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Zinc For Colds. Is it effective?

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We have just finished our latest article exploring the use of zinc products for the common cold. Check out our website for the full article:

http://www.pharmacistanswers.com/zinc-for-the-common-cold.html

Here is an excerpt from our article:

Zinc is a mineral that is absolutely necessary for many different biological functions in our body. It is important for growth, appetite, sexual maturation, skin strength, mental functioning, wound healing and immune system function, just to name a few. Deficiency of zinc is relatively uncommon in developed countries as we readily take in the mineral via a balanced diet. It is thought that supplementing with zinc products, such as Cold-Eeze helps to both prevent and treat the common cold. There have been numerous studies conducted on the matter and we are here to sort everything out for our readers. Is Zinc effective for the common cold? Let’s find out!

 

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Our latest question and answer

Check out our site for the latest question and answer!

Is it possible to delay your period by one week while taking birth control?”

Here is an excerpt of our answer:

While it is possible to skip or delay a period while taking birth control pills, it is more easily achievable on products that are mono-phasic, or pills that only contain one level of hormone throughout the entire pack.

 

Current birth control pills are designed to copy the natural menstrual cycle in women. They are used for both contraceptive purposes as well as for helping women maintain a normal menstrual cycle.  There are many different kinds of oral hormonal contraceptives available, but most options contain 3 weeks of active hormonal pills and one of inactive, or placebo pills. Menses occurs during the week you take the inactive pills with no hormones in them. As soon as you stop taking pills with active hormones in them, that is when you will get your period. For those wishing to extend the time until menses occurs, you would need to keep taking active hormonal pills. Again, stopping active hormonal pills WILL bring on the onset of menses. In fact, delaying menses by one month or more is a common way of dosing and is known as continuous dosing, or continuous cycling. While many patients on continuous cycles simply skip the inactive week in their pills and move on to the next pack, newer products on the market such as Seasonale provide 3 months of active pills followed then by 1 week of inactive pills

Read the rest of our answer on our site!

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From The Lab To You: Drug Discovery, Clinical Trials & The Pharmaceutical Industry

Check out our newest article posted over at http://PharmacistAnswers.com!

Here is an excerpt of our article:

From The Lab To You: Drug Discovery, Clinical Trials & The Pharmaceutical Industry

 Drugs have been part of human life since the beginning of recorded history. It started with the discovery of the various medicinal properties of plants. Plants, as we all know, are capable of containing and synthesizing countless chemical compounds, from powerful stimulants such as cocaine and caffeine, to the deadly neurotoxins like curare. Today, plants still yield many valuable compounds and a large portion of the drugs on the market today are variants of naturally occurring chemicals. Over the past 100 or so years, drugs are more commonly invented rather than discovered. Drug discovery in the past mostly consisted of observations of a plants effects (or a chemicals effect) when administered to a person or animal. The effects were noted and recorded with no knowledge as to how exactly that drug was working. Today, the opposite approach is taken in most cases. Instead of simply observing effects, modern drug development relies on knowledge as to how an alteration in a protein or pathway in the body could be effective against a disease. For example, if we wanted to come up with a medication to lower blood glucose levels, we wouldn’t have someone ingest a multitude of chemicals to find out which one works. Using our knowledge of the human body, we may want to find a chemical that alters a protein that regulates insulin release which will therefore help blood sugars.This description of the drug development process is of course a generalization but it gives a good idea of our current thinking behind the process. Even in disease states in which we don’t know everything about the pathophysiology (cancer for example), researchers hypothesize how an alteration in something can bring about a positive effect.  As new drugs are being developed, there are a variety of critical questions that must be answered through the course of clinical research to produce an effective drug.

 Questions That Must Be Answered When Researching New Drugs
  • Can we find a drug that has the desired effect on our intended target?
  • Does this effect on the target have the desired outcome on the disease we are attempting to treat?
  • Does it make economic sense to pursue this drug?
  • Can this drug be administered in a feasible way and is it a stable compound?

    Step 1: Finding A Suitable Chemical Compound

 

 

Most commonly, the first step of drug research is to screen millions of chemical compounds for their ability to interact with a specific molecular target or produce a specific biological response. This screening is mostly done by robotic systems that can process hundreds of thousands of chemicals. Chemicals that fit what is being searched for, or at least somewhat closely fit, are called “hits”.

 

It’s quite rare for a “hit” to actually become a future pharmaceutical drug. Most initial drug hits lack the absolute properties that are being looked for. In the majority of cases, chemists and pharmaceutical scientists have to synthesize derivatives of their “hit” chemical and optimize it so it interacts with its’ target and alters its’ function in the desired fashion. This of course comes with its’ own set of challenges.  The newly synthesized drug must have a high attraction to its target, it must be able to be easily administered and easily absorbed in the body, it must be metabolized safely and it must be free from major side effects.  The chemical must also be able to be produced on a large scale and have the appropriate properties in terms of stability.  Many times a chemical may have a deficiency in one area which prevents it from being realized into a marketable drug.

 

Step 2: Pre-Clinical & Toxicity Testing 

 

After our new chemical comes from the lab, it goes through general toxicity testing in two or more species of animals for a considerable amount of time. When possible, the toxicity testing is not performed in animals but very often it is necessary. The chemical will be particularly tested for its’ carcinogenicity and reproductive toxicity. If toxicity is observed, the researchers need to determine if the toxicity is due to how the drug works mechanistically in the body or if the toxicity is due to drug acting upon an unpredicted part of the body.

 

Step 3: Investigation New Drug Approval & Clinical Trial Testing 

 

 

At this stage in the process, the chemical that is being researched has been in process on average of 3-5 years. Only at this point can the drug company submit what is known as an Investigational New Drug application (IND) to the FDA. The IND is a request to the FDA for permission to test the drug in human subjects. The FDA has 30 days to review the application. The FDA can either approve it or disapprove it and request more data about initial safety and toxicity results. After the IND is approved, we finally move to the clinical trials. Clinical trials take place in four phases, the last of which is after the drug has already been approved by the FDA and can be marketed to patients. Below is a chart of the different phases of drug trials:

 

 

FDA Investigational New Drug Trial Phases
Phase I Phase II Phase III Phase IV
# Of Participants 10-200 50-500 Thousands Thousands-Millions
Subjects Healthy Volunteers Patients with disease being researched Patients with disease being researched Patients with disease being researched
Type Of Study Open Randomized & Controlled (Usually Blinded) Randomized & Controlled (Usually Blinded) Open
Purpose Of Phase Safety & Tolerability Effectiveness & Dosing Effectiveness In Large Populations & Side Effects Side Effects & Adherence
Length Of Phase < 1 Year 1-2 Years 3-5 Years No Fixed Duration
Cost (In $) ~$5-10 Million ~$20 Million ~$50-10 Million
Success Rate In Proceeding To Next Phase ~50% ~25-30% ~25-40%

 

 

Phase I: Phase I clinical trials are typically conducted in healthy volunteers. The purpose of this part of the clinical trial is solely to get safety and tolerability data in the human population for the first time. This phase of the clinical trial is not intended to determine efficacy, or how well a drug works.

 

 

Phase II: This is the phase of the clinical trial where things really begin to pickup and the  efficacy of the drug is trying to be established. Acceptable dosing ranges for safety and efficacy are beginning to be determined here as well. Phase II is the first time in a clinical trial that the drug in question is being tested in those in which the drug is intended for. If the medication is going to be used to lower blood pressure, it would be tested on those with high blood pressure. Phase II clinical trials are very small compared to phase III clinical trials.

 

Phase III: Phase III is the bread and butter of the drug testing process. It is where the most money is invested and it typically takes the longest amount of time to complete. Large scale statistical analysis is completed in this phase, typically with thousands of patients in different locations around the world. In order for FDA approval, a drug company must perform, in the words of the FDA, “adequate and well-controlled investigations”. Currently, the gold standard for clinical trials are randomized, placebo-controlled, double blind studies.

 

Even though the Phase III clinical trials are quite comprehensive, the requirements set forth for FDA approval has some severe disadvantages.

 

Disadvantage: What is a proper control?

Are placebos the best control? In many cases they are, especially if the drug being tested is a novel treatment for a disease. However, it can be somewhat misleading if an alternative treatment is available for comparison. Trials for new drugs very rarely are tested against an existing treatment for multiple reasons and unfortunately, they are often times in the best interest of the drug company. The main reason for testing against a placebo instead of an existing treatment is that the results are much more impactful. For example, let’s say a new drug was being tested for blood pressure and a study found it lowered systolic blood pressure by an average of 14 points. This would be great news for a drug company, as it shows efficacy versus a placebo, which we assume would not lower blood pressure (or would only slightly lower it due to a placebo effect). However, if the drug company tested their new drug against an existing treatment, the results would be much less remarkable. Let’s again assume our new drug lowers blood pressure on average 14 points. Let’s also say an existing treatment lowered blood pressure an average of 12 points. The trial in this case would only show a very slight improvement vs. an old treatment. Older medicatons tend to be drastically less expensive than newer medications. The fact that our new drug is only slightly more effective would spell bad news as the newer medication may very well be seen as not cost effective. Older drugs too have more safety data and physicians are sometimes unwilling or hesitant to prescribe newer drugs. Drug companies don’t want to pour in millions upon millons of dollars to a drug trial to determine their drug is only slightly better (or perhaps worse!) than an existing treatment. Again, it is very rare to see a comparative trial when a new drug is testing for FDA approval.
View the rest of our article over @ our website!!!
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Lipozene: A Pharmacist Review

Check out our newest article!

http://pharmacistanswers.com/lipozene-for-fat-loss–a-pharmacists-review.html

One of our pharmacists looks over the evidence for the popular weight loss drug Lipozene..

Here is a portion of the article:
 

     If you ever watch late night TV, there is a good chance you have come across a weight loss advertisement for a product known as Lipozene that is marketed by a company known as the “Obesity Research Institute”. We decided to take on the task of actually finding out what this stuff is and if it has any evidence for it’s weight loss claims. The most pertinent piece of information that any person starting on a new drug for weight loss wants to know is how well it works. Is it worth their time and money? Unfortunately, this can sometimes be difficult to find out without first trying the product. This often leads to disappointment and lost money. The trouble is for health and diet supplements, information can be extremely hard to find. They are just not well studied. As a pharmacist, I rely on making recommendations based off of evidence based medicine. I look for high quality clinical studies and information to base my guidance on. When someone comes up to me and asks if Hydroxycut is OK to take with their blood pressure medicine, I can only give an answer that is as accurate as the available information,which often is not much. To add to this, most health supplements are not just one ingredient. For example, Hydroxycut has more than 10 ingredients listed on the bottle and those 10 ingredients are not well tested for both safety and efficacy. With Lipozene, I wanted to take the time to give the product a good and thorough review based on the products ingredients and the data (if there is any) supporting its effectiveness for weight loss. I decided I would go through the commercial, and research some of the products claims to see if they can be validated. Feel free to give the commercial a watch as well so you can hear first hand the health claims of Lipozene.

Lipozene Commerical Claim #1:

​”The Obesity Research Institute has found the solution (for weight loss). It’s called Lipozene!”

First off, what is the Obesity Research Institute? I had never heard of them before this commercial. After a quick Google search, it became apparent this was not a large medical association with the goal of performing continuous research on obesity products. They do not actually have a website dedicated to their name. They appear to only sell two products, the aforementioned Lipozene and a product called MetaboUP. Now let’s talk about the actual drug. What is in Lipozene?  Below is a picture of the supplement facts. We see that Lipozene contains an ingredient called Amorphophallus Konjac (Konjac Root). This ingredient actually is nothing new. Amorphophallus Konjac is also known as the elephant yam or the konjac plant.  The root of this plant contains the ingredient we are interested in, glucomannan. It is the glucomanna that is thought to have an effect in weight loss. Glucomannan is a high viscous (thick) soluble fiber. Other soluble fibers you may have heard of include Metamucil (Psyllium) and Citrucel(Methylcellulose). The difference with glucomannan is that it absorbs A LOT of water. Some estimates say it can absorb almost 100 times its weight in water, far more than other types of fiber. When glucomannan is consumed, it absorbs water in the digestive tract and thereby reduces both the rate and extent of absorption of carbohydrates and cholesterol. It is this property that makes glucomannan a product of interest with respect to weight loss. In terms of the Obesity Research Center “finding” Amorphophallus Konjac, that is just not accurate. Glucomannan fiber has been used both as a food and as a medicinal agent in various Asian cultures for more than a thousand years. Its introduction into Western cultures is more recent; since the 1980s. If you were to buy Lipozene, just know that you are not buying some sort of medical breakthrough drug. It is a fiber supplement that been around for ages. 

 

Check out the rest of the article on our website!

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Vaginal itching question!

We just answered a question regarding vaginal itching:

http://pharmacistanswers.com/treatment-for-vaginal-itching.html

 

There are plenty of products out there that you can get over the counter without a prescription.

 

The first thing you want to try and find out however, is if you could possibly have a yeast infection. Products solely intended for feminine itching will not help clear up an infection.

 

Yeast infections can happen for any variety of reasons including antibiotic use, high levels of estrogen, an altered vaginal pH level, pregnancy and immune system status. If you have a few of the common symptoms for yeast infections, you want want to try a product intended to treat them. Some of the common symptoms are:

 

  • A thick,white discharge

  • Pain and itching

  • Painful urination

  • Swelling and redness in the vaginal area

So let’s get to the products you can buy over the counter. We will separate these into two groups. Firstly, the products you should get if you suspect a yeast infection and secondly, products that are intended to relieve vaginal discomfort.

 

Products for Yeast Infections

 

All of the over the counter products are intra-vaginal therapies and most be applied by the user. This differs from prescription products that you can take by mouth. All of the different products work just about the same and can clear 80-90% of yeast infections. In addition, the length of application for each product varies from 1 day to 7 days. Again, they are all about as effective as one another and even though a 1 day product obviously has less applications, it still takes about the same amount of days to clear up an infection. All of the following products are available over the counter and should range from about $5-$20.

 

  • Monistat (Miconazole) and the associated generic products are the most common thing you will see. They go by the name Monistat-1, Monistat-3 and Monistat-7.  The number indicates the days of therapy. They come as either a vaginal cream or tablet. Monistat (Miconazole) 3 day and 7 day therapies are the most commonly recommended by pharmacists and doctors. The longer day therapies are sometimes more recommended because women who have recurrent infections respond better to longer therapies.

 

  • Mycelex-7 (Clotrimazole) is another very common over the counter yeast infection cream. It simply has a different anti-yeast medication than Monistat. It just as effective as Monistat.

 

Products for Vaginal Itching:

 

These products are not intended to treat infections. If you symptoms aren’t going away in a couple of days, it is recommended to go and see a doctor. The following are some products you can buy over the counter for vaginal itching:

 

 

  • Vagisil and the associated generic products are very common and popular. They shouldn’t be over $10 at a local drug store or food market. Vagisil has many different brand name extensions with it including various washes and pH refreshers. The original Vagisil is what you would be looking for. It contains an anesthetic and some disinfectants to help sooth the area and get rid of the itch. It also helps to block odors.

 

 

 

  • Balneol is also a very common medication over the counter for vaginal itching. Balneol does NOT contain an anesthetic as does Vagisil. Think of it more as a moisturizing product. It is a good recommendation for those with sensitive skin.

 

 

 

  • Hydrocortisone is available in many different vaginal itching products and is considered a low strength steroid. It is commonly used on rashes and the such. It should not be used for more than a few days in the vaginal area. Also, if you itching is due to a yeast infection, it’s possible it may make it worse.

 

 

The that about does it for the over the counter medications. My personal recommendation is that if you are thinking it may be a yeast infection, use a generic Monistat product (Miconazole) that is either the 3 or 7 day therapy. If you do not think the irritation is from a yeast infection, I recommend Balneol. It usually is better tolerated than Vagisil for those with sensitive skin.

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