We hear them preached everywhere, every time.. Eat good cholesterol foods and reduce your figures. When it comes to cholesterol, we all know that there are “good” ones and “bad” ones, with HDL being the good type and LDL the bad type. The problem is how to stick with the good one and get rid of the bad one? It’s a rather complicated subject, so let’s start..

Cholesterol itself is actually very important to human life. It’s when they are present in high levels in your bloodstream that it becomes a problem. Diseases such as stroke, heart disease and other cardiovascular related diseases are associated with high cholesterol. Specifically, high LDL and low HDL should be avoided. LDL may become hardened and forms plaque in your arteries, therefore slowing blood flow. HDL on the other hand, has the ability to take back excessive LDL back into the liver.

We don’t exactly eat HDL or LDL, it forms in the body. Some of the foods that we eat do contain cholesterol, such as eggs, dairy and animal fat. Plant oils and fats contain a cholesterol-like substance called phytosterols. They help lower blood cholesterol levels. Saturated and trans-fats contribute to high LDL, as do simple carbohydrates, such as sugar and white flour.

In general, good cholesterol foods are foods coming from plants, because of the phytosterol they contain. Most animal meats are not good when it comes to cholesterol, except fish (especially deep sea fish) because they contain Omega-3 fats, which are found in canola oil as well.

Keeping a good diet to maintain low LDL level can be be done by eating lots of whole grain foods such as oatmeal and fish. Also don’t forget to eat plenty of fruits and vegetables daily. Eating a bowl of oatmeal every day has been shown to reduce LDL levels.

When you are cooking or baking, choose olive or canola oil, rather than lard or saturated fat. And, eat some nuts every day. It has been determined that eating certain nuts decreases the heart disease risk. So, you might call these good cholesterol foods: walnuts, almonds, peanuts, hazelnuts, pecans or pistachios. One ounce per day is the recommended intake, unless, of course, you are allergic to nuts.

Another thing you can try is replacing your coffee or soda with green tea. Green tea has many benefits related with health, and one of them is its LDL lowering capability. If you can’t stand the original taste of green tea, don’t use processed sugar. Use honey or raw cane sugar instead.

Try to add many kinds of antioxidants into your daily diet. Oxidized cholesterol is a potential danger, since they can form plaques. Antioxidants, such as green tea, vegetables and fruits can help prevent cholesterol from oxidizing and turning into dangerous plaques.

If you can’t stop eating meat or poultry, choose lean cuts. If you can’t stop milk or other dairy products, choose reduced fat products made with skim or low-fat milk.

Making the switch from bad to good cholesterol foods may be easier than you think. You just need to make the right choices.

How Medicines are developed in the European Union and how their safety is monitored.

This is a brief introduction to the complex environment in which are developed within the EU and how their safety is monitored. Most of the information can be applied generally across the world but the focus here is on the way it works in the UK and the European Union

How drugs are developed.

Once candidate molecules have been selected for development they go through a program of pre-clinical and clinical research which will hopefully end in an application for marketing authorisation. The vast majority of molecules fail to complete the course: as few as 1 in 10,000 of the molecules entering the program will be suitable to pass the entire programme and reach the market.

Pre-clinical research

Initially the molecules are tested in a research program of animal, ex vivo and in vitro experiments as required by the rules laid out in detailed regulatory guidelines. These guidelines demand that some short-term animal studies have to be carried out before the substance can be tested in single doses in humans. These animal studies comprise: toxicology studies - working out what are the effects of large doses; pharmacology studies - looking at the effects of the substance on how the body systems function; and pharmacokinetic studies - investigating how the substance is absorbed, distributed, metabolised and eliminated in animals.

The law then requires longer term animal toxicology studies to be carried out before multiple doses can be given to humans, lengthening the periods of exposure and using a larger range of animals as the exposure in humans increases during the clinical research.

In addition to and at the same time as the animal pre-clinical studies, other studies are carried out for example mutagenicity studies (looking at effects on chromosomes and on genetic processes), studies of the effects on the foetus etc. as well as extensive tests on tissue cultures, using computer modelling and other tests which don’t require a live organism.

The rolling program of pre-clinical studies will be synchronised with the clinical study program so that at every step in the clinical trial program, there will have been reassuring information from animal studies. In fact even when it comes to the time applying for a marketing authorisation, there may be ongoing long-term animal studies - usually cancer studies - whose results might only become available after the product is on the market.

Clinical research

Clinical trials in humans go through four phases:

Phase 1: This will usually consist of up to around 100 subjects, investigating the tolerability of increasing single doses of the drug and looking at its pharmacology and pharmacokinetics.

Phase 2: This will usually include the first studies of efficacy in patients with the disease and studies - usually in a few hundred patients - to find a dose that is both effective and well-tolerated. Phase 1 studies sometimes continue concurrently alongside phase 2 studies.

Phase 3: This will usually be an extension to the testing into 1,500 patients though it can include up to several thousand. Here the focus is to demonstrate the efficacy of the product as well as showing acceptable safety in the population that will be using the drug. Where a drug will be given for long periods of time, long-term studies will be carried out. When this program finishes, the registration dossier is assembled and submitted to regulatory authorities. The registration dossier is called the application for marketing authorisation (MAA in Europe, NDA in the US) and is usually submitted electronically. The paper copy of the pharmaceutical, pre-clinical and clinical files often comprises many hundreds of volumes of data, each volume comprising several hundred pages. During the registration review period the clinical trials will usually continue.

Phase 4: This is the post-marketing phase and any tests, trials or reviews once the marketing authorisation has been granted, are usually referred to as Phase 4 studies. These can be both interventional studies and observational studies looking at the pharmacoepidemiological statistics.

Every step and every part of every step in the clinical research program is heavily regulated. So prior to the drug first being tried in humans the regulatory authorities will carry out an assessment all the animal and in vitro studies. Every trial after this first assessment will have to be approved by the appropriate regulatory authorities and separately by ethics committees in each country. The assessments of the regulatory authorities will be based on summaries of the available evidence to date. All of the new relevant safety information from animal studies has to be submitted to the authorities and to the ethics committees during the clinical research program and if the results come through once marketing authorisation has been granted, the results must go to the regulatory authorities.

The pharmaceutical company then creates an investigator brochure which is a summary of all the knowledge about the drug, its safety, its efficacy and anything else known about the drug. The company must then keep this document updated at intervals and supply a copy to any investigators, ethics committees and regulators.

When unexpected serious adverse reactions occur during clinical trials that might have been related to the study drug (SUSARs), full details of them must be sent to the regulatory authorities within short time frames as set out in the various rules - these are called expedited reports. Comprehensive reports of these SUSARs also have to be sent to any investigators and to ethics committees working with the trial substance. Every year while the clinical trial program is running, annual reports (Annual Safety Reports in the EU, IND Annual reports in the US) which include a summary and analysis of all the serious adverse events that occurred during that period and any new safety findings from animal studies, as well as evaluations of benefit and risk, must be submitted to the regulatory authorities and ethics committees. The submission of these documents is required by law and companies are monitored to see if they are complying by a combination of internal company audit and regulatory authority inspection.

The Research and Development departments and Pharmacovigilance departments of sponsor companies will carry out the review of safety in clinical trials before registration. The trials are often run by Contract Research Organizations (CROs) - but responsibility for safety lies with the sponsor company. Safety may also be reviewed on an ongoing basis by independent Drug Safety Monitoring Boards which may be set up for specific studies.

I asked a few questions to Mr. McPherson, the Vice President and General Manager of a company which is a worldwide network of pharmacies, distributors, wholesalers and manufacturers. He also has his own online pharmacy.

1) Question- What are things a person should look for in an online pharmacy?

Answer- First and foremost, verify the pharmacy’s license. The license number should be posted on the website for all to see along with the Board of Pharmacy for that particular area. For example, our pharmacy license number is 1712 and the licensing body is the Alberta College of Pharmacists. One would simply call the College and ask to verify the number as current and in good standing. This is the consumer’s guarantee that the pharmacy is legitimate and is inspected on a regular basis.

In some cases an overseas pharmaceutical company is manufacturing for the U.S. market. In this instance our own FDA must inspect this facility every two years. This fact should be listed on the website; that the facility has been FDA inspected and approved.

Never buy from a pharmacy that does not require a prescription. A physician needs to be monitoring your medications.

Lastly, make sure you can consult with a pharmacist on staff if needed. If there is only space for an e-mail question and no person to talk to, run don’t walk to another pharmacy.

2) Question- How should a person shelve their prescription medicines to keep maximum potency until the medicine expires? (example, keep in closed container out of sun etc.)

Answer- Just about all containers now have these instructions printed on them. Follow the directions.

3) Question- Any advice you can give people about prescription medicines they might not know about?

Answer- Yes, and I’m glad you asked this question. Be an educated consumer. Know why a drug is being prescribed. Be aware of its side effects. How you should take the medication. What other food or drugs may interact with the drug you are taking. How can I do that you may ask? Get a copy of the “PDR Pocket Guide to Prescription Drugs” or “The Pill Book”. They are available in stores all over the country. The cost is very minimal. I believe I paid $5.95 for my pocket PDR. Amazon, I’m sure, has used copies for a couple dollars.