Push to use new antibiotics 'worrying'
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 favour of directly testing such drugs in very sick patients.
The Health and Human Services Department in the United States announced an agreement last month, under which it will pay US$40 million (S$50.5 million) to a major drug maker, GlaxoSmithKline, to help it develop medication 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 US$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 (FDA).
"It is bad now, and the infectious-disease doctors are frantic. But what is worse is the thought of where we will be five to 10 years from now."
Doctors, faced with dwindling options and little time to decide, are often left with agonising 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 liver.
"A drug like Colistin would not be developed today because it is too toxic," said Dr Helen 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 medicine is not enough, and that limited tests might not be adequate to determine a drug's safety and effectiveness.
They worry that the new medication, without more comprehensive testing, could then be used on healthier patients who do not need it.
"There is really no way of knowing how these drugs are going to perform," said Dr John Powers, a former FDA antibiotics reviewer who is now an associate professor at George Washington University in Washington.
Efforts to develop new antibiotics are not limited to the US.
In Europe, several big producers, including GlaxoSmithKline and AstraZeneca, became part of a joint government and industry initiative recently to develop antibiotics that kill resistant strains of bacteria. As part of the project, companies are pooling their resources and research data.
But one huge concern is what will happen, after a new antibiotic wins special approval for limited use, to prevent the next generation of antibiotics from being overused.
GlaxoSmithKline said that it would seek to limit the use of any new antibiotics it develops by publishing data, when possible, on rates of use at hospitals and by not licensing a drug's use in farm animals.
But some experts, like Dr Powers, said that unless strong safeguards are in place, the new drugs might become widely prescribed.