Kilocalories. The trick of food corporations. How Nutrivix helps vegans

The modern food industry is a global business comparable in terms of profit with the alcohol, tobacco, and even drug trafficking. Why is that? The answer is simple: in the modern world, food has long ceased to be a basic physiological need such as sleep or breathing. Food has become entertainment. Today we can’t just eat simple healthy food when we need it. They impose on us that food needs to be prepared deliciously and beautifully, and eating food is almost a religious ritual. In fact, gluttony has become a new religion. We do not eat to saturate the physical body, we eat to saturate our mind, in other words, to have fun.

How many of us today eat simple food without frills? No. Food has become an entertainment industry. On television, round-the-clock broadcasts of programs on how to spoil the product as much as possible in order to get the maximum effect of the product on the receptors of our language. This is the essence of culinary programs. In supermarkets we are offered what the good owner does not even feed the dog. 90% of the products that are in supermarkets are not suitable for consumption because they are pesticides. But it doesn’t matter, because we have been taught a simple rule – “just to be tasty.” And every day, food corporations come up with more and more tricks to make us consume more and more while constantly reducing the quality of the product. One of the tricks of food corporations is the theory of kilocalories and how much a person needs these kilocalories for a full life.

Kilocalories – a tale for food lovers

Surely each of us has met in the life of such strange people who are constantly talking about some kilocalories. Most often, the whole life of such people is divided into three parts: fitness and food, and in between, the calculation of kilocalories. Gradually, the meaning of the life of such “mathematics lovers”, as a rule, becomes weight loss or, conversely, building up “meat” in the gym. And they themselves turn into an ideal food processing machine. What are these very kilocalories and why are they needed?
The theory of kilocalories began with the use of a simple device – a calorimeter. This is a device for measuring the amount of heat that, during combustion (or any other chemical reaction), releases a particular substance. What does this have to do with proper nutrition? Very correct question. Nothing. But supporters of theories about kilocalories and their role in proper nutrition do not think so. In general, such a thing as “calorie content” originally meant the heat released during the combustion of fuel. Compare food with fuel, and a person with a fuel processor is, of course, funny, but nothing more. In general, various false theories about “proper” nutrition are most often built on inadequate comparisons and false interpretations of facts. This is important to understand. For example, ardent supporters of meat eating compare a person with a predatory animal. If a rational creature takes an example from a predatory animal, well, here, as they say, without comment.

vegan diet benefits

The idea of ​​the need for a certain amount of calories for a full life is absurd and has nothing to do with reality. In nature, there is a simple example that completely refutes the theory of the required number of calories as a source of energy.

Migratory birds travel vast distances during their movements between continents. Scientists have made calculations of the time, distance and the physical work that birds do. The numbers are incredible. During the flight, the birds were in the air for a hundred hours without a break. This is more than four days. In a hundred hours, birds covered two thousand kilometers, and during that time they made about six million flapping wings. Those who are fond of push-ups on the bars, for example, can imagine what a tremendous physical work this is. Strength and stamina for this should be incredible. But another is much more interesting. If we consider the work that the birds did in terms of the theory of caloric intake of food, we get a very interesting conclusion.

According to estimates, in the whole body of a bird, including not only food in its stomach and intestines, but even the body itself with all muscles, bones, and so on, there are not even half of those calories that are supposedly (in terms of caloric value of food) needed to be done this work. That is, if the whole body of the bird was counted in calories, the bird would not have had enough of these calories even halfway. It turns out that the bird’s body had to eat itself and dissolve in space, not having flown even half the right way. This simple example from the life of birds suggests that the whole theory of a balanced diet and the necessary calories is nothing more than a ploy of food corporations, which scientists strongly support, because they are simply afraid to oppose the prevailing paradigm of “proper” nutrition and to be ridiculed.

What is a calorie?

Calorie is a unit of measurement that indicates the amount of energy needed to heat 1 g of water per 1 degree Celsius. The first to propose this term was the physicist Johann Wilke, back in the 18th century. And, probably, then, in the XVIII century, he least of all thought that fanatics of diets, weight loss and muscle building would use his term. However, it was precisely at the end of the 18th century that food corporations began to actively introduce various concepts into society to increase consumption. For example, back in the 18th century, in most countries it was customary to eat only twice a day: people, as a rule, did not eat breakfast. But subsequently the imposition of the tradition began to use hot chocolate in the morning, which later developed into the habit of having a full breakfast. Thus, the number of meals increased from two to three.

But back to the theory of kilocalories. In 1780, a certain Antoine Laurent Lavoisier began experiments with a calorimeter and calorie counting as a result of the combustion of certain substances. It was he who first expressed the idea that food for the body is fuel, like firewood for the stove. This idea was picked up a little later by the German chemist Justus von Liebig, and it was he who authored these very first food-grade calorie tables, which are now full of the whole Internet. It was he who proposed dividing the products into proteins, fats and carbohydrates. Further, the baton of this theory was accepted by American scientist-chemist Wilbur Olin Etwater, who laid the foundations of dietetics and theories about metabolism and energy combustion in the human body. This was already towards the end of the 19th century.

Thus, the simple combustion of food in a calorimeter was identified with the complex chemical and biological processes of digesting food in the human body. The most interesting thing is that the founders of this theory were actually serious and authoritative scientists, and they simply could not help but understand that comparing the process of food combustion and the process of its digestion in the human body is, to put it mildly, strange. However, it was at the end of the 19th century that the process of introducing the so-called food culture into society, or, more precisely, the “food cult”, had already begun. Because all the concepts that were introduced into society by some strange combination of circumstances led precisely to an increase in the consumption of products, and it was this result that was beneficial to food corporations then and profitable today. Today, the theory with calorie consumption is also extremely popular, which, in particular, also serves the interests of the meat processing industry. When the conversation begins about the benefits / dangers of veterinaryism, the question of the “necessary” number of calories is raised one way or another and, as a rule, it is concluded that in the absence of meat in the diet this amount will be insufficient, which means there are two options:

  1. you can’t refuse to eat meat, as this leads to a lack of calories;
  2. if you still refuse, then you need to replace the meat with an increased consumption of other food.

And by and large, both options are again beneficial to food corporations. Also today, on the basis of the theory of kilocalories, all diets and weight loss programs, as well as training processes for pumping muscles, are built. No one tells people that in order to lose weight, it’s enough to exclude fatty, fried, refined, floury foods and eat only when there is a feeling of hunger, and not every hour or two, as it is imposed in modern society. On the contrary, people build whole theories about a “balanced” diet, about how many calories they need to consume, and the most interesting thing is that in the vast majority of so-called diets, meat and eggs are not excluded, and in some cases even the opposite: they recommend it completely replace whole meals.

What is Nutrivix and its betefits for vegans

Nutrivix is the modern remedy for weight loss. This is a course of pills that relieve obesity and cleanse the body.
With a low-calorie diet, as well as a vegetarian diet, you should receive unnecessary nutrients, vitamins and minerals. Nutrivix partially compensates for the deficiency of antioxidants and plant components. Its main composition is:

  1. Tea leaf extract;
  2. Artichoke juice;
  3. Birch leaf extract.

Some observers also note the presence of mint and ginger in the extracts. However, the manufacturer does not indicate the availability of these ingredients.

Who can take Nutrivix tablets?

If you are over 18 years old, suffer from excess weight, but do not have kidney and liver diseases – you can use Nutrivix. However, be careful. Some components may cause allergies. Observe your well-being after applying the first pill.

What effect to expect

Users who regularly took Nutrivix reported a weight loss of 4-7 kg per month. They did not fundamentally change their lifestyle; they only slightly adjusted their diet. Another group of users who began physical education in addition to Nutrivix, noted the result of 8-9 kg per month.

Side effects and contraindications

Some users have had negative Nutrivix side effects after taking these tablets. This was mainly due to improper use of Nutrivix, a dosage violation and personal intolerance to the components. Negative symptoms were:

  • Nausea;
  • Heartburn and stomach pain;
  • Kidney problems;
  • Frequent urination.

If at least one of these symptoms appears, you should stop taking Nutrivix and consult a doctor.

Contraindications for Nutrivix are pregnancy and lactation, under the age of 18 years, kidney and liver diseases, serious hormonal disorders.

The principle of Nutrivix

This drug speeds up metabolism. Due to this, the body burns fat deposits faster. Also, cleansing the body of excess fluid contributes to rapid weight loss.

The main consumers of Nutrivix are residents of the United Arab Emirates. They note a positive result of losing weight and actively share their experience in social networks.

Delusion of calories counting

There are diets that do not even rule out alcohol. But there are more exotic options, such as a “chocolate diet”, which is based on the theory of the “necessary” number of calories per day. That is, a person, based on the “necessary” number of calories per day, calculates how much chocolate you need to eat per day to get a daily calorie intake. And more than chocolate, it eats nothing! All this would be funny and amusing if hundreds and thousands of sad stories about ruined health were not behind these theories and diets. And man allows himself to be deceived very willingly. For example, if a person has a dependence on chocolate (and many now have it), then he will readily believe in the “chocolate diet”, because it is convenient. And here it is important to consider another myth generated by the theory of kilocalories – the “necessary” number of kilocalories.
How many kilocalories we need
How many kilocalories does a person need per day? The authors of the theory of kilocalories went even further: they determined how much we need to eat in order to fully saturate the body with energy. However, no one explains how and how these calculations are made, especially when you consider that the energy consumption of people is different. Someone sits at the computer all day, and someone in the morning for 10 kilometers on a run overcomes. But this, apparently, trifles. So, it is not clear what methods and calculations, but the “scientists” (apparently, according to the old tradition of the British) have determined that a man of average build (the term is extensible) needs 2500 kilocalories per day, and a woman – 2000 kilocalories per day.

It is worth noting that gender stereotypes are present even here. And even if we assume that the comparison of food combustion in the calorimeter and the process of digesting food in the stomach is adequate, then it is theoretically impossible to calculate the number of “necessary” calories per day. Each person’s daily energy expenditures are purely individual. Moreover, energy expenditures occur not only on physical actions, but also on emotions and mental activity, which is almost impossible to track even with individual observation of a person’s life. Therefore, even when taking into account weight, height, gender, type of activity and physical characteristics of the body, it is not possible to calculate the average number of calories. And where did the figure in 2000-2550 calories come from, is also not entirely clear. This is such an average value that it simply does not make sense to take it into account.

But there is a sense of introducing such a concept. Firstly, as already mentioned, using the concept of the “necessary” daily amount of calories, you can refute the benefits of vegetarianism, veganism and raw food diet. And since these types of nutrition are disadvantageous for food corporations for several reasons, it becomes obvious that the concept of the “necessary” number of kilocalories is speculative and false. Secondly, the concept of the “necessary” number of kilocalories allows you to promote various so-called “diets” and the principles of “healthy eating”, which, as mentioned above, sometimes do not exclude meat, confectionery pesticides and even alcohol. In fact, today, proper nutrition is the mainstream, and the fashion for it is growing every day. And here, food corporations apply the ancient principle of “you can’t win, head.” Therefore, they offer people concepts of “healthy eating” based on false theories about kilocalories, the need for protein, and more. And this is a very subtle trick, which, unfortunately, today many come across.

How Can Men Increase Their Potency?

Sexual activity is a necessary component of the life of all the inhabitants of the planet. Medical researchers have been able to prove that sex is not only a need, but also a key to health. It increases the youth of the whole organism, supports the person in good shape, stimulates renewal processes in the cells, affects not only the genital area, but also all the internal organs of a person.

Every man sooner or later faces embarrassment when his sexual appetite is reduced. Immediately there is a standard solution: you need to buy Hammer of Thor and all problems will be solved. Indeed, Thor Hammer helps to improve potency, increase sexual capabilities and make life easier for a man. This drug is aimed at a rush of blood to the genitals and maintaining an erection at the proper level for a long time.

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The first signs of erectile dysfunction

Most men experience embarrassment with an erection, preferably only after 50 years, but this is not always the case. Changes that occur with age, lack of hormone balance and a decrease in overall tone along with chronic diseases have their drawbacks. Often the first manifestations have such signs:

  1. a decrease or complete absence of a morning erection;
  2. insufficient erection, which is not enough to complete sexual intercourse;
  3. lack of desire to have sex, no excitement;
  4. short sexual intercourse that does not satisfy a woman;
  5. decreased erection directly in the process of having sex.

Buy Hammer of Thor is a good solution to the problem, helping to eliminate the problem with potency and bring true pleasure to your soulmate. Going to extremes with the development of the above symptoms is not advisable:

Do not have hope that what happened happened once and over time will pass on its own;

Do not panic or diagnose yourself with impotence, first consult and consult a doctor.

There are a huge number of ways that can increase potency and improve sexual capabilities. This includes both folk recipes and pharmacological drugs that help to solve the problem in a short time.

How to increase male sexuality?

Buy Hammer of Thor, of course, is a good solution, but there are additional ways to optimize potency, which will have an additional effect on the body. It is important to reconsider your lifestyle, slightly change your diet, get rid of bad habits in the form of smoking and drinking alcohol. The latter primarily affects the body of a man.

Inactivity and constant sitting in place are the main reasons for the development of a weakened erection. All this happens because a man stagnates blood and lymph, so a non-bacterial type of prostatitis develops. Eating fatty foods, concertogens, GMOs, lack of nutrients significantly disrupt the body’s vital activity, hence the inability to satisfy a person’s sexual appetites.

There are many places where you can order male enhancement pills, below is a link to a detailed review where you can get know more about the drug. They recommend buying Hammer of Thor original Malaysia for those who have certain problems with erection and its appearance. There are certain recommendations, observing which you can improve potency in 50 years:

  • Regular exercise that helps improve pelvic circulation.
  • It is worth eating nuts and seeds that have beneficial effects on erection and potency. They contain fatty acids and oils. You can eat all kinds of nuts.
  • Fresh vegetables and fruits will remove all unnecessary from the body, remove developing problems, eliminate excess fluid.
  • Low-fat meat, rich in protein, will make you feel active and alert, as well as maintain physical fitness.
  • Hammer of Thor as an addition to the above will improve the capabilities of men. It will facilitate his condition, optimizes blood flow.
  • Include seafood rich in healthy vitamins in your diet. They are considered natural aphrodisiacs that can affect potency.

Hammer of Thor price is quite acceptable for all men, so there will be no problems with the purchase. The drug is approved for use by persons over 18 years of age, but it is advisable to consult a doctor first and find out more about the proposed diagnosis. Do not self-medicate and diagnose.

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Psychological factors of potency disorder

Quite often, after the first failures, a man loses confidence in himself, Thor’s Hammer is no longer interested in the price, he loses the meaning of life and stops trying to change something. If for those over 60 this is acceptable, then for young men who are under the age of 40, this turns out to be unacceptable.

A man should have sex, enjoy the process. If there are problems, they need to be solved and in no case be closed, going deep into yourself. The most common psychological factors include:

  1. I can not start;
  2. I cannot complete the process;
  3. I am not worthy of such a woman;
  4. I do not want to solve the problem;
  5. I have no desire to have sex;
  6. nothing excites me;
  7. Hammer of Thor will not help me.

Quite often, it is denial that exacerbates the problem. A man does not want to go to the hospital because he is ashamed to tell the doctor about his problem. For many, this is unacceptable, but it is necessary to fight. Modern methods of treatment allow you to reach unprecedented heights, and together with Hammer of Thor after a few months you will not notice how your problem is gone. At the same time, throughout the course of treatment, Hammer will help you regain strength and experience healthy woman satisfaction.

Sex, along with the erectile capabilities of men, play a special role in the life of every person. Do not forget that your condition and capabilities directly depend on you, only you can improve your condition and continue to live a full life. Fight the existing problem, remove all unnecessary and unacceptable.

Feng Shui Money Tips for your Apartment

Rich house

FOur home is a living, breathing organism, says Feng Shui. He may be in harmony with his masters, or may not be friends with them. Our housing has plots of space, each of which is responsible for the well-being of a particular sphere of life of the owner. When something goes wrong, it is possible that some sector in the apartment is incorrectly designed and deactivated. This also applies to money.

Today we will talk about the zone of wealth, for we understand that in the context of the global crisis, this sector is more relevant than ever.

What is the Feng Shui wealth sector?

Feng shui wealth

The wealth sector, or in another way, the Feng Shui money zone is responsible for financial well-being in human life. This miracle zone is located in the SOUTHEAST part of the room. The compass will help you most accurately.

The Feng Shui money zone in the apartment requires cleanliness. Free this place from excess rubbish, unnecessary things. Moreover, there should not be any debris, dust and dirt. Now we need to get rid of such items that can not only inhibit monetary activity, but also destroy it.

There are various factors that influence monetary well-being, such as the front door, but 5 sectors are extremely important for monetary health at home.

Main zone of money

Southeast wealth sector

This sector is most often associated with the accumulation of wealth than with salaries or bonuses received from work, for example. Accumulation of wealth means savings accounts, return on investment, but not salary. If your bedroom or dining room or front door, bedroom or office door is in the southeast, consider yourself lucky!

Secondary wealth sectors

North / career zone

Problems in this area lead to problems at work, and, in particular, to the problem of making money. Difficulties arising from problems in this area: stagnation in income and business, you cannot find a job. Salaries are the same and you cannot increase your income.

Impacts on this area include annual (flying stars), bath / WC, fireplace (fireplace), laundry, trees, plants, large tree or kitchen. You can activate the zone with the help of a moving metal to get energy that helps to earn more money.

Northwest / Zone of assistants, sponsors, patriarch and providence sector

This is an extremely important sector in Feng Shui. This is the ultimate “yang” sector. He represents the man or patriarch (head of the family). This sector also represents the heavenly energy of providence, which comes from people to help us. This is one of the most critical areas of Feng Shui. When this sector is positive, you get helpers, support from influential, knowledgeable and monetary people.

Southwest / Woman, matriarch, marriage, “indirect” spirit

This is the second most important sector in Feng Shui after the northwest corner. Because it represents the “yin” energy of the house. Remember, everything comes from nothing. The house must have people within itself and the energy of love and relationships. This sector is also important if a woman is in business and career.

Center / heavenly palace of the heart, health, wealth, relationships

This sector is the heart and foundation of the house. Impacts on this sector manifest as health problems, relationships and money. Everything suffers if the center is exposed to harmful influences. Everyone who lives in such a house suffers from these problems. This is the third zone to be protected. If in this sector there is a living room, bedroom or dining room – this gives the most favorable effect.

Tips for raising money at home:

  1. The bin or any other collection point should be as far away as possible from the work area and from the wealth zone. In general, there should not be garbage in the room – it extremely negatively affects the circulation of energy;
  2. Money tree is an effective magnet for wealth. However, it should be located strictly in the southeast of the living room or main room, if you live in a one-room apartment;
  3. Ventilate the apartment more often. This will help to get rid of stagnation of energy and improve its circulation. It acts in all areas of life;
  4. If you pay a loan, then get yourself a folder in which you will add receipts for payment. One caveat – it should be red;
  5. Piggy banks, if you use them, should be located in the southeastern part of the apartment, be red, and have an inscription on what exactly you are collecting money;
  6. In the north corner of the apartment put a statuette of a turtle. If there is no angle, then place this talisman in the northern part, separately from all other elements;
  7. In the apartment in no case should there be leaking pipes and taps, and the toilet should always be kept closed.

How to attract wealth beyond the borders of your home?

Money amulet

Being away from home, the center of your financial well-being, luck will not cease to accompany you. The only condition is to carry a small portable money amulet with you.

There is one important thing regarding the question of how to use money amulet. it can never be passed into the wrong hands. For all requests to see or touch the talisman, answer with a categorical “no.” The fact is that magical power can leave the talisman when interacting with another person. In addition, of course, do not forget to communicate with your amulet. In difficult moments of life, hold the magic item in your hands, long and persistently asking for his help.

Titan Gel First Look

Titan-gel is an innovative product of a new generation allowing to increase the penis without additional drugs.

With regular use, the cream has the following effects: after 2 weeks of use, there is an increase in the penis by about 1 cm. Erection increases, the penis becomes as hard as possible. The duration of the orgasm becomes longer, the sensations become more bright. Increases the duration of coitus. The beneficial effect on the whole body. Do not forget to read the real titan gel testimonials from satisfied customers.

This cream, which does not cause any side effects, does not cause allergic reactions, and also TITAN GEL does not cause addiction, and most important the result that you achieved after applying remains forever.

TITAN GEL cream is a natural herbal preparation. It consists of:

  • Notoginseng, ginseng, and prickly needle – Stimulate sexual function.
  • Muira Puma – Increases sexual desire, stimulates testosterone production, contributes to the emergence and maintenance of a good erection.
  • Ginger, horse chestnut, ginkgo biloba – Strengthen the blood flow in the penis and increase the elasticity of the tissues, thereby providing a powerful long-lasting erection and create optimal conditions for the growth of the penis.
  • Betaine – Improves metabolism, prevents the growth of prostate adenoma.
  • Dimethicone – Provides excellent lubricating properties to the cream, improves the penis slip and protects the skin of the penis during sex and when performing exercises to enlarge the penis.


Lubricate the penis with cream. Let soak for 3-5 minutes. You will feel an unusual pleasant tingling – TITAN GEL has begun to act!


Liberally lubricate the penis with cream, let it soak for 3-5 minutes. By activating cell division processes with the TITAN GEL. Already after 2 months of applying the cream, you will see a significant increase in your penis, both in a calm and erection state.

Magic Mushroom’ Drug: Spirituality & Science

Volunteers whom tried the hallucinogenic component in psychedelic mushrooms throughout a controlled research funded by the U. S. federal government had “mystical” experiences, and many of these still felt unusually content months later. The aims of the Johns Hopkins researchers were simple: to explore the neurological mechanisms and ramifications of the compound, as well as its potential as a therapeutic agent.
Although psilocybin — the hallucinogenic agent in the Psilocybe category of mushrooms — first gained notoriety a lot more than 40 years back, it has rarely been studied because of the controversy encircling its use. This newest getting, which sprang from a rigorously designed trial, moves the hallucinogen’s effect closer to the hazy border separating hard technology and religious mysticism.”A lot more than 60 percent of the volunteers reported ramifications of their psilocybin session that met the requirements for a ‘full mystical encounter’ as measured by well-established psychological scales,” stated business lead researcher Roland Griffiths, a professor in the departments of neuroscience, psychiatry and behavioral biology at Johns Hopkins University in Baltimore. What’s more, the majority of the 36 mature participants — none of whom had taken psilocybin before — counted their experience while under the influence of the drug as “being among the most meaningful and spiritually significant experiences of their lives,” Griffiths said. The majority of said they became better, kinder, happier people in the weeks following the psilocybin session — an undeniable fact corroborated by friends and family. The experts also noted no permanent brain damage or negative long-term results stemming from utilization of psilocybin. But the research, published in the July 11 online edition of Psychopharmacology, did not neglect the hallucinogen’s “dark side.”Despite the fact that the applicants for the landmark research were carefully screened to lessen their vulnerability and closely monitored during the trial, “We still had 30 percent of these reporting periods of very significant fear or stress and anxiety that could easily escalate into panic and dangerous behavior if this received in any other sort of situations,” Griffiths said.”We simply have no idea what causes a ‘bad trip,’ ” he added, “and we can’t forecast who’ll possess a hard time and who won’t.”Still, many professionals hailed the research, which was funded by the U. S. National Institute of Drug Abuse and the Council on Spiritual Methods, as long overdue. A minimum of Dr. Herbert Kleber — previous deputy director of the White-colored House’s Office of Nationwide Drug Control Policy under former President George H. W. Bush — said these kinds of studies “could shed light on various kinds of brain activity and result in therapeutic uses for these types of drugs.”
He authored a commentary on the Hopkins research.”Over time, with appropriate research, probably we can figure out methods to decrease [illicit medications’] bad results,” while retaining those results beneficial to medical science, Kleber said. Scientific research in to the effects of illegal, Plan 1 drugs such as for example psilocybin are allowed by federal law. However the stigma encircling their use has kept this kind of research to the very least. The taboo surrounding medicines such as for example psilocybin “offers some wisdom to it,” Griffiths said, but “it’s unfortunate that as a tradition we so demonized these medicines that people stopped doing study on them.”Psilocybin appears to work primarily upon the brain’s serotonin receptors to alter states of consciousness. In their research, the Baltimore team sought to look for the exact nature of psilocybin’s effects on human beings, under strictly controlled conditions. To do so, they sought volunteers without prior history of drug abuse or mental illness who also had a strong interest in spirituality, because the drug was reputed to induce mystical states. The study included 36 college-educated participants averaging 46 years. It had been also randomized and double-blinded, meaning that half of the participants received psilocybin, as the other half received a non-hallucinogenic stimulant, methylphenidate (Ritalin), but neither experts nor the participants knew who got which drug in any given session.
Each volunteer was brought in for just two or three sessions in a “crossover” style that guaranteed that all participant used psilocybin at least once. During each eight-hour encounter, participants were carefully watched over in the lab by two skilled monitors. The volunteers had been instructed by the experts to “close their eye and direct their interest inward.”According to the Baltimore team, almost two-thirds of the volunteers said they achieved a “mystical encounter” with “substantial personal which means.” One-third ranked the psilocybin experience as “the single the majority of spiritually significant connection with his or her existence,” and another 38 percent positioned the experience among their “top five” many spiritually significant moments. The majority of also said they truly became better, gentler people in the following two months. “We don’t think that’s delusional, because we also interviewed family and friends by telephone, and they confirmed these kinds of statements,” Griffiths said. So, is this “God in a pill”?
Griffiths said answering queries of religion or spirituality considerably exceeds the scope of research like these.”We know that there were brain changes that corresponded to a main mystical experience,” he stated. “But that getting — as precise as it may get — will in no way inform us about the metaphysical question of the living of an increased power.” He likened scientific attempts to seek God in the mind to experiments where scientists watch the neurological activity of individuals consuming ice cream.”You could define exactly what mind areas lit up and how they interplay, but that shouldn’t be used as a disagreement that chocolate ice cream will or doesn’t exist,” Griffiths said. Another expert said the study should give insights into human consciousness.”We might gain a better understanding of how we biologically respond to a spiritual state,” stated Dr. John Halpern, associate director for drug abuse research at McLean Hospital, Harvard Medical College. Halpern, who’s executed his own analysis on the sacramental use of the hallucinogenic drug peyote by Native Us citizens, said he’s motivated that the Hopkins trial was arranged to begin with. “This study, by a few of the top-tier people in the united states, shows that it’s possible for all of us to re-seem at these substances and evaluate them safely in a research setting,” he said. For his part, former deputy drug czar Kleber stressed that agents such as psilocybin “carry a higher likelihood of misuse along with good use.”Griffiths agreed the analysis should not been viewed as encouragement for casual experimentation.”I think it could be awful if this study prompted people to use the drug under recreational conditions,” he said, “because we really do not know that there aren’t character types or conditions under that you could take things such as that and develop persisting damage.”

Opponents of Direct-to-Consumer Drug Ads Cannot Reduce Its Booming

Drug company shelling out for direct-to-consumer marketing continues to skyrocket, even while criticisms against it have soared. Calling to get a moratorium, instead of just restrictions, on such advertising might be in order, state the authors of a study in the Aug. 16 problem of the brand new England Journal of Medication.”Direct-to-consumer marketing spending is increasing when it comes to its discuss of total marketing spending budget, but it’s still a smaller share in accordance with promotion aimed at influencing prescribers,” said study author Julie M. Donohue, an assistant professor of health policy and administration at the University of Pittsburgh Graduate School of Public Health. The U. S. Food and Medication Administration started enabling direct-to-consumer advertising of prescription drugs on television a decade ago. Since that time, spots of Dorothy Hamill and Sally Field peddling Vioxx and Boniva, respectively, cartoon character types illustrating the consequences of the antidepressant Zoloft, and a wide selection of similar promotions have become commonplace on American TV screens and in other press. But so, too, has criticism of the practice. Skeptics say that direct-to-consumer advertising encourages overuse of medicines and drives up drug spending. The controversy reached critical proportions when the arthritis medication Vioxx, probably the most heavily promoted medications ever, was withdrawn from the market in 2004 because of serious cardiovascular risks.”It’s been a decade because the FDA clarified its policy regarding broadcast marketing and unleashed direct-to-consumer marketing on television, which was new,” Donohue said. “We wished to see, in the wake of the Vioxx withdrawal and an elevated focus on the security of medicines and a concentrate on drug costs in light of the implementation of the new Medicare drug advantage, what market and the FDA had been doing regarding advertising.”Because of this evaluation, Donohue and her colleagues looked at pharmaceutical company shelling out for direct-to-consumer advertising and advertising to physicians in the last decade. Total pharmaceutical industry spending on promotion soared from $11.4 billion in 1996 to almost $30 billion in 2005. Throughout that time, shelling out for direct-to-consumer marketing improved by 330 percent, yet this kind of advertising just made up 14 percent of total marketing expenditures. These mass-media advertising blitzes generally start before a drug’s safety background has been established available on the market, the researchers said.”In most of heavily advertised drugs, direct-to-consumer marketing starts within about a season of FDA approval and typically prior to the safety profile provides been established,” Donohue said. The most heavily marketed drug in 2005 was that “little purple pill,” Nexium, a proton pump inhibitor heartburn medication, on which AstraZeneca spent $224 million. Next came the sleeping pill Lunesta ($214 million), accompanied by the cholesterol-decreasing statins Vytorin ($155 million) and Crestor ($144 million), after that Advair, a corticosteroid ($137 million). Viagra was 17th on the list, with $80 million spent in 2005.Eight of the top 10 drug classes when it comes to sales had at least one item that was promoted through DTC advertising. Producers of proton pump inhibitors, statins and erythropoietin medicines (drugs such as for example Procrit, which increase crimson blood cellular counts) spent 34 percent, 34 percent and 31 percent of their total advertising budget on direct-to-consumer marketing in 2005, respectively.”In the majority of top-selling classes, in least one medication is advertised to customers and in more than half of the classes multiple drugs are advertising to consumers, so it really does play a major part,” Donohue said. “DTC marketing is used for a little subset of medications, whereas other forms of promotion like ‘detailing’ [person-to-person meetings] and free samples are used by manufacturers for practically all branded products.”The antidepressants known as selective serotonin reuptake inhibitors (SSRIs), such as Celexa, Paxil, Prozac and Zoloft, led the field in promotional spending with more than $1 billion spent in 2005. Next were statins ($859 million), then proton pump inhibitors ($884 million).At the same time, Donohue stated, “The FDA’s monitoring of drug advertising hasn’t kept pace with the quantity of advertising of prescription drugs. The amount of warning letters venturing out to drug companies has reduced markedly [from 142 in 1997 to 21 in 2006], and the amount of FDA staff accountable for ads was relatively flat in recent years, in spite of spending boosts.”It may be that the rules themselves are sufficient, but that enforcement powers are not.”My look at is that the marketing rules that are on the book now are adequate. Prescription medication ads are among the most heavily regulated advertisements if you look at all the consumer products,” Donohue said. “But the enforcement of the rules needs to be there aswell, and resources necessary for reviewing advertisements need to be sufficient.””And drug manufacturers don’t need to have FDA acceptance of advertisements before airing them, so an ad campaign can operate its course prior to the FDA will be able to review the advertisements,” she added. In response to the study, Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America (PhRMA), said in a statement: “DTC advertising has been demonstrated to play a key role in educating and empowering sufferers, improving patient understanding of disease and available treatments, and fostering strong relationships between patients and their health-care providers. Unfortunately, the study released today in the New England Journal of Medicine all but overlooks these important contributions to patient wellness.””Surveys display that DTC marketing brings patients into their doctors’ offices and helps start essential doctor-patient conversations about conditions that might otherwise proceed undiagnosed or untreated. Actually, a national survey by Prevention Magazine found that 29 million individuals talked with their doctor for the very first time about a health condition after viewing a DTC ad. The survey also found that of these patients, the majority of discuss behavioral and lifestyle changes and over fifty percent get a recommendation for nonprescription or generic alternatives,” the declaration said. Dr. A. Mark Fendrick, a professor of health management plan at the University of Michigan School of Public Health in Ann Arbor, stated: “As the health-care consumerism movement encourages more data on cost and quality, it is increasingly important to consider the source of information.””This research confirms that direct-to-consumer marketing of medications is here to stay and can contribute to the information overload confronted by the normal consumer. Patients, clinicians and payers should interact to implement steps to maximize the positive aspect of DTC advertising —
increased utilization of drugs in those most likely to benefit — while minimizing the safety concerns and unnecessary expenditure of inappropriate use,” this individual said.

Causes of Cancer Were Disclosed by Gene Researches

A close look at a tumor’s or patient’s genetics can offer important, possibly lifesaving clues to preventing and treating cancer. So say researchers who outlined their analysis Tuesday in five presentations at the American Association for Malignancy Research’s annual conference, in Denver.”That is an interesting set of presentations,” John S. Witte, a professor in the Institute for Human Genetics at the University of California, San Francisco, said during a midday press meeting. “All the studies impact on the potential to predict risk or recurrence or response to treatment,” he said. In the 1st study, experts led by Dr. Charles Mullighan, an assistant member at St. Jude Children’s Research Hospital, Memphis, found that children with acute lymphoblastic leukemia (ALL) who’ve mutations in the JAK tyrosine kinase gene generally have got poor outcomes, including a higher threat of recurrence of their malignancy. The getting suggests the gene is actually a potential diagnostic device and a new therapeutic focus on. Despite improvements in treatment, some children with All of the will relapse, Mullighan told reporters. For the study, the Memphis team analyzed the genes of 221 children with the condition. Although JAK mutations were not previously known to occur in children with ALL, they were discovered in 10 percent of these sufferers. The mutations were associated with a deletion of the genes IKZF1 and CDKN2A/B and poor result. And, over four years, 71 percent of the kids with JAK and IKZF1 alterations acquired a relapse of their disease, weighed against only 23 percent for individuals without these genetic alterations, the researchers found.
But there was good news, too. “Whenever we treated the cancer cellular material with a JAK inhibitor, the cells died,” Mullighan stated. “This shows that these JAC mutations certainly are a new therapeutic focus on in this subtype of leukemia.” Another study on leukemia discovered that a set of genetic variants increases the risk for chronic lymphocytic leukemia (CLL). The findings of this study add more items to the puzzle and may lead to better prevention and prognosis of the disease, according to lead researcher Susan Slager, associate professor of biostatistics at the Mayo Clinic in Rochester, Minn.
Regarding 15,000 Americans will establish CLL each year, and 4,000 will die, so it is one of the rarer cancers, Slager said during the teleconference. However, “in case you have a family member with chronic lymphocytic leukemia, your likelihood of getting the disease are eight times higher than that of the general population,” she noted. A youthful analysis identified seven DNA sequencing aberrations called “single nucleotide polymorphisms” (SNPs) that may result in chronic lymphocytic leukemia. In today’s study, researchers confirmed these findings in another sample of patients. They discovered the strongest genetic association for the condition was for a SNP on the 11q24 gene, where the risk was 50 percent higher. This was accompanied by a 39 percent increased risk with a separate SNP on the 6p25 gene.”Our results will hopefully understand the biology of the condition, which may help all of us predict the condition, and it could help us develop better treatments and prognostic markers,” Slager said. Results of another research presented at the conference showed that genetic variants in what’s referred to as the microRNA processing pathway may predict a woman’s risk for ovarian cancer.”Ovarian cancer is the fifth leading cause of cancer in women in the usa, and one of the major risk elements is a family history of ovarian cancer, indicating that a genetic component contributes to ovarian malignancy risk,” Dr. Xifeng Wu, a professor in the department of epidemiology at the University of Texas M. D. Anderson Cancer Middle in Houston, said through the teleconference. For the analysis, Wu’s and team evaluated 70 SNPs in eight microRNA pathway genes. We were holding taken from 380 ovarian cancer cases, as well as from 146 healthy ladies.
The researchers found 16 SNPs that were predictive of ovarian cancer risk. Patients who carried five or fewer of the SNPs had been at low risk for ovarian malignancy. However, patients with six and seven SNPs had greater than a twofold increased risk, and those with eight or even more had over a fivefold improved risk. In addition, as the number of these SNPs increases, so does resistance to treatment and poorer survival, Wu said.
This information, and also other genetic and lifestyle risk factors, could be used to build up an ovarian cancer risk-prediction model, Wu said. In a fourth study, researchers led by Dr. Gangning Liang, an associate professor of research in the department of urology at the University of Southern California, reported
acquiring a DNA modification called a “methylation design,” that may analysis bladder cancer and detect patients at risk meant for recurrence of the disease.
“Bladder cancer may be the fifth many common cancer in guys and the sixth the majority of common in females,” Liang said during the teleconference. “It really is mainly within smokers.”DNA methylation is an activity in which genes can be either silenced or activated in malignancy. For the study, experts measured DNA methylation in 12 patients who didn’t have bladder cancer, 52 patients with noninvasive bladder tumors and 39 sufferers with invasive bladder tumors.
Comparing cancerous tissue with regular bladder tissue, they discovered 158 “hypermethylated” loci and 366 “hypomethylated” locations. In addition, they found 21 places which were hypermethylated in the normal-appearing bladder cells in patients with bladder cancer.
These loci may be markers for identifying people at risk for bladder malignancy, the researchers said. In addition, the scientists found that noninvasive tumors had a definite pattern of hypomethylation compared with invasive tumors. This acquiring supports the idea that two forms of bladder cancer develop along different paths. Bladder cancer can easily recur, Liang noted. “It needs frequent and invasive monitoring. We think these email address details are clinically useful and also have benefits for the patient, because we can detect these methylation changes in the patient’s urine,” he explained.
“So, we are able to use a noninvasive solution to monitor the patient and may also have the ability to screen for bladder cancer in high-risk populations, like smokers,” this individual said. In your final report, experts led by Sunita Setlur, an instructor in pathology at Brigham and Women’s Hospital and Harvard Medical College, found simply no association between the gene variant UGT2B17 and the chance of prostate cancer. Although this gene had been from the risk for prostate malignancy in two earlier research, this new study found no such association. For the study, researchers looked at 269 guys of whom 156 had prostate cancer. The experts looked at the number of copies of the UGT2B7 gene and discovered that although deletion patterns for UGT2B17 and UGT2B28 genes were between 3.4 percent and 19.9,
this did not boost the risk for prostate cancer.”We did not see any association between polymorphism of UGT2B17 and UGT2B28 with cancer,” Setlur stated during Tuesday’s teleconference.

Do Naturopathic Remedies Treat Cancer and Hot Flashes?

Advocates for naturopathic remedies state their treatments may help fight menopausal symptoms, depression and also cancer. For example, “bio-identical hormone therapy” looks promising for relieving the symptoms of menopause, one study found, while an age-old herbal treatment for cancer is proving effective — at least in the laboratory and in pets. That’s according to naturopathic physicians presenting their research at the American Association of Naturopathic Physicians annual meeting, held previously this month in Portland. Ore. Naturopathic physicians are trained in “natural” health care at certified medical colleges, based on the AANP. Their approach is based on the belief that it is the nature of all things to return to balance. Remedies include dietary changes, counseling for lifestyle modification, organic medicine, natural supplements and homeopathy.”Bio-identical hormones,” a natural option to synthetic hormone alternative therapy, were effective in reducing the symptoms of menopause and perimenopause, said lead researcher Dr. Jan M. Seibert, a naturopathic doctor in Pleasant Prairie, Wis. She gave the hormone regimen, which includes estradiol/estriol via a face care cream or in drops, and also a progesterone cream and a multivitamin, to 50 ladies who were either menopausal or perimenopausal. Seibert’s group then followed the women’s improvement for one yr.”Eighty-two percent of the women showed improvement in estrogen-related symptoms, such as warm flashes,” she said. “Seventy-four percent showed improvement in progesterone-related symptoms such as irritability and fluid retention.”Seibert also looked at symptoms linked to low thyroid functioning, which can affect women at menopause. “When the thyroid begins to have complications, it can cause a state of depression and weight gain,” she described. In the analysis, “44 percent showed improvement with thyroid-related symptoms and 8 percent got worse. The additional 48 percent got no change.”What’s needed following, Seibert said, is a big, randomized trial of organic hormone therapy to find if it works as well as synthetic hormone therapy without the medial side effects. Long-term hormone alternative therapy (HRT) with synthetic estrogen and progesterone boosts dangers for breast cancer and stroke, as the large-scale Women’s Wellness Initiative study found.
That research was stopped early in 2002, and its troubling results caused many older women to abandon HRT. “This is a great start in conditions of providing preliminary proof benefits for menopausal concerns,” stated Dr. Wendy Weber, a study assistant professor of naturopathic medicine at Bastyr University, Seattle, who was simply not involved with Seibert’s study but knows its findings.”Based on this study, it seems there may very well be benefits, but we are still lacking [data upon] the efficacy and basic safety.” And, she mentioned, the study didn’t have a control group, which could have allowed a primary head-to-head comparison of bio-similar and synthetic hormones. The analysis is “interesting” however, not surprising, added Dr. Rick Frieder, a gynecologist at Santa Monica–UCLA INFIRMARY and a medical instructor of obstetrics and gynecology at UCLA’s David Geffen School of Medicine.”It generally does not convey anything new,” this individual said. Whether hormone replacement can be synthetic or the more organic “bio-identical” compounds, he stated, they are regarded as effective in enhancing the symptoms of menopause, such as incredibly hot flashes. One drawback to the analysis, he said, can be that they studied several items and doses, rather than have a more scientific strategy, such as comparing one dose of bio-identical hormones to the same dosage of synthetic medications. In another study presented at the meeting, the herbal formula Essiac — utilized by cancer patients for decades — was found to involve some antioxidant and anti-inflammatory activity along with the ability to kill cancer cells in the laboratory, said Deborah Kennedy, the lead author of the laboratory study and a co-author of another study looking at the result of the remedy in animals. The research had been funded by the maker of Essiac. Kennedy found that the formula, when applied to ovarian and prostate malignancy cellular lines, did kill the cellular material. “We were able to slow down and cause the ovarian and prostate malignancy cell lines to die,” she said. When the formula was used in animals, they discovered it protected the stomach but did not boost the disease fighting capability considerably.”The in vivo [lab] study discovered antioxidant activity,” noted Dr. Christine Girard, chief medical officer at the Southwest University of Naturopathic Medication in Tempe, Ariz., who chaired the research committee for the conference. She called the outcomes “encouraging,” and noted that the formula also seemed to have an anti-inflammatory effect.”It’s a good first step,” she said, but added that it’s tough to translate animal leads to humans. In the animal study, the formula did demonstrate gastric protection and protection to the liver, she stated. Not everyone is convinced Essiac fights cancer.
The American Cancer Society declined comment, noting that the study hadn’t undergone peer review and was merely submitted for presentation at a gathering. On its Site, however, the ACS cautions that, “There have been no published clinical trials showing the effectiveness of Essiac in the treatment of cancer.” Although it notes that some of the herbal products in the blend have shown anti-cancer effect in lab studies, it notes that no scientific evidence exists to aid its use in humans with cancer. Research after research, conducted in pets by researchers at the U. S. National Cancer Institute and various other prestigious institutions, possess concluded there is no evidence the formula functions, based on the American Cancer Society. In other presentations at the meeting:A researcher
at the University of Toronto warned that St. John’s wort, a favorite herb used to treat depression symptoms, should be used in combination with caution by pregnant and breast-feeding women, as it can interact with some medications prescribed during pregnancy and may cause colic or drowsiness in infants. The analysis received no outside funding. Another Canadian study discovered that naturopathic care — acupuncture, relaxation exercises and diet and lifestyle changes — relieved low back pain better than standard care in a report of 80 Canadian postal workers. Low back discomfort declined by 20 percent in the naturopathic group after the 12-week research but improved 8.8 percent in a group receiving standard care. The study was sponsored by the Canadian authorities and the postal employees union. A team at the National College of Naturopathic Medicine discovered that three common herbs — Echinacea purpurea, Astragalus membranaceus and Glycyrrhiza glabra — helped increase crucial lymphocytes in the blood, which are the basic building blocks of the disease fighting capability. In the analysis, 16 healthy individuals were assigned to obtain an herb only, all three, or a placebo. Each got a 7.5 milliliter dose twice daily for a week. Blood tests showed all three herbs boosted the immune system. The study was funded by a grant from the American Medical Association.

Taking Cancer Medicines With Food Helps Reduce Costs

Going for a pricey breast cancer drug called lapatinib (Tykerb) with meals rather than on an empty stomach may improve its absorption by the body — lowering the dosages needed and greatly cutting costs for patients, a new study shows. In a commentary published in the Aug. 10 issue of the Journal of Clinical Oncology, Drs. Tag Ratain and Ezra Cohen, of the University of Chicago, recommend that taking the lately approved medication with food
— particularly high-fat food — cuts the dosage needed by at least 60 percent. Ratain — a professor of medicine and associate director for clinical sciences in UC’s Cancer Research Middle — joined Cohen (from the hematology/oncology portion of UC’s division of medicine) to highlight the findings of a study presented in March in the American Culture for Clinical Pharmacology and Therapeutics. The study, which neither Ratain or Cohen was involved in, revealed that 500 milligrams of Tykerb taken with food appears to be as effectual as 1,250 milligrams of the drug taken on an empty stomach, the current prescription protocol.”What we have here is this unique situation where individuals are shelling out a lot more than they need to take a drug in a suboptimal way,” said Ratain. The current regimen of five 250 milligram tablets each day, taken on a clear stomach, costs about $2,900 monthly. But simply taking the pills with meals could save the individual about $1,740 monthly in drug expenditures, a real “value meal” for sufferers, according to the experts. Both Ratain and Cohen cautioned that physicians and patients shouldn’t alter Tykerb treatment protocols until further research substantiates these findings. The drug’s maker, GlaxoSmithKline (GSK), offered a much stronger warning in a statement released Tuesday, where they called Ratain’s and Cohen’s commentary “speculative,” with the “potential to be misunderstood and misused by clinicians and patients.””While dosing Tykerb with meals has been found to improve absorption, food effects are highly variable and hard to predict,” the business said. “Acquiring Tykerb with meals could lead to increased unwanted effects and decreased efficacy. Additionally, concurrent medicines that patients may be taking, which includes capecitabine, should be considered. Each medicine has its potential for drug and food interactions. Therefore, it really is imperative that sufferers follow the current FDA approved Tykerb dosing and administration recommendations without meals.”Tykerb was approved for use against breast malignancy by the U. S. Food and Drug Administration in March of the season. The oral tablet originated by the GSK for individuals battling a specific kind of advanced-stage breast cancer, where HER2 — a protein that promotes tumor development — is expressed. According to the American Cancer Society, each year approximately 180,000 American women are diagnosed with breast cancer. Annually, up to 10,000 ladies are projected to die from the advanced stage, HER2-positive version of the disease. The new treatment was approved for use in mixture with another medication known as capecitabine (or Xeloda), for cases when a selection of other drugs, such as Herceptin, have ceased to work. According to the FDA, Tykerb inhibits tumor growth by going inside cells containing the HER2 protein and blocking signals that promote tumor development. In contrast, older medications such as for example Herceptin have larger molecular structures that target the outside of the cell. The FDA approval of Tykerb was based on the results of a study involving approximately 400 breast cancer individuals with advanced-stage HER2 disease. That study revealed that women who had taken Tykerb in combination with capecitabine were significantly much more likely to respond positively to treatment and to experience a delay in tumor growth. The ultimate impact Tykerb may possess on long-term survival was still unidentified during approval. As is standard procedure with all new drug approvals, the FDA caused the drug’s producer to compose the instruction labeling accompanying Tykerb. Because currently worded, physicians and patients are obviously informed that the medicine should be taken on an empty stomach, in light of the fact that all the study individuals consuming Tykerb did take the drug without meals. However, another portion of the labeling material notes that absorption of the medication is boosted when ingested with food. Ratain said this sort of confusion happens when “obtaining items done quickly is considered more important than getting things done correct.””Here’s the problem: Since the drug organization didn’t do their trials with food, they can not recommend that their drug be given with meals,” he said. “I think if the company knew before they began their trial that food would help absorption, there is no issue they would have done the analysis with food. But they wanted to obtain the study started quickly, plus they guessed incorrect.””So,” concludes Ratain, “that they had two options: have the drug authorized by the FDA as they had examined it in their trials, or delay the medication until they do new examining with food. Which type of boxes them into a corner, since the market expectations for this drug is about a billion dollars a year in sales, plus they want to get it out there.””So, the bottom line is that, ultimately, the label in a single part says take it fasting, and in another place, it says the focus and absorption in the blood is markedly increased if taken with food,” Ratain noted. “The treatment is potentially to take a lower dose with food, which outcomes in a significantly lower cost to the individual and/or their payers.”Ratain emphasized that Tykerb’s interaction with food must now undergo further research before it can definitively end up being said that the existing labeling instructions should be altered. Nevertheless, he remarked that he is unaware of any current plans on the part of GSK or an authorized to conduct such a study. At the same time, Ratain said that this individual and his colleague Cohen basically want to draw attention to a obvious labeling discrepancy with main financial implications for breasts cancer patients — one which he believes might perfectly have slipped through the cracks in the complicated globe of oncology treatment. Dr. David Flockhart is usually director of the division of medical pharmacology at Indiana University College of Medicine in Indianapolis. He said he’s inclined to agree that Ratain and Cohen have identified a hidden cost saving for sufferers.”I believe Ratain’s probably correct,” said Flockhart. “Medications are usually studied for concentration results on fasting volunteers. That is routine, because it’s very hard to predict how meals may speed up or bind with a drug and alter absorption. So, the drug business did what they might normally perform. But there is undoubtedly a nice little accident right here that could benefit individuals.””Of course, they’re phoning for more research,” he observed. “As is needed. Meanwhile, because tons of labels don’t possess perfect guidelines in them, doctors will try to accomplish what they usually do: utilize the best info they have. And doctors may want to consider this new info,” Flockhart said.

FDA Plans to Eliminate Shortages of 2 Cancer Drugs

The U. S. Food and Drug Administration announced Tuesday what it called a series of steps to ensure the continued availability of vital cancer medicines that have experienced dangerously short supply. Among the drugs, methotrexate, is utilized in mixture with other drugs to combat — and in many cases cure — acute lymphoblastic leukemia (ALL), the most common type of cancer in children. It typically strikes kids aged 2 to 5.And another drug, Lipodox, will end up being temporarily imported from a pharmaceutical organization in India to help ease a shortage of the chemotherapy medication Doxil (doxorubicin), which is utilized to treat ovarian cancer, multiple myeloma and AIDS-related Kaposi’s sarcoma. Lipodox is comparable in chemical make-up to Doxil; there are simply no generic variations of Doxil.”Through the collaborative work of [the] FDA, market and other stakeholders, sufferers and families waiting for these products or anxious about their availability should right now be capable of geting the medication they want,” FDA Commissioner Dr. Margaret A. Hamburg stated in a news discharge. The FDA also stated it was issuing recommendations to the drug industry that spell out comprehensive requirements for “both mandatory and voluntary notifications” to the company of potential problems that could result in a medication shortage or supply disruption. Methotrexate is a cornerstone in the treatment of children with severe lymphoblastic leukemia. In high doses, the generic medication has prevailed in curing individuals and beneficial in preventing recurrence. Without the medication, a patient’s chance for a cure is reduced while the risk of recurrence rises, oncologists said. Some cancer doctors had warned the other day that items of methotrexate could be exhausted inside a fortnight. To offset the shortage of methotrexate, the FDA said Tuesday that it has worked with several drug producers to help maintain items to meet up all patient requirements. Preservative-free methotrexate is necessary for the intrathecal (injection in to the fluid surrounding the mind and spinal cord) treatment of children with ALL, the company said. The FDA stated the steps used with methotrexate included approving a preservative-free edition of the generic medication manufactured by APP Pharmaceuticals, of Schaumburg, Ill. Those supplies should become available in March and continue indefinitely, the agency said. Second, Illinois-based Hospira Inc., which currently manufactures methotrexate, has increased additional supplies, generating 31,000 new vials of the drug — enough for several month’s supply. Those extra vials are being shipped Tuesday to hundreds of U. S. hospitals and treatment centers, the FDA stated. The FDA also noted that it continues to utilize other producers of methotrexate which have also stepped up production. Those producers consist of Mylan Inc., of Canonsburg, Pa., and Sandoz US Inc., of Princeton, N. J. At a midday information conference Tuesday, one of the loudspeakers was Sara Stuckey, mom of 6-year-previous Nate Stuckey, who has been on methotrexate since he was identified as having ALL in ’09 2009. “It is hard enough to listen to your son or daughter has cancer, but to listen to that the treatment that’s successfully working is abruptly unavailable is devastating,” she stated. “My husband and I pray the recommended medicines to fight his cancer will be available if it is time for Nate’s next treatment. And we wish that later on no more families have to go through the tension of wondering whether confirmed, lifesaving treatments will become out of reach if they need it the most.”Speaking in the news meeting, Hamburg said: “There are way too many families like the Stuckeys who worry they won’t have the medication they need for his or her next treatment and are understandably anxious about switching to a medication that may have significantly more side results or may be less effective. Obviously this is not appropriate.” “We are making progress,” Hamburg added. “There have been 195 medication shortages prevented in 2011 and 114 medication shortages prevented since October 2011 when we made the call for early notification” of potential shortages. As for the ovarian cancer medication Lipodox, the FDA said it’ll allow the temporary importation of the medication made by Sun Pharma Global FZE. The company said in its information release that “short-term importation of unapproved foreign drugs is known as only in rare circumstances when there exists a shortage of an authorized drug that’s critical to individuals and the shortage cannot be resolved in a timely fashion with FDA-approved medicines.” The shortages of methotrexate and Doxil are simply the latest in a series of drug shortages that have existed for several years. In 2011, prescription drug shortages in the United States hit an all-time high. Last fall, some 200 drug shortages have been reported, in comparison to 178 in all of 2010, the FDA reported. Most of the scarce medications are injectables, such as cytarabine and cisplatin, used to treat serious conditions such as cancer. Some are only given in hospitals and are “absolutely important,” Valerie Jensen, associate director of the FDA’s medication shortage program, said during a news conference last September. Over fifty percent (54 percent) of shortages in 2010 2010 were due to quality problems, such as medication impurities. Some were caused by delays or manufacturing capacity problems, while 11 percent were caused by discontinuation of a drug and 5 percent resulted from raw materials shortages, Jensen said. Jensen also said the shortages tend to occur in drugs that aren’t “economically attractive.” This may mean that only one company produces the drug, making it harder to find alternatives if the supply dries up. Most of the problems are linked with generic drugs, health specialists explained, because few manufacturers make them and profit margins aren’t as high for brand-name drugs still under patent protection. On Oct. 31, 2011, President Barack Obama signed an executive purchase designed to help relieve the drug shortages. The purchase directed the FDA to “take action” to avoid and reduce worsening prescription medication shortages. In response to Tuesday’s announcement, Dr. Armand Keating, president of the American Society of Hematology (ASH), said in a declaration: “ASH is encouraged by the methods FDA is acquiring to ease drug shortages that have significantly affected so many patients with hematololgic malignancies under our associates’ care. The measures announced today are consistent with the Society’s recommendations to FDA, Congress and the Obama Administration to increase the agency’s authority to prevent medication shortages by requiring manufacturers to provide early notification of impending shortages and importing drugs in critical supply.”
“While ASH applauds the precise actions announced today,” Keating added, “we also understand that these measures represent only some of a remedy to a much larger problem. In addition to these steps, extra measures — such as developing a national drug registry and providing economic incentives to producers to produce a steady supply of generics — should be implemented to permanently prevent shortages. Until a full solution is set up, treatment will be delayed and treatment will be rationed for critically ill individuals.”