ADHD Drugs: Liver Injury, Heart Attack and Stroke

by Kevin Flatt

On March 21, 2000, 14-year-old Matthew Smith dropped dead of a heart attack while skateboarding. The ninth-grader had been on Ritalin since the first grade. Lawrence Smith, father of the youngster, has testified that he and his wife were forced by Michigan Social Services to put their child on Ritalin or else be charged for neglecting their son's educational and emotional needs. (WorldNetDaily.com January 3, 2003).

Stimulants like Ritalin could have dangerous effects on the heart, and federal regulators should require manufacturers to provide written guides to patients and place prominent warnings on drug labels describing these risks, a federal advisory panel voted on Thursday.

"I must say that I have grave concerns about the use of these drugs and grave concerns about the harm they may cause," said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic and a panel member. Dr. Thomas R. Fleming, a professor of biostatistics at the University of Washington and a panel member, said stimulants might be far more dangerous to the heart than Vioxx or Bextra, drugs that were withdrawn over the past two years because of their ill effects on the heart. (The New York Times 9 February 2006).

The person who drove the decision was Dr Steven Nissen who's in the Department of Cardiovascular Medicine at the prestigious Cleveland Clinic in Ohio. He's written about it in the New England Journal of Medicine.

On February 9, 2006, the Drug Safety and Risk Management Advisory Committee of the Food and Drug Administration (FDA) voted by a narrow margin - eight to seven - to recommend a "black-box" warning describing the cardiovascular risks of stimulant drugs used to treat attention deficit-hyperactivity disorder (ADHD).

These agents substantially increase the heart rate and blood pressure. In a placebo-controlled trial, mixed amphetamine salts (Adderall) administered to adults increased systolic blood pressure by about 5 mm Hg; similar effects were found with methylphenidate formulations. Blood-pressure changes of this magnitude, particularly during long-term therapy, are known to increase morbidity and mortality. (Steven E. Nissen. ADHD Drugs and Cardiovascular Risk. New England Journal of Medicine 2006; 354: 1445-1448).

And what I said to the panel is look, you have two drugs that are extremely closely related congeners and yet we are treating four million Americans with these agents, two and half million children, one and a half million adults and 10% of adults taking these powerful stimulants are over the age of 50. My concerns stem from the understanding that if you raise heart rate and blood pressure, particularly in adults, you will increase the risk of myocardial infarction, stroke and sudden death. (Dr, Steven Nissen, ABC Health Report 27/03/2006).

The Food and Drug Administration (FDA) is advising health care professionals about a new warning for Strattera, a drug approved for attention deficit hyperactivity disorder (ADHD) in adults and children.

The labelling warns that severe liver injury may progress to liver failure resulting in death or the need for a liver transplant in a small percentage of patients. The labelling also notes that the number of actual cases of severe liver injury is unknown because of under-reporting of post-marketing adverse events. (Medical News Today 18/12/2004).

A Food and Drug Administration advisory committee recommended Wednesday that the agency add information about a possible risk of hallucinations in children to the labels of attention deficit/hyperactivity disorder drugs.

The panel said the "MedGuide" also should note that ADHD drugs may increase the risk of aggressive behavior, although that can be a component of the disorder itself. And the guide should note that the drugs might increase the risk of heart attack, stroke or sudden death in patients who have undiagnosed heart problems. (USA Today March 23, 2006).

Copyright 2007 Kevin Flatt. Disclaimer: The information contained in this article is presented for information purposes only and is in no way intended to replace professional medical care or attention by a qualified practitioner. It cannot and should not be used as a basis for diagnosis or choice of treatment.

Breast Cancer: Has complementary/alternative medicine (CAM) become the "norm"?

by Kevin Flatt

Canadian and American researchers examining trends in complementary/alternative medicine (CAM) use by breast cancer survivors compared survey data from 1998 and 2005 to evaluate overall patterns of CAM use. The study was published in BMC Women's Health, 2007.

The researchers noted that the use of complementary and alternative medicine (CAM) by women with breast cancer is often said to be increasing, yet few data exist to confirm this commonly held belief.

The purpose of their paper was to compare overall patterns of CAM use, as well as use of specific products and therapies at two different points in time (1998 vs 2005) by women diagnosed with breast cancer.

Ontario has the highest incidence of breast cancer cases in Canada, with 8,200 of the 21,600 new cases in 2005, therefore this study was focused on complementary and alternative medicine use in Ontario. Surveys were mailed to women 18 years and older and diagnosed with breast cancer, randomly selected from the Ontario Cancer Registry (Canada) in the spring of 1998 and again in the spring of 2005.

In 2005, 81.9 percent of women reported using either a CAM product/practice or seeing a CAM therapist at some time in their lives as compared with 66.7 percent in 1998. Increases were seen in both use of at least one complementary and alternative medicine (CAM) product or therapy (70.6 percent in 2005 vs. 62 percent in 1998) and visits to CAM practitioners (57.4 percent of respondents in 2005 versus 39.4 percent of respondents in 1998).

Women in 2005 reported that 41 percent used complementary and alternative medicine (CAM) as part of the management of their breast cancer. The most commonly used products and practitioners for managing breast cancer included green tea, vitamin E, flaxseed and vitamin C, massage therapists and dieticians/nutritionists.

Significant increases were seen in use of body work practitioners (including Reiki practitioners, massage therapists, therapeutic touch practitioners and shiatsu practitioners), acupuncturists/traditional Chinese medicine (TCM) practitioners, homeopathic practitioners and a general "other" category in 2005 compared to 1998.

Significant increases were also seen in use of herbal remedies overall and specifically in the use of green tea and special foods/diets.

Overall, the researchers found that both the use of CAM products and visits to CAM practitioners by women diagnosed with breast cancer significantly increased from 1998 to 2005. In 2005, 81.9 percent of respondents reported using CAM (41 percent to help manage their breast cancer) compared to 66.7 percent in 1998, suggesting that in 2005 CAM use has become the "norm" in this patient population.

The biggest increases were seen in the percentage of women seeing bodywork practitioners (including massage therapists, but not chiropractors), traditional Chinese medicine practitioners/acupuncturists, homeopaths and "others". This may be related to the fact that massage therapy and acupuncture are two of the complementary and alternative medicine (CAM) practices which are generally the most accepted by the medical profession.

In addition, given that neither acupuncture nor massage involves taking anything orally, it is likely they are perceived to have fewer potential adverse effects or interactions with conventional cancer treatments than some other CAM therapies. So it is possible that conventional MDs are either recommending these options more often to patients or at least not discouraging patients from using them.

Perception of safety and perceived lack of drug interactions may also explain the increased use of homeopathy. In addition, the homeopathic community was under review by the Health Professions Regulation Advisory Council for consideration as a future regulated health profession in Ontario during 2005 when this survey was conducted. Although the council hearing did not receive much media attention at the time, it may partially explain the increased use of homeopathy reported here.

Overall, there was a significant increase in the use of herbal products such as garlic, ginger, ginseng and green tea and special foods/diets. Both green tea and special diets/foods are used by more than 10 percent of all women diagnosed with breast cancer specifically to help manage their breast cancer.

The researchers concluded that as more than 80 percent of all women with breast cancer report using CAM (41 percent in a specific attempt to management their breast cancer), CAM use can no longer be regarded as an "alternative" or unusual approach to managing breast cancer and that the increasing popularity of complementary and alternative medicine increases the urgency for research into the safety and efficacy of these products and therapies.

Abbreviations

CAM – complementary and alternative medicine

TCM – traditional Chinese medicine

Reference

Heather S Boon, Folashade Olatunde and Suzanna M Zick. Trends in complementary/alternative medicine use by breast cancer survivors: Comparing survey data from 1998 and 2005. BMC Women's Health 2007, 7:4 doi:10.1186/1472-6874-7-4. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

The electronic version of this article is the complete one and can be found online at: http://www.biomedcentral.com/1472-6874/7/4

Breast Cancer Progression Correlates with Lower Vitamin D Levels

by Kevin Flatt

The Daily Mail (U.K.) reported on 17th October 2006 that a new study shows women with advanced breast cancer had lower levels of vitamin D than those in the early stages of the disease. Researchers at Imperial College London claim it is more evidence the vitamin - which comes from sunlight - may protect against cancer, and are planning to investigate whether supplements can help fight the disease. (Daily Mail (U.K.) 17/10/2006).

Previous research has indicated that low levels of vitamin D in women may cause breast cancer to progress to more advanced stages, and studies have shown that having adequate levels of circulating vitamin D can reduce the risk of developing the disease. (NewsTarget.com 17/10/2006).

Example: Not only does the active form of vitamin D, calcitriol (the form made in optimal quantities by your body when your vitamin D blood levels are ideal) inhibit breast cancer cells from growing, it makes those cells grow and die more like natural cells. Furthermore, vitamin D inhibits the formation of excessive blood vessel growth around the cancerous tumour, a process called anti-angiogenesis. (Braz J Med Biol Res. 2002 Jan;35(1):1-9).

“Vitamin D levels are lower in women with advanced breast cancer than in early breast cancer,’ said Dr. Carlo Palmieri of Imperial College London. “It lends support to the idea that vitamin D has a role in the progression of breast cancer,” he told Reuters. “We know from previous studies that breast cancer incidence is higher in women who live in higher latitudes and have less sun exposure,” said Palmieri. (breastcancer.org 17/10/2006).

As reported in my earlier article “Vitamin D protects against Breast Cancer & curbs tumour progression” exposure to sunlight is the greatest source of vitamin D and population studies have previously suggested higher vitamin D levels may contribute to the lower incidence of breast cancer seen in sunny climates such as the Mediterranean.

Medical News Today reported on 17 Oct 2006 that the authors reached their conclusion from a study of 279 women with invasive breast cancer. The disease was in the early stages in 204 women, and advanced in the remainder. The results of blood tests to measure levels of vitamin D showed that women with early stage disease had significantly higher levels of vitamin D and significantly lower levels of parathyroid hormone than did the women with advanced disease.

The Medical News Today article went on to report that it is known that vitamin D treatment boosts the activity of certain key genes and dampens it down in others. One gene that is boosted is p21, which has an important role in controlling the cell cycle. Low levels of vitamin D may therefore promote progression to advanced disease, venture the authors. (Medical News Today17/10/2006).

Jessica Fraser, reporting for NewsTarget wrote that Natural health advocate Mike Adams, author of “The Healing Power of Sunlight and Vitamin D,” said having adequate vitamin D levels in the body correlates directly with a reduction in breast and prostate cancer risk.

“Vitamin D is, simply put, one of the best-known cancer prevention medicines in the world,” Adams said. “People can make it for free by seeking out sensible levels of sunlight exposure, without using sunscreen.” (Jessica Fraser, NewsTarget.com 17/10/2006).

The study was published in the Journal of Clinical Pathology. The authors stated that vitamin D levels have been shown to be higher in normal women compared with those who have primary breast cancer, and decrease with the progression of bone metastases. This report, while being an observational study, clearly shows that circulating vitamin D levels are lower in patients with advanced breast cancer than in those with early breast cancer. (J Clin Pathol 2006;0:1–3. doi: 10.1136/jcp.2006.).

Remember, 90 % of our vitamin D comes from sun exposure. Vitamin D from diet and supplements is close to insignificant due to the small amounts consumed. (Cancer Epidemiol Biomarkers Prev. 1999 May;8(5):399-406).

Dr. Michael Holick, a leading vitamin D researcher who serves as director of the general clinical research center at Boston University Medical Center, said it’s difficult to get enough vitamin D from food, noting that you’d have to eat a 3½-ounce serving of fish like salmon, mackerel or sardines “almost every day just to begin to satisfy your requirement.”

The NIH agrees: It can be difficult to obtain enough vitamin D from natural food sources. For many people, consuming vitamin D fortified foods and adequate sunlight exposure are essential for maintaining a healthy vitamin D status. In some groups, dietary supplements may be needed to meet the daily need for vitamin D.

Make sure you’re taking D3. If the label says vitamin D2, then it’s not the good kind of vitamin D. So often, you see orange juice or foods that say they’re vitamin D fortified. But many times, those are fortified with D2. Vitamin D has to be taken with fat. Taking a vitamin D pill with orange juice isn’t going to work, it won’t absorb.

Try to get brand-name recommendations. Sadly, many doctors haven’t learned about supplements in medical school, so your doctor may not be able to advise you on that. To find the best brands, do your homework. Either get names of products from people you trust, or go on the Internet and look these supplements up.

Finally, a new look at 528 melanoma victims over five years also found that increased sun exposure led to increased survivability, according to the study led by Marianne Berwick of the department of internal medicine at the University of New Mexico. “It’s totally counterintuitive, and we’re trying to investigate it,” said Berwick, who is doing a similar study of 3,700 melanoma patients worldwide. “It’s really strange, because sunburn seems to be one of the factors associated with improved survival.” (The Baltimore Sun 2/2/2005).

Related articles:
Cancer (General) Articles and News
Vitamin D protects against Breast Cancer & curbs tumour progression

References:

Bortman P, Folgueira MA, Katayama ML, Snitcovsky IM, Brentani MM. Antiproliferative effects of 1,25-dihydroxyvitamin D3 on breast cells: a mini review. Braz J Med Biol Res. 2002 Jan;35(1):1-9.

Journal of Clinical Pathology
Serum 25-hydroxyvitamin D levels in early and advanced breast cancer Online First J Clin Pathol 2006; doi.10.1136/jcp.2006.

John EM, Schwartz GG, Dreon DM, Koo J. Vitamin D and breast cancer risk: the NHANES I Epidemiologic follow-up study, to 1992. National Health and Nutrition Examination Survey. Cancer Epidemiol Biomarkers Prev. 1999 May;8(5):399-406.

http://www.baltimoresun.com/news/nationworld/bal-te.sun02feb02,1,.story?coll=bal-nationworld-headlines

Copyright 2007 Kevin Flatt. Disclaimer: The information contained in this article is presented for information purposes only and is in no way intended to replace professional medical care or attention by a qualified practitioner. It cannot and should not be used as a basis for diagnosis or choice of treatment.