Editor Emeritus on January 23rd, 2006

Those following the anti-aspartame, pro-health campaign currently underway in New Mexico may be heartened to learn that Stephen Fox, the leading activist, believes the fight can be won. Why all this language of warfare? Well, it appears that the support for banning aspartame is so strong that Ajinomoto Corporation, the world’s largest aspartame and monosodium glutamate manufacturer, has been stirred into action.

Stephen Fox reports that Ajinomoto "has not only hired one of the top law firms in New Mexico, the Rodey firm, but also the top lobbyist firm, Butch Maki and Associates, which includes two [former] govenors, David Cargo and Jerry Apodaca, to defeat these two bills." The aspartame makers are clearly planning to take action to protect their poison-making business interests.

If you have already conveyed your support for the campaign to protect people from the damaging effects of aspartame, thank you. Many of us who strive to promote health appreciate your efforts. Your support is still vital and I ask that you use the form mentioned below. If you are yet to express your support then I urge you to do so right now.

Wether or not you live in New Mexico this issue affects you. You can be heard.

Please go to http://www.organicconsumers.org/aspartame1.cfm to learn more. You will find links there to two online forms that enable you to easily send a message directly to Govenor Richardson of New Mexico and to Senator Ben Altaminaro. Please do this immediately as there is a tactical advantage at stake.

I am delighted to hear that Stephen Fox, who is in the best possible position to monitor progress, believes success is at hand. My concern is that a counter move by Ajinomoto cannot be far off and an overwhelming expression of support for protection from aspartame sent directly to key political leaders may be vital in heading it off.

Please express your support by sending a message to the New Mexico legislature. Help to correct the FDA’s errors in approving aspartame. Take a step in helping to protect yourself and those you care about from this toxic chemical.

There are safe sugar alternatives available, such as stevia for example. The only "need" for aspartame is to generate corporate profits. Those profits are made at the expense of your health. Even before aspartame is banned, be sure to read labels and avoid this pervasive chemical that is placed in thousands of consumer products, including hundreds of children’s medicines.

Editor Emeritus on January 21st, 2006

The FDA has released a Public Health Advisory related to the antibiotic Ketek (telithromycin). Interestingly, they only did so after a respected medical journal published case details of serious liver toxicity following administration of the drug.

Today, January 20, 2006,  Annals of Internal Medicine published an article reporting three patients who experienced serious liver toxicity following administration of Ketek (telithromycin). These cases have also been reported to FDA MedWatch. Telithromycin is marketed and used extensively in many other countries, including countries in Europe and Japan. While it is difficult to determine the actual frequency of adverse events from voluntary reporting systems such as the MedWatch program, the FDA is continuing to evaluate the issue of liver problems in association with use of telithromycin in order to determine if labeling changes or other actions are warranted. As a part of this, FDA is continuing to work to understand better the frequency of liver-related adverse events reported for approved antibiotics, including telithromycin.

While FDA is continuing its investigation of this issue, we are providing the following recommendations to healthcare providers and patients:

  • Healthcare providers should monitor patients taking telithromycin for signs or symptoms of liver problems. Telithromycin should be stopped in patients who develop signs or symptoms of liver problems.
  • Patients who have been prescribed telithromycin and are not experiencing side effects such as jaundice should continue taking their medicine as prescribed unless otherwise directed by their healthcare provider.
  • Patients who notice any yellowing of their eyes or skin or other problems like blurry vision should contact their healthcare provider immediately.
  • As with all antibiotics, telithromycin should only be used for infections caused by a susceptible microorganism. Telithromycin is not effective in treating viral infections, so a patient with a viral infection should not receive telithromycin since they would be exposed to the risk of side effects without any benefit.

The case review in today’s online publication by Annals of Internal Medicine reports three serious adverse events following administration of telithromycin. All three patients developed jaundice and abnormal liver function. One patient recovered, one required a transplant, and one died. When the livers of the latter two patients were examined in the laboratory, they showed massive tissue death. These two patients had reported some alcohol use. All three patients had previously been healthy and were not using other prescription drugs. The FDA is also aware that these patients were all treated by physicians in the same geographic area. The significance of this observation is not clear at the present time.

In pre-marketing clinical studies, including a large safety trial and data from other countries, the occurrence of liver problems was infrequent and usually reversible. Based on the pre-marketing clinical data, it appeared that the risk of liver injury with telithromycin was similar to that of other marketed antibiotics. Nonetheless, the product label advises doctors about the potential for liver-related adverse events associated with the use of telithromycin.

Telithromycin is an antibiotic of the ketolide class. It was the first antibiotic of this class to be approved by the FDA in April, 2004 for the treatment of respiratory infections in adults caused by several types of susceptible microorganisms including Streptococcus pneumoniae and Haemophilus influenzae.

 I don’t find the statement: "Based on the pre-marketing clinical data, it appeared that the risk of liver injury with telithromycin was similar to that of other marketed antibiotics." to be very comforting, do you? Work on building your overall health and resort to natural antibiotics if necessary. Try very hard to avoid pharmaceutical antibiotics.

Editor Emeritus on January 21st, 2006

Here is another good example of the warped thinking found in orthodox medicine. It’s more grist for the iatragenesis mill. Yes, more doctor-caused disease to support the medical financial model.

Now an approved drug marketed for treatment (we’ll come back to this) of mild to moderate eczema has been linked to cancer. That is like saying we are happy to operate to remove that splinter from your finger but we must warn you we know you could bleed to death from the method we like to use.

What absurd overkill, no pun intended. Who in their right mind would risk cancer for eczema?

Now back to clarify the concept of treatment. Here is a categorical statement of fact some people will feel uncomfortable confronting. The treatment does not and cannot cure the complaint. That’s right. Maybe some people suffering with eczema would run the risk of cancer to be cured, but this treatment cannot possibly achieve that; at best it masks the symptoms and signs. I repeat, It does nothing to cure the condition, it merely suppresses it.

Here is the latest warning from the FDA, an organization that supports drug and medical equipment companies in the guise of protecting your interests.

The Food and Drug Administration (FDA) has approved updated labeling on January 19, 2006 for two topical eczema drugs, Elidel Cream (pimecrolimus) and Protopic Ointment (tacrolimus). The labeling will be updated with a boxed warning about a possible risk of cancer and a Medication Guide (FDA-approved patient labeling) will be distributed to help ensure that patients using these prescription medicines are aware of this concern. The new labeling also clarifies that these drugs are recommended for use as second-line treatments. This means that other prescription topical medicines should be tried first. Use of these drugs in children under 2 years of age is not recommended.

And here is the FDA approved patient information sheet.

What is Elidel?

  • Elidel is a cream used to treat mild to moderate atopic dermatitis, a form of eczema. It should be used only for a short time. It is not for continuous long-term use.
  • Elidel should not be the first prescription treatment that you try to treat your atopic dermatitis. Use Elidel only after other prescription treatments did not work or you had too many side effects with other drugs.
  • Elidel is approved for adults and children 2 years and older with normal immune systems (not weakened or compromised).

Who Should Not Use Elidel?

Do not use if:

  • Your child with atopic dermatitis is younger than 2 years
  • Your atopic dermatitis is infected
  • You have Netherton’s Syndrome. This is an inherited condition where the skin is red, itchy, and covered with large coarse scales.
  • You are pregnant or breastfeeding, unless directed by your doctor.
  • You are allergic to Elidel or any of its ingredients

What are The Risks?

Do not use Elidel as the first prescription treatment for your atopic dermatitis since there are risks of some serious side effects. The following are the major potential risks and side effects of Elidel therapy. However, this list is not complete.

Possible risk of lymph node or skin cancer: As noted in the FDA Alert, FDA has issued a public health advisory to inform healthcare professionals and patients about a potential cancer risk from use of Elidel. This concern is based on information from animal studies, case reports in a small number of patients, and knowledge of how drugs in this class work. The potential for systemic immunosuppression is unknown and the role of Elidel in the development of the cancer-related events in the individual patient reports is also uncertain at this time.
Animal studies have showed that skin tumors formed faster in animals treated with pimecrolimus, the active ingredient in Elidel, and exposed to light. Because of this, you should limit exposure to natural or artificial sunlight, such as sunlamps or tanning beds.

Viral infections: Elidel may increase the chance of getting chicken pox, shingles, skin warts, or other viral infections.

Skin irritation: Elidel’s most common side effect is a sensation of warmth or burning where you apply the cream. See your doctor if your reaction is severe, or you have it for more than 1 week.

Other side effects may include headache, throat or nose redness and soreness, flu symptoms, fever, and cough.

What Should I Tell My Healthcare Professional?

Before you start using Elidel, tell your healthcare professional if:

  • You are getting light therapy for your skin (phototherapy, UVA or UVB) or a lot of sun exposure
  • You are taking any prescription or nonprescription (over-the-counter) medicine or supplements
  • You are using any other skin product
  • You are pregnant or planning to get pregnant

After you start using Elidel, tell your healthcare professional if:

  • Your atopic dermatitis does not get better after 6 weeks of use
  • Your atopic dermatitis gets worse

How Do I Use Elidel?

  • Wash your hands before using Elidel.
  • Put a thin layer of Elidel cream on the affected skin twice a day, unless otherwise directed by your doctor. Rub in completely. Use the minimum amount of Elidel necessary.
  • Wash your hands after applying Elidel unless you are treating your hands.
  • Do not use Elidel under a bandage or wrap that keeps out air.
  • Stop using Elidel once your symptoms go away.
  • Minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using Elidel, even while Elidel is not on your skin.

Elidel FDA Approved 2001
Patient Information Sheet Revised 3/2005

If you have eczema, sack the fool who prescribed it and find a naturopathic doctor. There is no need to use such dangerous rubbish. Yes, I probably do seem a little more blunt than usual. Chalk it up to frustration with the ignorance of so-called scientific medicine.

Editor Emeritus on January 20th, 2006

After enthusiastically supporting mammography many years ago I came to realize they posed too much risk and instead recommended against them, much to the stunned astonishment of my colleagues in health promotion. Instead I highly recommend effective monthly breast self-examination (BSE). I was therefore interested to see the following in a recent comment by Jon Herring, Health Editor, Early To Rise.

Do Mammograms Actually CAUSE Breast Cancer?

John Gofman, M.D., Ph.D., has concluded that at least 66% of breast cancer cases are caused by radiation exposure (including that from mammograms). I don’t know how he arrived at that number, but you can’t argue with his credentials. Dr. Gofman worked for decades at Livermore (a foremost radiation studies laboratory). And he was chosen by the Atomic Energy Commission to head their studies on the effects of radiation.

It wouldn’t be surprising if mammograms contribute to cancer. The female breast is highly sensitive to radiation. Compared to other cancer sites, the breasts are 2 to 3 times more vulnerable to cancer from radiation. But not only are mammograms potentially dangerous, they’re also highly unreliable. In a Swedish study of 60,000 women, 70% of the "tumors" detected by mammograms turned out not to be tumors. And according to the National Cancer Intsitute (NCI), mammograms miss the real thing 40% of the time.

The NCI has been campaigning for women to get a mammogram every year, starting at age 40. But given their questionable benefit and proven risks, I would advise against it. Instead, consider a monthly breast self-examination (BSE), and see a trained health professional every year for a clinical breast examination (CBE).

The direct radiation dammage has long been a concern to many who truely care for people over profits. I don’t propose to open that debate because some mammography advocates resolutely refuse to accept that the risk is real enough to deterr the practice. How does it go again…there are none so blind as those who will not see.

What are major and well acknowledged problems are the false negatives and false positives, as Jon’s comments above quantify. These problems are part of a "regretable acceptable error factor" according to some mammography specialists I know. Well, they’re not acceptable to me.

I recommend a low cancer-risk lifestyle and regular BSE. Prevention is always better than cure. Those with breast cancer should find a naturopathic doctor who can explain treatment options beyond the archaic and immune system devestating orthodox options.

Editor Emeritus on January 20th, 2006

We have already learned that high homocysteine levels are generally bad for health. In particular, high homocycteine is strongly implicated in development of cardiovascular disease, the number one killer. Now researchers have uncovered a link between high homocysteine levels in the blood and development of the devestating bone disease, osteoporosis.

Dr. Clara Gram Gjesdal, lead auther, from the University of Bergen in Norway conducted research published in Archives of Internal Medicine, January 9, 2006 that found women with high levels of the amino acid homocysteine in the blood are at increased risk for low bone mineral density (BMD). "Our finding adds to the increasing evidence that homocysteine is important for bone health," Gjesdal told Megan Rauscher of Reuters Health.

"Osteoporosis is a major public health problem with increasing consequences as people live longer," she said. "If the modest associations observed in our study are causal, the public health implications may be significant because high homocysteine levels respond to intake of folate and other B vitamins."

Using data from a population-based cohort of more than 5,300 middle-aged and elderly men and women, researchers observed that total homocysteine level was inversely related to hip BMD among middle-aged and elderly women, but not among men.

Women with high homocysteine levels were nearly twice as likely to have low BMD compared with women with low homocysteine levels. Furthermore, high homocysteine predicted osteoporosis among women after adjusting for confounding factors such as smoking, physical activity, intake of vitamin D and calcium, and use of estrogen.

Two "trendsetting articles" published last year, Gjesdal mentioned, showed that total homocysteine is a risk factor for osteoporotic bone fractures in men and women. Subjects in the highest quartile of homocysteine had an approximately two-fold higher risk of suffering a fracture compared to those in the three lower quartiles.

High homocysteine may be a "potential modifiable risk factor for osteoporosis in women," the authors conclude. "Randomized trials are needed to investigate whether B vitamin supplementation affects BMD and fracture risk," Gjesdal added.

There is no need to wait for these further studies. We already know the value of folate in reducing high homocysteine levels for heart health protection. As with all supplementation, it is far better to be both comprehensive and balanced.