Difference between revisions of "Safe and effective"
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{{concept | {{concept | ||
|wikipedia=https://en.wikipedia.org/wiki/Generally_recognized_as_safe_and_effective | |wikipedia=https://en.wikipedia.org/wiki/Generally_recognized_as_safe_and_effective | ||
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|constitutes=Medical terminology, Marketing terminology, Scientism | |constitutes=Medical terminology, Marketing terminology, Scientism | ||
| − | | | + | |description=A legal designation for [[drug]]s, but also a marketing term ''to foster acceptance''. |
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| + | '''"Safe and Effective"''' is terminology used to suggest that a drug has been tested and is safe for humans.<ref>https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/safety-of-vaccines.html</ref> The words in some way are synonymous with “Food and Drug Adminstration (FDA) approved” / [[FDA approved]] <ref>https://www.aaojournal.org/article/S0161-6420(03)01004-2/fulltext</ref> and at that are used in marketing <u>to foster acceptance</u>. Many things throughout history have been sold as safe and/or beneficial, that actually weren't. This page focuses on substances marketed for human consumption or use and so were implicitly suggested to be safe, but which turned out not to be so, whether the term "safe and effective" was used for marketing or not - to inspire caution about implausible claims of the lack of long term consequences of innovative products. | ||
| + | {{SMWQ | ||
| + | |subjects= | ||
| + | |text=Drug companies never talk about the benefits and harms of their [[drugs]] but about their efficacy and safety. Words create what they describe and the preferred semantic is seductive. It makes you think it can only be good for you to take drugs, as they are both efficacious and safe. Another reason why patients and [[doctors]] generally trust their drugs as being both efficacious and safe is that they think they have been carefully tested by the [[drug industry]] and carefully scrutinised by the [[drug regulatory agencies]] using high standards before they are allowed on the market.<br> | ||
| + | It is the other way round. | ||
| + | |authors=Peter C. Gøtzsche | ||
| + | |date=2013 | ||
| + | |source_name=Deadly Medicines and Organised Crime | ||
| + | |source_details=Chapter 3/Page 22 | ||
| + | }} | ||
| + | |||
| + | == Legal status == | ||
| + | The Association of British Pharmaceutical Industry (ABPI) Code of Conduct instructs “It must not be stated that a product has no adverse reactions, toxic hazards…” and notes that ”The word ‘safe’ must not be used without qualification”. <ref>https://dailysceptic.org/2024/09/03/there-is-still-no-honesty-about-the-scale-of-vaccine-deaths/</ref> | ||
| + | |||
| + | ==Regulatory capture== | ||
| + | [[Regulatory capture]] can lead to different approaches towards safety (see also [[precautionary principle]]): | ||
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| + | * around [[2004]] <ref>http://archive.today/2022.05.26-000649/https://en.wikipedia.org/wiki/European_Directive_on_Traditional_Herbal_Medicinal_Products</ref><ref>https://web.archive.org/web/20150221023749/http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:136:0085:0090:en:PDF</ref><ref>https://web.archive.org/web/20101126220658/http://eur-lex.europa.eu/Notice.do?mode=dbl&lang=en&lng1=en,de&lng2=bg,cs,da,de,el,en,es,et,fi,fr,hu,it,lt,lv,mt,nl,pl,pt,ro,sk,sl,sv,&val=343606:cs&page=1&hwords=</ref> the [[EU]] started the process of enacting legislation that prevented small producers of (herbal based) health remedies to sell their products - the testing processes for market approval were made too expensive for these smaller companies, practically ending their business,<ref>https://www.gesundheitlicheaufklaerung.de/eu-richtlinie-thmpd-naturheilmittel/ saved at [https://web.archive.org/web/20200926031501/https://www.gesundheitlicheaufklaerung.de/eu-richtlinie-thmpd-naturheilmittel/ Archive.org] saved at [https://archive.ph/NP86l Archive.is]</ref><ref>https://web.archive.org/web/20051013071221/http://www.winhs.org/</ref><ref>https://web.archive.org/web/20130124203552/http://www.winhs.org/ - https://web.archive.org/web/20130625004955/http://www.winhs.org/alert.htm</ref><ref>https://secure.avaaz.org/campaign/en/eu_herbal_medicine_ban/ saved at [https://web.archive.org/web/20181223063645/https://secure.avaaz.org/campaign/en/eu_herbal_medicine_ban/ Archive.org]</ref><ref>https://secure.avaaz.org/campaign/de/eu_herbal_medicine_ban/ saved at [https://web.archive.org/web/20200804062342/https://secure.avaaz.org/campaign/de/eu_herbal_medicine_ban/ Archive.org]</ref> or preventing start of it. The regulations went so far as to make <u>high quality genotoxic data</u> a requirement for approval (!) <ref>https://web.archive.org/web/20101011075820/http://www.anh-europe.org/files/100713_ANH-Briefing_Paper_THMPD_German.pdf</ref><ref>explained in this video (in German) by Dr [[Gottfried Lange]] ([https://web.archive.org/web/20120421041743/http://www.drgottfriedlange.com/Publications/Bio.html bio from old website], [http://doctorgottfriedlange.com/about-dr.-lange.html current website]): [https://www.youtube.com/watch?v=jfQk4bdWug4 Das Aus für Heilpflanzen und Naturheilmittel - Dr. Gottfried Lange] (ca 2010, via [[Alpenparlament TV]])</ref><ref>https://www.youtube.com/watch?v=Zxqda0zElmk saved at [https://web.archive.org/web/20201116010303/https://www.youtube.com/watch?v=Zxqda0zElmk&feature=youtu.be Archive.org] (video is archived, buffering may take a while) saved at [https://archive.ph/rUnVW Archive.is]</ref> | ||
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| + | * [[mRNA]] based [[vaccines]] did not have any safety data but were [[COVID-19/vaccine/mandationvery aggressively promoted]] | ||
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{{SMWDocs}} | {{SMWDocs}} | ||
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==References== | ==References== | ||
{{reflist}} | {{reflist}} | ||
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Latest revision as of 23:34, 4 September 2024
 "Safe and effective"  (Medical terminology, Marketing terminology, Scientism)   | |
|---|---|
 | |
| A legal designation for drugs, but also a marketing term to foster acceptance. |
"Safe and Effective" is terminology used to suggest that a drug has been tested and is safe for humans.[1] The words in some way are synonymous with “Food and Drug Adminstration (FDA) approved” / FDA approved [2] and at that are used in marketing to foster acceptance. Many things throughout history have been sold as safe and/or beneficial, that actually weren't. This page focuses on substances marketed for human consumption or use and so were implicitly suggested to be safe, but which turned out not to be so, whether the term "safe and effective" was used for marketing or not - to inspire caution about implausible claims of the lack of long term consequences of innovative products.
“Drug companies never talk about the benefits and harms of their drugs but about their efficacy and safety. Words create what they describe and the preferred semantic is seductive. It makes you think it can only be good for you to take drugs, as they are both efficacious and safe. Another reason why patients and doctors generally trust their drugs as being both efficacious and safe is that they think they have been carefully tested by the drug industry and carefully scrutinised by the drug regulatory agencies using high standards before they are allowed on the market.
It is the other way round.”
Peter C. Gøtzsche (2013) [3]
Legal status
The Association of British Pharmaceutical Industry (ABPI) Code of Conduct instructs “It must not be stated that a product has no adverse reactions, toxic hazards…” and notes that ”The word ‘safe’ must not be used without qualification”. [4]
Regulatory capture
Regulatory capture can lead to different approaches towards safety (see also precautionary principle):
- around 2004 [5][6][7] the EU started the process of enacting legislation that prevented small producers of (herbal based) health remedies to sell their products - the testing processes for market approval were made too expensive for these smaller companies, practically ending their business,[8][9][10][11][12] or preventing start of it. The regulations went so far as to make high quality genotoxic data a requirement for approval (!) [13][14][15]
- mRNA based vaccines did not have any safety data but were COVID-19/vaccine/mandationvery aggressively promoted
Examples
| Page name | Description |
|---|---|
| "COVID-19/Vaccine" | The "vaccine" for COVID 19? |
| Azidothymidine | Drug that wiped out a generation of people diagnosed with HIV in the early 1990s, but not before making GlaxoSmithKline/Wellcome Trust billions in revenue. |
| DDT | Originally developed as an insecticide, thanks to ineptitude (and possibly corruption) used without second guesses as to what it's health impacts may be. |
| Diethylstilbestrol | Given to pregnant women in 1938-1970s. Causes high risk of cancer and genital deformations for several generations. |
| Glyphosate | A herbicide heavily promoted by Monsanto, increasingly being agreed to be a carcinogen. |
| RNA Vaccine | A vaccine based on changing the human RNA. The concept has long been of high military interest. |
| Radithor | Radioactive energy drink in the early 20th century. |
| Statin | 40 million US adults on this drug this every day - |
| Sunscreen | |
| Thalidomide | A drug that caused a very high number of birth defects and deaths. |
| Thimerosal | Preservative for vaccines that was declared safe after a very fraudulent safety study. |
| Tobacco | A widely used and addictive recreational drug. Use is legal although restricted for adults in most nation states. |
| Vaccine | A vaccine is a biological preparation intended to provide active acquired immunity to a particular disease. |
| Vioxx | Big Pharma painkiller that might have killed 500.000 people in the United States alone, after the manufacturer Merck withheld evidence of its dangers. |
| Water/Fluoridation | Marketed as an anti-tooth decay improvement, there is increasing evidence that the fluoridation of water may have a range of deleterious effects upon the brain (e.g. lowering IQ) and may actually not have much affect on tooth decay. The academic community was for a long time extremely hostile to anyone who challenged this practice. |
Related Quotation
| Page | Quote | Author |
|---|---|---|
| Azidothymidine | “The reason why only one drug has been made available — AZT — is because it’s the only drug that has been shown in scientifically controlled trials to be safe and effective.” | Anthony Fauci |
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References
- ↑ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/safety-of-vaccines.html
- ↑ https://www.aaojournal.org/article/S0161-6420(03)01004-2/fulltext
- ↑ Deadly Medicines and Organised Crime Chapter 3/Page 22
- ↑ https://dailysceptic.org/2024/09/03/there-is-still-no-honesty-about-the-scale-of-vaccine-deaths/
- ↑ http://archive.today/2022.05.26-000649/https://en.wikipedia.org/wiki/European_Directive_on_Traditional_Herbal_Medicinal_Products
- ↑ https://web.archive.org/web/20150221023749/http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:136:0085:0090:en:PDF
- ↑ https://web.archive.org/web/20101126220658/http://eur-lex.europa.eu/Notice.do?mode=dbl&lang=en&lng1=en,de&lng2=bg,cs,da,de,el,en,es,et,fi,fr,hu,it,lt,lv,mt,nl,pl,pt,ro,sk,sl,sv,&val=343606:cs&page=1&hwords=
- ↑ https://www.gesundheitlicheaufklaerung.de/eu-richtlinie-thmpd-naturheilmittel/ saved at Archive.org saved at Archive.is
- ↑ https://web.archive.org/web/20051013071221/http://www.winhs.org/
- ↑ https://web.archive.org/web/20130124203552/http://www.winhs.org/ - https://web.archive.org/web/20130625004955/http://www.winhs.org/alert.htm
- ↑ https://secure.avaaz.org/campaign/en/eu_herbal_medicine_ban/ saved at Archive.org
- ↑ https://secure.avaaz.org/campaign/de/eu_herbal_medicine_ban/ saved at Archive.org
- ↑ https://web.archive.org/web/20101011075820/http://www.anh-europe.org/files/100713_ANH-Briefing_Paper_THMPD_German.pdf
- ↑ explained in this video (in German) by Dr Gottfried Lange (bio from old website, current website): Das Aus für Heilpflanzen und Naturheilmittel - Dr. Gottfried Lange (ca 2010, via Alpenparlament TV)
- ↑ https://www.youtube.com/watch?v=Zxqda0zElmk saved at Archive.org (video is archived, buffering may take a while) saved at Archive.is
