Are you up to the test?
How can corrupt medical research be stopped? In 2011, Susan Reverby, published a paper detailing a shameful moment in American history. From 1946 through 1948, the Public Health Service was involved in medical research on the disease syphilis which was being performed on 700 Guatemalan children, soldiers, prisoners and mental patients. Many of the patients were intentionally infected with syphilis, either by injecting infected fluids under their skin, or by giving them infected prostitutes. This awful project started with “The best of intentions”, to find a cure for the disease syphilis.
John Cutler, the doctor in charge of the two year project, was involved in many other research projects as well. He was one of the main researchers involved in the Tuskegee syphilis study, where black farmers were intentionally not treated from the late 1930’s to 1972. The project was stopped due to public exposure. Although finding a cure is important, is it worth cheating people of their health? In their award-winning book, Freakonomics, Steven D. Levitt and Stephen J.
Dubner explore, among many other things, bribing, cheating, and incentives. Levitt and Dubner explain that an incentive is just a way of urging people to do more good things and less bad things (17). Giving a child a promise of candy for behaving well in class will certainly help the child to change his behavior. The same goes for adults, the thought of being named a criminal and a thief for robbing a bank will certainly deter an adult from committing such a crime. According to Levitt and Dubner, “There are three basic flavors of incentive: economic, social, and moral. Very often a single incentive scheme will include all three varieties ” (17).
They also state that a few of the most compelling incentives invented so far have been placed to deter crime; such as jail (17). Levitt and Dubner state, by going to jail you risk, “losing your job, your house, and your freedom, all of which are essentially economic penalties-[the risk of going to jail] is certainly a strong incentive ” (18). Although the risk of going to jail is a strong incentive, people also respond to moral incentives, they don’t want to commit a crime they think is wrong. Social incentives are also important when it comes to crime, people don’t want other people to see them committing a crime. So, what Levitt and Dubner are saying is, through a constantly readjusting web of economic, social, and moral incentives, our modern society does its best to discourage people against committing a crime (18).
Who Cheats? According to Levitt and Dubner, if the stakes are right just about anyone will cheat: You might say to yourself, I don’t cheat, regardless of the stakes. And then you might remember the time you cheated on, say, a board game. Last week. Or the golf ball you nudged out of its bad lie. Or the time you really wanted a bagel in the office break room but couldn’t come up with the dollar you were supposed to drop in the coffee can. And then took the bagel anyway.
And told yourself you’d pay next time. And didn’t. (21) They also say that for every person who creates an incentive scheme, there is an army of people who will beat it (21). Levitt and Dubner state that in order for someone to find a cheater, one must think like a cheater (25). They explain, whether cheating is human nature or not, it is a big part of just about every human endeavor (21).
Cheating is an economic act: getting more for less. It’s not just the big names, such as ball players taking pills that cheat either, according to Levitt and Dubner, “It is the waitress who pockets her tips instead of pooling them. It is the Wal-Mart payroll manager who goes into the computer and shaves his employees’ hours to make his own performance look better. It is the third grader who, worried about not making it to fourth grade, copies test answers from the kid sitting next to him” (21-22). Some forms of cheating are more noticeable than others, however, cheating is cheating. So what is the incentive behind doing medical research on unknowing patients? There are many incentives behind doing medical research on unknowing patients, including, for the fame, for the money, and, of course, to “help” people.
However, is sacrificing people’s health to “help” others really worth the pain the guinea pigs go through? Medical advancement depends upon human experimentation. Scientists can do the most amazing wonderful research that can help so many people. It all starts with an idea which turns into a hypothesis, next comes the biochemical experiments, and then the in vitro, then they start to test it on animals. The scientist can understand all the levels of the disease, from the amino acid chain to the atomic structure, but even with all that knowledge he still needs to test his hypothesis on a real human being. In order for many of the scientific advances we have today to be made, there had to be test after test on human subjects. No matter how many tests are performed on animals, or in lab simulations, in order for the scientist to know if his idea will make real human patients better, he has to test it on human subjects.
Conducting experiments on human subjects has resulted in many of the medical advancements we use today. Sadly, many of the subjects were from poor parts of the world who only participated in the experiments for financial reasons. Many were not correctly informed as to exactly what the risks were. In the United States, African Americans, including children, were given the most brutal and invasive of the medical experiments. Harriet Washington’s award-winning book, “Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present”, focuses on this terrible mistreatment of African Americans as uniformed subjects in medical experiments. The medical establishment’s use their power by exploiting African American, men, women, and children.
Usually they had no legal protection, and could not fight for their rights, because of their color. Washington covers a wide range of topics in her book, including hospital abuse of black patients and cadavers, radiation experiments on the unsuspecting, and many medical experiments on African American men, both in the military and in prison. Thomas Jefferson, who was supposedly against slavery, used hundreds of his slaves to test an untried smallpox vaccine before ever using it on whites. James Marion Sims, M.D.
, is known as a selfless benefactor for women. He devoted his life to finding cures for diseases that ailed women. In New York, there are many statues erected in memorial to Dr. Sims. Washington describes a painting, in which Dr. Sims’ slave, Betsy, is portrayed as a fully clothed, calm slave who is kneeling on a small table, being prepped for surgery, before a trio of white physicians (2).
This portrait could not be more different than what really occurred during surgery. Each surgical scene was a gruesome bloody battle scene. Washington explains the horrific scene, Each Naked, anaesthetized slave women had to be forcibly restrained by the other physicians through her shrieks of agony as Sims determinedly sliced, then sutured her genitalia. The other doctors, who could, fled when they could bear the horrific scenes no longer. It then fell to the women to restrain one another. (2) Sims bought black slaves, addicted them to morphine, just so he could perform dozens of painful, intimate vaginal surgeries.
Only after experimenting on Betsy and her fellow slaves could Sims finally agree to test what he had discovered on white women. Martin Luther King, Jr., in 1965, stated, “Of all the forms of inequality, injustice in health is the most shocking and the most inhumane (qtd. In Washington 2).” The Office for Protection from Research Risks has been investigating abuses at over sixty research centers, including experimentation-related deaths at universities.
Scientific fraud is another important variable of human subject abuse. The scientists lied through falsified data or they gave false research agendas, often to research another disease. Many of these studies only allowed African Americans and Hispanics to enroll. These research studies specifically excluded white subjects, according to the terms of their official protocols, the federally required plans that detail their research. The subjects were given experimental vaccines known to have extremely high lethality rates. They were also enrolled in other experiments without their consent or knowledge.
They were subjected to surgical and medical procedures while unconscious, injected with toxins, and were deliberately monitored instead of being treated. The researchers also secretly harvested the test subject’s tissues that they would then use to attempt to perfect medical technologies such as infectious-disease testing. A few African American medical institutions have suffered run-ins with the federal oversight agencies, who were concerned about how they were treating their research subjects, but only a few. The infamous Tuskegee experiment begun in the 1930’s, and lasted over three decades. The African American men who were infected with syphilis, were studied, but not treated, all so the progression of the disease could be observed, until the death of the subject. In 1946, “The Nuremburg Doctors’ Trials”, conducted to bring Nazi physicians who performed medical experiments on humans to justice, began.
The U.S. chief prosecutor opened with the statement, “The wrongs which we seek to condemn and punish have been so calculated, so malignant and so devastating that civilization cannot tolerate their being ignored because it cannot survive their being repeated.” Yet, the American Medical Establishment allowed them to continue the Tuskegee Experiment, as well as many other risky medical experiments performed on African Americans. Clinical Trials have turned into a competition that everyone wants to be a part of.
Dr. Jiri Stanek, a Czech public health specialist, says, They receive good data quick. There was a need for services, and suddenly western companies realized the huge potential here. There was an extremely good population pool in terms of medical indicators for both chronic and acute diseases. Our population did not have access to remedies that were available in the West, so it was all quite attractive.
We had many untreated populations. There were treatment-naive, steroid-naive, statin-naive people-people you could hardly find in the United States or Western Europe. We had extremely high recruitment rates (qtd. In Petryna 3). Carl Elliot, author of Guinea Pigging, states that the IRB’s(Institutional Review Board) only asks questions such as, “Have the subjects been adequately informed of what the study involves?(4)” They don’t usually ask if they are recruiting illegal immigrants, or if the study poses a fire hazard. Elliot says, At some trial sites, guinea pigs are housed in circumstances that would drive away anyone with better options.
Guinea pigs told me about sites that skimp on meals and hot water, or that require subjects to bring their own towels and blankets. A few sites have a reputation for recruiting subjects who are threatening or dangerous but work cheaply. (4) The federal government provides very little protection for the test subjects. According to a 2007 H.H.S.
report they conduct, “more inspections that verify clinical-trial data than inspections that focus on human-subject protection (qtd. In Elliot 4)” According to Elliot, the FDA only inspects about one percent of clinical trials (4). The most recent disaster took place in March, 2006, at a testing site that was run by Parexel, at Northwick Park Hospital, just outside of London. Subjects were offered 2000 pounds to enroll in a Phase I trial of a prospective antibody for rheumatoid arthritis and multiple sclerosis. Elliot states, six of the test subjects had to be brought to an intensive care unit, after suffering life- threatening allergic reactions. They were hospitalized for over a week, one subject had to have his fingers and toes amputated.
All of the subjects were reportedly left with serious long term disabilities. The Northwick Park incident was not an isolated incident. Elliot spoke to an Iraqi immigrant who began doing drug trials because he needed the money. He was involved in a trial testing an immunosuppressant, when he found himself in a bed next to another subject who was continuously coughing up blood. Although he immediately inquired about being moved to a different room, he was not moved for nine days. He and eight other subjects later tested positive for Tuberculosis.
Elliot states, for some, the job of Guinea Pigging is the only means of work, The safety of new drugs has always depended on the willingness of someone to test them, and it seems inevitable that the job will fall to people who have no better options. Guinea-pigging requires no training or skill, and in a thoroughly commercial environment, where there can be no pretense of humanitarian motivation, it is hard to think of it as meaningful work. Most people who become guinea pigs do it for the money, but why do the medical researchers do their jobs? Charles Seif, author of Is Drug Research Trustworthy? explains that some pharmaceutical companies are paying medical researchers, In the past few years the pharmaceutical industry has come up with many ways to funnel large sums of money- enough sometimes to put a child through college — into the pockets of independent medical researchers who are doing work that bears, directly or indirectly, on the drugs these firms are making and marketing. The problem is not just with the drug companies and the researchers but with the whole system — the granting institutions, the research labs, the journals, the professional societies, and so forth (1). According to Seif, the entanglement between pharmaceutical companies and researchers has many forms.
There are those who are the speaker Bureaus, they get paid to fly around the world, first class of course, and give company-written speeches, and present company-drafted slides. There is also the Ghost writer, a pharmaceutical company drafts up a scientific paper and pays a scientist, the “guest author”, to put his name on it. And finally, there is the consulter; a company hires a researcher for “advice”. Researchers “think what these companies are after are their brains, but they’re really after the brand,” says Marcia Angell, former editor in chief of the New England Journal of Medicine. “To buy a distinguished, senior academic researcher, the kind of person who speaks at meetings, who writes textbooks, who writes journal articles — that’s worth 100,000 salespeople (qtd.
In Seif 1). If you are a guinea pig, unless you have medical knowledge, you are at the hand of the medical researcher. Scary thought isn’t it? Levitt and Dubner explain that having information is having power (62). Doctors and medical researchers most definitely have more information about the drug they are testing on you than you do. Most likely they will tell the guinea pigs all the good effects, but will leave out most of the horrible side effects.
Levitt and Dubner explain, Think about how you describe yourself during a job interview versus how you might lf on a first date. (For even more fun, compare that first-date conversation to a conversation with the same person during your tenth year of marriage.) Or even think about how you might present yourself if you were going on national television for the first time. What sort of image would you want to project (74)? It’s not as if medical researchers want to “cheat” you of your health, most likely that is not the case at all. The whole reason for them getting in that field was simply to help sick people get better.
But, in order to keep people honest, laws, bills, and acts must be passed. So what has been done to stop the wrongful collaboration between pharmaceutical companies and medical researchers? Congress passed a bill called the Physician Payments Sunshine Act, also known as the National Physician Payment Transparency Program and the Open Payments Program, requires that all manufacturers of drugs , medical devices to participate in the U.S. Health Care’s new program. The program requires all drug manufacturers to report specific payments made to physicians and teaching hospitals.
Congress also passed a Bill called, the Protection of Human Subjects in Medical Experimentation Act, which states, The Legislature hereby finds and declares that medical experimentation on human subjects is vital for the benefit of mankind, however such experimentation shall be undertaken with due respect to the preciousness of human life and the right of individuals to determine what is done to their own bodies (1). By passing the Protection of Human Subjects in Medical Experimentation Act, not only are the guinea pigs protected, but so are the medical researchers. People tend to cheat less when the stakes are higher, such as a terrible punishment, and when they know people are watching them. Levitt and Dubner, authors of award winning book Freakonomics, tested this with teacher cheating. In order to catch the teachers cheating, a special algorithm was produced and used on a standardized test. The test was given and a number of teachers were suspected of cheating for their students.
So, they re-administered the standardized exam to 120 classrooms, the majority was given to the classrooms that were suspected of having a cheating teacher, while the rest were divided between two control groups. The teachers were not allowed to touch the exams or the answer key; they were only allowed to be present in the classroom while the exam was being taken, with a CPS official inside as well. And, as suspected, the classrooms that had the cheating teachers scored far worse, an average of a full grade level below. If there had been a CPS officer in the classroom the first time the test was given, the cheating, most likely, wouldn’t have happened. So, if the public had known about the horrible reality of experimentation on humans, would it have been stopped? Would dozens of lives have been saved? Overall, the government and the people are doing a lot to stop the corrupt medical research. Is it enough? Both the Sunshine Act and the Protection of Human Subjects in Medical Experimentation Act seem to be protecting guinea pigs from harm, and keeping medical researchers honest.
Although nothing like the Tuskegee and the Syphilis experiments are happening today, there are still a lot of dishonest medical researchers out there. Medical researchers who only want to make a name for themselves, and don’t take great care into administering “help” to the guinea pigs needing a cure. In the end, it’s up to the public to decide whether or not a solution has been formed, or whether the issue is just being pushed under the table.
