Health and Therapy

Sunday, March 24, 2013

Low Carb Dieting the Truth: Part One

Almost everyone knows someone who has used a low carb diet. They have used it themselves had a friend use it or are getting ready to use it . Are these diets magic? Are they safe? Can I really eat all of the cheese and meat I want ? Will I die if I go into ketosis?

These are just a few common questions I hear in regards to questions that concern low carb diets. In this series of articles I will present readers with scientific facts and my practical observations for implications concerning low carb diets. Some low carb supporters will not like what I will have to say. Some low carb haters will not like what I have to say. The objective of these articles are to educate readers on the practical implications of low carb dieting. Some will be offended and some will say how can that be. Either way sit back and enjoy as I attempt to shed light on the highly talked about topic - low carb diets (ketogenic diets)

I have provided a brief overview of some the topics that will be discussed in this series of articles.

What type of changes occur while using low carb diets

Do low carb diets make me mean

Do low carb diets spare muscle

Can I gain weight on a low carb diet

How much weight can I expect to lose

Can this diet help my medical condition

Different types of low carb diets

Why you need to cycle higher days of carbs

Who needs low carb diets

Are they safe for children

Are they beneficial for athletes

The topics mentioned above are just a few that will be addressed in Low Carb Dieting.

Before we move any further let me introduce the word ketogenic. Must of you reading this article are probably familiar with the world as it implies low carb or restriction of carb intake. Simply put for our purposes the words ketogenic and low carb are synonymous. A couple of other comments I would like to make before we move on. This comment is for Low Carb supporters that swear of all vegetables and fruits. Get on medline.com and do some research. Go to the library and look through some journals. A complete diet for long term use needs to incorporate greens and some fruits to be healthy. A short term diet devoid of fruits and vegetables might not be that bad, but rejecting greens and any fruits for life is a bad idea.

This comment is for the low carb haters. One of the number one reasons most of America is fat is because of chronically high insulin levels. Which is primarily contributed to excessive carb intake. Don't get me wrong I am not blaming high carbohydrate intake on all of our obesity problems. I should probably say excessive and the wrong types of carbohydrate at the wrong times are the problem. At the same time the answer is not to eat all of the saturated fat we can find : which can contribute to insulin insensitivity, elevated TG's, increased lipogenesis and digestive problems.

What is a ketogenic diet? A diet that causes ketone bodies to be produced by the liver, and shifts the body's metabolism away from glucose in favor of fat burning. A ketogenic diet restricts carbohydrates below a certain level (generally 100 per day). The ultimate determinant of whether a diet is ketogenic or not is the presence or absence of carbohydrate. Protein and fat intake vary. Contrary to poplar belief eating fat is not what causes ketosis. In the past starvation diets were used often to induce ketosis. I will repeat myself again and say lack of carbohydrate or presence of ultimately determines if the diet is ketogenic.

In most eating plans the body runs on a mixture of protein, fats and carbohydrates. When carbohydrates are severely restricted and glycogen storage (glucose in muscle and liver) is depleted the body begins to utilize other means to provide energy. FFA (free fatty acids) can be used to provide energy, but the brain and nervous system are unable to use FFA's. Although the brain can use ketone bodies for energy.

Ketone bodies are by products of incomplete FFA breakdown in the liver. Once they begin to accumulate fast and reach a certain level they are released , accumulated in the bloodstream and cause a state called ketosis. As this occurs there is a decrease in glucose production and utilization. There is also less reliance on protein to meet energy requirements by the body. Ketogenic diets are often referred to as protein sparing as they help to spare LBM whiled dropping body fat.

In regards to ketogenic diets there are two primary hormones- insulin, glucagon that need to be considered. Insulin can be described as a storage hormone as it's job is to take nutrients out of the bloodstream and carry them to target tissues. Insulin carries glucose from the blood to the liver and muscles, and it carries FFA from the blood into adipose tissue (stored fat triglyceride). On the other hand glucagon breaks down glycogen stores (especially in the liver) and releases them into the blood.

When carbs are restricted or removed insulin levels drop while glucagon levels rise. This causes enhanced FFA release from fat cells, and increased FFA burning in the liver. This accelerated burning of FFA in the liver is what leads to ketosis. There are a number of other hormones involved with this process as well.

In general we refer to three different types of ketogenic diets.
1) STANDARD KETOGENIC DIET- A diet containing l00 or less grams of carbohydrates is referred to as STANDARD KETOGENIC DIET

2)TARGETED KETOGENIC DIET- consuming carbohydrates around exercise, to sustain performance without affecting ketosis.

3)CYCLICAL KETOGENIC DIET- alternates periods of ketogenic dieting with periods of high carbohydrate intake

The Beginning of Ketogenic diets
Originally ketogenic diets were used to treat obesity and epilepsy. In general ketogenic diets are similar to starvation diets in the responses that occur in the body. More specifically these two states can be referred to as starvation ketosis and dietary ketosis. These similarities have led to the development of modern day ketogenic diets.

Ketogenic dieting has been used for years in the treatment of childhood epilepsy. In the early 1900's times of total fasting was used to treat seizures. This caused numerous health problems and could not be sustained indefinitely.

Due to the impracticalities and health problems occurring with starvation ketogenic diets researchers began to look for a way to mimic starvation ketosis while consuming food. They determined that a diet consisting of high fat, low carb and minimal protein could sustain growth and maintain ketosis for a long period of time. This led to the birth of the original ketogenic diet in 1921 by Dr. Wilder. Dr Wilder's diet controlled pediatric epilepsy in many cases where drugs and other treatments failed.

New epilepsy drugs were invented during the 30's, 40's and 50's and ketogenic diets fell to the wayside. These new drugs lead to almost disappearance of ketogenic diets during this time. A few modified ketogenic diets were tried during this time such as the MCT (medium chain triglycerides) diets, but they were not welly accepted.

In 1994 the ketogenic diet as a treatment for epilepsy was re-discovered. This came about in the story of Charlie a 2yr old with seizures that could not be controlled with mediacions or other treatment including brain surgery. Charlie's father had found reference to the diet through his research and ended up at John Hopkins medical center.

Charlie's seizures were completely controlled as long as he was on the diet. The huge success of the diet prompted Charlie's father to start the Charlie foundation. The foundation has produced several videos, and published the book The Epilepsy Diet Treatment: An Introduction to the Ketogenic diet. The foundation has sponsored conferences to train physicians and dietians to implement the diet. The exact mechanisms of how the ketogenic diet works to control epilepsy are still unknown, the diet continues to gain acceptance as an alternative to drug therapy.

Obesity
Ketogenic diets have been used for at least a century for weight loss. Complete starvation was studied often including the research of Hill, who fasted a subject for 60 days to examine the effects. The effects of starvation were very successful in regards to treatment of the morbidly obese as rapid weight loss occurred. Other characteristics attributed to ketosis, such as appetite suppression and sense of well being, made fasting even more attractive for weight loss. Extremely obese patients have been fasted for up to one year and given nothing but vitamins and minerals.

The major problem with complete starvation diets is the loss of body protein, primarily from muscle tissue. Protein losses decrease as starvation contines, but up to one half of the total weight loss can be contributed to muscle and water loss.

In the early 1970's Protein Sparing Modified Fasts were introduced. These diets
allowed the benefits of ketosis to continue while preventing losses of bodily proteins.
They are still used today under medical supervision

In the early 70's Dr. Atkins introduced Dr. Atkins Diet Revolution With millions of
copies Sold the diet generated a great deal of interest. Dr. Atkins suggested a diet limited
in carbohydrate but unlimited in protein and fat. He promoted the diet as it would allow
rapid weight loss, no hunger and unlimited amounts of protein and fat. He offered just
enough research to allow the diet recognition. Although most of the evidence

supporting the diet was questionable.

During the 1980's Michael Zumpano and Dan Duchaine introduced two of the earliest
CKD's THE REBOUND DIET for muscle gain and then the modified version called
THE ULTIMATE DIET for fat loss. Neither diet became very popular. This was likely
due to the difficulty of the diet and the taboo of eating high fat.

In the early 90's Dr. Dipasquale introduced the ANABOLIC DIET . This diet promoted 5
days of high- fat-high protein-low carb consumption whle eating high carbs and virtually
anything you wanted for two days. The diet was proposed to induce a metabolic shift
within the five days of eating low carbs (30 or less). The metabolic shift occurred as your
body switched from being a sugar buring machine to a fat-burning machine.

A few years later Dan Duchaine released the book UNDERGROUND BODYOPUS: MILITIANT WEIGHT LOSS AND RECOMPOSITION . The book included his CKD diet which he called BODYOPUS. The diet was more specified than the Anabolic Diet and gave exercise recommendations as well as the basics concerning exercise physiology. Most bodybuilders found the diet very hard to follow. The carb load phase required eating every 2 hrs and certain foods were prescribed. I personally loved the book, but felt the difficulty of the diet made it less popular. In this author's opinion Ducahine's book is a must read for anyone interested in Nutrition.

Ketogenic Diets have been used for years to treat specific conditions such as obesity and childhodd epilepsy. The effects of these diets have proven beneficial in a number of these well documented cases, but for some reason when we mention any type of low carb diet (ketogenic diet) people begin to tell us about how their doctor or friend told them it would kill them or how that diet was shown to damage the liver or kidneys. Keep in mind epileptic children have been in ketosis for up to three years and shown no negative effects; quiet the opposite. The weight loss in morbidly obese patients has been tremendous and the health benefits numerous. Maybe before coming to the conclusion that all types of ketogenic diets are bad other factors need to be considered such as activity levels, type of ketogenic diet, length of ketogenic diet, past eating experience, purpose of ketogeninc diet, individual body type and response to various eating plans, current physical condition, and quality of food while following ketogenic diet. As you can see there are numerous factors that come into play when saying a diet is good or bad. I think people should take the time look at the research and speak with various authorities in regards to low carb diets before drawing conclusions from the they says.

Relevant research in regards to ketogenic dieting
Efficacy and safety of the ketogenic diet for intractable childhood epilepsy: Korea multicentric experience
Chul Kang H, Joo Kim Y, Wook Kim D, Dong Kim H,
Dept of pediatrics, Epilepsy center, Inje Univ Coll of Med, Sanggye Paik Hospital, Seoul Korea

The purpose of the study was to evaluate the safety of the ketogenic diet, and to evaluate the prognosis of the patients after successful discontinuation of the diet in infants, children and adolescents with refractory epilepsy. The study looked at patients who had been treated with KD during 1995 through 2003 at Korean multicenters. The outcomes of the 199 patients enrolled in the study at 6 and 12 months were as follows: 68% and 46% of patients remained on the diet, 58% and 41% showed a reduction in seizures, including 33% and 25% who became seizure free. The complications were mild during the study, but 5 patients died during the KD. No significant variables were related to the efficacy, but those with symptomatic and partial epilepsies showed more frequent relapse after completion of the diet. The researchers concluded the KD is a safe and effective alternative therapy for intractable epilepsy in Korea, although the customary diet contains substantially less fat than traditional Western diets, but life-threatening complications should be monitored closely during follow up.

Reference
McDoanld, L (1998) The Ketogenic Diet. Lyle McDonald.

Rating the Fad Diets

THE 200 POINT SYSTEM

With so many different diets available, how are we to know
what works and what is safe? The only way to be sure is to
discover the author's background and the research behind
the diet's methodology. Every good diet should give a
background about the author and his/her credentials and
experience in the fields of nutrition and biochemistry.
However, even a vast resume does not mean a credible and
safe diet. But it does suggest, at least, that the author has
some knowledge of nutrition. Providing research behind the
diet proves that the diet is not something the author
invented, so long as the research is not self-serving and
altered to fit a hypothesis.

Some diets may not need a great deal of tests and studies
behind them, simply because they are based on
fundamentals. For example, many women's magazines
have articles on dieting and weight loss, but they are
common sense suggestions that most people concerned
about weight should know already: "Eat smaller meals", "cut
down on sugar and fat", etc., are typical philosophies. More
structured diets should give some scientific reasons for its
suggested success, preferably case studies and research
performed on everyday test subjects, as well as athletes.

Since we have established the importance of eating a
balanced diet in accordance to selecting healthy foods and
obtaining RDA minimums, it is possible now to rate the
diets in accordance to those specific criteria. Begin with a
score of 200 and subtract 10 points from the total for each
statement below in which the diet concedes. An ideal diet
should maintain a score of 200, but a score of 160 or
greater is acceptable.

1. The diet does not include the food groups in adequate
amounts. Some fad diets eliminate one or more of the food
groups. Do not deduct 10 points if a food group's nutrients
(e.g., carbs, proteins, fats, fiber, vitamins, and minerals) are
adequately substituted with that of another food group.

2. The diet does not provide at least 45% of its calories from
carbohydrate sources. In order to prevent ketosis, at least
150g of glucose/day is required. That's 33-50% of total
calorie intake on a 1200-calorie diet. Keep in mind that is
the minimum. For highly active individuals, that amount
should increase to 60% at times, i.e., immediately after
exercise.

3. The carbohydrate content exceeds 20% concentrated
sugars. At least 80% of carbohydrate sources should be
complex, and preferably in the form of vegetables, seeds,
and legumes.

4. The protein content exceeds 30%. A very high protein
intake is unnecessary, it places additional strain on the
urinary system, and it is a poor source of energy. Thirty
percent is more than adequate, even for growing children
and teenagers. The only group that requires higher protein
intake are those who recently suffered a severe injury (e.g.,
leg amputation), infection, or surgery. However, these
individuals will be under the care of a physician with a
special high protein diet.

5. Protein content accounts for 15% or less of total calories.
Although unnecessary in large amounts, protein still has
many vital functions, including tissue repair and the
formation of enzymes.

6. Fats exceed 30% of total intake. Besides increasing the
risk of cardiovascular disease, high fat diets have not been
demonstrated to decrease weight better than other methods
of 'proper' eating.

7. Total fat consumption is less than 15% of total calories.
Fat in moderate amounts is essential for a healthy diet, and
such a diet provides taste to many foods. Fat intake below
15% for long periods, for most individuals, is unrealistic.
Fat intake that is too low can also be detrimental to children
and teenagers who require ample kcalories for continued
growth.

8. Total fat consumption is less than 25% essential fatty
acids, and saturated fat is more than 30% of total fat
consumption. Deduct 10 for each.

9. The diet does not suggest common foods, meaning
foods you should be able to obtain at any grocery store or
market.

10. The foods for the diet are expensive or monotonous.
Some diets require the purchase of 'their' foods or
expensive 'organic' foods only obtained through health food
stores. Some foods taste so bad they are difficult to
tolerate repeatedly (e.g., seaweed). Deduct 10 for each.

11. The diet consists of an inflexible meal plan. The diet
does not allow for substitutions or deviations, requiring a
person to live under 'house arrest' with the same food
selections every day.

12. The diet provides less than 1200 kcalories per day.
Less than that and the body's basic functions may not be
getting the energy, vitamins and minerals needed to work
properly, and the dieter almost is certain to feel hungry all
the time. Diets below 1200 kcalories should be reserved for
those under the supervision of a dietitian or licensed
physician.

13. The diet requires the use of supplements. If the diet
provides adequate energy and it is well balanced,
supplements are unnecessary. 'Fat accelerators,' such as
ephedrine, may increase the rate of weight loss, but the diet
should be able to stand on its own merit. Some diet clinics
promote a vast array of herbal preparations and fat
accelerators, and this is where these clinics make their
money - not in their knowledge and ability as nutritionists.

14. The diet does not recommend a realistic weight goal.
Diets should not be promoting the body of a Greek god or a
supermodel. They should not be suggesting that a person
lose 100 pounds (even if 100 pounds overweight). Nor
should diets recommend weight loss below an ideal
weight.

15. The diet recommends or promotes more than 1-2
lbs/week weight loss. Do not expect to lose more than 1-2
pounds of fat a week - it is physically impossible unless
chronically obese, at which point 3 pounds may be
possible. If more than two pounds is lost per week, the
body change is due to a loss of water and/or muscle tissue.
Gimmicks that promise 10 pounds in 2 weeks are either
simply not true or else something other than fat is being
lost. Also keep in mind that the more fat a person wishes to
lose, and the less a person has, the more difficult and
slower it will be to lose additional fat.

16. The diet does not include an evaluation of food habits.
Dieting should be a slow process by which a person
changes normal eating habits. It should not include looking
for quick fixes and quick plans promising short cuts and
extreme changes - a person would never stay with these
programs and such diets do not work long-term. The
number of kcalories eaten, and the food selections and their
amounts, should be reevaluated on a regular basis...
perhaps once every 1-2 months to determine the program's
effectiveness.

17. Regular exercise is not recommended as part of the
plan for proper weight loss. Weight loss occurs twice as
fast with exercise, and without exercise there is a greater
tendency to lose lean muscle tissue as well as fat. This is
not ideal.

OVERVIEW OF VARIOUS DIETS

Low Carbohydrate Diets: Ketosis occurs, and this presents
the same problems as fasting. Once glycogen stores are
spent (which happens quickly with athletes and those who
exercise regularly), glucose must be made from protein
sources, and there is greater wear on the kidneys as a
result. Even on a high protein diet, some protein will be
taken from body tissues in order to produce enough energy
for the nervous system and regular activity. The onset of
ketosis is an indication that this process has begun and it is
not a positive aspect, regardless of what pro-high-fat
authorities indicate.

Great weight loss on a low-carb diet is evident because of
the fact that carbs hold water in the muscles at a ratio of 1:3.
As carb intake decreases then so, too, does water retention.
Much water flushes as a result of lack of glycogen to hold
water molecules. Moreover, by increasing protein intake,
excess nitrogen flushes with even more water since the
kidneys use water to dilute the concentration of nitrogen.
Once leaving a low-carb diet and the muscles refill with
glycogen, fluid concentrations increase and the dieter
regains some of the weight.

Low calorie diets of 400-600 kcalories that consist primarily
of protein have the same problems as fasting and
low-carbohydrate diets: proteins are used for energy and
weight loss comes largely from water. Low-cal diets must
be supervised properly by a medical professional and only
as a last resort for those who cannot seem to lose weight by
other methods. However, even those individuals tend to
regain most of their weight back once they return to a
balanced diet.

Beverly Hills Diet - a diet consisting of grapefruit, eggs, rice,
and kelp; it is deficient in minerals and vitamins.

Cambridge Diet - a very low kcalorie (300-600 kcal/day);
protein/carb mixture with mineral imbalances; the dieter is
close to fasting.

Complete Scarsdale Diet - this diet is unbalanced
nutritionally; some days are calorically restricted; the dieter
alters portions of carbohydrate, protein, and fat; the diet
consists of low carbs (20-50 g/day), and high fat and
protein; the diet has a high meat (saturated fat and
cholesterol) content.

Dr. Atkin's Diet Revolution - this diet is unbalanced
nutritionally; some days are calorically restricted; the dieter
alters portions of carbohydrate, protein, and fat; carbs are
very low (20-50 g/day), whereas fat and protein are high;
there is high meat (saturated fat and cholesterol)
consumption.

Dr. Linn's Last Chance Diet - this diet has a very low
kcalorie intake (300-600 kcal/day); it consists of a
protein/carb mixture with a mineral imbalance; the dieter is
close to fasting.

Dr. Reuben's The Save Your Life Diet - this is a calorically
dilute diet consisting of high fiber (30-35g/day); the diet is
low in fat and animal products; there is poor absorption of
minerals because of too much high fiber.

"Fake" Mayo Diet - this diet consists of grapefruits, eggs,
rice, and kelp; it is deficient in minerals and vitamins.

F-Plan Diet - this is a calorically dilute diet consisting of
high fiber (30-35g/day); it is low in fat and animal products;
there is poor absorption of minerals because of too much
fiber.

LA Costa Spa Diet - this diet promotes weight loss of 1-1_
lbs/day; there are various plans of 800, 1000, and 1200
kcal/day composed of 25% protein, 30% fat (mostly
polyunsaturates), and 45% carbohydrate; the diets includes
the four food groups.

Medifast Diet - this diet is balanced nutritionally, but
provides only 900 kcal/day; use of liquid formulas makes
this diet monotonous and expensive.

Nutrimed Diet/Medifast Diet - this is a nutritionally balanced
diet, but it supplies only 900 kcal/day; the use of liquid
formulas makes this diet monotonous and expensive.

Optifast Diet - this diet is nutritionally balanced, but
supplies only 900 kcal/day; use of liquid formulas makes
this diet monotonous and expensive.

Pritikin Permanent Weight-Loss Diet - this is a nutritionally
unbalanced diet; some days are calorically restricted; the
dieter alters portions of carbohydrate, protein, and fat; the
diet consists of high protein (100 g/day); unless the foods
properly chosen, it may be low in vitamin B12.

Prudent Diet - this is a balanced, low kcalorie (2400
kcal/day) diet for men; it is low in cholesterol and saturated
fats; a maximum of 20-35% calories are derived from fat
with an emphasis on protein, carbohydrates, and salt; there
is ample consumption of fish and shellfish, and saturated
fats are substituted with polyunsaturated fats.

Quick Weight Loss Diet - this diet is unbalanced
nutritionally; some days are calorically restricted; the dieter
alters portions of carbohydrate, protein, and fat, although
there is low carbs (20-50 g/day), and high fat and protein;
there is high meat consumption (saturated fat and
cholesterol) with this diet.

San Francisco Diet - this diet begins at 500 kcal/day,
consisting of two meals per day of one fruit, one vegetable,
one slice of bread, and two meat exchanges; the second
week limits carbohydrates, with most food coming from the
meat group and with some eggs and cheese, and a few
vegetables; week three includes fruit; in week four there is
an increase in vegetables; week five the dieter add
fat-containing foods (e.g., nuts, avocados); week six
includes milk; week seven includes pastas and bread,
where the diet is maintained at about 1300 kcal/day; this
diet avoids the issue of saturated fats and cholesterol.

Slendernow Diet - this diet is unbalanced nutritionally;
some days are calorically restricted; the dieter alters
portions of carbohydrate, protein, and fat; the protein is
generally high (100 g/day); unless foods are properly
chosen, there may be a deficiency in vitamin B12.

Weight-Watchers Diet - this diet is balanced nutritionally, at
about 1000-1200 kcal; use of high nutrient-dense foods are
consumed; economic and palatable food makes it one of
the most successful diets with no real health risks.

Wine Diet - this diet is about 1200 kcal/day, containing 28
menus together with a glass of dry table wine at dinner;
besides the medicinal components of wine, it is believed
that individuals reduce portion sizes when wine is
consumed with a meal; the diet is low in cholesterol and
saturated fats; there is a focus on fish, poultry, and veal with
moderate amounts of red meat.

Yogurt Diet - this diet consists of two versions, being
900-1000 kcal/day, and 1200-1500 kcal/day; plain low-fat
yogurt is the main dairy dish, consumed at breakfast, lunch,
and as a bedtime snack; the diet is high in protein, and it is
low in cholesterol, saturated fat, and refined carbohydrates.

Diets that do not provide 100% of the U.S. RDA for 13
vitamins and minerals:

Atkins

Beverly Hills

Carbohydrate Craver's Basic

Carbohydrate Craver's Dense

California (1200 kcal) California (2000 kcal)

F-Plan

I Love America

I Love New York

Pritikin (700 kcal) Pritikin (1200 kcal)

Richard Simmons

Scarsdale

Stillman

Understanding US Food and Drug Administration Recalls

The Food and Drug Administration, the agency n charge of regulating the safety of drugs is the Food and Drug Administration, is empowered by the US government to review the application of a pharmaceutical company to manufacture and release to the market any new drug it develops. The FDA also can issue a recall for any drugs that it deems dangerous for consumers. It also issues valuable safety information so that the general public would know about which drug is unsafe to use.

Sometime, however, the important safety information which is being issued regularly by the Food and Drug Administration can be a little bit confusing. It is sometimes full of technical jargon that the consumer tends to get lost in the meaning of the words and paragraphs and some mistakes are made because of this.

To put it more clearly, the FDA can order a pharmaceutical company to recall what it deems as a dangerous drug that is being distributed in the market. The pharmaceutical company can also do it voluntarily if it finds out that the drugs in question are causing major side effects.

As soon as the recall is made by the FDA, the pharmaceutical companies must take full responsibility with regards to the pullout of these dangerous drugs and it also thoroughly checks that all the drugs in question are taken off the shelves. The pharmaceutical companies should also inform the FDA on the progress of the recalls until all the dangerous drugs are pulled out from the market.

During the drug recall, the FDA assumes the role of a monitoring agency and to ensure that the pharmaceutical company is following all the necessary procedures in pulling out all the drugs which have been found to cause serious side effects. After all the drugs have been pulled out, the FDA then would conduct an investigation on why the drug in question was defective and to supervise the destruction of all the recalled drugs or to make sure that the drugs are suitably reconditioned before they are reintroduced to the market.

There are three recall categories and these are Class I, Class II or Class III. In a Class I recall, the FDA finds that the drugs in question are causing serious side effects and a probable serious or fatal injury to the user exists and the drug has to be pulled out right away from the market. The Class II recall tells of a probability of injury to the user although not necessarily fatal but still one that can cause permanent damage to the user. The Class III injury meanwhile tells of a lesser, albeit, probable health risks which is why the drug is being recalled.

The United States Food and Drug Administration and NAFTA

The North American Free Trade Agreement (NAFTA) helps safeguard the ability of the United States Food and Drug Administration to ensure food safety and quality within North America. NAFTA is an agreement between Canada, the US and Mexico that took effect on January 1, 1994, designed to increase the scope for the free flow trade and investment among these three countries. The US Food and Drug Administration (US FDA), which participated in the negotiation of NAFTA, has reviewed the US Food and Drug Administration standards for safety, purity and appropriate labeling of foods and has determined that these standards are consistent with the terms of the agreement. This is why no changes in US Food and Drug Administration standards are needed or proposed to implement NAFTA.

NAFTA does not change existing or future US Food and Drug Administration standards regarding pesticide use or pesticide and other chemical residue or contaminant standards for fresh or processed foods. NAFTA provisions safeguard the ability of the US Food Drug Administration to ensure food safety. In short, existing US Food and Drug Administration standards will continue to be applied to imported foods as well as domestically produced foods. This means that the U.S. will continue to prohibit any food shipments determined not to meet pesticide residue or other food safety requirements.

NAFTA has no effect on U.S. Food and Drug Administration laws and regulations in the area of safety, effectiveness, and appropriate labeling of human and animal drugs and medical devices. Any products coming into the U.S. must continue to meet all US FDA standards and requirements.

Additionally, NAFTA does not change or affect US Food Drug Administration laws and regulations with respect to US Food and Drug safety and appropriate labeling of dietary supplements imported in to the U.S.

U.S. FDA and TWG

Within the auspices of the NAFTA, the three countries have developed a technical working group on pesticides called TWG. It serves as a focal point for all issues related to pesticides for these countries. TWG's aim is to ensure that the countries can be assured of the legality and safety of foods produced in any of the NAFTA countries. US food and drug administration is providing trilateral cooperation between Mexico and Canada to enforce the TWG standards.

Article 723(6) makes explicit that any party challenging a U.S. Food and Drug Administration safety measure would have the burden of showing that the US Food and Drug measure is inconsistent with NAFTA. Whether any particular level of protection is "appropriate" is a social and political judgment that the agreement reserves for the government applying the measure (see Articles 712(2) and 724). As provided in Article 712, a sanitary measure is to be based on a risk assessment "as appropriate to the circumstances," and is not to be maintained where there is no longer a scientific basis for it. US Food and Drug Administration standards are already based on risk assessments and have a scientific basis. These NAFTA requirements help assure that measures applied by the other parties will not unfairly exclude U.S. food exports.

Routes of Drug Administration

Introduction: Route of administration is an important factor which influences the absorption of a drug. The interval between administration and onset of action is determined by the route of administration. Biological lag is the interval between administration of a drug and development of response.

Classification of routes: The routes of drug administration can be classifies as:

Oral or enteral route: It is most commonly used route for drug administration.

Advantages of oral route:

1. It is a safe, convenient and economical route.

2. Self medication is possible.

3. Withdrawal of the drug is possible.

Disadvantages of oral route:

1. Onset of drug action is slow.

2. Drugs which are bitter in taste cannot be administered.

3. Drugs producing nausea and vomiting cannot be administered.

4. The drug may be inactivated by gastric enzymes.

5. This route is not possible in an unconscious patient.

Enteric coated pills and tablets: These are oral preparations coated with cellulose acetate or gluten. These coatings cannot be destroyed by the acid juice of the stomach. Only the alkaline intestinal juice removes these coatings. So inactivation of the drug in the stomach is avoided. Thus a desired concentration of the drug is released in the intestine.

Sustained release or time release preparations (Spansules): These are oral preparations containing various coatings. Each coating dissolves at different time intervals releasing the active drug. So the drug is released slowed for prolonged periods.

Parenteral routes: Routes of administration other than oral (enteral) route are termed as parenteral.

Advantages of parenteral route:

1. Absorption is rapid and quick.

2. Accurate dose of the drug can be given.

3. The drug enters into circulation in an active form.

4. It is useful in emergency.

5. It is useful in case of an unconscious patient.

Disadvantages of parenteral route:

1. Pain may be produced by injection.

2. Abscess procedures are required for injection.

3. Sterile procedures are required for injection.

4. It is an expensive route.

5. Self medication is not possible.

a. Injection

1. Intradermal: The drug is injected in the layers of skin e.g. B.C.G vaccine.

2. Subcutaneous: Non-irritant substance alone can be injected by this route. The rate of absorption is even and slow and hence the effect is prolonged.

3. Intramuscular: The drug is injected deep into muscle tissue. The rate of absorption is uniform and onset of action is rapid.

4. Intravenous: A drug is directly injected into a vein.

Advantages:

(i) The drug enters into circulation in an active form.

(ii) Desired blood concentration can be obtained.

(iii) Quick and immediate effect is produced.

(iv) It is useful in case of emergency.

(v) It is useful in an unconscious patient.

Disadvantages:

(i) Drugs which precipitate blood constituents cannot be administered.

(ii) Untoward reactions, if occur are immediate.

(iii) Withdrawal of the drug is not possible.

5. Intra-arterial: In this route, a drug is injected into an artery. The effect of a drug can be localized in a particular organ or tissue by choosing the appropriate artery. Anticancer drugs are sometimes administered by this route.

6. Intraperitoneal: In this route, a drug is injected into the peritoneal cavity. By this, fluid like glucose and saline can be given to children.

7. Bone - marrow: Bone marrow injection is very similar to intravenous injection. This route is useful when veins are not available due to circulatory collapse or thrombosis. In adults, the sternum is chosen and in children, tibia or femur is chosen for injection.

b. Inhalation: Gases, volatile liquids, aerosols or vapours can be administered by this route.

Advantages:

1. Immediate absorption of the drug.

2. Localization of the effect in diseases of the respiratory tract.

Disadvantages:

1. Poor ability to regulate the dose.

2. Local irritation of the respiratory tract may increase its secretions.

3. Difficulty in the method of administration.

c. Transacutaneous route: It is further classified as

i) Iontophoresis

ii) Inunctions

iii) Jet injection

iv) Adhesive units.

i) Iontophoresis: In this method, a drug is driven deep into the skin by means of a galvanic current e.g. salicylates. Anode iontophoresis is used for positively charged drugs and cathode iontophoresis is use for negatively charged compounds.

ii) Inunction: It is rubbing the drug on the skin. The drug gets absorbed and produces systemic effect e.g. nitroglycerine ointment for angina.

iii) Jet injection: This method does not require a spring. So it is painless. Using a gun like instrument with a micro-fine orifice, the drug solution is projected as a high velocity jet (dermojet). The drug solution passes through superficial layers of skin and gets deposited in the subcutaneous tissue. This method is useful for mass inoculation.

iv) Adhesive units: It is a trans-dermal drug delivery system. It is available in the form of adhesive unit. It delivers the drug slowly. So it produces prolonged systemic effect. e.g. scopolamine for motion sickness.

d. Transmucosal route: It is further classified as

A) Sub-lingual

B) Trans-nasal

C) Trans-rectal.

A) Sub-lingual route: A tablet containing the drug is put under the tongue and allowed to dissolve in the mouth e.g. nitroglycerine and isoprenaline.

Advantages of sub-lingual route:

1. Rapid onset of action.

2. Termination of the effect by spitting the tablet.

3. Inactivation of the drug in the stomach is avoided.

4. The drug enters directly into systemic circulation without inactivation in the liver.

B) Trans-nasal route: It is useful for drugs in the form of snuff or nasal spray. The drug is readily absorbed through the mucous membrane of nose. e.g. posterior pituitary powder.

C) Trans-rectal route: Drugs can be absorbed through the rectum for producing systemic effects. e.g. aminophylline for broncho-spasm, diazepam for status epileptic-us. Advantages of rectal route are:

1. Gastric irritation is avoided.

2. It is useful in old and terminally ill patients.

e. New drug delivery systems:

i) Occusert: It is placed directly under the eyelid. It can release drugs like pilocarpine for prolonged periods.

ii) Progestasert: It is an intrauterine contraceptive device. It produces controlled release of progesterone within the uterus for a year.

iii) Pro-drug: It is an inactive drug which after administration is metabolized into an active drug. For example, I-dopa is an inactive compound. After administration, it is metabolized to the active drug dopamine which is effective in Parkinson.

Local application: Drugs in the form of powder, paste, lotion, drops and ointment can be applied locally for action at the site of application. Drugs can be applied on mucous membranes of nose, conjunctiva, vagina, urethra and rectum. The following are some preparations which are meant for local application:

1. Bougie for urethra.

2. Pessary for vagina.

3. Suppository for vagina and rectum.

4. Enemata for rectum.

Understanding US Food and Drug Administration Recalls

The United States Food and Drug Administration and NAFTA

U.S. FDA and TWG