Drug Trials One of the

By upholding estern standards of ethics for drug trials, a company will not only meet its ethical obligations but will also ensure a higher standard of research. Clinical trials in emerging markets will still be cheaper than in estern markets, because the research staff will earn less, and because payouts to test subjects can be adjusted for living costs without violating ethical norms. Also, because standards provide structure, the quality of the research will be improved by applying estern standards in lieu of local standards.

Thus, the strongest ethical case lies for managing drug trials in emerging markets much as they would be managed in the est. The trials need to meet the specifications of the FDA anyway, and even with estern standards the cost of foreign drug trials will be lower. Additionally, when the drug company is free from the perception of ethical violation, not only will the results…… [Read More]

Uncontrolled Variables in Psychiatric Clinical Drug Trials

Medication Adherence and Compliance

Uncontrolled variables in psychiatric clinical drug trials

According to Griswold, Murray & Corrado (2012), one troubling aspect of psychotropic drug clinical trials is the lack of controls for subjects' adherence to medication protocols. Psychiatric patients in particular have historically been noted to have relatively low levels of compliance. In general, "as drug dosages increase, treatment adherence decrease" because of intensification of symptoms, difficulty remembering dosages, and other issues (Griswold, Murray & Corrado 2012). Under-medicating or discontinuing medications is common in schizophrenic and bipolar patients, due to reasons such as "perceived or real decreases in disease progression or symptomatology, perceived helplessness, defense mechanisms such as denial, motivational apathy, and lack of family or financial support"(Griswold, Murray & Corrado 2012). For potentially addictive substances such as stimulants and opioids, over-medication is a greater risk.

The study specifically took the form of a literature review. The authors conducted a…… [Read More]

Effects of Minimizing Risk in Drug Trials

Minimizing isk in a Study

One of the biggest challenges in conducting pharmaceutical research are the risks involved. This is because they can increase the potential legal liabilities and have a negative impact on everyone. To address them requires looking at: the circumstance for exclusion / inclusion / the maximum results, who approves the modifications and what can cause a study to end prior to its completion. Together, these different elements will illustrate how the process occurs and the different variables that are utilized throughout the process. (Konterman, 2010)

Under what circumstances would you modify inclusion and exclusion data to minimize risk and to maximize benefits of the research outcome? Who must approve modifications?

The circumstances that will shift modification of risk in Phase III trials are the side effects and the impacts they will have on participants. This is challenging, as these issues could have short or long-term consequences.…… [Read More]

Drug Culture and Horror

Drug culture at Temple U

Transitioning from high school to college may be shocking to some individuals, but as they begin to get more comfortable with their environment, classes, and fellow students, one may realize that there are many similarities that carry over from their previous academic environment. One social structure that carries over from high school to college are the formation of social groups and cliques. The groups are usually formed because the individuals have common interests -- curricular or extracurricular -- or they are in the same academic program or share classes. Some social groups are also formed based on a shared interest in drugs. While drug use is not something that is openly discussed on campus, nor are drugs consumed openly, there is still evidence that supports the argument that students sometimes engage in recreational drug use.

One of the more widely accepted illegal drugs is marijuana.…… [Read More]

Drug Policies Major Policies History

14). Soon, Congress passed the Marijuana Tax Act, which was signed into law in 1937. Like the Harrison Act, the Marijuana Tax Act placed marijuana into the same category as the cocaine and opium drugs. It was now illegal to import marijuana into the United States (McWilliams, 1991). However, this law was ineffective in curbing marijuana use (Brecher, 1986, p. 14).

By the early 1940s narcotic addiction had significantly reduced in the United States (Harrison, Backenheimer and Inciardi, 1999). However, this was not the result of legislative initiatives. Instead, it was because World War II was cutting off the "supplies of opium from Asia and interrupt the trafficking routes from Europe" (Inciardi, 1992, p. 24).

Several other legislative efforts in the supply reduction department served to establish more severe penalties for violations of drug laws, and tighten controls and restrictions over legally manufactured narcotic drugs (Harrison, Backenheimer and Inciardi, 1999).…… [Read More]

Drug Companies and Poor Nations

) (adhwa, Rissing, Gereffi, Trumpbour and Engardio, 2008).

Clearly, it is important to have standards for all pharmaceuticals. Perhaps the HO or TO could monitor the quality control of this globally, adding a few cents per dose to help defray the cost, or utilizing a United Nations budget to oversee this program. It is just as important, though, to realize that until the Developed Countries share in their own resources, whether that be intellectual property or certain types of manufacturing, there will remain a large inequity and thus, an inability for globalization to really work (See: Globalization, Patents and Drugs, 2001).

Drug companies like Pfizer do have a utilitarian and moral responsibility to their stakeholders and, conversely, to patients in emerging markets. If there is a drug that will help alleviate suffering, it is not moral to keep it only for the rich countries. Conversely, there is an argument to…… [Read More]

Drug Use in Teens

Drug Use in Adolescents

The author of this report has been charged with writing a brief scholarly report with a few key components. The author of this report has been asked to select a topic of interest. That selected topic shall be substance and drug abuse in adolescents. As part of this scholarly report, there will be three major components. The first will be a description of the area of interest and why the author of this report is interested in it. Second, there will be a brief literature review with scholarly sources that cover that same topic. Finally, there will be a reflection and reaction to the literature review including whether there was agreement, how the author of this report perceives the involved paradigm(s) and so forth. While many kids avoid the pitfalls and negative outcomes of drug use and abuse, many fall prey sometimes or many times and…… [Read More]

Drug Use Enforcement in the USA

Drug Trafficking

The author of this report is to answer a few questions relating to drug trafficking. The primary focus of the questions and answers will be on two sources in particular, those being the movie Traffic and the class text authored by Thio, Calhoun and Conyers. The questions include references to the links between drugs and crime, the roles and events surrounding certain people in Traffic and so forth. There will be references other than the two mentioned above throughout the answers, as is required by the parameters of the assignment. While many depict drug use as a victimless crime, this is far from being true and the scope of the people that can be affected by drug use, drug dealing and drug trafficking literally knows no bounds or limits.

Analysis

There is a heavy amount of examples of how drug use and crime are related, but the author…… [Read More]

Generic Drugs

India Pharma Mfg

Many Americans have responded to the high prices on U.S. pharmaceuticals by purchasing them from other countries. Several countries have built cottage industries around shipping drugs to the United States. Initially, Canada was a favored country for this, given the reliability of drugs coming from Canada. However, price caps or not Canada still has Western prices for its pharmaceuticals, which has led to buyers searching the world for even lower-cost options, one of which is India. India's drug export market has grown at 24% per year, and now equals $14.7 billion, of which 55% goes to Western markets, the U.S. being the largest of these (Taylor, 2013). The total U.S. pharmaceutical market is $359 billion and is expected to grow to $476 billion by 2020 (PWeb, 2013). This paper will analyze the impact that Indian pharmaceuticals are expected to have on the U.S. market. This discussion is…… [Read More]

Double Blind Trial This Is a Study

double blind trial. This is a study where neither the researchers or the participants know what they will receive. First and foremost, it removes any potential for bias, as there are no preconceived notions from the participants or those studying the reactions of the trial. Such studies often also "follow less restrictive methodological standards than phase III studies in terms of patient selection, comedictation, and other design issues," (Muller, 2011). Essentially they have greater room to better replicate real world scenarios. They are also much more able to be generalized than studies with more restrictions. However, there are also some downsides to double blind trials. For example, there is a much greater variance that the research will have to deal with. This is "caused by the different kinds of confounders as well as problematic design issues" that can lead to "wrong conclusions," (Muller, 2011). When there are issues it is…… [Read More]

Drug Use Among Teenagers

Rise of Illicit Drug Use Amongst Teenagers

According to recent surveys, there has been a rise in the use of illicit drugs amongst teenagers. One particular drug that has seen a steady increase in use is Ecstasy, while in other studies researchers have seen drugs become more available in a variety of markets, like the Internet, in order to cover a wider area for distribution.

Teenagers have been a prime source for these Internet-dealers, and while certain drugs have seen a drop in their use, it is only because they have been replaced by more illicit and easier to obtain drugs. Contrary to popular belief, teenage drug use is on the rise, and appears to only be heading on the up and up.

In a study conducted last year by the University of Michigan's Institute for Social Research, out of 44,000 students, "the proportions of eighth-, 10th-, and 12th-graders who…… [Read More]

Drugs and Gangs Among Detroit Teens

Street Drug Trade Is One of the Most Important Social Institutions for Young People in Detroit

From his perspective, Bergmann writes that the street drug is one of the most important social institutions for young people in Detroit. As an institution, the drug dealings and everything surrounding it are becoming a transforming force taking people in a certain way of life and perception. Detroit is known to be a major region of the drug trade, including heroin. Like any other society, it suffers consequences of this in many ways, including the economic, cultural, social, and even psychological repercussions arising from the presence of the drug. Drugs are commonly effective and, in some way, change the way people behave, live, and interact. This is seen from his submission that "drug dealing governed the seasonal cycles of their lives and taught them about the nature and power of the state, capitalism and…… [Read More]

Drug Tysabri That Was Tested

According to these authors, the fatal tragedy could easily have been avoided by taking more time for more focused and carefully planned clinical trials. According to this view, it was unethical to test Tysabri in the way it has been done, and furthermore irresponsible to enter it into the market before all side-effects were ascertained.

3. Interested parties: The interested parties in this case include Walter Smith, Anita's widower, as well as Cambridge biotechnology and Elan Corp. From Smith's point-of-view, the companies are at fault for causing harm to his wife, and potential harm to many others using the drug. His current assertions regarding the reentry of the drug into the market appear to be well thought out and mature, focusing on the future benefit of patients rather than on his own need for revenge.

From the point-of-view of the companies, the drug is developed to help those suffering from…… [Read More]

Drug Courts on Drug Abuse

The later stages focuses on dealing with the problems related to the drug use withdrawal like the withdrawal syndromes, the tendency to relapse. The later stages also focus on restoring the self dignity and also impacting the participant with the prerequisites to self-manage the drug abuse issue once the probation and treatment duration ends (Tara, 2007).

The drug courts are also said to be significant to the economy of the U.S. The drug courts save the taxpayer money for each participant in the treatment as compared to the same individual or one with a similar problem but going through the criminal court system. This is realized by the reduced recidivism cases among the graduates from the treatment facilities recommended by the drug court systems (Daniel, 2003).

In general, the drug use is very addictive and a problem that dealing with it in the U.S. society is very difficult. This is…… [Read More]

Legal Response to Drugs

Drugs

Decriminalization of drugs is an ineffective legal policy that has harmed millions of Americans. Since Nixon's declaration of "war" on drugs, American policy towards mind-altering substances has been as violent and futile as the term "war on drugs" would suggest. Drug use is not qualitatively different from alcohol use. The prohibition of alcohol failed miserably in the early 20th century, leading also to a proliferation in profitable black market businesses that fueled organized crime. The same pattern has been occurring with mind-altering substances of all types. Drug cartels have blossomed throughout the Americas, and the global black marketplace is teeming with criminal behaviors that are linked to protecting the lucrative but illegal drug trade. If trading in drugs were akin to trading in alcohol, then drug cartels would no longer need the massive stashes of weapons used to protect their property. The war on drugs has ruined far more…… [Read More]

Different types of'studies relating to drugs

drugs of varying sorts, whether legal or illegal. The studies in question are either quantitative, qualitative, or a mixture of both. Of course, quantitative refers to the use of numbers and statistics to draw conclusions. Qualitative studies make use of feelings, thoughts and summaries. Indeed, this is less academic and objective in nature but it can explain the "why" of things rather than just the "what." Of course, many other studies are a mixture of the two. This annotated bibliography has two of each of the different types listed above and these were chosen to show that the types of studies relating to drugs come in all three of the major forms.

Chandler, R. K., Finger, M. S., Farabee, D., Schwartz, R. P., Condon, T., Dunlap, L. J. & Lee, J.

(2016). The SOMATICS collaborative: Introduction to a National Institute on Drug

Abuse cooperative study of pharmacotherapy for opioid treatment…… [Read More]

Michael Lauren Who Is Struggling With Drug

Michael Lauren who is struggling with drug problem. Michele Lauren is twenty-one-year-old girl, single and a resident of New York City. Michele lives with her parents and is addicted to marijuana. She was arrested on various circumstances, each time for the violation of Health & Safety Code 11357 (Samaha, 2007) that is the possession of large quantity of drugs and was locked up behind the bars on trials during the years 2002 to 2008.

Lately, she had been arrested three times in a month for the violation of such law. Michele had also encountered the problem of alcohol along with her problem of smoking pot and marijuana, but she has not been arrested for excess drinking and violation of Health and Safety laws related to alcohol. She had not been arrested for any other related crimes, as she normally filched her mother's purse for money whenever needed.

a) Casual drinks…… [Read More]

Juvenile Drug Abusers

e. school, religious activities, sports, family involvement)." ("Juvenile detention," 2005, p. 11-12). These negative affects of increased usage not only directly affect juvenile drug abusers with increased occurrence of detention, but also make less effective rehabilitation programs needed for these young offenders.

Prevention Programs:

Over the last two decades, there have been a plethora of clinical trial research that have identified effective adolescent substance use prevention programs.

Sadly, funding for drug use prevention services has decreased over recent years, partly due to the increased need for drug user treatment for young people. As an example, in 2002, Congress reduced funding for community drug prevention studies at the U.S. Center for Substance Abuse Prevention (CSAP), by $50 million, in order to increase drug user treatment studies at the Center for Substance Abuse Treatment. With reduced funding, it is of even greater importance that prevention programs are as effective as possible. Kumpfer,…… [Read More]

Psychological Element in Drug Use and Dependence

Psychological Element in Drug Use and Dependence

Placebo, the Latin term for "I will please," refers to the psychological positive response that a patient exhibits to a non-specific treatment. It is a purely psychological element, which arises out of the patient's trust in the physician, or the belief in the positive medicinal effects of the drug. Researcher Henry eecher's famous study in 1955 showed that more than 30% of patients respond positively to a placebo. Since then, numerous studies that were focused on the effects of placebo have reported mixed results. The brain imaging study conducted by Leuchter, in 2002, revealed distinct patterns of cerebral blood flow as a response to placebo among depressed subjects. Similarly Evans (2004) reported that placebo effect was quite marked in medical conditions that involved acute phase response. (inflammtion, acute sensitivity, etc.). [Wikipedia] Since placebo trials report significant positive response (at least in one third…… [Read More]

Are Psychotherapeutic Drugs Overprescribed for Treating Mental Illness

psychotherapeutic drugs overprescribed for treating mental illness?

Pros

With the development of SSIs such as Prozac, some psychotherapists proclaimed the end of depression and there were even concerns that such drugs would change the human character by making treatment of the illness too easy. Now, after many years after the birth of Prozac, it is clear that no antidepressant is a silver bullet when it comes to eliminating a particular mental health problem. In fact, the concerns are that SSIs and other drugs commonly used to treat depression are substantially less effective than their manufacturers claim. "An analysis of all FDA clinical trials for four SSI antidepressants found that the drugs didn't perform significantly better than placebos in treating mild or moderate depression, and the benefits of the drugs were "relatively small even for severely depressed patients" (PLoS Medicine, 2008, cited by Smith 2012:36). Even studies which indicate a more…… [Read More]

New Respiratory Drugs

new respiratory drugs that have been approved for medical use over the past decade. The paper will highlight the diagnoses of the drugs i.e. when and why it is prescribed, how it is meant to be used and how often, its side effects, the impact for a missed dose or an overdose along with any other relevant information that will add depth to it appropriate use.

The main purpose for the respiratory drugs is to help cure the ailments directly or indirectly related to the functioning of lungs or general breathing of an individual. There are numerous sectors where studies on new respiratory drugs can be carried out and some of the most recent studies to include this particular aspect include allergies, asthma attacks, Acute espiratory Distress Syndrome (ADS), pneumonia and sinus infections.

In this paper we will focus on the following new respiratory drugs: Arcapta, Daliresp, Dulera, Tyvaso, Alvesco,…… [Read More]

Developing New Drugs for Cancer Patients

Cancer Drugs

For the past several decades, the news about cancer in the United States has been increasingly positive and that trend has continued unabated over the past decade. According to the National Cancer Institute at the National Institutes of Health, the overall incidence rate for men has declined by an average of 0.6% every year between 2004 and 2008, while for women, the incidence rate has dropped 0.5% per year from 1998 through 2006 and leveling off from 2006 to 2008 (National Cancer Institute). Just as importantly death rates from cancer have declined since 1975 and have sharply decreased between 19944 and 2008 for both men and women as shown in the graph below from the National Cancer Institute (National Cancer Institute).

There are myriad reasons for this decline in cancer deaths, including better education regarding healthy living, improved diets, and better treatment. Among the treatment options are improved…… [Read More]

Competency to Stand Trial

Competency to Stand Trial

DRAWING THE LINE

At any point in criminal proceedings that a defendant shows signs of mental illness, his competence to proceed to stand trial may be questioned (Winick, 2002). The issue may be brought up when he pleads guilty, waives certain constitutional rights, at sentencing hearing or when administering punishment, including capital punishment. Either the defense or prosecution or the court itself may raise the issue, even if the defendant himself objects to it. ut mental illness alone, even schizophrenia, does not automatically produce a finding of incompetence. Rather, it is based on the degree of functional damage produced by the illness. Two conditions must be satisfied in order to be adjudged incompetent to stand trial. It focuses on the defendant's mental state during trial. It is differentiated from the legal insanity defense, which is based on the defendant's mental state at the time of the…… [Read More]

Federal Mandatory Minimum Drug Sentences and Their

Federal Mandatory Minimum Drug Sentences and Their Impact on Recidivism

There is much controversy regarding mandatory sentencing and its impact on the American society throughout recent times. In many ways, prisons are used as a means to control crime, to protect society from it, with criminals being deterred from continuing to commit illegalities as a direct result of the time they spend behind bars. Mandatory minimums were generally introduced with the purpose of preventing future recidivism. The authorities considered that the uncomfortable nature of prison life and the social status associated with being in prison were enough to persuade criminals to refrain from ever expressing interest in illegalities once they were set free. Other schools of thought appear to think just the opposite as some believe that prison time actually has a negative impact on convicts, while others believe that criminals experience little to no change consequent to staying in…… [Read More]

Anti-Drug Marketing Campaign What Do

That is evidenced by the fact that prevention messages produced affirmative responses to questions about curtailment and curtailment messages produced affirmative responses to questions about prevention.

(4) Perception of realism is likely a critical element of any anti-drug messaging campaign expected to appeal to a teenage audience.

Exactly what do you recommend for the de-marketing communications campaign?

There would seem to be little basis to presume that either a prevention strategy or a curtailment strategy would be more effective than the other. It is most likely that both approaches would be advisable because teenagers who already use drugs are much less likely to respond as hoped to the curtailment messages whereas teenagers who do not already use drugs would be more likely to respond as hoped to the prevention messages. More specifically, teenagers who already use drugs are beyond the point where a prevention messaging strategy would be productive.

On…… [Read More]

United Drug Is a Dublin-Based Firm That

United Drug is a Dublin-based firm that describes itself as "a provider of outsourced commercialisation solutions to healthcare companies operating across three divisions." The three divisions are Healthcare Supply Chain; Sales, Marketing and Medical; and Packaging and Specialty. Supply Chain involves wholesaling, sales and distribution and sometimes manufacturing. The Sales, Marketing and Medical division includes as functions contrast sales outsourcing, sales force consulting, and healthcare communications. The Packaging and Specialty division focuses on a number of packaging functions, Cold Chain delivery, nursing services to the home and vaccines. According to the 2011 Annual Report, the company's vision is "to be a true innovator in the provision of value enhancing and integrated product/service solutions in key international healthcare markets, enabling better market outcomes for producers, providers, payers and patients."

The company's mission is "to be a leader in all key international markets in the provision of exceptional integrated and market specific…… [Read More]

Effects of the Experimental Anti-Cancer Drug Anaerobin on the Body

Anti-Cancer Drug Anaerobin

a) EFFECTS ON KIDNEYS, HEART AND BRAIN

Cytotoxic metabolites are created when bio-reductive drugs go through a metabolic process because they contribute to curing cancer by lowering oxygen to areas where the cancer affects the body. The local auto regulation process of the body provides the oxygen to all parts of the body where it is needed. The arterioles supplying that tissue for oxygen dilate to supply more oxygen than usual. This happens also in the case of the tumor when it demands more oxygen; it is supplied by the body and anaerobin affects the auto regulation process in all areas as it reduces the blood flow to all organs, except the lungs. It can reduce the oxygen and supply of nutrients to the tumor by up to 99%. Therefore this bio-reductive drug can help in treatment of cancer in modern therapy.

Anti-cancer drugs reduce the cell…… [Read More]

Understanding Drugs

FDA Drug Approval Process

In order for a pharmaceutical company to obtain FDA approval for a new drug, a long sequence of detailed testing and clinical trials must be administered. The approximate cost of putting a new drug through the approval is $500 million, and it takes an average of fifteen years for a drug to make it from initial testing to being available for patients. Furthermore, of every 5000 compounds that go through pre-clinical testing, only five advance to the human testing phase, and only one of these compounds will actually be approved. There are six key phases of testing that potential drugs go through on the path to FDA approval. These phases are early research / pre-clinical testing, clinical trials (phase I, phase II and phase III), FDA approval, and post-marketing testing.

The first phase of the drug approval process is pre-clinical testing. This consists of laboratory and…… [Read More]

Patient Access to Experimental Drugs Experimental Drugs

Patient Access to Experimental Drugs

Experimental drugs are being used in treating cancer and other life-threatening diseases in the hopes that effective cures and treatments can be identified. There are however, ethical questions relating to the use of experimental drugs and this work seeks to answer the question that asks whether patients should have access to experimental drugs and to answer why or why they should not have this access.

Experimental Drugs

Experimental drugs have carved inroads to treating cancer patients and most recently; this has been reported in the form of a drug that serves to "neutralize two mechanisms cancers need to survive." (Coghlan, 2012) The new drug is Cabozantinib. This drug is reported by one individual interviewed in this study to have been used by a family member who died while taking the drug for non-small cell carcinoma in the form of lung cancer. When asked the question…… [Read More]

Genome Project on Drug Design

IV. TESTING ON HUMANS

The only thing that is lacking at this point according to all reports is for testing on humans to be completed. The Time Asia articles states: "The last step for the ace-2 inhibitor, as for any drug, is human clinical trials. ecause the U.S. Food and Drug Administration requires such rigorous testing, this is by far the most expensive part of drug development. So for human trials in some cases, Millennium has formed partnerships with large pharmaceutical companies that have the necessary resources and will share in any eventual profits." (2001)

SUMMARY & CONCLUSION

According to the work entitled: "rave New Pharmacy" published in Time Asia (2001) "When the human genome was sequenced...scientists finally gained access to the full text of God's reference manual; the 3 billion biochemical 'letters' that spell out our tens of thousands of genes. These genes, strung out along the 46 chromosomes…… [Read More]

Criminal process from arraignment to pre trial

Criminal Process; Arraignment to Pre-Trial

The purpose of criminal law is to promote respect for the law by people and ensure a just, safe, and peaceful society. The American justice system has many commendable elements that are aligned to the objectives of a justice system. The trial system significantly addresses many point of subtlety and does a great job in its effort to uphold the rule of law. In the effort to deliver justice, it is important that the rights of the defendant be uphold. This paper seeks to shed light on three stages before the process of criminal trial, and how the rights of the defendant are catered for in each of the stages before trial commences. These stages include the information, arraignment and the subsequent hearings at pretrial.

Arraignment

The stage that precedes and leads to trial in a criminal case is called arraignment. Arraignment must be done…… [Read More]

Generic vs Name Brand Drugs

309).

The abbreviated approval process authorized by Hatch-Waxman lets generic drug manufacturers use the same clinical data that the original manufacturer used to obtain FDA approval, thereby avoiding these expenses. In this regard, Greene emphasizes that, "Whereas the pioneer drug manufacturer must incur great expense and undergo rigorous scrutiny when it files an new drug application (NDA) to secure FDA approval, a generic manufacturer may file an Abbreviated New Drug Application (ANDA) in which it may take advantage of the NDA holder's time and expense" (2005, p. 310).

The impact of the Hatch-Waxman Act on generic drug availability has been enormous. For instance, in 1984, generic drug prescriptions represented less than 20% of all prescription drugs marketed in the United States; however, due in large part to the Hatch-Waxman Act, by 1996, the market share for generic drugs had increased to 43% and by 2006, as many as 63% of…… [Read More]

Food and Drug Law in

S. Food and Drug Administration, because they were in wide use before the 1938 Act (grandfathered in, as it were). (Dunn 1938)

The problem was that Act contained a definition for a "new drug" (one in need of prior approval to market), as any drug "the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling." FDCA § 201(p) (1). The manufacturers set out to establish then, that anything GRAS/GRAE therefore was not a new drug, and needed no FDA blessing.

Many medicines are ancient, and the active ingredients of many drugs on were first introduced before 1938. To make matters worse, between 1938 and 1962, the FDA considered drugs that were identical, related, or similar…… [Read More]

Label Drug Use Useless Costly

The structure of yetta is similar to that of GLP-1 and performs the same functions. oth promote decreased appetite (Wilson).

Dr. Wysham was an observer at a study conducted on 20 Rockwood diabetic patients who were taking conventional diabetic medication for their uncontrolled blood sugar (Wilson 2005). She was not informed about their glucose levels for several months after the tests began. About two-thirds of the respondents were given different injectible doses of yetta to incorporate into their medication plan, while the rest were given placebos. All of them were instructed and trained to do the injections at certain times twice daily for a month. Then they were subjected to a physical exam. Dr. Wysham closely monitored their liver, kidney, blood counts, and other functions. She observed that the patients consistently lose weight while taking yetta. The average respondent-patient lost 15 pounds in the duration of the study, 5 lost…… [Read More]

Prescription Drugs and the Health

The FDA also, amongst others, has recommended that clinical trials used to support advertising claims be approved by the FDA and to institute stiff fines against those found gaily of deceptive tactics. (Turning Medicine Into Snake Oil...) There is little doubt from the research that pharmaceutical companies have to be made more accountable for their products and advertising promises.

eferences

Borden Anne. Vioxx Stroke isk could last for Years. 2007. etrieved June 1, 2007 at http://www.lawyersandsettlements.com/articles/00888/vioxx-stroke-risk.html

Deceptive Prescription Drug Marketing Tactics 'Common and Dangerous'. 2006.

etrieved June 1,2007, at http://www.uspirg.org/newsroom/health-care/health-care-news/deceptive-prescription-drug-marketing-tactics-common-and-dangerous

Introduction to the Health Care Industry: Health Expenditures and Services in the U.S. etrieved June 1, 2007, at http://www.plunkettresearch.com/HealthCare/HealthCareTrends/tabid/294/Default.aspx

O'Connor K. x for prescription drugs. etrieved June 1, 2007, at http://www.oconnorhealthanalyst.com/pgs/rx.html

Oxycontin Manufacturer Agrees to Plead Guilty and Pay Fine of $600,000,000.

etrieved June 1, 2007, at http://tyler.injuryboard.com/defective-products/oxycontin-manufacturer-agrees-to-plead-guilty-and-pay-fine-of-600000000.php?googleid=8636

Prescription Meds Changing Health Care. etrieved June 1, 2007, from Spending http://www.medicalnewstoday.com/medicalnews.php?newsid=60788…… [Read More]

Prozac Non-Drug or Supplement Treatments

Relevant Chapters

Textbook chapters most relevant to this particular component on the relevancy of cost utility and cost effectiveness as it relates to non-pharmacological or supplement treatment effectiveness in comparison to Prozac, will highlight in a balanced manner, the cost benefit of both interventions as evidenced by empirical study. Moreover, the side effects of flouxetine such as nausea, anxiety, insomnia, drowsiness, headaches, and loss of appetite should be taken into consideration when discussing the cost benefit to the client. In addition, any balanced discussion on the subject should include discourse with regard to the propensity for antidepressants to cause increased risk of suicidal ideations as compared to intervention via therapy such as rational emotive or cognitive behavioral therapy (Prigatano & Plinskin, 2003).

Summary

Flouxetine, or Prozac continues to be one of the most prescribed antidepressants for those clinically diagnosed with depression. Since its introduction some 20 years ago, Prozac has…… [Read More]

Kung San Trial Marriages and U S Divorce

Kung San Trial Marriages and U.S. Divorce Rates.

The!Kung San are a hunter-gatherer people that inhabit the Kalahari desert in Africa. They are the ushmen who have managed to live a contented, self-governed life while the rest of the world has sprung up around them in a mass of technology and dysfunction. They live a community life where the economy is based on sharing and "among the first words a child learns are na ("give it to me") and ihn ("take this")" (Shostak 2000:44) giving outsiders the impression of a quaint carefree nomadic life.

Nevertheless there are many similarities shared between Americans and the!Kung San, some of which are as simple as equal love for their children, to the interesting arrangements of a 'trial marriage'. A!Kung trial marriage could be acquainted with people living together before getting married, or cohabiting as part of a condition before marriage, depending on religious…… [Read More]

Mock Trial Opening Statement Your

I want you to put yourself in their shoes and then tell me how you would feel if someone--anyone -- got a hold of your personal information, your private information, your identity, and used that information to buy stuff online. To commit Grand Theft.

Now, the defense is going to try to steer your minds away from the crime that was committed and will tell you that the police were not entitled to use canines in their search for drugs at - school. Of course, we as the state believe 100% in the protection of your rights and freedoms as Americans. We hold strong to the 4th Amendment of the constitution.

But in this case, these children were attending school. A key phrase in this trial is the "reasonable expectation of privacy." You and I have a reasonable expectation of privacy when we are in our own homes, don't we?…… [Read More]

Role of the FDA with prescription drugs

Pharmacy Ethics

The author of this report has been asked to review the legal and ethical considerations in play given the test case scenario surrounding Pharmacare and Compcare. As is quickly apparent while reading the case study, the company engaged in a long and extensive list of ethical and/or legal violations as a means to maximize profit and minimize the legal and other red tape that seems to bother them even though it is there for a very good reason. The ethical issues involved will be touched upon and analyzed. There will also be an exploration and analysis of direct-to-consumer marketing of drugs, whether John is the "investor" of AD23, the arguments about John being a whistleblower and the associated protections he would have if he is and examples of intellectual property theft that have occurred in the last two years or so. While bad things do incidentally happen and…… [Read More]

U S Soldiers and Drug Abuse

One of the most frequent injuries is represented by the traumatic brain ones.. amongst other symptoms, one can mention anxiety, severe depression. Headaches and the difficulty to reason clearly. PTSD, post traumatic stress disorder is also manifested through depression, insomnia, flashback.

It is important to underline that these psychological disorders are usually associated with drug abuse. Taking this into consideration, it can be underlined that we are dealing with a social phenomenon. Most soldiers do not have the psychological training needed in order to do what they need to do once in combat. War has never been and could never be a pretty things, so the atrocities that these young men witness or are forced to do, shake them up psychologically. The use of drugs is to be understood in close connection to this factor.

Depression is not a factor that can be ignored. And there is no time for…… [Read More]

Short Answer Questions on Drugs

economic impact of drug use in the United States might initially seem easy to measure. A legal trial is an expensive proceeding: police officers, prosecutors or public defenders, judges, stenographers, and bailiffs are employees of the state, and even if jurors are barely remunerated, defense attorneys are lavishly remunerated. To prosecute someone for dealing marijuana is an expensive undertaking, and to do so under a "three strikes" law, where the crime is suddenly elevated to a horrific felony with extreme penalties, is even more expensive. The greater expense comes with convictions: America has the largest imprisoned population in the world, with more people behind bars in this country than comprise the entire populations of other sovereign nations. Imprisonment is not a cheap proposition. We can then consider the further economic impact, legally and morally speaking, of drug use in the current extensive misuse of civil forfeiture laws. Ostensibly designed to…… [Read More]

The Process of Development and Testing for Drug Manufacturers

Drug Development (From Nature to the Market)

The process of drug development is a complex one. The pharmaceutical industry is required to adhere to strict governmental regulations, set out by the Food and Drug Administration (FDA), which involve numerous phases of testing and clinical trials, close monitoring of the drug's effects on users, its stability, dosage forms (the preparation), and so on. This paper will describe the drug development process, as it proceeds from nature to the market.

Drugs that eventually make it to the marketplace can come from a variety of sources -- plants, animals, microbes, synthetic chemistry, biotechnology, and even modified molecules. Years of research and billions of dollars are invested by pharmaceutical companies as they seek out new, potential drugs for the market. All of this effort has resulted in the FDA's approval of 1,200 drugs for the marketplace since 1950 (Munos 960). The "recipes" that have…… [Read More]

Confidentiality Breaches & Informed Consent when Testing New Drugs

Confidentiality Breaches in Clinical Practice

The confidentiality and privacy of patients are considered as one of the fundamental freedoms that they should enjoy and are safeguarded under Health Insurance Portability and Accountability Act of 1996 (HIPPA). It is also a precept of the American Medical Association’s Code of Ethics and the Hippocratic Oath. The breach of confidentiality is unethical and illegal.
Medical professionals are under the obligation of protecting the patient’s confidentiality. Confidentiality and privacy prohibit medical providers from unlawful disclosure of the patient’s information. Some of the inappropriate disclosures include discussing a patient’s case in the elevators or corridors, giving out extra copies of handouts from conferences while they contain identifiable patients’ details and any other possible leakage of information to unauthorized individuals (Beltran-Aroca et al. 52). In clinical practice, the patients’ confidentiality can be breached due to indiscretion, carelessness, and sometimes malice. Medical practitioners are obligated legally and…… [Read More]

Design a Trail for New Drug

dosage levels of Cholestease on Serum Cholesterol levels and the side effects associated with them in human beings.

Cholesterol has been a major media issue in recent years, especially the negative effects on the heart and its role in the development of heart disease. There have been many studies that indicate a connection between serum cholesterol heart disease and depression (1-3). Developing new methods to lower serum cholesterol has become a major industry in recent years. Currently the leaders in the industry are American Pharmaceutical giants, Pfizer, Merck, and Warner-Lambert (1), who have developed medications that lower cholesterol.

The Endicon corporation recognizes the potential market in developing a drug that will significantly lower serum cholesterol without the side effects associated with long-term use of the drugs currently on the market. In addition, we recognize the potential of developing a ritish Product, primarily marketed in Great ritain. Endicon has been conducting…… [Read More]

New Drug Development and Approval

Initial product formulation utilizes knowledge acquired from pre-formulation outcomes to derive proper dose, dosage form, and type of administration for the proposed marketed use. A pilot batch of Clinical Trial Materials (CTM) may be produced after the new drug has completed these initial tests.

Upon completion of preclinical testing, the drug sponsor files an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA), after they have obtained prerequisite approval from the Institutional eview Board (IB). The purpose of the investigation is to assure that the new drug is safe and meets stated objectives for human consumption. Among other things, all formulations must meet FDA Current Good Manufacturing Practice guidelines before human testing can begin. Ordinarily, the FDA has 30 days to respond to the application. After the drug receives this initial approval clinical trials may begin within 30 days.

Clinical trials proceed in four phases, with…… [Read More]

Proper Documentation for Clinical Trials

regulatory requirements involved will be covered. The report will also include an answer to the question of what three of the file documentation requirements are before a study can be begin at a given site. While the rules and regulations regarding clinical trials may seem arduous and aggravating, they exist for a very good reason.

As explained by the class PowerPoint, the role of the Investigator's Brochure is to offer a compilation of all clinical and non-clinical information that is relevant to a study. It also serves as a reminder and review of the protocol that must be followed. That protocol includes the rationale for the study as well as the compliance that must be part of the study. For the sponsor in particular, the Investigator's Brochure serves several specific needs. These needs include all information known an investigational drug, whether serious or adverse events are "expected" or "unexpected" during…… [Read More]

Ethical Case Study Regarding Randomised Medical Trials in a Developing Country

Global Healthcare Ethics and the andomised HIV Trial

Healthcare professional face a range of ethical issues in the pursuance of their vocation. In the context of HIV research and the conducting of research among vulnerable population, such as poor expectant mothers in developing countries, the compete of global health ethics should provide a foundation for the assessment of ethical practices, both in planning, undertaking, and reviewing the work (WHO, 2014; Stapleton et al., 2013). Global health ethics is an interdisciplinary field, which covers not only health research, but also issues such as the provision of healthcare, and development of health policy, with the aim of understanding the moral values which should be implemented at a global level, undertaken utilising a predominantly geographic approach to macro level health issues (Stapleton et al., 2013). In this context, global health ethics is primarily concerned with issues such as pandemics, the effects of natural…… [Read More]

Ritalin The Case History of a Drug

Ritalin: The Case History of a Drug

One of the most noticeable and prevalent disorders occurring in children is attention deficit hyperactivity disorder (ADHD). It is commonly diagnosed when the child begins to attend school or kindergarten, and occurs in 3 to 5% of the population. A chronic condition, it normally carries over into adolescence and perhaps into maturity as well. ADHD children can be hyperactive, inattentive, distractible, aggressive and impulsive, and as a result tend to do poorly in school and present behavioral problems both in academic, social and familial settings. ADHD adolescents, in addition to the above-mentioned difficulties, may be disposed toward delinquency and involvement in car accidents and substance abuse. Co-occurring disorders such as conduct disorder, anxiety and depression tend to exacerbate both the symptoms and the difficulty of treating ADHD. (Hyman, 2000)

Unfortunately there is no single diagnostic test to establish ADHD, and the etiology of…… [Read More]

Testing of New Drugs

Flow Diagram

The author of this report has been to assess a data flow diagram that makes reference to clinical trials. For each step in the clinical trial, the author of this response will speak to what personnel would be involved with that step of the process. Indeed, the data flow diagram in question is seventeen steps long and the litany of personnel involved with each step can be moderate to extensive. While some may think that clinical trials are fairly mundane and easy to pull off, that is simply not the case and the process is indeed extensive and potentially circuitous depending on how things go (FDA, 2016).

Questions Answered

Step one of the diagram involves protocol development. The personnel involved would include medical writers, physicians, medical experts, project managers, biostatisticians and data managers. The protocols and rules of the study are important and must be defined. Step two…… [Read More]

Looking Into Using Technology in Managing Data in Clinical Trials

Technology in Managing Data in Clinical Trials

Even a casual observer will undoubtedly make note of the range of high-tech solutions that are causing disruptive change in the process of clinical trials. From webinars and multi-day meetings to an expanding pool of literature, technology has been establishing itself as the key to an era fixated on measurable improvements like accelerating the research start-up phase, restructuring clinical trial information transmission, and overhauling research monitoring. And the issue is no longer a distinct solution to apparently intractable glitches; instead, it revolves around sharing real-time information captured by these solutions for facilitating strategic decision-making by collaborators, with regard to a research's status as it is actually progressing. This constitutes a drastic change from the conventional paper-based techniques that underlie the industry's costly and time-consuming methods of carrying out international clinical research, in which data quality assessment depended on near-database locking or onsite monitoring,…… [Read More]

Direct to Consumer Advertising History of Drug

Direct to Consumer Advertising

HISTRY F DRUG ADVERTISING

THE DTC ADVERTISING PHENMENN

CREATING DEMAND

DECEPTIVE ADVERTISING - A WLF IN SHEEP'S CLTHING

CAUSE F DEATH

PRFIT

UTILIZATIN, PRICING, AND DEMGRAPHICS

LEGISLATIN, PLITICS AND PATENTS

LEGISLATIVE INITIATIVES REGARDING DTC

RECALLED and/or DEADLY DRUGS

In order to provide the most efficient method of evaluation, the study will utilize existing stores of qualitative and quantitative data from reliable sources, such as U.S. Government statistical references, University studies, and the studies and publications of non-profit and consumer oriented organizations. Every attempt will be made to avoid sources of information sponsored by or directly influenced by the pharmaceutical industry.

Existing data regarding the history, levels, content and growth of direct-to-consumer advertising will be examined. In addition, the industry's composition prior to and after the proliferation of direct-to-consumer advertising will be examined, with regard to market share, type of substances sold, benefits of substances sold, and…… [Read More]

Ethics of the Abortion Drug Ru-486

Abortion: Ethical and Political Issues of RU 486

Abortion is a totally unacceptable, cruel and unethical practice and should be considered illegal except under some special cases and medical circumstances that indicate a danger to the mother. Our judicial system must consider the ethical and moral aspects of abortion as an intrinsic part of the problem when approaching this social issue. Even from the practical prospective the abortion pill RU486 has not been a breakthrough and instead of making abortion a private and safe method it has only increased the physical discomfort and the psychological ordeal for the woman.

Abortion is the one of the most debated social issues of this century. The controversy as to the right that man has over the life of a baby in the fetus and in controlling its entry into the world is a much-debated topic. Abortion is nothing but putting an end to…… [Read More]

Inclined to Believe That Drug Discoveries Are

inclined to believe that drug discoveries are often the result of a fortunate set of events making it possible for a person to come across a combination of substances that have the exact effect the respective person considers when starting the discovery process. hile this was the case a few hundreds of years ago, things changed in recent decades, as society got actively involved in promoting drugs and in supporting individuals involved in creating them. One of the best example regarding drug discovery and widespread support from the public is the 1950s with psychotropic drug discoveries. A great deal of drugs from the period came to play an important role in society, considering the fact that they have been widely used during recent decades.

A series of drugs were discovered as a result of individuals using natural products with the purpose of exploiting some of the substances they contained. Fungal…… [Read More]

Pharmaceutical Drugs Have Become the

Michelson explains that buspirone could manipulate certain serotonin receptors in an attempt to ameliorate the overload of serotonin, and that amantadine was thought to increase dopamine activity. As such, either might theoretically help with SSRI-related sexual dysfunction. However, when the double-blind test was performed, it found that the success of treatment was roughly the same regardless of whether these pills were taken or a placebo was used. One significant difference was that those on admantadine had greater energy levels than they study-mates, which did not seem to directly affect sexual functioning. Michelson and his colleagues speculated that the reason for such marked improvement in all categories was the extensive journaling and attention paid to the sexual activity.

Ashton and Rosen report on "Bupropion as an antidote for serotonin reuptake inhibitor-induced sexual dysfunction"

Unlike the Michelson study, Ashton and Rosen's work on using bupropion to ameliorate the sexual dysfunctions associated with…… [Read More]

antipsychotic drugs weight gain and'schizophrenia

Particularly after her PANSS test results, the client in this case has been diagnosed with schizophrenia, paranoid type, in which positive symptoms like delusions are prevalent. The purpose of this paper is to clarify three key psychopharmacological treatment decisions made on behalf of the client. Goals of all three decisions are symptom reduction and the promotion of the client's mental health and psychosocial functioning.

Decision

The decision was to give the patient Invega Sustenna (paliperidone palmitate) 234 mg intramuscular X1 followed by 156 mg intramuscular on day 4 and monthly thereafter, instead of either Zyprexa (olanzapine) or Abilify. The reasoning is based primarily on the fact that Invega Sustenna is a long-acting injectable with fewer compliance complications than orally administered drugs. Although Abilify has been available as a long-acting injectable, Invega Sustenna is recommended in this case because it presents fewer side effects than either Zyprexa or Abilify, particularly those…… [Read More]

Bio-Statistics Research Activities Whether Clinical Trial Based

Bio-Statistics

esearch activities, whether clinical trial based, experimentally designed, or product oriented, must exhibit and command interest, enthusiasm, and passionate commitment. To this end the researcher must catch the essential quality of the excitement of discovery that comes from research well done. The first step in the attainment of the desired research goal is to develop a scientific approach toward that which is being investigated. A requirement within the scientific approach best-fit format that is oftentimes misunderstood, and consequently wrongly applied, is that of sampling.

In a rather philosophical approach to sampling Ohlson (1998) states that sampling is " ... But part of the whole. Check to make sure I fairly represent my larger connection " (p. 27). With these words Ohlson is informing the research enthusiast that sampling alone can skew testing results, infuse uncontrollable error into statistical processes, and violate the empirical premise under which the research investigation…… [Read More]

recent evidence from randomized trials

Programs for Parents of Infants and Toddlers: ecent Evidence From andomized Trials

My initial thoughts and feelings were:

Infancy is a very important stage in children's development. It is at this stage that children are most receptive to both mental and physical change and they are at greater risk of potentially harmful influences than their older counterparts. Infants also get affected much more by parental disruptions than older kids. It has been shown that parent-child interactions during the early stages are great predictors of several late and early developmental outcomes. Lending parents support in coming up and implementing good parenting skills can lead to great child development (Pontoppidan, Klest & Sandov, 2016). Since the child is most malleable during infancy, experiences at this stage shape the child's behavior, wellbeing and brain development and so the effects can last for the entire life of the infant. Parenting interventions given to newborn…… [Read More]

Best Practices for Handling Investigational Drugs

Product Accountability

This failure in drug accountability is an issue. One of the purposes of a closeout visit is to determine that all of the investigational product is accounted for, so when ten pills are missing, that means that not all of the product is accounted for. Unused supplies need to be destroyed or returned, and in either case there should be an accounting for that. Whatever happened to these ten pills should have been recorded, and apparently this is not the case, so nobody knows what happened to the pills.

This is as pertains to 21 CFR 312.57, which states that "a sponsor shall maintain adequate records showing the receipt, shipment or other disposition of the investigational drug." Furthermore, 21 CFR 312.59 states that "the sponsor shall assure the return of all unused supplies of the investigational drug from each individual investigator whose participation in the investigation is discontinued…… [Read More]

how to'store prescription drugs'safety

Article 1: McCauley, J.L., Back, S.E. & Brady, K.T. (2013). Pilot of a brief, web-based educational intervention targeting safe storage and disposal of prescription opioids. Addictive Behaviors 38(2013): 2230-2235.
In this article, McCauley, Back & Brady (2013) report on the results of an open pilot trial focusing on increasing patient knowledge of safe use of prescription opioids. Participants were 62 outpatients at a chronic pain management clinic or dental clinic who were prescribed opioids. All participants received informed consent and then completed the Script Safety intervention, which is an online information service containing information specific to the medication each participant was taking. Telephone interviews were conducted one week and one month following the intervention to assess knowledge retention and comprehension, misuse behaviors, and overall satisfaction. Results showed that satisfaction rates were high, knowledge comprehension and retention rates were also high, and that some self-reported misuse behaviors had decreased at the…… [Read More]

Role That Bail Is Playing in the

role that bail is playing in the criminal justice system and how these amounts are determined. This is accomplished by looking at the Robert lake murder trial, the Roman Polanski rape case and the Carlos Lehder drug trial. Once this occurs, is when we can understand how and why this applied differently in a host of court cases.

One of the core elements of the criminal justice system is bail. This is when someone who stands accused of a crime can be released from police custody, under the promise that they will return to court on the specified date of their trial. In all cases, this involves the person providing some kind of monetary or physical assets in exchange for being released from jail. The basic idea behind granting bail is three fold to include:

It assures that the accused will make their court date.

It maintains the presumption of…… [Read More]