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Healthcare

by Anuoluwa Akibu


Sick and tired of being diagnosed with Unaware-of-Healthcare-Issues-in-the-US Syndrome?  Well read this website and you'll be on your way to being cured!

Health
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Overview

What's with the website?

In my English class, I worked on a project where I spent 20% of my class time throughout the school year working on a project of my choosing. For my 20Time project, I chose to research some of the faults of healthcare people are provided. I did not focus on the healthcare systems and laws but more so the care itself. For instance, how sometimes the scientific information provided to you is not always the best information, overpriced drugs, and health agencies being corrupted by corporate interests. I focused on the healthcare in the United States because I believe it is important to be aware of the issues about something close to home. It is also an issue I can connect to more. I created a website so I can gather all of what I've learned in one place. Hopefully, with this website, I can achieve my goal of informing you so that you are aware of these issues and hopefully inspire you to continue to educate yourself about healthcare and share what you have learned with others.

 

I chose four main topics because healthcare is such a broad subject matter. For those topics, I explained them and then gave an example or two about the topic whilst also giving my opinions about the example. There are graphs and statistical evidence in the Figures section.

Overview

Overdo$ed America

Book by Dr John Abramson

For my 20Time project, I was tasked with finding a mentor, someone with more knowledge about my topic and could help me better understand it. I searched for someone online and found John Abramson M.D. on the Faculty page of the website Harvard’s Department of Health Care Policy website. I then saw him in a YouTube video and discovered that John Abramson, M.D. had written a book called Overdo$ed America. I decided to read the book and emailed him. He agreed to help me and allowed me to interview him. (Click the button below if you would like to read the interview.) Overdo$ed America is a book about how pharmaceutical companies are distorting medical science, compromising the health of millions of Americans and how agencies like the FDA have disregarded studies that show the harmful effects of some medications. This misguides doctors, leading them to give you medication that may not be as safe as they thought. Dr. Abramson has been a family doctor for over 20 years, he taught primary care at Harvard Medical School and now teaches health care policy. He left his practice in 2002 to write this book. Although his book was published in 2004 the information still pertains to today's healthcare issues and his book helped me a lot with my research. I highly recommend it because it is really eye-opening and personally it was interesting to compare healthcare in different times.

Interview
Overdosed America.jpg
Over A

Money? Money.

From Patient to Consumer

As drug-and-medical companies continue to spend more money on marketing and advertising their products it seems like that is all they are focusing on. For example, in 1991 drug companies spent $55 million on advertising drugs to their buyers (Abramson 80). According to Overdo$ed America from 1991 to 2003 drug companies spent "more than 50-fold to over $3 billion" (Abramson 80) knowing that it would entice the consumers (the patients). From Dr. Abramson's experience, his patients have requested drugs because of what they have seen being advertised and it put a strain on their doctor-patient relationship. According to the 2016 article, Drug makers now spend $5 billion a year on advertising, "prescription drugs accounted for nearly 17 percent of total health care spending in 2015, up from about 7 percent in the 1990s" (Robbins). The article also states that "one-quarter of the industries $5.2 billion in spending last year went to advertise just five drugs" Humira, Lyrica, Eliquis, Cialis and Xeljanz (Robbins). From these numbers, you can see how much drug companies are spending just to get their drugs out there. Some of these drugs may not even be safe, but it seems like the mindset is to just make sure it reaches audiences nationwide that way their company earns more money. In my opinion commercialization, the process of managing or running something principally for financial gain, and healthcare don't seem to mix. The sole purpose of manufacturing drugs should not be financial gain. Healthcare is a right and no one should be denied of it because some drug companies focus more on money than making sure the product is as safe as it can be.

 

 

The FDA has also approved drugs that shouldn't have been on the market. One example of this is the drug Rezulin. "The blood sugar-lowering diabetes drug Rezulin" (Abramson 86) was in a study done in 1996 designed to determine whether "diabetes could be prevented in people at high risk (overweight and with mildly elevated blood level) by drugs or by lifestyle interventions" (Abramson 87). In 1996 Warner-Lambert, the manufacturer of Rezulin submitted his drug to the FDA for approval and in 1997 it became a blockbuster (Abramson 87). This drug was approved before they heard of Dr. John Gueriguian, the medical doctor reviewing the drug's application, reviews on the drug (Abramson 87). Reports of liver toxicity (something Dr. Gueriguian expressed concerns about) due to Rezulin began showing up yet it was not taken from the U.S. market even after it was suspected that it caused "391 deaths and linked to 400 cases of liver failure" until March 2004 (Abramson 87). "By that time $1.8 billion worth of the drug had been sold" (Abramson 87). They approved of the drug before they even received the analysis from the medical doctor before they could be sure it was safe. Not only that, but they stopped giving Rezulin to those who participated in the study because one of the volunteers died from liver failure (Abramson 87). Deaths were not only occurring in the U.S. but in Japan as well; the United Kingdom even withdrew the drug from their markets in December of 1997 (Abramson 87).

 

 

There weren't many precautions or willingness to understand the drug's capabilities before it was approved. These issues show that there are areas that need improving especially how the FDA handles situations as stated previously. That may have been in the late 1990s to 2004 but it still pertains to today. There's always room for improvement especially when it comes to health.

 

 

Sources: Overdo$ed America & Drug Makers Now Spend $5 Billion a Year on Advertising

Money?

Overpriced Drugs

The drugs manufactured by drug companies have to go through a process before they can become FDA approved. This process costs a lot of money and it's very hard for drugs to become approved. According to MedicineNet, "it takes about 7 to 10 years and an average cost of 500 million dollars to develop each new drug. This money is spent before the FDA approves the drug, and if the drug is not approved, the company loses the money" (Ogbru 2) Drug companies like other companies need to make profit in order for them to thrive which is difficult since "only 3 out of every 20 approved drugs bring in sufficient revenue to cover their developmental costs, and only 1 out of every 3 approved drugs generates enough money to cover the development costs of previous failures. This means that for a drug company to survive, it needs to discover a blockbuster (billion-dollar drug) every few years" (Ogbru 2). Once the drug is approved the company spends millions of dollars on marketing and studies especially marketing (Ogbru 2). They are competing with other drug companies trying to keep their earnings from the drug high. The drug companies also spend money on finding "new uses for drugs or better ways of using them" (Ogbru 2) so their drug can be used more and so it can be more effective for the patients. According to the JAMA article The High Cost of Prescription Drugs in the United States manufacturers are "protected by monopoly rights awarded upon Food and Drug Administration approval and by patents" and can increase the prices of drugs as they please (Kesselheim, Avon & Sarpatwari). The article 5 Reasons Prescription Drug Prices Are So High in the U.S. (which uses information from the JAMA article stated previously) states, "drug prices decline to 55% of their original brand name cost once there are two generics on the market and to 33% of original cost with five generics" (Lupkin). The government-protected monopolies prevent generic drugs from reaching the market because they reduce the prices of drugs from the drug companies (Lupkin). But what happens when the price is set too high?

 

This brings me to my next point. Most of you probably know about the increase in the price of EpiPens. If you don't I'll be explaining it, but before I do that I will explain what an EpiPen is. An EpiPen (or Epinephrine Auto-Injector) is a device used to control potentially life-threatening anaphylactic reactions to allergens (Medical). It is usually the first thing someone uses when they are having life-threatening allergic reactions so patients are encouraged to keep it with them at all times. The "pen" contains a single dose of epinephrine that is injected into the thigh of someone showing signs of a serious allergic reaction (Medical). The problem was that Mylan, the pharmaceutical company that owns EpiPens, increased the prices for EpiPens 400% since 2009 according to the article Don’t Only Blame Mylan for $600 EpiPens. Mylan was in a great position to raise prices seeing as it didn't have much competition (Emanuel). Other EpiPen manufacturers either weren't seen as safe or effective for public use which allowed Mylan to gain more sales in 2015 (Emanuel). Even the CEO of Mylan's salary grew from $2.5 million in 2007 to $19 million in 2015 (Emanuel). With this increase in the price of a life-saving drug, families have looked to alternative sources like Ebay. This is a completely unsafe and it shouldn't be happening because not only is it illegal, it is dangerous. Of course, officials acted on it as well as the company itself. People were outraged by the insane prices and started petitions to send to Congress to get them to do something about it. Mylan was also sued multiple times for the overpricing of EpiPens and last September they agreed on a "$465 million settlement with the U.S. Justice Department over how the drug was classified for government buyers" (Pierson).

 

If companies can increase prices like that then that means it can happen again unless something is to be done with our drug pricing system. This isn't a matter of expensive items like computers its drugs that are very important to many people's health. I understand that the drug companies need to make a profit in order to supply themselves with their product and keep the company going, but when will it be more about giving people the care they need and less about putting a price tag on their health.

 

Sources: MedicineNet, JAMA article, 5 Reasons Prescription Drug Prices Are So High in the U.S. article, Don’t Only Blame Mylan for $600 EpiPens article, Mylan hit with new class action lawsuit over EpiPen pricing article

Overprice

What is the FDA?

FDA

The Food and Drug Administration also know as the FDA is an agency of the U.S. federal government authorized by the Congress to examine, test, approve and set the safety standards for foods, food additives, drugs, chemicals, cosmetics, and household and medical devices (Food and Drug). It was first known as the Food, Drug and Insecticide Administration and was formed as a separate law enforcement agency in 1927 (Food and Drug). It gets most of its regulatory power from the following laws: the Federal Food, Drug, and Cosmetic Act, the Fair Packaging and Labeling Act, the Radiation Control for Health and Safety Act and the Public Health Service Act (U.S. Food). They protect the public’s health by preventing untested products from being sold and they have the power to take legal action to stop the sale of harmful products/products that can cause a health or safety risk (Food and Drug). They can confiscate products and prosecute those responsible for legal violations however they are limited to interstate commerce. They can’t directly regulate prices and advertising except for prescription drugs and medical devices (Food and Drug).

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But even as the FDA is tasked with protecting the public's health they are not always responsible as they should be. For instance, in 2004 British drug authorities shut down an influenza vaccine plant in Liverpool, England (Abramson xii). Not the FDA, but British drug authorities. They shut down the plant because of "bacterial contamination of four million doses of flu vaccine" (Abramson xii). According to the article, U.S. Knew Last Year of Flu Vaccine Plant's Woes, the FDA "found serious problems of bacterial contamination at an influenza vaccine plant in England in 2003, 16 months before British regulators effectively closed the site" (Brown). A House Committee released about 100 pages of documents that included "FDA inspection reports, letters and e-mails, also revealed that the agency was nine months late in giving Chiron Corp., the owner of the plant, a detailed report of the problems it found and then rebuffed the company's efforts to learn more about what it could do to fix things. At the same time, FDA managers overruled its inspection team and made its fixes voluntary rather than mandatory" (Brown). Why didn't they try to stop the problem there before it spread? That could've allowed them time to look for another source for influenza vaccines instead of decreasing the public's chances of getting a vaccine to something that can be fatal. Although the FDA does work hard towards protecting the public's safety it's events like this that show that there needs to be more precaution and action done to prevent those events. 

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Sources: U.S. FDA website, Britannica School, Overdo$ed America, U.S. Knew Last Year of Flu Vaccine Plant's Woes article

FDA

Medical Journals

Not even the most trusted journals are safe

In the background, you can see some medical journals. The two I am going to be focusing on are The Journal of the American Medical Association or JAMA and the New England Journal of Medicine or NEJM. Medical journals were and are still used as a way for scientists, physicians, and other healthcare workers to communicate new research to each other. They can also be used to communicate new research to those who may not be medical scientists or in the field of healthcare. 

 

I

learned about medical journals when I was reading Overdo$ed America. As I was reading the part of the book that talked about medical journals I learned about two studies that both occurred in 2000. The CLASS study and the VIGOR study. The CLASS study was published in the JAMA and the VIGOR study was posted in the NEJM. 

 

MJ

The CLASS and VIGOR Study

The CLASS study was a Phase 4 post approval test, a study required by the FDA. Before a drug can be approved the manufacturers have to submit data to the FDA showing the drug's safety and effectiveness. "Occasionally, a drug that seems safe in preapproval trials is later found to cause unexpected side effects when used more widely. Therefore, the FDA often requires that drug companies conduct postapproval Phase 4 studies on a much larger group of people to make sure the drug is safe and effective as it appeared to be in the earlier, smaller trials" (Abramson 29). The CLASS study included over 8000 people with rheumatoid arthritis and osteoarthritis and compared the risks of gastrointestinal problems in people who took Celebrex with the risk of people taking ibuprofen and diclofenac (Abramson 29). The study was supposed to run for 12 months and it did, but in the JAMA article, only the first 6 months of the study was reported (Abramson 29). "Left unreported (and unmentioned) in the JAMA article were the data from the second 6 months of the study, during which time, as shown in the data on the FDA's website, six of the seven serious gastrointestinal complications occurred were in patients taking Celebrex" (Abramson 29). The author's of the article tried to show the favorable aspects of Celebrex, making it out to be this drug that was better than other nonsteroidal anti-inflammatory drugs (NSAIDs). When in reality it was not, the statistical evidence made available on the FDA website showed that Celebrex could cause more harm than good. The FDA's findings led them to send a Warning Letter to the CEO of Pharmacia, the manufacturer of Celebrex (Abramson 32) . "The letter cites repeated unsubstantiated marketing claims that Celebrex is the preferred NSAID for people taking a blood thinner and that it is safe and effective for the treatment of acute pain and use for which it is not-approved-an points out that Pharmacia's marketing material fails to warn of the possibility of serious GI complications caused by the drug" (Abramson 32). Pharmacia was also required by the FDA to send out a "Dear Healthcare Provider" letter which Dr. Abramson received (Abramson 32) and it's a letter sent "to communicate important new information about a marketed product" (Dear Health 5). 

 

Similar to the CLASS study the VIGOR study was a Phase 4 study that included over 8000 people in their study with rheumatoid arthritis. The study was done to compare the risk of serious gastrointestinal problems in people taking Vioxx and in people taking naproxen. In the NEJM article, it was concluded that Vioxx "'resulted in significantly fewer clinically important [major] upper gastrointestinal events than did treatment with Vioxx'" (Abramson 33). However, the data from the FDA files actually showed that those "who took Vioxx experienced 21 fewer GI complications than those who took naproxen, but they experienced 27 more serious cardiovascular complications. These were results that the November 2000 NEJM article on the VIGOR study acknowledged had been assessed, but did not report" (Abramson 34). Even those who didn't have a history of cardiovascular problems, taking Vioxx instead of naproxen "almost doubled the risk of developing serious cardiovascular complications" (Abramson 35). The article disregarded these details and published a source that others doctors used to see what medications they should prescribe their patients. Putting many lives and jobs at risk. In addition to this, Vioxx costed $100 to $134 a month compared to an $18.19 a month prescription naproxen, or $7.50 for an over-the-counter naproxen (Abramson 36). The FDA then sent a Warning Letter, about a month after the NEJM article was published, to Merck, the manufacturer of Vioxx (Abramson 36). Vioxx was then taken off the market worldwide on September 30, 2004, due to increased risks of heart attacks and strokes.

 

Because of these misleading articles doctors unknowingly put their patients at risk and patients ask their doctors to prescribe medication to them that they think could help them, but harms them instead. Not only that, but the drug costs more than a drug that actually helps you. "By the end of 2001, 57 percent of all money spent on prescription arthritis medication in the United States was spent on Celebrex and Vioxx, and both were among the top-selling drugs in the United States" (Abramson 38). The inaccurate information allowed the drug companies to gain profit over drugs that weren't safe as they made them out to be. Publishing that inaccurate information on most trusted medical journals even after the FDA had the data of the studies "6 months prior to the publication of the article" (Abramson 27) shows how our system is making more of an effort to improve sales rather than the health of the public. This is an important issue that needs to be addressed so we can prevent and hopefully stop unnecessary products like Vioxx from being marketed. These are well-known and most trusted medical journals and articles like this shouldn't be published especially when they alter scientific evidence and affect the public's health.

 

Sources: Overdo$ed America, Dear Health Care Provider Letters: Improving Communication of Important Safety Information PDF

 

 

Studies

Figures

Statistics and evidence. Click on the image to see its entirety.

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Sources: Drug makers now spend $5 billion a year on advertising article,  Record Numbers of FDA‑Approved Drugs: Recent Trends article, Link between health spending and life expectancy: US is an Outlier article

Fig

Interview 

With Dr John Abramson

I interviewed him via email and asked him questions mostly directed towards his opinions because most of the factual and evidence based questions could be answered by the book. The interview:

 

What have you learned about Healthcare over the years and do you believe anything has changed? How can people ensure they are getting the right medical information that helps them rather than harms them? Do you have any ideas on what can be done to help people not able to afford health insurance?

Unfortunately, the information in Overdosed America, published 12 years ago still stands. Before addressing how to obtain insurance when economically challenged, or get the most accurate medical information, the deeper problems with each must be addressed. It would be like asking how to do well on a test before reading the required materials. These are life-and-death serious questions that are all but ignored in our current healthcare debate. 

 

 

In your Introduction part of the book, it states you researched the consequences of providing health care to low-income inner-city residents through innovative HMO. What were the consequences? 

The most important finding was that when inner-city predominantly African-American families were allowed to join integrated suburban-oriented practices, their utilization of office, emergency room, and hospital services quickly transitioned from emergency room dominated care to primary care physician office dominated care. Along with this came a decrease in hospitalization rates of almost 90%.  The problem was that these families were the victims of de facto segregation, and were unable to access care like middle-class citizens.

 

In your opinion what are the deeper problems that should be addressed in our current healthcare debate?

The poor quality of the scientific evidence available to physicians and patients is an unrecognized and critically important problem. Doctors don't understand that--even when they avoid drug company marketing--the peer-reviewed clinical trial reports published in the medical journals upon which they rely for new information are primarily manufacturer-sponsored studies and the peer-reviewers and medical journal editors have not been granted access to the real underlying clinical trial data, rather they have to accept the submitted manuscript without verification. It would be like a court of law relying on hearsay evidence, which would never be allowed.

 

What other problem besides the corporate influence on medical science can you identify that has led to the corruption of medical science?

The transition in the US to corporations seeking to maximize shareholder value, over and above the totality of effect their business has on society, has created the larger context in which drug company corruption of science has become the norm. In a practical sense, the doctors are failing to fulfill their primary responsibility to act in the best interest of their patients by not insisting that the information published in medical journals has been independently verified.

 

Throughout your years of practice do you think the state America is in now concerning this matter of medical science being used for corporate interests is better or worse than before? 

The situation has become far worse, which led me to leave practice in 2002 to write Overdosed America, and has continued to move in a direction that serves corporate interests while the cost of healthcare skyrockets and the health of Americans continues to lose ground to the citizens of all the other wealthy countries.

 

What connections can you make between the corruption of medical science and the current healthcare system in place?

One could say, without a great deal of exaggeration, that the current healthcare system is optimally designed to allow the corporations to extract as much money as possible from working Americans rather than to optimize Americans' health most effectively and efficiently. Of course that is not to say that a) the vast majority of people working at all levels of healthcare in the US are dedicated to helping the people they serve; and b) that modern medicine is enormously beneficial, it's just that Americans don't get nearly as much benefit as the people in other countries.

 

If you were to compare health costs from when you wrote "Overdo$ed America" to now, what are some significant similarities and/or differences you've noticed? 

When I wrote OA, we were wasting about $500 billion per year, now that figure is up to $1.3 trillion per year: twice the annual budget of the Department of Defense, twice the federal budget deficit, and enough to retire all outstanding student debt in the US in one year.

 

Other than your book how have you raised awareness on the matter of medical science being corrupted?

Working with journalists and the media, teaching, and lecturing.

 

Have you ever confronted someone part of a medical journal that has given misleading information to its readers? If so how did it go?

Didn't go so well at all.

 

Who did you work with as you were researching the corruption in medical science? 

The internet has provided the opportunity for people who share interests to communicate with and support each other. This is very important because critical work does not have nearly the cache within academic circles as research that is more likely to produce or support profit-making activities.

 

In your book, you talk about medical journals and my question is are there any other sources doctors use to get information on the latest research?

There are other sources available, the best being FDA documents posted on the web. But these have not become a "normal" source of information, and therefore the journals become the standard basis for accepting information as fact.

 

Has your book ever been read by any federal healthcare executive? Do you plan on having any federal healthcare executive read your book?

Shortly after my book was published, I called the Senate Finance Committee--which was investigating Vioxx at the time--to tell them that I would be happy to share what I knew about Vioxx. The person who answered the call then yelled out in a busy room "Hey, they guy who wrote Overdosed America is on the phone. Who wants to talk to him?" That was a very productive relationship and left me understanding that one never knows how much influence something might have.

Interview

Real World

real world

So you might be thinking "Wow Anu what a wonderful presentation, but how does this affect me?" Well let's go back to the example I stated in previously in the Overpriced Drugs section. The Epipen pricing was a problem, a real life problem, that affected many people and maybe even you. The one drug that was made to save your life now costs over $600. Now, what if your family couldn't afford that? How would you feel? Angry? Scared that you could have an allergic reaction at any time and not be able to do anything about it? Maybe you don't even have to deal with this problem, but what if another family in your community does? A problem doesn't have to affect you directly in order for you to do something about it. The EpiPen pricing didn't affect me directly because I've never needed one, but that didn't stop me from doing something about it. It's actually the reason why I did my 20Time project on Healthcare. I may just be 14, but that doesn't mean I can't make a difference. This website could be viewed by anyone and maybe they become inspired like I did to take that extra step to help those affected by this problem. We can't sit back and allow people to suffer because we are only in this world for so long. This website is my first step to helping the world I live in and that is powerful because your first step doesn't have to be as big as speaking to millions of people or getting invited to talk on tv about your opinions on a certain issue. It can be as simple as gathering pennies to donate to a local charity, putting up posters around your neighborhood or even making a website. As long as you have taken that first step along with many others around the world your added efforts will force those apart of the problem to change their ways. So when will you make your mark?

Contact Me

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Works Cited

 Abramson M.D., John. Overdo$ed America. New York: HarperCollins, 2004. Print. ​

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---. “Link between Health Spending and Life Expectancy: US Is an Outlier.” Our World in Data, 3 Aug. 2016,

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www.fda.gov/AboutFDA/WhatWeDo/default.htm. Accessed 11 May 2017.

 

 

 

 

 

 

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