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Entries by tag: fda

My notes are behind the cut. These ladies review some recent FDA approvals and critique the process. The upshot is that the FDA is fast-tracking drugs without following their own rules regarding the supposedly scientific and independent review process. My take: Don't Use New RX drugs until they've been on the market at least 10 years. Otherwise YOU are part of the longterm followup studies that they aren't doing before approval.

SOURCE
http://healthaffairs.org/blog/2013/01/25/antibiotics-when-science-and-wishful-thinking-collide/
my notes on Zuckerman & Yttri articleCollapse )
WHAT TO DO ABOUT THE RICE FINDING
**eat less rice
**vary rice products with other grains
**eat a varied diet and don't fret
**rinse before cooking
**cook differently: boil in excess water and then strain (removes 30% of inorganic)
**limit cereals to one serving/day esp for babies
**avoid baby formula containing domestic rice
notesCollapse )

Salt: You Need the Right Kind

http://articles.mercola.com/sites/articles/archive/2099/12/31/dangers-of-salt-restriction.aspx?e_cid=20120213_DNL_artTest_C3

Bottom line: "real" salt (ie from the earth or sea) contains oodles of minerals that support heatlh. Eating this salt is beneficial to health. Eating processed NaCl with added iodine is not as beneficial, but it still supports adrenal function and fluid balance. Ceasing sodium consumption can be destructive to your health. Don't listen too carefully to the FDA, whatever you do.

FDA Yanks HCG Diet Products

Why? It is the #1 diet fad in the world right now. And it was WORKING for lots of people, and did not require a prescription. Or was it really because it was dangerous? We shall see.
http://www.medpagetoday.com/ProductAlert/OTC/30042?utm_source=breaking-news&utm_medium=email&utm_campaign=breaking-news#.Tt5Y7Lifxrw.facebook

Here's a decent orientation about the HCG diet if you haven't heard:
The drug is also known as Bevacizumab. It's not approved but Medicare is still paying for it. It's the #1 selling cancer drug on the planet, made by Genetech, Inc that is owned by Roche. Why was it removed from FDA approval? Because there's no proof that it extends life at all, and has potentially life-threatening side effects. The side effects possible include severe hypertension, hemorrhage, heart attack and failure, and gastrointestinal perforations. Avastin is considered a last ditch option for metastatic breast cancer patients.

Why was it approved in the first place? Your guess is as good as mine. Money, probably. The cost for a year's treatment is $100,000, and it is covered by medicare. How's that for a bailout? That bailout of course is for the pharmaceutical companies. Genetech, and a bunch of patients, are lobbying hard to keep the drug as an option. Genetech says it does work, when combined with traditional chemo, and so is appealing the FDA decision. I wonder how much cashola the FDA will get back during the appeals process. The FDA approval happened while studies were in progress to prove its efficacy--but those studies turned out to prove no such thing.

SOURCES
http://www.washingtonpost.com/business/fda-says-avastin-should-no-longer-be-used-for-breast-cancer-citing-no-proof-it-extends-life/2011/11/18/gIQAHJmHYN_story.html?wpisrc=al_national
http://www.ibtimes.com/articles/171447/20110629/avastin-breast-cancer-genentech-fda-drug-roche.htm

FDA Set to Ban Supplements

http://articles.mercola.com/sites/articles/archive/2011/09/13/fda-to-ban-new-supplements-and-classify-them-like-food-preservatives.aspx?e_cid=20110913_DNL_art_1

The battle has gotten hot again. We could use your help, if you're willing. This change would be the supplement equivalent of them banning us from growing food in our yards. The FDA needs to back off and let people take care of each other without participating in multinational corporate scams.
Obviously Mercola has been studying hard on fluoride lately, because he keeps posting about it. Unfortunately it is becoming apparent that we are ingesting this toxin with our food, not just from drinking water. And as usual the EPA, FDA and business have danced their dance, compromising the health of the people for the profits of business. Fluoride is in a fumigant used on produce, especially walnuts and raisins out of California, and other foods are also suspect. Bottom line: whole organic food is just about your only way to avoid all the nasty shit that industry puts on food. Better yet: whole organic local homegrown food.

SOURCE
http://articles.mercola.com/sites/articles/archive/2011/08/11/sulfuryl-fluoride-what-is-it-the-story-so-far.aspx?e_cid=20110811_DNL_art_1

A GOOD ORG where you can find answers to legal questions and TAKE ACTION
http://www.fluoridealert.org/
Pretty interesting overview of the newest attack here on Natural News: FDA's scheme to outlaw nearly all nutritional supplements created after 1994 would destroy millions of jobs and devastate economy. In the new proposed rules synthetic nutrients are exempted. The target of administrative control appears to be animal and plant-derived supplements. Botanicals. There are many health practitioners who prefer to use natural products as opposed to chemically synthesized ones. But the FDA wants to put us under. It's too dangerous to eat plants and animals; the content is not standardizable. We don't really know what's in there.

More here. You can make noise there too by signing the petition if you care.

And I did not know this, but the FDA has already banned the P5P form of vitamin B6---which some people cannot manufacture on their own and must get from their diet. They're basically trying to trap us into purchasing pharmaceuticals when relatively inexpensive natural alternatives exist. Because some people need to take top quality B6 for life (because of inherited metabolic handicaps), they see a market, just like any drug they can get you to buy for life. It's much more profitable for pharmaceutical corporations to make drugs that you need forever more.

It's time to start gardening, folks. They can't keep us from eating the weeds that grow by our house.
Cardiac devices. Yep. Most of them are covered by insurance. All those fancy gizmos that they are so eager to install in us, whenever we have a little heart trouble, those gizmos are increasingly suspect. The situation has gotten so bad that the GAO is pushing the FDA to take a more active role in overseeing devices used by the cardiac care medical industry.

During the period covered by the report ('05-'09), medical-device makers initiated 3510 device recalls, which cover everything from "field corrections" to revised labeling to retrieving a device from customers. The agency categorized about 83% of these recalls as class II, indicating the devices may cause temporary adverse health consequences, and 14% as class III, indicating the device is not likely to cause any adverse consequences. Only 4% were class I recalls, deemed by the FDA to have a reasonable risk of causing serious adverse health consequences or death.

During this time, cardiovascular devices were the most commonly recalled products: 532 recalls, making up 15% of all recalls during this period, while the 40 class-I recalls of cardiovascular devices represented 31% of all class-I recalls in the period. The largest number for cardiovascular devices involved automatic external defibrillators.

The next most common category is radiological devices, which accounted for 484 total recalls but only two class I recalls, followed by general hospital and personal-use devices, which accounted for 388 recalls overall, including 31 class I recalls.


SOURCE
http://www.theheart.org/article/1244193.do?utm_campaign=newsletter&utm_medium=email&utm_source=20110627_EN_Heartwire
http://www.zacks.com/stock/news/52768/FDA+Approves+Abbott's+AndroGel
It's supposedly for hypogonadal adult males but we shall see who gets scripts.

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