Next big thing: predicting drug results

Figuring out how to predict whether a drug will have negative consequences before investing the millions of dollars required to conduct clinical trials with human beings is eminently to be desired. Now there's a name for doing this; it's called toxico-genomics (predictive toxicology), according to the latest print edition of Fast Company magazine.

Young companies are entering the field selling their services to big pharmaceutical and biotech firms. The big guys like Schering-Plough and GE Healthcare are talking about it at conferences and in boardrooms, and you can be sure, where this much money is in the balance, it's going to happen--sooner rather than later--that predictive toxicology will become the place to be for aggressive young bioscientist entrepreneurs.

The same way that researchers learn everything they can about a particular step in a disease process and then have to go one step backwards in the process and start examining an earlier piece of the puzzle, so in the macro sense the industry is looking for ever-earlier ways to intervene in the long, expensive and laborious process of getting drugs and treatments finally approved by governing bodies like FDA.

The winners of this race backwards will be the winners of the pot of gold.

Little did we know, nitric oxide

A new male enhancement product is created with the powerful properties of arginine, a precursor to nitric oxide, the smooth muscle relaxer and blood flow encourager.

It'll be fascinating to see what we think of next for this wonderful little substance.

Bone marrow stem cells associated with stomach cancer

In a startling discovery, researchers have found that bone marrow stem cells, which can travel to the stomach to help heal inflammation or injury (such as the infection that starts ulcers), may also play a part in the origins of stomach cancer. In the experiment, the "rescue" bone marrow stem cells became infected themselves and eventually turned into stomach cancer.

This research belies the long-held belief that cancerous tumors originate from the cells that surround the site of the tumor--in this case, it would have been stomach cells. So in another dramatic case of what's good for us can also be bad for us, the incredible power of stem cells to heal is turned around into a destructive force.

What is the message of finding that so many substances are both good and bad for us? Seems like it might simply be a vivid illustration of the old adage... moderation in all things.

Less invasive--less dangerous--way to test for heart disease

It's been around for only a little while, but now some Seattle physicians are saying using CT angiography (computed tomography of the blood vessels around the heart) is really valuable for evaluating patients potentially at risk for coronary heart disease--and that it will save money and save lives as well. "Every year in the United States about 1.4 million invasive, expensive cardiac catheterizations are performed to evaluate for heart disease." These procedures increase the risk of stroke and of damaging the vessels you're trying to see. The new technique has none of those risks, is far less traumatic to the patient, and costs a great deal less money.

Not everyone will be a good candidate, they say, but you should know about this option when you talk with your personal physician or cardologist.

Less invasive testing is an exciting trend that many researchers are trying to follow. What a blessing to those already struggling with disease to at least get a break on the front end. Now if we can just keep up the trend of finding less invasive ways to harvest stem cells and apply those to more and more conditions, we'll be well on our way to the science fiction world of taking a pill, or touching a button, or entering a quiet chamber to cure all our ills.

Wonder what we'll start dying of then....

Happy Thanksgiving to all the U.S. folks who celebrate...

Fertility treatment accessibility going backwards in Ohio

Infertility is rampant and the incidence of it is growing as more women delay childbearing. At last count more than 6 million couples a year suffer from this heartbreaking condition, according to The National Center for Health Statistics (a division of the Centers for Disease Control and Prevention). That's 1 out of every 10 couples--that's more than 12 million people suffering the devastation of being unable to have a family of their own.

Not surprisingly, many couples pay substantial amounts of money for medical help to overcome this disability. But interestingly, most health insurance plans will cover the cost of tests to determine whether a couple is infertile, but there the assistance stops. Almost no health plans at this time cover the drugs and therapies required to try to become pregnant.

In Cleveland, Ohio there's a large city chamber of commerce with a division called COSE (Council of Smaller Enterprises) that provides health care plans for small businesses. Notice was sent out to members this week that, contrary to previous provisions, all coverage for fertility drugs will be removed from all COSE health plans effective January 1, 2005.

These kinds of discrepancies send very mixed messages. You have to wonder what the motivation is behind this withdrawal of coverage in Ohio, when nationally the trend is towards more generous assistance. A state government agency in New York is already supporting infertility treatments in the form of grants to private medical practices that do the work.

Having heard from an official spokesperson for Medicare recently that the goverment is really big on supporting Health Savings Plans (HSAs) as a way for people to cut the cost of healthcare, and this announcement of withdrawing fertility coverage coming in the same letter that announced more advanced HSA options for COSE members almost makes you think that the federal government's position had some influence on this decision.

Let's hope this isn't a trend. Bioscience could develop some new stumbling blocks to free business development if it is.

Turkey ingredient helps produce nitric oxide!

Turkey is good for you, say the scientists. Not only is it high in protein and low in bad fat, "Turkey is also a good source of the amino acid arginine. The body needs arginine to produce nitric oxide, a compound that helps dilate blood vessels.

Now they hasten to tell us they don't know for sure if eating foods rich in arginine actually helps keep your arteries clear. But hey, we hear practically every day some new way that nitric oxide is beneficial; so they just haven't gotten around to exploring the next step down the chain. I'm going to go out on a limb here and say you're probably safe to assume turkey is really good for you.

So buy a big one, cook it with love, and have a great holiday.

1) Grape juice and 2) stem cell miracles

More evidence that grape juice may have some of the same beneficial effects on your heart as red wine (the good news on that's been in for some time now). Both can reduce inflammation and raise levels of good HDL cholesterol, according a small study reported in a recent issue of Arteriosclerosis, Thrombosis, and Vascular Biology. Superoxide, one indicator of inflammation, was lower in subjects after they'd drunk grape juice for a couple of weeks; and now there's a new one: CD40 ligand. Ligand is a word scientists use loosely to describe a molecule that binds to a receptor (though it's apparently somewhat arbitrary as to which they decide to call the ligand and which the receptor). Anyway, CD40 ligand, described in this WebMD article as "an emerging indicator of heart disease," was also lower in the grape-juice-slugging folks.

And I love this one. An author berates a New York Times writer for stating inaccuracies about the effectiveness of adult stem cells. In a very user-friendly style, Michael Fumento describes the "miraculous" healings that are taking place on a regular basis using adult--that is, not politically loaded embryonic--stem cells. The article on the Heartland Institute site explains how stem cells--even those taken from fat, for heaven's sake--can be used to heal wounds and improve functioning in muscle, veins and arteries in the heart and in other areas of the body. He says the technology is sufficiently advanced that when his bypass goes bad in a few years Clinton won't have to undergo another open-heart surgery--a process the article outlines with gruesome clarity and describes as "positively medieval" compared to inserting stem cells via a catheter.

This is incredibly encouraging and exciting news.

Revolution: The official end of the snake-oil sales era

No kidding. A manufacturer, Medical Research Institute, which makes health and strength supplements, invested in proving that its nitric-oxide-enriched product works. The company created and funded a study to prove that its NO2 product, sold in GNC stores around the country, actually did what it's claimed to do: enhance strength and endurance for exercise enthusiasts who use it.

This article about the Baylor University study of how NO2, the MRI nutritional supplement, increases strength at the bench press by nearly 350% over a placebo. Read the article for more startling findings.

The point is that MRI is setting a precedent: shifting the burden of proof of effectiveness from the consumer's hands into its own. The supplements and other industries will never be the same again. Makers will now all be challenged to design studies that support their claims--or run the risk of losing consumers' confidence--and their dollars.

This move creates a bit of an Alice-in-Wonderland rabbit hole. Will it significantly change the way consumers behave? For some, certainly the answer is yes. But the truth is, we humans are so passionately in pursuit of easy answers that many of us will simply let the "proof" part slip by and continue purchasing products that make bold claims and promise dramatic solutions we can achieve without working too hard.

Clearing mucus from your lungs - help for the common cold one day?

While searching for a preventive agent for the contaminant "Florida red tide" (microscopic cells that get dispersed in the air and irritate human mucus membranes--lungs, eyes, nose, etc.), researchers discovered anit-toxins that actually seem to help clear mucus from the lungs.

They are thinking this discovery could be really important for treating cystic fibrosis (a fatal disease) and other respiratory illnesses that produce excess mucus. All that mucus is bad because it harbors bacteria and facilitates infections--besides making it hard to breathe. The anti-toxins, ?-Naphthoyl-brevetoxin (manmade) and brevenal (produced by the organism itself), work by causing "a combination of increased movement of the cilia, the tiny hair-like structures that line the airways, and a thinning of mucus."

Since there are so many diseases, including congestive heart failure, that affect people's ability to breathe freely, it seems reasonable to hope researchers will eventually be able to extend this discovery and one day apply it those other illnesses--and maybe even to things like the flu and the miserable condition we all know as the common cold.

Nitric oxide implicated in acid reflux

A long-term study has determined that smoking and high salt intake contribute somehow to the development of acid reflux [stomach acid causing heartburn, belching, etc.]. Tea and alcohol, long thought to be responsible, have no identifiable effect on the disease.

Seems that nitrites in the stomach (from a salty diet) can cause an excess of nitric oxide--which, as we know, is good for relaxing blood vessels--also relaxes the muscle at the bottom of the gullet and thus encourages reflux. Astonishing what a single substance can do--both positive and negative--in our bodies. Apparently you can decrease your risk, though, by regularly eating fiber and exercising.

Geez, will they never run out of reasons for telling us to eat healthy and exercise?

Nitric oxide responds to light energy to help wound healing and circulatory issues

This nitric oxide is amazing--it rushes to help rebuild your tissues after injury, but it can get too enthusiastic. Just read this in a press release from a company called LymphaCare (good, descriptive name...kind of like BioMedNews) that's making a more effective--and cheaper--way to deliver "non-visible and visible infrared light energy to promote regeneration and revascularization of damaged capillaries by releasing excess nitric oxide [emphasis added]from cells.

The system uses a combination of lights because each type penetrates the skin to different depths. Visible light helps heal infections as it reaches problems near the surface like wounds, cuts, scars, "trigger points, and acupuncture points." I'm putting quotes around that because it's key to realize that the concepts of Eastern "that-stuff's-only-for-weirdos" medicine is creeping its stealthy way into the everyday language of Western professionals.

This reminds me of the way the Catholic Church announced one day that "a sin" it had been condemning people to hell for for generations (eating meat on Friday) was no longer a sin--and offered nothing in the way of explanation or apology. Oh, well, it's okay. At least this marriage is coming off, no matter that we may choose not to acknowledge it.

The other light, the Invisible Infrared light, goes deeper and helps heal bones, joints, deep muscles, etc. in the same way as the visible light.

It makes sense that light would heal--look how we feel to walk out into a sun-drenched day, especially after a few days of cloudy weather (let alone we midwesterners, after weeks of the gray, rainy stuff). And isn't it strange--and wonderful--that now we know one of the reaasons: 'cause nitric oxide responds to it, too.

Nature's help: Seaweed speeds breakdown of DDT in polluted soil

I bet if we look hard enough, we will eventually find a natural solution to a lot of the problems we've created with our chemical creations. In the April, 2004 Journal of Chemical Technology and Biotechnology you find this on how seaweed can speed up the neutralizing process: 'DDT gets into this 'box,' so the microbes that would normally break it down can't get at it. Seaweed has sodium in it. Sodium opens that box. It separates the tightly bound matrix that holds soil particles together and allows microbes to get in."

My dad was a farmer in his retirement--just a little half-acre garden in deep-sandy-soil Indiana. He tried his best always to identify and use natural ways to battle the Japanese bettles and the moles and chipmunks and fungi and viruses. The local county extension agent probably got tired of all his calls. But dad lived on the land, so he knew and respected it. As we isolate ourselves form the earth with technology and offices and buildings, we forget to ask Nature for help.

The rise of "green" and "sustainable" as respected business terms is a good sign. But nothing will make us smarter like actually being in contact with the earth. That's where bioscientists have an edge--they deal with life in all its myriad forms every day.

High risk, yes. Immeasurable returns, yes, indeed.

Video on your cell phone - mixing work and play

Imagine observing a surgery live while you're on vacation. Imagine being able to review functionality on a new model of spectrophotometer without having a salesperson present.

Motorola has handed out sample models of a new cell phone with a video camera in it. And they've given free rein to a professional cinematographer just to see what he can do with it. These short films viewable online give you a good idea of the clarity this new technology can achieve. Not sure how splitting the screen into 6 or 9 slightly different views works--or if it has any function other than artistic...

A media observer says "cellphone marketing will become even more personalized than the Internet." Imagine getting a custom-made-for-you television show--say a technology review or a travel guide--delivered to your phone when you ask for it. It's kind of the AAA (auto club) model of come in here and we'll draw a "triptik" for you while you watch--only you don't have to go to the storefront.

I know how much I enjoy having an embedded digital camera in my PDA--half the time I carry the thing more for the camera than for the information content--since if I'm going to be actually working, I'm starting to bring my laptop with me. (Tried implementing the use of a portable computer a little bigger than a PDA, but have never succeeded in getting the thing to work properly--so I gave up the idea of buying a folding keyboard for it.)

So maybe it's going to be a race to see who gives us truly everything-in-a-box first: our laptops, our cell phones, or some entirely new device that's lurking in the minds of the technogeeks out there.

Where will you be going when you can carry your office in your pocket?

FDA believes information will help fight obesity

If we know the facts, we're less likely to overeat and/or eat stuff that's bad for us. So goes the thinking at the FDA lately.

It's commendable that they are wanting to help people understand the consequences of their dietary choices. But I wonder if the proposal they'll be making next month, that
FINDINGS (washingtonpost.com)"would tell food manufacturers for the first time to list on packages the percentage of daily recommended calories the product contains" will really make a difference. They believe it will "shock" people to see that a food item constitutes 50% of their daily allowance of calories...

Well, maybe. It's certainly valuable to have the information handy and may help some, but fighting obesity is about paying attention. And that's what many of us don't want to do. So having more information means simply that there's more evidence we can ignore as we choose to eat the cream-filled chocolate cupcake or the greasy fried chicken anyway--just 'cuz we want to.

Stroke research gets boost at Columbia University - neurology

Stroke probably doesn't mean much to you--unless you know someone who's had one. If you do, you may know something about how devastating the physical and mental consequences can be. Now $12 million from the National Institute of Neurological Disorders and Stroke has gone to Columbia University, which won against many other competing institutions. Worthy studies they'll be doing:

They'll be studying the safety of taking high-dose statins--typically used to lower cholesterol--as a preventive measure. There's some evidence that people already taking statins for other reasons tended to have less severe strokes and a better recovery.

They'll also be looking to see if brain activity patterns shortly after the onset of stroke can predict recovery. They've observed that activity begins on the other side of the brain from where the stroke is, but they don't yet know what this might mean. That want to see if treatment can be adjusted to mitigate neurological deficits.

Fast treatment for stroke is essential to minimize damage. Columbia U. scientists are also going to test a novel technique in behavioral change to see if they can get stroke survivors (who are more prone to additional strokes) to recognize stroke symptoms quickly, get to the hospital faster and negotiated their way through the Emergency Department for faster treatment. They'll start by testing the information on people in northern Manhattan.

If you know someone who's had a stroke, tell them about this study so they can keep an eye on it--maybe even ahead of their own doctor. Keeping up on the latest developments is a way to keep our health truly in our own hands.

Nitric-oxide boosting drug saves African American lives

Exciting, incredible, "political incorrect" discovery. Adding a combination of a couple of older drugs to the current heart medications increases longevity by 40% for African Americans being treated for heart disease--while it does nothing for white people. Here's an quote from this student-operated online newspaper called "The MNDaily":

:...blacks seem to be more predisposed to heart disease than whites because some unknown factors — genetic, environmental or both — predispose them to having less active nitric oxide systems, which are protective of the heart and arteries. BiDil [the new combo drug] contains nitric oxide enhancers" which two university researchers suspect will make the drug more effective for African Americans. They're out to get FDA approval and getting flack from various quarters for even suggesting that drugs might be race specific.

The students of the University of Minneapolis who run the paper call for the medical and legal communities to quit beating around the bush and admit that there can be physiological differences between the races--without implying there are differences on which discrimination might be based.

Encouraging news: $5.8 million to fight lifestyle issues

The CDCP (now tellingly known as the Centers for Disease Control and Prevention) have awarded St. Louis University's School of Public Health millions to examine chronic health issues like "OBESITY, SMOKING, NUTRITION, EXERCISE, HEALTH, WELLNESS, FLU, and CANCER."

My first reaction is, hallelujah! This makes so much sense: to look at helping people change the lifestyle factors that so influence our human health and wellness. It's going to be a long struggle to find out how to affect how people make choices--which has so much, if not everything, to do with emotional health--but it's so the right place to look. And if the project takes full advantage of the discoveries of quantum physics about energy and thought and of the Candace Pert discoveries about emotions and neuropeptides, chances are great that truly meaningful progress will be made.

My second reaction is, holy mackerel, what a drop in the bucket $5.8 million is for a work of such vast scope. BUT I guess that means other schools of health in other locations and perhaps some public companies may be able to tap into this kind of funding, too. It's an amazing, exciting time to be a scientist or researcher or doctor or bioscience company owner or employee.

And it's an amazing time to be alive to see all the miracles that their discoveries and inventions are creating.

When should we be suspicious of a study?

As a writer, I'm always conscious of the power of words to influence thoughts. As a marketing professional I know how careful any company is about the words its people use in a press release or marketing materials. That's why the opening paragraph of this story on WebMD.com sent my antennae up:"Getting tough on cholesterol with high doses of the cholesterol medication Lipitor may help prevent heart attacks."

"Getting tough" is not an expression you use in a press release. It's an expression our politicians love to use--I said "politicians" because we can be pretty sure that anything they say is profoundly aimed at influencing our thoughts, often with only a casual nod towards truth. An unbiased source of news would never use an opening sentence like this one. And not surprisingly, we find at the bottom of paragraph 3 these statements: "The study was funded by Parke-Davis and Pfizer Pharmaceuticals. Pfizer is a WebMD sponsor."

Now pharmaceutical companies often pay for research studies. And it's natural and okay that this one wants to use its own website to promote its products. But it's not okay that they want to act as if this is an objective news story. Their choice of words was the first clue. Having previously written about the questionable results of a number of studies (including Vioxx) for some legal websites, I know some of the ways in which study results can be skewed.

When you read a supposedly unbiased news story starting with "Getting tough" keep your eyes and your mind open. What you won't hear is probably the most important part of the "study."

Protein found to stimulate--and guide--blood vessel growth - cardiology, neurology

Always wondered how it happened that when my father had his heart attack and they looked closely at his cardiac situation, they found that though he'd had a mild attack earlier in his life (that went undiagnosed and untreated because he was a stubborn guy about his health when he was younger), they found a huge vein that had grown around his heart to replace an artery that had become blocked. So now we can safely assume it was a protein called Netrin-1, one of a family of "neural guidance cues" that coax nerve fibers to go in specific directions as they grow, that must have caused his vein to kick in for the damaged vessel.

The scientist discovered this property of Netrin-1 after he found there was a receptor for a different neural guidance factor. Heck, they probably could have imagined this idea years before if they thought much about what they saw in my dad's chest. When we see a miracle in a body, chances are we'll be able to find a physiological mechanism in the body that made it happen.

But the "why" is another story.That's where quantum physics and neuropeptides come in. If you haven't yet seen the movie "What the #$@##$^ do we know?" I highly recommend it. Documentary style interviews with eminent physicists around the world are interspersed with a little story of self-discovery acted out by the young, attractive deaf actress Marlee Mattlin. The scene with the red, blue and silver emotional cells alone is worth the price of admission.

But the point is the existence of receptors in every part of our bodies and the power of our thoughts to influence the behaviors of those receptors and of our cells themselves. It's worth seeing.