How Big Pharma Gets Dangerous Drugs Approved | System Error
VICE News・10 minutes read
Dr. Francis Kelsey of the FDA prevented birth defects in the US by refusing to approve the drug thalidomide in the 1960s, underscoring the FDA's crucial role in drug safety. However, issues like the opioid epidemic have arisen due to FDA failures, exemplified by the approval of Purdue Pharma's OxyContin and other opioids despite their clear dangers.
Insights
- Dr. Francis Kelsey's refusal to approve thalidomide in the 1960s showcased the FDA's pivotal role in safeguarding public health by preventing potential harm.
- The FDA's approval processes, exemplified by cases like OxyContin and Aduhelm, underscore the critical balance between drug innovation, safety, and public health concerns, necessitating vigilant oversight and leadership.
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Recent questions
What drug did Dr. Francis Kelsey refuse to approve in the 1960s?
Dr. Francis Kelsey refused to approve the drug thalidomide in the early 1960s, preventing birth defects in the US. Thalidomide was later found to cause severe birth defects in other countries, highlighting the importance of Dr. Kelsey's decision in protecting public health.
What drug led to a surge in opioid-related deaths due to downplaying addiction risks?
Purdue Pharma's OxyContin led to a surge in opioid-related deaths by downplaying addiction risks. The misleading marketing of OxyContin contributed to widespread addiction issues, prompting lawsuits against the company for its role in the opioid epidemic.
How did the FDA's approval of OxyContin's misleading label contribute to addiction issues?
The FDA's approval of OxyContin's misleading label allowed for aggressive marketing practices that downplayed addiction risks. This approval facilitated the spread of addiction issues associated with OxyContin, contributing to the opioid epidemic in the US.
What impact did the FDA's approval of new opioids have on the public health crisis?
Despite clear dangers, the FDA approved a stream of new opioids, worsening the public health crisis. This decision to approve additional opioids without adequate consideration of the risks further exacerbated the ongoing opioid epidemic in the US.
What concerns have been raised about the FDA's approval of costly and unproven drugs like Aduhelm for Alzheimer's?
The FDA's approval of costly and unproven drugs like Aduhelm for Alzheimer's has raised concerns about efficacy and industry influence. The approval of such drugs without sufficient evidence of effectiveness has sparked criticism and calls for investigations into the FDA's decision-making processes.
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Summary
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FDA's Role in Drug Safety and Controversies.
- In the early 1960s, Dr. Francis Kelsey of the FDA refused to approve the drug thalidomide, preventing birth defects in the US.
- The FDA's role is crucial in ensuring drug safety, with decisions impacting lives, although failures have contributed to issues like the opioid epidemic.
- Purdue Pharma's OxyContin, downplaying addiction risks, led to a surge in opioid-related deaths, with lawsuits filed against the company.
- FDA's approval of OxyContin's misleading label allowed aggressive marketing, contributing to addiction issues.
- Despite clear dangers, the FDA approved a stream of new opioids, worsening the public health crisis.
- The FDA's relationship with the pharmaceutical industry changed with the Prescription Drug User Fee Act, leading to industry funding and potential conflicts of interest.
- The FDA's approval of costly and unproven drugs like Aduhelm for Alzheimer's raises concerns about efficacy and industry influence.
- The FDA's decisions, like approving Aduhelm, have led to resignations and calls for investigations, highlighting the agency's need for a pro-public health leader.
