Modern Medicine

[Haggis@wk]

Fighting antibiotic-resistant infections with phages:: “The Food and Drug Administration was another story. Since 1963, the agency has mandated a strict approval process for all medications sold in America. Phage therapy has yet to be subjected to it, so Wolcott had to petition his state regulatory board to allow him to administer it only to people who had exhausted all other options. Then, because you can’t find phages in U.S. pharmacies, he had to trek all the way to the former Soviet republic of Georgia to get it. There it’s sold over the counter like eyedrops. He bought, for $2 each, three clear glass bottles, each filled with a liquid containing hundreds of types of phages.” Plus this: “Our whole regulatory environment has been one major thing that has slowed people down.”

I must confess that I’ve never even heard of phages. Like leeches and maggots, they seem to work in certain circumstances treating antibiotics resistant infections.

[jamiebk]

Interesting article Haggis. I don't know much about them either. From the looks of Brillion, I suspect that he may be diabetic and thus perhaps have a impaired peripheral circulation (to the legs). That may have contributed here...don't know. I also wonder why they did not try hyperbaric oxygen treatments. I have heard that they too are effective with this sort of thing since bacteria loath oxygen. The guy is lucky though...thankfully he had a doc who just would not give up. Many would

[dai bread]

The only phages I know of come with white blood cells. They eat debris and foreign protein, so presumably they're what this man has used. Seems odd, though. I wonder why treatment with a blood product requires so much approval. It's not as if blood products are new therapy.

[Selma in Sandy Eggo]

About the third screen into the whole article, we get some details. The phages that they're talking about are bacteriophage viruses and the FDA's problem seems to be that applying a set of viruses to an open wound seems a bit, um, odd. They're definitely not an antibiotic, in the traditional sense. The theory seems sound, though, and sending in semidomesticated viruses to eat up the nasty bacteria ought to be a useful therapy - is there any way we can get around calling it a drug? It's not a drug and if we can get the FDA out of the loop it might be marketable as a homeopathic therapy, perhaps?

The process of tailoring the exact virus set to the specific bacteria set that a particular patient is suffering from makes each phage mixture different enough from every other phage mixture that the whole drug approval process won't fly at all. How do you do the whole statistics thing with a sample size of one?

[piqaboo]

phages are being used in trials in the Us. they're a common delivery device for gene therapy.
No one really know if the reason the gene therapies so often have dreadful side effects is due to the spliced in gene, or the delivery system, or ... something altogether different.

I cant see the US getting too much into custom mixes of phages. I can see the FDA wanting manufacturers to be ableto produce predictable pure packages of phage, not contaminated wtih anything that isnt supposed to be there.

I've not done it but I dont think phages are all that hard to grow (any more).
Serenity would know more about probable production practices.

[Shapley]

I see that the House has voted to give the FDA regulatory power over tobacco. If the bill also passes the Senate and is signed into law by the President, will the Bureau of Alcohol, Tobacco, and Firearms become the Bureau of Alcohol and Firearms, or will there be some sort of power-sharing deal worked out?

[jamiebk]

I see that the House has voted to give the FDA regulatory power over tobacco. If the bill also passes the Senate and is signed into law by the President, will the Bureau of Alcohol, Tobacco, and Firearms become the Bureau of Alcohol and Firearms, or will there be some sort of power-sharing deal worked out?

Doesn't ATF just enforce the laws? The FDA creates controls and restriction on substances. I am really not sure what the lines are. I wonder if they will put as much emphasis on tobacco as they do on marijuana?

[Shapley]

Doesn't ATF just enforce the laws? The FDA creates controls and restriction on substances. I am really not sure what the lines are. I wonder if they will put as much emphasis on tobacco as they do on marijuana?

According to their website, they are an enforcement and regulatory agency. As a branch of the DOJ, I would expect the focus to be on enforcement. I really think tobacco could have been dropped from their name long ago, since firarms and explosives seem to have become their prime focus in recent years, more so perhaps since 9/11/01. Alcohol and tobacco really seem to be secondary issues. I'm sure they have a few old guys at a small desk overseeing that, while the young guys in the black BDU's are looking for guns and bombs. Perhaps the FDA could take both those 'drugs' off the DOJ's hands as far as regulation is concerned.