You are a new associate at the law firm of Dewey, Chetum, and Howe. John, a former researcher at PharmaCARE, comes to your office. He has concerns about PharmaCARE’s use of AD23, one of the company’s top-selling diabetes drugs. Two (2) years ago, after PharmaCARE’s research indicated that AD23 might also slow the progression of Alzheimer’s disease, John and his team of pharmacists began reformulating the drug to maximize that effect. In order to avoid the Food and Drug Administration’s (FDA) scrutiny, PharmaCARE established a wholly-owned subsidiary, CompCARE, to operate as a compounding pharmacy to sell the new formulation to individuals on a prescription basis. CompCARE established itself in a suburban office park near its parent’s headquarters. To conserve money and time, CompCARE did a quick, low-cost renovation.

CompCARE benefited from PharmaCARE’s reputation, databases, networks, and sales and marketing expertise, and within six (6) months had the medical community buzzing about AD23. Demand soared, particularly among Medicare, Medicaid, and Veterans Affairs patients. Seeing the opportunity to realize even more profit, CompCARE began advertising AD23 directly to consumers and marketing the drug directly to hospitals, clinics, and physician offices, even though compounding pharmacies are not permitted to sell drugs in bulk for general use. To circumvent this technicality, CompCARE encouraged doctors to fax lists of fictitious patient names to CompCARE. PharmaCARE sold CompCARE to WellCo, a large drugstore chain, just weeks before AD23 was publicly linked to over 200 cardiac deaths.

As CompCARE and its new parent company enjoyed record profits and PharmaCARE’s stock price approached $300 per share, reports started surfacing that people who received AD23 seemed to be suffering heart attacks at an alarming rate. The company ignored this data and continued filling large orders and paying huge bonuses to all the executives and managers, including John, whose wife recently died from a heart attack after using AD23.

John has come to you with an internal company memo describing the potential problems with AD23, and information describing the company’s willingness “roll the dice” and continue to market the drug.

Your senior partner has asked you to write a memo outlining the following issues for review by the senior partners.

In preparation for this assignment, use the Internet or Strayer Library to research examples of intellectual property theft that occurred within the past two (2) years.

Write an eight to ten (8) page paper in which you:

1. Research three to five (3-5) ethical issues relating to marketing and advertising, intellectual property, and regulation of product safety and examine whether PharmaCARE violated any of the issues in question.
2. Argue for or against Direct-to-Consumer (DTC) marketing by drug companies. Provide support for your response.
3. Determine the parties responsible for regulating compounding pharmacies under the current regulatory scheme, the actions that either these parties or the FDA could / should have taken in this scenario, and whether PharmaCARE could face legal exposure surrounding its practices. Support your response.
4. Analyze the manner in which PharmaCARE used U.S. law to protect its own intellectual property and if John has any claim to being the true “inventor” of AD23. Suggest at least three (3) ways the company could compensate John for the use of his intellectual property.
5. Summarize at least one (1) current example (within the past two [2] years) of intellectual property theft, and examine the effect on that company’s brand.
6. Analyze the potential issue surrounding the death of John’s wife and other potential litigants against PharmaCARE as a result of AD23.
7. Specify both the major arguments that John can make to claim that he is a whistleblower and the type of protections that he should be afforded. Justify your response.
8. Use at least three (3) quality resources in this assignment. Note: Wikipedia is not an acceptable reference and proprietary Websites do not qualify as academic resources.

Your assignment must follow these formatting requirements:

• Be typed, double spaced, using Times New Roman font (size 12), with one-inch margins on all sides; citations and references must follow APA or school-specific format. Check with your professor for any aIDitional instructions.
• Include a cover page containing the title of the assignment, the student’s name, the professor’s name, the course title, and the date. The cover page and the reference page are not included in the required assignment page length.

The specific course learning outcomes associated with this assignment are:

• Analyze and assess legal and ethical restraints on marketing and advertising, relative to both consumers and organizations.
• Analyze and evaluate laws and regulations relative to product safety and liability.
• Explore copyright laws and intellectual property rights and assess how well they balance competing interests.
• Use technology and information resources to research issues in law, ethics, and corporate governance.
• Write clearly and concisely about law, ethics, and corporate governance using proper writing mechanics.

Paper instructions:
1. Create a policy or program that would reduce/prevent/treat a specific type of mental disorder and related criminal activity.
2. What theory (or theories) is your policy or program based?
3. What are the costs of your policy or program? 

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4. How would you implement your policy or program?
5. How would you evaluate if your policy or program worked?
6. How would you respond to your critics?

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Find reputable Web sites on the Internet that list signs to look for when children and adolescents are being abused, using drugs, and have suicidal tendencies.
o Create a list of key signs that can signify to an educator that a student is potentially being abused, using drugs, or having suicidal tendencies.
o Provide a brief 100 to 150 word explanation of what you would do if you saw these signs in your students.

Learning Resources

 

Required Resources

 

• Web Site: American Psychiatric Association: Children”s Mental Health

  http://www.psychiatry.org/mental-health/people/children

• Web Site: LD Online: ADHD Basics: Treatment of ADHD

  http://www.ldonline.org/adhdbasics/treatment

• Web Site: The Bipolar Child: Frequently Asked Questions About Early Onset Bipolar Disorder

  http://bipolarchild.com/resources/jbrf/

• Web Article: Prozac on the Playground: The Dangers of Off-Label Use of Psychiatric Medications in Children by Sydney Spiesel

  http://www.slate.com/articles/health_and_science/whats_up_doc/2008/10/prozac_on_the_playground.html

• Web Article: Drug-Therapy Combo Best for Anxiety in Kids ” Study by Julie Steenhuysen

  http://www.reuters.com/article/2008/10/30/anxiety-treatment-idINN3031219120081030?rpc=44

 

Optional Resources

 

• Web Site: New York Times Series: Troubled Children

  http://www.nytimes.com/ref/health/troubled-children.html

  Note: This page links to a series of articles that examine the transition to adulthood, the uncertainty of diagnosis, the use of multiple medications, and the role of parent

Discussion 2: Final Reflection

 

In Week 1, you composed your own definition of the phrase the well-being of children. You considered what the term well-being meant to you at that time, how you would determine a child”s well-being, and what factors have the most influence on children”s well-being. Now, as you complete this course, consider your original definition and how it has changed, expanded, or been corrected by your work and learning over the past 12 weeks. To help you prepare for this Discussion, reflect on the following:

 

• In what ways has your personal definition of the phrase the well-being of children changed through your work in this course?
• How did your learning in this course confirm, expand upon, and/or conflict with your prior knowledge with regard to factors that influence a child”s well-being?
• What are the most valuable insights you gained from this course? How might you use these insights in the future?

With your thoughts in mind, follow the instructions for this Discussion.

By Day 3 of Week 12:

Post your responses to the following:

• Write a definition of the phrase the well-being of children that reflects what you have learned in this course. Identify the factors that have the most influence on the well-being of a child. Cite your sources to support your reasoning.
• Compare your current definition with your explanation of the well-being of children from the Week 1 Dscussion. Explain in what ways your work in this course has confirmed, expanded upon, or corrected your prior knowledge at the beginning of the course.
• Explain your most valuable insight from this course and how you can apply it to your future work with young children and families.