FDA approves fluoroquinolone for use in poultry More than 5 years after its last approval of an antibiotic for use in poultry, the US Food and Drug Administration has cleared a water-soluble form of sarafloxacin hydrochloride for the treatment of Escherichia coli infections in flocks of chickens and turkeys raised for food. This first approval for animal use of fluoroquinolone in the US follows two public meetings in 1994. : FDA has authorised only 38 veterinarians to prescribe Saraflox WSP (Abbott), . but they write prescriptions for many
any
major
poultry-producing
companies.
Saraflox is expected to be used in the treatment of the 2% of 7 billion commercial chickens that develop E coli-associated disease each year. : Abbott must provide sales and production information so that FDA can be certain that Saraflox is shipped only in appropriate amounts to regions of the country with intensive poultry farming. FDA also requires Abbot to report results from surveys of antibiotic resistance in bacteria from poultry, and the Federal Government is instituting other monitoring steps. The Department of Agriculture is determining a baseline for the frequency of fluoroquinolone resistance in salmonella of animal origin and will establish a surveillance system to measure fluoroquinolone resistance in bacteria from food animals. The Centers for Disease Control and Prevention will add antibiotic susceptibility testing to its surveillance of E coli : 0157:H7 and salmonella in five states. Susceptibility testing will be initially limited to measuring minimum inhibitory
OTC petition for cholestyramine denied in USA a joint meeting, the US Food & Drug Administration’s Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committees unanimously voted to prevent Bristol-Myers Squibb’s Questran (cholestyramine) from being sold directly to consumers. Questran is available over-the-counter (OTC) in New Zealand, and has been recommended for OTC On Sept 27, at
use in the UK. The National Cholesterol Education Program guidelines recommend Questran as a first-line therapy for hyperlipidaemia not controlled by diet. However, the drug has never been very well accepted by patients because of its bulk, taste, and side-effects. Bristol-Myers argued that patient compliance would improve once the drug was available without prescription, claiming that often doctors do not take the time to develop a regimen with patients. The company also said that it hoped that OTC availability would increase public awareness of the link between cholesterol and cardiovascular disease, and said that it was prepared to spend lavishly on television and print advertising. The proposed OTC packaging would warn consumers to see a doctor and to read instructions fully before starting therapy. The panel, however, was worried that many consumers would not consult a doctor, and that many would not understand that Questran would have to be taken for life. Panel member Dr Louis R Cantilena, director of the Clinical Pharmacology division at the Uniformed Services University of the Health Sciences in Washington, DC, said that he felt the company was downplaying the potential for drug interactions. Questran can inhibit the absorption of anticoagulants (conversely, it can also increase the anticoagulant effect), digitalis, thiazide, thyroid hormones, and folic acid. The experts asked the company for more studies to show how consumers actually use Questran.
Alicia Ault Barnett concentrations tor mhibitng bacterial : draw its approval, noting that the advisory growth. If, however, fluoroquinolone- : committees in May, 1994, took no formal resistant bacteria arise, a Federal Inter- : vote on the matter. : Sales of Saraflox could have begun with agency Group, which met for the first time on Sept 11-12, will advise about FDA’s approval in August. The monitorusing molecular methods to trace the oriing systems are still largely in the initiation stages. gins and spread of the resistant bacteria. A food safety organisation FACT (Food Animals Concerns Trust, Chicago, Illinois) has petitioned the FDA to with- Michael Gough ,
One in hundred Ashkenazi may carry BRCA1
HIV gene arrests cell
cycle
of Eastern European may carry a missense mutation in the BRCA1 gene that puts them at especially high risk of breast
in Ashkenazi women before Researchers at the University of California the researchers said. For comLos Angeles AIDS Institute report that a 50", age parison, in the general population all little-understood gene in HIV-1, vpr, is inherited BRCA1 mutations combined able to halt T-cell replication by causing
and/or ovarian cancer, according to a study by researchers in Israel and the USA (Nature Genet 1995; 11: 198-200). They tested DNA samples from 858 unrelated Ashkenazi individuals, descendants of Jews from Central and Eastern Europe. The samples were randomly selected without regard to the individual’s family history of cancer. The researchers found that 8 of those studied had one copy of a specific twobase deletion BRCA1 called 185delAG. The findings indicate that the carrier rate of the 185delAG mutation among the Ashkenazi women is at least three times higher than the estimated carrier rate for all BRCAl mutations combined in the general US population. "The 185delAG mutations might account for 16% of
thought to be responsible for only about 4-1% of breast-cancer cases and 12% of ovarian cancers cases diagnosed before the age of 50. To date, screening for BRCA1 mutations has been practical only for women from families that have a high risk of breast and ovarian cancers. These findings in Ashkenazi suggest that for the first time it may be possible to screen individuals from a large adult population to assess their risk for these diseases. : NIH now plans to test for the mutation in 3000-5000 people of Ashkenazi Jewish descent in the Washington DC area, and the National Cancer Institute will conduct a similar study in Long Island, New York. :
cell-cycle arrest in the G2 + M phase of the host cell, thus keeping the T-cell in an activated state while preventing it from moving into mitosis ( Virol 1995; 69: 6304-13). The finding may explain how the virus gradually undermines the immune system, the researchers said. The researchers speculated that such a cell-cycle arrest may offer the virus several advantages. It lengthens the time that the host cell is activated and thus may maximise the ability of the virus to produce progeny; it might prevent the T-cell from undergoing apoptosis, thus prolonging the life of the host cell; and at the same time it prevents T-cell replication, thus blunting the immune system’s ability to respond to the infection.
Michael
Michael McCarthy
1 in 100
women
Jewish descent
breast cancers 39% of ovarian
960
(range 7-9-23-1%) and cancers (range 22-49%)
diagnosed
are
McCarthy