Melody Petersen
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 As soon as the fda approved OxyContin in 1995, executives ordered the company's battalion of sales reps to sell the drug to doctors for everything from back pain to arthritis, conditions that could be readily treated with a myriad of nonnarcotic pain relievers that did not come with the serious risk of addiction.
Purdue's own confidential documents explain that a key goal of executives was to set consumers straight on the "myths and misconceptions about addiction. |
Brenda Watson and Leonard Smith
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 For example, in August 2003, the fda approved a statin drug called Crestor (rosuvastatin calcium). But because high amounts of it can cause muscle destruction that may lead to kidney damage (and failure), it can be prescribed only in small doses and requires doctors to monitor a patient's muscle enzymes and kidney and liver functions every three months. (For more about toxins and pharmaceutical drugs, see Appendix C.)
A connection has also been found between exposure to cadmium and lead and an increase in cholesterol levels. |
Ann M. Coulston and Carol J. Boushey
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 Orlistat
The fda approved the use of orlistat for the long-term treatment of obesity in 1999. Orlistat is a minimally absorbable agent (<1%) that works in the gastrointestinal tract by blocking gastrointestinal lipases and reducing the subsequent absorption of ingested fat by approximately 30% [99]. Orlistat has been studied in 1- and 2-year clinical trials [100-102]. In general, the orlistat-treated groups lost more weight and had a higher percentage of subjects able to achieve a 10% weight loss than subjects in the placebo-treated group [103]. |
J. Douglas Bremner
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 For example, in May 2007 the fda approved the first pill, called Lybrel, that if taken daily halts women's menstrual periods indefinitely and prevents pregnancies. Because so many women use oral contraceptives, it is especially important to consider the side effects and consequences. What on the surface looks like an easy choice (to take "the pill") may not be for all women. |
| It is not clear why the fda approved these drugs. Potassium-sparing diuretics also increase risk of heat stroke. For all these reasons they should be avoided.
BETA-BLOCKERS
Again, beta-blockers, the second type of hypertension drug, act by making your heart beat less hard. Common beta-blocker medications are metopro-lol (Toprol XL, Lopressor), atenolol (Tenormin), carvedilol (Coreg), biso-prolol (Zebeta), and propanolol (Inderal). Specifically, they work by blocking the noradrenergic beta-1 receptor in the heart, which is responsible for making the heart pump. |
by Michael Murray, N.D. and Joseph Pizzorno, N.D.
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| In 1983, the fda approved irradiation of spices and seasonings, and in 1985, it approved irradiation to prevent trichinosis in pork. The following year, approval was extended to fruits and vegetables. In 1990, the fda approved irradiation of poultry to prevent Salmonella and other foodborne bacterial pathogens. And in December 1997, the agency approved its use for red meat to kill E. coli. Next on the list of foods approved for irradiation may be fish and shellfish, to kill Salmonella, Vibrio (the organism that causes cholera), and other bacteria. |
J. Douglas Bremner
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| Before Meridia was approved in 1997, an FDA advisory panel voted five to four that the drug's benefits did not outweigh its risks; however, despite the five-to-four vote, the fda approved its use. (The FDA isn't required to follow the recommendations of its advisory panel, although it's almost unheard-of for it not to.)
Meridia leads to a 4.45-kg (9-lb) weight loss after twelve months of treatment.1 Some studies have shown up to a 10-kg (22-lb) weight loss with Meridia.2 Unfortunately, weight returns to pretreatment levels once Meridia is discontinued. |
Jeffrey M. Smith
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 And when Canadian government scientists analyzed how the fda approved rbGH, they wrote that the "evaluation was largely a theoretical review taking the manufacturer's conclusions at face value. No details of the studies nor a critical analysis of the quality of the data was provided." Because critical studies were not conducted, "such possibilities and potential as sterility, infertility, birth defects, cancer, and immunological derangements were not addressed. |
Shannon Brownlee
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 Throughout the current debate over prescription drugs, Vioxx has become the poster child for everything that's wrong with both the pharmaceutical industry and the agency that is supposed to regulate it. The fda approved Vioxx knowing there was the possibility that the drug caused heart attacks. Once the company published its large study in 2000, which further substantiated the possible danger, agency higher-ups ignored FDA safety officers like Graham, who wanted Merck to launch a clinical trial aimed at pinning down the cardiovascular risk. |
Melody Petersen
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| The fear that Vioxx could harm the heart continued to roil Merck's executives, scientists, and marketers in the following years, as the fda approved the drug in May 1999, and the company began spending tens of millions of dollars a month to promote it.
In March 2000 Merck's scientists received the results of a large corporate study they had called the VIGOR trial. The study showed that patients taking Vioxx still suffered from ulcers, but at about half the rate as those patients taking a pain reliever called naproxen, which is sold under the brand name Aleve. |
Ann M. Coulston and Carol J. Boushey
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| As of this writing, only one SERM, raloxifene (Evista), is fda approved for prevention and treatment of osteoporosis. Raloxifene has been shown to prevent the development of frank osteoporosis in women with low bone mass and to offer substantial long-term protection against vertebral fracture in women with established osteoporosis [71]. d. Bisphosphonates
Bisphosphonates are analogs of the naturally occurring phosphate ester, pyrophosphate, in which the central oxygen bridge has been replaced by a carbon atom. |
Joseph E. Mario
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 A C; improves blood flow, normalizes blood pressure, lowers risk of heart attack, angina pain, hemorrhoids, prostatitis, varicose veins and varicose ulcers (by topical spray with Vitamin E); diabetic neuropathy, dilates lower limb bloodvessels; acts as adiuretic, for phlebitis; interstitial cystitis (the only fda approved use); and delivers anthelmintics against parasites. |
Mike Adams, the Health Ranger
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 The very label of "FDA approved" is now synonymous with "Poison." It sort of makes you wonder about all the other drugs the agency has approved, doesn't it? The agency sure has a funny way of defining "safe."
And if you, like many Americans, were holding out in the hopes that the FDA would, for once, do the right thing and protect the American public, you now realize that the agency is so blatantly corrupt that only radical, wholesale reform will ever restore any sense of credibility. |
Joe Graedon, M.S. and Teresa Graedon, Ph.D.
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 Atopiclair
In 2005, the fda approved a nonsteroidal cream for eczema. Atopiclair is a prescription product that contains a number of botanical extracts in an emollient base. Like CamoCare, it contains bisabolol, but Atopiclair also contains a vitamin E-like compound, a licorice
**? Atopiclair
This nonsteroidal cream is significantly better than a simple moisturizer at alleviating itch and reducing rash. It should be applied two or three times a day.
Side effects: Local irritation Downside: People allergic to any of the ingredients, including nuts, should avoid Atopiclair. |
Fred A. Baughman, Jr., M.D. and Craig Hovey
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 I found out that desipramine is a tricyclic antidepressant that is not fda approved for children because its safety and effectiveness for children have not been proven. Physicians continue to prescribe "off label" medications like these that are not safe. For people who get an overdose of desipramine there is no antidote to counteract it, they die. Side effects are not properly discussed and you are told what they want you to know, not what you need to know. If for one minute we had been told the proper side effects of desipramine, Shaina would never have taken one dose. |
Mike Adams, the Health Ranger
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 Psychiatrists dream up disorders, and drug companies market the "treatment" that just happens to have been recently fda approved. Notice how new diseases or disorders only get publicized and advertised after the FDA approves a Big Pharma drug to treat them? These diseases apparently spontaneously afflict huge numbers of Americans only in the days following the FDA approval of any drug that might treat such diseases. Imagine the odds.
To think, all these years, we've all been running around with Intermittent Explosive Disorder and we didn't even know it! The horrors! |
KC Craichy
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 In 1992, the fda approved irradiation of poultry; and in 1997, it approved irradiation of red meats. There are many foods now that are being delivered to our supermarkets that have gone through this process. The food irradiation industry and the FDA claim that the food itself is not radioactive or contaminated. However, somewhat contradictorily, the FDA has also reported that irradiated food can increase the risks for developing tumors in laboratory animals; this report was made public in 1968. |
Joe Graedon, M.S. and Teresa Graedon, Ph.D.
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| Alternatives for Arthritis
Many physicians complain about alternative therapies on the grounds that they are not scientifically valid or fda approved. But we have just established that FDA-sanctioned drugs like corticosteroids, NSAIDs, and COX-2 inhibitors have caused untold misery and countless deaths. Many of the treatments you will now read about have not been tested in double-blind, randomized, placebo-controlled trials the way Vioxx and Bextra were. Nevertheless, we doubt that any could trigger the kind of public health catastrophe these "well tested" pharmaceuticals have caused. |
by Michael Murray, N.D. and Joseph Pizzorno, N.D.
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| In 1990, the fda approved irradiation of poultry to prevent Salmonella and other foodborne bacterial pathogens. And in December 1997, the agency approved its use for red meat to kill E. coli. Next on the list of foods approved for irradiation may be fish and shellfish, to kill Salmonella, Vibrio (the organism that causes cholera), and other bacteria.
While more than forty countries have approved food irradiation, it is an extremely controversial practice. On one end of the spectrum, proponents say that food irradiation is safe and, in fact, necessary to make the food supply safer. |
Samuel S. Epstein, M.D.
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 At the time fda approved Monsanto's first bGH trials at Cornell University, agency documents show human safety questions resulted in cautionary withdrawal periods for milk and meat following bGH injections.
At the Cornell trials, FDA stipulated in 1982 that treated cows' milk could not be consumed for five days following final injections. And bGH-treated cows' meat could not be sent to slaughter for 15 days following the last injection.
The above-mentioned tryptic bGH digests may have been the reason for caution in FDA's establishing withdrawal periods for bGH-induced milk. |
Phyllis A. Balch, CNC
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 The fda approved the drug combination after a study of 511 cancer patients demonstrated improvements in overall response rates, lengths of time before the disease worsened, and survival rates. Capecitabine and docetaxel individually are associated with side effects including gastrointestinal symptoms, nausea, vomiting, and painful inflammation of the mouth. If side effects occur it may be necessary to reduce dosages or to interrupt or discontinue treatment. Dosages also may have to be modified for people with impaired kidney function. |
Greg Critser
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 For reasons never stated, and with no response to Elashoff's damning analysis, the fda approved Relenza in time for flu season in 1999. Almost immediately Elashoff's FDA career plunged. "I was told I wouldn't be doing any more advisory committee meetings, I wouldn't be working on any drugs that were quote unquote controversial. And there was the suggestion, it's probably better if you leave the division." A few months later he left the FDA for a position in a genetic research company. |
Mike Adams, the Health Ranger
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 This is a modern version of Al Capone, except instead of carrying pistols, his gang is carrying prescription drugs and rubber stamps that say "FDA approved."
Clearly, it is time to dismantle the FDA and reform it from the ground up. The FDA needs to be a regulatory body that actually regulates industries rather than promoting their financial interests. This should be common sense, but it has been long forgotten in the United States during the rush for corporate greed and shareholder profits.
But people like New York State Attorney General Eliot Spitzer have not forgotten these principles. |
Mike Adams
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 Here's an account of one such doctor, as mentioned in Herbal Defense:
Also, in February 1994 the fda approved the use of rBGH (recombinant bovine growth hormone) to increase milk production. The FDA refuses to implement a test for rBGH levels in all dairy products, insisting there is no need because it is safe. Not everyone is so sure, however.
Dr. George Tritsch, a cancer researcher recently retired from the Roswell Park Cancer Institute in Buffalo, New York, says that drinking milk from rBGH-supplemented cows increases insulin growth factor (IGF-1), which may enhance tumor cell growth. |
| The petition, including fifteen volumes of research studies, said the sweetener is not metabolized and would not add calories to the diet. The fda approved acesulfame K on July 27, 1988, for use in dry food products and for sale in powder form or tablets that can be applied directly by the consumer. It has about the same sweetening power as aspartame, but unlike aspartame, has no calories. Hoechst obtained approval to use acesulfame K as an ingredient in liquids, baked goods and candies. The sweetener had previously been approved for use in twenty countries including France and Britain. |
| Despite concerns over the safety of this new sweetener, including brain tumor induction in experimental animals, seizures, precipitation of headaches, and an adverse effect on the developing brain, the fda approved its use as an artificial sweetener. Sales began to grow immediately. The NutraSweet® company spent over $60 million on advertising alone during its first three years.
NutraSweet® hit the market at just the right time. Americans had become weight conscious and were looking for a sugar substitute, and it replaced the recently outlawed cyclamate. Soon, it surpassed saccharin in sales. |
| In other words, when the fda approved health claims for oats, they made no consideration for the form of those oats. Manufacturers can take an otherwise healthy whole grain and convert it into a high-carbohydrate grain that's digested much like white flour. That's primarily what you get when you purchase instant rolled oats.
Instead, look for steel cut oats, or oat groats. These offer the best health benefits. Even then, you have to eat them sparingly, since they do provide a hefty dose of carbohydrates. |
Joe Graedon, M.S. and Teresa Graedon, Ph.D.
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| In 2004, the fda approved a low-dose estrogen patch to prevent osteoporosis. This transdermal patch, called Menostar, releases 14 micrograms of estrogen as (17-beta)-estradiol a day. This form of estrogen is different from the mixture found in Premarin or Prempro but the same as that found in some other estrogen pills for postmenopausal women. Estrogen is absorbed well through the skin, so the dosage delivered in a skin patch can be a lot lower than the dosage in a pill. This dose is quite a bit lower than those of other commonly prescribed estrogen patches used to treat menopausal symptoms. |
Phyllis A. Balch, CNC
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| The fda approved Phase II clinical trials of maitake in 1998.
Q People with AIDS are almost always underweight and often have malabsorption problems that contribute to malnutrition, which is common in people with AIDS. A lack of quality protein and adequate calories is a common reason for immune deficiency. (See malabsorption syndrome in Part Two.)
Q Researchers are studying the effects of phytonutrients in the blue-green algae spirulina as potential weapons in the fight to cure AIDS. |
Joe Graedon, M.S. and Teresa Graedon, Ph.D.
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| Such drugs were perceived as so safe that once they lost their patent protection, the fda approved them for over-the-counter sale. Although these drugs can relieve heartburn by making stomach contents less acidic, they are not as fast-acting as antacids.
• • •
Q. / had two hip replacement surgeries in my mid-forties. I was given cimetidine (Tagamet) to prevent stress ulcers post-op for the first one and it gave me very nasty hallucinations. I had already withdrawn myself from the pain medications, and the staff assured me nothing I was taking could induce these things. |
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