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Pharmaceutical Industry

Protecting Consumers Through Increased Regulation

Created by: Natalie Wells, Karla Melchin, Ryan Paull, Kaydelyn Stewart


TABLE OF CONTENTS Introduction........................................................ 1-2 Solution One..................................................... 3-4 Solution Two.......................................................

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Solution Three....................................................

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Additional Resources........................................

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Strengths & Weaknesses.................................

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Appendix.............................................................. 9-16


Introduction The pharmaceutical industry has been under fire for many things; too little current regulation, increasing the price of prescription drugs, and not passing drugs that could potentially help patients. In 1906 the FDA was created when the Food and Drug act was signed by President Theodore Roosevelt (1). This act provided for the federal inspection of meat products and forbade the manufacture, sale, or transportation of poisonous patent medicines. This act was brought about by the rise of educational exposes from individuals such as Upton Sinclair and Samuel Hopkins Adams. According to Erik Bergstrom, a Registered Pharmacist who works at the Rexburg, Idaho Walgreens Pharmacy, Each drug undergoes a series of test with three phases: 1- tested on healthy people, 2tested on sick people, and 3- market research to determine of the drug will sell. The FDA has been tasked with trying to keep people safe and the Food and Drug Industry well regulated.

In 2005, the seven pharmaceutical companies with the highest revenues had more than 17 percent of their revenues were dedicated to profits, compared with 13.9 percent spent on R&D and 32 percent on marketing, advertising and administration (2). The seemingly unreasonably high prices of prescription drugs have people wondering if these prices are really necessary to cover the costs of research and development. Much research has shown that these companies tend to spend much more of their money on advertising the products than actual research and development. This research leads people to think that prices of drugs are being inflated by the companies out of a greedy interest in profits. In 2005 over 40 million people in the United States were doing without pharmaceuticals, eye-glasses, and other prescribed medical equipment because they couldn’t afford it (3).

1- Castner, Morgan; Hayes, Joanna; Shankie, Daniel. “Political Determinants: Governments and Trade Agreements the Affect the Industry. The Global Pharmaceutical Industry, 19 April 2007. 26 June 2012. 2Porter, Diane M. “The Cost of Prescription Drugs Is Outrageous.” Outrageous Fortune: How the Drug Industry Profits from Pills. Washington, DC: Alliance for Retired Americans Educational Fund, 2007. Rpt. in the Pharmaceutical Industry. Ed. Jamuna Carroll. Detroit: Greenhaven Press, 2009. Opposing Viewpoints. Gale Opposing Viewpoints In Context. Web. 20 June 2012. 3- Maggie Fox. “Over 40 million in U.S. can’t afford health care.” Reuters. Thompson Reuters, 3 December 2007. Web. 19 June 2012.

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Introduction Cont. Nearly 15 million adults did not obtain eyeglasses, 25 million did not get dental care, 19 million did not get needed prescribed medicine, and 15 million did not get needed medical care due to cost. The prices of brandname medications have continued to increase despite calls from all three major presidential candidates for pharmaceutical companies to make their products more affordable, the Wall Street Journal reports. In some cases, pharmaceutical companies have increased the prices of brand-name medications scheduled to lose patent protection to prompt patients to switch to similar, newer products that will have patent protection for a number of years.

They will want their results to please their benefactors so that they will get more funding in the future. Mistrust has developed in these companies due to the fact that much of the clinical testing data on a given drug is not presented to the public. There may be many studies which show a drug is not effective, but the company will only present the one study that has positive results. In one instance with Paxil, there were 5 clinical trials done and only one had somewhat positive results.

Clinical research must be conducted on any given drug before it is released to the public. Much of this clinical research is conducted in universities and hospitals. As this statistic showed, the pharmaceutical company itself is usually the one to fund the majority of this research. This raises and ethical issue because having the company be the primary money source could bias the results and erode the scientific integrity of the study.

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Solution One To set up a review board, equivalent to the Canadian Patented Medicines Prices Review Board (PMPRB) which will slow down drug price increases. The PMPRB is an independent quasi-judicial body established by Canadian parliament in 1987. Its purpose is to ensure that drug prices are not excessive by reviewing the prices set by the companies and if found to be excessive, the board can hold public hearings and order price reductions (1). The General Accounting Office, an investigative arm of Congress, suggests that the United States should consider establishing a board to review prices similar to the one in Canada. One member released the following statement in a report: “Canadian experience shows that a drug-price review board can restrain prescription drug prices,” the accounting office report said. “Relative to U.S. drug prices, the Canadian prices of some drugs, subject to board review, were on average one-third lower than had there been no board.” (2)

Key Components of the Program

o The first step will be to set up a review board consisting of various professionals such as doctors, pharmacists, members of the FDA, lawyers, and a few members from the general public. This review board will evaluate new drugs released from the manufacturers. The manufacturers must submit all important data for the board to review including:

• Price.

• Reviews of the product in recog- nized journals.

The PMPRB uses the following guidelines to determine if the price of a drug is excessive:

• (1)The price of an existing patented drug cannot increase by more than the Consumer Price Index (CPI).

• (2) The price of a new drug (in most cases) is limited so that the cost of therapy with the new drug is in the range of the costs of therapy with ex- isting drugs in the same therapeutic class.

•Results of two to five well-controlled trials. o Next, the review board will determine if the price set by the manufactures is exces sive or reasonable.

(3) The price of a breakthrough drug is limited to the median of its prices in France, Germany, Italy, Sweden, Switzerland, Britain, and the United States. In addition, no patented drug can be priced above the highest price in this group of countries(3).

1- http://www.pmprb-cepmb.gc.ca/english/View.asp?x=1433 2- http://www.nytimes.com/1993/02/22/us/canada-is-found-to-lead-usin-holding-drug-prices-down.html 3- http://content.healthaffairs.org/content/20/3/92.full

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Solution One Cont. o If the price is deemed excessive, the board can take the following measures to reduce the price:

o The board should also be responsible to give annual reports about the price trends of drugs. Reports should include the following information:

• They can discuss with the company and the company can volun- • Sales of patented drug products. tarily reduce the price of the drug. • Price trends. • Hold a public hearing and then • Prices compared to foreign prices. order the manufacturer to re- duce the price so it is no longer • Patented drug product utilization. considered excessive. • Drug expenditures in the global context.

• Provide key statistics on the current state of pharmaceutical research in vestment (1).

Figure 8 is from the PMPRB 2012 report. It showed that in 2011, the U.S. saw a 10.9% increase on drug prices while Canada remained constant.

1- http://www.pmprb-cepmb.gc.ca/english/View.asp?x=1433

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Solution Two Identify a program that could potentially decrease the ability for patients to abuse prescription drugs, due to the fact that after years of regulation there is still such a high level of prescription drug abuse in the United States. The Centers for Disease Control & Prevention reported in 2004 that 14 million patients misuse their medications and more than 20,000 cases a year result in an unintentional death (1). In the U.S., painkillers such as OxyContin and Vicodin are more likely to cause a fatal overdose than heroin or cocaine.

Key Components of the Program o Establish a four-fold analysis for patients who have been on long-term prescription drugs.

• At the initial prescription of a drug only one refill should be allowed.

• After that one refill has been used, a patient must return to the doctor who prescribed the drug to them for a thorough check up before any additional refills may be filled.

• At the discretion of the medical doctor and depending on the severity of the drug in question a visit with a psychologist may be prescribed in order to ensure that the drug is being used properly.

• If a patient is found to be abusing prescription drugs, prescription drug rehab should be prescribed.

1- Castner, Morgan; Hayes, Joanna; Shankie, Daniel. “Political Determinants: Governments and Trade Agreements the Affect the Industry. The Global Pharmaceutical Industry, 19 April 2007. 26 June 2012.

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Solution Three There needs to be an oversight committee that can go in and maintain accurate reporting of all drug companies and manufacturers. There needs to be greater transparency for the people of the United States to see the tests, research, analysis and overall creation of drugs that they may be taking. We need to find a way to curb the greed that is running rampant in this industry.

Key Components of the Program o There needs to be committees formed that can help oversee the industry as a whole.

• We are seeing problems of greed which leads to less care about the betterment of Americans health. An oversight committee will be able to monitor the activities of drug companies and make sure that the tests that they are doing are not covered up, the prices they are charging are legitimate, and all side effects are made known.

• I think too many times people can call their Dr. and get a prescription refilled over the phone. Riddlin and Adoral are two drugs I think are running wild in the US and need to be better understood before they are just given out.

o Are patients who have been on drugs for an extended period of time being annually reviewed? How do we know these drugs are even helping if they are not seeing a doctor?

• Patients need to have annual reviews and be meeting with their doctor on a regular basis so that they can monitor the effects of the prescription drugs they are taking.

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Additional Resources

Learn more Online... The latest development news in the pharmaceutical industry as well as access to a variety of articles written by journalists. http://www.pharmaceutical-business-review.com/ A variety of media sources covering events in the pharmaceutical industry. www.pharma-iq.com Current data on trends in the industry. http://www.opensecrets.org/industries/indus.php?ind=H04 Prescription drug abuse. teens.drugabuse.gov and http://www.rehabinfo. net/prescription-drug-rehab/statistics/ Jyoti Mirdha, a doctor and Congress MP, is urging the country to bring all drugs under price regulation. http://www.dnaindia.com/analysis/column_should-drug-prices-be-regulated_1691574 iii. Wholesale prices for the 50 brand-name medications with the most sales increased by an average of 7.82% in 2007, compared with increases of 6.73% and 6.22% in the previous two years, according to Delta Marketing Dynamics. http://www.medicalnewstoday.com/releases/98208. php.

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Strengths and Weaknesses Solution

Strength

Weakness

Set up a review board, A strength of this solution A weakness of this solution equivalent to the Canadian is that an independent is that it will take money to Patented Medicines Pricgroup can help to make sure fund the board which may es Review Board (PMPRB), prices are fair. This board not be an expenditure that which will slow down drug never sets the prices of the the government or other drugs; the manufacturer is organization is willing to price increases. the one who sets the prices. take. Another weakness is The board is there to review that the companies may argue that in a free market, the data about the drug to supply and demand should determine if the price that regulate the prices and not the manufacturer has set is fair. an independent board. Identify a Identify a program Such a program could lead A person cannot be forced that could potentially deto a decrease in prescripto unwillingly heal from an crease the ability for pation drug abuse through addiction. This program may tients to abuse prescription monitoring by medial and not show as many measurdrugs, due to the fact that psychology professionals able, concrete, and tangible after years of regulation and could promote the use results as another form of there is still such a high level of healthy measures to heal regulation might. of prescription drug abuse from a prescription drug in the United States. abuse. This type of oversight group The strengths to having There needs to be an overwill have to be funded and a committee like this will, sight committee that can where those funds are comgo in and maintain accurate hopefully, decrease the amount of fraud I believe is ing from could cause some reporting of all drug comproblems. Also, who will be going on. Tests and studies panies and manufacturers. will no longer be able to be on the committee? Making There needs to be greater sure that this group of peotransparency for the people covered up or thrown out if the “desired results” aren’t ple has the peoples’ best of the United States to see given. People will feel more interests may be difficult. the tests, research, analysis and overall creation of drugs comfortable if they know that there is an organization that they may be taking. out there that has their best interests at mind; I think people don’t view these drug companies as a “trustPharmaceutical Industry 8


Appendix

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Karla Melchin My name is Karla Melchin and I am currently finishing my junior year at Brigham Young University-Idaho. I am a psychology major with two clusters in sociology and interpersonal communications. I am originally from Calgary, Canada but I moved to Rexburg, Idaho in order to go to school. I will be graduating with my bachelor’s degree next year and then will be continuing on to graduate school. I hope to eventually become a counselor for troubled youth. Team Member Tasks: • Research and discussion of the scope of the problem • Submission of strategic research done about the issue including 8 resources, 3 organizations, and 3 websites • Conducting an interview with someone directly/indirectly related to the industry (Shawn Andreasen, Pharmacist at the BYU-Idaho Student Health Center) • Proposing a potential solution to the problem (to implement a review board equivalent to the Canadian PMPRB) • Providing constructive feedback to my teammates on their submissions Selection of the Issue: I first became interested in this issue through my studies in my psychology classes. I had known for a while that there were issues in the pharmaceutical industry, but I wasn’t certain what the exact problems were. I recently had a class where my teacher led a discussion about anti-depressant drugs and we followed a particular case where many clinical trials had been done on the drug, but out of the many studies, only a select few were chosen to be presented. Many of the unreported studies showed results that the drugs weren’t nearly as effective as the industry was promoting them to be. Upon hearing this, I became frustrated with the obvious deceit in the advertising and I wanted to learn more. I became very intrigued in this topic because I knew this would be something I would face in my future career as a psychologist. I desired to do more research and so I proposed the topic to my group who all agreed it would be a worthwhile topic of study. Personal Reflection: For me, the research into the pharmaceutical industry has been an eye-opening experience. I had always known that there were issues between the public and the industry, but until now I had never really understood the depth of the issues. There were many sources that expressed a deep mistrust with the industry—often relating to their greed and deception in the marketing and selling of their products. At first, I was completely horrified at all the allegations made against the industry and I wondered why serious actions weren’t being taken to correct some obvious problems. However, upon further reflection I realized something: the pharmaceutical industry is a business. I associate the pharmaceutical industry as part of the health care system and so I expect it to be under more scrutiny from the government. Of course there are certain regulations put in place to help protect consumers, but it is important to realize that the industry is still a business first and foremost and the purpose of any business is to make a profit. All businesses use strategy and they scheme of ways to make their products more appealing to the public in order to sell their products and thus make money. Every commercial we see on TV is going to highlight their product in a way that shows off the advantages and minimizes the disadvantages. Why would we expect anything less from a business selling pharmaceutical drugs? I believe that this particular industry has created a bigger uproar than most because its products directly contribute to the health, safety, and wellbeing of consumers. Many people might argue that because it is a business it should be left alone in the free market, but because of the significant impacts on the health of consumers (for better or for worse) regulations must be put in place. We must strive to ensure that those who require medication can have access to necessary drugs at a reasonable price. We should work to increase the transparency of the marketing strategies so that consumers have a better understanding of the drawbacks of any given drug. While I hope that the end goal will be increased regulations on the industry, I believe that the first step in achieving that goal is for consumers to take a more active role in the process. As we do our research and become more knowledgeable, we will be better prepared to combat these issues and realize our powerful influence as we advocate for change. Pharmaceutical Industry 10


Karla Melchin- Research and Sources Strategic Research: While there have been an increasing number of regulations placed on the pharmaceutical industry in the last several years, there are still many concerns about the practices of the industry that need to be addressed. Many people are concerned about the prices of drugs released by pharmaceutical companies. While most companies claim that the costs are necessary to offset the expenditures on research and development, research has shown that more of the profits earned are dedicated to marketing, advertising, and administration rather than research and development. There is also an issue of mistrust about the relationship with doctors and pharmaceutical companies. The industry has been condemned for bribing doctors to push the company’s drugs to their patients. People are worried about the tremendous amount of power that these companies have and that they are using it to push people into doing what they want. Another inappropriate relationship may also stem from the many universities who conduct much of the clinical testing data on a drug. These universities require funding for the research and the majority of that funding comes from the pharmaceutical industries. Concerns have been raised regarding the maintenance of scientific integrity: will these universities be able to remain objective when their funding may depend on getting specific results from their research? Finally, another problem with the industry are incidences where not all of the clinical testing data on a given drug is released and thus people are misled about the true effectiveness of drugs. Many studies are generally conducted on a drug, but the companies can pick and choose which studies to highlight. Steps must be taken soon in order to protect consumers from the ills of the industry. Baines, Donald A. “Problems Facing the Pharmaceutical Industry and Approaches to Ensure Long Term Viability.” PhD Thesis. 2010. Document. 19 June 2012. Bandow, Doug. “The Pharmaceutical Industry: Problem or Solution?” 1994. The Freeman Ideas on Liberty. Document. 19 June 2012. Chordas, Lori. “Generic Drugs Reduce the Cost of Prescriptions.” The Pharmaceutical Industry. Ed. Roman Espejo. Detroit: Greenhaven Press, 2012. Opposing Viewpoints. Rpt. from “Refilling a Need: Thanks to a Growing Number of Generic Drugs, Health Plans Are Better Able to Manage Prescription Costs.” Best’s Review 109.4 (Aug. 2008). Gale Opposing Viewpoints In Context. Web. 20 June 2012. Loehwing, Rudi C. “Pharmaceutical Companies Paid Health Experts to Hype the H1N1 Threat.” Epidemics. Ed. David Haugen and Susan Musser. Detroit: Greenhaven Press, 2011. Opposing Viewpoints. Rpt. from “H1N1 Swine Flu Vaccines Driven by Illegal Graft and Pay Offs.” Your Story. 2010. Gale Opposing Viewpoints In Context. Web. 20 June 2012. Porter, Diane M. “The Cost of Prescription Drugs Is Outrageous.” Outrageous Fortune: How the Drug Industry Profits from Pills. Washington, DC: Alliance for Retired Americans Educational Fund, 2007. Rpt. In The Pharmaceutical Industry. Ed. Jamuna Carroll. Detroit: Greenhaven Press, 2009. Opposing Viewpoints. Gale Opposing Viewpoints In Context. Web. 20 June 2012. McGeough, Caroline. “Research Without Drug Industry Sponsorship May Not Be Feasible.” The Pharmaceutical Industry. Ed. Roman Espejo. Detroit: Greenhaven Press, 2012. Opposing Viewpoints. Rpt. from “The Research Industrial Complex: Is Unbiased Research Economically Feasible?” Chronicle 22 Apr. 2010. Gale Opposing Viewpoints In Context. Web. 20 June 2012. Oroho, John Patrick, Christopher R. Corallo, and Christine N. Bradshaw. “Pharmaceutical Marketing Practices Are Strictly Regulated.” The Pharmaceutical Industry. Ed. Roman Espejo. Detroit: Greenhaven Press, 2012. Opposing Viewpoints. Rpt. from “Sales Rep Nightmares: Emerging Issues in Marketing Compliance.” Update 3 (2009): 40-45. Gale Opposing Viewpoints In Context. Web. 20 June 2012. “When Drug Companies Hide Data.” New York Times. 6 June 2004. Web. 4 June 2012.

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Natalie Wells Hi! I’m Natalie Wells. I am a Senior studying Communication with an emphasis in Public Relations. I am from a small town in Southern Illinois. After graduation in December I am hoping to find a fabulous job. Team Member Tasks: • Researched and discussed the background of the problem • Submitted 8 resources, 3 related organizations, and 3 websites • Conducting an interview with Eric Bergstom, a Registered Pharmacist • Proposed a solution to the problem • Provide constructive feedback to my group members Selection of the Issue: I first became interested in this issue when I was in high school and I job-shadowed at my local pharmacy. Until I completed the job-shadow experience I had not realized that there were so many regulations and issues surrounding the pharmaceutical industry. As I learned more and more about these issues I became more interested in learning about them, and so I was very grateful to have the opportunity to work on this assignment. Personal Reflection: Exploring this issue has been very interesting to me. I have learned a lot about the products that I put into my body in order to try to make myself well. It has also been eye opening to realize just how many people in the United States struggle to receive pharmaceutical drugs. On the flip side, however, is prescription drug abuse, from those who are easily able to get pharmaceuticals. I do believe that the answer is more regulation, and while I do not claim to have all of the answers I would suggest that a heavier monitoring of prescription drug use should be instated.

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Natalie Wells- Research and Sources Strategic Research: Drugs are evaluated for safety, efficacy, and manufacturing quality as a condition of market access, and promotional messages must adhere to approved product characteristics. The 1962 Amendments to the FDA Act extended the powers of the FDA to review safety, efficacy, manufacturing quality, and promotion. Subsequent studies concluded that the safety and efficacy requirements added to the intrinsically high cost of R and D, led to launch delay of new drugs and favored large over small firms. Increasingly, new drugs originate in small firms, which often out-license their products to more experienced firms for later-stage drug development, regulatory review, and commercialization. Although patents bar generically equivalent products for the life of the patent, they do not prevent entry of similar products that may be therapeutic competitors. Thus, neither natural monopoly nor patents provide a rationale for regulating pharmaceutical prices. One country’s system of price regulation can affect not only its domestic prices and availability, but also prices and availability of drugs in other countries. Such external spillovers can occur because of price regulation with external referencing. Mike Barrett. “Drug Labels Contain 70 Negative Side Effects on Average.” Natural Society. National Society, 2012. Web. 19 June 2012. Maggie Fox. “Over 40 million in U.S. can’t afford health care.” Reuters. Thompson Reuters, 3 December 2007. Web. 19 June 2012. Oscar Raymundo. “Prescription Drug Abuse: Blame Doctors.” The Debate Room. Bloomberg Businessweek, 2012. 19 June 2012. Patricia M. Danzon. “Economics of the Pharmaceutical Industry.” The National Bureau of Econimic Research. NBER Reporter: Research Summary, Fall 2006. 19 June 2012. OECD. “Competition and Regulation Issues in the Pharmaceutical Industry.” Policy Roundtables. OECD, 2000. 19 June 2012. Judith L. Wagner. “Should the Pharmaceutical Industry Be Regulated?” HealthAffiars. HeathAffiars, 2012. 19 June 2012. “Pharmaceutical cGMPS for the 21st Century — A Risk-Based Approach: Second Progress Report and Implementation Plan.” U.S. Food and Drug Administration. U.S. Department of Health and Human Services, 2012. 19 June 2012. Agnes Shanley. “Taking the Plunge to Harmonize Pharmaceutical Regulations.” PhamaceuticalMagazine. com. Putman Media, 2012. 19 June 2012.

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Ryan Paull My name is Ryan Paull and I’m a senior at BYU-Idaho getting ready to graduate in July of 2012. I am from Titusville Florida and love to surf. Team Member Tasks: • I completed strategic research for the assignment. • I looked into the ramifications of the problem of the pharmaceutical industry. • I also looked into solutions for the problem; some of those being more regulation for the pharmaceutical industry. • I interviewed an expert in the pharmacy field and was able to get some inside information on his thoughts and experiences in the field. Selection of the Issue: My team selected this issue, I believe, because we all have a passion for this topic. I was drawn to the topic because I have done research in the past on the medical and pharmaceutical industry and feel like I have a good grasp of the industry as a whole. Personal Reflection: In doing the research for this project I have learned so much about the pharmaceutical industry and have been able to formulate many new opinions. It is interesting to note that before doing this assignment I had created ideas and opinions just based simply upon things I had heard from others. After doing my own research and reading the many articles out there on this industry I was able to see a shift in my opinions and thoughts. In doing the research on the pharmaceutical industry I have come to the conclusion that there needs to be more regulation and oversight in this industry. I came up with an idea for a separate organization to be the one who actually oversees the industry. There is a lot of research pointing to the fact that some drug companies will do research and if it does not come out the way they want it to they will essentially hide the research or trash it all together. There needs to be an organization out there that has the people’s best interests in mind. Drugs and pharmaceuticals are so important because they have a direct impact with people’s health and wellbeing. I am not saying that there is a big conspiracy in the United States; however, the pharmaceutical industry is a company like any other and they are out to make a profit. Wherever there is money available to be made there are trust issues as well.

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Ryan Paull- Research and Sources Strategic Research: The pharmaceutical industry has been under fire for many things; too little current regulation, increasing the price of prescription drugs, and not passing drugs that could potentially help patients. Since its introduction in 1906 the FDA has been tasked with trying to keep people safe and the Food and Drug Industry well regulated. Ramifications: Less Regulation means the pharmaceutical industry can run wild and make their own decisions on drugs. RadiThor was a drug that came out in the early 1900’s and had absolutely no studies done to support the claims that this was a “miracle drug.” It was sold to the wealthy and was essentially just water and isotopes of radium; after killing someone the media put this company and drug out of business. Without regulation, as was the case in the early 1900’s, drugs like this can hit the market and cause massive problems. Pharmaceutical industry can freely raise prices on drugs. Drug pricing is like a monopoly until the drug patents expire and other manufacturers can enter the market with a similar drug. Drug companies have almost a zero marginal cost and have almost 100% margins, so you price them to maximize the product of sales and units sold. The prices of brand-name medications have continued to increase despite calls from all three major presidential candidates for pharmaceutical companies to make their products more affordable, the Wall Street Journal reports. In some cases, pharmaceutical companies have increased the prices of brand-name medications scheduled to lose patent protection to prompt patients to switch to similar, newer products that will have patent protection for a number of years. Siemens. (n.d.) Exploring the potential of continuous manufacturing in the pharmaceutical industry. Retrieved June 22, 2012. http://www.industry.siemens.com/verticals/global/en/pharma-industries/continuous-manufacturing/pages/continuous-production-benefits.aspx Angell, Marcia. July 15,2004. “The Truth About the Drug Companies.” Retrieved June 22, 2012. http:// www.nybooks.com/articles/archives/2004/jul/15/the-truth-about-the-drug-companies/?pagination=false Dubner, Stephen. January 1st, 2008. “What don’t we know about the pharmaceutical industry?” Retrieved June 22, 2012. http://www.freakonomics.com/2008/01/24/what-dont-we-know-about-the-pharmaceutical-industry-a-freakonomics-quorum/ Better Body Journal. May 16th, 2008. “Pharmaceutical Drug Companies Killing Middle America Legally while Robbing You Blind.” Retrieved June 22, 2012. http://www.betterbodyjournal.com/health/pharmaceutical-drug-companies-killing-middle-america-legally-while-robbing-you-blind DMA. April 24th, 2008. “Pharmaceutical Sales via Direct Marketing To Reach 10.6 billion in 2008.”Retrieved June 22, 2012. http://www.marketingcharts.com/print/pharmaceutical-sales-via-direct-marketing-toreach-106b-in-2008-4331/ Castner, Morgan. April 19, 2007. “The Global Pharmaceutical Industry.” Retrieved June 22, 2012. http:// www.duke.edu/web/soc142/team2/social.html#citations Warren, Noreen. June 2001. “Pharmaceutical Regulation in the United States.” Retrieved June 22, 2012. http://www.bio-link.org/GMP/KELPOST.html Boldrin & Levine: Against Intellectual Monopoly, Chapter 9. June 22, 2012. http://levine.sscnet.ucla.edu/ papers/ip.ch.9.m1004.pdf

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Kaydelyn Stewart

My name is Kaydelyn Stewart. I am a senior at BYU-Idaho working on completing my Bachelors in University Studies with a minor in Organizational Communications and a minor in Home and Family Management. I was raised in Idaho and currently live in Oregon. I am married and have two beautiful children. Team Member Tasks: • I am the editor of the issue book. • Came up with design and layout of the book. • I compiled all of the information and research provided by the writers and organized it in a clear, meaningful way. Selection of the Issue: The team selected the issue of pharmaceutical regulations because there are clear issues within this industry. Prescription medications continue to increase in price as well as abuse and the misuse of prescription drugs. Personal Reflection: I was never really aware of an issue within pharmaceutical industry until I began reading the research and information provided by the writers of this issue book. I have learned that the price of prescription drugs has steadily increased in the United States over the past several years. I have also learned that not all clinical research done on a drug is released to the public. Prescription drug abuse continues to be a problem among patients. I know it is easier said than done, but programs need to be developed to help regulate the price of prescription drugs and to help decrease the misuse of prescriptions. Patients have the right to know all of the research done on a drug that is prescribed to them.

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Pharmaceutical Industry