It’s important to understand an ‘approved’ drug must be proven to be effective in treating a specific disease, at a specific dose, and be safe. (In this case, safe means the benefits from using a drug outweigh potential risks. As anyone that watches a drug commercial knows, all drugs have risks.)
Physician may, and do prescribe medicines ‘off-label’ by using it to treat a similar disease if other treatments have failed, or prescribe at a dosage level outside the approved range. But it’s important to understand in doing so without the approval of the patient, a individual physician is putting his medical license at risk – she’s misusing an approved drug.
While Off-label uses may put a legal responsibility on the prescriber’s shoulders, there are also the anecdotal evidence of effectiveness that becomes the basis for further controlled studies.
If there is an urgent need of a treatment for a specific disease, like COVID-19, the FDA may use anecdotal evidence as a basis for a provisional approval. That is the situation with some of those listed here. The following is extracted from the website listed at the bottom.
SNG001SNG001 uses a protein called interferon beta, which our bodies produce during a viral infection. It is inhaled directly into the lungs using an inhaler, with the hope it will trigger a stronger, more targeted anti-viral response. The drug was developed by Southampton-based pharmaceutical firm Synairgen and trialled by researchers from the city’s university.
Preliminary results from a trial of more than 100 hospitalised Covid-19 patients found it prevented 79 per cent of people from needing intensive care. The treatment also slashed the average time patients spent in hospital by a third, down from an average of nine days to just six.
The £5 steroid is the only drug scientifically proven to treat Covid-19. It is a type of anti-inflammatory medicine given as either an injection or once-a-day tablet. Oxford University scientists found it saved the lives of up to 35 per cent of patients relying on ventilators – the most dangerously ill – and reduced the odds of death by a fifth for all patients needing oxygen at any point.
The results came from the RECOVERY trial – the world’s largest investigation of promising Covid-19 therapies. Researchers say the steroid prevents the release of substances in the body that cause inflammation, a nasty Covid-19 complication that makes breathing difficult. In seriously unwell patients, the lungs become so inflamed they struggle to work.
Remdesivir was developed by Gilead Sciences to treat Ebola. Trials produced encouraging results earlier this year when it showed promise for both preventing and treating MERS – another coronavirus – in macaque monkeys. Studies on humans have produced mixed results.
In a US government-led study, remdesivir shortened recovery time by 31 per cent — 11 days on average versus 15 days for those given just usual care. But it had not improved survival according to preliminary results after two weeks of followup. Results after four weeks are expected soon.
The drug appears to help stop the replication of viruses like coronavirus and Ebola alike. It’s not entirely clear how the drug accomplishes this feat, but it seems to stop the genetic material of the virus, RNA, from being able to copy itself. That, in turn, stops the virus from being able to proliferate further inside the patient’s body.
It has been approved for emergency use in the UK, despite its mixed results.
The anti-malaria drug was first touted as a ‘game changer’ by US President Donald Trump in April. It works in the treatment of malaria by blocking the virus from replicating. It also has anti-inflammatory properties which stop the immune system from going into hyper-drive and attacking healthy cells.
Trump said there were ‘very strong signs’ hydroxychloroquine could treat the viral disease based on limited anecdotal reports from US doctors and poor studies. But last month, Oxford University’s RECOVERY trial stopped enrolling participants to its hydroxychloroquine arm after concluding that it showed no clinical benefit.
A quarter of NHS patients given hydroxychloroquine died from Covid-19, compared to 23.5 per cent who were not prescribed the drug. The scientists running the trial said the results were ‘pretty compelling’, adding: ‘This isn’t a treatment that works.’
President Trump has also admitted to taking the drug as a preventative therapy, to stop him from getting infected from the disease in the first place. Trials are currently ongoing to see if the tablets can work in this way.