On Wednesday, Medtronic announced that the FDA has informed them that it has classified its communication to physicians related to inflammatory mass formation associated with intrathecal drug delivery as a Class I Recall.  On January 16, 2008, Medtronic sent a letter to inform clinicians worldwide of an increase in the rate of reported inflammatory mass cases in patients who have received intrathecal drug delivery through its implantable infusion systems. Even though Medtronic has issued communications regarding this issue since 2001 it was still deemed necessary by the FDA to issue a class I recall, something that Medtronic has downplayed. Physicians and patients will need to do nothing regarding this issue as it is Medtronic’s responsibility to follow the guidelines set by the FDA.

 Regarding FDA recalls, many people are confused when the FDA issues a recall, evident in this 2002 brochure released by the FDA to help explain its recall policies. Some interesting points, The FDA has a classification system regarding recalls which is as followed:

“The guidelines categorize all recalls into one of three classes according to the level of hazard involved.

• Class I recalls are for dangerous or defective products that predictably could cause serious health problems or death. Examples of products that could fall into this category are a food found to contain botulinal toxin, food with undeclared allergens, a label mix-up on a life saving drug, or a defective artificial heart valve.
• Class II recalls are for products that might cause a temporary health problem, or pose only a slight threat of a serious nature.  One example is a drug that is under-strength but that is not used to treat life-threatening situations.
• Class III recalls are for products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing regulations. Examples might be a container defect (plastic material delaminating or a lid that does not seal); off-taste, color, or leaks in a bottled drink, and lack of English labeling in a retail food.”

From this information we can see that even though Medtronic is issuing a press release saying that this recall is a non-issue, the fact that the FDA has classified this as class I would suggest otherwise.

The plight of the Great Barrier Reef has been reported at length for the last decade. In 2003, an article in Science, believed that part of this decline was due to the loss of herbivores. According to the authors the loss of herbivores and preadators exposed the reef to pollution and natural disasters of which it could not recover. This is due to the fact that when a reef is damaged it can usually recover if it is not overrun with algae, which herbivores eat. If the algae is left to grow unchecked it becomes tall, like grass that has not been mowed for a while, preventing common herbivore fish from being able to clean up the mess. Recently researchers at James Cook University noticed a new fish in town.

Prof. Bellwood and fellow researcher Rebecca Fox commented “To our surprise and disappointment, the fish that usually ‘mow’ the reef – parrot fishes and surgeon fish – were of little help when it came to suppressing well established weedy growth. Most herbivores simply avoided the big weeds.
 
“Then, to our even greater surprise a fish we had never seen in this area before was observed grazing on the weed. The rabbit fish (Siganus canaliculatus), came out of nowhere and began to clear-fell the weed placed on the reef crest. The rabbit fish is not a fish you tend to take a lot of notice of,” Prof. Bellwood explains. “Like its terrestrial counterpart, it is brown, bland and easily overlooked – but it could be very important when it comes to protecting the GBR. We hadn’t seen it previously at this site despite conducting over 100 visual censuses. This made its appearance in numbers sufficient to check the weedy growth all the more remarkable.”

This is great news for such an amazing natural wonder. We at Biotech Mashup salute the hard work and strong work ethic of the rabbit fish.

The European Space Agency working with the United Nations Food and Agriculture Organization have announced a new land cover, the observed biophysical cover of the earth’s surface, map. The map, called GlobCover, is based upon twenty Terabytes of data and will offer resolution ten times greater than any previous attempt. Current Plans are for the map to be released freely to the public sometime after it’s completion in July.

Scientist will use the map to continue to further refine climate models, analyze the impact of human development, and help manage resources. GlobCover comprises of twenty two different land types and is compatible with the UN Land Cover Classification System. John Latham of FAO said ”The GlobCover product will be the first freely available product at 300m resolution and is therefore a milestone product which will be fundamental to broad level stakeholder community.”

Biotech Mashup is eager to see the final product and cannot wait for the inevitable Google Earth modification. A demonstration of the current map is available in the link.

Here’s what happened last week on Biotech Mashup:

Sunday, March 9th, 2008

DNA Fabrication One Strand at a Time

Monday, March 10th, 2008

HemCon Medical Technologies Uses Shrimp to Save Lives

Building Small Molecules using a DNA Program

Tuesday, March 11th, 2008

Hormones from the Heart

Wednesday, March 12th, 2008

Stem Cells Used to Create Kidneys and Pancreas in Mice

Roaches’ Secret to Moving is Unveiled, Motels Around the World Rejoice!

Thursday, March 13th, 2008

A Crabby Personality

Friday, March 14th, 2008

Mosquito Repellent Haywires Neurons

As reported yesterday in LiveScience, Mark Briffa, a behavioral ecologist published in Proceedings of the Royal Society B that hermit crabs have different personalities. In the past he has examined how they behave in combat and the value they place on a shell.

Dr. Briffa’s method for determining a crab’s personality was to flip crabs upside down and measure how long it took them to exit their shell. Based on this measurement he did a statistical comparison between a crabs behavioral consistency verses their behavioral plasticity. From this result he found a pattern in behavior and was able to show statistically that certain crabs are more bold than others.

In 2006, I remember reading an interesting article in the New York Times, by Charles Siebert, describing the different personalities of the giant Pacific octopus, an article definitely worth a read if you have the time. What was so surprising by this report was the distinctive stories passed to Charles by the marine biologist working at the aquarium. They could specifically describe the distinct personalities of each octopus, the jealous one or the one sensitive to light who would spray you with water if you flashed him , etc. This brings up a very interesting and perplexing ethical question that I think is far too often overlooked in the Biotech community. Is animal testing an appropriate way for testing new drugs or technologies? For example, monkeys clearly have personalities, so is it proper to be injecting them with Ebola to determine if the new vaccine is successful? These are questions that if the community is being intellectually honest, at a minimum, should be discussing. We all know the benefits from testing on animal models but have we recognized or even acknowledged some of the negatives.

A group at University of Cambridge released a study Wednesday detailing a mystery a century old, how did that roach get there? Lead Researchers, Walter Federle and Christofer Clemente, explain that the nemesis of modern motels has two pads on the feet which allow the legs to pull or push. This allows the buggers to skim across sufaces ninety degrees and even one hundred and eighty degrees from normal.

Past research has shown that the pads on the legs of roaches contains a thin oily liquid which uses surface tension to allow them to stick firmly to a surface, allowing them to pull themselves along. However, no one has managed to figure out how these insects could travel up walls as this requires pushing as well as pulling on the surface. Using some very clever methodology, Federle and Clemente amputated legs from adult cockroaches, froze the limbs, and examined them under an electron microscope. Then after examination they tested the movement of the legs on a mount and monitored the action using a high speed camera. The end result is the theory that roaches pads are comprised of two parts, a toe and heel. The toe is used to pull the roach and the heel to push. The insect is able to scurry along by using a combination of legs and pushing/pulling their way on the surface.

This is another leap forward in understanding adhesive movement. Similar to how the gecko’s movement has helped to develop a new glue, this could help robotic engineers develop better robots or develop a new construction machine which could reach areas in the past that have been inaccessible. As well motels around the world now have a reason to dump money into a research fund. This fund would of course be focused on development of a new paint to prevent a roach’s pad from pushing and pulling, ridding motels of roaches once and for all.

Most of us think of the heart as a highly sophisticated and durable pump. But another function of the heart is to secrete peptide hormones, which are small proteins that function as hormones. Multiple hormones are encoded by the atrial natriuretic factor (ANF) gene that help to regulate blood pressure and volume. At the Experimental Biology 2008 conference in San Diego this April, Dr. David Vesely, a doctor at the James A. Haley Veterans Hospital in Tampa and a professor at the University of South Florida (USF), will present findings that hormones from the heart are also extremely effective at fighting both pancreatic and breast cancers in mice, with no observed side effects. More than 75% of mice treated with the hormones were cured of human pancreatic cancer, and more than 66% of mice with human breast cancer were cured, according to Dr. Vesely. No other treatments were given. In uncured mice with pancreatic cancer, which is fast-moving and typically has a poor prognosis, tumors still shrank to less than 10% of their original size.

The hormone treatments have not yet been tried with humans, and a private biotechnology company is now raising money to start trials. We can only hope that the treatment will work equally well in humans, but the sobering fact is that a mouse with cancer is in a lot better luck than a human, since many treatments that work in mice do not translate to humans. 

Source: EurekAlert!

Ten years ago if you had a car wreck and suffered deep lacerations the standard treatment would have been a tourniquet to prevent bleed out. While waiting to reach a hospital, the result of this treatment could have been loss of a limb or death. Now, it is the year 2008, and treatment procedures have slowly been changing to use a new revolutionary product to greatly reduce these incidents, the HemCon Bandage. The HemCon Bandage provides an instant antibacterial barrier to control bleeding, replacing the need for traditional gauze bandages or tourniquets. This innovative new treatment for hemostatic control is the reason that HemCon Medical Technologies is on Biotech Mashup’s list of 15 companies that have the potential to change medicine.

HemCon Medical Technologies launched in 2001 under the auspice of grants provided by the united states ARMY with additional capital from the two founders, Dr. Bill Wiesmann and Dr. Kenton Gregory. Doing a lot of hard work and having a little bit of luck, the doctors, have turned a small startup into what HemCon Medical is today. The company before last week had three products on the market; HemCon Bandage, ChitoFlex, and HemCon Dental Dressing. Using these products HemCon’s technology was only available to the military, hospitals, and emergency responders until now. This last week HemCon announced a new product, KytoStat, bringing the company’s technology from the hospital and military battlefield to your backyard. The KytoStat is the next generation band-aid, providing instant wound care.

The HemCon bandage contains chitosan, an organic substance found in crustacean shells. In 1984, scientists published in Neurosurgery the use of chitosan to stop bleeding in cats. Since then numerous journal articles have been published describing this new hemostatic agent but it was not until the doctors Wiesmann and Gregory founded HemCon did someone develop a chitosan bandage. As described by HemCon’s website the process starts with chitosan processed in Iceland from shrimp shells. After mixing it with acetic acid and turning it into a gel, the material is cast into square tiles. The squares are then freeze-dried in a vacuum chamber, compressed to about half their original thickness, and backed with a thin sheet of brown plastic. This completes the manufacturing of what is now a HemCon bandage, each bandage is then sealed in foil and sterilized by gamma radiation.

The benefits of a chitosan bandages are two fold; first when it is placed on a wound the chitosan has been found to have antimicrobial properties, second the bandage promotes clotting because blood cells and platelets carry a negative electrical charge and are attracted to chitosan, which bears a positive charge. The bandage has stopped or slowed down severe bleeding from combat wounds in 97 percent of the cases according to this special report in 2006. Hemcon’s media department responded to our inquiries with some interesting additional information, such as “are the HemCon dressings kosher? Hemcon dressings are made from shellfish, a creature that is considered forbidden from consumption by some religious groups. Although the dressing is not technically consumed, it is not considered kosher.” An interesting ethical dilemma may occur if a patient who must follow kosher laws is or could be saved by HemCon bandages.

HemCon may have a presence in the market, a new product that is direct to consumers and an exclusive license agreement with Cardinal Health but, a large number of challenges are still ahead. Two other companies offering next generation hemostatic control technologies are in the market, Celox Medical and Z-Medica. Celox Medical has a granule hemostatic agent which was tested by the United States Marine Corps and obtained 100 percent survival rates. Celox however, still does not have a product for sale. Z-Medica on the other hand sells the QuikClot, which is currently being used by the military, hospitals, and first responders. As well the company has multiple product offerings. In a recent study done by the Naval Medical Center, they compared all three hemostatic methods and found that all substantially improved outcomes verses traditional dressings but, Celox technology appeared to show the greatest improvement for control and survival. It should be noted this was a very small study with only 12 animals in each group and should be taken only lightly until larger studies can be carried out. This study points out that HemCon has some tough competition in the near future. Even with this competition Biotech Mashup feels that with the benefits of chitosan and the current leverage that HemCon has in the market, they stand a very good chance of greatly impacting the medical community and the standard of care for the foreseeable future.

Here’s what happened this week on Biotech Mashup:

Monday, March 3rd, 2008

mircoRNAs Help Develop Skin

Is Good Parenting Genetic?

Tuesday, March 4th, 2008

A snow cone full of bacteria

Transgenic Mice Used to Improve Antibody Production

Wednesday, March 5th, 2008

15 Companies That Could Change Medicine

Pacific Biosciences Working Toward the 15-minute Genome

Thursday, March 6th, 2008

Sangamo Designing Proteins that Target DNA

PDL BioPharma Couldn’t Sell Company, Announces Downsizing

Friday, March 7th, 2008

Do You Speak Fly?

Menssana Research Takes Your Breath Away

If you are a computational biologist you may want to learn “Fly.” A group of researchers published in PLoS ONE Computation Biology that through the use of electrodes they have been able to monitor neuron impulses in a fly as it was “flying.” The group was able to simulate flying by harnessing the fly into a turntable mechanism which mimics the flies normal vertigo flight as it avoids predators and chases other flies. The electrodes that were attached to the fly recorded pulses from the neurons in a surprisingly regular pattern. One of the lead researchers, Nemenman commented “Historically, people have observed a lot more random spike intervals. The research is a departure from the traditional understanding in that we see that the precision of spike timing that carries information about the fly’s rotation is a factor of ten higher than even the most daring previous estimates.”

This departure from previous findings questions some assumptions of how neuron networks respond to heightened situations. Furthermore this could change how artificial neural networks are designed as many of the current approaches have relied on previous research looking at sensory neuron impulses. New understanding in how neural networks function could improve the design of computers, increase the efficiency of network interfaces, and help solve numerous other technical architecture problems.