Advocacy Project Final Draft

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While writing my Advocacy Project, I had a slightly better grasp on multimodals and what they can do for my paper. I learned to find graphs that worked complimentary to my thesis and paper as a whole. I kept the photograph of MaryLou Townsend from my HCP because I felt that it was the best tool for incorporating pathos into my argument, while serving as a good hook. I got better at deciphering scholarly articles and was able to pick quotes that are better integrated than my HCP. In dealing with a national solution to pharmaceutical price gouging, I widened the scope of my lens appropriately and discussed the political turmoil around the issue and expanded on the more recent history that was not covered by my HCP.

 

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Pretium iustum est:

The Price is Right?

 

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Figure 1: “Melinda Townsend-Breslin holds a photo [of her mother and her]…in the parking lot of a favorite thrift store in 2013 a year before her death.”

"Medical Bills Linger, Long After Cancer Treatment Ends." NPR. NPR, 27 Mar. 2015. Web. 28 Jan. 2016.

 

People fight battles in hopes of finding peace. Fifty-eight-year-old MaryLou Townsend, a pancreatic cancer patient, approached her will to fight following her diagnosis in much the same way. However, somewhere between the frantic trips to the OR and frequent chemotherapy treatments, the bills piled up. And while the insurance company covered charges in the plan, the plan did not cover everything. Amanda Aronczyk, writer and reporter at National Public Radio, recounts the family’s story of how finances affected MaryLou’s care. During her treatment, Townsend suffered from blood clots and her body did not respond to the standard medication. The alternative, outpatient medication ended up costing over $1000 a month and “had to be paid out of pocket” (Aronczyk). As a result, the financial toll took more out of Townsend than the physical toll from her cancer. After Townsend’s death, her husband and daughter were left with around $100,000 in medical debt, which they slowly worked toward paying off.

Millions of American families face the looming cloud of rising pharmaceutical drug prices that overshadow the benefits of treatment each year. The price of prescription drugs for terminal illnesses contributes largely to medical expenses that often leads to bankruptcy. In 49 out of 50 states, the leading cause of bankruptcy in 2014 was found to be medical debt (Stech). Pharmaceutical companies go unchecked as they set astronomical, arbitrary prices on medicines for diseases. Due to the Food and Drug Administration’s (FDA’s), a regulative body responsible for promoting and protecting the state of public health in the nation, lack of regulation over pharmaceutical drug prices, the corporations who market and sell the biomedical drugs make enormous profits through price spiking while their consumers are left scrambling to pay for them.

America’s regulation of health policy began in 1984 with the Hatch-Waxman Act, more formally known as the Drug Price Competition and Patent Term Restoration Act. Its purpose encompasses the establishment of cheaper manufactured generic drugs by the pharmaceutical industry and marks the first regulation on drug pricing. Clinical trials, studies, and research that are normally performed prior to FDA approval for new medications are no longer requirements for small-molecule drug equivalents with active properties similar to already licensed medications. The act decreases prices up to 80% (Grabowski 2157). This victory in price reduction is short-lived due to the patent period extension in response to the lack of innovation incentive for brand-name companies in the Hatch-Waxman Act.

The United States increased its patent term to 20 years from the filing date, or 17 years from the issue date in 1995. The revision stands as a response to the Hatch-Waxman Act and the World Trade Organization’s (WHO) standards on intellectual property. The patent period extension provides innovation incentive for pharmaceutical companies by eliminating competing drugs equivalents in the market for lower rates. This permits them to set prices as they wish. According to a study conducted by Ronald J. Vogel, PhD, patent protection grants pharmaceutical companies “a period of above-normal profits for a technically [commercial] …product (1204). Patents also act as a safeguard for biomedical companies, “because pharmaceuticals that are not derived from biotechnology can be imitated easily and inexpensively” (Vogel 1204). Instead the extension causes exclusivity resulting in higher prices for longer periods of time before generics hit the market.

The Center for Medicare & Medicaid Services (CMS) sets the standards for health insurance coverage and has insured Americans for over 50 years and insures over 100 million Americans today, making it the largest health care insurance provider in the country. Although the 2006 amendment aims to bridge the gap between consumers and out-of-pocket prescription payments, as of 2003 the “Medicare Prescription Drug, Improvement, and Modernization Act forbids Medicare [and the FDA] from negotiating drug prices” (Tefferi 997). The 2003 Act was not overturned when Medicare Part D was added as a part of the 2006 amendment. The overlap speaks to the contradiction of U.S. law on health care regulations. If neither the largest medical service provider in the country nor the standard regulatory body cannot negotiate drug prices, it grants pharmaceutical companies the leeway to sell drugs at the highest, consumable market value.

Turns out not all press is good press, with the controversies that have brought pharmaceutical price gouging to the forefront of the media in the past year. Turing Pharmaceuticals, in September 2015, was caught in a controversy over the increased the cost of Antiretroviral pills (AIDS drug) by more than 5000 percent that they authorized overnight. After much public scrutiny and national media coverage, the former CEO, stated that they would “mull over the decision to reduce prices,” but no doubt, intentionally failed to mention how (Harven). The poorly documented journey of how Pfizer reached its price tag proves the necessity for regulation and finally has U.S. Congress rallying for its citizens. With the recent massive media coverage given to Big Pharma exploiting their sick consumers such as the cases with Turing Pharmaceuticals and Pfizer, Congress has taken to run a hearing against former CEO of Turing Pharmaceutical, Martin Shkreli. In December of last year, Pfizer, one of the largest multinational, pharmaceutical corporations, set the price for a new breast cancer drug at $9850 per month. The House bill introduced by Rep. Elijah Cummings stands as proof that Congress can no longer debate this issue as if it is just another political debate on the extent of regulating a capitalist free market economy. In place of a petty political debate stands a battle for the welfare of America’s constituents and their fiscal and physical health.

One solution to this national issue is the United States House of Representatives Bill 3513 and the equivalent Senate Bill 2023, the Prescription Drug Affordability Act of 2015. Representative Elijah Cummings of Maryland, and Senator Bernie Sanders of Vermont. introduced the Prescription Drug Affordability Act on September 16, 2015 on September 10, 2015 in the United States House of Representatives and Senate, respectively. The bill has not been voted on yet in either the House or the Senate. It allows CMS (Center for Medicare & Medicaid Services) to intervene in the regulating of prescription drug affordability. The Act states that all drugs covered under Medicare Part D, which includes all inpatient treatments and some outpatient treatments, will be subject to price negotiations with drug manufacturers. And those manufacturers will then be required to issue prescription drug rebates to qualified low-income individuals. Thus resulting in the closure of the Medicare Part D coverage gap. The bill will amend the Federal Food, Drug, and Cosmetic Act to “allow the importation by individuals of prescription drugs from Canada, and potentially other countries” as well as to establish “conditions on the award of market exclusivity” with severe consequences to the manufacturers who break these laws (U.S. House). Meanwhile this Act, if passed, will modify the Federal Trade Commission Act to enforce restrictions on “anticompetitive patent settlements [called] ‘pay-for-delay’…[that] block generic drug competition” (H.R.).

While the Prescription Drug Affordability Act covers many essential parts to the issue of unchecked, astronomical prescription drug pricing, it leaves room for quite a few loopholes. For this reason the a policy from physicians at the Mayo Clinic, a nonprofit worldwide leader in medical care, research and education, came up with their recommendations to fight rising drug costs in their scholarly article, In Support of a Patient-Driven Initiative and Petition to Lower the High Price of Cancer Drugs. Doctors like Ayalew Tefferi, M.D., hematologist at the Mayo Clinic, claim that a “post-FDA approval review mechanism to propose a fair price for new treatments” will help reduce drug costs (Tefferi). The petition states that the direct negotiation of drug prices by Medicare should be established, similar to the Prescription Drug Affordability Act of 2015. In order to solve the issue of newer drugs on the market not improving quality of life, but only increasing life span by a matter of weeks or days, the petition advocates for allowing Patient-Centered Outcomes Research Institute, department created by the Affordable Care Act Initiatives to evaluate the specific benefits of new treatments before the drugs are approved by the FDA to hit the market. Again similar to the above congressional bill, the article suggests for the legalization of imported prescription drugs and legislation prevent the pay-for-delay avenue that prevents access to generic medications.

If the policy recommendations of H.R. Bill 3513 and the Mayo Clinic Petition are established in conjunction with each other, they contain the power to revolutionize prescription drug affordability and fight the rising drug costs with as much punch as pharmaceutical companies are countering with. The establishment of these laws creates a comprehensive protection against pharmaceutical companies’ astronomical prices and greed, with a barely-existent dent on their profit margin. The recommendations confront the source of the issue through covering the basis of international drug equivalents importation, price negotiations, and FDA review processes in terms of changing the way this country and all its residents approach drug treatment programs and paying for them. The bill and article encompass delay of generic drugs to the market, patent system reform, increasing competition for medications using the thus-far successful method of America’s European counterparts. The House Bill is still undergoing changes regarding its content, but has steady support many Democrats and fair number of Republican congressmen giving it a fighting chance with the long-term money-saving investment outweighing its minimal implementation costs. These recommendations are the face of the consumer-driven grassroots movement fighting Big Pharma and their skyscraper prices on life-saving medication. Such a significant commodity must be available without an “if-clause” attached the life-saving contract. The Prescription Drug Affordability Act of 2015 and Mayo Clinic’s Petition to Lower the High Price of Cancer Drugs possess the potential to rid the pharmaceutical market of its exclusivity from public acquisition.

The root cause behind price gouging and the resulting market exclusivity over pharmaceutical prescription drugs stems from a lack of regulation by the CMS and FDA. There is currently no possible way of negotiating with pharmaceutical companies, before their market price is set at whatever irrational number they choose. Both H.R. Bill 3513 and the Mayo Clinic Petition remedy this by giving CMS negotiating power over biomedical firms “on behalf of beneficiaries for drugs covered under Medicare Part D” (U.S. House). Negotiation periods cap at 180 days. Within that time a price should be set, and the medication should be well on its way to the shelves. Negotiations will be key, because Dr. Hagop Kantarjian, Chairman of the Leukemia Department at the University of Texas Medical Anderson Cancer Center and his colleagues state that disease “regression and prolongation of life are the goals [which should]… guide drug pricing” (“Cancer Drug in the United States: Justum Pretium—The Just Price” 3600). This will allow the standard to be set based off of the FDA approval process and prices will be based off of the best recommendations for patient care both financially and physically.

Having CMS negotiate medication rates fares logically, according to Hagop Kantarjian, M.D., and his colleagues at UT Medical Anderson Cancer Center, “given that elderly people suffer…disproportionately” from various terminal illnesses and Medicare is the leading insurance provider in the United States, not only for elderly people, but also as a whole (“Cancer Drug in the United States: Justum Pretium—The Just Price” 3600). Now although, this directly does not affect patients covered by private insurance companies, it has been seen that those private insurance companies follow the model of CMS in terms of various levels of coverage plans. Whether other insurance providers follow CMS’s guidelines because it is easier for them to meet the government standards on coverage, or they do so because it is the best for competition is not made clear. Regardless, the result is that all insurance providers in America receive standard prices on prescription medications and the effect leaves no patient untouched. Hence, CMS’s negotiations will benefit all American residents no matter the source of their drug coverage plans. Healthcare is a trickle down business when it comes to costs. They get passed down from manufacturing to insurance companies, to hospitals, and finally to patients. Then the out-of-pocket expenses for patients will decrease overall.

Meanwhile, Dr. Ayalew Tefferi and his colleagues at the Mayo Clinic, state in Petition to Lower the High Price of Cancer Drugs that “creating a post-FDA approval review” that will allow the FDA to compare any newer versions of drugs to their old ones. Currently the FDA can approve the biologics of a drug. However, they can neither “review…[nor] propose a fair price” nor can they “distinguish the amount of improvement from a new drug to its predecessor” (Tefferi). For example a marketed drug may not necessarily improve quality of life, but instead it increases life span for an individual suffering from a life-threatening disease by a matter of a few weeks. This drug costs significantly more than its predecessor while a price is again put on length of human life. And while a few weeks with a loved one are cherished, the medication neither prevents patient suffering, nor does it significantly impact the healthcare industry by qualifying as a breakthrough. These are the kinds of medications that are bankrupting our health care system. This policy changes the approval process so that prior to approval, the FDA must check medications before biomedical firms sit down with CMS and discuss price negotiations for a medication where the value of medication is far less than its cost. According to Dr. Lowell Schnipper, Chief of Harvard Medical School, and his colleagues, “there is increasing emphasis on providing clear and objective information not only on clinical benefits and risks of treatment options but also on cost” (2565). The impact of an ideal treatment plan on patients and their families yields happier consumers. The optimal image of patient satisfaction originates from more affordable prices on care and the value of care given. And as the face of healthcare is changing, so must its policies to keep the system alive and sustainable by ensuring prescription drug prices are no longer based off of bearable market value.

The bill’s coverage spans across the country from rich to poor and conservative to liberal. Everybody deserves a fighting chance at affordable medications that will improve their quality of life. According to Hagop Kantarjian, M.D., Chairman of the Leukemia Department at the University of Texas Medical Anderson Cancer Center, streamlining the drug approval process and bureaucratic burdens will “eliminate unnecessary steps that increase cost, delay-timelines, shorten patent terms” (“High Cancer Drug Prices in the United States: Reasons and Proposed Solutions”). This will benefit pharmaceutical companies as well, because they will have to pay less than what they currently do in terms of manufacturing and approval costs. And while the gross profit of biomedical companies will decrease, the percent decrease in profit will stagnate similar to the current numbers. And it is likely that even the slight decrease in gross profit for pharmaceutical companies will be a drop in the ocean to the $300 billion, international industry (WHO). The policy will turn right back and benefit consumers and insurance companies. With the help of financial analysts, it has the potential to lower insurance premiums and get drugs on the market faster. This would also promote more market competition, resulting in lowering costs of even specialty medications. H.R. Bill 3513 will support consumers by lowering governmental costs to the large biomedical corporation. And ironically the domino effect that plagues industry will turn around to still benefit everyone across the board.

Various countries have different methods of regulation upon the inflation of drug prices and how they are set, such as Great Britain’s Pharmaceutical Price Regulation Scheme of 2014. This requires their government to set a cap on all medications that enter its market. Contrastingly, United States law does not currently contain regulative policies applicable to the skyscraper prescription drug prices set by for-profit companies. Dr. Ayalew Tefferi and his colleagues depict the opposing situations of nations like Great Britain where the profit-driven market only commands 5% gross domestic product compared to the 18% demand of America’s gross domestic product. So the considerably more expensive American medications are marketed at a different rate than their European or Asian counterparts—and many times by the same company no less! Another speed bump is hit when Americans attempt to outsource medication by ordering from abroad. However, in an effort to prevent illegal substance abuse, the FDA placed a 90-day limit on imported medications as a part of the 2006 revision to the 2003 Medicare Prescription Drug, Improvement, and Modernization Act—an example of misplaced results to good intentions. Thus, preventing American physicians from prescribing and residents from consuming imported drugs. However, both the H.R. Bill 3513 and the Mayo Clinic Petition propose to amend the Federal Food, Drug, and Cosmetic Act, allowing the importation by individuals of prescription drugs from Canada and other countries, and revise the Federal Trade Commission Act, enforcing restrictions on restriction access to generic drugs (U.S. House & Tefferi). This will result in increased competition through the international market rather than the direct source of American drugs. Through negotiations of with CMS and market regulations and the modifications to the Federal Trade Commission Act and Federal Food, Drug, and Cosmetic Act, pharmaceutical firms will have to succumb to similar rates for the same medication across the world. The goal exists to diminish the exclusivity of the drug manufacturing market, as a direct response to free-market regulation of a dire commodity in the United States.

 

 

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Figure 2: Views on Favorability and Effectiveness of Actions to Keep Drug Costs Down

"Kaiser Health Tracking Poll: August 2015." Kaiser Health Tracking Poll: August 2015. The Henry J. Kaiser Family Foundation, 20 Aug. 2015. Web. 01 Mar. 2016.

 

As part of this policy recommendation is stemmed from Congress’s introduced bill, it is a viable option. Both the doctors at Mayo Clinic and members of Congress are slowly adopting parts of other countries’ healthcare system that have been working for years. Other countries have set caps on medication costs (like Great Britain), and have had a negotiating body for years, appealing to Big Pharma on behalf of their citizens. Recently, Representative Elijah Cummings of MD, who introduced the Prescription Drug Affordability Act of 2015 in U.S. House, opened a hearing on Prescription Drug Market: Oversight with drug companies, the FDA, and stakeholders. He states that Secretary of State Hillary Clinton wrote letters to the FDA and FTC on “stronger regulatory action…on [drug] companies” (Committee on Oversight and Government Reform). He states that Democrats, Republicans, and Independents alike, ally on the necessity to take action on this issue. Even presidential candidate Donald Trump supports. Nonpartisan groups such as the Kaiser Family Foundation fully support the reduction of medical costs and these policies. According to a poll on bills H.R. 3513 and its equivalent S. 2023 support from individual constituents is constantly rising. Currently this bill garnered over 15 congressmen and 2 senators as cosponsors. All this media attention and support only benefits the establishment of standardized prescription drug prices across the nation through these policy recommendations.

And while the iron is red hot with scalding media attention, Congress must strike now. The past has proved illuminating with the failure to pass health coverage bills during President FDR’s The New Deal policies. “Arguments concerning the relationship of drug prices to industry research investments and the need to pay for future cures through present spending have been persuasive primarily to policymakers” (Daemmerich 159). It proved almost impossible to move toward antitrust regulations to fight for lower prices in healthcare beginning with drug price reduction. The political situation did not allow for change. From President Kennedy’s Medicare Push of 1962 to President’s Johnson’s Medicare Part A Act in 1965 to the establishment of PPO and HMO insurances during the Nixon Administration, politics with healthcare always has loopholes. President Kennedy’s approach was too radical for the time and did not receive enough support on the hill. President Johnson gained a small victory after a long battle with American Medical Association and their lobbyists. The Nixon administration allowed PPO and HMO insurances to have significant power over the American people through the Health Maintenance Organization Act; they also served as a safety net for pharmaceutical companies to raise their prices, in hopes that insurance companies would pay the premium rates, not realizing that those premium rates were indeed passed on to the consumers and patients. Thus began the vicious cycle that is in the process of being broken through the initiative to regulate those that have had unprecedented power over consumers like no other industry. The conservative opinion from where the Republicans get there stance against free-market regulation thrived through the 20th century. However, in a recent political turn of events with a more liberal outlook on wealth distribution, America for the first time in over 50 years, may have opportunity to fight back and pass legislation to lower the costs of prescription medications by regulating the economy and negotiating prices. And Congress has a real chance of passing the Prescription Drug Affordability Act of 2015.

In 2013, the U.S. spent $59 Billion on Medicare Part D, the prescription drug program associated with Medicare according to the Congressional Budget Office. And with each year, this number continues to grow. And implementing the Prescription Drug Affordability Act of 2015 with amendments from Mayo Clinic’s Petition will grow government slightly simply due to the expansion of responsibilities for government organizations like the CMS and FDA. However, the long-term effects will actually end up saving the government and its constituents their money. The year 2015 was largely involved with Congressional hearing against pharmaceutical corporations, their drug manufacturing and marketing teams, and their CEOs. Perhaps the most famous of which, is former CEO of Turing Pharmaceuticals, Martin Shkreli’s current hearing. These hearings actually cost thousands upon thousands of taxpayer dollars every day. It is a waste of Congressional time and session and doesn’t accomplish anything other than trying to prove exploiters guilty. It does not address preventing price gouging all together, which means people are still vulnerable to exploitation by Big Pharma and their ironically life-endangering prices. From the expensive diagnostic tests to therapeutic interventions, health care for terminal illness is not easy or cheap on any forefront. These pre-diagnosis costs “coupled with, or even driving, some of these rising costs are sometimes unrealistic patient and family expectations” (Schnipper). The regulation of prices and the free market economy would actually decrease GDP spending on pharmaceutical drug, to bring it closer to that of other nations with more successful healthcare systems.

While the idea that action must be taken to prevent further exploitation of its citizens, all parties and bipartisan groups support the cause. Democrats across the board support the Prescription Drug Affordability Act, as healthcare is always on their radar. On the other side the Republican Party is split. About 76% of Republicans believe that free-market competition would do a better job of regulating itself (The Henry J. Kaiser Family Foundation). And yet the United States pays more in gross domestic product in comparison to other countries, but our quality of healthcare is not proven to be any better. Many centrist Republicans are likely to support the idea of taking action through this bill because of outrageous action of pharmaceutical companies. There are multiple sponsors currently in both the Senate and the House, with the bill still undergoing revisions within its respective committee of origin. However, many tea party congressmen are pushing for the repeal of healthcare regulation period. According to Politico news correspondants and writers, Paul Demko and Sarah Karlin many are “caught in the box of Republican free market orthodoxy.” They believe that no regulation is better than some regulation. The GOP agrees that action must be taken with respect to price gouging, but they don’t believe that “Medicare should be the one to negotiate drug prices or that the government should limit drug maker’s profits” (Demko). They believe in punishing those who price gouge to bring justice to their constituents, however they do no understand the need to encroach on a for-profit company’s profit margins regardless of the repercussions. This stance seems counterproductive because it only affects the perpetrators of the problem after they have created a mess. And it doesn’t prevent the issue of unaffordable drugs to the extent that people skimp on treatment plans to begin with. Thanks to loose campaign finance laws, Big Pharma consists of 60% of GOP politicians’ endorsements, which help them monetarily and politically in elections. So the alternative to outright going after preventing the problem and angering Big Pharma, is to attack Obamacare, as GOP party has done, and blame it for the problems in the healthcare industry including pharmaceutical prices.

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Figure 2 Rate of Increase on Monthly Cost of Treatment for Cancer Drugs

"Price & Value of Cancer Drug." Center for Health Policy & Outcomes:. Memorial Sloan Kettering Cancer Center, 2015. Web. 01 Mar. 2016.

 

Pharmaceutical companies verify that even failed attempts cost money that must be included in cost analysis. They declare this as the reason for high research costs, and high overall prices. Recently PhRMA president and CEO, John Castellani, in a statement against presidential candidate Secretary Clinton, stated “her proposal [to lower costs] would turn back the clock on medical innovation and halt progress against diseases that patients fear most” (qtd. in Ferris). Stopping or limiting the cash influx into drug development investments may lead to a shortage of the required drug, a slower process of innovation, and by result more difficult access to the prescription of those drugs. And this is what pharmaceutical companies are threatening with their production of medications. The drug maker corporations are now collecting allies with the insurance company moguls and the two opposing industries are coming together on the idea that regulation of prices will decrease both their profits. Because pharmaceutical drug prices in will be regulated as effect of this policy, the device industry may be affected next. This domino effect does not sit well with any service provider in the healthcare industry. As a result the large biomedical corporations are banding together in opposition to this policy. Companies like Ubl are threatening to pull political endorsements and their campaign finance contributions if any antagonistic action is taken. While the opposition is concerned about their monetary detractions, the real issue lies with the price of life and how rising medication prices can be battled in order to improve quality of life for our citizens.

However, the current situation must be fixed, if there is to be any hope of securing a financially stable medical future for the United States and its residents. According to Arthur Daemmerich, Professor in the Dept. of History and Philosophy of Medicine at the University of Kansas Medical Center, “America’s drug pricing regime may be difficult to sustain in the future” despite all the actions that have been attempted to reduce costs in the healthcare, and more specifically the pharmaceutical industry (159). Thus, it proves the futile effort to keep pharmaceutical drug prices in the stratosphere. Already, many are skipping days in treatment plans to make medication last longer, or not picking up their prescriptions at all, which ultimately means the pharmaceutical companies are losing money, as is everyone else involved in the cycle. If there is a decrease in profit, then in an industry like healthcare, where the service is providing longevity of life and improving quality of life, there is minimal ways in which supply and demand can kick in. It ultimately results in higher prices for everyone, resulting increased gross domestic product spending on prescription drugs. This is not sustainable. In comparison to the past failed legislation, American Congress is no longer blindly attempting to take a big step forward in the river with a backward current. The only remaining dam is support in both houses as well as from the White House to pass this bill.

To live and thrive, anything and everything must evolve with the times. And pharmaceutical companies have lost touch with the needs of people suffering from illness. They believe themselves to be primarily saving lives, when in reality their exorbitant prices hinder the safety of lives. Manufacturers set themselves apart from “the patient-driven grassroots movement” for more affordable healthcare and outpatient drugs (Tefferi). With companies like Pfizer holding “$74 billion in unrepatriated profits overseas,” American taxpayers are paying “$30 billion a year on basic biomedical research” (Engelberg). This makes clear that the humanitarian mission that Pharmaceutical firms state does not align with the advice of their money-minded financial analysts. And the contradictions and uncertainties in United States laws pose as a clear indication of the source of discrepancy. Without regulations, health care will either become too expensive for common man or cease to exist altogether. The risk of failure is higher in the biomedical industry than other industry. And the hypersensitized high risk-high profit game exhibits its urgency and bittersweetness at the corner of uncontrollable pricing and misplaced intentions; one mistake and it can be fatal.

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