Tuesday, January 31, 2012
FDA’s New Claim: “Your Body Is a Drug"
We wish this were a joke, but it’s the US Food and Drug Administration’s latest claim in its battle with a Colorado clinic over its Regenexx-SD™ procedure, a non-surgical treatment for people suffering from moderate to severe joint or bone pain using adult stem cells.
The FDA asserts in a court document that it has the right to regulate the Centeno-Schultz Clinic for two reasons:
- Stem cells are drugs and therefore fall within their jurisdiction. (The clinic argues that stem cell therapy is the practice of medicine and is therefore not within the FDA’s jurisdiction!)
- The clinic is engaging in interstate commerce and is therefore subject to FDA regulation because any part of the machine or procedure that originates outside Colorado becomes interstate commerce once it enters the state. Moreover, interstate commerce is substantially affected because individuals traveling to Colorado to have the Regenexx procedure would “depress the market for out-of-state drugs that are approved by FDA.”
We discussed the very ambiguous issue of interstate commerce last September—it’s an argument the FDA frequently uses when the basis for their claim is otherwise lacking. As we noted then, the FDA holds that an “interstate commerce” test must be applied to all steps in a product’s manufacture, packaging, and distribution. This means that if any ingredient or tool used in the procedure in question was purchased out of state, the FDA would in its view have jurisdiction, just as they would if the final product had traveled across state lines.
This time the FDA just nakedly says in court documents that the agency wants to protect the market for FDA-approved drugs. No more beating around the bush—their agenda is right out in the open! This appears to be a novel interpretation of the Food Drug and Cosmetic Act (FD&C), as evidenced by the government’s failure to cite any judicial precedent for their argument.
The implication of the FDA’s interpretation of the law, if upheld by the court, would mean that all food, drugs, devices, and biologic or cosmetic products would be subject to FDA jurisdiction. The FDA is expanding its reach even to commerce within the state, which we argue is far beyond its jurisdiction, in order to protect drug company profits.
The Centeno-Schultz Clinic takes your blood, puts it into a centrifuge machine that separates the stem cells, and a doctor puts them back in your body where there is damaged tissue. The clinic has argued numerous times that stem cells aren’t drugs because they are components of the patient’s blood from his or her own body.
The FDA says otherwise: “Stem cells, like other medical products that are intended to treat, cure, or prevent disease, generally require FDA approval before they can be marketed. At this time, there are no licensed stem cell treatments.” There they go again, saying that components of your body are drugs and they have the authority to regulate them! It’s the only way the agency can claim that adult stem cell therapy is within FDA’s purview.
However, the agency seems to be of two minds. When ESPN magazine was doing a story on stem cell treatments, the FDA stated that US policy is to allow the injection of stem cells that are treated with “minimal manipulation,” which federal regulations define as “processing that does not alter the relevant biological characteristics of cells or tissues”—which is certainly the case with the Regenexx clinic.
Despite this policy, FDA has been attacking the clinic for the past four years. They have tried injunctions and demanded inspections in their attempts to make the company bend; this court battle is merely the latest salvo.
The primary role of adult stem cells in a living organism is to maintain and repair the tissue in which they are found. The hard part has been to get enough of them. But new technology is giving doctors the ability to obtain more stem cells from a patient than previously thought possible, which is why we’re now seeing new treatments. Blood, fat, or tissue is withdrawn from the patient, stem cells are obtained using one of these new processes, and the cells are injected back into the patient where they can repair the patient’s tissue.
Gov. Rick Perry received this kind of stem cell therapy. We and others noted that the governor’s defense of freedom of healthcare choice when it came to his own treatment was starkly at odds with his directive to administer HPV vaccines to young girls against their own (and their parents’) wishes. It’s also at odds with his support for some of the most egregious witch-hunters on the Texas State Medical Board, which he appoints.
Behind Perry’s blatant inconsistency and the latest FDA attempted power grab lies the same problem: a medical system run by special interests under the leadership of the US government, the same government that is supposed to represent “we the people.”
Monday, January 30, 2012
A Greek study led by Adamantia Fragopoulou and Lukas Margaritis has demonstrated important protein changes in the brain of animals following whole body exposure to RF electromagnetic fields, similar to the kind of microwave radiation emitted from cell phones, portable phones, WiFi and wireless computer equipment. The study, was published in Electromagnetic Biology and Medicine, Early Online: 1-25, 2012.
Important regions of the brain necessary for learning, memory and other functions of the mammalian brain were impacted by the microwave radiation, including the hippocampus, cerebellum and frontal lobe, at exposures below the ICNIRP (International Commission on Non-Ionizing Radiation Protection) safety guidelines. A total of 143 proteins in the brain were impacted by the RF radiation over a period of 8 months, providing new evidence for a potential relationship between everyday cell phone use, wireless transmitters and wireless computer equipment and electrosensitivity symptoms, such as headaches, dizziness and sleep disorders, as well as with tumors, Alzheimer's and even metabolic effects.
The study simulated 3 hours of cell phone exposure over eight months, 8 hours of DECT portable phone exposure over eight months, and included a sham exposure control group. The results showed both down regulation and up regulation of the proteins.
Several neural function related proteins (i.e. Glial Fibrillary Acidic Protein (GFAP), Alpha-synuclein, Glia Maturation Factor beta (GMF), and apolipoprotein E (apoE)), heat shock proteins, and cytoskeletal proteins (i.e. neurofilaments and tropomodulin), were shown to be impacted by the radiation, as well as proteins of the brain metabolism (i.e. Aspartate aminotransferase, Glutamate dehydrogenase), in nearly all of the brain regions studied.
Figure 2 from the study shows the 143 proteins that have changed (up- or down-regulated) and their functional relationship based on a literature survey.
Adamantia F. Fragopoulou, M.Sc., PhD Candidate, in the Dept of Cell Biology and Biophysics at University of Athens, Greece, lead author of the study, says, "Our study is important because it shows for the first time protein changes in the mouse brain after EMF exposure and in particular in very crucial regions like hippocampus, cerebellum and frontal lobe, all involved in learning, memory and other complicated functions of the mammalian brain. We have demonstrated that 143 proteins are altered after electromagnetic radiation, including proteins that have been correlated so far with Alzheimer's, glioblastoma, stress and metabolism. In its perspective, this study is anticipated to throw light in the understanding of such health effects like headaches, dizziness, sleep disorders, memory disorders, brain tumors, all of them related, to the function of the altered brain proteins
Lukas H. Margaritis, PhD, Professor Emeritus (as of Sept 2010) of Cell Biology and Radiobiology, Dept of Cell Biology and Biophysics, University of Athens, head of the Athens research group, says, "A high throughput approach (mass characterization of biomolecules, similar to microarrays that analyze the total genes of an organism) as that of the Proteomics* has never been used so far in EMF research of BRAIN TISSUES following whole body exposure of model animals (mice) at SAR values below ICNIRP's recommendations. It is also the first time that wireless DECT phones base radiation is involved in lab animal studies and specifically in such molecular effects. The message taken out of this work is that people should be very cautious when using mobile phones next to their body (especially next to their brain), whereas the wireless DECT should be located as far away as possible from places that people use to spend many hours a day, not to mention children of all ages."
PRESS RELEASE RELEASED BY UNIVERSITY OF ATHENS TEAM
Athens, Greece. January 21, 2012. The research group of Professor Lukas Margaritis (Faculty of Biology, University of Athens and the Biomedical Research Foundation of the Academy of Athens), within the framework of the activities seeking for the truth underlining the possible effects of daily life electromagnetic fields, has performed this study as part of the Doctorate Dissertation of Adamantia F. Fragopoulou.
Using ordinary working conditions of mobile phone and wireless DECT base and by applying state of the art proteome science approaches, they demonstrated that a large number of major brain proteins have been changed. Namely proteins that are responsible for the integrity of brain functions, in such critical regions like hippocampus, cerebellum and frontal lobe are below normal levels whereas an equally large number are found well above physiological levels. These “underexpressed” or “overexpressed” proteins may play a role in the short term or long term effects reported as a consequence of mobile phone exposure, including memory deficits, headaches, sleep disorders, brain tumors.
As pointed out in the “DISCUSSION” section of the paper, the possible start-up events may involve the production of ROS (reactive oxygen species) leading to oxidative damage (as suggested recently by Blank and Goodman of Columbia University in New York City); heat shock protein activation; and finally, changing the expression of a large number of brain proteins, as was demonstrated in this study.
The Fragopoulou et al. study is the first large-scale analysis of the mouse brain proteome to be published so far. The research team having recently been awarded a large “Thalis” grant is potentially aiming in elucidating the EMF effects from the molecular level up to the organism level, exploiting the most suitable model systems (mice, insects, nematodes, lizards, cell cultures, human skin).
Published in Electromagnetic Biology and Medicine, Early Online: 1–25, 2012 Copyright Q Informa Healthcare USA, Inc.
Brain proteome response following whole body exposure of mice to mobile phone or wireless DECT base radiation
Adamantia F. Fragopoulou1, Athina Samara2, Marianna H. Antonelou1, Anta Xanthopoulou3, Aggeliki Papadopoulou3, Konstantinos Vougas3, Eugenia Koutsogiannopoulou2, Ema Anastasiadou2, Dimitrios J. Stravopodis1, George Th. Tsangaris3 & Lukas H. Margaritis1
1Department of Cell Biology and Biophysics, Athens University, Athens, Greece, 2Genetics and Gene Therapy Division, Center of Basic Research II, Biomedical Research Foundation of the Academy of Athens, Athens, Greece, and 3Proteomics Research Unit, Center of Basic Research II, Biomedical Research Foundation of the Academy of Athens, Athens, Greece
The objective of this study was to investigate the effects of two sources of electromagnetic fields (EMFs) on the proteome of cerebellum, hippocampus, and frontal lobe in Balb/c mice following long-term whole body irradiation. Three equally divided groups of animals (6 animals/group) were used; the first group was exposed to a typical mobile phone, at a SAR level range of 0.17- 0.37 W/kg for 3 h daily for 8 months, the second group was exposed to a wireless DECT base (Digital Enhanced Cordless Telecommunications/Telephone) at a SAR level range of 0.012- 0.028 W/kg for 8 h/day also for 8 months and the third group comprised the sham-exposed animals. Comparative proteomics analysis revealed that long-term irradiation from both EMF sources altered significantly (p , 0.05) the expression of 143 proteins in total (as low as 0.003 fold downregulation up to 114 fold overexpression). Several neural function related proteins (i.e., Glial Fibrillary Acidic Protein (GFAP), Alpha-synuclein, Glia Maturation Factor beta (GMF), and apolipoprotein E (apoE)), heat shock proteins, and cytoskeletal proteins (i.e., Neurofilaments and tropomodulin) are included in this list as well as proteins of the brain metabolism (i.e., Aspartate aminotransferase, Glutamate dehydrogenase) to nearly all brain regions studied. Western blot analysis on selected proteins confirmed the proteomics data. The observed protein expression changes may be related to brain plasticity alterations, indicative of oxidative stress in the nervous system or involved in apoptosis and might potentially explain human health hazards reported so far, such as headaches, sleep disturbance, fatigue, memory deficits, and brain tumor long-term induction under similar exposure conditions.