History, Religion, Epistemology and Communication
with a little Politics, Economics and Legal Theory thrown in for good measure. Plus . . . whatever strikes me as interesting or humorous.
As if Congress does not have enough urgent work to do, a bill has just been introduced that would vastly expand the FDA’s power to put food makers in jail for ten years!
Just a few days ago, [we informed you] that a walnut [distributor] capitulated to FDA pressure and removed truthful health claims from its website. [I have copied the article below. --JAH] The bill just introduced in the Senate would grant the FDA far more draconian powers to censor this kind of health information.
This Senate bill will enable the FDA to incarcerate food makers if they cite findings from peer-reviewed published scientific studies on their websites.
The pretext for these draconian proposals is a bill titled the Food Safety Accountability Act (S.216). The ostensible purpose of the bill is to punish anyone who knowingly contaminates food for sale. Since there are already strong laws to punish anyone who commits this crime, this bill serves little purpose other than enriching pharmaceutical interests by censoring what healthy food makers can say about their products.
The sinister scheme behind this bill is to exploit the public’s concern about food safety. Drug companies want to convince your senators that an overreaching law needs to be enacted to grant the FDA powers to define “food contamination” any way it chooses.
The problem is the FDA can proclaim a food as “misbranded” even if the best science in the world is used to describe its biological effects in the body. The fear is the FDA will use the term “misbranded” in the same way it defines “adulterated” in order to jail food makers as if they were selling contaminated food.
While the new bill only refers to food violations and not supplements, the FDA may not interpret it this way. The big issue here is that if this bill is passed, it would give the FDA legal authority to threaten and coerce small companies into signing crippling consent decrees that will deny consumers access to truthful non-misleading information about natural approaches to protect against age-related disease.
Please tell your two senators to OPPOSE the Food Safety Accountability Act (S.216) in its present form. You can do this in a few minutes on our convenient Legislative Action Center on our website.
And the story of the walnut distributor?
Walnut [Distributor] Capitulates to FDA Censorship
Life Extension® has published 57 articles that describe the health benefits of walnuts.
Some of this same scientific data was featured on the website of Diamond Foods, Inc., a distributor of packaged walnuts.
Last year the FDA determined that walnuts sold by Diamond Foods cannot be legally marketed because the walnuts “are not generally recognized as safe and effective” for the medical conditions referenced on Diamond Foods’ website.
According to the FDA, these walnuts were classified as “drugs” and the “unauthorized health claims” cause them to become “misbranded,” thus subjecting them to government “seizure or injunction.”
Despite pleas from health freedom activists to challenge this blatant example of censorship, Diamond Foods capitulated and removed from its website statements about the benefits of walnuts.
FDA thus scored a victory by denying some Americans access to scientific data about a food that can reduce the risk of the most common diseases afflicting aging humans.1-15
You now have the opportunity to strike back
On April 5, 2011, a bipartisan bill was introduced into the House of Representatives called the Free Speech about Science Act (H.R. 1364). This landmark legislation protects basic free speech rights, ends censorship of science, and enables the natural health products community to share peer-reviewed scientific findings with the public.
The Free Speech about Science bill has the potential to transform medical practice by educating the public about the real science behind natural health.
For this very reason, the bill will have opposition. It will be opposed by the FDA since it restricts their ability to censor the dissemination of published scientific data. It will be opposed by drug companies fearing competition from natural health approaches based on diet, dietary supplements, and lifestyle.
The public, on the other hand, wants access to credible information they can use to make wise dietary choices. Please don’t let special interests stop this bill.
I ask that each of you log on to our Legislative Action website that enables you to conveniently e-mail and ask your Representative to cosponsor the Free Speech about Science Act (H.R. 1364).
Passage of the Free Speech about Science Act will stop federal agencies from squandering tax dollars censoring what you are allowed to learn about health-promoting foods.
Our Legislative Action website provides you direct contact with your Representative to let them know that you want H.R. 1364 (Free Speech about Science Act) enacted into law.
References
1. Ros E, Núñez I, Pérez-Heras A, et al. A walnut diet improves endothelial function in hypercholesterolemic subjects: a randomized crossover trial. Circulation. 2004 Apr 6;109(13):1609-14.
2. Feldman EB. The scientific evidence for a beneficial health relationship between walnuts and coronary heart disease. J Nutr. 2002 May;132(5):1062S-1101S.
3. Blomhoff R, Carlsen MH, Andersen LF, Jacobs DR Jr. Health benefits of nuts: potential role of antioxidants. Br J Nutr. 2006 Nov;96 Suppl 2:S52-60.
4. Mozaffarian D. Does alpha-linolenic acid intake reduce the risk of coronary heart disease? A review of the evidence. Altern Ther Health Med. 2005 May-Jun;11(3):24-30; quiz 31, 79.
5. Zhao G, Etherton TD, Martin KR, West SG, Gillies PJ, Kris-Etherton PM. Dietary alpha-linolenic acid reduces inflammatory and lipid cardiovascular risk factors in hypercholesterolemic men and women. J Nutr. 2004 Nov;134(11):2991-7.
6. Tapsell LC, Gillen LJ, Patch CS, Batterham M, Owen A, Baré M, Kennedy M. Including walnuts in a low-fat/modified-fat diet improves HDL cholesterol-to-total cholesterol ratios in patients with type 2 diabetes. Diabetes Care. 2004 Dec;27(12):2777-83.
7. West SG. Alpha-Linolenic Acid from Walnuts P85 and Flax Increases Flow-Mediated Dilation of the Brachial Artery in a Dose-Dependent Fashion. Pennsylvania State University. American Heart Association’s 5th Annual Conference on Arteriosclerosis, Thrombosis, and Vascular Biology in San Francisco. May 2004.
8. Iwamoto M, Imaizumi K, Sato M, Hirooka Y, Sakai K, Takeshita A, Kono M. Serum lipid profiles in Japanese women and men during consumption of walnuts. Eur J Clin Nutr. 2002 Jul;56(7):629-37.
9. Morgan JM, Horton K, Reese D, et al.Effects of walnut consumption as part of a low-fat, low-cholesterol diet on serum cardiovascular risk factors. Int’l J for Vit & Nutr Research. 2002 72:341-347.
10. Hu FB, Stampfer MJ, Manson JE, et al. Frequent nut consumption and risk of coronary heart disease in women: prospective cohort study. BMJ. 1998 Nov 14;317(7169):1341-5.
11. Chisholm A, Mann J, Skeaff M, et al. A diet rich in walnuts favourably influences plasma fatty acid profile in moderately hyperlipidaemic subjects. Eur J Clin Nutr. 1998 Jan;52(1):12-6.
12. de Lorgeril M, Renaud S, Mamelle N, et al. Mediterranean alpha-linolenic acid-rich diet in secondary prevention of coronary heart disease. Lancet. 1994 Jun 11;343(8911):1454-9.
13. Cortés B, Núñez I, Cofán M, et al. Acute effects of high-fat meals enriched with walnuts or olive oil on postprandial endothelial function. J Am Coll Cardiol. 2006 Oct 17;48(8):1666-71.
14. Ros E, Mataix J. Fatty acid composition of nuts—implications for cardiovascular health. Br J Nutr. 2006 Nov;96 Suppl 2:S29-35.
15. Ma Y, Njike VY, Millet J, et al. Effects of walnut consumption on endothelial function in type 2 diabetic subjects: a randomized controlled crossover trial. Diabetes Care. 2010 Feb;33(2):227-32.
One of my new favorite magazines, Acres USA, included a striking opinion piece this month.
"Newspapers, magazines and electronic media outlets all over the world recently announced a breakthrough vaccine that will hopefully protect women against breast cancer," the author began.
In the current study, genetically cancer-prone mice were vaccinated -- half with a vaccine containing the antigen and half with a vaccine that did not contain the antigen. None of the mice vaccinated with the antigen developed breast cancer, while all the other mice did.
Dr. Vincent Tuohy, Ph.D., the principal investigator on the project, said, "We believe this vaccine will someday be used to prevent breast cancer in adult women in the same way that vaccines prevent polio and measles in children. If it works in humans the way it works in mice, this will be monumental."
All well and good. Indeed, exciting.
But, asked the author of the Acres USA article, if this research is worthy of excitement, why have so few people heard of research conducted close to 60 years ago that produced similar results based solely on diet changes?
Specifically, why have so few of us ever heard of the pioneering work of Dr. Maynard Murray, M.D., who conducted multiple experiments from 1938 through the 1950s that showed that animals fed vegetables, fruits and grains that had been fertilized with sea minerals were able to overcome cancers that the same animals fed the very same foods grown in more conventional ways were not?
Murray first became interested in sea minerals when he realized that he had never found a sea creature suffering from cancer, even though cancers are very common in similar species that live in freshwater. "For example, fresh-water trout all develop terminal cancer of the liver at the average age of five and one-half years; cancer has never been found in sea trout. It is also known that all land animals develop arteriosclerosis, yet sea animals have never been diagnosed as arteriosclerotic." (Sea Energy Agriculture, p. 30)
So what kind of experiments did Murray do?
In 1954 he had Ray Heine and Sons Farms of Rutland Township, Illinois, grow oats, corn and soybeans--approximately half of each of these crops the normal way, and the other half exactly the same except for one difference. The experimental crops were grown in soil that received an application of 2,200 pounds of sea solids (sea salts--including whatever trace elements were present in the sea water before evaporation) per acre.
Murray was interested in how the crops grew. (The crops grown with the sea solids did better.) But then, after the crops were harvested, Murray wanted to see if these crops, now used as feed, would offer any differential benefits to the animals that ate them.
They mixed up similar blends of the control grains and experimental grains--one part soybeans, two parts oats, and four parts corn--and fed them to different kinds of animals.
For example,
C3H mice were obtained. . . . This strain of mice has been bred so all females develop breast cancer which causes their demise. The mice were two months of age when received and started on the feeding experiments. The life expectancy of this strain for females is no more than nine months which includes the production of two or three litters. The experimental and control groups both consisted of 200 C3H mice and those fed on control food were all dead within eight months, seven days. The experimental mice that were fed food grown on the sea-solids-fertilized soil lived until they were sacrificed at 16 months; definitive examination revealed no cancerous tissue. The experimental group produced ten litters compared to the usual two to three litters and none developed breast cancer.
--Ibid., pp. 50-51
Then there were the Sprague Dawley rats: 25 controls and 25 experimentals were all injected with Jensen Carcino-Sarcoma (cancer).
All of the rats fed on the control diet died within 21 days of cancer. Nine of the rats that were fed the experimental diet died of cancer within 40 days; 16 lived five months until they were sacrificed; there were no cancer "takes" in the 16 . . . survivors that were fed experimental food.
--Ibid., p. 51
And the 24 rabbits, 12 experimentals and 12 controls. This time, both groups were fed a high cholesterol diet for six months and then fed their respective soybeans, oats and corn diets.
The control group did develop hardening of the arteries and all had died within ten months. The experimental group did not exhibit hardening of the arteries.
--Ibid., p. 52
Murray was very careful in the way he reported these results:
I want to emphasize that these feeding experiments and the results are only preliminary and it must be kept in mind that the mice, rabbits and rats used in these feeding experiments have a different physiology than human beings. The results are not definite but merely indicate an interesting trend and further research should be done to further document the findings. . . . In no way . . . do I suggest that the same results would occur in a human being due to the preliminary stage of research.
--Ibid., p. 50
Sounds like good science to me! So why don't we hear about it? Has it been disproven? Not that I've seen!
So what has become of Murray's work? What has the medical establishment done with it?
As far as I can tell, absolutely nothing.
Why?
Maybe it has to do with money . . . and the cozy relationship between the major pharmaceutical companies and the FDA. After all, the FDA can't permit people to think of foods as possessing healing qualities!
[The FDA] has structured the rules to categorize anything that treats or prevents disease as a drug. So if you eat walnuts, and those walnuts lower high cholesterol (which they do), the FDA declares your walnuts to be "drugs."
Existing law dictates that if anything is advertised as providing health benefits without the FDA's approval, it's automatically considered to be an "unapproved drug", even if it's a common, everyday food like walnuts, cherries, grapes or oranges.
Amazingly, references to peer-reviewed scientific studies are not allowed to be made by companies without permission from the FDA because the agency considers this to be an illegal health claim. So if you sell walnuts, and your website merely links to published scientific studies that describe the cholesterol-lowering benefits of walnuts, then you can be threatened, arrested, imprisoned and fined millions of dollars by the FDA for selling "unapproved drugs."
If you flee the country, you can be then be listed on INTERPOL as an international fugitive wanted for "drug offenses." This is exactly what happened to Greg Caton, who was recently kidnapped from Ecuador by U.S. agents working on behalf of the FDA, brought back to the USA against his will, and sentenced to federal prison where he remains to this day. . . .
If you're skeptical that what I'm saying here is true, take a look at the warning letter the FDA sent to Diamond Food, Inc. back in February concerning the health claims the company had been making about its walnuts.
How is our federal government serving us, helping us, by engaging in this kind of behavior?
And then there was this gem from Dr. Jonathan Wright's Nutrition and Healing newsletter (received 5/8/2009):
For decades, the FDA has been a danger to you and your family's health. Nearly 20 years ago, the government's own General Accounting Office (GAO) wrote: "GAO found that of the 198 drugs approved by FDA between 1976 and 1985...102 (or 51.5%) had serious post-approval risks...the serious postapproval risks...[included] heart failure, myocardial infarction, anaphylaxis, respiratory depression and arrest, seizures, kidney and liver failure, severe blood disorders, birth defects and fetal toxicity, and blindness."
That terrible record continues into the 21st century (Vioxx is just one example that springs immediately to mind).
And to add insult to injury, while it has been busy approving all those potentially lethal patent medicines, the FDA has also been actively fighting against your right to keep yourself healthy with foods and food supplements! Picking on cherries is just one recent example. All the way back in 1949, former FDA commissioner Dr. George Larrick said: "The activities of...so-called health food lecturers have increasingly engaged our attention....[we are fighting] the good fight against dried vegetables, vitamins, and similar products."
I first wrote the majority of this post last October, but abandoned it when I felt it wasn't quite ready for publication.
Following my post about my encounter with the naturopath, however, I thought I should provide this as a kind of "background"--and, perhaps, as a wake-up call to those who are unaware of the issues I describe, and, finally, perhaps, as useful information for someone who is struggling with thyroid issues.
******* ---The following text was written in October 2009---
I had my thyroid destroyed back in 1984 as a result of a hyper-hyper case of Grave's Disease. --The lab that did the tests said they had never seen thyroxine levels as high as mine; they were "off the charts."
So my doctor gave me the radioactive isotope Iodine-131 to destroy my thyroid gland . . . and a few months later I had none.
I have been taking thyroxin/thyroxine tablets ever since. For some time, now, I've been taking the "natural" stuff sold under the Armour® brand name by a company named Forest Pharmaceuticals (what, in just the last few days, I found out are desiccated and pulverized pig thyroid glands formed into pills). Most of the time, however, I've been taking synthesized thyroxine sold as generic levothryroxine or a branded product like Synthroid®.
What's the difference between the two? I mean, physiologically . . . for the person like me who is ingesting the stuff?
I will confess that, for me, I haven't really been able to tell the difference. But then, I haven't been all that attentive to my physical condition until the last couple of years.
For many people, however, the difference between the two concoctions is dramatic, though the majority of doctors seem to believe the difference is all in hypothyroid sufferers' heads.
Happily, only one of my doctors has actively opposed my use of the Armour® tablets. But despite his opposition, I've been able to use the Armour® product for the past seven years or so.
This last year, however, I started bumping into supply difficulties. Back in January I was told the pharmacy didn't have 120 mg tablets (the daily dose I needed at the time). . . . Happily, they "simply" gave me the equivalent in the form of two 60 mg tablets per day. No big deal.
Last time I refilled, in late May, I still had almost a month's worth of pills left when I got a three-month supply of 60 mg tablets from our insurer's mail order pharmacy. . . . Then, only a few days after I got my three-month supply, I was told I should reduce my dose to only 90 mg--1½ tablets--a day. So in mid-October, I was just coming to the end of my supply.
Meanwhile, in mid-October I had another blood test to see how my thyroxine levels are.
My doctor wanted to run with the "standard" TSH-only (thyroid stimulating hormone-only) test. I said I believed we really needed the T4 and T3 levels measured as well. (Since then I have found some interesting data on the need for all three tests.)
TSH measures what your body "thinks" it needs in the way of thyroxine. T4 and T3 measure actual thyroxine levels in the blood--and, based on tests I've been having done throughout this past year on the direction of my longevity and vitality doctor, I know that one or more of these numbers can be "out" of range while TSH is "in" range.
My doctor relented.
The tests came back: TSH and T4 levels both indicated a significant deficiency, but T3 was slightly out-of-range on the high end.
"How about bumping your dose back up?" my doctor asked.
"Sounds reasonable," I said. (I had gotten the sense, somehow, that my body was slowing down a bit.)
But what should we make of the T3? Why is that so high?
Is it that kind of anomalous/strange number that got Armour's thyroxine in trouble, here, in the last year [so that it is unavailable for purchase]?
I still have a few weeks' worth of Armour left if I take it at 120 mg/day.
Meanwhile, I asked, "Is there any 'natural' thyroxine that can/will replace Armour while they are out of production?"
I thanked him for any help he could provide.
He replied:
1. I've been in touch with my pharmacologist. She states that since Armour is an animal product, the amount of T3 and T4 will vary from batch to batch which might explain the high T3 and low T4. Synthetic products like synthroid are more consistently dosed.
2. I don't think Kaiser has any of the other brands of the natural thyroid of any kind so we might have to get you to get it elsewhere during the shortage.
Somehow, I had this feeling the pharmacologist was misinformed. I can't imagine Armour/Forest Pharmaceuticals has been able to get away with inconsistent product quality for all these years.
So I did a little research. And then some more. And then a lot more.
The amount of thyroid hormone present in the thyroid gland may vary from animal to animal. To ensure that Armour Thyroid tablets are consistently potent from tablet to tablet and lot to lot, analytical tests are performed on the thyroid powder (raw material) and on the actual tablets (finished product) to measure actual T4 and T3 activity.
Different lots of thyroid powder are mixed together and analyzed to achieve the desired ratio of T4 to T3 in each lot of tablets. This method ensures that each strength of Armour Thyroid will be consistent with the United States Pharmacopeia (USP) official standards and specifications for desiccated thyroid lot-to-lot consistency. The ratio of T4 to T3 equals 4.22:1 (4.22 parts of T4 to one part of T3).
Despite these statements by the manufacturer, you can still read claims such as this:
Armour Thyroid was the only treatment for hypothyroidism for about 50 years, but it was found that the amounts of T3 and T4 varied greatly from batch to batch. Eventually, synthetic T4 (Synthroid) was being produced and widely used because it did not have similar problems of standardization in common with the naturally derived Armour Thyroid.
But, as Mary Shomom notes in the About.com Guide to Thyroid Disease, there may be good reasons for this kind of disinformation "from the top." Just follow the money--from Abbott Laboratories, maker of Synthroid, to the American Thyroid Association, for example. [Look toward the bottom of this article for the evidence.] --Or how about the payments from all the synthetic hormone manufacturers to the FDA in order to get their products approved in the early 2000s after virtually all of them were found to show "significant stability and potency problems"?
Canada has a generic natural desiccated thyroid drug, referred to as 'Thyroid,' which is made by ERFA Drugs . . . [and s]ome of the foreign pharmacies that ship to the US may have some remaining stock of Nature-Throid, Westhroid, Armour Thyroid, or foreign brands of natural desiccated thyroid like Thyroid-S.
I had my doctor write me a highly "generic" prescription for natural thyroid along the lines of the following advice from the http://is.gd/4hhvT article:
During the shortages, ask your doctor to write your prescription for desiccated thyroid as broadly as possible. For example, a prescription for 'desiccated thyroid, 1 grain' can be filled with Armour, Nature-Throid, Biotech, or a generic. But if they write 'Armour Thyroid, 60 mg' for example, you won't be able to get 'Nature-Throid.'
I should have learned these things years ago, but I just now discovered: the synthetic thyroxines normally prescribed by the medical profession supply only one form of thyroxine, "T4"--tetraiodothyronine--commonly formulated as levothyroxine sodium (a synthetic thyroxine molecule that contains four molecules of iodine bonded by sodium). Our bodies, however, use T4, T3 (triiodothyronine--i.e., thyroxine with three iodine molecules), T2 (diiodothyronine--thyroxine with two iodines), T1 (monoiodothyronine), and something called calcitonin, a hormone that participates in and/or regulates calcium loss from bone, calcium levels in the blood, and, possibly (proven in rats and monkeys; not yet demonstrated in humans), satiety.
Not only do our bodies use all five of these hormones, when they are healthy, our bodies manufacture them. If--as happened to me via Iodine-133 therapy--your thyroid has been knocked completely out of commission, the only way you're going to get the T2, T1 and calcitonin is if you take natural thyroid. Yes, your body can convert some T4 to T3, but, I am given to understand, it cannot further break down the T3 to T2, T1, or calcitonin.
An article published in the February 11, 1999 issue of the New England Journal of Medicine (1999;340:424-429, 469-470) reports that treatment with thyroxine [T4--the commonly prescribed synthetic levothyroxine/Synthroid hormone] plus triiodothyronine [T3--rarely prescribed by American doctors, but available under the brand name Cytomel] improved the quality of life for most hypothyroid patients. Indeed, "Among 17 scores on tests of cognitive performance and assessments of mood, 6 were better or closer to normal after treatment with thyroxine plus triiodothyronine. Similarly, among 15 . . . scales used to indicate mood and physical status, the results for 10 were significantly better after treatment with thyroxine plus triiodothyronine [i.e., T4 plus T3]."
Of course, that is a dispassionate medical/scientific statement.
[I]n nearly ALL patients on T4 meds, the T4 does NOT convert into an adequate amount of T3, leaving you with symptoms that neither you OR your uninformed doctor realize are related to inadequate treatment—poor stamina compared to others, chronic low grade depression, thinning hair or outer eyebrows, feeling cold when others are warm, cholesterol problems, aches and pains, hard or small stools, easy weight gain, memory problems, foggy thinking, a diagnosis of Chronic Fatigue Syndrome or Fibromyalgia, difficulty conceiving . . . the list is long and pathetic. In other words, healthy thyroids are NOT meant to rely solely on T4-to-T3 conversion!
Despite the fact that the medical profession recently tightened the definition of "normal TSH" to no more than 3.04 mU/l (they used to say "normal" went as high as 5 mU/l), a 1997 article in the British Medical Journal concluded, "Thyroid stimulating hormone concentrations above 2 mU/l are associated with an increased risk of hypothyroidism." --And again the author at StopTheThyroidMadness.com ups the ante:
Around 1973, the TSH lab test was developed. Based on a sampling of several volunteers, a so-called “normal” range was established—.5 to 5.0 (recently lowered to 3.0). But volunteers with a history of family hypothyroid were NOT excluded, leaving us with a range that leans towards being hypothyroid! In fact, the TSH RARELY corresponds to how a patient feels [i.e. to actual hypothyroid symptoms]. There is a large majority of patients who have a “normal” TSH, even in the “one” area of the range, and have a myriad of hypo symptoms. There is a complete chapter on the TSH with more information in the Stop the Thyroid Madness book.
Nature-Throid and Westhroid have served many people well. But the Armour shortage--together with a shortage of USP desiccated thyroid powder--has now created a shortage of these alternatives.
---End of October 2009 Text---
Yesterday, as I spoke with my naturopath, I was surprised to hear him tell me that the desiccated thyroid products are now readily available in the US.
I have to confess, the mess last year kind of "converted" me away from US suppliers. After a while, when you get hassled every step of the way here in the US, and you find that their price is somewhere around $1 per per day, the easy access and 11- or 12-cent/pill prices of overseas suppliers become pretty attractive. So I hadn't even looked at U.S. suppliers in almost a year (since last I worked on the article above).
One last note: I thought I should at least check on what I wrote last October before simply posting it.
A brief status update on "Current Drug Shortages" posted at the FDA website on March 2, 2010, states that, as of February 12, 2010:
"Forest reports manufacturing issues involving the raw material and RLC reports increased demand. FDA has not ordered Forest or RLC to remove these thyroid (desiccated) tablets from the market. This has been a long term shortage and any new information will be posted as soon as it becomes available. FDA approved levothyroxine products continue to be available from multiple manufacturers."
It's good to see that the FDA felt it necessary to include the brief statement that they have not ordered Forest or RLC to remove these thyroid (desiccated) tablets from the market. This very likely reflects a concern on the part of the FDA that it not be perceived as taking action that can endanger the many thyroid patients who rely on natural thyroid drugs, and may be a response to thousands of inquiries by telephone, email and fax the FDA received from thyroid patients and practitioners regarding concerns about various FDA actions regarding natural desiccated thyroid drugs.
The FDA's statement does not address a critical issue for thyroid patients however. According to the natural desiccated drug manufacturers, the FDA has indicated that they still consider natural desiccated thyroid drugs "unapproved," and intend to call for a new drug application process for natural desiccated thyroid drugs.
This leaves us with several important questions:
When will the FDA requirement for new drug application for natural desiccated thyroid drugs be issued?
Will the FDA call for the faster (and less costly) abbreviated new drug application (ANDA) or the lengthier, costlier complete new drug application (NDA) process?
Will natural desiccated thyroid drugs be allowed to remain on the market during the ANDA/NDA process?
We still do not have answers to these questions, though manufacturers are still working behind the scenes with the FDA and with their own scientific experts, doing their best to ensure that natural desiccated thyroid drugs will continue to be available in sufficient supply to all patients who need them in the short term, and throughout a federally-mandated approvals process.
I received an ad for a webinar that, I was told, would feature a woman who was "locked up with felons, thieves, hoods and thugs in one of the world's most notorious prisons -- Rikers Island" for "a crime [she] didn't commit."
No friends... no support... no help... only YOU!
What would you do? How would you react?
On February 16th at 7:00 p.m. Eastern, you'll meet a very special person who suffered that very fate... and you'll also hear her inspiring story of hope and triumph in the face of overwhelming adversity.
Would you give up? Would you run? Would you flee the country?
Not this person! In fact, she turned this adversity into one of the greatest personal True Life Success Lessons I've ever heard... and you'll hear her first-hand account of how she did it.
The guest sounded fascinating. I wanted to see if I could figure out who she was before--or without--having to take the time to listen in on the phone call.
I did a Google search on rikers island adversity she and thought maybe the first site on the list would take me to my target.
Apr 9, 2009 ... Last year this time I was sitting in Riker's Island. ... I learned how to be a better person through this adversity. ... yesterday after 2 yrs fighting her case from Riker's Island. She is facing 40+ years in prison. ...
www.manhattanmadam.com/kristins_blog?category=1 - Cached
After having spent some time on her site, however, and now that I compare notes, I think most probably Kristin Davis is not the one whom Jim Edwards had in mind. Because she says she knows she did break the law though she wants to change it and she is hopping mad about how the legal system turns a blind eye to the behavior of societal heavy-weights even while crushing those of lesser stature.
Kind of reminds me of how our president has appointed so many people to positions of high authority, and Congress has approved them: people who are supposed to hold "the rest of us" to account in and for laws of which they have been found in gross violation. (I'm thinking of people like Treasury Secretary Timothy Geithner (who is in charge of the IRS). In 2009, as he was being examined for fitness for the job, someone discovered that Geithner had failed to pay some $34,000 in Social Security and Medicare taxes on his salary at the IMF (International Monetary Fund) between 2001 and 2004. Oh! Geithner finally paid what he owed: most of it, anyway. Just not any of the hefty penalties that anyone else would have been unable to avoid. Geithner got a pass from his political buddies. . . . Oh. But while we're on the subject, let's consider how it also came out last year that Geithner had employed "household help" that was ineligible to work in the United States. --Y'know, "the rest of us" could face time in prison for such dereliction of duty to the law of the land. But Geithner? --He merely had to acknowledge that he had done something illegal. And now he holds one of the most powerful positions in the government of the United States. . . . Or how about Rep. Rangel of New York, one of the men responsible for legislating tax policy for the nation? He has yet to explain to anyone's satisfaction how he "forgot" to pay taxes on $75,000 in rental income he earned from an off-shore rental property. . . . Y'know, a lot of critics of the most outspoken leaders of the "Religious Right" note that those who are most outspoken on matters like homosexuality seem, most often, to be involved themselves in the very behavior they speak so vociferously against. --One wonders if the same may be true about our legislators in Washington. . . . But I get ahead of myself.)
Now when I think about it, I am glad I had the experience. I am truly a better person for what I have gone through. I really and truly value the people in my life and the experiences I have. Its not so much about the outcome of the event, its about having the experience. I learned how to be a better person through this adversity. I learned how to value and love those who love me.
A lot of people ask me if I'm mad at those who ratted me out and how I feel. I actually don't think about it much. I don't have time for bad energy. I have had a lot of people do me wrong - that I can't dispute. If you think I think twice about it - I don't. Why should I? It has nothing to do with me and everything to do with that person's character. If you think I'm dwelling on anything from the past then you don't get what I'm about. The past is the past and its better left in the past. The "now" for me is amazing and I am so incredibly happy its not even funny. I have met so many amazing people and have a great group in my life, I couldn't ask for more.
Don't get me wrong, I could have completely done without the Riker's Island Experience. However, I think this is the path that was chosen for me. I have the opportunity to do some good now and thats what I am doing.
A little further down the page, I read her "next" post in the series.
She described two of the women with whom she spent time in prison:
Janet Redmond-Mercereau . . is the Staten Island woman who was on trail for murdering her husband, an NYFD marshall, while their 2 young children slept. She was convicted by a jury yesterday. . . I don't know if she did it or not. It is not my place to judge.
Another woman I was in jail with was Nizelie Santiago. She was convicted of manslaughter of her daughter when her husband beat her to death and they left her sitting there for 1 day. She got 40 years in prison. . . .
These are the types of criminals I was in jail with. Me- little old promoting prositution charge (class D felony-these are class A)....a victimless crime was sitting there befriending murderers. When I think about it, it makes me sick that our society would classify my crime in the same manner as theirs. My crime which happens to be legal in 2 states yet just not the one I was operating in.
I sat there day in and day out surrounded by baby and husband killers. These are people who confided in me about their cases and the people I LIVED with every day. Can you imagine that? . . .
I'm writing this to point out the hypocrisy of our system. That me, a former madam, with a "promoting prostitution" charge was classified in the same manner as a murderer. That is ridiculous. And there sits Elliot Spitzer in his plush Park Avenue apartment with NUMEROUS pending felonies in the Class C category (worse than mine) and he gets away scott-free.
I'd like for us to address why there is a different set of rules for the elite and connected then there are for those of us who worked our way up from nothing???
It was when I read about the "promoting prostitution charge" that I suddenly paid attention to the fact that Kristin's site is titled The Manhattan Madam Kristin Davis.
You get a good idea what she's "all about." She's about trying to expose hypocrisy. And about taking personal responsibility. She wants
to highlight the inequities and sexism in our criminal justice system which penalizes women, minorities and poor people while wealthy, connected white men like Eliot Spitzer evade justice. Our system that allows Spitzer to walk on money laundering and violating the Mann act (transporting a prostitute across state lines), but sends Plaxico to prison for seven years for shooting himself in the foot is ripe for real reform. . . .
New York's so-called " political class" is driving this state into the toilet. Crushing income and property taxes pay for sweetheart public employees union compensation deals with the State. The unions, in turn, give money and manpower to re-elect the very same politicians' who gave them this deal and everybody benefits- but the taxpayers.
Now adding to this disgrace is Senator Hiram Montserrat. This thug beat up his girlfriend in a jealous rage and slashed her face with a broken glass. Convicted of a misdemeanor (for anyone else it would have been a felony) he still sits in the Senate, making decisions that effect the lives of all New Yorkers. Every woman in New York should be outraged. What kind of role model is he for young people looking at our system and trying to figure out if democracy really works? This bum needs to be expelled from the Senate now!
Having once run a multi-million dollar escort business- a business I'm through with and will never return to-I've seen the battered women syndrome up close. I've helped dozens of women get away from abusive husbands and boyfriends. While not everyone will agree, I always looked at my business as empowering to women and encouraged them to set their own boundaries and make their own way. Hiram will beat up his girlfriend again. In fact, if he get's away with it this time it will only embolden him to do it again when he thinks he is safe and no one is watching.
I wasn't very "political" until I got embroiled in the Spitzer scandal and I experienced first hand the inequities and unfairness of the criminal justice system, which discriminates against women, poor people and those without political influence. How could Manhattan DA Robert Morgenthau send me to Rikers Island for four months and set my bail at $2M for arranging for escorts when Eliot Spitzer who paid for and utilized the services of those escorts walked away scot-free? . . .
When I was finally moved into my housing unit, Closed Custody (CCH), reality began to set in. Here I was in this tiny 8x8 cell with no mirror, no running water, no human interaction of any kind- I had only my thoughts to contend with. And all I thought about was if I would have a life after this experience.
I know that might sound extreme. But, you have to realize that I'm sitting in jail with a $2 million dollar bail for promoting prostitution. There are people in there for robbery and armed assault whose bail is $25,000. H*ll, even my friend Remy Ma who was arrested for assault with a deadly weapon for a shooting, her bail was $250,000. All I could think of is that I'm in jail to keep me silent, because I know too much about some powerful people. . . .
If Eliot Spitzer runs, I will also take the plunge and enter the Democratic Primary for New York State Comptroller. I am confident I can gather the necessary signatures to get on the Primary ballot. . . .
Eliot Spitzer has violated the public trust. His hypocrisy--patronizing escort services while prosecuting others--and his lies about the illegal financing of his campaigns for Attorney General should exclude him from any position of trust.
His black socks in the boudoir are an additional affront to good taste. His abuse of some of the women I arranged for him to spend time with raises serious questions about his character.
If I run, I will advocate the legalization, regulation and taxation of both prostitution and marijuana to solve New York's fiscal problems. Eliot Spitzer, Andrew Cuomo, and Tom DiNapoli offer only tax increases, more borrowing, greater debt and service cuts: I will offer a plan for new revenues from two activities that are going to happen anyway.
Under my plan New York's budget can be balanced without raising taxes on working people or cuts to vital services. Who else can say that?
Prostitution should be legalized for both the public safety and to fill the public coffers. No more Craig's List murders. No more Johns robbed. Regular medical check ups and licensing of service providers by the State.
Millions of pot smokers are prepared to pay taxes on an activity no more dangerous than drinking alcohol, which is legal in New York State. Let people grow their own up to a reasonable amount. Standardize distribution and tax.
I really would like to see a Candidate for Governor articulate this platform.
I [am] ready to match my ideas with the Steamroller- not to mention asking him some pointed questions. I am ready to throw my hat in the ring. I will be the first candidate in New York history to run while on probation. See you at the debates, Eliot.
Clearly, there's a lot of anger there. I think that's the motive (or emotive!) force behind Davis's candidacy. But there's a lot of serious thinking, too.
I know it's almost beyond imagination that a conservative Christian would speak up in behalf of decriminalizing pot or prostitution. But I'm willing to put the case before you. Though I myself have never imbibed marijuana or any other illegal or mind-altering drugs; though I have absolutely no interest in ingesting such things; though I have drunk only the bare minimum of wine upon occasion when social convention--including participation in certain communion services at some Christian churches!--required it; though I have never engaged in any form of pre- or extramarital s*xual intercourse; I find the arguments compelling for the decriminalization of drug use and of prostitution.
Davis's brief but (I think) potent argument is to be found in her article Legalize It! (speaking of prostitution).
If you're more of an auditory than visual learner, check out these pointed interviews on national TV:
Fox News "Your World" (???; sorry, I don't know who the interviewer is):
Sean Hannity:
ABC's "20/20":
Y'know, I think Kristin could be a formidable candidate if she and her campaign manager decided to present her in a more serious and professional light.
On this last point, see the New York Daily News article, Kristin Davis, alleged Eliot Spitzer madam, to run for New York governor with GOP Roger Stone's help. Clearly, a very serious headline, but it is accompanied by a very un-serious news story . . . including a photo showing too much of Ms. Davis' ample cleavage; an opening line about how "'Manhattan Madam' Kristin Davis is tossing her lacy brassiere into the political ring - with the help of one of the GOP's most fearsome strategists"; and the following conclusion, quoting her campaign manager:
"Kristin knows lots of Penthouse Pets," he said. "We'll get four, make them notary publics and have them, suitably attired, collecting signatures at Grand Central Station during rush hour."
Davis is also ready to put her own pulchritude to work, having posed for a topless photo with "pot" written on one arm, "sex" on another and "legalize" across her chest.
"Unlike other candidates, she has nothing to hide," said Stone.
Again, the article begins with a salacious comment (this time about how she "is preparing to throw her sizable bust into the race for the state's highest office"), and it is accompanied by a photo more oriented to selling Ms. Davis' s*x appeal than her business sense, brains, or political platform.
If I lived in New York, and if Davis would actually pursue her candidacy in all seriousness, I could imagine actually voting for her.
She has established her credentials in a couple of areas; she has certainly demonstrated poise and quick wit in her response to some rather antagonistic interviewers; can she demonstrate competency on a wider range of issues?
If so, her campaign could prove very interesting, indeed!
[NOTE: If you are reading this article on Facebook and can't use links or don't see videos, please realize it originally appeared and is still available on my personal blog.]
Problems with Safe Deposit Boxes
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I have been told that you want to stay away from safe deposit boxes for
documents your executor and heirs will need. I.e., store your will, your
living tru...
Husband to the wife of my youth (Proverbs 5:18) * Father of four * Grandfather of thirteen born (twelve still living) * Author of Dating With Integrity * Co-founder and co-owner of InquisiCorp Corporation (Sonlight Curriculum, Ltd. and BookShark homeschool curricula companies
