Archive for April, 2007

Tuesday April 24, 2007

April 24, 2007 - 10:45 am 1 Comment

Overall, our team placed 4th in the nation! Quite incredible, considering that we were in shambles the previous year. It was a true collective effort – the pooled result of strong prelim rounds and a good showing in elimination rounds. Ahh, I feel somewhat vindicated. Next year, I’ll do much better.

Debate council elections tonight…I’m ready for a major political battle!

Monday April 23, 2007

April 23, 2007 - 12:26 am 1 Comment

Debate nationals has felt like an eternity – I’ve been stuck in Rome, Georgia for the past five days. Thankfully, I’ll leave tomorrow evening and arrive back Tuesday morning…in time for one day’s rest and a statistics final.

I’m not sure what my preliminary record was, but I ended up breaking to elimination rounds (top 32 out of approximately 150-200 debaters). I lost in double-octos, meaning that I took 17th place overall, but I admit that the result was very disappointing, especially since my opponent didn’t really understand my case and ran a counterplan that inherently contradicted the principles of feed-in tariffs. Granted, there were aspects that I could have handled better, but I honestly thought I had a much greater advantage on him, especially since he could not respond to any of the price/structural criticisms that I made during my 1AR.

Yes, I’m disappointed, but at least we have one teammate who is advancing further! The team is cheering for him all the way! He’s quite the underdog, especially since no one really expected him to get as far as he did. (But that of course, makes the victory all the more sweet.) GO TEAM!!

I’ll admit I’m kind of stressed out since I accomplished next to no studying due to the constant distractions of the environment. My loss, of course, exacerbates the situation, coupled with sleep deprivation and a mild case of anxiety.

Tuesday April 17, 2007

April 17, 2007 - 1:07 pm 3 Comments

In light of the tragic Virginia Tech shootings, my mundane preoccupations about studying seem so trite. As a testament to the fact that our conception of the world order is so easily shattered, the incident reminds us that it takes only one disenfranchised individual to disrupt the lives of thousands.

Thankfully, Grace is safe. But my heart goes out to all the families, students, and professors affected by the tragedy. Two professors in my sister’s ESM department were killed, as were many students from our Northern Virginia hometown. The cruelty of the situation is unimaginable – indiscriminate killing based on a personal vendetta.

Sunday April 15, 2007

April 15, 2007 - 9:14 pm 2 Comments

The team will leave for debate nationals on Wednesday morning, 3 AM. I will not get back until the following Tuesday, 9 AM. Due to budget constraints, we’ll have to brave a 10 hour drive each way, though I suspect I’ll attempt to sleep through it.

Effectively, I have one day to rest before I have to take my statistics final and submit my anthropology paper, followed quickly by finance and calculus on the next day. Then, I have one day of reprieve before the management final.

Quite an awful schedule, considering that unlike the rest of Penn, my reading days will be filled with debate rounds on USFG energy policy rather than academic material! If I am able to muster the capacity to study in-between rounds, I will be fine. Nevertheless, given that I am quite familiar with the sad fact that either a bad or overly exciting round can really upset my mood and ability to concentrate, I maintain a rather dubious outlook on my net studying time. I can’t let this last week upset a semester’s worth of effort!

As for squeezing the life of out my remaining time before departure, I propose the following plan:

 

Sunday night:

STATISTICS

1.      Cover independent normal variables (5.3) and conditional distributions: discrete case (6.1)

2.      Do corresponding practice problems

FINANCE:

1.      Cover investing internationally and exchange rate expectations

2.      Do corresponding practice problems

Wharton Research Scholars Application

Set up interviews with Pfizer, GSK, Novartis, WHO

Monday night:

STATISTICS

1.      Cover conditional distributions: density case (6.2) and covariance and correlation (6.4)

2.      Do practice problems

3.      Do homework and check answers with TA on Tuesday

DEBATE

1.      Inherency evidence search

FINANCE:

1.      Mexico macroeconomic analysis presentation preparation

2.      VAR analysis

Finish everything that I did not get to complete Sunday night.

Wednesday April 11, 2007

April 11, 2007 - 11:45 pm 4 Comments

So many things have happened since I last posted…an embarrassing mishap in management, progress with YouthBank, debate nationals prep, a scholarship reception in New York, anthropology ethnographic research (or sad simulacrum of a noble attempt), a Goldman Sachs reception, the Penn Microfinance Conference, a University Scholars project proposal, among many other things. As finals draw nearer, I am confronted with the challenge of reconciling my priorities and obligations. Spanning from the 19th to the 23rd, debate nationals effectively excludes me from the last week of school and the majority of reading days. I must intensify my efforts then! Can’t let something trivial spoil my semester’s worth of work, especially in management.

I desperately need critical feedback on my pharmaceutical corporate social responsibility global medicine access research paper – I am afraid my thesis is not focused enough, given that my topic spans both the firm and industry-level perspective. Like always, leave a comment if you have the time to help. The file is a bit large, but I will gladly send through e-mail.

The Ethics of Drug Research

Joyce Meng

 

Given increasing pharmaceutical company demand for clinical trials, stringent regulatory standards in the United States, and the deplorable state of health care in many developing countries, globalized human subjects research in Eastern Europe, Latin America, the Middle East, and Africa has raised the possibility of fundamental human rights violations. In short, the global growth in research has engendered a new debate about the possibility of exploitation – the risk of a modern-day Tuskegee. In light of the lack of regulatory policy monitoring global clinical trials and the excessively narrow procedural framework dominating bioethics, contract research organizations have cheaply found large pools of treatment naïve people, luring potential subjects with the promise of medical relief for the duration of the trial. Often ignorant of the high potential risks of the trial, these vulnerable medical research subjects may be exposed to potentially harmful experimental drugs or regimented to a placebo test, thereby effectively restricting access to proven treatments.

 

The globalization of human subjects research raises two fundamental questions: Given that the standard of living and quality of health care in the United States diverges greatly from that of many developing countries, should research ethics be uniform? Hence, to mitigate the possibility of abuse, what ethical framework and system of checks and balances should be developed to ensure that control groups and vulnerable experimental trial subjects receive fair treatment?

 

In response to the first question, Sidney Wolfe and Peter Lurie, physicians who head the Health Research Group of Public Citizen, strongly argued that researchers have an ethical obligation to conform to the standard of care in the sponsoring countries. Similarly, Peter Singer’s One World Theory and the hypernorms governing the International Social Contracts Theory (ISCT) attest to the importance of setting a core of invariable ethical standards in any area potentially harming human dignity and human life. According to ISCT, although peripheral concessions can be made to accommodate the specific socioeconomic and cultural context, these compromises must not violate the hypernorms of core human rights, which are clearly jeopardized in placebo trials and haphazardly approved experimental trials. In direct contrast, proponents of the AZT trials, including the head of NIH and the executive director of the WHO Global Program on Aids, defended the legitimacy of placebo trials, citing potential noncompliance and higher expenses. With many powerful organizations supporting an ethical interpretation that legitimizes the placebo trial, the treatment naïve face greater fundamental risks as ethics are shifted in order to accommodate an efficiency-based outcome, regardless of the costs of human dignity. Moreover, cultural relativist excuses justify the restricted access of trial subjects to proven treatments, conflating cost-saving with research efficacy.

 

Sadly, the current state of human subjects research attests to the externalities created by a market-driven logic. As long as the demand for human research subjects exists and the supply of treatment naïve and desperate poor continually high, pharmaceutical companies and contract research organizations have the leverage to continue cost-cutting and reduce standards of care, no different from many multinational corporations in pursuit of low-wage and lax regulatory environments. Since pharmaceutical companies benefit greatly from the abundant, low-cost clinical trials in developing countries, governments ought to intervene to ensure that a fair cost is levied according to the externalities created as a means to protect the most vulnerable world citizens from a disproportionately more powerful and more informed counterparty.

 

In the name of scientific research and the greater future good, ethical boundaries have been stretched and unlikely alliances forged, as in the case of post Chernobyl US-Soviet joint venture. Discursively, bioethics literature has focused too narrowly on the procedural framework, dangerously neglecting the greater metadebate on the impact of research on human dignity. The Helsinki Declaration provides a crucial ideological basis for the ethics underlying global research, but proves hazy and insufficient in light of the changing industry context. According to David Rothman, the latest revision in the Helsinki principles not only reduces researcher responsibility to assure the best proven therapy for their subjects, but also legitimizes placebo trials and releases the obligation to provide “first world treatments in the third world”. Moreover, upon deferring to local IRBs, persistent ambiguity and the lack of standardization may drive a potential “race to the bottom” as increasingly lax standards become the norm over time – a form of desensitization. Is any treatment preferable to none at all? Certainly, the outsourcing of clinical trials has facilitated access to short-term health care for some of the world’s poorest, while simultaneously advancing potential medical breakthroughs. Nevertheless, until a global consensus can be achieved to establish a uniform brightline for research ethics accountability and states more involved in the enforcement of international ethical codes, the risk of exploitation remain high – the cost unquantifiable in terms of human lives, rights, and dignity.

Thursday April 5, 2007

April 5, 2007 - 12:44 pm 1 Comment

Private-Public Partnerships: Synergies or Dissonance?

Joyce Meng

 

In response to globalization processes that have promoted the growth and influence of non-governmental organizations, private-public partnerships have increased dramatically, spanning diverse health agents and project focuses. Simultaneously, growing emphasis on corporate social responsibility and the theory of competitive philanthropy have prompted multinational companies to engage in neglected-disease R&D as a means to respond to emergent shareholder concerns. As a new institutional structure, private-public partnerships potentially generate many powerful synergies by leveraging resources and enhancing overall performance through increased creativity, cost-efficiency, innovation, and speed of development. For example, according to Moran, the public-private partnership approach delivered the best health outcomes for developing country patients in comparison to the 13 drugs developed by the pharmaceutical industry working alone. Clearly, through information sharing and efficient cost-distribution (pharmaceuticals focusing on upstream costs, letting public partners finance downstream clinical trials), private-public partnerships have achieved substantially more breakthroughs, facilitating productive research in an otherwise high-risk, high-cost environment.

 

Although private-public partnerships have tremendous potential social impact, researchers warn that divergent goals, values, and institutional processes may undermine trust and cooperation critical to delivering strong health outcomes. In other words, the challenge of reconciling diverse, bounded social worlds with cooperative work remains a key issue. On one hand, scientific work involves a diverse group of individual actors, while simultaneously, science requires cooperation to gather information, ensure reliability, and create common understandings. As Star and Griesemer’s notion of a boundary object reveals, organizations involved in private-public partnerships face many uncertainties in defining the appropriate sharing of roles and responsibilities, thus increasing the urgency of finding plastic commonalities essential to a shared identity.  Furthermore, current concern over the appropriate ethical framework to guide private-public initiatives addresses the issue of a potential conflict of interest and the resultant mutual mistrust. To assuage partner suspicions, the WHO created the Guidelines on Interaction with Commercial Enterprises in an attempt to garner companies’ long-term commitment, promote effective management of the collaborative program, and guard against clear conflicts of interests, though many activists have censured the document for failing to provide sufficient oversight. In addition to the potential shortcomings of private-public partnership operations, other critics have contested the idea itself for potentially undermining UN objectives for cooperation and equity among states. Under this perspective, advocated by Buse and Walt, the UN should strictly regulate partnerships in order to assure that they serve pressing public health interests instead of narrowly-defined, convenient private goals.

 

As an empirical example, the complex case of Merck and ivermectin exposes the fundamental challenges involved in private-public initiatives in defining the appropriate cooperative framework for pricing and distribution decisions. Overall, the high volume of applications and tablets approved by the Mectizan Donation Program suggests effective partnership management – between 1988 and 2000, 195 million treatments have been approved for community-directed mass treatment programs. Reich and Fujisaki attribute the effective partnership to the use of three defined boundary objects (ivermectin; Dr. William Foege, Executive Director of the Task Force for Child Survival and Development and the Carter Center; the Mectizan Expert Committee) in bridging the two social worlds as a means to achieve goal congruence, trust, and international support. The success of the ivermectin initiative created a powerful public image for Merck, thus motivating other pharmaceutical companies to engage in similar initiatives as a means to improve shareholder value and reputational benefits. Under Michael Porter’s theory of competitive philanthropy, such initiatives enhance overall value creation by improving the competitive context – opening up potential future markets, forging new partnerships with key international organizations, and developing expertise in grassroots disbursement mechanisms. In light of Merck’s recent controversy over Vioxx, however, critics call into question the possibility of a “bait and switch” tactic in which corporate social responsibility initiatives and goodwill partnerships fulfill a primary role of liability management, diverting attention away from areas of industry neglect (for example, inflexible pricing mechanisms hindering greater access in the developing world).

 

In conclusion, by definition, private-public partnerships involve agents with different missions and work activities. Under the social worlds framework, such divergent interests and competencies potentially engender tensions in cooperative pursuits. Consequently, researchers and theorists have attempted to strike a balance – to preserve sufficient heterogeneity in order to leverage core competencies and broaden the overall sphere of knowledge, without compromising the fundamental basis of common understanding and cooperation. Easier said than done, the struggles of the ACHAP initiative reveals the tensions resulting from divergent objectives, institutional confusion over partner boundaries, and mutual skepticism among Merck and the Botswanan government, among other donors and financiers. Attesting to the fact that despite Merck’s success with the Mectizan Donation Program, successful private-public partnership strategies and experience are not always easily transferable given completely different local contexts, the ACHAP initiative reveals the importance of developing a “learning organization”, willing to adapt to partner values, learn from past mistakes, adopt flexible initiatives, and commit fully to building relations at the technical and operational levels.