Kano trovafloxacin

Using the sources below answer the following questions:

1. Do you believe that Pfizer should have faced harsher repercussions due to their negligence?

2. Do you believe that companies should be forced by law to publish all studies they took part in/ funded?

3. Did the claims made by Pfizer indicate that established protocols for choosing who to test on were in place?

Sources:

CDC. Meningitis. 2022, March 30th. [accessed 9th April, 2022]. [whole page]. 

Garba I, Paquette D. 2021, March 20. In this Nigerian city, Pfizer fears loom over the vaccine rollout. The Washington post. [accessed 9th April, 2023].

Lenzer J. Secret report surfaces showing that Pfizer was at fault in Nigerian drug tests. BMJ. [accessed 9th April, 2023]; 332(7552). 1233.

Smith D. August 11, 2011. Pfizer pays out to Nigerian families of meningitis drug trial victims. The guardian. [Accessed 9th April, 2023].

Using the following sources answer the following questions

Questions:

1. What preventative actions could GlaxoSmithKline have taken/implemented to prevent these compliance issues?
2. What could have been the result if Cheryl Eckard’s concerns were heard and acted upon when she first warned the company about the ongoing issues?
3. Why do you think the company decided to hide their mistakes and continue to produce/sell contaminated products? What advantage could they have had by producing adulterated drugs?

References:

Cette, D. CBS. 2010 Dec 29. Glaxo Whistle-Blower Lawsuit: Bad Medicine. Cbsnewscom. [accessed 2023 Feb 25] 

Harris G, Wilson D. 2010 Oct 26. Glaxo to Pay $750 Million for Sale of Bad Products. The New York Times. [accessed 2023 Feb 25] 

Wearden, G. 2010 Oct 27. GlaxoSmithKline whistleblower awarded $96m payout. the Guardian. [accessed 2023 Feb 25] 

Using the sources below answer the 3 questions. 

• United States Department of Justice. 2007. Four Managers of Now-Defunct N.J. Generic Drug Maker Admit Fraud that Led to Collapse and Bankruptcy of Company. [online] Available from:  Accessed 2023, Feb 19.
• Taylor, N. 2012. [online] Outsourcing Pharma. Available from:  Accessed 2023, Feb 19.

Questions:

1) Is there anything Able Labs could have done to prevent this, yes or no? explain your thoughts. 

2) Why is this scandal important? in your opinion 

3) What do you think was the root cause of the Able Laboratory scandal? 

Using the source below answer the following 3 questions

Source:

Schneider, K. 1983. Faking it: The Case against Industrial Bio-Test Laboratories. The Amicus Journal. [accessed 2023 March 8].

Questions

1. What are your thoughts on how the FDA and the government could have handled this matter differently?
2. If you are in the position of Dr. Philip Smith, the IBT technician, how could you have handled a situation like this?
3. What are some Good Laboratory Practices that could have been implemented in IBT labs?