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When Experiments Travel

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Jaime Welsh

on 31 October 2012

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Transcript of When Experiments Travel

By Colin Atkinson, David Gast, Ramil Goonetilleke, Jessica Lahrs and Jaime Welsh When Experiments Travel Chapter One:
Ethical Variability Adriana Petryna's Chapter Two:
Arts of Drug
Development Treatment
Saturation Chapter Three: Conclusion Disproportionate Burden of Disease Gostin, Lawrence O., and James G. Hodge, Jr. "Global Health Law, Ethics, and Policy." Journal of Law, Medicine & Ethics (2007): 519-25. Print. Biological Citizenship An informal economy of disease and claims.
Massive demand for but selective access to a form of social welfare based on scientific and legal criteria that acknowledge injury and compensate for it.
Citizens are looking beyond the state for safeguarding their health -- people are valuable not only to the state, but to capital as well.
"Assaults on health are the coinage through which the proliferating figure of the biological citizen stakes claims for biomedical resources." Thalidomide Crisis
Alerted government to lax testing standards
Safety AND Efficacy
1962 Kefauver-Harris Amendment
1970 FDA Regulations Published Drug Development The Global Clinical Trial How Many Clinical Trials Are Being
Carried Out Worldwide? “Unfortunately, and really quite embarrassingly, we
don’t know how many trials are being
carried out worldwide today.” -Dr. Ida Sim (2006) -Selective Reporting Chapter 4
Pharmaceuticals and the the Right to Health Pharmaceuticals are the New Gold The value of a drug is a disputed political and economic matter.

Patients from all social classes are insisting on receiving the more expensive drugs. WHO's Efforts "Selective reporting distorts the body of evidence available for clinical decision making" -ICMJE -Industry Resistance
-Lack of a funding amount for
a serious and sustained effort
-Lack of a mechanism for
enforcement of policies
-Lack of awareness of the
importance of the problem Significant Barriers to a Global Registration of Trials -See trials registered at their inception

-Increased public access to information about "ongoing, completed and published clinical trials." Offshoring Clinical Trials http://www.reuters.com/article/2011/05/06/us-pharmaceuticals-trials-idUSTRE7450SV20110506 To what extent? -In 2008, 78 percent of all subjects participating in trials to support drug applications submitted to the FDA were enrolled at foreign sites, and the numbers are set to increase further. -Clinical off shoring is driven, in part,
by cost savings and market expansion (1) (1) Offshoring Clinical Trials Behind the trend -Foreign “Treatment-naive” patients The Polish Clinical Trials Industry -Desirability -Sustainable? The Polish Clinical Trials Industry What makes it so desirable? Reality of Polish Healthcare -Technical and Professional excellence
-Seen in mentioned individuals
and interviews

-Patient recruitment


-Reality of Polish healthcare http://www.pwc.com/en_GX/gx/pharma-life-sciences/assets/clinical-trials-in-poland-2010.pdf Impact of the Clinical trials industry -Pharmaceutical companies invest approx. $322. million in clinical research in Poland each year, suggesting that clinical trials have become an important source of the country's healthcare delivery. Brought regulatory authorities from the US, Western Europe, and Japan together with industry experts.
Created international standards to ensure that high-quality and safe drugs would be developed and registered in the most efficient and cost-effective way. Good Clinical Practice (GCP) Defined in the ICH as an international ethical and scientific quality control standard for assuring the protections of subjects and credibility of data. Contract Research Organizations (CROS) Highly competitive transnational businesses.
Run clinical trials for pharmaceutical, biotechnology, and medical device firms.
Have knowledge of regulations and investigational procedures in various countries as well as the time it takes for studies to be approved and launched and the market possibilities there.
Involved in locating research sites, recruiting patients and, in some cases, drawing up the study design and performing analysis.
Sometimes work directly with primary care facilities, hospitals, or groups of therapeutic specialists. Clinical trials data are typically highly edited. Negative or neutral results can be suppressed.
Can "engineer out" the possibility of adverse events being seen using super selective subject inclusion criteria.
Can "engineer up" a side effect in another drug (by doubling its dose, for example) in order to demonstrate that their drug is better.
Senior scientist at ARCH says that "the [science of drug development] has no credibility left." Research in Prisons
Prison wardens & correctional facility physicians=Brokers
Direct Payment
Verbal Contracts
Prisoners not allowed to earn money
Why? From Vulnerable to Professional Subjects Prison Research Benefits
Few variations, stable lifestyle
Control over inmates daily lives, habits, medicinal intake, and food consumption
All of this lead to patient uniformity which is what the FDA required From Vulnerable to Professional Subjects Negatives of Prison Research
Free to participate or coerced?
Don’t know how research is done in each location
Find population that is more informed, true free will, and can walk away from research at any moment they want to
The Belmont Report From Vulnerable to Professional Subjects Called for the establishment of insitutional review boards (IRBs) to evaluate ethical conduct of research
Authorized formation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Deliberated over conditions of research among vulnerable subjects: children, prisoners, pregnant women, and mentally disabled
Globalization 1974 National Research Act Lack of oversight
Different standards and approaches to conducting trials
Monetary lure for subjects in low-income countries
Results cannot be generalized due to medication variance (Poor vs. Wealthy)
Slowly Improving
Pfizer - http://www.pfizer.com/files/research/nejm_paper_globalization_of_trials.pdf Controversies Surrounding Globalization Dr. Carl Elliott Professor of Bioethics at the University of Minnesota
Exploitation hasn’t stopped, just taken a different form
Don’t intentionally make people sick, but recruit vulnerable (uninsured, poor)
This group is so vulnerable that they cannot take action Exploitation of Poor "Controversies in Clinical Trial Globalization." CISCRP. The Center for Information and Study on Clinical Research Participation, May 2009. Web. 27 Oct. 2012. <http://www.ciscrp.org/professional/participant/newsletters/may09/Participant0509-3.pdf>.

"The Globalization of Clinical Trials." Pfizer. Pfizer, Mar. 2009. Web. 27 Oct. 2012. <http://www.pfizer.com/files/research/nejm_paper_globalization_of_trials.pdf>. Perry, Susan. "MinnPost." MinnPost. N.p., 10 Oct. 2010. Web. 27 Oct. 2012. <http://www.minnpost.com/second-opinion/2010/10/too-many-clinical-trials-still-exploit-poor-and-other-vulnerable-people-says->. Clinical Research Ethics Some argue that clinical researchers assuming a therapeutic approach with participants in clinical research is detrimental to the efficacy of research outcomes. Average life expectancy in Africa is nearly 30 years less than that in the Americas or Europe. Life expectancy has been decreasing in the least developed countries and transitional states such as Russia. Wealthy populations are increasingly healthy and living longer while poorer populations are getting sicker and dying younger. The poorest populations shoulder the greatest amount of disease. Global Health Ethics Danger: fear that scientists will treat the subjects as a means to a scientific end, failing to consider that subject as a patient and human being. Even in cases involving human subjects, physician investigators acting as scientists still have to uphold an acceptable level of ethical obligation to the patient.

He or she must:
Minimize risk and burden to the subject.
Respect the person(s) privacy and autonomy before, during, and after the study. Is clinical research ethically distinct from medical care -Quote from Dr. Ivan Hovarth http://www.reuters.com/article/2011/05/06/us-
pharmaceuticals-trials-idUSTRE7450SV20110506 The Polish Clinical Trials Industry -Is the demand sustainable? Clinical Trials Life Cycle Patient Recruitment Stakeholders of Clinical Trials -Poland is ranked 10th in the world and 1st among
emerging and CEE markets in terms of number of
clinical trials sites. (2010) (Address selective reporting in-depth) (additional WHO efforts and reasoning) (highly applicable to the polish market) (Polish clinical trial size is much larger than other CEE nations. Martin CzR dipping, consider.) (1) (1) http://www.pwc.com/en_GX/gx/pharma-life-sciences/assets/clinical-trials-in-poland-2010.pdf (2) (2) -Phase 1: The Opportune Moment



-Phase 2: The Peak Moment



-Phase 3: Exhaustion -The “Gold Rush” -“Normal part of health delivery” -Dr. Martin and the history of Clinical Trials in the
Czech Republic -Dr. Mazur Dr. Mazur's statement
- Population size

- Efficient patient recruitment

- High quality of execution -Key drivers of the Polish clinical trials market Patient recruitment & quality of medical staff
are perceived as the most significant qualities. (2) Complications and "Over-Eager" Investigators -Rise of Complicated Protocols -Stems from an increase in very selective
patient group trials -These trials study minute differences and have a
slim number of variables. -Over-Eager Investigators -Relax eligibility requirements to enroll more
patients -We don't see patients, we see data Clinical Research Frontiers -Clinical Trial Stakeholders -Sponsors
-CROs
-Authorities/Regulators
-Sites(Impatient/Outpatient)
-Researchers/Investigators
-Patients -Scop/e -The Concept of Frontiers Why are clinical trials globalizing? 2005 Comparative ethnographic inquiry in two popular trial destinations and emerging pharmaceutical markets:
Poland and Brazil Methods
Dealt with two mid-sized CROs: Temp/po and AR/CH
Worked with executives subcontracted investigators, clinical trial monitors, and some of the industry representatives as well as regulatory officers and lawyers with whom these firms' personnel interacted regularly. Findings
Repeated emphasis on productivity, seamlessness, and transparency.
Excess of monitoring.
Industry-funded trial infrastructures compensate for inadequately funded state research. CROs put a premium on time, speed and profitability. Public distrust of clinical trials process in the U.S. and Western Europe

Key advantages to conducting clinical research in poorer countries with underdeveloped healthcare systems.
Underserved patients as participants in clinical research trials receive treatment they would otherwise not have access to.
Fewer variables affecting research outcomes; patients probably have not previously been treated with the particular drug or class of drugs being studied. Experimentality Ukraine & Chernobyl Rapid growth in dispensation and use of imported pharmaceuticals.
Changing attitudes toward health and treatment.
Widespread distrust of doctors and of Soviet-made medicines.
Medicinal philanthropy: a mixed blessing. Samples, humanitarianism, and drug "dumping" now coexisted with discredited Soviet pharmacopeia, yielding one large uncontrolled experiment in cobbled-together access and unregulated consumption. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) A Problem of Control Ethical implications of using controls such as placebos and sham-surgeries in clinical research dealing with human subjects. A globalized community with global health problems requires global health policy, law, and ethics. 1994: Controversy over placebo use in Africa during trials of short-course AZT treatment to halt peri-natal transmission. Position 1 Position 2 U.S. National Institutes of Health (NIH) and the U.S. Centers for Disease Control (CDC).

Use of placebo in this experiment was ethically sound. Critics of the experiment's use of placebo instead of an active-control trial.

Would the same experiment have been allowed in a more developed nation like the United States? Brazilian Academic Research Team They worry about what happens when clinical trials are over and if participants will have access to treatment. "We have to deal with the problems that begin when the study ends, the right dosages, and the quality of care as patients return to their hometowns." "What isn't in the file is the evidence to back up the claim that the drug works or the commerical interests behind the claim"
- Dr. Picon Universal Healthcare in Brazil Pharmaceutical assistance is an essential part.
Brazil's progressive constitution of 1988 assured its citizens universal access to healthcare.
Drug companies take advantage of this. Litigation and Healthcare “The litigiousness over the right to health is woven out of many different threads, including social mobilization anchored in long histories of citizen exclusion from formal legal mechanisms, fragile health systems, industry marketing, pharmaceuticalized approaches to health, medically uninformed judges, and a general judicialization"

”Who is at fault? The patient, the judge, or the doctor? Clinical Protocols and Therapeutic Guidelines:
Exceptional Medicines "The health ministry wanted us to make sense of all this. Up until then, the ministry was just a good payer. It just paid for these medicines."
- Dr. Picon Drugs for All: The Future of Global AIDS Treatment Editorial by Joao Biehl

Brazil has been a leader in universalization of access to AIDS therapies.
In 1996, it became the first developing country to make ARVs available through public health care.
The government is paying for the therapies of roughly 200,000 citizens.
Both AIDS mortality and the use of AIDS-related hospital services have fallen by 70%.

Brazil has become proof that the fight against AIDS is possible. Reference Centers Dr. Picon was now creating a network of disease-based centros de referencia.

They created a reference center for Gaucher patients.
After 6 months of operation, the order for the number of vials of medication for the Gaucher patients began to drop from 400 to 250 vials per month.
They saved 1.2 million in 2005 in this one hospital. After a Clinical Trial Do you think that pharmaceutical companies should have to provide the drugs to the participants even once the trial is over? "The United States is not
prevention focused" 3. Address the issues with the one problem one solution model.

Ambulatist- An ambulatist is a pharmacist with a background in nutrition and exercise science who understands that the medical approach to treatment is only part of the solution 2. Regulate the clinical trials that we already have going on!
Improve IRB registry
Create a better clinical trials database
Improve information systems
Establish post auditing feedback mechanisms Diminish the dependence on clinical trials for medical care and funding in impoverished countries by “[narrowing] the gap between clinical research and public health and to promote access to lifesaving medicines for the neediest” Holistic Solutions “The most difficult thing about my job is keeping up with the drug world. There is a very high turnout of new drugs. There is no possible way that I can stay up to date on all of them. In fact, staying up to date on the drugs I focus on, namely those involved in the treatment of Type II diabetes and chronic diseases, is hard enough!” How is Type II Diabetes Treated/Prevented?
Metformin (drug)
9th most prescribed drug in the world

Are drugs the only possible treatment/prevention mechanism?

NO.
2. Exercise!! Type II Diabetes How is Type II Diabetes
Treated/Prevented? Type II Diabetes Brief summary of main points
Integrate a larger body of research knowledge on the topic
Petryna's suggestions for improved drug research
An example of the technological imperative employed by drug companies
Finish with a holistic medical approach to address larger issues at play than just poor drug research In Conclusion Overview How is Type II Diabetes Treated/Prevented?
Metformin (drug)
9th most prescribed drug in the world

Are drugs the only possible treatment/prevention mechanism? Type II Diabetes Does a disproportionate burden of disease lead to a disproportionate burden of clinical research? The Human Right
to Health
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