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Merck Vioxx

In the late 90’s a leading pharmaceutical manufacturer Merck had been working on a treatment for osteoarthritis, rheumatoid arthritis and other conditions associated with pain (Prakash S, Velentine V. 2007). Merck’s solution to this health issue came in the form of Vioxx, showing promising therapeutic effects with minimal and reduced side effects associated with competitors (Union of Concerned Scientists, 2017). 1998 saw the submission by Merck for approval by the FDA for vioxx after being tested on 5400 subjects in 8 separate studies (Prakash S, Velentine V. 2007). Come 1999 another study was conducted in order to compare the drug to a popular competitor known as naproxen in which, 8000 participants were observed (Prakash S, Velentine V. 2007). Half of the participants took vioxx and the other naproxen (Prakash S, Velentine V. 2007). By the end of the year the results of the study were compiled among the Vioxx Gastrointestinal Outcomes Research study AKA Vigor where vioxx showed far fewer ulcers and intestinal bleeding than those taking naproxen (Prakash S, Velentine V. 2007). A second meeting however was focused on heart problems where 79 patients of the 4000 taking vioxx were found to have a serious event compare too 41 of 4000 taking naproxen (Prakash S, Velentine V. 2007). These figures were deemed as comparatively small and to be re-evaluated in 30 days (Prakash S, Velentine V. 2007). VIGOR re convened and were notified that vioxx patients were twice as likely to have serious heart problems and or death than those of naproxen (Prakash S, Velentine V. 2007). A vote was successfully held to continue the study under the defense of not knowing if vioxx caused the heart problems or if the patients taking naproxen was acting as a low dose aspririn and protecting patients from them (Prakash S, Velentine V. 2007).

Many pharmaceutical studies are conducted using a placebo in their control group whereas here Merck decided to use naproxen. The reason placebos are commonplace is so to have an understanding of what the effects a drug can have on an individual that isn’t taking the drug at all in order to deem its safety and effectiveness (National Institute on Aging. 2020). The comparative nature of the study was seen as a means of skewing data to push the drug through FDA approval (Union of Concerned Scientists, 2017). Scientists were seen as highlighting the benefits of naproxen making it appear as though Vioxx was safer than the results suggested (Union of Concerned Scientists, 2017). Weinblatt, a safety chair as part of the advisory committee had initially pushed for information in 2000 on cardiovascular risks but ultimately succumbed to waiting on the results to be combined with all other studies (Union of Concerned Scientists, 2017). Another form of data manipulations was found when the first draft of 16 out 20 reports listed an employee as the author but upon final draft the author had changed to an external academic drawing questions of a ghost writer (Union of Concerned Scientists, 2017). Furthermore evidence of three heart attacks were removed from records of patients taking vioxx, thousands of deaths and 100,000 heart attacks due to its approval in 1999 to its recall in 2004 (Union of Concerned Scientists, 2017). Patients who have stopped taking vioxx are still facing complications related it its use (Union of Concerned Scientists, 2017)

An estimated 20 million Americans are thought to have taken the drug and the company began facing 13000 lawsuits on behalf of 23,000 plaintiffs (Union of Concerned Scientists, 2017). Trials persisted for years to which Merck defends the study and withholding information on grounds of certain instance reporting falling outside the timeline required by the studies reporting guidelines(Union of Concerned Scientists, 2017). Of the 7 trials held Merck won 3 and came to a settlement in 2007 noted as the largest drug settlement of its time  seeing Merck pay $4.85 Billion into a settlement account and allowing them to avoid personal injury lawsuits of approximately 47,000 plaintiffs and 265 class action lawsuits (Union of Concerned Scientists, 2017).

1. How much fault would you place on the scientists conducting the study vs the company itself and do you think they should bare any of the repercussions?
2. Do you think including a placebo in this study either as a replacement to naproxen or in addition to it would have prevented this from happening?
3. Weinblatt the safety chair, agreed to wait for all results to be compiled before reviewing the cardiovascular study specifically. A few months later filled out a financial disclosure statement stating he and his wife had purchase $72,985 of Merck stock. Do you think this is indicative of anything fishy?

References:

Merck Manipulated the Science about the Drug Vioxx. 2017 Oct 12. Union of Concerned Scientists. 

Prakash S, Valentine V. 2007 Nov 10. Timeline: The Rise and Fall of Vioxx. NPRorg. 

National Institute on Aging. 2020. Placebos in Clinical Trials. National Institute on Aging. 

Has hip-hop music, culture and style been co-opted and commercialized to the point of cultural bankruptcy, support your answer.

What are the five most important musical instruments?

Explain the Meaning of school management:

School Management and Education

School management involves the evolution and development of the management system in educational institutions. Education is not just about guiding the past, but also advancing the future. Music education is the key to unlocking the potential of education institutions. The first day of school is better than the last day because it's the beginning of a new journey.

The management system becomes the rationale for program planning and exploitation of goals for students who are to be educated. The society provides not only human and non-human resources but also certain expectations that the education system will achieve certain goals. Education planning involves designing actions to be done beforehand.

The education system is a subsystem of society, and therefore, the society influences the education system. The management system is planned before education, and the dictionary was planned before some action was taken for the English dictionary updates in 1964.

Efficiency, reducing stress and culture, saving time and money are the goals of the management system, not perfection. The organization of education is not about efficiency, but rather about the management system, which needs to be organized and efficient

In 400 words or more answer the following questions

1 Why do textbooks discourage informed critical thinking habits among students?  

2 What are the main problems with trying to give a fair narrative that pleases all social groups?  Or if that’s possible, what are the educational or social costs involved? 

3 How would you reform the ways in which historical content is presented in textbooks?  What types of changes in the writing of history textbooks would you strongly suggest?

Write an essay detailing the history of Hagia Sophia and the variety of functions this mosque has served. Include a detailed description of the architectural modifications (both structural and decorative) to the Hagia Sophia.

In this case you will produce a chronology that places major (violent) social upheavals of the early colonial period (mostly dealt with in chapter 3 & 4) in their proper historical periods and explain how their Historical Significances subsequently shaped American history back then (colonial society) and today (think about serious contemporary racial, economic, social issues we’re witnessing right now).  Below is a list of the events  you will explore in a chronology with dates/events correctly laid out in a historically ascending or descending order:

• King Philip’s War

• Yamasee Uprising

• Pontiac’s Rebellion

• Stono Rebellion

• Leisler’s Rebellion

• Bacon’s Rebellion

Reference Guide: How To Determine Historical Significance?

Please consider the steps below to determine the significance of any historical events,

figures, or processes in this course:

Step #1) Name your Topic of investigation (who/what, events, actions, deeds, achievements,

etc.)

Step #2) Briefly indicate What & Where your topic happened.

Step #3) Briefly describe Why (causes or reasons) and How (main actions, deeds, plot) the

event occurred?

Step #4) Briefly explain or note the main wider social and historical effects or consequences of

the event at the time it occurred?

● Some Helpful Questions: How people’s lives were changed afterward? How did

it affect major cultural, political, social and economic developments at the time?

Or how did its aftermaths change the course of history for people in the societies

involved? What can we learn from it? And/or what useful precedent was set for our understanding for the history of that period

Noteworthy Black Canadians

Do some research on how The Honourable Lincoln M. Alexander have contributed to canadian history and culture.

Make sure it’s a good paragraph at a university level

Answer these questions in full sentences:

1. how can black history month highlight the untold history of Black Canadians?

2. What can be done to celebrate Black Canadian’s achievements all year l?

1. The European Union (EU) is a cooperative political and economic alliance of European nations that began to help limit restrictions on trade between the numerous countries. However, over the last decade the EU has taken a number of steps to create a unified "National" identification. Explain what programs and actions the EU has taken to help create this European culture. 

2. The city of Jerusalem is considered one of the holiest places in the world. Millions of people visit the city each year to tour and pray at its ancient shrines and buildings. The city is shared by three of the world's largest religions. Although the city's tourists often respect the religious differences of the other visitors, the city has come under violent civil strife between worshipers of different religions. List the three religions that regard Jerusalem as a holy city and give an example of how the city is shared by these religions. 

3. The Cold War began shortly after the end of World War II as the democratic nations of the west and the communist nations of the east began establishing alliances in contrast to each other. The Cold War lasted over 40 years, ending in the dissolution of the Soviet Union. Give 2 examples of events that occurred that were reflective of the Cold War between the United States and the Soviet Union and describe how the two sides were in conflict. 

4. The United Nations was started after the devastation of World War II to help prevent further wars and conflicts through international cooperation. Today, the UN is involved in a variety of missions and has created a number of programs and organizations that are used throughout the globe. Give an example of two of these programs and explain how they are used world wide and what impact they might have. 

While CNN, FOX, ABC, NBC and other major news outlets spend countless hours reporting on the conflicts and atrocities of the Middle East, Lebanon, and Asia, the continent of Africa rarely makes the news. There are currently nearly 30 conflicts on the continent that have led to the deaths of over 5 million people since 2000 and displaced at least as many.

Yet, our media rarely reports on it. View the article discussing the conflicts of Africa in comparison to other nations. (Use the following keywords in an online search engine: global issues conflict in Africa introduction)

1 . Which of these current conflicts has had the biggest toll on civilians?

2. How does this compare to the conflict in Lebanon? What about in Europe or the Americas?

3. What reasons do you think contribute to the media ignoring the African conflict?

Respond to the following answers in your own words.

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If there's no internet connection, how can the students do research work?

Direction: Read the text and analyze the claim and the supporting evidence presented. Then, judge the validity of the evidence.

The Digital Divide

By: Kim Czaccei Dacanay

The digital divide exists in the Philippine education system for the longest time, but the Pandemic exposed just how bad it is. The digital divide is the barrier between those who have access to computers and the internet and those who don't.   Educational attainment is heavily affected by the digital divide, and this remains true to many countries in the world. Many provinces in the Philippines have a slim to none access to the internet connection. Students and teachers would have to climb high places to get internet access. Also, as reported by STAR last year, 13 million Filipino households don't have electricity.   Therefore, the transition to online classes will put certain Filipino student population at a stark disadvantage. If there's no internet