HIV, PHARMACEUTICALS AND GLOBAL GOVERNANCE: PERSPECTIVES FROM AN INDIVIDUALISED INTERNATIONAL VISITOR LEADERSHIP PROGRAM (IVLP) IN THE UNITED STATES

The International Visitor Leadership Program (IVLP) is the U.S. government’s premier professional exchange program, established in 1940 and designed to increase mutual understanding through communications and diplomacy. Participants are chosen in areas that the U.S. Embassy has deemed of bilateral interest to the host country and the US.[1]

Since 2010, the Malaysian AIDS Council has been involved in coordinating a national campaign on access to generic medication and the Trans-Pacific Partnership Agreement (TPP), opposing TRIPS-plus provisions including patent extensions, data exclusivity, data linkage, and investor-state dispute settlement (ISDS), among other provisions, on the grounds that they would reduce access to generic medication. The TPP, a 12-country multilateral trade agreement contains IP proposals that are ‘widely acknowledged as the latest manifestation of the US maximalist agenda in international intellectual property rulemaking.’[2] Malaysia, a country of 29 million people, is categorised as upper middle income, but has an average household income of USD$1614 per month. A study conducted in 2011 showed that Malaysian pharmacists recommend generic medicine substitution for 84.7% of all brand name medicine requests.[3] Due to these and other considerations, I represented the Malaysian AIDS Council at several stakeholder sessions at four TPP negotiation rounds: Auckland, Singapore, Kota Kinabalu, and Brunei, and through these rounds became acquainted with economic counsellors and other economic staffers at the US Embassy in Malaysia. I made several media appearances criticising TRIPS-plus provisions in the TPP on both Malay-language and English-language television and radio networks, and reached a certain level of visibility and prominence on the topic. I also participated in closed-door meetings with high-level trade officials. I was nominated for the IVLP in 2014 and after a vetting process, was notified in April 2015 of selection for a 3 week individualised program on HIV, pharmaceuticals and global governance to begin in May 2015, with target cities of Washington, D.C., New York City, Chicago, Indianapolis, and Los Angeles.

The implicit goals were that I would be sensitised as to the American healthcare system, barriers and obstacles to quality healthcare in the US, and rationales as to intellectual property policy in international trade, and engage with persons who – for reasons of socioeconomic or sociocultural marginalisation – have difficulty accessing healthcare. These persons included undocumented persons, multi-ethnic populations, and young black and Latino LGBT populations, among others. The following are observations from visits and meetings and analyses of those meetings.

Sexual transmission of HIV among black and disadvantaged populations in Washington DC

DC has HIV rates that mirror rates in some African countries. [4] In 2009, the highest prevalence was disproportionate among black residents, at 4.3%.[5] While overall HIV prevalence has reduced, it remains at epidemic proportions, at 2.5% of the population.[6] In addition to HIV statistics, DC also has among the highest STD rates in the US.[7] 60% of District residents living with HIV are between the ages of 40-59[8] suggesting an aging population of people living with HIV. A 2014 study among 1553 black men-who-have-sex-with-men (MSM) in 6 US cities (including Washington DC) found that newly diagnosed HIV-infected black MSM were more likely to be unemployed, have bacterial STIs and engage in unprotected receptive anal intercourse than other black MSM, and concluded that there was a need for culturally-tailored programs addressing economic disenfranchisement and increased engagement in care, among others.[9]

On 7 May 2015, I met with Dr Celia Maxwell, Associate Dean for Research at Howard University Hospital, a historically black institution operating opt-out HIV testing. At the time of meeting, her project had tested 93,599 persons, out of which 93,298 had known insurance statuses. From this figure, 67% were covered by Medicaid.[10] Here I learnt that people living with HIV in the poorest DC wards (7 & 8) also faced a number of co-occurring diseases and comorbidities, complicating healthcare. These wards have the District’s highest obesity rates, and are home to large ‘food deserts’ i.e. a lack of access to full service grocery stores and farmers markets due to uneven distribution.[11] These poor wards also have been most recently associated with up to 10 times higher mortality rates for infants as compared to the richest wards.[12]

HIV epidemic in Scott County, Indiana

At the time of writing, Scott County, Indiana, is undergoing a HIV epidemic among injecting drug users. Governor Mike Pence recently declared it a public health emergency, and reluctantly approved needle-and-syringe exchange programs towards the end of the first quarter of 2015.[13] While there was a perception that the epidemic emerged out of nowhere, health professionals in Indiana soon negated this. Scott County for some time has been characterised by poverty, a lack of opportunity, and a culture of drug use.[14]

On 19 May 2015, I visited a Community Outreach Centre in Austin, Scott County. It was a standalone white building set in a patch of grass, and as we drove up at 9:45am we were amazed at the number of cars that were already there. Inside, the environment was bustling. They had some kind of support group or training going on that morning. The actual room where sterile injecting equipment was given out had a surgical screen running across it, behind which were two tables where staffers and clients sat for consultations and needle-and-syringe exchange. There I met with the Preparedness Coordinator, Patti Hall, who was a recent convert to needle and syringe exchange programs and explained with enthusiasm the services that were available there. She attested as to the lack of opportunity stimulating injecting use, stating that there was no motivation for kids to finish high school because even if they did, there was no guarantee that jobs would be available for them.

The day before, I had met with an infectious diseases physician who proudly related their upcoming treatment program for Hepatitis C with the new revolutionary direct-acting antiviral, Sovaldi. I enquired as to the price of the medication, given that it was registered in the US at the price of $84,000 for a 12-week regiment[15], and at varying prices in middle income ($5000-10000 for 12 weeks) and low-income countries. When she professed that they were providing it at the full price, I wondered as to (1) the apparent lack of negotiation power; (2) intellectual property barriers in place that would prohibit generic competition; and (3) the strength of the pharmaceutical lobby. It seemed amazing to me that given the HIV epidemic and that it was a given that Hepatitis C rates would be higher than the HIV rates, and given that it was clear that the demographic was low-income, that they would be offered sofosbuvir at the exorbitant price of $84,000. This price seems highly inappropriate given recent estimates that when produced at volume, treatment with DAAs could cost US$171-360 per person without genotyping for 12 weeks.[16]

Treatment access for undocumented immigrants in California

California has more immigrants than any other US state.[17] While the majority are documented, 7% of the state’s total population, or 2.6 million people, are undocumented.[18] Language and cultural differences continue to constitute barriers to health delivery and registration for coverage under the Affordable Care Act. On 21 May 2015 I met with Gerald Kominski, Professor of Public Health and Management, and Director of the UCLA Centre for Health Policy Research. Under the latter designation, Kominski’s centre conducts and coordinates the California Health Interview Survey (CHIS), a statewide survey examining, among other things, uptake of health insurance schemes, and compiles Californian health status information. Data from CHIS shows that 3.5 million persons in California remain uninsured, and that tremendous disparities exist between white and latino populations, among others.

Access to healthcare in California for undocumented immigrants is significantly worse when compared to other populations. They have the highest rate of no usual access to care (35%) when compared to lawful permanent residents (LPRs), naturalized citizen immigrants, and U.S.-born nonelderly adults.[19] In a 2013 report, the UCLA Center for Health Policy Research found that healthcare reform law was unlikely to improve the situation for undocumented immigrants given that they would be excluded from Medicaid expansions, among other reasons.[20]

During my time in California I became aware of non-profit organisations providing affordable HIV care to undocumented immigrants under a program called 340B, which mandates discounts on medications.

Analysis and Thoughts Pertaining to IP, TPP and the IVLP

As time passed and I got closer to finishing my 3-week program, it was clear that my sensitisation to US healthcare policy had not made me any less against the TPP. If anything, it had made me realise that there are many disadvantaged and disenfranchised Americans that deserve access to affordable generics, and that the strength of the pharmaceutical lobby that is so much more strongly entrenched compared to elsewhere around the world contributes greatly to health disparity. I also became acutely aware of the diversity of health issues across the US, but also that poverty was often a common denominator.

Americans pay far more for healthcare than people in any other developed country, even though US life expectancy falls below the average for developed countries.[21] Patent abuse is common, and this year Senators Chuck Grassley and Patrick Leahy, among others, introduced legislation to end abusive patent trolling.[22] Given that the percentage of new drugs that are ‘highly innovative’ continue to be decreasing over time[23], and many pharmaceutical companies rely on incremental innovations to maintain or continue patents[24], the risk of patent abuse from TRIPS-plus provisions are high. Patent extensions i.e. evergreening and patents for new uses and forms of medication are part of the IP provisions in the TPP, and would create an environment for patent abuse in TPP countries.

In regard to health centres providing more affordable drugs under the 340B program, the transparency annex of the TPP would require the US government to allow the pharmaceutical corporations to appeal drug pricing decisions such as the rebate amounts set under the 340B program.[25] This would affect medicines prices provided by migrant health centres, homeless health centres, and family planning clinics.[26]

Arguments for the TPP in the US have revolved around the creation of jobs – the Obama administration claims that 650,000 jobs will be created as a result of the TPP but this figure comes from calculations from the heavily criticised Peterson Institute study. Glenn Kessler of the Washington Post elaborates: ‘Essentially, the book suggests that an income gain of $121,000 would be “roughly equivalent to creating an extra job”. So the Obama administration took the figure of $77.5 billion (the estimated gain in income) and divided by $121,000, which yields 640,000. Rounded up, that becomes 650,000.’[27] And even on the off chance that it would create jobs, arbitrary medicines provisions in the TPP would keep healthcare costs high, raising real doubts as to the net benefit.

Proponents of the strong IP provisions in the TPP repeatedly say that the rules are to recoup R&D costs – but there is increasingly more evidence that R&D costs are overestimated.[28] Gagnon and Lexchin’s (2008) study estimating pharmaceutical promotion costs interestingly quotes the late Democratic Senator Estes Kefauver, Chairman of the United States Senate's Anti-Trust and Monopoly Subcommittee, who said that costs and prices were extravagantly increased by large expenditures in marketing. The authors in this study found that pharmaceutical companies spend almost twice as much on promotion as they do on R&D[29], and that while this isn’t confirmatory of Kefauver’s arguments, they certainly generate cause to reexamine prices of medications in relation to pharmaceutical marketing costs.

The defeat of Fast Track/key prerequisites for Fast Track for the TPP twice in the US was demonstrative of increasing unease with this secretive trade agreement and its dubious benefits. In June 2015, Nancy Pelosi did not back Obama on Trade Adjustment Assistance, a prerequisite for Fast Track. Sherman, Bresnahan and French in Politico elaborated: ‘By Friday morning, it was clear that a crucial piece of Barack Obama’s trade initiative was barreling toward defeat. Democrats were disjointed, dispirited, even angry in some cases… On Friday morning, before she spoke to Boehner, Pelosi told Obama — sitting in her office during a last-ditch visit to the Capitol — that she probably wouldn’t back TAA, a necessary precursor to the fast-track vote he worked hard to pass. But when Pelosi’s decision was final that she would split with the president, one of her aides – not the California Democrat herself – delivered the news to the White House.’[30]

This political divisiveness on the TPP was welcome to many civil society groups in TPP countries, but many were acutely aware that the defeats could be temporary. Their suspicions were well founded. On 24 June 2015, Senate gave Obama fast-track authority with a 60-38 vote[31], and on 29 June 2015, President Obama signed into law the bill that would give him fast track power.[32]

While this in itself does not mean the fight is over, my worry is that we are of course much closer to the conclusion of the TPP. The silver lining, of course, is that the White House is on the defensive and rightly so. The medicines issue is colossal, Malaysia as a major currency manipulator might be, actual impact on US jobs, and the secrecy element could still throw a wrench into the finalisation of the TPP. Our task is to up the opposition to it before it goes to Congress for that up or down vote. Livelihoods across the world depend on it.

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[1] Embassy of the United States of America, Kuala Lumpur, International Visitor Leadership Program (IVLP)

[2] Sean Flynn et al. The US Proposal for an Intellectual Property Chapter in the Trans-Pacific Partnership Agreement. 28 Am. U. Intl. L. Rev. 105, 108 (2013), quoted in Burcu Kilic, Defending the Spirit of the DOHA Declaration in Free Trade Agreements: Trans-Pacific Partnership and Access to Affordable Medicines (2014) 12(1) Loyola University Chicago International Law Review 23-57

[3] Chong CP, Hassali MA, Bahari MB and Shafie AA. Generic medicine substitution practices among community pharmacists: a nationwide study from Malaysia. Journal of Public Health 2011; 19(1): 81-90.

[4] Janice Hopkins Tanne, HIV Prevalence in US capital is at Epidemic Level (2009) 338(1205) BMJ

[5] Ibid.

[6] Government of the District of Columbia, Department of Health, HIV/AIDS, Hepatitis, STD and TB Administration (HAHSTA), Interim HIV/AIDS Surveillance Report: Preliminary 2013 Data (December 2014)

[7] Matt Cohen, Report: D.C. Has One Of The Highest STD Rates In The Country (25 March 2015) DCist <http://dcist.com/2015/03/report_dc_has_one_of_the_highest_st.php> Accessed 14 June 2015

[8] DC Department of Health (DOH) HIV/AIDS, Hepatitis, STD and TB Administration (HAHSTA) 2013 HAHSTA Annual Report. Released June 2014.

[9] Kenneth H Mayer, Lei Wang, Beryl Koblin, et al. Concomitant Socioeconomic, Behavioral, and Biological Factors Associated with the Disproportionate HIV Infection Burden among Black Men Who Have Sex with Men in 6 U.S. Cities. (2014) 9(1) PLOSOne e87298

[10] Dr Celia Maxwell (2015) unpublished data.

[11] DC Hunger Solutions. When Healthy Food is out of Reach: an Analysis of the Grocery Gap in the District of Columbia (2010)

[12] Save the Children. The Urban Disadvantage: State of the World’s Mothers 2015 (2015) <http://www.savethechildren.org/atf/cf/%7B9def2ebe-10ae-432c-9bd0-df91d2eba74a%7D/SOWM_EXECUTIVE%20SUMMARY.PDF> Accessed 14 June 2015

[13] Sarah Kaplan, Indiana is battling the worst HIV outbreak in its history (26 March 2015) The Washington Post <http://www.washingtonpost.com/news/morning-mix/wp/2015/03/26/indiana-is-battling-the-worst-hiv-epidemic-in-state-history/> Accessed 14 June 2015

[14] Danielle Lama, Why Scott County? An in-dept look at the HIV epidemic that’s hit so close to home (12 May 2015) WRDB.com <http://www.wdrb.com/story/29033419/why-scott-county-an-in-depth-look-at-the-hiv-epidemic-thats-hit-so-close-to-home> Accessed 14 June 2015

[15] Drew Armstrong, At $84,000 Gilead hepatitis C drug sets of payer revolt (28 January 2014) Bloomberg Business <http://www.bloomberg.com/news/articles/2014-01-27/at-84-000-gilead-hepatitis-c-drug-sets-off-payer-revolt> Accessed 14 June 2015

[16] van de Ven et al. Minimum Target Prices for Production of Direct-Acting Antivirals and Associated Diagnostics to Combat

Hepatitis C Virus (2014) Hepatology

[17] Marisol Cuellar Mejia and Hans Johnson, Immigrants in California (May 2013) Public Policy Institute of California <http://www.ppic.org/main/publication_show.asp?i=258> Accessed 14 June 2015

[18] Enrico Marcelli, Manuel Pastor, and Steve Wallace. Ensuring California’s Future by Insuring California’s Undocumented: Why Excluding Undocumented Californians from the Affordable Care Act Hurts All of Us. (May 2014)

[19] Steven P. Wallace, Jacqueline M. Torres, Tabashir Z. Nobari, and Nadereh Pourat, Undocumented and Uninsured: Barriers to Affordable Care for Immigrant Populations (August 2013) UCLA Center for Health Policy Research <http://healthpolicy.ucla.edu/publications/Documents/PDF/undocumentedbrief-aug2013.pdf> Accessed 15 June 2015

[20] Ibid.

[21] Alexander EM Hess and Michael B Sauter, Countries spending most on healthcare (2 July 2013) 24/7 Wall St (Accessed 14 June 2015)

[22] Chuck Grassley, Senators Aim to End Patent Abuses that Cost U.S. Economy Billions of Dollars Every Year (29 April 2015) <http://www.grassley.senate.gov/news/news-releases/senators-aim-end-patent-abuses-cost-us-economy-billions-dollars-every-year> Accessed 15 June 2015

[23] National Institute for Health Care Management, Changing Patterns of Pharmaceutical Innovation (2002)

[24] Cynthia M Ho, Drugged Out: How Cognitive Bias Hurts Drug Innovation (2014) 51(2) San Diego Law Review 419-508

[25] Public Citizen, TPP: the ‘Trade’ Deal that Could Inflate Your Healthcare Bill < http://www.citizen.org/documents/TPP-threats-to-US-healthcare.pdf> Accessed 15 June 2015

[26] Ibid.

[27] Glenn Kessler, The Obama administration’s illusionary job gains from the Trans-Pacific Partnership (30 January 2015) < http://www.washingtonpost.com/blogs/fact-checker/wp/2015/01/30/the-obama-administrations-illusionary-job-gains-from-the-trans-pacific-partnership/> Accessed 15 June 2015

[28] Donald W Light and Rebecca Warburton, Demythologizing the high costs of pharmaceutical research (2011)

The London School of Economics and Political Science 1745-8552 BioSocieties 1–17

[29] Gagnon M-A, Lexchin J (2008) The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States. PLoS Med 5(1): e1. doi:10.1371/journal.pmed.0050001

[30] Jake Sherman, John Bresnahan, and Lauren French, How Pelosi Broke with Obama (12 June 2015) Politico < http://www.politico.com/story/2015/06/how-pelosi-broke-with-obama-118961.html#ixzz3cuBxoYSm> Accessed 15 June 2015

[31] Paul Lewis, Barack Obama given ‘fast-track’ authority over trade deal negotiations (24 June 2015) The Guardian <http://www.theguardian.com/us-news/2015/jun/24/barack-obama-fast-track-trade-deal-tpp-senate> Accessed 30 June 2015

[32] The Straits Times, US President Obama signs 'fast-track' trade bills into law, says tough battle still ahead (30 June 2015)