Safe and effective

"Safe and effective" link (Medical terminology, Marketing terminology, Scientism)
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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. The words in some way are synonymous with “Food and Drug Adminstration (FDA) approved” / FDA approved 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. {{#subobject: |Has superobject=Safe and effective |Has objectClass=Quotation |Has author=Peter C. Gøtzsche|+sep=, |Has 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.
It is the other way round.” |Is about=Safe and effective,|+sep=, |Has wikipediaPage= |Has location=|+sep=, |Has publicationDate=2013 |Sourced from=Deadly Medicines and Organised Crime |Has sourceDetails=Chapter 3/Page 22 |Has sourceTitle= |Has sourceName=Deadly Medicines and Organised Crime |Has sourceURL=

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“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) 

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”.

Regulatory capture

Regulatory capture can lead to different approaches towards safety (see also precautionary principle):

• around 2004 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, or preventing start of it. The regulations went so far as to make high quality genotoxic data a requirement for approval (!)

• mRNA based vaccines did not have any safety data but were COVID-19/vaccine/mandationvery aggressively promoted

References