Skip to comments.New Antibiotics, Stat! - The drug makers are in a bind — and public health is in danger.
Posted on 12/21/2010 10:46:30 AM PST by neverdem
New Antibiotics, Stat!
The drug makers are in a bind and public health is in danger.
The development of new antibiotics has slowed to a trickle, just when we need them most. As drug-resistant bacteria are on the rampage worldwide, we find ourselves in a most precarious situation — one not unlike the pre-antibiotic era, before penicillin, when staphylococcal and pneumococcal infections were the dominant pathogens. Now MRSA (methicillin-resistant Staphylococcus aureus) kills more people than AIDS every year, and various multiple-drug-resistant organisms have appeared, leaving doctors with few therapeutic weapons for treating a number of prevalent infections.
How did this happen? Much of the blame can be laid at the feet of the FDA.
In the mid-1990s, the FDA tightened up rules for approval of new antibiotics, requiring companies to provide evidence not only that the new drug candidate was effective and safe, but also that it was more effective than existing antibiotics. Bad move. The drug regulators also began requiring that more patients be enrolled in clinical trials, increasing the cost of drug development. The results were predictable: Drug companies dropped out of antibiotic research en masse.
This trend is clearly demonstrated in the number of new antibiotics. In successive four-year periods beginning in 1983, the number of new antibiotics approved has dropped from 16 (in the period from 1983 to 1987), to 14, 10, 7, and 4 (in the period from 2003 to 2007). And it’s getting worse, not better: only two since 2007. With so many companies having discontinued antibiotic research, the current pipeline is very weak, and so it is unlikely that any magic bullets will soon appear on the horizon.
This repeats a pattern seen two decades ago from which we failed to learn — what happened when the production of vaccines became too onerous and expensive. In 1984, Wyeth Laboratories announced that it would no longer produce its diphtheria-pertussis-tetanus (DPT) vaccine, which the company had been manufacturing for three decades. This was a continuation of an alarming trend, in which most vaccine makers had dropped out of the market, mostly because of the escalating cost of protecting themselves from predatory and frivolous lawsuits. By 1984, the number of companies producing the flu vaccine had fallen by more than half, and the only maker of live polio vaccine left was Lederle Laboratories.
In response to this problem, Congress created the Vaccines for Children Program (VFCP) in 1986. This was designed to provide a mechanism through which a child actually sickened by a vaccine could receive a settlement from a pool funded by fees collected from the vaccine makers. The fees were high –greater than 25 percent of the cost of the DPT vaccine — and the parents of the affected children could still opt out of the program and file civil suits. Despite this program, costs continued to skyrocket, and between 1988 and 2001, ten of 14 global vaccine makers stopped making routine childhood vaccines. Today just four companies are responsible for producing 80 percent of the world’s vaccines. And not surprisingly, between 2000 and 2003, there were unprecedented shortages of eight of the eleven vaccines routinely given to children.
Now, more than 20 years have passed, and Congress has finally awoken to the urgent need to encourage new antibiotic development. Our lawmakers are considering offering drug companies patent extensions and tax breaks, which are intended to regenerate a development pipeline for new antibiotics. Whether this extension will provide a sufficient incentive for drug companies is not clear, since antibiotics are far less profitable than drugs that must be taken for chronic conditions. But even in the best-case scenario, the flow of effective new drugs to combat resistant bacteria won’t start for several years.
Meanwhile, the bugs keep growing and mutating. If the resistance problem jumps ahead of the discovery process, we may again find ourselves with no reliable weapon against infection. Perhaps summing it up best, Dr. Brad Spellberg of the Harbor UCLA Medical Center said: “For these infections we’re back to dancing around a bubbling cauldron while rubbing two chicken bones together.”
— Josh Bloom, Ph.D., is director of public health, and Gilbert Ross, M.D., is medical director, of the American Council on Science and Health.
Government at its best, regulating us to death, literally.
The “protections” (food, drugs, air, water, internet, transportation) are to make us not think, or give up because they make it too easy to merely quit.
Yep...good ole FDA....F the Da*n Americans..
I assume they're not including antiviral drugs, just antibacterial drugs.
The FDA sets one of the four horseman free.
they’d just as soon see a few of the infirm and dependent 6 feet under.
“Now MRSA kills more people than AIDS every “
It is my understanding that AIDS actually kills very few people. AIDS (and HIV that precedes it) weaken the immune system so that the person dies of pneumonia or some other disease or infection due to a weak immune system.
So the article seems like a lot of gobbledygook. What we need is naturally strong immune systems and less reliance on drugs. That means changes in lifestyle are more important than changes in the drug development process. I’m not against drug development. But let’s get some perspective here.
Pre-existing conditions is one example. Health Insurance companies, Medicare, etal should be allowed/required to set rates based on lifestyle. Those engaged in promiscuous sex, alcoholism, Drug addiction and similar lifestyle choices should pay a higher rate than those with good lifestyle choices.
The health insurance market would do this naturally if allowed to do it. But government regulations protect and encourage risky lifestyle choices.
Unfortunately this propaganda piece leaves out the data about the billions in settlements the drug companies have to pay out for the harm caused by other drugs besides antibiotics. If they want to protect antibiotic research, fine. But this shouldn’t be used to let the drug companies avoid responsibility for drugs like Fen-Phen or the workplace shootings and child suicides occasioned by behavior modifying drugs.
This was largely a side effect of Hillarycare. The flu vaccine industry was killed by hillary's child protection law, and the regulators did all sorts of other stupid things.
The FDA has killed so many Americans it's astounding.
Not a word about the gross over-utilization of antibiotics in viral upper respiratory infections, or the HUGE number of antibiotics pumped into the food chain through livestock and poultry. No wonder bacteria are becoming resistant. They are constantly exposed to conventional antibiotics.
In the meantime, don’t abuse antibiotics.
Don’t take them unless you know you have an bacterial infection.
Take all the antibiotics prescribed for you, on schedule, and finish them.
Hey, but there’s plenty of erectile dysfunction drugs, anti-depressants and advertisements.
Big pharma doesn’t get a pass from me.
The FDA, protecting us to death.
This reads like the typical propaganda from the medical industry: No need to use existing drugs wisely, lets just crank out more of them quicker. No doubt the new ones will cost more too.
Spineless politicians putting the interests of the Trial Lawyers ahead of the American people
“What we need is naturally strong immune systems and less reliance on drugs.”
True...but that may not save your life if you have an acute infection, particularly MRSA. Young athletes, which one could reasonably assume to have functional immune systems, have been taken down by MRSA. We need both - a strong immune system and the availability of effective antibiotics for worse-case scenarios.
Much of the blame for resistant bugs falls squarely on the HIV+ and gay community in general.
The HIV+ are immune-suppressed and so are dependant on lots of anti-biotics. They continue with their reckless livestiles, not only spreading HIV, but spreading drug-resitant bugs of other sorts that get out into the community.
All part of the joy that tolerance of irresponsbile people bring.
Our Government Masters fr!gging around, again; this time endangering citizen lives, rather than merely wallets.
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