Most New Drugs Offer More Harm Than Benefit

In a recent study, independent reviewers found that approximately 85% of new drugs brought to market have few if any new benefits over existing drugs and that many are associated with harmful adverse effects.

Donald Light, author of “Pharmaceuticals: A Two-Tier Market for Producing 'Lemons' and Serious Harm,” explained in a press statement that only “one in seven new drugs is superior to existing drugs, but two in every seven new drugs result in side effects serious enough for action by the U.S. Food and Drug Administration (FDA), including black box warnings, adverse reaction warnings, or even withdrawal of the drug.”

According to Light, an analysis of 111 pharmaceutical applications for FDA approval revealed that evidence of efficacy was lacking in 39%, flawed testing of dosages was found in 40%, adequately randomized trials were lacking in 42%, and 49% raised concerns about serious side effects.

Pharmaceutical companies design their own studies and the research is often biased, too short to uncover long term problems, and conducted on people who are healthier than the target population. And because the FDA is funded in part by the drug companies it oversees, applications are often sped through the review process without adequate consideration. When important details of dangerous drugs finally come to light, many times it is too late.

According to the FDA, studies published in the Journal of the American Medical Association indicate that more than 2 million serious adverse drug reactions (ADRs) occur each year and that ADRs are the fourth leading cause of death in the United States.

References

American Sociological Association. Toxic drugs, toxic system: sociologist predicts drug disasters. Washington DC, 3 August 2008. http://www.asanet.org/press/20080803_2.cfm (accessed September 2010).

Lazarou J et al. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. Journal of the American Medical Association. 1998 Apr 15;279(15):1200-5.

Light D. Pharmaceuticals: A Two-Tier Market for Producing 'Lemons' and Serious Harm. 105th Annual Meeting of the American Sociological Association, Atlanta, 17 August 2010.

US Food and Drug Administration. Preventable Adverse Drug Reactions: A Focus on Drug Interactions. http://www.fda.gov/drugs/developmentapprovalprocess/developmentresources/druginteractionslabeling/ucm110632.htm#ADRs:%20Prevalence%20and%20Incidence (accessed September 2010).

Ghosts, Ghouls, and Worms

The Lower East Side Ecology Center promotes a sustainable New York City through recycling programs, green space preservation, urban gardening and educational events.

Join them this fall for two fun and informative workshops on indoor composting.

Ghosts, Ghouls, and Worms:  Halloween Composting

Join the NYC Compost Project in Manhattan to learn about indoor worm composting, make biodegradable Halloween decorations, and take home your own pumpkin. Costumes are welcome and all project materials will be provided.

Date:  Tuesday October 26, 2010
Time:  3:00pm - 4:00pm
Location:  Whole Foods Market Tribeca, 270 Greenwich Street, New York, NY 10007
Open to:  Children age 5 and over accompanied by parents
Attendance fee:  $5

Teacher Wormshop:  Composting for the Classroom

Next month, the NYC Compost Project is hosting a special workshop for teachers. It will cover worm bin set-up and maintenance, troubleshooting, and how to incorporate composting into your lesson plans. Worms and worm bins will be available for purchase at a reduced cost.

Date:  Monday November 15, 2010
Time:  6:00pm - 8:00pm
Location:  Friend's Seminary, 222 East 16th St, New York, NY 10003
Open to:  Teachers only
Attendance fee:  $5

Forest Therapy


The popular practice of shinrin-yoku in Japan translates to forest bathing, or being surrounded by a forest environment. It may not seem like therapy but forest bathing has been shown to improve mental and physical health. Studies have documented reduced stress, lower blood sugar, better concentration, diminished pain, improved immunity and even anti-cancer effects.

Results have been so impressive that Japanese companies are starting to include forest therapy in employee health care benefits and wellness programs with free check-ups are available inside Japanese forests. A look at the research reveals why a walk in the woods is an unusual but promising prescription.

Reduced Stress

A recent review of field experiments across Japan compared physical markers of stress in natural environments to those in city settings. 280 adults spent time in forest and urban areas on alternate days. Compared to city environments, forest settings were associated with lower levels of cortisol, slower heart rates, lower blood pressure, greater activity of parasympathetic nerves that promote relaxation, and reduced activity of sympathetic nerves associated with “fight or flight” reactions to stress.

Another study of forest bathing measured fluctuations in salivary amylase, an indicator of changes in sympathetic nervous activity, and also concluded that forests were associated with less environmental stress.

Researchers have studied the psychological effects of forest bathing as well. Almost 500 Japanese adults were surveyed on days they spent time in a forest and also in their normal environment. Statistical analyzes revealed that, compared to their normal environments, inside a forest the participants reported significantly less depression and hostility, and felt significantly more lively. And the greater the level of stress individuals experienced, the greater the positive effects of forest bathing. Researchers concluded that forests are “therapeutic landscapes” and that forest bathing may decrease the risk of stress-related diseases.

Lower Blood Sugar

Forest therapy may also help control blood sugar. A Japanese study followed 87 adults diagnosed with type-two diabetes for six years. During this time, participants walked in a forest for 3 or 6 kilometers (1.9 or 3.7 miles), depending on their physical ability, on nine different occasions. At the end of the study, researchers found that the forest walkers had lower blood glucose (synonymous with blood sugar), improved insulin sensitivity, and decreased levels of hemoglobin A1c, an indicator of how well blood glucose has been controlled over the past 3 months.

This wasn’t a controlled study and, in general, any form of exercise practiced regularly can help improve blood sugar regulation in people with diabetes. But given the frequency of the walks (only nine times in six years) and the fact that blood sugar levels were significantly decreased but not significantly different between those who walked the long distance and those who walked the short distance, researchers concluded that factors other than exercise also contributed to the positive long-term results, including changes in hormonal secretion and nervous system function associated with blood sugar metabolism.

Better Concentration

Research in the United States has investigated the effects of outdoor green spaces on symptoms of attention-deficit/ hyperactivity disorder (ADHD) in children. In a randomized controlled study, doctors specializing in environmental psychology at the University of Illinois studied 17 children diagnosed with ADHD who were exposed to three different environments.

After 20-minute walks in a city park, children experienced substantially improved concentration compared to 20-minute walks in downtown and residential settings. Researchers concluded that the positive results were comparable to the effects of Ritalin.

Diminished Pain


Researchers at Johns Hopkins University School of Medicine studied the effects of nature scenery and sounds on pain perception. The randomized controlled clinical trial included 120 adults undergoing bone marrow aspiration and biopsy performed with only local anesthetic, a painful procedure, in one of three settings.

One group experienced nature scenery and sounds during the biopsy, the second group city scenery and sounds, and the third group a standard medical setting. Overall, the procedure was poorly tolerated, but researchers concluded that viewing a nature scene and listening to nature sounds is a safe and inexpensive way to reduce pain during bone marrow biopsy.

Improved Immunity

Studies in Japan have examined markers of immunity in both men and women after three-day trips to the forest. Healthy volunteers participated in three two-hour sessions of walking in a forest. Before, during and after the experiences researchers measured the number and activity of natural killer cells, immune cells that destroy cancerous cells in the body; anti-cancer proteins including perforin, granulysin and granzymes A/B; and levels of stress hormones adrenaline and noradrenaline. They also measured levels of phytonicides in the forest air. (Phytonicides are essential oils released by trees and plants to defend against insects, animals and decomposition.)

Compared to control measurements taken on normal working days, forest walking significantly decreased levels of stress hormones, increased anti-cancer proteins, and increased the number and activity of natural killer cells. 30 days after the experience, natural killer cells were still more active, suggesting that monthly forest walks could be an important lifestyle factor in the prevention of cancer as well as helpful adjunctive therapy for people diagnosed with cancer.

Researchers believed that the wood essential oils were at least partially responsible for the positive effects of forest air. Separate studies have further investigated phytonicides in laboratory settings and confirmed that they can increase anti-cancer proteins and enhance natural killer cell activity.

A Pleasant Prescription


The therapeutic benefits of forest bathing may be difficult to fully explain. Green scenery, soothing sounds of streams and waterfalls, and natural aromas of wood, plants and flowers in these complex ecosystems likely all play a part. Forest therapy is a good example of how our own health is dependent on the health of our natural environment. It’s also an excellent reason to go for a walk in the woods.

References


Karjalainen E et al. Promoting human health through forests: overview and major challenges. Environmental Health and Preventive Medicine. 2010 Jan;15(1):1-8.

Kawakami K et al. Effects of phytoncides on blood pressure under restraint stress in SHRSP. Clinical and Experimental Pharmacology and Physiology. 2004 Dec;31 Suppl 2:S27-8.

Kuo FE and Taylor AF. A potential natural treatment for attention-deficit/hyperactivity disorder: evidence from a national study. American Journal of Public Health. 2004 Sep;94(9):1580-6.

Lechtzin N et al. A randomized trial of nature scenery and sounds versus urban scenery and sounds to reduce pain in adults undergoing bone marrow aspirate and biopsy. The Journal of Alternative and Complementary Medicine. 2010 Sep;16(9):965-72.

Li Q et al. A forest bathing trip increases human natural killer activity and expression of anti-cancer proteins in female subjects. Journal of Biological Regulators and Homeostatic Agents. 2008 Jan-Mar;22(1):45-55.

Li Q. Effect of forest bathing trips on human immune function. Environmental Health and Preventive Medicine. 2010 Jan;15(1):9-17.

Li Q et al. Forest bathing enhances human natural killer activity and expression of anti-cancer proteins. International Journal of Immunopathology and Pharmacology. 2007 Apr-Jun;20(2 Suppl 2):3-8.

Li Q et al. Phytoncides (wood essential oils) induce human natural killer cell activity. Immunopharmacology and Immunotoxicology. 2006;28(2):319-33.

Morita E et al. Psychological effects of forest environments on healthy adults: Shinrin-yoku (forest-air bathing, walking) as a possible method of stress reduction. Public Health. 2007 Jan;121(1):54-63.

Ohtsuka Y et al. Shinrin-yoku (forest-air bathing and walking) effectively decreases blood glucose levels in diabetic patients. International Journal of Biometeorology. 1998 Feb;41(3):125-7.

Park BJ et al. The physiological effects of Shinrin-yoku (taking in the forest atmosphere or forest bathing): evidence from field experiments in 24 forests across Japan. Environmental Health and Preventive Medicine. 2010 Jan;15(1):18-26.

Taylor AF and Kuo FE. Children with attention deficits concentrate better after walk in the park. Journal of Attention Disorders. 2009 Mar;12(5):402-9.

Tsunetsugu Y et al. Trends in research related to "Shinrin-yoku" (taking in the forest atmosphere or forest bathing) in Japan. Environmental Health and Preventive Medicine. 2010 Jan;15(1):27-37.

Yamaguchi M et al. The effects of exercise in forest and urban environments on sympathetic nervous activity of normal young adults. The Journal of International Medical Research. 2006 Mar-Apr;34(2):152-9.