FDA 2020: analisi del report con giudizio finale!
Victor Leach of ORSAA: Critical review of the FDA 2020 Report
Below is the next in a series of Guest Blogs on BRHP. The opinions expressed in this Guest Blog are of Victor Leach himself. Publication of these opinions in BRHP does not imply that BRHP automatically agrees with or endorses these opinions. Publication of this, and other guest blogs, facilitates an open debate and free exchange of opinions on wireless technology and health.
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READ ALSO BRHP OWN POST ON FDA 2020 REPORT:
US FDA 2020 REPORT ON CARCINOGENICITY OF RF-EMF CONTRADICTS SAFETY CLAIMS OF ICNIRP
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Comment on the FDA 2020 Report
‘Review of Published Literature between 2008 and 2018 of Relevance to Radiofrequency Radiation and Cancer’
by Victor Leach
The FDA is responsible for protecting and promoting public health through the control and supervision of many consumer products, drugs, vaccines, medical devices, electromagnetic radiation etc. They have a responsibility to protect consumers from biotoxins, and hence this FDA review of wireless radiation.
As outlined below I believe this report is inadequate and biased in favour of industry. The following revelations that emerged from my analysis of this report in detail will explain why I have come to this conclusion.
Epidemiological Studies
Several criticisms can be leveled at this FDA 2020 Report. I will focus on the very poor quality of the assessment of causation within the epidemiological studies.
While epidemiological studies are very difficult to perform, and there are many flaws visible in studies, the FDA selection can only be described as biased. The word “bias” (plural or past tense) was the most commonly used word in the FDA statement of limitations. When a direct cause and effect relationship has not been established, there is an accepted tool for moving from a position of association to causation. This tool is the Bradford-Hill assessment, used by epidemiologists around the world. This tool appears to have been overlooked by the FDA assessors in this very limited selection of papers.
The FDA only reviewed cancer research, and within that, selected 69 papers with only 67 being experimental papers excluding the 2 commentary papers; see Table 1 below. There are a further 7 other review studies. Some of these selected references can only be described as “obscure” and some are not exclusively wireless studies, such as Balekouzou et al 2017, Neupane et al 2017. If these studies are removed, there are 58 studies remaining, which can be categorised as shown in Table 1 below.
While the FDA focus was on cancer, there are many epidemiological studies that look at the totality of health related problems associated with wireless technology, which have been ignored in the FDA report. As is the case with other cancers, there are a number of underlining chronic health conditions that are associated with RF-EMF exposure that affect well-being. Table 1 shows that in the ORSAA database in addition to the 55 “cancer only” studies there are 66 epidemiological papers pertaining to other health issues associated with chronic exposure to RF-EMF. These papers fall into health categories such as:
- Circadian Rhythm Changes;
- Cardiovascular Effects;
- Haematological Effects.
These studies are important for health and well-being and should not be dismissed when making an assessment of long-term health effects. To use an analogy, it’s important not only to look at the major cancers associated with tobacco smoking, namely lung cancer, but to also consider the long list of chronic effects that are side effects of consuming this biotoxin.
Table 1 compares the available papers selected by ARPANSA (TR-164) and the ORSSA database collection for the period between 01/01/2008 and 31/12/2018 for mobile phones. TRS-164 is another example of a flawed assessment.
Table 1. Comparison of available Epidemiological studies on wireless technology.
The conclusion is very clear. The selection of papers in the FDA report is inadequate and unrepresentative of the available literature.
This recent review by Pareja-Peña F et,al 2020, of the 400 MHz – 3 GHz radiofrequency electromagnetic field influence on brain tumor induction is a much more balanced review.
In-vivo Animal Studies (Genotoxicity/Carcinogenicity and Tumorigenesis)
I have reviewed the in-vivo animal studies cited in the FDA report and compared these with the ORSAA database records, as follows:
The FDA report reviewed 37 studies and the comparison with the ORSAA database is in Table 2. The period used to select studies was from 2008 to 2018 (01/01/2008 to 31/12/2018) as stated in the FDA report.
Table 2: In-vivo animal studies in FDA report versus ORSAA database.
It is clear that the FDA report reviewed only about half of the available scientific papers.
Even with their poor quality review of 37 papers, the trend is clear: the in-vivo experimental animal studies show overwhelming genotoxicity resulting from RF exposures.
Once again, the non-cancer bioeffects are omitted in the FDA review. The bioeffects that need to be considered are listed below in their respective categories. Effects found in any of these categories have the potential for long-term chronic health implications. The glaring question is ’Why has the FDA ignored these subject areas?’:
- Altered Electrophysiology
- Altered Enzyme Activity
- Altered Protein Levels
- Audiological Effects
- Autonomic Nervous System Effect
- Cardiovascular Effects
- Cell Membrane Effects
- Cellular Signaling Effect
- Central Nervous System Effects
- Circulatory System Effects
- Dermal Effects
- Gene Expression Changes
- Growth/Development Effects
- Learning Effects
- Mitochondrial Effects
- Neurodegeneration
- Neurological System Effects
- Neurotransmitter Effect
- Ocular Effects
- Pregnancy Effects
- Renal Effects
- Salivary Gland Effects
- Skeletal Effects
- Sleep Effects
- Thyroid Effects
CONCLUSION
While the FDA report purports to be a scientific assessment, it falls short in many respects. I conclude that this is just another political report trying to justify the rollout of further wireless technology. We are rolling out wireless 5G technologies without pre-market health testing and this is an unethical experiment on large population groups and the environment. This is not how a reputable risk management approach works. For example, when considering the health risks of ionising radiation at low doses (below 100 mSv), there are biological effects, but no proven health effects. In this case, the International Commission on Radiological Protection ICRP, apply risk management principles such As Low As Reasonably Achievable (ALARA). This principle means that we do the following:
- design equipment to minimise exposure to users;
- administratively advise users on the safe use of devices;
- use alternative methods of service delivery to limit exposure.
In Health and Safety management, the “Hierarchy of Controls” for dealing with risks are:
- elimination
- substitution
- engineering controls
- administrative controls
- personal protective equipment.
These philosophies of protection are completely absent from the rollout of wireless technology. This is even more important because man-made EMF, unlike low dose ionising radiation, is not found in our environment. Life on earth has not biologically evolved with this man-made pulsed EMF. ICNIRP statements that a short-term (6 minute) thermal guideline protects everyone are reckless and negligent.
The current research on existing wireless technologies tells us clearly that we should be taking a precautionary approach.
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