Q. I have heard you say that there are problems with the flu vaccine. We are coming up on that season. What are the problems, and do you have a solution for the prevention of the flu? This is a controversial subject on which some of my medical colleagues and I do not agree.

I have problems with the flu vaccine on many levels.

While the concept of vaccination is valid, the execution is often flawed. I believe the flu vaccination falls in the flawed category. We assume that if we collect a couple of flu viruses from animal sources on the other side of the world in the year 2003, then we can grow them and vaccinate people in 2004 to prevent this year´s epidemic.

The nature of a virus is that it constantly changes and, therefore, it is difficult for me to see this as a logical endeavor. It is also interesting to note that the flu vaccination does not go through the normal testing required of other drugs, so it is not proven safe or effective.

Last year, a publicity campaign encouraged everyone to get a flu shot. The vaccination was sold using the fear of death, the ultimate sales manipulation.

Many people were vaccinated, supply was short, patient screenings were implemented for high-risk individuals, panic took hold to find a vaccination and, in the end, the vaccine did not work because it did not match the virus causing the illness.

This year, there is the promise of 100 million doses of the flu vaccine. The focus is on high-risk people, including babies, toddlers, pregnant women, anyone older than 50 and people with chronic health problems.

The people with chronic health problems usually have a compromised immune system, which why they are high-risk. Infants and toddlers do not have a fully developed immune system.

These issues raise questions that may not have an exact answer: If an immune system is not developed or is compromised, can the individual adequately respond to a vaccine? And, what if you are vaccinated and exposed to a flu virus the same week? Can your immune system deal with both?

The flu vaccination is a health-care choice, just as with any decision. I personally use drops of the homeopathic Influenza 1M monthly as a preventative.

While there is no scientific way to determine its effectiveness, the same is true for the vaccine. You only know it did not work if you get sick, and you cannot prove it did work if you stay healthy.

Your immune function is a complex system that is affected by your diet, exercise and some supplementation, as well as your overall health picture. It is also normal to get sick occasionally. The best approach to health is a comprehensive wellness approach.

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Q. Your recent article about the flu vaccine left me with the impression that the flu vaccine was not tested for safety. That was a slight misinterpretation of what you wrote. On the Centers for Disease Control and Prevention Web site is a listing of the safety procedures the vaccine undergoes. Clearly, it´s not the same scrutiny drugs undergo, I suspect because it has such a quick turnaround every year. Would you clarify this issue?

I can see how this could be confusing. As with any drug product, there are production standards known as Good Manufacturing Practices. The FDA requires GMP-compliance with all drug manufacturers.

This basically means that a drug product is tested for purity, manufactured in a clean facility, stored properly and has end-product testing to ensure the quality of the product. The influenza vaccination is no exception.

The basic process for the influenza vaccine is as follows: The CDC selects different strains of the virus approximately eight months before the flu season. The virus is then grown in a chick-egg media. It is inactivated, or killed, with formaldehyde. The inactivated virus is then sterilized and tested to confirm sterility.

The general safety test is done on laboratory animals. The animal is observed for seven days after the injection. If the animal is determined to be in good health after that time, then it is considered safe.

Influenza vaccine usually contains the preservative thimerosol, which is a mercury-containing compound.

Most drugs go through a process of testing and clinical trials designed to demonstrate safety and effectiveness of a given drug product. These clinical trials take years and therefore would be impractical to have such testing for the flu vaccine, since they are made approximately nine months before the need.

Even with such testing, there are some drug products that have later been deemed unsafe and/or ineffective. As far as I know, the flu vaccine has not been tested and shown to be safe as in this standard drug testing scenario.

Since my last column on the flu, one flu vaccine manufacturer will not be able to supply the product, and the audio and visual news media will sensationalize the entire issue.

As with many health choices, it is difficult to separate the emotional aspect from the rest of the issues. When anything is in short supply, there is an automatic attraction to posses that item. We see it with every winter storm threat. Just how bad is it to be out of milk or white bread?

This article is written for general informational purposes only. This information should not be used for a diagnosis or as a recommendation for treatment. Nor should it be considered a replacement for consultation with a health care professional.

If you have questions or concerns about your health, please contact your health care provider.