Thalidomide is the reason we CAN still trust Science
In today’s Medium article I will be writing about why Thalidomide is also a reason we CAN still trust science and not completely dismiss it because this disaster went horribly wrong, what science learned from this terrible mistake and the nirvana fallacy that happens when people use Thalidomide as a way to discredit science and use this as a comparison against vaccines. So without further ado, let’s get into the article.
➡️ History of Thalidomide
Thalidomide which was applied by a West German pharmaceutical company Chemie Grünenthal in 1957 [1], it’s first uses were intended to be for sedatives or tranquilisers [2] but was repurposed to treat all sorts of other ailments [3] or diseases.
The disaster happened when it was repurposed for use on pregnant women without proper evidence, where 10,000 babies were born with physical abnormalities, however, science did rectify this mistake (I’ll be speaking about this later). Scientists did brand this as the biggest man-made disaster ever [4].
In the UK there was a massive assumption that it was completely safe for humans, yet the evidence only came from animal studies on mice which Chemie Grünentha performed (so no human clinical trials, if this was done today, it probably would never have been used), so it was used on pregnant women for morning sickness. Dr. Alexander Leslie Florence was the first healthcare professional to start scrutinising this [5].
Later on, following this, tighter controls, protocols and the MHRA’s Yellow Card Scheme was created, to ensure this mistake would never happen again. To this day, this mistake has never happened since or again.
References: [1] https://web.archive.org/web/20141009110927/https://www.rpharms.com/museum-pdfs/e3a-thalidomide-and-its-aftermath-2011.pdf
[2] https://www.sciencemuseum.org.uk/objects-and-stories/medicine/thalidomide
[3] https://www.oxfordlearnersdictionaries.com/definition/english/ailment
[4] https://onlinelibrary.wiley.com/doi/full/10.1002/bdrc.21096#bdrc21096-bib-1004
[5] https://www.bmj.com/content/361/bmj.k1937
➡️ Medical Reforms & Creation of the Yellow Card Scheme
In the USA The Kefauver-Harris Amendments addressed shortcomings of previous legislation in 1936 which previously manufacturers were allowed to market drugs if the FDA had not acted within 60 days of an application. Which is no longer the case, obviously. A quote from a former FDA commissioner Dr. Margaret Hamburg, which included her thought about the new reform — “With the passage of the amendments, the FDA was no longer a helpless bystander while unproven medicines were streaming into pharmacies and onto patients’ bedside tables,” [1].
These were the changes:
- require that manufacturers prove the efficacy of drugs before they go on the market and report any adverse reactions
- require that this evidence be based on adequate, well-controlled clinical studies conducted by qualified experts
- require informed consent from study participants
- give the FDA 180 days to approve or reject a new drug application
- allow the FDA to set good manufacturing practices and mandate regular inspections of production facilities
- transfer to the FDA control over prescription drug advertising, which must include accurate information about potential side effects
In the UK, in 1964 we saw the creation of the MHRA’s Yellow Card Scheme [2] in the wake of the thalidomide disaster that occurred, the Yellow Card Scheme was established in the UK to collect suspected adverse drug reactions ( ADRs ) to provide an early warning of possible hazards. The Scheme has played a vital role in the safety of medicines for the last 50 years.
The UK Government also set up a mandate that companies must provide evidence from clinical trials showing that any new drug is safe for use in pregnancy before the drug is marketed to pregnant people. Also, set up the Medicines Act 1968 [3] which regulates the licensing, supply and administration of medicines. Another change that occurred is that conclusions cannot be derived solely from animal studies anymore, which is very good to see. Prof. Neil Vargesson, chair in developmental biology at the University of Aberdeen also noted the resulting transformations that came about as a result of these changes put in place (see reference number). [4]
References: [1] https://web.archive.org/web/20190905092327/https://www.fda.gov/consumers/consumer-updates/kefauver-harris-amendments-revolutionized-drug-development
[2] https://www.gov.uk/government/news/yellow-card-scheme-looks-to-the-future-at-50th-anniversary-forum
[3] https://www.legislation.gov.uk/ukpga/1968/67/contents
[4] https://onlinelibrary.wiley.com/doi/full/10.1002/bdrc.21096
➡️ Thalidomide still in use today
Whilst reading this article you may be surprised that this drug is still being used in the medical industry today, the FDA has approved it’s use for Hansen’s disease (leprosy) [1], however, what has to be mentioned is that since 1998 [2] the drugs use has been tightly restricted and regulated by the System for Thalidomide Education and Prescribing Safety program.
Thalidomide has also been repurposed as a possible drug to be safely used in a low dosage regimen alongside hormone for the treatment of Covid-19 [3].
Thalidomide is also being used to treat multiple myeloma a type of blood cancer [4], it’s also advised that breastfeeding women DO NOT [5] take this at all, which can all be seen on the BNF website.
References: [1] https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/thalidomide-marketed-thalomid-information
[2] https://pubmed.ncbi.nlm.nih.gov/10211535/
[3] https://ichgcp.net/clinical-trials-registry/NCT04273581
[4] https://bnf.nice.org.uk/drug/thalidomide.html#drugAction
[5] https://bnf.nice.org.uk/drug/thalidomide.html#pregnancy
➡️ Nirvana Fallacy of never trusting science again
Nirvana fallacy is a logical fallacy [1] where one imagines a perfect solution exists and rejects realistic answers in favour of it or “is the informal fallacy of comparing actual things with unrealistic, idealized alternatives” [2].
The whole argument of “science was wrong before” is a poorly designed argument made by woomeisters to discredit arguments made around modern vaccines which they state apparently “harms” people, so some also redirect the conversation to homoeopathy which is an alternative to medicine, rather than being alternative medicine. [4]
References: [1] https://rationalwiki.org/wiki/Nirvana_fallacy
[2] https://link.springer.com/chapter/10.1007/978-1-349-15486-9_14
[3] https://rationalwiki.org/wiki/Category:Woo-meisters
[4] https://www.nccih.nih.gov/health/homeopathy#:~:text=Homeopathy%2C%20also%20known%20as%20homeopathic,similar%20symptoms%20in%20healthy%20people.
➡️ Conclusion
What this tragedy showed us was there was a greater need for strictly enforced regulation of drug testing, marketing, dispensing, and use, which we now have. This is a major reason why vaccination for a global population is considered to be highly safe from the clinical trial procedures that it went through.
💥 Thanks for reading, Lawrence. Please consider a small contribution, in the form of a beer as all articles are created in my small amount of spare time: https://www.buymeacoffee.com/LawrenceRob