Blood Clot: Epogen, Procrit, and Aranesp

Introductory project description

A blood clot is defined as “the clumps that occur when the blood hardens from a liquid to a solid (coagulates). A blood clot that forms inside a blood vessel or within the heart and remains there is called a thrombus.” (Stitham, 2008) There are several causes of a blood clot. This can result due to long trips by train or air, history of a blood clot, heart trouble, bad veins, obesity, bruise, and a broken bone, or if one is over the age of 65. (Wittkowsky, 2008) However, some drugs cause blood clots and are available in the market.

The innocent-looking crossing guard in the familiar Procrit commercial has been found to be the bearer of a dangerous message. Unexpected large numbers of patients taking the drugs Epogen, Procrit, and Aranesp have suffered blood clots. Statistics show that a doctor who prescribes one of those drugs to an anemic patient on chemotherapy could write a prescription for that patient’s early death. However, a proper evaluation should be formulated to examine the rate of causalities these drugs cause in the context of blood clots.

Research question

It has been reported that patients taking the drugs Epogen, Procrit, and Aranesp have suffered blood clots. However, the hypothesis estimates that not more than 5% affected are fatal. Thus, the research question states:

What is the percentage of people affected by these drugs out of the total population?

What percentage of the affected population has been severely affected by the use of these drugs?

Review of the literature

The ability of drug companies to manufacture drugs such as Epogen and Procrit derives from the growing knowledge of molecular biology, most specifically genetic engineering. Scientists have found a way to put the gene for a protein called erythropoietin inside of cells that can be grown in the laboratory. Those growing cells then become a ready source of erythropoietin. (Drug Information Service; 2007)

In a healthy individual, the production of erythropoietin spurs the creation of added red blood cells. Drug companies sold the engineered erythropoietin with the promise that it would work as effectively as the natural protein. Now the most recent information suggests that the protein made in the laboratory might not be as safe as consumers had been promised. (Online Legal Marketing, 2008)

Doctors have no doubt exacerbated the dangers of the engineered protein by promoting its off-label uses. Some doctors have prescribed the drugs for cancer patients, not on chemotherapy. Other doctors wanted to accelerate the production of red blood cells in patients who had undergone orthopedic surgery. While such use had not been tested by an FDA trial, doctors still anticipated healthy red cell production following the use of drugs such as Epogen and Procrit. (FDA News, 2007)

Studies now show that the doctors’ expectations for a healthy recovery could fall a bit short of the intended mark. Not all patients respond as expected to the engineered protein. Some, apparently, undergo alarming changes to their circulatory system. Medical research must now turn its attention to why the use of the engineered protein can sometimes cause a patient to have blood clots. (Marks, 2007)

The expense of health care has become an ever-growing influence on the ability of the American economy to exhibit a sustained expansion. For that reason, every American should take an interest in his or her ability to remain healthy. Advertisements for pharmaceutical products feed on the desirability of that interest. (Reinhardt, 2008)

Society at large has demonstrated increased attention to all aspects of health. As people spend more on health-related products, they demand more of those products. Consumer demand for goods that can guarantee health, occurring in combination with repeated mention of the costs of health care has underlined how news from the drug industry can affect the economy. They help to fuel interest in the American economy. (Reinhardt, 2008)

However, as per the summary table, it is clear that the economy has a deep implication in this context. Out of the large numbers of patients, taking the drugs Epogen, Procrit and Aranesp have suffered blood clots are actually from the bottom half of the social-economic zone. Particularly, this holds much truth when the infection is more than mild i.e. critical and death. It is clear from the table that people who are mostly out of the parameters of the health insurance policies due to lack of economic stability are more prone to suffer from the use of the drugs Epogen, Procrit, and Aranesp and suffer blood clots to the point of death. This is how the economy becomes directly related to the aspects of medical science as society is based on the economy.

However, from the parameters of medical science even as scientists behind the development of Epogen and Procrit looked with alarm at statistics about apparent risks associated with the use of those drugs, other scientists at PromoCell shared with their colleagues some good news. They published that news in a scientific journal, away from the public eye. Their news could offer real help to the scientists puzzled by the poor performance of the engineered erythropoietin. (PromoKine; 2006)

Those scientists have perfected the technique used to put a gene inside a living cell. That process, what scientists call transfection, is used at the pharmaceutical plants where drugs such as Epogen and Procrit are produced. Improvements made by the scientists at PromoCell have increased the diversity of cell types that can be used for “growing” cell lines with an inserted gene.

Since no one has yet determined why the engineered protein increases patients’ risk for heart attack and stroke, the scientists must examine every parameter. They will want to grow the protein in a different cell line and to see if that makes any difference. The products made by PromoCell will help scientists in their search for an answer to the “Epogen puzzle.”

The information from PromoCell contains even more good news. The new product for transfection has no components that came from any sort of animal. Scientists have shown increased caution about using products that might contain material from an animal that could be infected with a prion. Prions are the strange new particles that are causing “mad cow disease.”

PromoCell’s new product for transfection allows that process to be carried out more efficiently. It permits the completion of a transfection without the time-consuming need to change the media on the transfected cells. It protects the inserted DNA (the gene) and speeds the rate at which the gene’s information reaches the needed parts of the cell. Those features should hasten the discovery of a way to make a less risky form of engineered erythropoietin. (PromoKine; 2006)

Summary Table

  1. Male

  1. Female

  1. White

  1. Color

  1. Mid income

  1. Low income

  1. Infected

  1. 25

  1. 10

  1. 30

  1. 5

  1. 20

  1. 15

  1. mild

  1. 10

  1. 7

  1. 12

  1. 0

  1. 5

  1. 12

  1. Moderate

  1. 5

  1. 5

  1. 10

  1. 0

  1. 3

  1. 7

  1. Critical

  1. 5

  1. 3

  1. 4

  1. 4

  1. 2

  1. 6

  1. Death

  1. 1

  1. 0

  1. 0

  1. 1

  1. 0

  1. 1

  1. Favor of ban

  1. 15

  1. 9

  1. 24

  1. 2

  1. 20

  1. 6

  1. Favor of drugs

  1. 10

  1. 1

  1. 11

  1. 3

  1. 4

  1. 10

It should be noted that in the upper-income level none was found to be infected. Thus, this group is excluded from the summary.

Methodology

A Qualitative method of study differs from the usual quantitative methods in the sense that it tends to be far more subjective. Being open to qualitative methods of study also allows social scientists to incorporate non-quantitative data (i.e. non-numerical data, such as words, images, gestures, impressions, etc.) in their study. Since human beings tend to operate in terms of such data and not in terms of the terminology used in ordinary sciences this broader outlook is far more applicable in the study of social sciences.

In keeping with the methodology employed in marketing researches the theories too are formulated and used keeping in mind that they are not necessarily applicable to all conditions. Be it psychology, history, political science, or economics human events are most likely to influence the rules which define the basic theories of a social subject. Success in the field of social researches can therefore be achieved if and only if it is understood that the subject has no space or opportunity for watertight methodologies or theories.

The basic advantages of qualitative measures are multifold. Firstly, it presents a completely realistic approach that the statistical analysis and numerical data used in research based on quantitative research cannot provide. Another advantage of qualitative measures is that it is more flexible in terms of collected information interpretation, subsequent analysis, and data collection. It also presents a holistic point of view of the investigation. Furthermore, this approach of research allows the subjects to be comfortable thus be more accurate as research is carried on in accordance with the subject’s own terms. (Babbie, 2002) Thus, this particular method has been selected to convey the social context of the issue with the needed humane touch as this method allows the social voice to formulate into statistical records.

Research participants & Data collection

The best statistical method would be to interview long well-formulated day-to-day working procedures at a specific and well-selected location. Throughout the procedure, it should be noticed whether there are specific variables within the testable population or not. These variables would be extremely important while evaluating the basic data in the final stages where the adjustments would be made to the formulated data in accordance with the observations. However, it is important to completely take into account the aspects of fundamental variables of an individual such as ethnicity, religious belief, or positive support from the sales structure of the management and individual.

All these variables are considered as very relevant and important features of the statistical method and it is to be seen if these aspects are fundamentally acceptable in the practical world and it could well be mentioned that service, especially the commerce service industry, is a very relevant manifestation of the social dimensions. As a result, if the test is carried out in a proper manner with proper calculations of the population involved then there is no reason that the results would be both logical and true at the end consideration.

Risks and benefits of the research

Protections for participants in the context of health, safety, confidentiality, informed consent are vital. However, as interviews would be taken of patients and relatives of the patients it can be stated as safe. It should be stated that there would be few independent variables in the context of the test that could not be explained by the statistical method statements. Here the ethical consideration of the patients and relatives of the patients or the ethnic background of the patients and relatives of the patients may not be a very relevant factor. Thus, there could be some flaws to the collection of the population but if these aspects were kept in mind then the shortcomings would easily be negotiated during the ultimate computations. As a result, the test would appear to be a full proofed measure that would be able to define and prove the fundamental aspects and statistical method applied.

The variables involved would also include age groups, amount of education, and understanding of security needs and responsibilities. Other variables may be inclusive of the economic standings. The third series of variables include the types of studies that are managed and the cultural background of the patients in each of these areas. The research paradigm considered by the researcher in regard to this work included the consideration of groups and how strategically developed planning would target them. These considerations included in management and how the different respondents would in fact classify usage of the drug and its impact on the health of the patients.

The data for this work was managed through a single questionnaire handed out to patients and relatives of the patients. The researcher utilized gender identifiers and numbers or letters to separate each questionnaire for validity and reliability of results and to ensure bias reductions. Each question had either a ‘yes’ or a ‘no’ answer or followed positive or negative reactions to certain questions. The process to deliver and collect these questionnaires would be spanned around approximately two weeks.

The choice to use patients and relatives of the patients alone in this research was made for three reasons. First, it was far simpler to have access to patients and relatives of the patients in regard to the researcher’s availability. Second, the focus itself is on patients’ attitudes and understanding of the issue. Third, the quantification of such information allows the researcher to gain a broader perspective on how patients and relatives of the patients observe and realize the validity and reliability of the information received from a variety of sources and how they apply it to daily life in terms of the issue.

It should be noted that reliability for the researcher was achieved in the assurance that only a specified group of men and women were utilized in regard to the research. That group was focused mostly on patients and relatives of the patients and retails along with administrative personnel. This gave the research a more focused view of the research goal. The validity was managed as a result of this focus and emphasized in the considerations involved in the data collection, variables, and sampling methods. Privacy and confidentiality methods included assigning numeric and alphabetic coding to each responding questionnaire. This ensured anonymity in regard to the researcher and the subjects of the research process.

Schedule

The study was undertaken according to the following Gantt Chart.

  1. Week 1

  1. Week 2

  1. Week 3

  1. Week 4

  1. Week 5

  1. Week 6

  1. Week 7

  1. Week 8

  1. Week 9

  1. Week 10

  1. Introduction

  1. x

  1. X

  1. Literature Review

  1. x

  1. X

  1. Methodology

  1. x

  1. Interviews

  1. x

  1. x

  1. Data Interpretation

  1. X

  1. Results Compilation

  1. x

  1. Results and Conclusion

  1. x

References

Stitham, Sean O; 09 September 2008; “Blood clots: Medical Encyclopedia”; U.S. National Library of Medicine. Web.

Wittkowsky, Ann; 2008; “Your Guide to Preventing and Treating Blood Clots”; AHRQ Publication: Agency for Healthcare Research and Quality, Rockville. Web.

Babbie, Earl & Lucia Benaquisto; 2002; “The Fundamentals of Social Research”; Toronto: Nelson.

Marks, Jay W; 2007; “Drug Class And Mechanism”; Food and Drug Administration. Web.

Drug Information Service; 2007; “Erythropoiesis-Stimulating Agents (Darbepoetin [Aranesp], Erythropoetin [Epogen, Procrit]) – New Black Box Warnings” ; Drug Information Service: University of Utah Hospitals & Clinics. Web.

Online Legal Marketing; 2008; “Aranesp, Epogen, and Procrit”; Online Legal Marketing. Web.

FDA News; 2007; “FDA Advisory Committee Recommends New Restrictions For Anemia Medications”; Compliancehome.Com: Supremus Group. Web.

Reinhardt, Uwe E; 2008; “Health Care Spending And American Competitiveness”; Health Affairs. Web.

PromoKine; 2006; Innovative Tools for Cell Biology; PromoCell GmbH, Heidelberg, Germany. Web.