Last Grand Rounds of Year is Up!

Nick Genes the creator of Grand Rounds has taken the helm for this weeks Grand rounds – the best of the medical blogosphere.  This edition over at blogborygmi is the highlights of the best posts of the year. Officially edition 3.14 it is a great wide range of posts and styles.  Levity, medical news, poetics it’s all there!!

Thanks to Nick for including not one but two posts from yours truly docinthemachine right up there as the first set of links!.  As Nick writes:

Bloggers are renowned for their abilities to comment on the news (often, in pajamas) but on a few memorable occasions, bloggers can report news, too. Such is the case with Dr. Steven Palter of Doc in the Machine, who announced his award-winning endometriosis diagnosis technology on his blog. It’s part of a series Dr. Palter has written, on the radical transformation of surgery.

Thanks Nick for creating GR and for the recognition!

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FDA Humanitarian Device Approval for Fetal Surgery

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The FDA approved a device set for fetal surgery from Karl Storz Endoscopy America (KSEA) under its little known humanitarian device exemption (HDE) program.  Interestingly many of the devices approved under this program are artificial hearts or heart assist devices.  It’s worth checking out the link above to see what sort of things fall into this category by the FDA.

First a bit of interesting background on the FDA HDE Program:  As the FDA says

On June 26, 1996, FDA issued a final rule to carry out provisions of the Safe Medical Devices Act of 1990 regarding humanitarian use devices (HUDs). This regulation became effective on October 24, 1996. An HUD is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects fewer than 4,000 individuals in the United States per year. A device manufacturer’s research and development costs could exceed its market returns for diseases or conditions affecting small patient populations. FDA, therefore, developed and published this regulation to provide an incentive for the development of devices for use in the treatment or diagnosis of diseases affecting these populations.

The regulation provides for the submission of an humanitarian device exemption (HDE) application, which is similar in both form and content to a premarket approval (PMA) application, but is exempt from the effectiveness requirements of a PMA. An HDE application is not required to contain the results of scientifically valid clinical investigations demonstrating that the device is effective for its intended purpose. The application, however, must contain sufficient information for FDA to determine that the device does not pose an unreasonable or significant risk of illness or injury, and that the probable benefit to health outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment. Additionally, the applicant must demonstrate that no comparable devices are available to treat or diagnose the disease or condition, and that they could not otherwise bring the device to market.

An approved HDE authorizes marketing of the HUD. However, an HUD may only be used after IRB approval has been obtained for the use of the device for the FDA approved indication. The labeling for an HUD must state that the device is an humanitarian use device and that, although the device is authorized by Federal Law, the effectiveness of the device for the specific indication has not been demonstrated.

Why HDE is so important:  In addition to being a fertility specialist I work on and consult with industy on surgical device development.  Countless times I have seen a wonderful device that fills a clinical need to help my patients.  Unfortunately, the cold reality of what it will cost to bring the device to market often prohibits anyone making it!  I am not talking about an idea that is not pursued (that happens every day) but about real devices that exist and have completed trails showing they work– only to be killed off prior to commercialization because the millions it will take would not be recouped by sales.  It can easily cost $5 million to take a product through a clinical trial and FDA approval process. If it’s just an idea in the hands of a start up it can cost $25 million to develop and bring it to market. Hense the “well doc it’s important for the disease you treat but unlessyou can tell me how to sell millions I can’t bring this to market” conversation.  You can read how military research with medical trickle-down overcomes this hurdle often here

The approval of this device for twin-to-twin transfusion syndrome:  I myself have performed this exact kind of fetal surgery. Back when I was at Yale I led a team of gyn endoscopic surgerons, general surgery laparoscopy specialists, and maternal fetal medicine specialists trying to save a twin pregnancy that was dying from twin-to-twin transfusion syndrome.  Additional information about the disease is available at the twin-twin transfusion syndrome foundation and in a detailed medical tech post here and a list of fetal therapy centers here and a list of treatment options here.  In this disease, there is an abnormal link in the blood supply between two twins (they are normally totaly separate).  What happens is that the blood from one overwhelms the other twin causing multisystem failure and ultimately death.  Back when we did this there were no approved devices but we used this exact type of equipment. The manufacturer here did not invent somethig new but is getting approval to market and use the device which will hopefully make it easier for doctors to use it. This approval from the FDA is for a special kind of microlaproscope (read about the history and uses of tiny microlaparoscopes here)

How the new set works: 

The Karl Storz Fetoscopy Instrument Sets are surgical tools used in the treatment of twin-to-twin transfusion syndrome (TTTS). TTTS is a rare condition in which there is an imbalance in the amniotic fluid of some identical twins. This imbalance is caused by an uneven flow of blood between the twins through shared blood vessels that are present when the twins share one placenta.

The Karl Storz Fetoscopy Instrument Sets consist of a fetoscope (telescopic camera used to view a fetus) and sheaths which are used to pass other surgical instruments and/or fluid through the entry site. After identifying the shared blood vessels on the placenta with the fetoscope, a laser can be passed through a sheath. The laser, which is already cleared for marketing, is used to photocoagulate (destroy with heat) the shared vessels which should help to normalize the flow of blood between the twins.

How does it work? After a tiny cut in the mother’s abdomen is made, the fetoscope and sheath are inserted through the mother’s abdomen and uterus under ultrasound guidance. Through the fetoscope the surgeon is able to view the placenta and determine which blood vessels are being shared by the twins and which ones are not. The Fetoscopy Instrument Set provides a pathway for a laser that can be used to destroy these shared or shared vessels after they have been identified. After all of the target vessels are identified and treated, the laser, fetoscope and sheath are removed.  

Stay tuned for posts reviewing the FDA device approval process in more detail as well as my thoughts on how profoundly the medical device climate has changed in the last decade.

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Risky Business:Why DARPA Does What Medical Industry Won’t

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I previously wrote about the government cutting the soldier of the future LandWarrior program.  The point of my post was the myriad next-generation medical developments destined to come from the program that would be lost in the military cutbacks.  The post was picked up widely including slashdot and grandrounds.  Many commenters were angry at the concept of spending hundreds of millions of dollars on military development to get medical byproducts rather than spending less money more efficiently directly on medical development.  The point of that post and this one is not to say war is great because it leads to medical advances.  Here I will review why and how breakthroughts come from the military and not from other avenues which is suprising (and upsetting) to many.

This military effect applies to all science and not just medicine.  A summary of this concept is here. As they write:

The sheer scale of military funding for science since World War II has instigated a large body of historical literature analyzing the effects of that funding, especially for American science. Since Paul Forman’s 1987 article “Behind quantum electronics: National security as a basis for physical research in the United State, 1940-1960,” there has been an ongoing historical debate over precisely how and to what extent military funding affected the course of scientific research and discovery. Forman and others have argued that military funding fundamentally redirected science—particularly physics—toward applied research, and that military technologies predominantly formed the basis for subsequent research even in areas of basic science; ultimately the very culture and ideals of science were colored by extensive collaboration between scientists and military planners. A more traditional view (consistent with that of many of the involved scientists themselves) has been defended by Daniel Kevles, that while military funding provided many new opportunities for scientists and dramatically expanded the scope of physical research, scientists by-and-large retained their intellectual autonomy.

What are some examples of military medical offshoots?:  microwave therapies for tumors, ultrasound diagnostics, active prostetics, head mounted endoscopic displays, surgical robots.

Why does military research lead to these bold new medical developments rather than medical research directly?  To put it simply, because they can and have to.  I have spoken to quite a few venture capitalists while reviewing devices for development and commercialization.  Universally they tell me of the enormous costs of development and the fixed time frame to commercialize.  Products looking too far in the future or with too high development costs are often simply too much risky business to bet on. 

The military is different for better or for worse.  First a budget overrun of 500% can be absorbed by the military while it can spell death for a medical start-up.  In times of war, there is often no limit to the resources that can be expended to achieve an important goal.  A review of the history of medical breakthroughts resulting from wars can be found here.  Medicaladvances achieved during the civil war are reviewed here WWI here In addition, the military has a R&D arm that focuses on very long term high risk huge payoff projects– DARPA.

Defense Technology International has a lead article about DARPA and Risky Business Research that no one else will do.  As they write about DARPA:

The mission of the Defense Advanced Research Projects Agency (Darpa) is “to maintain the technological superiority of the U.S. military and prevent technological surprise by sponsoring revolutionary, high-payoff research that bridges the gap between fundamental discoveries and their military use.” Its traditional strength has been its ability as a small, technology seed money agency with an expert technical staff and minimum bureaucratic red tape to respond to emerging military needs and technological opportunities and to independently pursue revolutionary solutions. In fact, to maintain its entrepreneurial atmosphere and flow of high-risk technical ideas, Darpa rotates program managers in and out of the agency, with most of them serving only 4-6 years.

Dr. Anthony J. (“Tony”) Tether, Darpa’s director since 2001 says of the agency:

Darpa’s job is to show that something is technically feasible. It doesn’t mean that people are automatically going to use it, because there are funding and other issues involved. But they can’t say that it can’t be done.

While we’re on the subect- here are some more things coming down the pike from the military courtesy of defensetech.org

Remore control neural activation covered here

Details of this emerged in a heavily-censored document released to Ed Hammond of the Sunshine Project under the Freedom if Information Act. Called “Sensory consequence of electromagnetic pulsed emitted by laser induced plasmas,” it described research on activating the nerve cells responsible for sensing unpleasant stimuli: heat, damage, pressure, cold. By selectively stimulating a particular nociceptor, a finely tuned PEP might sensations of say, being burned, frozen or dipped in acid — all without doing the slightest actual harm

While using this to remotely trigger pain or disable an attacker sounds ominous, the same technology could lead to revolutionary pain blocking or anesthetic techniques. 

New trauma surgery development is here and remote vehicles as prototypes of implantable rovers here.

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Kurzweil: Computers Will Enable People To Live Forever (if the machines let us…)

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graph of exponential rise of human progress over time- and the future?

The inventor, author, and futurist Ray Kurzweil predicts that in 15 to 30 years, nanobots will roam our blood streams fixing diseased or aging organs, computers will back up our human memories, and conference calls will be replaced by meetings in virtual resorts.   Information week reports on Kurzweil’s lecture and conducts a fascinating interview

Kurzweil told a keynote audience at last week’s SCO6 supercomputing conference his predictions of life after the technological singularity.  For those of you not familiar with his work, Ray is not a science fiction writer nor a crazy man–Bill Gates, a robotics director at Carnegie Mellon University, an MIT professor, and a physicist have all endorsed his book. He has received the National Medal of Technology and the Lemelson-MIT prize and is in the  National Inventors Hall of Fame

What is the concept of the technological singularity?: 

Kurzweil says within a quarter of a century, non-biological intelligence will match the range and subtlety of human intelligence. He predicts that it will then soar past human ability because of the continuing acceleration of information-based technologies, as well as the ability of machines to instantly share their knowledge.

Key points of his lecture and the article:

1) people and computers will intermix with nanobots, blood cell-sized robots, that will be integrated into everything from our clothing to our bodies and brains.

2) Think of replacing everyone’s “human body version 1.0″ with nanotech that will repair or replace ailing or aging tissue, he says. Parts will become easily replaceable.

3) “A $1,000 worth of computation in the 2020s will be 1,000 times more powerful than the human brain,” says Kurzweil, adding that in 25 years we’ll have multiplied our computational power by a billion.

At midnight last night as I lie in bed thinking of this — all I could think of was this was how Cyberdyne and the Matrix machines started. 

4) “Fifteen years from now, we’ll have cured cancer and heart disease, or at least rendered them to manageable chronic conditions that aren’t life threatening.

5) We’ll get to the point where we can stop the aging process and stave off death.” (ok I don’t buy that one yet…)

Does mankind’s Progress Follow Moore’s Law:  Moore’s Law essentially says that computing power doubles approximately every 18 months.  Actuallly human progress follows an exponential curve (each year has 10 times the progess of the past- there is a fantastic discussion of this here)-  Kurzweil says he’s simply looking back and measuring the computational progress the human race has made over the last century and then projecting that same line of progress forward into the near future.

You can read more about Kurzweil’s work on trying to make sure we don’t make ourselves extinct or enslaved to the machines in this post about the Lifeboat Foundation where he and I serve on the Scientific Advisory Board..   

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Grand Rounds – Volume 3, Number 12 is Up!

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This week’s grand rounds has a Charlie Brown Christmas Theme and is hosted at Nurse Ratched’s Place .  I am happy to see that she chose a diverse group of faactual and literary posts (they way I think grand rounds should be). Many of my favorite bloggers are there Kim from Emergiblog, Doctor Hébert’s Medical Gumbo, Surgeon’s Blog, Dr. Anonymous, and yours truely docinthemachine.

I appreciate being selected again for this round-up of the best of the medical blogosphere.  My post is a bit different from what I usually do.  No military medical wizz-bang here but the topic has the potential to radically transform medicine nonetheless.  In my post Is medical publishing dead? I write about the rise of medical epublishing in research journals.  You’ll find info about the general literary trend in fiction of e-pub and then information about how medical research journals anre faolowing this path.  Why so important?  Well-  this is the start of an open source opne access movement in medical research that will open access like never before to new findings.  It also changes how medicical research is accessed and the worldwide submission and review process.  I provide info from articles on the subject, my experience as a journal reviewwer and ineterviews with a journal editor.  The challenge is for the journals to not go bankrupt in the process.  Hope you enjoy! 

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Docinthemachine Nominated for Best Medical Technology Blog 2006!

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More proud announcements!  I just found out that we have been nominated for Best Medical Technologies/Informatics Weblog in the 2006 Medical Weblog Awards hosted by Medgadget.com.  The award nominees are definitely worth checking out – they represent the best of the medical blogosphere and have some amazing sites I had not seen before.

Thanks to everyone who nominated us.  Polls will be open from Wednesday, January 3, 2007 and will close at midnight on Sunday, January 14, 2007 (PST).

The original announcement of the awards is here and list of nominees here.

Update:  it looks like we were nominated for best new medical blog also! Thanks everyone

 

 

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Docinthemachine Top 5 for Best Medical Blog 2006!

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The results are in!  I am proud to report docinthemachine was selected as a finalist for the best medical blog of 2006 in the weblog awards.  There were 4500 total nominations in all categories.  The voting ended Friday night and the organizers report over 500,000 total votes!  From their online report so far we finished 4th.  4th in the world is pretty awesome as far as we are concerned – especially considering we were the baby of the competition.  DITM started blogging only 3 short months ago on 9/11/06. 

Thanks to everyone who voted for us.  Traffic has been spiking lately!

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Brain Control Robot- It’s Alive!

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The concept of “thought control”- using a brain neural interface to control a robot (or other device) takes another step forward with this research from U Washington.

Rajesh Rao, associate professor of computer science and engineering, and his students have demonstrated that an individual can “order” a robot to move to specific locations and pick up specific objects merely by generating the proper brain waves that reflect the individual’s instructions. The results were presented last week at the Current Trends in Brain-Computer Interfacing meeting in Whistler, B.C.

“This is really a proof-of-concept demonstration,” Rao says. “It suggests that one day we might be able to use semi-autonomous robots for such jobs as helping disabled people or performing routine tasks in a person’s home.”

The controlling individual – in this case a graduate student in Rao’s lab – wears a cap dotted with 32 electrodes. The electrodes pick up brain signals from the scalp based on a technique called electroencephalography. The person watches the robot’s movements on a computer screen via two cameras, one mounted on the robot and another above it.

Right now, the “thought commands” are limited to a few basic instructions. A person can instruct the robot to move forward, choose one of two available objects, pick it up, and bring it to one of two locations. Preliminary results show 94 percent accuracy in choosing the correct object.

I previously wrote about DARPA’s work on Braingate- the implanted neural interface and monkeys controlling robot arms.  Both of these projects are precursors to thought controlled prosthetic arms  or overcoming neurodegenerative disease(or Doc Oct for those of you focusing on the scarier military side).  

This project differs in that it’s a removable cap that uses a “dirty brain signal”- opening up the potential for everyday use including games, industrial uses, and control of surgical tools.

One of the important things about this demonstration is that we’re using a ‘noisy’ brain signal to control the robot,” Rao says. “The technique for picking up brain signals is non-invasive, but that means we can only obtain brain signals indirectly from sensors on the surface of the head, and not where they are generated deep in the brain. As a result, the user can only generate high-level commands such as indicating which object to pick up or which location to go to, and the robot needs to be autonomous enough to be able to execute such commands.” 

A link to the original report at psyorg is here including a video of the brain control robot.

Further progress is of course being made also by the gamers as reported here.  Several PhD’s I spoke with in the VR development field told me that significant progress is being made in their field now by gamers as much as the basic science researchers.  Does not surprise me. 

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Urban Robot Race

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“Never underestimate the power of people willing to take on a challenge.”
- Ron Kurjanowicz, Grand Challenge Program Manager,

Urban Challenge Participants Conference, Reston, VA, May 20, 2006

DARPA has granted prize money of $3.5 million for its milestone urban robotics race next November.

The urban road race is an unbelievable challenge. 

First a bit of History of the Challenge:

The first Grand Challenge took place in 2004 on a desert course stretching from Barstow, California to Primm, Nevada, but did not produce a finisher. At the second DARPA Grand Challenge, held in 2005, the Stanford Racing Team completed the 212.4 km (132-mile) course in just under 7 hours to win a US$2M prize.  The participants raced in the first long distance competition for robot cars in the world

Both the first and second DARPA Grand Challenge competitions advanced the technologies needed to create the first fully autonomous ground vehicles capable of completing a substantial off-road course within a limited time.

The 2007 Urban Challenge:  This one will be tough

On May 1, 2006, DARPA announced that there would be a third Grand Challenge race. It will occur on November 3, 2007 at an “undisclosed location in the western U.S.” It will consist of a 60 mile course on primarily paved roads, but this time, the vehicles will have to drive in traffic. They will have to stop at stop signs, look for other vehicles, obey the rules of precedence at intersections, obey traffic laws (don’t cross double yellow center lines), pass other stationary and slow moving cars,  back up, park, make a U-turn and plan a new course when the main road is blocked, and take evasive action if a collision with another vehicle is imminent. Sort of makes a 132 mile drive on a closed course in the desert seem like a walk in the park.

 

Medical Tie- In.  For some time I have been speaking about the coming radical transformation of medicine.  I have written before about the “fantastic voyage” surgical idea.  In this 1966 movie, a submarine and its scientis/doctor team are shrunk down and inected into the body to diagnose and treat a blood clot (they use a laser of course.  You can see past posts about rmars rover technology in medicine here, an implantable cardiac robot here and a self-propelled swimming robot here.  My podcast that reviews the coming surgical revolution including self-contained miniature robots here. 

 

Makiing a little med rover in the body does not seem so hard compared to the urban challenge or hte mars rover.

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Sloppy Docs Miss The Diseases

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A paper in today’s New England Journal of Medicine concludes that sloppy docs suck.  In this very simple study of colonoscopy they showed that the docs who took longer to examine the colon with a telescope (ie were more careful and thourough) found more disease.  When I was in residency there was a doc in my program who we called “Dr. Daddledoo” – because his attitude was basically “that-will-do”.  Minimally good is not as good as it can be.

The study reports:

Doctors who take more time (more than 6 minutes) to look for cancerous and pre-cancerous tumours in the bowel using colonoscopy tend to be better at detection than those who take less time.
Dr. Robert L. Barclay compared rates of detection of colorectal adenomas (polyps or abnormal growths in the bowel or digestive tract) against the time doctors spent searching for them. They looked at data from nearly 8,000 colonoscopies performed by 12 experienced gastroenterologists over more than a year.

The researchers found large variations in the detection rates among the doctors.  The time the doctors spent on searching for growths varied from 3.1 to 16.8 minutes for examinations where no polyps were removed.

The results indicated that those procedures that lasted an average of 6 minutes or less tended to detect fewer polyps than those that took more time.

This true in many specialties and is intuitively obvious to most- the more thorough docs find more disease.  Interestingly in my fertility practice we keep track of out outcome data as part of mandated federal reporting.  Ouf IVF success rates are far above the national averages.  One reason may be that we are extremely thorough in making complete and accurate diagnoses.  We find that in most other programs patients had single etiologies reported for their infertility while most of our patients have multiple diagnoses.  We are thorough in making a complete diagnosis and it helps us have the best possible treatment and success.

Don’t be a Dr. daddledo. 

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