среда, 29 апреля 2009 г.
Did You Know That Natural Herbs And Vitamins Will Help With Allergy Relief?
More than 50 million Americans suffer from allergic diseases. A recent nationwide survey found
that more than half (54.6 percent) of all U.S citizens test positive to one or more allergens;
among specific allergens, dust mite, rye, ragweed, or cockroach caused sensitization in
approximately 25 percent of the population.
This article will provide tips for allergy relief. The information covered below will address
the following questions:
1.Why do we develop allergies? 2.What causes allergies? 3.Allergy symptoms 3.Tips to obtain
allergy relief 4.Herbs, vitamins and supplements
Most individuals with allergies are not sensitive to just one substance but a host of them.
There is an endless list of allergy causing substances present in our food, drinks, the air,
and the clothes we wear to name a few examples that can trigger an allergic reaction.
Why do we develop allergies?
The exact cause of allergic reactions is still under debate. Heredity seems to play an
important role according to some researchers and being exposed to allergens at certain times
when the body's defenses are low or weak, such as after a viral infection or during pregnancy,
also may contribute to the development of allergies. Allergies are the immune system's
exaggerated response to a foreign substance. Exposure to what is normally a harmless substance,
such as pollen, causes the immune system to react as if the substance is harmful. Substances
that cause allergies are called allergens.
What causes allergies?
Allergies may be caused by any of the following. NOTE: this is just a partial list; there are
countless substances that may cause an allergic reaction. The only way for someone to know
whether they're allergic to a particular substance is to get tested by an allergist.
1.Mold 2.Animal Dander 3.Latex 4.Certain Foods (EX: Nuts) 5.Insect Venom 6.Medications (EX:
Penicillin) 7.Pollen 8.Dust Mites
What are allergy symptoms?
Allergy symptoms can be categorized as mild, moderate or severe (anaphylactic). Mild reactions
include local symptoms (affecting a specific area of the body) such as a rash or hives; itchy,
watery eyes; and nasal congestion. Mild reactions do not spread to other parts of the body.
Moderate reactions include symptoms that spread to other parts of the body. Symptoms may
include itchiness that spreads or difficulty breathing.
A severe allergic reaction, known as anaphylaxis, is a life-threatening emergency in which the
body's response to the allergen is sudden and affects the whole body (systemic). Anaphylaxis
may begin with severe itching of the eyes or face and within minutes progresses to more serious
symptoms including swelling, which could result in difficulty swallowing and breathing;
abdominal pain; cramps; vomiting; diarrhea; hives; and angioedema (hives in the throat). Mental
confusion or dizziness also may be symptoms, since anaphylaxis causes a quick drop in blood
pressure.
Tips to obtain allergy relief
Dust often to control mites - By dusting surfaces and washing bedding often, you can control
the amount of dust mites in your home.
Vacuum often - Although cleaning can sometimes trigger allergic reactions, with dust in the
air, vacuuming once or twice a week will reduce the surface dust mites. Wear a mask when doing
housework and consider leaving for a few hours after you clean to avoid allergens in the air.
You can also make sure your vacuum has an air filter to capture dust.
Reduce pet dander - If you have allergies, you should avoid pets with feathers or fur like
birds, dogs and cats. Animal saliva and dead skin, or pet dander, can cause allergic reactions.
Avoid pollen - Keep windows and doors closed. Use an air filter and clean it regularly or run
the air conditioner and change the filter often.
Avoid mold - Mold spores grow in moist areas. If you reduce the moisture in the bathroom and
kitchen, you will reduce the mold. Clean moldy surfaces. Dehumidifiers will also help reduce
mold.
Herbs, Vitamins and Supplements
Herbs, vitamins and other supplements can help by boosting the immune system and/or provide
allergy relief.
Herbs that may help by boosting the immune system 1. Echinacea 2. Garlic
Vitamins that may help by boosting the immune system 1.Vitamin A 2.Vitamin C - Very effective
at fighting allergies. It is a powerful antioxidant. It promotes immune functions and is
natural anti-histamine. 3 Vitamin E - It fights allergies. It is a potent intercellular anti-
oxidant. 4.Green tea - Contains EGCG, a potent antioxidant more powerful than vitamin C and E
Other supplements (1) Bioflavonoids such as Quercetin work well with Vitamin C as an anti-
histamine to tackle allergens.
Obtaining allergy relief involves a 2 pronged attack.
1. Avoid allergy triggers such as the one's mentioned above 2. Boost the immune system by using
herbs, vitamins and supplements
If the above don't work than medications such as antihistamines, decongestants or a combination
of both are available over-the-counter or by prescription to treat allergy symptoms. Nasal
sprays such as topical nasal steroids and cromolyn sodium also can be used to treat allergy
symptoms. Immunotherapy and allergy shots are recommended for relief needed over a long period
of time.
Obtaining allergy relief through natural means such as taking the herbs and vitamins
recommended above is the best route to take without incurring side effects, however, if the
allergy is severe and debilitating than prescription or over the counter medications may be
needed. PREVENTION IS THE BEST MEDICINE., Keep your immune system healthy so chances of
developing disease are reduced.
For more information please visit http://www.innervibrance.com/allergy_relief/
воскресенье, 26 апреля 2009 г.
Natural Home Remedies For Common Cold
Causes and Symptoms:
Call it corya or catarrh of the nose; a common cold is a very irritating condition. It may be caused by a variety of factors, the most common being a sudden chilling because of a change of temperature, coming out of the cozy bed into a blast of cold air or walking form an air-cooled room into a blazing sun. According to allopathy, these are only pre disposing factors, the real culprit being a virus, which incidentally has not yet been separated or counteracted. Traditional remedies fail to cure the cold as a apparent form the old adage that if you take medicines, the cold is cured in a week, otherwise seven days.� But in the case of weak constitutions a cold may lead to more serious diseases like tonsillitis, laryngitis, bronchitis, pneumonia and tuberculosis. What is worse, a catarrh of the respiratory organs may degenerate into a catarrh of the alimentary system.
A cold is an extremely irritating condition: You are not sick enough to get into bed, yet not well enough to lead a normal life. A running nose, feverishness, heaviness of the head, pains and aches in the body, loss of appetite and of smell are the main features of a cold which makes life miserable.
Treatment:
Like other diseases to which human beings are subject, a cold is the result of inappropriate diet. It is nature�s way of expelling poisonous humours from the body. We must attack the malady at its source and that is the putrifying mater in the intestines. The patient must fast till the cold is gone�it will not take more than two days-and take a warm water enema followed by a cup of warm water after every two hours.
If he is unable to take the enema, let him try the following method:
Take half a kilogramme of spinach, 250 grammes of turnips (along with their leaves), 250 grammes of tomatoes, 75 grammes of coriander leaves and boil them in about one litre of water. If some of these vegetables are not available, radishes or other greens may be used. Cover the lid of the vessel with a flat dish full of water so that the water does not evaporate and there is sufficient left. When the vegetables are done, strain them through muslin or other fine cloth. Add a little salt, the juice of lime and roasted and ground cumin seed and take it in tumblerfuls after every two to three hours. This will clear the bowels and also open the pores by producing sweat.
Chronic Cold: A cold sometimes becomes chronic. Such patients should also follow the regimen suggested above. It will clear their bowels. Let them also take some exercise so that their pores open. Those who are too weak should soak their feet in warm water for fifteen to twenty minutes the last thing at night. Let the patient wear a blanket while he is doing it; it will help open his pores and the nose will stop running.
четверг, 23 апреля 2009 г.
The Fact Women Should Know
In this age of diseases, where women is more prone to fatal conditions, it is important to know that how can she reduce or minimize the chances of risk.
Be it a sexual intercourse, where she is vulnerable of STDs and HIV�s, or be it the pregnancy or child birth, where the death rates are alarmingly high, she must know the measures which she can take to avoid this. In this fast developing world everything is in reach, and which can be used to their benefit.
Prevention is better than cure. Life is not the matter of choice; it is to be lived and to be enjoyed with better health. A good and balanced diet, is what one must take. Healthy eating habits go a long way, so it must be induced at the early age. Women are prone to be anemic because of the blood loss every month, which is to be replaced by a proper and healthy diet. It reduces the chances of complications while child birth. Only a healthy mother can deliver a healthy baby.
Every woman should know the unprotected sex can play havoc to their lives, especially if they are in multiple sexual relationships. They should know that a condom reduces the chances of sexually transmitted diseases, and they must insist to their partner on using the condom, every time, whenever, wherever, they have sex. Right use of condom is also must, otherwise it is ineffective. It is a shield to protect the women from the unwanted pregnancy and STDs, like Syphilis, Gonorrhea Hepatitis (viral), Pelvic Inflammatory Disease (PID), or Genital Warts.
To get rid from the unwanted pregnancy women often go to the wrong places to terminate it. Abortions are killing millions of women worldwide, every year. It must be done under the medical supervision, in any case. Whenever she feels that she wants to go ahead with the baby, she must plan it accordingly. Till then, she must use the contraceptive methods. She has the vast choice, oral pills, condoms, shields, Copper T, and even female condoms. These all are available at any nearest drug store. Within the reach of every women.
Try to have sex with the partner, who you know is not carrying any virus. If he is suffering from STD, she should stop having sex. It is the matter of no-compromise. It is the matter of life.
Sexually Transmitted Diseases
Among sexually transmitted diseases or STDs the main ones include AIDS and HIV. Other minor ones include Genital Herpes and Genital Warts, etc. Doctors recommend that contraception be used each time one engages in any kind of sexual activity. In fact recent research shows that the incidence of cervical cancer in women is greatly reduced incases where the partner uses a condom each time before engaging in a sexual act. Doctors recommend that even in pregnant women it is completely safe to stay sexually active incase of a normal pregnancy for the entire duration of the pregnancy provided two precautions are taken. The first being that only certain positions are permitted which should not put pressure on the womb and secondly, the partner should always use a condom to prevent any kind of external infection being passed onto the unborn child.
Other than providing protection from AIDS and HIV, the use of condoms also prevents others minor viral infections like genital herpes. Genital herpes is a common viral infection. One in every five people who are sexually active acquires genital herpes in their lifetime. Unfortunately it�s a viral infection that has no cure. The infection last for about a week to ten days and then subsides. The virus stays dominant and settles as the base of the individual�s spine. Genital herpes has no cure but with recurrent infections the individual builds up immunity and the intensity of the infection reduces over a period of time. Genital herpes is highly infectious and spreads easily with proximity. AIDS/HIV is likewise viral infections that spread. A simple handshake does not cause it, hugging or kissing someone does not cause it. Unprotected sex, blood transfusion, using an infected needle, drug users that inject themselves are at a very high risk of using an infected needle and thereby getting infected, infection can spread from a mother to her child during child birth, are some of the main reasons for the spread of infection.
The bottom line is to �use a condom each time�, that is the only way to protect oneself and �protection is better than cure�, trust me on this one.
Prevention Of Cerebral Palsy
Cerebral Palsy Prevention
Measures of Cerebral Palsy prevention are increasingly possible today. Pregnant women are tested routinely for the Rh factor and, if Rh negative, they can be immunized within 72 hours after the birth (or after the pregnancy terminates) and thereby prevent adverse consequences of blood incompatibility in a subsequent pregnancy. If the woman has not been immunized, the consequences of blood incompatibility in the newborn can be prevented by exchange transfusion in the baby.
If a newborn baby has jaundice, this can be treated with phytotherapy (light therapy) in the hospital nursery. Immunization against measles for all women who have not had measles and are susceptible to becoming pregnant is an essential preventive measure.
Other preventive programs are directed towards the prevention of prematurity; reducing exposure of pregnant women to virus and other infections; recognition and treatment of bacterial infection of the maternal reproductive and urinary tracts; avoiding unnecessary exposure to X-rays, drugs and medications; and the control of diabetes, anemia and nutritional deficiencies.
Of great importance are optimal well being prior to conception, adequate prenatal care, and protecting infants from accidents or injury.
The best prescription for having a healthy baby is to have regular prenatal care and good nutrition, and to avoid smoking, alcohol consumption, and drug abuse. Other forms of prevention include:
Prevent head injuries by using child safety seats in automobiles and helmets when riding bicycles, skateboards, etc. Supervise young children closely during bathing and swimming. Prevent child abuse. Keep poisons out of reach.
Treat jaundice in newborns with phototherapy. Exposing jaundiced babies to special blue lights that break down bile pigments and prevent them from building up and causing brain damage. In rare cases, a blood transfusion may be necessary.
Identify potential Rh incompatibility in expectant mothers. Incompatible Rh factor usually is not problematic with first pregnancies, as the mother's body typically produces the unwanted antibodies only after delivery. A special serum given after each delivery can prevent the production of antibodies.
If antibodies develop during a first pregnancy, or if antibody production is not prevented, the developing baby is monitored closely. If necessary, a transfusion may be given to the infant in the womb or an exchange transfusion may be given after birth, removing and replacing a large volume of the infant's blood.
Be vaccinated against German measles (rubella) before becoming pregnant.
To prevent CP, prospective parents should follow these guidelines:
* Get regular prenatal care.
* Expectant mothers and, in some cases, expectant fathers should get a simple blood test to determine their Rh factor. An incompatibility between mother and child usually does not cause problems with the first pregnancy. And an immunization given to the mother after delivery of an Rh positive child can prevent problems for future pregnancies.
* Women should be immunized against rubella (German measles) before getting pregnant.
* Women who are expecting or who plan to become pregnant should try to avoid toxoplasmosis by not eating undercooked pork or lamb and by keeping away from cat litter boxes.
* Parents should follow safety precautions such as using child safety seats in vehicles to prevent head injury and having children wear safety equipment, such as helmets, for bike riding or other activities.
* Parents should seek treatment right away for a baby who is jaundiced. If phototherapy isn't effective, as in some severe cases, a special form of blood transfusion can correct the jaundiced condition.
The cause of cerebral palsy (CP) sometimes is not known. However, links have been identified between CP and certain conditions during pregnancy, birth, and early childhood. Some of these can be prevented; some cannot.
You can help prevent CP before and during your pregnancy by adopting and maintaining healthy habits.
* Eat nutritious foods.
* Do not smoke.
* Avoid exposure to harmful substances.
* See your health professional regularly.
Also, help prevent CP in your young child by minimizing your child's risk for sustaining a brain injury.
* Take measures to prevent accidents.
* Make sure you are familiar with the signs of jaundice in newborns.
* Know how to prevent lead poisoning.
* Keep your child away from people who have serious contagious illnesses, such as meningitis.
* Make sure your child's immunizations are up to date. For more information, see the topic Immunizations.
среда, 22 апреля 2009 г.
Neem Uses And Benefits
Neem needs no introduction in today�s world. A very famous herb of India with worldwide fame and having magical properties known for its miraculous medicinal values from past 5000 years. Neem is known as free tree of India as it is found almost everywhere in India. It is considered as a magic tree, which has properties that not only relieves but also cures from illness. Neem tree is commonly known as margosa tree in English language and Azadirachta indica in biological terms. It is part of every Indian home due to its great application and hence is considered as a place of worship.
Margosa tree attains a maximum height of 40 to 50 fts. It is an evergreen tree whose branches spread all over. It is a very densely crowned tree, which may reach to a diameter of 30 to 40 fts. The trunk is relatively straight. Bark is thick and rough with whitish to reddish brown in appearance. A fluid called neera excrudes out of the bark. Leaves are pinnate 12 to 15 inch long with about 20 to 31 green colored leaflets, which are about 3 to 5 cm in length. Flowers are small and white in colour that blossom in spring i.e. February to march. Fruits are oval in appearance green in colour, when in raw form and turns pale yellow when it ripes. Every fruit contains one seed, which contain oil. Neem tree fruits in summers i.e. in May to July. Neem has been used as pesticide since early ages because of its remarkable property of fighting away with pest and microorganism, that are supposed to be harmful for agricultural and homely purpose and hence makes neem the most wonderful partner of human in his evolution.
Margosa tree possesses the sheet (cold) virya potency. It contains tickt and kashaya rasa, it possesses the laghu (light) gunna (property). Combination of these makes neem a unique herb. Due to tickt rasa it suppresses kapha and due to sheet virya potency it suppresses pitta dosha. Chemically neem contains complex compounds called triterpenes, limonoids, nonterpenoids, hexanortriterpenoids, and pentattriterpenoids. The most important active ingredient of neem is azadirachitin, which makes neem possess the power, what it projects in its usage. Every part of the plant is used i.e. flower, leaves, bark, seed, oil, branches and the excludant called neera, which flows out of the bark
Neem is a multipurpose herb, which is recommended in every type of ailment. Following are the wonders of neem, which ayurveda has to offer to this world and modern life style of living.
Local action
� Neem act as anti bacterial, anti parasitic, anti fungal, anti protozoal and anti viral thus helps in protection from all the microorganisms, which are always ready to invade in our body causing serious ailments.
� Local application of neem powder or neem oil has miraculous results. As it is a famous anti microbial herb, it renders all the microorganisms inactive therefore helping in proper healing of wound without causing any infections and septic conditions.
� Taking bath of neem leaves water is a very common sight in Indian homes that helps our body to counter mild infections, which our body might get in day-to-day activity.
� Its tropical application makes us relieved from acne, eczema and even ringworms
� In skin related diseases, neem works as blessing of God on mankind. It has an action on almost every kind of skin disease thus making its indication in eradicating every kind of itch, rash, infection and allergy.
� Neem water is extensively used in burn injuries, thus to protect them from any kind of infection and also promote healing.
� Neem oil is extensively used in hair fall and early graying of hairs with very satisfying results. It also find its application in dandruff and in lice growth
� Its local application on arthritic conditions like rheumatoid arthritis, gout, Osteoarthritis, lower back pain, and musculo skeletal pains is highly recommended with good results
Internal action
� Due to presence of tickt rasa it is beneficial in indigestion, constipation and restoring taste of mouth.
� It helps in fighting with the intestinal worms there by act as a deworming agent
� It is highly recommended in hyperacidity and epigastric pain as it suppresses pitta that is the main culprit in the aggravation of such illness.
� Good results have also been seen in gastritis
� Widely and extensively used as blood purifier as it possess the properties like tickt rasa which helps in detoxifying any toxins floating in our blood stream which may lead to illness.
� It gives wonderful results in diabetes incipidus and diabetes mellitus due to presence of tickt rasa.
� It is very helpful in curing urinary tract infection
� It stimulates liver for proper functioning therefore helps in maintaining proper secretions of liver
� It acts on all kinds of skin disorders and provides great relief.
� It works as an anti inflammatory and pain relieving agent
� It also helps in suppressing extra heat generated in body due to any reason thus helps in maintaing normal condition in hyperthermia. Very useful in suppressing fever.
� Anti malarial action of neem has also been seen
� Since old times neem leaves have been used as an agent that helps in increasing vision as it helps in suppressing kapha disorders thus releasing congestion on eyeballs caused due to mucus accumulation in sinuses.
� Coughing is relieved by use of neem water
� It helps in reducing excess micturation
� It has given very good results in diseases like gonorrhea and syphilis
� It works as an immunoboosting agent therefore making our immune system very strong and efficient to fight against any foreign invasion making our body strong and disease free
воскресенье, 19 апреля 2009 г.
Causes Of Cerebral Palsy
This leads naturally into the second question: Why does your child have brain damage? There are many possible answers to this second question, because there are many reasons children can sustain brain damage. Your doctor must carefully review your child's health history and conduct a variety of medical and neurological tests to help determine the cause. Cerebral palsy is caused by an injury to the brain before, during, or shortly after birth. In many cases, no one knows for sure what caused the brain injury or what may have been done to prevent the injury. A large number of factors which can injure the developing brain may produce cerebral palsy. In general, however, there are two problems that can cause cerebral palsy:
1. failure of the brain to develop properly (developmental brain malformation)
2. neurological damage to the child's developing brain
Whatever the cause of your child's cerebral palsy, the severity of the brain damage generally depends on the type and timing of the injury. For example, in very premature babies, bleeding into the brain (intraventricular hemorrhage) can cause extensive damage. Also, the longer an unborn child goes without oxygen, the greater the extent of brain tissue damage.
Ten to fifteen percent of cerebral palsy is caused from a recognized brain injury, such as infection (like meningitis), bleeding into the brain, and damage caused by lack of oxygen. It is very important that you understand that a brain injury caused during delivery in many cases could have been prevented. Medical mistakes are responsible for thousands and thousands of cerebral palsy cases. It would be virtually impossible for a parent, on their own, to determine if a medical mistake caused their child's cerebral palsy or brain damage. It is only through the concerted efforts of a legal/medical team that can answer the question, "was my child's cerebral palsy preventable?"
Risk Factors for Cerebral Palsy
A risk factor is not a cause, it is a variable which, when present, increases the chance of something occurring. In other words, a risk factor for cerebral palsy is not a cause of cerebral palsy, it is a variable that could increase your child's chances of developing cerebral palsy. The presence of a risk factor does not mean cerebral palsy will occur, nor does the absence of a risk factor mean that cerebral palsy will not occur. If a risk factor is present, it should alert parents and health care professionals to be even more observant of the infant's development. Risk factors can be associated with the parents, as well as the child. The following are risk factors related to parents that can increase the risk of cerebral palsy:
* Mother 40 years or older
* Mother 20 years or younger
* Father 20 years or younger
* African-American ethnicity.
The following are risk factors related to the child that can increase the risk of cerebral palsy:
* A first child or child born fifth or later in the family
* One of a pair of twins, especially if one twin dies
* Low birth weight, less than 3.5 pounds
* Premature infant, less than 37 weeks.
The following are other known risk factors that can increase the risk of cerebral palsy:
* Rh or ABO blood type incompatibility between mother and infant
* Infection of the mother with German measles or other virus in early pregnancy
* Attack by micro-organisms on the central nervous system of the infant.
More than one risk factor can be present at the same time, such as low birth weight and being a twin. Such combinations can further increase the risk of cerebral palsy occurring.
Therapy and Treatment for Cerebral Palsy
Following your child's interdisciplinary assessment, the professionals providing care for your child will develop recommendations for his or her treatment. Many treatments are available to help a child function at the highest level possible. Although many treatments are available, we will touch upon a few of the most basic approaches used today to help a child achieve their optimal level of functioning.
Since no two children are affected by cerebral palsy in exactly the same way, individual treatment programs vary widely. But because all children with cerebral palsy have movement problems, you can expect that an important component of your child's treatment will be a therapeutic exercise program. Depending on your child's needs, a physical therapist, an occupational therapist, and a speech-language pathologist will work with your child to help him or her improve posture and movement.
At first, your child will likely see his or her therapist quite often, sometimes at least twice a week. As your child grows, he or she may need a less intensive program. The therapists will probably expect you to work on the child's movement skills at home, and will train you in special exercises and handling techniques. Because the time commitment to a therapy program is tremendous, it is wise for both parents, or other caretakers, to be involved. In general, it is considered very early intervention if a baby begins therapy before six months of age. Most infants are not referred until later in the first year or sometime in the second year of life. Of course, the age at which your child is referred will depend to some extent on how quickly the physicians diagnose cerebral palsy, or other problems requiring therapy. Researchers are still studying the long term benefits therapy can offer. But it is generally agreed that children who receive good treatment not only have fewer movement limitations, but also have better postures, better muscle development, and better abilities in toileting, feeding, and dressing themselves. Furthermore, therapy programs enrich children's lives by enabling them to explore and experience activities that they might not otherwise be able to do independently.
Causes And Risk Factors
Causes
during birth and pregnancy
Cerebral palsy is not one disease with a single origin, like chicken pox or measles. It is a group of disorders that are related but probably stem from a number of different causes. When physicians diagnose cerebral palsy in an individual child, they look at risk factors, the symptoms, the mother's and child's medical history, and the onset of the disorder.
About 10 to 20 percent of children who have cerebral palsy acquire the disorder after birth, while many more cases are caused by an incident that occurs during pregnancy or birth. Acquired cerebral palsy is the result of brain damage in the first few months or years of life. Common causes of brain damage are sickness-such as bacterial meningitis, viral encephalitis, or even jaundice. Another common cause is head injury-such as from a motor vehicle accident, a fall, or child abuse. When a baby is "born" with cerebral palsy, the causes may be due to avoidable or unavoidable incidents that occurred during pregnancy or birth.
Causes: During Pregnancy
Cerebral Palsy can also be caused by things that happen during pregnancy which cause permanent damage to the fetus.
Prenatal Infections
Certain bacterial and viral infections can damage the fetus during pregnancy. More commonly, untreated or maltreated maternal infections can induce premature labor and delivery. These newborn babies may suffer the consequences of brain damage from infection directly, or they may be damaged as a direct result of prematurity. Sometimes the mother can be unaware of the source of the infection if it goes undetected by her health care provider. Maternal infections such as German measles (or rubella), cytomegalovirus and toxoplasmosis, can cross the placenta and infect the fetus as well, causing damage to the developing nervous system.
Improper Dating of the Pregnancy
One of the most important influences in prenatal care is the accurate dating of a pregnancy. Ultrasounds have made the estimation of due dates far more reliable. Failure to properly date the pregnancy may result in either premature delivery or post-mature delivery, both of which may be responsible for brain damage to your newborn baby.
Rh Incompatibility
In this blood condition, the mother's body produces immune cells called antibodies that destroy the fetus's blood cells, leading to a form of jaundice in the newborn. Severe, untreated jaundice can damage brain cells.
Bleeding In The Brain
Bleeding in the brain has several causes, including broken blood vessels in the brain, clogged blood vessels, or abnormal blood cells. Although bleeding in the brain (or stroke) is better known for its effects on older adults, it can also occur in the fetus during pregnancy or the newborn around the time of birth, damaging brain tissue and causing neurological problems. Ongoing research is testing potential treatments that may one day help prevent stroke in fetuses and newborns.
Causes: Birth Injury
Sometimes cerebral palsy is the result of a birth injury that causes the infant to be traumatized or deprived of oxygen (asphyxia). A number of things can cause trauma or asphyxia, including:
* Difficult forceps delivery
* Difficult vacuum extraction delivery
* Exceptionally long labor
* Low amniotic fluid
* A twisted or compressed umbilical cord
* Macrosomia or a baby that is "large for gestational age"
* Placental abruption
* Hemorrhage
Most often when a baby is damaged, she is damaged late in labor from a continuous lack of oxygen and/or trauma. While a newborn infant's blood is specially equipped to compensate for low levels of oxygen, and asphyxia (lack of oxygen caused by interruption in breathing or poor oxygen supply) is common in babies during the stresses of labor and delivery, this ability is not infinite. If asphyxia severely lowers the supply of oxygen to the infant's brain for lengthy periods, the baby may develop brain damage called hypoxic-ischemic encephalopathy. A significant proportion of babies with this type of brain damage die. Others may develop cerebral palsy, which is then often accompanied by mental impairment and seizures.
During most labors, electronic fetal heart rate monitoring and fetal scalp pH sampling are used to assess fetal well-being and to detect fetal distress. Experts can preview the fetal heart monitoring strips and take appropriate action, often an emergency cesarean section.
Premature Delivery and Neonatal Intensive Care
Another major cause of cerebral palsy / mental retardation is premature birth. Premature labor can often be halted by medication, but it must be diagnosed at the earliest stage. Medication given to the mother can accelerate fetal lung development. Immature lungs at birth are a major factor in subsequent complications, including brain hemorrhage and death.
Risk Factors
Scientists have examined thousands of expectant mothers, followed them through childbirth, and monitored their children's early neurological development. As a result, they have uncovered certain characteristics, called risk factors, which increase the possibility a child will later be diagnosed with cerebral palsy.
Knowing these risk factors helps doctors keep a closer eye on children who may exhibit later warning signs for cerebral palsy. However, do not become too alarmed if your child has one or more of these factors. Most such children do not have and do not develop cerebral palsy.
Cerebral palsy risk factors include:
Breech presentation
Babies with cerebral palsy are more likely to present feet first, instead of head first, at the beginning of labor.
Complicated labor and delivery
Problems with the baby during labor, or a long and complicated delivery may sometimes be the first sign that a baby has suffered brain damage during the pregnancy or in the early stages of birth, or that a baby's brain has not developed normally. Additionally, the complications themselves can cause permanent brain damage in an otherwise normal baby.
Birth defects
Babies with physical birth defects-such as malformation of the spinal bones, hernia (a protrusion of organs through an abnormal opening inside the body) in the groin area, or an abnormally small jaw bone-are at an increased risk for cerebral palsy.
Low Apgar score
The Apgar score (named for anesthesiologist Virginia Apgar) is a numbered rating that reflects a newborn's condition. To determine an Apgar score, doctors periodically check the baby's heart rate, breathing, muscle tone, reflexes, and skin color in the first minutes after birth. They then assign points (0-2 for each of the five areas); total scores closer to 10 are desirable. A low score at 10-20 minutes after delivery is often considered an important sign of potential problems.
Low birthweight and premature birth
The risk of cerebral palsy is higher among babies who weigh less than 2500 grams (5 lbs., 7 1/2 oz.) at birth and among babies who are born less than 37 weeks gestation. This risk increases as the less the baby weighs.
Multiple births
Twins, triplets, and other multiple births are linked to an increased risk of cerebral palsy.
Nervous system malformations
Some babies born with cerebral palsy have visible signs of nervous system malformation, such as an abnormally small head (microcephaly). This suggests that problems occurred in the development of the nervous system while the baby was in the womb.
Maternal bleeding or severe proteinuria late in pregnancy
Vaginal bleeding during the sixth to ninth months of pregnancy and severe proteinuria (the presence of excess proteins in the urine) are linked to a higher risk of having a baby with cerebral palsy.
Maternal hyperthyroidism, mental retardation, or seizures
Mothers with any of these conditions are slightly more likely to have a child with cerebral palsy.
Seizures in the newborn
An infant who has seizures at birth is at a higher risk of being diagnosed later in childhood with cerebral palsy.
четверг, 16 апреля 2009 г.
Your Body Wants To Fight The Flu
The body's immune system is our first line of defense against attacks from germs, bacteria, and viral agents like the flu. The immune system detects these harmful invaders and begins the process of isolating and destroying them. But the immune system only works if it has the fuel that it needs.
You see, the immune system is called a "system" because it is comprised of various organs and sub systems that work together in harmony. The major parts of the immune system include:
Thymus
Spleen
Lymph system
Bone marrow
White blood cells
Antibodies
Complement system (30 specific proteins which circulate in our blood plasma).
Hormones
Each part of the immune system depends upon proper nutrition in order to be able to function at peak efficiency. If even one component of the immune system under-performs, the entire system is at risk of failing. A failed immune system leaves the body with no protection from any type of attack. That's why HIV and AIDS are such devastating diseases.
Unfortunately, most people have diets that fail to provide even the minimum nutritional levels that our immune systems requires to do its work. And that's one of the major reasons why this flu season may be the worst one ever. Citizens of developed countries are eating diets that are high in saturated fats and sugars and low in vitamins and minerals. Many citizens of underdeveloped nations are suffering from malnutrition and even starvation. Whether the immune system is affected by too much of the wrong food, or not enough of any food is not what's important right now. What is important is that most people's immune systems are ill prepared to ward off this latest flu menace.
But you don't have to let your immune system fail you when you need it the most. You have options.
You can give your body's immune system exactly what it needs to operate a peak efficiency, and you can do it without having to eat a variety of special foods or ingesting handfuls of vitamins and minerals. All you need to do is Winterize your body by taking just one capsule per day.
понедельник, 13 апреля 2009 г.
Flu Shots, Pneumonia Shots, And Diabetes
We all know what the flu is like: upset stomach, fever, and general misery. But now we are able to prevent many types of influenza. We can even immunize against pneumonia. These precautions will lower your chance of getting sick this year. Of course, maintaining a healthy dose of common sense is also important: wear your hat and mittens in the cold, and take a multivitamin to help boost your immune system.
A flu shot is a vaccine that helps to prevent the occurrence of flu, and other viruses. Flu viruses change every year, so it is important to get a new shot each year. Last year�s shot cannot protect you from this year�s viruses.
The shot works by injecting your body with inactive flu virus. Your body is then able to develop antibodies to protect you against the flu, which will help you avoid getting sick. Because there are many types of flu in circulation every year, there is no guarantee that you will not get the flu. However, flu shots lessen your chance of getting the flu, and they will also help minimize flu symptoms if you do get sick.
Because the flu vaccine does not contain active flu viruses, you cannot catch the flu from getting the vaccine. Some people complain that they get a cold the week after their flu shot, but this cold is not the flu, and is not a danger.
There are also pneumonia shots available. Pneumonia shots are not yearly, like flu shots. These are generally only taken once in your lifetime, and sometimes refreshed once you are 65. Ask your doctor about getting a pneumonia shot so that you can breathe easy, and literally take this weight off your chest.
People who are allergic to eggs should speak to their doctor before taking a flu shot. Ask your doctor before you get vaccinated to see if you should be vaccinated.
Consider asking your family to get vaccinated with you. The flu is highly contagious, and if you can lower your exposure to flu viruses by vaccinating your family, you will be being safer. Your family will also thank you when they don�t get sick.
You can get flu shots at any doctor�s office. These shots are often free or of very minimal cost. There are flu shot vaccine clinics that often travel around to many locations, and offer free vaccination in your community. Often, these clinics occur in the fall before �flu season� starts. Speak to your doctor about cost-effective ways to prevent the flu.
If you are unwilling to get a shot, you can consider an alternative flu vaccine nasal spray. This nasal spray, which was approved in 2003, uses an active flu virus, and so works differently than the flu injections. These active viruses have been modified to only live in the nasal passages, and so help the body create antibodies in this way. FluMist has been proven to be particularly helpful to children, who often develop nasal or aural complications with flu. It also helps prevent the flu altogether, and sometimes even prevents new strands. Speak to your doctor about your options.
Preventing the flu and pneumonia can be as simple as making one appointment a year; it might even just require asking your doctor for an extra injection during your regular appointment. Like healthy diet and glucose monitoring, preventing these illnesses is a simple part of diabetes management that will help you lead a happy and healthy life.
пятница, 10 апреля 2009 г.
How Important Is Condom Vending Machines In School And Colleges
In this fast spreading world of HIV and AIDS, the youth is getting lost day by day. Over exposure to the world of pornography and sex material, they are fast slipping into these unsafe activities. The mounting score of STD and HIV patients is alarming and at the same time threat to these young lives. They are mindlessly indulging into sex, without any protection, and falling prey to these killing diseases.
Increasing number of HIV cases in is the adolescents is the deep concern for the authorities. They are trying their best to spread the sex education in schools. Many schools conduct sex education classes for these adolescents. It is a mountain task and means are not sufficient, keeping this in view, schools have instalted the condom vending machines, for the use of these kids. Only in USA there are around three million adolescent kids suffering from STDs, every year. The deaths due to the AIDS in age group of 15 to 24 years is the sixth cause of killing youths in USA. Knowing this figure, certainly raise the question of their safety, so it is a welcome step towards their health. Many people object strongly against the use of it, and many school have sccumbed to their pressure to stop the machines. But these people are living in fool�s paradise. They are simply pushing their youth to the ditch of STDs and HIVs. They are simply playing with their lives. Stoping these condom vending machines will not stop them from having sex. It is as simple as that.
These condom vending machines should be made compulsary for every school, and it should be instalted at a very convenient place, from where the kid can take it without giving any explaination, and use it. School toilets are supposed to be the best. Anybody can just take it, without telling anyone. This will increase the demand of condom, and kids would tell their friends about the easy availability of the condom. This is the safest and the surest way of preventing them from STDs and HIVs. This, no way is a promotion of sex, as most of the people feel, but promotion of health awareness, of safety, of prevention.
Condoms are the most effective way of preventing these diseases. Its latax material, does not transmitt the virus to the other partner. These are easy to use and affordable, so makes a good choice for everyone.
вторник, 7 апреля 2009 г.
Why Government Is Pumping Money To Promot The Condoms.
Dangerously increasing datas of deaths, caused due to the HIV and AIDS, is giving sleepless nights to the governments of respective countries. It is a shame that these so called devloped and devloping countries are facing the threat of these diseases, which they are not able to stop or even prevent. There is no cure for the deadly virus called AIDS. So, the best they can do is to prevent it.
Us president Bush decleared, that his country will spend $15 billion over five years for the fifteen countries. The money was proposed for the life saving drugs for the two million HIV effected people, for the prevention of nearly seven million new infection cases, and for the care of orphaned and sick. Maximum chunk of this money was for the sub-Saharan Africa, which is supposed to be the home of around forty million people, which is nearly 40% of the total population, suffering from HIV and AIDS. Almost twelve million children have lost one of the parents, in this continent, due to these infections.
Most effective mode to prevent these STIs, HIVs, AIDs is total abstinence from the sex. Many governments are making people to believe that this awareness can stop them from falling prey to these diseases. But, the practicality of the times is not this. Condoms are so far the second best option. Its use can stop the virus to get transmitted to the other partner. Right now, it is so far the only alternate to stop these infections from spreading.
Developing countries are spending millions of dollars, to install the condom vending machines, in the schools, colleges, and work places. It is to give the easy accasibility to the user. They are promoting sex educational programmes, providing the counselling and free medical aid to the patients. It is to ensure that they prevent themselves from this deadly epidemic. Growing number of their youth is sccumbing to these diseases, so it is a genuine cause of their worries. Condom is easy to use and if used properly, is the best option for people to prevent from STIs. If the Governments are pumping millions of dollors to promote condoms, it is justified. These millions are saving their billions of people. These millions are assuring them a healthy and happy nation, with vigour and zest for life. It is giving them the satisfacation of running a truly devloped and successful country.
воскресенье, 5 апреля 2009 г.
Control Plant Diseases Before It Destroy Your Plants
Plant diseases are usually produced by different kinds of organisms. Diseases that affects the leaf and the stems are bacteria, fungi or viruses. Soilborne diseases on the other hand are caused by various fungi. Bacterial diseases are caused by bacteria who are unable to manufacture their own food thus they depend on the host plant for food depriving the plants of the nutrients necessary for a healthy growth.
Fungal diseases are the most widespread plant maladies. Fungi parasitically obtain their food from green plants, causing diseases in the process. Fungi produces spores in great number which are tiny reproductive bodies. These spores can be carried by wind or water. Each spore will germinate and grow producing new infections. Viral diseases are viruses capable of invading plant tissue and reproducing in it. Viruses can be spread by aphids, leafhoppers and thrips. Even humans can spread viruses by propagating virus-infected plants.
Other factors that causes this are the plants own interaction with unfavorable environmental factors. This includes air pollution, a deficiency or excess of sunlight which is its main source of nutrients. It can also be the climate. Climate adaptability in plants is very important. Plant disease can be caused by climate which is too hot, too cold, too dry or too wet.
Kinds of Leaf and Stem Diseases
1. Anthracnose - infects leaves, produces large, irregular brown blotches which causes premature dropping of leaves.
2. Black Spot - it appears on leaves and stems as roughly circular spots of black with fringed edges, usually circled with yellow.
3. Dutch Elm Disease - also known as DED. Can be spread from infected trees to nearby healthy ones by natural root grafting.
4. Fireblight - it is carried to blossoms by splashing water, flies and other insects. Infection can also enter a plant through any fresh wound in the bark or foliage.
5. Leaf Spot - it is red, brown, yellow, or black disease spots on leaves and stems. Severe infection of this disease can cause some plants to defoliate.
6. Peach Leaf Curl - the curled and distorted leaves may be tinged with red, pink, yellow or white. Later they may become covered with white spores that can be carried by the wind to other leaves or plants.
7. Powdery Mildew - if first appears as small gray or white circular patches on plant tissue, spreading rapidly to form powdery areas of fungus filaments and spores.
8. Scab - the scab fungus differs from other leaf-infecting fungi in that the dark spots on leaves represent fungus growth on the foliage rather than areas of dead tissue.
9. Rust - this disease is specific to a certain type of plant. Rose rust will not infect hollyhocks and vice versa.
Soil borne Diseases
1. Damping Off - the stem of a seedling collapses at or near the soil surface and the seedling topples. It can also rot the seedling before it emerges from the soil or causes the seed to decay before sprouting.
2. Oak Root Fungus - the fungus kills its host by gradually decaying the roots and moving into the main stem, where it girdles the plant.
3. Root Rots, water Molds - the damage to roots from overwatering is, in almost all cases, not caused by water itself but by water-mold fungi that thrive when free water stands too long around roots - especially when soil is warm.
4. Verticillium Wilt - it invades and plugs the water conducting tissue in the roots and stems. A common symptom is a wilting of one side of the plant.
Ways to Control Plant Diseases
As with any kind of diseases, prevention is still the best line of defense. As much as possible choose plants that are disease resistant. Also make sure that planting locations and conditions don't encourage diseases.
There are products readily available in the market for this purpose. One classification are called preventives - as the word suggest it prevents diseases from occuring, but these products are ineffective once the disease are already established. The other classification is called eradicants - once the disease is established, eradicants are helpful in controlling them.
Before using any of these products, it will be wise to read the labels very carefully. Be sure to apply the products only if the plant is listed. It can cause damaged if applied to inappropriate plants.
Here are some of these products and the common disease they each control.
1. Sulfur - used to prevent powdery mildew, scab and rust. It is one of the oldest and safest fungicides
2. Lime Sulfur - It controls some mites, scale insects and thrips. Also used to prevent various leaf spots, peach leaf curl, and powdery mildew.
3. Captan - for prevention or eradication of damping-off, leaf spots and many other fungal diseases.
4. Triforine - for prevention or eradication of powdery mildew, rust, black spot and a variety of other diseases.
5. Copper Compounds - often used to prevent fireblight, peach leaf curl, and shot hole diseases.
6. Chlorothalonil - it prevents diseases on lawns, fruits, vegetables and ornamentals.
7. Triadimefon - effective against azalea petal blight. It can also prevent powdery mildew, rust and some lawn diseases.
суббота, 4 апреля 2009 г.
25 Years Later: Aids And The Forgotten Victims
Science has taken important steps toward treating the condition in the 25 years since the first cases of a nameless, deadly disease now known as the human immunodeficiency virus were recorded in the U.S. The problems of one group affected by the disease, however, need addressing in a different way.
Over the last quarter century, the tragic story of HIV/AIDS has often been told-but the story of children orphaned by this disease is often forgotten. Without mothers, fathers, doctors and community leaders, millions of children are left unprotected and deprived of a normal childhood. Children are suffering because the world has not recognized that the disease is wreaking havoc on childhood.
The AIDS pandemic is unraveling decades of progress for children. School enrollment, immunization rates and child survival around the world are suffering significant reversals because of the impact of AIDS.
To date, an estimated 15 million children worldwide have been orphaned by HIV and AIDS. In Sub-Saharan Africa, the world's hardest-hit region, eight out of 10 orphans lost their parents to AIDS. Meanwhile, in Latin America and the Caribbean, it is estimated that 752,000 children have lost one or both parents to the disease.
Through its Unite for Children, Unite Against AIDS campaign, UNICEF (United Nations Children's Fund) hopes to record significant global progress in addressing HIV/AIDS by 2010. UNICEF's goal is to prevent mother-to-child transmission of the disease by offering services to 80 percent of women in need; increase pediatric treatments to 80 percent of children in need; reduce the percentage of young people living with HIV by 25 percent; and reach 80 percent of the world's children most in need with support services.
In 2001, UNICEF and the Kimberly-Clark Corporation partnered to support children orphaned and made vulnerable by AIDS in Sub-Saharan Africa and Latin America. The $5.2 million pledged by Kimberly-Clark has helped UNICEF to ensure orphans are fed, protected and educated. The evidence of the effects of these programs can be measured one child at a time, such as Werner, a bubbly 3-year-old who was brought to San Jose Hospice in Guatemala by his mother, who later died from HIV/AIDS. Through UNICEF-supported programs at the facility, Werner is receiving food, medicine and other supplies, which are helping him to grow up strong and healthy. Soon he will be going to school.
"The fight against the HIV/AIDS pandemic is not an easy one. Through successful partnerships like our relationship with Kimberly-Clark, we can bring hope to children affected and infected by HIV/AIDS and offer them a brighter future," said Charles J. Lyons, president of the U.S. Fund for UNICEF.
Although Sub-Saharan Africa receives the most attention regarding HIV/AIDS, there are many other areas of the world that are at a crucial juncture in their response to the disease. For example, now is a pivotal time to address HIV/AIDS in China. The country has seen unprecedented economic growth, but the social stigma of HIV and AIDS is still very negative. Given that 20 percent of the world's 10-to-24-year-olds live in China, ensuring the health and well-being of the world's children cannot be accomplished without considering this country.
The estimated 530,000 children in China who have lost one or both parents to AIDS, or who are living with parents who are currently ill, are often outcast from their schools and ostracized by their communities-and they fall victim to inadequate social services.
Recognizing this, UNICEF and Kimberly-Clark have expanded their partnership to China to ensure that children made vulnerable by HIV/AIDS have the opportunity to lead normal lives. The goal is to keep orphans in loving, caring families and communities, and to provide them with access to education, health services, medicines and psychological support in the face of negative social stigma.
Together with the Chinese government, UNICEF has launched a campaign to help to reduce the shame and discrimination of the disease through awareness efforts and to protect those children who have been orphaned and made vulnerable by HIV/AIDS. Kimberly-Clark support of this campaign will help to provide subsidies for school fees, summer camps and a youth ambassador program. The company will also help to fund UNICEF-established Red Ribbon Centers in local communities, where vulnerable children and families receive care and support through education, training and income-generation activities.
пятница, 3 апреля 2009 г.
"the Top 11 No-hype Traffic Generation Strategies That Makes You Money Like Crazy."
The paid ones:
1. Classified ads for mailing lists
When you purchase a classified ad for mailing lists, you purchase a small advertising space in someone�s e-zine or newsletter. The main reason is so that when the owner of the list sends out any of his emails, your ad will be shown with it.
Classifieds in e-zines of newsletters are read more than classified ads publicly shown on websites. Therefore, they can bring much more response.
2. Solo ads for mailing lists
This is the ultimate version of classified ads. While classified ads takes away a small advertising space in an issue of a newsletter of e-zine, solo ads take up the whole issue. The ad will be mailed in a single email without any other ads together.
You can purchase classified ads or solo ads by either contacting or negotiating straight forwardly with someone/some company you know which have a huge list of subscribers. A few websites you can search for mailing lists which offers advertising spaces in their newsletter or e-zine are:
�http://www.buyselloffers.com
�http://www.mywizardads.com
�http://www.advertisetomillions.com
3. Pay-per-click
Search engines like Google, Overture, and MSN have services which allow you to advertise your ad to the right a search result page. When you advertise your ads using pay-per-click services and visitors click on the ads shown, you will need to pay a fee depending on your biddings.
4. Purchase advertising space from a website
Although this way of advertising costs a lot, it can be very useful. Purchasing a web space off a website with high traffic which can allow you to promote your text ads, text links, banners etc can drive you a lot of visitors as well.
The free ones:
5. Submitting Articles
Although writing articles and submitting them to article directories is free, you can generate very good traffic to your websites far better than the paid ones sometimes. Other than that, submitting your own articles help you build long term traffic as well.
This is the best way to generate steady, long term and huge traffic to your site. The more popular article directories are:
�http://www.ezinearticles
�http://www.goarticles.com
�http://www.articlecity.com
�http://www.ideamarketers.com
�http://www.isnare.com
6. Reciprocal Linking
This is a way of exchanging links with other websites. If your website has a decent page rank of 4 and above, or it is bringing in swarms of visitors each day, it is best that you exchange links with other high traffic websites.
7. Affiliates
If you are selling a product, having an affiliate program to let others promote it as affiliates and earn commissions is a great way of driving traffic to your site.
8. Joint ventures
This is one of the most effective ways of generating traffic. It can be done by ad-swapping, which is by endorsing each other�s website to both of your own mailing lists. Subscribers who are interested will then visit the recommended sites and you will gain traffic that way.
9. Viral reports
Another proven way of bringing in enormous traffic to your website - creating viral reports embedded with links to your website which contains good contents, and give them away to people. Other than that, you can also give free distribution rights along with your report so that others can give it away as well.
10. Participate in discussion boards
Most discussion boards or forums will allow you to have your own signature. This way, you can put down your link and get it shown every time you make a post. In order to drive traffic to your site, make sure you find a high traffic discussion board or forum to contribute in.
11. Submitting Press Releases, Stories
Similar to submitting an article, writing your press releases and submitting them to press release directories will drive great traffic to your site as well. The best place to submit your press releases is at http://www.prweb.com or http://www.prleap.com.
If you can generate fresh contents on your website, write interesting information for people, submitting it to http://digg.com can generate a huge instant buzz of traffic to your website. What�s more, if it gets �dugg�, which is to get voted, your stories can go to the front page where you can pull in four to five figured visitors in a day.
четверг, 2 апреля 2009 г.
The Fda's Drug Review Process: Ensuring Drugs Are Safe And Effective Part I
The path a drug travels from a lab to your medicine cabinet is usually long, and every drug takes a unique route. Often, a drug is developed to treat a specific disease. An important use of a drug may also be discovered by accident
For example, Retrovir (zidovudine, also known as AZT) was first studied as an anti-cancer drug in the 1960s with disappointing results. It wasn't until the 1980s that researchers discovered the drug could treat AIDS, and the Food and Drug Administration approved the drug, manufactured by GlaxoSmithKline, for that purpose in 1987.
Most drugs that undergo preclinical (animal) testing never even make it to human testing and review by the FDA.The drugs that do must undergo the agency's rigorous evaluation process, which scrutinizes everything about the drug--from the design of clinical trials to the severity of side effects to the conditions under which the drug is manufactured.
Stages of Drug Developmentand Review
Investigational New Drug Application (IND)--The pharmaceutical industry sometimes provides advice to the FDA prior to submission of an IND. Sponsors--companies, research institutions, and other organizations that take responsibility for developing a drug--must show the FDA results of preclinical testing they've done in laboratory animals and what they propose to do for human testing. At this stage, the FDA decides whether it is reasonably safe for the company to move forward with testing the drug in humans.
Clinical Trials--Drug studies in humans can begin only after an IND is reviewed by the FDA and a local institutional review board (IRB). The board is a panel of scientists and non-scientists in hospitals and research institutions that oversees clinical research.
IRBs approve the clinical trial protocols, which describe the type of people who may participate in the clinical trial, the schedule of tests and procedures, the medications and dosages to be studied, the length of the study, the study's objectives, and other details. IRBs make sure the study is acceptable, that participants have given consent and are fully informed of their risks, and that researchers take appropriate steps to protect patients from harm.
Phase 1 studies are usually conducted in healthy volunteers. The goal here is to determine what the drug's most frequent side effects are and, often, how the drug is metabolized and excreted. The number of subjects typically ranges from 20 to 80.
Phase 2 studies begin if Phase 1 studies don't reveal unacceptable toxicity. While the emphasis in Phase 1 is on safety, the emphasis in Phase 2 is on effectiveness. This phase aims to obtain preliminary data on whether the drug works in people who have a certain disease or condition. For controlled trials, patients receiving the drug are compared with similar patients receiving a different treatment--usually an inactive substance (placebo), or a different drug. Safety continues to be evaluated, and short-term side effects are studied. Typically, the number of subjects in Phase 2 studies ranges from a few dozen to about 300.
At the end of Phase 2, the FDA and sponsors try to come to an agreement on how the large-scale studies in Phase 3 should be done. How often the FDA meets with a sponsor varies, but this is one of two most common meeting points prior to submission of a new drug application. The other most common time is pre-NDA--right before a new drug application is submitted.
Phase 3 studies begin if evidence of effectiveness is shown in Phase 2. These studies gather more information about safety and effectiveness, studying different populations and different dosages and using the drug in combination with other drugs. The number of subjects usually ranges from several hundred to about 3,000 people.
Postmarketing study commitments, also called Phase 4 commitments, are studies required of or agreed to by a sponsor that are conducted after the FDA has approved a product for marketing. The FDA uses postmarketing study commitments to gather additional information about a product's safety, efficacy, or optimal use.
New Drug Application (NDA)--This is the formal step a drug sponsor takes to ask that the FDA consider approving a new drug for marketing in the United States. An NDA includes all animal and human data and analyses of the data, as well as information about how the drug behaves in the body and how it is manufactured.
When an NDA comes in, the FDA has 60 days to decide whether to file it so that it can be reviewed. The FDA can refuse to file an application that is incomplete. For example, some required studies may be missing. In accordance with the Prescription Drug User Fee Act (PDUFA), the FDA's Center for Drug Evaluation and Research (CDER) expects to review and act on at least 90 percent of NDAs for standard drugs no later than 10 months after the applications are received. The review goal is six months for priority drugs. (See "The Role of User Fees.")
There is also continuous interaction throughout the review process. For example, over roughly six years, the sponsor, Merck Research Laboratories of West Point, Pa., and the FDA had several face-to-face meetings and about 28 teleconferences regarding the asthma drug Singulair (montelukast sodium).
"It's the clinical trials that take so long--usually several years," says Sandra Kweder, M.D., deputy director of the Office of New Drugs in the CDER. "The emphasis on speed for FDA mostly relates to review time and timelines of being able to meet with sponsors during a drug's development," she says.
Reviewing Applications
Though FDA reviewers are involved with a drug's development throughout the IND stage, the official review time is the length of time it takes to review a new drug application and issue an action letter, an official statement informing a drug sponsor of the agency's decision.
Once a new drug application is filed, an FDA review team--medical doctors, chemists, statisticians, microbiologists, pharmacologists, and other experts--evaluates whether the studies the sponsor submitted show that the drug is safe and effective for its proposed use. No drug is absolutely safe; all drugs have side effects. "Safe" in this sense means that the benefits of the drug appear to outweigh the risks.
The review team analyzes study results and looks for possible issues with the application, such as weaknesses of the study design or analyses. Reviewers determine whether they agree with the sponsor's results and conclusions, or whether they need any additional information to make a decision.
Each reviewer prepares a written evaluation containing conclusions and recommendations about the application. These evaluations are then considered by team leaders, division directors, and office directors, depending on the type of application.
Reviewers receive training that fosters consistency in drug reviews, and good review practices remain a high priority for the agency.
Sometimes, the FDA calls on advisory committees made up of outside experts, who help the agency decide on drug applications. Whether an advisory committee is needed depends on many things.
"Some considerations would be if it's a drug that has significant questions, if it's the first in its class, or the first for a given indication," says Mark Goldberger, M.D., director of one of CDER's drug review offices. "Generally, FDA takes the advice of advisory committees, but not always," he says. "Their role is just that--to advise."
Accelerated Approval
Traditional approval requires that clinical benefit be shown before approval can be granted. Accelerated approval is given to some new drugs for serious and life-threatening illnesses that lack satisfactory treatments. This allows an NDA to be approved before measures of effectiveness that would usually be required for approval are available.
Instead, less traditional measures called surrogate endpoints are used to evaluate effectiveness. These are laboratory findings or signs that may not be a direct measurement of how a patient feels, functions, or survives, but are considered likely to predict benefit. For example, a surrogate endpoint could be the lowering of HIV blood levels for short periods of time with anti-retroviral drugs.
Gleevec (imatinib mesylate), an oral treatment for patients with a life-threatening form of cancer called chronic myeloid leukemia (CML), received accelerated approval. The drug was also approved under the FDA's orphan drug program, which gives financial incentives to sponsors for manufacturing drugs that treat rare diseases. Gleevec blocks enzymes that play a role in cancer growth. The approval was based on results of three large Phase 2 studies, which showed the drug could substantially reduce the level of cancerous cells in the bone marrow and blood.
The sponsor, Novartis Pharmaceuticals Corp. of East Hanover, N.J., submitted the IND in April 1998. The FDA received the NDA in February 2001, and the drug was approved two-and-a-half months later in May 2001. Novartis has made commitments to conduct studies that confirm Gleevec's clinical benefit, such as increased progression-free survival in the treatment of CML.
Most drugs to treat HIV have been approved under accelerated approval provisions, with the company required to continue its studies after the drug is on the market to confirm that its effects on virus levels are maintained and that it ultimately benefits the patient. Under accelerated approval rules, if studies don't confirm the initial results, the FDA can withdraw the approval.
Because premarket review can't catch all potential problems with a drug, the FDA continues to track approved drugs for adverse events through a postmarketing surveillance program.
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