HIV Medicine and Social Problems - Term Paper Example

HIV Medicine and Social problems In layman’s’ terms, HIV or Human immunodeficiency virus is the of the virus that causes the infection whereas Acquired immune deficiency syndrome (AIDS) refers to the actual infection. AIDS is the state of person where his immune system is compromised to such an extent that infections which may seem harmless to a normal person or child can lead to life threatening situations. This occurs because the individuals’ immune system is too weak to fight off external infections. Although, there is no ‘complete’ cure for AIDS through medicines, there are number of treatment options available. From 1980’s, when AIDS made its presence felt, number of medicines are being developed and tested, but it is not giving a complete cure. To further add to these setbacks, FDA’s polices regarding HIV medicines as well as their testing mechanisms and clearances of those medicines are giving rise to varied issues, particularly social problems involving AIDS affected individuals and even other people. The subject of the origin of AIDS is even more complicated and mysterious than the virus itself. Though many believe the disease to have started in the 1980’s research has proved that the virus was present even in the 1940’s with the earliest known HIV positive blood sample dating back to 1959 in Kinshasa, Central Africa. The significance of the disease and the lack of proper information have lead to a plethora of stories and rumors regarding the topic of origin of the disease. Many consider an African American, homosexual, Air Canada flight attendant as ‘patient zero’ and accuse him of spreading the disease through North America (Sapatkin). Researchers consider the above theory to be fake, but believe in another which is equally, if not more, strange. They consider the disease to have spread from monkeys of central Africa. An excerpt from a nurse stationed at a hospital in Central Africa states “…men copulated with them (monkeys), some apparently picking up some sort of virus as a result.” (Kirk). Stories like these, though outrageous is currently being considered as the true reason for the virus. When viewed from the perspective of medicines, protease-inhibitors and anti-viral drugs can delay the symptoms of AIDS, and can also delay spread of the virus. However, as of date, there is no drug that can totally eradicate the virus, save individuals from the imminent death. Although, AIDS could be fatal, there are many individuals who have been surviving and living healthy by taking drugs. Thus, it is crucial to at least delay the symptoms, and help the victims live a semblance of healthy life for a sizable time. Because of such significance, drugs have to be developed, put for clinical trials and make it available for the affected in a very quick time, and this is where the role FDA comes into the picture. “Patient access to experimental treatment options was increased both during clinical trials and by making drugs available in the marketplace sooner by expediting the approval process.” (“HIV/AIDS Treatment.”). Food and Drug Administration or FDA for short, is an agency of the US Department of Health and Human Services, which is responsible for protecting as well as promoting health of the Americans through legal regulations and by overseeing food safety, trials of medical devices, cosmetics, importantly vaccines as well as OTC drugs. However, when it comes to HIV drugs, FDA was condoned for not expediting the approval process, particularly in the initial period. When many people got affected with AIDS in 1980s and with little awareness about the diseases, FDA was criticized for not supporting them by facilitating drug introduction, thus leading to social problems involving the affected individuals as well as their relatives and friends. The HIV affected individuals were left in the lurch, as they did not have approved medical options to depend on. With social exclusion being one of the major problems of this disease, many of the affected individuals were forced to try unapproved, experimental drugs. It was in the late 1980s; AIDS Coalition to Unleash Power (ACT UP) in association with other HIV activist organizations accused the FDA of needlessly prolonging the approval of HIV medicines, and even went to the extent of closing down FDA offices in Washington, DC, with around 1000 activists participating in the demonstration. “A historical event, shutting down the FDA represents to a vast audience the lethargy of this dysfunctional bureaucracy, which is in charge of testing and approving possible AIDS treatments.” (“ACTUP Capsule History 1988”). After this protest earned public and media attention, then chairman of a government advisory panel on drug approval, Louis Lasagna also criticized FDA’s approval process. Due to these criticisms, FDA put into action expedited drug approval mechanism for many life-threatening diseases particularly AIDS, and that led to the introduction of the first HIV drug, AZT. Although, FDA has been facilitating speedy introduction of HIV medicines since then, its’ role in HIV related medicines as well as procedures is still under scrutiny. One of the key issues is regarding FDA’s approval process for emerging treatments, which has good potential. Although, FDA is quite clear in approving only the drugs and the related treatments that has been successfully passed through clinical trials and testing, it has reoriented its policy in 1992 by adopting the Parallel Track policy. Parallel Track is the name of the policy under which FDA as well as U.S. Public Health Service Agency “permits the distribution of drugs for HIV during the development phase when there is a lack of satisfactory alternative therapies.” (“HIV/AIDS Treatment.”). That is, with the clinical trials, other testings and the eventual distribution of drugs being a long winding process that could take many years, AIDS affected individuals could be left in a detrimental condition without effective treatment options and would be forced to take unsuccessful drugs. To overcome this social problem, as part of the Parallel track policy, potential “drugs are distributed under a protocol which is run “parallel” to the clinical trial being conducted to collect data necessary for approval.” (“HIV/AIDS Treatment.”). However, there are criticisms levelled against this policy due to the risks involved in taking unapproved drugs. Critics of this policy point out the fact that unapproved drugs will mostly lack precise information about the ingredients, and will also be missing the warning labels, which are meant to guide the patients regarding drug administration, side effects, etc. Even according to FDA’s own Marketed Unapproved Drug Compliance Policy Guide, it is being estimated that around thousands of unapproved HIV drugs are being currently available in the market, which could seriously impact the already affected or compromised body of the AIDS infected individuals. “Prescribed by the million every year in the United States, these products pose a potential danger to all patients, but HIV/AIDS patients who suffer weakened immune systems are at an even higher risk as they are more vulnerable to injury due to their disease.” (Puckrein). However, as discussed earlier, when no effective treatment is available, people tend to go for these potential but unapproved treatment options. This is where the role of FDA assumes importance because they can only do the balancing act by providing both the greatest access as well as the protection to the AIDS individuals. The other social problem in which FDA has a crucial role is regarding blood donation of the individuals who are homosexual in their sexual orientation. That is, FDA has come up with guidelines, which prohibits blood collecting agencies or banks from accepting “blood and bone marrow donations from any man who has had sex with another man at any time since 1977.” (Vaughn). This guideline of FDA has created social problems with the homosexual section of the population terming it has discriminatory. Although, they want to constructively contribute to the blood donation process, and would also want to help their friends and relatives, they feel these guidelines restrict them from doing it. However, according to FDA, this guideline is to ensure that blood is not collected from the risky section of the population, and so is being implemented mainly as a preventive measure. FDA has strong facts in hand to support their guideline, and that is, In 2010, men who have sex with men (MSM) accounted for at least 61% of all new HIV infections in the U.S. Between 2008 and 2010, the incidence in MSM increased 12%, while it decreased in other populations. (“Blood Donations from Men”). In addition, even with the advanced testing options like PCR based testing, blood cannot be thoroughly screened for HIV, because there are chances of HIV virus remaining dormant for a sizable “window period”. Although, this issue have been periodically revaluated by the Blood Products Advisory Committee within the FDA, as of the decision in 2007, the ban on homosexual individuals providing blood donation continues. Although, the first national Gay Blood Drive was held in July 2013 with the intention “to pressure the US Food and Drug Administration (FDA) into lifting a ban on blood donations from gay and bisexual men”, the ban continues. (“Gay Blood Drive”) From the above analysis, it is clear that FDA’s role in HIV drugs is crucial. For the past few decades, FDA has been criticized for slowing down the approval process for new HIV drugs. Although, FDA has fast-tracked that process, its restriction as well as facilitation regarding emerging treatments is key issue. In addition, its policies regarding blood donation by MSM have also led to controversies, with both sides having valid arguments. Works Cited “ACTUP Capsule History 1988.” ACTUP, n. d. Web. 23 April 2014. “Blood Donations from Men Who Have Sex with Other Men Questions and Answers.” FDA. 19 Aug 2013. Web. 23 April 2014. “Gay Blood Drive Puts Pressure on U.S. FDA Over Rules.” CDC National Prevention Information Network. 16 July 2013. Web. 23 April 2014. “HIV/AIDS Treatment.” Resolve, n. d. Web. 23 April 2014. Kirk, Polly. “How Aids Began: A Nurses Account.” The Heretical Press, 17 May 1999. Web. 23 April 2014. Puckrein, Gary. “HIV sufferers benefit from the FDA’s unapproved drugs initiative.” KevinMD, 13 Oct 2010. Web. 23 April 2014. Sapatkin, Don. “AIDS: The truth about Patient Zero.” The Star, 6 May 2013. Web. 23 April 2014. Vaughn, Alexa. “Gay Blood Drive puts pressure on FDA over rules.” Seattle Times, 14 July 2013. Web. 23 April 2014. Annotated Bibliography “ACTUP Capsule History 1988.” ACTUP, n. d. Web. 23 April 2014. This source is the official website of the AIDS activist organization, AIDS Coalition to Unleash Power, and features details about activities the carried out by it for the past few decades. The website has listed the activities in a chronological manner, and under the activities in 1988 only, the relevant information regarding FDA’s role in prolonging HIV drug approval process was featured. This source did not have in-depth and detailed discussions regarding FDA role, but mainly snippets, and so this source was useful only in a minimal manner. “Blood Donations from Men Who Have Sex with Other Men Questions and Answers.” FDA. 19 Aug 2013. Web. 23 April 2014. This source is a webpage in the official website of FDA, and mainly features details about the blood donation by MSM. As blood donation by MSM was fraught with risks, this webpage provide details about how blood donation by MSM are regulated and restricted. This source was really helpful to study and discuss about FDA’s policies regarding blood donation by MSM. “Gay Blood Drive Puts Pressure on U.S. FDA Over Rules.” CDC National Prevention Information Network. 16 July 2013. Web. 23 April 2014. This article presented by CDC National Prevention Information Network, provides good details about the issues that are arising due to the blood donation attempts by MSM. It points out how gay men are viewing these restrictions by FDA as a discriminatory action, and are carrying out counter actions like conducting mass blood donation camps. This article was helpful as it aided in writing the arguments regarding FDA’s dubious role in blood donation by MSM “HIV/AIDS Treatment.” Resolve, n. d. Web. 23 April 2014. This source or webpage is featured in the website, Resolve, which focuses on public health issues including AIDS. The webpage provided strong discussion regarding emerging treatment options for HIV, and how FDA is responding to those treatments. This source was helpful in analysing FDA’s role in the case of newer treatments, and how it could cause social impacts. Kirk, Polly. “How Aids Began: A Nurses Account.” The Heretical Press, 17 May 1999. Web. 23 April 2014. This article, featured in the website Heretical Press, is actually a letter written by a nurse to the editor of the London Daily Telegraph newspaper. It provides key information regarding the origins of the AIDS, particularly from angle of a nurse. Although, this source did not contribute to the analysis part, it provided key background information for writing this paper Puckrein, Gary. “HIV sufferers benefit from the FDA’s unapproved drugs initiative.” KevinMD, 13 Oct 2010. Web. 23 April 2014. This source written by Gary Puckrein, President of the National Minority Quality Forum, focuses on how FDA’s strong role regarding unapproved drugs is benefiting the HIV sufferers. In this source, the author particularly points out unapproved drugs could cause major problems for the already affected AIDS affected individual. This source was helpful in providing alternate viewpoints regarding unapproved drugs. Sapatkin, Don. “AIDS: The truth about Patient Zero.” The Star, 6 May 2013. Web. 23 April 2014. This article featured in the Canadian newspaper, The Star, mainly provided details about the origins of the HIV infection. It particularly focused on the news or rumour of how a Canadian Flight attendant was the first HIV infected individual. Due to paucity of relevant information for analysis, this source had minimal use. Vaughn, Alexa. “Gay Blood Drive puts pressure on FDA over rules.” Seattle Times, 14 July 2013. Web. 23 April 2014. This article written by Alexa Vaughn and featured in the newspaper, Seattle Times, also focused on the steps taken by gays against the FDA’s discrimination in blood donation. It particularly talks about the blood donation driven done by the gays to pressurize FDA. This article had good inputs regarding blood donation controversy Read More