The US Food and Drug Administration (FDA) has significantly watered down its requirements for approving new drugs and biologics. A new study published in JAMA Network Open reveals evidence showing recent approvals of new drugs and biologics by the FDA is based on far less rigorous evidence than was required in 1995. The authors suggest that as a result there should be a requirement for ongoing monitoring of safety and efficacy following approval. This may be beneficial for pharma companies and their profits, but it leaves little or no protection for patients affected by adverse events due to limited evidence and poor quality, rushed trials.
Baby snacks rise in popularity!
Given the link between obesity, chronic disease and increased susceptibility to developing a severe reaction to Covid-19, news of the increased popularity of highly processed baby snacks is nothing short of shocking. The analysis from Innova Market Insights shows development of such products aimed at babies and young children is a key growth area that is being driven by adult requirements. Many of these products, often marketed as being healthy, contain unacceptably high levels of sugar due to being made from highly processed fruit and vegetables. Damage to a child’s metabolic function and resilience due to poor food choices puts them at increased risk of becoming overweight and obese adults with all the inherent health risks. The ANH-Intl Food4Kids guidelines can help future proof kids health and reduce their risk of developing metabolic disease later in life.
CBD trade group calls for extension to FSA Novel Food deadline
The UK based Cannabis Trades Association (CTA) has called for an extension to the Food Standards Agency (FSA) deadline to submit Novel Food applications due to the impact of the coronavirus pandemic on the sector. The FSA has rejected the call saying it “…has not received any evidence in support of the suggestion that recent events with COVID-19 has rendered CBD businesses incapable of formulating novel food applications to the appropriate standard to meet next year’s deadline.” It also revealed some companies have already submitted initial applications. Countering the FSA’s response, the CTA point out that the effects of lockdown on the CBD industry, along with its contribution to the manufacture of PPE and the gifting of supplies and sanitisers to support the NHS, could impact businesses ability to meet the 31st March 2021 deadline. The CTA also expressed concerns that many products would not meet Novel Food standards as they are manufactured from natural rather than synthetic ingredients.
6G approved in the US
With the jury still out on the safety of 5G and a large sector of the public demanding proper evidence of safety before roll out, the corporate profit machine motors on regardless. Incredibly, the next generation of electronic communications has been approved in the US. The Federal Communications Commission (FCC) has taken advantage of the current pandemic to open the 6 GHz band up to wi-fi and unlicensed uses to cope with the burgeoning Internet of Things. Such a move will only add to the burden from existing electromagnetic frequencies. The move comes following ICNIRP’s declaration that 5G is safe despite evidence to the contrary and the FCC’s continued refusal to review its guidelines prompting the Children’s Health Defense to file a lawsuit against the organisation. The potential health impacts of electromagnetic frequencies are varied and myriad often increasing the more exposure you have. The addition of yet more bandwidths will benefit Big Tech and its cronies, but at what cost to us and the planet?
European Immunization Week
The world is being told life cannot get back to normal without a vaccine to combat Covid-19. Organisations around the world have joined a race to produce the first viable vaccine and avail themselves of the billions of dollars of investment being made available. With somewhat timely (alarming!) synchronicity, this week hosts both World Immunization Week and European Immunization Week, which aim to “…promote the use of vaccines to protect people of all ages against disease” and to “…raise awareness of the importance of immunisation for people’s health.” In its campaign, the World Health Organization calls vaccines “heroes” as it seeks to convince citizens of the safety and necessity of vaccines. What is seriously lacking from the current vaccine narrative is an open and transparent discussion around the safety of these novel vaccines that are being raced through trials and regulatory scrutiny at breakneck speed. Until such discussions take place there will, not surprisingly, continue to be push back by those who question the insistence of authorities that vaccines cannot and do not harm individuals.
Parkinson’s is an autoimmune disease
A new study adds to existing evidence that Parkinson’s is driven by an autoimmune response from within the body. Publishing in Nature Communications, the researchers report that signs of autoimmunity can appear in Parkinson’s disease patients’ years before they receive a diagnosis. Comparing blood samples from Parkinson’s patients with a healthy age-matched group they found Parkinson’s patients had a strong T cell response to alpha-synuclein prior to diagnosis, but the T cells then disappeared in the years following diagnosis. As with most autoimmune conditions, Parkinson’s disease has also been found to start in the gut. The good news is there’s lots that can be done to prevent the development of autoimmune conditions by making changes to our diet and lifestyle. Meleni Aldridge’s recent presentation at this year’s Get Well Show shares insights into the multiple reasons for the development of autoimmune conditions and how you can become well again.