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Drug-rush plan spurs concerns on safety

By Barry Meier
New York Times

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 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 drugmaker, GlaxoSmithKilne, 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 liver.

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 FDA antibiotics reviewer who is now an associate professor at George Washington University in Washington, D.C.

Drugs not keeping up

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 FDA, 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 Fowler Jr., an infectious disease expert at Duke University.

Congress passed legislation last year that gives producers five added years of market exclusivity for effective drugs. The measure also directed the FDA to review and approve newer antibiotics more quickly, though it did not provide specifics.

In April, two senators, Michael Bennet, D-Colo., and Orrin Hatch, R-Utah, said they saw legislation as a way to circumvent the time it takes for the Food and Drug Administration to change its testing procedures. Their letter highlighted the plan championed by the Infectious Disease Society of America.

Best of few options?

Under the plan, a new antibiotic, after testing in a small group of healthy patients to show that it is capable of killing regular bacteria, would be tested next, not in a larger group of healthy patients, but in those infected with drug-resistant strains of bacteria.

Woodcock of the FDA likened the speedier testing to the one used for orphan drugs, medications used to treat rare conditions. Unlike an orphan drug, however, an antibiotic might eventually be used in millions of people, an issue that even experts who support faster testing say can produce complications.

For one thing, testing a drug in patients infected with resistant bugs may not yield strong conclusions about the medication, because it can be hard to determine whether a patient’s death or recovery is related to the drug, Fowler of Duke said.

But he added that he believed if such studies were rigorously done they could provide answers.

“It is not perfect, but it can provide a body of evidence in an environment in which we have little or few options,” he said.

Another 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.

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