©REUTERS/Andrew Kelly
Vocabulary:
I will read the words, meanings, and sample sentences. Then, repeat after me.
- plea /plee/
- wrinkle /RING-kuhl/
- adverse /ad-VURS/
- definitive /dih-FIN-i-tiv/
- scrutiny /SKROOT-n-ee/
[noun] – an urgent and emotional request
The family made a plea for help from the community during their time of need.
[noun] – a small line in the skin caused by old age
She used a specialized cream to reduce the appearance of wrinkles on her face.
[adjective] – having a negative or harmful effect on something
The medication had adverse effects on his overall health, causing unexpected side effects.
[adjective] – not able to be changed or improved
The scientist conducted extensive research to provide definitive proof of the theory’s validity.
[noun] – the careful and detailed examination of something in order to get information about it
The company’s financial records underwent intense scrutiny to ensure accuracy and transparency.
Article reading:
Please read the whole article. Then, I will check your pronunciation and intonation.
Public Citizen, a consumer advocacy group, lodged a formal request with the U.S. Food and Drug Administration (FDA) urging for enhanced cautionary measures within the labels of Botox and similar injections. Their plea centered on the necessity for heightened warnings concerning the potential risk of a severe muscle-paralyzing ailment, which could prove fatal.
While these injections, utilizing diverse types of botulinum toxins to target specific muscles and erase wrinkles, currently carry a ‘black box’ warning detailing the hazards of the intended effect spreading to other areas, Public Citizen pressed for more explicit indications that these adverse effects might transpire even when administered at recommended dosages. Their petition specifically targeted six toxin-based injections, encompassing the prominent Botox by AbbVie, Daxxify by Revance Therapeutics, Jeuveau by Evolus, Myobloc by Supernus Pharmaceuticals, Dysport by Galderma, and Xeomin by Merz Therapeutics. In addition to advocating for clearer warnings on the labels, Public Citizen requested the FDA eliminate promotional statements asserting the absence of definitive serious side-effects linked to the distant spread of the toxin effect associated with these treatments. Their initiative stemmed from an extensive analysis encompassing over 5,400 reported instances of fatalities, life-threatening incidents, and other severe side effects related to Botox and rival toxin-based wrinkle treatments. This scrutiny was based on records from the FDA’s adverse events database, aimed at identifying unusual or emerging side effect patterns necessitating further investigation or regulatory measures, like adding warnings to a product. The group’s petition was prompted by the need for explicit alerts about systemic iatrogenic botulism, a condition capable of causing progressive muscle paralysis if the toxin extends beyond the designated treatment area.
While these injections, utilizing diverse types of botulinum toxins to target specific muscles and erase wrinkles, currently carry a ‘black box’ warning detailing the hazards of the intended effect spreading to other areas, Public Citizen pressed for more explicit indications that these adverse effects might transpire even when administered at recommended dosages. Their petition specifically targeted six toxin-based injections, encompassing the prominent Botox by AbbVie, Daxxify by Revance Therapeutics, Jeuveau by Evolus, Myobloc by Supernus Pharmaceuticals, Dysport by Galderma, and Xeomin by Merz Therapeutics. In addition to advocating for clearer warnings on the labels, Public Citizen requested the FDA eliminate promotional statements asserting the absence of definitive serious side-effects linked to the distant spread of the toxin effect associated with these treatments. Their initiative stemmed from an extensive analysis encompassing over 5,400 reported instances of fatalities, life-threatening incidents, and other severe side effects related to Botox and rival toxin-based wrinkle treatments. This scrutiny was based on records from the FDA’s adverse events database, aimed at identifying unusual or emerging side effect patterns necessitating further investigation or regulatory measures, like adding warnings to a product. The group’s petition was prompted by the need for explicit alerts about systemic iatrogenic botulism, a condition capable of causing progressive muscle paralysis if the toxin extends beyond the designated treatment area.
Discussion Questions:
I will read each question. Then, please answer them.
- Have you or anyone you know ever considered or undergone cosmetic treatments involving Botox or similar injections? If yes, how did you or they weigh the risks versus the benefits before opting for the procedure? If not, what factors do you think people consider when contemplating such treatments?
- Have you encountered situations where the potential risks associated with a medication or treatment were not adequately disclosed in the product’s warnings or promotional materials? If yes, how did this impact your perception of the product or the healthcare provider? If not, how important do you believe it is for consumers to have comprehensive and clear information about potential risks when using medical treatments or pharmaceuticals?
- Do you agree that regulatory bodies like the FDA should enforce more explicit warnings on labels of medical treatments, such as Botox, to address potential severe side effects, even if the reported adverse events are rare?
- How might increased transparency about potential adverse effects, such as the risk of severe muscle-paralyzing ailments associated with Botox injections, impact the decisions of both consumers and healthcare professionals regarding the use of such treatments?
- Considering the extensive analysis of reported fatalities and severe side effects linked to Botox and similar toxin-based injections, what ethical responsibilities do pharmaceutical companies and regulatory agencies like the FDA have in balancing the promotion of medical benefits against the necessity of warning consumers about potential risks?
Summarization
Please summarize the whole article using your own words and expressions. You will have one minute to prepare before you answer.
Describe:
Please explain the definition of each word listed below based on your understanding. You can provide example sentences if needed.
- injection
- FDA
- eliminate
- life-threatening
- side effect