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What are the different phases that a Drug Company goes through

Resolved Question:

What are the different phases that a Drug Company goes through in order to bring a new drug product to market in the U.S. and Europe?
Did Pfizer behave unethically by rushing to take advantage of an epidemic in Nigeria to test experimental drugs on children?
Should it have been less opportunistic and proceeded more carefully?
Were corners cut with regard to patient consent in the rush to establish a trial?
Did doctors keep patients on Trovan too long when they should have switched them to another medication?
Is it ethical to test experimental drugs on children in a crisis setting in the developing world where the overall standard of health care is so much lower than in the developed world and proper protocols might not be followed?
Submitted: 10 months ago.
Category: Essays
Expert:  Josie-Mod replied 10 months ago.

Hello,

I'm Josie and I'm a moderator for this topic.

We have been working with our professionals to try to help you with your question. Sometimes it may take a bit of time to find the right fit.

I was checking to see if you had already found your answer or if you still need assistance from one of our professionals.

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Customer: replied 10 months ago.

Hi,


 


Please proceed to provide me with the answers today.


 


thank you Josie.Here is the passage to the questions:


 


 


Pfizer's Drug-Testing Strategy in Nigeria


The drug development process is long, risky, and expensive. It can take 10 years and cost in excess of $500 mil lion to develop a new drug. Moreover, between 80 and 90 percent of drug candidates fail in clinical trials. Pharmaceutical companies rely upon a handful of successes to pay for their failures. Among the most successful of the world's pharmaceutical companies is New York- based Pfizer. Given the risks and costs of developing a new drug, pharmaceutical companies will jump at opportunities to reduce them, and Pfizer thought it saw one.


Pfizer had been developing a novel antibiotic, Trovan, that was proving to be useful in treating a wide range of bacterial infections. Wall Street analysts were predicting that Trovan could be a blockbuster, one of a handful of drugs capable of generating sales of more than $1 billion a year. In 1996, Pfizer was pushing to submit data on Trovan's efficacy to the Food and Drug Administration (FDA) for review. A favorable review would allow Pfizer to sell the drug in the United States, the world's largest market. Pfizer wanted the drug to be approved for both adults and children, but it was having trouble finding sufficient numbers of sick children in the United States to test the drug on. Then a researcher at Pfizer read about an emerging epidemic of bacterial meningitis in Kano, Nigeria. This seemed like a quick way to test the drug on a large number of sick children.


Within weeks a team of six doctors had flown to Kano and were administering the drug, in oral form, to children with meningitis. Desperate for help, Nigerian authorities gave the go-ahead for Pfizer to give the drug to children (the epidemic would ultimately kill nearly 16,000 people). Over the next few weeks, Pfizer treated 198 children. The protocol called for half the patients to get Trovan and half to get a comparison antibiotic already approved for the treatment of children. After a few weeks, the Pfizer team left, the experiments complete. Trovan seemed to be about as effective and safe as the already approved antibiotic. The data from the trial were put into a package with data from other trials of Trovan and delivered to the FDA.


Questions were soon raised about the nature of Pfizer's experiment. Allegations charged that the Pfizer team kept children on Trovan, even after they failed to show a response to the drug, instead of switching them quickly to another drug. The result, according to critics, was that some children died who might have been saved had they been taken off Trovan sooner. Questions were also raised about the safety of the oral formulation of Trovan, which some doctors feared might lead to arthritis in children. Fifteen children who took Trovan showed signs of joint pain during the experiment, three times the rate of children taking the other antibiotic. Then there were questions about consent. The FDA requires that patient (or parent) consent be given before patients are enrolled in clinical trials, no matter where in the world the trials are conducted. Critics argue that in the rush to get the trial established in Nigeria, Pfizer did not follow proper procedures, and that many parents of the infected children did not know their children were participating in a trial for an experimental drug. Many of the parents were illiterate, could not read the consent forms, and had to rely upon the questionable translation of the Nigerian nursing staff. Pfizer rejected these charges and contends that it did nothing wrong.


The FDA approved Trovan for use in adults in 1997, but it has not approved the drug for use in children. Trovan was launched in 1998, and by 1999 there were reports that up to 140 patients in Europe had suffered liver dam- age after taking Trovan. The FDA subsequently restricted the use of Trovan to those cases where the benefits of treatment outweighed the risk of liver damage. European regulators banned sales of the drug.29


 


 


 


 

Expert:  Josie-Mod replied 10 months ago.

Hello

Thank you for you reply.

I am sorry for the confusion, I am a moderator, not a professional who answers questions. We will continue to look for a professional to assist you, but we can not predict or guarantee response time, just because the volume of questions, number of professionals online, complexity of questions, and other factors vary. Please let me know if I can be of any further assistance while you wait.

Best,

Josie~Moderator

Customer: replied 10 months ago.

Hi,


 


The passage and the questions are there in your database I guess,because I saw the passage on your website requesting me to register my details.


 


Will appreciate if I am provided with answers today to enable me conclude on the assignment.


 


Many thanks Josie.

Expert:  Josie-Mod replied 10 months ago.
Hello again :)

We are still working with our professionals to find you the best possible match. The question appears to have been asked previously but there is no stored answer. I wanted to touch base to see if you were still needing our professionals' assistance.

Please let me know if you would like to continue to wait or if you would like to cancel your question at this time. We sincerely XXXXX XXXXX the extended wait time.

Thank you,

Josie~Moderator
Customer: replied 10 months ago.

How early and possible can I have solutions to the questions?Still in need of solutions please.


 


Thank you.

Expert:  Josie-Mod replied 10 months ago.

Thank you for your reply. Your question is open to all professionals and marked high priority. You'll receive an email notification if a professional replies.

 

We can not predict or guarantee response time, just because the volume of questions, number of professionals online, complexity of questions, and other factors vary.

 

We appreciate your patience.

Expert:  DXJWriter replied 10 months ago.
Hi!
I might be able to help! Could you please tell me how long the response should be and if there is a reference requirement? Thanks! Smile DXJ
Expert:  DXJWriter replied 10 months ago.

Hi!

Your answers are here. They should open in a new window. I hope they help! Smile DXJ

Customer: replied 10 months ago.

I appreciate the response but have a problem with comprehending the solution.Please align the answers to the questions accordingly for a better presentation.That is question 1 followed by answer,question 2 followed by answer and so on.


 


thank you

Expert:  DXJWriter replied 10 months ago.
Hi!

I submitted a response when you did not respond to the information request. I can reorganize the answer, if you'd like. DXJ
Customer: replied 10 months ago.

Please reorganize the answers in line with the questions.References should not be made as this is a case study questions that does not require external referencing.


 


the material were the case was taken can be found at


 


highered.mcgraw-hill.com/sites/dl/.../Hill6e_IB_Sample_Chapter04.pdf


 


or


 


[PDF]


Ethics in International Business - McGraw-Hill Higher Education


 


what is relevant for the questions are


 


ETHICAL DILEMMAS


THE ROOTS OF UNETHICAL BEHAVIOR



  • Personal Ethics

  • Decision Making Processes

  • Organizational Culture

  • Unrealistic Performance Expectations

  • Leadership


Management Focus: Pfizer’s Drug Testing Strategy in Nigeria


 


All these are available in the material pls.Thank you

Expert:  DXJWriter replied 10 months ago.

Hi!

Many apologies!!! Unfortunately, I cannot access that chapter via the link provided. I can give your responses but you will have to include your references. Does that work?

I am also opening this to other experts Maybe one of them has access to your chapter. Smile .DXJ

Customer: replied 10 months ago.

Please I have attached the document to you on email communication


 


 


Please treat as urgent .


 


Sule

Expert:  DXJWriter replied 10 months ago.
Hi!

I can do that. I got the second link to work.
Could you please copy the citation information here? The chapter does not provide that. Thanks! DXJ
Customer: replied 10 months ago.

I do not need citations to the solutions.Provide answers based on the passage based purely on ethical understanding.The material forwarded might be of help.


 


Many thanks for your effort

Expert:  DXJWriter replied 10 months ago.
Hi!

Thanks so much for your patience. Your answers are here.
They should open in a new window. Hope they help!Smile DXJ
DXJWriter, Master's Degree
Category: Essays
Satisfied Customers: 2044
Experience: 20+ years of writing, research, problem-solving & training
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