space that can be dangerously crowded and full of patients with exposed wounds, will have a hard time making a safe landing, hopefully leading to fewer infections.

The fabric is also resistant to mold, mildew, and fungus and the anti-microbial properties are permanent for the life of the fabric and do not fade over time.

This is a great advancement for the well-being of our military health-care personnel and their patients.  My thought is perhaps it could also be used at sleep-away camps where nasty colds are only a sneeze away.

 

 

 

 

 

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What Will They Think of Next? From Surround Smell to the Extreme Urge to Urinate

October 19, 2011 By Leave a Comment

I saw this article titled “The Study of the Extreme Urge to Urinate Wins Ig Nobel Medicine Prize and Other Scientific Silliness” and, I’ll admit it, I had to take a look.

The 2011 Ig Nobel Medicine prize went to a group of investigators from around the world who examined the effects of the urge to urinate.  In one study, entitled  ”The effect of acute increase in urge to void on cognitive function in healthy adults,” volunteers consumed 250 mL of water every 15 minutes until they could no longer resist the urge to micturate, all while being subjected to standardized cognitive tests.  Unsurprisingly, “having an extreme urge to void exerted a large negative effect on attentional and working memory functions (d?>?0.8)” (Reference below).  In fact, the magnitude of the detrimental effect on working memory was greater than that of being sleep-deprived for 24-hours or having a blood alcohol concentration of 0.05%.

All I can say is, this gives new meaning to the phrase “Don’t drink and drive.”

As if studying the extreme urge to urinate wasn’t enough, I came across another uniquely titled article called “Smell-O-Vision Product Concept Brings the Smell of the Clinic Home.”

Olf-action, a French manufacturer of olfactory generators for the film industry, has added an interesting product design to their portfolio of “olf-actuators.” The device is called the SMELL-IT and is essentially a surround sound system for your nose.

The SMELL-IT concept contains a number of disposable scent capsules, which it can be programmed to release much like an automated scratch and sniff. The product design is quite slick, looking like a cross between a desktop speaker array and a jet-engine. According to the company’s website, Olf-Action currently supplies 40 different scents for their existing devices ranging from “hospital atomsphere” to “smell of cakes”.

Will either one of these discoveries revolutionize the health-care world? Probably not, but I find it fascinating that even if your interest is something as bizarre as  urination urges or surround smell, there is a place for you in the medical industry.

 

 

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No More Fake IDs?

October 10, 2011 By Leave a Comment

India is embarking on an massive, arduous program aimed at addressing a simple problem with complex ramifications, a task that has implications for the rest of the world.  India’s Unique Identification Project, also known as Aadhaar, (which means “the foundation”) is a large scale biometrics project.

Its goal is to issue identification numbers linked to the fingerprints and iris scans of every single person in India.  This would seem to be an almost impossible task as there are 1.2 billion people in India, speaking more than 300 languages and dialects. The biometrics and the Aadhaar identification number will serve as a verifiable, portable, national ID.

The hope is that this program can be used for people to have access such things as food subsidies, basic medicine, and housing programs. The potential benefits to medicine are also significant. For instance, a single vaccination worker travelling to a remote village with just a smartphone, a few peripherals, and supplies, if linked to a centralized EHR, could immediately know each person’s medical history and provide a much more complete service.

I can’t even imagine the logistics involved with trying to implement a program such as this.

If all goes well, will we in the USA attempt to implement a similar program in the future?   For those of us who tend to frequently lose things, such as our driver’s licenses, this would be great.  Imagine going into a bar and simply having to press your fingertip onto a sensor to verify your age, or not having to show umpteen pieces of ID at the license branch.  The flip side is, could an overly zealous government take advantage of the situation?  If I go into a bar several times a week scanning my finger each time, will my health insurance suddenly go up as a result of being a “high risk” patient?  Will we someday look back nostalgically on the days when our college roommate was able to sneak into the local watering hole with the “borrowed” driver’s license of 26-year old?

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BioHarness Helps to “Measure Life”

July 22, 2011 By Leave a Comment

Earlier this year,  I blogged about the shirts that Under Armour debuted at the NFL Combine.  The shirts contained electronic sensors that measured heart and breathing rates and skin-surface temperature, and a triaxial accelerometer to measure force and direction. The sensor pack was developed by Maryland-based Zephyr Technology.

Now Zephyr Technologies has struck a deal with AT&T to embed AT&T’s 3G/4G technology inside its BioHarness™ wearable biosensor technology. This deal has major implications for the future of the company’s mobile apps, and gives the company a jump-start on its competitors.

Zephyr’s stated mission is to “Measure Life” and they license their products to academic researchers, military, athletes, physicians and anyone else who wants to build custom mobile applications using the company’s wearable sensor technologies and remote monitoring devices.

“With the BioHarness™, connected by AT&T, cardiologists will be equipped to remotely monitor ECGs, athletes will have the ability to share live performance data, and medics will have on-demand visibility into the condition of military personnel – all occurring seamlessly over the AT&T network,” said Glenn Lurie, president of emerging devices, resale and partnerships, AT&T. “Today, smartphones capture Zephyr’s BioData and send it to the cloud for analysis, presentation and health record purposes. By Embedding wireless into the BioHarness™, we’re arming healthcare professionals with the technology needed to access timely data in ways not previously possible.”

Once again, technology continues to amaze me…

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South Africa Goes Mobile

July 13, 2011 By Leave a Comment

In South Africa, there is no shortage of diversity. Immigrants, natives, city-dwellers and tribal members share a landscape that ranges from cosmopolitan to provincial. However, even in rural areas where basic infrastructure may be lacking, people can now stay connected to family and keep up on global events through their cellphones. Thus, the mobile technology boom has led to a leap-frog effect on communication.

Now, taking advantage of this mobile infrastructure, South Africa has started to roll out a series of new projects aimed at improving access and lessening the burden on the health system.

  • Cell-life, a project involved with the government’s HIV testing campaign, using donated phones
  • eThekwini – a S. African Dept of Health endeavor to use cellphones in the monitoring and management of Tuberculosis patients
  • Patient data collection via cellphone by S. African-based research company, Mobenzi.

I must confess, I never would have thought of South Africa as a place that would have a “mobile health technology boom”, but I am pleased to see that my narrow mindedness is not a reality and that South Africans may soon be using mobile technology to improve their health system.

I also couldn’t help but notice that most of the technologies being developed in South Africa utilize “basic” cellphones. This is because, while most South Africans have cellphones, only a limited number have smartphones.  This makes me feel like there is still hope for my “basic cellphone carrying” self.  If there are technologies being developed that utilize “my kind,”  perhaps I can hold out from purchasing, and thus having to learn how to use, a smartphone for awhile longer.

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