Day: 03/27/2015

AFLIBERCEPT NOW FDA APPROVED FOR DIABETIC RETINOPATHY IN PATIENTS WITH DIABETIC MACULAR EDEMA.

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The U.S. Food and Drug Administration expanded the approved use for Eylea (aflibercept) injection to treat diabetic retinopathy in patients with diabetic macular edema.

In February, the FDA approved Lucentis (ranibizumab injection) 0.3 mg to treat DR in patients with DME.

Eylea is administered by a physician as an injection into the eye once a month for the first five injections and then once every two months. It is intended to be used along with appropriate interventions to control blood sugar, blood pressure and cholesterol.

The safety and efficacy of Eylea to treat DR in patients with DME were evaluated in 679 participants in two clinical studies where participants were randomly assigned to receive Eylea or macular laser photocoagulation. At week 100, participants being treated with Eylea showed significant improvement in the severity of their DR, compared to patients who did not receive Eylea.

The most common side effects associated with Eylea include bleeding of the conjunctiva ; eye pain; cataracts; floaters; increased intraocular pressure; and vitreous detachment. Serious adverse reactions include endophthalmitis and retinal detachments.

The FDA granted breakthrough therapy designation to Eylea for the treatment of DR with DME.

The FDA previously approved Eylea to treat wet (neovascular) age-related macular degeneration

FDA APPROVES NEW TREATMENT FOR INHALATIONAL ANTHRAX.

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The U.S. Food and Drug Administration approved Anthrasil, Anthrax Immune Globulin Intravenous (Human), to treat patients with inhalational anthrax in combination with appropriate antibacterial drugs.

Anthrasil is manufactured from the plasma of individuals vaccinated against anthrax. The plasma contains antibodies that neutralize toxins produced by the anthrax bacteria.

The efficacy of Anthrasil was studied in animals because it was not feasible or ethical to conduct adequately controlled efficacy studies in humans. Rabbits and monkeys were exposed to a lethal aerosolized dose of B. anthracis spores, then treated with Anthrasil or a placebo, and evaluated for survival. Survival in anthrax-infected monkeys treated with Anthrasil ranged from 36 to 70 percent compared to 0 percent survival in the placebo group with a trend toward increased survival at higher doses of Anthrasil. Rabbits treated with a moderate dose of Anthrasil after infection exhibited 26 percent survival compared to 2 percent survival in the placebo group. Another study in rabbits showed that a combination of Anthrasil and antibiotics resulted in 71 percent survival compared to 25 percent survival in animals treated with antibiotics alone.

The results of studies in research animals provided sufficient evidence that Anthrasil is reasonably likely to benefit humans with inhalational anthrax. The FDA’s Animal Rule allows efficacy findings from adequate and well-controlled animal studies to support FDA approval when it is not feasible or ethical to conduct trials in humans.

The safety of the product was tested in 74 healthy human volunteers. The most commonly observed side effects were headache, back pain, nausea and infusion site pain and swelling.

Chyluria – a clinical and diagnostic stepladder algorithm with review of literature.

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Objectives: Chyluria is an infrequently discussed urological problem and a rare urological manifestation of filariasis. Apart from few isolated case reports the lit­erature regarding the etiology, diagnostic approach and management of chyluria is grossly inadequate. We un­dertook the present study to review chyluria in its entirety so as to have a broader insight in to its etiopathogenesis and to suggest the clinician with a proposed stepladder protocol approach (algorithm) towards its management.
Methods: We made a detailed systematic data search for the period covering the last 37 years on the “Pubmed” for published English literature using the key words ‘chy­luria’, `milky urine’ and ‘hematochyluria’. The signifi­cant findings and recent advances on chyluria were reviewed.
Results: About 250 articles were found; these were analyzed, tabulated and reviewed for their clinical ap­proach and management of chyluria.
Conclusions: Though generally a harmless condition in a majority, chyluria should not be ignored, instead all cases must be aggressively investigated to arrive at a cause. These should then be managed on the lines similar to as proposed in our 10-stepladder protocol.

 

Disrupted biological clock linked to Alzheimer’s disease

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New research has identified some of the processes by which molecules associated with neurological diseases can disrupt the biological clock, interfere with sleep and activity patterns, and set the stage for a spiral of health concerns that can include a decreased lifespan and Alzheimer’s disease.

The research was published in Neurobiology of Disease by scientists from Oregon State University and the Oregon Health & Science University, in work supported by the National Institutes of Health.

Previous studies have shown that disruption of the – the natural pattern of day-night activity that’s genetically controlled in many animals – can cause neurodegeneration, loss of motor function and early death.

The newest results help outline the molecular mechanisms involved, and show how proteins associated with neurological disease can diminish the biological clock function and ultimately lead to very serious health problems, including severe cognitive deterioration. It also confirms that these risks increase significantly with age.

“The molecular basis underlying biological clock deficits in Alzheimer’s disease has been difficult to tease out,” said Matthew Blake, an OSU faculty research assistant and author of the study. “Only recently have we been able to utilize our model system to accurately dissect this mechanism.”

This research was done with fruit flies, which have many genes and biological processes that are similar or identical to those of humans, retained through millions of years of evolution. Circadian clocks are so essential to health that they are found throughout the nervous system and peripheral organs.

Proper function of circadian rhythms has been shown to affect everything from to stress reaction, feeding patterns, DNA repair, fertility and even the effectiveness of medications.

“Alzheimer’s disease has always been of interest in this research, because sleep disruption is one of its earliest symptoms, and almost everyone with Alzheimer’s has some sleep problems,” said Jadwiga Giebultowicz, corresponding author of this study, a professor in the Department of Integrative Biology in the OSU College of Science, and expert on the biological and genetic underpinnings of the biological clock.

“This research adds more support to the hypothesis that neurological damage is a circular process that, in turn, causes more disruption of the biological clock,” Giebultowicz said. “We’ve identified a new player in this process, a fragment of the amyloid precursor protein called AICD, that is able to enter the nucleus of cells and interfere with central clock function.”

One known cause of Alzheimer’s disease is cleavage of an amyloid precursor protein, which creates a peptide that’s toxic to neurons. An enzyme involved is elevated in Alzheimer’s patients. This study took that process further and showed that increased production of the enzyme, which in flies is called dBACE, reduced the expression of a core clock protein.

The results suggest that dBACE acts via dAICD to cause the disruption of the biological clock and loss of daily sleep and activity cycles. This disruptive process was much more severe in older flies.

“A general message from this is that normal day-night, sleep and activity cycles are important,” Giebultowicz said.

“There’s evidence that proper sleep allows neuronal repair activity and the maintenance of neuronal health,” she said. “Since neuronal damage is a destructive process that can build on itself once it begins, it’s important that sleep issues should be taken seriously by people and their doctors, especially as they age.”

Molecular clock oscillations decline with age, Giebultowicz said, and finding ways to help maintain or restore them might form the basis for a possible therapy to reduce or prevent the associated health problems.

SSRI Drugs Linked to Germanwings Kamikaze Crash?

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Germanwings co-pilot Andreas Lubitz, who deliberately crashed a plane with 150 people onboard, had undergone psychiatric treatment, a fact that should prompt questions about whether the 28-year-old had been taking SSRI drugs which have been linked to numerous cases of mass murder and suicides.

SSRI Drugs Linked to Germanwings Kamikaze Crash?

“Lubitz had spent 18 months overall under psychiatric treatment, Bild reported on Friday, citing anonymous sources within Lufthansa, Germanwings’ parent company. The pilot was diagnosed with a “severe depressive episode” in 2009, the German daily says. It claims it got access to Lubitz’s profile, indicating the pilot had “psychological problems” and required a “special, exemplary regular medical examination,”reports RT.

Lubitz was also going through a personal crisis after breaking up with his girlfriend having previously taken a six month break from flight training due to “burnout-syndrome” or “depression”.
During a search of Lubitz’ apartment, German police also announced that they had discovered a “significant clue” that might help to determine why Lubitz deliberately crashed the Airbus A320. Authorities said that the item was not a suicide note.

“We have found something which will now be taken for tests,” Markus Niesczery from Dusseldorf Police told the Daily Mail. “We cannot say what it is at the moment, but it may be a very significant clue to what has happened.”

In addition, it has subsequently emerged that Lubitz had made an effort to conceal and unspecified medical condition from his employers.

“Documents with medical contents were confiscated that point towards an existing illness and corresponding treatment by doctors,” said the prosecutors’ office in Dusseldorf, where the pilot lived and where the flight from Barcelona was heading, reports Reuters.

“The fact there are sick notes saying he was unable to work, among other things, that were found torn up, which were recent and even from the day of the crime, support the assumption based on the preliminary examination that the deceased hid his illness from his employer and his professional colleagues,” they said.

Ascertaining whether Lubitz was on or had come off anti-depression drugs should be a crucial part of the investigation given the clear connection between SSRI pharmaceuticals and incidents of suicide and mass murder.

As CCHR documents, psychiatric drugs have been involved in at least 31 different school shootings and other massacres over the last 25 years.

Despite it being reported that prescription drugs were found in the apartment of ‘Batman’ shooter James Holmes days after the Aurora massacre, it took nine months to find out exactly what those drugs were. Like Columbine killer Eric Harris, Holmes had been taking Zoloft, an SSRI drug linked with episodes of mania.

The connection between Zoloft and violent outbursts is well documented. Countless studies identify Zoloft as being responsible for more than 1,000 suicides and hundreds of episodes of mania and aggression.

There was also an apparent attempt to shield information concerning whether or not Sandy Hook gunman Adam Lanza was taking psychiatric drugs. In September 2013, we reported on the State of Connecticut refusing to release Lanza’s medical records over fears that divulging the identity of the antidepressants he was taking would, “cause a lot of people to stop taking their medications,” according to Assistant Attorney General Patrick B. Kwanashie.

Fort Hood gunman Ivan Lopez, who shot dead three colleagues and injured 16 others before turning the gun on himself in April last year, was also taking psychiatric medication before the shooting. Staff Sgt. Robert Bales was also taking anti-depressant drugs when he massacred 16 Afghan civilians in 2012.

As the website SSRI Stories profusely documents, there are literally hundreds of examples of mass shootings, murders and other violent episodes that have been committed by individuals on psychiatric drugs over the past three decades. The number of cases is staggering, but the media has completely failed to generate a national conversation about the issue due to its obsession with exploiting mass shootings to demonize the second amendment.

In the aftermath of revelations that Germanwings co-pilot Andreas Lubitz deliberately crashed the airliner, there has also been complete silence amongst the establishment press as to whether psychiatric drugs played a role, despite Lubitz’ known history of depression.

Pharmaceutical giants who produce drugs like Zoloft, Prozac and Paxil spend around $2.4 billion dollars a year on direct-to-consumer television advertising every year. By running negative stories about prescription drugs, networks risk losing tens of millions of dollars in ad revenue, which is undoubtedly one of the primary reasons why the connection is habitually downplayed or ignored entirely.

‘Safe antifreeze’ works better with added nanoparticles .

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Replacing toxic ethylene glycol – the principal component of antifreezes and de-icers – with the food additive propylene glycol, and adding nanoparticles to improve the mixture’s properties, researchers at US company ACTA Technologyhave created an antifreeze formula that they say is safer, more environmentally friendly and performs better than existing products.

Although poisonous, ethylene glycol has a sweet taste and every year thousands of people, many of them children, and countless pets and wild animals, are poisoned by accidentally drinking antifreeze. Propylene glycol, on the other hand, is safe to consume, and is used as an additive in some foods to keep them moist. It is already used as an antifreeze in some industries such as food production, but its viscous, syrup-like consistency makes it unsuitable for widespread use.

‘Our goal was to create a non-toxic heat transfer fluid that overcomes the traditional limitations of a propylene glycol-water mix,’ says Michael Minard, ACTA’s chief executive, speaking at the 249th ACS National Meeting & Exposition in Denver, US. Adding metal oxide nanoparticles to the mixture reduces its viscosity, he explains. ‘One of the properties we see is shear-thinning which reduces the viscosity substantially.’

Other researchers working on ‘nanofluids’ like this have struggled with viscosity, adds ACTA’s chief technology officer Edward Clancy, because they use surfactants to stop the nanoparticles sticking together. The nanoparticles that ACTA use, however, are stable without surfactant because of their positive charge and non-spherical, branched chain structure. ‘Because we’re not bound by using a surfactant we’re not paying the viscosity penalty that so many of our predecessors have stumbled into,’ says Clancy.

Replacing ethylene glycol with propylene glycol makes antifreeze non-poisonous, but viscosity has traditionally been a problem

The resulting solution is not only non-toxic, but may actually be more effective as antifreeze, with nearly double the heat transfer capacity of ethylene glycol-based formulations. ‘The thermal conductivity of these metallic [nanoparticles] is much higher than that of the base fluid, so if you put them in you increase the overall heat transfer,’ Clancy explains.

ACTA have patented their antifreeze and are currently investigating ways to scale up production. Minard says the overall cost of making it will be ‘near to or lower than’ ethylene glycol antifreezes, and they are optimistic it will be reach the market within a few years. ‘We believe that the finished product will have a wide variety of uses in various industries,’ says Minard.

Consultant toxicologist John Hoskins, who was not involved in the research, says replacing ethylene glycol with propylene glycol is, on the whole, a positive step that would reduce poisonings, but points out that the environmental impacts of any new formula must be considered, as well as toxicity. ‘In the environment ethylene glycol degrades more quickly than propylene glycol,’ he says. ‘[And in existing products] ethylene glycol is more effective at depressing the freezing point, so more propylene glycol may needed in antifreeze to achieve the same effect.’