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What are the two sides of the biotechnology?
One of the sides is the technique that allows DNA to be manipulated to move from genes from one organism to another while the other involves new technologies whose consequences are not yet tested and thus should be met with caution.
Define and distinguish bio-equivalence from therapeutic equivalence.
Bioequivalence is a term used to assess the absence of a significant difference in the rate and extent to which the active ingredient in pharmaceutical equivalent becomes available at the site of drug action when administered at the same molar dose under similar condition, therapeutic equivalence is differentiated from bio-equivalence in how the human body metabolizes a drug.
Briefly explain why industry-university cooperation in biotechnology research and development is advancing even though large sums of money have been lost in the sector.
Apart from the fact that a good total sales biotechnology industry exceeding $30 billion, the leading research universities have research development departments that provide commercialization services to the universities. Thus, the creation of research owning companies provides with the required medical companies to enter into contracts for development of medical products.
Briefly explain the conflict between the biotechnology industry and the National Science Board regarding financial support.
Financial relationships have been seen to create confects of interest between researchers’ obligations especially with biotechnology companies. The problem may be between theoretical ideals and market limitations that may require development of a more equitable system with available financial resources.
Name one aspect of Internet pharmacies that is of concern to the FDA.
The FDA has been concerned with the idea that internet has substituted a health care professional in interacting with the patient resulting to patient self diagnosing and treating themselves and the sites practicing unlawful pharmacy practices like the issue of confidentiality.
One of the most notorious examples of violation of privacy policies involving data mining involves Choice Point. Choice Point provides a wide range of individually identifiable information on persons. Name at least three of these areas.
Choice Point is involved in marketing services, data authentication services and software and technology services.
a) Briefly explain why the guiding principle of information privacy for adolescents is that certain areas of care require that an adolescent be treated more as an adult than a child.
Without persuasive reasons, parents or physicians should not exclude adolescents from making decisions. Although physicians should seek parental guidance most of the times, their focus should be providing appropriate medical care and even go as far as seeking legal intervention if the parent places the patient at a clear risk.
b) Describe a criticism of P4P programs that is present in the Smelik v. Mann case.
The pay-for performance programs, according to Smelik v. Mann case shows that the health plan was liable for failing to provide the case management services they promised. As with other advisories, the services may be gratuitous and go beyond the financial support that the health plan is expected to provide. The case is widely criticized because of its unusual outcome for Humana, the plaintiff. This showed that high-deductible income health programs are a litigation hazard for health users.
c) When and where did evidence-base medicine begin? What type of program uses this as a key component?
Evidence based medicine was used as far as in the 1940s but it was up until 1972 that the concept came into play. It originated by Professor Archie Cochrane and was funded in 1992 by the UK government but it was in 1995 in the British Medical Journal that evidence-based Medicine gave the definition of EBM.
d) Every five to ten years, major legislation addresses pressing issues concerning the federal Food and Drug Administration (FDA). Briefly describe the primary concerns regarding drugs a decade ago and today.
The FDA receives an increasing report of drug products that fail to work in patients. This may be because the drug has no effect or is toxic.
e) What is UNOS and what does it do?
UNOS stands for United Network for Organ Sharing. The organization coordinates the transplant system in the U.S., and work to ensure quality control of policies regarding transplantation research.
f) Describe briefly and generally what the federal and state governments are doing to encourage organ donation.
UNOS is a non-profit organization and the federal government is the one that funds the UNOS, the money is used to cover the cost of transplants.