New York Times
by Barry Meir
2 Jun 13
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.
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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.
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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.
In addition, Congress passed legislation last year that gives producers five more years of market exclusivity for effective drugs. The measure also directed the F.D.A. to review and approve new antibiotics more quickly, though it did not give specifics.
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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, Dr. Fowler of Duke said.
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But some experts, like Dr. Powers, the former agency reviewer, said that drug companies might have little incentive to run broader tests once a medication received limited approval. Unless strong safeguards are in place, the new drugs might become widely prescribed.
“The big problem is controlling the marketing,” said Dr. Steven E. Nissen, a cardiologist at the Cleveland Clinic and a frequent critic of the F.D.A. “Companies can get a drug on the market for a narrow indication and before you know it, it is being used in everybody.”
http://www.nytimes.com/2013/06/03/he...ment.html?_r=0
