[show abstract][hide abstract] ABSTRACT: The U.S. pharmaceutical industry is defined by the U.S. Census Bureau as "companies engaged in researching, developing, manufacturing and marketing of medicines and biological for human or veterinary use". Besides its main role in improving human health, the US pharmaceutical industry represents one of the most critical, key decision makers' lobbying prone and competitive sectors in the economy. The cost in the environment of very limited government price regulation remains one of the major problems fuelling aggregate health care cost inflation. Pharmaceuticals have created huge benefits for public health and economic productivity by the means of saving lives, increasing life expectancy, reducing illness related suffering, preventing surgeries and decreasing hospital stays.
The goal of this review paper is to show the present conditions and future trends of the pharmaceutical industry in the U.S.
THIS PAPER REPRESENTS A THOROUGH LITERATURE REVIEW OF THE MULTIFACETED SOURCES INCLUDING: studies, books, peer reviewed journals, U.S. government sources (i.e. U.S. Census Bureau, U.S. Bureau of Economic Analysis, etc.).
In the thirty years pharmaceutical companies have consistently developed and launched new medicines, bringing hope to sick or - at risk patients. They also usually provide above the average financial returns for its shareholders. U.S. pharmaceutical companies had as their goal to discover blockbuster drugs. Blockbuster drugs are generally defined as drugs that solve medical problems common to hundreds of millions of people and, at the same time generate large sales increases and profits for the pharmaceutical companies. The main approach of these companies includes huge investments in research and development (R&D), innovation, marketing and sales. The trend analysis shows that for the most part the era of blockbuster drugs is nearing an end.
Numerous blockbuster drugs will be coming off patent in the next few years, opening the way to generics and eliminating a major source of the industry's profits. Still, there is plenty of room for improvement in the medications people take while there is no shortage of human suffering to alleviate. It is doubtful whether big pharmaceutical firms will be able to pursue these goals within the old model of developing exclusive new drugs that can be sold further in the future. In the past, medicines for the ailments that were never before addressed, like anti-cholesterol or anti-depression drugs were developed. Currently, and in the future, it is expected that only blockbuster modifications will be developed. This phenomenon is expected to create market saturation, which will significantly reduce profits. The business model that drove the major drug makers' success is not working anymore. Pharmaceutical companies must create new ways and to bring new ideas. The survivors will be those that market strategies supported by innovative approaches and winning capabilities.
[show abstract][hide abstract] ABSTRACT: This study represents a new approach to the extended analysis of correlation of findings of oligoclonal bands on gels and the level of intrathecal synthesis of immunoglobulin G in the central nervous system. Previous studies have shown that there is no correlation at this level as well as the number of tape or finding does not correlate with the forecast effect of therapy or patient outcome.
To determine the correlation of level of immunoglobulins IgG in CSF with the number of oligoclonal bands on the gel.
The retrospective study based on data processed in Clinical Immunology Clinical Center University of Sarajevo. Patients were assumed of multiple sclerosis according to clinical findings and magnetic resonance imaging. All CSF and serum samples were processed by nephelometry, isoelectric focusing on the gel. Statistical analysis of results was also performed by using SPSS statistical analysis program.
Analyses were performed on 254 samples of cerebrospinal fluid and serum of patients from neurological clinic, suspected of multiple sclerosis. We concluded that there is no correlation between the level of intrathecal synthesis obtained by Reibergram with the number of oligoclonal bands on gels. We think that the reason could be a small sample of patients analyzed and it leaves room for future analysis on a larger sample.
For most patients with established MS we found intrathecal humoral response, type two, and the number and arrangement of IgG bands generally does not change during the disease, because they reflect long-term non-specific immune stimulation rather than a specific immune response that during infectious disease changes (quantitatively and qualitatively).
[show abstract][hide abstract] ABSTRACT: Autoimmune diseases occur in 3-5% of the population. Study included 30 patients with clinically diagnosed SLE and 30 healthy controls (American college of Rheumatology, 1997). SLE was diagnosed according to criteria issued in 1997 by the American College of Rheumatology (ACR). The aim of this study was to evaluate concentration values of each antigen of ENA-6 profile in SLE, to investigate possible correlation between the concentration of Sm antibodies and CIC, and to test their use as possible immunobiological markers in SLE. Furthermore, the aim of our study was to determine whether there is a correlation between Sm antibodies and CIC and SLE activity. The results revealed that all of these ENA-6 and Sm antibodies as biomarkers complement diagnoses of active SLE but their use as solo markers does not allow classifying patients with SLE. Our study has shown that based on calculations from ROC curves, Sm/RNP was clearly a very important marker for diagnosis of SLE (cut off ≥ 9.56 EU, AUC 0,942). The high incidence of Scl-70 (10%) reactivity suggests that ELISA monitoring of this antibody produces more false positive results than other multiplex assay. An important conclusion that can be drawn from the results of our study is that laboratory tests are no more effective than clinical examination for detecting disease relapse, but are helpful in the confirmation of SLE activity.
[show abstract][hide abstract] ABSTRACT: This study researched the distribution of desirable, borderline and high-risk values of certain lipid status parameters in healthy young individuals.
The purpose of this study was to research the statistical distribution of desirable, borderline and high-risk values of certain lipid status parameters in healthy young individuals (i.e. medical university students).
In this research we tested 112 students studying at the University of Sarajevo, of both genders and 20-30 years of age.
Total serum cholesterol was minimally elevated in 7.1% of tested students, elevated with high risk in 2.7% and triglycerides were minimally elevated in 1.8%. Presence of elevated LDL cholesterol was found to be 2.7% minimally and 1.8% with high risk. HDL cholesterol was minimally decreased in 1 tested student.
Standard biochemical methods were used to determine the values of total cholesterol, triglycerides and HDL-cholesterol. The level of LDL cholesterol was also calculated.
Our results point to the need for performing gradual laboratory diagnostic procedures for routine check-ups of university students.
[show abstract][hide abstract] ABSTRACT: In this study the authors have analyzed the costs associated with the immunosuppressive therapy in patients who underwent organ transplantation in two countries: the United States of America and Bosnia and Herzegovina (i.e. the entity Federation B&H).
The goal of this paper is to compare and contrast the costs of the immunosuppressive therapy in two countries against the total costs of the organ transplantation. Further, the costs, dosages and effectiveness of the particular types of immunosuppressant were also analyzed. Problem of the Study: Immunosuppressive medications are essential in preventing kidney transplant rejection. Most available pharmaco-economic information to date is for induction and maintenance therapies, while the data on the financial impacts of the rejection are still limited. Immunosuppressive regiments are expensive in the socio-economic environment of limited resources and constraints.
This academic article has utilized the publicly available sources of information from the Federation Entity of B&H, (i.e. Federal Department of Insurance and Reinsurance) in period 2006 to 2010, as well as peer-reviewed academic articles, books, private and government data from the United States of America from 2006 to 2010, including projections for 2011.
In the U.S. the cost of the immunosuppressive medications for the major types of organ transplantations typically range from US $19,300 to $34,600 per year based on commonly prescribed doses at average wholesale prices. In the Federation entity of B&H in 2009, the average cost per patient in F.B&H in 2010 was 6,009.00 KM (U.S.$4,292.00), which represents an absolute cost decrease of 740 KM or 11.00%, when compared to the higher average cost per patient in 2009, which was 6,749.00 KM (US $4,821.00).
The process of finding the ideal medication regiments to minimize morbidity and mortality, while maximizing quality of life and optimizing the cost is the major challenge to the transplantation community. Pharmaco-economic analysis can provide valuable insight toward achieving of these, rather difficult goals.
A sensitive pharmaco-economic analysis must be undertaken in order to achieve the best results in the world of limited/constrained resources and increasing demands for the expensive and quality of life improving immunosuppressive therapy in organ transplantation.