The Pharmaceutical drug companies have a tendency to focus more on the sales and revenue than the research of any given product. This trend leads to misrepresentation of crucial scientific research on products. “A wide variety of research practices has been described as being used to distort the medical literature in favor of a clinical trial sponsor’s pharmaceutical intervention,” (Ross, Gross, & Krumholz, 2012, para. ).But also, not only do the drug companies practice unethical research studies, they spend money pushing products and incentives to physicians for writing the prescriptions for those drugs. That monetary value of those incentives is, often, more than the research on the drug itself. Two companies have been accused, tried, and charged for smudging results and falsifying findings for their benefit. It appears that pharmaceutical companies have interchanged the quest of treating and healing sickness and disease with the sole purpose of making money.…
References: Division of Drug Marketing, Advertising, and Communications (DDMAC). 2010. Retrieved August 6, 2010 from http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm Food and Drug Administration (2010). Division of Drug, Marketing, Advertising, and Communications. Retrieved from http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm Us Food and Drug Administration. (2010). Retrieved August 9, 2010 from website: http://www.fda.gov/AboutFDA/WhatWeDo/default.htm US Food and Drug Administration (2010). “Inspection, Compliance, Enforcement and Criminal Investigations.” Retrieved August 16, 2010 from www.hhs.gov.…
I would be writing about interest groups and bureaucracy. The FDA bureaucracy article in a way stresses the importance or impact of the executive agency in carrying out its functions. I find testing how politicians try to sway the FDA (and other administrative agencies) in a way to suit their purpose is both necessary and may have a potential for undermining the administration. I thought the research question is of high importance; being able to test the efficiency (in terms of timeliness and quality of outcomes) of an administrative agency using the FDA as a case study. While different agencies will have their peculiarities, it is still necessary to be able to assess them this way. A drawback to this test could be something entirely unrelated…
Pharmacies have an enormous responsibility toward the community they serve because even a minor mistake can cause a big damage (temporal or permanent) on a patient’s…
The causes for medication errors are multiple and interrelated in ways that a single person or device cannot be solely blamed. According to Paul Seligman, M.D., director of the FDA's Office of Pharmacoepidemiology and Statistical Science, " it's important to recognize that medication errors are due to multiple factors in a complex medical system." Many medication errors reported to the FDA may stem from one or more of the following:…
Discovering dangers of prescription drugs after they have been marketed to the medical community and public is common. Generally, 51% of FDA-approved drugs have serious adverse effects not detected prior to approval.1 Each year prescription drugs injure 1.5 million people so severely they require hospitalization. In addition, prescription drugs cause 100,000 deaths annually. With these numbers, how can the public be protected from dangerous…
In the United States there have been numerous medication issues that healthcare institutions have dealt with. The medication has risen in cost; few medications that have been approved by the FDA have resulted in severe side effects. That has led to the health institution liable for legal disputes, lawsuits and a tarnished reputation. This medication issue continues to affect the productivity and the growth of healthcare institution. According to National Academies there at least 1.5 million people every year that deal with medication errors (Dobbins, C., Stencel, C., 2006). That the extra medical cost alone is about 3.5 billion dollars, but does not include the lost wages, the productivity and additional health care cost.…
Some medicines are beyond the scope of the FDA regulatory authority or some are approved to be used in other ways. Often some problems occur after the product has been approved by the FDA (Hooper, 2008). A manufacturer of the popular cholesterol reducing drug recalled 40 batches after finding out that it may contain small particles of glass. The glass particles were similar to the size of a grain of sand. If ingested it could be dangerous. There were no true adverse effects related to the recall are very low which means there are no injuries reported The pharmaceutical company Ranbaxy is recalling bottles of 10, 20, and 40 milligram tablets atorvastatin calcium, the generic version of Lipitor. The FDA granted the company approval of the manufacture of drug in New Jersey in 2011. Ranbaxy has been under the radar since 2006 for submitting false data to FDA and barred the company from manufacturing drugs in the United States until they met standards. Patients needed to find out if they pills they are taking are in the recall. All pharmacies recommend patients to check and see if their medicine is included in the recall before they take another dosage of their medicine. The patients do not have to do much as far as insurance purposes because they are automatically notified. If patient receives their medicine from the pharmacy they can swap out their pills there and mail order patients will…
The milestone drug legislation I have chosen is the “Pure Food and Drug Act” of 1906 which was the first of a series of significant consumer protection laws enacted by Congress in the 20th century and led to the creation of the Food and Drug Administration. Its fundamental design was to boycott remote and interstate movement in contaminated or mislabeled sustenance and medication items, and it coordinated the U.S. Department of Chemistry to review items and elude wrongdoers to prosecutors. It required that dynamic fixings be set on the mark of a medication's bundling and that medications couldn't fall beneath virtue levels built up by the United States Pharmacopeia or the National Formulary (Burnham, John C 1991).…
Your standing in line at your local drug store, head killing you, your face feels like it’s ready to explode, and you cannot breathe if your life depended on it. In short your allergies are making your life unbearable, and you are completely out of Sudafed. When you finally arrive at the pharmacist and ask for a box, you are asked for your driver’s license and then promptly turned away. Recent laws have you waiting one more week before purchasing anything that contains pseudoephedrine or ephedrine. Disgruntled and in pain, you walk away and as you leave the store you overhear the cashier tell a customer “instead of buying a pack a day, why don’t you just buy a carton?” Right about now the FDA’s “…goal of a healthier, safer nation…” ("Overview Of The FDA Mission", 2007) does not feel so accurate. The FDA’s regulations are unjust, because they place corporate profits above consumers’ safety, ban proven natural beneficial health medications, and allow the public’s lifestyle demands to alter their mission.…
The current FDA protocol calls for pharmacies to be registered under the FDA and these pharmacies must get approval from the FDA to sell these drugs (Kindy and Sun 3). Even though the FDA approves the drugs, there is no way to monitor how many doctors are prescribing, In addition, the FDA was forced to change its rules because pharmacies were ordering drugs without the government’s consent (Tavernise 1). However, with the advancement of technology, patients should be required to undergo strict background checks, aimed at identifying those individuals who go from one doctor to another obtain additional prescription drugs. This will allow the FDA to identify drug abusers and assist them in finding the help they need to overcome addiction or dependency. With this drug monitoring program, doctors will be able to help reduce drugs abuses, saving the medical industry millions of dollars in medical costs associated with drug addicts and…
risk, for drugs and medical devices, weighing risks against benefits is at the core of…
When it comes to the topic of prescription drugs being regulated, most of us will readily agree that this is a big concern for many Americans. Where this argument usually ends, however, is on the question of why do Americans pay some of the highest prices for prescription drugs compared to other countries. Whereas some are convinced that these high costs are set solely for the fact of the amount of money spent on producing these drugs, others maintain that there is an opportunity for medication prices to be regulated and also an opportunity to allow Medicare to negotiate with pharmaceuticals and possibly help bring down those high prices . I agree that prescription drugs should be regulated because there are many people that are victimized…
The speed of medical research together with drug companies race to create products has overtaken the system designed to keep people safe (Robert Davis par 2).…
Some medications are not necessarily safe for humans even if it provides positive results in animals. In 950, there was a pill called the sleeping pill that caused 10,000 babies to be brought into this world with severe deformities which was tested prior to it’s commercial release. Another drug called Vioxx which is a arthritis medication showed that it provided a protective effect on an animal’s heart, yet the drug went on to cause more than 27,000 heart attacks and sudden cardiac deaths before it was finally pulled off the market. Rezulin or as some know it as troglitazone was approved by the FDA in 1997. The drug was intended to treat adult onset type 2 diabetes. Rezulin did indeed lower the blood sugar pressure in rats without negative effects, but later the animals reportedly began to have severe and sometimes fatal liver failure. The medication still hit the market and was not withdrawn until 2000 after it causes more than 400 deaths, but only because Los Angeles Times did an intensive investigation which caused them to change their label four times. Despite, all the drugs out there that has caused harm to humans animal testing still continues. Can you imagine all the drugs that could have helped the people in the world if we were actually able to get relevant results. Results that are actually beneficial and 100% guaranteed to work for humans. The percentage rate of a medication to actually been effective on humans is extremely low. 10% that is the percent we are suppose to rely on; the percentage that is used to predict a cure for diseases. Even the supposed animals that best replicate to us can still give us false results. For example, TGN1412 was tested on monkeys, rats, and rabbits and the results were positive for the medication to work, but in the human clinical trials, the subjects began to scream in agony. The drug was suppose to increase the immune responses to a virus, but instead it…