Wishing all my blog readers, followers, subscribres and fans a very happy Holy month of Ramadan.
One Religion. One God. One Love.
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Most spices have powerful medicinal properties, which is precisely why they’ve been used to promote healing for thousands of years prior to the advent of modern, synthetic drug-based medicine.
One such spice is turmeric, the yellow-pigmented “curry spice” often used in Indian cuisine. Turmeric contains curcumin, the polyphenol identified as its primary active component and which exhibits over 150 potentially therapeutic activities, which include antioxidant, anti-inflammatory and anti-cancer properties.1
Curcumin is capable of crossing the blood-brain barrier, which is one reason why it holds promise as a neuroprotective agent in a wide range of neurological disorders. Researchers have investigated curcumin for its potential role in improving Parkinson’s disease .
Preliminary results indicate that it may hold even more promise than the drugs currently used for this disorder, many of which (ironically) have serious neurotoxic side effects, including dyskinesia – a movement disorder identical to the symptoms of Parkinson’s disease.
Parkinson’s is a neurodegenerative disease caused by a steady depletion of dopamine-producing nerve cells, particularly in the area of your brain referred to as the substantia nigra. Most of the current drug treatments for Parkinson’s disease, known as dopamine agonists, focus on replenishing dopamine.
Although such treatments provide symptomatic relief during early Parkinson’s disease, they are ineffective in the long term where they may actually increase symptoms such as tremor, postural instability and cognitive deficits that are common with this disease. They are also associated with motor complications and a laundry list of other strange and disturbing side effects, including:
|Causing or worsening psychosis||Unusual tiredness or weakness|
|Orthostatic hypotension (a dizzy spell caused by a sudden drop in blood pressure)||Dizziness, drowsiness, lightheadedness, or fainting|
|Increased orgasmic intensity||Twitching, twisting, or other unusual body movements|
|Weight loss||Pathological addiction (gambling, shopping, internet pornography, hypersexuality)|
As researchers noted in the journal Current Pharmaceutical Design:2
“Most of the current pharmacotherapeutic approaches in PD [Parkinson’s disease] are aimed at replenishing the striatal dopamine. Although these drugs provide symptomatic relief during early PD, many patients develop motor complications with long-term treatment. Further, PD medications do not effectively tackle tremor, postural instability and cognitive deficits.
Most importantly, most of these drugs do not exhibit neuroprotective effects in patients. Consequently, novel therapies involving natural antioxidants and plant products/molecules with neuroprotective properties are being exploited for adjunctive therapy.”
Unlike Parkinson’s drugs, curcumin is neuroprotective and several studies strongly support its use for the treatment of Parkinson’s. For example:
For years now turmeric, and its active ingredient curcumin, have shown powerful benefits to your brain health. One of the ways that it works, similar to vitamin D, is modulating large numbers of your genes; in fact, curcumin has been shown to influence more than 700 genes.
The potential healing power of this spice, which is an important part of Eastern cultural traditions including traditional Chinese medicine and Ayurveda, perhaps first came about when it was noticed that the prevalence of Alzheimer’s disease among older adults in India is more than four times lower than the rate in the United States.
Why such a significant difference?
Some researchers believe the answer for this drastic disparity in Alzheimer’s disease prevalence is a direct result of curcumin. Research has shown that curcumin may help inhibit the accumulation of destructive beta amyloids in the brain of Alzheimer’s patients, as well as break up existing plaques. People with Alzheimer’s tend to have higher levels of inflammation in their brains, and curcumin is perhaps most known for its potent anti-inflammatory properties. The compound can inhibit both the activity and the inflammatory metabolic byproducts of cyclooxygenase-2 (COX2) and 5-lipooxygenase (5-LOX) enzymes, as well as other enzymes and hormones that modulate inflammation.
And that’s not all. The growing interest in curcumin over the past 50 years is understandable when you consider the many health benefits researchers have found when studying this spice. According to an ever-expanding clinical body of studies, curcumin may help:
|Support healthy cholesterol levels||Prevent low-density lipoprotein oxidation||Inhibit platelet aggregation|
|Suppress thrombosis and myocardial infarction||Suppress symptoms associated with type 2 diabetes||Suppress symptoms of rheumatoid arthritis|
|Suppress symptoms of multiple sclerosis||Suppress symptoms of Alzheimer’s disease||Inhibit HIV replication|
|Suppress tumor formation||Enhance wound healing||Protect against liver damage|
|Increase bile secretion||Protect against cataracts||Protect against pulmonary toxicity and fibrosis|
There is a correlation between insufficient levels of vitamin D and the development of early Parkinson’s disease, and research has suggested that long-term deficiency may play a role in the pathogenesis of the disease. There are three major points you want to remember about vitamin D:
From my perspective, the preferred test your doctor needs to order is 25(OH)D, also called 25-hydroxyvitamin D, which is the better marker of overall D status. This is the marker that is most strongly associated with overall health. You’ll want to optimize your levels according to the chart below. If you currently have Parkinson’s disease you will want to keep your vitamin D level in the higher 70-100 ng/ml range to help fight the disease.
Animal-based omega-3 fats are also a powerful defense against Parkinson’s, as they contain two fatty acids crucial to human health, DHA and EPA. Most of the neurological benefits of omega-3 oils are derived from the DHA component rather than the EPA component.
In fact, DHA is one of the major building blocks of your brain. About half of your brain and eyes are made up of fat, much of which is DHA — making it an essential nutrient for optimal brain and eye function. Your brain activity actually depends greatly upon the functions provided by its outer, fatty waxy membrane to act as an electrical nerve-conduction cable. In your brain alone, DHA may help to ward off Parkinson’s by:
I believe krill oil is your best option for getting animal-based omega-3 fats because of the fact that the omega-3 is attached to phospholipids that dramatically increase its absorption, especially into brain tissue.
Parkinson’s disease is related to lifestyle factors, including the following:
|Environmental toxins and pesticides||Aspartame consumption|
|Petroleum-based hydrocarbon solvents, like paint and glue||Deficiencies in vitamin D and vitamin B folate|
|Excess iron in your body||Pasteurized milk|
In addition to avoiding these toxic exposures, I recommend lifestyle adjustments including:
As for getting the full benefits that curcumin has to offer, look for a turmeric extract that contains 100 percent certified organic ingredients, with at least 95 percent curcuminoids. The formula should be free of fillers, additives and excipients (a substance added to the supplement as a processing or stability aid), and the manufacturer should use safe production practices at all stages: planting, cultivation, selective harvesting, and then producing and packaging the final product.
Unfortunately, at the present time there really are no formulations available for the use against cancer. This is because relatively high doses are required and curcumin is not absorbed that well. There is much work being done to provide a bioavailable formulation in the near future.
In the event you need higher doses (such as in the case of treating cancer), use the curcumin powder and make a microemulsion of it by combining a tablespoon of the powder and mixing it into 1-2 egg yolks and a teaspoon or two of melted coconut oil. Then use a high-speed hand blender to emulsify the powder (be careful when doing so as curcumin is a very potent yellow pigment and can permanently discolor surfaces if you aren’t careful).
Another strategy that can help increase absorption is to put one tablespoon of the curcumin powder into a quart of boiling water. It must be boiling when you add the powder; it will not work as well if you put it in room temperature water and heat the water and curcumin. After boiling it for 10 minutes you will have created a 12 percent solution that you can drink once it has cooled down. It will have a woody taste. The curcumin will gradually fall out of the solution, however. In about six hours it will be a 6 percent solution, so it’s best to drink the water within four hours.
More than 30 million Americans are now taking statin cholesterol-lowering drugs, but the majority is completely unaware that if you take statin drugs without taking CoQ10 (and particularly its reduced form, ubiquinol), your health is at serious risk.
Statins lower your CoQ10 levels by blocking the pathway involved in cholesterol production — the same pathway by which Q10 is produced. Statins also reduce the blood cholesterol that transports CoQ10 and other fat-soluble antioxidants.
The loss of CoQ10 leads to loss of cell energy and increased free radicals which, in turn, can further damage your mitochondrial DNA, effectively setting into motion an evil circle of increasing free radicals and mitochondrial damage.
Tragically, despite all this overwhelming evidence and research, there are no official FDA-required warnings regarding CoQ10 depletion from taking statin drugs, and nearly all physicians fail to inform you about this problem if you are taking statins.
As your body gets more and more depleted of CoQ10, you may suffer from fatigue, muscle weakness and soreness, and eventually heart failure. So if you’re taking statin drugs, it’s imperative that you take CoQ10 or, preferably, ubiquinol, the reduced, electron-rich form of coenzyme Q10.
One of the most common side effects associated with statins is rhabdomyolysis, a serious degenerative muscle tissue condition that causes muscle pain and stiffness, and may lead to kidney damage.
It’s known that statin-induced suppression of ubiquinol may contribute to rhabdomyolysis, so in a new study researchers determined what would happen if cells were treated with the statin medication simvastatin along with ubiquinol.1
As expected, treatment with simvastatin significantly reduced the cells’ mitochondrial content, as well as cell viability. However, “both [were] rescued by simultaneous treatment with ubiquinol.” The researchers noted:
“This work demonstrates that the addition of ubiquinol to current statin treatment regimens may protect muscle cells from myopathies.”
Again demonstrating the necessity of CoQ10 supplementation during statin therapy, another recent study evaluating the benefits of CoQ10 and selenium supplementation for patients with statin-associated myopathy found that, compared to those given a placebo, the treatment group experienced significantly less pain, decreased muscle weakness and cramps, and less fatigue.2
Although neither study investigated timing, it is important to supplement right from the start, as according to Dr. Duane Graveline (a medical doctor with 23 years of experience whose health was seriously damaged by a statin drug).
Once the mitochondrial damage and mutations are formed they cannot be reversed — no matter how much CoQ10 or ubiquinol you take. So early intervention is key. As for dosage, Dr. Graveline makes the following recommendation:
If you’re taking statins and trying to decide between supplementing with CoQ10 or ubiquinol, conventional CoQ10 (also known as ubiquinone) is in essence oxidized CoQ10; it is “electron deficient.” While the molecular structure of each is the same, because ubiquinol has two extra electrons.
It can donate them, enabling it to slip through the cell membrane more readily, and making it a very strong fat-soluble antioxidant – strong enough to even help regenerate other antioxidants (like vitamins E and C) in your body.
In essence, taking CoQ10 is also like taking oxidized vitamin C or E—something that would not be recommended; the unoxidized form is preferable. Further, according to Dr. Robert Barry, every single publication on ubiquinol to date has shown that the bioavailability is higher compared to CoQ10; in some cases the difference is very small while in others it is a large difference.
So even though the per-milligram dose costs more, it is FAR more cost effective than conventional CoQ10 because much less is needed to achieve the same or better result. The increased absorption rate means you only need to take about one-third the amount of ubiquinol compared to CoQ10.
Interestingly, although ubiquinol is a fat-soluble antioxidant, which typically means it’s more difficult to absorb, ubiquinol is ‘peculiar’ in that its rate of absorption appears to be based on your body’s metabolic demand—which is great. Meaning, if you’re healthy, you absorb less, and when you’re ill, or struggle with chronic disease, your body will absorb more. Its absorption rate is basically self-adjusting so it becomes very difficult to take too much.
Ubiquinol isn’t just for those taking statins. Against diseases such as Huntington’s and Parkinson’s in particular, CoQ10/ubiquinol has been found to slow progression of the disease. Research over the years has looked into its benefits for diseases such as:
|Alzheimer’s disease||Huntington’s disease||Periodontal disease|
|Parkinson’s disease||ALS (Amyotrophic lateral sclerosis, often referred to as Lou Gehrig’s Disease)||Renal disease|
One of the most dramatic benefits of ubiquinol, however, lies in its potential to slow down the aging process. There’s compelling evidence indicating this, which was instrumental in convincing me of its clinical benefits and motivating me to start taking ubiquinol personally.
One powerful example of ubiquinol’s anti-aging effects was an early mouse study, performed by researchers at a major medical center in Japan. Specially bred mice that age very rapidly were used to test CoQ10 and ubiquinol against a control group that did not receive supplementation. At the end of the study, when the mice were the equivalent age of 90 to 100 in human years, the differences between the control group and the ubiquinol groups were quite dramatic.
While the control mice were near death, the ubiquinol mice ran around like teenage mice, and the only difference during their entire lifespan was taking ubiquinol. Your body does produce ubiquinol naturally, in fact it is the predominant form in most healthy cells, tissues and organs, but as you age, not only does this conversion become less efficient, your cellular energy (ATP) production also diminishes. And that’s when you start seeing chronic and acute disease associated with aging and the aging process itself. And a special note for anyone taking statins… since statins diminishes your ubiquinol, these drugs also promote premature aging throughout your entire body…
I’ve discussed why ubiquinol is a crucial supplement for those taking statins, but perhaps the more fundamental question you need to ask yourself (and your health care provider) is whether you really need to take statins in the first place. For certain individuals born with a genetic defect called familial hypercholesterolemia, statin drugs may be useful. But ordinarily total cholesterol will tell you virtually nothing about your heart disease risk, unless it’s exceptionally elevated (above 330 or so, which would be suggestive of familial hypercholesterolemia).
The odds are very high — greater than 100 to 1 — that if you or someone you love is taking a statin drug, you or they don’t need it. Remember, your body needs cholesterol for the production of cell membranes, hormones, vitamin D and bile acids that help you to digest fat. Cholesterol also helps your brain form memories and is vital to your neurological function. There is also strong evidence that having too little cholesterol INCREASES your risk for cancer, memory loss, Parkinson’s disease, hormonal imbalances, stroke, depression, suicide, and violent behavior.
There is a growing body of research indicating that statins really have nothing to do with reducing your heart disease risk. In fact, this class of drugs can increase your heart disease risk by directly harming your muscles and nerves, with the heart muscle (a highly nerve dense muscle) being a highly susceptible target — especially if you do not take ubiquinol (CoQ10) along with it.
The most effective way to optimize your cholesterol profile and prevent heart disease is with diet and exercise. Remember that 75 percent of your cholesterol is produced by your liver, which is influenced by your insulin and leptin levels. Therefore, if you optimize your insulin and leptin levels, you will naturally optimize your cholesterol ratios and reduce your risk of heart disease (and other chronic diseases).
There is no drug to cure or prevent heart disease, as the underlying cause is insulin resistance and arterial wall damage — both of which are caused by eating too many sugars, grains, and especially fructose. So, my primary recommendations for safely regulating your cholesterol and reducing your risk of heart disease include:
I pray on the principle that wine knocks the cork out of a bottle. There is an inward fermentation, and there must be a vent. ~Henry Ward Beecher
Here’s a difficult topic — are you a gossiping Gerty or is your mouth sealed so tight, you’ve become a clam?
This has been a hot topic in my circle of friends lately as we are all trying to remain in our integrity and avoid that dastardly, lower vibrational activity that is gossip.
Have you noticed that when you are either amongst people whose mouths are flapping off about someone else that you feel quite uncomfortable — like a squirmy little worm who needs to wiggle away to find richer soil?
Maybe it’s you who has started yapping about someone else and you later feel incredible guilt about this — you bad dog, you!
I’m sure that most of us have been guilty of the odd gossip at some stage in our lives but what is the difference between talking behind someone’s back and actually venting about a situation?
Sometimes two friends get talking and the next thing you are venting about someone who is causing some irritation or discomfort in your life. You feel that the kettle is boiling and a little steam needs to be let out. It’s healthier to blow off a bit of steam than it is to wait until you explode!
Now, how do you do this without gossiping?
Let’s clear this up with an example of a dialogue:
You: My sister is really irritating me lately. She just keeps on getting into trouble and I have to bail her out all the time. I’ve had enough.
Your friend: Maybe you need to give her a little bit of space so she can work things out on her own.
You: Yes, it will be difficult but you’re right. Helping her out every time she’s in a mess is actually disempowering her and frustrating me. She needs to face the consequences of her choices.
Your friend: Exactly. Make sure she knows you love her and the reasons that you are detaching and see how it goes from there.
Okay, now I know that this scenario is like the most ideal dialogue ever and in real life it’s going to sound a teensy-weensy bit different (especially if you are really pee’d off) but you get the gist of it, right?
This is an example of allowing yourself to vent or talk about something/someone that is on your mind in a way that is in your integrity (i.e. the truth of the situation) and is done in a tactful manner.
Let’s take a look at the flip side of the coin:
You: My sister is such a mean person. I can’t handle her rubbish anymore. She needs to just get out of my life for good!
Your friend: I know! I’ve never really liked her. She is such a leach and you have done so much for her.
You: Tell me about it! And what do I get in return? All her grief and worries!
Your friend: I’m going to give her a piece of my mind when I see her again.
I’m going to stop there because I can carry on for hours (*grin*). It’s like the script from ‘Days of our Lives’. Drama, drama and a little more drama!
Here is a prime example of gossip. Can you notice the difference?
The latter dialogue is not coming from a place of integrity, it is coming from your ego that is offended and taking things personally. There is no form of love in this rant.
Even though the person in question might be doing things to you that are less than loving, it doesn’t require for you to fight fire with fire. The best thing you can do is to detach with love and find the compassion for that person.
Why are they hurting?
No-one who is in alignment with their core will find the need to cause you grief ergo they must be in pain. You don’t need to heal their pain, only they can do that. But you can exercise compassion and love them from afar.
Help if you can and it isn’t going to cause your energy to be drained.
We must learn how to explode! Any disease is healthier than the one provoked by a hoarded rage. ~Emil Cioran
So the upshot is to recognize the need to get something off your chest and to act it out in your integrity without giving into the ego and dramatizing the situation. Tell it like it is and give yourself that much-needed space and time to open up and vent instead of bottling things up inside.
Blow off that steam whilst remaining impeccable with your words — I think it is possible, do you?
Novartis announced today top-line results from the head-to-head Phase III psoriasis study which showed the superiority of secukinumab (AIN457) in clearing skin to Enbrel®* (etanercept), an anti-tumor necrosis factor (anti-TNF) therapy. In addition, secukinumab (AIN457) met all primary and secondary endpoints.
The FIXTURE trial (the Full year Investigative eXamination of secukinumab vs. eTanercept Using 2 dosing Regimens to determine Efficacy in psoriasis) was a randomized, double-blind, double-dummy, placebo-controlled, multicenter global study of subcutaneous secukinumab (AIN457) in moderate-to-severe plaque psoriasis involving 1,307 patients. It was designed to demonstrate efficacy after 12 weeks of treatment, compared to placebo and etanercept, and to assess the safety, tolerability and long-term efficacy up to 52 weeks. Established treatment measures were used to assess the efficacy of secukinumab (AIN457) including PASI 75 (Psoriasis Area and Severity Index 75) and the Investigator’s Global Assessment (IGA mod 2011), a standard tool to assess the clearing of skin after treatment.
“These results showing that secukinumab (AIN457) is superior to Enbrel, a current standard-of-care therapy, are great news for people living with moderate-to-severe plaque psoriasis,” said Tim Wright, Global Head of Development, Novartis Pharmaceuticals. “With 40-50% of people living with moderate-to-severe plaque psoriasis dissatisfied with their current therapies, there is clearly an unmet medical need for new therapies that act faster and longer to relieve pain, itching and other symptoms.”
Full results from the secukinumab (AIN457) Phase III study program, the largest undertaken in moderate-to-severe plaque psoriasis to date, are expected to be presented at major medical congresses later this year.
Secukinumab (AIN457) is the first medicine selectively targeting IL-17A to present Phase III results. IL-17A is a central cytokine (messenger protein) in the development of psoriasis, and is found in high concentration in skin affected by the disease-. Research shows that IL-17A plays a role in driving the body’s autoimmune response in disorders such as moderate-to-severe plaque psoriasis and is a preferred target for investigational therapies-.
In the FIXTURE study, the observed safety profile of secukinumab (AIN457) was consistent with previously reported results from Phase II studies in moderate-to-severe plaque psoriasis and no new safety concerns were identified,.
About plaque psoriasis
Approximately 2% of the world’s population, or around 125 million people, are affected by plaque psoriasis,, with more than one third of these suffering from its moderate-to-severe form. Psoriasis is a chronic disease characterized by thick and extensive skin lesions, called plaques, known to cause itching, scaling and pain. This common and distressing disease is not simply a cosmetic problem – even those with very mild symptoms find their condition affects their everyday lives. Psoriasis is also associated with psychosocial effects and those with more severe disease are at a greater risk of death from comorbid diseases such as heart disease and diabetes,.
About the secukinumab (AIN457) clinical trial program in psoriasis
The robust secukinumab (AIN457) Phase III clinical trial program involved more than 3,300 patients in over 35 countries on five continents. Primary endpoints for four studies related to PASI 75 and IGA (IGA mod 2011) and the fifth study evaluated the proportion of patients who maintained PASI 75 after having achieved PASI 75 after 12 weeks of active treatment. The studies evaluated 150 mg and 300 mg doses of secukinumab (AIN457).
About secukinumab (AIN457)
Secukinumab (AIN457) is a fully human monoclonal antibody that selectively binds to and neutralizes IL-17A, a key pro-inflammatory cytokine-. Proof-of-concept and Phase II studies in moderate-to-severe plaque psoriasis and arthritic conditions (psoriatic arthritis, ankylosing spondylitis and rheumatoid arthritis) have suggested that secukinumab (AIN457) may potentially provide a new mechanism of action for the successful treatment of immune-mediated diseases,,-. The Phase III programs for these potential indications are ongoing. Results are being released this year for moderate-to-severe plaque psoriasis, and in 2014 and beyond for arthritic conditions. Phase II studies are also ongoing in other areas, including multiple sclerosis.
About Novartis in specialty dermatology
Novartis is committed to developing innovative, life-changing specialty dermatology therapies redefining treatment paradigms and transforming patient care in severe skin diseases where there are remaining high unmet medical needs. The Novartis specialty dermatology portfolio includes two unique targeted products in Phase III development, secukinumab (AIN457) for moderate-to-severe plaque psoriasis and omalizumab (Xolair®) for chronic spontaneous urticaria (CSU). There are also more than 10 compounds in early stage development for a wide range of severe skin diseases in the Novartis specialty dermatology portfolio.
 Gaffen SL. Structure and signaling in the IL-17 receptor family. Nat Rev Immunol. 2009; 9(8):556-67.
 Ivanov S, Linden A. Interleukin-17 as a drug target in human disease. Trends Pharmacol Sci. 2009; 30(2):95-103.
 Kopf M, Bachmann MF, Marsland BJ. Averting inflammation by targeting the cytokine environment. Nat Rev Drug Discov. 2010; 9(9):703-18.
 Onishi RM, Gaffen SL. Interleukin-17 and its target genes: mechanisms of interleukin-17 function in disease. Immunology. 2010; 129(3):311-21.
 Krueger J, Fretzin S, Suárez-Fariñas M, et al. IL-17A is essential for cell activation and inflammatory gene circuits in subjects with psoriasis. J Allergy Clin Immunol. 2012; 130(1):145-154.
 Papp KA, Langley RG, Sigurgeirsson B, et al. Efficacy and safety of secukinumab in the treatment of moderate-to-severe plaque psoriasis: a randomized, double-blind, placebo-controlled phase II dose-ranging study. BJD 2013; 168, pp412-421.
 Rich PA, Sigurgeirsson B, Thaci D, et al. Secukinumab induction and maintenance therapy in moderate-to-severe plaque psoriasis: a randomized, double-blind, placebo-controlled, phase II regimen-finding study. BJD 2013;168: 402-411.
 Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med 2009; 361(5):496-509.
 Brezinski EA, Armstrong AW. Off-Label Biologic Regimens in Psoriasis: A Systematic Review of Efficacy and Safety of Dose Escalation, Reduction, and Interrupted Biologic Therapy. PLoS ONE; 7(4):e33486.
 Krueger JG, Koo J, Lebwohl M, et al. The impact of psoriasis on quality of life: Results for a 1998 National Psoriasis Foundation patient membership survey. Arch Derm. 2001; 137:280-284.
 Mason AR, Mason J, Cork M et al. Topical treatments for chronic plaque psoriasis. Cochrane Database Syst Rev. 2009;15;(2):CD005028.
 Abuabara K, Azfar RS, Shin DB, Neimann AL, Troxel AB, Gelfand JM. Cause-specific mortality in patients with severe psoriasis: a population-based cohort study in the U.K. Br J Dermatol. 2010 Sep;163(3):586-92
 Gelfand JM, Troxel AB, Lewis JD, Kurd SK, Shin DB, Wang X, Margolis DJ, Strom BL. The risk of mortality in patients with psoriasis: results from a population-based study. Arch Dermatol. 2007 Dec;143(12):1493-9.
 Genovese MC, Durez P, Richards HB, et al. Efficacy and safety of secukinumab in patients with rheumatoid arthritis: a phase II, dose-finding, double-blind, randomised, placebo controlled study. Ann Rheum Dis 2013;72:863-869.
 Baeten D, Sieper J, Emery P, et al. The anti-il17a monoclonal antibody secukinumab (AIN457) showed good safety and efficacy in the treatment of active ankylosing spondylitis. At: EULAR 2011, The Annual European Congress of Rheumatology, 25-28 May 2011, London, UK. Abstract 0174.
 McInnes IB, Sieper J, Braun J, et al. Efficacy and safety of secukinumab, a fully human anti-interleukin-17A monoclonal antibody, in patients with moderate-to-severe psoriatic arthritis: a 24-week, randomised, double-blind, placebo-controlled, phase II proof-of-concept trial. Ann Rheum Dis 2013 Jan 29; doi:10.1136/annrheumdis-2012-202646.
Source: Novartis Newsletter.
Deaths attributed to prescription opioid overdose rose fivefold among women between 1999 and 2010, according to an MMWR article. The increase among men was lower, at 3.5-fold, although men remained more likely to overdose than women.
Analyzing two national databases, CDC researchers also found that in 2010, more than 15,000 drug overdose deaths occurred among women. Since 2007, more women have died from drug overdoses than vehicle accidents. Prescription drugs were involved in 85% of overdose cases with drug-specific information; of these, opioids were implicated in 71%. In addition, women had nearly 950,000 emergency department visits for drug abuse or misuse, most often for cocaine/heroin, benzodiazepines, and prescription opioids.
MMWR‘s editors urge providers to screen and monitor patients for substance abuse and mental health issues when prescribing opioids. They also emphasize the risks posed by opioid abuse during pregnancy, advising clinicians to discuss pregnancy plans with patients who are using the drugs for medical and nonmedical reasons.
Novartis today announced that it has entered into a development and licensing agreement with Biological E Limited (BioE), abiopharmaceutical company based in India, for two vaccines to protect against typhoid and paratyphoid fevers. The agreement advances the Novartis goal to deliver accessible and affordable vaccines that address unmet medical need in endemic regions.
In just five years, the Novartis Vaccines Institute for Global Health (NVGH), part of the Novartis Institutes for BioMedical Research, has developed a typhoid vaccine with funding by the Fondazione Monte dei Paschi di Siena and Regione Toscana through the Sclavo Vaccines Association (Italy). In addition, a dual-acting vaccine with components against both typhoid and paratyphoid fevers is being developed with on-going support from the Wellcome Trust. Both could reduce the burden of these diseases in endemic regions.
“NVGH uses its innovative know-how to tackle important problems in public health,” said Don Ganem, VP and Global Head of Infectious Diseases, Novartis Institutes for BioMedical Research. “BioE has a proven track record in vaccine manufacture, and capabilities to clinically develop and deliver WHO pre-qualified affordable vaccines to the developing world. We are pleased to be working with them to address this unmet need.”
More than 21 million cases of typhoid fever and five million cases of paratyphoid A fever are reported worldwide in a year, especially in areas that lack appropriate sanitation and access to clean water. Many victims are children under the age of two for whom there is no widely available typhoid vaccine, while no vaccine is available for any age group against paratyphoid fever.
Under the license, NVGH will transfer technology to BioE, which will have financial and operational responsibility for manufacturing, further clinical development, approval and distribution in the developing world. The typhoid vaccine (Vi-CRM197) has achieved Proof of Concept, had successful Phase 2 results, and will be transferred to BioE. A combined typhoid-paratyphoid vaccine will be transferred once Proof of Concept is completed through early, small-scale studies in humans to determine safety and immunogenicity. The Wellcome Trust continues to support the development of the dual-acting vaccine through a Strategic Award that was awarded in 2009.
“Typhoid and paratyphoid are major causes of life-threatening disease worldwide and with the emergence of resistance to all of the commonly used antibiotics, they are becoming increasingly difficult to treat,” said Ted Bianco, Director of Technology Transfer and Acting Director of the Wellcome Trust. “This licensing deal takes us a step closer to getting much-needed affordable vaccines into the communities that need them most.”
BioE is committed to achieving World Health Organization (WHO) pre-qualification and fulfill specific obligations to meet Novartis standards. The agreement is worldwide except for developed countries, where Novartis will retain rights.
Information about typhoid and paratyphoid fevers
The bacteria Salmonella enterica serovar Typhi (S. Typhi) causes typhoid fever and is a significant public health problem in developing countries where access to clean water and proper sanitation is limited and causes over 21 million cases and over 200,000 deaths per year worldwide. S. Paratyphi A causes a clinically similar disease (paratyphoid fever) and is reported to cause five million cases in a year. Given limitations of current typhoid vaccines and increasing antibiotic drug resistance of the bacteria, there is an urgent need for effective vaccines.
 Bulletin of the World Health Organization 2004; 82:346-353 (http://www.who.int/rpc/TFDisBurden.pdf)
Source: Novartis Newsletter.
Salsalate, a prodrug of salicylate, is associated with lower glycated hemoglobin levels and markers of inflammation in patients with type 2 diabetes, according to a multicenter study in the Annals of Internal Medicine.
Researchers randomized some 290 patients with poorly controlled diabetes to add-on therapy with either salsalate or placebo for 48 weeks. By study’s end, the mean glycated hemoglobin level was 0.37% lower in the salsalate group than in the placebo group. Fasting glucose levels dropped an average 15 mg/dL more with salsalate. Leukocyte and neutrophil counts were also lower with salsalate.
There were, however, modest increases in LDL cholesterol, weight, and urinary albumin that the authors say “warrant further assessment” before salsalate can be recommended for general use in diabetes.
Source: Annals of Internal Medicine
Here’s a quick look at what the FDA was up to while we were away last week:
New hot flash therapy: The agency approved the first nonhormonal treatment for hot flashes in menopausal women. Brisdelle contains 7.5 mg of paroxetine, lower than the doses used to treat depression, anxiety, and other psychiatric conditions. The pill is taken once daily at bedtime. Like other formulations of paroxetine, Brisdelle’s label includes a boxed warning noting an increased risk for suicidality.
Olmesartan warning: The antihypertensive medication olmesartan, an angiotensin-receptor blocker marketed as Benicar, Azor, and others, can cause spruelike enteropathy, the FDA warned. Providers should counsel patients to contact them if severe diarrhea with substantial weight loss occurs, even if symptoms develop years after starting the drug.
Estarylla recall: One lot of the combination oral contraceptive Estarylla (norgestimate and ethinyl estradiol) has been recalled after a consumer found a placebo pill in a row of active tablets. The lot number is LF01213A.
Source: FDA news
The bromeliad family of plants very rarely produce edible fruit – with the exception of pineapple, that is. The pineapple is the only available edible bromeliad today! One pineapple is actually made up of individual flowerets that grow and weave together to form the beautiful golden fruit we call a pineapple.
The pineapples lush, sweet, exotic flavour make it a family favourite – but did you know that pineapple is also one of the most healthful foods available today?
Bromelain, a proteolytic enzyme in pineapples, is often used as a supplement itself to help boost health and clear up various health issues. Of course, eating pineapple in itself will deliver these same effects such as better heart and circulatory health, improvement in asthma and other breathing conditions as well as improved immunity, reduced inflammation and suppressed growth of cancer cells.
Bromelain possesses anticoagulant properties, and thus slows down the ability of blood to clot. This, combined with bromelain’s anti-inflammatory properties, make it a great nutritional supplement (in pure form – aka. eating a pineapple) for bruise prevention and to reduce swelling and redness from burns or sports injuries. Consuming pineapple after surgery is another way to reduce the trauma associated with incisions or injections.
There are a variety of inflammatory-related conditions, ranging from arthritis to inflammatory bowel disease and sinusitis as well as inflammatory skin conditions like eczema, acne, rosacea, dermatitis and psoriasis. The list doesn’t end there. In fact, many diseases nowadays are caused by a major influx of inflammation in the cells and tissues, whether that be from consuming the wrong foods or living in less-than-optimal environmental conditions (i.e., chemical hazards, smog, pollution, etc.).
Bromelain has been useful in treating all of the above inflammatory disorders. The major mechanism of action of bromelain is proteolytic in nature, and may also involve immunomodulatory and hormone like activity acting via intracellular signalling pathways. It has also been shown that bromelain significantly reduces CD4+T lymphocytes, which are the primary effectors involved in inflammation in the body.
Research also indicates that the pain and discomfort associated with arthritis can be reduced by supplementing with 200 – 400 mg of bromelain per day (or you could just eat lots of pineapple every day and get the same effects – remember, the natural, real form of these enzymes are far better than their modified, synthetic form).
Immunity & Cancer
Research published in the journal Planta Medica, found that the chemotherapy drug, 5-fluorauracil, was incredibly inferior to bromelain when treating cancer in an animal study. Those treated with bromelain survived 263% times more than those treated with 5-fluorauracil, relative to the untreated control. Bromelain caused no external harm to the animals, other than improving their health. Chemotherapy drugs do more harm than good, and actually kill off your healthy cells, and make more chemo resistant and malignant cell types within the tumour (meaning the cancer becomes resistant to the chemo drugs).
In addition, the anti-inflammatory and anti-coagulant effects of bromelain help to boost our immunity. Studies have shown that it may be able to enhance certain immune receptors in the body, and thus enhance the ability of the body to defend against bacteria and viruses at a more efficient rate. Bromelain helps mechanisms that are already in place to work faster, and more efficiently together, and to allow cells to communicate better with one another.
Pineapple is also incredibly rich in vitamin C, which is the body’s primary water-soluble antioxidant. It defends against free radicals that attack and damage normal cells. Vitamin C is essential for proper immune function, and has also been extensively studied by Dr. Ronal Hunninghake (15-year research project called RECNAC), who showed that vitamin C was selectively cytotoxic against cancer cells in cell cultures.
Heart & Circulatory Health and Breathing Conditions
Bromelain, being an anti-coagulant, means that it may allow blood to flow more freely through the circulatory system. Blood that flows more freely is thinner, and is associated with a reduced chance of stroke, heart attack and other circulatory and heart related issues.
Not only does it help with cardiovascular health, but pineapple’s bromelain enzyme also works in such a way that it breaks down mucus and thins its consistency. In conditions like asthma where breathing is often blocked by thick mucus in the lungs, bromelain acts as a mucus thinner, and helps un-clog the bronchial tubes of the lungs, helping patients breathe better.
All parts of the pineapple contain bromelain, however, the core of the pineapple has more concentrated amounts – be sure to stick the core through a juicer to get all the benefits out of your next pineapple feast!
Sources: Live Love Fruit
Tochi, B., Wang, Z., Xu, S., & Zhang, W. (2008). Therapeutic application of pineapple protease (bromelain): A review. Pakistan Journal of Nutrition, 7, 513-520.
Gaby, A. (1999). Alternative treatments for rheumatoid arthritis. Altern Med Rev, 4, 392-402.
Maurer, H. (2001) Bromelain: biochemistry, pharmacology, and medical use. Cellular and Molecular Life Sciences CMLS, 58, 1234-1245.