Posts Tagged ‘drugs’

The worsening threat of antibiotic-resistant super bugs

February 7, 2009  |  General  |  2 Comments

Since the dawn of the antibiotic era bacteria have been able to acquire resistance to these drugs. Some are better at it than others. Up until recently, though, antibiotic researchers have by and large been able to stay one jump ahead of the bugs. No longer. We are now seeing some truly frightening super-bugs — bacteria resistant to all known antibiotics. Equally disturbing is that there really aren’t any drugs in the immediate research pipeline that will help us.

There are two reasons this has happened. The first is that bacteria reproduce very, very rapidly — sometimes as rapidly as every 20 minutes or so. The result is pure evolution in action. Every time DNA, the stuff of our genes, reproduces itself there is a very small, but still real, chance that the DNA will not be replicated accurately. These random mutations are most often of no consequence. But sometimes they have major effects; they can alter the makeup of the bacterial cell by changing some aspect of it that was targeted by an antibiotic, rendering the bacteria resistant to its effects. So that antibiotic no longer works in an infection from that kind of bacteria. The offspring of such resistant bacteria are themselves resistant. Worse, in some situations resistant bacteria can pass their resistance on to other bacteria that are not even their progeny, or even the same species of bug.

The second reason for emerging resistance, as most of us should know, is the truly widespread use of antibiotics — in medicine, veterinary practice, and agriculture — when they are not needed, such as for colds. Antibiotics don’t help colds because viruses, the cause of colds, aren’t affected by them and never have been. This situation gives a selective advantage to those bacteria that are resistant over those that aren’t. It’s pure evolution.

So the scary situation we find ourselves in is party caused by biology and partly caused by us. The biology we can’t change — but we must restrict our antibiotic use to situations where they really work.

Troubled times at the FDA

April 24, 2008  |  General  |  1 Comment

The FDA (Food and Drug Administration) has been battered with another serious incident, this one involving bad batches of the drug heparin (a blood thinner) that originated in China. Nearly a hundred people have died and many others experienced serious reactions after receiving heparin which appears to have been deliberately adulterated with a dangerous (and much cheaper) chemical. Until I read about it I had no idea such a large proportion of our drug manufacturing, like our clothes and our children’s toys, has been outsourced, primarily to China. In fact, now over 80% of the medicines you take, or at least the major ingredients in them, come from abroad. How can we be sure those medicines are safe?

As it turns out, we cannot — assuring the safety of these products is nigh impossible. The FDA is charged with inspecting all factories that make drugs. This was at least manageable when these facilities were in the USA, although staffing cutbacks at the FDA have even made this very difficult. In the case of foreign sites, it is unclear where some of these factories even are, and there are four times as many of them as there were 25 years ago. You can read a good discussion of the FDA’s woes here.

What to do? As one knowlegable person has pointed out, playing “kick the FDA” is not the answer. At its current level of funding, the agency will never have enough inspectors to scour the globe inspecting all these facilities. Increasing this surveilance will cost money. Where should that money come from? Drug manufacturers have reaped the financial benefit of outsourcing — I think it is time they either shoulder a major share of insuring the safety of our medicines, or else bring the manufacturing process back to this county where at least it will be easier to monitor. The recent heparin tragedy shows us what can happen if we do not do this.

Would universal health care save money or cost more?

March 20, 2008  |  General  |  No Comments

It seems to me there are two sorts of arguments about the advisability of having a universal healthcare program, one which would cover all Americans. One of these is a moral and philosophical one — that we should have it because it is the right of all Americans to have access to healthcare. If you subscribe to that view, as I do, then the issue is not if, but how. Working through how best to structure it — public, private, or some combination of those — would necessarily involve trying to make the program as cost-effective as possible. But saving money is not the reason to do it.

Proponents of universal healthcare, however, often make the argument it will save money in the long run. The notion is that with better primary and preventative care, people will be able to avoid costly medical needs later by heading off complications of chronic conditions. I have no doubt many individuals would be helped in this way. But I think any savings of that sort would be swamped by the huge influx of people, bringing with them previously unmet demands for medical services. This demand will inevitably increase costs.

Can we do anything about this? Since any budget would be limited in some way, would we need to ration care? Honestly, perhaps we would. But the first thing to do to reduce demand is to weed out the many, many treatments research has shown to have marginal benefits over cheaper alternatives; some are even worthless.

There are many good places you can read about this giant gorilla in the room — the need to control demand for healthcare services in some way — and suggestions about how to do it. One key observation for the most expensive new drugs and services is that their development tends to drive the demand for them, rather than the other way around. You can read more about how this works (with some good illustrations) on Maggie Mahar’s excellent Health Beat blog.