On February 3, 2006, the Food and Drug Administration (FDA) announced clearance of a new test for the presence in a sample of one strain of avian influenza. Its long name is the Influenza A/H5 (Asian Lineage) Virus Real-Time Reverse Transcription–Polymerase Chain Reaction (RT-PCR) Primer and Probe Set and together with inactivated virus as a source of positive RNA control it is for the in vitro qualitative detection of highly pathogenic influenza A/H5 virus (Asian lineage).
Two genetic lineages of influenza A/H5 viruses exist: Eurasian (Asian) and North American. The primer and probe set, developed at CDC, is designed to detect highly pathogenic influenza A/H5 viruses from the Asian lineage associated with recent laboratory-confirmed infections of avian influenza in humans in east Asia and, most recently, in Turkey and Iraq.
From December 1, 2003, through February 3, 2006, the World Health Organization (WHO) reported 161 confirmed human cases of avian influenza A (H5N1); of these, 86 (53%) were fatal (1). The infections occurred in Cambodia, China, Indonesia, Iraq, Thailand, Turkey, and Vietnam. No infections with avian influenza A/H5 (Asian lineage) have been reported in animals or humans in North America. Since February 2004, CDC has recommended enhanced surveillance in the United States for possible cases of human infection with avian influenza A (H5N1) virus (2).
Consistent with these interim recommendations, testing for this virus is indicated when a patient has symptoms of severe respiratory illness and a risk for exposure (e.g., direct contact with ill, dead, or infected poultry in a country with outbreaks of influenza H5N1 among poultry). Testing for influenza A/H5 (Asian lineage) should be considered on a case-by-case basis in consultation with local or state health departments.
Testing with the FDA-cleared laboratory RT-PCR assay should be conducted in conjunction with other laboratory testing and clinical observations to help diagnose influenza in patients who might be infected with influenza A/H5 (Asian lineage) viruses and to provide epidemiologic information for surveillance purposes. The test also will help to identify influenza A/H5 (Asian lineage) viruses in laboratory viral cultures.
Definitive diagnosis of influenza A/H5 (Asian lineage), either directly from patient specimens or from viral culture, might require additional laboratory testing and clinical and epidemiologic assessment in consultation with national influenza surveillance experts. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions.
Testing with the new assay will be limited to laboratories designated by the Laboratory Response Network (LRN), which consists of approximately 140 U.S. laboratories in 50 states. LRN-designated laboratories ensure that the laboratory employs experienced personnel who 1) are trained in standardized rapid molecular procedures, 2) perform analyses in facilities with appropriate biosafety equipment and containment procedures, and 3) use established means for communication with public health programs.
Influenza A/H5 (Asian lineage) assay protocols and reagents will be distributed by CDC to designated LRN laboratories nationwide during the week of February 6–10, 2006. The real-time RT-PCR primer and probe set is the only laboratory method that has been cleared by FDA for avian influenza A/H5 (Asian lineage) testing and in vitro diagnostic medical device use in the United States. Additional information about the laboratory assay is available at http://www.fda.gov.
References
World Health Organization. Cumulative number of confirmed human cases of avian influenza A/(H5N1) reported to WHO. Geneva, Switzerland: World Health Organization; 2006. Available at http://www.who.int/csr/disease/avian_influenza/en.
US Department of Health and Human Services. HHS pandemic influenza plan. Supplement 2: laboratory diagnostics, appendix 2. Interim recommendations: enhanced U.S. surveillance and diagnostic evaluation to identify cases of human infection with avian influenza A (H5N1). Washington, DC: US Department of Health and Human Services. Available at http://www.hhs.gov/pandemicflu/plan/sup2.html#app2.
The drugs approved as safe for marketing and prescription to consumers in the U.S. are constantly monitored by the Food and Drug Administration (FDA). The monitoring system is seriously flawed, being little more than the next stage of drug testing "in the wild". This effectively reduces consumers to the level of "lab rat" as their experiences, or some of them anyway, are recognized and reported to the FDA.
If consumers grin-and-bear-it through some unwanted reaction and hence it is not reported or if for any other reason it is not conveyed to the FDA, it will not contribute to knowledge of the drug’s performance. Equally, if the reaction is already well documented it will frequently go unreported.
Nevertheless, every month the FDA releases one more month’s worth of changes to the Contraindications, Boxed Warnings, Warnings, Precautions and Adverse Reactions information associated with the drugs and medical equipment it has previously approved. This data is released in a quite timely fashion actually, but monthly summaries are provided in arrears. For example, the November 2005 summary has just been released.
In this November data some 55 products are included. Eight Contraindcation updates were made, three Boxed Warning updates, 14 Warnings updates, 41 Precautions updates and 17 Adverse Reactions updates. That’s a lot of updates and they represent a lot of problems associated with these approved products. I think this is actually just the tip of the iceberg.
While much of the material is best suited to medical or health professional consumption, there is some value for anyone in perusing the data. In any event, take a look at the scope and the types of problems that the FDA is comfortable continuing to expose consumers to. Their Summary is presented below.
Summary View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) — November 2005
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I regularly make references to using natural antibiotics for bacterial infections in preference to the synthetic drugs from the pharmaceutical companies. There are some very good reasons for this.
Every single prescription antibiotic from the drug companies carries significant risks. To exemplify, just some of the direct risks to the consumer include:
- Allergic reactions ranging from a mild rash to severe anaphylaxis resulting in death.
- Mild to severe and debilitating gastrointestinal upset, most of which patients are encouraged to put up with unless very severe.
- Serious damage such as permanent deafness resulting from damage to the acoustic nerve, in the case of intravenous gentamycin, for example.
Another type of risk to the consumer is being prescribed an antibiotic that increases risk but conveys no benefit whatsoever (not including rare cases where prophylaxis can be justified). This includes:
- When a viral illness or allergy is seen but no bacterial infection is present (a very common occurrence, with doctors who over prescribe and mis-prescribe for various reasons).
- When an incorrect antibiotic is prescribed which is not specific for the particular infecting organism.
Other risks apply to the patient and everyone else. These are the risks that the medical profession has to accept ultimate responsibility for. These relate to the massive problem caused by over reliance and indiscriminate prescription of antibiotics resulting in development of so-called super bugs, bacteria that are resistant to one or more antibiotic groups.
This population-wide risk is quite serious. It means that very dangerous bacteria have been developed, antibiotics that may have been helpful have been rendered useless and in response to the evolving strains of bacteria, the drug makers have responded with ever more powerful — and more dangerous — antibiotics. The results to date have had devestating consequences and many lives have been lost as a result.
Interestingly, the above problems are virtually unheard of when natural antibiotics are used instead of pharmaceuticals. The worst I have encountered in decades is some very mild irritation with my favorite topical antibiotic and some very minor gastric upset with my favorite oral antibiotics. These risks are entirely justified given the efficacy of the treatment and absence of the major risks cited above.
So what are these natural antibiotics? Well, there are plenty, but here are just a few.
My favorite topical antibiotic is tea tree oil. It is a remarkable substance derived from the leaves of the native Australian Melaleuca alternifolia tree. Unlike conventional antibiotics tea tree oil is effective against yeasts and fungi in addition to bacterial infections and I have even used it very successfully on viral erruptions.
For example, it has proven effective in bacterial conditions as diverse as acne, throat infections, halitosis (from infections in the oral cavity) and wound infections. It is also effective in treating conditions such as athlete’s foot, jock itch, ringworm, fungal infections of the toenails or fingernails and yeast infections. Applied to cold sores, a manifestation of herpes viral infection, either during the warning tingling stage or early after eruption, it is extremely effective (just keep it out of your eyes).
If using tea tree oil, be sure that you have 100% pure tea tree oil. For most applications use 5-15% solutions daily, whether applied to the exterior or used as a gargle or mouthwash (don’t swallow) or douche. In the case of herpes I disregard some people’s advice and use a neat strength applied very specifically to the affected area with a cotton bud. Everyone should have a bottle of tea tree oil at home. Just remember to store it securely away from children because it is a concentrated product, though every bottle I’ve ever seen has had a secure tamper-proof cap.
Notice that while oral pharmaceutical antibiotics can be very hit and miss antibacterials, they have no effect against viral, fungal or yeast infections. Indeed, they often are the cause of overgrowths of yeasts. This is because, whether or not they kill the infecting organism, they always kill good bacteria which keep these in check, thereby allowing yeasts and undesirable bacteria to flourish.
The natural antibiotics don’t have this problem. Not only do they tend not to kill the desirable bacteria, avoiding the overgrowth problem, several also are actually effective against the other types of organisms. So instead of having undesirable side effects they have bonus beneficial effects. Let’s consider some examples.
The first is grapefruit seed extract (GSE). I will allow the following quote to explain the usefulness of GSE because it presents the use of a natural antibiotic to deal with antibiotic-resistant infections. This illustrates the effectiveness and serves to introduce the care with which natural antibiotics should be used. Note the recommended treatment regimen in the second paragraph.
There are many herbs and essential oils that kill enterococcus, staphylococcus and other bacteria as well as viruses, which antibiotics are unable to treat. One of the most popular is grapefruit seed extract, or GSE, made from the seeds and connecting tissue of citrus fruit. In the October 1996 edition of his Alternatives newsletter (Mountain Home Publishing, 1201 Seven Locks Road, Rockville, MD 20854), David G. Williams, D.C., described an elderly woman with VRE [Vancomycin Resistant Enterocci] who was successfully treated for five days with a product that contains 100 mg grapefruit seed extract, 200 mg Artemisia annua (annual wormwood or sweet Annie) and 200 mg Echinacea angustifolia, 1 capsule 3 times daily. After repeated cultures showed her to be free of the VRE infection, two other VRE patients received the same treatment. Because conventional medicine has nothing to offer VRE patients, this is exciting news — but, as Williams explained, it isn’t news you’re likely to read outside of his publication, for the physicians using this unapproved, unconventional therapy have no interest in creating a medical controversy by reporting their results. “If you have any upcoming surgery or hospital stays, or if you work in a hospital setting,” he wrote, “I would suggest keeping some of this [type of]product around. I would also consider pre-dosing 3 or 4 days prior to any surgery, as well as taking the product for a week or so following the procedure.”
Although pathogens have a more difficult time adapting to natural products, which have a more complex molecular structure than pharmaceutical chemicals, daily exposure might eventually allow some microbes to survive, mutate and become resistant to grapefruit seed extract, just as they are resistant to penicillin and other antibiotics. Although GSE is believed to be free of adverse side effects, large doses over time may disrupt the body’s balance of beneficial bacteria. Two healthcare professionals of my acquaintance have mentioned seeing this disruption in people who have taken large doses of grapefruit seed extract for a month or more. Any herb that is used on a daily basis may become less effective when needed. Alternating grapefruit seed extract with other antiseptic herbs is an effective strategy. So is taking these herbs in “courses,” in which a product is taken for several days and then stopped for a day or two before being resumed (five days on and two days off is a popular regimen), for no more than a month or six weeks before being replaced by another herb.
Puotinen, C.J. Natural solutions to drug-resistant infections, Well Being Journal, 9,1, January/February 2000.
The next natural antibiotic is at least equally effective as an antiviral agent and also eliminates fungal and yeast infections. It is olive leaf extract (OLE). When early investigation by the pharmaceutical industry encountered problems they lost interest. Those problems have been solved and OLE is now used for a wide variety of health benefits besides those mentioned here. The following quote demonstrates the broad spectrum of anti-viral and anti-bacterial effectiveness.
… the researchers at Upjohn found calcium elenolate effective in test tube experiments against the following viruses: herpes, vaccinia, pseudorabies, Newcastle, Coxsacloe A 21, encepthlomyocarditis, polio 1, 2, and 3, vesicular stomititus, sindbis, reovirus, Moloney Murine leukemia, Rauscher Murine leukemia, Moloney sarcoma, and many influenza and parainfluenza types.
They found it effective against these bacteria and parasitic protozoans: lactobacillus plantarum W50, brevis 50, pediococcus cerevisiae 39, leuconostoc mesenteroides 42, staphylococcus aureus, bacillus subtilis, enterobacteraerogenes NRRL B-199, E. cloacae NRRL B-414, E. coli, salamonella tyhimurium, pseudomonas fluorescens, P. solanacearum, P. lachrymans, erwinia carotovora, E. tracheiphila, xanthomonas vesicatoria, corynesbacterium Michiganese, plasmodium falciparum, virax and malariae.
The researchers credit a number of unique properties possessed by the olive leaf compound for the broad killing power:
- An ability to interfere with critical amino acid production essential for viruses.
- An ability to contain viral infection and/or spread by inactivating viruses or by preventing virus shedding, budding or assembly at the cell membrane.
- The ability to directly penetrate infected cells and stop viral replication.
- In the case of retroviruses, it is able to neutralize the production of reverse transcriptase and protease. These enzymes are essential for a retrovirus, such as HIV, to alter the RNA of a healthy cell.
- It can stimulate phagocytosis, an immune system response in which cells ingest harmful microorganisms and foreign matter.
The research suggests that this may be a “true anti-viral” compound because it appears to selectively block an entire virus-specific system in the infected host. It thus appears to offer healing effects not addressed by pharmaceutical antibiotics.
James R. Privitera, M.D., Olive Leaf Extract A New/Old Healing Bonanza for Mankind
Other popular natural antibiotics include garlic, echinacea and golden seal. Also, you should not overlook the role of vitamin C (usually by high-dose intravenous therapy in serious infections) in either directly providing antibiosis or, like the herbs mentioned already, assisting by boosting immune function to help the body help itself in combatting infections.
Natural antibiotics are powerful and effective and should be treated with great respect. Given the serious damage caused by pharmaceutical antibiotics, both at the individual and community levels, we are very fortunate to have natural antibiotics. I recommend that you take action to ensure your good health and avoid infections but if you do ever need an antibiotic I suggest you locate an enlightened doctor who will use natural antibiotics. If your infection is minor you may even be able to successfully treat yourself.
Australian Neuroscientist Darryl Eyles will travel to Denmark next week to launch a study which has the potential to unlock a major risk factor for developing the debilitating mental disorder schizophrenia. Dr Eyles’ research to date has involved animal studies but he will access human blood samples overseas.
Dr Eyles, of the Queensland Centre for Mental Health Research, presented the results of animal studies to the Australian Neuroscience Society meeting in Sydney this week. Rats, a commonly used model prior to human studies, were deprived of vitamin D from the point of conception. This resulted in psychotic-like behaviours in their offspring. The rodents also had structural changes in their brains similar to those found in people with schizophrenia.
Interestingly, Dr Eyles said if vitamin D was added to the diets of rats at the point of conception their offspring developed no such problems.
If the theory proves sound, and vitamin D exposure at conception and during pregnancy can reduce the risk of schizophrenia, the finding would have a major impact in the field of mental health. It would have immediate implications for women planning to get pregnant.
Dr Eyles now intends to investigate the possibility of an association between low maternal vitamin D levels and later schizophrenia risk in humans. He hopes to do that by comparing 16,000 blood samples taken from Danish babies 30 years ago and comparing them with meticulously kept records to determine whether those born with low vitamin D levels had a greater risk of developing schizophrenia in early adulthood.
This study design illustrates the value of retaining samples and maintaining excellent records as it effectively saves almost a 30 year wait for the outcome. If successful it will be possible to recommend that women considering becoming pregnant should ensure they have moderate exposure to sunlight or supplement their diets with vitamin D before they conceive.
Vitamin D is made by the body when the skin has moderate exposure to sunlight and can also be taken as a supplement in the diet. Long associated with normal bone development, vitamin D has more recently been shown to have a significant role in cancer prevention.
Low developmental vitamin D is increasingly being investigated as a possible risk factor for later onset neurological disease including degenerative conditions like multiple sclerosis as well as schizophrenia. Dairy products, though widely promoted as an ideal source, are not the best way to boost vitamin D. Do remember to carefully control your sun exposure, which must be directly on your skin to make this essential vitamin.
The February 2006 edition of The Health Gazette Ezine or Newsletter will be published today, February 1st.
In this month’s edition Dr Jenny Tylee again offers two main articles.
The first article, titled Dealing With Motion Sickness, offers some practical guidelines and some herbal remedies for this common problem. This article continues the series relating to children, though motion sickness is also experienced by many adults.
The second article, titled Heart Disease Risk, continues the series dealing with heart disease, the number one killer that is largely preventable.
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