Day: 03/29/2014

Judge allows Arizona boy to be treated with marijuana extract

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Last Friday, an Ariz. judge made a significant decision that could potentially revolutionize the way Americans utilize medical marijuana.

Superior Court Judge Katherine Cooper of Maricopa County ruled in favor of allowing five-year-old Zander Welton, who was suffering from debilitating epileptic seizures, to use cannabidiol (CBD), one of 60 cannabinoids discovered in marijuana.

Marijuana

CBD oil, which makes up approximately 40 percent of the plant’s extract, has been proven to help treat severe medical problems including Parkinson’s disease, schizophrenia, anxiety, depression and even cancer.

Fighting for natural health freedom

The judge’s ruling was in response to a lawsuit filed by the American Civil Liberties Union on Nov. 13 on behalf of the little boy. The motion requested the court to “rule that the state’s medical marijuana law allows uses of marijuana extracts such as resins added to baked goods and creams,” reported AZ Central.

While voters approved the Arizona Medical Marijuana Act (AMMA) in 2010, there seemed to be some confusion over whether or not the act included the use of pot extract.

A report by Medical Jane describes how badly the Welton family and their young child had been suffering. Just nine months into the boy’s life, he began experiencing violent seizures, and subsequently had portions of his brain removed in two separate surgeries. Not only did the surgeries fail, but prescribing the child heavy doses of deadly pharmaceutical drugs left him with harmful side effects, and no reduction of his seizures.

Finally, the family was introduced to medical marijuana, both the CBD oil and the plant in its dried form. This treatment worked wonders on the boy’s health, and his parents soon began to see changes in their child, including increased happiness and the abilities to sleep peacefully, walk backwards and play with his siblings.

Miraculously, he was finally able to go weeks without a single seizure.

The little boy’s family finally found hope in what had been a painful, helpless situation, but they were still facing one big problem.

Maricopa County Attorney Bill Montgomery aggressively pursued the Welton family, threatening to prosecute them for administering what he considered illegal marijuana to their son.

Under Montgomery’s interpretation, the AMMA only allowed the use of dried flowers, and not CBD oil. Facing prosecution and understandably frightened, the family stopped treating Zander with marijuana extract. “My husband and I made the heartbreaking decision to stop giving Zander the medical marijuana oil,” said the boy’s mother.

Fortunately for the Welton family, the ACLU got involved and fought for the boy’s freedom to choose the treatment that his family deemed most effective. The lawsuit specifically asked for clarification on what exactly is considered legal under the AMMA.

Five months after the ruling, Judge Katherine Cooper ruled that nothing in the AMMA “limits the form in which patients may use medical marijuana…. The AMMA authorized qualifying patients to use extracts, including CBD oil, prepared from the marijuana plant.”

She also concluded that marijuana extract “make it feasible for patients who cannot consume the medicine in plant form to receive it another way.”

The judge’s decision is a giant step forward in granting all Americans natural health freedom and, importantly, immediately saving one boy’s life.

Cashy Hyde

Other children have not been so lucky. A three-year-old from Mont. named Cash Hyde suffered from recurring life-threatening brain tumors but finally found relief once he began using cannabis oil. Once on the cannabis oil, Cash’s cancer went into remission and he began to get healthy.

The decision to treat Cash with CBD oil came with dire consequences, including threats by police, prosecution that could result in incarceration for the family and also steep fines.

“I’ve had law enforcement threatening to kick my door down, but I would have done anything to keep Cashy alive,” said the boy’s father, Mike Hyde.

Aggression from law enforcement against patients using pot extract stems from Big Pharma’s determination to keep pot extract illegal. Why? Because they’re fully aware that they could lose billions of dollars if pot extract were to replace prescription drugs, which it’s fully capable of doing for many medical conditions.

Currently, Big Pharma is unable to regulate CBD oil because it’s a naturally occurring compound and therefore cannot be patented. The last thing this billion-dollar-a-year industry wants is for patients to effectively treat themselves with a natural herb that can grow relatively easily in their backyard.

Tragically, under pressure from the Feds, the state of Montana cracked down on medical marijuana, forcing many dispensaries to close and subsequently cutting off Cash’s cannabis oil supply. His cancer soon returned and he passed away in his father’s arms in late 2012.

His story was featured in a documentary called America’s Drug War 2: Cannabis Destiny, produced by Kevin Booth.

Saving lives

Despite the horrible outcome for the Hyde family, thanks to Judge Cooper the outcome will not be the same for the Welton family.

Now that Zander’s seizures have been significantly reduced, the possibilities surrounding the improvement of his health are endless.

Hopefully the judge’s decision will bring awareness and change, both legislatively and in the health community. Suffering and dying patients deserve the freedom to choose which treatment best suits them and their condition.

Other sources:

http://www.economist.com

http://www.azcentral.com

http://abcnews.go.com

http://americandrugwar2.com

http://science.naturalnews.com

Learn more: http://www.naturalnews.com/044489_marijuana_extract_cannabidiol_Arizona.html#ixzz2xS2sCWDo

45-Year-Old Man with a Rash.

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In the latest Case Record of the Massachusetts General Hospital, a 45-year-old man was admitted to the hospital because of diffuse, purple, blanching livedo over his arms and legs and signs of severe sepsis. Three days before presentation, the patient was bitten on his hands and forearms while bathing his dog. A diagnostic test result was received.
With respect to infections related to dog bites, one needs to consider organisms that colonize human skin and can be inoculated into the soft tissue through a dog bite. Staphylococcal and streptococcal species are common infecting organisms that can cause sepsis. Pasteurella multocida and Capnocytophaga canimorsus are considered normal oral flora in dogs.


Clinical Pearls
• What are the characteristics of infection with Pasteurella multocida after a dog bite?
Infection with P. multocida, a gram-negative coccobacillus, can resemble the rapidly progressive soft-tissue infections caused by Streptococcus pyogenes, and there can be evidence of a wound infection hours after injury. P. multocida infection commonly causes cellulitis or abscesses; it can cause bacteremia, pneumonia, meningitis, and endocarditis, although these infections are less common. The organism is easy to culture and relatively sensitive to antibiotic agents.
• What are the manifestations of Capnocytophaga canimorsus infection?
C. canimorsus is a fastidious gram-negative bacillus that can cause overwhelming infection after a dog or cat bite. Patients with C. canimorsus infection present with symptoms ranging from cellulitis and local infection to meningitis, endocarditis, sepsis, and shock. Many cases of severe systemic C. canimorsus infection are associated with such underlying risk factors as splenectomy, alcoholism, cirrhosis, or immunosuppression, although in approximately 40% of cases, no identifiable risk factor is found. The end of the incubation period for C. canimorsus is typically marked by the abrupt onset of symptoms. Physical examination usually reveals a purpuric rash that can evolve to purpura fulminans and frank gangrene. The clinical manifestations of sepsis are caused by a profound inflammatory response that leads to microvascular injury and endothelial damage; if hypoperfusion and inflammation persist, then disseminated intravascular coagulation, gangrene, multiorgan failure, and death can occur. A patient’s clinical history is the key to the diagnosis of C. canimorsus infection, because the organism is difficult to culture and may take up to 14 days to identify.
Morning Report Questions
Q: What are the tenets of treating patients with sepsis?
A: The guidelines of the 2008 Surviving Sepsis Campaign include fluid resuscitation for intravascular volume expansion, with crystalloids for urine output (goal, >0.5 ml per kilogram per hour), optimization of mean arterial pressure at more than 65 mm Hg, maintaining central venous pressure at a goal of 8 to 12 mm Hg and central venous oxygen saturation at >70%. Lactic acid clearance should be monitored closely, because it indicates the success of the resuscitation in improving tissue perfusion. Patients should be pancultured and soon after arrival receive broad-spectrum antibiotics in addition to circulatory support.
Q: What is purpura fulminans?
A: Purpura fulminans is a syndrome most commonly related to an acute infectious process that is characterized by intravascular thrombosis and hemorrhagic skin infarction. It is rapidly progressive, and accompanied by disseminated intravascular coagulation and overall vascular collapse. The hallmark findings in acute infectious purpura fulminans are fever, hypotension, large purpuric skin lesions, and disseminated intravascular coagulation. Meningococcus infection is commonly associated with this condition, but it may also present in the setting of infection with varicella zoster virus, gram-negative bacilli, staphylococci, Rickettsia species, streptococci, and measles virus. Pathologic examination often reveals diffuse arterial and venous thrombosis. Microscopic foci of acute inflammation may be present in the vascular adventitia.

The Promise of Combination Therapies.

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Recent technical advances, new business strategies, and FDA policies will speed combination therapy development.

Combination therapies frequently target proteins in different pathways involved in cell proliferation and disease spread in the body.

A number of diseases are complex multigene or multifactor diseases. Some major ones are cancer, neuropsychiatric conditions such as schizophrenia and depression, obesity, and bacterial infections. All these diseases extract a heavy financial toll on society. For instance, neoplasms (cancer and related abnormal cell growth) cost $217 billion per year in the U.S. in 2009, second only to cardiovascular diseases. Combination drugs for cancer and bacterial infections are the focus here. Cancer therapies often don’t work, cancer cells often develop resistance to drug therapies, and many bacterial pathogens resist a wide range of antibiotics.

Advantages of Combination Therapies

Successful combination therapies often target proteins in different pathways involved in cell proliferation and disease spread in the body. Combination therapies should increase the likelihood that the disease will be arrested or cured, reduce the likelihood that drug resistance will develop, and slow the rate of drug resistance.

Unsuccessful first-round, single-drug therapy could be a disaster as it may be too late to save the patient in the second round, so it is important to arrest or cure cancer and infections as quickly as possible. A potential disadvantage of combination therapies is toxicity, especially for cancer drugs if high doses of each drug in the combination are necessary; cancer drugs are usually highly toxic to begin with.

Drug Combinations for Cancer and Bacterial Infections

Hodgkin’s lymphoma combination therapy is one of the great success stories in cancer therapy. Before the 1960s, Hodgkin’s lymphoma was almost always fatal. In the mid-1960s, a four-drug combination was developed called MOPP for the first letter in the names of the four drugs. It cured almost 70% of patients with advanced-stage disease. MOPP had a big problem, however: It was fairly toxic. In the mid-1970 a different four-drug combination, ABVD, was shown to increase effectiveness to well over 80% five-year survival in patients under sixty years old and with less toxicity. The four cancer drugs in this combination are Adriamycin, Bleomycin, Vinblastine, and Dacarbazine.

Thomas Roberts, co-chair of the department of cancer biology at the Dana-Farber Cancer Institute, points out that in the 60’s and 70’s there were relatively few cancer therapies and hence a limited number of combinations. There are now a very large number of possible two, three, and four drug combination therapies for cancer. To be precise, based on today’s 365 therapies from the National Cancer Institute’s list of cancer therapies, there are 736 million two, three, and four drug combinations, a staggeringly large number. At present, there are only 38 combination therapies on the NCI list, so we have barely scratched the surface.

The World Health Organization has identified antibiotic resistance as one of the greatest threats to human health. No new antibiotics were approved by the FDA in 2013, only one monoclonal antibody drug for anthrax in 2012, and none in 2011. Moreover, the clinical trial pipeline is nearly dry as there are only two new classes of antibiotics in late-stage trials. We desperately need new antibiotics to combat bacterial infections. Unless we find some way around widespread antibiotic resistance, we may find ourselves back to the days before antibiotics when serious infections often caused deaths of people of all ages.

Combination antibiotic therapies should kill bacterial pathogens more effectively and, just as important, slow the rate of antibiotic resistance. If p1 and p2 are the probabilities that resistance develops for antibiotics 1 and 2, the probability that resistance develops for the two-antibiotic combination is the much smaller product p1 x p2. When antibiotic resistance develops in a few bacterial cells during infection, the resistant bacteria will multiply and survive. It is important to kill them all to slow the development of antibiotic resistance in that pathogen.

The status of combination therapies for several diseases and various research approaches are reviewed in “Multi-target therapeutics: when the whole is greater than the sum of the parts.”

Speeding Cures for Complex Diseases

Two developments—precompetitive partnerships to understand disease pathways and to identify targets for drugs, and FDA policies to expedite clinical trials—will speed combination therapies for complex diseases to market.

Why precompetitive partnerships? When the human genome project was completed, many researchers thought all that was now needed to cure disease was to find out which of the 25,000 human proteins were implicated in which diseases, then make drugs to manipulate the proteins. But identifying the proteins is not nearly enough.

An analogy may help explain where we were then. If you had a map of New York’s subway system and a schedule of train arrivals at stations, you might think you know all there is to know about the subway system. But your train doesn’t show up one day. Did it stall at the station just before yours? Is there a labor strike, shutting down the whole system? You realize you really know very little about the system. The subway map and schedule is analogous to the completed human genome project. The train not arriving is analogous to being ill. And depending on the illness, to cure it you may need to know only a little bit more or you may need to know a lot more.

Understanding the complicated pathways to disease and how pathways and their molecules interact requires the work of many kinds of experts: molecular biologists, chemists, materials engineers, computer scientists and so on, all contributors to systems biology. This is a big undertaking best achieved with many partners.

The GenomeNet website provides pathway diagrams for many diseases including a generalized cancer pathway, pathways for specific cancers, and infection pathways for many bacterial pathogens. Clicking on the generalized-cancer-pathway hyperlink reveals how complicated the cancer process is. The pathway diagram leaves an impression that a very lot is known about the cancer process, giving us many choices for combination drug targets. Moreover, pathways and drug targets are being discovered continually.

 

A general flow diagram for precompetitive partnerships is presented in the Figure. The basic idea is that a large group of partner research institutions and companies contribute their resources to discover pathways and drug targets for complex diseases. With this knowledge in hand, each partner is free to develop and market its own proprietary drugs and drug combinations.

In a thoughtful analysis of cancer research strategy, the funding organization Cancer Research UK places considerable emphasis on partnerships and combination drugs.

For bacterial pathogens, a major new precompetitive partnership was announced in February 2014. The partnership called “European Gram Negative Antibacterial Engine (ENABLE), will bring together 32 partners in 13 countries, led by GlaxoSmithKline and Sweden’s Uppsala University.” An article from the Lancet Infectious Disease Commission, “Antibiotic resistance—the need for global solutions,” details approaches for addressing antibiotic resistance, again with a heavy emphasis on partnerships.

The FDA policies for drug development include three programs, two newer ones and an older one, to help support developers and speed clinical trials. The new program is Breakthrough Therapy Designation. In the FDA’s words, “A breakthrough therapy is a drug: intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies.” A breakthrough therapy designation speeds the development and approval of promising therapies and provides FDA guidance for conducting clinical trials efficiently.

The FDA Fast-Track Program is designed to aid the development and speed review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. The FDA decision to fast track a drug candidate is based on preclinical data, whereas the breakthrough designation is based on early clinical trials.

The old program is the Orphan Drug Act of 1983, which provides a number of benefits to developers of drugs for “orphan” diseases, those with less than 200,000 victims in the U.S. Benefits include seven years of exclusive marketing regardless of patent status, tax incentives for clinical research, possible grant funding for Phase I and II clinical trials.

Calls for FDA reform such as doing away with Phase III clinical trials would bring drugs to market three years faster and reduce clinical trial costs by 25%. Of course, such a radical reform would require intensive post-market surveillance for the drug’s safety and efficacy in patients.

A Business Opportunity Illustration

Small biotechnology and big drug companies alike will find many ways to take advantage of these recent activities to speed development of combination drugs. As an illustration, let’s look at a hypothetical small cancer drug-discovery company that had researched a new pathway, found promising targets, and now has drug candidates for an orphan cancer. In addition to entering clinical trials with a lead drug candidate for single-drug therapy, our company should look at companion drug(s) for combination therapy, focusing on companion drugs that are either expensive FDA-approved drugs with minimal efficacy and so have poor pharmacoeconomics or on drugs that failed in Phase III clinical trials for unclear efficacy. Combination therapies could “rescue” these marginal drugs.

There are many signs that pharmacoeconomic considerations are beginning to affect decisions on whether to use particular drugs. In a New York Times Op Ed titled “In Cancer Care, Cost Matters”, physicians from Memorial Sloan-Kettering Cancer Center wrote “we are not going to give a phenomenally expensive new cancer drug to our patients.” The particular drug that prompted their decision was Zaltrap for metastatic colorectal cancer. The drug is priced around $11 thousand for a month of treatment and median survival is about twelve months. A quick cost-effectiveness calculation yields CE = (12 x $11,000) /1 lys = $132,000 per life-years-saved, well above the $50,000 to $70,000 maximum for acceptable cost-effectiveness. (Basic pharmacoeconomic measures are covered in an earlier GEN article.) Cost utility is even less favorable since the saved life-years are most likely to be of low quality.

Our hypothetical company’s drug combinations would then be screened in cell culture to find combinations that are noticeably better than the drugs singly. Going further could be a lot to handle for a small company. At this point, it could negotiate a partnership with the patent holder of the companion drug(s), or it could seek the help of the National Cancer Institute’s long-established cancer drug-screening program for further screening, identifying the best combination candidate, and taking the combination through animal testing ready to enter clinical trials.

The NCI’s screening program is massive. About 80,000 cancer-drug candidates have been screened since 1990. The NCI accepts drug candidates from government laboratories, research institutes, academic institutions, and companies throughout the world. For small biotechnology companies with proprietary or expert knowledge of novel pathways and targets, the NCI program could be a valuable resource.

What has our company gained by this strategy? By picking an orphan cancer, our company would be eligible for orphan drug benefits. Since the combination therapy appears to be a significant advance, it should be eligible for fast-track or breakthrough therapy designations. By taking advantage of NCI’s screening program, the combination therapy should be well positioned for clinical trials and for a partnership with the developers of the other drugs in the combination.

The Mystery of Kissing.

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It’s not clear why we do it, but we know it works.

A recent visitor to my website complained that her husband’s aversion to kissing was stressing their marriage. This is not the first time I’ve heard people complain about a lover’s poor kissing or unwillingness to kiss. Kissing is a frequently overlooked element of sexuality. Also known as smooching, necking, snogging, making out, lip locking, bussing, and osculation, kissing is rarely mentioned in sexology resources, which is odd, because for many lovers, kissing is one of the most important, most erotic elements of sex.

One reason the sex literature largely ignores kissing is that it often occurs in nonsexual contexts with non-erotic meanings, among them: kissing another’s cheek to signal greeting or farewell; kissing children’s minor injuries to heal them; kissing the Pope’s ring or kings’ hands to signal reverence and fealty; or kissing dice for good luck. There’s also kissing that signals betrayal, condemnation, or contempt, as in Judas’ kiss, the Mafia’s kiss of death, or the phrase “kiss my ass.”

Percy Bysshe Shelley defined kissing as “soul meeting soul on lovers’ lips.” It’s certainly possible for lips-only kissing to express deep love, but for soul to meet soul, most lovers engage in open-mouth kissing with tongue contact, known in the English-speaking world as French kissing. Most—but not all—people consider kissing with tongue contact to be extremely intimate. Some consider it as intimate as intercourse. This intimacy is also reflected in a term used to describe fellatio and cunnilingus—“genital kissing.” Meanwhile, many sex workers who routinely provide fellatio and vaginal and anal intercourse refuse to kiss customers on the lips because, they say, it’s “too intimate.”

Ancient Sanskrit texts (c. 1000 B.C.) provide the earliest documented evidence of human kissing. Ancient Europeans kissed, but the paucity of references in ancient Greek literature suggests that the practice was less frequent 2,000 years ago than it is among Europeans today. Most world cultures kiss, but not all. Europeans introduced the practice to the indigenous peoples of Australia, Tahiti, and several locales in Africa. In some Asian cultures, lovers kiss only in private. Doing so in public is considered indecent.

Kissing is a mystery. Only two other species are known to kiss as humans do, chimpanzees and bonobos. They kiss to communicate attachment and to reduce group social tensions. But only humans and bonobos kiss deeply during sex.

Nor is it clear why kissing evolved. Some scientists speculate that it originated with mammalian infant suckling. Human lips contain a wealth of touch-sensitive nerves, and lip stimulation activates a surprisingly large area of the brain. But all mammals suckle their young while only a tiny minority of mammals kiss. Other researchers suggest that kissing originated in mammalian pre-chewing of food before feeding it to young mouth to mouth. Again, many more mammalian species pre-chew food than kiss. Some scientists theorize that kissing evolved to bring noses close enough to sense others’ pheromones, chemicals that play a subtle but well-documented role in attraction and attachment. Again, many species respond to pheromones but only a few kiss.

Kissing boosts levels of the neurotransmitters dopamine, serotonin, and the endorphins. Dopamine regulates sexual desire while serotonin and endorphins elevate mood. Kissing also increases blood levels of the hormone oxytocin, which mediates interpersonal attachment, and decreases levels of the stress hormone cortisol. As a result, kissing reduces anxiety and blood pressure.

Many people use kissing as a test of compatibility. In one survey, 59 percent of men and 66 percent of women said they’d ended budding relationships because the other person kissed “badly.”

Studies show that men are more likely than women to initiate kissing with tongue contact. The reason is unclear, but saliva contains trace amounts of testosterone, the hormone responsible for sexual desire in both men and women. Researchers speculate that unconsciously men may open their mouths to deliver this hormone and perhaps increase women’s sexual receptivity. But on the other hand, plenty of lovers’ kissing doesn’t lead to sex.

Among English speakers, open-mouth kissing was not called French kissing until World War I, when large numbers of English and American soldiers fought in France, and discovered that it’s common among the French. However, the French do not call it French kissing. It’s baiser amoureux (the kiss of love) or baiser avec la langue (kissing with the tongue).

Studies show that kissing is erotically more important to women than to men. Women are more likely to insist on kissing before, during, and after sex. Not surprisingly, when I’ve received complaints about kissing, they’ve almost always been voiced by women about men.

Kissing often makes people feel self-conscious, especially about the freshness of their breath. This concern accounts for significant sales of lifesavers, breath mints, toothpaste, and dental floss.

One study asked 1,041 young adults how best to kiss. The vast majority said that fresh breath, clean teeth, and good grooming were essential prerequisites. A large majority also valued soft, moist lips, deep breathing, mutual caressing, and assertiveness—leaning in and putting emotion into kissing rather than remaining passive. Finally, most said the best kissing begins with mouths closed, and proceeds to mouths opening only if things heat up.

 

References: Kirshenbaum. Sheril. The Science of Kissing: What Our Lips Tell Us. Grand Central Publishing, 2011.

Ryan, Christopher and Cacilda Jetha. Sex At Dawn: The Prehistoric Origins of Modern Sexuality. Harper-Collins, 2010.

Teifer, Lenore. “The Kiss: The Kinsey Institute 50th Anniversary Lecture,” Oct. 24, 1998.

No Mortality Benefit from a Higher MAP Target in Septic Patients – NEJM Journal Watch

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No Mortality Benefit from a Higher MAP Target in Septic Patients

A target mean arterial pressure of 80 to 85 mm Hg conferred no mortality benefit over the standard 65 to 70 mm Hg target.

Current sepsis guidelines recommend using fluids and vasopressors to maintain a mean arterial pressure (MAP) target of at least 65 mm Hg in patients with septic shock, as part of a sepsis treatment bundle that has been shown to confer a mortality benefit (NEJM Journal Watch Emerg Med Feb 22 2013 and NEJM Journal Watch Emerg Med Sep 7 2012). However, it is unknown whether a higher MAP target might improve mortality and decrease end-organ dysfunction. In a 29-center French study, researchers compared outcomes in 776 patients with septic shock who were randomized to MAP targets of either 65 to 70 mm Hg or 80 to 85 mm Hg.

The actual measured range of MAP values was about 5 mm Hg higher than the target ranges in both groups. There were no significant differences between the low-target and high-target groups in 28-day mortality (34% and 37%), 90-day mortality (42% and 44%), or median intensive care unit length of stay (8 days in both groups). However, the high-target group was more likely to develop atrial fibrillation and among patients with chronic hypertension, those in the high-target group were less likely to require dialysis.

COMMENT

A higher MAP target was not associated with decreased mortality in this study. Although patients with septic shock who have chronic hypertension may be less likely to need dialysis if a higher MAP is targeted, this benefit may be offset by an increased risk for atrial fibrillation. The findings in this study should not change our practice. The current guideline-recommended MAP target of at least 65 mm Hg for patients in septic shock is still appropriate.

Vitamin D supplementation lacks benefits, study suggests.

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The results of a new study suggest that vitamin D supplementation provides little, if any, health benefits.

A meta-analysis of 40 randomized controlled trials found that vitamin D supplementation, with or without calcium, did not alter rates of myocardial infarction or ischemic heart disease, stroke or cerebrovascular disease, cancer, total bone fractures, or hip fractures by a pre-defined risk reduction threshold of 15 percent or more. [Lancet Diabetes Endocrinol 2014. http://dx.doi.org/10.1016/S2213-8587(13)70212-2%5D

“In view of our findings, there is little justification for prescribing vitamin D supplements to prevent [such outcomes],” wrote the study authors, led by Dr. Mark Bolland of the University of Auckland, New Zealand.

The authors also suggested that any further trials similar in design to existing trials are unlikely to alter these conclusions. “Investigators and funding bodies should consider the probable futility of undertaking similar trials of vitamin D to investigate any of these endpoints,” they said.

Previous observational studies have shown that vitamin D deficiency is strongly associated with poor health and even early death. Claims that people can therefore benefit from vitamin D supplementation have been lent strong support by several leading scholars in the field and this has had a major impact on health practitioners prescribing patterns. To illustrate this point, US sales of vitamin D supplements increased by more than 10 times from 2002 to 2011, from US$42 million to $605 million.

In an accompanying editorial, Professor Karl Michaëlsson from Uppsala University in Sweden, said that evidence now suggests that low levels of vitamin D are a consequence, not a cause of poor health, and he cited a report from the US Institute of Medicine emphasizing that both high and low concentrations of vitamin D can lead to health risks in individuals. [J Clin Endocrinol Metab 2011;96:53-58]

“Without stringent indications – ie, supplementing those without true insufficiency – there is a legitimate fear that vitamin D supplementation might actually cause net harm,” said Michaëlsson.

Most recent data from UK points to substantial public health benefits of electronic cigarettes.

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While most anti-smoking organizations continue to oppose electronic cigarettes (e-cigarretes), warning of the hypothetical risks of these products, new data from the UK suggest that in real life, e-cigarettes are producing substantial public health benefits.

Recent data (monthly tracking of key performance indicators; e-cigarettes in England – latest trends) from the Smoking Toolkit Study (Cancer Research UK, UK Centre for Tobacco Control Studies) reveal the following critical points:

The use of e-cigarettes has increased dramatically, ever since the fourth quarter of 2011.
Precisely coincident with the rise in e-cigarette use in the UK has been a significant increase in quit smoking attempts.
E-cigarettes have surpassed nicotine replacement therapy (NRT) and other drugs as the most commonly used smoking cessation method.
Overall motivation to quit has increased since the dramatic rise in e-cigarette use.
The majority of dual users (e-cigarettes and cigarettes) are using e-cigarettes every day, and half are using at least two cartridges/disposables per day.
Very few non-smokers or long-term ex-smokers are using e-cigarettes.
Report STS140122 (Electronic cigarettes in England – latest trends) draws the following conclusions:

The increase in e-cigarette use prevalence may have stalled;
There is no evidence that e-cigarettes are undermining motivation to quit or reduction in smoking prevalence; and
Use of e-cigarettes by never smokers or long-term ex-smokers is extremely rare.
The rest of the story
Based on these most recent data from the UK, it appears that there just is not evidence to support the wild contentions that anti-smoking groups, advocates, and health agencies like the Centers for Disease Control (CDC) and WHO are disseminating to the public. Contrary to what Stan Glantz [Professor, Department of Medicine, and Director, Center for Tobacco Control Research and Education, University of California San Francisco, US] is telling the press, there simply is no evidence that the use of e-cigarettes is undermining smoking cessation or impeding the decline in smoking prevalence. Nor is there evidence that e-cigarettes are causing non-smokers or ex-smokers to return to cigarette smoking. Moreover, there is no evidence that dual use is decreasing the motivation of smokers to quit or precluding these smokers from reaping any health benefits.

In contrast, however, to the lack of evidence that e-cigarettes are having any negative public health effects, there is strong evidence to suggest that these products are having a substantial positive public health impact. In particular, there is evidence that not only do these products help many smokers quit smoking, but more generally, they increase population interest in smoking cessation, enhance levels of motivation to quit smoking, and lead to increased quit attempts among current smokers.

The only bad news coming out of the actual data is that the efforts of anti-smoking groups and advocates appear to be working: they are being successful in discouraging smokers from trying to quit smoking using e-cigarettes. Ironically, the results of public health efforts have been to impede smoking cessation, lower the overall motivation of smokers to quit, and decreasing the number of quit attempts among current smokers.

In other words, the anti-smoking movement is violating the first principle of public health practice by doing public health harm.

While it is difficult for me to have to criticize anti-smoking groups because these are groups with which I have had a career-long collegial relationship, it appears that these groups are substantially harming the health of the public by impeding smoking cessation. Sadly, this means that their efforts are going to result in a significant amount of unnecessary disease and death.

This is not the way public health is supposed to be. But this is what happens when an abstinence-only mentality takes over in any area of public health, whether it be nicotine addiction or heroin addiction.

 

Two doses of HPV vaccine may suffice for genital warts prevention.

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Just two of the recommended three doses of human papillomavirus virus (HPV) vaccine may be enough to reduce the risk of condyloma (genital warts) infections and potentially the risk of cervical cancer, a Swedish study has shown.

Completing the three-dose HPV vaccine series still conferred the most protection, but an examination of data from national Swedish population-based health data registers showed that the difference in risk reduction between the second and third doses was small, especially among girls who received their first dose before age 17. [JAMA 2014;311:597-603]

“The number of condyloma cases prevented by three doses versus two doses was 59 cases per 100,000 person years, which is a small difference,” said researchers from the Karolinska Institutet in Stockholm, Sweden.

The researchers identified 20,383 new cases of condyloma among a population of 1,045,165 females in Sweden aged 10 to 24 years, followed up between 2006 and 2010. Of these new cases, 322 occurred after at least one dose of HPV vaccine.

Risk reduction was highest among females who completed their vaccine course. However, two doses of vaccine also conferred significant protection.

For example, among girls aged 10-16, the incidence rate ratio (IRR) for condyloma was 0.18 for those who completed the vaccine course, 0.29 for those who received two doses, and 0.31 for those who had only one dose (p<0.001 for all), compared with those who did not receive the vaccine.

These corresponded to an incidence rate difference (IRD) of 459 cases of condyloma per 100,000 person years for three doses, 400 cases per 100,000 person years for two doses, and 384 cases per 100,000 person years for a single dose (p<0.001 for all) compared with no vaccine.

The IRR and IRD was consistently the least different between two and three doses among girls of any age, suggesting significant, if not the most, risk reduction.

Accounting for the impact of varying vaccine dose levels is important because “actual vaccination programs include substantial numbers of women who do not complete the full vaccination schedules,” the researchers said.

HPV serotypes 6 and 11 cause about 90 percent of condylomas, which are the first measurable endpoint for HPV infection and have an incubation period between 1 and 6 months. The females included in the study received the quadrivalent HPV vaccine, which also protects against serotypes 16 and 18, which are related to cancer outcomes, including cervical cancer.

The researchers said further investigations need to be done to determine if there is any reduced risk of cervical cancer with fewer than three doses of HPV vaccine. The current data may have also underestimated the number of condyloma cases since some patients can’t or won’t seek medical care, nor did it account for disease outcomes other than condyloma.

Defer dialysis in ESRD: New guidelines.

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New clinical practice guidelines from the Canadian Society of Nephrology recommend deferred – over early – initiation of dialysis in patients with end-stage renal disease (ESRD).

With the deferred strategy, patients with an estimated glomelular filtration rate (eGFR) of <15 mL/min per 1.73 m2 need to be closely monitored by a nephrologist. Dialysis is initiated only when uremic symptoms (fluid overload, refractory hyperkalemia or acidosis) emerge or when the eGFR drops to ≤6 mL/min per 1.73m2. [CMAJ 2014;186:112-117]

The updated recommendation was based on a review of 23 studies, including the Initiating Dialysis Early and Late (IDEAL) study, a large clinical trial which showed that early dialysis did not improve survival, quality of life, or hospital admission rates in patients with chronic kidney disease (CKD) compared with late or deferred strategy. The findings start to reverse a trend toward early initiation of dialysis.

There is a lack of compelling benefit for early initiation of dialysis in CKD, said guideline chair Professor Louise M. Moist from the Western University in London, Ontario, Canada. Veering away from the practice will avoid the burden and inconvenience of an early start, which has been associated with longer time on dialysis and greater resource use, she added.

The new guideline covers adult patients (age >18 years) with ESRD (stage 5 CKD) initiating chronic hemodialysis or peritoneal dialysis. It does not consider the timing of pre-emptive transplantation, dialysis for acute kidney injury, pediatric patients, or those electing conservative management without dialysis.

The Canadian guidance does not recommend earlier initiation of dialysis in higher-risk subgroups, such as patients with diabetes. It also dropped previous recommendations to initiate dialysis based only on a decline in nutritional status (as measured by serum albumin, lean body mass, etc). The recommendation differs from that of the National Kidney Foundation’s Kidney Disease Quality Outcomes Initiative (KDOQI), which calls for nephrologists to evaluate the benefits, risks and disadvantages of beginning kidney replacement therapy at eGFR <15 mL/min and the Caring for Australians with Renal Impairment (CARI) guidelines which recommend initiation of dialysis at eGFR <10 mL/min or if uremic symptoms or signs of malnutrition occur.

The guideline is intended not only for nephrologists but for primary care physicians, other internal medicine subspecialties, and nursing specialists caring for, referring, or co-managing treatment for patients with CKD.

7 Steps to Creating Your Own Magical World

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“Magic is believing in yourself, if you can do that, you can make anything happen.” ~ Johann Wolfgang von Goethe
When I was a little girl, there was this children’s television series produced in Czechoslovakia called Arabela. I used to love that show mainly because there was a lot magic in it. The whole show revolved around the members of a regular family, the Majers, who encounter people from the Fairy Tale Kingdom. And I remember the series featured several magic items amongst which a magic ring. That ring had the power to make any wish come true And I so wanted to have that ring. I remember fantasizing about all of the cool things I would’ve done if only I had that ring…

I was just a little kid at that time, and we all know that children have no trouble believing in magic and believing in fairy tales. I really believed that if I had that ring I could’ve create anything I wanted. I would’ve made all my wishes become reality.

Now, whenever I think about Arabela and the magic ring, I smile simply because I know that we can all create magic, we can all make our dreams come true and we can do it without a magic ring. We only need an open mind, a burning “desire, imagination, and a steadily focused attention on the feeling of the wish fulfilled.” ~ Neville, The Power of Awareness

What I will share with you here today are 7 things that are meant to help you to create your own fairy tale, your own magical world. Something that has taught me how to live life on my own terms and bring magic back into my life. And I trust it can do the same for you. Enjoy.

1. Withdraw your attention from the problems of the world
We like to stay informed, to know about all the horrible things that are happening in world and for some strange reason, we get a sort of twisted pleasure from sharing this newly acquired “knowledge” with those around us. We talk about our problems more than we talk about our joys and if we don’t have problems, we create some for ourselves just so we can stay busy.

It’s one thing to get interested in the problems of the world because you want to come up with solutions, and another thing to just do it because you’re bored and you have nothing better to do with your life. Placing your focus and attention on problems will not make them go away, on the contrary, it will create even more problems for yourself and those around you. Withdraw your attention from the problems of the world and start placing you attention on creating something that will make you feel better about yourself and your life.

“Everything is perfect in the universe – even your desire to improve it.” ~ Wayne Dyer

2. Ask your Soul to lead the way
I believe that we are all souls and that our bodies are nothing but the vehicles we need to express ourselves in this material world. It’s our Soul who has the power to create worlds and to make magic happen. If we can learn to align ourselves with who we truly are underneath it all, if we can get ourselves out of the way and allow our Soul to lead the way, nothing will be impossible for us to create and achieve.

“The Spirit gives life; the flesh counts for nothing. The words I have spoken to you – they are full of the Spirit and life” ~ Jesus

3. Leave the crowd
Leave the crowd. Commit yourself to staying true to yourself at all times. Promise yourself to never allow the noise of those around you to distract you from your newly chosen path and learn to listen to your inner voice, guidance and intuition.

Learn to think your own thoughts, to create your own ideas and to come up with your own rules. Always remember this – if you follow the crowd, you will get no further than the crowd. If you want your life to be different than that of the majority of people, you have to have to do things that the majority of people doesn’t have the courage to do.

“Each one of you has something no one else has, or has ever had: your fingerprints, your brain, your heart. Be an individual. Be unique. Stand out. Make noise. Make someone notice. That’s the power of individuals.” ~ Jon Bon Jovi

4. Make good use of your imagination
Imagination is one of our most precious gifts. With the power of your imagination you can create worlds, making all kind of wonderful things happen to you and because of you. In his book, Hostage at the Table, George Kohlrieser talks about the power of imagination in a really powerful way, “The power of imagination is incredible. Often we see athletes achieving unbelievable results and wonder how they did it. One of the tools they use is visualization or mental imagery… they made the choice to create their destinies and visualized their achievements before they ultimately succeeded.”

Make good use of your imagination. Focus your attention on that which you want to be, do and have. Imagine yourself having it all and being it all. Allow yourself to feel the rush, the adrenaline and the excitement that comes from having all those things happen and start creating your life from that place.

5. Make your future dream a present fact
If you want to create a new reality for yourself, you have to have faith in who you are and you have to change your awareness of yourself. You have to become that which you want to create and you have to start embodying all the qualities of the person you wish to become. “Then you must make your future dream a present fact. You do this by assuming the feeling of your wish fulfilled. By desiring to be other than what you are, you can create an ideal of the person you want to be and assume that you are already that person. If this assumption is persisted in until it becomes your dominant feeling, the attainment of your ideal is inevitable.” ~ Neville, The Power of Awareness

6. Assume the feeling of your wish fulfilled
The more time you spend thinking, imagining and feeling the feelings that come from having your wish fulfilled, the faster things will begin to manifest and the easier it will be for you to create all the things you want to create.

When I first started writing on my book, I had no idea how will I publish it nor did I know who will publish it. All I knew was that I was writing a book and that my book will be published. I saw it in my mind’s eye, I felt it in my heart and I knew that all the other things that were needed for my book to be shared with the world will be taken cared of. In fact, I wrote in one of my notebooks, and I quote “Have book published by the biggest and most respected publisher in the world.”

Well, not long after I started writing on my book, I had the chief editor of the world’s largest book publishers in the world emailing me and asking if I wanted to write a book and publish it with them and guess what? My book will be published by them. I guess I do have magic powers, but then again, we all do 🙂

“To be conscious of being poor while praying for riches is to be rewarded with that which you are conscious of being, namely, poverty. Prayers to be successful must be claimed and appropriated. Assume the positive consciousness of the thing desired.” ~ Neville Goddard, The Power of Awareness

7. Don’t worry about the HOW
I have come to realize that once you become aware of who you truly are and once you align your mind with your heart and your body with your Soul, life starts to take very good care of you. The right people seem to show up in your life, the right books, the perfect circumstances… and if before you used to stress a lot about HOW you are going to make it all happen, you now focus mostly on the WHAT and the WHY without worrying about the HOW.

I’m telling you, life is meant to be easy, very easy but our attachment to the past, to our fears and to all our limitations makes life hard.

Don’t worry about the HOW. Learn to delegate authority to life itself. Focus on WHAT you want and WHY you want what you want. If you intentions are good and if having your dreams come true will benefit a lot of people, life will take care of the HOW and will take very good care of you 🙂

“Most men believe that fame, great wealth or political power would secure them against the storms of life. So they seek to acquire these as the anchors of their life, only to find that in their search for these they gradually lose the knowledge of their true being. If man places his faith in things other than himself, that in which his faith is placed will in time destroy him; at which time he will be as one imprisoned in confusion and despair.” ~ Neville Goddard, The Power of Awareness

And this is how it’s done. This is how you make magic happen. If you don’t like what you see, if you don’t like the world you live in and if you want to create your own world, your own reality, you can do so by putting all of these things into practice. You can make magic happen and I hope you will.

Why do you think so many people sell themselves short, settle for way less than they are worth? Why do you think people find it so hard to leave the crowd and create their own rules and their own reality?

I really want to know what are your thoughts on this. You can share your insights by joining the conversation below.