Pressure Grows to Create Drugs for ‘Superbugs’
By BARRY MEIER
Government officials, drug companies and medical experts, faced with outbreaks of antibiotic-resistant
“superbugs,” are pushing to speed up the approval of new antibiotics, a
move that is raising safety concerns among some critics.
The need for new antibiotics is so urgent, supporters of an overhaul
say, that lengthy studies involving hundreds or thousands of patients
should be waived in favor of directly testing such drugs in very sick
patients. Influential lawmakers have said they are prepared to support
legislation that allows for faster testing.
The Health and Human Services Department last month announced an agreement under which it will pay $40 million to a major drug maker, GlaxoSmithKline,
to help it develop medications to combat antibiotic resistance and
biological agents that terrorists might use. Under the plan, the federal
government could give the drug company as much as $200 million over the
next five years.
“We are facing a huge crisis worldwide not having an antibiotics
pipeline,” said Dr. Janet Woodcock, director of the Center for Drug
Evaluation and Research at the Food and Drug Administration.
“It is bad now, and the infectious disease docs are frantic. But what
is worse is the thought of where we will be five to 10 years from now.”
Annually, tens of thousands of Americans die from infections, largely
acquired in hospitals, that are resistant to antibiotics, experts say.
Doctors, faced with dwindling options and little time to decide, are
often left with agonizing choices over how to save a patient’s life. For
example, some doctors, in extreme cases, are again using Colistin, an
older antibiotic that was largely abandoned years ago because of the
damage it can cause the kidneys.
“A drug like Colistin would not be developed today because it is too
toxic,” said Dr. Helen W. Boucher, an infectious disease expert at Tufts
University in Boston.
Under a plan proposed by a professional medical group, the Infectious
Disease Society of America, new antibiotics approved through quicker
testing would carry a special label specifying that their use be limited
to very sick patients.
But critics of the plan argue that merely putting a restrictive label on
a medicine is not enough, and that limited tests might not be adequate
to determine a drug’s safety and effectiveness. They say they worry that
the new medications, without the more comprehensive testing, could then
be used on healthier patients who do not necessarily need them.
“There is really no way of knowing how these drugs are going to
perform,” said Dr. John H. Powers, a former F.D.A. antibiotics reviewer
who is now an associate professor at George Washington University in
Washington.
The overuse of antibiotics in people and animals, often for conditions
for which the drugs are ineffective or not needed, is seen as a driving
force in the development of resistant bacteria. As these organisms have
evolved and developed resistance, the development of new drugs has not
kept pace.
Pharmaceutical companies have frequently chosen to put their resources
into developing drugs with bigger payoffs than antibiotics. Also, the
F.D.A., after a scandal several years ago involving an antibiotic called
Ketek, which the agency approved on the basis of fraudulent data and
was subsequently linked to severe liver damage, has been cautious in approving new drugs, infectious disease experts say.
“It has been progressively more difficult to usher a new anti-infective
to market,” said Dr. Vance G. Fowler Jr., an infectious disease expert
at Duke University.
Efforts to develop new antibiotics are not limited to the United States.
In Europe, several big producers including GlaxoSmithKline and
AstraZeneca recently became part of a joint government and industry
initiative to develop antibiotics that kill resistant strains of
bacteria. As part of the project, companies are pooling their resources
and research data.
Along with the recent grant to GlaxoSmithKline, federal officials have also been giving grants to drug makers worth tens of millions of dollars to help them underwrite the costs of developing new antibiotics.
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http://www.nytimes.com/2013/06/03/health/experts-debate-plan-to-speed-antibiotic-development.html?nl=afternoonupdate&emc=edit_au_20130603
Copyright JM Hamilton Publishing 2013
Copyright JM Hamilton Publishing 2013
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