Bluemel 1
Drug Legalization: Why It Is Harming American Citizens
For a drug to be approved by the United States Food and Drug Administration (FDA), it must undergo preclinical research, three phases of clinical studies, and ultimately New Drug Application (NDA) approval. Don A. Ballington, pharmacy technician training program coordinator at Midlands Technical College, collaborated with Robert J. Anderson, a pharmacist in both the hospital and retail settings, to create Pharmacy Practice for Technicians, a textbook used in the training of pharmacy technicians in preparation for pharmacy work. Pharmacy Practice informs readers of general pharmacy practices, as well as legislation concerning pharmacy work. In this textbook, Ballington explains the FDA Drug approval process in detail: Prior to the commencement of investigational research, an Investigational New Drug Application (INDA) must be submitted and approved by the FDA (Ballington 67). Only after INDA approval can investigational studies begin (Ballington 67). This research includes data about synthesis of active ingredients and fillers, as well as animal testing and a review from an institutional review board (Ballington 67). The first phase of investigational studies is composed of trials on a small number of healthy volunteers to learn about any side effects that come with the use of the drug (Ballington 67). Phase two involves a small group of patients with the targeted disease or condition that is intended for treatment in order to determine the effectiveness of said drug (Ballington 67). Phase two is heavily monitored by the FDA, and if both phase one and two “are promising,” phase three (phase two but with a larger patient pool) may commence (Ballington 67). Phase three is followed by the submission of a New Drug Application (NDA) to the FDA, and if approved, the drug may be marketed and is considered safe for public use. This process can take anywhere from five to fifteen years, making it difficult for drugs that could be an immediate help to be available for use. To help combat this, drug manufacturers can “fast-track” the drug approval, making the timeline drop from five years to 60 days. Although lawmakers meant well, this fast tracking has led to the premature approval of many drugs, causing an increase in drug-related accidents, such as overdose and death. In order for the US to properly treat its citizens in the sense of health care, the FDA must regulate brand name drug prices and to use people who will benefit the most from the potential benefits of the drug in phase two of the drug approval process.
The drug approval process, both the full and the streamlined versions, can cost millions of dollars for drug companies. These companies try to offset the cost of research and development by charging more from customers to use the brand name drug. According to Diane M. Porter, a journalist for The Pharmaceutical Industry, writes that prescription drug prices have skyrocketed in recent years and continue to climb, having increased from $40.3 billion to $200.7 billion in just fifteen years (1). Health and science journalists Jessica Wapner, Katharine Greider, and Richard A. Epstein all write similar articles concerning the increasing prices of prescription drugs, and the potential ways to combat this increase and save American citizens time, money, and some hassle. Experts in the medical field, such as Richard A. Friedman, a professor of Clinical Psychiatry and director of Psychopharmacology at Payne Whitney Psychiatric Clinic in New York, New York, also weighed in on this topic, speaking about the price difference between brand name and generic name drugs (1). Not only have medical experts inserted two cents, but there have been many news stories across the world concerning the rise of prescription drug prices. Rreporter Nick O’Malley, a United States Correspondent based out of Washington D.C., speaks about how the passing of Medicare Part D (a law that prohibits the federal government from regulating brand name drug prices) has created a greedy pharmaceutical industry that is hurting not on the US economy, but the world economy at large (“Scandal” 1).
Porter writes that the reason for this price increase and the resulting economic damage, according to the pharmaceutical industry, is that “research and development costs $800 million (1).” It has been recently determined, however, that research and development of a new drug costs closer to half of that stated amount, ringing in at 13.9% of the total spent on the drug, whereas marketing used 30% of the funds (Porter 1). From the time research begins on a brand name drug, the manufacturers have 20 years of patent on the drug (Epstein 1). This patent is to motivate and reward drug companies for doing research to better the healthcare system, as pharmaceutical companies do not have any competition in the drug market as far as generic counterparts. To take advantage of the 20 year “free period,” many drug companies are increasing their marketing approach, which is evidenced by the employment of “100,000 drug representatives, or 2.5 for every practicing doctor in the country (Porter 1).”
This patent, like many laws, was put in place with good intentions, but is often manipulated by drug manufacturers for personal gain. Greider writes that “some pharmaceutical giants have resorted to unethical (or outright illegal) tactics to extend patents on their top sellers (1).” This is supported by Porter, who states that “89% of new drugs in the U.S. offer little or no additional benefit over existing drugs, yet U.S. drug prices are the highest in the world (1).” This small difference between drug therapies is often due to the development of generic drugs, a brand name drug that can be sold for a lower price under a different name after the patent has expired. These generic drugs often cost much less than the brand name equivalents. Major pharmaceutical companies are able to extend their patents through various means, such as adding a filler into the medication, settlements with a generic drug company, or by simply using the congressional connections to buy more time (Porter 1). These generic drugs and the price difference between the original and the brand name counterparts underscores the point that brand name companies are raising prices constantly. James Love, director of Knowledge Ecology International, a nonprofit organization focused on helping populations that are at greater risk for being taken advantage of, says that “there’s just no relationship between the price of a drug and what it costs to make, [because] the manufacturing process is the same, but branded drugs are, on average, 32 times more expensive than generics (Wapner 1).”
Brand name drug companies also keep prices high to keep profits increasing. By creating and passing legislation that regulates brand name drug prices, situations like that of Martin Shkreli’s will be more of an anomaly, rather than a normal, everyday occurance. When Shkreli, Chief Executive Officer at Turning Pharmaceuticals, was first appointed, he “[hiked] the price of Daraprim, a 60-year-old drug used to treat infections, from $13.50 a pill to $750 a pill (“Greed” 1).” Similarly, Alexion Pharmaceuticals made the “‘world’s most expensive drug,’ a $700,000-per-year treatment for two rare blood disorders (“Greed” 1).” This increase in price causes problems with patient insurance providers, including the patients as well, and most Americans do not have thousands of dollars lying around. Many patients cannot continue to afford their medications, and stop the drug therapies, which in turn leads to further complications. The creation and implementation of an amendment to Medicare Part D stating FDA involvement in the decisions concerning brand name drug prices is a necessary part of reforming the drug approval process.
Price is not the only obstacle standing in the way of health care. The FDA Drug Approval Process also stops many potentially lifesaving drugs from seeing the market because of the complexity of the approval process. Mny families seek medical help when a member is diagnosed with a life-threatening disease, much like the Fowler family in Mundelein, Illinois, who are seeking help for their son, Jack, who has a life-threatening disease called Hunter Syndrome. Hunter Syndrome is extremely rare, affecting only 2,000 people worldwide. Also known as mucopolysaccharidosis II, Hunters Syndrome means that Jack’s body “lacks an enzyme needed to break down sugar molecules and, as a result, suffers damage throughout his body (“Drugs” 1).” Doctor, CEO of the digital healthcare company healthEgames, Inc., Clinical Professor of Medicine at the Emory University School of Medicine, molecular cardiologist, Scientific Co-Founder, former President and CEO of Atherogenics Inc., Chairman of Georgia Biomedical Partnership, Inc., and Director of Cesca Therapeutics Inc. Russell M. Medford asked the question that many American health care professionals are asking: “How do we balance the rapid and accelerated approval of drugs that we can establish definitively are safe and effective versus the immediate needs of individual patients who cannot wait for us to come to those final determinations?” (“Bloomberg 1).
In the Drug Legalization Process, multiple phases of clinical trials are performed, as outlined earlier. However, in the early phases of the clinical trials, only a few hundred people are chosen to test a drug, most often adults that have been diagnosed with said disease for a long period of time ( Commissioner 1). While these trends in the patients that are chosen to take part in these trials are not necessarily bad, they are very narrow. Many children are contracting diseases that have potential drug therapies in the clinical trial stage of the FDA Drug Approval Process, and due to the narrow scope of people chosen to partake in said trials, many of these children will not live to see the legalization of these potentially lifesaving drugs. That is the case for Jack Fowler, the boy whose family moved to Illinois for the sole purpose of being closer to potentially lifesaving treatment for Jack (“Drugs” 1).
There are compassionate use programs available for those who are willing to hunt on the websites of drug corporations for hours on end (“Drugs” 1). For those families who do not have that time, social media is the method of choice to capture the attention and compassion of drug companies who have drugs in the Drug Approval Process that could treat a specific condition (“Drugs” 1). Many states, such as Missouri, Louisiana, and Colorado, are now passing “Right to Try” laws, which enables patients to receive “experimental drugs without going through the FDA (“Drugs” 1).” This allows patients like Jack to have access to potentially lifesaving drugs. However, these states do not require drug companies to make these drugs available to patients, nor do insurance companies have to cover the cost of the drug therapy (“Drugs” 1). In order to lower the number of patients that die while potential therapies are in the process of being legalized, either legislation similar to that of the “Right to Try” laws needs to be implemented on a national scale, or the caliber of patients chosen to participate in the clinical trials of the FDA Drug Approval Process needs to be changed to include those who have a high need for drug therapy, based on prognosis (the predicted course of a disease or injury), severity, and having a broad range of subjects, as to obtain the most inclusive data from the least amount of trials possible.
In late January of 2017, President Donald Trump met with the head of many large pharmaceutical companies to discuss the future of the drug industry while under the current presidency. Trump was quoted at this meeting promising the pharmaceutical companies that the FDA Drug Approval Process will be sped up, as well as the removal of obstacles stopping drug manufacturers from creating their drugs here in the United States: “You can’t get approval for a new plant, you can’t get approval for a new drug, so we’re going to take care of that (Wapner 1).” By shortening the FDA Drug Approval Process, the potential for drug violations increases. The rumored first choice for the Chief of the Food and Drug Administration plans to remove phases two and three of the drug approval process, which would cut down on the time needed for approval (Wapner 1). The FDA has been steadily increasing the number of trials needed in phases two and three to pass the clinical trials, to the point that currently “60 separate trials are often required (Epstien 1).” Despite this, the removal of these phases of the Drug Approval Process would do nothing to change the price of brand name drugs. Due to Medicare Part D, drug companies are able to charge whatever their hearts desire, and the government cannot regulate the prices in any way. The only way to eliminate this monopoly of the drug industry is to amend Medicare Part D with a statement that brand name drug prices must be approved by the FDA. This will create more affordable health care for customers, as well as cut down on the potential for drugs that don’t have an accurate active ingredient. Not only would getting rid of part of the FDA Drug Approval Process create drugs that don’t treat anything, but it would also create violations of the Pure Food and Drug Act of 1906, an act that regulates “the development, compounding, distribution, storage, and dispensing of drugs (Ballington 28).” The Pure Food and Drug Act requires the correct labeling of drugs, including name, dosage, and purity, as well as the correct information for storage, dosing, and a list of ingredients for both compounded and readily available drugs (Ballington 28). By getting rid of phases two and three, there would be no verification of the efficiency of a drug in respect to its treatment of a specific ailment, nor would there be a known effective dose that has been verified or a known lethal dosage. This will lead to more prescription drug related deaths, which, as of 2014, sat at 22,134 deaths out of 49,714 total drug related deaths, which comes out to 44.5% (“Annual” 1). This number reflects the necessity for properly labeled and marketed drugs, as well as the need for correct dosages and attention given from medical professionals to potential drug interactions.
The FDA Drug Approval Process is a long, tedious process in which many drugs will not be approved due to adverse effects (side effects), safety, or cost. For many drug companies, the cost of research, as well as the clinical trials, creates a hole they must pull themselves out of before their patent runs out 20 years after the research begins. Most companies often have 5-12 years of slowly making money to displace 5-8 years of excessive spending. More often than not, these companies use their patent as a scapegoat for inflating drug prices. When the difference between a brand name drug and a generic drug is extreme, the profit difference is used to pay off the costs of research and pay the members of the company, mainly the higher up executives as well as stock holders and other big wigs. Often, the profits are not split evenly, and human greed leads to an even bigger gap between the brand and generic drugs, which leads to more money in the pockets of CEOs and owners of drug companies like Turing Pharmaceuticals and Alexion Pharmaceuticals. As these company’s pockets get deeper and deeper, the average American that is forced to pay these insane prices is often running out of funds, which leads to termination of treatment. This termination causes more problems for patients, as their ailments are not being treated and are progressively worsening, which can lead to a compounding of health problems. This partial completion of drug therapy has led to the evolution of diseases that are resistant to medication, such as MRSA (Methicillin-resistant Staphylococcus arueous), Ebola, HIV/AIDS, and SARS (Severe Acute Respiratory Syndrome). These infections, called superbugs, evolved from patients that are given antibiotics to get rid of an infection and stop taking their medication prior to completion of drug therapy to save on the cost of doctor visits and medications, and these infections mutate and become immune to previously tried therapies. There are also some cancers that have shown this progression, and are often resistant to radiation and chemotherapy, as well as alternative therapies such as biological detoxification, autohemotherapy, and blood ozone therapy. By keeping brand name drug prices at a 1600% increase over generic drugs, the health problems, economic issues, and corruption within the government will continue to increase until there is legislation to stop the human greed from taking over the pharmaceutical industry more than it already has (Wapner 1).
Clinical trials can take between 2 and 7 years alone, without the potential need for back tracking in the process, like adding a filler to a drug to combat a certain side effect that could put a certain number of patients at risk. During this time, there are three phases that a drug must pass through to obtain legal status: cleverly, these are named phases one, two and three.
In phase one, the drug therapy is used on a few healthy volunteers to determine potential side effects and the dosages that are lethal and/or dangerous. About 70% of drugs make it past phase one and proceed to phase two (Commissioner 1). Phase two is when patients with the disease or condition that the drug is meant for are being treated. Only a few hundred people partake in this trial, and about a third of the drugs move on to phase three. Phase three can be broken into two parts: the first part is a larger version of phase two, and the second part is an even larger version of phase two. Part one usually has 300 to 3,000 volunteers, while part two has several thousand volunteers. As the most exclusive phase, phase two has the most room for improvement in terms of who to accept for the trials. Those who apply to volunteer but are not chosen for phase two should be informed of their Right to Try. This could lead to lives being saved from not only phase two of the FDA Drug Approval Process, but also those who, for whatever reason, aren’t used (bad word, choose another) for these trials. BY informing patients of this option, they would still have a chance to access potentially lifesaving medications.
Drugs now have the opportunity to bypass most of the FDA Drug Approval Process with the ability to “fast track” a drug for approval. Most drugs are not approved through this method, as the timeframe of 5 years is squished into 60 days. The drugs that are approved through this method, however, have a huge probability of success, and many times the FDA believes the good the medication could bring will outweigh the potential negative outcomes. Fast tracking, however, is not always a fairy tale. There are times when a drug is approved after the 60-day fast track method, but due to the hastiness of the FDA, these drugs can have unknown adverse reactions, as well as potential drug interactions that weren’t tested prior to FDA approval. This often leads to a total drug recall, as well as a refund and/or compensation for patients who took those drugs.
The FDA is constantly updating its laws and regulations to keep American citizens as safe as possible. As these laws are created and updated, medical professionals are required to take “continuing education credits” every two to five years, so as to keep these professionals as current as possible on the specificity of laws that could impact how they run or operate their work environments (“For” 1). By requiring continuing education credits, the FDA is keeping healthcare providers in the know with current processes and laws, as well as keeping them updated on new brand and generic drugs. These credits outline what these professionals should do in the case of a total drug recall, as well as how to find out if there is such a recall.
The United States Food and Drug Administration approves between 40 and 50 drugs every year, all of which have to go through some sort of research and clinical trial (Munos 1). Many of these drugs are safe and viable options for caregivers to prescribe; however, many of these newly approved medications can cost patients an arm and a leg. Due to research and greed, brand name medications cost 32 times the amount of their generic counterparts on average (Wapner 1). This price difference is so large because the FDA has no control over the prices that drug manufacturers charge due to the portion of Medicare Part D that prohibits the FDA from pricing new brand name drugs (“Scandal” 1). New legislation is needed to protect patients from the bullying of the pharmaceutical industry. This should come in the form of an amendment to Medicare Part D, stating that brand name drug prices must be approved prior to marketing and sale of a newly approved medication.
Similarly, the FDA must rethink their requirements for participation in clinical trials, as many pediatric patients are often overlooked when it comes to being selected for treatment. When a patient is declined participation in a phase of clinical trails, they should be informed about national legislation that gives them the Right to Try, meaning that they can have access to non-FDA approved drugs in a lifesaving situation. This will lead to more lives saved during the approval process. The first steps in reforming the US healthcare system are for the FDA to intervene and approve not only the prices at which brand name drugs will sell for, but also to choose patients that will benefit the most from partaking in phase two of the clinical trials of the FDA Approval Process. The FDA should also inform those who are not chosen to participate in this portion of the Drug Approval Process of their Right to Try, and encourage them to pursue that means of obtaining lifesaving medication. The only way things will get better is if the attention to detail on a national level increases.
Works Cited
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