The Deceivers of Drugs Merck and FDA
Introduction
A blockbuster drug, Rofecoxib, with sales of 2.5 billion dollars of annual sales was pulled off the market (Topol, 2004). The drug was pulled off after epidemiological studies had noted 1.4 million people have had a serious side effect (Medscape Medical News, 2004; Topol, 2004). Rofecoxib side effects were all associated with myocardial infarction, cardiovascular risks, and even death (Smith, 2007; Topol, 2004). Merck a drug manufacturing company and the Food and Drug Administration (FDA) commissioners apparently did not or concealed relevant data from the public that would otherwise be known to protect population health.
A summary of the facts associated with the case including the primary leaders
The rights to protect the public were brutal to public trust provided that the leaders of Merck and the FDA abused their powers to gain social control by deliberately marketing a deadly drug (Mumford, Zaccaro, Harding, Jacobs, & Fleishman, 2000; Smith, 2007). The leaders involved that of FDA commissioners received data from Merck regarding Rofecoxib also known as Vioxx about the health risks, yet failed to release
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Dr. Topol issued in the New England Journal of Medicine stating “ The senior executives at Merck and the leadership at the FDA share responsibility for not having taken appropriate action and not recognizing that they are accountable for the public health…” (Medscape Medical News, 2004, para. 7). Dr. Topol, skilled approach leadership role along with his traits as a leading cardiologist, was simply to acknowledge that FDA leaders and Merck demonstrated poor and corrupt leadership traits, which eventually cost the lives of his patients and their significant
Kaiser Permanente’s mission is to provide care assistance to those in need. As a health maintenance organization, Kaiser Permanente provides preventive care such as prenatal care, immunizations, diagnostics, hospital medical and pharmacy services. Also, they take responsibility and provide exceptional training for their future health professionals for better clinical performance and treatment for the patients. The organization is to ensure fair and proper treatment towards their employees for a pleasant working environment in hospital and to provide medical services especially in a growing population in suburban communities, such as Tracy and Stockton in California.
Dr. John Abramson’s book Overdosed America debunks the myths about the excellence of American medicine. Abramson backs up this claim by closely examining research about medicine, closely examining the unpublished details submitted by drug manufacturers to the FDA, and discovering that the unpublished data does not coincide with the claims made about the safety and effectiveness of commonly used medicines. Abramsons purpose is to point out the flaws of the pharmaceutical industry in order to warn the readers about the credibility of the drugs they are buying. Given the critical yet technical language of the book, Abramson is writing to an audience that may include academic physicians as well as those who want to learn about the corruption of the pharmaceutical industry.
In Melody Peterson’s “Our Daily Meds” , the history of marketing and advertising in the pharmaceutical industry is explored. The first chapter of the book, entitled “Creating disease”, focuses on how major pharmaceutical companies successfully create new ailments that members of the public believe exist. According to Peterson, the success that these drug manufacturers have experienced can be attributed to the malleability of disease, the use of influencial people to promote new drugs, the marketing behind pills, and the use of media outlets.
"In the past two decades or so, health care has been commercialized as never before, and professionalism in medicine seems to be giving way to entrepreneurialism," commented Arnold S. Relman, professor of medicine and social medicine at Harvard Medical School (Wekesser 66). This statement may have a great deal of bearing on reality. The tangled knot of insurers, physicians, drug companies, and hospitals that we call our health system are not as unselfish and focused on the patients' needs as people would like to think. Pharmaceutical companies are particularly ruthless, many of them spending millions of dollars per year to convince doctors to prescribe their drugs and to convince consumers that their specific brand of drug is needed in order to cure their ailments. For instance, they may present symptoms that are perfectly harmless, and lead potential citizens to believe that, because of these symptoms, they are "sick" and in need of medication. In some instances, the pharmaceutical industry in the United States misleads both the public and medical professionals by participating in acts of both deceptive marketing practices and bribery, and therefore does not act within the best interests of the consumers.
Confronted with two failed methodologies, Merck then falsified the test data to guarantee the results it desired. Having achieved the desired efficacy threshold, Merck submitted these fraudulent results to the FDA and European Medicines Agency. Merck attempted to cover up their fraudulent testing actions by destroying evidence of the falsified data and then lying to an FDA investigator. Merck also attempted to bribe the team on the MMRII testing process with financial incentives to cooperate and remain silent about the fraudulent activities and testing taking place. Merck went as far as to threaten Stephen Krahling with jail if he reported fraud to the FDA. Clearly, Merck’s purposes are corrupted and its actions of manipulating science distained its very mission of making the public healthier. Merck is doing the exact opposite of what its company’s objective is to do, it is putting young children and the public’s health at risk, all for the objective of continuous profit, reputation, power, influence, and maintaining its precious license to continue to distribute this vaccine. Thus, Merck’s actions and behaviors are unethical for defrauding the FDA and European Medicines
When it comes to EHR’s a patients medical record follows them wherever they go electronically, whether it be home based care, physicians office or a hospital. Access to medical records are easily accessed through smartphones, and computers depending on the EHR system that particular person or company is using. There are many EHR systems that different health facilities use but one in particular has stuck out to me because I constantly see or hear it being used in health facilities Ive personally been too. The particular EHR system I am talking about is Meditech, and it is one of the largest electronic health record softwares that many hospitals as well as small clinics and health facilities are using in order to transfer patient information, and provide detailed information about a person’s medical history such as their medical records electronically. But lately has Meditech been facing substantial issues with their software and why is Meditech the number one ranked EHR system that is being used still despite these complications? By the end of this paper I hope to have all your answers to these questions addressed and answered.
In August of 2001 Robert Ray Courtney was arrested in Kansas City, Missouri and charged with diluting drugs used to treat cancer patients. Courtney’s actions not only violated criminal and civil laws but they shattered the ethical code and the oath he took as a licensed pharmacist. His actions left many people wondering why anyone would commit such a horrible act, let alone a trusted pharmacist who was providing medication to patients whose very lives depended on him doing his job.
FDA, so many people were harmed. Even other countries versions of the FDA approved it which
Many people throughout the world visit the United States every year to receive medical treatment. This is due to our excellent pharmaceutical industry as it spends million of dollars and many hours of research to come up with what we can only describe as “miracle” drugs and treatments. Part of the success of many of these medications is because the pharmaceutical industry is highly regulated by policies that protect the public from accessing drugs that have not been fully tested and found to be “safe”. However, this was not the case until the late 1990s and early 2000s. One time in history that highly influenced the strict regulations we currently have was the nationwide contamination of patients through blood transfusion or by consuming medications
.... Arkansas has one of the highest numbers of STLs in the United States. In an effort to recoup the costs of dealing with the meth epidemic, twenty counties in Arkansas filed a suit in a federal district court against Pfizer, Inc., and other companies that make or distribute cold and allergy medications. What is the defendants’ ethical responsibility in this case, and to whom do they owe it? Why? [Ashley County, Arkansas v. Pfizer, Inc., 552 F.3d 659 (8th Cir.2009)]
Since its humble beginning as a small drugstore, Merck has placed a large amount of importance on improving the health and well-being of its customers. As drug patents expire and genetic forms of their top products become available, Merck’s strategy is to do the unexpected; instead of raising the price of their older products in favor of patent protected new drugs, Merck focuses on reducing their cost in order to better compete with their generic counterparts. Additionally, Merck’s plan for growth now encompasses a much more aggressive pursuit of new drugs in their pipeline through extensive research. Merck became the second largest health care company in the world after the merger with Schering-Plough in 2009 and has contributed great discoveries like the first cervical cancer vaccine and great resources like the Merck Manuals which are utilized as a source of information to doctors, scientists and consumers worldwide .
In 2010 alone, three drugs reviewed by the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) have failed to gain approval. EMDAC felt each drug (naltrexone/bupriopion, lorcaserin and phentermine/topiratate) had unacceptable safety issues (particularly cardiovascular risk profiles). The committee also concluded that lorcaserin did not provide enough convincing evidence of efficacy and safety to gain approval. EMDAC cite lack of diversity in the phase 3 trial population might result in efficacy of the drug being overstated while potential safety risks understated. Whi...
Bacterial infections are a problem among people of all ages and populations for centuries. Bacterial infections differ from viral infections, flu or cold. Meropenem is newer to the market than many other medications, as it was only approved by the FDA on June 24, 1996. Meropenem treats complicated intra-abdominal infections and skin and skin structure infections (2). These types of treatments are for both adults and children and are also used for children with bacterial meningitis. “To reduce the development of drug-resistant bacteria and maintain the effectiveness of Merrem I.V. [Meropenem] and other antibacterial drugs, Merrem I.V. [Meropenem]. should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.”(1) This quote shows that this medication is a last resort medication. It is to be used in only extreme cases. This makes Meropenem a more effective drug for treating bacterial infections.
Abstract: Systems biology is the new branch of biology which is developed recently as a result of the Human Genome Project. It helps in decoding the various systems in biology by studying different genes, proteins and pathways and ultimately making their computerized models to learn how they react differently to different drugs. So, by studying systems we can design medicines for individuals according to their susceptibility rate and response time to different drugs. In near future, personalized medicine will create novel therapeutics by combining various drugs according to individual optimization [1]. Together, systems biology and individualized medicine will focus on each individual rather than on the concept based on “one size fits all”. They focus more on health rather than illness which is a plus point for curing various deadly diseases such as
Even before the medicine price increase, his business practices had come under scrutiny. He had acknowledged and has had criminal investigations and other claims of wrongdoing made against him. He has run into problems at both a hedge fund he once controlled and has also had other problems at a company called Retrophin another pharmaceutical company he ran and from which he was replaced and later sued by. He also lacked some of the essential qualities of a good leader those being empathy, humility, experience, and general interest in truly leading a company altogether. Martin Shkreli is the epitome of a bad leader. Firstly, he had a major lack of experience in both leadership and the basis of the company he was running. Most successful CEOs have a deep experience and truly understand the products that they are selling. However, Martin Shkreli had no such experience his major qualifications was a business degree and only major experience was running hedge funds which he had got in trouble with the law. Martin lack of experience and knowledge in the field medicine as well running business overall was a strong indicator of his poor leadership. Although he Shkreli is a minor part in a more major issue his ability to even do what he did and be able to be so morally bankrupt and inept at running company yet do so is even more