Free Essay

Medicine

In: Science

Submitted By chestdocmd
Words 3525
Pages 15
-------------------------------------------------
Top of Form

Bottom of Form
Text size: A A * Theodore Lange ID: 1113086 * Log Out * Help
CITI Program
Collaborative Institutional Training Initiative at the University of Miami
-------------------------------------------------
Top of Form

Bottom of Form * Main Menu * My Profiles * My CEUs * My Reports * Support * Main Menu › VA Human Subjects Protection › Informed Consent Informed Consent
Content Author * Diane Paul, M.S., RN
National Comprehensive Cancer Network
Introduction
It is important to understand that informed consent is a process that begins with the recruitment and screening of a subject and the signing of the consent document, continues throughout the subject's involvement in the research, and continues beyond study termination. It includes: * Recruitment efforts encompassing the means of first creating awareness or contact and spanning everything from medical record review to advertisements and other recruitment materials. * Providing specific information and answering questions about the study to subjects in a way that is understandable to them while giving subjects adequate time to consider participation. * Obtaining the voluntary agreement of subjects to take part in the study. While the subject may agree to participate in the study, subjects may withdraw at any time. Part of the ongoing nature of the consent process is verifying the subject's continued interest in participating in the study. * Making plans for the provision of new information to be shared with former subjects, even after the study ends.
There is consensus regarding the importance of informed consent. Informed consent is a demonstration of how investigators and those involved in human subjects research show respect to research subjects, and it is mandated by the Department of Health and Human Services (HHS) at 45 CFR 46 and the Food and Drug Administration at 21 CFR 50*. The regulation was developed to: * Protect human subjects/volunteers. * Ensure that potential study subjects clearly understand the benefits and risks associated with their participation in a study. * Provide the potential study subjects with all information needed to reach a decision on whether or not to participate in a research study.
*The Code of Federal Regulations (CFR) is published in the Federal Register, a publication of the Federal Government that codifies the general and permanent rules of executive departments and agencies. There are 50 titles that represent broad areas subject to federal regulation. The CFR is updated once each calendar year and is issued on a quarterly basis.
The purpose of this module is to provide a basic understanding of informed consent and the process of obtaining informed consent.
Learning Objectives
By the end of this module, you should be able to: * Describe the requirements for complying with informed consent regulations. * Describe the process for obtaining informed consent. * Define vulnerable populations. * Describe the regulations for waiving informed consent.
Informed Consent Requirements
General Requirements
The framework for informed consent can be found at 45 CFR 46.116(a) and 21 CFR Part 50.25(a). Legally appropriate informed consent will include the following elements: 1. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental. 2. A description of any reasonably foreseeable risks or discomforts to the subject. 3. A description of any benefits to the subject or to others which may reasonably be expected from the research. 4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject. 5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and that notes the possibility that the Food and Drug Administration may inspect the records. 6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained. 7. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject. 8. A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
Additional Requirements
In addition, if relevant to the research, legally effective informed consent will also include the following elements, outlined in The Code of Federal Regulations 45 CFR 46.116(b) and 21 CFR 50.25(b): 1. A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable. 2. Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent. 3. Any additional costs to the subject that may result from participation in the research. 4. The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject. 5. A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject. 6. The approximate number of subjects involved in the study.
ClinicalTrials.Gov Requirement
The FDA also issued an addition to the elements of informed consent adding a new requirement that went into effect March 2012. When seeking informed consent for applicable clinical trials, as defined in 42 U.S.C. 282(j)(1)(A), the following statement shall be provided to each clinical trial subject in informed consent documents and processes. This will notify the clinical trial subject that clinical trial information has been or will be submitted for inclusion in the clinical trial registry databank under paragraph (j) of section 402 of the Public Health Service Act. The statement is: * "A description of this clinical trial will be available here, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time."
In February 2012, the FDA also issued Guidance for Sponsors, Investigators, and Institutional Review Boards - Questions and Answers on Informed Consent Elements, 21 CFR 50.25(c)
Regulatory Groups
Compliance with informed consent regulations is regulated by the: * FDA, 21 CFR 50 - see FDA-Regulated Research module * HHS, 45 CFR 46 - through OHRP * Applicable Institutional Review Boards (IRBs)
Obtaining Informed Consent
Obtaining informed consent involves: * Providing information to the subject. * Answering questions the subject may have to improve his/her comprehension * Obtaining the voluntary agreement of the subject to participate in the study.
Providing Information
Guidelines for providing information include: * Advertising may be the first information about research seen by subjects and is most often used in recruitment. It cannot be coercive or make false promises or claims. The process of informed consent is often conceptualized to begin at the recruitment stage. Additionally, some areas to consider with respect to recruitment include: * Laws, guidelines, or institutional policies that govern advertising for study subjects, particularly in multi-site research; * Whether compensation for study volunteers is allowed where the research is proposed, and how it will be noted in recruitment materials; * What the "norms" for recruiting are in the particular location where recruitment will occur and with the proposed population. * Procedures to screen potential subjects for eligibility must protect the rights and welfare of prospective subjects. * The information should be communicated in a manner and language that is clear and understandable, be communicated in an organized fashion, and allow for questions the subject may have to be answered. * The information communicated should not use exculpatory language either in the written consent or in discussions about the research. "No informed consent, whether oral or written, may include any exculpatory language through which the subject is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence". --- 45 CFR 46.116
Improving Understanding
Guidelines for improving understanding include: * Providing consent in a language that is understandable to the subject or his/her representative. * Providing non-English speaking subjects a translated informed consent document that is accurate as determined by the IRB. * If a translator is used, providing a written translation of the consent document is still required. Some IRBs allow use of a short form translation of the IRB consent document, see 45 CFR 46.117 (b)(2). * Giving the person enough time to think about his/her participation in the research before giving consent.
The National Comprehensive Cancer Network (NCCN) provides a free online database for researchers and IRB members that contains standardized lay language descriptions of risks and events associated with clinical research. (NCCN 2015) This resource aims to help increase subject understanding by providing lay language terms approved by academic IRB's that can be used in consent forms for clinical terms (for example, the term "acuity reduced" could be replaced with the lay term "blurry vision").
Obtaining Voluntary Agreement to Participate
Legally effective informed consent shall: * Be obtained from the subject or the subject's legally authorized representative. * Be obtained under circumstances that provide the subject with an opportunity to consider whether or not to participate and that minimize coercive influences. Coercive tactics such as inappropriate financial compensation or other rewards cannot be used. * Not include any language through which the subject is made to waive or appear to waive any of his/her legal rights or any language that releases the investigator, sponsor, or institution from liability for negligence. * Illiterate English-speaking subjects can "make their mark" on the informed consent document, as long as it is consistent with applicable state laws.
Special Challenges
Language Issues
The consent process should be conducted in the language spoken by the subject, and the consent form should be translated into that language. An IRB may require independent confirmation of the accuracy of the translation. Subjects who are not literate in their language must have an interpreter present to explain the study to the subject and translate questions and answers between the subject and the person obtaining consent.
Cultural Issues
Issues other than literacy may affect comprehension. For example, in some cultures it may be considered rude to ask questions of an investigator researcher, or rude to decline what is perceived of as a request for a favor. In these circumstances, the questions of who conducts the consent process and how it is explained become even more important.
Vulnerable Populations
The concept of subject vulnerability is important to research ethics and to regulatory compliance. FDA regulation 21 CFR 56.111(b) requires that "when some or all of the subjects are likely to be vulnerable to coercion or undue influence, additional safeguards have been included in the study to protect the rights and welfare of these subjects." These regulations do not provide a definition of vulnerable subjects or an explanation of the causes of vulnerability, but they do provide the following list of examples of vulnerable subjects: "children, prisoners, pregnant women, handicapped, or mentally disabled persons, or economically or educationally disadvantaged persons." Other examples include: * Patients in emergency situations * Subjects who are marginalized in society (for example, Gay/Lesbian/Bisexual/Transgender individuals, undocumented workers) * Members of a group with a hierarchical structure, such as students in medicine, pharmacy, dental, and nursing subordinate hospital and laboratory personnel, and members of the armed forces * Patients with fatal or incurable diseases * The elderly * Persons in nursing homes * Unemployed or impoverished persons * Ethnic minority groups * Homeless persons, nomads, refugees
While vulnerability is not a term clearly defined in the regulations, thinking of vulnerability as a limitation on autonomy provides a valuable tool for considering whether there are sufficient safeguards in a given research project to protect the rights and welfare of these subjects.
Regulations for Waiving Informed Consent
Sometimes, under specific circumstances with IRB approval, informed consent can be waived.
HHS Regulations for Waivers
The HHS (45 CFR 46.116) allows an IRB to waive or change the requirements for informed consent under two sets of circumstances:
1) Government Projects and 2) General Waivers and Alterations.
Government Projects
If the research/project is approved and/or conducted by state or local government and is meant to study/evaluate: * A program to benefit the public. * Procedures under those programs. * Alternatives to those programs or procedures. * Changes in payment methods or levels for the services of those programs. * The research could not practicably be carried out without the waiver.
General Waivers and Alterations are permissible if the IRB determines that: * The research involves no more than minimal risk to subjects. * The waiver or alteration will not adversely affect the rights and welfare of the subjects. * The research could not practicably be carried out without the waiver or alteration. * Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
Special Considertaions for NIH Funded Research:
NIH funded research using newborn dried blood spots collected on or after March 18, 2015, is considered research on human subjects (which requires the informed consent of the subject) according to the Newborn Screening Saves Lives Reauthorization Act of 2014. The Act also eliminates the ability of an IRB to waive informed consent requirements for research on newborn dried blood spots. This means that researchers would need parental permission to use the dried blood spots. NIH-funded research with non-identifiable dried blood spots collected before March 18, 2015, is considered non-human subjects research and is exempt from the regulations.
FDA Regulations for Exceptions from Informed Consent Requirements
The FDA 21 CFR 50.23 and 21 CFR 50.24 provide exceptions to the requirement for informed consent under the following circumstances: * In situations where requirements for exception from informed consent are met for emergency research (21 CFR 50.24). * In life-threatening conditions involving an individual subject where requirements for an exception from informed consent are met and include documentation of all of the following: * The investigator, with the concurrence of another physician, believes the situation necessitates the use of a test article (an investigational drug, device, or biologic). * The subject and/or legally authorized representative is unable to communicate consent
(FDA definition of Legally Authorized Representative: an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research). * There is insufficient time to obtain consent. * No alternative exists that will provide an equal or better chance of saving the subject's life.
Waiver of Signed Consent/Use of Oral Consent
Signed consent may be waived and oral consent used under the following circumstances:
FDA
The U.S. FDA allows waiver of documented informed consent (21 CFR 56.109(c)[1]) when study participation presents minimal risk to the subject and the research involves no procedures requiring consent outside the context of participation in a research study. The IRB may require the investigator to provide the subject with written materials about the research.
HHS
According to HHS (45 CFR 46.117), an IRB may allow waiver of a signed consent document in either of the following circumstances: * The consent would be the only link between the research and the subject and the principal risk to the subject would be due to a breach of confidentiality, and each subject will be asked if they want consent to be documented. * Study participation presents minimal risk of harm to the subject and the research involves no procedures requiring consent outside the context of participation in a research study. * The investigator may be required by the IRB to provide a written summary about the research to the subject if either of these methods is used.
Appendix - Internet Resources and References
Is Telephone Consent From a Legally Authorized Representative Appropriate?
FDA
Verbal approval does not satisfy the 21 CFR 56.109(c) requirement for a signed consent document, as outlined in 21 CFR 50.27(a). However, according to FDA guidance it is acceptable to send the informed consent document to the legally authorized representative (LAR) by facsimile and conduct the consent interview by telephone when the LAR can read the consent as it is discussed. If the LAR agrees, he/she can sign the consent and return the signed document to the clinical investigator by facsimile.
HHS
Documentation of informed consent is required by HHS 45 CFR 46 unless a waiver of documentation is granted by the IRB. The regulations dictate that the signature must be the subject's or the subject's legally authorized representative. HHS guidance regarding informed consent can be found at OHRP's FAQs. HHS does allow the exchange of consent information to take place face-to-face or by mail, telephone, fax or video. Informed ConsentA researcher proposes a randomized trial of an investigational drug in patients about to undergo surgery for acute appendicitis. The investigational drug (or placebo, depending on which arm the subject is assigned to) is administered immediately prior to the surgery. If the investigational drug works it will mean less pain and maybe less need for other pain medicines like morphine. The investigator who is also the surgeon performing the operation, proposes to have a nurse explain the research in the "pre-op" area. The nurse will explain the research while the patient is being prepared for the operation and having an IV started, as well as blood pressure and other measurements taken. The surgeon will then arrive, get consent for the operation and get the patient's signature on the research consent form. If the patient does not speak English, an interpreter will answer the patient's questions. The patient will sign the English language consent form. * Is the proposed consent process appropriate for this situation? The consent process is flawed in several aspects. First, the federal regulations mandate that investigators, in this case the surgeon, provide subjects or their representatives, sufficient time to consider whether to participate or not. Obtaining consent in the "pre-op" area immediately before an emergency operation, and while other clinical procedures are being performed, is not conducive to thoughtful deliberation or decision-making.Second, investigators also must obtain consent under circumstances that minimize the possibility of coercion or undue influence. In this case, the patient's surgeon is obtaining consent for research immediately before performing a potentially lifesaving procedure. The patient may be under undue influence, or possibly coercion, to participate in the research even though it may be against his actual wishes. In addition, the aspect of this participant being vulnerable must be considered. In this stressful situation, how can one access the participant's ability to comprehend information and make sound decisions?Third, obtaining consent at the same time for both performing the operation (a clinical indicated procedure), and for participating in the research might confuse the patient. It may be difficult for the patient to understand which procedures are standard care and which are part of the research. Finally, investigators must present information about the research in a language understandable to the subject or the representative. Having an interpreter available only to answer questions and not present for the explanation, and using a consent form written in English, rather than a subject's native language, does not fulfill this requirement.As a final point, obtaining informed consent in this setting (particularly as concerning the first two points above) may be nearly impossible. It would be more appropriate to choose a different subject population, for example, patients undergoing elective procedures, where consent can be obtained well in advance of the research and participants will have time to ask questions and demonstrate understanding.Close Case Study |
References & Resources * Code of Federal Regulations for the Protection of Human Subjects in Research, U.S. Department of Health and Human Services, 1998, 21 CFR Part 50 and 45 CFR Part 46. * U.S. Food and Drug Administration, Information Sheets [Online] Guidance for Institutional Review Boards and Clinical Investigators, 1998. * National Cancer Institute (NCI), Informed Consent [Online]. * National Cancer Institute (NCI). Cancer Diagnosis Program Offers an Educational Video on Cancer Treatment and Tissue Dontation. 2015. "Donating Your Tissue for Research." Accessed December 3. * NCCN Informed Consent Language (ICL) Database [Online]. 2015. Accessed August 7. * Klimaszewski, A.D., Anderson, S., Good, M. (2000). Informed Consent. Manual for Clinical Trials Nursing. 213-219.
Original Release: July 2003
Last Updated: April 2016

*
-------------------------------------------------
Top of Form

Bottom of Form
-------------------------------------------------
Top of Form

Bottom of Form * Accessibility * Copyright * Privacy Notice * Terms of Service * Contact Us
<div class="old-browser-warning" style="z-index: 2147483647"> <div class="old-browser-warning-vertical-spacer"></div> <div class="old-browser-warning-content text-large"> <p>JavaScript is required.</p> <p>Please enable JavaScript and refresh your browser window.</p> </div> </div>

Similar Documents

Premium Essay

Medicine

...over the telephone, and overlooked changes in status.1 Lack of communication creates situations where medical errors can occur. These errors have the potential to cause severe injury or unexpected patient death. Medical errors, especially those caused by a failure to communicate, are a pervasive problem in today’s health care organizations. According to the Joint Commission (formerly the Joint Commission on Accreditation of Healthcare Organizations, JCHAO), if medical errors appeared on the National Center for Health Statistic’s list of the top 10 causes of death in the United States, they would rank number 5—ahead of accidents, diabetes, and Alzheimer’s disease, as well as AIDS, breast cancer, and gunshot wounds.1 The 1999 Institute of Medicine (IOM) report, To Err Is Human: Building a Safer Health System, revealed that between 44,000 and 98,000 people die every year in U.S. hospitals because of medical errors.2 Even more disturbing, communication failures are the leading root cause of the sentinel events reported to the Joint Commission from 1995 to 2004. More...

Words: 7203 - Pages: 29

Premium Essay

Medicine

...Plants and gardens have a greater purpose than simply to be an eye catching source of food. While mainstream medicine largely continues to deny the inherent healing capacity of natural plants and herbs, the insect world is abuzz with activities that confirm the plant world to be nature's medicine cabinet. According to a new study published in the journal Ecology Letters, the Monarch butterfly routinely uses medicinal plants to help its offspring resist disease and infection. Researchers observed that Monarch butterflies prefer to lay their egg larvae on milkweed leaves, so they decided to investigate why this is the case. They discovered that milkweed plants contain vital compounds that help the larvae to stay healthy. "We have shown that some species of milkweed, the larva's food plants, can reduce parasite infection in monarchs," explained Jaap de Roode, an evolutionary biologist at Emory University, and author of the study. "[W]e have also found that infected female butterflies prefer to lay their eggs on plants that will make their offspring less sick." There are many types of milkweed plants, and some contain very high levels of cardenolides. Cardenolides are toxic to predators, but safe for Monarch butterflies. So when Monarch butterflies eat milkweed rich in the chemical, or lay their larvae on it, they build up a natural resistance to invading predators. The same chemical also helps to stop parasites that can develop in the butterflies' intestines and kill......

Words: 334 - Pages: 2

Free Essay

Personalized Medicine

...Personalized Medicine SCI 115 Abstract Personalized medicine is a healthcare field that deals with the different and unique genomic, genetic, clinical, and environmental information of each person. Personalized medicine is based on making treatment or prevention of disease focus on the individual and the factors that do or will affect that particular individual. Some of the advantages of personalized medicine are the ability to make more informed medical decisions, earlier disease intervention, and reduced probability of negative side effects. Although there is a large upside to personalized medicine and the medical advantages that come along with it implementation, there lyes the challenge. The implementation of personalized medicine is the largest limitation. Whether it is lack of push from the healthcare industry or lack of proven technology to properly diagnose individual patients, personalized medicine is very young and has a long way to go. Personalized medicine or medical treatment that is unique to the individual definitely has it advantages. Some of those advantages are the ability to make more informed medical decisions, earlier disease intervention. Laberge and Burke (2008) describe personalized medicine as health care that is tailored to the individual. They go on to say that (Laberge and Burke 2008) recently the term has been used to refer specifically to genetically-based health care. Some of the drawbacks to personalized medicine according to......

Words: 839 - Pages: 4

Free Essay

Personalized Medicine

...Running Head: PERSONALIZED MEDICINE PERSONALIZED MEDICINE Margaret Barnes SCl115-Introduction to Biology November 07, 2012 PERSONALIZED MEDICINE Personalized Medicine and Modern Genetics Technology: “Introduction” In today’s world DNA sequences are frequently and constantly improving, modern instruments can analyze DNA by the millions within a twenty-four hour period (Mader, 2010, P.178). Because of technology, these instruments have been made available now and in the future for the use of personalized medicinal products. This paper provides an overview of how modern genetic technology may lead to personalized medicine, and to give examples two or more specific benefits of personalized medicine: a discussion of its drawbacks and limitations of the approach to human medicine. “Modern Genetic Technology and Personalized Medicine” Modern technology is constantly growing in our world, for us to understand how modern genetic technology may lead to personalized medicine and the importance personalized medicine. Personalized medicine is the tailoring of medical treatment for an individual with the unique characteristics for each patient. This approach is a......

Words: 821 - Pages: 4

Free Essay

Personalized Medicine

...Personalized Medicine Kenneth Weddle Strayer University Science 115 Professor Meri Stanec May 21, 2012 Personalized Medicine Personalized medicine refers to the medical model that entails the customization of healthcare. Under personalized medicine, all the decisions and practices relating to an individual patient are advanced using genetic or any other vital pieces of information. The emergence of personalized medicine has helped in the reduction of costs, time, and the rate of failure of pharmaceutical clinical trials, has eliminated trial and error inefficiencies in the diagnosis of diseases, and has aided in the prescription of effective drugs and averted those that pose dangerous side effects to patients. This essay explicates the manner in which genetic technology may contribute to personalized medicine, examples of the benefits of personalized medicine, and drawbacks of personalized medicine. Modern genetic technology has played an instrumental role in leading to personalized medicine. It has led to in depth understanding of the impacts of genetics in a given disease. The understanding of the impacts of the disease has helped in the development of personalized medicine, as practitioners are able to identify the correct prescription for different diseases. Modern genetic technology has also led to personalized medicine by helping practitioners understand the significance of genes in the normal......

Words: 680 - Pages: 3

Premium Essay

Personalized Medicine

...have been breakthrough and impressive. The benefits of personalize medicine are easily recognized. The major benefits of personalized medicine are early diagnostics and, medication and treatments are personalized to an individual for maximum results. Diagnostics use molecules to measure the levels of genes, mutation, and proteins that can be used in the provision of specified therapy that fits the patient health condition. (Science daily, 2010). Our DNA and genes can determine the likelihood of an individual developing certain diseases and how an individual can react to certain medication and treatments. With personalized medicine, medical professionals can analyze a patients genome and identify risk factors to intervene and begin a treatment plan that will best cure/treat/delay the disease of that particular patient. Personalized medicine can change the way professionals approach diseases and illnesses. It has the ability to alter healthcare to further fit their individual needs. Using the individuals genome, personalized medicine has become a future possibility. Personalized medicine is developing medicine, specifically for the individuals genetic makeup and therefore, the effectiveness of treatments for diseases is more effective for each specific patient. Medicine and treatments can be customized to an individual's medical care, to better treat that individual's specific needs. Personalized medicine will be...

Words: 577 - Pages: 3

Free Essay

Personalized Medicine

...Personalized Medicine Na’Tasha Slade SCI 115 Professor Palaniswamy August 5, 2012   Personalized Medicine has great influence on the way we think towards identifying and managing healthcare problems and diseases.   Personalize medicine aids in providing an in depth analysis of hereditary differences within genetically difference of people and also how it may affect the healthcare that they may need. With technology being modified daily the advancements in technology may improve the levels of personalize medicine by, giving details on someone metabolic, genetic, and proteinaceous profile that in the future be used to customize individual medical care. The concept of personalized medicine has broadened to include evaluation of your genetic risk of developing disease and determining how serious it may be as well as detecting diseases at much earlier stages—usually before you have symptoms. A personalized medicine approach will also tell you what medicines will work best for you, depending on many different factors, and reduce or eliminate the trial-and-error process of trying to find the right ones. A personalized medicine approach will better monitor disease and treatments and have a better chance of predicting outcomes of therapies and treatment approaches. Personalized medicine usually involves a combination of genetic testing (to determine propensity for certain diseases); suggestions for lifestyle changes; detection of diseases at the molecular level; and......

Words: 541 - Pages: 3

Premium Essay

The Medicines Company

...In 1996, Clive Meanwell formed the Medicines Company whose corporate objective was to “acquire, develop and commercialize pharmaceutical products in late stages of development”. The company looked for abandoned drugs that met four specific criteria: 1) Required less than four years to get to the market 2) Required less than $60 Million to get to the market 3) Had at least a 65% chance of getting to market 4) Had the potential to generate at least $100 Million per year in sales In March 1997, the company got control of the rights to an anticoagulant called Angiomax which has been developed by Biogen but abandoned after test results showed it to be no more effective than the cheaper, entrenched alternative, Heparin. In December 2000, the Medicines Company received FDA approval for the use of Angiomax to prevent blood clots during angioplasties and by early 2001 had taken the drug to the market. The Value of Angiomax to hospitals Angiomax is a blood thinning drug, or anticoagulant which achieved Phase III clinical trials with Biogen, its pharmaceutical creator, in 1994. Upon trial III completion, further investment and trials for the drug were abandoned due to what was understood as marginal results and the forecast of high production costs. Its rights were later purchased by The Medicine Company who continued clinical trials, securing FDA approval and introducing Angiomax to the U.S. market in 2001. Heparin, is the most widely used prescribed drug for acute coronary......

Words: 689 - Pages: 3

Premium Essay

Bio-Medicine

...the medical profession. The sociology of health and illness is concerned with the social origins of and influence on disease rather than exploring its organic manifestation in individual bodies. The sociology of medicine is concerned with exploring the social, historical and cultural reasons for the rise of medicine particularly the bio-medicine model in the definition and treatment of illness. A more refined version of this common sense view underlies the long standing bio-medical model of disease based on the following assumptions. Firstly that disease is an organic condition and non-organic factors associated with the human mind are considered unimportant or are ignored altogether in the search for biological causes of pathological symptoms. Secondly that disease is a temporarily an organic state that can be eradicated and cured by medical intervention. Disease is experienced by a sick individual who then becomes the object of treatment. Disease is therefore treated after the symptoms appear and the application of medicine is a reactive healing process. It I treated in a medical environment in a surgery or hospital away from the site where the symptoms first appeared. During the course of this, scientific medicine has efficiently displaced folk or lay medicine. Modernity is about expertise not tradition. Rather though scientific and technical regulation of the body than mistaken...

Words: 990 - Pages: 4

Free Essay

Medieval Medicine

...David Dubkov 24. Mar.2016 EAC 150 - Aleksandra Bida In the Middle Ages, medical knowledge was limited and remedies were not as effective as they are in the twenty first century. This is because the people of the Middle Ages did not have the vast and in depth knowledge of the human anatomy the way, we do today. They were not able to pinpoint the causes of most diseases, and as a result, were not able to cure them as effectively. People in the Middle Ages also had certain personal beliefs, which affected medical treatment. For instance, the people of medieval England believed that infectious diseases occurred due to the wrath of God because that individual was practicing unethical behaviour (Truman, Health and Medicine in Medieval England). Doctors of the Middle Ages even cured migraines by digging a hole into the skull. They believed that evil spirits were the cause of one’s pain and this was the way to release them. This method was ineffective, and was due to their beliefs, the lack of knowledge of the human body, and the use of unsanitary and dangerous methods of treatment (Trueman). The lack of knowledge stemmed from the fact that dissection was not commonly done. Nowadays, it is routine practise for a medical student to dissect dead animals and perhaps even a human body. This has allowed modern society to understand the workings of the human body on a deeper level. In this essay, I will explain how current day medical professionals have had more......

Words: 1216 - Pages: 5

Free Essay

Future of Medicine

...The future of medicine Thesis: The future of medicine holds advancements in medical technology that will greatly increase our longevity and quality of life. I. Introduction A. Attention Getter: Everyone in this room is going to DIE, what matters to each one of you is when and how your death is going to happen. B. Relevance: The answer to both how and when you are going to die will change dramatically with new medical technology emerging. C. Credibility: As a Pre-Med neuroscience student, I’ve been very interested in the up and coming technology in medicine. In fact, this summer I studied in Germany learning about brain computer interfaces, but I will get more into that later. D. Thesis: (What matters to each one of you is that) the future of medicine holds incredible technological advancements that will greatly increase our longevity and quality of life. E. Preview: In the not so distant future, medicine will tell you if you are about to get sick, or if any of your organs need replacing new ones will be grown with your DNA, and if you are paralyzed or disabled you will be able to control robotic exoskeletons to compensate for any loss with your brain waves. Transition: Now I know this sounds kind of technical and boring and you are probably thinking why do I care, let me answer that. Currently medicine is set up so that if you feel sick you go to the doctor, but by the time you feel symptoms, for instance of cancer, you have a later stage of the disease...

Words: 946 - Pages: 4

Premium Essay

Personal Medicine

...Personal Medicine Pxxxx Gonzalez Strayer University SCI III Instructor: Professor Leon Li August 9, 2012 The Future of Medicine Every living human being on earth is susceptible to future disease. In the future, by screening a patients DNA, scientists and doctors will eventually be able to predict a patients possible health risk factors. By gathering this information doctors will be able to manage better healthcare outcomes for their patients. This information can be used to detect future major illnesses such as cancer, heart disease, hypertension and diabetes as well as other chronic and terminal illnesses. DNA screening will allow a patient to have important medical information in their medical file for illnesses that might otherwise not show up for decades. The Benefits of Personalized Medicine 1. Doctors will know years in advance if their patient will get cancer in the future. By utilizing this information, doctors can help to ensure a longer, healthier life for their patients. 2. By having a patient’s future medical information on file, the patient’s doctor can be better prepared to handle their patient’s healthcare, thereby possibly preventing a major illness from becoming terminal. 3. Personalized Medicine has a future economic benefit as well. In the future, as more and more people get their DNA screened for possible chronic and terminal illnesses. Doctors will be able to stop an otherwise fatal illness from progressing past the......

Words: 606 - Pages: 3

Free Essay

Travel as Medicine

...Due: 7-11-11 The serenity of Caribbean waters or the rich culture of European countries all take me to a place far from the monotonous day to day routine of life. The mere thought of getting away from it all immediately brings calmness to my spirit and a recharge to my battery. Travel carries a universal theme of being therapeutic and has often been noted as one of the best forms of medicine. Therapy is played out by the simple idea of being in a place outside the norm, taking time to rejuvenate with rest and relaxation and creating lasting memories to draw from for those times when travel is needed but not warranted. These are instances where getting away may not be conducive to a persons schedule or budget and memories then become priceless commodities that can be pulled out at any given time. There are millions of places to travel to nationwide and abroad. Tourists are constantly seeking new beaches, museums, national parks and places that allow them to see and visit sites outside of their normal cities. Frequent travelers often take trips seasonally, annually or at will if money is no issue. However, the average consumer may simply look for outlets to relieve stress and places that allow them to do so. Taking a vacation does not necessarily have to constitute flying clear across the country just to get away. Going to a place that you have never visited before could be medicinal therapy in and of itself if it allows a break in routine. Rest and relaxation are......

Words: 686 - Pages: 3

Free Essay

Personalized Medicine

...Wuanda S Green Introduction to Biology Dr. Russell Barnett Personalized Medicine Personalized medicine is a new field of healthcare that is based on an individual’s unique genetic, genomic, clinical and environmental information. The factors vary from one person to another just like the onset of diseases so the purpose of personalized medicine is to react to the individual’s symptoms in the way, with personalized treatment (Jain, 2007). Personalized medicine primary goal and target is to make a treatment as individualize as the person receiving the treatment. This method involves identifying genetic, genomic, and clinical information that will allow accurate predictions to be made about an individual’s susceptibility to a developing disease, the course of that disease and the response to treatment (Cohen, 2008). Modern genetic technology started with the genome project which leads to the benefits and development of personalized medicine (Cohen, 2008). The human genome is the blueprint for each person's body, influencing how we look, our genetic predispositions for certain medical conditions, how well our bodies fight disease or metabolize food, and which therapies our bodies do and do not respond to (Hart, 2005). The genome consists of an organism's total DNA, including its genes. DNA—the famous "double helix"—is composed of four chemicals, which are repeated many times in different sequences (Jain, 2007). (The names of the chemicals are abbreviated as A, T, C, and G.......

Words: 751 - Pages: 4

Premium Essay

Retainer Medicine

...The Argument for using Retainer Medicine as a Means of Improving Primary Care Huddle, M.D., PHD, Centor, M.D. (2011) “Retainer Medicine: An Ethically Legitimate Form of Practice That Can Improve Primary Care.” Annals of Internal Medicine, Volume 55, Number 9 In retainer practices, Primary Care Physicians (PCPs) contract with patients who are willing to pay a flat annual fee either for all primary care services or for services beyond those covered by conventional insurance. The physician with a retainer practice limits his or her patient panel size to a manageable number, creating a more satisfying practice style and more time for both practice and other pursuits; these physicians and their patients have a better primary care experience than before. Critics of retainer medicine suggest that such arrangements breach a de facto social contract between physicians and society and will worsen the current imbalance between the number of primary caregivers and the patients who need them. So far, professional organizations have not taken a stance on retainer medicine, although the American College of Physicians has sounded a cautionary note about its ethical status. The authors contend that retainer medicine is an ethical form of practice that will eventually improve the work conditions for primary caregivers and thereby diminish the shortage of PCPs in the United States. Part of the authors’ argument is they do not believe the pursuit of social justice is an integral aspect......

Words: 1723 - Pages: 7