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FDA: Center for Drug Evaluation and esearch (CDE)
And Over-the-counter Weight Loss Medications
Obesity is one of the most serious epidemics facing the American public. "Over two-thirds of adults in the United States are overweight or obese, and over one-third are obese" (Overweight and obesity statistics, 2012, WIN). To address concerns about obesity, many adults turn to over-the-counter medications like dietary supplements that promise the user easy weight loss. The medications usually claim to increase metabolism and suppress appetite, while some also claim to inhibit the absorption of carbohydrates and calories. According to a recent study: "an estimated 15.2% of adults (women 20.6%, men 9.7%) had ever used a weight-loss supplement and 8.7% had past year use (women 11.3%, men 6.0%); highest use was among women aged 18 to 34 years (16.7%)" (Blanck et al. 2007). The FDA has tried to prevent the use of weight loss supplements with tainted…… [Read More]
Given that there is no expectation of substantial equivalence, the following process will need to be undertaken.
The 510(K) that needs to be submitted is the Traditional. A Special is for modifications to products that already have 510(k) approval, so that does not apply in this case. An Abbreviated 510(K) applies when a product is approved for this process by the FDA. There is little explanation on the FDA website of what that means, or what the definitions of the terms it uses are. But with a device that does not have equivalence, there is little likelihood that with new technology this product would be eligible for the abbreviated FDA process.
The different types of documentation that need to be submitted along with the Traditional 510(K) can be found here: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134572.htm
The decision letter is the final stage of the process, wherein the FDA informs the company of its decision…… [Read More]
Phase II consists of efficacy trials of the drug, which are tested on volunteers of the target population. When everything goes right, the drug manufacturer discusses the development process, continued human testing, other concerns and protocols for phase III with the FDA. Phase III is the more extensive. It is at this time that the manufacture can work for the accelerated development and review of the drug. Treatment IND and parallel tracking also occur at this stage or phase. Upon completion of phase III, the manufacturer files a New Drug Application or NDA, which is reviewed for 1-2 years. At this stage, the FDA consults advisory committees of experts for advice on safety, effectiveness and labeling. If and when approved, marketing may be done with FDA-regulated labeling. FDA also collects safety information on the drug's use and adverse effects, if any. There will be occasional requests for changes in labeling…… [Read More]
Ethics can be considered to come from personal values. From both a medical and a business perspective, ethics are the reasons that some news stories should be followed from beginning to end and all in between. "On Sunday morning, 23 February 1997, the world awoke to a technological advance that shook the foundations of biology and philosophy. On that day, we were introduced to Dolly, a 6-month-old lamb that had been cloned directly from a single cell taken from the breast tissue of an adult donor." (Brannigan 10) This report is not about cloning per se, but it is about the underlying industry for gene therapy and the Food and Drug Administration regulations as they pertain. The secondary goal is to point out who controls the legal aspects of a new drug application process. Like cloning, gene therapy is in some circles a great medical and scientific…… [Read More]
Divisions of the FDA
The FDA is in charge of the regulation of pharmaceutical drugs and medical devices, as part of its mandate to safeguard the U.S. health care system. One unit for this is the Center for Devices and adiological Health (CDH), which approves medical devices. The unit that approves drugs is the Center for Drug Evaluation and esearch (CDE). There is also the Center for Biologics Evaluation and esearch (CBE), which is responsible for the evaluation of biological products used in health care.
Each of these organizations will have a number of different products that are going through the different stages of approval. The agencies do not comment on drugs that are currently going through the approvals process, as that would be unfair to the drugs, the companies that make them, and their shareholders. The new drug approval process, however, does not end when the initial drug is…… [Read More]
REGULATING STEM CELL THERAPY
Administrative Agency: Food and Drug Administration
Article 1 Section 1 of the federal Constitution creates administrative agencies, which are law-making entities but with limited powers (USLegal, 2014). The rules and regulations created by an administrative agency are lawfully enforceable. It assists in the faster management of cases and is, therefore, a big help to U.S. courts. The administrative process is also a valuable resource for other important case. Members of an administrative agency are necessarily experts in their field (USLegal)..
One such agency is the Food and Drug Administration or FDA, which is under the U.S. Department of Health and Human Services or HHS (USgov, 2014). It is charged with the mandate to protect the health of the public by insuring the safety, efficacy and security of human veterinary drugs, biological products, medical devices, food supply for the country, cosmetics and radiation production. It…… [Read More]
This situation illustrates the difficulties in navigating an uncertain regulatory environment.
3. It is reasonable that the HO guidelines are used as the framework for U.S. policy. The U.S. system, however, is unique in certain ways. You alluded to the need to encourage innovation. The balance between innovation and cost control is different in the U.S. than in Europe, so I think that is why U.S. policy will look slightly different than European policy. It will be interesting to see how that plays out. In Europe, there has obviously not been much innovation in this field in the past few years, if new product introductions are any indicator. If the U.S. system can stimulate more innovation, that can actually be used to demonstrate the power of the American model and perhaps drive changes in Europe, rather than the other way around.
Riley, K. (2009). FDA approves first drug…… [Read More]
The philosophy behind clinical trials goes back nearly fifty years, to the Kefauver-Harris Drug Amendments. The objective of a trial is twofold -- to understand the benefits and risks of a drug. The FDA has an obligation to the public that is just as great if not greater than their obligation to the industry. They are willing to support the industry through the most important approvals processes when necessary, such as with AZT. From the researcher's point-of-view, the requirements for additional data may be a pain, but they are also a pain for the FDA as well because of the additional resources they must dedicate to analyzing that data. There are a lot of sides to this debate. From the point-of-view of the researcher or the drug company, additional trial requirements and demand for larger data sets may be onerous, but it is worth considering the issue in the context…… [Read More]
Perhaps one of the greatest ethical challenges of pharmaceutical marketing will be a result of overreach of the Justice Department with respect to its interpretation of the First Amendment. Indeed, in his dissenting opinion in Sorrell v. IMS Health, Inc., Justice Breyer argued, "If the Court means to create constitutional barriers to regulatory rules that might affect the content of a commercial message, it has embarked upon an unprecedented task -- a task that threatens significant judicial interference with widely accepted regulatory activity" (Berman, 2011, p. 36). A pharmaceutical manager would do well to observe how contemporary views about free speech and the robust influence of money -- whether legitimate or corrupt -- have on the pharmaceutical industry. The influence of the digital age on commerce and communication cannot be overstated. The strength of this influence is particularly evident in the article on off-label promotion (Berman, 2012) and…… [Read More]
Medical devices: FDA should take steps to ensure that high -Risk device types are approved through the most stringent premarket review process.
Medical Device Reporting (MDR)
Medical Device Reporting (MDR) is the name of the Act that allocates control to the Food and Drug Administration to monitor results of medical devices in order to make sure that no adverse effects results to society. The FDA receives information on this account from all manufacturers, users, and importers of medical devices who, if they experience a problem, are obligated to report this problem to the FDA so that these problems can be treated directly. User Facilities (e.g., hospitals, nursing homes), moreover, are required to report these problems to both the FDA and the manufacturer. Even if the user facility only suspects a serious result to have occurred because of the device but is not certain, nonetheless, the suspicions should still be reported…… [Read More]
Responsibility and Awareness of Regulatory Status
The responsibility or lack thereof concerning the Food and Drug Administration (FDA) to the public is cause for concern and is of personal interest. Regulations and deregulations are important as a father, husband, and member of the community for personal views that I hold. First, a loved one has a red meat allergy that has been disregarded by pharmaceutical companies and the FDA. Secondly, she is employed by the local hospital and observes a concerning number of individuals with like immunocompromising deficiencies. If the FDA standardizes and regulates suppliers instead of third-party inspection agencies, millions of others like her may conclude viable alternatives in the United States and abroad. The FDA’s inability to regulate effectively can transform personal relationships adversely.
A review of academic literature consists of detailed analysis and observations concerning regulatory schemes. In 1938 the Federal Food, Drug, and Cosmetic Act was…… [Read More]
ICH Guidelines and FDA egulations
One of the biggest challenges with drug regulations is the different standards which are utilized by numerous countries around the globe. This is problematic, as these disparities make it hard for manufacturers to follow certain protocol when researching, testing and introducing new drugs to the marketplace. As a result, ICH and FDA regulations are becoming streamlined to offer greater amounts of transparency. To fully understand the way that this is occurring requires examining ethical and regulatory requirements which must be accounted for in the design of a clinical research study. This will be accomplished by conducting a literature review of various sources. Together, these elements will illustrate how the two standards are becoming integrated to achieve these larger objectives. (Carson, 2007)
Carson, P. (2007). Good Clinical, Laboratory and Manufacturing Process. Cambridge: Cambridge University Press.
In 1996, the FDA and ICH guidelines were integrated together. The…… [Read More]
Narcotics Lollipop a. Should the FDA ban the narcotics lollipop? Go through the steps of the linear model to decide how this issue could be resolved.
The problem to be addressed is whether or not the narcotic lollipop should be barred. Answering this question requires consideration of various factors. Questions raised include:
Is the narcotic fentanyl too dangerous for children?
Is the narcotic fentanyl more dangerous than the tranquilizers used?
Is the lollipop as a means of distributing the drug also a problem?
Do doctors make up their own unregulated sedatives to calm children before surgery?
Is the lollipop preferable if the alternative is the unregulated sedatives doctors use?
Is there a problem with controlling the dosage of the drug?
Fentanyl is a drug used to treat chronic pain, pain associated with operative procedures and used to enhance general anaesthetics. It is commonly used as a…… [Read More]
Although the United States succeeded in averting the same thalidomide tragedy that occurred in Europe by refusing to approve the drug, some observers counter that the action introduced unnecessary delays in the approval of many useful drugs. Given that thalidomide is now accepted as an effective treatment for leprosy, this paper provides an evaluation concerning whether Dr. Frances Kelsey was correct in stopping the development of thalidomide in the United States in 1960, followed by a summary of the research and important findings in the conclusion.
In 1961, two doctors working independently in Australia and Germany determined that thalidomide, a sedative and n anti-nausea drug that was being prescribed for pregnant women, was responsible for a wave of birth defects (Carpenter, 2010). Based on their analysis of the available data concerning thalidomide, the two physicians, Drs. McBridge and Lenz, determined that thalidomide caused birth defects when taken during the…… [Read More]
Limiting DTC drug ads
The moratorium on direct-to-consumer (DTC) prescription drug ads protected patients because it enabled health care practitioners and other professionals to make educated, informed decisions about potentially harmful substances rather than the consumer relying on materials designed exclusively at sales, promotion, and marketing.
DTC drug ads should be again limited by the FDA because the advertisements are potentially misleading, causing consumers to request drugs that they have seen on television or in print ads. These ads can offer what are essentially "miracle" cures, while downplaying potential harmful side effects or by failing to mention other alternatives. "Most direct-to-consumer advertising does not warn patients of drug-drug interactions," ("Direct to Consumer Advertising"). Moreover, many patients might stop taking the medication they are currently on because they see an ad for something else.
The FDA should be dedicated to promoting public health and safety. If prescription drug advertisements interfere at…… [Read More]
Clinical Protocol Differences
The author of this response is asked to do a few things from a research standpoint. After which, the author shall answer a question related to the activities completed. First, the author of this response is to conduct a literature review about the protocols and methods used to develop a new drug and get it approved by the Food and Drug Administration and other relevant regulatory bodies. Second, the author is asked to a similar review but one that pertains to studies and research that is simply meant to add to the knowledge base that exists in the medical and clinical sphere. The author must then consider the differences and similarities between the two and summarize that in the form of the author's discussion response.
Both knowledgebase studies and drug approval processes have one major similarity and that is to advance the field of medical science.…… [Read More]
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]
http://usbiotecheg.nbii.gov / http://www.libay.ca.gov/cb/96/07/BIOT_CH3.html
http://esciencenews.com/aticles/2009/02/18/extensive.publication.bias.phase.i.dug.tials http://clinicaltials.gov/ct2/info/undestand http://www.bmj.com/cgi/content/extact/315/7106/480
http://www.antigenics.com/tials/about/… [Read More]
Press releases can provide indications of the motivations behind the approvals in their subtext. I would look to uncover evidence of communication between the White House or Congress and the FDA, indicating that some approvals be given priority. These may be found in press clippings or via the Freedom of Information Act.
There should also be evidence of health outcomes for past accelerated approvals. A study of these, measured against conventional approvals with respect to their effectiveness can determine the differences in the outcomes of the two processes. In particular, attention should be paid to the negative outcomes -- for example in H1N1 the incidence of children becoming sick from a mis-dose of the vaccine. By establishing common measures of success, and researching health outcomes of accelerated approvals, the efficacy of such approvals can be measured against evidence of political pressure to make those approvals.… [Read More]
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]
The FDA is responsible for the regulation of both dietary supplements and dietary ingredients. They are not regulated as food products, but are governed by the Dietary Supplement Health and Education Act of 1994 (DSHEA). The companies that market these products are responsible for ensuring that they are correctly branded and that they are unadulterated. However, the FDA does not regulate them as drugs (FDA, 2014).
I believe that this approach is adequate. I do not believe that supplements should be regulated in the same way that drugs are. There are several reasons for this. The major reason is the cost-benefit. The FDA exists to protect the public. The cost of the new drug approval process is tremendous -- it can take years and millions to bring a new drug to market, and the costs to the FDA are not inconsequential. With pharmaceuticals, this is a necessary process…… [Read More]
Robins & Robins
THE RIGHT THING TO DO
Robbins & Robbins
Possible Defenses by Casings, Inc.
It was the primary responsibility of Robbins & Robbins to have foreknown the risk of explosives getting into its medication before it entered into any formal agreement with Casings, Inc. Although both companies share the ethical responsibility, Robbins & Robbins should have had the greater interest in avoiding the risk. Second, the accounting firm, which worded the clause, was selected by Robbins & Robbins and was necessarily partial towards the company. And the clause was written in small 9-point font and on page 285, signifying the minimal significance given by the framer of the contract and agreed to by Robbins & Robbins. And lastly, Robbins & Robbins had known about the contamination two months before making the recall.
lanchard and Peale Analysis
Their first of three ethics checks to determine whether a decision is…… [Read More]
Future egulatory Improvements (FDA)
The Prescription Drug User Fee Act allows the FDA to collect fees from drug manufacturers to fund the new drug approval process. The new drug approval process is costly for both drug companies and for the FDA. The latter is funded primarily through the federal government, so this law allowed the FDA to be more self-funded. Theoretically, this would also allow it to charge fees that reflected the costs associated with conducting new drug approvals. The legislation also contained a provision that requires the FDA to conduct its approvals at a certain speed. Essentially, the bill came about because there was the risk that the FDA was going to be very slow in approving new drugs, because it was short on money. The FDA in particular was concerned at the pace Congress was providing it with more funding, during the eagan years. This was resulting in…… [Read More]
Direct to Consumer Advertising
HISTRY F DRUG ADVERTISING
THE DTC ADVERTISING PHENMENN
DECEPTIVE ADVERTISING - A WLF IN SHEEP'S CLTHING
CAUSE F DEATH
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]
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]
Yet, the benefits of the technique above could have turned into disadvantages if the spokesperson lost his temper, didn't know what to answer or provided details that shouldn't have reached the media.
Fourthly, the corporation established non-stop toll-free numbers. These offered two major benefits: the softening of the corporate image (PepsiCo appeared as an entity open to dialogue and concerned about the safety of its consumers) and the permanent feedback provided by consumers. Yet, the main drawback is that some joking callers could use a false identity and report untrue events just to put the company on the wrong track and make it lose time. However, benefits are heavier than drawbacks, in this case.
Fifthly, the corporation used a slogan at the end of the crisis - "Pepsi is pleased to announce...nothing." This was a witty remark suggesting that the company remained the producer of the same qualitative beverage and…… [Read More]
Thus, if any of us was one of the "actors', we would be tempted to judge each alternative in a subjective manner. If we were the patients, the AECL board or the hospitals we would want Therac-25 to be approved. If we were the public or FDA we would want the equipment out of the market.
The main alternative to the reality would have been for AECL to take under consideration a software error. One other alternative would have been for the company to assign more accurate probabilities for hazard occurrence, while running the Fault Tree Analysis. Finally, the third alternative would have been to use a better method to determine hazard occurrence. A better method is a method that would have been capable to return higher risks associated with the use of Therac-25 and which would have determined AECL to adjust the equipment. The first alternative is superior to…… [Read More]
Hyland's Teething Tables
What evidence exists about the adverse events associated with Hyland's teething tablets?
According to investigations conducted by the U.S. Food and Drug Administration (FDA) regarding the Hyland's teething tablets in 2010, it was established that the drug does contain belladonna. Belladonna is a substance known to cause serious harm when consumed in huge doses. The FDA recognized whenever such a product was being used there should be careful controls in place to ensure that the amount being used is properly measured and controlled. According to the FDA laboratory results, it was established that Hyland's teething tablets contained inconsistent amounts of belladonna (Food and Drug Administration, 2016). This shows that the amounts specified by the company on its website is not true and each dosage of the drug could have too much or too little. Therefore, it would not be wise to use the drugs until there is…… [Read More]
Marketing, Product Safety, and Intellectual Property
Legal and ethical considerations
PharmaCAE intentionally bypassed the Food and Drug Administration when it established CompCAE a compounding pharmacy. This was done in order to avoid FDA scrutinization, which indicates that the company was aware of the side effects that the drug would have on patients. By evading FDA scrutiny and approval, PharmaCAE was able to sell the new formulation on a prescription basis without the need to seek approvals. CompCAE was not supposed to market directly to consumers, but it still conducted direct marketing to consumers and hospitals. Furthermore, the company encouraged doctors to fax them lists of fictitious patient names. This was done to demonstrate that the company was not selling directly to consumers, but rather it was doctors who were prescribing the drug to the patients.
When reports started surfacing indicating that the drug was causing heart attacks, the…… [Read More]
Any weight loss, say doctors, is good weight loss. If there is some minor contribution the medication gives to the whole process, then that's positive. If taken strictly according to instructions, at worst, diet pills are harmless for the most part.
Effects of Dietary Supplements
The FDA regulates dietary supplements only in that it is required to ensure their safety. A manufacturer is not required to register a supplement or have it approved prior to going to market with it. They must only make certain the product is safe. It is the FDA's post-sales responsibility to keep them safe. Manufacturers must ensure that the label on the product is accurate and not misleading in any way.
There are definite benefits in taking dietary supplements per directions. They can assist anyone in obtaining nutrients not consumed through a balanced diet. And some can reduce the risk of certain diseases even though,…… [Read More]
The Living Essentials company claims it markets its high-powered beverage (which is sold in a 2-oz bottle as a "shot") to "…hardworking adults who need an extra boost of energy" (Meier, p. 2).
Another article in the respected New York Times reports that in addition to the 13 fatalities linked to 5-Hour Energy, another 5 deaths have been linked to "Monster Energy" (Meier, 2012). These data were released by the FDA in November, 2012, because, according to spokeswoman Shelly Burgess, the FDA is making "…an effort to be transparent" (Meier, p. 1). hile the FDA did not officially find the product at fault -- at this point there are linkages but no empirical proof that the deaths were a direct result of consuming the energy drinks -- Burgess added that if a "relationship between the consumption of the product and harm" can be proved, the FDA will take "appropriate action…… [Read More]
S. Department of Health and Human Services et al., 2006). This first study will involve limited human exposure and extreme caution.
Most significantly, the study itself has to be based on sound scientific principles with a thorough knowledge of the properties of the chemical, and the potential results on the human subject. Standard clinical safety evaluations will include serial assessment of patient symptoms, physical signs, and clinical laboratory tests amongst other tests monitoring possible adverse effects. These tests will be of sufficient duration in order to catch potential negative effects. Safety hazards for patients and health care workers during and after administration of the radio labeled product will also be identified, evaluated and appropriately managed.
Finally, as prescribed by Section 505(d) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 355(d)), adequate tests must be taken on the drug first before applying to a human individual. The…… [Read More]
Integrating Theory and Needs Assessment
A major challenge that a number of health care facilities are facing is accidents related to medical devices. This is from many providers becoming overwhelmed with larger amounts of patients. As a result, the odds have increased of overworked staff members making some kind of error. Evidence of this can be seen in a study that was conducted by the Food and Drug Administration (FDA) along with the Consumer Product Safety Commission (CPSC). They found that between 1999 and 2000 there was a total of 454,383 injuries. ("Estimated 454,383 People," 2004) To deal with these issues the FDA has implemented the MedSun project. This was launched in 2002 with the regulators working in conjunction with hospitals to reduce the number of errors from medical devices. Moreover, the program is built upon the principals of the Safe Medical Devices Act of 1990, the Medical Devices Amendments…… [Read More]
Government Created a Committee
An electronic health record is a digital record of a patient's health information generated from every medical visit a patient makes. This information includes the patient's medical history, demographics, known drug allergies, progress notes, follow up visits, medications, vital signs, immunizations, laboratory data and radiological reports. The EH automates and streamlines a clinician's workflow. (Himss, 2009)
Due to the multiple advantages of an EH, health care agencies have been aiming to push up this technology. In 2004, the FDA approved of an implantable EH microchip into patients. Each microchip has a specific code which is identified through sensors. The device is implanted under the skin, in the back of the arm, requiring a twenty minute procedure, without needing the use of sutures. ("Fda approves computer," 2004)
According to the Center for Disease Control and Prevention, deaths due to preventable medical errors rank as the fifth most…… [Read More]
What is worth noting here is the fact that behavior disturbances, ranging in severity from repeated questioning to physical violence, are common (National Institute of Mental Health, 1989).
It is unclear whether Alzheimer's disease represents a single entity or several variants. Some experts believe that there are distinct subtypes of Alzheimer's disease, such as Lewy body disease (in which the signs of Parkinson's disease, visual hallucinations or alterations in alertness or attention, or all of these symptoms, are conspicuous) and frontotemporal dementia (in which disinhibition, misconduct or apathy, or all of these signs, are prominent). The well-established risk factors for Alzheimer's disease are age, a family history of the disease and Down syndrome (National Institute of Mental Health, 1989).
Confusions about Alzheimer's Disease and the Need for Alternative Actions
There have been numerous studies conducted in relation to Alzheimer's disease. At the same time, there are a number of reports…… [Read More]
Product Safety, And Intellectual Property
Legal and Ethical Considerations in Marketing, Product Safety, and Intellectual
Ethics and legal issues refer to the morals and principles that govern the behavior and conduct of individuals or organizations. These legal principles and ethics serve to guide and offer directions on how to act or respond when faced with moral dilemmas. Marketing, advertising and product safety are areas of importance to everyone in the community. Production, distribution and use of products or services are areas guided by the laws of the land. The laws function to protect the community from exploitation or mishandling by the participants in the above sectors. In the marketing and advertising framework, the concept of ethics deals with personal moral principles and values. Under this framework, the society understands that laws are values and standards that are enforceable in the court. In the production of goods and services, the…… [Read More]
A., eynolds, Y., odriguez, G., Camesano, T.A. (2008). Cranberry changes the physicochemical surface properties of E. coli and adhesion with uroepithelial cells. Colloids Surf B. Biointerfaces. 2008 Feb 26 [Epub ahead of print]. etrieved April 5, 2008 at http://www.ncbi.nlm.nih.gov/pubmed/18378432?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_esultsPanel.Pubmed_VDocSum
Mirkin, G. (2003). Acid/Alkaline Theory of Disease Is Nonsense. Quackwatch. etrieved April 5, 2008 at http://www.quackwatch.org/01QuackeryelatedTopics/DSH/coral2.html
National Center for Complementary and Alternative Medicine (NCCAM). Cranberry. etrieved April 5, 2008 at http://nccam.nih.gov/health/cranberry/
Natural Standard esearch Collaboration (2006). Cranberry. MedlinePlus. etrieved April 6, 2008 at http://www.nlm.nih.gov/medlineplus/druginfo/natural/patient-cranberry.html
az, ., Chazan, B., Dan, M. (2004). Cranberry juice and urinary tract infection. Clin Infect Dis. 2004 May 15;38(10):1413-9. Epub 2004 Apr 26. etrieved April 5, 2008 at http://www.ncbi.nlm.nih.gov/pubmed/15156480?ordinalpos=3&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_esultsPanel.Pubmed_VDocSum
Schmidt, D.. & Sobota, a.E. (1988). An examination of the anti-adherence activity of cranberry juice on urinary and nonurinary bacterial isolates. Microbios. 1988;55(224-225):173-81.
Sobota, a.E. (1984). Inhibition of bacterial adherence by cranberry juice: potential use for the treatment…… [Read More]
Pharmaceutical industries have to operate in an environment that is highly competitive and subject to a wide variety of internal and external constraints. In recent times, there has been an increasing trend to reduce the cost of operation while competing with other companies that manufacture products that treat similar afflictions and ailments. The complexities in drug research and development and regulations have created an industry that is subject to intense pressure to perform. The amount of capital investment investments required to get a drug from conception, through clinical trials and into the market is enormous. The already high-strung pharmaceutical industry is increasingly investing greater amounts of resources in search of the next "blockbuster" drug that can help them gain market position and profits. Laws, regulations and patents are important to the industry while spending billions of dollars in ensuring the copyright of their products.
It is the intention of this…… [Read More]
Instead, the research shows that the faster pace of the review process was due to where financial resources went -- to FDA staffing -- not where it came from. The more funding for review scientists there is, the more scientists are on staff, and more work gets completed at a faster rate. The study found that the decrease in turnover time from application submission to completed review began a few years before the passage of the Prescription Drug User Fee Act, thus before the collection of those user fees started (Carpenter et al., 2003).
The question for us to consider is whether the increased efficiency observed by Carpenter et al. means that the FDA is moving back toward a Type I error orientation from the Type II orientation observed by Miller et al. Viewing the drug review process along the dimension of rate of review alone might suggest that a…… [Read More]
In the case of breast augmentation, the parent must guide the minor to the right decision -- and that is usually not to have the surgery unless it is necessary for the teen's overall health. It is up to the adult to think responsibly. There are dangers to any surgery and infections are not among the least of them. Perhaps low self-esteem is a reason for counseling by a professional, but not necessarily reason to alter one's body artificially.
The ethical responsibilities of the parent in a discussion with their underage teen regarding whether or not to have her breast augmented, are even greater and more impacting than the legal issues.
The 1800 girls under the age of 18 who had their breasts augmented last year alone are under the ethical (and rational) reasoning of the parent. These are the parents who are taking out financing to do the surgery…… [Read More]
Making Prescription Drugs Affordable?
Parallel Trade and the Pharmaceutical Industry
The skyrocketing cost of prescription drugs remains one of the most contentious issues in America. In this presidential election year, especially, politicians are continually debating ways to make life-saving drugs more affordable. Alone in the world, the United States prohibits the free importation of prescription medications from abroad. Yet, as is so often pointed out by those in favor of changing the law, such drugs are nearly always much less expensive in foreign countries - even medicines that are actually manufactured by American corporations. Of central importance in the argument is the precise rationale for current pricing levels. The pharmaceutical companies and their allies claim that high prices are necessary to finance the continuing innovation of American medicine. Foreign nations, they say, artificially control drug costs, thereby depriving corporations of the sizeable funds required for new research. New medications…… [Read More]
" Concerning the type of complementary strategic alliance, it is a horizontal one, because it is formed "when partners who agree to combine their resources and skills to create value in the same stage of the value chain," it is focused "on long-term product development and distribution opportunities" and "the partners may become competitors which requires a great deal of trust between the partners."
The answer to the second question is "no," it's not a "competition response strategy" because the two companies are not really competitors, even if the profile for both company is pharmaceutical. Excel research can be consider in this case as an ally, a support for Century Pharmaceuticals, and even as a consultancy company that works for C.P.
The answer to the third question is "yes," it can be an" uncertainty reducing strategy" because if it functions as it is established, it can reduce the uncertainty about…… [Read More]
There is proper way of using Sucromates. Firstly, we need to shake it well before use. One dose accounts for 1 ml of Sucromate, which is to be injected 48 hours before desired ovulation. Sucromate Equine is a suspension of deslorelin and so with the passage of time it will settle down (Equine, pg. 9). Therefore, for this we need to warm the product for atleast 2 minutes so that it can reach room temperature. arming is done by rolling the vial between two palms. e should at least wait for 30 more minutes by keeping the vial at room temperature. After this, we need to shake the vial forcefully one minute before use. Then we inject 1 ml of the vial in the neck through an intra-muscular injection.
Sucromate has proven to be quite effective as it advances the ovulation process in the mares within 48 hours after the…… [Read More]
During the consumer movement of the 1960s and 1970s, Congress enacted a substantial amount of legislation to protect "the good of the people." There is only one problem with consumer protection laws -- they are slow to react and even harder to enforce. As a result of this situation, corporations are allowed to profit at the expense of consumers' health. The resistance comes in a number of stages. The first is denial of the problem, wherein the corporations argue that there is not enough evidence to link their products with the negative outcomes that are being reported. Then there is the lobbying that causes politicians to defer action until a later date, or ignore the call to action altogether. Too often, when statutes are enacted, corporations fight them to the end, resulting in flawed legislation that either has loopholes, require interpretation from the judicial branch or is difficult…… [Read More]
Johnson and Johnson issued a public relations response immediately naming their number one priority: to aggressively protect any consumer from the potential hazards that may be present in any of their family of products.
Symptoms of the Problem -- Quickly, the crisis reached epic nationwide coverage. The panic that ensued, somewhat as the result of the twenty-four hour media coverage, fueled this panic into a frenzy. One hospital in Chicago, for instance, received 700 calls in one day; while Johnson and Johnson received averaged almost 150 calls per day. Across the country people were admitted into hospitals on suspicion of cyanide poisoning (Tifft, 18). Johnson and Johnson worked rapidly and decisively with the media to disseminate information. When the news spread, copycat criminals began to tamper with the products on the shelves of stores, which only deepened the crisis. ndeed, the FDA confirmed more tampering had taken place, but this…… [Read More]
Demand is dependent on the frequency of a condition in the population. This number, for most conditions, is generally known. Thus, the equilibrium point can be determined that would deliver the cost recovery and markup pharma companies seek, without allowing costs to escalate to gouging levels. The problem is that once the monopoly has been granted there are no serious cost controls beyond market controls.
There are two problems with this. The first is that without cost controls, it is difficult to improve bargaining power. First, buyers have little bargaining power because most buyers -- even insurance companies -- lack size to bargain over prices. Only Medicare and Medicaid have the size to drive prices down, because pharma companies are dependent on their money even with the monopoly. The second is that there is information asymmetry, which reduces the bargaining power of buyers. Again, only the largest and most sophisticated…… [Read More]
In addition to sexual intercourse and its variations, sexual liberation refers to the universe of human issues affecting all genders. America was propelled from the sexual enslavement of the 1950's to considerably increased sexual liberation of the 1980's and beyond. Two significant events of the 1960's that contributed to sexual liberation were the FDA approval of The Pill and the birth of the omen's Liberation Movement.
Sexual Suppression of the 1950's
An examination of liberation should begin with the sexual slavery of the 1950's. By current standards, sexual suppression was a numbing fact of 1950's America, particularly for women. For example, the legendary "Good ife's Guide" (Housekeeping Monthly, 1955) spouts standards that are otherworldly by today's norms. Perhaps its most oppressive statement is "A good wife always knows her place" (Housekeeping Monthly, 1955), though the guide serves up plenty of other now-hilarious goodies. "Assisting" housebound married women in…… [Read More]
The healthcare costs associated with major depression are astronomical. Compared to antidepressants, costs for treatments with NeuroStar are economical. One session is expected to cost approximately $400 per treatment session, with typical patient needing four to six treatments (Neuronetics, Inc., 2008). Compared to ongoing medicine and therapy sessions, this is a quite cost effective alternative. This will be another key selling point for the device. However, it is expected that clinicians will see the potential to increase their clientele as a more important factor than the initial costs of the device.
The NeuroStar TMS is already in use in a few treatment centers around the country (Neuronetics, Inc., 2008). This provides credibility that others find the device to be beneficial. Testimonials from doctors and patients would be another supportive element to add to the marketing campaign. However, this element is not expected to hold as much weight as clinical evidence…… [Read More]
These are called inclusion/exclusion criteria, and not only protect the participants from harm but also allow the researchers to be sure that the studies they do provide reliable data on the safety and efficacy of the drug. Each person who takes part in a drug study must go through an informed consent process. The potential participant will be given facts about the study, and is allowed to make a good decision regarding whether or not to participate. Even if the participant agrees to join a study, the participant can quit the study at any time. Participants may join a study for many reasons: they may want to try an experimental treatment, or want to help in medical research. Often time's participants will receive some sort of financial benefit for participating in studies, usually based upon the risk or requirements of the study.
The funding for clinical trials comes from many…… [Read More]
P&G is looking to make the Supplier Environmental Sustainability Scorecard methodology a global standard (P&G, 2010). To support this effort to make the scorecard a global baseline of sustainability measurement, P&G freely distributes Microsoft Excel models of the methodology and baseline analysis tools from their website. The foundations of the methodology can be seen in Figure 2: Procter & Gamble's Supplier Environmental Sustainability Scorecard Methodology. The key metrics measured include energy, emissions, waste, water and an environmental management system performance ranking that can be used for evaluating supplier performance within and across product categories.
P&G has also differentiated this model by rewarding excellent business performance as measured by the key performance indicators (KPIs) first, while also using the methodology to evaluate areas where performance can be improved. The use of incentives and rewards for the top 400 suppliers at P&G have been announced and are actively being applied to supplier…… [Read More]
This has been the traditionally used mode of treatment for non-Hodgkin's Lymphomas, but the fact remains that there have not been many clinical trials conducted that would reveal the benefits of CHOP in comparison to various other chemotherapy options for the treatment of CLL, which is a very slowly growing form of cancer and is therefore conversely very difficult to treat and cure because of the fact that all the traditional methods of treatment, whether chemotherapy or radiation, are meant to quickly and rapidly destroy the fast growing cancerous cells. (Cancer Treatment and Prevention)
Curing a patient with the CLL or SLL forms of cancer is considered to be highly unusual, but it is true that these patients will b able to lead productive lives even after 6 to 10 years after the cancer have been diagnosed for them. A patient when he is making the choice of treatment for…… [Read More]
Internet Information Quality
hitehouse.gov vs. hitehouse.net
hitehouse.gov, under first impressions is accurate, far more professional, and updated. In fact, whitehouse.net is outdated and still has George . Bush as the President. hitehouse.gov is extremely informative, but focused on the current President, Barak Obama, and his agenda. The site is divided into photos and videos of conferences, appearances, and there is a briefing room that focuses on the major issues of the day. The site is appropriate for education, it has information about the way the government worlds, and about the topics that are in the news -- immigration, gun violence, energy policy, and more. The site is current with top political news of the day, the visits, and the travel plans of the President and his staff. There is a link for email updates, contact information, and a way to receive answers back from various departments of the government. Ironically,…… [Read More]
According to various research and countless newspapers, institutional pharmacy has an undoubtedly positive role in our society. By definition, institutional pharmacy is that which provides "a range of services to residents of nursing homes, hospitals, or hospice environments which do not have an on-site pharmacy." As such, and without this service, long-term care facilities, such as nursing homes, would not be able to function smoothly nor take care of patients properly. Thus, due to institutional pharmacies, the facilities that utilize them can play a role in helping the patient firsthand with important matters. [1: "Institutional Pharmacy." Gerson Lehrman Group. Web. 20 Sept. 2011. .]
It is important to note, however, that there are various rules regulating these pharmacies. This is due to the fact that, in addition to providing pharmaceuticals, these entities also provide consulting services, and these can include the following:
monitoring control of drugs monitoring the…… [Read More]
76), ROE has ranged from 21.6% to 28.3% in recent years, with the 2007 figure being 25.6%. This reflects outperformance of both the industry and the market. The ROA has exhibited similar outperformance of both industry and market. The return on assets for JNJ over the past several years has ranged from 13.1% in 2007 to 17.l% in 2005. The industry five-year average is 8.85% and the market five-year average is 7.50%.
Net Income increased despite decline in revenues
Growth in each business segment
R&D expense growing slower than revenues
2-year upward trend in net income
Upward trend in cash levels
Upward trend in cash flow from operations
Current ratio 46.36% higher than industry
Interest coverage 80.09% higher than industry
Net margin 14.04% higher than industry
Return on Equity 1414.79% higher than industry
Return on Assets 48.02% higher than industry
Decline in revenue this year (1st…… [Read More]
NSF occurs only in patients with advanced kidney disease. ven though the cause-and-effect link is not proven, the association of NSF with gadolinium exposure is strong enough for the FDA to issue a warning. If an MR study with contrast is absolutely required, a nongadodiamide contrast using the lowest possible dose is preferable." It would also seem prudent to perform hemodialysis to enhance gadolinium elimination and to identify other potential cofactors (Busko, M.2007).
There are many issues that impact MR safety that should be considered during site planning for a given MR installation. These have historically not been dealt with in the prior versions of the ACR MR Safe Practice Guidelines. For the first time, we include in this article, as separate appendices, sections that address such issues as well, including cryogen emergency vent locations and pathways, 5-gauss lines, siting considerations, patient access pathways, etc. Yet despite their appearance herein,…… [Read More]
Organics trip to the local grocery store will reveal that organic vegetables and fruits not only look better than their non-organic counterparts: they are in many cases also not that much more expensive. As a result, many mainstream supermarkets are starting to carry organic lines of produce, offering more choice to consumers. The Albertson's chain in ashington State recently started stocking shelves with organic coffee; UK food retail giant Safeway added organic meats to its shelves, all of which is locally produced. Increasing numbers of packaged foods are being made with organic ingredients and many of them don't cost more than non-organic counterparts. However, the organic food industry still has a long uphill battle to fight. Organic agriculture is a system of production that eliminates "the use of synthetic inputs, such as synthetic fertilizers and pesticides, veterinary drugs, genetically modified seeds and breeds, preservatives, additives and irradiation," replacing them with…… [Read More]
nursing is changing. Recent healthcare legislation is projected to increase the need for nurses at an exceedingly high rate. Improvements in technology and equipment are providing newer forms of treatment; the role of nurses is expanding to include more diagnostic and rehabilitative work, particularly in light of current demands on physicians. The day in which nurse practitioners can provide patients with holistic treatment augmented by the most innovative technological advancements and discoveries is soon approaching, making this profession one of the most valued throughout the healthcare industry. As a student who has recently completed the first year of a three-year program to earn a Master's of Science in Nursing as a family nurse practitioner, I fully expect to play an important role in the elevation of patient care at a time in which our country needs it most.
My interest in this profession spans well beyond the past 12 months…… [Read More]
genetically modified (GM) foods in the last half of the 20th century created a whirlwind of controversy in the developed. Critics argue that genetically modified foods are unnatural and unsafe, while supporters note that genetically modified foods can improve crop yields, increase nutrient content, and improve food safety. Over the past decades, the production and distribution of genetically modified foods in North America and Europe has long been discussed, and governmental controls have been implemented. In contrast, many African countries have not had the opportunity to develop GM food policies. hen the U.S. offered genetically modified foods as part of an aid package to African countries in the past years, the act renewed the controversy around genetically modified foods.
This paper will focus on the debate surrounding the use of genetically modified foods as food aid to African countries. First, a brief background to the GM food industry, and GM…… [Read More]
Meatpacking Industry: Progressive Reforms and the Shaping of National Policy
In 1906 the Pure Food and Drug Act was passed in the United States. This was the culmination of a furor that had reached tipping point with the success of Upton Sinclair's novel The Jungle, a story based in the meat packing industry published in 1905. The novel explored the lives of a group of immigrant workers as they struggled to survive in the "jungle" of early 20th century.
The story was, however, merely the straw that broke the camel's back. The Pure Foods Movement had actually begun thirty years earlier in the post-Civil War years when Industrialization was already underway and the landscape of America was rapidly changing. It was the Pure Foods Movement that was really the driving force behind the Pure Food and Drugs Act of 1906.[footnoteRef:1] [1: Wallace Janssen, "The Story of the Laws behind the…… [Read More]
Business operations are deemed viable of they succeed in establishing conditions that guarantee safety for its product consumers. Specified standards are applied by business entities to attain such viability. These considerations are critical in product safety, intellectual property, and marketing in general. If a company or business entity violates any of the aspects mentioned, it stands a high risk being caught in a web of ethical and legal complications that might destroy it. PhamaCARE finds itself in such a precarious predicament owing to its blatant violation of a number of legal and ethical standards. There were both ethical and legal problems that impacted on its clients and businesses. Investigating behavior is paramount in uncovering issues related to legal and ethical problems of any business entity.
Pursuant to the scenario above, identify three (3) legal issues and problems PharmaCARE has in relation to marketing and advertising, intellectual property, and regulation of…… [Read More]