FDA Update: Ophthalmic Device Panel Meeting To Review LASIK Safety

eyeballLASIK Safety Review

On April 25, 2008, the committee will discuss general issues concerning the experience and quality of life of patients who have had LASIK.

How Serious is the Problem?  Are the Patients Going Blind?

Dr. Daniel Schultz, director of FDA’s Center for Devices and Radiological Health, said a number of concerns have been raised concerning patient satisfaction with LASIK.

Companies that could be affected by such a meeting include LASIK device makers such as Advanced Medical Optics Inc, as well as LASIK providers such as TLC Vision Corp and LCA-Vision Inc.

Obviously, it’s a technology that has caught on and is used very, very widely. And there have been questions raised in terms of … quality of life and what does it actually do for the patient as opposed to the technology itself,” Schultz told reporters.  Shultz said the meeting will focus on the quality of patients’ lives after surgery.

Known complications from the procedure can include dry eyes, glare, double vision, an increased risk of corneal inflammation or infection, and blindness.

Patients Call for Ban: In July 2007, the FDA responded to petitions from an individual asking for a halt to the procedures and a withdrawal of their approval. The agency said the devices were safe and effective but advisory panel discussions “could complement” its other safety monitoring.

The Boston Globes writes on the adverse effect of the current economic downturn on Lasik numbers and the potential adverse effect of this meeting on Lasik businesses.

But the declining U.S. economy continues to impact the number of laser vision correction surgeries, and Biegelsen cautioned investors that the outcome of the upcoming FDA Lasik advisory committee meeting on April 25 will likely be neutral at best.

“A best case scenario is little-to-no negative headlines in the media and the panel endorses the long safety of Lasik and encourages further use of femtosecond lasers,” he wrote in a note to clients. “On the downside, negative media coverage of unhappy Lasik patients and a panel recommendation to narrow the indications could drive volume down further. We think the most important variable is the media coverage which tends to be negative.”

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FDA Update: Ophthalmic Device Panel Meeting To Review Implantable Eye Telescope

The FDA Ophthalmic Devices Panel will meet Apr 24, 08 8:30 AM – 5:00 PM & Apr 25, 08 8:30 AM – 5:00 PM in the Gaithersburg Holiday Inn, Ballroom – 2 Montgomery Village Ave. Gaithersburg , MD

On April 24, 2008, the committee will discuss, make recommendations, and vote on a premarket approval application, sponsored by VisionCare Technologies, Inc., for an implantable miniature telescope (IMT™). The IMT™, a visual prosthetic device, is indicated for monocular implant in patients with stable, moderate to profound central vision impairment due to bilateral central scotomas associated with end-stage macular degeneration with geographic atrophy or disciform scar, foveal involvement and cataract.

Since these diseases lead to central dysfunction of the retina the implantable telescope spreads the visual image over a larger area of normal retina.

The prosthetic telescope, together with the cornea, acts as a telephoto system to enlarge images 3X or 2.2X, depending on the device model used. The telephoto effect allows images in the central visual field (‘straight ahead vision’) to not be focused directly on the damaged macula, but over other healthy areas of the central and peripheral retina. This generally helps reduce the ‘blind spot’ impairing vision in patients with AMD

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New Monitoring System Approved by FDA- Potential for Future Robotic Diagnostics

freestyle glucose sensor

The FDA has just approved the FreeStyle Navigator Glucose Monitoring System – a glucose sensor that reports glucose values continuously for up to 120 hours.  Here is a copy of the FDA PMA letter.  This device is interesting to me since it works with a sensor inserted in either the abdomen or the back of the upper arm.   The device then continuous provides glucose readings and updated glucose trend information for viewing and contains a built-in alarm that can be programmed to alert the user when results fall below pre-set values.  Other similar devices have been approved that monitor for 7 days

Potential for Future Robotic Diagnostics  I have written before that I predict a whole new field of chip based biologic disease screening and monitoring in the future.  This is another step to that result.  Here a sensor is placed under the skin that measure blood sugar.  In the future minitaturized chips could be placed in any body cavity or organ to sense any imaginable molecule.

Options for Future Diagnostics: 

  1. DNA based sensors screen for cancer metastasis or recurrances such as an intrabdomnal ovarian cancer detector.
  2. Sensore that measure drug levels in target tissues – chemotherapy of course comes to mind
  3. protein sensors that look for the earliest stages of disease development.

As personalized genetics becomes more widespread, we will identify individuals at particular risk for particular diseases before they occur.  Since the genetic basis of these diseases will be known markers will likely exist.  Implanted chip sensors could then be placed to sniff for these markers and wireless transmit the alarm- or even deliver a predetermined treatment agent- all before there is any external sign of the disease.  First generation implantable devices such as this for blood sugar monitoring are lisated here (none yet available):

Here are links to some of the technology that will be involved for these future diagnostics including tiny sensors that transmit with RFID, smartdust sensors the size of a speck of dust or less, smart pills that travel through the body transmitting data and the concept of personalized genetic information based diagnostics and personalized genetics in general.

All approved continuouis blood sugar monitoring devices are here and a comparison from a patient site here:  

As an aside – in terms of glucose monitoring the use of thse devices may come into question.  An ongoing diabetes study called ACCORD was cut short in one treatment arm when it was shown that ultra tight strict blood sugar control in diabetics with heart disease actually WORSENED outcomes!

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How Smartdust, Souveillance, Web 3.0, and Personalized Genetics Will Transform the Future of Medical Diagnostics

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There has been a flurry of debate in the military, industrial, and privacy sectors on “smartdust” and the concept of “souveillance” – but no one has yet realized this technology is poised to springboard into medicine and transform medical diagnostics.  Here I wanted to give you an overview of what this idea is and why you should keep your eye on it. 

First the general concept background:

“Smartdust” refers to micro devices (called motes) which are detection microchips each potentially the size of a speck of dust.  These grains of sand however can automatically self-network.  So far people have conceived of these low-power distributed sensing networks as having functions for climate control systems, entertainment devices and especially for big brother type surveillance systems.  

Wikipedia wrote “the smartdust concept was introduced by Kristofer S. J. Pister (University of California) in 2001 , though similar ideas existed in science fiction before then. A recent review discusses various techniques to take smartdust in sensor networks beyond millimeter dimensions to the micrometre level.  A typical application scenario is scattering a hundred of these sensors around a building or around a hospital to monitor temperature or humidity, track patient movements, or inform of disasters, such as earthquakes. In the military, they can perform as a remote sensor chip to track enemy movements, detect poisonous gas or radioactivity. The ease and low cost of such applications have raised privacy concerns.”  Beyond web 2.0 vast networks of these real time sensors are once possible technology leap of the yet inknown web 3.0.

General concept – What is Souveillance?:  is a term from Steve Mann that refers to “bottom up” surveillance using smart dust as opposed to “top down” big brother networks looking at us little people.  Here instead activities are recorded from the “perspective of a participant in the activity, typically by way of small portable or wearable recording devices that often stream continuous live video to the Internet.”  Remember the impact of the Rodney King video and of all the user generated video content on the web.  Now fast forward to a world where a large segment or even a majority of the populice had real time streaming video devices on all the time (no we are not going to discuss the porn angle on this).   This has also been called “inverse surveillance”.

Privacy advocates have been debating the merits or horrors of this type of sensor technology.   I serve on the Scientific Advisory Board of the Lifeboat Foundation which is dedicated to protecting us from future technological threats through advocacy research and education.  They have been having a heated debate on the “paradox of smart dust: we may not live without the greater security provided by smart dust, but many think they could not live with smart dust impinging on our privacy.’  

Medical Implications:  I have a vision that once this type of low power networked microsensor technology exists it will logically lead to medical sensor technology.  Potential uses I see include:

  1. mass screening for infectious disease or bioterror agents.  Subjects walking into screening areas could be checked for signature molecules associated with infectious agents.  Just as we have metal detectors and now have molecular signature detectors (the litle wipe test for explosives at the airport) we will have such biological screening techology.
  2. The next step will be similar screening for disease states.  Metabolomics is one such technology. Metabolomics is the study of the small-molecule metabolite byproducts left behind from cellular processes.  In simple terms it’s like examining poop.  The concept is that by measuring the collection of all the byproducts of the cells metabolism you can get a snapshot of the physiology of a cell or organism that translates to health.  One such sensor is being developed as a breath sensor for disease.  This could lead to Star Trek like medical sensors. 
  3. Similarly, such technology will lead to individual genetic screening for disease risk using chips that interact with the tiny bits of DNA we shed every time we touch something. Companies commercializing this approach also already exist and have products
  4. Taking a clue from smart dust we will then inject such sensors into our bodies where thy could circulate in the bloodstream or sit in the abdminal cavity silently sensing for disease, infectious agents, or the DNA or signature molecules of a cancer cell.  Alternative chips could exist that sit and slowly release drugs when such cell reappear once a patient is diagnosed.

I will be writing more about the details of these concepts and devices being developed in future posts now that I have introducted the concepts.  Let me know what you think! 

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New Generation of Performance Enhancing Drugs

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NatureNews has just reported on a new drug that plugs calcium leaks in muscles and boosts stamina (in mice).  I have previously written of the next wave of what I call “designer drug abuse” coming- performance enhancing drugs.  The first batch are called eugeroics and offers improved memory, mood enhancement, improved alertness and cognitive powers without any of the nasty side effects and mass murder of speed and crank.  This new class is a physical performance enhancer.   You can read my thoughts on how far people will go in the future to enhance their bodies hereIf you think plastic surgery is the rage of body enhancement – wait until we get performance and congnitive enhancing bionics, drugs, and implants!

Nature writes of the published in the online edition of the Proceedings of the National Academy of Sciences today (Bellinger, A. M. et al. Proc. Natl Acad. Sci. USA 105, 2198-2202 (2008).

Researchers have shown how intense exercise can damage muscles, and developed a drug that can hinder the effect in mice. Mice on a taxing work-out schedule were stronger and had more endurance when given the drug.

The drug, called S107, prevents calcium from leaking into muscle cells. Calcium causes muscles to contract, but calcium leaks can reduce the force of contraction and activate an enzyme that chews up muscle protein.

They go on to say that “leaky calcium channels have been associated with the fatigue and soreness that follows intense, sustained exertion, such as running a marathon or long-distance cycling. This weakness can last for days or weeks, and is not the same as the brief discomfort that follows a typical work-out.”

As expected there is a start-up ARMGO Pharma, that plans to develop S107 and others like it for clinical use in patients with chronic tiredness from disease.

Nature hits upon the potential for abuse just as I predicted.  “Don Catlin, director of the Olympic Laboratory drug-testing centre at the University of California, Los Angeles, says that a drug such as S107 could also become prime fodder for athletes looking to improve their stamina.

I myself had dinner with the former chief medical director of the olympic committee (the guy in charge of thesting if the women really are women and vice versa).  He told me he is very concerned about athletes and students using performance enhancing drugs.  Imagine a high school athlete or student offered a pill that could makethem run faster or longer or increase memory without adverse effects.  How many do you think would take them.  I recall his worry- your child saying daddy I want to be a track star- can you amputate my legs so I can get the new bionic ones. 

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New Flexible Biodegradable Battery Invented

paperbatt

ars technica reports on the invention of a paper thin flexible biodegradable battery.

Researchers from Rensselaer Polytechnic Institute and MIT have developed a new material that eliminates the need for a multilayer battery. They grew carbon nanotubes on a silicon substrate and impregnated the gaps between the tubes with cellulose—that’s right, plain old paper. The cellulose also covered the ends of the nanotubes, but once it had dried, the paper material could be peeled off of the silicon substrate, leaving one end of the carbon nanotubes exposed to form an electrode.

By putting two sheets of paper together with the cellulose side facing inwards (and a drop of electrolyte on the paper), a supercapacitor is formed. These supercapacitors retain the flexibility of normal paper, but they have a rating that is comparable to that of standard commercial hardware.
By putting a drop of electrolyte on a single sheet and then putting a metal foil consisting of lithium and aluminum on each side, a lithium ion battery is formed. Researchers indicate that small prototypes could already power small mechanical devices like fans. These batteries operate over a wide range of temperatures, with the research showing that they can operate between -78–150°.

Potential Medical Applications:  Its been reported that bodily fluids can act as the electrolyte. The capacitor would be put into a patient fully charged but dry, and when more power was needed, bodily fluids would be allowed into the device to allow it to discharge.

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Army’s Robotic Prosthetic Arm Demo’d

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I have previously written about the Army’s robotic prosthetic arm projects – run of course through DARPA.  You can see my posts and a video fest at Video Fest of Brain-Computer Links & Control

An equally amazing story is how the project has come to be- DARPA contacted Deam Kamen (and team at DEKA of Segway fame) and challenged him to create this amazing feat of technology. The NYT reports

Eighteen months ago Segway entrepreneur and serial inventor Dean Kamen received a visit from Anthony Tether, the electrical engineer who runs the Defense Advanced Research Projects Agency, the military’s research and development agency.

Mr. Tether had come to Mr. Kamen’s rural western Massachusetts workshop to persuade him to tackle a challenging engineering problem: a robotic arm that would make it possible for any of the 1,600 or more Iraq veteran amputees to resume a semblance of a normal life.

Mr. Kamen, who designed the two-wheeled Segway balancing transporter and several high tech wheel chairs, and who has a wealth of robotic engineering expertise, said that he initially thought the idea “was nuts.”

A more extensive review of the two parts of the project is at Wired’s Danger Room where Noah reports on the two phases of the program. 

Project 1 – the Holy Grail: Kuniholm and his fellow engineers at Johns Hopkins University’s Applied Physics Laboratory, or APL, are at work on the most ambitious prosthetics project in history. They seek the field’s holy grail — to build an artificial human arm that acts, looks and feels to its user like his native arm, and to do it with astonishing speed by the end of 2009.  (called Revolutionizing Prosthetics 2009)

Project 2- Hedge your bets:  The Kamen project: produce the best prosthetic arm possible with currently available technology

For now, both Deka and APL are based on cutting-edge myoelectric control systems pioneered by Todd Kuiken at the Rehabilitation Institute of Chicago, or RIC. Conventional myoelectric controls use electrodes on the surface of the skin to read muscle signals from some part of a user’s body unaffected by his amputation — his back for example — and pass the signal on to an artificial limb. The user twitches her back, and the limb moves in response.

 

A video has been released of the project’s progress so far in a demo. It was shown at the DARPA tech conference.  You can check it out here (sorry can’t get the youare.tv player to run in wordpress blog engine).

Another video is here

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Human-Animal Mutant Animal Developed: It’s Not the First!

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Many reports on-line are coming out about chimeric man-sheep creatures developed.

Scientists have created the world’s first human-sheep chimera – which has the body of a sheep and half-human organs.  The sheep have 15 per cent human cells and 85 per cent animal cells – and their evolution brings the prospect of animal organs being transplanted into humans one step closer.  Professor Esmail Zanjani, of the University of Nevada, has spent seven years and £5million perfecting the technique, which involves injecting adult human cells into a sheep’s fetus.

What is the promise:

He has already created a sheep liver which has a large proportion of human cells and eventually hopes to precisely match a sheep to a transplant patient, using their own stem cells to create their own flock of sheep.

The process would involve extracting stem cells from the donor’s bone marrow and injecting them into the peritoneum of a sheep’s foetus. When the lamb is born, two months later, it would have a liver, heart, lungs and brain that are partly human and available for transplant.

What many don’t realize is that chimeric, transgenic, and xenograpted human-animal research has been going on for some time.  THe genetic research focuses on placing the genes of one species inthe cells of another.  Xenograft research has not gotten much press.  This is what I was extensively involved in.  Here we actually graft human tissue into animals (usually mice) that lack an immune system

My research involved grafting human ovarian tissue into immunodeficient mice and then allowing it to grow, develop, and function.  This ia called a xenograft and the technique has now been developed by several groups.  The hope was to develop techniques to preserve fertility in cancer patients.  There has now been a case reported where human ovarian tissue was frozen, reimplanted (into the woman not a mouse) and resulted in a pregnancy.

The biggest controversies

    1. this could potentially lead to a mouse ovulating a human egg that gets fertilized and become a person
    2. there is unknown potential for interactive effects between the species
    3. there is possibility for new animal viral contamination of the human cells that can be transmitted

When I did xenograft research the animals were locked down as if they has Ebola.   Made Alcatraz look like a Holiday Inn.

The top photo is NOT MY RESEARCH —it is a human ear growing on the back of an immunodeficient mouse by a group working on growing human organs for replacement. This is part of the emerging field of tissue engineering where human tissue and even organs are gorwn in lab dishes.  Read more on that subject ere: Creating tissues that can augment or replace injured, defective, or diseased body parts.

Yes, it is real…

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Grand Rounds Is Up!

Grand Rounds is upat medviews - this weeks he has a very wide range of great pieces – unencumbered by themes.  I appreciate him including my post on cadaveric surgical implants – and why synthetic is a much better route to take.

 Doc in the Machine takes exception to the use of cadaveric disks for spinal surgery, pointing out the advantages of using synthetic disks.

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Biotech Missteps: Would You Prefer a Synthetic Implant or One From A Human Cadaver?

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Yahoo is reporting on a Lancet study of a new spinal surgery “breakthough” today – the use of a spinal disk transplant from a cadaver by Chinese doctors.  One step forward, two giant leaps backwards.  The move towards cadaveric implants in a era of evolving synthetic disks is a move in the wrong direction.  Reasons follow the details of the news.

Study Details First

Chinese surgeons are reporting long-term success with the first use of transplanted spinal discs to relieve back pain.  Spinal discs from human donors were transplanted five years ago into five patients with chronic back pain caused by disc degeneration, physicians at the University of Hong Kong and the Naval General Hospital in Bejing said.  As reported in the March 24 issue of The Lancet, the five-year follow-up found an improvement in symptoms, no signs of immune rejection and only mild degeneration of the transplanted discs.

Why This is a Step in the Wrong Direction

There is a huge movement in biomedicine to move away from products derived from humns, cadavers, and animals and move towards synthetics.  The reasons are many and profoundly important.  Anything derived from a human source has biological variability- that is the implants are all as different as we are from each other.  This variability leads to unpredictable outcomes.  A huge step away from this happened in my field of infertility with our major drugs – gonadotropins.  These for decades were extracted from the urine of cloistered menopausal nuns and when they became more scarce grandmothers in the Netherlands.  Millions of gallons of urine was processed to extract the hormones.  Unfortunately the spectre of contamination, infection, and variability between lots not to mention the cost and logistical issue of manufacture have led to replacement to a great extent with pure forms of the hormone quietly created in the laboratory.  No human extractions, no variability, no contamination, and pure consistant results.  Sorry to the nuns. 

Next, there have been horrific recent scandals regarding horrific and dangerous procurement (Mastromarino case) of cadaveric tissue or selling stolen body parts for medical use without consent and there is great concern about the methodology potentially used in China where organs are harvested and sold from executed prisoners.  

There are now synthetic spinal disks approved for use. 

I don’t know about you but I’ll take a synthetic cyborg implant over a cadaver anyday.  More exciting is the idea I keep shouting about- that in the near future synthetic implants will outperform natural human abilities anyway and enhance performance.  Read about that idea here and here!

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