Pfizer and the Nigerian Trovan Suit
There has been a controversy about the experimental testing of the drug Trovan (trovafloxacin), by Pfizer, a major pharmaceutical company. Pfizer held clinical trials of the drug in Kano, Nigeria, during the 1996 epidemic of bacterial meningitis. The experiments were conducted on 200 children and were said to be successful. Recently, 30 Nigerian families of the children used in the experiments filed a lawsuit against Pfizer claiming they had violated laws by not obtaining permission from the families. (Reliefweb) This lawsuit is unprecedented. I believe Pfizer handled this experiment with good intentions and the press, namely the Washington Post, has unfairly portrayed them.
The Food and Drug Administration (FDA) has recently restricted the use of the antibiotic, Trovan, after it has been proven to cause liver failure and a small number of deaths when prescribed for many types of infections. Doctors were warned to reserve the use of Trovan for use only in the treatment of patients who meet very specific requirements. (Branch Law) Although it is harmful when used for certain ailments, Pfizer reports that Trovan has proven to be effective in treating meningococcal meningitis. This was determined during the experiments in Nigeria which were supervised by both American and Nigerian doctors. (Pfizer)
This experiment took place in Africa because of its recurring meningitis epidemic, which kills thousands of people. Pfizer took the opportunity to compare Trovan with ceftrixone, which was the commonly used drug at the time, to prove its effectiveness. One hundred patients were given Trovan and another 100 ceftrixone. In each group ninety-four percent of patients survived. “This mortality rate of 6% for both patient groups was lower than that seen in …patients with non-epidemic meningitis (range 6-10%), and lower than the overall fatality rate for this particular epidemic (10-30%).”(Pfizer) The incidence of side effects while using Trovan was not any higher than with ceftrixone. Oral Trovan proved to be a very safe, useful and promising treatment for this disease as compared to using other methods, which had to be given intravenously and could spread hepatitis or HIV.
Pfizer states that, “The trial was designed and conducted in accordance with good medical practice and ethical norms.” They also said that both the Nigerian Ministry of Health and a local Nigerian ethics committee approved the experiment and a copy of this was sent to the FDA. “Prior to treatment, informed consent was obtained.
To continue the license, Merck had to convince the FDA that the effectiveness stayed at a similar rate over the years. Merck then designed an even more scientifically flawed methodology, this time incorporating the use of animal antibodies to artificially inflate the results, but it too failed to achieve Merck’s fabricated efficacy rate. Confronted with two failed methodologies, Merck then falsified the test data to guarantee the results it desired. Having achieved the desired efficacy threshold, Merck submitted these fraudulent results to the FDA and European Medicines Agency.
Why do consumers purchase specific drugs for various ailments, sicknesses or diseases they might have? Why do physicians prescribe certain drugs over competitive drugs that may be available to the public? Why is it that most of us can easily name specific drugs that fit the many ailments of today’s society? On the surface the answer might be as simple as good TV advertising or radio commercials or even internet adds. The truth of matter is the major pharmaceutical manufacturers own the patents on these drugs and this gives them all of the marketing budget and muscle they need to promote the drug and control the pricing. The incentives for larger pharmaceutical companies are very enticing and as a result, they don’t mind spending the time in clinical trials and patent courts to get their drugs approved. Some will even get patents on the process by which the drug is manufactured, ensuring that no competitor can steal the drug or the process. This protects their large financial investment and nearly guarantees a large return for their investors. Many consumer rights groups claim this is nothing more than legalizing monopolies for the biggest manufacturers.
Patient consent is the law. Even though the test can provide unsatisfactory results they cannot anticipate the way the drugs will affect the present. This could lead to one patient favoring one treatment over another. The problem that comes from specific informed consent cannot be addressed solely by demanding more rigorous standard for research (Truog et al. 1999).
Though the research seems pretty sound in the ethical department, one could say that placebo controlled studies could be unethical in themselves. Accepting someone into a clinical trial gives him or her hope of improvement, but they may not ever get that chance. If they were placed in the control group, they would only receive a sugar pill that would have no health implications. Though part of many successful and effective experiments, it could be raised as an ethical issue.
. Many doctors and patients are unaware that antibiotics are designed to treat bacterial infections, not viral infections (Antibiotic resistance, N.D.). Many bacteria within our bodies are not harmful at all, and some of them actually provide health benefits. The bacteria that are harmful are disease-causing bacteria, which generate sicknesses such as strep throat, the common cold, and ear infections (Get, 2013). Viruses are smaller than bacteria and require hosts, such as plants or animals, in order to proliferate (What, N.D.). Doctors play a vital role in administering antibiotics, for patients rely on their knowledge and expertise in order to receive proper medication for ailments throughout their lives. According to www.acponline.org, 190 million doses of antibiotics are administered every day. Among patients that do not reside in hospitals, doctors prescribe more than 133 million antibiotic programs every year. Of those 133 million programs, it is estimated that over 50 percent of them are unnecessarily prescribed because the doctor is prescribing them for viral infections such as common colds or simple coughs (Antibiotic resistance, N.D.). However, doctors are not the only ones to blame in regard to misuse of antibiotics because their patients are just as guilty when it comes to ignorance in respect to antibiotic usage. Many preventable factors have emerged because of irresponsibility of patients, including self-medication practices and the temptations of cheap, counterfeit drugs, all of which have aggravated drug resistance in the last 20 years (What, N.D.). Also, many patients are unaware of the dangers that can result from leaving medication behind because they don’t use it. It is extremely ill-advised to leave behind eve...
The authors quote a vast amount of credible sources from prestigious universities such as Princeton and from well-known animal rights groups such as PETA. I will use this as my main source of information. George, Patricia and Geraldine Wagner. “Point: Medical Experiments on Animals Are an Important Element of Drug Development.” Animal Experimentation 2015: 7.
When a person seeks medical attention they go with the hope that their personal rights will not be violated with the belief that doctors will uphold their personal standards. Unfortunately, this is not always so for people who visit the hospital. There are documented cases in United States history involving African Americans being experimented on for the greater good without their knowledge or consent, and some of the most heinous cases involve doctors injecting their study groups with life threatening diseases. What happens when good science goes bad and who has the right to relegate the status of another human being as less than? In this research paper we will examine a clinical testing case study featuring the violation and exploitation
In the last decade, the number of prescriptions for antibiotics has increases. Even though, antibiotics are helpful, an excess amount of antibiotics can be dangerous. Quite often antibiotics are wrongly prescribed to cure viruses when they are meant to target bacteria. Antibiotics are a type of medicine that is prone to kill microorganisms, or bacteria. By examining the PBS documentary Hunting the Nightmare Bacteria and the article “U.S. government taps GlaxoSmithKline for New Antibiotics” by Ben Hirschler as well as a few other articles can help depict the problem that is of doctors prescribing antibiotics wrongly or excessively, which can led to becoming harmful to the body.
Bibliography:.. References 1) Lewis, Ricki, “The Rise of Antibiotic-Resistant Infections”. Food and Drug Administration Publications. http://www.fda.gov/fdac/features/795_antibio.html September, 1995. 2) Levy, S., Bittner, M., and Salyers, A. Ask the Experts about “Ask the Experts”.
Throughout history, beginning as early as 500 BC, animals have been used to test products that will later be utilized by humans (“Animal Testing” 4), what isn’t publicly discussed is the way it will leave the animals after the process is done. Many innocent rabbits, monkeys, mice, and even popular pets such as dogs are harmed during the testing application of cosmetics, medicine, perfumes, and many other consumer products (Donaldson 2). Nevertheless, there are many people whom support the scandal because "it is a legal requirement to carry out animal testing to ensure they are safe and effective” for human benefit (Drayson). The overall question here is should it even be an authorized form of experimentation in the United States, or anywhere else? The fact of the matter is that there are alternatives to remove animals out of the equation for good (“Alternatives” 1). They are cheaper, and less invasive than the maltreatment of the 26 million innocent animals that are subjected to the heartlessness of testing each year (“Animal Testing” 4). All in all, due to the harsh effects of animal testing, it should be treated as animal cruelty in today’s society.
Thesis: With the advent of antibiotics in 1929 Fleming said, "The time may come when penicillin can be bought by anyone in the shops.Then there is the danger that the ignorant man may easily underdose himself and by exposing his microbes to non-lethal quantities of the drug make them resistant."With the overuse of antibiotics today we have seen this very idea come to be.Over usage is caused most prevalently by a lack of education on the part of the patient.Thus stated, the way to overcome such a circumstance is to educate, not only the patient but also the physician.
Since experiments are cruel and expensive, “the world’s most forward-thinking scientists have moved on to develop and use methods for studying diseases and testing products that replace animals and are actually relevant to human health” (“Alternatives to Animals”). Companies claim that this sort of cruelty will benefit the human population by testing the “safety” of the products, as they have been for hundreds of years, and although this may have been helpful in the past, scientists have discovered otherwise. “While funding for animal experimentation and the number of animals tested on continues to increase, the United States still ranks 49th in the world in life expectancy and second worst in infant mortality in the developed world” (“Animal Testing Is”). This evidence shows that while we still continue to support and spend money on animal testing, it is not working as well as we thought.
Penicillin, a vital antibiotic for infection is toxic to ginea pigs. Animal testing isn’t reliable option for human medication or products. Animals have different genetic make up than humans. Mike Leavitt, The Health and Human Service Secretary, states “ Nine out of ten experimental drug fail in clinical studies because we cannot accurately predict how they will behave in people based on laboratory and animal studies.” (Animal Research is Unethical and Scientifically Unnecessary). Humans have obvious differenced than animals like physiology and anatomy. These differences are the reason drug testing on animals isn’t equal when medication or product is used in a human trial. Pfizer reported in 2004 that they “wasted more than $2 billion over the past decade on drugs that “failed in advanced human testing or, in a few instances, were forced off the market, because of liver toxicity problems” (Animal Research is Unethical and Scientifically Unnecessary). Some drugs have caused serious and unexpected health problems even after they were tested on animals. Animal
Viral meningitis, the most common form of the disease, often resolves itself without treatment within a few days. However, bacterial meningitis, somewhat rare in the United States but rampant in West Africa, requires immediate attention in order to prevent fatality. The bacteria that cause meningitis include Streptococcus pneumoniae, Neisseria meningitidis, Streptococcus agalactiae, and Listeria monocytogenes. The severity of the body’...
Kardos, N. & Demain. A. L. 2011. Penicillin: the medicine with the greatest impact on therapeutic outcomes. Applied Microbiology and Biotechnology, 92: 677-687.