Off-label use of medicines, though acceptable, is at times still controversial in the medical world. Sometimes the off-label usage is really warranted, at others times it is rarely warranted. But how efficient is the US food and pharmaceutical drug regulator, “the FDA,” in forestalling inappropriate promotion of off-label drug use?

The well-known phenomenon called “Off-label use,” refers to the practice of writing prescriptions for drug usage that’s beyond the approved scope of a pharmaceutical drug. Some examples of such usage include SSRI medication (approved for depression) prescribed off-label to treat men suffering from premature ejaculation, Carbamazepine (an anti-convulsant), used to help individuals with bipolar disorder, and Methotrexate or (MTX), which has an approved use in treating choriocarcinoma, if often prescribed to manage an un-ruptured ectopic pregnancy.

In the United States the approval process requires that the Food and Drug Administration (FDA) be convinced of a drug’s safety and effectiveness in treating a disease. Once there’s enough convincing evidence, the manufacturer and the FDA formulate relevant language for the drug’s label.

However, recently a report compiled by the Government Accountability Office (GAO) brought out the fact that the FDA takes about 7 months to send warnings to pharmaceutical companies promoting potentially harmful for off-label uses of medicines. And it takes yet another 4 months for these companies to take corrective action on the violations.

The prevalence of off-label prescriptions can be assessed by the fact that more than 20 percent of prescriptions for 100 most commonly used drugs were found to be for off label use. Further, 60 percent of randomly selected drug prescriptions were again found to be for off-label use.

So, is the FDA sluggish in regulating undesirable off label use promotion?

Experts believe that it might be to quite an extent, due to the following reasons:

1. It takes about 7 – 11 months on an average to address violations.

2. The FDA doesn’t specifically monitor off-label promotion. Rather, it’s just a part of a larger number of oversight activities for combating all promotional violations. Further, not all submissions to the agency are scrutinized, hence there’s a greater chance for violations bypassing the filter.

3. Its capacity to monitor is not at par with the high volume of materials submitted to it (it received 68,000 final submissions in 2007 itself). For instance, the FDA is only able manage a fraction of the thousands of continuing medical education (CME) activities each year, some of which include complaints from doctors to identify off-label promotions in the form of unsolicited statements from sales persons.

4. It doesn’t keep a tab on all submissions, or the status of reviews supporting off label use, which gets in the way off regulating potential violations.

5. There isn’t a standardized tracking system to manage the reviews.

6. Some violations by their very nature are difficult to track, such as the violative conversations between physicians and pharmaceutical drug sales representatives.

While on one hand the FDA’s Sentinel Initiative is a great program, the recently highlighted inadequacies of the system regulating off-label promotion of drugs doesn’t seem to be encouraging. On the whole it seems that FDA might need to consider a much needed review of the system aimed at addressing unauthorized off label drug promotion, whether it is for conventional drugs or alternative medicines.

2 Natural Treatments For An Enlarged Prostate

There are a number of natural and alternative treatments for the problem of an enlarged prostate and two of these are the use of pumpkin seeds and saw palmetto.Odd as it might seem, pumpkin seeds have a number of healing properties and they have been found to be especially effective for many man suffering from an enlarged prostate. Pumpkin seed have three properties which are particularly useful in this case.The first is that pumpkin seeds contain fatty oil that acts as a natural diuretic and helps to improve urine flow and counter the restrictive effect of an enlarged prostate gland on the urethra.The second property of pumpkin seeds is that they contain high levels of zinc so that a half a cup of seeds contains about eight milligrams of zinc. Studies have clearly shown that taking zinc can literally reduce the size of an enlarged prostate and many doctors recommend taking sixty milligrams a day in order to combat benign prostatic hypertrophy (an enlarged prostate). Care should be taken though and it is a good idea to talk to your doctor before raising your zinc intake to this level as it is above the normally recommended daily level.The third benefit of pumpkin seeds is that they are high in animo acids such as alanine, glycerine and glutamic acid, all of which have again been shown to provide significant symptomatic relief.Saw palmetto is also widely used for prostrate problems. Found in the southeastern states, saw palmetto is a small palm tree the seeds of which formed an important part of the diet of Seminole Indians. Saw palmetto works by turning testosterone into dihyrotestosterone which is precisely the process used in Proscar, which is one of the very few over-the-counter treatments approved for prostate problems by the Food and Drug Administration. Its essential benefit is that it increases urinary flow, reduces the problem of residual urine and, as a consequence of both, also lessens the frequency of urination.As with most natural treatments opinions vary widely as to the effectiveness of saw palmetto, but there have been a number of studies carried out over the years which have clearly shown that it does produce a significant benefit. In one study, a clinical study involving more than two thousand men in Germany suffering from benign prostatic hypertrophy, a daily dose of just one or two grams of saw palmetto seeds produced a substantial easing of symptoms.These are of course just two of the many alternative cures available but there is no doubt that these and similar natural treatments can and do work. Just as an example, it is thought that about thirty percent of American men suffer from an undiagnosed prostate cancer by the time they reach the age of sixty compared to just one percent of Arctic Inuit men at the same age. There may of course be several reasons for this enormous difference, but one difference which most doctors consider to be very significant is simply the fact the diet of Arctic Inuit men is high in fish oil.So, if you are suffering from an enlarged prostate then, before you turn to your doctor for treatment, you may find that simply adjusting your diet and looking at your intake of various vitamins and minerals may be all that is needed.

More than 40 million Americans take vitamin supplements and less than 10 percent of them are doing so under a doctor’s guidance. Where, then are they getting the information they need to make informed decisions about vitamin supplements?

My friend, the Vitamin Queen, takes more vitamins and supplements than a strawberry has seeds. I’m in the process of remembering not to say anything hurts around her for fear she will make me swallow her latest discovery. Her middle name is Antioxidant and I asked her once how she knew this particular supplement would wash her car, iron her clothes and paint her toenails pink. She showed me this catalogue-type publication and pointed to the article – by the very man who was selling it!

She gets mad at me when I talk to her about doing independent research on her potions but that’s what you’ve got to do. If all you’re going to do is believe the hype that every manufacturer gives you, then you’re likely to miss some valuable information. Instead, why not check trusted independent sources for your vitamin supplement information?

The United States Department of Agriculture (USDA) has a website full of nutritional facts and figures, including vitamin supplement information. The American Cancer Society addresses this very issue as unfortunately, cancer patients can sometimes be particularly susceptible to wild claims of health and healing by unscrupulous marketers of vitamins, minerals and herbs.

The Federal Trade Commission (FTC) has a wealth of vitamin supplement information on their website, including what the law says about the labeling on dietary supplements. The FTC regulates the advertising end of this industry and has taken action with more than a few who have made false claims about their products. You can find examples of some who have erred on their website.

The Food and Drug Administration (FDA) regulates dietary supplements as food, not as drugs. Therefore, the claims made by the manufactures of these supplements have not been evaluated by the FDA. You’ll find some such statements on most dietary supplements. The FDA also has a wealth of vitamin supplement information on their website along with reports of fraudulent claims made by some perpetrators.

The National Institutes of Health (NIH) website is a comprehensive source of vitamin supplement information. The Mayo clinic’s website and about.com are other independent sources of dietary supplement information.

It’s important to make an informed decision about which vitamins and supplements you feel are safe and necessary to take. The websites and publications developed by those who sell these supplements are not always honest about them. Vitamin supplement information is especially important when you are taking prescription or over-the-counter medication as even vitamins can interact negatively with some drugs. Be proactive and read more than just the label when evaluating your dietary supplement choices.

Your Cholesterol Medication May Be Making You Sicker

Statin drugs are being prescribed in higher and more potent doses to increasing numbers of people (even those with normal cholesterol levels) for “hypercholesterolemia” - which some doctors call a non-illness. What most physicians often overlook is that patients on statins deplete their Coenzyme Q10 (CoQ10) supplies, which often leads to fatigue, muscle weakness, soreness and eventually heart failure!A petition has been issued to the U.S. Food and Drug Administration (FDA), to label statin packages with a warning regarding statin-induced CoQ10 depletion along with a review of animal and human studies supporting the issue. Experts are not sure that the warning will be heeded however.The Truth about StatinsStatins have become the drug of choice for millions of people. If the recommendations issued by experts two years ago are to be believed, nearly 40 million Americans should be on statins by now. What you don’t realize is that, statins kill people! And cause complications in many more. Patients taking statins become depleted in Coenzyme Q10. The elderly and patients with heart failure begin to show symptoms of CoQ10 depletion in as short as six to twelve months! Younger patients can tolerate the drug longer, but they eventually develop CoQ10 depletion symptoms after several years.When you get to the heart of matters, treating the symptoms of high cholesterol with a drug doesn’t treat the cause. Not only doesn’t it treat the cause, artificial drugs may even cause serious side effects!Don’t risk your health when you can normalize cholesterol levels by observing some simple steps:Normalize your insulin levels by eliminating sugar and grains. Eliminating sugar and grains will ultimately have beneficial side effects, such as normalizing your weight, increasing your energy and lowering your blood pressure and triglycerides. Take a high-quality fish oil that is rich with beneficial omega-3 fatty acids. Find a fish oil that is independently tested by a lab to conform to purity guidelines. Regular exercise may further reduce your risk of heart disease!You can also think of a potent enzyme called nattokinase, from the food natto. It has been used for circulatory problems for decades, and it is found in CardioEssentials, a supplement often recommended to those who have been diagnosed with heart disease.

For cigarette smokers, CHANTIX is a new tool to fight the habit of smoking. Even though, Chantix isn’t a magic pill, but it may make it easier to stop smoking. Chantix (varenicline) has been approved by The Food and Drug Administration (FDA) in 2006 as an effective pill for adult smokers who want to stop smoking. This smoking cessation pill, also known as Champix in Europe, is marketed by its manufacturer Pfizer, as Chantix in the U.S.

CHANTIX contains no nicotine, but it targets the same receptors that nicotine does. And this drug is believed to block nicotine from these receptors. It is the only prescription treatment of its kind. Studies show that at the end of 12 weeks of using Chantix, 44% were able to quit smoking.

Among the four million Americans who have been prescribed this drug are its biggest fans. A 30-year smoker, David, who used Chantix after developing Coronary Artery Disease said, “For me, I thought it was a miracle drug.” Besides that Chantix has been proven to be more effective in helping smokers quit than Zyban. The average person in these studies had been a smoker for more than 24 years. The trials involved a mix of men and women who smoked on average 10 or more cigarettes a day.

Pfizer, the company that makes the drug, claims that 44 percent of people who begin taking Chantix are not smoking after 12 weeks. But, it is also suggested to take Chantix exactly as it was prescribed to you. Do not take the medication in larger amounts; make it a point to take it as recommended by your doctor. Follow the directions on your prescription label. On the other hand, there are also some side effects of this drug that include nausea (30%), trouble sleeping, changes in dreaming, heart palpitations, constipation, gas, and/or vomiting. If you have some serious side effects that bother you or don’t go away then stop taking Chantix and consult your doctor as soon as possible.

Apart from that Chantix should not be taken with other quit smoking medicines. Plus, you may need to consult with your doctor if you have kidney problems or other problems before using this drug. The other thing is that before starting Chantix; tell your doctor if you are pregnant, plan to become pregnant, as well as all the medications and supplements you’re taking, especially if you’re taking inhaled insulin, asthma medicines or blood thinners.

And above all, the last important thing is that to be successful in smoking cessation, you need persistence and commitment to your goal.

Magnetic Replacements For Prozac

Magnetism has been the crux of many a medical myth since the 19th century, where magnets supposedly could cure everything from aches and pains to the common cold. Most of those claims, obviously, were false and modern medicine has managed to move away from the crazy assumptions of the past. However, remember that magnetism is one of the fundamental forces of the physical universe, and there is more than one researcher out there that is interested in delving into the possible medical applications of it. One of the more recent potential applications comes as a potential substitute for Prozac in cases of extreme depression.The procedure, which sounds a lot more like science fiction than real medical science, has been approved by the government as the first noninvasive stimulator for the brain. The device, which is supposed to help treat cases of depression that is unresponsive to drugs such as Prozac, is designed to send magnetic pulses through the skull. This action is supposed to stimulate certain areas of the brain, creating small electrical charges that cause brain cells to fire up. This is similar in action to the last resort of depression treatments, shock therapy, but does not have the same risks that the aforementioned procedure would have. It also does not have the same risks as using surgically implanted electrodes on the brain would.Transcranial magnetic stimulation is considered a gentler approach, but the doctors who developed it believe it is not for everyone. According to the information made available by the Food and Drug Administration, the therapy was developed with one particular group of patients in mind. The targets are patients who have been given pill after pill and have found no success in alleviating their problems. In other words, the procedure is designed to be a last resort for those who have not responded to other, conventional treatments (Prozac being an example), and not something that should be suggested as a first attempt at treatment.

Enhance Breasts Using Natural Methods

Show me a woman who doesn’t want to look beautiful and to remain such until she is 99 or so. The reason why modern beauty salons bring so much profit to their owners is that every young girl (even if she is nearly 99 already) dreams of hearing the notorious “you are the fairest one of all” each time she looks at the mirror.But what does “beauty” mean?According to the stats, woman’s breast is the second thing after the face men pay attention to at first encounter. That is why full and gorgeous breast can be considered an essential part of the pretty girl concept. And here is a real stumbling block to peace and happiness in the feminine soul: not all breasts are “full” and “gorgeous”. Some women find their breasts start sagging after childbirth, others can’t boast tempting curves by nature. To enhance their breast appearance women make all kinds of sacrifices, undergoing dangerous surgery procedures or spending money on expensive push-up bras. They try severe dieting, autohypnosis and no one knows what else, but most of these methods are rather unsafe, as well as useless. The nature dislikes when people interfere in its job using a scalpel and a couple of lifeless implants.So, the only progressive way to improve breasts is to have a NATURAL breast enhancement program, such as BreastActives.The program includes natural supplements, exercise techniques and enhancement cream meant to provide nutrients which your body may be missing. All ingredients of BreastActives have been known and successfully used for centuries and figure on the Food and Drug Administration’s GRAS list of safe foods. Thanks to the healing power of herbs and other natural components, BreastActives is a quite effective - as well as absolutely safe - solution for enhancing your breasts. Women who had already tried BreastActives expressed their deep satisfaction with the program, and what is more exciting, they noticed the changes very soon.Other benefits of buying BreastActives include discreet shipping and billing worldwide and a strong money back guarantee. Actually BreastActives is so sure in its quality that it even offers 2 free months of treatment.To believe the doctors, basically woman’s breast may start sagging and shrinking as early as at 25 years. So, it is quite reasonable to take measures beforehand, isn’t it? BreastActives will make all heads in the street turn and give your lovely breast a second look.When you decide to change something is your appearance - confide in Mother Nature, and she’ll help you quickly and efficiently.

pH Miracle Diet for Good Health

When you eat an alkaline diet, you are getting close to nature. This will leave you fresh, healthy and light. The foods created by humans may give a sense of heaviness and fullness inside the body. An alkaline diet is a diet that is sugar free. The diet is also free of high carbohydrates, heavy saturated fat. When on an alkaline diet, you need to focus on natural form of food that’s free of toxins and chemicals. The pH miracle diet understands that the human body consists of pH with slightly alkaline in nature. When the body performs its natural functions, at a slight alkaline level, the diet must consist of alkaline ingredients. Usually, the standard diet taken by a person comprises of foods high in caffeine, sugar, packaged foods and animal protein. These foods are acidic and have the ability to disturb the pH balance of the body, thereby creating a lot of health problems. pH miracle diet proposes that acidic foods tend to interrupt the body’s use of alkaline minerals including sodium, magnesium, potassium and calcium. This develops the risk of an individual suffering from many chronic diseases. When on a pH miracle diet, you need to stay away from foods that you eat regularly. Steer clear of wheat products. According to the Food and Drug Administration, wheat products are healthy. However, the pH miracle diet believes the opposite. It believes that oats, millet and wheat are acidic and can harm the body. One should switch over to alkaline grains such as buck wheat, spelt and quinoa. These products are full of alkaline benefit. Next, you must avoid all dairy meals and products. In case, you are concerned about getting a lot of protein through goat’s milk, you are right. This is because goat’s milk is alkaline in nature. You can derive protein from a variety of vegetarian options such as beans, tofu and certain nuts and seeds. Limit your fruit intake to coconut, lime and grape fruit lemon. People, who have been on an alkaline diet, have felt that it has good effects on their overall health in just first few weeks. All you require to do is to reduce your intake of processed foods and focus on eating more vegetables. If you have already decided to cook pH miracle food, here are some useful tipsThere are more than about thousands of recipes when it comes to cooking pH miracle diet. You can look for some interesting recipes on the internet. There are several books available on different interesting pH miracle diet. You would love to cook these recipes and even relish them.First, you need to take a note of all alkalizing foods and then think of certain foods you want to use. One of the most interesting recipes is an alkalizing broth. This broth is prepared from alkalizing vegetables and distilled water. It also consists of essential minerals and helps in restoring pH balance to your body. It facilitates internal cleansing of all the tissues and organs of the body. You can use this broth as a complex soup and serve it before serving the food. You can also prepare a lot of juices to cleanse your body. Try fruits like apples, raspberries and strawberries. You can also go for sweet potato.

All worries related to diet have come to an end with the Resveratrol supplements
by Adam trevorz

Nutritional supplement, is a preparation intended to supply nutrients, such as vitamins, minerals, fatty acids or amino acids, that are missing or are not consumed in sufficient quantity in a person’s diet. Some countries define dietary supplements as foods, while in others they are defined as drugs.

Resveratrol Supplements contain vitamins or dietary minerals are recognized by the highest authority on food standards, as a category of food.

The Resveratrol supplements consist of dietary ingredients like vitamins, minerals, herbs or other botanical and amino acids.

a dietary substance for use by people to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of any of the above Furthermore, Resveratrol supplements also confirms to the criteria like it is intended for ingestion in pill, capsule, tablet, powder or liquid form. The Resveratrol supplements are not represented for use as a conventional food or as the sole item of a meal or diet.

Pursuant to the DSHEA, the Food and Drug Administration (FDA) regulates dietary supplements as foods, and not as drugs. While pharmaceutical companies are required to prove the safety or effectiveness of their products, until recently supplement manufacturers were not, and the FDA could take action only after a dietary supplement had been proven harmful.

The DSHEA, passed in 1994, was the subject of lobbying efforts by the manufacturers of dietary supplements. After several years of intense efforts, manufacturers, experts in nutrition, and legislators, acting in a conscientious alliance with consumers at the grassroots level, have moved successfully to bring common sense to the treatment of nutritional supplements under regulation and law.

The researchers found that a majority of Americans supported pre-marketing approval by the FDA, increased oversight of harmful supplements, and greater scrutiny of the truthfulness of supplement label claims.

To maintain the product’s status as a dietary supplement, the label and labeling must be consistent with the provisions in the Dietary Supplement Health and Education Act (DSHEA) of 1994.

Labeling refers to the label as well as accompanying material that is used by a manufacturer to promote and market a specific product. Our Resveratrol supplement is aware of all such rules and regulations.

Resveratrol supplements are demonstrated to be safe, both in quantity and quality. Some vitamins are essential in small quantities but dangerous in large quantities, notably Vitamin A. Consequently, only those supplements that have been proven to be safe may be sold without

prescription.

Nutritional supplements were originally considered as dietary supplements for people who had heightened requirements for some normal dietary components Later, they were employed as preventive medicines against chronic diseases.

To know more about the Resveratrol supplement log on to our website: www.Trevorz.com

The Importance of Chelation Therapy

Chelation treatment means a substance matter which is employed to eradicate all the unwanted particles like mineral deposits and other solid metals commencing in the body. It clutches such metallic particulars mutually forcefully to make possible their secretion away the body. It eliminates poisonous metals beginning in the body prior to some harm is made to the body. It is expansively applied in cases of noxious and poisoning. One of the main varieties of chelating instrument is EDTA. The EDPA is one of the main forms of man made amino acid. EDTA gets rid of reserves and solids metallic substances away from the body. All these metallic minerals comprises of calcium, iron as well as copper. The chelation treatment is accepted through the Food and drug Administration which has its head quarters in the United States. Chelation treatment is the medically established management for lead and additional weighty metal venomous. It is moreover, sometimes exercised in the dealing of atherosclerosis although which is not accepted by the FDA. However as a substitute medication chelation assists advance blood passage as well as eliminate the commemorative inscription created in the heart and the blood vessels. It contains the capability to break up all the solid metallic components. There is an extensive submission of chelation these days. This treatment is as well utilized in chemical breakdown as well as water malleable. It is widely exercised as a constituent in hairs soap, shampoos as well as some of the washing powders.Some substantial circumstances in which chelation treatment is influential are circulatory problems, coronary blood vessels illness, gangrene as well as angina. Nevertheless all these cures necessitate a number of remedial and medical experiment and investigation. Some of these analyses may take account of blood heaviness check, cholesterol trial, kidney utility check as well as sugar level investigation. All these tests are to be done for the safety and betterment of the patients. This treatment widely requires the inoculation that encloses EDTA. This injection has to be managed at least 3 to 4 times in a week. A single gathering of vaccination of the chelation treatment is three hours extended as well as at least thirty conferences are essential for the preferred effects. Most importantly one should always consult to a doctor before going for any of the medicines. This is very significant as it minimizes the risks of harmful effects.