Clinics that can test for consumers’ genotypes and give out dietary advice based on findings could be set up in the near future, according to an Australian scientist speaking at Asia’s first major nutrigenomics conference last week.
Dr Michael Fenech, head of the Nutrigenomics and Genome Health project funded by Australia’s research body CSIRO, told those attending the meeting in Singapore that ‘genome health clinics’ will soon be possible as knowledge on gene-diet interactions grows.
"There is good evidence that genome and epigenome damage ‘markers’ are sensitive indicators of deficiency or excess in micronutrients (vitamins and minerals) which are needed as components of DNA repair enzymes and/or to make new copies of DNA," he said.
"We now know that moderate micronutrient deficiency can cause as much genome damage as significant doses of radiation and increases the risk of developmental and degenerative disease."
A deficiency of micronutrients can limit the DNA’s ability to replicate itself properly and thus reduce the body’s ability to fight diseases. Growing work in this area is creating a new opportunity in disease prevention based on the fact that genome damage caused by micronutrient deficiency is preventable.
"Specific micronutrient deficiencies that cause genome damage may themselves cause developmental defects in the foetus or increased risk of cancer later in life. Supplementation of diet with appropriate vitamins, such as folate and B12, at the correct dose for each individual could help our DNA to remain healthy, and in some cases, actually help to repair damaged DNA," said Fenech.
According to Dr Fenech, in the future consumers could take a simple blood test at a special clinic and have the damage to their DNA assessed as well as their genotype determined. From there, they would be offered a micronutrient supplement and diet plan tailored to optimise their health.
I find these developments and the research and funding attention being invested to be very refreshing, even exciting. It demonstrates clear recognition of the importance of micronutrition with vitamins and minerals, including the absolutely foundational role this area plays in health. It also strongly supports the notion that I and many others have been saying for many years; beyond certain basics everyone’s individual nutritional needs can vary markedly from person to person.
It is good to see high quality, government funded research attention being focussed on the importance of individual nutrition. Sure beats all that medical toxicity!
If you have read the Health Gazette for a while you know that I am against statins. They respresent one of the biggest cons in history and any informed analysis makes a lot of people look pretty foolish. All of the brilliance, when it comes to this class of drugs, is in the marketing department.
Consider the following heart disease statistics for example.
- 60.8 million Americans had one or more forms of cardivascular disease
- 40.6 percent of all deaths in the USA were related to heart disease
- Almost a million people (946,619) died in the USA from heart disease
- 12.4 million heart attack survivors lived at high risk of further attacks
- 4.5 million stroke survivors lived at high risk of further strokes
These figures relate to data from 1998 and the results today are actually worse, not miraculously better. Yet, as the following article poits out, drug companies, doctors and the stock market all consider "the ’90s were the decade of the statins." So what went wrong? Why is it that so many billions of dollars were spent on this class of wonder drugs during this period and there is zero discernible improvement in the targeted health problems?
Could it be that in fact all the materials produced about these drugs are simply clever marketing? Yes. Even the carefully crafted ‘scientific’ studies? Yes. The pontifications by the FDA and other international equivalent approval authorities? Yes and yes. All marketing.
Take a look at the following article from Bloomberg.
Dec. 12 (Bloomberg) — Kos Pharmaceuticals Inc.’s Niaspan is the only U.S.-marketed drug to prevent heart disease by boosting "good" cholesterol. Soon there may be a lot of company.
Niaspan is the first of what doctors, drugmakers and investors say may be the next multibillion-dollar generation of medicines for fighting heart disease. By raising blood levels of HDL, the so-called beneficial form of cholesterol, researchers say they can lower a patient’s risk of developing clogged arteries, heart attacks and strokes.
Drugs such as Pfizer Inc.’s Lipitor that lower the "bad" kind of cholesterol already are transforming efforts to prevent heart attacks. These so-called statin drugs generate $20 billion annually. U.S. research cardiologists, who say patients at high risk of heart disease need even more help, now are turning to Niaspan and a half-dozen HDL medicines being tested.
"If the ’90s were the decade of the statins, this is the decade of the HDL’ raising drugs, said Allen Taylor, director of cardiovascular research at Walter Reed Army Medical Center in Washington in a Dec. 2 telephone interview. "If we’re going to make more headway against heart disease, we need to focus on new areas. HDL is a perfect one."
Sales of Niaspan, approved in 1997, jumped 37 percent in the first nine months of this year to $311 million. The company’s stock doubled in the past 12 months. Shares of Cranbury, New Jersey-based Kos gained 7 cents to $71.29 on Dec. 9 in Nasdaq Stock Market composite trading.
Prescriptions for Niaspan may increase in the next year as drugmakers present new patient studies testing whether boosting HDL, short for high-density lipoprotein, lowers heart-disease risk. Next year, Pfizer will be releasing a large study of its experimental HDL-raising drug, torcetrapib.
Only Player
"Right now Kos is the only player in town," said RBC Capital Markets analyst Ken Trbovich in Denver, who has an "outperform" rating on Kos and doesn’t own any shares, in a Nov. 29 interview. With Pfizer publishing new HDL research, "it’s simply affirming what Kos has been telling doctors," Trbovich said.
Kos started selling Niaspan in the U.S. five years ago with a 90-person sales force, Chief Executive Officer Adrian Adams said in a telephone interview Nov. 30. Through a marketing partnership with Takeda Pharmaceutical Co., Japan’s largest drugmaker, almost 2,000 sales representatives now are pitching the importance of HDL boosting to doctors.
"In the early days where we were focusing a lot on convincing people, it was quite challenging," Adams said. The recent buzz about HDL "reinforces the message we’ve been saying for many, many years," he said.
Vitamin B
Kos, founded in 1988, created Niaspan by reformulating niacin, a type of vitamin B. Niacin assists in the functioning of the digestive system and had been known for years to lower bad cholesterol, increase HDL and reduce triglycerides, another fatty protein in the blood,
The reformulated version doesn’t have side effects, such as liver damage, associated with the high doses of niacin needed to affect blood fat levels.
It wasn’t until 1998 that heart researchers got the first proof that raising HDL levels can save lives. A study found that Warner-Lambert Co.’s drug Lopid, which works in part by increasing HDL, cut the risk of heart attacks and dying from cardiovascular disease by 22 percent.
That study, later confirmed by more research, found that to prevent heart disease, the amount of HDL in a person’s blood should register at 60 or higher. Readings below 45 for men and 55 for women increase disease risk, doctors say. Research suggests that for every 1 point that the HDL reading rises, the risk of heart disease drops by 2 percent to 3 percent.
Ferrying Fats
Lopid, acquired by Pfizer when it purchased Warner-Lambert in 2000, is little prescribed because of side effects including potentially fatal muscle damage that can occur when used with other drugs, including statins.
Researchers speculate that HDL plays a key role in picking up the dangerous, fatty lipids from the arteries and ferrying them to the liver for disposal.
The premise still isn’t fully proven. Unlike bad cholesterol, which comes in one form, there are a variety of types of HDL cholesterol and increasing the levels of only some varieties may help counter disease, said Christopher Cannon, a cardiologist at Brigham and Women’s Hospital in Boston, in a Dec. 2 phone interview.
"To be honest, the first step we are looking for is proof of principle that raising HDL by any means is good," he said.
Combination Pills
Kos is now working on a combination of Niaspan with Merck’s, which loses U.S. patent protection next year. Zocor reduces blood levels of "bad" cholesterol, known as LDL for low-density lipoprotein. Kos expects to start selling the product in the U.S. in late 2007 or early 2008.
In a few years, Niaspan may face competition from products made by Pfizer and a partnership between Merck and Arena Pharmaceuticals Inc., a new drug under development at Eli Lilly & Co. and a therapeutic vaccine from Avant Immunotherapeutics Inc.
New York-based Pfizer plans to sell its HDL-boosting drug in a combination pill with Lipitor, the world’s biggest-selling medicine, generating $11 billion in sales this year. If the major patient study proves the pill protects against heart disease, the company will promote the drug as a double-barreled attack on cholesterol that raises HDL and lowers LDL.
"Pfizer’s bet a billion dollars on these trials," said Steven Nissen, a cardiologist at the Cleveland Clinic in Ohio who is heading one of the pivotal studies, in a Nov. 14 interview. "It’s either going to be a big bust or the biggest drug ever."
Side Effects
Results from early studies suggest the combination drug may boost good cholesterol levels as much as 50 percent. Other data show it may also increase blood pressure, a potentially troubling side effect.
"This is by far and away the most important product under development" for Pfizer, said David Heupel, a Minneapolis-based portfolio manager at Thrivent Investment Management, with $66.8 billion in assets, including Pfizer shares, in a Dec. 1 interview. The market for HDL "has multi, multibillion-dollar potential," he said.
There’s no doubt about it. Statins are all about money. Given the hype of the claims made about them and the stark evidence now that they have completely failed to deliver the promised benefits it is now time for them to be replaced by a new generation of cholesterol-related drugs.
Will they be any better? No. Why need they be, after all, people pay for the sizzle, there’s no need for the steak.
If you are interested in preventing heart disease and stroke go to our nutraceuticals page. Don’t stop there though. Check the offer of a free report on the right side of the page, get the relevant one and read it. It is genuinely informative and not just marketing! Then check out the products found on the site, you’ll be glad you did.
Rheumatoid arthritis (RA) is an autoimmune disease characterized by chronic inflammation of the joints, which gradually erodes the cartilage and bone. The agents of destruction include inflammatory cells, cytokines, and protein-degrading enzymes known as matrix metalloproteinases (MMPs).
The destructive cycle begins when inflammatory cells infiltrate the tissue lining the joints and consume excess oxygen. In addition to unleashing MMPs, the oxidative stress provokes non-enzymatic glycation – a chemical binding of sugar molecules and proteins. Telltale signs of glycation have been found in blood, urine, and joint fluid of RA patients.
The primary protein in cartilage, Type II Collagen (CII) is crucial to joint health and function. Yet, the involvement of CII in the process of joint inflammation has proven difficult to substantiate. However, a recent study featured in the December 2005 issue of Arthritis & Rheumatism (www.interscience.wiley.com/journal/arthritis) has shed light on this.
To gain a clearer understanding of CII’s role in the pathogenesis of RA, researchers at Queen Mary, University of London and others studied its behavior within an inflamed joint, when modified by oxidants linked to inflammation or by ribose, a five-carbon sugar common to all living cells. Their findings support CII’s potential contribution to antibody binding and RA’s devastating progression.
Full details are published here: "Generation of Neoantigenic Epitopes After Posttranslational Modification of Type II Collagen by Factors Present Within the Inflamed Joint," Ahuva Nissim, Paul G. Winyard, Valerie Corrigall, Rewas Fatah, David Perrett, Gabriel Panayi, and Yuti Chernajovsky, Arthritis & Rheumatism, December 2005; 52:12; pp. 3829-3838.
"The present findings support the possibility that chemical modification of self antigens, in RA in particular and in inflammation in general, is the cause of formation of neoepitopes," the study’s leading author, Ahuva Nissim, Ph.D. said. "We propose that the oxidative modification of CII creates a CII autoantigen."
This hypothesis has important implications for the further study and enhanced understanding of the pathology of RA – a complex autoimmune disease. In the meantime, try to avoid drugs with dangerous and unwanted side effects. There are helpful suggestions for people with arthritis in the Musculoskeletal Needs page at Healthy Vitamin Choice and in the Bones and Muscles pages at Herb Health Guide. Very helpful products with a guarantee and no unwanted side effects are available via our Health Products Site.
There is no doubt about the dangers of caffeine. You may wonder at times when you see the foolish promotion of coffee by people who should know better, but such errors of judgement and poor values foundations are a fact of life. Just look at the promotion of pharmaceuticals. However, for now let’s just confine ourselves to caffeine.
Caffeine is the most widely used mood-altering drug in the world, with 80 percent to 90 percent of children and adults in North America regularly consuming caffeine-containing foods. Mean daily caffeine consumption among adult caffeine consumers in the United States has been estimated to be 280 milligrams per day, which is equivalent to about three 6-ounce cups of coffee or five 16-ounce bottles of cola soft drink.
A study led by Johns Hopkins investigators and published in the December issue of the American Journal of Psychiatry has shown that women with a serious caffeine habit and a family history of alcohol abuse are more likely to ignore advice to stop using caffeine during pregnancy.
Withdrawal symptoms, functional impairment and craving were cited by the women as reasons they could not cut out or cut back on caffeine use. None of the women had a current alcohol-use diagnosis, and none had been treated for alcohol problems.
"Results of this study suggest that genetic vulnerability reflected in a family history of alcoholism may also be at the root of the inability to stop caffeine use," said co-lead author Roland R. Griffiths, Ph.D., a professor in the departments of Psychiatry and Neuroscience at The Johns Hopkins University School of Medicine.
Griffiths, whose past studies of caffeine use helped establish the drug’s addictive nature, collected data on caffeine and alcohol use from 44 pregnant women seeking prenatal care from a private obstetrics and gynecology practice in a suburban community. Results showed that half of the women who had both a lifetime history of caffeine dependence and a family history of alcoholism ignored their doctor’s recommendation to abstain from caffeine use and consumed caffeine in amounts greater than those considered safe during pregnancy.
Women in the study without these dual risk factors were able to abstain from caffeine during pregnancy.
"This study helps to validate the diagnosis of caffeine dependence as a clinically significant phenomenon," Griffiths said. "It’s one thing to speculate how powerful the dependence is, but here we have an example of people who are not following physician recommendations and are unable to quit caffeine in spite of wanting to do so."
Caffeine use during pregnancy has been associated with a variety of adverse consequences, including spontaneous abortion and reduced fetal growth. Government health agencies in the United States, Canada and the United Kingdom have issued health warnings about limiting the use of caffeine during pregnancy.
The U.S. Food and Drug Administration has advised pregnant women to "avoid caffeine-containing foods and drugs, if possible, or consume them only sparingly." Health Canada and the Food Standards Agency of the United Kingdom have advised that pregnant women consume less than 300 milligrams per day of caffeine, according to the study.
It has been well established that family members of people with alcoholism are more likely to be alcohol dependent. Studies involving adopted children and identical twins have suggested that genetic factors play a role in alcohol and drug dependency within families. Twin studies have also demonstrated genetic factors in relation to problematic caffeine use, including heavy caffeine use, caffeine tolerance and caffeine withdrawal.
With regard to a link between alcoholism and caffeine, there is a high co-occurrence between alcoholism and caffeine use, and twin studies examining alcohol use, caffeine use and cigarette smoking concluded that a common genetic factor underlies the use of these three substances.
Remember that caffeine is a potent drug. If you consume caffeine it does have an effect, though you will most likely develop a level of tolerance at low to moderate doses that masks the changes most of the time. You should ideally avoid caffeine, but if you can’t (or perhaps you will claim you simply don’t want to) then at least strictly limit your consumption. Be particularly watchful of your intake of coffee, cola, chocolate and black tea. Caffeine is frequently also added to other softdrinks, confectionary and some medicines.
See my earlier caffeine related posts for more information about this drug.
There are some further references that you can find by doing a site search on caffeine. Be well now.
Following criticism over their handling of drug safety controversies, FDA officials promised earlier this year they would release more information about potential risks. Accordingly, yesterday, Friday 9 December, the FDA issued an alert that appears to be more about demonstrating that they can keep their promise than actually being about maintaining drug safety standards.
A bit harsh perhaps? I don’t think so. The alert issued is particularly well documented and explained (hence, they may be seen to be releasing more information) yet it says that while they note striking evidence suggesting harm is caused by Biaxin (clarithromycin), they are not inclined to suggest any changes at all.
This, I think is an extraordinary glimpse into the values and culture of the FDA. Where does the benefit of the doubt belong? Surely it should obtain to benefit the public, to the consumers of drugs. But no, it appears that the FDA awards the benefit of the doubt to the drug company, so it’s business as usual for Abbott Laboratories.
How could they justify such a decision? Astonishingly, it is based on what they admit they do not understand. So, because the FDA doesn’t already understand or know of some methods or in vivo mechanisms of action of the drug in question, they are allowing it to remain available for use. This is breathtaking arrogance. Once more we see what I regularly point out: patients receiving approved drugs are really just subjects in a lucrative experiment.
The FDA did indeed alert the public to the study showing a higher death rate among heart disease patients a year after taking an Abbott Laboratories antibiotic called Biaxin. They really had to, since the study was published on the previous day in the British Medical Journal.
The study evaluated data from about 4,373 Danish heart disease patients who took the drug, Biaxin, or a placebo for 14 days. Patients ranged in age from 18 to 85. The researchers said 9.8 percent of Biaxin patients died within three years of treatment, compared with 7.8 percent of people who got a placebo. There were no differences in the death rates until a year following therapy. The scientists said the result was surprising and that the long-term safety of Biaxin should be further examined.
Indeed it should, along with all similar drugs used for a similar purpose. However, Abbott spokesman Brian Kyhos said the Danish findings were "at odds with 50 years of data and patient experience" with macrolides, the family of antibiotics that includes Biaxin, which has been sold for 15 years. "We believe the results are a random finding," Kyhos said.
Kyhos said: "It is important to be careful not to create undue alarm for patients" but what Abbott means is that it is important not to create undue alarm in the stock market.
Otherwise it would seem much more responsible to voluntarily suspend sales of the drug pending further evaluation. Again, one has to ask, is it patients who are being protected or stock holders? Does the FDA protect consumers or drug marketers?