Before my retirement from FDA in 2002, the problem of antibiotic resistance has already been a hot topic and a big concern in the Division of Anti-Infective Drugs, where I worked as the Chemistry Team Leader. I had not read much publicity on this subject until today. Curious? Please read on..
" A threat to modern medicine-Antibiotic Resistance -From The Washington Post. One of the great medical advances of the last century, the invention of antibiotics, is at risk of being lost. Increasingly, microbes are becoming untreatable. Margaret Chan, director general of the World Health Organization, warned in March of a dystopian future without these drugs. "A post-antibiotic era means, in effect, an end to modern medicine as we know it," she said. "Things as common as strep throat or a child's scratched knee could once again kill."
Since the 1940s, antibiotics have greatly reduced the amount of human illness and death and transformed modern medicine, making possible such sophisticated interventions as hip replacements, organ transplants, cancer chemotherapy and care of premature infants. But evidence is mounting that antibiotics are losing efficacy. Through the relentless process of evolution, pathogens are evading the drugs, a problem known broadly as antimicrobial resistance.
Some bacteria, such as those causing tuberculosis and gonorrhea, have become resistant to multiple antibiotics. In the past few years, researchers discovered a new enzyme known as NDM-1 that can confer resistance to antibiotics on bacteria and can easily jump among different species. As the first-line antibiotics are lost, the replacement treatments are often more expensive, and more toxic.
Meanwhile, the pipeline of new antibiotics is drying up. Major pharmaceutical companies have pulled out of the market, unwilling to make the sizable investments in research and development required for new drugs. Since antibiotics are usually taken for a brief period and then stopped, they aren't as profitable as drugs for chronic diseases. The number of new antibiotics approved by the Food and Drug Administration has steadily declined.
For years, antimicrobial resistance has been a secondary issue in public policy. Now Congress has taken a promising step with provisions in legislation President Barack Obama signed last Monday. As an incentive to develop new antibiotics, the FDA Safety and Innovation Act gives pharmaceutical companies an extra five years of exclusivity to the data behind their product, on top of the existing five years. The intent is to keep competitors, including generics, at bay for longer. It is not clear whether this incentive alone will be sufficient to bring new antibiotics to market, but it is a recognition of the problem.
Far more ambitious action will be needed. Europe has launched a $741 million, seven-year, public-private collaborative research effort to accelerate drug development. For new and existing drugs, it is essential that patients and doctors avoid the irresponsible overuse of antibiotics that occurred in the past. For the most serious infections, where few alternatives exist, the FDA should create streamlined regulatory pathways for approval of new antibiotics".
Alarm bells have been ringing for a long time about the march of the microbes. It is time to pay attention. Indeed, as consumers of antibiotic drugs, we should all be concern on this development which can seriously affect our daily lives. br />
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