ORGLIST: Drug Agency Approves Antibiotic

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From: Merlin (medchem$##$home.com)
Date: Thu Sep 23 1999 - 00:19:45 EDT


I decided (upon another's advice) to resend this article since some
people may not be able to read HTML in the email.

Source:
http://www.nytimes.com/library/national/science/health/092299hth-fda-antibiotic.html

**********************************
September 22, 1999


                                        Drug Agency Approves Antibiotic


                                        Forum
                                        Join a Discussion on Health in
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                                        By SHERYL GAY STOLBERG


WASHINGTON -- With drug-resistant bacteria on the rise, doctors have
watched

helplessly as patients died from germs that cannot be cured by
vancomycin, long

considered the antibiotic of last resort. On Tuesday, the Food and Drug
Administration

approved a new antibiotic that promises to rescue some patients when
vancomycin
                                        fails.

                                        The drug, Synercid, manufactured
by Rhône-Poulenc Rorer Inc., is not a panacea for antibiotic
                                        resistance. It is effective only
against a handful of disease-causing microbes, and does not work in
                                        all cases.

                                        And experts worry that
resistance to Synercid could develop as well.

                                        But the drug could be a
lifesaver for some of the 16,000 hospital patients who become infected
                                        each year with a resistant
strain of the enterococcus bacterium, enterococcus faecium, that has
                                        emerged over the last decade.
And so the Federal agency gave the drug fast-track approval,
                                        permitting the company to market
it even though tests of its effectiveness are still going on.

                                        "This is an important drug to
help patients who have no alternative therapies," said Dr. Sandra
                                        Kweder, who heads the drug
agency's division that evaluates new antibiotics. She urged doctors to
                                        use Synercid "judiciously in
order to attempt to minimize the likelihood of widespread resistance to
                                        this drug as well."

                                        For the last 10 years,
scientists at the Centers for Disease Control and Prevention and
elsewhere
                                        have been sounding alarms about
the growth of antibiotic resistance, a problem that is particularly
                                        prevalent in hospitals, where
microbes spread quickly and attack the elderly, people with weak
                                        immune systems and other
vulnerable patients.

                                        Vancomycin-resistant
enterococcus faecium, which goes by the scientific acronym VREF and is a

                                        leading cause of infections from
surgical wounds, on the skin and in the urinary tract, was first
                                        reported in this country in
1989. By 1997, according to the centers, more than half of all
                                        enterococcus faecium strains
could not be treated with vancomycin. Dr. David M. Bell, who
                                        coordinates antibiotic
resistance programs for the centers, called the approval of Synercid
"very
                                        good news" for patients with the
infections.

                                        In addition to being the first
alternative to vancomycin in 30 years, Synercid is the first drug in the

                                        class known as streptogramins to
be approved for sale in the United States. The drug is given by
                                        injection only; it will cost
hospitals $85 a dose and will be available next week, a spokesman for
the
                                        manufacturer said.

                                        Rhône-Poulenc has been making
Synercid available in emergencies to treat VREF infections since
                                        1993; so far, the company said,
7,000 patients around the world have received the drug, including
                                        5,000 in the United States.

                                        But conducting rigorous
scientific tests of Synercid's effectiveness has proved tricky, said Dr.

                                        Kweder of the drug agency, in
part because the patients were so sick they often died of their
                                        underlying diseases, and in part
because there is no other treatment with which to compare the
                                        drug.

                                        Synercid was tested in 1,222
patients with VREF infections. Over all, the drug agency said, the
                                        antibiotic proved effective for
52 percent of patients who were not too sick to be fully evaluated.

                                        In addition to drug-resistant
enterococcus bacteria, scientists have grown increasingly concerned
                                        about the rise of another
microbe, staphylococcus aureas, that has outwitted most antibiotics.
Just
                                        last month, the Federal centers
announced that more than 200 people in North Dakota and
                                        Minnesota had become sick, and
four children had died, from a drug-resistant strain of staph that, in
                                        theory, should succumb to
vancomycin. The deaths suggest that the bacterium, which until
                                        recently has been confined to
hospitals and nursing homes, may now threaten the public.

                                        Rhône-Poulenc asked the drug
agency to approve Synercid for use against these microbes,
                                        known as methicillin-resistant
staph aureas. But the agency refused, saying the company had not
                                        proved the drug's effectiveness.
However, the drug did win Government approval to be marketed
                                        for treatment of skin and
soft-tissue infections caused by staph bacteria, as well as Group A
                                        streptococcus microbes, that are
susceptible to other medications.

                                        The big question about Synercid
is whether, or when, widespread resistance will develop to it.
                                        Virginiamycin, a chemical cousin
of Synercid, has been used over the last decade to promote
                                        growth in animals, and some
experts say it is only a matter of time before resistance to Synercid
will
                                        develop.

                                        "It's not the answer," Dr.
Stuart B. Levy, an expert in antibiotic resistance at Tufts University,
said of
                                        Synercid.

                                        "It is just a temporary
Band-Aid."
**********************************
I apologize to those who were noty able to read the original
attachement.

Sincerely,

--
George D. 'Merlin' McCallion, Research Chemist
Department of Anesthesiology
The Children's Hospital of Philadelphia
Post Office Box 143
Bala-Cynwyd, PA 19004-0143

Office: 1.215.590.6894
Fax: 1.215.590.4443
Email: medchem$##$home.com


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