Safety and Effectiveness of Herbs and Pharmaceuticals

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St. John's wort (Hypericum perforatum) has been widely claimed to be effective as an antidepressant. The mechanism of action is unknown; and the active ingredient, if any, has not been ascertained [1]. Studies of extracts standardized for hypericin (one of the herb's constituents) have found it to be about twice as effective as a placebo. A few studies have found it somewhat more effective than a standard antidepressant. However, none of these studies lasted more than six weeks, which is not long enough to determine how long the herb would be effective or to detect any long-term adverse effects [2]. In addition, some of the studies were not well-designed [3,4]. In most of these studies, the diagnosis was not well established, the placebo response rate was lower than usually seen in such studies, the dosage of standard antidepressants was low, and the dosage of hypericin varied more than six-fold. [1]. No serious side effects were reported, but minor side effects include gastrointestinal discomfort, fatigue, dry mouth, dizziness, skin rash, and hypersensitivity to sunlight. However, in February 2000, British journal Lancet carried reports that St. John's wort could interfere with the effectiveness of an AIDS remedy (indinavir) [5]; an immunosuppressive drug (cyclosporin) used to protect patients after heart transplantation [6]; and an anticoagulant (warfarin) [7]. Based on this study and other reports in the medical literature, the FDA issued a Public Health Advisory stating:

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St. John's wort appears to be an inducer of an important metabolic pathway, cytochrome P450. As many prescription drugs used to treat conditions such as heart disease, depression, seizures, certain cancers or to prevent conditions such as transplant rejection or pregnancy (oral contraceptives) are metabolized via this pathway, health care providers should alert patients about these potential drug interactions to prevent loss of therapeutic effect of any drug metabolized via the cytochrome P450 pathway [8].

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St. John's wort should not be used by women who are pregnant or are breastfeeding. Nor should it be used together with standard antidepressants. The potency and purity of the preparations sold in the United States are unknown [1].

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There is no published evidence that St. John's wort is effective against severe depression, which, in any case, should receive professional help. For mild depression, psychotherapy directed at resolving the cause of the depression might be more prudent.

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The NIH Office of Alternative Medicine has funded a 3-year, $4.3-million clinical trial that will compare the effects of hypericum, a placebo, and a standard antidepressive drug on patients who are followed for up to six months [9]. The results are expected in the year 2002. Regardless of the outcome, however, another problem must be overcome before consumers could use St. John's wort effectively. A Good Housekeeping Institute analysis of six widely available St. John's wort supplement capsules and four liquid extracts revealed a lack of consistency of the suspected active ingredients, hypericin and pseudohypericin. The study found:

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* A 17-fold difference between the capsules containing the smallest amount of hypericin and those containing the largest amount, based on manufacturer's maximum recommended dosage.
* A 13-fold difference in pseudohypericin in the capsules.
* A 7-to-8-fold differential from the highest to the lowest levels of liquid extracts [10].

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A sinilar investigation by the Los Angeles Times found that 7 of10 products contained between 75% and 135% of the labeled hypericin level, and three contained no more than about half the labeled potency

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St. John's wort, often marketed as an herbal anti-depressant, may interfere with birth control pills, a medicine used to treat HIV, and other prescription medications. While the FDA has issued alerts to that effect, it hasn't required warning labels on the products. As a result, some brands bear warnings while others do not.

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Pediatricians at Penn State Children's Hospital in Hershey, PA, gave 100 children either dextromethorphan, diphenhydramine, or a non-medicated, sugar water placebo solution 30 minutes before bed. They compared the symptoms on the night when the children received either the medicines or placebo with the prior night when no treatment was given.

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The research showed that the children's symptoms (cough frequency, cough severity, sleep difficulty) improved over time, but those that received the sugar water placebo improved just as much as those that got the medicines. Additionally, their parents slept just as well regardless of their treatment, meaning that there was no benefit in giving the children the medicines compared to the sugar water. Further, those that got the medicines had more side effects--difficulty falling asleep from the dextromethorphan and drowsiness from the diphenhydramine.

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Thimerosal as a preservative was removed from most childhood vaccines by 2001 and the last lots of thimerosal preservative-containing vaccines expired in January 2003. It is still being discussed only because of ongoing litigation in both state courts and the Vaccine Injury Compensation Program. Thimerosal is still contained in some of the flu vaccines routinely given to children since 2004. There are also vaccines that contain trace, often unmeasurable, levels of thimerosal.

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During the nineties, the number of persons reported to be receiving services for autistic spectrum disorders increased substantially. Rates are tenfold higher than in the 1970s; in the MMWR, rates ranged from 4.5 to almost 10 per thousand eight-year-olds. Newspapers have reported that one in 150 children has autism. A study published in Nature Genetics from the Autism Genome Project analyzed genes from more than 1100 families with at least two children with autism. There is some very promising research identifying some loci of genes on chromosomes, particularly Chromosome 11...
An ecological study in Denmark analyzed data from almost 1,000 children diagnosed with autism over 30 years. Thimerosal was used in childhood vaccines from the early fifties until 1992, and there was no trend for an increase in autism up through 1990. From 1991 to 2000, the incidence of autism increased, after thimerosal was discontinued from vaccines, suggesting no relationship between thimerosal and autism in Denmark.

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Indeed, there is considerable uncertainty in the scientific and public-health communities about the meaning of the dramatic rise in autism numbers. Several factors other than a true increase in autism incidence have contributed to the ballooning numbers. These include greater awareness on the part of parents, pediatricians and educators; much broader definitions of autism than in decades past, when only the most severe form of the disorder was recognized (today, ASD includes the milder forms known as Asperger's syndrome and pervasive developmental disorder, not otherwise specified); earlier diagnosis of ASD, which can now be recognized by age 2 in many cases; and the growing availability of special services and interventions for children identified with ASD...
HRSA researcher Michael Kogan, the lead author of the study, admitted that it was hard to explain these vanishing cases of autism which is by definition a lifelong condition. Yet nearly 40% of children who were diagnosed with autism, according to parents, no longer had the condition. It may be that such children received the autism label "to facilitate services for other conditions such as developmental delays," Kogan said. Or it could be that children were only tentatively classified as having ASD when they were very young and then the disorder was ruled out.

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Vitamin D overdose typically happens over a period of time rather than from a single large dose. This is because, unlike most other essential nutrients we consume, the body does not excrete excess vitamin D. Instead, it is stored in the body's fat cells where it can accumulate to toxic levels over time.

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According to the National Institutes of Health, the Upper Intake Levels (ULs) for the vitamin D are as follows:

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* Birth to 12 months of age: 25 micrograms (1,000 IU)
* One year of age or older: 50 micrograms (2,000 IU)

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Studies have also shown that, taken over long periods of time, consumption of vitamin D in amounts above the UL will result in toxicity. For children under the age of 12 months, a sustained intake of 1,000 micrograms (40,000 IU) a day will produce toxicity in just one to four months. For adults, 2,500 micrograms (100,000 IU) a day may result in toxicity in a few months.

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