Shannon Brownlee
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 One in seven adverse events tallied in the study involved an infection acquired in the hospital. More than half of the adverse events were due to mistakes the reviewers deemed were preventable. In one out of three of these errors, there was actual negligence—a surgeon cut off the wrong limb or left a retractor inside a patient's abdomen by mistake, for instance, a pharmacist provided an incorrect dose, or an emergency room doctor misdiagnosed a serious condition. |
Mike Adams, the Health Ranger
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 That law authorizes a new program so that reports of serious adverse events related to the use of a dietary supplement or over-the-counter drug would be reported to the Food and Drug Administration, FDA, on a priority basis.
As I said, the Durbin amendment contemplates a new adulterated food registry. Under the provisions establishing that registry, reports of adulterated foods would be made by many, if not all, of the same parties who are required to file reports of serious adverse events associated with the use of dietary supplements under Public Law 109-462. |
Shannon Brownlee
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| More than half of the adverse events were due to mistakes the reviewers deemed were preventable. In one out of three of these errors, there was actual negligence—a surgeon cut off the wrong limb or left a retractor inside a patient's abdomen by mistake, for instance, a pharmacist provided an incorrect dose, or an emergency room doctor misdiagnosed a serious condition. Some critics of the two large studies that formed the basis for the Institute of Medicine's report argue that the number of adverse events may be inflated. |
Ann M. Coulston and Carol J. Boushey
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 Higher doses do not have any additional efficacy in weight loss and may result in more adverse events [105]. Orlistat is minimally absorbed; therefore, any systemic adverse events would be expected to be negligible. Orlistat should be used with a diet that is less than 30% energy from fat to prevent adverse side effects that include oily stools, oily spotting, flatus with discharge, fecal urgency, and fecal incontinence [105]. These events are due to the drug inhibiting fat absorption rather than a direct effect of the drug itself. |
Charles Barber
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 John Curtis, a psychologist and expert on the neurobiology of resilience (which he defines as good adaptation in the face of adverse events) at the University of Rochester, explained to me what might have transpired in Rex's brain. "There's no doubt that there were chemical and structural changes that occurred in Rex's brain as a result of the some of the positive things that he was exposed to when he got off crack and into treatment. The chemical changes were introduced by the Haldol, which clearly worked beautifully for him. |
Dr. Arthur Janov
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 Lower level painful feelings cause the higher level production of ideas and beliefs, just as in the evolution of mankind adverse events helped to produce a frontal cortex that could eventually develop ideas to flee from internal danger. This is based on the assumption that ontogeny (our personal evolution) recapitulates phylog-eny (the evolution of the species). With the development of the prefrontal area, we could at last flee from internal danger, which, in animal life, we could not. |
Thomson Healthcare, Inc.
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 WS 1490 was well-tolerated and produced no drug-related adverse events or post-study withdrawal symptoms. The special kava extract was found to be effective and safe in the treatment of non-psychotic anxiety syndromes in a daily dose of 150 mg (Geier & Konstantinowicz, 2004).
Six-week treatment with Kava reduced insomnia in subjects with stress-induced insomnia (23 to 65 years) in an open-label, uncontrolled clinical trial. Subjects (n=24) received 120 mg of oral Kava daily for 6 weeks. |
| Consumers and healthcare providers are requested to report any adverse events associated with Kava use to the FDA's MedWatch program (FDA, 2003).
Kava has also been reported to cause mild and reversible gastrointestinal complaints, central nervous system complaints, including dizziness and headache, and various hyper-sensitivity/dermatological reactions. Pupil dilatation, near-vision abnormalities, and eye movement coordination abnormalities have been reported. |
| Under the final rule, manufacturers are required to substantiate the identity, purity, quality, strength, and composition of dietary supplements, and, further, to report all serious dietary supplement adverse events to the FDA.
The compilation of monographs in this book should not be construed as a claim or warranty of their efficacy for any purpose. Furthermore, it should be understood that, just as omission of a product does not signify rejection, inclusion of a product does not imply endorsement, and that the publisher is not advocating the use of any product or substance described herein. |
Shannon Brownlee
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| If I as a family doctor gave Vioxx instead of naproxen to a hundred patients, there would be two and a half extra serious adverse events in the following year—serious as in hospitalization, permanent disability, or death—and I would have caused them." Abramson had already been sifting through other papers in the journals and finding similar problems—papers presenting results of drug research that glossed over risks or accentuated benefits. But the most unnerving discovery of all was the Vioxx research. |
| Estimates for the number of patients injured or killed by adverse events involving a drug range between ninety thousand and four hundred thousand. The Institute of Medicine calculated that drug errors alone add on average nearly $5,000 to the cost of every hospital admission, or about $2.8 million annually for a seven hundred-bed teaching hospital.
Why are so many errors committed? To much of the public, medical error seems to be a problem primarily of bad doctoring. We think physicians and nurses who make mistakes are either incompetent or uncaring, or some lethal combination of both. |
| Some critics of the two large studies that formed the basis for the Institute of Medicine's report argue that the number of adverse events may be inflated. Yet even using the institute's lower, more-conservative estimate makes preventable hospital error the eighth leading cause of death annually, ahead of motor vehicle accidents (43,458), breast cancer (42,297), and AIDS (16,516).
Drug errors are the most common mistakes of all, and on average at least one occurs for every patient admitted to the hospital. |
Craig Pepin-Donat
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 This system allows health professionals and the general public to voluntarily report adverse events associated with medical products that fall under FDA jurisdiction. It is worth repeating: The FDA does not pull the majority of drugs off the market; it is the manufacturers of the drug that voluntarily do so under extreme duress from the FDA via the medical community and the public. |
Jonny Bowden, Ph.D., C.N.S.
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 The rate of adverse events with the hypericum extract was in the range of the placebo group but lower than that of the (drug) group," researchers noted.
A Rich Cast of Plant Chemicals
There are many active ingredients in St. John's Wort, but for a long time the one believed to be responsible for the herb's antidepressant action was hypericum. But the plant actually contains dozens of active components (including chloro-genic acid, flavonoids, and xanthones). More recently, researchers have focused on hyperforin, another active ingredient in St. John's Wort. |
Shannon Brownlee
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| Yet as Fisher's research suggests, involving another specialist leads to more procedures and tests—and the more procedures and tests, along with more days in the hospital, the greater the opportunity for complications and for latent errors to pile up into catastrophic adverse events.
At first, the idea that more specialists can make for worse medical care seems thoroughly wrongheaded. After all, isn't the specialist the doctor with the most knowledge about a given condition and therefore the one person most able to help us get better? Well, yes and no. |
Thomson Healthcare, Inc.
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| Awareness of these interactions helps minimize adverse events and facilitates appropriate clinical management. (For this reason, individuals are advised to inform their healthcare professionals about all medicines and supplements they use, especially before surgery.) This section provides herb-drug interactions and clinical management guidance from the Thomson Micromedex database. Further, drug interactions are evaluated as to their likelihood of occurrence and categorized by risk level—Major Risk, Moderate Risk, Minor Risk, and Potential Interactions. |
Too Profitable to CureBrent Hoadley, Ph.D.
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| An earlier chapter shows that 90-99% of adverse events go unreported.) Reporting is time-consuming, requiring not only paperwork, but a responsibility for follow-ups. And reporting is voluntary!
Pseudo-science
The suspects in our mystery also consider reported numbers as nothing more than anecdotal events. Victims are not smart enough to know what is happening to them. Anecdotal events are considered by "experts" to be the mistaken facts reported by a hysterical victim or a close third-party. |
Mike Adams, the Health Ranger
See article keywords and concepts |
| Under the provisions establishing that registry, reports of adulterated foods would be made by many, if not all, of the same parties who are required to file reports of serious adverse events associated with the use of dietary supplements under Public Law 109-462. And so passage of the Durbin amendment could be seen to supersede the law we enacted last year for supplements, which I am relieved to hear was not the intent of our colleague, Senator Durbin. |
Mike Adams, the Health Ranger
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| Furthermore, these biologic drugs will be far more powerful because they throw gene switches in cells -- meaning the risk for adverse events skyrockets. Initially, just patients with no other medical hope will be the guinea pigs. The FDA wants to run this technology in all doctor's offices around the country -- which will require your DNA in an FDA-owned government database. This is not science fiction -- this is what the FDA is on public record as wanting to do.
Keep Taking Action -- Revised sample letter
Anti S. |
Bottom Line Health
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| These figures are from the FDA's adverse events reporting database, which has tracked patient reports of medication-associated sleepwalking since 1997. Based on those numbers, Arand says she believes, "Overall, the medications that are available are safe for almost everyone."
Michael H. Silber, codirector of the Mayo Clinic's Sleep Disorders Center, and president of the AASM, who has studied the phenomenon of Ambien-linked binge sleep-eating, says, "There's little doubt in my mind or those of my colleagues that Ambien can do this. |
Too Profitable to CureBrent Hoadley, Ph.D.
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| When a drug manufacturer covers up the flaws in a drug and submits to government information that is artfully skewed to diminish the flaws; when the FDA — that arm of the government meant to afford protection to the citizenry against unscrupulous behavior and dangerous drugs — refuses to give credence to the outcry of adverse events being reported to them; and when the politicians and reporters fail to do their jobs, whether from ignorance, self-aggrandizement, or ennui, what is left of the government of the people, by the people, and for the people? |
Fred A. Baughman, Jr., M.D. and Craig Hovey
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 That is an incredible estimate, only 1 % of the serious adverse events. Think of it, the 186 deaths due to methylphenidate/Ritalin 1990-2000, just 1% of the actual number! But wait, much worse is in store.
During the same 1990-2000 time period the Food and Drug Administration received 2,500 reports of death resulting from Prozac, out of 46,000 total reports of adverse events for the drug. Remember that 1% estimate from Kessler of the FDA above? Remember how Prozac is being touted as the one safe and effective antidepressant for kids? |
Kelly Patricia O'Meara
See book keywords and concepts |
 Government Accountability Office (GAO) is correct and only 1 percent to 10 percent of the actual adverse events are reported and "are unlikely to be representative of the much larger number of unreported events," then the numbers of adverse events associated with Prozac should be substantially higher."
But is it really necessary to continue to calculate the ever-increasing number of adverse drug events associated with Prozac or any of the SSRI/SNRI antidepressants? After all, how many adverse reports of suicides and attempted suicides does it take to get the FDA's attention? |
Fred A. Baughman, Jr., M.D. and Craig Hovey
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| Now consider them again in light of the following statement made by David Kessler in 1992, when he was commissioner of the Food and Drug Administration: "Although the FDA receives many adverse event reports, these probably represent only a fraction of the serious adverse events encountered by providers. Only about one percent of the serious events are reported to the FDA." That is an incredible estimate, only 1 % of the serious adverse events. Think of it, the 186 deaths due to methylphenidate/Ritalin 1990-2000, just 1% of the actual number! But wait, much worse is in store. |
Kelly Patricia O'Meara
See book keywords and concepts |
| Government Accountability Office (GAO) is correct and only 1 percent to 10 percent of the actual adverse events are reported and "are unlikely to be representative of the much larger number of unreported events," then the numbers of adverse events associated with Prozac should be substantially higher."
But is it really necessary to continue to calculate the ever-increasing number of adverse drug events associated with Prozac or any of the SSRI/SNRI antidepressants? After all, how many adverse reports of suicides and attempted suicides does it take to get the FDA's attention? |
Too Profitable to CureBrent Hoadley, Ph.D.
See book keywords and concepts |
| Because our reporting system for adverse events is so poor and based on voluntary reports of clinical occurrences, the sudden rise in Type 2 diabetic deaths due to liver failure went unheralded. Between mid-1997 and its withdrawal from the U.S. marketplace in 2000, 63 deaths attributed to this drug were confirmed.4
Rezulin received FDA approval in a field already crowded with drugs. It offered no real improvement for most Type 2 diabetics over drugs already on the market. |
| An independent, online reporting system for adverse events would identify problem drugs quickly. Results would be immediately available to doctors and pharmacists. With no affiliation to any pharmaceutical company, this system would prevent the hiding — sometimes for very long periods —of dangerous events being experienced by drug consumers.
Good Corporate Citizenship
Pharmaceuticals, the most profitable corporate industry in America, continually point to their "good citizenship" practices. |
Tori Hudson, N.D.
See book keywords and concepts |
 Reports and human clinical trials including more than 2,800 patients demonstrate the low incidence of adverse events associated with black cohosh. The World Health Organization (WHO) Collaborating Center for International Drug Monitoring database of adverse reactions to pharmaceutical and herbal products revealed a total of 35 adverse reactions to black cohosh as of July 31, 2000. The reactions were primarily general and temporary symptoms and were not concentrated on a particular organ system. |
| A recent review of research found that the most frequent adverse events reported were headache, gastrointestinal disturbances, menstrual disorders, acne, itching, and rash, and no known drug interactions were reported.77
Chaste Tree (Vitex Agnus Castus)
40 drops liquid or extract per day or
Capsules of standardized extract: 175 mg per day
Ginkgo (Ginkgo Biloba). We don't normally think of ginkgo for PMS. But when you consider that some PMS symptoms have to do with congestion, it makes sense that it might be useful. |
Too Profitable to CureBrent Hoadley, Ph.D.
See book keywords and concepts |
| Again, without insulin being treated as a biotech drug, without batch testing, without independent labs for analysis/ research, and even more importantly, with no accurate reporting results for adverse events, corporate dollars increase regardless of product efficacy.
The truth be known, no one knows what is in a bottle of rDNA insulin because the GBATT crew know their cronies in other high places do not care. The health care professionals who administer the products "trust" the FDA, and we all know the FDA does no research of a qualitative or quantitative nature. |
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