For my sequence 4 project, I targeted the student population in my video. I did so because so many students here at Miami are unaware of the effects the FDA has on them. Practically everything a student consumes is FDA approved. The food they eat, the pencils they write with, the laundry detergent they use every week. All of these products are made safe by FDA approval. The purpose of my video is to inform my students of what FDA approval means. I am also trying to persuade students to take action against the FDA. They must ask questions when it comes to the food they consume and the medicine they buy.
When it came to my video, I was very specific in the items I used to put it all together. My text boxes were short and simple but added to make an impact on the viewer. I also added a video clip of a victim affected by the FDA. I included this so that students could see that people everywhere are ill or even dying due to FDA procedures. My audio was carefully chosen because I thought that it would grab the viewer’s attention. It had a good beat but also words that fit my pictures well. I used photos of protesters in my video to show students that many people are aware of this issue and are taking action. I included pictures with teenagers so that students would have an easier time relating to the matter at hand.

As a Miami student, my days are often busy, filled with classes, meetings, lunch with friends, and occasional errands. Today, I started my morning off by taking my vitamins and eating a granola bar, and then I sat down to write this paper. That’s when I realized that everything that I had just put into my body had actually been approved by some organization. It had been approved for public safety, my safety. But who exactly has the power to “approve” almost everything that I consume every single day?

The Food and Drug Administration is the federal agency in the Department of Health and Human Services established to regulate the release of new foods and health-related products. The power they hold over the country is significant. Their “approval” represents anything from apples to high tech medical devices. I, as a student here at Miami University, strongly believe that the Food and Drug Administration often fails to properly regulate and release new foods, drugs, and equipment into the hands of the student population.

FDA approval should be a label that comforts the consumer. It should give them reassurance that what they are putting into their bodies is not a harmful substance. The hard truth is that the FDA has approved substances that have actually killed people. This means that government approved products have actually resulted in death. This results in the fact that FDA approval does not guarantee safety. The administration was developed to act as a “watchdog” in our society, but they aren’t looking out for society’s best interest. Even the people working for the FDA are starting to realize this. In July of 2008, the Union of Concerned Scientists published the results of a survey of just under 1,000 doctors who work for the FDA. The collected results were disturbing: Almost one in five (18 percent) responded, “I have been asked, for non-scientific reasons, to inappropriately exclude or alter technical information or my conclusions in an FDA scientific document.” (Food) Three in five (60 percent) also knew of cases “where commercial interests have inappropriately induced or attempted to induce the reversal, withdrawal or modification of FDA determinations or actions.” (Food) These comments, made by FDA hired scientists, are outrageous. The FDA has become a political organization looking out for it’s best interest instead of for the people it originally vowed to protect.

The above instance is not the first time that FDA scientists have revolted against the group. In November of 2008, scientists working for the Center for Devices and Radiological Health (CDRH) wrote a letter to the government complaining of corrupt managers. In the letter, they reported that managers within the CDRH knowingly corrupted the scientific review process and approved or cleared medical device applications in violation of laws and regulations designed to assure safety and effectiveness of medical devices. Such activity could allow potentially unsafe and ineffective medical devises into the U.S. market. So, not only is the FDA becoming political, but also criminal. The organization is now engaging in tactics of intimidation, censorship and oppression. The scientists that took the initiative to write the letter alleged top FDA managers “ordered, intimidated, and coerced FDA experts to modify their scientific reviews, conclusions and recommendations in violation of the law.” (FDA) These allegations are deeply concerning and the actions of the FDA are compromising the health and safety of student consumers.

Imagine how often a Miami student visits the Health Center. The medical equipment used, the medicine prescribed, all of these objects are reviewed and released by FDA approval. Government investigations have found that the FDA has allowed contaminated food and unsafe drugs to enter the market, our market! Some may argue that the FDA is doing everything in its power to protect us. They may argue that there just isn’t enough manpower to monitor everything. But if unsafe food is knowingly being released into the market, then it is being monitored, just in an irresponsible and unacceptable fashion.

Another area being “approved” by the FDA is found in every store across America. What is the most common action one does at the market? That’s right, read labels. Food and product labels are a huge problem in the FDA approval process. As consumers, we have been taught to read labels to enhance our knowledge of health and nutrition information. A recent announcement by the FDA stated that it had checked 28,000 food labels in a 14-month period; however, it failed to mention that they had merely checked to see if labels were present, and not if they were accurate. How are students supposed to learn from labels that are misleading and not necessarily FDA approved?

Another huge problem within this corrupt system is that drug companies are doing their own testing. This means that drug companies have to prove their own success when testing drugs. This alone is enough incentive to cheat the program. The FDA controls everything from the drug safety information used to evaluate their products to lab safety information used by the FDA.

Another disturbing side is the alliance between the FDA and drug companies. The FDA is supposed to work as an activist group for the protection of the people, but is failing greatly in the task. Over 60,000 Americans died from COX-2 inhibitors. The drug was removed from the market by it’s own manufacturer following the revelation of studies showing alarming increases in heart attack risk. However, the FDA advisory panel voted to allow the drugs to return to the market with full FDA safety approval. The fact that a single COX-2 drug had reportedly killed more Americans than the Vietnam War was apparently not sufficient for the FDA to characterize it as unsafe.

With this decision, a “safety approval” by the FDA has now become meaningless. Mike Adams, a NaturalNews Editor, states that this instance “Was a moment where the agency could have sided with public safety and held fast to a position of responsibility and ethics. Instead, It chose to favor drug company profits and put its stamp of approval on a class of drugs that is arguably the most deadly drugs ever to hit the open market.” The re-allowance of COX-2 inhibitors back into the market dramatically boosted stock prices of drug companies and kept the drug profit machine churning away. There were also allegations that many of the people on the FDA advisory panel owned stock in the very companies impacted by the final decision. This ultimately means that some of the most deadly drugs to ever hit the market are simply “safety approved” by a big rubber stamp. Adams further went on to say, “When the FDA is attacking herbs and nutritional supplements, they will claim there’s not enough evidence to prove they are safe. But when it comes to prescription drugs, the agency says there’s not enough evidence to prove they’re dangerous. All drugs approved by the FDA, it seems, are deemed safe until proven deadly. And even when proven deadly, they apparently aren’t deadly enough to warrant banning them.”

The power of drug safety should be put into the hands of people that actually care about public safety and health. Students everyday are consuming products approved by the FDA, and they are unaware of the possible consequences. The chicken fingers, salad and fruit bars they love so much are all approved by the FDA. The Advil and cough drops they purchase at the on-campus drug store, also FDA approved. The student population needs to be aware of how affected their lives are by the FDA approval process. Students need to be activists to realize that the Food and Drug Administration is not serving the public as an activist group. Students especially need to question whether or not the FDA’s promise to public safety is truly being upheld.

Works Cited
Cook, Aaron M. “Pharmacists’ role in facilitating evidence-based prescribing for unlabeled use of medications.” American Journal of Health-System Pharmacy 66.19 (2009): 1735-739.

Energy and Commerce Committee. Web. 29 Oct. 2009. .

“FDA Scientists Revolt Against Corrupt Food and Drug Administration Officials.” Alex Jones’ Prison Planet.com. Web. 28 Oct. 2009. .

“Food Contaminants & Adulteration.” U S Food and Drug Administration Home Page. Web. 28 Oct. 2009. .

“It’s Time to Pin the FDA Down.” National Health Federation – a not-for-profit consumer-education, health-freedom organization. Web. 28 Oct. 2009. .

“With COX-2 decision, no longer any doubt about FDA corruption and U.S. drug racket
by Mike Adams the Health Ranger.” Independent news on natural health, nutrition and more. Web. 01 Nov. 2009. .

Your topic: A corrupt FDA

Your claim/position: The FDA is not correctly releasing new foods and products to student consumers.

List your reasons and grounds here.
[Note: you do not have to have 4 reasons; this is only a guide.]

Reason #1:

Grounds supporting this reason: The FDA has released drugs to the public that have been considered harmful or even deadly.
Warrant underlying the enthymeme: There is documented evidence that the FDA has allowed a drug to re enter the market that was originally banned due to the 60,000 people that died from taking it.

Reason #2:

Grounds supporting this reason: The FDA has released medical equipment and safety approved it when it is not necessarily safe.
Warrant underlying the enthymeme: FDA scientists have come forward to announce that they have been intimidated and threatened to hide or alter evidence by FDA managers.

Reason #3:

Grounds supporting this reason:
Warrant underlying the enthymeme:

Reason #4:

Grounds supporting this reason:
Warrant underlying the enthymeme:

Counterargument

What are the main claims and reasons of your audience/those who disagree with you? The FDA is working as an activist group and truly doing the best that they can for the public.

Which do you think is the most powerful and/or credible? I believe that mine is the most powerful because there is solid evidence of people dying due to drugs and products approved by the Food and Drug Administration.

How will you respond to the arguments against your claim? The FDA is clearly not doing all that it can if people are dying. They also aren’t doing everything that they can if they are working more for money, power, and politics rather than for the general health and safety of the public.

As a Miami student, my days are often busy, filled with classes, meetings, lunch with friends, and occasional errands. Today, I started my morning off by taking my vitamins and eating a granola bar, and then I sat down to write this paper. That’s when I realized that everything that I had just put into my body had actually been approved by some organization. It had been approved for public safety, my safety. But who exactly has the power to “approve” almost everything that I consume every single day?
The Food and Drug Administration is the federal agency in the Department of Health and Human Services established to regulate the release of new foods and health-related products. The power they hold over the country is significant. Their “approval” represents anything from apples to high tech medical devices. I strongly believe that the Food and Drug Administration often fails to properly regulate and release new foods, drugs, and equipment into the hands of the student population.
FDA approval should be a label that comforts the consumer. It should give them reassurance that what they are putting into their bodies is not a harmful substance. The hard truth is that the FDA has approved substances that have actually killed people. This means that government approved products have actually resulted in death. FDA approval clearly does not guarantee safety. The administration was developed to act as a “watchdog” in our society, but they aren’t looking out for society’s best interest. In July of 2008, the Union of Concerned Scientists published the results of a survey of just under 1,000 doctors who work for the FDA. The collected results were disturbing: Almost one in five (18 percent) responded, “I have been asked, for non-scientific reasons, to inappropriately exclude or alter technical information or my conclusions in an FDA scientific document.” (Food) Three in five (60 percent) also knew of cases “where commercial interests have inappropriately induced or attempted to induce the reversal, withdrawal or modification of FDA determinations or actions.” (Food) These comments, made by FDA hired scientists, are outrageous. The FDA has become a political organization looking out for it’s best interest instead of for the people it originally vowed to protect.
The above instance is not the first time that FDA scientists have revolted against the group. In November of 2008, scientists working for the Center for Devices and Radiological Health (CDRH) wrote a letter to the government complaining of corrupt managers. In the letter, they reported that managers within the CDRH knowingly corrupted the scientific review process and approved or cleared medical device applications in gross violation of laws and regulations designed to assure safety and effectiveness of medical devices. Such activity could allow potentially unsafe and ineffective medical devises into the U.S. market. So, not only is the FDA becoming political, but also criminal. The organization is now engaging in tactics of intimidation, censorship and oppression. The scientists that took the initiative to write the letter alleged top FDA managers “ordered, intimidated, and coerced FDA experts to modify their scientific reviews, conclusions and recommendations in violation of the law.” (FDA) These allegations are deeply concerning and the actions of the FDA are compromising the health and safety of student consumers.
Just think how often a Miami student visits the Health Center. The medical equipment used, the medicine prescribed, all of these objects are reviewed and released by FDA approval. Government investigations have found that the FDA has allowed contaminated food and unsafe drugs to enter the market, our market! The government is also further investigating the ability and commitment of the Food and Drug Administration to protect Americans from unsafe food, drugs, and medical devices. Their findings will most likely be upsetting and shocking all at once.
Another huge problem is that drug companies are doing their own testing. This means that drug companies have to prove their own success when testing drugs. This alone is enough incentive to cheat the program. The FDA controls everything from the drug safety information used to evaluate their products to lab safety information used by the FDA.
What is the most common action one does at the grocery store? That’s right, read labels. Food and product labels are a huge problem in the FDA approval process. As consumers, we have been taught to read labels to enhance our knowledge of health and nutrition information. A recent announcement by the FDA stated that it had checked 28,000 food labels in a 14-month period; however, it failed to mention that they had merely checked to see if labels were present, and not if they were accurate. How are students supposed to learn from labels that are misleading and not necessarily FDA approved?
Another disturbing side is the alliance between the FDA and drug companies. The FDA is supposed to work as an activist group for the protection of the people, but is failing greatly in the task. Over 60,000 Americans died from COX-2 inhibitors. The drug was removed from the market by it’s own manufacturer following the revelation of studies showing alarming increases in heart attack risk. However, the FDA advisory panel voted to allow the drugs to return to the market with full FDA safety approval. The fact that a single COX-2 drug had reportedly killed more Americans than the Vietnam War was apparently not sufficient for the FDA to characterize it as unsafe.
With this decision, a “safety approval” by the FDA has now become meaningless. Mike Adams, a NaturalNews Editor, states that this instance “Was a moment where the agency could have sided with public safety and held fast to a position of responsibility and ethics. Instead, It chose to favor drug company profits and put its stamp of approval on a class of drugs that is arguably the most deadly drugs ever to hit the open market.” The re-allowance of COX-2 inhibitors back into the market dramatically boosted stock prices of drug companies and kept the drug profit machine churning away. There were also allegations that many of the people on the FDA advisory panel owned stock in the very companies impacted by the final decision. This ultimately means that some of the most deadly drugs to ever hit the market are simply “safety approved” by a big rubber stamp. Adams further went on to say, “When the FDA is attacking herbs and nutritional supplements, they will claim there’s not enough evidence to prove they are safe. But when it comes to prescription drugs, the agency says there’s not enough evidence to prove they’re dangerous. All drugs approved by the FDA, it seems, are deemed safe until proven deadly. And even when proven deadly, they apparently aren’t deadly enough to warrant banning them.”
The power of drug safety should be put into the hands of people that actually care about public safety and health. Students everyday are consuming products approved by the FDA, and they are unaware of the possible consequences. The chicken fingers, salad and fruit bars they love so much are all approved by the FDA. The Advil and cough drops they purchase at the on-campus drug store, also FDA approved. The student population needs to be aware of how affected their lives are by the FDA approval process. Students need to be activists to realize that the Food and Drug Administration is not serving the public as an activist group. Students especially need to question whether or not the FDA’s promise to public safety is truly being upheld.

Works Cited
Cook, Aaron M. “Pharmacists’ role in facilitating evidence-based prescribing for unlabeled use of medications.” American Journal of Health-System Pharmacy 66.19 (2009): 1735-739.

Energy and Commerce Committee. Web. 29 Oct. 2009. .

“FDA Scientists Revolt Against Corrupt Food and Drug Administration Officials.” Alex Jones’ Prison Planet.com. Web. 28 Oct. 2009. .

“Food Contaminants & Adulteration.” U S Food and Drug Administration Home Page. Web. 28 Oct. 2009. .

“It’s Time to Pin the FDA Down.” National Health Federation – a not-for-profit consumer-education, health-freedom organization. Web. 28 Oct. 2009. .

“With COX-2 decision, no longer any doubt about FDA corruption and U.S. drug racket
by Mike Adams the Health Ranger.” Independent news on natural health, nutrition and more. Web. 01 Nov. 2009. .

1. What are reasons for consulting sources and incorporating them into your work? To provide credibility to your paper.
2. In this chapter Lunsford describes two ways of approaching and organizing a position paper: the classical system (based on classical Greek and Roman rhetoric) and the Toulmin system (click here for more details on the Toulmin approach). What is your response to the two approaches? Which seems more appealing to you and why? I find the Classic system to be most appealing because I think it creates a more interesting paper to read. By providing an introduction, background, arguments, and a conclusion, I feel as if the paper would be easier to read and relate to.
3. Read Teal Pfeifer’s essay at the end of the chapter. What is her claim/position statement about which she’s trying to convince her readers? What reasons does she provide to support her claim/position? Is her argument convincing to you? Why or why not? What do you think she did well? What could she have done better? Where do you see evidence that she used the classical or Toulmin systems in her piece? Her claim is that the advertising industry has forced many women and young girls to aspire to be thinner and more beautiful. She supports her claims by using percentages to add credibility to her statement. She did a good job at starting off her paper, it caught my attention right away. I think her writing was the classical system because she started out with an introduction to grab the reader’s attention, and then went on to provide background and supporting arguments.
4. What did you learn from this chapter that you didn’t know before? I had never heard of the classical or Toulmi systems before.
5. What questions do you have after reading this chapter?

In Prison Planet’s, “FDA Scientists Revolt Against Corrupt Food and Drug Administration Officials,” the role of FDA scientists is finally addressed. Food and Drug Administration scientists are revolting against their own managers for their specified area in the FDA. The scientists claim that, “There is extensive documentary evidence that managers at CDRH have corrupted and interfered with the scientific review of medical device.” (FDA) The scientists wrote a letter of complaint to the government accusing the managers of overlooking the importance of public safety. This wasn’t a letter written by some random person ranting about the criminal activities of the FDA, but was instead written by FDA’s own scientists! The FDA director has repeatedly ignored these letters sent to him, and yes, there’s been more than one. The FDA has become a political organization, instead of acting as a protective service for our student population. These scientists are: “routinely overruled by politics and Big Pharma deception, which they know will result in the loss of human life as consumers are harmed or killed by dangerous medical devices and pharmaceuticals.” (FDA) We are unable to trust our FDA, a government-supported organization, and are forced to live with the drug and food approvals made by people not looking out for our best interest, but who are instead preoccupied with money and political competition.

Reviewing Your Summary for Effectiveness
Analyze the effectiveness and accuracy of your summary by responding to the following questions.
1. Does the first sentence of the summary include the source information and the original author’s main point. yes
2. List the main points of the summary. Are they the same as the main points of the original article? The article is about scientists disagreeing with the work they are doing for the FDA and their letters of complaint. My summary addresses both of these issues.
3. Is there any information in the summary that should have been left out, for example, something that is too detailed or is a side note rather than a main point? No, I find most of my information provided to be relevant to the article.
4. Judging by the summary, what was the original author’s thesis or main point? Do you think the summary accurately reflects the author’s main point? The main point was that the FDA is a political organization rather than a group devoted to public safety and human health. The summary, in my opinion, accurately reflects the author’s main point.
5. Are there places in the summary where your opinion about the subject matter is evident? Where? (Remember that summaries should be objective without your opinion or analysis of the subject matter, unless the instructor has also asked for this.) The last sentence may stress my opinion a little more that need be.
6. Wherever you have borrowed a string of three or more words from the original text, did you use quotation marks and a citation? Yes.

I believe that the Food and Drug Administration often fails to properly regulate and release new foods and drugs to the human (and in our case, student) population.
FDA approval does not guarantee safety. The administration was developed to act as a “watchdog” in our society, but they aren’t looking out for it’s best interest. Drug companies are doing their own testing, and this is a serious problem. This means that drug companies have to prove their own success when testing drugs. Drug companies have been given too high of a role in defining their own approval process. They control everything from drug safety information used to evaluate their products to lab safety information used by the FDA. The FDA’s job is to protect the student population from harmful drugs and foods, but many important issues are being overlooked so that money is made rather than public safety maintained.
This paper is written for the student population, because I believe a lot of our youth to be misinformed and gullible when it comes to the statements of the FDA. By using scholarly journals, and informational accounts from activist groups, I will formulate a paper to convince my student audience that the FDA is not doing it’s job to it’s full potential.

Works Cited
Cook, Aaron M. “Pharmacists’ role in facilitating evidence-based prescribing for unlabeled use of medications.” American Journal of Health-System Pharmacy 66.19 (2009): 1735-739. Print. I’m using this source because the author presents an overview of legal considerations for the unlabeled use of medications and Food and Drug Administrations guidance on reprint practices in the U.S.

Energy and Commerce Committee. Web. 29 Oct. 2009. . I’m using this particular source because it addresses the issues with the law, rather than human ethics.

“FDA Scientists Revolt Against Corrupt Food and Drug Administration Officials.” Alex Jones’ Prison Planet.com. Web. 28 Oct. 2009. . I’m using this source because it addressing the issue from a different perspective. This addresses the beliefs of the scientists and how they feel about the work that they are doing for the government.

“Food Contaminants & Adulteration.” U S Food and Drug Administration Home Page. Web. 28 Oct. 2009. . This source is valuable to my research because it allows me to analyze what the FDA says it is doing and then for me to research if it’s true and reliable information that they are providing to the public.

“It’s Time to Pin the FDA Down.” National Health Federation – a not-for-profit consumer-education, health-freedom organization. Web. 28 Oct. 2009. . This source is important because it is addressing drug issues with the FDA that go against our health-freedom beliefs.

How is Booth defining “rhetoric” in this piece? Reality consisting of any “fact” about “the world.” How we feel about it and how we react to it.
How is “discourse” related to his notion of “rhetoric”? [Look up a definition of discourse as he doesn’t define it in this section] It’s the communication of thought (how we feel) through words.
Why is it important that rhetoric or discourse or language actually affects our realities? What do you think about this idea Booth argues for that “rhetoric makes realities, however temporary” (50)? Can you think of an example that hits close to home for you? Because the way we think and feel should affect our realities. Our thoughts and feelings can change our futures.
Next week we’ll talk about constructing arguments for your position paper, and one of the approaches you’ll read about in The Everyday Writer for Tuesday is the Toulmin approach, where you’ll attempt to find warrants, or common ground, with your audience. Booth writes that “all successful communication within any given domain will depend on tacit shared assumptions about standards and methods, including what Stephen Toulmin taught us to call ‘warrants’” (51). Read this link about Toulmin and warrants: http://owlet.letu.edu/contenthtml/research/toulmin.html
Why are warrants important in making an argument and attempting to communicate with an audience? Because warrants give reliable or formal assurance of something. They can guarantee or pledge assurance to an audience.
Why is “listening to the other side” important in communication and attempting to persuade an audience? (see pg 52 Booth) Listening to the other side’s arguments will only improve our own rhetoric as we force ourselves to learn to listen.