Hope for Patients with environmental illnesses? Bill to Fund Neuroendocrine Immune Disorder Center of Excellence in New Jersey 

The New Jersey Assembly has unanimously passed Assembly Resolution 202 to fund a Center of Excellence in New Jersey for Chronic Neuroendocrine Immune Disorders – which include CFS, FM, MCS and related illnesses. The bill is now going to the New Jersey House as Senate Resolution 133. 

The Research Center would be dedicated to ME/CFS, Fibromyalgia, Gulf War Illness, Lyme disease, Multiple Chemical sensitivity and other environmental illnesses 

SENATE RESOLUTION No. 133

STATE OF NEW JERSEY

213th LEGISLATURE

INTRODUCED JUNE 22, 2009

Sponsored by: 

Senator CHRISTOPHER “KIP” BATEMAN

District 16 (Morris and Somerset)

Senator LORETTA WEINBERG

District 37 (Bergen)

SYNOPSIS

Urges Governor and memorializes Congress to encourage establishment of research center in New Jersey dedicated to chronic neuroendocrine immune disorders.  

CURRENT VERSION OF TEXT

As introduced. 

A Senate Resolution urging the Governor and memorializing Congress to encourage the establishment of a research center in New Jersey dedicated to chronic neuroendocrine immune disorders. 

Whereas, Neuroendocrine immune disorders (NEIDs) currently include Chronic Fatigue Syndrome/Myalgic Encephalopathy, Fibromyalgia, Gulf War illness, Lyme disease, Multiple Chemical Sensitivity Syndrome, and other environmental illnesses; and 

Whereas, Chronic Fatigue Syndrome/Myalgic Encephalopathy, Fibromyalgia, Gulf War illness, Lyme disease, and Multiple Chemical Sensitivity Syndrome have been characterized as being as disabling as Chronic Obstructive Pulmonary disease, End-stage Renal failure, and Rheumatoid Arthritis; and as life-impairing as Multiple Sclerosis, AIDS, and cancer chemotherapy treatments; and 

Whereas, The mechanisms of transmission of NEIDs include parasite-borne infections; and 

Whereas, The similarity of symptoms of NEIDs imply a common pathophysiology of these illnesses; therefore, discoveries and advances made in the etiology and treatment of any one of these illnesses will be applicable and beneficial to the other NEIDs because of their common pathophysiology; and 

Whereas, An estimated 20 million American adults and children suffer with NEIDs; and 

Whereas, The time from illness onset to diagnosis of NEIDs is approximately three to seven years, except for Lyme disease which may take decades to diagnose; and

Whereas, There is mounting evidence of similarities of presentation and origins of NEIDs with Autism, Alzheimer’s disease, Multiple Sclerosis, Lupus, Parkinson’s and other autoimmune diseases; and   

Whereas, Having a research center in this State is essential to: promoting research into the etiology of, and therapeutic interventions for, NEIDs; establishing treatment protocols and providing patient care for all individuals in the State of New Jersey afflicted with NEIDs; serving as a repository for NEIDs research data, patient data and research publications; serving as a resource for NEIDs researchers by sponsoring scientific meetings and encouraging discourse among researchers; serving as a tertiary resource for both physicians and patients in their efforts to manage NEIDs; and advancing both NEIDs research and patient care by disseminating the most recent advances in NEIDs research, diagnostics and treatment protocols; now, therefore,

Be It Resolved by the Senate of the State of New Jersey:

1.    This House urges the Governor to encourage the establishment of a research center in this State dedicated to chronic neuroendocrine immune disorders. 

2.    This House respectfully memorializes Congress to encourage the establishment of a research center in this State dedicated to chronic neuroendocrine immune disorders. 

3.    Duly authenticated copies of this resolution, signed by the President of the Senate and attested by the Secretary thereof, shall be transmitted to: 

a.     Governor Corzine and the Commissioner of Health and Senior Services; and

b.    The Majority and Minority Leaders of the United States Senate, the Speaker and

Minority Leader of the United States House of Representatives, and to every member of the United States Congress from this State.

STATEMENT

This resolution urges the Governor and respectfully memorializes Congress to encourage the establishment of a research center in New Jersey dedicated to understanding and treating chronic neuroendocrine immune illnesses (NEIDs) such as Chronic Fatigue Syndrome/Myalgic Encephalopathy (CFS/ME), Fibromyalgia, Gulf War illness, Lyme disease and Multiple Chemical Sensitivity Syndrome. 

It is estimated by the Centers for Disease Control and Prevention (CDC) that CFS/ME affects between one and four million Americans and that 85% of individuals suffering with this debilitating and disabling illness have not been properly diagnosed.  The economic impact and loss of worker productivity in the United States due to CFS/ME, alone, is estimated to be over $9 billion per year.  Census data, and the incidence rate of CFS in the United States, projects that an estimated 28,000 to 30,000 citizens of New Jersey will suffer from CFS/ME.  The symptoms of CFS/ME include flu-like symptoms (sore throat, fever, chills, tender neck and armpit lymph nodes, unrefreshing or non-restorative sleep, headaches, and post-exertional malaise lasting more than 24 hours), as well as body-wide muscle and joint pain, cognitive impairment, and short term memory loss. 

The CDC reports that Fibromyalgia (FM) affects five million women, men, and children in the United States.  FM is a condition characterized by body-wide muscle pain, tender points, sleep disturbance, cognitive impairment (“fibro-fog” or “brain fog”), overwhelming fatigue, swelling, joint pain, non-restorative sleep and migraine headaches. 

According to the Research Advisory Committee on Gulf War Veterans’ Illnesses, Gulf War illness (GWI) is estimated to affect between 175,000 to 200,000 U.S. veterans, some of whom have been suffering for over 17 years.  GWI is characterized by multiple, diverse symptoms that include a combination of memory and concentration problems, chronic headache, unexplained fatigue, widespread pain, chronic digestive problems, respiratory symptoms, and skin rashes. 

The CDC has announced that Lyme disease is the fastest-spreading infectious disease in the United States, and that New Jersey ranks third in the nation for reported cases of Lyme disease. Yet, Lyme disease is seriously underreported in the United States.  Current literature suggests that co-infections associated with Lyme disease play a major role in precipitating chronic illness with symptoms that include flu-like symptoms, extreme fatigue, skin rashes, unexplained weight gain or loss, other endocrine disorders, urinary problems, sexual and reproductive dysfunction, gastrointestinal dysfunction, heart problems, joint pain or swelling, muscle twitching and muscle pain, peripheral neuropathy, vision and/or hearing problems, disorientation, psychiatric disorders, cognitive dysfunction, disturbed sleep, and poor balance. 

Multiple Chemical Sensitivity Syndrome and other environmental illnesses are estimated to affect 10% of the American population.  These illnesses have a variable, and overlapping presentation with other NEIDs, and have symptoms that include any combination of extreme fatigue/lethargy, muscle/joint pain, sleep disturbances, headaches/migraine headaches, sensitivity to light and noise, dizziness/vertigo, poor memory/poor concentration, nausea/digestive problems, sore throat, constant coughing, wheezing, skin rashes or burning/stinging eyes.

Selenium is an essential trace element with antioxidative, antimutagenic, antiviral and anticarcinogenic properties.  

There is increasing evidence that the dietary selenium intakes are sub-optimal in the populations of many countries and that human cancer mortalities would significantly decline if additional selenium was made available either through supplementation or the fortification of certain foods. An important property of selenium is its interaction with other elements that may be present in foods, the water, the workplace and the environment, e.g. As, Cu, Ni, Co, Cr, Mn, Zn, Cd, Sn, Pb, Hg, Bi, Mo, Ag, Au, etc.  

The sequestration of elements by selenium represents an efficient natural detoxification mechanism for some of these elements but also results in the physiological inactivation of selenium.  

Animal experiments confirm that the chronic exposure to low levels of these elements abolishes the cancer-protective effect of selenium. Human cancer is likewise significantly determined by the interactions of selenium with other elements, as evidenced by epidemiological, ecological and case-control studies. Cadmium, for example, is a key risk-increasing element for prostate cancer; for breast cancer, Cd, Cr, Zn are mainly contributing; for bronchial cancer (in smelter workers), Cd, As, Cr, Sb, Co, La, all these elements are in a reciprocal relationship with Se.  

While selenium remains the key cancer-protective trace element, the interpretation of its mode of action necessitates consideration of the effects of selenium antagonistic elements. 

Reference: Schrauzer GN., Selenium and selenium-antagonistic elements in nutritional cancer prevention, Department of Chemistry and Biochemistry, University of California-San Diego, La Jolla, CA, USA., Crit Rev Biotechnol. 2009;29(1):10-7

PET scans critical for early, accurate diagnosis and treatment of dementia, say researchers at SNM’s 56th Annual Meeting  

TORONTO—A new study shows that the use of positron emission tomography (PET) scans may improve the accuracy of dementia diagnoses early in disease onset for more than one out of four patients. The results were presented at SNM’s 56th Annual Meeting.  

Early, accurate diagnosis of dementia is critical for providing the best available courses of treatment and therapies in the beginning stages of disease, when treatments can be most effective. PET scans enable physicians to identify the neurological conditions underlying each patient’s mental decline and choose appropriate courses of treatment.

 “Routine clinical assessments do not accurately identify the root causes of dementia in the early stages,” said Kirk A. Frey, a physician with the University of Michigan Hospitals’ Division of Nuclear Medicine and lead author of the study. “Our preliminary results clearly indicate that molecular imaging technologies, such as PET scans, can help diagnose a patient’s specific type of dementia. This is critical for providing the best possible care. Additionally, PET’s ability to pinpoint neurological underpinnings of different forms of dementia could lead to new, more targeted drugs and therapies.”

More than 5 million people each year are newly diagnosed with dementia, a disease that takes many forms and includes memory loss or other mental impairments that interfere with daily life. The most common type of dementia is Alzheimer’s disease. Other types include frontotemporal dementia, which affects the frontal and temporal lobes of the brain, and Lewy body dementia, which involves degeneration of dopamine nerves in addition to the temporal and parietal lobes. Although these types of dementia have different causes, patients can express similar symptoms in the early stages, making accurate diagnosis difficult. Providing appropriate treatments and therapies as early as possible can avoid unnecessary, and sometimes severe, side-effects and complications.  

The new study identified 66 patients with mild dementia or mild cognitive impairment who were evaluated through standard neurological testing and anatomic brain imaging. Three clinical experts reviewed the results of these data to make diagnoses of either Alzheimer’s disease, frontotemporal dementia or dementia with Lewy bodies. Patients then underwent PET scans for amyloid deposits and for dopamine nerve integrity. Patients’ initial diagnoses changed more than 25 percent of the time after PET imaging. PET scans provided images of important signals for disease that other examinations missed, such as deposits of amyloid plaque, which are a common indicator of Alzheimer’s disease, and damage to dopamine nerves in Lewy body dementia.  

The study will track patients for two years to confirm the accuracy of their diagnoses. 

Reference:

Scientific Paper 251: K. Frey, J. Burke, B. Giodani, R. Koeppe, R. Albin, The University of Michigan, Ann Arbor, MI; “PET neurochemical vs. clinical phenotypes in mild-early dementia,” SNM’s 56th Annual Meeting, June 13-17, 2009.

SNM – Society of Nuclear Medicine, PET Scans May Improve Accuracy of Dementia Diagnosis, June 10, 2009

About SNM – Advancing Molecular Imaging and Therapy

SNM is an international scientific and medical organization dedicated to raising public awareness about what molecular imaging is and how it can help provide patients with the best health care possible. SNM members specialize in molecular imaging, a vital element of today’s medical practice that adds an additional dimension to diagnosis, changing the way common and devastating diseases are understood and treated.  

SNM’s more than 17,000 members set the standard for molecular imaging and nuclear medicine practice by creating guidelines, sharing information through journals and meetings and leading advocacy on key issues that affect molecular imaging and therapy research and practice. For more information, visit www.snm.org.

Patients with curable early-stage breast cancer died from chemotherapy solvent
A chemotherapy drug that is supposed to help save cancer patients’ lives, instead resulted in life-threatening and sometimes fatal allergic reactions.

A new study from the Research on Adverse Drug Events and Reports (RADAR) pharmacovigilance program at Northwestern University Feinberg School of Medicine identified 287 unique cases of hypersensitivity reactions submitted to the FDA’s Adverse Event Report System between 1997 and 2007 with 109 (38 percent) deaths in patients who received Cremophor-based paclitaxel, a solvent-administered taxane chemotherapy.

Adverse event reports generally only represent from 1 to 10 percent of actual incidence, so the number of hypersensitivity reactions and deaths is likely significantly higher. The severe allergic reactions are believed to be caused by Cremophor, the chemical solvent – a derivative of castor oil — that is used to dissolve some insoluble drugs before they can be injected into the blood stream.

Two patients who died from an allergic reaction had early-stage breast cancer, which had been surgically removed, and were being treated with Cremophor-containing paclitaxel to prevent the cancer from coming back. Both of these patients had received medications before the chemotherapy to reduce the risk of hypersensitivity reactions.

The study was led by Charles Bennett, M.D., RADAR program coordinator and a professor of hematology/oncology at Northwestern’s Feinberg School, and Dennis Raisch, a professor of pharmacy at the University of New Mexico.

“The deaths of women with early-stage breast cancer are particularly disturbing because without the adverse reaction, they could have likely had 40 years of life ahead of them,” Bennett said.

RADAR investigators also found that 22 percent of all fatalities occurred in patients despite patients having received premedication to prevent hypersensitivity reactions, while another 15 percent of such patients experienced life-threatening respiratory arrest.

The report was presented at the 45th Annual Meeting of the American Society of Clinical Oncology held recently in Orlando, Fla.

Cremophor-containing paclitaxel has been associated with hypersensitivity reactions, with responses ranging from mild skin conditions to more severe effects, including anaphylaxis and cardiac collapse. Current U.S. product labeling for Cremophor containing paclitaxel includes a black-box warning alerting physicians and patients of potential toxicity and recommending the use of corticosteroids and other medications before chemotherapy administration to reduce the risk of hypersensitivity reactions.

“The results of our review suggest that physicians should be vigilant in monitoring the safety of their patients undergoing chemotherapy treatment,” said Bennett, who also is the A.C. Buehler Professor in Economics and Aging at the Feinberg School and a member of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.

“Patients receiving Cremophor-based paclitaxel should be given medications to prevent hypersensitivity reactions, but what is sobering, as the study has shown and as the black-box warning indicates, women suffer anaphylaxis despite receiving steroid premedication,” Bennett said. “Physicians should be diligent in reporting adverse events to regulatory agencies to better monitor the impact of Cremophor on patient safety. Physicians may also want to consider exploring other alternative chemotherapy options that do not include Cremophor.”

In addition to the two women with early-stage breast cancer who died after treatment with the Cremophor-based paclitaxel, four other women with early-stage breast cancer experienced life-threatening anaphylaxis reactions. Each of them had received prior medications to prevent the reactions.

“The fatal outcomes observed in patients with early-stage breast cancer were particularly striking as this is a patient population with a good prognosis that is generally treated with curative intent,” said Raisch.

For the report, Bennett and Raisch reviewed adverse event reports submitted to regulatory agencies in the U.S., Europe and Japan. The most common cancer diagnosis for these patients with allergic reactions was lung cancer followed by breast cancer and ovarian cancer.

Reference: Northwestern University, Common chemotherapy drug triggers fatal allergic reactions, Press Release, 8-Jun-2009

Letter from Martin L. Pall, Saturday 6th June 2009:

I was delighted when I was asked by the three editors of the future publication, “General and Applied Toxicology, 3rd Edition” (John Wiley and Sons) to write a review on multiple chemical sensitivity (MCS) for this prestigious multivolume set. MCS, as I am sure you know, has been largely ignored by toxicologists in general and I was delighted that these three prominent scientists, all of whom had extensive published research on the actions of chemicals implicated in MCS, asked me to write such an article. This was important recognition not only for my own work on MCS but also that MCS is now recognized as a toxicological phenomenon.

The paper, entitled Multiple Chemical Sensitivity: Toxicological Questions and Mechanisms is the most extensively documented publication on MCS, and will be a 54 page chapter in this multivolume set. While the majority of this paper comes from my earlier publications on MCS, it also contains several very important sections that are largely novel.

1. There are seven classes of chemicals implicated in MCS and all seven of these can indirectly produce a common response in the body, increased NMDA activity. Furthermore, animal studies have shown that members of all seven of these classes of chemicals can have their toxic responses lowered by using an NMDA antagonist. This clearly demonstrates not only that they produce such increased NMDA activity but those increases play an important role in producing the toxic responses to these chemicals. Given that we previously had six types of evidence implicating excessive NMDA activity in MCS, we now have compelling evidence that this common response plays a key role in MCS.

2. The role of these chemicals acting as toxicants in MCS has been confirmed by four genetic studies, showing that genes that determine the rate of metabolism of these chemicals, influence susceptibility to MCS (only three were available when the review was written). These studies implicate six genes as determining such susceptibility, all of which have roles in the metabolism of chemicals otherwise implicated in initiating cases of MCS. It follows that the roles of chemicals in initiating cases of MCS is undeniable.

3. There have been a series of published studies reporting objectively measurable responses to low level chemical exposure among MCS cases that are distinct from any responses in normals. At least three of these should be practical specific biomarker tests that can be applied in clinical settings. All of these studies are consistent with the NO/ONOO- cycle mechanism as it is thought to play out in MCS and all provide, therefore, evidence supporting this mechanism. We have been in great need for such specific biomarker tests for MCS and these and other approaches to developing such tests must be further studied and may provide recognized specific biomarker tests in the near future, in my judgment.

4. All except one of the elements of the NO/ONOO- cycle as it is thought to play out in MCS have been studied in animal models and all elements studied are implicated in these animal models. It follows that one can make a strong case for a NO/ONOO- cycle mechanism based on animal model studies alone.

5. The paper finishes with a list of five areas of future research which are in most need of further study, in my judgment.

We do have observational evidence that a protocol based on down-regulating the NO/ONOO- cycle mechanism is helpful in the treatment of most cases of MCS as well as most cases of ME/CFS and most cases of fibromyalgia. However, at this point this treatment fails to produce any substantial number of cures and seems to be quite variable in the extent of improvements apparently produced by it. Nevertheless, this approach does produce substantial apparent improvements in many people who have been ill for one, two or more decades. It is my hope that we will be able to add a second phase to such treatment that may start to produce at least some such cures, but that is a hope at this point.

Autor: Martin L. Pall, Professor Emeritus of Biochemistry and  Basic Medical Sciences, Saturday 6th June 2009

(Letter reprinted by CSN with personal permission)