Free Prescribing Experimental Drugs Name: Institution: Research Paper Example
The drug development process is a long and tedious process. It involves many specialists: pharmacists, chemists, physicians, and clinicians. At best, these experts may take averagely twelve years to prepare an experimental from the laboratory to the drugs cabinet. Most experimental drugs fall along the way and do not reach the prescription stage, which the final phase of drug development. There is a 0.1 percent chances of medications that proceed to the preclinical testing manage to reach the human testing phase (MedicineNet.com, 1999). This percentage represents essentially five in every five thousand drugs under trial. Surprisingly, only one out of the five experimental drugs that reach the human testing stage get the green light to be used as human medicine. Therefore, there a chance of 0.02 percent for a new drug to reach the intended market.
Stages of drug testing
Governmental regulatory agencies are responsible for the process of approving new medicines in each country. Examining the drug approval process in the United States, the drug being developed has to go through several stages:
a). Preclinical testing
During this stage, animal and laboratory studies are carried out on the drug. This is precisely done to check the biological activity of the drug under development against the disease that it is intended to manage or cure. The safety of the experimental drug to be used is tested (MedicineNet.com, 1999).
b).Investigational New Drug Application (IND)
The pharmaceutical company involved in the development of the drug will apply for an Investigational New Drug with the regulatory authority, Food, and Drug Administration before human trials’ of the drug commence. The IND will take effect after 30 days since application. The IND includes information such as previous experimental results, which people, which place, and how the human studies will be conducted. Additionally, the IND gives the chemical structure of the active ingredient, simulations of how it works in the body, its toxicity levels registered during the animal studies, and how the active ingredient is to be manufactured (MedicineNet.com, 1999). Thereafter, the Institutional Review Board reviews and approves the IND.
c).Phase I Clinical Trials
Here, the drug being developed is tested in healthy people normally between 20 to 80 people- who voluntarily present themselves for drug testing. These tests are undertaken to test the safety levels of the drug, the dosage range that is safe, and the absorption, distribution, metabolism, and excretion characteristics of the drug. The duration of the experimental drug activity is also examined. These trials generally take one year to conclude.
d). Phase II Clinical Trials
They are typically larger studies conducted in patients suffering from the disease for which the drug is being developed for. The trials are used to determine the maximum and minimum levels of dosage. It involves a population of between 100-300 patients who volunteer to take part. During this stage, the effectiveness of the drug is assessed. For this step to finish, two years are required (MedicineNet.com, 1999).
e). Phase III Clinical Trials
During this phase, the safety-particularly adverse effects, and effectiveness of the drug are examined. These trials are large in scale-involving between 1000-3000 patients hospitalized or in clinics- and are carried out randomly. Thereafter, they are submitted to the Food and Drug Authority for further approval. The patients taking part in the test are put to task to note any side effects of the drug in their bodies. On average, this phase lasts for three years.
f) New Drug Application (NDA)
The drug gathers all data from previous trials and applies to the FDA for an NDA. This is guided by safety and effectiveness registered in the new drug. An NDA has all up to date data gathered about the drug. The average review time for an NDA is about two and half years.
g). Phase IV Studies
During this phase, data is collected from patients who are using the drug as part of their medication. This is for drugs that have been approved by the FDA. Patients may be required to report any symptoms that accompany the usage of the drug.
These stages present the journey an experimental drug has to travel before it can be used in curing diseases or managing ailments. However, there have been instances whereby by an experimental has been prescribed for use by patients before approval. The most recent use has been the use of experimental drugs in the management of the Ebola virus. The definite cure of Ebola virus has not been discovered. Moreover, no vaccine has been developed to check the explosion of the virus in humans. The sudden emergence of the deadly Ebola virus in three West African countries presented the world with major challenge of containing the spread the virus.
The virus is exceedingly contagious and can spread very fast among population. It is believed the virus is spread via bodily fluids such as sweat, urine, semen, and, and vomit. Against this backdrop, there was an immediate need to cure those already infected. There are numerous experimental drugs still under development to be used in eventual management of the virus. However, some of the experimental drugs were prescribed for patients who had registered contracting the Ebola virus even before they had been approved for use by human (Hellerman, 2014). These are still in various developmental stages, but the severity of the virus tempted the authorities to tamper with drug development rules and give a nod for the drugs to be used management of the Ebola Virus Disease. Therefore, this research tempts to check the success of experimental drugs prescribed for patients who had contracted the deadly Ebola Virus Disease.
Hypothesis: The experimental drug ZMapp can cure Ebola Virus Disease.
ZMapp is an experimental drug that is still in the development phases, and it is intended to treat patients diagnosed with Ebola. Its biological makeup is a combination of three monoclonal antibodies that differ from each other. The monoclonal antibodies have been studied to prevent the spreading of Ebola Virus disease in the human body (Mapp Biopharmaceutical, 2015).
Methodology-how information was gathered
The information for this research paper was gathered mainly from secondary sources encompassing newspapers and credible electronic media; credible websites. Both Dr. Kent Brantley and Nancy Writebol came down with Ebola while working as missionary workers in Liberia-one of the West African countries affected by the Ebola menace. Both were working Samaritan’s Purse, an aid organization (Gupta and Dellorto, 2014). The two are believed to have contracted the virus at the Liberian hospital they worked, probably from fellow healthcare workers. On July 22, 2014. Dr. Brantley felt a fever, and he immediately put himself in a self-induced isolation. Writebol showed symptom on July 25, 2014. A blood test was contacted on the three while at their Liberian hospital, and it emerged that that had been infected with the deadly virus (Gupta and Dellorto, 2014). The two showed symptoms of Ebola: diarrhea, vomiting and intense fever.
Both Dr. Brantley and Nancy Writebol were evacuated to the United States and placed under medical surveillance at Emory University Hospital that is located in Atlanta. Dr. Brantley had written off his chances of emerging from this deadly disease. He had called his wife pronouncing his final goodbyes (Gupta and Dellorto, 2014). Both the Ebola patients were given the experimental drug, ZMapp, as the last ditch to save them. The two patients had been informed that this kind of treatment had not been tried on anybody. However, small experiments of the drug had been done on monkeys, and it indicated some bit of success in eradicating the virus in monkeys. The experimental drug is property of Mapp Biopharmaceutical Inc, a biotechnology firm that is in the process of developing the drug for eventual use in containing the Ebola Virus Disease in humans (Gupta and Dellorto, 2014).
Results: The working of ZMapp and its production
The experimental drug ZMapp is composed of monoclonal antibody obtained from three mice. Primarily, fragments of the Ebola virus were exposed to mice. This caused antibodies to be generated within the blood of mice. These antibodies were then harvested to create the medicine (Gupta and Dellorto, 2014). The working mechanism of the experimental is such that it acts as a barrier that prevents the Ebola virus from getting into the body and infecting new cells that have been formed (Mapp Biopharmaceutical, 2015). The drug had earlier been used in monkeys whereby four monkeys that had been infected with Ebola. The result was that the monkeys all survived the fatal Ebola virus (Mapp Biopharmaceutical, 2015). Moreover, two other monkeys were supplied with drug almost two days after they had contracted the virus, and they all survived. However, one experimental monkey that was not given the experimental drug but had contracted the virus died five days later after it had been exposed to the virus (Mapp Biopharmaceutical, 2015).
The dominant antibodies that make up ZMapp are grown in tobacco plants currently. The antibody genes are introduced into tobacco plants to manufacture the antibodies of ZMapp. To manufacture them, it requires one week of producing the ZMapp antibodies. Afterward, the harvesting of tobacco plants takes place, and the purification of antibodies occurs. After purification, they are formulated to make them ready for injection and eventual evaluation (ZMapp Biopharmaceutical).
The administration of the drug involves the direct introduction of the drug into the bloodstream of the patient. The drug being an experimental therapy, it has to be continuously checked for effectiveness and safety. However, other monoclonal antibody drugs that have been approved by the Food and Drug Agency have recorded good safety levels (Mapp Biopharmaceutical, 2015).
The World Health Organization had cautioned the use of untested drugs when the Ebola Virus Disease was in a full-blown condition. The health authorities noted that providing therapies and vaccinations that are early phases of development was breaching the health rules because there are numerous ethical and scientific implications it portents (Gupta and Dellorto, 2014). Making a choice to try untested drugs on patients was a hard choice one to make, and they lacked the surety that the experimental therapy would cause more harm than the anticipated good. The ZMapp has not yet received any approval to be used in human treatment. Moreover, it has not even completed the clinical trials. The decision to use the drug in treatment of the virus was against the ethical standards of the healthcare systems.
The ZMapp drug is one of the most recent instances of experimental drugs prescribed and used as therapies in the cure of a fatal disease. It represents one of the successful stories of an experimental drug being used to manage a disease. There is a likelihood that many drug regulatory bodies would have disapproved its use had it not been the severity of they Ebola situation; Ebola was decimating villages and if left unchecked, its effects would have been tremendous. The use of ZMapp prematurely to heal the United States citizens, on missionary work, who had contracted the virus, went against the norm among regulatory authorities but it was necessitated by the terrible situation of the virus. Secondary sources of collection of data have been specifically been used so as to get access to credible data which can be incorporated in the research to show the extent of prescription of experimental drugs among humans. The website of ZMapp manufacturer provides factual information about the drug and its working, and this information was gleaned and used in the development of the research paper. Such information was valuable in corroborating the research paper’s information about experimental drugs and their prescription.
The research paper has been developed in the context of prevailing challenges in healthcare, especially with the devastating effects of the Ebola Virus Disease in three countries in West Africa. The prevailing conditions present an opportunity for one to examine the issues surrounding the prescription of experimental drugs in as therapies in human diseases. It is a relevant situation that pokes many questions into safety of experimental drugs and arouses the health professional into deep contemplation on how to overcome such situations in future; fatal diseases without no cure cropping up. The Ebola case also challenges the limit to which ethical and scientific regulations may reach when it comes to prescription of experimental drugs.
It is my opinion that experimental drugs should not be used on humans before establishing their efficacy and safety. Doing this may be a big gamble because there can be a likelihood of the viruses or bacteria developing resistance against the active ingredient of the drug under development even before it gets approval to be used in treatment of human diseases. The side effects of the experimental drugs may be more fatal to entire patients as compared with the illness itself. This calls for initial approval of drugs before they can be used on humans. I believe the best way to contain diseases is through prevention mechanisms that are well practiced. As an example, Ebola virus can be prevented from getting into humans through avoidance of contact between persons and the virus careers like the fruit bats. Malaria is best prevented through sleeping under mosquito nets during the night, clearing of bushes near homesteads and draining of stagnant water that may become breeding grounds for mosquitoes.
MedicineNet.com. (1999, July 14). Drug Approvals - From Invention to Market. Retrieved February 14, 2015, from http://www.medicinenet.com/script/main/art.asp?articlekey=9877
Gupta, D., & Dellorto, D. (2014, August 6). Experimental drug likely saved Ebola patients - CNN.com. Retrieved February 14, 2015, from http://edition.cnn.com/2014/08/04/health/experimental-ebola-serum/index.html
Mapp Biophamaceutical Inc. (2015, February 6). ZMAPP ™ FAQ. Retrieved February 14, 2015, from http://www.mappbio.com/zmappfaq.pdf
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