Green Leafy Vegetables And Other Dangerous Foods

It looks like November is food safety month here at the Meow. Last week, after regaling you with tales of the family poultry farm where my husband learned the fine art of chicken catching as a boy (I didn't tell you that he knows how to hypnotize chickens--honestly, he does), I sent you to an article about the Kentucky Colonel's favorite bird and the diseases that roost in poultry, slipping past government inspectors on the way to your kitchen. Disease, you see, cannot always be detected via visual inspection, and many of the birds that grace your dinner table could make you sick if you don't make sure they are thoroughly cooked. You just can't tell by looking at a chicken what microorganisms have found a home there. One of the ways the article's author, John Stossel, proposed we address the problem of poultry contamination is irradiation, designed to kill even the bacteria that escapes detection, before the bird gets packed off to the supermarket. Stossel explains that for a variety of reasons, irradiation isn't common. Important safety changes are slow in coming to this industry, so chicken really needs to be cooked to death, after it has been butchered, for safety's sake. Let's put chicken on the scary but tasty list for now.

Joining chicken these days in warranting "Caution: Severe Potential Body Damage" warnings is spinach. We're just starting to be able to find Popeye's secret weapon in the stores again after an E. coli outbreak, which started a couple of months ago, was traced to fresh bagged spinach, which infected about two hundred people, causing three deaths. Revealing my own ignorance here, I've always thought of E. coli as a meat-borne illness, undercooked burgers and all that. I really didn't know you could get it from the plant kingdom, but I sure do now. Spinach salad is a staple in Meowville, and we've been particularly aware of the unavailability of this extremely important member of the food chain. Until this week, our green leafy vegetable of choice was nowhere to be found. That made us sit up and take notice.

We are glad to have our favorite back, but I'm not ready to just return to my pre-spinach-drought state of ignorance. I have wanted to know how the infection got to the plants in the first place, how it spread, and why all the washing, that is the primary reason for buying bagged spinach, didn't do its job and cleanse away the germs. Some answers are coming out now; it's starting to look like the infection invaded spinach crops in California because wild hogs found their way onto farms in Salinas Valley. Okay, that answers how the plants got "defiled." (It's the best word I can think of to describe the ruination of perfectly good spinach.) So, how did the E. coli make it past the packaging plant?

Dr. Henry I. Miller, of TCS Daily, says that washing sometimes simply can't do the job of ridding produce of disease, because the germs aren't on the surface of the produce, they're inside it. Miller says, "Exposure to E. coli or other microorganisms at key stages of the growing process may allow them to be taken into the plant and actually incorporated into cells." Even the irradiation, which Stossel recommends for meat, and Miller agrees is an important tool, can't deal with all the complications from infection, because some bacteria secrete toxins which remain even after irradiation has eliminated the germs themselves. These toxins can make you sick no matter how dead their germy progenitors are. What's Miller's solution? Biotechnology.

I've often discussed Miller's TCS articles here, and frequently the focus of his writing has been the ever-expanding and much-debated field of biotechnology, or gene-splicing, as it is more descriptively labelled. Repeatedly he has come down on the side of the safety and efficacy of gene-splicing to introduce desirable traits into plants. He's explored the concept of biopharming, altering plants so that you can, in effect, grow drugs to meet pharmaceutical needs. It's basically programming plants. (If you want to find more post and links to Dr. Miller and biopharming, just do a search at the top of this page. Blogger will list for you the four or five other posts I've done on Dr. Miller's articles.) Miller describes the benefit to be found in addressing the problem of infected food with biotech, but, as usual, also acknowledges the objections that inevitably go hand in hand with such an approach:

There is technology available today that can inhibit microorganisms' ability to grow within plant cells and block the synthesis of the bacterial toxins. This same technology can be employed to produce antibodies that can be administered to infected patients to neutralize the toxins, and can even be used to produce therapeutic proteins that are safe and effective treatments for diarrhea, the primary symptom of food poisoning.

But don't expect your favorite organic producer to embrace this triple-threat technology, even if it would keep his customers from getting sick. Why? The technology in question is biotechnology, or gene-splicing -- an advance the organic lobby has vilified and rejected at every turn.

Read Dr. Miller's article for more about this current spinach situation and its implications, and more of the posts here if you want to follow up further on what he has to say about gene-splicing. He comes down very firmly on the side of pro-biotech, but does address in some detail the issues and problems that others raise with ongoing development in this burgeoning industry. He's gradually been winning me over to the idea that manipulating genes to introduce desirable outcomes can be safe and effective, if proper care is given to how the technology is used, and a firm set of precautions is in place. I wasn't always this sanguine about it, thinking, basically, that God knew what He was doing when He made things, and who are we to mess with them, but I've really come, over time, to see these genes they are manipulating as God-made building blocks, that get shifted around all the time in nature. Shifting them is not inherently dangerous or wrong, but it does require a great deal of wisdom to know what's appropriate and what's not. It's interesting to me watching where the science is heading. I still say they need to keep their hands off people, but making spinach safer so I don't ever have to face another spinach fast? I think there I'm cautiously in favor of ongoing research.

Trust? No--Verify

I'm awfully fond of TCS Daily, as some of you know, and find a good deal of intellectual fodder amongst the many and varied perspectives on technology, commerce and society which fill its electronic pages. Much of it is rather libertarian, with the occasional conservative twist, which suits me fine, and the authors are as diverse as the topics. I head there frequently. One of my favorite TCS authors is Dr. Henry I. Miller, and I have posted on his articles more than once. He writes about things that interest me; medical research, medical trends, biopharming, bioengineering and the like. Frequently, not surprising in a publication with a libertarian bent, I've seen him criticize government over-regulation in scientific matters. From the development of new drugs and treatments to gene-splicing, he usually comes down in favor of letting science come up with the best options possible, and scientists and scientific testing, rather than bureaucrats, judge their efficacy. From what I've read, I've gathered that he believes that over-regulation slows needed medical progress. I fully agree. (Note: I said over-regulation, not all regulation.) So, when I started reading an article in which Miller started calling for more regulations, I took note.

The problem he's addressing in an article titled "Are Bad Drugs Coming to a Pharmacy Near You?" is the growing number of counterfeit pharmaceuticals making their way into the medicine chests of the unsuspecting. According to Miller, it's a problem worldwide, and consumers in the U.S. are by no means exempt:

Although quantitative estimates are difficult, it appears that something on the order of ten percent of the world's drug supply is counterfeit, encompassing not only products that are completely fake, but also those that have been tampered with, contaminated, diluted, repackaged or mislabeled in a way that misrepresents the contents, dosage, origin or expiration date. The World Health Organization estimated in 2003 that as much as five to seven percent of all drugs sold in the United States may be fraudulent in some way.

Mafia and terrorist groups, drug cartels and other such nefarious do-badders make a huge profit producing knock-offs and slipping them through the vast and confusing pipelines that eventually bring them to that pharmacy near you. Actually, though, what's more likely, says Miller, is that they are coming to a pharmacy not near you, but that the chances you're going to get less than you "bargained" for go up when you try to save money by buying medicines from outside the country, especially online:

How do fraudulent medicines enter the drug supply? Primarily by counterfeiters taking advantage of an alternative to the mainstream pathway of pharmaceutical manufacturing and distribution through which drugs normally move linearly from manufacturer to distributor to pharmacy to patient.

He adds:

Increasingly, consumers are making the counterfeiters' job easier by buying drugs abroad. In a 2003 operation, spot-checks by the FDA and U.S. Customs Service found that 88 percent of drugs imported into the country by mail or courier violated federal safety standards in some way.

The risks here are obvious. Diluted, out of date, or outright fake medicines aren't going to perform as required. I'm sure you will agree that this could be a slight to serious problem. The slight problem may be self-correcting. For example, I have a medicine I take daily for chronic pain. If my pills weren't doing their job, I'd probably figure it out soon enough and see my doctor for an alternative. This could cause me discomfort, and inconvenience, but is unlikely to cause me any real harm. My mom, on the other hand, has a heart condition, and medication that she must take daily, without fail. What if the drug she takes was replaced with a replica, indistinguishable, but ineffective? She might not have any warning symptoms that the pill she was faithful to take wasn't doing its job until her heart wasn't doing its job either.

So, by Miller's account, what is the solution to this dilemma? I think it's worth quoting him directly again:

First, Congress must increase the penalties for drug counterfeiting, and the FDA must more aggressively enforce regulations that require documentation of the "pedigree," or history, of a drug as it moves through distribution channels.

Second, we need to apply new track-and-trace technologies to uniquely identify and track the distribution of drugs. (And similar to our confrontations with dealers of illicit drugs, in order to keep ahead of the bad guys we will have to innovate constantly.)

Third, new authentication technologies, such as holograms and ultra-violet and forensic tags, must be developed to make it more difficult for counterfeiters to imitate legitimate drugs. A promising new technology would attach mixtures of pH-sensitive fluorescent dyes to drug molecules and measure changes in fluorescence in the presence of solutions of different compositions.

Fourth, when making Internet purchases, consumers should patronize only pharmacies on the National Board of Pharmacy's recommended list ( www.nabp.net/vipps/consumer/listall.asp).

Finally, consumers should be vigilant for anything amiss in any prescription drug obtained anywhere - unusual color, texture, markings or packaging and, when feasible, for any differences in effectiveness or side effects.

I'm surprised to find an area in life which I actually agree could need more regulation. That's not an easy sell with me, but Miller makes the case quite successfully that this is a matter of public safety. It's important that we know what we're getting, and that we can trust the source. In order to trust it, we need to know what that source is. Fortunately, as Miller explains, there are improving technologies which can help in the quest for reliable tracking and content verification methods. These, no doubt will add to the cost of popping prescription pills. So be it. I'm not a spendthrift kind of gal, and I do part with my money reluctantly, but this revelation that some of our pharmaceuticals may come from "mystery manufacturers" and be "fake pharma" has certainly made me more inclined to value safety over price.

More Biotech Breakthroughs

Dr. Henry I. Miller is schooling us again on the benefits of biotech, and they are many--some of the most impressive being environmental. As usual, he's also pointing out some of the hindrances, and illustrating why activists against biotech might want to change sides in the debate. Dr. Miller is one of the Meow's favorite authors at TCS Daily, and once again, I think this piece is worth your time. Go ahead. Get an education.

Milk It

Dr. Henry I. Miller at TCS Daily is, as ever, keeping an eye on advances in medicine and agriculture, and pointing to a potentially life-saving treatment coming out of biopharming--and the inevitable objections coming out of the woodwork. According to Miller, two million children a year die in the developing world due to diarrhea, which presents little real threat to people in more advanced countries, but is a serious danger in places without ready access to the clean water and the many medical advantages that most of us with easy access to the Internet enjoy. Moreover, this illness, which can lead to death by dehydration, can also become chronic, with damage to the digestive system making victims more vulnerable to further attacks, leading to malnutrition and anemia, among other conditions. However, this scourge can be lessened in duration and intensity by an innovative twist on nature developed by a California company called Ventria Bioscience, and pursued in cooperation with "...researchers at the University of California, Davis, and at a leading children's hospital and a nutrition institute in Lima, Peru." The twist is the introduction of two human proteins into rice, which is then used to produce an oral rehydration solution.

Oral hydration as a treatment for diarrhea is nothing new. In fact, Miller says that an orally administered glucose-based, high sodium liquid has become, "the standard of care for childhood diarrhea in the developing world," and has saved countless lives. He points out, though, that this treatment does nothing to address the problem of shortening the length of illness, nor reduce its severity. That's where the modified rice comes in. You might ask what adding human proteins to a hydration solution could do to put the clamps on a bout of the revenge. Miller explains that these proteins, lactoferrin and lysozyme, are present in breast milk, and breastfed children, "...get sick with diarrhea and other infections less often than those fed with formula. " Lysozyme has an anti-microbial effect, and lactoferrin "...promotes repair of the cells of the intestinal mucosa damaged by diarrhea," thus reducing recurrence.

So, the proteins help heal kids quicker, and have the long term effect of making them more resistant to future infection. I guess this could make one draw the conclusion that children should be weaned at high school graduation, but this is hardly practical, eh? What Ventria has done is make the protein easy to incorporate into an oral treatment solution:

What makes this approach feasible is Ventria's invention of a method to produce human lactoferrin and lysozyme in genetically modified rice, a process dubbed "biopharming." This is an inexpensive and ingenious way to synthesize the huge quantities of the proteins that will be necessary. (In effect, the rice plants' inputs are carbon dioxide, water and the sun's energy.)

If the proteins are grown in the rice, which is then used to grow more rice, a lot of the chemistry is done up front, with the rest being a matter of farming. The rice is then used as the base for the hydrating solution--another example where scientists are basically "growing medicine". This is where the objections are raised. Opponents cite fears that the modified rice will contaminate other rice fields, cross-pollinating and spreading the modification. Miller points out, however, that because rice is self-pollinating, this is unlikely, but even if it were to happen, it's hard to conceive of actual danger, because the proteins in question are already in us anyway, not just in breast milk, but in our tears and saliva as well. It's interesting to note that the people objecting, at least the ones Miller references, are mostly rival rice producers. It looks to me like that might be more fear of competition than a real concern about the dangers of modified rice. I don't mean to belittle legitimate concerns about biopharming, and the need for caution and safeguards, but, at least judging by Miller's article, the objections seem weak in this case.

I continue to be amazed at the ways that scientific ingenuity is taking the blocks that God created and building with them. I suspect there are limits beyond which God will not let us pass, but who knows where those limits are? Until we find out for sure, I'm getting more and more comfortable with the notion that searching for answers to the common problems that plague mankind, by utilizing the elements He used in our creation, is a good use of resources, and part of the stewardship with which He entrusted us. I don't want to see people start to tinker with other people, but rice? Grow forth and multiply.

Old Cures For New Times

It started as a little tickle in the throat, with just the occasional sneeze, or two. It built gradually to an irritating cough that burned her throat each time another spasm took hold. Then the fever kicked in, and the chills, and the Earth's gravity turned up about three notches. Everything felt so heavy she thought she had better go to bed and stay there. The next morning after a restless sleep, she knew that she was really sick, get to the doctor now sick, so she called her MD's office, only to find that they couldn't fit her in. It seemed everyone else in town had come down with this bug too. The receptionist told her not to bother going to the emergency room either. They'd be full up as well, and worse, full of people who were probably sicker than she was. She asked if they could phone in a prescription to her pharmacy, an antibiotic to knock the infection down to size. The receptionist replied that she'd have the nurse phone some time that day.

During an interminable wait, she got sicker and sicker, which surprised her, because she didn't think that was possible. She turned on the TV, hoping to give herself some mental relief, distract herself from her misery. Flipping from channel to channel, she finally settled on a news station, figuring she might as well get caught up with what was going on in the world. What she saw shocked and scared her. They were talking about this bug she had caught as if it were a real news story. Half the country had come down with it, and it was still spreading. Worse, it wasn't responding to treatment. People were dying. None of the antibiotics that should have been working were having any effect. None. Whatever new mutation had brought this thing into being had made it completely immune to the defenses of man. All those years of over-prescribed antibiotics, all that pill popping, "just in case," had finally caught up with medical industry. So few new antibiotics had come out in the last few years, and most of them were simply modifications on the old formulas. They had no way to stop this thing.

Okay, melodrama over. My husband has a work emergency tonight, so I have extra time on my hands. I was just setting you up for the question: Do we have any defenses against antibiotic-resistant bacteria? It's true that very few new antibiotics are finding their way to market. The expense of R&D, coupled with a truckload of regulations are making real breakthroughs more and more rare. Bacteria are getting more resistant, too. Between half-finished prescriptions (stopped when the patient feels better, and not when the infection is really dead), antibiotics prescribed at a patient's insistence (rather than actual need), and disinfectants that kill "most" of the germs they target, what we are doing is making sure the strong survive. The bacteria that come away from the battle with our modern miracles alive, do so because they had some bit of resistance the other bugs didn't, resistance that they pass on to their offspring, who pass it on to the next generation, and so on, until what used to be an easy illness to beat, when antibiotics were the new miracle on the block, is defying treatment and demanding new approaches.

Well, sort of new approaches. Actually, one of them isn't new at all, but has been around at least as long as antibiotics. Daria Vaisman writes at Slate.com about bacteriophages. What are they? According to Vaisman, they are bugs that eat bugs, and were themselves hailed as a breakthrough until antibiotics took some of the effort out of fighting bacteria:

Bacteriophages are viruses found virtually everywhere—from soil to seawater to your intestines—that kill specific, infection-causing bacteria. In the United States, the drug company Eli Lilly marketed phages for abscesses and respiratory infections. (Sinclair Lewis' Pulitzer-winning Arrowsmith is about a doctor who uses phages to prevent a diphtheria epidemic.) But by the 1940s, American scientists stopped working with phages for treatment because they no longer had reason to. Penicillin, discovered by the Scottish bacteriologist Alexander Fleming in 1928, had become widely available thanks to synthetic production and zapped infections without the expertise needed for finicky phages.

American doctors shouldn't have given up on phages altogether. They are flexible little guys. Apparently, just as bacteria mutate, so can the phages. It takes expertise to lead them in the right direction, but Vaisman says that with that expertise, new batches of phages can be grown to meet the challenge of keeping up with the changing bacteria. A sort of "if you build them, they will eat" scenario. Just as scientists come up with a new flu vaccine each year, to meet the demands of mutating flu viruses, new phages can be developed quickly, unlike antibiotics, which take many years, and many millions of dollars to produce.

As the article in Slate continues, Vaisman discusses the work being done at "...Eliava phage research institute, which Stalin helped set up in Tbilisi in 1923, the treatment center offers personalized cures for a host of infections the United States says it can no longer do anything about." You read it right; after antibiotics were all the rage here in the west, phages were still a cheaper alternative, and continued to be used in the former Soviet Union. (Wow, something Stalin did that has endured in a positive way. Who'da thunk it?) Work on phages is still going on there:

The word phage comes from the Greek "to eat." A phage contains genetic material that gets injected into a virus's host. Whereas "bad" viruses infect healthy cells, phages target specific bacteria that then explode. At Eliava, phages are produced as a liquid that can be drunk or injected intravenously, as pills, or as phage-containing patches for wounds. Though few published articles in Western journals report positive clinical trials—most of the recent long-term research on phages comes out of the Soviet Union—some Western scientists say that phages are safe and that they work.

Vaisman says that the treatment center in the former Soviet Georgia takes on cases of infection on which western doctors have given up. She points out that phages were repeatedly shown to be effective at stopping infection in Soviet clinical trials. Georgia has gone into the "medical tourist" business, gaining patients from western countries, where such treatments are less available:

So, why do American patients need to go to all the way to Georgia for treatment? For starters, in their natural state phages are hard to patent, the route by which drug companies lock up future profits. The first company to spend millions of dollars to prove that a particular phage is safe could allow its competitors to capitalize on the results. As important is the difficulty of regulation. There are two ways that phages are currently used in the former Soviet Union, and both pose problems from the point of view of the Food and Drug Administration. At the Tbilisi phage center, phages are personalized: You send your bacterial sample to the lab, and it's either matched up with an existing phage or a phage is cultured just for you. In the United States, by contrast, drugs are mass produced, which makes it easier for the FDA to regulate them.

Phages are also sold over-the-counter in Georgia. People take the popular mixture biobacteriophage, for example, to fight off common infections including staph and strep. These phage mixtures are updated regularly so they can attack newly emerging bacterial strains. In the United States, the FDA would want the phages in each new concoction to be gene sequenced, because regulations require every component of a drug to be identified. To do so would entail prohibitively expensive and lengthy clinical trials.

Leave it to regulation to be a blessing and a curse. Regulations do protect us. Vaisman reports that early bacteriophages killed more people than they cured. The sources for the phages were dirty water. For example, the first phage found came from the Ganges river. There are other dangers, too, for those who don't know what they're doing. Regulations do protect us to a degree from some of the risks inherent to medical research. However, there's the flip side of regulation as well, the side that makes everything prohibitavely expensive, and take a lot of time--the side that makes it impossible to put out a phage cocktail, because the FDA would require gene sequencing that would possibly make the phage obsolete before it came out of clinical trials.

There are workarounds for some of the FDA issues, and there are companies venturing into this arena here in the States, looking to find ways to make phage production a viable alternative to antibiotics. There are agricultural applications as well, that don't have the FDA restrictions. However, options for the widespread use of phages to fight infection here at home, especially as over the counter remedies, are pretty dim at this point. Georgia may be the best option for a while, so that "medical tourism" thing could really take off, for patients wealthy enough to travel the globe in search of a cure for what ails them. On the other hand, I'm betting that if we did see some major outbreak of antibiotic-resistant bacteria, phages would start looking a lot more feasible in a hurry. Regulations serve their purpose, but if any serious percentage of the population became ill with something our doctors couldn't fight, those regulations would become a whole lot less attractive, even to the regulators, especially if they have children. It's comforting to know that there are other options out there, even if the world would have to look like a made-for-TV disaster movie before they were given the nod. I simply have to believe that even bureaucrats aren't so dense as to watch the country die of some horrible disease because they didn't have gene sequencing data available on the cure yet. The Pollyanna in me insists on having hope.

Just so you know. The girl in our story which introduced us to this topic is fine. She recovered after a couple of weeks in bed, and got a big raise when she went back to work, because her bosses discovered they couldn't get along without her. She also finally made it into her doctor's office, and when she filled out her prescription for a cough suppressant, she met a wonderful young pharmacist who asked her out to dinner. They had a lovely time. (Since I made it up, I get to make it a happy ending. The Pollyanna in me likes a happy ending. My husband says I'm going through a phage.)

Note: If you're interested in the topic of antibiotic-resistant bacteria, and the obstacles to developing new drugs, here's an article at TCS Daily by Dr. Henry Miller. It's not particularly cheerful, but it's informative.

Biopharming

At TCS Daily, Dr. Henry Miller has a piece on biopharming and the effects of over-regulation on this promising scientific industry. Biopharming, for those of you who, like me, had never heard of the term, is "the programming of plants to produce pharmaceuticals that can be purified, or that might even be delivered by eating the plant material itself." He describes one woman's efforts to introduce genes into bananas so that they essentially "grow" vaccines for typhoid fever, rabies and the HIV virus. She's trying to make vaccine that's deliverable by banana chip. It's a fascinating article, that looks at the possibilities for amazing medical advances, the potential risks and abuses of the field, and the roadblocks to further progress. Have a look. It's educational.

Bombing The Bird Flu?

Dr. Henry I. Miller, writing at TCS Daily, proposes A Bird Flu Manhattan Project. For those of you not up on the latest looming medical calamities, the scientific community is more than a little concerned about the potential of a flu virus that has been killing birds in China for a decade, and is rapidly spreading around the globe via bird migration, to trigger a human influenza pandemic. The H5N1 virus is currently contagious from birds to humans, and the fear is that the virus will mutate into something easily transmitted from human to human. The virus has proven quite deadly to people, so a mutation of that kind would certainly warrant great concern.

I've been watching the development of this story for a while now, and have seen both alarmist viewpoints and cautions against panic. The most reasonable discussions tend to come to the conclusion that whether or not this particular virus turns into a major threat to humans, at some point we are going to face a pandemic of some sort, if history is any indication, especially given the way the globe has shrunk with the ever-increasing ease of transportation. Our potential to create enough vaccine to face any pandemic, by all accounts, is woefully inadequate. Currently, new scientific approaches are hindered by FDA regulation and the lack of financial profitability, and there are nowhere near enough facilities available for the mass production of an effective vaccine, once one is developed. Dr. Miller believes we need to address the problems created by government regulation and financial disincentive that have made vaccine development of all kinds a shrinking field, and prepare for possible pandemic now, while there's still time to develop effective countermeasures.

The Manhattan Project approach seems to be a wise suggestion; let the government spearhead medical advances previously hindered by its own bureaucracy. Dr. Miller's article isn't all negative. Quite the contrary. There is some encouraging progress on the scientific front. Those advances will affect our ability to immunize the world's populations against disease of all sorts, not just the bird flu. That is worth some investment. What the doctor is suggesting is that the government start acting like a conduit for advancement, rather than a bureaucratic roadblock. The whole notion is a little counter-intuitive, and might take a bit of getting used to, but wouldn't that be an adjustment we'd all be happy to make?