It is Non-Pharma time again! Safe Harbor’s fourth annual medical conference, Non-Pharma IV, kicks off on June 4-5 this year and we are very excited about the broad scope of presenters we have gathered together for your enlightenment.
As only Safe Harbor can do it, we ensure attendees come away with an understanding of how to unravel the often complex factors that can manifest as mental disorders. We also strive to bring you the latest research in safe, non-invasive treatments.
Below are samplings of comments from last year’s attendees.
“This weekend was fabulous!!”
“As a physician, I want to thank you for bringing us Safe Harbor – this was a part of my ‘divine appointment’ toward being better informed on how to help people towards true health.”
“I can’t think of a way to improve this conference. This was awesome. Many thanks!”
“The talks by attorney Karen Barth Menzies and the dentist Raymond Silkman, DDS, were extraordinary!”
“Best conference ever. Thanks, Safe Harbor.”
“Fabulous information. The Recovery Panel was fantastic. Very informative and moving experiences and lectures.”
“Moved fast — well organized.”
“Great!! Look forward to next year.”
“Very well organized, excellent presentations. Thank you.”
“Thank you for a very interesting conference offering hope for the future.”
“I’m now armed with enough information to get the help my son needs….Thank you.”
“Great! Very well organized.”
Safe Harbor’s 2005 Medical Conference, June 4-5
Safe Harbor’s Fourth Annual Medical Conference:
“Non-Pharmaceutical Approaches to Mental Disorders”
Open to the general public as well.
Join Safe Harbor and the nation’s leading voices on safe, non-drug treatments for the mentally unwell.
- When: Saturday, June 4, 2004, 8:30 AM to 6 PM; Sunday, June 5, 2004, 8:30 AM to 5:30 PM
- Where: Glendale Hilton Hotel, Glendale, CA (just outside Los Angeles). The Hilton is next to downtown Glendale with an array of nearby shopping, restaurants, theaters, etc.
- Fees: Before May 19: $140 for both days (lunch not included) After May 19: $170 (lunch not included)
- Day Rates Available
- 15 hours of Continuing Medical Education (CME) for physicians ($160 extra)
- 15 Continuing Educational Units (CEU) for California nurses, LSCWs, and MFTs ($60 extra)
Register by phone – (323) 257-7338, email – SafeHarborProj@aol.com
Seating is limited!
With nearly a dozen speakers, presentations will include:
Vitamin D and Mental Health: John Jacob Cannell, MD, Executive Director, Vitamin D Council, Psychiatrist, Atascadero State Hospital, with little-known research on the pervasiveness of vitamin D deficiency.
The Crazy Makers: How Food Additives and Processed Foods Contribute to the Rise in Mental Disorders: Carol Simontacchi, MS, CCN, Nationally-renowned Author, Columnist, and Radio Host, speaking on the hazards of modern-day fast foods.
Neurotoxicity of Fluoride in our Water: David Kennedy, DDS, past president of the International Academy of Oral Medicine and Toxicology and world lecturer on the safety of dental materials, examines the research on how fluoride and water fluoridation affect mental health.
The Role of Infection and Xenobiotics (Toxins) in Behavior Disorders: Aristo Vojdani, PhD, immunology expert, author of over 90 scientific papers, holder of 10 patents and CEO of Immunoscience Lab.
The Integrative Medicine Approach to Depression and Anxiety – With Case Histories: Joseph Sciabbarrasi, MD, details his protocols in treating depression and anxiety from a holistic perspective.
Is It Mental or Is It Dental? – Part 2 – How Mercury Fillings, Root Canals, Temporo-Mandibular Joint (TMJ) Syndrome, and Other Dental Issues Affect Mental Health: Raymond Silkman, DDS, practicing holistic dentistry, orthodontics, and treatment of TMJ and related disorders since 1992, returns to our conference by popular demand to further discuss the relationship of dental problems and mental health.
The Importance of Methylation in Psychiatric Disorders: Nancy Mullan, MD, nutritional psychiatrist, Safe Harbor medical advisor, reviews one of the most critical nutritional biochemical cycles which, when faulty, can contribute to autism, schizophrenia, depression, and bipolar disorder.
Natural Treatments for Postpartum Depression: Nancy Lins, ND, Hawaiian specialist in postpartum health, on the common physical contributors to and nondrug solutions for the post-birth blues.
Can Visual Correction Improve Symptoms of ADHD, Anxiety, Depression, Learning Disorders, and other Mental Symptomology? Herbert Solomon, OD, presents his research spanning forty years on the remarkable connection between vision and mental health and how visual correction can improve it.
Safe Harbor’s 2005 Recovery Panel: 6 people tell there personal stories of recovery without drugs.
And MUCH, MUCH more…
(ACAM-approved. Provider approved by the California Board of Registered Nursing, Provider Number 13857 for 15 contact hours – Course meets the qualifications for 15 hours of continuing education credit for MFT and/or LCSWs as required by the California Board of Behavioral Sciences – CA BBS Prov. No.: PC2516- No refunds after May 27.)
Oriental Medicine Specialist Speaks: Safe Harbor L.A. Support Group, April 13
On Wednesday, April 13, Safe Harbor will hold it’s monthly Los Angeles support group featuring an hour of group discussion followed by a presentation on the Oriental Medicine approach to mental health by licensed acupuncturist Jeremiah Krieger.
The meeting place will be at Glendale Adventist Medical Center.
Please RSVP to the Safe Harbor office at 323 257-7338.
When: 7PM-9PM, Wednesday, April 13, 2005
Where: Glendale Adventist Medical Center
Committee Room C
1509 Wilson Terrace
(Note: Parking lot is a maximum of $6 – there is free street parking outside the lot.)
Announcing Safe Harbor Oklahoma
We are pleased to announce the formation of Safe Harbor’s newest chapter in Oklahoma. Anyone wishing to work with the new chapter may contact them as follows:
Sandra Lykins, President
8177 S. Harvard # 826
Tulsa, Oklahoma 74137
Julia Ross Amino Acid Therapy Training, April 30-May 1
Join us for a Professional Training with Julia Ross, MA, co-sponsored by Safe Harbor:
“Amino Acid Therapy: Eliminating Negative Emotions and False Appetites That Block Healing”
Proven Alternatives to Antidepressants
Core Training: Saturday, April 30
Advanced Seminar: Sunday, May 1
Marin County, California
For details go to: http://www.moodcure.com/marintraining.html
Readers have brought to our attention some inaccuracies in our “Action Alert” in Issue 55 regarding the Codex Alimentarius (see definitions below) initiative to reclassify nutritional supplements as drugs, severely limiting their distribution.
One reader objected to our statement that the U.S. would be required to adhere to Codex standards, pointing to language in the Codex documents stating that participation is voluntary. Another reader, Dr. Rima E. Laibow (firstname.lastname@example.org), responds as follows:
“Currently, Codex Alimentarius is a voluntary set of standards. Nations (like Australia, Canada and the EU) which have ‘harmonized’ or adopted the Codex Alimentarius regulations (in total, by the way, even though the standards have not yet been fully promulgated) can be hit with trade sanctions by the WTO if they do not comply with these ‘voluntary’ standards.
“The picture changes totally, however, once the Codex Alimentarius standards are ratified, as they are expected to be during the Rome Codex Alimentarius Committee meeting (July 4 – 9, 2005). Once that ratification takes place, Codex Alimentarius becomes a mandatory, binding regulation for all members of the WTO (including, of course, the United States). The WTO Treaty states that the regulations of the WTO (of which Codex is a part) supersede and take precedence over the laws and regulations of nation states.
“The Codex Alimentarius documents clearly state that lack of compliance with the standards after ratification will be be met with sweeping trade sanctions by the WTO against the offending country. Thus, after ratification in July, Codex Alimentarius will no longer be a voluntary standard.
“The US has the right to vote itself out of the WTO every 5 years and 2005 is one of those years according to the office of the Counsel to the World Trade Organization in Washington, DC.
“There is a complex series of ‘Steps’ which Codex Alimentarius has gone through with final approval known as the Eighth Step. That process was, in fact, completed in 2004 but ratification is the last and final step which will, as I have said, take place in July at the Rome meeting. There is a great deal of misinformation about Codex Alimentarius (some of it useful to the propagators of Codex and some of it simple error since there are so many regulations, documents and interlocking pieces to this puzzle).”
Dr. Laibow informs us that the legislative numbers we referenced were terminated upon the end of the 108th Congress. In your letters to Congress, refer to those bills and voice your opposition to any similar legislation which will be introduced in the future, any limitation on health freedom in the US and any attempt to “harmonize” the US with the regulations promulgated by Codex Alimentarius.
The issues are complex. www.healthfreedomusa.org/letters.htm provides sample letters which can be customized and faxed to members of your Congressional delegation and to the members of the Committee which will act on these issues.
“Additionally,” says Dr. Laibow, “you ask your readers to support the law suit brought by the British Alliance for Natural Health. I am a signator on the brief which was entered in the European Court of Justice in support of that case but that particular horse is out of the barn: final arguments were entered in the ECJ on January 25, 2005, an opinion will be released in April and the final ruling in July. Therefore, support of this case is moot.
“Finally, and most significantly, your Action Alert does not alert your readers to the profound damage which Codex Alimentarius will wreak on the planet and on all of us who live on it.
“As Medical Director of the Natural Solutions Foundation I am working hard to bring about a state of American awareness such that our health freedoms are not further impaired and we are not ‘harmonized’ with Codex Alimentarius. In addition to a million-plus fax (not letter or email) campaign to Congress to make it clear that the public will not tolerate restriction of our health freedoms, we have commissioned a major documentary on Codex Alimentarius and the battle against health freedom which will be released in mid-April, we are sponsoring the First International Congress on Health Freedom on Tuscany, Italy (because Tuscany has officially declared itself an area welcoming all types of medicine) and are engaged in numerous other health-freedom activities.”
Rima E. Laibow, MD, Medical Director, Natural Solutions Foundation
*The World Trade Organization website tells us that Codex Alimentarius is the “FAO/WHO commission that deals with international standards on food safety.” FAO is the U.N. Food and Agriculture Organization; WHO is the World Health Organization. A codex, literally, is an early book made of papyrus, from Latin caudex, tree bark. “Alimentarius” evidently refers to food, because the alimentary canal is the digestive tract.
Safe Harbor, Well Mind Association Seek Collaboration
The Well Mind Association of Seattle has, for decades, been at the forefront of educating the public about non-drug approaches for mental health, very similar in mission to Safe Harbor. Recently they have had to close their doors as the managers have moved on in years and younger leadership has not stepped in to take the organization’s reins.
In Safe Harbor’s recent discussions with Elaine Stannard of the Well Mind Association, she suggested the Well Mind Association of Seattle become a Safe Harbor Chapter and that, hopefully, this might attract volunteers interested in carrying on the great work of this venerable organization.
If you are interested in helping this extremely valuable group in Seattle prosper and help others, please contact Safe Harbor at Safeharborproj@aol.com or (323) 257-7338.
Safe Harbor Main Office is Moving!
Safe Harbor’s Los Angeles headquarters is expanding into larger offices in the nearby township of Altadena, California.
The new address will be 787 W. Woodbury Rd., #2, Altadena, CA 91001. The new phone number is not known at this time but will be announced soon. The current number will also work for a number of months.
Books by Harold Foster Available as Free Downloads
The book What Really Causes Schizophrenia is available to be read online at http://www.hdfoster.com/.
It gives a good look at the primary physical factors underlying the syndrome so often called “schizophrenia.”
Also available for free download on the site: What Really Causes Alzheimer’s Disease.
Help Update Safe Harbor!
If you have a new postal mailing or e-mail address, please send it to
email@example.com, so that we can keep our databases current. We will be sending out the information on this year’s medical conference (NP4) soon, so don’t miss out. Send us your updates. Thanks.
Book Review: 8 Weeks to Vibrant Health by Hyla Cass
Nutritional psychiatrist Hyla Cass has hit a home run with her latest book, 8 Weeks to Vibrant Health – A Woman’s Take-Charge Program to Correct Imbalances, Reclaim Energy, and Restore Well-Being.
Other books on the shelves offer 6-week or 12-week “eat-right-and-exercise” programs for health, but we all know that such programs can fail if the person is inundated with despair, food cravings, fatigue, anxiety and a host of other modern plagues. Dr. Cass, working with Woman’s World columnist Kathleen Barnes, has put together a thorough text that covers the underlying reasons why today’s women (and men) feel lousy and lose their verve, along with self-tests, lab tests, and natural approaches for putting the zing back into life.
Backing up the 8-week plan are chapters on sex hormones, thyroid and adrenal issues, food allergies, digestive problems, and a host of other roadblocks on the path to wellness. It would be pretty hard not to succeed with this knowledge under one’s belt.
Lives will change because of this book and Dr. Cass can rightly be proud of 8 Weeks to Vibrant Health. It will be part of Safe Harbor’s recommended reading for some time to come. Be sure to visit her website, www.drcass.com.
From the World of Integrative Psychiatry: Natural Options for “Childhood Bipolar Disorder”
The subject of childhood bipolar disorder came up on Safe Harbor’s Integrative Psychiatry listserv for professionals. Here are the comments of Patric Darby, M.D., child psychiatrist from Washington state (Ishrinkkids@msn.com ):
“Although I believe childhood bipolar disorder can exist is rare cases, I see a lot more of it diagnosed than ever before. I know of one 2-year-old who was diagnosed by another child psychiatrist and medicated for it. There are two books out, The Bipolar Child and The Explosive Child, that people quote, but often mistake the intention of the book. It is often quoted to me that bipolar children crave carbs. Actually, from what I see, kids who eat lots of refined sugar products or carbs appear to have symptoms of bipolar. I had one 14-year-old boy who was so sensitive to sugar that he went ballistic on half of a banana. Several kids, who have had food sensitivity panels, have shown high sensitivity to refined sugars, and the 14-year-old was one of them.
“So many parents bring in their teenagers who claim their kids are bipolar, because of everything they hear in the media. Most teenagers have a ‘disinhibition of emotions.’ Their brains aren’t fully developed and they still have problems with their impulsivity coupled with their hormones causing extreme moodiness.
“Their eating habits are very poor. Most eat nothing all day long, so they cannot maintain their blood sugar, and when they do eat, it’s junk food full of sugar. So they complain of everything from irritability or moody or angry, not being able to focus, being hyper, being tired and even falling asleep in class.
“And to top it all off, their sleep patterns are poor, so they are tired when they begin their day. And then not to eat breakfast or lunch aggravates their mood / situation even more so. Or to eat Twinkies or Ho-Ho’s like some parents give their kids for breakfast, again makes these kids go off.
“So before a kid is considered for medication, I would first modify their diet, and attempt to alter some of their lifestyle by getting them involved in school or after school activities so they can burn up their excess energy and improve their social skills, and if at all possible, try to adjust their sleep schedule, which is near impossible.”
Surprising Health Benefits for Pet Owners
© 2005 Patricia Wagner
Did you know that there are key health benefits that can result from owning a pet? Having one can enhance your physical, mental and social wellbeing.
- How can a pet help your physical health?
Owning a dog, for instance, will encourage you to get more exercise. With your faithful friend at your side, you’re much more likely to go for a walk. Walking is one of the best health activities you can do. While walking you’re also more likely to socially interact with your neighbors because your special pal often acts as an ice-breaker.
Research led by Dr. Karen Allen at the State University of New York at Buffalo shows that pets can help lower blood pressure. Stockbrokers with high blood pressure were studied to see what happened when they adopted a pet dog or cat. Researchers concluded that having a pet nearby helps control increases in blood pressure due to stress.
In his studies Alan Beck, ScD (Professor of Animal Ecology, Purdue University) found that the simple act of petting your dog slows your heart rate and causes your blood pressure to drop.
An added health advantage from pet ownership is that patients may live longer after heart attacks. Some doctors recommend that a heart attack survivor adopt a dog because research has shown that a faithful canine companion can help prolong an owner’s life.
- How Can A Pet Improve Your Mental Health?
Sharing your life with a cat may help your mental health. A study conducted at Australia’s University of New England found that people who own feline friends may experience fewer psychiatric disturbances than those without cats.
Pets can help their owners overcome depression through their companionship and unconditional love. They seem to possess the natural ability to help you relax and enjoy life more.
Pets can also help when you experience times of loneliness. English poet, Alexander Pope, has stated that histories are more full of examples of the fidelity of dogs than of friends. According to a Chinese proverb, dogs have so many friends because they wag their tails, not their tongues.
When you take care of a pet you have to develop a routine of getting out, buying food and providing exercise. This can help fight off depression and loneliness. The simple responsibility of pet care can help you get your mind off yourself and your problems.
- How can a pet enhance your wellbeing in the area of relationships?
AAHA (American Animal Hospital Association) President, Link Wellborn, believes that pets are more than just a member of the family – they’re central to a healthy lifestyle.
Pets help lessen tension between family members and add a lot of fun and unconditional love to the homes where they live. When pets do cute and funny things – which they often do – family members react by laughing and being more relaxed.
If you don’t have a pet yet, consider making one part of your family, but make sure you have the time and resources necessary to provide a stable loving home for your new friend.
If you choose a dog as your new pal, remember this wise old saying. “A dog is man’s best friend.” That’s true in more ways than one. You’ll get unconditional love, companionship, loyalty and relaxation in return for your investment of time and material resources.
What a bargain!
Patricia Wagner offers informative tips and a free newsletter to help you live a more more energetic lifestyle. Check out http://www.a-to-z-wellness.com. She is also an artist and you can view her original paintings at http://www.artbywagner.com.
Ritalin Study Reveals Chromosome Damage
In a preliminary study, Texas researchers have found that 100% of a dozen children treated with “normal therapeutic doses” of methylphenidate (sold as Ritalin, Concerta, Metadate CD, et al) registered a threefold increase in chromosome abnormalities three months later — abnormalities associated with increased risks of cancer and other health problems.
Chromosomes are the bodies within cells that carry genetic information.
Researchers at the University of Texas M.D. Anderson Cancer Center in Houston and the University of Texas Medical Branch at Galveston (UTMB) reported their detection of the chromosome abnormalities in the journal Cancer Letters. Their peer-reviewed paper is available on the journal’s website.
The researchers believe their study is the first of its kind. They found surprisingly few human or animal studies — though the drug has been used on humans for over 50 years — exploring serious side effects such as mutations or cancer. Lab mice given high dosages developed liver tumors, according to a 1996 report discussing several two-year-long animal studies, but rats did not.
In the study, blood was drawn from the children before they began taking methylphenidate to get a baseline level of chromosomal abnormalities. Three months after the children had begun taking the drug, the researchers examined a new blood sample.
Most of the abnormalities found in the studied blood cells consisted of chromosome breaks. “A higher frequency of aberrations is reported to be associated with an increased risk of cancer down the line,” said lead author Randa A. El-Zein, M.D., Ph.D., an assistant professor of epidemiology at M.D. Anderson who performed the blood studies using several techniques.
“It was pretty surprising that all of the children taking methylphenidate showed an increase in chromosome abnormalities in a relatively short period of time,” El-Zein said.
UTMB Professor of Environmental Toxicology Marvin Legator, the study’s principal investigator and senior author, cautioned, “This study doesn’t mean that these kids are going to get cancer, but it does mean they are exposed to an additional risk factor, assuming that this study holds up.” Of the 53 known human carcinogens, Legator said 48 could be detected using the chromosome analysis methods employed in this study.
El-Zein stressed that much larger studies at several medical centers are needed to confirm the results of this study and to answer other questions not addressed by it. One of these issues is the question of what happens when patients stop taking methylphenidate. “Do the levels of chromosome abnormalities go back to normal?” El-Zein said. “We don’t know.”
The Cancer Letters article by Randa A. El-Zein, Sherif Z. Abdel-Rahman, Matthew J. Hay, Mirtha S. Lopez, Melissa L. Bondy, Debra L. Morris and Marvin S. Legator can be found on the Web by clicking the “Articles in Press” button at
Depression Linked to Birth Control Pill
Women taking the oral contraceptive pill are almost twice as likely to be depressed than those not on the Pill, according to the results of a new study undertaken at The Alfred.
The Alfred Psychiatry Research Centre has completed a pilot study, which looked at the association between mood and the use of the Combined Oral Contraceptive Pill.
APRC director and principal investigator Jayashri Kulkarni said the study looked at whether women who use “the pill” are more likely to experience lower mood (depression or depressive symptoms), than non-users.
The study involved 62 women and compared depression symptom scores between users and non-users of combined oral contraceptives. Those using the Pill had an average depression rating scale score of 17.6, compared to 9.8 in the non-user group.
“Past studies have indicated a significant relationship between the use of the Pill and experiencing depression,” said Kulkarni. “There have also been studies that have found a link between depression and hormonal changes such as during pregnancy, menopause or with the use of hormonal contraceptives. However, these studies’ findings have been inconsistent so we will investigate this link further with a larger study.”
Study participants were over 18, not pregnant or lactating, had no clinical history of depression and were not on antidepressant medication in the previous 12 months.
The Alfred Psychiatry Research Centre stated its intention to run a more extensive study comparing different contraceptive pills, exploring the effects of longer use, mitigating and precipitating factors.
Headaches, Depression May Be Result of Aerosol Use
Frequent use of aerosols and air fresheners in the home could make mothers and babies ill, according to research from the University of Bristol’s Children of the 90s study, published in late 2004.
The research showed that mothers who used aerosols and air fresheners in their homes every day were more likely to be ill than those mothers who used them once a week or less. Aerosols included polish, deodorant and hairspray, while air fresheners included sticks, sprays and aerosols. The children of the mothers who used aerosols daily were also more likely to have some illnesses. More than 40 percent of families use air fresheners regularly.
Researchers randomly selected 170 homes of the mothers taking part in the Children of the 90s study. They studied the household levels of volatile organic compounds (VOCs) over the course of a year, and looked at which household products appeared most likely to increase the levels of VOCs. They then asked 10,000 mothers to complete questionnaires about their use of these household products.
The researchers also asked the mothers to report any symptoms they and their children suffered at various points during pregnancy and childhood.
Volatile organic compounds (VOCs) are chemical gases that have no color or taste, although many have a characteristic smell. VOCs are released from a variety of household products, including air fresheners, paint, cleaners and solvents. Car exhaust is loaded with them.
Of the mothers who used air fresheners, 16 percent suffered from depression compared with 12.7 percent of those mothers who hardly ever used air fresheners. Mothers who used air fresheners daily suffered almost 10 percent more headaches than those who used them less than once a week.
Pregnant women and babies up to the age of six months may be particularly at risk of the effects of aerosols in the homes, because they spend such a large proportion of their time in the home. Other people who spend a lot of time in the home, such as elderly people, may also be at risk of illnesses that may result from overexposure to volatile organic compounds (VOCs).
Although there has been a lot of research that links increased volatile organic compound (VOC) levels in the home with headaches and feeling unwell, the mechanism is not very well understood and more research is required.
There are so many sources of volatile organic compounds (VOCs) that it isn’t possible to make your home completely free of VOCs. A leading British provider of healthcare insurance, BUPA, suggests these methods to minimize VOC levels in the home:
- limit the use of air fresheners and aerosols when using aerosols
- do not use in a confined space when using aerosols
- follow the manufacturers’ guidelines
- throw away unused or old aerosols, because gases can leak even from closed containers
- make sure there is plenty of ventilation if you are using paints or solvents
- If you want to make your home smell fresh, try squeezing a lemon into a dish as this is just as effective as an air freshener.
(More at http://www.bupa.co.uk/)
The Children of the 90s study (also known as the Avon Longitudinal Study of Parents and Children study — see http://www.alspac.bristol.ac.uk) is an ongoing research project based at the University of Bristol. The project began in 1991 to 1992 with the enrollment of 14,000 pregnant women. The women and their children have been followed since then.
Antidepressant Suicide Risks Confirmed by Hundreds of Clinical Trials
An analysis released Feb. 16 of hundreds of clinical trials involving tens of thousands of patients reveals that adults taking antidepressants such as Prozac, Paxil and Zoloft are more than twice as likely to attempt suicide as patients given placebo.
Epidemiologist Dean Fergusson, his colleagues at the Ottawa Health Research Institute, and scientists from McGill University examined 702 controlled clinical trials involving 87,650 patients treated for a variety of conditions, including sexual dysfunction, bulimia, panic disorder and depression. It is the largest study of its kind to date.
FDA officials have said they are conducting an “independent” analysis.
Adults with severe depression should continue to be considered for drug treatment, but those with milder symptoms should probably not be medicated, said John Geddes, a professor of epidemiological psychiatry at Oxford University, whose comments were published in the British Medical Journal alongside the new study.
“For a lot of time, these drugs were seen as a panacea for low mood in general,” he told the Washington Post. “We do need to ensure they are only prescribed for patients with clearly diagnosed depressive disorders.”
New analyses of clinical trials in children last year prompted FDA to require a prominent black box warning on labels that the medications could increase the risk of suicide in children.
British authorities last year recommended that depressed patients who were able function at home and work should not be medicated right away, but should be counseled to try exercise, self-help, talk therapy — or watchful waiting.
David Healy, a psychiatrist at the University of Wales who helped conduct the new study, feels that such a meta-analysis is long overdue. “For whatever reason, an awful lot of people didn’t want to think there was a risk.” Healy expects U.S. managed-care companies to balk at the “watchful waiting” approach.
Due to the relative infrequency of suicide in a population, it takes a large sample to yield meaningful percentages. Fergusson’s meta-analysis pooled data from a large number of studies in the same manner as the recent FDA analysis involving children’s trials.
According to The Post, the American Psychiatric Association considers untreated depressed patients a greater suicide risk than those treated with SSRIs, though no statistical evidence was offered in support of this claim. An APA spokesman expressed concern that depressed patients who were getting better through medication might be more likely to tell doctors about a suicide attempt, thereby skewing the results. This reasoning runs counter to the more commonly voiced concern that suicide attempts and suicidal thoughts all too often go unreported.
While Fergusson agreed that better trials are needed, he expressed confidence in his analysis, relying as it does on placebo-controlled trials — considered the most definitive. He added that increased suicide risk with SSRIs was found in patients being treated for a variety of disorders, not just depression.
Suicide “is uncommon but serious,” Fergusson said in an interview. “The biggest concern is these drugs are widely prescribed. There are millions of people on the drugs, so even a risk of one in a 1,000 when you amplify it to the millions, it becomes a public health issue.”
St. John’s Wort Compares Favorably to Paroxetine for Major Depression
Extract of Hypericum perforatum (St. John’s wort) is at least as effective as paroxetine (Paxil) for the treatment of moderate to severe major depression, while being better tolerated, Germany investigators reported in the British Medical Journal online edition of February 10.
Dr. Meinhard Kieser, at Dr Willmar Schwabe Pharmaceuticals in Karlsruhe, and his associates enrolled outpatients in 21 clinics. All scored 22 points or higher on the 17-item Hamilton depression scale. A total of 125 were randomly assigned to hypericum extract and 126 to paroxetine. Doses were doubled after 2 weeks if the depression score had not improved by at least 20%.
After 42 days, Hamilton depression scores declined by 57% (14.4 points) in the hypericum group, as compared to 45% (11.4 points) in the paroxetine group. Study authors characterized the difference as “clinically relevant.”
Responder rates were 70% and 60%, respectively, and remission rates were 50% and 35%. The authors observed differences favoring hypericum in the Montgomery-Asperg depression rating scale, Beck depression inventory and clinical global impressions as well.
76% of the paroxetine group and 55% of the hypericum group reported adverse events at some time during the trial.
“Our results support the use of hypericum extract WS 5570 as an alternative to standard antidepressants in moderate to severe depression, especially as it is well tolerated,” Dr. Kieser’s group concluded.
In Germany, where St John’s wort is a prescription drug, it outsells Prozac by four to one. However, it may reduce the effectiveness of other prescription medications used at the same time.
Complementary/Alternative Medicine Helps Tourette Sufferers
Tourette syndrome (TS) is a neuropsychiatric disorder associated with motor and vocal tics. Some people with TS have reported using alternative or complementary medicine (CAM), including nutritional supplements to control their tics. In a recent national survey, approximately 40% of people reported having used CAM in the prior year.
A group of researchers set out to explore the use of supplements and other CAM among TS patients. They developed a survey instrument based on anecdotal accounts of CAM use and distributed it to the mailing list of the New York Chapter of the Tourette Syndrome Association and the subscription list of Latitudes, a newsletter exploring CAM treatments for neurological conditions. Responses were entered in a database and analyzed.
Of 115 respondents, 87.8% reported using 1 or more of 29 nutritional supplements to control symptoms. Many also reported using other CAM. Most supplement users reported an improvement in tics.
(Mantel, Meyers, Rogers, Jacobson; BJM Consulting, New York, New York.)
Health Canada Suspends Sale of Adderall
FDA issued a Public Health Advisory to notify healthcare professionals that Health Canada, the Canadian drug regulatory agency, has suspended the sale of Adderall XR in the Canadian market. Adderall XR is a controlled release amphetamine used to treat “ADHD.” The Canadian action was based on U.S. post-marketing reports of sudden deaths in pediatric patients. FDA is continuing to evaluate these and other post-marketing reports of serious adverse events in children, adolescents, and adults being treated with Adderall and related products. Adderall XR is approved in the United States for the treatment of adults and pediatric patients 6-12 years old diagnosed with “ADHD.”
Read the complete MedWatch 2005 Safety Summary, including links to the Public Health Advisory, FDA Statement and other supporting information for healthcare professionals and patients, at: