Nutraceuticals seek credibility in USA supplement, herbal, pharma-
iet ceutical,
and major food
manu-
9 to debate
facturers May how to stimulate more scientific research to back up health claims for a variety of natural substances. These so-called "nutraceuticals" are gaining prevalence in Americans’ armamentarium against disease despite some controversy (see Lancet, March 23, p 755). Recently, there have been a spate of US deaths linked to herbal products, and published studies appear to debunk the salutary effects of increased intake of supplements such as vitamin E and p-carotene. US food and drug laws, with a few exceptions, do not allow these products’ makers to claim any preventive or disease-modifying effects. Stephen DeFelice, chairman of the non-profit in Foundation for Innovation Medicine (Cranford, NJ, USA), convened the recent meeting to draw up recommendations for a new law that would allow for such health claims if research bore them out. DeFelice, who takes the credit for coining the word nutraceutical, helped push for the passage of the 1994 US Dietary Supplement Health and Education Act, which allows manufacturers to claim that their products support nutritional requirements. This was a follow-up to the 1990 US Nutritional Labelling Education Act, which provided US with fat, cholesterol, consumers and other nutritional sodium, met on
food labels. A commission is due to report on the effects of DSHEA in October of this year, but the industry already says that the laws are not good enough. Consumers still do not get enough information about what they ingest, and manufacturers are not being given an incentive to do more intensive research, claims DeFelice. As an example of the shortcomings of the law, DeFelice discussed a study that showed that cranberry juice could prevent urinary-tract infections. Even though the study was published in JAMA, Ocean Spray, who paid for the study, could only say that its juice "promotes a healthy urinary tract" and other cranberry juice makers were able to cash in on the study. Major food and drug makers want marketing exclusivity if they pay for research, and DeFelice seemed to think that a trademarked, branded product would protect a company’s investment. The consensus at the meeting was that the industry would content on
encourage
nitric reduces
the need for surgical with extracorporeal membrane oxygenation (ECMO) for neonates with
to
create
a
Alicia Ault Barnett
Nitric oxide may reduce need for of inhaled Administration oxide (NO) significantly intervention
Congress
system like the Orphan Drug Act, whereby a firm would get a defined period of marketing exclusivity after having done innovative research. However, it is still unclear whether the food and diet supplement industry will acquiesce to meeting the full requirements of the pharmaceutical and biotechnology industry.
Normal development after prenatal heroin born Babies parent(s), foster
to
heroin-addicted
when moved
tive
or
homes,
can
adopdevelop like to
children matched for age and socio-economic status. This finding comes from a study of 330 0-5-6-year-old children directed by Asher Ornoy (Hebrew University Medical School and Jerusalem Institute of Child Development). 40 children separated early from their heroin-addicted parents had developmental quotients (DQ) and intelligence quotients (IQ) similar to those of non-exposed babies-despite low birth weight, small head circumference, behavioural impairment and withdrawal symptoms in the heroinexposed babies. The development of 120 children raised by drugdependent parents was impaired relative to matched controls but the DQ and IQ scores of 40 children raised by their heroin-dependent mothers were better than those of 50 children raised in severe environmental deprivation. "Developmental delay in drug-exposed infants appears to result from environmental deprivation in homes of drug addict parents and not from prenatal exposure, except in 6% of babies where there is frank neurological impairment", said Ornoy. He added that "In-utero heroin exposure should not discour-
non-exposed
age
prospective adoptive parents ".
Rachelle H B Fishman
extracorporeal membrane oxygenation
infants with hypoxic respiratory failure. 230 infants were randomised (all born after 34 weeks gestation) to receive either 100% inhaled oxygen
hypoxic respiratory failure, delegates heard
the annual meeting of the Pediatric Research (May for Society 7, Washington, DC, USA). NO has proved so effective that the National Institute of Child Health and Human Development and Medical Research Council of Canada funded study was halted 2 months early. Researchers from the NICHD Neonatal Research Network and the Canadian Inhaled NO Study Group were investigating whether NO, a potent regulator of vascular tone, could act as a specific pulmonary vasodilator and reduce the incidence of death and/or ECMO among at
Baby
in oxygen controlled environment
or NO in oxygen. Results showed that 62% of babies receiving conventional management went on to require ECMO, compared with only 42% of the NO group. The death rate in both groups was similar-
Janet Fricker
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