Should drug regulation in the United States be significantly revamped in order to encourage development of drugs targeted at chronic disease? In the United States drug regulation is taken very seriously. Congress holds the power to regulate the distribution, manufacture, and use of narcotics. Congress has the power to regulate narcotics through the Bill of Rights. “Congress may not authorize unreasonable searches and seizures or cruel and unusual punishment of narcotics violators” (Kaplan). Congress is able to see where and how drugs get transported. As of right now new medications for people with rare diseases are being created and approved through the FDA very slowly. There are a lot of regulations that they have to meet which takes a long time to go through. Because these drugs are becoming available to patients so slowly their disease could be getting worse. There are mixed viewpoints for whether drug regulation should be encouraged or looked down upon.
The National Health Council supports the MOODERN Cures Act. The MODDERN in MODDERN Cures Act stands for Modernizing Our Drug and Diagnostic Evaluation and Regulatory Network. This is a policy that is supposed to help patients whom have rare diseases. Their treatments and cures are created a lot slower than more common diseases. The MODDERN Cures Act would make the approval process for new medicines a lot faster. “It would establish ‘dormant therapies’ class for drugs that treat complex conditions with few or non-existent treatments, and allow these therapies additional years for patent and data protection to incentivize their development” (O’Connor). This would encourage research into more personal medications for patients. It would help doctors by letting them ...
... middle of paper ...
... Industry. Ed. Roman Espejo. Detroit: Greenhaven Press, 2012. Opposing Viewpoints. Rpt. from "Cost of Caution: The Impact on Patients of Delayed Drug Approvals." Project FDA Report 2 (June 2010). Opposing Viewpoints in Context. Web. 25 Nov. 2013.
Tandy, Karen P. "Doctors Who Treat Chronic Pain Patients Do Not Need to Fear the War on Drugs." Drug Trafficking. Ed. Karin L. Swisher. San Diego: Greenhaven Press, 1991. Current Controversies. Rpt. from "Dispensing Controlled Substances for the Treatment of Pain." Drug Enforcement Administration, U.S. Department of Justice. 2006. Opposing Viewpoints in Context. Web. 25 Nov. 2013.
Usdin, Steve. “MODDERN Thinking.” BioCentury. Washington Editor. 30 May 2011. Web. 22 November 2013. http://www.biocentury.com/biotech-pharma-news/regulation/2011-05-30/patient-groups-propose-moddern-cures-act-to-promote-personalized-medicine-a16
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.
An ethical dilemma that is currently happening in the medical field regards pain management. Doctors and other medical professionals are faced with this ethical decision on whether to prescribe strong pain medication to patients who claim to be experiencing pain, or to not in skepticism that the patient is lying to get opioids and other strong medications. “Opioids are drugs that act on the nervous system to relieve pain. Continued use and abuse can lead to physical dependence and withdrawal symptoms,” (Drug Free World Online). Opioids are often prescribed to patients experiencing excruciating pain, but doctors are faced with prescribing these drugs as an ethical issue because only a patient can measure the pain they are in, it is simply impossible
In 1906, the Pure Food and Drug Act, that was years in the making was finally passed under President Roosevelt. This law reflected a sea change in medicine-- an unprecedented wave of regulations. No longer could drug companies have a secret formula and hide potentially toxic substances such as heroin under their patent. The law required drug companies to specify the ingredients of medications on the label. It also regulated the purity and dosage of substances. Not by mere coincidence was the law passed only about five years after Bayer, a German based drug company began selling the morphine derivative, heroin. Thought to be a safe, non-habit forming alternative to morphine, heroin quickly became the “cure-all drug” that was used to treat anything from coughs to restlessness. Yet, just as quickly as it became a household staple, many began to question the innocence of the substance. While the 1906 law had inherent weaknesses, it signaled the beginning of the end for “cure-all” drugs, such as opiate-filled “soothing syrups” that were used for infants. By tracing and evaluating various reports by doctors and investigative journalists on the medical use of heroin, it is clear that the desire for this legislative measure developed from an offshoot in the medical community-- a transformation that took doctors out from behind the curtain, and brought the public into a new era of awareness.
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 and the efficient usage of media outlets.
Doctors work under intense pressure, and if a pill could fix a patient’s problems than many saw nothing wrong with that. What exacerbated the problem was that many hospitals also changed their modus operandi with regards to treatment. In some hospitals, “doctors were told they could be sued if they did not treat pain aggressively, which meant with opiates (95). However once the patient became addicted and could no longer get their prescription legally refilled, the drug dealers saw their chance. What is surprising is the fact that pharmaceutical companies acted in the same manner as drug dealers. Both sides did not care about the end user, and the problems they would have to deal with after using what was given to them. Their motive was purely to profit as much as possible, and they did not care about who would get hurt as a result of their
The system has been fraught by delays in receiving treatment, a backdrop of layered bureaucracy, and lack of advanced technology. Currently, the UK system has a limitation on the use of experimental treatment which deprives people of their rights as citizens. Regulating cost and price points will serve as a disincentive for companies in the healthcare sector from coming up with new technologies to better health
As of 2011, Risk Minimization Action Plans (RiskMAPS) have been created to ensure risks of a drug never outweigh the benefits of that drug within the postmarketing period. This program requires that manufacturers design and implement periodic assessments of their programs' effectiveness. The Risk Minimization Action Plans are set in place depending on the overall level of risk a prescription drug is likely to pose to the
Government factors into the equation of the argument. Critics of the drug industry say that there is not enough regulation, while supporters of the pharmaceutical companies argue that there is too much regulation and that that is one...
Per capita spending on prescription drugs in America is far greater than any other country. Kesselheim goes on to say that this is a natural result of America’s free market approach to healthcare resulting in monopolies. These healthcare monopolies are not held accountable for their high drug prices. The claims that these costs can be justified through research and development is rubbish, according to
These patients are desperate and are vulnerable, often consenting to research studies without fully understanding the potential outcome. Therefore, it is imperative to educate the patients, public, and regulatory agencies regarding the pros and cons of these therapies.
There exists rich and extensive literature on pharmaceutical use, chronic pain, morality, and the relationships create...
The war on drugs in our culture is a continuous action that is swiftly lessening our society. This has been going on for roughly 10-15 years and has yet to slow down in any way. Drugs continue to be a problem for the obvious reason that certain people abuse them in a way that can lead to ultimate harm on such a person. These drugs do not just consist of street drugs (marijuana, cocaine, ecstasy), but prescription medications as well. Although there are some instances where drugs are being used by subjects excessively, there has been medical research to prove that some of these drugs have made a successful impact on certain disorders and diseases.
By the year 2000 opioid medicine containing oxycodone etc., are being abused and misused and more than doubled in 10 years’ time.
Rettner, Rachael. "Prescription Drug Problem Sparks Debate Over Solutions." LiveScience.com. LiveScience.com, 21 June 2012. Web. 07 Dec. 2013.
United States. President’s Council on Bioethics. Beyond Therapy: Biotechnology and the Pursuit of Happiness: A Report of the President's Council on Bioethics. New York: Dana Press, 2003. Print.