Editing Medication (section)

==Controversies==

Controversies concerning pharmaceutical drugs include patient access to drugs under development and not yet approved, pricing, and environmental issues.

===Access to unapproved drugs===
{{Main|Expanded access}}
Governments worldwide have created provisions for granting access to drugs prior to approval for patients who have exhausted all alternative treatment options and do not match clinical trial entry criteria. Often grouped under the labels of compassionate use, [[expanded access]], or named patient supply, these programs are governed by rules which vary by country defining access criteria, data collection, promotion, and control of drug distribution.<ref>{{cite journal |author=Helene S |title=EU Compassionate Use Programmes (CUPs): Regulatory Framework and Points to Consider before CUP Implementation |journal=Pharm Med |volume=24 |issue=4 |pages=223–229 |year=2010 |doi=10.1007/bf03256820 |s2cid=31439802 |doi-access=free }}</ref>

Within the United States, pre-approval demand is generally met through [[treatment IND]] (investigational new drug) applications (INDs), or single-patient INDs. These mechanisms, which fall under the label of expanded access programs, provide access to drugs for groups of patients or individuals residing in the US. Outside the US, Named Patient Programs provide controlled, pre-approval access to drugs in response to requests by physicians on behalf of specific, or "named", patients before those medicines are licensed in the patient's home country.  Through these programs, patients are able to access drugs in late-stage clinical trials or approved in other countries for a genuine, unmet medical need, before those drugs have been licensed in the patient's home country.{{cn|date=May 2023}}

Patients who have not been able to get access to drugs in development have organized and advocated for greater access.  In the United States, [[ACT UP]] formed in the 1980s, and eventually formed its [[Treatment Action Group]] in part to pressure the US government to put more resources into discovering treatments for AIDS and then to speed release of drugs that were under development.<ref>{{cite news |first=Gina |last=Kolata |work=The New York Times |date=12 September 1994 |url=https://www.nytimes.com/1994/09/12/us/fda-debate-on-speedy-access-to-aids-drugs-is-reopening.html |title=F.D.A. Debate on Speedy Access to AIDS Drugs Is Reopening |archive-url=https://web.archive.org/web/20170701041550/http://www.nytimes.com/1994/09/12/us/fda-debate-on-speedy-access-to-aids-drugs-is-reopening.html |archive-date=1 July 2017 |url-status=dead }}</ref>

The [[Abigail Alliance]] was established in November 2001 by Frank Burroughs in memory of his daughter, Abigail.<ref>{{cite journal
 |last=Phillips |first=Lisa |date=4 September 2008 |title=Contract Law and Ethical Issues Underscore the Latest Lawsuit About Access to Experimental Drugs for Duchenne Muscular Dystrophy |journal=Neurology Today |volume=8 |issue=17 |pages=20–21 |doi= 10.1097/01.nt.0000337676.20893.50}}</ref> The Alliance seeks broader availability of investigational drugs on behalf of terminally ill patients.

In 2013, [[BioMarin Pharmaceutical]] was at the center of a high-profile debate regarding expanded access of cancer patients to experimental drugs.<ref>{{cite news | title = Andrea Sloan Faces Pharma Firm With History of Indifference | date = 26 September 2013 | url = http://www.huffingtonpost.com/2013/09/26/andrea-sloan-biomarin_n_3997527.html | work = Huffington Post | access-date = 24 December 2013 | archive-date = 25 December 2013 | archive-url = https://web.archive.org/web/20131225134640/http://www.huffingtonpost.com/2013/09/26/andrea-sloan-biomarin_n_3997527.html | url-status = live }}</ref><ref>{{cite news | title = In cancer drug battle, both sides appeal to ethics | date = 20 September 2013 | url = http://www.cnn.com/2013/09/28/health/compassionate-drug-use/ | work = CNN | access-date = 24 December 2013 | archive-date = 25 December 2013 | archive-url = https://web.archive.org/web/20131225100423/http://www.cnn.com/2013/09/28/health/compassionate-drug-use/ | url-status = live }}</ref>

===Access to medicines and drug pricing===
{{Main|Essential medicines|Societal views on patents}}

Essential medicines, as defined by the [[World Health Organization]] (WHO), are "those drugs that satisfy the health care needs of the majority of the population; they should therefore be available at all times in adequate amounts and in appropriate dosage forms, at a price the community can afford."<ref>{{cite web|url=http://apps.who.int/medicinedocs/en/d/Js4875e/5.2.html |archive-url=https://web.archive.org/web/20140201194528/http://apps.who.int/medicinedocs/en/d/Js4875e/5.2.html |url-status=dead |archive-date=1 February 2014 |title=The Selection and Use of Essential Medicines – WHO Technical Report Series, No. 914: 4. Other outstanding technical issues: 4.2 Description of essential medicines |publisher=Apps.who.int |date=14 April 2016 |access-date=25 June 2016}}</ref>  Recent studies have found that most of the medicines on the WHO essential medicines list, outside of the field of HIV drugs, are not patented in the developing world, and that lack of widespread [[Access to medicines|access to these medicines]] arise from issues fundamental to economic development – lack of infrastructure and poverty.<ref>{{cite web |first=Stanley P |last=Kowalksy |date=2013 |url=http://www.accesstopharmaceuticals.org/wp-content/uploads/2013/02/Kowalski.pdf |title=Patent Landscape Analysis of Healthcare Innovations |archive-url=https://web.archive.org/web/20160304025500/http://www.accesstopharmaceuticals.org/wp-content/uploads/2013/02/Kowalski.pdf |archive-date=4 March 2016 |url-status=dead |work=The Franklin Pierce Center for Intellectual Property |publisher=University of New Hampshire School of Law }}</ref> [[Médecins Sans Frontières]] also runs a [[Campaign for Access to Essential Medicines]] campaign, which includes advocacy for greater resources to be devoted to currently untreatable diseases that primarily occur in the developing world. The [[Access to Medicine Index]] tracks how well pharmaceutical companies make their products available in the developing world.{{cn|date=May 2023}}

[[World Trade Organization]] negotiations in the 1990s, including the [[TRIPS Agreement]] and the [[Doha Declaration on the TRIPS agreement and public health|Doha Declaration]], have centered on issues at the intersection of international trade in pharmaceuticals and [[intellectual property rights]], with developed world nations seeking strong intellectual property rights to protect investments made to develop new drugs, and developing world nations seeking to promote their generic pharmaceuticals industries and their ability to make medicine available to their people via [[compulsory licenses]].

Some have raised ethical objections specifically with respect to pharmaceutical patents and the high prices for drugs that they enable their proprietors to charge, which poor people around the world, cannot afford.<ref name="Banta, D.H. 2001">{{cite journal | author = Banta D.H. | year = 2001 | title = Worldwide Interest in Global Access to Drugs | journal = Journal of the American Medical Association | volume = 285 | issue = 22| pages = 2844–46 | pmid = 11401589 | doi=10.1001/jama.285.22.2844-JMN0613-3-1}}</ref><ref>{{cite journal | author = Ferreira L | year = 2002 | title = Access to Affordable HIV/AIDS Drugs: The Human Rights Obligations of Multinational Pharmaceutical Corporations | url = http://ir.lawnet.fordham.edu/cgi/viewcontent.cgi?article=3874&context=flr&sei-redir=1& | journal = Fordham Law Review | volume = 71 | issue = 3 | pages = 1133–79 | pmid = 12523370 | access-date = 20 January 2014 | archive-date = 1 April 2014 | archive-url = https://web.archive.org/web/20140401205420/http://ir.lawnet.fordham.edu/cgi/viewcontent.cgi?article=3874&context=flr&sei-redir=1& | url-status = live }}</ref> Critics also question the rationale that exclusive patent rights and the resulting high prices are required for pharmaceutical companies to recoup the large investments needed for research and development.<ref name="Banta, D.H. 2001"/> One study concluded that marketing expenditures for new drugs often doubled the amount that was allocated for research and development.<ref>{{cite journal | author1 = Barton J.H. | author2 = Emanuel E.J. | year = 2005 | title = The Patents-Based Pharmaceutical Development Process: Rationale, Problems and Potential Reforms | journal = Journal of the American Medical Association | volume = 294 | issue = 16 | pages = 2075–82 | pmid = 16249422 | doi = 10.1001/jama.294.16.2075 | s2cid = 10277752 }}</ref> Other critics claim that patent settlements would be costly for consumers, the health care system, and state and federal governments because it would result in delaying access to lower cost generic medicines.<ref>{{cite web|title = Misguided Policy on Patents|url = http://www.gphaonline.org/gpha-media/press/gpha-ftc-misguided-policy-on-patentsettlements|publisher = Generic Pharmaceutical Association (GPhA)|access-date = 8 October 2015|archive-date = 28 September 2015|archive-url = https://web.archive.org/web/20150928124131/http://www.gphaonline.org/gpha-media/press/gpha-ftc-misguided-policy-on-patentsettlements|url-status = live}}</ref>

[[Novartis]] fought a protracted battle with the government of India over the patenting of its drug, [[Gleevec]], in India, which ended up in a Supreme Court in a case known as [[Novartis v. Union of India & Others]].  The Supreme Court ruled narrowly against Novartis, but opponents of patenting drugs claimed it as a major victory.<ref>Charlotte Harrison [http://www.nature.com/nrd/journal/v12/n5/pdf/nrd4007.pdf?WT.ec_id=NRD-201305 Patent watch] Nature Reviews Drug Discovery 12, 336–337 (2013)</ref>

===Environmental issues===
{{Main|Environmental impact of pharmaceuticals and personal care products}}

Pharmaceutical medications are commonly described as "ubiquitous" in nearly every type of environmental medium (i.e. [[Lake|lakes]], [[River|rivers]], [[Stream|streams]], [[Estuary|estuaries]], [[seawater]], and [[soil]]) worldwide.<ref name=":0">{{Cite journal |last1=Richmond |first1=Erinn K. |last2=Grace |first2=Michael R. |last3=Kelly |first3=John J. |last4=Reisinger |first4=Alexander J. |last5=Rosi |first5=Emma J. |last6=Walters |first6=David M. |date=2017-01-01 |title=Pharmaceuticals and personal care products (PPCPs) are ecological disrupting compounds (EcoDC) |url=https://doi.org/10.1525/elementa.252 |journal=Elementa: Science of the Anthropocene |volume=5 |page=66 |doi=10.1525/elementa.252 |bibcode=2017EleSA...5Q..66R |issn=2325-1026}}</ref><ref name=":1">{{Cite journal |last1=Ebele |first1=Anekwe Jennifer |last2=Abou-Elwafa Abdallah |first2=Mohamed |last3=Harrad |first3=Stuart |date=2017-03-01 |title=Pharmaceuticals and personal care products (PPCPs) in the freshwater aquatic environment |url=https://www.sciencedirect.com/science/article/pii/S2405665016300488 |journal=Emerging Contaminants |volume=3 |issue=1 |pages=1–16 |doi=10.1016/j.emcon.2016.12.004 |issn=2405-6650}}</ref><ref name=":2">{{Cite journal |last1=Patel |first1=Manvendra |last2=Kumar |first2=Rahul |last3=Kishor |first3=Kamal |last4=Mlsna |first4=Todd |last5=Pittman |first5=Charles U. |last6=Mohan |first6=Dinesh |date=2019-03-27 |title=Pharmaceuticals of Emerging Concern in Aquatic Systems: Chemistry, Occurrence, Effects, and Removal Methods |journal=Chemical Reviews |language=en |volume=119 |issue=6 |pages=3510–3673 |doi=10.1021/acs.chemrev.8b00299 |pmid=30830758 |issn=0009-2665|doi-access=free }}</ref><ref>{{Cite web |last=Environment |first=U. N. |date=2020-09-17 |title=Environmentally Persistent Pharmaceutical Pollutants (EPPPs) |url=http://www.unep.org/explore-topics/chemicals-waste/what-we-do/emerging-issues/environmentally-persistent-pharmaceutical |access-date=2024-01-07 |website=UNEP – UN Environment Programme |language=en}}</ref> Their chemical components are typically present at relatively low [[Concentration|concentrations]] in the ng/L to μg/L ranges.<ref name=":3">{{Cite journal |last1=Liu |first1=Jin-Lin |last2=Wong |first2=Ming-Hung |date=2013-09-01 |title=Pharmaceuticals and personal care products (PPCPs): A review on environmental contamination in China |journal=Environment International |volume=59 |pages=208–224 |doi=10.1016/j.envint.2013.06.012 |issn=0160-4120|doi-access=free |pmid=23838081 |bibcode=2013EnInt..59..208L }}</ref><ref name=":2" /> The primary avenue for medications reaching the environment are through the [[effluent]] of wastewater [[Water treatment|treatment plants]], both from [[Industrial water treatment|industrial plants]] during production, and from [[Sewage treatment|municipal plants]] after consumption.<ref>{{Cite journal |last1=Gadipelly |first1=Chandrakanth |last2=Pérez-González |first2=Antía |last3=Yadav |first3=Ganapati D. |last4=Ortiz |first4=Inmaculada |last5=Ibáñez |first5=Raquel |last6=Rathod |first6=Virendra K. |last7=Marathe |first7=Kumudini V. |date=2014-07-23 |title=Pharmaceutical Industry Wastewater: Review of the Technologies for Water Treatment and Reuse |url=https://pubs.acs.org/doi/10.1021/ie501210j |journal=Industrial & Engineering Chemistry Research |language=en |volume=53 |issue=29 |pages=11571–11592 |doi=10.1021/ie501210j |issn=0888-5885}}</ref> [[Agricultural pollution]] is another significant source derived from the prevalence of [[antibiotic use in livestock]].<ref name=":3" />

Scientists generally divide environmental impacts of a chemical into three primary categories: persistence, [[bioaccumulation]], and [[toxicity]].<ref name=":1" /> Since medications are inherently bio-active, most are naturally degradable in the environment, however they are classified as "pseudopersistent" because they are constantly being replenished from their sources.<ref name=":0" /> These [[Environmental persistent pharmaceutical pollutant|Environmentally Persistent Pharmaceutical Pollutants]] (EPPPs) rarely reach toxic concentrations in the environment, however they have been known to bioaccumulate in some species.<ref>{{Cite journal |last1=Anand |first1=Uttpal |last2=Adelodun |first2=Bashir |last3=Cabreros |first3=Carlo |last4=Kumar |first4=Pankaj |last5=Suresh |first5=S. |last6=Dey |first6=Abhijit |last7=Ballesteros |first7=Florencio |last8=Bontempi |first8=Elza |date=2022-12-01 |title=Occurrence, transformation, bioaccumulation, risk and analysis of pharmaceutical and personal care products from wastewater: a review |url=https://doi.org/10.1007/s10311-022-01498-7 |journal=Environmental Chemistry Letters |language=en |volume=20 |issue=6 |pages=3883–3904 |doi=10.1007/s10311-022-01498-7 |issn=1610-3661 |pmc=9385088 |pmid=35996725|bibcode=2022EnvCL..20.3883A }}</ref> Their effects have been observed to compound gradually across [[Food web|food webs]], rather than becoming acute, leading to their classification by the [[United States Geological Survey|US Geological Survey]] as "Ecological Disrupting Compounds."<ref name=":0" />