YourHealthMatters

Doc, Is My Generic Drug OK?

I frequently am asked if a generic drug is really equivalent to the original brand drug. I find certain patients can tell a difference in effect repeatedly when switched back and forth between the brand and the generic. What is going on?

Generic drugs are tested by the FDA for equivalent absorption to the original brand. The testing involves college age people, healthy and on no other medications. Blood levels for 72 hours are measured after a single dose of the drug and compared to the brand name absorption after a single dose. BUT, one generic form of a given drug is never tested against another generic. The FDA allows a variation of absorption of plus or minus 10%. In Canada a variation of plus or minus 20% allowed. By contrast the variation allowed between different lots of any prescription drug, brand or generic, is only 1%.

The FDA claims that no more than 1% of generic drugs tested fail their testing. However, 1% is enough to mean some people will have a problem. And remember, the testing is done with a single dose in a healthy young individual who likely has optimal acid production and absorption compared to the typical person taking medication. Consider what could happen if you take one generic that  is 10% better absorbed than the brand and then you take a second generic version that is 10% less aborbed - you have a difference of 20% in possible effectiveness. When talking about blood pressure control, anticoagulation, seizure control, thyroid management, diabetes and heart disease, these differences can be apparent clinially and can be very significant.

Ontario, where I practiced for 25 years, has different rules about which drugs they will allow generic switching. They do not allow Lanoxin, a  brand name heart medication to be substituted and they also do not allow Coumadin, a brand name anti-coagulant, to be substituted. The FDA allows both these drugs to be substitituted.

Insurance companies have different rules about paying for brand name drugs. Usually a patient has to show the generic failed first before brand name drugs will be covered.

Ever since the first generics were released over 20 years ago I have seen some people who show differences in effect when switched to generics. This is not common. I also see people who likely react to the different so-called inert filler ingredients used to make the tablets and capsules. These "inert" fillers can cause allergy and other reactions in sensitive people. The fillers used by different manufacturers of the same drug are usually not the same. This issue is never acknowledged or tested by the FDA.

Bottom line - I prescribe generics when possible and am sensitive to the possible problems switching sources of prescription drugs can cause in people.

drBob

Making Sense of Cold Remedies

With cough, cold and flu system in full swing right now, I get many questions about what to take for treatment and symptom relief. The shelves are lined with many products all trying to stake out a special niche for your buying attention. In reality when it comes to symptom relief of fever, aches, coughs, colds, sniffles, and stuffy heads they are only five major ingredients in all the products and understanding their uses can help save you money and frustration.

Treatment of fever has alwas been possible with ASA, acetominophen or any of the over the counter NSAIDs such as ibuprofen or naproxen. These may be added to any cough or cold product so the product can claim to treat more symptoms in a single tablet or capsule. Children under 12  and anyone on an anticoagulant such as warfarin, should not take ASA.

For drying up drainage and shrinking swollen tissue in the nose and throat you need a decongestant and there are only two common ingredients, phenylephrine and pseudoephedrine. The former is available on the shelf and for the latter, you have to ask the pharmacy staff for pseudoephedrine. This is one of the ingredients highly sought after for illegal methamphetamine production so it is now only sold from behind the pharmacy counter and you may have to sign for it.

Which is better? Pseudoephedrine is far superior to phenylephrine so it is worth asking for it

For cough symptoms you need to decide if you want to loosen a cough or suppress it. I recommend loosening a cough only in daytime and using a cough suppressant overnight for better sleeping.

Guiafenesin is the best common expectorant for loosening a cough and sold under the brand name Mucinex© and also in plain Robitussin© cough syrup. Dextromethorphan is the best OTC cough suppressant and is found in many products and often identified in the label with the abbreviation DM. So you can take Mucinex-DM or Robitussin-DM or countless others. But consider what you are trying to do with the combo products. On one hand you are trying to loosen the cough with the guiafenesin and on the other hand you are trying to suppress the cough with the DM ingredient. Does that make any sense to you? It does not make sense to me.

The fifth ingredient in many products is an antihistamine. Common ones are chlorpheniramine and brompheniramine. They are not really very useful for cold symptoms, however they can help with allergy symptoms, which is what they were designed for in the first place.

So to summarize -

Phenylephrine - weak decongestant
Pseudoephedrine - stronger decongestant

Guiafenesin - expectorant for loosening a cough
Dextromethorphan - cough suppressant

antihistamines - not really very useful

There are new FDA rules out for what is safe for children under 2 so my comments on these ingredients are primarily for older children and adults.

Then I often get asked how to kill the infection. Stay tuned.....

drBob

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Finally - The Truth About Anti-Depressants!

Finally someone looks at the real research results on anti-depressants. Publishing in the current New England Journal of Medicine, a group of researchers from Oregon found that about one half of the studies done on 12 anti-depressants between 1987 and 2004 were never published. Not surprisingly of 38 positive studies, 37 were published and of 36 negative studies, 3 were published and 12 were re-written and made to look positive. The rest just got filed somewhere and no one is admitting why or how yet.
It's the positive published studies which influence the FDA to approve a drug and also influence doctors to use them. For a fairly benign account of the results read this article posted on MSNBC-

http://www.msnbc.msn.com/id/22690043/

To get a better sense of what these studies actually showed, read what my mentor and friend Dr. Norm Shealy, MD writes in his newsletter this week.Opening line in his article is "The January 17, 2008 issue of  The New England Journal of Medicine  has the most FDA-incriminating article I have seen in an establishment publication!" He shoots straight from the shoulder about the fact that overall these studies show about a 31% effectiveness when taking anti-depressants. Most placebos work about 30-35% of the time in medical studies. He then goes on to discuss other more effective natural approaches. He does not mention the use of natural building blocks for increasing neurotransmitter levels in the brain, partly because this is not what he uses in his practice. I have written extensively about natural ways to improve your brain chemistry on this site in my series entitled Change Your Brain Chemistry. Norm's article is here-

http://www.selfhealthsystems.com/archiveletter.php?id=187 

Why are only the positive studies published and is this happening with all major medications we have on the market? There is no obvious proven answer for this and I'll bet the "spin doctors" working for Big Pharma will find a way to push this finding under the rug, just as the negative studies on these drugs were.

drBob

"Which Emerging Research May Suggest..."

Have you seen the latest TV ad for a Calcium supplement with Vitamin D which tries to claim it can benefit both your bone and breast health? After stating that calcium helps build stronger bones which is correct, the ad then states it contains Vitamin D "which emerging research may suggest" can help your breast health. It's wonderful to see this recent research already touted on TV in an ad but the facts are not quite what the ad claims. Of course they have to be mindful of the FDA and FTC always watching what is advertised. I've noticed that more than one drug or supplement are now trying to claim two benefits, as opposed to their competitors who may only claim one benefit. This ad is aimed at women obviously, even though the research shows that Vitamin D3 also lowers prostate cancer risk. The ad does not state which type of calcium or Vitamin D is in the product. Let's look at the real facts -

Recent research has shown quite strongly that if your blood level of Vitamin D3 is at least 58 ng/ml, this can reduce your risk of breast cancer, colon cancer, prostate cancer and lung cancer by up to 50%. The problem is most adults have nowhere near this level of Vitamin D3, even if they take any over the counter Vitamin D supplement, which typically have either 400 or 800 units per dose. In my experience it takes at least 2000 units per day to achieve the protective level of vitamin D3.

It is imperative to measure your Vitamin D3 level before deciding what dose is needed. This test costs about $125 locally for a cash-pay patient. This is one of the cheapest tests I know of to help you improve your cancer protection. To take 2000 units daily of Vitamin D3 costs less than $5 monthly, again the cheapest way I know to decrease cancer risk for a number of common killers.

To learn more about picking a calcium supplement or a Vitamin D3 supplement, use the search bar at the top right of this page and search my previous posts.

drBob

Hazardous to What...?

Have you ever thought about what that Postal Clerk could be asking when he or she asks if the package you are shipping "contains anything fragile, liquid, dangerous or hazardous to anything?"

I was mailing a box of vitamins last weekend and when asked if the box contained anything that could be hazardous to anything I had this odd thought.

"Yes, it contains vitamins which could be hazardous to your bad health." The clerk didn't get the joke.

This led me to think about a novel way to think about your health and your habits. Let's make a list with two columns - Great for Your Health and Hazardous to Your Health. Think of everything you do and don't do about your health and fill up that list. Hopefully the first column will far out-run the second column. If not, you have some great ideas for goals for 2008.

Because Your Health Matters

drBob

For My Patients - February Trip

4 weeks from now on February 7, Lynda and I will be going on a holiday until Feb 17.
The office will be open with our staff Thursday Feb 7 and Feb 11-14. You can call in for refills if needed during that time, and drop by for supplements.

We will be back in the office Monday, February 18.

Check your prescriptions for refill dates and let us know before we leave if you need any refills that require written prescriptions.

drBob