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.
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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.
13. The amount of money paid by the New York Medicaid
program to Petitioner Ross as a consequence of the mail
fraud of which Petitioner Ross was convicted was $85,137.25.
The author's comments are right on the money. If the American people were aware of the great new products and technologies stifled by EPA and FDA there would be outrage. The problem is that the bureacrats at these organizations can only look at new technology through the paragdigm of their own knowledge base. As such, they often don't understand or find new technology too risky because it does not fit a predefined category.
The author's comments are right on the money. If the American people were aware of the great new products and technologies stifled by EPA and FDA there would be outrage. The problem is that the bureacrats at these organizations can only look at new technology through the paragdigm of their own knowledge base. As such, they often don't understand or find new technology too risky because it does not fit a predefined category.
You talk as if politics and regulation are the only problem, the situation is actually worse than you say. Three things are happening:
-regulatory/political problems that you describe.
-increase in antibiotic resistance (described in many other articles).
-the old methods that we used to discover new antibiotics (isolation of actinomycetes (esp Streptomycetes) from soil and then testing for antibacterial/fungal activity) no longer work. We still find antibiotics in soil of course but they are almost always already discovered antibiotics. Alternatives are being developed (metagenomics, viral therapy) but not much of practical value has appeared so far.
Even if the regulations were changed we would still face a serious problem.
You talk as if politics and regulation are the only problem, the situation is actually worse than you say. Three things are happening:
-regulatory/political problems that you describe.
-increase in antibiotic resistance (described in many other articles).
-the old methods that we used to discover new antibiotics, i.e. the isolation of actinomycetes (esp Streptomycetes) from soil and then testing for antibacterial/fungal activity, no longer work. We still find antibiotics in soil of course but they are almost always already known antibiotics. Alternatives are being developed (metagenomics, viral therapy) but not much of practical value has appeared so far.
Even if the regulations were changed we would still face a serious problem.
I'm surprised National Review would publish an article which is in such stark contrast to conservative principles.
The basis of our democracy is full and open debate on all ideas and products used by our citizens. The Vaccine Court is cited as an example of a good step in litigation, and one might think that the 2 billion dollars it has paid out in vaccine damages show the program has worked.
However, let's put the program in another context. Let's say your car unaccountably accelerated and crashed, severely injuring you. Would you like the court which heard your claim to be run by Special Masters who owe their job to the same government which is in business with the car company, and have no right of discovery for similar accidents?
There is no doubt that the Vaccine Court has been a boon for the pharmaceutical companies, allowing them to increase the number of childhood vaccines from 10 to 39, but doesn't the 2 billion dollars already awarded make you a little bit curious as to what's causing these problems which are being compensated even in this "ideal forum?"
The Vaccine Court allows companies to simply pay a fine (not event that as the court is subsidized through a seventy-five cent fee for every vaccine) and move on.
A recent decision of the Vaccine Court found a child's death as a result of epileptic seizure (oh, and he had autism by the way) was due to his diptheria-pertussis-tetanus shot. Wouldn't it be better to find out why some children have these reactions rather than simply compensating their grieving parents?
