FOR IMMEDIATE RELEASE
Orthomolecular Medicine News Service, October 9, 2008
(OMNS, October 9, 2008) “Dietary supplements cause 600 ‘adverse events'”, reported USA Today on 22 Sept, 2008. In an article that looks much like an official US Food and Drug Administration press release, it said that “Serious side effects from the use of food supplements resulted in 604 “adverse-event” reports – a list that includes at least five deaths – through the first six months that such accounts have been required by law.” (1)
Good grief! Looks like all those supplement-popping health nuts really are nuts after all. Food supplements simply must be dangerous!
Or are they?
Later on in the article, far from the headline, USA Today conceded that “An adverse event can be anything from a concern that a supplement isn’t working to a serious illness that follows consumption.” And, FDA spokesman Michael Herndon admitted that of the five deaths and 85 hospitalizations reported, “Some of these deaths were likely due to underlying medical conditions.”
FDA’s method of gaining data is suspect at best and biased at worst. Their “Dietary Supplement Adverse Event Reporting” webpage,
http://www.cfsan.fda.gov/~DMS/ds-rept.html,
states: “FDA would like to know when a product causes a problem even if you are unsure the product caused the problem or even if you do not visit a doctor or clinic.” The measure of uncertainty involved in publicly soliciting adverse reports “even if you are unsure that the product caused the problem” is noteworthy.
But most significant of all is that FDA refused to disclose exactly which supplements allegedly were causing problems. Doesn’t the public have a right to know? In the absence of FDA disclosure to the contrary, it is likely that the five or fewer deaths attributed to “food supplements” were in fact due to medicinal substances marketed as dietary supplements. FDA acknowledges this in a round-about way at their website
(http://vm.cfsan.fda.gov/~dms/mwgblghb.html).
There you will find an “Important Message” which asks health professionals to “Report Serious Adverse Events Associated with Dietary Supplements Containing GBL, GHB, or BD . . . a group of products sold as dietary supplements for bodybuilding, weight loss and sleep inducement which have been determined to pose a significant public health hazard. These products are chemically related ! to gamma butyrolactone (GBL), gamma hydroxybutyric acid (GHB), and 1,4 butanediol (BD), and can cause dangerously low respiratory rates (intubation may be required), unconciousness/coma, vomiting, seizures, bradycardia and death. GBL, GHB and BD have been linked to at least 122 serious illnesses reported to FDA, including three deaths.”
But these substances are not foods. They are not vitamins, and they are not minerals, and they are not amino acids. They should not be considered with or as food supplements. Over half of all Americans safely take nutritional supplements every day. If each of those persons took only one tablet per day, that would be some 145,000,000 individual doses daily, for a total of over 53 billion doses annually. Many healthy people take more. And yet, according to national statistics compiled by the authoritative American Association of Poison Control Centers, there is not even one death per year from vitamins. (2) Look at the reports, which detail each individual vitamin, mineral, amino acid and herb, and see for yourself at
http://www.aapcc.org/dnn/NPDS/AnnualReports/tabid/125/Default.aspx
By comparison, FDA acknowledges that prescription drugs resulted in 482,154 adverse-event reports in the year 2007. That is nearly 400 times as many adverse events from prescription drugs per six-month period. And this much higher number does not include over-the-counter drugs, a striking omission. Many non-prescription drugs, such as Tylenol (acetaminophen), are a long way from safe. Liver toxicity from acetaminophen poisoning is by far the most common cause of acute liver failure in the United States. Acetaminophen accounted for 51% of all acute liver failure cases in 2003. (3) Indeed, the Associated Press previously reported that common drug dangers are so bad that “Harmful reactions to some of the most widely used medicines – from insulin to a common antibiotic – sent more than 700,000 Americans to emergency rooms each year.” (4)
Vitamin supplements compete with FDA-sponsored drugs. FDA has been trying to eliminate availability of vitamin supplements for over 45 years. As early as 1962, writes constitutional attorney Jonathan W. Emord, “FDA perceived a competitive threat emerging to drug regulation from the sale of dietary ingredients at above RDA doses.” In 1966, “FDA published a rule that any dietary supplement exceeding 150% of the RDA for a vitamin or mineral would automatically be regulated as a drug.” In 1976, after a “public outcry,” the Proxmire Amendment prohibited FDA from deeming a vitamin or mineral a drug solely because of potency. “Undaunted,” continues Emord, “FDA tried yet again to rid the market of vitamins in the 1970s by claiming on a case by case basis that they were adulterated based on their potency.” FDA also tried to have supplements declared to be unapproved food additives. “FDA’s position was a logical absurdity: Single ingredient dietary supplements were food additives b! ecause the ingredients were added to a gelatin capsule which was, FDA said with a wink and a smirk, a food. . . The United States Court of Appeals for the Seventh Circuit described FDA’s position as an “Alice in Wonderland” approach.” In 1980, FDA tried to get vitamins classified as over-the-counter drugs. . . FDA has repeatedly exceeded the limits of its statutory authority to bring about changes designed to protect drug companies from competition.” (5)
Additional evidence comes directly from FDA, whose own Dietary Task Force Report, released June 15, 1993, said: “The task force considered many issues in its deliberations including to ensure that the existence of dietary supplements on the market does not act as a disincentive for drug development.” There is also this statement was made by FDA Deputy Commissioner for Policy David Adams, at the Drug Information Association Annual Meeting, July 12, 1993: “Pay careful attention to what is happening with dietary supplements in the legislative arena . . . If these efforts are successful, there could be created a class of products to compete with approved drugs. The establishment of a separate regulatory category for supplements could undercut exclusivity rights enjoyed by the holders of approved drug applications.”
FDA wants control of vitamins. Their latest ploy is to frighten the public into thinking vitamin supplements are dangerous, without proof, and without even naming the supplements they accuse. Don’t fall for what Abram Hoffer, M.D., calls “the FDA’s grand lie that, if told over and over again, is accepted as somehow true.”
Vitamin supplements are not the problem. Poor eating habits, and too many medicines, are the problem. Food supplements are a solution. They are effective, and vastly safer than drugs. The US Food and Drug Administration knows this full well.
References:
(1) Perez AJ. Dietary supplements cause 600 ‘adverse events’. USA Today, Sept 22, 2008:
http://www.usatoday.com/news/health/2008-09-22-supplements-adverse-events_N.htm
or http://www.usatoday.com/news/health/2008-09-22-supplements-adverse-events_N.htm?POE=click-refer
(2) Annual Reports of the American Association of Poison Control Centers’ National Poisoning and Exposure Database, 3201 New Mexico Avenue, Ste. 330, Washington, DC 20016. Download any report from 1983-2006 at
http://www.aapcc.org/dnn/NPDS/AnnualReports/tabid/125/Default.aspx
free of charge. The “Vitamin” category is usually near the end of the report. Summary and commentary at:
http://www.doctoryourself.com/vitsafety.html
(3) Larson AM et al Acetaminophen-induced acute liver failure: results from a United States multicenter, prospective study. Hepatology 2005;42:1364-1372. See also:
http://www.medpagetoday.com/Psychiatry/Depression/tb/2233
(4) Associated Press, Oct 17, 2006.
http://www.msnbc.msn.com/id/15305033/
(5) Emord JW. FDA violation of the rule of law. Speech from the Health Freedom Exposition in Richmond, Virginia September 23, 2006.
http://www.emord.com/events/speeches/fda_violation.htm
Nutritional Medicine is Orthomolecular Medicine
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From: http://alobar.livejournal.com/3062139.html
The following questionnaire is being sent to the Presidential and Vice-Presidential candidates of the two governing parties and also of the major Third Party Candidates, Ralph Nader (independent), former Congresswoman McKinney (Green Party), Rev. Chuck Baldwin (Constitutional Party) and former Congressman Barr (Libertarian Party). We will keep you informed of their answers… or failure to answer. You have the right to know the candidates’ positions and Natural Solutions Foundation is here to make sure they answer. Please copy and send this to the candidates of your choice.
———————-
Natural Solutions Foundation
www.HealthFreedomUSA.org
2008 Presidential Campaign Questionnaire
The Natural Solutions Foundation has several hundred thousand people who have opted in to our email list and millions more who read our information when those people forward it to them. Our constituency has serious health care concerns and we would like to share your position on each of these issues with them. The following questions are being submitted to each of the presidential and vice presidential candidates. The natural solutions foundation will compile your responses and inform our supporters and their contacts about your answers (or lack thereof) to each question. In addition, we will issue a press release announcing the results. These questions cover the four issues our supporters have told us concern them the most.
The Natural Solutions Foundation, founded in 2004, is an international NGO (non governmental organization) active and registered in several countries and is a not for profit 501(c )(3) tax exempt organization in the United States.
We are the largest health freedom organization in the world. The mission of the Foundation is to discover, develop, demonstrate and disseminate natural solutions to the problems facing us and threatening our health and freedom, achieving and maintaining a healthy self, community and world. To do this, we seek to educate the President, Congress and decision makers as well as the general public.
1. International Harmonization of Health Freedom Policy: Codex Alimentarius
a. Do you support vigorous enforcement of the anti-harmonization act, 19 USC 3512, which forbids harmonization of our health freedoms with international restrictions, such as those represented by Codex Alimentarius (the world food code) despite US leadership at Codex in violating that statute domestically and globally?
Yes [ ] no [ ]
b. Do you support the health freedom of speech principles unanimously enacted by Congress with the Dietary Supplement Health and Education Act of 1994 (DSHEA) and currently threatened by both the Codex position on health claims and the attempted FDA restriction on truthful, scientifically supported health claims and information?
Yes [ ] no [ ]
c. Do you support HR 2117, “The Health Freedom Protection Act,†introduced by Congressman Ron Paul MD, that would mandate FDA approval of dietary supplement health claims for which scientific evidence exists?
2. National Policy Regarding Labeling Genetically Modified Organisms (GMOs).
The FDA takes the position that GMO products are deemed safe without testing, following a 1992 Executive Order to that effect and therefore holds that there is no reason to required truthful GMO labeling and that “GMO Free†labels will not be allowed. According to a New York Times / CBS poll in June 2008, 87% of Americans want GMO labeling and over fifty percent do not want to buy such products.
a. As president will you tell the FDA to stop preventing truthful GMO labeling?
Yes [ ] no [ ]
b. Do you support Congressman Kuchinich’s bill, HR 6636, “The Genetically Engineered Food Right To Know Act,†That would require mandatory labeling of all foods that contain or are produced with GM material?
Yes [ ] no [ ]
3. National Policy Regarding Safety of Genetically Modified Organisms (GMOs).
The FDA takes the position that GMO products are deemed safe without testing following a 1992 executive order to that effect and is prohibited from requiring or examining any safety studies after the initial, preliminary studies by the patent holders. Independent studies in the US and elsewhere make it clear that both the short term and long term effects of GMOs may be hazardous to unborn children, babies, and adults and may have disastrous impact on fertility and health.
a. As President will you tell the FDA to require, under the Precautionary Principle, rigorous scientific evidence of GMO safety?
Yes [ ] no [ ]
b. Do you support Congressman Kuchinich’s bill, HR 6637, “The Genetically Engineered Safety Act,†would require that GE foods follow a food safety review process.
Yes [ ] no [ ]
4. National Vaccination Policy: No Forced Vaccination
We do not believe that mandating the uninsurable risk of vaccination is ever justified, that it violates constitutionally guaranteed rights and we support the broadest medical, religious and philosophical exemptions from all mandated drugging.
a. As President, will you stop all federal funding for mandated vaccinations imposed on American families and will you stop all federal funding to states which impose such forced drugging and vaccinations on the people in their jurisdiction?
Yes [ ] no [ ]
We are deeply concerned that the states have been induced by the Federal CDC to pass legislation which we believe is both ill-advised and unconstitutional which forces citizens to submit to medical procedures which they may not agree with or accept on pain of felony charges and penalties, or loss of access to government schools or other government activities.
b. As President will you refuse to implement those presidential emergency actions necessary to impose the emergency medical powers acts passed by nearly all states, which make refusing mandatory vaccination or drugging a felony act once the governor of a state has declared a pandemic to be in effect?
Yes [ ] no [ ]
5. National Policy Regarding Pandemic Flu Preparations
We are concerned that the current pandemic flu preparations may actually bring about the very pandemic we all seek to avoid.
a. Will you appoint a blue ribbon committee including at least equal numbers of physicians who oppose the use of weaponized vaccinations and anti-virals to review all current federally funded pandemic influenza research, ensuring that it does not (like the Federal anthrax program) become the source of the disease it is alleged to be established to prevent, study the serious possibility that the avian Flu is non-pathogenic in its natural form and may have been turned into a serious disease-producing virus in laboratories, and release your committee’s findings openly and transparently to the American people?
Yes [ ] no [ ]
Thank you for participating in this Candidate Questionnaire. Please send all responses, including your additional comments, to dr.laibow@gmail.com with “Candidate Questionnaire†in the subject line.
Yours in health and freedom,
Natural Solutions Foundation Trustees
Maj. Gen. Bert Stubblebine (USA, ret)
Rima E. Laibow, MD
Ralph Fucetola JD
There is good news making its way slowly, slowly into the medical world: little by little allopathic medicine is finally noticing how effective nutrients are in diseases and clinical conditions. Too slowly for most of us, but, still, there are creeping changes.
Instead of antibiotics, for example, pediatricians have noticed that pediatric diarrhea responds to zinc. Why? Because immune systems need zinc to do their job. So give the child zinc and it can fix the problem by itself without dangerous, expensive drugs. Well, well!
And even better, infection yields to silver. Well, of course it does. Burn centers have know that for decades and so has every natural doctor and naturopath for the last how many decades? But the derision and scorn heaped on us when we tried to talk about these and a thousand other ways of treating people when they come to us for cheap, simple, effective and safe means of getting well or staying that way is profound.
It is, however, the derision and anger born of fear.
Laibow’s First Law of Human Psychology is “Anger Drives Out Fear, Or At Least It’s Supposed To!” And conventional medicine is very, very afraid of the natural competitors to its expensive, dangerous and very limited drugs.
Oh, yes, one more thing: Codex Alimentarius makes the international trade of supplements very difficult since supplements may only be sold at doses so low that they have no clinical impact. Codex copmpliance in Europe through the European Food Supplements Directive is, in fact, stripping the shelves of stores of the nutrients previously avaialbe which might have allowed people to use the information in this article. Just ask any one you know, for example, in the UK, what is happening to their supplements: they are vanishing like the morning mist. Poof! Just like that.
If you don’t want the same thing to happen to you, it is imperative that you take action now, join the Natural Solutions Foundation’s distribution list for the free and secure Health Freedom eAlerts and take the action steps therein. I can assure you that legislators are not going to protect your health freedom without an effective outcry from us, the consumers who make our own choices about our own health paths.
Yours in health and freedom,
Dr. Rima
Rima E. Laibow, MD
Medical Director
Natural Solutions Foundation
www.HealthFreedomUSA.org
www.GlobalHealthFreedom.org
www.NaturalSolutionsFoundation.org
www.Organics4U.org
www.NaturalSolutionsMedia.tv
www.NaturalSolutionsMarketPlace.org
Changes in Folate and Homocysteine Linked to Incident Dementia
http://www.medscape.com/viewarticle/579216?sssdmh=dm1.378114&src=nldne
NEW YORK (Reuters Health) Aug 18 – Onset of dementia is associated with decreasing folate and increasing vitamin B12 and homocysteine, results of a study published in the August issue of the Journal of Neurology, Neurosurgery, and Psychiatry indicate.
“Several cross-sectional studies have found significant associations of lower folate and hyperhomocysteinemia with dementia or cognitive impairment, but the direction of cause and effect is not known,” Dr. Jin-Sang Yoon, of University Medical School, Kwangiu, Republic of Korea, and colleagues write. “Results from prospective studies have been controversial.”
In their study, the researchers examined both baseline levels and changes in folate, vitamin B12, and homocysteine as predictors of incident dementia in 625 elderly patients free of dementia at baseline; 518 (83%) were followed over 2.4 years.
Incident dementia occurred in 45 of the 518 (8.7%). The only baseline factor that predicted incident dementia was lower folate concentrations
However, “The onset of dementia was significantly associated with an exaggerated decline in folate, a weaker increase in vitamin B12 concentrations and an exaggerated increase in homocysteine concentrations over the follow-up period,” the team reports.
After adjustment for weight change, these associations were reduced.
“Further research is required to clarify these complex longitudinal interrelationships,” Dr. Yoon and colleagues conclude. “In the meantime, attention needs to be paid to the nutritional status of people with dementia from the time of diagnosis onwards, regardless of whether this is a cause or effect of their condition.”
J Neurol Neurosurg Psychiatry 2008;79:864-868.Silver-Coated Endotracheal Tube Reduces Risk for Ventilator-Associated Pneumonia CME
News Author: Laurie Barclay, MD
CME Author: Penny Murata, MD
Disclosures
Release Date: August 19, 2008; Valid for credit through August 19, 2009
Credits Available
Physicians – maximum of 0.25 AMA PRA Category 1 Credit(s)â„¢ for physicians;
Family Physicians – up to 0.25 AAFP Prescribed credit(s) for physicians
To participate in this internet activity: (1) review the target audience, learning objectives, and author disclosures; (2) study the education content; (3) take the post-test and/or complete the evaluation; (4) view/print certificate View details.
Learning Objectives
Upon completion of this activity, participants will be able to:
1. Compare the incidence of ventilator-associated pneumonia in patients intubated for at least 24 hours with a silver-coated endotracheal tube vs an uncoated endotracheal tube.
2. Report whether use of a silver-coated endotracheal tube affects duration of intubation, length of stay in the intensive care unit or hospital, mortality rates, and adverse events.
Authors and Disclosures
Laurie Barclay, MD
Disclosure: Laurie Barclay, MD, has disclosed no relevant financial relationships.
Penny Murata, MD
Disclosure: Penny Murata, MD, has disclosed no relevant financial relationships.
Brande Nicole Martin
Disclosure: Brande Nicole Martin has disclosed no relevant financial information.
August 19, 2008 — Use of a silver-coated endotracheal tube significantly reduces the incidence of microbiologically confirmed ventilator-associated pneumonia (VAP), according to the results of a large, randomized, multicenter study reported in the August 20 issue of the Journal of the American Medical Association.
“VAP causes substantial morbidity,” write Marin H. Kollef, MD, from the Washington University School of Medicine in St. Louis, Missouri, and colleagues from the North American Silver-Coated Endotracheal Tube Investigation Group. “A silver-coated endotracheal tube has been designed to reduce VAP incidence by preventing bacterial colonization and biofilm formation.”
The goal of this prospective, single-blind study conducted in 54 centers in North America was to evaluate whether use of a silver-coated endotracheal tube would reduce the incidence of microbiologically confirmed VAP.
Of 9417 adult patients aged 18 years or older who were screened between 2002 and 2006, a total of 2003 patients who were expected to need mechanical ventilation for at least 24 hours were randomly assigned to undergo intubation with 1 of 2 high-volume, low-pressure endotracheal tubes. These tubes were similar except that the experimental tube had a silver coating.
The main endpoint was incidence of VAP, diagnosed from quantitative bronchoalveolar lavage fluid culture with at least 104 colony-forming units/mL in patients intubated for at least 24 hours. Secondary endpoints were VAP incidence in all intubated patients, time to VAP onset, length of intubation and duration of intensive care unit and hospital stay, mortality rates, and adverse events.
Rates of microbiologically confirmed VAP in patients intubated for at least 24 hours were 4.8% (37/766 patients; 95% confidence interval [CI], 3.4% – 6.6%) in the group receiving the silver-coated tube and 7.5% (56/743; 95% CI, 5.7% – 9.7%; P = .03) in the group receiving the uncoated tube (relative risk reduction, 35.9%; 95% CI, 3.6% – 69.0%).
Rates of microbiologically confirmed VAP in all intubated patients were 3.8% (37/968; 95% CI, 2.7% – 5.2%) in the experimental group and 5.8% (56/964; 95% CI, 4.4% – 7.5%; P = .04) in the control group (relative risk reduction, 34.2%; 95% CI, 1.2% – 67.9%).
Use of the silver-coated endotracheal tube was associated with delayed occurrence of VAP (P = .005), but there were no statistically significant between-group differences in durations of intubation, intensive care unit stay, and hospital stay. Mortality rates and frequency and severity of adverse events were also similar in both groups.
“Patients receiving a silver-coated endotracheal tube had a statistically significant reduction in the incidence of VAP and delayed time to VAP occurrence compared with those receiving a similar, uncoated tube,” the study authors write. “The silver-coated endotracheal tube appears to offer a unique approach because it is the first intervention that becomes user-independent after intubation, requiring no further action by the clinician.”
Limitations of this study include single blinding rather than double blinding; use of a small, fixed block size stratified by center; other factors possibly contributing to between-group differences in VAP rates; study protocol not standardizing prevention strategies; and a protective effect of higher severity-of-illness scores against development of VAP.
In an accompanying editorial, Jean Chastre, MD, from Institut de Cardiologie, Groupe Hospitalier Pitié-Salpê trière in Paris, France, discusses the study limitations.
“Important uncertainties exist regarding the exact benefit of silver-coated endotracheal tubes,” Dr. Chastre writes. “Consequently, silver coated tubes should not be viewed as the definitive answer for VAP prevention, and, until additional data confirm the clinical effectiveness and cost benefit of these devices, their use should be restricted to high-risk patients treated in ICUs [intensive care units] with benchmark value-based infection rates that remain above institutional goals despite implementation of a comprehensive strategy of usual preventive measures to prevent VAP.”
CR Bard Inc supported this study and provided grant support to all of the study authors. Some of the study authors have disclosed various financial relationships with Kimberly Clark, Elan, Merck, Pfizer, Bayer, GlaxoSmithKline, Boehringer Ingelheim, KCI, sanofi-aventis, Johnson & Johnson, Easi, Hospira, Nomir Medical Technologies, Arpida, Cubist, Elan, Ortho-McNeil, Sanofi Pasteur, Wyeth, Bayer-Nektar, Nestle Clinical Nutrition, Lilly, Corbett Accel Healthcare, National Institutes of Health, Novartis, and/or Maquet. Dr. Chastre has received consulting and lecture fees from Pfizer, Brahms, Wyeth, Johnson & Johnson, Bayer-Nektar, and Arpida.
JAMA. 2008.300:805-813, 842-844.
Clinical Context
Rello and colleagues reported in the December 2002 issue of Chest that VAP is linked with increased morbidity rates and generally occurs in the first 10 days after endotracheal intubation. Probable causes of VAP include colonization with pathogenic bacteria and aspiration, as noted by Kollef in the June 2005 issue of Respiratory Care. In the November 2006 issue of Critical Care Medicine, Rello and colleagues found that a silver-coated endotracheal tube decreased bacterial colonization of the airway. The silver ions in a polymer on the inner and outer lumen migrate to the surface of the tube to potentially reduce bacterial adhesion, impede biofilm formation, and promote antimicrobial activity.
This prospective, randomized, controlled, multicenter, single-blind study assesses the efficacy of a silver-coated endotracheal tube in reducing the incidence of VAP in patients needing mechanical ventilation for at least 24 hours.
Study Highlights
* 2003 adults aged at least 18 years and expected to need at least 24 hours of mechanical ventilation were randomly assigned to use of a silver-coated endotracheal tube vs an uncoated endotracheal tube.
* Exclusion criteria were enrollment in a conflicting study, bronchiectasis, severe hemoptysis, cystic fibrosis, pregnancy, silver sensitivity, and more than 12 hours of endotracheal intubation in the previous 30 days.
* 1932 subjects were intubated: 968 in the silver-coated tube group and 964 in the uncoated tube group.
* 1509 subjects were intubated for at least 24 hours: 766 in the silver-coated tube group and 743 in the uncoated tube group.
* Baseline characteristics for both groups were similar for age (mean age, 60.9 – 62.2 years; range, 18 – 102 years), sex, Acute Physiology and Chronic Health Evaluation II score, immunocompetency, enteral nutrition use, and endotracheal tube size.
* Both groups had similar VAP risk factors, except chronic obstructive pulmonary disease was less common in the silver-coated tube group vs the uncoated tube group (24-hour intubation subjects, 11.6% vs 16.4%; P = .007; all intubated subjects, 9.2% vs 12.7%; P = .02).
* The primary outcome measure was VAP incidence, defined by at least 104 colony-forming units/mL in bronchoalveolar lavage fluid culture, in patients intubated for at least 24 hours.
* VAP incidence in patients intubated for at least 24 hours was lower in the silver-coated tube group vs the uncoated tube group (4.8% [37/766 patients] vs 7.5% [56/743 patients]; P = .03; relative risk reduction, 35.9%).
* VAP incidence in all intubated patients was lower in the silver-coated tube group vs the uncoated tube group (3.8% vs 5.8%; P = .04; relative risk reduction, 34.2%).
* Bronchoalveolar lavage fluid culture was also obtained in those with suspected VAP or with new radiographic infiltrate and at least 2 qualifying signs (fever or hypothermia, leukocytosis or leukopenia, or purulent tracheal aspirate).
* Of 220 patients who underwent bronchoalveolar lavage for suspected VAP, the most common pathogens for the silver-coated tube group vs the uncoated tube group were Staphylococcus aureus (9 vs 16), Pseudomonas aeruginosa (8 vs 11), Enterobacteriaceae (10 vs 5), and polymicrobial infections (7 vs 13).
* VAP incidence within 10 days of intubation in patients intubated for at least 24 hours was less common in the silver-coated tube group (relative risk reduction, 47.6%; 95% CI, 14.6% – 81.9%; P = .005).
* Delayed occurrence of VAP was linked to silver-coated tube use (P = .005).
* There was no difference between groups in median duration of intubation, intensive care unit stay, hospital stay, and mortality rates.
* Regression analysis showed that silver-coated tube use was associated with decreased risk for VAP at any time, VAP within 10 days of intubation, and delayed time to occurrence.
* Adverse events occurred with similar frequency and severity for both groups.
* 59 endotracheal tube–related adverse events occurred: 21 in the silver-coated tube group vs 38 in the uncoated tube group.
* 74 intubation procedure–related adverse events occurred: 39 in the silver-coated tube group vs 35 in the uncoated tube group.
* Post hoc analysis showed that VAP in patients intubated for at least 24 hours was linked with longer duration of intubation and longer length of stay in the intensive care unit or hospital but not with mortality rate.
* Limitations of the study included lower than expected VAP incidence in the uncoated tube group, more subjects with chronic obstructive pulmonary disease in the uncoated tube group, and lack of blinding of investigators.
Pearls for Practice
* The incidence of VAP in patients intubated for at least 24 hours is reduced and delayed with use of a silver-coated endotracheal tube vs an uncoated endotracheal tube.
* Use of a silver-coated endotracheal tube does not affect duration of intubation, length of stay in the intensive care unit or hospital, mortality rates, or adverse events.
http://www.medscape.com/viewarticle/579239?sssdmh=dm1.378114&src=nldne
Oral zinc for treating diarrhoea in children.
Cochrane Database Syst Rev. 2008; (3):CD005436 (ISSN: 1469-493X)
Lazzerini M; Ronfani L
Unit of Research on Health Services and International Health, WHO Collaborating Centre for Maternal and Child Health, Via dei Burlo 1,34123, Trieste, Italy.
BACKGROUND: Diarrhoea causes around two million child deaths annually. Zinc supplementation could help reduce the duration and severity of diarrhoea, and is recommended by the World Health Organization and UNICEF. OBJECTIVES: To evaluate oral zinc supplementation for treating children with acute or persistent diarrhoea. SEARCH STRATEGY: In November 2007, we searched the Cochrane Infectious Diseases Group Specialized Register, CENTRAL (The Cochrane Library 2007, Issue 4), MEDLINE, EMBASE, LILACS, CINAHL, mRCT, and reference lists. We also contacted researchers. SELECTION CRITERIA: Randomized controlled trials comparing oral zinc supplementation (>/= 5 mg/day for any duration) with placebo in children aged one month to five years with acute or persistent diarrhoea, including dysentery. DATA COLLECTION AND ANALYSIS: Both authors assessed trial eligibility and methodological quality, extracted and analysed data, and drafted the review. Diarrhoea duration and severity were the primary outcomes. We summarized dichotomous outcomes using risk ratios (RR) and continuous outcomes using mean differences (MD) with 95% confidence intervals (CI). Where appropriate, we combined data in meta-analyses (using the fixed- or random-effects model) and assessed heterogeneity. MAIN RESULTS: Eighteen trials enrolling 6165 participants met our inclusion criteria. In acute diarrhoea, zinc resulted in a shorter diarrhoea duration (MD -12.27 h, 95% CI -23.02 to -1.52 h; 2741 children, 9 trials), and less diarrhoea at day three (RR 0.69, 95% CI 0.59 to 0.81; 1073 children, 2 trials), day five (RR 0.55, 95% CI 0.32 to 0.95; 346 children, 2 trials), and day seven (RR 0.71, 95% CI 0.52 to 0.98; 4087 children, 7 trials). The four trials (1458 children) that reported on diarrhoea severity used different units and time points, and the effect of zinc was less clear. Subgroup analyses by age (trials with only children aged less than six months) showed no benefit with zinc. Subgroup analyses by nutritional status, geographical region, background zinc deficiency, zinc type, and study setting did not affect the results’ significance. Zinc also reduced the duration of persistent diarrhoea (MD -15.84 h, 95% CI -25.43 to -6.24 h; 529 children, 5 trials). Few trials reported on severity, and results were inconsistent. No trial reported serious adverse events, but vomiting was more common in zinc-treated children with acute diarrhoea (RR 1.71, 95% 1.27 to 2.30; 4727 children, 8 trials). AUTHORS’ CONCLUSIONS: In areas where diarrhoea is an important cause of child mortality, research evidence shows zinc is clearly of benefit in children aged six months or more.
Subject Headings
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* PreMedline Identifier: 18646129
The following is an announcement by the manufacturers and marketers of Poly-MVA, a dietary supplement which many have found to be useful for people diagnosed with cancer. We post it here as a public service.
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Rima E. Laibow, MD
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Poly-MVA — The First Dietary Supplement to be Cleared by the FDA for Use in a Cancer Study
CancerAssistanceCenter.org announces the immediate availability of free information packets for cancer patients and physicians regarding Poly-MVA, a dietary supplement that has been shown to be very effective in clinical studies conducted by a renowned board-certified oncologist, Dr. James Forsythe. When Poly-MVA (Palladium Lipoic Complex) was administered to terminally ill (Stage 4) cancer patients as an adjunct to the therapy they received during the 2005-2008 clinical studies completed by Dr. Forsythe, the Overall Survival Rate was 71% in the Poly-MVA group, an extraordinary result in view of the fact that less than 10% of those patients would have been expected to survive 2 years if they had continued to receive conventional therapy alone.
(PRWEB) June 14, 2008 — CancerAssistanceCenter.org announces the immediate availability of free Cancer Information packets for cancer patients and physicians regarding Poly-MVA, a dietary supplement that has been shown to be very effective in clinical studies conducted by a renowned board-certified oncologist, Dr. James Forsythe. When Poly-MVA (Palladium Lipoic Complex) was administered to terminally ill (Stage 4) cancer patients as an adjunct to the therapy they received during the 2005-2008 clinical studies completed by Dr. Forsythe, the Overall Survival Rate was 71% in the Poly-MVA group, an extraordinary result in view of the fact that less than 10% of those patients would have been expected to survive 2 years if they had continued to receive conventional therapy alone.
Dr. Forsythe’s work was compelling and significant enough to convince the FDA to approve, for the first time in history, a cancer-related IND study (Investigational New Drug study) utilizing a dietary supplement. This FDA approved study has been designed to further validate the benefits of Poly-MVA for cancer patients. View Dr. Forsythe’s Research on Poly-MVA here Cancer Research
Poly-MVA was invented by Dr. Merrill Garnett, a biochemist. It is a dietary supplement based on the nontoxic lipoic acid-palladium complex (LAPd). LAPd is a liquid crystal that works in cancer cells by transferring excess electrons from membrane fatty acids to DNA via the mitochondria. It appears to be a safe and effective dietary supplement for cancer patients when used with or without conventional chemotherapy. Its safety profile is excellent and there were no treatment related deaths, significant adverse reactions or negative interactions with chemotherapy or hormonal treatments. The best responding tumors in Dr. Forsythe’s studies were prostate cancer, breast cancer and lung cancer. Some of the remissions in Dr. Forsythe’s studies involved brain cancer patients who had tried and failed conventional cancer treatment protocols. In addition to the remissions reported by Dr. Forsythe, there are other cancer remission case reports written by the patients themselves that can be found on the Foundation for Advancement in Cancer Research Web site: Cancer Survivors
Is Poly-MVA the long waited solution for terminally ill cancer patients? Let’s compare the facts. According to a report from the Journal of Clinical Oncology (2004) 16:549-560, the 5-Year Overall Survival Rate for Stage 4 cancer patients receiving chemotherapy treatments was 2.1%. In the clinical study conducted by Dr. Forsythe, 71% of the cancer patients in the Poly-MVA group were still alive and enjoying a good quality of life after 2 years. Additional articles on can be seen at: Cancer Articles
”Will (the FDA) eventually re-categorize Poly-MVA as a drug? Quite possibly,” said Dr. Frank Antonawich, Senior Scientist at Garnett McKeen Laboratory and Biology Dept. Chairman at St. Joseph’s College in Patchogue, New York. “We’ve received an investigational new drug application from the FDA, and we’re in the process of running tests…who knows, maybe in the future every physician will prescribe Poly-MVA as part of their patient’s chemo and radiation package. That would be phenomenal too.” — St. Josephs College Magazine, February 2008, Vol. 6 No. 1 (Cancer Research)
Dr. Albert Sanchez, Founder of the Foundation for Advancement in Cancer Research, has been working with Poly-MVA ever since the supplement was first introduced 13 years ago. ”When Dr. Forsythe began his now famous clinical studies utilizing Poly-MVA for Stage 4 cancer patients who had failed conventional treatment, we had already been documenting one remission after another during the previous 9 years as one cancer patient after another realized the benefits of taking this extraordinary dietary supplement,” said Dr. Sanchez. ”But we needed to move beyond purely anecdotal evidence in order to have a scientifically valid basis for bringing this news to the world. We now have that validation and I consider it my duty to shout the news from every mountain top.”
While there are many questions waiting for answers and additional studies to be completed, life cannot be put on hold. For further information about the science supporting the use of Poly-MVA by cancer patients, please contact:
Dr. Albert Sanchez, Founder
Foundation for Advancement in Cancer Research
http://www.facr.org
Phone: 1-866 991-9942 (8 AM – 4 PM Pacific Time)
Email: DrAlbertSanchez@msn.com
or
Rick Shalvoy, Founder
Row for a Cure Foundation
http://www.CancerAssistanceCenter.org/
Phone: 1-800-ROW CURE
Phone: 1-800-769-2873
Email: RickShalvoy@gmail.com
Further information can also be found on the following Web site:
http://www.PolyMVAHealthClub.com/