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BioTech and the FDA, Transcranial Direct Current Stimulation and Hyperbaric Oxygen Therapy

For those of you who aren't aware of the FDA, it is the regulatory agency called the Food and Drug Administration in the United States that regulates all pharmaceuticals and medical devices. In the UK, there is a similar agency called the Medicines and Healthcare Products Regulatory Agency (MHRA) that is sponsored by the Department of Health. Approval of any medicines or devices must first be approved by the European Medicines Agency (EMA) through their centralised procedure for all of the EU, before compliance with the UK MHRA.

Typically biotech companies working with nascent technology must clear FDA or EMA approval before having their product be available for sale in the US or the EU. In the past several companies have come under fire for not attaining FDA approval before their products became available. 

The most recent case was Theranos, the blood diagnostics company lead by Elizabeth Holmes, in which their drug testing devices became available at Walgreens before they had cleared FDA approval. The other high profile case was 23andme- which had sold genetic testing kits for predisposition towards certain diseases in 2006 before the FDA banned those tests in 2013. Although a modified version of the 23andme kits are available in the US market- for ancestry testing only, the complete kit received MHRA approval in the UK in 2014 and became available to purchase at places like Superdrug for around £125. These are examples of two companies utilising innovative, nascent technology that had failed to first receive FDA approval before their products became available for widespread use.

23andme complete testing kit available at Superdrug

Although in the media, the Theranos technology had been criticised, quite personally, I would rather trust the results of the Theranos blood diagnostics- which analyses your blood in real time, as opposed to the one taken at a traditional laboratory, which could take 2-3 weeks before results can be processed, and often the blood samples are treated with heparin (to prevent coagulation) which can ulimtately lead to inaccurate results. I have previously written about Theranos here. Theranos had indeed launched an exciting new era of blood diagnostics; unfortunately, when they came out of stealth mode, they forgot that little thing called the FDA. Certainly it is the kind of agency one does not want to make enemies with. Despite the fact that the FDA has been a thorn in the side of many biotech companies, and even for doctors practicing alternative treatment methods for cancer, the FDA has the power to ban devices, treatments and medications, hence limiting the growth of biotech companies that wish to sell their products in the US market.

South Korea's yBrain tDCS headbands

Currently I've been researching BCI startups, especially those in transcranial direct current stimulation (tDCS). South Korea has been innovative in this space for over a decade, with yBrain (founded 2013) creating devices that resemble headbands which are worn that sends electrostimulating signals to potentially treat neurodegenerative diseases. They released a consumer version of brain fitness devices for healthy individuals in Nov of 2014 and another transcranial stimulation headband called the yBand for people with Alzheimer's (AD) and Mild Cognitive Impairment (MCI).

Similarly, in the US, Halo Neuroscience is following yBrain's lead and also has developed a brain stimulation headband for athletes and consumers who wish to enhance strength and athletic skill. However, the problem with these sorts of headbands is that because they are worn, only certain parts of the brain might be stimulated- whereas, athletic activity and learning is located holistically around different parts of the brain.

In addition with the case of AD and MCI patients, the disease often is placed in multiple places in both sides of the hemisphere, whereas due to the positioning of the headband, can only stimulate the areas of direct contact. 

Although I am far from an expert in this field, thus far, after perusing through the research materials, and various published papers, I am not convinced that tDCS could potentially be a treatment method for healthy people nor for people with AD or MCI. Because the brain has numerous cells and connections, it would be difficult to target many different areas at once, and the neural connections must themselves be repaired for the stimulation to even be moderately effective. In addition, typically Transcranial Magnetic Stimulation (TMS as opposed to tDCS) has been utilised in the past to induce alpha, beta or delta waves in the brain. Where tDCS passes an electrical current through your brain, affecting the neurons that the electrons travel through, TMS uses electromagnetic induction to create a similar effect.TMS has been successful in this area for treatment of depression and other mental illnesses.

Music and meditation have also been used for centuries to induce calm states in the brain and to alter brain waves. 

According to my research, the most promising technology for Alzheimer's, stroke victims and people with MCI is one that has been around for a long time: hyperbaric oxygen therapy (HBOT). All our cells need oxygen to repair itself. Being a chamber with pressurised oxygen allows the cells in our bodies and brain to received a concentrated source of oxygen, hence quickly repairing damaged nerves, tissues and neural connections.

Hyperbaric oxygen therapy was pioneered in the UK, beginning with English scientist Joseph Priestley who discovered oxygen in 1775, then moved towards treatment for people with "the bends", a decompression sickness that deep sea divers can suffer from in 1937. In the 1950s and 1960s, hyperbaric oxygen therapy was also utilised to enhance the radiosensitivity of tumours, for people with diabetic ulcers and the treatment of carbon monoxide, cyanide and hydrogen sulfide poisoning. In 2013, an scientists at Tel-Aviv University carried out a study of HBOT treatment on 74 patients, with some astonishing results.

Several patients, who had suffered from strokes up to 20 years before, had re-learned to walk and talk, suggesting that neurons in the brain can be revived when exposed to pressurised oxygen. In the past, a lack of oxygen was thought to cut off and kill brain cells, as in the instance of stroke, however, this study suggest these neurons are in fact, dormant and have anaerobic metabolism which are enough to stay alive, but need oxygen in order to fully function.

Currently in the US, HBOT is standard treatment for decompression sickness, and in some cases for traumatic brain injury. In the UK, HBOT treatments are also available via a referral were covered by the NHS for a wide variety of conditions until 2008, when a change in the Public Health Commissioning Network only allowed certain conditions to be covered.

Hyperbaric Oxygen Therapy portable pod

HBOT is also popular amongst athletes- such as US NFL football players, who use portable HBOT chambers that they can use in their comfort of their own homes. HBOT treatment accelerates recovery and sports injuries.

Although I am rather sceptical about the effects of transcranial direct current brain stimulation (tDCS) and lean more towards transcranial magnetic stimulation (TMS) and Hyberbaric Oxygen Therapy (HBOT) treatment, the latter which already has a high track record for effectiveness, I would still be willing to see how tDCS could be applied for consumer use cases despite all of its hype. I'm not sure I would want to put on a Halo headband however, as I'm not keen on the idea of an external device so close to my head sending direct electrostimulation currents as the long-term effects of this technology are still unknown. However, I would be interested in getting my own HBOT inflatable pod.

(Disclaimer: This post is not intended to diagnose any conditions and are the opinions of the author)

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