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The Forbidden Silver Bullet Against Infection

It's illegal to use cures sold over-the-counter in other countries.

By Will Offensicht  |  April 16, 2010

Mankind has known for a hundred years that there are two basic mechanisms by which you get sick - you can be infected by bacteria or you can be infected by viruses.  Bacteria are living cells which reproduce themselves; most bacteria multiply by splitting in half every few hours.  Unless they're in an environment where something eats them, bacteria multiply until there's no more food at which point they starve to death.

Along the way, unfortunately, deadly bacteria generate waste chemicals which poison humans, so we die of the infection long before the bacteria eat all the food available from our bodies.  The bacteria die eventually once they've eaten whatever's left of our corpses after we die, but that's cold comfort to a person dying of infection.

Viruses are far simpler than bacteria.  Some scientists argue that viruses aren't really alive because they can't reproduce themselves.  Viruses multiply by sneaking through the membrane around a cell and taking over the mechanism by which the cell makes copies of itself, like hijacking a factory.  Instead of making another cell, the cell makes many copies of the virus, falls apart, and dies.

Like bacteria, unless something destroys the viruses, they'll multiply until all the cells are gone then starve to death.  Along the way, they destroy enough of your cells that you die.  The viruses die when all your cells die because they need living cells to reproduce, but knowing that isn't much comfort when you're dying.

When penicillin came on the market shortly after WW II, it was literally a miracle drug - it killed harmful bacteria, cured infections, and saved many lives.  Unfortunately, doctors overused it.

Bacteria reproduce every few hours and go through many generations while you're fighting a disease.  Any bacteria that survive pass on their resistance by natural selection.  Eventually, bacteria were able to defend themselves against penicillin and it didn't work very well any more.

Drug companies developed and sold as many different antibiotics as they could.  Eventually, bacteria became resistant to the point that we have MRSA, a potentially fatal strain of bacteria that resists almost all antibiotics.  Some experts predict that we'll soon find ourselves back in pre-penicillin days as resistant bacteria spread further and further.

The Road Not Taken

There is another way, however.  In "Viruses Stop Antibiotic Resistant Bacteria," Science News reports:

Nearly a century ago, biologists discovered viruses that prey upon bacteria. When penicillin and other antibiotics emerged a few decades later, however, physicians largely abandoned their efforts to use these bacteriophages, or phages, to thwart infectious diseases.

There were sound reasons why drug companies concentrated on artificially-manufactured antibiotics as opposed to phages:

No patient wants to take broad-spectrum viruses which can infect many different kinds of cells, that would be like becoming infected with H1N1 in order to cure a cold.  The only medically-useful phages kill one or two kinds of bacteria.

This makes it a lot harder to make money selling phages because there's no point in giving a patient a phage which doesn't destroy the specific bacteria that's causing the infection.  Doctors have to culture the infection, determine precisely which phage kills it, and give the patient that phage and only that phage.

On the other hand, because phages are so specific, they have certain advantages.  They don't kill off the good bacteria you need to digest food, for example.  Also, phages die out when the bacteria are gone as opposed to antibiotics which some researchers claim hang around in your tissue and keep killing off the good bacteria you need to digest food.

As more bacteria develop resistance to antibiotics, there's renewed interest in phages (SN: 6/3/00, p. 358: Scientists now report that these viruses can prevent mice from dying after being infected with an antibiotic-resistant bacterium.

Taking the Road

Popular Science reports on one of the very few American doctors who're using phages:

How to heal an infection that defies antibiotics? Another infection. Doctors in Eastern Europe have used lab-grown viruses to safely cure millions of wounds. So why can't we do the same here?

The article discussed Roy Brillon who nearly died from an infection which antibiotics couldn't touch.  After a great deal of research, his doctor suggested that they try phages:

Even U.S. drug companies sold them until the early 1940s, when penicillin came along and proved easier to use, generally more effective and, in the end, more lucrative than phages. The viruses might not help, he [the doctor] admitted, but if they didn't hurt, what was the harm in trying?  [emphasis added]

Brillon didn't need much convincing. 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.

The phage mixtures the drug stores sold were effective against the most common types of infectious bacteria.  The sellers could not guarantee that these mixtures would cure a patient who had a rare infection, but patients found these mixtures effective against common infections so it was at least worth a try.  In Mr. Brillon's case, the infection that had defeated every tool known to modern Western science was healed in three weeks for $6 plus travel costs.

Having cured Brillon, Dr. Wolcott reasoned, the same therapy might work for the estimated 100,000 American who die each year due to resistant infections.  Problem: The fact that the phages to cure a major infection sold for $6 means that there's not enough profit in phages for any American firm to go through the approval process.

The Road We're Not Allowed to Take

The researchers at the George Eliava Research Institute in the Republic of Georgia who've used phages sinde 1923 to cure literally millions of patients have found that as bacteria change to resist phages, the phages change right along with them.  The fact that phages can be expected to change during a clinical trial means that the FDA's method of approving medicine won't work - there's no guarantee that the phages will be the same at the end of the study as at the beginning.

Nobody can say how a phage might mutate when exposed to different bacteria.  This makes bureaucrats nervous.  The fact that phages are safe enough to sell over the counter in faraway Georgia cuts no ice with the FDA, of course.

What's worse, any given infection may be caused by many different strains of bacteria.  In difficult cases, the Institute cultures bacteria from the wound and mixes up a custom cocktail containing hundreds of phages from their library of thousands.  It can take several weeks to tune the mixture to attack all the bacteria and cure the patient, but it's better than dying and cheaper than intensive care.

The FDA has not only ruled that phages can't really fit into their clinical trial process, they've also ruled that each individual combination has to be tested the same way.  This is utterly impractical; custom mixes of phages are essentially out of reach to save your life unless you personally travel to the Institute.

The irony is that phages are in commercial use in the United States.  The FDA says that when they're sprayed on lunch meat to kill harmful bacteria, they're a food additive which is OK.  When you use phages to save a dying patient, they're a drug, which is against the law.

Some researchers argue that the regulatory hurdles combined with phages' tendency to mutate along with the bacteria they eat makes them too risky.  The millions of people who've been cured by phage-based therapy would beg to differ, but the fact that phages have cured millions of infections in real, live patients is irrelevant to the FDA:

It's clear that unless the FDA is willing to consider revised approval guidelines, phage therapy in the U.S. will remain in a holding pattern indefinitely.

Today's FDA has enough power over medical treatment to be hazardous to your health.  Obamacare will make matters worse by giving government agencies yet more power.

On the bright side, the more people who're killed because they're not allowed to try cures that work in other countries, the less we'll spend on Social Security payments.