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Federal policy enabling 'deadly superbugs'

Posted By Greg Corombos On 05/11/2014 @ 5:19 pm In Front Page,Health,Money,Politics,U.S.,World | No Comments

The World Health Organization recently warned that common infections are becoming increasingly resistant to antibiotics and putting many more lives in danger, a trend one expert says is attributable in large part to government “chains” squashing incentives for drug makers to develop new antibiotics.

In it’s latest report, the WHO released data showing that common infections like E. coli and staph, which can turn into the deadly MRSA infection, are far tougher to conquer with traditional antibiotics than in the past. E. coli was resistant to traditional antibiotics in 48 percent of the samples taken in the Western Hemisphere. The numbers are higher everywhere else in the world and shoot as high as 82 percent in Europe.

Staph infections were even harder to kill, with 90 percent of the samples in the Americas surviving antibiotic treatment. The number is 80 percent in Africa and 60 percent in Europe.

β€œIt’s clear that rates are very high of resistance among bacteria causing many of the most common serious infections – the ones that we see both occurring in the community as well as in hospitals,” said WHO Assistant Director General Keiji Fukuda. “In all regions of the world, we now see that hospitals are reporting untreatable, or nearly untreatable, infections.”

While experts have cast doubt on the reliability of WHO numbers on various issues in the past, Center for Medicine in the Public Interest Co-Founder Robert Goldberg said this report captures the concern pretty well. He said we get this warning about once a decade as a result of bacteria mutating and more people coming into contact with it.

The good news, according to Goldberg, is that this isn’t a hard threat to combat, but he said there are unnecessary hurdles blocking an effective response and putting lives in danger.

“We need to take the chains off companies that would otherwise develop antibiotics but aren’t because it’s too expensive or too complicated to do so,” said Goldberg, who then elaborated on the federally imposed hurdles facing drug makers.

“Every time you produce a new antibiotic, you’ve got to show that it’s better than a placebo or a sugar pill. The problem with that is, in many of these cases, these are patients that are dying, so the placebo was basically assuring them death. Companies need to know that they can try these products on people who need them the most and follow them after the fact instead of doing these large randomized studies,” Goldberg said.

“Secondly, their safety requirements are so much higher for antibiotics than they are for other diseases because the (Food and Drug Administration) says, ‘Well, (with) cancer we can take a risk of toxicity because it’s a fatal disease but antibiotics are going to be used generally so we’ve got to be really, really careful,” he said.

Listen to the WND/Radio America interview with Robert Goldberg:

Goldberg added, “That has led to companies selling off their antibiotic, anti-infective portfolios to focus on stuff like cancer. The answer is pretty simple. The answer is to lower the unwarranted regulations and give companies incentives to produce antibiotics that can address the next generation of pathogens.”

If given the incentive to produce antibiotics again, it would not take pharmaceutical companies long to develop effective treatments for the latest version of these bacteria. Goldberg said the current technology is astounding.

“Craig Venter, who sequenced the human genome, now has a company called Synthetic Genomics, where you’re able to sequence the genome of the bacteria in record time, in a week, and then develop the prototype pill that would block the [bacteria]. Craig can do that in a matter of weeks, but to get the FDA to approve something that is matched to shut off all the deadly signals of the bacteria takes years to get to market,” he said.

“The technology is there to both the natural born mutations and even pathogens that would be developed by terrorists to create a bioweapon.”

So what needs to happen to relax federal restraints on drug makers?

“I think Congress would have to address it. I think they need to pass legislation to expand what is known as the breakthrough pathway. That allows drugs of real health importance to speed through the FDA, much like HIV drugs did in the 1980s. The FDA can do stuff today to change its guidances. I can encourage companies right now to use these breakthrough pathways and could be held accountable for doing so the next time their funding comes up because they’re supposed to meet certain performance standards,” Goldberg said.

“I think one of the performance standards they ought to have to meet is you’ve got to get a number of these antibiotics out the door for these emerging pathogens and make that a national goal.”

However, with bacteria becoming increasingly resistant to current antibiotics, Goldberg said the price of government not getting out of the way could be big and could come due rather soon.

“I think you’ll definitely see an increase in community-acquired pneumonia,” he warned. “You’ll see an increase in hospital-borne infections that are the leading cause of death in hospitals. You will also see many exotic bacteria coming over to the United States. The first time a doctor will see it will be in the emergency room. You’re going to see more and more of that if we don’t use the tools and know-how that we have to solve the problem in a lot faster time than we’re doing it right now.”


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