Safety assessment of homeopathic medicines: The Adonis vernalis paradox and the 'analysis trap' of using different pharmacopeias.

Regulatory agencies have to ensure the end-user safety of botanically derived homeopathic medicines prepared with diluted starting materials derived even from toxic plants. In the case of plant-derived homeopathic products, assessment must consider the particular characteristics of an extract and its component molecules, even if diluted. The identification and quantification of these molecules have a crucial role in risk assessment, as it allows complete toxicological evaluation in a regulatory perspective. Different results can be achieved using different approaches and references supported by the same regulatory framework, as different methods of preparation used, assays and test analysis performed in compliance with different referent pharmacopoeias. All these facts can introduce a bias in the safety assessment and the paradoxical outcome for homeopathic Adonis vernalis underlines the need for caution. The case also demonstrates the relevance of considering the analytical method for assessment of all herbal medicinal products or herbal supplements, with the purpose of finding the total amount of toxicants as a good approach.

Questionnaire survey of disease prevalence and veterinary treatments in organic layer husbandry in the Netherlands.

Disease prevalence and veterinary treatments in organic animal production differ from those in conventional systems. In order to gather information about current practices in organic layer husbandry, 33 organic egg producers of 16 small, 12 medium-sized, and 5 large farms were asked to complete a questionnaire on disease prevalence and treatments. On these farms, the mean mortality was 9% and the mean laying percentage was 79%. In contrast with the regulations for organic farming, the use of chemotherapeutics was not recorded on 30% of the farms. One third of the farmers were not aware of the type of vaccination given to their hens, and on the other farms hens had been vaccinated as pullets against nine or more viral and bacterial diseases. Several health problems were mentioned, such as feather pecking, red mites, helminths, infectious bronchitis, colibacillosis, and coccidiosis. On 19 farms, diseases were treated with homeopathic, phytotherapeutic, or other alternative medicines; on 10 of these farms chemotherapeutics were also used. On 4 farms only chemotherapeutics were used, on 10 farms no products were used, and on some farms up to seven products were used. Although quite a large number of organic layer farmers in the Netherlands used homeopathic, phytotherapeutic, or other alternative medicines, the use of chemotherapeutics is currently inevitable to prevent animal suffering or distress in organic husbandry.

The return of the pharmaceutical industry to the market of contraception.

In the 1980s and 1990s, the litigious climate in the US had a catastrophic effect on sales of many major contraceptives. Although oral contraceptives escaped controversy, the intrauterine device (IUD) and Norplant(R) were two targets of damaging litigation. The IUD was withdrawn from the market in 1985. Since 1994 when the attacks began against Norplant, its US sales have dramatically declined, even though no fault has been found in the method or its development. In general, pharmaceutical companies were extremely hesitant to develop new contraceptives during this period. The bleak outlook, however, began to shift in the late 1990s, as fertility rates began to decrease worldwide and contraceptive users increased. By 2025, 2500 million women will comprise the customer base for contraception. Global pharmaceutical companies are now participating in expanding markets overseas and have launched and continue to develop a range of new long-term reversible, and highly effective, contraceptive products outside the traditional oral contraceptive field. Two new contraceptives on the way to the US market are: Mirena, a levonorgestrel-releasing intrauterine system manufactured by Schering-Leiras; and Implanon, a single implant system manufactured by Organon of the Netherlands. Other birth control methods soon to be launched include: emergency contraceptives, the contraceptive patch, monthly contraceptive injections, mifepristone for medical abortion, and modified oral contraceptives.

Homeopathic products, not as innocent and safe as they seem? A case report.

Although homeopathic and other alternative products are very popular and are supposed to be safe and harmless they are not free of risks. We present the case of a 29-year-old woman who had to be treated for a state of extreme agitation after using speed, alcohol and homeopathic slimming droplets (LOCO X112). Toxicological analysis of these droplets revealed the presence of thyroid extract and diethylpropione, an amphetamine-like noradrenergic anorectic agent banned in Belgium. This case among other reports in the literature proves that homeopathic products are not as safe and harmless as they seem. Medical professionals as well as the public should be aware of this.

[The hygienic examination and quality research of Chinese crude drug scorpion].

We selected the method of hygienic test to determinate the infection of colibacilli, salmonelli, mixed bacteria, mould fungus and yeasts on Chinese crude drug scorpion from 29 commerical samples in different storaged period, habitats and commerical standard. The results showed there were not colibacilli and salmonelli in all 29 samples, but infectious mixed bacteria rate is 100%, which is 2.1 times more than salty scorpion in 29 tested samples, and the infectious fungi rate is 72.4%. The fungi of salty scorpion is 15% more than fresh scorpion. The quantity of infected yeasts on salty scorpion is much more than scorpion. There are 4 species of fungi such as Alternaria neesex Wallroth, Aspergillus fumigatus Fresenius, Nocarcia sp. and Tricophyton violaceum Sabouraud. Because of infectious pathogenic bacteria rate is so high, we suggest to increase the item of hygienic test to control the quality of crude drug scorpion and strengthen the administration of commerical drugs, so as to reduce the contaminative condition.

Orrin hatch and the dietary supplement health and education act: Pandora's Box revisited.

Products of unknown safety and efficacy were once referred to as "quackery," and the US Food and Drug Administration (FDA) was empowered to protect public health by preventing their sale and forcing them from the market. However, in 1994, the Dietary Supplement Health and Education Act legitimized their sale as "dietary supplements." Sales increased dramatically, and many Americans now use herbals, homeopathics, and other so-called supplements. The Food and Drug Administration cannot act against them until patients have already been harmed, a dangerous situation. Furthermore, no governmental agency has the authority to force the manufacturers to furnish proof of efficacy. It is vital for physicians to warn their patients that they should use these unproven products only with great caution, and must never discontinue legitimate medical therapy in lieu of unproven products.

Viral safety in homoeopathic medicinal products.

To guarantee the safety of medicinal products as regards infectious agents, numerous national guidelines and recommendations have in recent years been included in the pharmacopoeia general monographs and have influenced the content of the substance monographs. Although the stipulations of the European Pharmacopoeia set out objectives, there is still a certain scope in how the requirements are implemented. This is reflected in the very different responses in Europe to the problems of safety from infection. Different traditions in the use of homoeopathic and anthroposophic therapy and varying levels of expertise among the regulatory authorities within the European Union have resulted in varying standard of assessment. The aim of this publication is to present a standard form of assessment for medicinal products in these therapeutic systems. Demonstrated hereunder is an approach that can be adopted to ensure that the high safety standard required is met for homoeopathic and anthroposophic medicinal products.

Disclosure of the quackery: testing of the bactericidal action of products based on the "hydronic" technology ("informed glass") on ATCC strains of Enterococcus faecalis, Salmonella enteritidis and Candida albicans.

To disclose a quackery called "revitalisation of tired water by hydronic technology", scientific experiments have been conducted with drinking water kept in "ordinary, everyday-use" drinking glasses and so-called 'informed' glasses, a patent-protected product supposed to have an effect on the "structure, vitality and memory of water". Drinking "informed" water is claimed to have a wide range of positive revitalising health effects (blue informed glass), to facilitate weight loss (red informed glass) and to have a stress-relieving action (green informed glass). Allegedly, by the use of the "orgon methodology", information is coded into the glass, which action is additionally enforced by the addition of the "magic life" symbol - a specially designed energy condenser which, together with the selected information, is permanently introduced into the liquid contained in the glass. Since the manufacturer claimed the products to have a broad bactericidal action, regardless of the external conditions and completely independent from additional factor that would lead to the activation of the system, the efficacy of the informed drinking glass was tested using standardised, microbiological tests. Respecting the principle of a single-blind test for each of 5 samples of each type of the informed glass, growth reduction factor (RF) (difference log cfu/ml - colony per unit/ml of control glass and log cfu/ml of each informed glass) was determined after 0,2,4,6 and 8 h in spring water experimentally contaminated with standardised ATCC strains of two types of bacteria and one yeast. The results showed a statistically significant bactericidal action of the blue informed glass with all strains-Enterococcus faecalis (RF 0.62/0.76), Salmonella enteritidis (RF 0.87/0.97), and Candida albicans (RF 0.5/0.60) - as opposed to the red and green glasses where this effect was negligible (RF < 0.1). However, when the tests were repeated in complete darkness, none of the three informed glasses showed any bactericidal action. The obtained results indicate a fraud: bactericidal effect is rather a result of photocatalytic action of a hidden component used on purpose in the production of glass or subsequently applied by the use of nanotechnology (possibly antimony trioxide or titanium oxide) than of the so-called "orgon and hydronic technology".

Perioperative considerations for the patient taking herbal medicines.

There has been a significant increase in the proliferation and use of dietary supplements known as neutraceuticals. Since 1994, herbal products have been regulated by the Dietary Supplement Health and Education Act (DSHEA), which does not require burden of proof to demonstrate premarketing safety and efficacy studies. Scientific literature and government policies have not adequately addressed this fast-emerging group of more than 20,000 health supplements. Lack of purity and standardization of these agents, combined with minimal education in traditional homeopathic medical education, has led to serious health-related problems including arrhythmias, cardiovascular compromise, strokes, and deaths. Even though 30% of our traditional medicines are derived from botanicals, most physicians are either unfamiliar or unwilling to develop any level of expertise with neutraceuticals. A review emphasizing perioperative considerations is provided of the history of herbal medicines, governmental policies, and specific herbal agent-drug interactions.

Quality, efficacy and safety of complementary medicines: fashions, facts and the future. Part II: Efficacy and safety.

This is the second of two papers which review issues concerning complementary medicines. The first reviewed the extent of use of complementary medicines, and issues related to the regulation and pharmaceutical quality of these products; the second considers evidence for the efficacy of several well-known complementary medicines, and discusses complementary-medicines pharmacovigilance. The term complementary medicines describes a range of pharmaceutical-type preparations, including herbal medicines, homoeopathic remedies, essential oils and dietary supplements, which mainly sit outside conventional medicine. The use of complementary medicines is a popular healthcare approach in the UK, and there are signs that the use of such products is continuing to increase. Patients and the public use complementary medicines for health maintenance, for the treatment or prevention of minor ailments, and also for serious, chronic illnesses. There is a growing body of evidence from randomized controlled trials and systematic reviews to support the efficacy of certain herbal extracts and dietary supplements in particular conditions. However, many other preparations remain untested. Strictly speaking, evidence of efficacy (and safety) for herbal medicines should be considered to be extract specific. Pharmacovigilance for complementary medicines is in its infancy. Data are lacking in several areas relevant to safety. Standard pharmacovigilance tools have additional limitations when applied to investigating safety concerns with complementary medicines.

Implanon status report: not on U.S. market yet.

PIP: This article reports on a new single-rod progestin contraceptive implant (Implanon) produced by Netherlands-based Organon NV for market introduction in the US. While Organon considers the timing of Implanon's entrance in the federal Food and Drug Administration (FDA) approval process, Wyeth Ayerst Laboratories of Philadelphia has already FDA clearance in hand to market its two-rod levonorgestrel implant system. However, Wyeth Ayerst continues to conduct additional research. The company's research includes an assessment of potential design, with changes in the trocar insertion device for the two-rod implant being under consideration. Insertion and removal of the single-rod implant system is easier and quicker than with the original six-implant Norplant system. US clinicians and their patients are looking forward to the availability of Implanon.^ieng

Deteccao de fenolftaleina em alguns medicamentos ditos homeopaticos / Phenolphtalein detection in some homeopathic-like drugs

In order to evaluate the composition of some homeopaticmedicaments six products are investigated. The phenolphtalein presence is demonstred in differents proportions by chromatographyc and infrared methods