FDA Issues Public Health Advisory on Antidepressants
The U.S. Food and Drug Administration has requested that drug companies put prominent warnings on the labels of 10 antidepressant drugs, “to include stronger cautions and warnings about the need to monitor patients [both children and adults] for the worsening of depression and the emergence of suicidal ideation, regardless of the cause of such worsening.”
In clinical trials, these high-risk behaviors occurred in children taking the drugs, not the placebo group. Thus the FDA would appear to be pulling its punches. Nonetheless, doctors will be on notice that these drugs are not benign, as they had been led to believe; they may be less inclined to hand out prescriptions for life’s momentary crises.
Testimony by grieving families at a public advisory committee hearing (February 2) may have prompted the FDA’s move. The testimonies corroborated independent analyses linking
antidepressants to harm of self and others.
The FDA continued to deny that a problem existed until evidence disclosed in court proceedings became public. The Agency’s chief counsel had even filed a brief stating that labeling Zoloft for suicide risk would be “misbranding,” and that FDA would forbid it.
The new advisory was issued on March 22, 2004, and is available at www.fda.gov/cder/drug/antidepressants. The decade-old clinical trial data will finally be “re-analyzed” at Columbia University. The Alliance For Human Research Protection (AHRP) charges that Columbia has financial incentives to return favorable results. (See www.ahrp.org or contact Vera Hassner Sharav, (212)595-8974, veracare@ahrp.org.)
Editorial: FDA’s Antidepressant Warning Misses Mark
By Dan Stradford, President, Safe Harbor
The following editorial ran March 29 in the main Atlantic City, New Jersey, newspaper called The Press and on March 31 in the Seattle Post-Intelligencer. We have been told by editors of the Los Angeles Times, the Cox newspaper chain of daily papers in Ohio, and the Brattleboro Reformer (Vermont) that it has been or will be printed in those publications and we are awaiting confirmation.
Let’s be honest: If you or I were as dependent on psychotropic drugs as America is, we’d be in rehab.
The FDA has finally proposed warning labels on antidepressants because they may promote suicidal tendencies – and we should be thankful. But isn’t this just a small patch on a nasty wound?
In the early 1960s tranquilizers were introduced into the United States and were marketed so heavily that by 1968, Valium became the most prescribed drug in America. And the party hasn’t stopped since. Didn’t doctors know at the time that the drug was being abused and overprescribed, that it was addictive? Of course. Did they continue to prescribe it? Of course. Did the manufacturer continue to provide it? Need you ask?
Our society once had an old commonsense virtue that psychotropic drugs should be used as a last resort. Why? Because these drugs, while useful in extreme circumstances, can have nasty effects like addiction, rages, altered judgment, divorces, and yes, suicidal impulses. These “side effects” have been around for thousands of years, prompting most civilized groups to have prohibitions on mind-altering substances.
Yet we have become so muddle-headed by the constant marketing to take these drugs for every emotional malady, that we now live in a ridiculous world where we have signs that say “This is a Drug-Free Zone” on the front of a school that is handing out tons of psychotropics to the children for depression, hyperactivity, anxiety, etc.
Psychiatric drugs have become a FIRST resort in America. That is the real nightmare the FDA should confront. Doctors no longer look for causes of depression, such as thyroid problems, lack of exercise, a bad diet, a guilty conscience, medical problems, allergies – the likely culprits could be many. By using drugs to treat the symptoms they not only expose patients to the effects of the drugs but they let the real causes go untreated. And by encouraging drug use to get over ordinary life experiences, such as a death in the family or teenage shyness, physicians numb the pain that so often contributes to maturity and emotional growth.
The FDA needs to step up to the plate: Psychiatric drugs as a LAST resort. What a concept.
NON-PHARMA III:
“Non-Pharmaceutical Approaches to Mental Disorders”
FEATURING: A special afternoon with Michael Lesser, M.D., author of The Brain Chemistry Diet, with a new book, Nutrition and The Mind, to be released in 2004, and one of the pioneers of nutritional psychiatry in the United States. When: Saturday, June 5, 2004, 8:30 AM to 6 PM; Sunday, June 6, 2004, 8:30 AM to 5:30 PM Where: Glendale Hilton Hotel, Glendale, Califonia (just outside Los Angeles). The Hilton is next to downtown Glendale with an array of nearby shopping, restaurants, theaters, etc. Rooms $109.00 per day. Mention Safe Harbor when booking. Event parking $8.00 per day. For reservations, call (818) 956-5466. Fees: Before May 20: $130 for both days (lunch not included) 15 Hours continuing education units (CEUs) for CA LCSW/MFTs and nurses – $60 extra. (BBS Prov. No. BCE 2516; BRN Prov. No. pending – No refunds after May 24.) FLASH! Register by phone – (323) 257-7338, email – Seating is limited! Safe Harbor is accepting applications for a limited number of exhibitors for Non-Pharma III. If you would like to exhibit at the conference, please contact wendy@alternativementalhealth.com for information and an application. With a dozen speakers, presentations will include:
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Canadian Member of Parliament Urges Disclosure of SSRI Evidence
In the following letter, reprinted with permission, Canadian Member of Parliament Svend Robinson calls for full disclosure of the evidence that:
- in the drug companies’ own tests, the drugs failed to outperform placebo in children and
- using the drugs puts children in harm’s way.
March 4, 2004
Honourable Pierre Pettigrew, PC MP
Minister of Health
507 Confederation Building
House of Commons
Ottawa, ON K1A 0A6
Dear Pierre,
I have recently been contacted by a number of concerned Canadians regarding the potentially dangerous side effects of some anti-depressants prescribed to children and adolescents. As the Canadian Medical Association Journal noted, some new antidepressants known as selective serotonin re-uptake inhibitors (SSRIs) or serotonin noradrenaline re-uptake inhibitors (SNRIs) have been shown to increase the risk of suicide in youth.
This in itself should be sufficient to prompt Health Canada to take steps to prevent the prescription of these drugs to children, however, there is also significant evidence that indicates that SSRIs and SNRIs are no more effective than placebos in treating children. It would appear then, that these drugs are at best useless, and at worst deadly, when prescribed to children and adolescents.
Unfortunately, it appears that Health Canada, as the federal prescription drug regulatory body in Canada, has been aware of these problems with SSRIs and SNRIs prescribed to children for some time, and yet has only recently issued an advisory on the matter. It is widely acknowledged that such advisories are rarely noticed by doctors or their patients.
What steps has the department taken to ensure that families are immediately made aware of the risks of these drugs? Has Health Canada called on the manufacturers of these drugs to issue proper monographs with proper boxed warnings to children and their parents when prescribed these drugs? Has Health Canada asked the manufacturers to fund a Health Canada media campaign to inform Canadians of the risks of SSRIs, including television ads or materials distributed in schools? Finally, if manufacturers are not able to certify that parents and children are being appropriately warned as to the dangers of SSRI use, will Health Canada ask them to withdraw their products from the Canadian market?
I would also note that Health Canada has stated that it would assess the safety data of the medications supplied by their manufacturers. I would urge you to direct Health Canada to proceed with its assessment of the drugs’ safety in a public and open manner, so that Canadians can see the evidence for themselves.
As Canadian media reports have recently revealed, the practice of most pharmaceutical companies is to withhold any negative results of clinical drug trials. At the same time, positive results from these trials are promoted, giving both the public and doctors a false impression of drug safety and effectiveness.
Currently, Health Canada receives all clinical trial results from pharmaceutical companies, but keeps them confidential. In the United States, the Food and Drug Administration publishes the comments of reviewers on its website, and releases trial results through Freedom of Information requests without the consent of the manufacturer. Sadly, Health Canada does not take even these meagre steps towards transparency in the drug approvals process.
I would therefore urge you to direct Health Canada not only to release all trial results of prescription drugs – both positive and negative — to the public, but to bring in the necessary regulatory changes to compel all drug companies to register trials when they begin, to release results from discontinued trials, and to publish the results of all trials promptly after their termination.
It seems that the health and safety of Canadians is being threatened by Health Canada’s inappropriately close relationship to the pharmaceutical industry. The more drug companies are able to keep their records out of the public eye, the easier it will be for potentially dangerous drugs like SSRIs to claim the lives of unsuspecting Canadians.
I would therefore urge you to stand up for the safety of Canadians and ensure that the protection of public health – rather than the protection of corporate interests – remains the top priority of Health Canada.
I await your earliest possible reply.
Sincerely yours,
Svend Robinson, MP
Burnaby-Douglas
Dr. Ann Tracy and Columbine Victim Speak in Anaheim, California, Apr. 5
Ann Tracy, Ph.D., author of Prozac Panacea or Pandora and director of the International Coalition for Drug Awareness www.drugawareness.org will be speaking on: “The Downsides of Modern Antidepressants – A Look at Side Effects, Violence, and Suicide”
Dr. Tracy is one of the nation’s leading experts on the negative effects of SSRI’s (antidepressants).
Also speaking will be Mark Taylor, the first student who was shot at the Columbine High School massacre in Colorado. At least one of the shooters was on psychiatric medication.
The evening is co-sponsored by Mothers Against Manufactured Madness (MAMMA) and Safe Harbor.
For more information, contact MAMMA at (619) 670-3552.
When: 7:30 PM, Monday, April 5, 2004
Where: Anabella Hotel, 1030 W. Katella Ave., Anaheim, California, in the La Rosa Room
Admission: $11.00 Donations are also welcome.
Announcement: L.A. Safe Harbor Support Group Meeting, Wed., April 14
The monthly Safe Harbor support group in Los Angeles will meet on Wednesday, April 14, 2004, at the Safe Harbor office at 1718 Colorado Blvd. in the Eagle Rock area of Los Angeles from 7 PM to 9 PM.
Group sharing will occur the first hour. Our speakers for the second half of the evening will be two individuals who have recovered from schizophrenia and bipolar disorder, respectively, and now live drug-free lives.
Please RSVP to SafeHarborProj@aol.com or (323) 257-7338.
For info on Safe Harbor Boston, New York, or New Mexico support group meetings, see contact info in left sidebar.
Article: 1 Percent of Children Test Positive For Early-Stage Celiac index
We have reported previously on the connection between celiac disease and Recurrent Brief Depression (Alternative Mental Health News, Issue 42) and other mental disorders, and the treatment of Celiac Disease with a gluten-free diet.
A study by Bingley and colleagues tested 5,470 children at age seven for indications of subclinical (early stage) celiac disease. These children and their parents were a part of a long-term study, the Avon longitudinal study of parents and children. In the first stage of this test, the children were tested for antibodies to an enzyme called tissue transglutaminase. Those who tested positive were then screened for antibodies to a second enzyme, IgA antiendomysial. These children were compared to geographically-matched controls who tested negative to the first enzyme. One percent of children tested IgA-EMA positive, a prevalence similar to adult sufferers of celiac disease. This group of children were approximately nine months behind in height and weight compared to the control group. However, only one in ten of these children were on a gluten-free diet. It could be concluded that celiac disease is present in childhood.
For the entire article, see
http://bmj.bmjjournals.com/cgi/reprint/328/7435/322.pdf.
Article: What Does a Gluten-Free Diet Look Like?
An article on www.msgtruth.org notes that gluten and MSG (monosodium glutamate) are closely related, and urges celiac patients to stay away from msg as well as the following common food products (shortened list):
FOODS TO AVOID:
- Most commercial canned or processed foods.
- Most candies.
- Wheat flour, oats, rye, barley, graham flour, semolina flour, triticale, bulgur, spelt, durum, couscous.
- Hydrolyzed Vegetable Protein (HVP) or Hydrolyzed Plant Protein, which contain free glutamates (equivalent to MSG, says the FDA).
- Sirimi (imitation seafood), which may use wheat as a binder.
- Modified Food Starch – found in over-the-counter medications as well as processed foods.
- Beer, ale, gin, vodka, whiskey.
- Flavored and instant coffees, some herbal teas, root beer.
- Anything with malt flavoring or malt syrup.
- Flavored yogurts, some ice creams, some light or fat-free dairy products, artificial cream, processed cheese
- spreads, some chocolate milk drinks.
- Prepared meats.
- Self-basting turkeys (often injected with Hydrolyzed Vegetable Protein).
- Canned Soups, dehydrated soup mixes, and bouillion.
- Creamed, breaded and scalloped vegetables.
RECOMMENDED ALTERNATIVES:
- Amaranth
- Buckwheat
- Garbanzo beans (unless soy allergy is present)
- Corn
- Potatoes
- Rice
- Quinoa
- Milo – used for baking
- Millet – crumbly so use with binder
- Mandioca – use for crackers
- Chestnut – crumbly so use with arrowroot
- Tapioca – use for binding and thickening
- Teff
- White sweet potato
- Cassava
- Malanga
- Yams
The books The Gluten Free Gourmet Bakes Bread and More From the Gluten Free Gourmet (written by Bette Hagman) contain recipes to help the celiac sufferer avoid gluten. However, rice milk is sometimes used in the recipes. Rice milk contains a tiny amount of gluten from barley protein (less than .002%).
Article: Web Search Helps Thyroid Patient
The other day, I asked a co-worker about a thyroid condition that had afflicted her a few months before — a condition triggered by eating a brownie. Suddenly she was unable to swallow, started to choke, and couldn’t breathe. The choking sensation had persisted
and still troubled her frequently.
While waiting about seven months for a public health clinic to complete their testing and diagnosis, she turned to antidepressants (apparently prescribed earlier) to help her cope with life. Hours of Web searching yielded no alternatives, partly because her assumption that she had hypothyroidism (underactive thyroid) was incorrect.
I remembered a discussion thyroid and depression in this ezine. All the back issues are available at AlternativeMentalHealth.com, but in my experience a Google search is the easiest way to find them.
I went to google.com and clicked the “Advanced Search” link at the top of the page. (Don’t worry, the “advanced” features are simple and clearly explained.) I typed the words “thyroid” and “depression” into the “find results with all of the words” text box. Then I narrowed the search with “only return results from the site or domain alternativementalhealth.com.” (You can do this with any website!)
I hit paydirt within five minutes, on a page linked to our site: www.ithyroid.com/chocolate.htm. I learned that chocolate contains cadmium and lead — good for batteries, not so good for humans with hyperthyroidism. I printed the page and took it to my friend.
As it turns out, she already wanted to quit her chocolate habit, without ever associating it with her illness. Armed with this new information, she got rid of all her chocolate. The choking sensation was gone by the next day.
If you have any information about tasty chocolate substitutes (besides carob, which makes her feel “drunk”), please email your suggestions to SafeHarborProj@aol.com.
— Alan Graham, assistant editor
Article: Possible Bacterial Trigger for Alzheimers Found
The increased lifespan of Americans has been offered as an explanation for the rising incidence of Alzheimers disease in this country. The underlying assumption seems to be that Alzheimers is a natural or inevitable result of reaching a certain age, at least for those who are genetically predisposed — as many as half of us.
Perhaps there is another answer.
A few years ago, Brian Balin of the Philadelphia College of Osteopathic Medicine examined the brains of 19 people who had died of Alzheimer’s and 19 people of the same age who had died of other causes. He found Chlamydia pneumoniae bacteria in 17 of the 19 “Alzheimers brains” and only in one of the others. Dr. Balin has now completed a follow-up study that is scheduled for publication in journal Neurobiology of Aging.
Evidence of Chlamydia in brain tissue is not significant in itself. Chlamydia is a common bug that causes mild pneumonia, a persistent cough and a low-grade fever; most of us will be exposed to it at some time in our lives. The link to Alzheimers might be nothing more than an increased susceptibility to infection.
However, it would be a tremendous breakthrough to find a bacterial trigger for Alzheimers — and not unprecedented. Until recently, stomach ulcers yielded only to the surgeon’s scalpel; now they yield to antibiotics. Chlamydia itself is being investigated as a possible culprit in heart disease.
Dr. Balin set out to determine whether or not the bacterium could induce Alzheimers-like symptoms in mice. He and his colleagues chose a kind of mouse that does not naturally develop the amyloid brain plaques characteristic of Alzheimers. (Plaque: a small area of damaged tissue. Amyloid: a starchlike protein that is deposited in the brain, liver, kidneys, etc., in certain diseases.)
The researchers sprayed a strain of the bacterium that had been harvested from human Alzheimer’s patients, up the mice’s noses. One to three months later, Dr. Balin killed his mice and examined their brains. All the animals had developed plaques, the size and number of which were greater the longer the animals had lived.
Meanwhile, the Scripps Research Institute’s Jeffery Kelly and colleagues have duplicated what they believe to be the early stages of plaque formation in a test tube by combining amyloids with one of the toxins produced in the body when ozone attacks normal body chemicals. Ozone, a highly reactive form of oxygen, occurs as a result of inflammation.
Dr. Balin’s working hypothesis is that inflammation from a low-grade infection jump-starts the plaque formation process.
Article: MSG by Any Name Is Still a Neurotoxin
A highly reactive amino acid, monosodium glutamate (MSG) is used by scientists in studies to purposely cause death to areas of the brain and is fed to rodents to make a strain of obese and pre-diabetic test subjects, says www.truthinlabeling.org. MSG is classified as a neurotoxin: too much of it introduced to the brain can cause rapid cell death.
In his book, The Slow Poisoning of America, John Erb argues that this neurotoxin is a key cause of ADHD and autism. His conclusions are based on a survey of hundreds of medical journal articles about glutamate and its effects on the brain and other organs.
Citing scientific studies suggesting that food laced with MSG causes people to eat more of it, and faster, Erb states: “Corporations use this knowledge to sell their products. Their competition uses MSG, so they keep adding it in larger amounts to keep up with them.” See www.spofamerica.com for details.
The FDA announced in 1995: “FDA considers foods whose labels say ‘No MSG’ or ‘No Added MSG’ to be misleading if the food contains ingredients that are sources of free glutamates, such as hydrolyzed protein.” Since then, FDA-regulated products have been more truthful in their labeling.
The same cannot be said of products regulated by the United States Department of Agriculture, according to the Truth in Labeling site. The USDA approves labels of meat and poultry products that claim “No MSG,” “No MSG Added,” or “No Added MSG” even when they contain free glutamic acid.
Only if there is zero free glutamic acid in an end product can one legitimately claim that there is no MSG. The burden of proof for a claim about the absence of MSG lies with those making the claim.
To find out if there is processed free glutamic acid in a product, you must ask the manufacturer about “free glutamic acid,” not “MSG.” If the label mentions autolyzed yeast, hydrolyzed pea protein, carrageenan, or sodium caseinate, there may be abundant free glutamic acid in the product — and the same types of reactions may result.
If the manufacturer says an ingredient is “naturally occurring,” remember that many poisons occur in nature. Monosodium glutamate itself is “natural” by the FDA definition.
It is the amount of processed free glutamic acid that determines the “MSG” reaction. If the manufacturer expresses uncertainty, ask that the product be analyzed for free amino acids, including free glutamic acid.
Truthinlabeling.org was advised by the FDA that if any misbranded products are brought to their attention, they will act to correct the situation. You can call the FDA at 888-723-3366 between 10 a.m. and 4 p.m., Eastern time – and keep a record of your call.
Article: Nutritional Supplement Used for Tapering Off Psych Drugs
A nutritional supplement called Immunocal has been generating attention in the past few years as a useful treatment for helping people wean off of psychiatric drugs.
Below are the comments of one individual. Many more such examples are available at
www.prozactruth.com/tapertest.htm
“I had tried to taper off Paxil 4 times in the past. None successful. I’ve been using 20 mg of Paxil for 2 years and had been able to cut down to 15 mg a day but no further. The side effects were severe.
“I needed to function while I tapered and thought I would try the Immunocal.
“I know you want people to e-mail you before they start the taper but I did not want to fail again and have you know about it.
“Are you ready? I AM NOW PAXIL FREE FOR 1 MONTH!!!!!!
“There were a few mild side effects during the taper but none that interfered with my daily life. I had a few headaches but when I took 2 packets of Immunocal in a day the side effects went away in a matter of hours!
“THANK YOU. I HAVE A LIFE AGAIN!”
The product is a milk serum protein isolate and is taken while on medication to relieve the withdrawal effects of tapering off of medication and is also reported by some to alleviate the original symptoms that caused the person to take psychiatric drugs in the first place.
For more information on the product, see www.immunocalwins.com.
National Geographic Consults with Safe Harbor index
We are pleased to report that National Geographic has commissioned a show to be done on the topic “Food and Mood.” The London producer in charge of the project contacted Safe Harbor in March seeking information and recovery stories of people who have experienced improved mental and emotional functioning from dietary changes and improvements.
We were happy to oblige and look forward to the show, which, we are told, will be run in 130 countries.