Tools for Content


During the term, the class will develop a set of useful links for this page. I expect that each of you will make a suggestion that I can post to this page. The most obvious general sources are:

• Health & Medical Resources at the FLITE Library.
  
  Humanities Resources at the FLITE Library. Some of our reading, e.g. Miller, are in the JSTOR database, but you will probably want to consult "History of Science, Technology, and Medicine" and other databases.

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Links for Peer Review in Pharmacy: student generated.

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Links for literature review: FDA drug approval assignment: student generated.

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For the Vioxx assignment, Professor Courtright-Nash has generously identified the following links:
1998

• * Clinical Trials of Vioxx reveal "no CV signals". However, there were concerns regarding "pro-thrombotic effects in vitro" from: FDA Report entitled "Drug Regulation in Controversy: Vioxx" November 10, 2004
  
  
• * Study "090" conducted by Merck reveals serious cardiovascular problems as compared to patients not taking Vioxx. This study was never published; Merck insisted that it was not large enough to provide definitive data.

1999

• *The FDA approves Vioxx.
  
  
• * Vioxx enters the market, now the second NSAID. (Celebrex was the first.)
  
  
• * Merck initiates VIGOR, a study to measure the effects on the stomach in comparision with other pain relieving medications. However, VIGOR revealed "an increased risk of serious cardiovascular events, including heart attacks and strokes, in patients taking Vioxx compared to patients taking naproxen" - FDA News Release - September 2004

2000

*The VIGOR study concludes. It was published in the New England Journal of Medicine . [use FLITE to read article]
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• *Some experts believe that based on evidence provided by Study "090" and VIGOR combined, there is a strong possibility that VIOXX is an unsafe drug.

2001

• *The FDA recommends label warnings on Vioxx to Merck. It also warns Merck to stop misleading doctors regarding the CV side effects of the drug.
  
  
• * The FDA and Merck hold ongoing discussions about label changes for Vioxx.

2002

• *As a result of the VIGOR study, the "FDA implemented labeling changes to reflect the findings from the ... study. The labeling changes included information about the increase in risk of cardiovascular events, including heart attack and stroke." -

2003
The Year of the Vioxx:

• *Vioxx sales reach $2.5 billion. Vioxx is sold in 80 countries.

2004
Vioxx Withdrawn

• *September 30 - Vioxx is withdrawn from the market.
  
  
*The Vioxx withdraw stimulates concerns and critical questions about other Cox-2 inhibitor drugs Bextra and Celebrex.


• *Health Advisory regarding pain relieving drugs is issued.
  
  
• *FDA orders bold-faced warnings on Bextra labels, according to Web MD.

2005
Relabeling and Recalls Abound

• *February - A federal inquiry of Cox-2 inhibitors is opened by the FDA. According to Web MD , the panel recommended Vioxx return to the market, and that Celebrex and Bextra be allowed to stay, provided packages be labeled strictly as to potential CV side attacks. This is submitted to the FDA, who generally heeds these types of recommentations.
  
  
• *More studies are done, revealing evidence to back concerns.
  
  
• *Bextra is pulled off the market. Maker Pfizer plans to reintroduce it later.

2005 - 2006
Vioxx Lawsuits and Follow Up Studies for all Cox -2 Inhibitors.:

• *The first Vioxx lawsuit is settled in favor of the plantiff.
  
  
• *The awareness of the increased cardiovascular risk associated with Vioxx and Bextra has many people wondering if all drugs in the Cox-2 inhibitor class, i.e., those still on the market, will increase the possibility of heart disease in takers. Two studies, published in The Journal of the American Medical Society in 2006, lend insight into this issue.

Coverage of the First Vioxx Lawsuit:

• About's Arthritis editor, Carol Eustice , has written and very thorough and provocative article on the first Vioxx trial and decision.
  
  
• Also, USA Today did a special on chronic pain. It is a good source of general information about this serious public health problem. Updated: October 2, 2006

Sources

• FDA News Release - September 2004 Will All Cox-2 Inhibitors Cause Heart Problems? From About's Arthritis Editor

More Sources

• Association of Trial Lawyers of America
  
  
• USA Today
  
  
• USA Today (2)

Suggested Reading

• Cox-2 or Opioids?
  
  
• Promising New Pain Medications
  
  
• NSAIDs and Spinal Arthritis

Related Articles

• Vioxx Lawsuit - Jury Holds Merck Liable In First Vioxx ...
  
  
• COX-2 Inhibitor Safety Issues Being Scrutinized At FDA ...
  
  
• FDA Advised on Celebrex and Vioxx
  
  
• Celebrex And Vioxx Set To Battle
  
  
• COX-2 Inhibitors - What Are COX-2 Inhibitors?

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Patient Education Links

• Interview With Edward Tufte
  
  
• Bad visual information . . . really really bad
  
  
• Visual Data: how electronic tools produce bad representations
  
  
• View a a good example of integrated text and image.

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1. Peer Review: discourse
2. FDA Approval Processes
3. The Limits of Discourse
4. Patient Education

1. Writing Resources
   
   
2. Content Tools
   

1. Instructor Email hugh@culik.com
   
   
2. Peer Assistance [list serve]