Mercury Fillings--The FDA Forced to Change its Position

I received an email tonight with fantastic news. After 30 years of defending the use of toxic mercury fillings, the FDA is being forced to restate its position. A team of lawyers and consumer advocacy groups should be thanked for working tirelessly to help protect the public. Below is the email I received, which was written by Charles G. Brown, National Counsel for Consumers for Dental Choice.

If you have mercury amalgam fillings, you should speak to a dentist who specializes in mercury-free dentistry to see if you should have yours removed. You should also consider being tested for mercury accumulation in your body. Mercury toxicity can cause anxiety, autoimmune diseases, depression, fatigue, hair loss, insomnia, irritability, memory loss, recurrent infections, restlessness, tremors and ulcers.

To learn more, read the article, "Heavy-Metal Toxicity--With Emphasis on Mercury" and accompanying patient handout, "Toxic Metal Contamination: Mercury." These were written by Drs. John Neustadt, ND and Steve Pieczenik, MD, PhD and published in 2007 in the journal, Integrative Medicine.

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And now, here is the email message written by Charles G. Brown:

We have won our ten-year battle to get the Food and Drug Administration to comply with the law and set a date to classify mercury amalgam.

On Monday, we settled our lawsuit, Moms Against Mercury et al. v. Von Eschenbach, Commissioner, et al . FDA will finish classifying within one year of the close of the public comment period on its amalgam policy, that is, by July 28, 2009.

There’s more good news. During a several hour negotiation session, FDA agreed to change its website on amalgam -- dramatically. Gone, gone, gone are all of FDA’s claims that no science exists that amalgam is unsafe, or that other countries have acted for environmental reasons only, or that the 2006 Scientific Panel vote affirmed amalgam’s safety. Instead -- see http://www.fda.gov/cdrh/consumer/amalgams.html -- FDA has moved to a neutral course, while recognizing the serious health concerns posed by amalgam in particular for children and unborn children, for pregnant women, for those with mercury immuno-sensitivity or high mercury body burdens. FDA now states, for example:

“Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetus.”

“Pregnant women and persons who may have a health condition that makes them more sensitive to mercury exposure, including individuals with existing high levels of mercury bioburden, should not avoid seeking dental care, but should discuss options with their health practitioner.”

Perfect? No. A 180-degree reversal from FDA’s 30-year policy of protecting mercury fillings? Absolutely.

To change FDA policy, we tried petitions, Congressional hearings, state fact sheet laws, Scientific Advisory Committee hearings, and letters galore -- to no avail. So in the great American tradition, we sued. The case came to a head this spring. On April 22, working with Johann Wehrle and Gwen Smith, I filed a motion for an injunction before Judge Ellen Huvelle. Three sets of briefs later, the government and I presented our oral arguments on May 16. In a crucial ruling, Judge Huvelle ruled that our 11 plaintiffs -- the diverse group listed below -- have standing. She said FDA should classify, and invited the two sides to mediate. On May 30, before Magistrate Judge John Facciola, Bob Reeves (who flew in from Lexington KY) and I hammered out an agreement with FDA officials and lawyers.

The impact of the re-writing of its position on amalgam can hardly be understated. FDA’s website will no longer be cited by the American Dental Association in public hearings. FDA shows awareness of the key issues involved. As it prepares to classify amalgam, FDA has moved to a position of neutrality. Indeed, having repeatedly raised the question of amalgam’s risk to children, young women, and the immuno-sensitive persons in its website, I find it inconceivable that FDA will not in some way protect them in its upcoming rule.

PS 1: Our talented (and pro bono publico ) legal team includes Consumers for Dental Choice president Sandy Duffy, Bob Reeves, Johann Wehrle, Sandra Keech, Mike McClory, and Gwen Smith; Larry Pilot served as legal advisor on the FDCA.

PS 2: Great appreciation to our gutsy plaintiffs, a team of four nonprofit groups, two public officials, three dental professionals, and two consumer victims: Moms Against Mercury (Amy Carson and Angela Medlin), Connecticut Coalition for Environmental Justice (Dr. Mark Mitchell), Oregonians for Life (Mary Starrett), mercury expert Michael Bender (in his capacity as Commissioner of a Vermont advisory board on mercury), Arizona Senator Karen Johnson, Dr. Andy Landerman, Dr. Corrie Crowe, dental assistant Karen Palmer, consumer advocates Linda Brocato and Anita Vazquez Tibau, and (of course) Consumers for Dental Choice.

More Bad News for The Pharmaceutical Industry--A Broken Paradigm

Note: This blog is a reprint of a Guest Opinion piece written in August 2007 by Drs. John Neustadt and Steve Pieczenik, and published in the Bozeman Daily Chronicle.

The news for the pharmaceutical industry has been very bad lately. A study published in the August 2007 issue of the Journal of the American Geriatrics Society conclude that people who use the histamine-2 receptor antagonists (“H2 blockers”) medications that block stomach acid, which include Zantac, Prilosec and Tagamet, have a nearly 250% increased risk of dementia.

Just a few months earlier, in May 2007, the US Food and Drug Administration (FDA) issued a warning for the diabetes medication, Avandia, which was shown to increase the risk of heart attacks by 30-40 percent, and last year the Journal of the American Medical Association (JAMA) reported that the risk of hip fracture increases by 22% after one year and nearly 60% after four years in people taking proton-pump inhibitors, another class of stomach acid blocking medications that includes Prilosec, Nexium, Prevacid. These revelations are just the surface of a very serious problem in the American healthcare system that are putting millions of people at risk.

This story of medications causing dangerous, sometimes fatal, adverse effects is not new. Another JAMA study in 1998 concluded that fatal drug reactions for hospital patients “appear to be between the fourth and sixth leading cause of death,” and that the rate of fatal drug reactions had been stable for the past 30 years, killing more than 100,000 people annually. We don’t want to give the impression that we condemn pharmaceuticals; however, the data are clear, medications can be very dangerous as well as very helpful. One has to always balance out the potential risks with the potential benefits, and that discussion should always be between you and your physician.

It’s not even that pharmaceuticals per se are the culprit, but it’s the underlying paradigm in medicine that needs to be changed. The current philosophy underlying medicine today is that diagnoses are based on symptoms and treated with medications to simply suppress the symptoms instead of identifying and treating the underlying causes of disease. For example, depression is treated conventionally by prescribing antidepressant medications, which, while they may be very helpful, do nothing to correct the underlying biochemical causes of the depression. Taking Prozac may lift someone’s mood and help them through a difficult period, but no one has a deficiency in Prozac.

In contrast, a medical system that approaches diseases by first evaluating the underlying biochemical causes of the disease and then correcting them using targeted biochemical therapies, can correct the underlying causes. The biochemical pathways for depression are well documented. Without being too complicated, the mood-lifting hormone serotonin is produced in the body by transforming the amino acid tryptophan into serotonin, and requires vitamin B6 and magnesium to do so. There are other relevant pathways for generating mood and energy, but this simple example illustrates a central point about the underlying biochemical dynamics of depression.

The concept of causality versus symptoms is a major shift in paradigm, which the pharmaceutical companies and the medical profession in general have not accepted. The premises for this new biochemical medicine are simple:

• Premise 1: health and disease are biochemical;
• Premise 2: if someone was healthy and they’re not now, something’s changed in their biochemistry;
• Premise 3: if you identify and treat the underlying biochemical dysfunction(s), disease may be prevented and cured.

Dr. Pieczenik’s case is a perfect example. Several years ago he was diagnosed with mature-onset asthma, for which he was prescribed steroids and an inhaler. He refused to take these medications because he knew that they would cause their own adverse effects. Instead, he made an appointment with Dr. Neustadt, who ordered a comprehensive biochemical screen that tested more than 450 variables of biochemical function. Biochemical testing revealed the underlying cause for Dr. Pieczenik’s asthma. His symptoms resulted from an inability to produce the hormone epinephrine, which is a bronchodilator, because he became deficient in copper, which is required to convert the amino acid tyrosine to epinephrine. Within two weeks of starting the therapy to realign his copper, all of his breathing difficulties stopped and he has had no breathing problem since then.

The problems with the pharmaceutical industry and our current medical system stem from an inherently incorrect philosophy where symptoms are treated and not their causes, and medical testing does not evaluate the underlying biochemical causes of disease.

These revolutionary concepts in medicine and how they can help you are described in great detail in the book, A Revolution in Health through Nutritional Biochemistry, written by Drs. Neustadt and Pieczenik. It is available on Amazon.com.

About Drs. Neustadt and Pieczenik
John Neustadt ND studied naturopathic medicine at Bastyr University, is clinic director of Montana Integrative Medicine (www.montanaim.com) and president of NBI Testing and Consulting Corp (NBITC, www.nbitesting.com) and Nutritional Biochemistry, Inc. (NBI, www.nbihealth.com) in Bozeman, Mont. He is an editor of the next edition of the textbook, Laboratory Evaluations for Integrative and Functional Medicine, and the author of the books, Thriving through Dialysis with Jonathan Wright, MD and A Revolution in Health through Nutritional Biochemistry with Steve Pieczenik, MD, PhD.

Steve Pieczenik MD, PhD, trained at Cornell, Harvard and MIT. He is a board certified psychiatrist, was a board examiner in neurology and psychiatry and is chairman of NBITC and NBI.

Oprah's Thyroid

My wife Romi, a big Oprah fan, showed me the October 2007 issue of O Magazine, in which she discussed her recent struggle with hypothyroidism (low thyroid function). Oprah's public discussion of her health issues has brought widespread attention to this condition. Thyroid hormone is sometimes called the "master hormone" since it affects every system in the body. That's why I wanted to spend some time educating my readers about this essential element to good health.

The thyroid gland is a butterfly-shaped gland at the base of the neck. It produces the thyroid hormones levothyroxin (T4) and triiodo-thyronine (T3). About 80% of thyroid hormone is T4 and about 20% is T3. T4 is inactive and is converted into active T3 in different tissues in the body.

This is why low thyroid function can cause such wide-ranging symptoms. According to the Merck Manual, the American Association of Clinical Endocrinologists, and the Thyroid Foundation of America symptoms of hypothyroidism in adults include feeling cold; depression; fatigue; weight gain; inability to lose weight; coarse, dry hair that is brittle and falling out; constipation; dry, coarse skin; puffiness or swelling around the eyes; joint aches; restlessness; forgetfulness; decreased sex drive; and more frequent infections. And this is just a partial list. Low thyroid function can also occur in neonates and children, which requires immediate medical attention as it can cause stunted growth and developmental delays.

Within adults there are two general categories of hypothyroidism--autoimmune and non-autoimmune. An autoimmune condition is one where the immune system attacks the person's own tissues. Autoimmune thyroid dysfunction is called Hashimotos Thyroiditis after the doctor who discovered it in 1912. There appears to be a genetic link, as Hashimoto Thyroiditis tends to run in families. Therefore, if a relative of yours has been diagnosed with an autoimmune thyroid condition and you are experiencing any of the symptoms above, you may want to get your thyroid tested. More on thyroid testing in a moment.

If the reason for low thyroid function is not an autoimmune condition, there are several explanations. First, some medications and diseases may decrease thyroid function. Second, it may be that the conversion of T4 (inactive thyroid hormone) to T3 (active thyroid hormone) is not happening well enough. This conversion requires the minerals selenium and zinc. If a person is deficient in either of these nutrients, they could have difficulty creating T3. This condition is called "functional hypothyroidism" because your thyroid gland is producing enough of the thyroid hormones, but they're not being transformed into the active form. Additionally, high levels of cortisol, a stress hormone secreted when people are under stress, inhibits the creation of T3.

Finally, thyroid hormones come from the phenylalanine, an essential amino acid, meaning that your body cannot produce it, but that it must be ingested from food or dietary supplements. Phenylalanine is transformed in the body to tyrosine, which requires iron, and then down its pathway to form thyroid hormones.

While there can be many different explanations for the myriad symptoms associated with hypothyroidism, a comprehensive thyroid evaluation includes a physical exam and blood tests for TSH (thyroid stimulating hormone), Free T4, Total T3, red blood cell intracellular selenium and zinc, serum ferritin (the most sensitive laboratory indicator of iron deficiency) and plasma amino acids. If an autoimmune hypothyroid condition needs to be ruled out, then your doctor will order an antithyroglobulin antibody and antithyroid microsomal antibody blood tests.

Unfortunately, conventional medical screening for thyroid function does not test for the actual thyroid hormones themselves or for any of the nutritional factors required to produce and activate thyroid hormones. Instead, the standard screening test for low thyroid function is a measurement of TSH, which is actually produced in a region of the brain called the anterior pituitary gland. Its role is to stimulate the production T4 and T3 in the thyroid gland. In "functional hypothyroidism" the TSH and T4 are normal, but the T3 is low. This may simply be due to low selenium or zinc.

People who only receive the conventional medical workup can experience depression, fatigue, difficulty losing weight, and frequent coldness when the underlying cause may be low thyroid function because of nutritional deficiencies and/or chronic stress. I have had many cases of people with normal TSH, normal T4 and low T3, which have been corrected by identifying nutritional deficiencies and prescribing those nutrients to the patients.

This leads me to the interpretation of the TSH test. Many labs are still relying on the old reference range, which has an upper limit of normal of 5.0. An elevated TSH is the laboratory criteria for diagnosing hypothyroidism. However, what is considered "normal" has been changing. In 2002 the American Association of Clinical Endocrinologists (AACE) recommended that upper limit of normal be lowered to 3.0, and also in 2002 the National Academy of Clinical Biochemistry (NACB) suggested the correct upper range of normal will someday be lowered to 2.5.

Many clinicians use a combination of laboratory values and symptoms to determine when to treat, and most, including myself, will consider prescribing thyroid replacement hormone when the TSH is 2.5-5.0 when the patient is symptomatic and other causes are ruled out. If your TSH is greater than 2.5 and you are symptomatic, you may want to discuss with your doctor if it's appropriate to try low-dose thyroid replacement hormone.

The thyroid gland is incredibly important. If you have not been getting regular thyroid tests at your annual physicals, I recommend you do so. At the very least, get your TSH checked regularly.

(Note: Dr. Neustadt was voted as one of the leading thyroid doctors in the Thyroid Top Doctors Directory.)