Wednesday, January 30, 2008

Sham: Off Label Prescriptions, or Human Experimentation?

Recently a news report circulated about the practice of "off label" prescriptions. This happens when a doctor believes he or she knows something about the drug and your malady that the pharmaceutical company or FDA doesn't, and they decide to prescribe the drug for whatever it is that ails you--even though it wasn't developed for that purpose.

This recent news report came about because one out of four physicians in the USA continue to prescribe antidepressants for patients with low back pain, despite the fact that there is no evidence this is helpful. (Other than, of course, the patient feels better about their suffering; their attitude about the pain has been chemically-enhanced by antidepressants!)

The review appears in the latest issue of The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates medical research.

“The review found no convincing evidence that antidepressants relieve back pain or depression more effectively than placebo,” the main author said. Nor did researchers find any difference in patients’ ability to function, whether receiving antidepressants or placebo.

There are a host of areas where physicians prescribe pharmaceutical drugs for purposes that they were not intended when they were developed. The FDA does not concern themselves with this issue, because once a drug has been proven safe through FDA approval, their responsibility has ended.

Personally, if my doctor prescribes a drug for something other than what it was intended to treat, I would want to do significant research on my own to find out what others in this "human experimentation process" have discovered about the combination.


Wham: Sperm Quality Improvements Via Pomegranate Juice

Any couple that has been trying to have children should seriously consider having a bottle of fresh, 100% pomegranate juice in their refrigerator at all times. New studies are lining up to show that regular consumption of this juice may enhance the quality and mobility of sperm. Other research is showing that the juice can have a positive effect on erectile dysfunction, as well. While the newest work has been done on male rats, it is hoped that the success will hold true in humans.

These new results were published in Clinical Nutrition. In this work, seven weeks of pomegranate juice consumption caused increased spermatogenic cell density, epididymal sperm concentration, sperm motility and decreased abnormal sperm rates.

In the past, it has looked like most of the health-benefits of pomegranate have been linked to improved heart health, and claims that it may offer protection against prostate cancer, Alzheimer's, and may slow cartilage loss in arthritis. Most of these health advantages are due to the antioxidants, and particularly compounds like punicalagin.

Another pilot studey recently showed that pomegranate juice may help manage erectile dysfunction (from the International Journal of Impotence Research). Significant further research is necessary to investigate if such observations would be reproducible in humans, and the doses required to gain such improvements.

Consumption of pomegranate juice has been on the rise all over the world. Sales have grown in the last year because of media coverage of the antioxidant-rich fruit that has commonly been linked to improved heart health, as well as claims that pomegranate could protect against prostate cancer and, as reported above, slow cartilage loss in arthritis.


Sham: Resperate For Blood Pressure Reduction

How can a product that often does what it is designed to do be considered a sham?

That's the question that I asked myself as I sat down to write this review of the Resperate Blood Pressure Reduction system. For anyone with higher than normal blood pressure readings, you've probably been bombarded with advertisements for this device. You see it everywhere on the Internet. It's a small electronic device that looks like a CD player, and its built-in tunes and a breathing sensor help you slow down your breathing. With regular use, it is designed to make a dent in your high blood pressure readings.

So the questions I asked when I checked out Resperate for review were, 1) Does it work? and, 2) Is it worth the money?

With regards to the first question, I did get a small reduction in my blood pressure readings. But, the second part of my question, the "is it worth it" part, is so flagrantly out of kilter with reality that I believe it moves Resperate into the category of a sham. This is one little $50 or $75 product that has ballooned out of proportion (due to the costs of marketing and advertising) into a $300 medical device.

When your small positive effect is counterbalanced by a huge ding in your checkbook, I believe this can still represent a SHAM. Others may feel differently.

Here's how it works . . . the Resperate device helps you to slow your breathing down by monitoring your breaths and telling you to breath with the little "tune" it generates (you have a choice of several of these little musical passages). The tune slows down, as does your breathing, until you've moved from 12 or 15 breaths per minute to 4 or 5. This "therapeutic breathing zone" has been shown in meditation to reduce blood pressure, so it is indeed based upon science. And for some people who just can't mediate any other way, perhaps Resperate is the way to go.

But, as my doctor told me, you can buy a CD to slow your breathing down, such as "Ken Cohen's Guide to Healthy Breathing" for about $12. The difference between this CD and the Resperate is that the device guides you through it. For some people, perhaps this is worth the additional $280. I may have considered keeping the device myself if it hadn't been so visibly a poor value.

When you receive Resperate, it's clearly not worth the investment by its outer appearance. Like many guys, I'm a gadget nut. When I buy a $300+ electronic goodie, I'm expecting a certain level of quality. After opening the box and seeing those less-than-airline-quality headphones included, my impression went downhill fast.

In this case, the first Resperate unit didn't work at all and had to be returned. Then, I started noticing that the device (which resembles a $20 or $25 WalMart portable CD player) had some real design problems. The chintzy cable for the chest sensor is wired directly inside the case instead of plugging into a jack so that it could be replaced when its 2¢ cable frays and breaks. When cables break on Resperate, the whole unit is dead in the water. And the headphone jack on mine had to be held in just a certain way in order to get the sound, because it was shorted out.

The long and the short of this "sham" is that while the device may do what it says it will do for some people, there remains a big caveat. The savvy shopper will invest $12 first as opposed to $300. Resperate is simply a good $50 idea with an added $250 in marketing costs, (sadly) picked up by the consumer.

I'll stick to the CD, thanks Resperate.


Sunday, January 27, 2008

Wham: New York City Socks it to The Fast Food Industry

The New York City Department of Health and Mental Hygiene has recently announced that it will, as of the end of March, begin enforcing a new regulation that says all chain restaurants in the city must now have the calorie content of menu items reflected right there on the posted menu. This is a first-rate law and one that the Board of Health is to be congratulated for.

It is the city's hope that the fat-filled truth will shock city residents into eating healthier.

The new version of the law applies to any chain restaurants operated in the city that has 15 or more outlets nationwide. This means that approximately 10 percent of restaurants in the city will be affected. While it is a shame that the "little guy" fast food places don't have to put up similar notices, it is a law that will definitely have an effect on the health of many.

Thomas Frieden, New York City Health Commissioner, was quoted by the local press as saying "Obesity is the only major health problem in the country and in New York City that is getting worse rapidly." He adds that the regulation "will help New Yorkers make healthier choices about what to eat; living longer, healthier lives as a result."

Burger King, McDonald's and others have already posted calorie information on their internet sites and in other media, but the information still remains hard to find. Now, with the new regulation, the city wants calorie information to actually be displayed on the menu so the diners can use the information while they are making their purchase decision.

The fast food industry is, of course, arguing the measure. "It would overly complicate menus and provide little benefit to consumers," remarked one company in an official statement.


Thursday, January 24, 2008

Sham: Low Cal Fast Food - Quizno's Fraud in Advertising

As everyone knows, the USA has a lot of weight to lose. Most of it stems from the fast food society, a culture that we seem bent on exporting throughout the world. This does no one any good.

I think it is a SHAM the way that certain fast food corporations treat the consumer who is trying to eat healthy. Let's use Quizno's as an example of what I mean here.

I'm sure you've been to one of these restaurants. It's basically a Subway with a toaster in the middle, and the sandwiches taste relatively good although they have been criticized for the excessive calories and fat count in most of their sandwiches. And, of course, it goes without saying that they really push their side orders of chips and large soda drinks as well.

But I personally never felt bad about Quizno's until their recent round of advertising. They are now pushing a flatbread sandwich they call the "Sammie." Have you seen these ads? The photographs are guaranteed to get you into their franchises, especially if you are watching calories and trying to eat healthy. There's a photo in your Sunday paper of a Sammie Grilled Chicken Balsamic sandwich . . . the sandwich is literally bursting at the seams, stuffed with 12 or 13 visible chunks of grilled chicken, a ton of lettuce and tomato, and right above it -- in giant letters -- ONLY 200 CALORIES.

That, my friends, is one of the most blatant shams I've seen in a long time.

The ad drew me into my local Quizno's franchise, where I ordered the above sandwich and then sat there in disbelief looking at the tiny little thing that I was served. Yes, the sandwich you GET might be only 200 calories. The guy making the Sammie used what appeared to be a teaspoon to dole out one level spoonful of a lettuce and tomato mix, on top of what were 6 or 7 small bites of chicken. All of it very carefully measured onto a tiny round piece of bread. (The sodium content of the balsamic dressing was off the charts, giving this little appetizer sized "meal" an overly-salty and unhealthy flavor.)

I'm a consumer advocate, so I called the 800 number on the door of my franchise with a complaint. Oddly, the number was right below a giant photo of the sandwich I was eating - or, I should say, the sandwich I THOUGHT I'd be eating.

They have "never gotten a complaint about this before" according to the Quizno's representative I spoke with. When I later spoke to the franchise owner, he told me that he hears this same concern from everyone, and agrees 100% with me that this is unorthodox advertising.

Looking for truly healthy and low-cal food in a fast food restaurant? Look further than Quizno's. Those folks are SHAM operators, at best.


Wednesday, January 23, 2008

Medical Industry Bias Shows in Review of Heart Health Herb

A newly published review has gone into great detail and examined dozens of clinical trials of the herb Hawthorn to determine if traditional use of this herb for heart health can be validated. The way that this review was managed, and how others are reacting to it, is a great study in the ongoing debate from medical doctors allied to the pharmaceutical industry.

This new article, a review of existing research, suggests that hawthorn extract “significantly” improves symptoms. That's good news for anyone with heart failure, a common condition that is both debilitating and deadly. Dick Cheney is a well-known example of this heart condition . . . an estimated five million Americans suffer from the same problem, which is often the result of clogged arteries that put stress on the heart by forcing it to work harder.

This review co-author, Dr. Max Pittler, deputy director of complementary medicine at Peninsula Medical School in Exeter, England, tells reporters that he would certainly take hawthorn extract if he had heart issues. According to his report, the hawthorn bush produces one of the most commonly used herbal medicines in the United States. Many believe that hawthorn extract improves heart health, lowers cholesterol and boosts antioxidant levels.

To determine whether hawthorn is actually an effective treatment, Pittler and colleagues searched the medical literature for high-quality studies into the use of the herb in chronic heart failure patients. Their review appears in the current issue of The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates medical research. Systematic reviews like this one draw evidence-based conclusions about medical practice after considering both the content and quality of existing medical trials on a topic.

Decisions about the research considered for inclusion in a review include whether or not the trial was double-blinded, or whether it was placebo controlled, and whether or not it was published. The new hawthorn review does NOT include the results of one large study — unpublished to date — that suggested hawthorn has only a limited affect on lifespan.

It is in the way that other doctors treat this other, unpublished study that shows us exactly the problem with certain doctors and their strong allegiance to the pharmaceutical industry. Despite the evidence in this new review that hawthorn "improved" or "improved significantly" various elements of heart failure, some doctors remain unconvinced.

Dr. Gregg Fonarow, director of the Heart Failure Program at the University of California at Los Angeles, said the larger hawthorn study whose results were released last year impressed him more. The study, which was not included in the review because it thus far remains unpublished, found only limited benefit.

Why would a doctor such as Fonarow look at the proof in these 14 analyzed trials and STILL suggest that the one trial that really matters is the unpublished one? Research that goes unpublished has a problem. It usually remains unpublished because it doesn't pass muster for one reason or another. By allying himself with the unpublished data, this doctor is stubbornly refusing to recognize the potential importance of this herbal supplement.

“It’s naturally attractive to think there is something over the counter or naturally occurring that may help improve outcome. Unfortunately, we’ve not been able to identify that so far,” Fonarow was quoted as saying. This new review will provide greater understanding of a valuable herbal supplement to open-minded doctors all over the world. To doctors like this one, nothing will move them from the pharmaceutical world to consider the potential of plants and natural products.


Tuesday, January 22, 2008

Sham: Candle Smoke Dangerous, Carcinogenic

We love candles around our house, especially my wife. We get new ones every week-- large or small, and scented with everything from a clean pine scent (my favorite) to cherry or pomegranate. We enjoy them every evening as we wind down from a busy day.

But -- it really hit home last night how dangerous candles are, and what a health hazard they can be.

We have some cheap gold candles that must have been painted on the outside to give them a glittery appearance. When my wife blew them out and we went to bed, one of them continued to smolder for half an hour in the dark, without a flame but with the wick still red and smoke pouring into the room. When I went out later to see what the smell was, the entire house was filled with paraffin smoke. This little 99¢ candle had trashed our living room.

When I began to investigate paraffin smoke and its ingredients, I found out why my wife and I should have checked into a hotel last night instead of lying there breathing that disgusting air. Did you know that candles throw out as many as 11 different carcinogens? It's not only after you blow them out, but the entire time they are lit you are experiencing a steady stream of these compounds, generally due to the petroleum-based wax used to produce the candle. This wax is mixed with synthetic fragrance that in most cases is not even meant to be burned. Many candles have chemical fixatives added to them, synthetic glosses or "paints" as our candle had, and more.

In fact, candle ingredients are not even listed on the package, despite the fact that anyone within range inhales those ingredients when it is lit. There are so few regulations that a candle listed as "beeswax" can still have petroleum paraffin as an ingredient. Some wicks even have small amounts of lead in their core to help them burn just right, and no one regulates the amount of lead that gets inhaled during those romantic, candlelit nights. Candles seem to have bypassed the regulatory agencies in most countries, probably because many of them are purely decorative and never meant to be lit.

My advice is to stick to quality brands of plant-based wax, such as "soy" candles. And any candle, when it is extinguished, needs to be covered for some time in order to trap those huge volumes of smoky carcinogens that are released when the candle is blown out!


Monday, January 21, 2008

Caffeine Poses Large Risk of Miscarriage

A new study by the Kaiser Permanente has shown that high doses of daily caffeine during pregnancy – whether from coffee, tea, caffeinated soda or hot chocolate -- cause a significant risk of miscarriage. The study controlled, for the first time, pregnancy-related symptoms of nausea, vomiting and caffeine aversion that tended to interfere with the determination of caffeine’s true effect on miscarriage risk. The research appears in the current online issue of American Journal of Obstetrics and Gynecology.

While previous research showed a link between caffeine consumption and miscarriage, this is the first study to thoroughly control for morning sickness, which typically causes many women to avoid caffeine, explained De-Kun Li, MD, Ph.D., an investigator with the Kaiser Permanente Division of Research and lead investigator of the study. “This study strengthens the association between caffeine and miscarriage risk because it removes speculation that the association was due to reduced caffeine intake by healthy pregnant women,” Li said.

This study was a large one, and it looked at 1,063 pregnant Kaiser Permanente members in San Francisco from October 1996 through October 1998. It examined the caffeine effect among women who never changed their pattern of caffeine consumption during their pregnancy. Women who consumed 200 mg or more of caffeine per day (two or more cups of regular coffee or five 12-ounce cans of caffeinated soda) had twice the miscarriage risk as women who consumed no caffeine.

The increased risk of miscarriage appeared to be due to the caffeine itself, rather than other possible chemicals in coffee because caffeine intake from non-coffee sources such as caffeinated soda, tea and hot chocolate showed a similar increased risk of miscarriage.


Thursday, January 17, 2008

Sham: Pharma Industry Selects Only Positive Trials for Publication

It's been hinted at for years, but the phenomenon known as the "file drawer effect" has come back to haunt the pharmaceutical industry. It's no shock to many experts, but the public is generally not aware of the fact that many pharmaceutical industry research studies are not published. Oddly (sarcasm intended) those studies tend to be the ones which showed that the drug was not effective.

In particular, it has been discovered that in the antidepressant drug arena, many of the clinical trials published in the medical literature were positive. The others? Sitting in a file drawer somewhere.

A research team led by Erick Turner of the Oregon Health & Science University has published an exposé on this practice, referring to the phenomenon as "selective publication."

"Even if not deliberate, this can be bad news for patients" the authors say in this publication from the New England Journal of Medicine. "Selective publication can lead doctors to make inappropriate prescribing decisions that may not be in the best interest of their patients and, thus, the public health," they wrote.

Here's an example . . . 74 studies were started for 12 leading antidepressants. Of these, 38 produced positive results for the drug. With the exception of one, all of those trials were published. On the other hand, only three of the 36 studies with negative or questionable results were published. Another 11 were written up in a style that made it appear as if the drug had worked.

"Not only were positive results more likely to be published, but studies that were not positive, in our opinion, were often published in a way that conveyed a positive outcome," said the authors.


Tuesday, January 15, 2008

Battle Between Pharmaceuticals and Supplements Heating Up!

Today, I was shocked to see a press release from the University of Texas Southwestern Medical Center hit the streets which was so blatant in its scare tactics and purposeful slant that I reacted immediately with an angry call and letter. While the press release is too lengthy to publish here, I've included some of the gems below.

The news release shows up on most sites as "Natural" Supplements Cause Cancer in Two Men." (Do you agree that this headline shows the slant?)

It starts out as a serious issue, something that anyone should be concerned with... product contamination. In this case, however, these dietary supplements are for "male enhancement." The authors, or those who wrote this press release (now seen all over the Internet and on tonight's TV news) use this as an opportunity to brand an entire industry.

Let's face it readers -- products for "male enhancement" are not mainstream supplement products. Companies that sell male enhancement products use spam as marketing, and they do not follow FDA and FTC guidelines for promotion of their product claims. in other words, this stuff is the "outcast" of the dietary supplement industry, as far into the fringe as you can get.

And yet, these authors use this example to paint an industry as untrustworthy. Here are a few excerpts:
“Unlike prescription and over-the-counter drugs, the law does not require nutritional supplements to undergo pre-market approval for safety and efficacy,” Dr. Shariat said. “The current FDA regulatory system provides little oversight or assurances that dietary supplements will have predictable pharmacological effects or even that product labels provide accurate information for consumers."


“For most supplements efficacy is not established in randomized, controlled trials. What is worse, safety is often equally poorly established,” said Dr. Roehrborn, who directs the Sarah M. and Charles E. Seay Center for Pediatric Urology.

along with,

"An estimated 42 percent to 69 percent of U.S. adults use dietary supplements, at an estimated out-of-pocket expenditure of about $34.4 billion, according to published reports cited in the study. Individuals often use supplements because they believe these natural products are safe and drug-free."

This is just one more barrage in a continuing campaign from pharmaceutical industry-allied doctors to brand the dietary supplement industry as untrustworthy. Here's my letter to the authors. If you care about your supplements, do something about this trend before those in Congress start telling you what you can and cannot buy over the counter:

Dear Dr.'s Roehrborn and Shariat:

As a freelance writer working in both the pharmaceutical as well as the dietary supplement industries, I have a unique viewpoint which allows me to see both sides of a very cantankerous debate. That is, from my vantage point I can see very clearly when a "slant" has been taken, either by the natural products industry arguing against pharmaceutical industry practices, or (as in the case of your press release) when doctors attack the dietary supplement industry.

I believe you've done a great disservice to the public. You've painted an entire industry as untrustworthy, when in reality your examples are from a fringe category of supplement . . . "male enhancement" products.

Products like these are fringe because the companies that supply them do not adhere to dietary supplement industry practices or even our government's requirements (FDA and FTC) for proper marketing. They include compounds that come from China, for example, where regularly enhancement products are tainted with chemicals or even drugs such as Viagra.

Gentlemen, this has nothing to do with the calcium your Mom takes for her concerns about osteoporosis, the garlic your neighbor takes for her blood pressure, or the numerous other safe and effective natural products that Americans use regularly for preventative healthcare. Your press release takes a very small niche ("male enhancement") and draws conclusions about a huge industry that millions of us count on to provide needed vitamins, herbs and supplements to keep us on a healthy track.

Personally, I am surprised to see such a slant coming from academia and from such a distinguished institution. My opinions are my own and not those of my employers. I list these credentials so that you will recognize that my viewpoint encompasses both pharmaceutical as well as natural product industries.

Regards, Dave Jensen

Monday, January 14, 2008

Wham: Calorie Restriction Leads to 10x Life Span Increase in Yeast

Anyone who reads about the booming research field of life extension would be interested in this one. Here's yet another proof that calorie restriction works . . . A new study in PLOS Genetics shows that biologists have achieved a 10-fold life span extension in ordinary baker's yeast. This new discovery provides insight into aging mechanisms shared with humans and other mammals and will really set the stage for more R&D in the anti-aging market.

Biologists have created baker’s yeast capable of living to 800 in yeast years without apparent side effects. This important discovery, achieved through a combination of dietary and genetic changes, brings science closer to controlling the survival and health of the unit of all living systems: the cell.

“We’re setting the foundation for reprogramming healthy life,” said study leader Valter Longo of the University of Southern California.

A companion study, showing that the same genetic changes in yeast reverse the course of an accelerated aging syndrome, appears in the Jan. 14 issue of the Journal of Cell Biology. This research team put baker’s yeast on a calorie-restricted diet and knocked out two genes, RAS2 and SCH9, that promote aging in yeast and cancer in humans.

“We got a 10-fold life span extension that is, I think, the longest one that has ever been achieved in any organism,” Longo said. In 2005, the same research group reported a five-fold life span extension in the journal Cell. Normal yeast organisms live about a week.

“I would say 10-fold is pretty significant,” said Anna McCormick, chief of the genetics and cell biology branch at the National Institute on Aging and Longo’s program officer.

The NIA funds such research in the hope of extending healthy life span in humans through the development of drugs that mimic the life-prolonging techniques used by Longo and others, McCormick added.

Baker’s yeast is one of the most studied and best understood organisms at the molecular and genetic level. Remarkably in light of its simplicity, yeast has led to the discovery of some of the most important genes and pathways regulating aging and disease in mice and other mammals.

Calorie restriction – in practice, controlled starvation – has long been shown to reduce disease and extend life span in species from yeast to mice.

Scientists believe that a nutrient shortage kicks organisms into a maintenance mode, enabling them to re-direct energy from growth and reproduction into anti-aging systems until the time they can feed and breed again. Calorie restriction is now being tested by other researchers on primates and even humans.


Friday, January 11, 2008

The Many Colors of Salt

I'm trying to watch my sodium intake. It's hard, and I am sure that I have many readers of this column who will agree with me on this one.

No matter what kind of prepared foods you buy at the Grocery, even those that come from a healthy foods store like a Whole Foods or New Frontiers (our store in Sedona), you find that behind the organic ingredients and the "natural" labels lies a ton of sodium. You almost can not get away from it. Which means that you may, like me, come home from the grocery store with your bags of veggies and fruits, vowing to lead a low-sodium lifestyle even if it kills you trying.

Unfortunately, that's when you find that salt comes in many colors.

I like the way that Dr. Lori Daniels, cardiologist at the University of California, San Diego Medical Center describes this issue to her cardiac patients. She recently wrote that you may be able to significantly lower your blood pressure by reducing the sodium, but you must be aware that white table salt is just one form of sodium in your kitchen.

The other colors of culinary culprits with high sodium content are black (soy and teriyaki sauce), yellow (mustard), pink (lunch meats) and brown (canned soups and gravies.) Check the sodium content before ingesting a processed product; if you dramatically reduce your intake of sodium, you might, under your doctor’s care, be able to eliminate some blood pressure medications.

I'm now in the process of trying a number of dietary supplements personally, those that suggest on their boxes that they benefit high blood pressure. I will let you know how I do in a future blog!


Wednesday, January 9, 2008

Sham: Medical Press Releases and Ethics

As a writer in the medical and healthcare blogosphere, I read and write about press releases all the time. I've seen a disturbing new trend. Many of them, in an attempt to get noticed, read like this "breakthrough" is happening tomorrow and that the crippled will walk, etc.

You be the judge. Tell me if I am right or wrong to have written the following letter to the two researchers behind a huge press release that went out today. I don't think it does anyone any good to have sensational headlines attached to press releases like this. Here's my letter to Dr's Tobinick and Gross:

As an Alzheimer's caregiver for a loved one, I must tell you that sensationalized press releases of the kind that went out today ("Reversal of Alzheimer's Symptoms Within Minutes") are not only damaging to families, but they are unethical.

You have allowed the University of Arkansas to publish something that reads as if a cure for the disease is right around the corner. There should have been a statement in that press release that describes the "real world" effect and timing of your work. The headline should have been cranked down significantly from the sensational and misleading one that was used.

This, gentlemen, appears to be a sham. While your work is real and quite meaningful, you have allowed it to be packaged and sold in a manner that doesn't do credit to your science.

David Jensen

Headline: Reversal of Alzheimers Symptoms Within Minutes

An extraordinary new scientific study, which for the first time documents marked improvement in Alzheimer’s disease within minutes of administration of a therapeutic molecule, has just been published in the Journal of Neuroinflammation.

This new study highlights the importance of certain soluble proteins, called cytokines, in Alzheimer’s disease. The study focuses on one of these cytokines, tumor necrosis factor-alpha(TNF), a critical component of the brain’s immune system. Normally, TNF finely regulates the transmission of neural impulses in the brain. The authors hypothesized that elevated levels of TNF in Alzheimer’s disease interfere with this regulation. To reduce elevated TNF, the authors gave patients an injection of an anti-TNF therapeutic called etanercept. Excess TNF-alpha has been documented in the cerebrospinal fluid of patients with Alzheimer’s.

The new study documents a dramatic and unprecedented therapeutic effect in an Alzheimer’s patient: improvement within minutes following delivery of perispinal etanercept, which is etanercept given by injection in the spine. Etanercept (trade name Enbrel) binds and inactivates excess TNF. Etanercept is FDA approved to treat a number of immune-mediated disorders and is used off label in the study.

The use of anti-TNF therapeutics as a new treatment choice for many diseases, such as rheumatoid arthritis and potentially even Alzheimer’s, was recently chosen as one of the top 10 health stories of 2007 by the Harvard Health Letter.

Similarly, the Neurotechnology Industry Organization has recently selected new treatment targets revealed by neuroimmunology (such as excess TNF) as one of the top 10 Neuroscience Trends of 2007. And the Dana Alliance for Brain Initiatives has chosen the pilot study using perispinal etanercept for Alzheimer’s for inclusion and discussion in their 2007 Progress Report on Brain Research.

The lead author of the study, Edward Tobinick M.D., is an assistant clinical professor of medicine at the University of California, Los Angeles and director of the Institute for Neurological Research, a private medical group in Los Angeles. Hyman Gross, M.D., clinical professor of neurology at the University of Southern California, was co-author.

The study is accompanied by an extensive commentary by Sue Griffin, Ph.D., director of research at the Donald W. Reynolds Institute on Aging at the University of Arkansas for Medical Sciences (UAMS) in Little Rock and at the Geriatric Research and Clinical Center at the VA Hospital in Little Rock, who along with Robert Mrak, M.D., chairman of pathology at University of Toledo Medical School, are editors-in-chief of the Journal of Neuroinflammation.

Griffin and Mrak are pioneers in the field of neuroinflammation. Griffin published a landmark study in 1989 describing the association of cytokine overexpression in the brain and Alzheimer’s disease. Her research helped pave the way for the findings of the present study. Griffin has recently been selected for membership in the Dana Alliance for Brain Initiatives, a nonprofit organization of more than 200 leading neuroscientists, including ten Nobel laureates.

“It is unprecedented that we can see cognitive and behavioral improvement in a patient with established dementia within minutes of therapeutic intervention,” said Griffin. “It is imperative that the medical and scientific communities immediately undertake to further investigate and characterize the physiologic mechanisms involved. This gives all of us in Alzheimer’s research a tremendous new clue about new avenues of research, which is so exciting and so needed in the field of Alzheimer’s. Even though this report predominantly discusses a single patient, it is of significant scientific interest because of the potential insight it may give into the processes involved in the brain dysfunction of Alzheimer’s.”

While the article discusses one patient, many other patients with mild to severe Alzheimer’s received the treatment and all have shown sustained and marked improvement.

The new study, entitled “Rapid cognitive improvement in Alzheimer’s disease following perispinal etanercept administration,” and the accompanying commentary, entitled “Perispinal etanercept: Potential as an Alzheimer’s therapeutic,” are available on the Web site of the Journal of Neuroinflammation, at

Author Hyman Gross, M.D., has no competing interests. Author Edward Tobinick, M.D. owns stock in Amgen, the manufacturer of etanercept, and has multiple issued and pending patents assigned to TACT IP LLC that describe the parenteral and perispinal use of etanercept for the treatment of Alzheimer’s disease and other neurological disorders, including, but not limited to, U.S. patents 6015557, 6177077, 6419934, 6419944, 6537549, 6982089, 7214658 and Australian patent 758523.

UAMS is the state’s only comprehensive academic health center, with five colleges, a graduate school, a medical center, six centers of excellence and a statewide network of regional centers. UAMS has 2,538 students and 733 medical residents. Its centers of excellence include the Winthrop P. Rockefeller Cancer Institute, the Jackson T. Stephens Spine & Neurosciences Institute, the Myeloma Institute for Research and Therapy, the Harvey & Bernice Jones Eye Institute, the Psychiatric Research Institute and the Donald W. Reynolds Institute on Aging. It is one of the state’s largest public employers with about 9,600 employees, including nearly 1,000 physicians who provide medical care to patients at UAMS, Arkansas Children’s Hospital, the VA Medical Center and UAMS’ Area Health Education Centers throughout the state. UAMS and its affiliates have an economic impact in Arkansas of $5 billion a year. Visit

I believe that it is important to ask "Is this appropriate?" when sending a press release out to the media as the example above. I can only assume that the motivation for this release came from the University of Arkansas, which may have been looking for some kind of publicity. Others may see a more sinister connection between the lead author and the commercial company which licenses his work.

Either way, I believe the way it was packaged was inappropriate and unclear, both of which put this wonderful science into the "sham" category for many readers. I have called and written the UAMS and given them the opportunity to respond here.


Monday, January 7, 2008

Too Much Water Can Kill You: Hyponatremia

Don't get me wrong -- water IS good for you. Every expert who talks about healthy eating says to make sure that you drink plenty of water throughout the day. But, recently it has been made very clear that drinking too much water can actually be quite dangerous. In fact, it can kill you.

You may remember the story about the California disc jockeys who ran the "Hold Your Wee for a Wii" promotion; this was an incredibly dumb stunt where contestants drank water in the radio station studio to see who could hold it the longest in hopes of winning a Wii video game console. One of the final contestants, a young mother of 3, died the next day due to the amount of water she drank.

This problem is back in the news today. Hyponatremia is a concern because it occurs on a regular basis in marathon running, and there are nearly 40 marathons being run from Honolulu to Cape May County, NJ in the next three months. It affects a lot of runners and the frightening part is that many don't know they have it until they become very sick.

“This condition, hyponatremia, occurs when you have low sodium in your body,” said Dr. James Muntz, internal medicine service chief with The Methodist Hospital in Houston. “When sodium levels drop in the fluids outside the cells, water will get in there and attempt to balance the concentration of salt outside the cells.”

As Muntz describes it, this abundance of water will cause the cells to swell. While most cells can adapt to change, the brain cannot. Symptoms of hyponatremia include vomiting, loss of appetite, headache, restlessness/fatigue, an abnormal mental status (hallucinations, confusion, change in personality) as well as muscle weakness and convulsions.

You can prevent hyponatremia several days in front of the race by using sports drinks during training and increasing your salt intake.(This last recommendation only if you don't have high blood pressure).

“During the marathon a good rule of thumb is to drink about one cup of fluid every 20 minutes,” Muntz says. “Drinking any more than that over the course of the race can get you into trouble.”

A study of runners had been performed after the 2002 Boston Marathon. It found that 13 percent of those who finished the race developed hyponatremia, with the majority of these affected runners "feeling fine” after the race. However, if someone who feels “fine” continues to drink water because they believe the nausea and weakness they are feeling is due to dehydration, they could easily end up having a seizure and falling into a coma.


Thursday, January 3, 2008

Consumers Avoiding Foreign Ingredients

An industry trade magazine, The Natural Foods Merchandiser recently reported on a large survey that was done of the supplement purchasing population. It was found that consumers vastly underestimate the percentage of ingredients in their vitamins and supplements that come from China. This falls into line with what has been reported here in the past about the fact that many products do not state the country of origin for their compounds.

This survey, conducted November 16th and 17th, was a nationally representative group of more than 1,000 people, about 50% of whom self-reported themselves to be purchasers of dietary supplements. It was apparent in the survey that the respondents felt that very few of the ingredients in these products originated from China. At the same time, nearly two-thirds of the same group said that they would be far less likely to purchase a product if they knew it was of Chinese origin.

Little did these consumers know that the percentage of Chinese ingredients in popular products is considerably higher than even their most pessimistic estimates.

Unfortunately, the whiplash effect of the Chinese contamination stories in the press appears to have rubbed off on other countries of origin as well . . . 40% of these consumers say they would be less likely to buy a Japanese product, and 27% for European goods. "The surprise finding was that there's a negative afterglow for foreign products, generally," said Loren Israelsen, president of LDI Group Inc, an industry consulting firm.

Some countries (notably Scandinavia and Germany), are noted by industry experts as being on par or having even higher quality standards than the USA. It is a shame that the Chinese issue seems to have tainted all "foreign" dietary supplements with this concern in the public's mind.


Wednesday, January 2, 2008

Wham: Herbal Products for Depression Include Saffron

In the fall of 2007, Sham vs. Wham reported on the new clinical trial published in the Nordic Journal of Psychiatry about the herb Rhodiola rosea. In that trial, there was a significant mood elevation shown for the herb, on a par with SSRI antidepressants. Now, another trial has been reported on which uses the spice Saffron.

Depression is a common health problem worldwide; it is estimated that depressive disorders will represent the second largest disease burden by the year 2020. Unfortunately, the side effects associated with many of the drugs for depression make these therapies intolerable for some. In addition, many patients do not respond to these agents adequately. That's why there is such an interest right now in exploring herbal options.

Unfortunately, St. Johns Wort (one of the major herbs in this category) has been found to have significant cross-interaction with pharmaceutical products, which makes it unusable for many patients.

Recent clinical trials have shown that extracts from the petal and stigma of saffron (Crocus sativus) are effective in the treatment of mild-to-moderate major depression. The objective of the most recent study was to compare the antidepressant effect of a conventional antidepressant (Prozac) with that of the petal of saffron (the least expensive part of this rather expensive spice.)

Forty-eight patients aged 18-55 years with major depression were enrolled in this randomized, double-blind, clinical trial, which was conducted at the University of Tehran (Tehran, Iran). The patients had a Hamilton Rating Scale for Depression (HAM-D) of between 17 and 25. The patients were randomly assigned to receive a 15-mg saffron petal extract capsule (standardized to 0.30-0.35 mg safranal) or a 10-mg Prozac capsule twice daily (morning and evening) for 8 weeks.

A significant effect for both saffron and Prozac was observed. The difference in scores between the 2 treatment groups was not significant at week 8. The main finding of this study was that extract from the petal of C. sativus "may be of therapeutic benefit in the treatment of mild to moderate depression." This finding agrees with that of previous studies, which showed that extracts from the petal and stigma of this plant have antidepressant effects.

Unfortunately, this trial wasn't as modern and sophisticated as the Rhodiola trial, which had a Placebo element and much more detail paid to statistical analysis. Still, it is good to see that researchers are working on safe and effective herbal treatments for a growing worldwide health concern.