Problems in Cancer Cure Development - Essay Example

Problems in Cancer Cure Development Submitted by: Submitted Submitted 0 Introduction According to Altman and Sarg (2000), cancer is defined to be a group of diseases wherein cells become malignant, multiply abnormally and destroy normal cells in the process. The disease differs from benign tumors because it is metastatic or can spread to other locations of the body. Cancer affects people of all ages but tends to more prevalent as people age. It is also found throughout the world and manifests itself even in other animals and plants. There are a variety of methods of treatment which includes surgery, chemotherapy, radiotherapy, monoclonal antibody treatment, immunotherapy and alternative treatment. Surgical treatment involves surgical excision of a tumor or an entire organ but the propensity of cancer cells to microscopically metastases makes it effective only in localized small cancers such as breast and prostate tumors. Radiation therapy can come in the form of radiotherapy, X-ray therapy and irradiation and uses ionizing radiation to kill cancer cells. Chemotherapy involves the treatment of cancer with cytotoxic drugs that can have many effects specifically geared towards the elimination of cancer cells. One of the effects of the drugs is to interfere with cell division by hindering the duplication of DNA and the separation of chromosomes. The anticancer drugs travel through the bloodstream making it useful for cancers that have spread. Monoclonal antibody therapy involves the administration of antibodies that bind to a protein on the surface of the cancer cells. Cancer treatment depends on factors such as location, degree of severity, grade of tumor and the general state of the patient. In essence, the goal of cancer treatment is to remove or destroy the malignant cells without excessive damage to the body. This is easier said than done. Indeed, the treatments mentioned are far from being the panacea for cancer as they are severely limited not only by financial challenges but also of scientific obstacles that makes it very hard for scientists to make a breakthrough in the field of cancer research. The aim of this paper is to determine the challenges facing the development of a cure of cancer. While a discussion on financial constraints would be provided, I will be focusing more on the theoretical and scientific aspects that inhibit the development of cancer cure. Possible solutions for overcoming developing cancer cure that are based on studies will then be discussed and explored to determine the principles of how it would work. 2.0 The Current State of Cancer Research 2.1 Development Processes in Clinical Studies Developing a new drug is an expensive, time-consuming process that usually takes ten years to push through. Development and determination of effectiveness of possible cancer treatment usually comes in the form clinical trials. Clinicaltrials areresearch studies wherein the treatment is applied to human patients to determine if it is effective. Regulating bodies such as the Food and Drug Administration (FDA) oversee medical and ethical panels that review the research methods and ethics of the clinical trial to be undertaken and monitor the trial phases. The standard phases are the following (Coleman, 1998): Synthesis and Purification (1st and 2nd year) - researchers identify a substance that may be useful as a drug. Animal Testing (1st and 2nd year) - the substance is tested on animals to obtain preliminary information on whether the drug is safe and how it is metabolized in the body. Phase 1 Clinical trials (3rd year) - patients who have advanced cancer and are not helped by any other known treatments are recruited for the trial. They would be subjected to an analysis for the best dosage and delivery method of a new drug treatment. Phase 2 Clinical trials (4th and 5th year) - the drug is tested with groups of patients each having a different type of cancer. This is done to determine what types of cancer can the substance provide treatment, Phase 3 Clinical trials (6th, 7th and 8th year) - substances showing promise are further evaluated in larger groups. Control groups are established and they receive placebo- an inactive substance. Their conditions are then compared with the experimental group to know the effectiveness of the substance. Review and Approval (9th and 10th year) - the regulating body such as the FDA reviews and approves the studies. Upon recommendation, the treatment becomes part of the standard treatment regimen and is also tested for its effectiveness when combined with other treatments. There are different focuses in cancer research. Antimetastasis focuses on ways to halt tumor cells from spreading throughout the body and cause new tissues to become malignant. Antiangiogenesis is concerned with inhibiting tumor cells from developing blood vessels. Examples of this include angiostatin and endostatin. Drugs that block oncogene signals are also being analyzed in clinical trials. Introduction of genes into the immune cells that recognize and kill cancer cells is also being researched. Investigations are also underway regarding the effects of introducing normal genes into tumor cells to increase its sensitivity to chemotherapeutic drugs. A relatively new field is chemoprevention which seeks to identify natural or synthetic compounds that can decrease the risk of cancer and be manufactured as pills or food additives is also underway. 2.2 Financial Cost of Development According to DiMasi et al (2003), the average cost of developing a new molecule into a cancer curing drug is about 500 million dollars invested on the 10 year span. The huge cost is primarily due to human clinical trials which takes at least half of the amount. This is only true if the molecule is indeed found to be effective. What is more perplexing is the search for the proper molecule that would be developed. A candidate molecule may fail anywhere in the development process which would make the previous investment meaningless. Oftentimes, cancer researchers go back to the drawing board and the millions of dollars spent will be but a waste of investor and taxpayer's money. 2.3 Lack of Support for Researchers and Scientists Directly related to the problem of financing cancer research is the lack of adequate human resource management. The single most threatening issue resulting from the shifting economies in health care provision is the migration of talented and creative physicians from research to practice. According to Altman (2000), there is a lack of a definite career path for scientists in the world of cancer research. There is also the lack of expertise as scientists have limited stipends and programs needed to upgrade their knowledge and understanding. There is also the tendency to rush There are also claims that regulating bodies such as the Food and Drug Administration are conspiring to prevent the development of a cancer cure by certain entities to favor large pharmaceutical corporations who are conducting their own research on a medication that they can sell to the public. It is claimed that the stakes are so high that large corporations are willing to shell out money so as to protect their investment. A case in point is the imprisonment of James Kimball and the closure of his company Discovery Experimental and Development Inc. (DEDI). DEDI was developing an extract derived from Shiitake mushrooms called lantana. The said products is said to be capable of boosting the immunosystem enough to prevent cancerous cells from developing as evidenced by the results of their experiments with cows. The Food and Drug Administration repeatedly raided and handed out gagged orders to the company which climaxed in the arrest of Kimball and the closure of the company. The propensity of large corporations to prevent the development of products that would greatly endanger their market is somewhat a public knowledge. 2.4 Limitations of in the current paradigm of cancer research The current trend in the search for cancer research is to find a molecule that kills cancerous cells but saves normal cells. However, existing agents do not discriminate between the two and the possibility of normal tissue damage is high. The assumption that tumor cells grow at a different rate relative to normal cells have not really translated into discovery and / or design of tumor selective molecules. In recent years effort has been made to identify and target pathway / protein unique to cancer cells. There is currently an effort to develop drugs around cancer cell specific targets because it may be free of adverse effect of cytotoxic agents. (Kamb, 2000) It was previously mentioned that human clinical trials take up the bulk of the budget. One of the purposes of these studies is to determine whether the drug has some adverse effects in the human body. This has to be proven in all of the three phases in the ten-year period of research. The problem is that adverse effects can be expressed anytime in this period thereby wasting financial resources and years of research. 3.0 Perceived Solutions 3.1 Shift in Paradigm Roy (2006) stressed the need for a paradigm shift in the search for a cure for cancer. Instead of the usual hit and miss tactics of clinical studies wherein researchers discards a drug whenever adverse effects are observed, they could employ a strategy of stratifying patients by their genetic profiles. The idea is establishing the common genetic profiles where the treatment appears to work and to know the genetic makeup where it has adverse effects. According to Roy (2006), such a feat is already possible due to the advancement in recombinant DNA technology which has enabled scientists to determine that certain genes and gene products are produce differently from tumor and normal cells. It has been shown by Roy (2006) that the treatment of cancer with monoclonal antibodies such as Trastuzumab and HER2 neu positive patients that had undergone genetic stratification have resulted to significant savings by improving success rate and the decreasing the number of patients needed for a positive outcome. In other words, Roy (2006) is stressing the need for using the pharmacogenetics for refining the target based process of developing cancer cures which has been the topic of various research such as that of Cimarusti (1997). 3.2 Establishment of Infrastructure There are significant efforts to provide a more conducive environment for research. The National Cancer Institute (2003) plan for Cancer Research Training and Career Development, for example, provides many measures that can address the issues of inadequate human resource human management. The crux of their plan is to provide basic scientists with more attractive career paths by providing them the necessary training for conducting research that employs multidisciplinary and expert approaches. Trainees will also be provided with stipends that reflects their education and skills and at par with industry standards. Safer and more comfortable research facilities will also be provided. The institution is also planning to create a more ethnically and racially diverse research community and integrate technical and informatics expert in the research so as to facilitate the use of high performance systems. 4.0 Conclusions Developing a cure for cancer is a tedious process primarily because of the different forms of cancer and different physiological response of patients. It is a resource intensive process that could only lead to negative returns on the investing entity. In light of this, measures such as shifting paradigms and employing a more intensive human resource management scheme can provide the suitable environment for fast tracking the development of a cancer cure. List of References: Altman, Roberta, and Michael J. Sarg (2000). The Cancer Dictionary. Rev. ed. Facts on File, 2000. Defines some 2,500 terms for cancer patients. Cimarusti, C. M. (1997) Integration of discovery and development phases : A paradigm for Project Acceleration, in Drug Discovery Technology, ed. Hori, W., International Business Communications Inc., 1997;7.1.1.7.1.28. Coleman, C. Norman, M.D. (1998). Understanding Cancer: A Patient's Guide to Diagnosis, Prognosis, and Treatment. Johns Hopkins University Press, 1998. DiMasi JA, Hansen RW and Grabowski HG (2003). The price of innovation: new estimates of drug development costs. J Health Econ. 2003;22:151-185 Kamb, A (2005) Whats wrong with our cancer models. Nature Rev Drug Discovery 2005;4:161-165 Read More