Thursday 29 June 2017

DIETERS MAY UNKNOWINGLY BUY DANGEROUS WEIGHT LOSS SUPPLEMENTS Read more at: Http://Thrombokinase1.blogspot.com

A potentially hazardous weight loss supplement that has been recalled in the United States continues to be sold and consumed in significant amounts, a new study suggests.


The study found that women are taking Pai You Guo, a weight loss supplement from China that has been found to contain banned pharmaceutical substances, including a drug linked to cancer.

 In 2009, the Food and Drug Administration (FDA) announced a voluntary recall of Pai You Guo and issued alerts about the supplement's potential health risks.

 The new study found nearly a quarter of Brazilian-born women surveyed in Boston use Pai You Guo. No one who took the supplement was aware of the recall, and most experienced side effects. 


The findings demonstrate a much larger problem — that regulation of dietary supplements in the United States is too lax, said study researcher Dr. Pieter Cohen, an assistant professor of medicine at Harvard Medical School and a general internist at Cambridge Health Alliance. "Even when the FDA clearly determines that there's a hazardous product," the agency is incapable of effectively removing it from the market, Cohen said. 



The doses of banned drugs in the supplements "convinces us that this was no error" on the part of the manufacturer, Cohen said. 

Because consumers, standing in a store aisle, can't be sure whether the supplements they buy have been recalled or contain dangerous substances, they should steer clear of them for now, Cohen said. "I do not believe that it's safe to purchase weight loss supplements in the United States at this time," Cohen said. 



Adulterated pills The FDA regulates dietary supplements, but the agency can only step in after the supplements come to market and recall ones they find to be hazardous. Since 2005, the FDA has identified more the 300 weight loss supplements that contain banned pharmaceuticals . 




That's likely only a small fraction of the actual number of adulterated supplements, Cohen said. Cohen and colleagues surveyed more than 500 women in the Boston area originally from Brazil. 


Earlier research identified a particularly high use of diet pills among Brazilian-born women. Twenty-three percent reported using Pai You Guo, in either capsule or pill form. Eighty-five percent reported at least one side effect, including dry mouth, anxiety and insomnia. About 66 percent of users purchased Pai You Guo from acquaintances, 30 percent from stores and 9 percent over the Intenet. 



Most participants bought the supplement after the recall. People take Pai You Guo thinking they're using a natural weight loss remedy . "Instead, they're consuming banned pharmaceutical product," Cohen said. 
Pai You Guo has been found to contain sibutramine, a weight loss drug that was recalled in 2010 due concerns it might increase the risk of heart attack and stroke. Some capsules and teas containing Pai You Guo have been found to contain doses of sibutramine six times higher than the doses found in prescription pills, Cohen said, and the substance is not even listed on the product label. This problem likely extends beyond the Boston area, CoA potentially hazardous weight loss supplement that has been recalled in the United States continues to be sold and consumed in significant amounts, a new study suggests. 



The study found that women are taking Pai You Guo, a weight loss supplement from China that has been found to contain banned pharmaceutical substances, including a drug linked to cancer.


 In 2009, the Food and Drug Administration (FDA) announced a voluntary recall of Pai You Guo and issued alerts about the supplement's potential health risks. The new study found nearly a quarter of Brazilian-born women surveyed in Boston use Pai You Guo. 


No one who took the supplement was aware of the recall, and most experienced side effects. The findings demonstrate a much larger problem — that regulation of dietary supplements in the United States is too lax, said study researcher Dr. Pieter Cohen, an assistant professor of medicine at Harvard Medical School and a general internist at Cambridge Health Alliance. "Even when the FDA clearly determines that there's a hazardous product," the agency is incapable of effectively removing it from the market, Cohen said. 



The doses of banned drugs in the supplements "convinces us that this was no error" on the part of the manufacturer, Cohen said. Because consumers, standing in a store aisle, can't be sure whether the supplements they buy have been recalled or contain dangerous substances, they should steer clear of them for now, Cohen said. "I do not believe that it's safe to purchase weight loss supplements in the United States at this time," Cohen said.



 Adulterated pills The FDA regulates dietary supplements, but the agency can only step in after the supplements come to market and recall ones they find to be hazardous. Since 2005, the FDA has identified more the 300 weight loss supplements that contain banned pharmaceuticals .



 That's likely only a small fraction of the actual number of adulterated supplements, Cohen said. Cohen and colleagues surveyed more than 500 women in the Boston area originally from Brazil. Earlier research identified a particularly high use of diet pills among Brazilian-born women. 


Twenty-three percent reported using Pai You Guo, in either capsule or pill form. Eighty-five percent reported at least one side effect, including dry mouth, anxiety and insomnia. About 66 percent of users purchased Pai You Guo from acquaintances, 30 percent from stores and 9 percent over the Intenet. Most participants bought the supplement after the recall. People take Pai You Guo thinking they're using a natural weight loss remedy . "Instead, they're consuming banned pharmaceutical product," Cohen said. Pai You Guo has been found to contain sibutramine, a weight loss drug that was recalled in 2010 due concerns it might increase the risk of heart attack and stroke. Some capsules and teas containing Pai You Guo have been found to contain doses of sibutramine six times higher than the doses found in prescription pills, Cohen said, and the substance is not even listed on the product label.




 This problem likely extends beyond the Boston area, Cohen said. Pai You Guo has been reportedly sold in California, Florida and Washington state. "We're talking about a national problem," Cohen said. Others say the problem is likely not common in the general population. It is likely confined to certain pockets of the population, said Dr. Bimal Ashar, an associate professor of medicine at John Hopkins School of Medicine in Baltimore. Rotten tomatoes Congress should re-write the rules that govern dietary supplements, Cohen said. 




The FDA should be given the authority to approve dietary supplements before they go to market, Cohen said, and should ensure the drugs are safe and really contain what's on the label, he said. Right now, "supplements are regulated by the FDA as if they are food," Cohen said. But unlike, say, a spoiled tomato, "the consumers has absolutely no ability when they're popping a pill to know if it's spoiled or rotten or not," Cohen said. 




Ashar agreed regulation of weight loss supplements should be enhanced. And the FDA, he said, should increase awareness about the way these products are regulated. "I don't think the public really knows that this stuff is not regulated," before it comes to market, Ashar said. "They think ok, this is in a bottle”¦it must be pure, it must be fine to take." "There needs to be a very, very highly publicized campaign about dietary supplement," in which the FDA says what it can do and will do to regulate these substances, Ashar said. 




However, even if better regulations are put in place, it may be tough to prevent the sale of these weight loss supplements if most are acquired through acquaintances, Ashar said. The FDA would not have the resources to track down such sales the way law enforcement tracks down the sales of narcotics, making it practically impossible, 




hen said. Pai You Guo has been reportedly sold in California, Florida and Washington state. "We're talking about a national problem," Cohen said. Others say the problem is likely not common in the general population. 



It is likely confined to certain pockets of the population, said Dr. Bimal Ashar, an associate professor of medicine at John Hopkins School of Medicine in Baltimore. Rotten tomatoes Congress should re-write the rules that govern dietary supplements, Cohen said. 



The FDA should be given the authority to approve dietary supplements before they go to market, Cohen said, and should ensure the drugs are safe and really contain what's on the label, he said. Right now, "supplements are regulated by the FDA as if they are food," Cohen said. But unlike, say, a spoiled tomato, "the consumers has absolutely no ability when they're popping a pill to know if it's spoiled or rotten or not," Cohen said. 




Ashar agreed regulation of weight loss supplements should be enhanced. And the FDA, he said, should increase awareness about the way these products are regulated. "I don't think the public really knows that this stuff is not regulated," before it comes to market, Ashar said. "They think ok, this is in a bottle”¦it must be pure, it must be fine to take." "There needs to be a very, very highly publicized campaign about dietary supplement," in which the FDA says what it can do and will do to regulate these substances, Ashar said. 




However, even if better regulations are put in place, it may be tough to prevent the sale of these weight loss supplements if most are acquired through acquaintances, Ashar said. The FDA would not have the resources to track down such sales the way law enforcement tracks down the sales of narcotics, making it practically impossible, Ashar said


FDA WARNS HEALTH OFFICIALS ABOUT COUNTERFEIT CANCER DRUG

THE FDA ANNOUNCED ON TUESDAY THAT A COUNTERFEIT VERSION OF THE DRUG AVASTIN HAS MADE ITS WAY INTO THE U.S. MARKET.


 Doctors, hospitals, and pharmacists are being urged to check their supply of the drug to make sure it was manufactured by Roche Group partner Genentech, the maker of the real Avastin.

WHAT IS AVASTIN?


Avastin is a "designer drug" created to treat cancer by isolating a protein known as vascular endothelial growth factor, or VEGF, according to Genentech.

VEGF helps the body create new blood vessels, which in a person with cancer, can help feed the cancerous cells. By blocking VEGF, Avastin theoretically can "starve" cancer cells and kill them off, according to NPR.

Avastin has only been approved to help treat certain kinds of cancers, including colorectal, brain, kidney, and lung cancer. It was initially approved late last year for treating breast cancer as well, but the FDA withdrew the approval while it is re-evaluating the drug's effectiveness in treating advanced cases of the disease.

HOW DID THE FDA FIND OUT ABOUT THE COUNTERFEIT?


CNN reports that the FDA tracked purchases made from Quality Specialty Products, which in the U.S. appears to also go under the moniker Montana Health Care Solutions.
The company is alleged to have been sourcing counterfeit drugs from overseas distributors and then selling them to U.S. practitioners.

Genentech themselves tested the suspected counterfeit version of the drug and found it to be not merely repackaged but fraudulent. Some 19 different potential buyers have been identified.

The FDA warned all of them individually about the counterfeit drug before releasing a more general press statement on Tuesday.


IS THE COUNTERFEIT VERSION DANGEROUS?

Yes, in that it is missing the active ingredient bevacizumab, the key component in the real Avastin medication. Therefore, anyone who has been treated with the counterfeit would not have been getting needed cancer therapy.

Roche and Genentech released a statement on Tuesday giving details on how to identify fake medications, as well as warning practitioners that the counterfeit should not be considered either safe or effective.


DOES THE FDA KNOW IF ANYONE HAS ACTUALLY BEEN GIVEN THE COUNTERFEIT?


Not at this time. The path of the counterfeit drug once it hit American shores is still being investigated, according to MSNBC. Because the agency is still unsure just how much of the counterfeit was purchased and distributed, the FDA hasn't been able to determine whether anyone was actually administered the faux treatment.


MEDICAL STUDENTS HAVE SUBSTANTIAL EXPOSURE TO PHARMARKETINGMACEUTICAL MARKETING

MEDICAL STUDENTS ARE COMMONLY EXPOSED TO PHARMACEUTICAL MARKETING IN THE USA.



This exposure is considerable even during their preclinical studies. Researchers from the Harvard Medical School explain in the journal PLoS Medicine that students have positive attitudes to their contact with pharmaceutical companies - they tend not to think that their exposure might undermine their training and ability to subsequently do their job properly.


Study leaders, Kirsten Austad and Aaron S. Kesselheim believe that educational strategies for medical students regarding their relationship with the pharmaceutical industry should directly address commonly-help myths about the effects of targeted marketing.



They evaluated all published studies on pharmaceutical marketing targeted at medical students and gathered data from 9,850 students from 76 different medical schools.



The researchers wrote that the majority of medical students were involved in some form of interaction with drug companies.


This contact grew with nearly 90% of clinical students receiving educational materials from the industry.

The majority of students felt it was OK to receive gifts from pharmaceutical companies. They cited financial hardship, plus the fact that most students studying other subjects also received and accepted presents, among their reasons to justify entitlement to such gifts.


Nearly two-thirds of the medical students said they were in no way influenced or affected by bias induced by interactions with sales reps, gifts or promotional materials.


There was no consensus among them on whether doctor-industry interactions should be controlled by either the government or medical schools. The authors believe that better education on doctor-industry relationships, as well as institutions pushing for reforms may help achieve an environment which is good for the student and medicine in general.


They authors added: "Given the potential for educational and institutional messages to be counteracted by the hidden curriculum, changes should be directed at faculty and residents who serve as role models for medical students." They concluded: ​ "These changes can help move medical education a step closer to two important goals: the cultivation of strong professional values, as well as the promotion of a respect for scientific principles and critical review of evidence that will later inform clinical decision-making and prescribing practices."


ASTHMA INHALERS TO BECOME PRESCRIPTION-ONLY

 Environmentalists can breath a little easier after the Food and Drug Administration announced that it's banning over-the-counter asthma inhalers, citing hazardous chemicals the spray emits.


The epinephrine inhalers violate an international ban on chlorofluorocarbons, an ingredient formerly found in many aerosol products that has been shown to be harmful to the ozone layer.


Armstrong Pharmaceutical's Primatene Mist is the final inhaler to use chlorofluorocarbons, and other inhalers that have substituted the more environmentally friendly hydrofluoroalkane are prescription only.


That could pose logistical and financial problems for asthma sufferers who rely on inhalers to stave off attacks. The alternatives to the soon to be banned epinephrine inhalers are more expensive and require a prescription to obtain." If you rely on an over-the-counter inhaler to relieve your asthma symptoms, it is important that you contact a health care professional to talk about switching to a different medicine to treat your asthma," Badrul Chowdhury, FDA's director of pulmonary drug division, said in a statement.


The ban derives from the Montreal Protocol on Substances that Deplete the Ozone Layer, an international agreement in which the U.S. and 195 other countries agreed to take off the market all products releasing chlorofluorocarbons into the atmosphere.


The FDA finalized plans to phase out the dangerous inhalers in 2017. The ban officially goes into effect on Dec. 31. 



SEVEN TOP SELLING DRUGS IN THE WORLD

THE TOP TEN SELLING DRUGS IN THE WORLD HAVE A MARKET SHARE OF 9.6% OR US$ 63 BILLION. 

The total pharmceutical market for all these drugs is about US$ 663.5 Billion. The figures excludes countries with un-audited markets, and Russia, Ukraine and Belarus.

The Brand names are listed first followed by drug generic names in brackets. All these are figures sales are from the year 2007.



1. LIPITOR (ATORVASTATIN) - is a drug from Pfizer and has a US$ 13.5 billion market worldwide. Atorvastatin is a statin i.e it is a cholesterol-lowering drug. It is used to lowers LDL cholesterol and triglyceride levels and reduce the risk of heart attacks or angina in patients with increased risk such as those who have hypertension, are 55 years or older, smoker, or those with family history of early coronary heart disease. One in 5 adults in developed countries have high cholesterol and only about 20% of it comes from the foods we eat whereas the rest 80% is produced by our body.



2. PLAVIX (CLOPIDOGREL) is drug marketed in nearly 110 countries by Bristol-Myers Squibb and Sanofi-Aventis and has sales of US$ 7.3 billion. Clopidogrel inhibit blood clots in arteries such as coronary, carotid and peripheral arteries of the limbs and prevents ischemia. It is also used to prevent thrombosis in arterio-venous fistula in patients with chronic kidney failure.



3. NEXIUM (ESOMEPRAZOLE) a drug from AstraZeneca with Sales of US$ 7.27 Billion in 2007. Esomeprazole is a proton pump inhibitor which is used in the treatment of DYSPEPSIA, peptic ulcer disease, gastro esophageal reflux disease. Esomeprazole is a proton pump inhibitor which reduces gastric acid secretion through inhibition of gastric parietal cells by inhibiting H /K -ATPase enzyme thereby the drug prevents formation of gastric acid. NEXIUM has helped many people find relief from persistent heartburn. It can also help heal damage to the esophagus that may be caused by acid reflux.



4. SERETIDE/ADVAIR (FLUTICASONE SALMETEROL) - a drug from GlaxoSmithKline with Sales of US$ Billion 7.1 in 2007. Salmeterol xinafoate is a bronchodilator which relaxes the muscles in the walls of the small air passages in the lungs which helps to open the airways and makes it easier for air to get in and out of the lungs. The effects of salmeterol xinafoate usually last long for at least 12 hours. It should be taken regularly for small air passages to remain open.



5. ENBREL (ETANERCEPT) a drug from Amgen and Wyeth with Sales of US$ 5.3 Billion in 2007. Enbrel is a tumor necrosis factor (TNF) blocker. It is widely used in immune diseases such as rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis where TNF level is high. Enbrel tends to block the TNF and reduce inflammation.



6. ZYPREXA (OLANZAPINE) a drug from Eli Lilly with Sales of US$ 5.3 Billion. Olanzapine is an atypical antipsychotic used in the treatment of: schizophrenia, depressive episodes associated with bipolar disorder, acute manic episodes and maintenance treatment in bipolar disorder. Olanzapine was found to be effective for treating the prodromal symptoms, but was associated with significant weight gain. The olanzapine formulations are manufactured and marketed by the Eli Lilly and Company, whose patent for olanzapine proper expires in 2011.



7. RISPERDAL (RISPERIDONE) a drug from JANSSEN-CILAG with Sales of US$ 4.9 Billion. Risperidone is an antipsychotic used to treat schizophrenia including adolescent schizophrenia, the mixed and manic states associated with bipolar disorder, and irritability in children with autism. Risperidone was approved by the US -FDA in 1993 for the treatment of schizophrenia.
Risperdal was approved as the only drug agent available for treatment of schizophrenia in youth ages 13


Wednesday 28 June 2017

JET DEVICE INJECTS DRUGS WITHOUT NEEDLES

Researchers from the Massachusetts Institute of Technology, led by Ian Hunter, the George N. Hatsopoulos Professor of Mechanical Engineering, have developed a jet-injection system that injects the drug through the skin. Instead of using a hypodermic needle, the device uses a high-pressure system that can penetrate the skin and deliver the drug into the bloodstream. Not only will the device save some patients the pain of needles, but can also reduce needle-related injuries and also help patients who need to self-inject medication. 


The jet-injection system goes beyond other methods of delivering drugs through the skin, like a nicotine patch. Previously, drug molecules needed to be small enough to get past the pores of the skin which restricts what type of medicine one can use via this method. 



The MIT-developed jet-injection system allows easy control of medication delivery by using the Lorentz-force actuator. Current jet-injection systems on the market allow no control of the method of delivery, from the depth of the injection or the amount of medicine to use.



The new jet-injection system solves this problem by the Lorentz-force actuator, which is a sealed vial that contains a piston in which a small magnet, surrounded by coils, is attached to. Researchers can control an electrical current to cause the piston to move forward at a high velocity, based on how much current is used, through the nozzle, which is "as wide as a mosquito's proboscis." Using this method, the drug can get through the skin's pores and into the needed depth. Once at the right depth, pressure is reduced and the drug is released into the tissue around the injection site.



This method allows the jet-injection system to be used on anyone, from infants to adults. Researchers can reduce the pressure inject vaccines in children or use it regularly on adults for a flu shot. Diabetics who have to inject themselves with insulin can use this device to avoid the pain of needles which may help improve diabetes management. It can also be useful for anyone who is needle-adverse.




The MIT researchers are also adapting the device to inject drugs that are in powder form. The device would create enough vibration that would cause the powder to act like a liquid and be injected into the  skin. 

ACEI MNEMONIC

CAPTOPRIL

 Advesrse effects:

 :cautious:
 
C: Cough.
A: Angioedema.
P: Potassium excess.
T: Taste changes.
O: Orthostatic hypotension.
P: Pregnancy.
R: Rash.
I: Indomethacin inhibition.
L: Liver toxicity.

Saturday 3 June 2017

IF YOU TOUCH YOUR PINKY TO YOUR THUMB AND YOU SEE A TENDON RAISE UP, IT MEANS THIS

There Are Certain Behaviors That Humans Do, Or Parts Of The Body That If You Look Back You Can See The Evolutionary Advances. 
One test you can do is lay your arm on a flat surface and touch your pinky finger to your thumb and tip your hand slightly up.
 One of two things will happen, either the tendon in your wrist will raise up, or there will be no visible tendon there.
 If you see a raised band in the middle of your wrist, you’ve got a vestigial muscle in your forearm.
That tendon connects to muscle called palmaris longus, and 10 to 15 percent of people are missing on one or both of their arms.
 But lacking this muscle doesn’t make the person any weaker, and there is no difference in grip strength.
It is actually one of the first tendons that surgeons will take out when doing reconstructive and cosmetic surgeries.
 The palmaris longus is in many mammal species, but is most developed in the animals that use all four limbs to walk around.
In primates, the muscle is longer in animals like monkeys and lemurs, and is shorter in animals like chimps, gorillas, and other animals that don’t do a lot of running and climbing through the trees.
 If you are one of the people that has this tendon, than you learned more about your past and how humans have evolved in this particular way. If you do not have the tendon, it is nothing to worry about. This tendon was really important for early humans that perhaps needed to swing from the trees in order to survive.
A few other interesting parts about our ancestral past is how we don’t need body hair to survive unlike previous humans did, and goose bumps were necessary in order for their skin to retain heat. Or the fact that we don’t need wisdom teeth to eat, and most people get them removed.

THE HANDS TELLS US ABOUT CADAVER

“OK, IT IS TIME TO MOVE ON,” MY PROFESSOR CLAPS HIS HANDS TOGETHER AND YELLS ABOVE THE CHATTER.

We all look up from our Netter’s anatomy books and our cadavers.
The smell of formaldehyde burns my nose as the fluorescent lights flicker above.
 “We have explored the chest cavity and the abdominal cavity.
It is now time to move onto the extremities, starting with the arms.
I want you to unwrap the arms and study the anatomy of the arms and the hands.
 I’ll come by each group to go over exactly what I want you to do.
 Okay, everyone, let’s get started,” he says. I turn to my group. “Who wants to do the unwrapping?” “I’ll do it,” Eric says.
He begins to slowly unwrap the right arm, taking care to carefully furl up the gauze.
 He moves onto the left arm, repeating the same motions.
 With each unfurl, we see more skin, and then we see the hands. My heart skips a beat as I stare at the hands. The skin has a greyish pallor. The veins cross the thin, translucent skin like a spider web. The fingers are skinny and long, perfect for playing  the piano. Each fingernail is perfectly shaped as if a visit to the nail salon had occurred right before death. Silence overtakes our group. After a minute or so, Mike says, “The hands … they really are the scariest part of the body.” We all nod our heads in assent. It dawned on me that we were all freaked out about seeing our cadaver’s hands because somehow the hands had humanized our cadaver. We had forgotten that our cadaver was not just a body but had once been a woman very much alive. Perhaps those hands had belonged to a mother, and had cradled her newborn child’s head. Perhaps those hands had belonged to a master artist and had performed the finest strokes with a paintbrush on a blank canvas. Or perhaps those hands had belonged to a scientist and had pipetted various bacteria onto a petri dish. We would never know but somehow seeing the hands allowed us to imagine the person our cadaver had once been

Friday 2 June 2017

AUGMENTED REALITY TURNS LIVE VOLUNTEERS INTO ANATOMY LESSONS

A new augmented reality system lets physiotherapy students see inside the human body by projecting different layers of muscles and bones over the top of a volunteer “patient.”

 the technology, called the augmented studio, is designed to enhance the teaching of physiotherapy,in which students currently use their knowledge of anatomy to understand how muscles work beneath the skin of patients they can’t see into.

But the Augmented Studio bridges the gap between that theory and practice. ‘Underneath our skin’ By using tracking sensors mounted on a scaffold it projects images of our muscles and skeleton directly onto a volunteer.

The images automatically follow the shape and movement of the body, giving students in the studio space an interactive all-round view of how our bodies work. It can even allow them and their teachers to “draw” on the projected image to make information and action more explicit. “What we are doing is overlaying virtual models of what we look like underneath our skin and synchronizing that with real human action,” says Thuong Hoang, a research fellow at the Microsoft Research Centre for Social Natural Users Interfaces at the University of Melbourne. The Augmented Studio was built by Hoang, computer engineer Zaher Joukhadar, and doctoral student Martin Reinoso, who adapted Microsoft’s Kinect body sensing and tracking device as well as “RoomAlive” projection technology; both of which were originally designed for computer gaming. Once a person steps into the projection space and forms a T-shape with their arms outstretched, the trackers lock on to them and the projected image conforms to their shape and movement. At the moment the projected “overlay” doesn’t show how our muscles actually move when we contract and relax our muscles. Instead, it tracks the body and movement at the joints. But eventually Hoang wants to add in “animation” that can show the actual movement of muscles as the model moves. Physiotherapy lecturer David Kelly says the students quickly embraced the technology during pilot sessions in 2016, which are continuing in 2017. He says the combination of live movement and interaction, in which students could actually move and feel the model’s limbs, helps them to grasp the relationship between their learned anatomy and how it works dynamically. “For first year students it can be really hard to bring together anatomical knowledge with how the body actually works because it can be difficult to visualize. But when they see a real person who they can interact with, while also seeing the muscles and skeleton projected over the top, combined with the ability to draw and write on the body, it all becomes much easier for the students to learn about how the body moves,” says Kelly, from the university’s School of Health Sciences. Tactile learning The Augmented Studio also provides a more visual and intuitive way of learning that Kelly says will benefit those students who naturally learn more easily by direct visualization, rather than through reading and listening. “There has always been a group of students that struggle because the limited ways in which we have to teach may not conform to how they learn best,” he says. Developments in AR, which seeks to use technology to enhance what we can already see, hear, and feel in the real world, are far ahead of chasing GPS-tracked Pokémon. There are viewing devices such as glasses that can overlay what we see with three-dimensional graphics, video, and holograms, and we can generate projections like games that people manipulate by moving our hands. The big advantage of the Augmented Studio over advances like 3D holograms is that the students can actually touch and move the body, making it a much more interactive experience. They also don’t have to wear headgear, which means it could potentially be used in bigger settings with larger numbers of students. “It has always been hard to capture the dynamic side of how our anatomy works, so the difference here is the high level of interaction you can achieve. The student can, for example, ask the model to kick and they can then look at variations from different angles at what is happening as someone kicks,” Kelly says. The Augmented Studio is still in early-stage development and Kelly would love to see it migrate to using muscle animations. Hoang is also working to develop a system for the student interaction with the model to be automatically recorded onto their tablets so they can have a permanent record of what they were learning. Another challenge is to find a way to make the studio more transportable and quicker to set up. At the moment the studio can work very effectively in a dedicated tutorial space where it could be permanently set up, but Kelly says a more portable set up would increase its flexibility for teaching. Martial arts Hoang is now working on extending the tracked projection technology to various health and fitness areas, and even in performance art. He says that using tracking sensors with projections it is possible to create guides that show people how to position their bodies for practicing fitness, sport, and dance. Using virtual reality headsets he and doctoral student Martin Reinoso have already developed a prototype that allows a martial arts teacher to remotely instruct students on the right position to hold. By using body tracking and linked headsets student can match their movement to align with those of their teacher. There is also scope to project information on our own body’s performance, such as heart rate and breathing, so it is visible either on our projected selves or on a nearby surface. “The innovation we have created isn’t just limited to the fixed information that we have been projecting so far. If can be used to project dynamic information onto yourself or any surface around you,” Hoang says. “All of what I’m dreaming of is very possible.” 

The Woman Who Stood Between America And An Epidemic Of Birth Defects

In 1960, America had a stroke of luck.
That was when the application to begin mass-marketing the drug thalidomide in the United States landed on the desk of Frances Oldham Kelsey, a reviewer at the Food and Drug Administration. Today we know that the drug causes severe, devastating birth defects when taken by pregnant women for nausea.
BUT THE TIME, THALIDOMIDE’S DARKER EFFECTS WERE JUST BECOMING KNOWN Between 1957 and 1962, the sedative would leave thousands of infants in Canada, Great Britain and West Germany permanently and tragically disabled.

The U.S., however, never had a crisis of thalidomide-linked birth defects on that magnitude. Why not? What stood between the drug and the health of the American public was none other than Kelsey and the FDA. As a medical reviewer, Kelsey had the power to prevent a drug from going to market if she found the application to be lacking sufficient evidence for safety. After a thorough review, Kelsey rejected the application for thalidomide on the grounds that it lacked sufficient evidence of safety through rigorous clinical trials.

Today we take it for granted that the FDA wisely spurned an unsafe drug. But in many ways, Kelsey’s education and experience up to that point made her especially well-suited for her position as a medical reviewer—and, in particular, for the thalidomide application. After completing a master’s degree in pharmacology at McGill University in her home country of Canada, Kelsey was recommended by her graduate advisor to write to a Dr. Eugene Geiling at the University of Chicago to inquire about a research assistant position and to express her interested in obtaining a PhD. Geiling, a medical officer at the FDA known for his studies of the pituitary gland, wrote back offering Kelsey a research assistantship and a scholarship for doctoral study.
  IN 1936, KELSEY JOINED GEILING AT THE UNIVERSITY OF CHICAGO.

That consequential step in Kelsey's career may been due to a fortuitous error on the part of Geiling. In her short memoir “Autobiographical Reflections,” Kelsey describes Geiling as “very conservative and old-fashioned,” noting that “he really did not hold too much with women as scientists.” This might explain why Geiling, in his response letter to Kelsey, addressed it to “Mr. Oldham”—believing her to be a man. Kelsey said she continued to wonder “if my name had been Elizabeth or Mary Jane, whether I would have gotten that first big step up.” Kelsey was first introduced to the dangers of mass marketed unsafe pharmaceuticals in 1937, when the FDA enlisted Geiling to solve the mystery of Elixir of Sulfanilamide. Sulfanilamide effectively combated infections, but it came in a large and bitter pill that needed to be taken in large dosages. To make the drug more appealing, especially to children, manufacturers added it to a solvent with artificial raspberry flavor. The problem was that the solvent they chose was diethylene glycol—commonly known as antifreeze. Between September and October, the drug killed 107 people. Geiling and his lab of graduate students, including Kelsey, set out to determine what exactly in the elixir was killing people: the solvent, the flavor or the sulfanilamide. Through a series of animal studies—which at the time were not required by federal law for a drug to go to market—Geiling and his lab were able to determine that it was the diethylene glycol that was the cause of death. The public outcry to this tragedy prompted Congress to pass the Federal Food, Drug, and Cosmetic Act of 1938, which added a New Drug section requiring manufacturers to present evidence that a drug was safe before going to market. Though this new law “provided for distribution of a new drug for testing purposes,” FDA historian John Swann says “the law did not provide in any explicit or detailed way how oversight of that testing should be conducted.” In other words, clinical trials continued to undergo little to no oversight. Kelsey graduated from medical school in 1950, and went on to work for the Journal of the American Medical Association before starting work as a medical reviewer at the FDA in 1960. As reviewer of New Drug Applications (NDA), she was one of three people charged with determining a drug’s safety before it could be made available for public consumption. Chemists reviewed the chemical makeup of the drug and how the manufacturer could guarantee its consistency, while pharmacologists reviewed animal trials showing that the drug was safe. Though this appears to be a rigorous and thorough process of checks and balances, Kelsey admitted to some weaknesses in her memoir, including the fact that many of the medical reviewers were part-time, underpaid, and sympathetic to the pharmaceutical industry. The most troubling deficiency in the process was the 60 day window for approving or rejecting drugs: If the 60th day passed, the drug would automatically go to market. She recalls that this happened at least once. Fortunately, drug manufacturer Richardson-Merrell’s NDA for Kevadon—the U.S. trade name for thalidomide—was only the second NDA Kelsey received, meaning she didn’t yet have a backlog of reviews to get through. For Kelsey and the other reviewers, thalidomide did not pass muster. Not only were there pharmacological problems, but Kelsey found the clinical trials to be woefully insufficient in that the physician reports were too few and they were based largely on physician testimonials rather than sound scientific study. She rejected the application. Reports of the side effect peripheral neuritis—painful inflammation of the peripheral nerves—were published in the December 1960 issue of the British Medical Journal. This raised an even bigger red flag for Kelsey: “the peripheral neuritis did not seem the sort of side effect that should come from a simple sleeping pill.” She asked for more information from Merrell, who responded with another application merely stating that thalidomide was at least safer than barbiturates. Kelsey then sent a letter directly to Merrell saying that she suspected they knew of the neurological toxicity that led to nerve inflammation but chose not to disclose it in their application. Merrell grew increasingly upset that Kelsey would not pass their drug, which had been used in over 40 other countries at this point. If neurological toxicity developed in adults who took thalidomide, Kelsey wondered: What was happening to the fetus of a pregnant woman who took the drug? Her concern hit on what would be the most sinister effect of thalidomide in other countries. Kelsey had asked these questions before. After getting her Ph.D. in 1938, she stayed on with Geiling. During World War II, Geiling’s lab joined the widespread effort to find a treatment for malaria for soldiers in wartime. Kelsey worked on the metabolism of drugs in rabbits, particularly an enzyme in their livers that allowed them to easily break down quinine. What wasn’t clear was how this enzyme broke down quinine in pregnant rabbits and in rabbit embryos. Kelsey found that pregnant rabbits could not as easily break down quinine and that the embryos could not break it down at all. Though there was already some work being done on the effects of pharmaceuticals on embryos, it was not yet a well-researched area. By November of 1961, physicians in Germany and Australia had independently discovered birth defects in infants whose mothers had taken thalidomide during early pregnancy. In embryos, thalidomide could cause critical damage to organ development—even just one pill could result in infant deformities. And since many doctors prescribed thalidomide for the off-label treatment of morning sickness, 10,000 infants all over the world were affected, and countless others died in utero. Merrell eventually withdrew the application on their own in April of 1962. But the drug had already been distributed to “more than 1200 physicians, about 15,000-20,000 patients—of whom over 600 were pregnant,” according to Swan. In the U.S., 17 cases of birth defects were reported, but as Swan says via email, “that could have been thousands had the FDA not insisted on the evidence of safety required under the law (despite ongoing pressure from the drug’s sponsor).” In 1962, soon after Merrell withdrew their application and the horrors of the drug became internationally known, Congress passed the Kefauver-Harris Amendment. This key amendment required more oversight for clinical studies, including informed consent by patients in the studies and scientific evidence of the drug’s effectiveness, not just its safety. In the wake of its passage, President Kennedy awarded Kelsey the President’s Award for Distinguished Federal Civilian Service, making her the second woman to receive such a high civilian honor. In her memoir, Kelsey says that the honor did not belong just to her. “I thought that I was accepting the medal on behalf of a lot of different federal workers,” she writes. “This was really a team effort.” She was quickly promoted to chief of the investigational drug branch in 1963, and four years later, she became director of the Office of Scientific investigation—a position she held for 40 years until she retired at the age of 90. She lived until the age of 101, and passed away in 2015. Kelsey spent the majority of her life in public service, and her story continues to stand out as a testament to the essential role of the FDA in maintaining drug safety 

2011 NOREPINEPHRINE SHORTAGE LINKED TO INCREASED PATIENT DEATHS

In 2011, hospitals in the US faced a shortage of the drug norepinephrine.
The shortage has been shown to be associated with increased mortality of admitted patients due to septic shock.

Shock occurs when the body’s blood supply is inadequate, failing to provide nutrients and remove waste products from our organ’s cells.

This leads to decreased organ function, and ultimately, the cellular death of organs.

When the cause of reduced blood supply is a widespread infection in the body, it is called septic shock.
The symptoms of septic shock are increased body temperature, decreased blood pressure, decreased urination, and confusion.
As septic shock is life-threatening, diagnosis based on symptoms and a blood sample is critical.
The aim of treatment is to increase blood supply to organs and stop infection from spreading. Norepinephrine increases the blood supply to organs by constricting artery blood vessels to increase blood pressure and accelerate circulation. In 2011, US hospitals experienced shortages of norepinephrine due to production interruptions at three drug manufacturers.
The US Food and Drug Administration (FDA) called it a nation-wide shortage that lasted for approximately one year.
Other drugs such as phenyl-epinephrine with the same effect as norepinephrine were used to compensate for the shortage.
Although patients were administered alternative medication, doctors questioned whether these drugs were as effective as standard norepinephrine treatment.
Nation-wide data collected and published in JAMA looked at the link between the shortage of norepinephrine and the health outcomes of patients that required the drug.
Data from 27,835 adults with septic shock admitted to 26 US hospitals between July 1, 2008 and June 30, 2013 was analyzed.
The shortage of norepinephrine was declared when the hospital rate of norepinephrine use decreased by more than 20% from baseline, assessed every three months.
The study showed that the rate of administration of norepinephrine to patients declined from 77% before the shortage to 55.7% after.
Phenyl-epinephrine was the most common drug used as a replacement.
The results of the research suggest that the mortality rate of admitted patients increased during periods of norepinephrine shortage.
The study highlights the need for further investigation, primarily in the choice of the alternative medication used.
T  he increased use of phenylephrine among patients is being questioned by researchers due to the availability of better alternatives such as dopamine. Studies show that dopamine as effective as norepinephrine. Second, drug allocation management is being questioned due to the unavailability of trained pharmacists to effectively allocate limited drug supplies and the delayed treatment of patients with alternative medications. Third, there is concern regarding the dose and titration of alternative medications prescribed by medical professionals. Limitations of the study include a lack of data describing the method by which decisions were made to administer norepinephrine to selected patients, lack of information on the dosage or duration in a 24-hour period, and slight ambiguity surrounding the criteria under which patients were rendered septic. Nevertheless, the information provided by this study argues for increased investigation, and the need to find resources to prevent the increased mortality of patients due to septic shock if such circumstances were to arise again

Thursday 1 June 2017

ULTRA-TOUGH ANTIBIOTIC TO FIGHT SUPERBUGS

US scientists have re-engineered a vital antibiotic in a bid to wipe out one of the world's most threatening superbugs.
Their new version of vancomycin is designed to be ultra-tough and appears to be a thousand times more potent than the old drug, PNAS journal reports. It fights bacteria in three different ways, making it much less likely that the bugs can dodge the attack. It is yet to be tested in animals and people, however.
 The Scripps Research Institute team hope the drug will be ready for use within five years if it passes more tests.
 Fighting superbugs Experts have repeatedly warned that we are on the cusp of a "post-antibiotic era", where some infections could become untreatable.
One hard-to-treat infection that has been worrying doctors is vancomycin-resistant enterococci or VRE. It has been found in hospitals, can cause dangerous wound and bloodstream infections and is considered by the WHO to be one of the drug-resistant bacteria that pose the greatest threat to human health. Some antibiotics still work against VRE, but the 60-year-old drug vancomycin is now powerless.
The Scripps team set out to see if they could revamp vancomycin to restore its killing ability. They made some strategic modifications to the molecular structure of the old drug to make it better at attacking bacteria where it hurts - destroying cell walls.
Three changes in particular seem to be important, increasing the strength and durability of the drug. Lead researcher Dr Dale Boger explained: "We made one change to the molecule vancomycin that overcomes what is the present resistance to vancomycin.
And then we added to the molecule, two small changes that built into the molecule, two additional ways in which it can kill bacteria. So the antibiotic has three different, we call them 'mechanisms', by which it kills bacteria. And resistance to such an antibiotic would be very difficult to emerge. So it's a molecule designed specifically to address the emergence of resistance." The modified drug was able to kill samples of VRE in the lab and retained nearly full potency after 50 rounds of exposure to the bacterium. Dr Boger said: "Organisms just can't simultaneously work to find a way around three independent mechanisms of action.
 Even if they found a solution to one of those, the organisms would still be killed by the other two. "Doctors could use this modified form of vancomycin without fear of resistance emerging." Prof Nigel Brown of the Microbiology Society said: "This development could be hugely important. "Vancomycin is an antibiotic of last resort against some serious infections. There has been great concern that resistance has been emerging."

HOW TO RECOGNIZE SOMEONE USING ANABOLIC STEROIDS

Physical changes are typically the most pronounced short-term symptoms as they are not easily concealed by the novice user and include:


1-Unusually greasy hair or oily skin (often with stretch marks on the inner joints)


2-Small red or purplish acne, including breakouts on the shoulders and back


3-Gynocomastia, the abnormally excessive development of the breast tissue in males


 4-Persistent bad breath


5-Thinning hair throughout the head or receding hairline (male pattern baldness)



6-Increased length and thickness in hair (on body parts other than the head)



 7-Hair loss in bed, shower, comb or brush



8-Jaundice or yellowing of the skin; this signals liver damage



9-Skin eruptions and infections, such as abscesses and cysts



10-Drastic appetite shifts (extreme hunger or lessened/loss of appetite)



11-Joint pain; greater chance of injuring muscles and tendons



12-Disrupted sleep patterns (not sleeping well or sleeping too much)




13-Fluid level changes, bloating (face & body), and night sweating




14-Dizziness, trembling, nausea or vomiting



15-Rapid or progressive weight gain



16-Increased muscle size (sudden or progressive)



17-Hyperactivity or lethargy (too little energy)



18-Trouble urinating; discoloration or blood in urine



19-Rare and occasional side effects




 20-Steroid abusers often experience mood swings Personality and Psychiatric changes often happen suddenly and without visible triggers or reasons. They include:



1-Extreme mood swings


2-Increased aggression or irritability



 3-Becomes disrespectful or abusive (verbally and/or physically)



4-Poor decision making stemming from feelings of invincibility



5-Becomes secretive and/or starts lying


6-Withdraws from family members 7-Depression (usually when steroids are discontinued) 8-Hallucinations - seeing or hearing things that aren't there 9-Paranoia - extreme feelings of mistrust or fear Social changes may be mistaken for natural teenage distancing or independence.


 THESE ARE

1-Closes and/or locks bedroom door more often



2-Takes longer showers or baths (this time is often used for injecting)




3-Phone conversations become more private



4-Begins receiving more packages in the mail



 5-Asks for money more often, or has more money than usual




6-Is stealing or losing belongings




7-Begins taking naps and/or falls asleep in class




 8-Loss of focus or concentration (at work, school or home)



9-Decline in grades



10-Forgets plans, dates and activities


11-Loss of interest in friends, or suddenly gains new friends 

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