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Posts tagged ‘FDA’


by Logan

Are You Taking Fake Medications?

Have you ever picked up a medication tablet or capsule, looked at it, and wondered what in the world you were really taking. Luckily for you, the FDA governs medications very closely. Pharmacies are held to a very high standard when they are getting their medication that they in turn dispensing them to you and me, their customers.

But, as health insurance prices are climbing higher and fewer employers are offering insurance, people are looking at different avenues to get their prescription medications.

I have been approached by several people about my opinion of getting medications through the internet. Of course, this is often without a prescription.

Their argument is that they have been on the medication for years. Why do they need to see a Doctor, just to be written for another prescription that they have already been taking.

On one hand, I understand their dilemma. Doctor visits are expensive, especially if you don’t have health insurance.  But, they need to be followed and evaluated for improvement on the medication or lack of improvement despite the medication.  So, for me this argument doesn’t hold water.

But regardless, more and more people are looking to Canada,  Mexico, China, and other countries for their medications

The problem is that they can no way verify that what they are actually taking is what is being sold.

Absorption of a Medication

Every time you take a medication, whether it is Acetaminophen or a Depression medication, a portion of the medication will be lost in the digestive process.

What does this mean?  

For arguments sake, lets say that 50% of the medication is lost from the moment in enters your mouth, until it is absorbed in the stomach.  As the process of digestion begins, the medication usually is intended to be digested through the stomach. As this happens, the medication is actually broken down and absorbed. Sooner or later it enters your blood stream.

This is why dosing is very important. A larger does may mean more absorption. This will help treat you more effectively.  Though there is a saturation point, where more medication doesn’t mean a better effectiveness. A balance is needed to be found.

Counterfeit Medication

This is also called fake medication. Often the medication cannot be verified.  This means you could be taking IBU instead of that expensive muscle relaxer that you are trying to find.   Even if they work to make the medication look like what you are used to taking, you just never know.

Then we are back to dosing. Even if you are taking the right medication, how do you know the dosing is right. This is the real problem. Maybe you are over or under medicating. It is hard to tell, unless you are a pharmaceutical and analysis genius to know if you are taking what you need to be taking.

Some medications, even off by a small amount will drastically change the effectiveness of the medication.

I’ve brought this argument up with my friends, and they think that even some medication is better than no medication. It is hard to sway them differently. But, I hope that they at least know the risk that they are taking.

The WHO or World Health Organization has also looked into this large problem.  They are identifying several areas where fake medications are being used and abused.

They are following several cases where treatment failure and death have resulted because of fake medications.   They tend to call fake medications SFFC medicines.  SFFC means Spurious – Falsely labeled – Falsified – Counterfeit (SFFC) medicines.

The WHO also came up with some of the fake medications.  In 2012 in the US, a counterfeit medication for cancer was found. Avastin was the medication name and it lacked the active ingredient in the medication.

For the last several years Viagra and Cialis have been counterfeited.  This medication is for erectile dysfunction and is a common “underground” medication.

Other medications that have been targeted are HIV medications, Weight loss medications, depression medications, high blood pressure medications, and more.

Overall, the risk of fake medications far outweighs the benefits they could provide. You must think that whoever is creating these medications is doing so for a profit. They will cut corners, even if they are well intended. There is a reason medications are so closely controlled. It is a very difficult and important area and we need to make sure we are doing it right.


by Logan

HPV Vaccination for Girls and Boys Part II

This is the second of two blog posts that will discuss the topic of HPV for girls and boys. This post will look at the two types of vaccines for girls and boys. In Part I we will took a look at HPV and what it causes.  We also looked at Cervical cancer, Pap smears, and how HPV is transmitted.

Vaccines for HPV

Girls

HPV vaccines for girls has come about in the last few years.  Currently there are two vaccines on the market:  Gardasil and Cervarix.

Of the several types of types that cause cancer. The HPV vaccine looks at the higher risk population and the higher risk viral types.  Types 16 and 18 are the most risk because they account for over 70% of the cervical cancers.

Types 6 and 11 don’t cause cancer, but do cause genital warts and this vaccination protects against those types.  These two viral types cause most all genital warts.

So far, HPV vaccine is not approved to be administered to women who are pregnant. There has been no alarming or adverse findings during trial stages.

Gardasil

This was approved for use in June of 2006 by the U.S Food and Drug Administration  or also called, the FDA.

The vaccine was intended for use in girls aged 9 through 26.  It was not approved for use for women aged 27 to 45.  The reason was not because of safety but rather efficacy at preventing cervical cancer at that age.

It must be understood that it is to prevent cancer in those who are becoming sexually active and have not yet come in contact with the virus.  That is primarily why the age is so young. If you’ve already come into contact with the virus, you are already at risk and don’t qualify for vaccinations.

There are 3 injections that are given over a six month period.

The vaccine is considered very safe and only minor side effects have been seen. This is usually around the area where the injection was given.

Cervarix

This vaccine is very similar to Gardasil. It helps protect against the same viral types. Additionally, virus types 45 and 31 had some improvement or protection during clinical studies. 

This vaccine is made from a different pharmaceutical company than Gardasil. It is manufactured by GlaxoSmithKline.

It received approval from the FDA in October of 2009.

It also is given in 3 injections over a six month period of time.

It has a comparable safety history as Gardasil and a similar set of side effects.

The largest difference seems to be the antibody level after it was given was higher in Cervarix than Gardasil when retested after 6-7 months.

It is approved to be given in females from age 10 to 25.

Boys

HPV vaccine has been approved in several countries. This includes the United States, Australia, South Korea, the United Kingdom, and more.

Gardasil is the recommended vaccine currently and in 2009 was granted approval by the FDA. Typically for boys it is given to prevent transmission and prevention of genital warts and penis and anal cancers.  

For boys who have never had the treatment before,  it is recommended to begin at age 9. It has been approved until age 26. This is very similar for approval for girl vaccinations.

A three dose series will also be given.

Gardasil is currently approved and in demand for gay men.  Though if they’ve never been given the vaccination before, the recommended age remains the same. Over 26 and the approval is no longer given.

Administering of the vaccination is effective prior to transmission of the HPV to the male.

Initially the benefits of vaccination for boys was primarily for also protecting the girls. This has been expanded to include genital warts and anal cancers.

Safety for boys if very similar to girls.

Overall

The risk for HPV is very high for both boys and girls, men and women. For the most part, HPV infection will not lead to any serious consequences.  But the risk is high that a serious medical issues, genital warts and cancer could lead to serious medical issues.

Vaccinations are preventative care and will remain such. As a parent, you may not think that at age 9 or 10 or even much older, that your child will have issues with HPV. But studies are showing that this vaccination is helping with HPV infections, even at such a young age.

The new realization is upon us. Vaccinations are beneficial but sometimes it is our own fear that prevents us from getting treatment.

At least now, you are better informed to make a good decision.


by Logan

What is the FDA? Part II

Today we are going to look more into the FDA or Food and Drug Administration.  In Part I we looked at the primary location, including field offices in all 50 states and several countries.  The most important aspect was the regulating power of the FDA.  Much more powerful than most of us even understand.

FDA History

Now let’s jump into the history of the FDA.   It appears to have started in 1906 by President Theodore Roosevelt that signed into law the Food and Drug Act. This prevented seizure of food and goods along interstate transport.  It also stopped movement of food and medications that had been changed from the standard.  At the time it was looking at food with chemical addictives.

Later in 1927, the regulatory powers were reconstructed into a new organization. At the time it was called, USDA body, the Food, Drug, and Insecticide organization.  The name became too cumbersome and was again changed to the FDA in 1930.

Additional control was given to this agency as additional problems, tragedies, and when reformation was required. Such tragedies include the Thalidomide deformity of 1959 where thousands of babies in Europe were born with deformities after their mother was given a medication to treat nausea.  Continued growing problems involving food, vitamins, and cosmetic products increased the FDA control.

Pharmaceutical Testing

Drug testing is one of the larger aspects of the FDA control. A New Drug Application must be submitted to the FDA.  Several rounds of testing, requirements, and follow ups are required during this process. Even after the drug has been approved and used by consumers, post market surveillance is required.

FDA Criticism

The FDA, as many other organizations, has their fair share of criticism. This barrage of attacks has come from both inside the government and outside. Typically it is from the over or under regulations that they are striving to hold. In some cases, it is believed that a certain sector it is not being regulated closely enough by the FDA.

A large criticism is in regards to drug safety. In 2006, a report sent out by the Institute of Medicine indicated that they believed that the regulatory powers were not constant and fair between companies to ensure the safety of drugs on the marked.  This leads to a difficult time with drug approval and may lead to higher drug prices because of the over regulation and possible safety problems.

In the end, the FDA is essential to ensure the best products are given to you and I…The Consumers.

In addition to the best product, the safest, and ensure that manufactures aren’t doing what they say they are doing. As you eat your next piece of food, or take your next tablet of medication, imagine that you are taking something that isn’t really in the pill. You could be given anything and who would be the wiser.  The FDA is a critical and important aspect of ensuring consumer satisfaction.

Criticism though needs to be addressed and a continued balance of regulatory powers is a must. A too overwhelming or controlling government may just as easily run a good product out of availability because of the regulatory process.  It is an important and almost essential thing to have balance.


by Logan

What is the FDA? Part I

The FDA stands for Food and Drug Administration.  This is a government agency that is responsible for the welfare of the general public through governing of several broad areas. This agency is part of the United States Department of Health and Human Services.

They have been given the responsibility to protect the safety of the public through a process of regulating the manufacturing, transporting, production, research, labeling, and pricing of the countries’ goods and products.

The primary building for the FDA is found in White Oak, Maryland.  In addition, there are over 200 field offices throughout the 50 states.  There are a half dozen offices in foreign countries of China, England, Belgium, as well as a few others.

They supervise several areas for regulation including:

1.)     Prescription medications
2.)     Over-the-Counter pharmaceutical drugs
3.)     Vaccines
4.)     Medical Devices
5.)     Tobacco Products
6.)     Dietary supplements
7.)     Food Safety
8.)     Cosmetics
9.)     Veterinary Products
10.)   and a few others

In addition to these departments, the FDA is in charge of enforcing certain laws of the Public Health Service Act.  This could be sanitation along interstate travel or control of pet diseases and include sperm donation. It is surprising the overall vast area where the FDA has oversight.

More recently the FDA has been associated with counterterrorism.  The belief is that security of the food supply and medical products could help prevent the potential dangers to our public health.

Dr. Margaret A. Hamburg is the current Commissioner of the FDA.  She was appointed by President Obama a month after he was sworn in, in February of 2009. He was given advice and a final consent by the Senate. Dr. Hamburg reports to the Secretary of Health and Human Services.

The FDA has power of over $1 trillion dollars in the forms of monetary control, consumer goods, and expenditures.  This is broken up from food sales – over $450 billion,  Medications – $275 billion, Cosmetics – $50+ billion, Vitamins $20 billion, and more.

As of 2008, the budget for the FDA totaled $2.1 billion.  But often, as was the case for 2008, Congress can appropriate funds to the FDA, and $150 million was granted.

More information about FDA can be found at http://www.fda.gov

 

This is Part 1 of a 2 part series.  Check back tomorrow for more information on the FDA.  We will be looking at the history of the FDA and its criticsm.