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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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In the Pipeline: Don't miss Derek Lowe's excellent commentary on drug discovery and the pharma industry in general at In the Pipeline

In the Pipeline

« Kinases and Their Komplications | Main | Empty Shelves »

August 18, 2004

Resistance to Resistance

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Posted by Derek

Forbes has an article on some recent work of Paul Rubin, an economist at Emory. He's looking at the situation in approvals of new antibiotic drugs, which isn't an encouraging sight.

He's of the opinion that too much government effort has gone into cutting overuse of the existing drugs (to try to slow down the development of resistant bacteria) and not enough has been done to make new drugs easier to bring to market. The use of antibiotics in general is being discouraged, and at the same time the FDA has made the regulatory environment for new submissions tougher. A quote:

". . .the FDA policy of requiring additional testing for antibiotics is a fairly bizarre policy and makes no sense. . .A much more cost-effective alternative would be to approve the drug in the normal manner (or even provide an accelerated approval) and spend additional resources on...post-approval surveillance."

He's probably right about this, but (and here's the usual problem) it makes sense only if you ignore the tort lawyers. If your new antibiotic goes out and causes trouble in some subset of the patient population, it's no use telling the attorneys that, hey, the FDA approved it. They're not going to get money out of the FDA; they're going to get it out of you. Nope, it was your willful, stupid, perverse, dare I say evil negligence that led to this completely avoidable tragedy, and. . .aargh, you can write the rest as well as I can.

That's the thing: the FDA requires that we show safety and efficacy. We can prove the presence of efficacy, but safety is merely the absence of harm. No one can prove a trial lawyer's definition of safety. A clinical trial can tell us that in the population that participated in the trial, X adverse events took place. Whether X is a greater or lesser number than we'd expect in the general population is a question that can be answered statistically, but whether our drug caused those X events isn't a question that can usually be answered at all.

In such cases, our best chance is to see if the affected patients had something in common, or if the problem increased in proportion to the dose. Often enough, neither is the case - does that make the compound safe, or not? Even if there weren't any signs during the trials, what will happen when our drugs hit the orders-of-magnitude larger population of paying customers? We don't know. We can rule out what our clinical trials were powerful enough to see, but we will never see the one-in-fifty-thousand kinds of trouble. Not until the lawsuits start flying.

There's yet another problem with Rubin's argument, scientific rather than regulatory, which I'll address tomorrow. . .

Comments (6) + TrackBacks (0) | Category: Infectious Diseases


COMMENTS

1. Dawn B. on August 19, 2004 4:52 PM writes...

Growl. I saw a new Dial soap in the supermarket the other day and wanted to pull my own hair own. It was "hospital" strength antibiotic soap. Uh huh. 'Cause we really *need* that on an everyday basis with normal bugs.

Dawn

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2. Rene on August 20, 2004 1:27 PM writes...

I don't follow the counterargument. Does FDA testing as-is currently provide some protection (for drug makers) against tort lawyers?

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3. Derek Lowe on August 20, 2004 1:58 PM writes...

It provides some cover, definitely, to have a government agency approve your drug as both safe and efficacious. And if they identify potential problems (required liver tests in patients, and so on), then that's an issue that's already out there on the table, too.

The sort of extra surveillance that Rubin speaks of could fall under this heading. As legal protection, it's certainly better than nothing. But my fear is that if the FDA deliberately rolls back an existing safety regime, it'll give the lawyers more room to argue that a "defective" drug was let through when there's a problem. And they don't sue the FDA, they sue us.

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4. Maynard Handley on August 21, 2004 3:36 AM writes...

Are supposedly "antibiotic" soaps and so on a real problem for "real" antibiotics? My understanding is that, while real antibiotics utilize specifics about the chemistry of bacteria that aren't quite the same in humans, the stuff you buy in soaps, lysol and so on is just your run-of-the-mill cellular poison that would doubtless kill humans if ingested, perhaps a strong alcohol or oxidizing agent or suchlike.

I have no stake in this argument either way, I'm just curious about the science and whether this is a real problem.

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5. fin2ut on August 24, 2004 2:55 PM writes...

I'm not sure there's a reasonable alternative to the tort lawyers, they're part of the great circle of American Pie we dine upon, a needful inevitability much like the cockroach or tic. Why you ask?, well let me tell you why: we live in an adversarial culture that maxmimizes Total Utility by acknowledging certain tenents of human nature- to wit, the Corporate Type. If assured of rate-limited damages, this beast will calculate the cost of human life & round down, if you follow me. The unpredicatbility of the tort lottery is nature's negative feedback mechanism to limit the Corporate Beast's venality. Or something like that..........

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6. Dawn B. on August 24, 2004 8:44 PM writes...

Well, since there are antibiotic & "non" antibiotic soaps, I would suspect there is more than just an oxidizer.

A quick Google search turned up Triclosan as the antimicrobial of choice.

A quick abstract from the Journal of Hosptial Infection as showing that triclosan resistance change confer resistance other antibacterial drugs.

So, I would say there is some worry about the increased use of triclosan in the antibacterial soaps. Especially if Dial really is using the "hospital strength" as claimed.

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