Thyroid difficulties . . . and the U.S. government

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.
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---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.

I'm astonished at what I have found.

• First--not terribly astonishing, but worth noting: The pharmacist really was "blowing smoke." Armour Natural Thyroid is carefully controlled for potency and purity:
  

  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.

  And even stranger and more inaccurate information from the American Thyroid Association.
  
  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"?
  
• Armour REFORMULATED its thyroid product in the spring of 2009--changing its binders and excipients . . . and causing a bunch of problems for many patients.
  
• Whether Armour thyroid is efficacious or not, it turns out there really is no source of natural thyroid in the United States as of this moment. And, it appears, the FDA may have actually outlawed--or may be in the process of outlawing--the manufacture of this product in the United States, a product that has been on the market and helping people like me for more than 100 years.
  
  The more I have read, the more disturbed I have become at this turn of events.
  
• Despite the shortage here in the United States,
  

  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.

  It took a while, but eventually I discovered the natural thyroid preparation made by Greater Pharma of Thailand: a product that goes by the brand name Thiroyd and available in wholesale quantities at a wonderful price. I also found a Canadian source with very good prices of the ERFA Thyroid and in a wide variety of specific dosages.
  
  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.
  
  A more partisan description comes from the StopTheThyroidMadness website:
  

  [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.

I found the following update in About.com's Thyroid area:

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.

--Natural Desiccated Thyroid Drugs: An Update
March 2010 - - Where Are We Now?

Thorough doctor

I continue looking for help with my rheumatoid arthritis.

The other day, Sarita saw an article in The Week about studies that have shown "a link between certain pollutants, including PCBs and DDT, and conditions such as heart disease, hypertension, diabetes, and rheumatoid arthritis." Moreover, "people who'd lost 22 pounds or more in a decade had the highest levels of pollutants in their bloodstreams."

Hmmmm. I did make an effort, beginning about three years ago, to cut back and lose some weight. Indeed, by the time the rheumatoid started hitting, I had lost a good 30 pounds or so. (The day I hit 199.5, I said to myself, "So far and no further!" I'm now bouncing somewhere between 159 and 163.)

And there is the matter that Jonelle has been going to an ND (Naturopathic Doctor) in hopes of "healing up" or "strengthening up" to be able safely to bring another baby to term.

In evaluating Jonelle's present condition, the doctor discovered she is high in a number of heavy metals . . . and has been giving her certain injections to help remove them from her system. (It's called chelation.)

After reading the article in The Week, Sarita said, "I want you to go to Jonelle's doctor."

So I called the office and set up an appointment, which I kept yesterday afternoon.

Prior to the appointment, however, the doctor sent me a patient profile/health history questionnaire the likes of which I have never seen. Eight pages of fine details.

I thought: "Man! If I didn't have at least a vague idea of why he asks all these questions [except the one where he wants my Social Security #!], I might think he was massively invading my privacy."

After we met, however, I was even more impressed by the thoroughness of his interview and exam. We spent two hours together . . . and I am scheduled to go back in a week for beginning diagnosis and health improvement plan.

*********

While I'm at it, let me share two things he said that struck me during our time together yesterday.

1. "Let me tell you about my philosophy of health. I believe we were created to be healthy. We are supposed to be healthy. We should be able to self-heal . . . if we could only get out of our own way. So when I meet a person who is unhealthy, I ask, 'What is this person doing--or not doing--that is getting in the way?"
   
   He said that he believes good health is based on four legs or foundations:
   
   1. What we ingest--i.e., what we eat or don't eat and what we drink or don't drink.
      
   2. Movement or exercise.
      
   3. Sleep--both quantity and quality. And,
      
   4. What he called Interconnectedness--which includes not only social relations, but spirituality. How are we doing in relation to others (which may include God or the spirit world).
      
   "Take that four-legged bench over there," he said. "With four legs under it, you and I could both sit on it and it will hold us comfortably. Because it has four strong legs.
   
   "If I remove a leg, it will still stand. And, in fact, if I am careful, I could even sit on it and it would hold me. But if I sit in the wrong place, I'm going to collapse it.
   
   "And if it has only two legs? It cannot stand any longer. It will collapse.
   
   "So I want to know how you are doing with your four foundation pillars."
   
2. We got onto the subject of thyroxin--a hormone I have had to take ever since I had my thyroid removed back in the mid-80s as a result of Grave's Disease.
   
   I mentioned to him some of the hassles I have faced as a result of seeking to use natural thyroxin (desiccated and processed bovine or porcine thyroid gland) rather than the synthetic variety. (Natural thyroxin contains the full complement of thyroxin variants--T4, T3, T2, T1 and calcitonin, at least, while the standard synthetic contains T4 only. There is an additional synthetic that includes T3. None for T2, T1, calcitonin, or any of the other minor fractions that may be present--and unstudied--in desiccated thyroid gland.)
   
   My regular doctor, for example, is convinced that synthetic is better. He really doesn't want me to be taking the natural stuff. (I had one doctor who refused to treat me if I refused to take the synthetic. My current doctor was unwilling to help me locate natural thyroxin when the FDA made it almost impossible legally to acquire it last year. Happily, though he is obviously critical of my approach, he lets me "do my thing," as it were.)
   
   My naturopath, yesterday, said he has found, in his practice, that 9 out of 10 patients do better on the natural thyroxin, but, for some reason, one out of 10 seems, actually, to do better on the synthetic. (Point--which I had not considered before: I ought not simply to assume natural is better.)
   
   But what really bothered me was what he had to say about why he believes most doctors prefer to prescribe synthetic hormones.
   
   He referenced John Abramson's Overdosed America as his source.
   
   He said that Abramson shows how the Journal of the American Medical Association has a practice (policy?) of printing only those scientific studies that are critical of the non-synthetic hormones or that show them in a bad light. "There are ten studies showing the efficacy of the natural hormones, but JAMA won't talk about them. But when it gets one study that is critical, it will publish that immediately."
   
   Supposing he had accurately recalled Abramson's data, and supposing Abramson is right, he concluded, "With that kind of input, you really can't criticize mainstream medical doctors for believing that natural hormones are ineffective."

And I wonder: Can't we?

Hey! Let's game the system!

As the rules become clear, the opportunities to push personal responsibility onto the foolish and gullible taxpayers also come to light.

If you don't have a major or chronic illness, forget buying insurance under the new national health care system. Save your money for when you really need it!

Brilliant, easy-to-understand, and mercifully short explanation of how to save thousands of dollars a year in medical expenses now that the government is here to save us all.

What's the word for this?

Oh, yes! "Moral hazard."

Reality begins to make itself known . . .

Since the passage of the new health care legislation, several major U.S. companies, including AT&T, Verizon, Caterpillar, Deere, Valero Energy, AK Steel and 3M, have announced that they expect the law will cost them billions of dollars in higher health care expenses and so they have announced they are taking one-time charges on their first-quarter balance sheets. Democrat leaders accuse them of politicking and have said they would hold hearings in late April to investigate "claims by Caterpillar, Verizon, and Deere that provisions in the new health care reform law could adversely affect their company's ability to provide health insurance to their employees."

I hope they do hold the hearings . . . and that the CEOs will be well-prepared with detailed answers--far more detailed, I expect, than any of their congressional inquisitors might be expected to have!

One corporate lobbyist said the CEO of the firm he represents had attempted to forewarn the president and lawmakers.

My CEO sat with the president over lunch with two other CEOs, and each of them tried to explain to the president what this bill would do to our companies and the economy in general. First the president didn't understand what they were talking about. Then he basically told my boss he was lying.

It will be interesting to see what comes from the hearings!

I expect they will be quite revealing.

Neither Waxman or Stupak . . . had anything more than a cursory understanding of how the many sections of the bill would impact business or even individual citizens before they voted on the bill, says House Energy Democrat staff. "We had memos on these issues, but none of our people, we think, looked at them," says a staffer. "When they saw the stories last week about the charges some of the companies were taking, they were genuinely surprised and assumed that the companies were just doing this to embarrass them. They really believed this bill would immediately lower costs. They just didn't understand what they were voting on."

Do these guys really believe that they and their staff members are able--even in a 3,000-page document--to put together something in a couple of years that is more efficient and effective than what thousands of companies working independently for dozens of years have put together?

These stories are just now beginning to leak.

• Deere announcement;
  
• Caterpillar press release;
  
• Wall Street Journal article;
  
• Editorial in the Las Vegas Review-Journal;
  
• Article in The American Spectator.

A medical story . . . for a bit more than "fun" . . .

I've been using LDN (low-dose naltrexone) for several months as an alternative therapy in hopes of treating my rheumatoid arthritis.

(Report: I'm not sure it's really done all that much good. Actually, I'm not sure how much good anything I'm doing has done. . . . I am quite sure that wheat is bad for me. I'm getting the impression that heavy doses of sugar (as in soda pop) can trigger inflammation. By and large, my inflammation and pain has been kept down to a very dull roar. But is that because I would have experienced a very slow progression of the disease anyway? --I don't know.)

Anyway.

I am continuing on my various therapies, and I continue to read what I can and pursue potential remedies.

So this morning I came across a reference in my Yahoo RheumatoidArthritis-LowDoseNaltrexone group to an article by Dr. Joseph Mercola in The Huffington Post. The article was actually primarily about a Dr. Burt Berkson and Berkson's work with Alpha Lipoic Acid (ALA).

I imagine the reason this article was referenced in the LDN group, however, was this statement:

Dr. Berkson uses ALA along with low dose naltrexone (LDN) for the reversal of a number of more serious health conditions such as:

• Lupus
  
• Rheumatoid arthritis
  
• Dermatomyositis (an inflammatory muscle disease)
  
• Autoimmune diseases 

Most of his patients normalize in about one month on this combination of ALA and LDN.

Whoa! I've been taking both LDN and ALA for quite some time. --I wonder how much ALA Berkson recommends?

So I did a search on burt berkson alpha lipoic acid rheumatoid arthritis and eventually came to Burt Berkson, MD, PhD, Talks With Honest Medicine About His Work and Our Medical System.

Mercola had summarized a bit of Berkson's story when he said,

Early on in his career, while an internist, he was given several patients who were expected to die from hepatitis C. His job was more or less to simply baby sit them in the ICU and watch them die.

But Dr. Berkson was a rebel at heart and he simply couldn't do that. Instead he called an associate at the National Institutes of Health and found out how he could treat them. He learned that alpha lipoic acid had some impressive experimental support. Remarkably, although these patients were expected to die within a few weeks, they all completely recovered!

However not all went well for Dr. Berkson. As he made his superiors look foolish, they simply could not tolerate that so rather than embrace his findings, they actively suppressed the results and made his life miserable for showing them up.

This was a pivotal moment in Dr. Berkson's career and caused him to make choices that eventually led to where he is at now. Since then, Dr. Berkson has lectured all over the world on this topic, and published a study on the use of antioxidants for the treatment of hepatitis C.

His first book, The Alpha-Lipoic Acid Breakthrough was published in 1998.

Well, the article I discovered--actually, an interview--told the whole story, in Berkson's words. Very much more interesting!

DR. BERKSON: I was a resident in internal medicine in a teaching hospital in Cleveland Ohio, and one day the chief of medicine came by and said, "I am very upset with you." And I said, "Why?" (I thought he was kidding.) And he said, "You have no deaths on your service. Most people have seen several deaths by now and you haven't seen any." And I told him that I really try to keep people alive. He said, "It’s very unusual. I’m going to give you two people who will surely die. They have acute and fulminant liver disease. They ate poisonous mushrooms, and the expert on liver disease said we cannot get a transplant for them, and nothing can save them. So I want you to go upstairs, watch them die, take notes and present this to grand medical rounds."

And I went upstairs and I looked at these two very sick people. And as a medical doctor, especially in internal medicine, you're supposed to follow the orders of the chief, just like a private would follow the orders of a sergeant. But I had six years of education above my medical training, for a masters and a PhD in microbiology and cell biology, and I was always looking for new things. So I called Washington and spoke to the head of the National Institutes of Health in Internal Medicine, Dr. Fred Bartter, and I asked him, “Is there anything in the world that he knew of that might regenerate a liver?” And he said he was studying alpha lipoic acid because he knew it would reverse diabetic neuropathy and other complications of diabetes. But when he gave it to people, it seemed to regenerate their organs. It seemed to stimulate their stem cells and to start growing and regenerating new organ tissue.

He sent the lipoic acid to me. I picked it up at the Cleveland airport about three hours later. The commercial pilot handed it to me. I ran back to the hospital and injected it into these two people for a period of two weeks. And in two weeks, they regenerated their livers fully. And they’re still alive and well, in their 80s, thirty some years later.

( NOTE: One of the people whom Dr. Berkson saved by "not following orders," Eunice Goostree, wrote a very personal review of The Alpha Lipoic Acid Breakthrough on Amazon.com.)

I was all excited. Washington was all excited. But the chiefs were not happy with me.

JULIA SCHOPICK: They were actually angry at you?

DR. BERKSON: Well, they seemed to be angry. They said, “We told the families that these people were going to die, that there was no hope. And now they’re alive and well. You know, it makes us look bad. And you did something without asking us for permission.” And I said, “You told me that these people were my responsibility, so I did what I thought was correct.”

I said, “Do you want to know what I did?”

“No.”

JULIA SCHOPICK: They were not even curious?

DR. BERKSON: They said: “This is not an approved drug. And it’s not on our formulary. And you did not follow orders like a good internal medicine doctor.”

I was sort of depressed by this. You know, it was very different from what I had seen as a professor of biology. You know, when I discovered something new in biology, everybody would pat me on the back and give me awards. In medicine, it seemed to me that if you discovered something new, you were sort of thought of as an outlaw.

JULIA SCHOPICK: If I had not heard this story -- I heard you speak at NOHA so long ago, and of course, I read your book -– it’s too depressing.

DR. BERKSON: Well, anyway, more people came in, and I was told I should not do this again. They'd also eaten poisonous mushrooms, which really destroys the liver, and there’s not much you can do for these folks, except a transplant or, in this case, lipoic acid.

And the National Institutes of Health started supporting my work. I think because of that, the people at the hospital I was at had to go along with what I was doing, and eventually Dr. Bartter and I published a paper on 79 people with so-called terminal liver disease, and 75 of them regenerated their livers, with just intravenous lipoic acid.

There was no interest in the United States; almost nothing.

JULIA SCHOPICK: Where was your article published?

DR. BERKSON: My first short note was in the New England Journal of Medicine.

And they weren’t really interested in a big study. My own personal opinion was that it was because there was no large pharmaceutical company sponsoring the work. There was no one to take out ads in the magazines (i.e., the medical journals), or to buy reprints from them.

But, Dr. Bartter and I were invited to Europe to be visiting scientists at the Max Planck Institute and we published it in Europe.

I think you will find the rest of the article equally interesting.

Check it out!
*******
Short political commentary.

Since it is only just over a week since our "representatives" in the federal government agreed to take over medicine in our country, I would like to ask you: do you really want people like the uninquisitive (but, I'm sure, truly compassionate--he was very concerned, for Dr. Berkson's benefit, that Berkson would become familiar with death and dying) . . . --Would you want such a man--the chief of medicine at the teaching hospital in which Dr. Berkson was working-- . . . Would you want such a man to be in charge of your medical care?

It's looking more and more as if that is exactly what you and I are in for.

(I spent many hours a couple of months ago writing a lengthy post about the problems associated with acquiring natural thyroxin here in the United States, but never quite finished it, due to the time it was taking me. --That's just one story, perhaps, that I should yet tell about how our medical options are, even now, and even without nationalized health care, being severely curtailed "from the top." . . . And now, with greater and greater centralization, I'm afraid the squeeze is going to become ever tighter.)

Maybe we're still the land of the brave. Maybe. But we are rapidly becoming the land of the very un-free.

"The Jungle" redux

I've been sitting on this one for a while.

Ever hear that Teddy Roosevelt tossed his sausage out the window when he read a particularly revolting passage in Upton Sinclair's The Jungle at breakfast one morning?

The Roosevelt incident, I'm told, is apocryphal. But the impact of Sinclair's novel is not. It led to the Meat Inspection Act, the Pure Food and Drug Act, and, eventually, to the creation of the federal Food and Drug Administration.

Well, the New York Times broke a new "Jungle" story on December 30th last year. I didn't see it till a week later when Mike Adams of NaturalNews.com picked it up in his article,
Window cleaning chemical injected into fast food hamburger meat
The gist of the story? A certain company, Beef Products, Inc., has come up with what they thought was a brilliant plan to maximize efficient use of every scrap of beef trimming in their meat processing plants. And so, we are told, a majority of the hamburger sold in the United States, including "beef sold to McDonald's, Burger King, school lunches and other fast food restaurants" is being injected with ammonia. Why? Because at high enough levels, ammonia will kill the E. coli, salmonella, and whatever other bugs might be present in these beef scrapings.

The only problem? Well, actually, two:

1) It takes a lot of ammonia to kill the pathogens.

2) High ammonia content leads to customer complaints about taste and smell.

So Beef Products, Inc., has engaged in a not-so-delicate balancing act as it attempts, unsuccessfully, to fulfill its fiduciary duties related to health while it works even harder to avoid the problems of poor aesthetics.

Here's a summary of the story:

Officials at the United States Department of Agriculture endorsed [Beef Products, Inc.]’s ammonia treatment, and have said it destroys E. coli “to an undetectable level.” They decided it was so effective that in 2007, when the department began routine testing of meat used in hamburger sold to the general public, they exempted Beef Products.

With the U.S.D.A.’s stamp of approval, the company’s processed beef has become a mainstay in America’s hamburgers. McDonald’s, Burger King and other fast-food giants use it as a component in ground beef, as do grocery chains. The federal school lunch program used an estimated 5.5 million pounds of the processed beef last year alone.

But government and industry records obtained by The New York Times show that in testing for the school lunch program, E. coli and salmonella pathogens have been found dozens of times in Beef Products meat, challenging claims by the company and the U.S.D.A. about the effectiveness of the treatment. Since 2005, E. coli has been found 3 times and salmonella 48 times, including back-to-back incidents in August [2009] in which two 27,000-pound batches were found to be contaminated. The meat was caught before reaching lunch-rooms trays.

In July, school lunch officials temporarily banned their hamburger makers from using meat from a Beef Products facility in Kansas because of salmonella — the third suspension in three years, records show. Yet the facility remained approved by the U.S.D.A. for other customers. . . .

The company says its processed beef . . . is used in a majority of the hamburger sold nationwide. But it has remained little known outside industry and government circles.

Federal officials agreed to the company’s request that the ammonia be classified as a “processing agent” and not an ingredient that would be listed on labels. . . .

Besides the fact that the USDA itself has gotten involved in a cover-up of sorts, reclassifying ammonia as a "processing agent," I think it might be helpful to consider what Beef Products' "processed beef" is really all about.

It's hamburger--"ground beef." Right?

Well. Not quite. . . .

The author of the New York Times article offered this mild description: "a mashlike substance frozen into blocks or chips." A USDA microbiologist, obviously not impressed with the . . . ahem . . . "product," described it a bit more graphically back in 2002. He called it "pink slime."

But what is in this "mashlike substance," this "pink slime," besides the "processing agent" that has now been revealed as ammonia?

Let's see . . .

It includes "fatty slaughterhouse trimmings" which includes "most of the material from the outer surfaces of the carcass" and, along with such "material," since E. coli and salmonella are more prevalent in fatty trimmings than in higher grades of beef, "larger microbiological populations."

And how does Beef Products, Inc. process these "materials"?

Well, they liquefy the fat and use a centrifuge to extract what protein they can. Then they send this mash "through pipes where it is exposed to ammonia gas, and then flash frozen and compressed."

The Times article, I think, makes clear: Beef Products, Inc. has permitted aesthetics to beat safety for many years, and only after the Times pursued the story did the USDA finally decide to rouse itself and reconsider whether maybe Beef Products, Inc. and its strange product ought to receive inspections like all its competitors do.
*******
See what industrial food companies--and the U.S. government--will do to save three cents a pound on beef. Read p. 4 in the New York Times story.

But for another view of industrial food production, see this article from USA Today. --Interesting!

Follow-up to DCA post

You may recall my post on a potential semi-universal cure for cancer.

One of my readers contacted a professional cancer researcher, a friend-of-a-friend, who offered the following input:

• A quick literature search indicates that there have been promising in vitro studies (using cells grown on plates) which show cancer cells dying after treatment. However,
  
• In vivo there has only been one animal study using rats to show a decrease in tumor size (one lab did it with Michelakis as first author on the paper).
  
• Keep in mind that nothing is really believable until it can be replicated in other labs.
  
• Many other papers indicate that ingestion of DCA in mice caused liver cancer and another showed damage to peripheral nerves.
  
• Basically, there are no human or even monkey studies to support the claims of DCA being a safe and effective drug for cancer treatment.

The same researcher then forwarded original versions of two articles:

1. A popular article from Nature magazine, written in March 2007 (almost three years ago, and just a month after the DCA story first came out in the scientific press: Cancer patients opt for unapproved drug

and,

2. An academic (but relatively readable) article by Dr. Michelakis, the researcher who first brought DCA to the attention of cancer researchers: Dichloroacetate (DCA) as a potential metabolic-targeting therapy for cancer. (This article was published in September 2008, but was first received for publication in December 2007.)

The first article takes a generally antagonistic stance toward patients who would ingest "unapproved" drugs:

Jim Tassano, who owns a pest-control and marketing company in Sonora, California, came across DCA when researching alternative cancer therapies to help his dying ballroom-dance instructor. He wanted something that was effective, safe and that he could lay his hands on: DCA fit the bill. He ordered some from chemical supply companies, teamed up with a chemist friend and they worked out a way to synthesize the compound themselves. “I couldn’t walk away from it,” Tassano says. “It could do so much good for so many people.”

Tassano set up two websites. The first of these (thedcasite.com) hosts information on DCA and a patient chatroom. On the second (buydca.com) Tassano is selling his homemade DCA. . . . Many patients taking DCA — acquired from Tassano, chemical companies or other sources — are reporting their progress on thedcasite.com.

And the problem with this, according to Dr. Michelakis and others?

Although DCA seems safe overall, they point to a clinical trial that was stopped early because those taking the drug developed damage to their peripheral nerves (P. Kaufmann et al. Neurology 66, 324–330; 2006). Without a control group, they point out, it will be impossible to tell whether any improvement in the patients’ condition is caused by the drug. Patients could also be taking DCA that is not of pharmaceutical grade and might contain harmful impurities.

Michelakis says the patients could end up undermining efforts to do a controlled clinical trial if, for example, some develop harmful side effects and the drug earns a bad reputation. “It’s destroying efforts to do this right,” he says. “Any way you look at this, it’s a negative development.”

"Any way you look at it," it's a negative development? From the perspective of the patients who have, otherwise, been given no hope?

The article's author continues:

The battle between dying patients who want immediate access to unapproved drugs and doctors who urge trials and caution is a perennial one. Some patients argue that they cannot wait for trials and should have the right to take unapproved drugs, regardless of the risks.

But there are arguments against this. An estimated 95% of cancer drugs that enter clinical trials do not get approval, many because they are ineffective or unsafe, so patients risk shortening their life or making their last days more uncomfortable.

Okay. But shouldn't it be up to the patients themselves to determine whether they are willing to take the risks? On what grounds should that decision be left to the government or the "powers that be" who get to "approve" drugs for trial?

Oh. And then there's another argument "against" permitting patients to make their own decisions about whether to use "unapproved" drugs:

[I]f patients can access DCA — or other unapproved drugs — there is no incentive for them to enter a clinical trial. So in terms of public health, ethicists argue, more people will be helped if access to unapproved drugs is restricted and proper trials performed.

So, apparently, selflessness is to be mandated by law. You must, by law, sacrifice yourself for the potential of helping others--"one day, maybe, long after you're dead, if we can just get the funding."

Peter Jacobsen, an expert in ethics, health and law at the University of Michigan in Ann Arbor, doubts whether any good can come of the patients’ efforts. They are so desperate to see results, he says, that there is no way they can report unbiased results and no mechanism to ensure the reports are accurate. “I don’t trust the data,” he says. “It’s hard enough to rely on them in clinical trials, let alone this.”

Okay. I'll buy that. I'll buy the need for caution and the need for skepticism. But . . .

Then I read Michelakis' article.

Remember that clinical trial that was "stopped early because those taking the drug developed damage to their peripheral nerves"? Michelakis notes,

[T]he first two randomised control trials of chronic oral therapy with DCA in congenital mitochondrial diseases were reported in 2006. In the first, a blinded placebo-controlled study was performed with oral DCA administered at 25 mg kg^-1 day^-1 in 30 patients with MELAS syndrome (mitochondrial myopathy, encephalopathy, lactic acidosis and stroke-like episodes) (Kaufmann et al, 2006). Most patients enrolled in the DCA arm developed symptomatic peripheral neuropathy, compared with 4 out of 15 in the placebo arm, leading to the termination of the study.

Whoa! Sounds bad!

But he continues:

Seventeen out of 19 patients had at least partial resolution of peripheral neurological symptoms by 9 months after discontinuation of DCA. . . . No other toxicities were reported.

Beyond this,

It is important to note that peripheral neuropathy often complicates MELAS because of primary or secondary effects on peripheral nerves; for example these patients also have diabetes and diabetes-related peripheral neuropathy.

And then,

In contrast [to the negative results of this one study that was terminated], another randomised placebo-controlled double-blinded study failed to show any significant toxicity of DCA, including peripheral neuropathy. In this study only one of 21 children with congenital lactic acidosis treated with DCA orally at 25 mg kg^-1 day^-1 for 6 months demonstrated mild peripheral neuropathy. Serial nerve conduction studies failed to demonstrate any difference in incidence of neuropathy in the 2 arms (placebo vs DCA). Sleepiness and lethargy, muscular rigidity of the upper extremity and hand tremor were reported in one patient in each group (Stacpoole et al, 2006).

So what is Michelakis' view of the divergent results with respect to neuropathy?

The higher incidence of peripheral neuropathy in adult MELAS patients may represent an intrinsic predisposition to this complication in MELAS or its associated conditions, that is, diabetes mellitus; this toxicity might also be age-dependent. . . . [Moreover, a]s peripheral neuropathy is a frequent complication of taxane, platinum and vinca-alkaloid chemotherapies, the risk for DCA-associated peripheral neuropathy may depend on whether cancer patients have prior or concurrent neurotoxic therapy. . . . [But i]n summary, peripheral neuropathy is a potential side effect of DCA that appears to be largely reversible.

I want to quote one more section from Michelakis' article. Before I do, however, I would like to add some weight to what he said in the section I have just quoted. One of the moderators on thedcasite.com, Jay C, comments,

Researchers at the University of Alberta have reported that DCA is relatively non-toxic, since it has already been used as a medicine on adults and children to treat metabolic disease, and for hypertension. It has been known to have some mild side effects in a minority of patients and they include a change in gait [and] some nerve problems, but both of these symptoms appear to be reversible upon cessation of DCA. This is certainly in positive contract to most of the poisons being administered today as "chemo", including IL-2 (requires on[e] week in ICU), Interferon, and DTIC.

So why the apparently special concern over possible complications from DCA? Is it really scientific objectivity at work here? Or, possibly, something else? [Fear of losing power on the part of gatekeepers like the FDA? Fear of lost profits on the part of major pharmaceutical companies? "The preclinical work on DCA (showing effectiveness in a variety of tumours and relatively low toxicity) (Bonnet et al, 2007), its structure (a very small molecule), [and] the low price (it is a generic drug) . . ., provide a strong rationale for rapid clinical translation," Michelakis says early in his article. Oh. I should probably include the last comment that I elided from the immediately preceding quote. One other factor that ought to provide a rationale for rapid clinical translatioin? " . . . and the fact that DCA has already been used in humans for more than 30 years" (presumably without notable safety concerns).]

The concluding paragraph in Michelakis' article adds another note of interest to this reader:

[E]ven if DCA does not prove to be the ‘dawn of a new era’ (Pan and Mak, 2007), initiation and completion of clinical trials with a generic compound will be a task of tremendous symbolic and practical significance. At this point the ‘dogma’ that trials of systemic anticancer therapy cannot happen without industry support, suppresses the potential of many promising drugs that might not be financially attractive for pharmaceutical manufacturers. In that sense, the clinical evaluation of DCA . . . will be . . . [a] paradigm shift.

While I'm at it, I ought to include one last note. A "Note to Proof" appended by the editors of the British Journal of Cancer at the end of Michelakis' article:

Since the acceptance of this review two important papers have confirmed the novel anticancer effects of DCA in prostate and endometrial cancers: Wong JY et al, Dichloroacetate induces apoptosis in endometrial cancer cells. Gynecol Oncol June 2008; 109(3): 394–402 and Gao et al, Dichloroacetate (DCA) sensitizes both wild-type and over expressing Bcl-2 prostate cancer cells in vitro to radiation. Prostate 1 August 2008; 68 (11):1223–1231.