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American Authorities Wish for Better Information and Reporting about Dietary Supplements

Claus Hancke

April 12, 2004

Since 1994 liberal legislation in the United States has secured the American population full access to safe dietary supplements. 2½ year ago FDA asked the Institute of Medicine (IoM) to investigate the extent of harmful effects of supplements. The FDA received this report from IoM last week.

The conclusion is, among other things, that there are very few safety data for the 29,000 different dietary supplements sold in the United States, and the concern seems to be that this market grows by 25% a year, and today amounts to about 18 billion. dollars annually.

When the IoM was asked to do a safety assessment of the market, it was because there was growing concern about one supplement in particular, namely “Ephedra”, which was sold as a popular slimming and energy aid. The effect is somewhat reminiscent of the Danish, now banned drug, Letigen.

Ephedra does not exist in Denmark, and if it did, it would have to be registered as medicine, just as Letigen was in its time.

The FDA has now banned Ephedra as a dietary supplement after it caused 155 deaths and 16,000 cases of side effects. By comparison, over-the-counter arthritis medications (NSAIDs) cause 16,000 deaths in the United States each year.

The IoM also found products with wide variation in content, and products, particularly Chinese herbal preparations, which were contaminated with heavy metals and medicines. In some of the Chinese supplements, the medicine was actually added to promote the effect.

The IoM therefore proposes a “whistleblower” system with a central registration of side effects, similar to the Danish Side Effects Board, which is a fine idea. However, the IoM also writes that many side effects could be avoided if the consumer was sufficiently well informed.

This is a memento to the Danish system, where the Danish Food and Drug Administration prohibits information to both consumers and retailers of dietary supplements. Yes, not even doctors and pharmacists must be taught even the most factual information regarding dietary supplements.

This should be changed so that we increase security for the Danish consumer.

By: Vitality Council

Reference:
Special report: A health fad that’s hard to swallow, New Scientist Special Report, 12. April 2004.

Dietary Supplements Reduce the Need for Medicine

Claus Hancke

March 1, 2004

Like nutrition, many supplements have a positive effect on the physiological processes of the body. A new scientific study has shown that Pycnogenol, a substance extracted from pine bark, can lower the blood pressure to such an extent that the need for hypotensive medicine is reduced by 50%.

As is the case with food, a lot of dietary supplements have a positive effect on the body’s physiological processes.

For instance, new scientific research has shown that Pycnogenol can lower the blood pressure to such an extent that the need for hypotensive medicine can be reduced by 50%.

Pycnogenol is an extract of a particular type of pine bark that is found along the French southwest coast. Pycnogenol has the effect of an antioxidant, i.e. it inhibits the damaging processes that contribute to making us ill and grow old before our time.

In recent years, studies have shown that hypertension is responsible for more than 50% of all strokes and heart attacks.

Previous studies have also shown that Pycnogenol has a long line of positive effects on the body’s functions, but the news is that it is capable of lowering the blood pressure as well.

According to a scientific article in Life Sciences (no 74;7:855-862), Professor Rohdewald from Hamburg has made a so-called double-blind, placebo-controlled trial along with colleagues from Beijing in which the trial subjects were given either 100 mg. Pycnogenol or placebo during a period of 12 weeks.

It turned out that Pycnogenol was capable of lowering the blood pressure to such an extent that the amount of hypotensive medicine (Nifedipine) could be reduced by 50% after the 12 weeks.

Socioeconomically, it might open up to interesting perspectives as almost 17 million people in the UK suffer from hypertension which increases the risk of coronary thrombosis, cardiac failure, and stroke.

The hospital expenses for cardiovascular diseases are several billion pounds a year and so are the expenses to heart medicine.

If a dietary supplement like Pycnogenol can reduce this consumption of medicine by 50%, it can turn out to be just as interesting as when Glucosamine was able to reduce the consumption of antirheumatic medicine and the number of operations for arthrosis.

By: Vitality Council

Reference:
Life Sciences 74;7:855-862.

www.els.net/els/public/whatsnew/whatsnew_aboutels.asp
www.iom.dk

The Role of Antioxidants May Have To Be Reassessed

Claus Hancke

February 27, 2004

British scientists have discovered that it is enzymes and not antioxidants that are the active factor, when white blood cells attack bacteria.

Free radicals are aggressive molecules that are capable of destroying the structure of other molecules. For example, the body uses free radicals to cut large molecules into pieces and build complex protein structures. So far so good.

But an abundance of free radicals has been shown to be able to damage the body due to the deterioration (oxidation) of certain molecules, such as LDL cholesterol, which then becomes dangerous because it causes arteriosclerosis in its rancid (oxidized) form.

In order to slow down this harmful oxidation, we form the so-called antioxidants. These are also found in our diet and in several dietary supplements. For example, vitamins C and E are such antioxidants.

However, a British research team has investigated the reactions that occur in the white blood cells when these attack bacteria. And they found that free radicals did not play a role, but rather that it was enzymes that the white blood cells use to attack and destroy bacteria.

Until now, it has been believed that the white blood cells used free radicals, and therefore people have been reluctant to use excessive doses of antioxidants, because it was believed that this would neutralize the white blood cells’ free radicals, so that they could not fight bacteria.

The new theory may explain why even large doses of antioxidants have not shown an inhibitory effect on the antibacterial effect of the white blood cells.

A large number of questions now remain, including the scientifically documented inhibitory effect on the occurrence of cancer and cardiovascular diseases.

There is no doubt that there will be renewed debate about this every time we see new research in this very exciting area. – Also because opinions are divided. But one thing is theory, another is practice.

We must remember that the knowledge of medical science today is wrong. All the history of science has taught us that. In 100 years, our current theories will be replaced by new ones, and people will smile at the official knowledge of today.

We must therefore be careful, and above all let ourselves be guided by the large clinical studies. The theories must then try to explain these results.

By: Vitality Council

Reference:
Nature, vol 427;6977:853.

www.nature.com/index.html
www.iom.dk

You are Safe to Eat Fruit and Vegetables. No Basis for Over-interpretating scientific study

Admin

December 23, 2003

An observational study of 400 women having breast cancer compared with 400 women not having breast cancer has shown, that there is increased risk of Vitamin C intake by eating fruit and vegetables compared with Vitamin C intake by taking dietary supplements.

When we think about it a little bit, we know that it is healthy to eat fruit and vegetables, and so in the name of decency you have to check out such a study carefully.

The authors themselves write quite sensibly that its result is contrary to previous scientific studies about this and that it needs to be investigated further. – Fair enough.

By: Vitality Council

References:
1. Intake of vitamins A, C and E from diet and supplements and breast cancer in postmenopausal women. Cancer Causes and Control 2003;14:695-704. Oct. 2003.
2. Fish intake is positively associated with breast cancer incidence rate. J. Nutrition 2003;133:3664-3669. Nov. 2003.
3. Fruits and vegetable intake differentially affects estrogen receptor negative and positive breast cancer incidence rates. J. Nutrition 2003;133:2342-2347. July 2003.

www.cancer.dk
www.iom.dk

Important Nutrient Substance Protects Women Against Pre-eclampsia

Admin

December 17, 2003

According to a new British study, defiency of the trace mineral selenium might quadruple the risk of pre-eclampsia in pregnant women.

According to British researchers, pregnant women with a low content of the vital trace mineral selenium have up to four times as high a risk of developing pre-eclampsia compared to women who are not deficient in this substance.

This is the result of a new study published in the November issue of the American Journal of Obstetrics and Gynecology. The researchers behind the study are not quite aware why some women develop pre-eclampsia which involves hypertension, kidney damage, and reduced blood supply to the placenta.

They suggest, however, that it might be connected with the decreasing intake of selenium in several countries. In Britain, the selenium content of wheat is 10 – 50 times lower than that of the USA and Canada, for example, making it difficult to maintain an adequate intake of this important substance.

The risk of premature delivery
In the recently published study made by a group of scientists led by Dr. Margaret P. Rayman at the University of Surry in Guildford, the toe nail clippings of 53 pregnant women with early signs of pre-eclampsia were studied and compared to toe nail clippings from 53 healthy women. Selenium accumulates in nails which makes nail clippings such a good gauge of people’s selenium status.

The researchers observed that the average selenium content of the toe nail clippings were considerably lower in the women with early signs of pre-eclampsia. The researchers also found that the pre-eclamptic women with the lowest selenium values were far more likely to deliver prematurely.

One of the reasons for pre-eclampsia is believed to be oxidants (a kind of toxins) that arise as a consequence of a poorly functioning placenta. As selenium is an effective antioxidant, it is very likely that a lack of this substance can contribute to the development of pre-eclampsia.

Worries of reduced selenium intakes
The leading researcher, Margaret Rayman, has expressed her concern about the declining intake of selenium in Britain where the dietary selenium intake is reduced by more than 50% compared to what it was 20 – 25 years ago. This is due to the selenium content of crops being significantly lower than it used to be.

“Selenium is an extremely important substance which is known to be able to prevent various forms of cancer, including prostate cancer and skin cancer. What really worries me is the observation that the authorities systematically reduce the recommended daily dose of selenium while new research shows just how important it is to get adequate amounts of this substance. 15 – 20 years ago, the recommended daily dose (RDA) was 125 mcg. a day – recently the RDA was reduced to 40 mcg. This completely opposes common sense,” says Claus Hancke, the chairman of the Danish Vitality Council.

The British group of researchers are already planning a new study intended to clarify if dietary supplements of selenium can protect against pre-eclampsia.

By: Vitality Council


Reference:
American Journal of Obstetrics and Gynecology (vol. 189, no. 5).

www.ovid.com/site/catalog/Journal/369.jsp
www.iom.dk

Multivitamins May Reduce HIV Death Rate

Claus Hancke

December 12, 2003

A placebo controlled study made by scientists at the The London School of Hygiene and Tropical Medicine shows that a daily supplement of vitamins and minerals can reduce the HIV death rate. According to the scientists this may have great relevance for the treatment of HIV patients in countries which do not have access to optimal medical therapy.

The number of HIV infected persons continues to rise at a lightning speed. Worldwide, there are almost 5 million that are infected with HIV every year. In Denmark, 250-300 people are diagnosed with HIV every year, and the number is increasing. According to the AIDS Fund, there are approximately 4,500 HIV infected in Denmark, of which only 1,500 are in medical treatment.

In the latest issue of the journal AIDS, the results of a new startling study are published. 481 HIV-infected men and women participated in the study. All participants were from Thailand and none were receiving medical treatment for HIV.

The participants were divided into two groups, one of which received a placebo (cheat pill) and the other a special supplement of vitamins, minerals and amino acids. The participants were followed for a total of 48 weeks, with follow-up every 12 weeks.

After 48 weeks of treatment, the results showed a significantly lower mortality in the group that received the active treatment.

“This is the first time that reduced mortality has been demonstrated by giving something as simple and cheap as multivitamins/minerals to HIV patients. It is a very strong and thought-provoking result”, says the chairman of the Vitality Council, medical specialist Dr. Claus Hancke.

Traditional medical treatment costs approx. 100,000 DK kr. per year for each patient. The treatment extends the HIV-infected person’s life on average by 6-7 years.

“Other studies have shown that multivitamins/minerals can increase the body’s resistance, and now it turns out that it also provides better survival. Further documentation needs to be on the table, but already now patient associations such as HIV-Danmark should inform their members about the result“, says Claus Hancke.

By: Vitality Council

Reference:
AIDS (17 (17):2461-2469).

www.hivinfo.dk
www.iom.dk

Alcohol Counteracts the Effect of Folic Acid in Women

Claus Hancke

October 29, 2003

Epidemiologic study shows folic acid deficiency in women with a daily alcohol consumption of 2-3 drinks and thereby increased risk of chronic joint disease, coronary disease (blood clots) and breast cancer.

Women who drink 2-3 glasses of red wine or more daily have an increased risk of developing chronic joint disorders, cardiovascular disease and breast cancer due to lack of folic acid.

A study by researchers at the Harvard School of Public Health in Boston shows that daily alcohol consumption not only reduces the effects of folic acid, but also significantly increases the risk of disease.

The researchers, who have just published the study in an article in the American Journal of Epidemiology, have followed approx. 83,000 women aged between 34 and 59 over a period of 16 years.

The researchers found the highest risk of getting cardiovascular disease and breast cancer in women who received only a small amount of folic acid – 180 micrograms – daily, and who also had a high alcohol consumption of 30 grams of alcohol a day or 2.5  Danish unit of alcohol. The greatest risk was found in women under 60 years of age.

Conversely, women who did not drink alcohol and received a lot of folic acid – 400-599 micrograms daily – had the lowest risk of developing the same diseases.

Against this background the Vitality Council comes with a call for women who drink more than 2-3 units of alcohol a day or 17-18 units of alcohol a week. Partly to reduce the intake of alcohol in accordance with the Danish Health and Medicines Authority’s recommendations and partly to take an extra supplement of folic acid:

“To prevent the increased risk of cardiovascular disease and breast cancer, women with a daily alcohol consumption should consider taking a folic acid supplement,” says Vitality Council Chairman, Specialist in general medicine, Claus Hancke.

“Thus, we do not want to encourage women to continue drinking. As the risk is significantly increased and the statistics show that about 15 percent or every sixth woman in the age group drinks more than the National Board of Health’s recommended maximum of 14 units of alcohol per week, one should take this seriously” the chairman of the Vitality Council points out.

As it is difficult to get enough folic acid through the diet, it is recommended to take a vitamin pill or a multivitamin tablet with folic acid. In the diet, especially vegetables like broccoli and kale are rich in folic acid.

The Danish National Board of Health already recommends pregnant women take approx. 400 micrograms of folic acid daily to prevent spina bifida in children.

By. Vitality Council

Reference:
American Journal of Epedemiology 2003;158:760-771.

aje.oupjournals.org
www.iom.dk

“Amateur-like” Statement from the Organization Anti Doping Denmark

Admin

October 27, 2003

In October 2003 one could read pretty harsh warnings against the combination of dietary supplements and sports in several Danish newspapers. The medical doctor, Rasmus Damsgaard, from Anti Doping Denmark was the originator of these judgmental statements.

Damsgaard is quoted for several bastant announcements – among others: “Dietary supplements do not work – Basto”. And he calls it quite amateurish when respected coaches like Ulrik Wilbæk, give supplements to their players.

By: Vitality Council

(No references)

www.doping.dk
www.iom.dk

Alternative Treatment of Osteoarthritis

Admin

September 16, 2003

The (Danish) Arthritis Association must get their proportions right:
The association recently published a questionnaire study showing that 86% of osteoarthritis patients use alternative medicine, even if several products do not seem to have a documented effect.

For example, fish oil, which 65% of the osteoarthritis patients report using, and 62% of them are satisfied with the effect. This information the Danish arthritis association “Gigtforeningen” find surprisingly “paradoxically.”

“It is correct that there are not yet well-established clinical trials on fish oil and osteoarthritis, but data from population surveys and other studies suggest that there may be an effect,” says the chairman of the Vitality Council – specialist physician Claus Hancke.

By: Vitality Council

(No references)

www.gigtforeningen.dk
www.iom.dk

Vitamin C and E Protects Children Against Arteriosclerosis

Per Larsen

September 1, 2003

Children and young people with increased cholesterol levels may reduce the risk of developing arteriosclerosis if they take a daily supplement of Vitamin C and E. This is the conclusion of a study published in Circulation, published by the American Heart Association.

15 children and young people of the age of 9 to 20 years were part of this study. Half of the children took a daily 500mg Vitamin C and 400i.e. (international units) Vitamin E supplement. The rest of the children took placebo. After 6 weeks the groups were switched.

After 6 weeks of active treatment the results showed a significant betterment of the inner wall of the artery. Vitamins alone do not reduce increased cholesterol, but the vitamins seem to be able to protect the blood vessels against sclerosis and thereby secure that the arteries remain their elasticity.

“This is the first time anyone has studied how antioxidants like Vitamin C and E can better circulatory function,” says the chairman of the Vitality Council, specialist doctor in general medicine, Claus Hancke.

“Even if it is a small study, the results are important for children with increased cholesterol. If they alternatively must have cholesterol lowering medicine for several years, the risk of serious side effects will be pretty high. It is therefore wise to give priority to diet changes and extra Vitamin C and E supplements as a first choice in therapy,” Claus Hancke says.

The American study also involved diet recommendations, but they did not follow those recommendations. Among other things the children got too much animal fat and too little fruit and vegetables. Therefore the doctors chose to combine the diet changes with Vitamin C and E supplementation.

The study is carried out at the University of California, under the supervision of Marguerite Engler, M.D.

By: Per Tork Larsen, DSOM

Reference:
Circulation 2003;108:802

www.circulationaha.org
www.amhrt.org/presenter.jhtml