‘Case of the Week’ 6: Drug Test Ethics

CotW Lesser Disclaimer: As a free service, Case of the Week cases are not subject to the same editorial process as the COG 2010 sourcebook, and don’t generally have extensive work put into them. You may find material and sources in these cases that would not appear in the sourcebook. We hope this case will be useful to you; enjoy!

About the Author: Daniel Gaskell is the lead editor for COG 2010, a nationally-qualified debater and speaker, and developer of the Factsmith research software. He’d come out and introduce himself, but right now he’s buried under four tons of debate evidence.

1AC: Pharmaceutical Testing Ethics

By Daniel Gaskell

“By the time word of the little girl’s death reached the United States, her name had been replaced by numerals: No. 6587-0069. She was 10 years old and a scant 41 pounds. She lived in Nigeria, and in April 1996 she ached from meningitis.

An epidemic raged and scores lay dying in this frenetic city of amber dust. Somehow the girl found a refuge: a medical camp where foreign doctors had arrived to dispense expensive medicines for free.

Behind a gate besieged by suffering crowds stood two very different clinics. A humanitarian charity, Doctors Without Borders, had erected a treatment center solely in an effort to save lives. Researchers for Pfizer Inc., a huge American drug company, had set up a second center. They were using Nigeria’s meningitis epidemic to conduct experiments on children with what Pfizer believed was a promising new antibiotic–a drug not yet approved in the United States.

The experimental drug was a potential blockbuster: Wall Street analysts said Pfizer might reap $1 billion a year if Trovan, as it was known, won approval for all its potential uses. Pfizer also wanted to test the drug for use against meningitis, including an epidemic strain. The company couldn’t find enough patients in the United States, so its researchers had come to Kano, among the dying.

Doctors working with Pfizer drew spinal fluid from the girl, gauged her symptoms and logged her as patient No. 0069 at testing site No. 6587 in experiment No. 154-149. They gave her 56 milligrams of Trovan. A day later, the girl’s strength was evaporating, Pfizer records show, and one of her eyes froze in place. On the third day, she died.

Pfizer records are explicit. Action taken: “Dose continued unchanged.” Outcome: “Death.”

Joe Stephens, Washington Post, December 17, 2000, “Where Profits and Lives Hang in Balance”, http://www.washingtonpost.com/wp-dyn/content/article/2007/07/02/AR2007070201255.html

This true story from the Washington Post is, unfortunately, not an isolated example. Hundreds of drug trials are being conducted in poor countries around the world today, many with little ethical oversight. It is because there are simple steps that can be taken to prevent a repetition of this tragedy that my partner and I stand Resolved: That the United States Federal Government should significantly reform its policy toward Russia.

First, let’s make sure we’re all talking about the same thing by defining a few terms in:

Part 1. Definitions

Significant: “Having or likely to have influence or effect.” (Merriam-Webster Online Dictionary, Accessed June 2010, “Significant Merriam-Webster”, http://www.merriam-webster.com/dictionary/significant)

Clinical Trial: “A scientific study to determine the effects of potential medicines in people; usually conducted in three phases (I, II, III), to determine whether the drug is safe, effective, and better than current therapies, respectively.” (Allison Davis, PhD, U.S. Department of Health and Human Services, July 2006, Medicines By Design – Glossary, http://publications.nigms.nih.gov/medbydesign/medbydesign.pdf)

Now, let’s look at the problems with the status quo in:

Part 2. The Risk

The FDA requires extensive clinical testing of new medical treatments before they can be approved. It’s often difficult to get willing test subjects for such trials in the United States, so many pharmaceutical companies have moved their testing overseas, where poor people are willing to undergo risky procedures in exchange for guaranteed treatment. One country becoming increasingly more popular is Russia:

1. Drug testing shifting to Russia

Yevgenia Shtilman (staff writer for the Boston College Third World Law Journal), 2009, Boston College Third World Law Journal, “Pharmaceutical Drug Testing In The Former Soviet Union: Contract Research Organizations As Brokerdealers In An Emerging Testing Ground For America’s Big Pharma”, Vol. 29, No. 2 (pages 427-428)

“In recent years, countries of the former Soviet Union have attracted the attention of Western pharmaceutical companies that previously focused their clinical trials in India and Africa. The former Soviet Union offers many of the same opportunities for pharmaceutical companies that make India, a country nicknamed the “guinea pig of the world,” an attractive option. Namely, the former Soviet Union offers pharmaceutical companies three advantages. First, the area offers an abundance of clinical test subjects – volunteers who, because of poverty and poor health, are willing to gain access to healthcare by participating in risky trials without explanation of potential health consequences. Second, the former Soviet Union is home to many highly trained civilian doctors willing to carry out clinical trials on their own countrymen – even to the point of exploitation – in exchange for the steady, competitive salaries offered by American pharmaceutical companies. Third, the centralized hospital system found in many former Soviet republics facilitates the process of recruiting clinical trial participants, further lowering costs for American pharmaceutical companies conducting trials there.”

Testing is important to ensure that drugs are safe, and can be beneficial to test subjects in poor countries who have no other way to get affordable healthcare. Where the problems arise is when unethical tests are carried out – tests where the subjects are not adequately informed about the risks and alternatives, as in the opening story. It is essential that such unfortunate events are prevented before they happen, because test subjects in Russia often have:

2. No legal recourse

Yevgenia Shtilman (staff writer for the Boston College Third World Law Journal), 2009, Boston College Third World Law Journal, “Pharmaceutical Drug Testing In The Former Soviet Union: Contract Research Organizations As Brokerdealers In An Emerging Testing Ground For America’s Big Pharma”, Vol. 29, No. 2 (page 429)

“Despite known instances of abuse of test populations in these countries, the dearth of lawsuits by test subjects against pharmaceutical manufacturers and the researchers they employ suggests that underprivileged clinical test subjects in the former Soviet Union lack access to the justice system when the research process proves harmful.”

It would seem obvious that patients should be fully informed about the consequences of becoming a test subject, but a report in the New England Journal of Medicine in February 2009 reported that tests in developing countries often have:

3. Little ethics oversight

Dr. Kevin Schulman, Dr. Robert Califf, Dr. Robert Harrington, Dr. Charles Cairns, Dr. Eric Peterson, Dr. John McHutchinson, and Dr. Seth Glickman, February 19, 2009, New England Journal of Medicine, “Ethical and Scientific Implications of the Globalization of Clinical Research”, Vol. 360, No. 8, http://www.contentnejmorg.zuom.info/cgi/content/full/360/8/816

“In one study, only 56% of the 670 researchers surveyed in developing countries reported that their research had been reviewed by a local institutional review board or health ministry. In another study, 90% of published clinical trials conducted in China in 2004 did not report ethical review of the protocol and only 18% adequately discussed informed consent.”

The result? Drug companies can carry out risky procedures on ill-informed and sometimes nonconsenting patients, resulting in injury or even death, and get off scot-free. While the majority of tests are assuredly fully ethical, we believe that the risks are sufficient to warrant the following Plan:

Part 3. Plan

We have one simple mandate: Any drug company that cannot offer proof of informed consent for overseas drug tests will:

a) be banned from selling the tested drug in the United States, and

b) permanently lose patent protection for the drug.

Agency: Congress and the President will pass legislation directing the FDA to carry out this plan.

Enforcement: will be through the Food and Drug Administration, or FDA.

Timeline: Immediately.

Funding: Since this plan is primarily legislative, we do not anticipate additional funding being required, but any nominal enforcement costs will be provided through normal budgetary means.

Now, let’s look at the success of this plan in:

Part 4. Solvency

1. Informed consent is the foremost protection

Finnuala Kelleher (in 2004 a law student at Columbia University and Articles Editor of the Columbia Journal of Law and Social Problems, now a trial attorney at the Department of Justice), 2004, Columbia Journal of Law and Social Problems, “The Pharmaceutical Industry’s Responsibility for Protecting Human Subjects of Clinical Trials in Developing Nations”, http://www.columbia.edu/cu/jlsp/pdf/Fall%202004/Kelleher38-1A.pdf (page 72)

“The foremost protection for human subjects of clinical trials is the principle of informed consent. In general terms, informed consent requires that subjects of trials be adequately informed of the risks and benefits of the trial, of their rights as participants, and their choice whether or not to participate. Informed consent protects research subjects by ensuring that their interests are considered when they are in conflict with those of the researcher and by protecting the subject’s “right to bodily integrity” – to “‘exercise sovereignty over her body’.””

Speaking of a proposal which would deny market access and patent protection to unethically-developed drugs, Professor Fazal Khan concluded in 2007 that it would result in a:

2. Dramatic increase in ethical compliance

Prof. Fazal Khan (MD, JD, assistant professor of law at the University of Georgia), 2007, “The Human Factor: Globalizing Ethical Standards in Drug Trials Through Market Exclusion”, http://works.bepress.com/cgi/viewcontent.cgi?article=1000&context=fazal_khan (page 43)

“This proposal clearly enables and creates a strong market incentive for large institutional investors to conduct due diligence of drug company’s ethical practices around the globe so that they can safeguard their investments. This type of market pressure alone, outside of any drug regulatory agency action, should dramatically increase ethical compliance even in developing countries.”

By implementing our plan, you can help avoid a repetition of the Trovan tragedy. For the sake of patients in Russia who have no other voice, I would urge you to vote Affirmative.

Backup: Pharmaceuticals

Note: CRO stands for Contract Research Organization, a private organization that carries out clinical trials on contract.

Strategy Notes

You may want to expand the mandates of this case to include various other ethical considerations, such as those in the Nuremburg Code, or other medical ethics conventions. This may require increased enforcement, etc. Some of the evidence in the “backup” is aimed more at this sort of case, and doesn’t always directly apply to informed consent.

A common argument you’ll hit at first is that the drug testing is good for Russians (guaranteed but risky treatment is better than no treatment at all, which may be all they can afford.) Additionally, clinical trials offer sources of income for local physicians charged with recruiting test subjects. This argument misses the point, because the case doesn’t reduce clinical trials, it reduces unethical clinical trials. You get all of the cupcake without the poisoned sprinkes, so to speak.

Topicality Notes

Topicality on this case is a bit complicated. There are two objections you may frequently run into:

First, “This is a general policy (i.e. not exclusively towards Russia) so it isn’t topical.” The best way to respond to this is with a simple three-point argument:

  1. Policies can be towards more than one country. For example, take missile defense. Missile defense is definitely a policy towards Russia, but it’s also a policy towards North Korea and China, and could eventually become a policy towards Iran.
  2. The resolution does not require the policy to be exclusively towards Russia. The resolution says “reform its policy towards Russia”, not “reform a policy that is toward Russia, and only Russia.”
  3. Therefore, there is no resolutional basis for this argument.

Second, “This is a policy towards drug companies, not Russia.” Once again, a look at missile defense is useful. Missile defense exists to protect against the risk of a nuclear attack, by doing things with missile defense installations. This case exists to protect against the risk of unethical testing, by doing things with pharmaceutical companies. The goal of the case is wholly to protect Russians. In order for this argument to be valid, missile defense would have to be a policy towards defense contractors, not Russia. This doesn’t make any sense.

ETHICS BACKUP

Informed Consent: Foremost protection

Finnuala Kelleher (in 2004 a law student at Columbia University and Articles Editor of the Columbia Journal of Law and Social Problems, now a trial attorney at the Department of Justice), 2004, Columbia Journal of Law and Social Problems, “The Pharmaceutical Industry’s Responsibility for Protecting Human Subjects of Clinical Trials in Developing Nations”, http://www.columbia.edu/cu/jlsp/pdf/Fall%202004/Kelleher38-1A.pdf (page 72)

The foremost protection for human subjects of clinical trials is the principle of informed consent. In general terms, informed consent requires that subjects of trials be adequately informed of the risks and benefits of the trial, of their rights as participants, and their choice whether or not to participate. Informed consent protects research subjects by ensuring that their interests are considered when they are in conflict with those of the researcher and by protecting the subject’s “right to bodily integrity” – to “‘exercise sovereignty over her body’.”

INHERENCY: RUSSIAN TRIALS COMMON

Testers focusing on Russia – three advantages

Yevgenia Shtilman (staff writer for the Boston College Third World Law Journal), 2009, Boston College Third World Law Journal, “Pharmaceutical Drug Testing In The Former Soviet Union: Contract Research Organizations As Brokerdealers In An Emerging Testing Ground For America’s Big Pharma”, Vol. 29, No. 2 (page 427-428)

In recent years, countries of the former Soviet Union have attracted the attention of Western pharmaceutical companies that previously focused their clinical trials in India and Africa. The former Soviet Union offers many of the same opportunities for pharmaceutical companies that make India, a country nicknamed the “guinea pig of the world,” an attractive option. Namely, the former Soviet Union offers pharmaceutical companies three advantages. First, the area offers an abundance of clinical test subjects – volunteers who, because of poverty and poor health, are willing to gain access to healthcare by participating in risky trials without explanation of potential health consequences. Second, the former Soviet Union is home to many highly trained civilian doctors willing to carry out clinical trials on their own countrymen – even to the point of exploitation – in exchange for the steady, competitive salaries offered by American pharmaceutical companies. Third, the centralized hospital system found in many former Soviet republics facilitates the process of recruiting clinical trial participants, further lowering costs for American pharmaceutical companies conducting trials there.

Testing much easier and cheaper in Russia

Abrahm Lustgarten, August 8, 2005, Fortune Magazine (CNN Money), “Drug Testing Goes Offshore”, http://money.cnn.com/magazines/fortune/fortune_archive/2005/08/08/8267653/index.htm

He is like thousands of others at hospitals across Russia who are participating in clinical trials of all types, run by almost every major Western pharmaceutical company. The trials have become not a choice but a necessity for patients with few alternatives. And the nation’s centralized hospital system makes recruitment for trials quick and easy, which in turn makes them relatively cheap for Western sponsors. Patients can be recruited ten times faster in Russia than in the U.S., doctors say, shaving precious time and millions of dollars off the drug-development cycle.

Testing much faster and cheaper in Russia

Abrahm Lustgarten, August 8, 2005, Fortune Magazine (CNN Money), “Drug Testing Goes Offshore”, http://money.cnn.com/magazines/fortune/fortune_archive/2005/08/08/8267653/index.htm

An average new drug costs $900 million to bring to market, and more than half the cost is tied to the four trial phases in which new medicines are tested on humans for safety and efficacy. Recruiting patients is the most expensive part of drug development, accounting for 40% of the trials’ budget, according to published studies.

Working in countries such as Russia, says Pfizer senior vice president Adrian Otte, can cut three to six months off a trial, meaning a drug can get to market that much faster. And the trials are cheaper.

HARM: PATIENT EXPLOITATION

Exploitation easy

Abrahm Lustgarten, August 8, 2005, Fortune Magazine (CNN Money), “Drug Testing Goes Offshore”, http://money.cnn.com/magazines/fortune/fortune_archive/2005/08/08/8267653/index.htm

The very business model that summons drug companies to those places also risks exploiting the vulnerability of foreign patients–they are eager to sign up because they lack a viable alternative and tend to have blind faith in medicine. “Patients believe in doctors more here,” says Dr. Viktor Kostenko, who has been the chief investigator for 11 drug trials in St. Petersburg. “They are ready to give cooperation to see some benefits. It makes recruitment easy.” Ruth Macklin, a bioethicist who works with the World Health Organization, agrees: “People who are not familiar with research can mistake guys in white coats giving them injections for their doctors. It takes some sophistication to tell the difference.”

FDA fails to protect patients

Prof. Adriana Petryna (PhD, associate professor of anthropology at the University of Pennsylvania), 2007, London School of Economics and Political Science, BioSocieties, “Clinical Trials Offshored: On Private Sector Science and Public Health Research”, http://www.sas.upenn.edu/anthro/system/files/trials%2Boffshored.pdf (page 31)

The largest increase in clinical trial participation occurred in Eastern Europe and Latin America. This global growth has brought with it a new set of unknowns over the circumstances of research and concerns over possible exploitation of foreign subjects. In 2001, the Office of the Inspector General, a body that carries out periodic reviews of the FDA, told that agency after careful review that, in spite of its active promotion of the search for sites and subjects elsewhere, the FDA is not able to protect human subjects in research elsewhere.

Dangers understated and only dealt with after the fact

Prof. Adriana Petryna (PhD, associate professor of anthropology at the University of Pennsylvania), 2007, London School of Economics and Political Science, BioSocieties, “Clinical Trials Offshored: On Private Sector Science and Public Health Research”, http://www.sas.upenn.edu/anthro/system/files/trials%2Boffshored.pdf (page 32-33)

One CRO professional went further and suggested that current drug development operates on what he called the ‘the paradigm of expected failure’. He told me that: “In any industrial system, if you spend 10 times as much on repair as on prevention, you are just going to live in a continued cycle of loss. I’ll just say that for every dollar spent on an investigation, 10 dollars are spent on going back and fixing the data after the fact.”

In this find-and-fix approach, safety problems are detected after the fact and this makes everybody anxious, not just the public but some of my contract research informants as well. The dangerousness of some protocols is typically understated in the original outsourcing contract. Consequently, liability issues too are an after thought. As one American contracts lawyer working for a small pharmaceutical company told me, ‘Unfortunately, it takes an injury in clinical trials to figure out who is going to be responsible.’ The recent multiple organ dysfunction and catastrophic immune response in six test subjects during an outsourced phase I trial of the monoclonal antibody TGN1412 in England serves as an example.

No legal recourse

Yevgenia Shtilman (staff writer for the Boston College Third World Law Journal), 2009, Boston College Third World Law Journal, “Pharmaceutical Drug Testing In The Former Soviet Union: Contract Research Organizations As Brokerdealers In An Emerging Testing Ground For America’s Big Pharma”, Vol. 29, No. 2 (page 429)

Despite known instances of abuse of test populations in these countries, the dearth of lawsuits by test subjects against pharmaceutical manufacturers and the researchers they employ suggests that underprivileged clinical test subjects in the former Soviet Union lack access to the justice system when the research process proves harmful.

Extension: Lawsuits unlikely to succeed

Yevgenia Shtilman (staff writer for the Boston College Third World Law Journal), 2009, Boston College Third World Law Journal, “Pharmaceutical Drug Testing In The Former Soviet Union: Contract Research Organizations As Brokerdealers In An Emerging Testing Ground For America’s Big Pharma”, Vol. 29, No. 2 (page 429)

Even if clinical trial subjects in the former Soviet Union were to file suit-domestically, or in the United States-against American pharmaceutical manufacturers, such plaintiffs would have very little chance of success because of the absence of positive law granting specific court jurisdiction over such cases.

Research norms structurally permit abuses

Prof. Adriana Petryna (PhD, associate professor of anthropology at the University of Pennsylvania), October 2005, “Drug Development and the Ethics of the Globalized Clinical Trial Health Research”, http://sss.ias.edu/files/papers/paper22.pdf (page 2)

The ethics committee model for monitoring the conduct of research, as sociologists and anthropologists of bioethics have noted, turns the ethical universe in which researchers operate into an essentially procedural one (Bosk 1999, 2002, 2005; Bosk and de Vries 2004; de Vries 2004; Guillemin 1998) and deflects attention from structural circumstances that can contribute to increased risk and injustice (Chambliss 1996; Marshall and Koenig 2004; Kahn et al.). Their commercialization also poses problems concerning credibility and necessary independence.

Story: Trovan deaths

Prof. Fazal Khan (MD, JD, assistant professor of law at the University of Georgia), 2007, “The Human Factor: Globalizing Ethical Standards in Drug Trials Through Market Exclusion”, http://works.bepress.com/cgi/viewcontent.cgi?article=1000&context=fazal_khan (page 2)

She was only ten years old and suffering from a serious infectious disease that was sweeping through West Africa, bacterial meningitis. Meningitis attacks the protective membranes covering the brain and spinal cord and can cause for serious neurologic damage or even death. The good news for this girl’s family was that there is an effective treatment for this disease, intravenous antibiotics. Further, once they arrived at the clinic in Kano, Nigeria, they saw Western doctors in white coats offering to provide drugs for free. However, three days later the girl died, not having received any proven antibiotic therapy, but only an experimental drug called Trovan. The family of the girl later claimed, along with many others, that instead of receiving medical care, they were unwitting participants in a multinational drug company’s experimental trial that led to the deaths or serious impairment of many children.

Story: Trovan deaths – details on the lawsuit & informed consent

Finnuala Kelleher (in 2004 a law student at Columbia University and Articles Editor of the Columbia Journal of Law and Social Problems, now a trial attorney at the Department of Justice), 2004, Columbia Journal of Law and Social Problems, “The Pharmaceutical Industry’s Responsibility for Protecting Human Subjects of Clinical Trials in Developing Nations”, http://www.columbia.edu/cu/jlsp/pdf/Fall%202004/Kelleher38-1A.pdf (page 67-68)

In August 2001, thirty Nigerian families sued Pfizer, the world’s largest pharmaceutical company, in the United States under the Alien Tort Claims Act, alleging that Pfizer had violated the law of nations in the course of clinical trials conducted during a meningitis epidemic in Kano, Nigeria.1 The plaintiffs claimed that Pfizer and its researchers violated international standards for the protection of human subjects in clinical trials. In particular, they claimed that Pfizer, the sponsor and conductor of the trials, violated the principle of informed consent by failing to explain the experimental nature of the treatment, that the patients could refuse it, and that other organizations offered conventional treatment free of charge.

A/T “PhRMA guidelines solve”: Does little – exceptions and vagueness

Finnuala Kelleher (in 2004 a law student at Columbia University and Articles Editor of the Columbia Journal of Law and Social Problems, now a trial attorney at the Department of Justice), 2004, Columbia Journal of Law and Social Problems, “The Pharmaceutical Industry’s Responsibility for Protecting Human Subjects of Clinical Trials in Developing Nations”, http://www.columbia.edu/cu/jlsp/pdf/Fall%202004/Kelleher38-1A.pdf (page 96, 97)

While trials conducted in more than one country should follow ICH/GCP practices, those confined to a single country, even if funded by another country, must only conform to local standards. As previously noted, these local standards may be virtually nonexistent. PhRMA’s only discussion of trials conducted in the developing world merely requires that “sponsors collaborate with investigators and seek to collaborate with other relevant parties such as local health authorities and host governments to address issues associated with the conduct of the proposed study and its followup.”

[later, in the same context:]

While the articulation of these goals by the leading industry group is a positive step, PhRMA’s statement itself does little to ensure improved protection of human subjects in clinical trials.

A/T “corporate codes etc. solve”: Little transparency and accountability

Finnuala Kelleher (in 2004 a law student at Columbia University and Articles Editor of the Columbia Journal of Law and Social Problems, now a trial attorney at the Department of Justice), 2004, Columbia Journal of Law and Social Problems, “The Pharmaceutical Industry’s Responsibility for Protecting Human Subjects of Clinical Trials in Developing Nations”, http://www.columbia.edu/cu/jlsp/pdf/Fall%202004/Kelleher38-1A.pdf (page 99)

None of these industry-articulated standards provides any basis for ensuring compliance. IRBs, investigators, and the pharmaceutical companies may have to account to one another under voluntary compliance standards, but they do not have to account to anyone outside the industry, nor do they make available to the public the rates of compliance or problems in the clinical trial process. What information they do make public is at their own discretion. In short, there is no structural transparency in the attempts by the pharmaceutical industry to ensure protection of human subjects of clinical trials.

HARM: LACK OF OVERSIGHT

Most research in developing countries not reviewed for ethics or consent

Dr. Kevin Schulman, Dr. Robert Califf, Dr. Robert Harrington, Dr. Charles Cairns, Dr. Eric Peterson, Dr. John McHutchinson, and Dr. Seth Glickman, February 19, 2009, New England Journal of Medicine, “Ethical and Scientific Implications of the Globalization of Clinical Research”, Vol. 360, No. 8, http://www.contentnejmorg.zuom.info/cgi/content/full/360/8/816

In one study, only 56% of the 670 researchers surveyed in developing countries reported that their research had been reviewed by a local institutional review board or health ministry. In another study, 90% of published clinical trials conducted in China in 2004 did not report ethical review of the protocol and only 18% adequately discussed informed consent.

Insufficient FDA inspections

Abrahm Lustgarten, August 8, 2005, Fortune Magazine (CNN Money), “Drug Testing Goes Offshore”, http://money.cnn.com/magazines/fortune/fortune_archive/2005/08/08/8267653/index.htm

The FDA requires that international sites be open to spot inspections, but judging by the numbers, those inspections are woefully inadequate. There were more than 500 trials conducted in Russia alone last year at some 3,000 sites. The FDA inspected only about 100 sites around the world in 2004.

Even approved sites need improvement

Abrahm Lustgarten, August 8, 2005, Fortune Magazine (CNN Money), “Drug Testing Goes Offshore”, http://money.cnn.com/magazines/fortune/fortune_archive/2005/08/08/8267653/index.htm

Investigators like to point out that an FDA inspection has never resulted in rejection of Russian data. And while it’s true that most sites meet FDA standards, even those that pass are often deemed in need of improvement. Of the international sites inspected last year, more than 30% were criticized for failure to follow protocol, and one in 12 was cited for failure to report adverse patient reactions.

SOLVENCY

Summary: Denying market access & IPR “should dramatically increase ethical compliance”

Prof. Fazal Khan (MD, JD, assistant professor of law at the University of Georgia), 2007, “The Human Factor: Globalizing Ethical Standards in Drug Trials Through Market Exclusion”, http://works.bepress.com/cgi/viewcontent.cgi?article=1000&context=fazal_khan (page 43)

Therefore, this proposal [denying market access and intellectual property rights to unethically-developed drugs] clearly enables and creates a strong market incentive for large institutional investors to conduct due diligence of drug company’s ethical practices around the globe so that they can safeguard their investments. This type of market pressure alone, outside of any drug regulatory agency action, should dramatically increase ethical compliance even in developing countries.

Better oversight will reduce ethical violations

Prof. Fazal Khan (MD, JD, assistant professor of law at the University of Georgia), 2007, “The Human Factor: Globalizing Ethical Standards in Drug Trials Through Market Exclusion”, http://works.bepress.com/cgi/viewcontent.cgi?article=1000&context=fazal_khan (page 40-41)

The simple fact of clinical investigators knowing that they are being watched and being reported on would tend to make them more diligent in applying ethical standards. Furthermore, if monitoring and subsequent investigations by the WHO or some other trusted organization does turn up evidence of ethical abuses, then this information can be made public and be used to pressure drug regulatory agencies to use the legal authority they possess to block market approval of experimental drugs that were tested unethically.

Removing IPR helps keep the violator from profiting

Prof. Fazal Khan (MD, JD, assistant professor of law at the University of Georgia), 2007, “The Human Factor: Globalizing Ethical Standards in Drug Trials Through Market Exclusion”, http://works.bepress.com/cgi/viewcontent.cgi?article=1000&context=fazal_khan (page 42)

A thorny social cost issue might arise if Trovan was the only drug that could treat certain diseases and if no adequate market substitute existed after it was removed from the market. This article will not go into the details of addressing this problem as this will be the focus of Part II of this paper. But very briefly, Part II proposes the stripping of intellectual property rights for the fruits of unethical drug testing under the TRIPS Agreement of the World Trade Organization. The rationale for this particular proposal is to allow generic manufacturers to step into the fray to make the beneficial drug so society can benefit without enriching a violator of ethical norms.

DISADVANTAGE RESPONSES

A/T “Takings clause requires compensation”: Not applicable

Prof. Fazal Khan (MD, JD, assistant professor of law at the University of Georgia), 2007, “The Human Factor: Globalizing Ethical Standards in Drug Trials Through Market Exclusion”, http://works.bepress.com/cgi/viewcontent.cgi?article=1000&context=fazal_khan (page 43)

Another possible objection is that this proposal runs afoul of the common law “takings” principle by depriving parties of valuable economic and intellectual property rights. Under the principle of eminent domain, if the government takes property because it is useful to the public then this is a “regulatory taking” and the property holder must be compensated. However, in this proposal, these valuable rights are not being taken from the owner because they are useful to the public, they are being taken to protect human research subjects from ethical abuses. In this sense, the protection of the public from ethical abuses is a valid exercise of “police power” and thus a regulatory taking is not implicated.

A/T “Retroactive punishment”: Deterrent

Prof. Fazal Khan (MD, JD, assistant professor of law at the University of Georgia), 2007, “The Human Factor: Globalizing Ethical Standards in Drug Trials Through Market Exclusion”, http://works.bepress.com/cgi/viewcontent.cgi?article=1000&context=fazal_khan (page 42-43)

One possible objection would be that this proposal is unjust because it is retroactive as it seeks to punish past behavior which in turn may unfairly take away profits from investors who think they are investing in a company with a highly lucrative drug. However, the incentives created by this proposal are clearly ex ante as it provides a strong deterrence during the drug development process to not use unethical means as such actions can prove to be very costly.

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6 Responses to ‘Case of the Week’ 6: Drug Test Ethics

  1. Andrew says:

    Ya’ll see to have a thing for uber abusive fxt.

    • cogdebate says:

      Not in real life… we’re just throwing these together on the weekend, so you take what you get. :-)

      Actually, though, I don’t think this is nearly as abusive as it looks at first glance. After thinking it through a bit, I really couldn’t come up with any solid topicality objection besides some sort of vague educational something. I wish it was more directly topical, though.

      – Daniel

  2. Brian says:

    Interesting case idea. Thou I’d find a Russian rathe than Nigerian example before running at a tourney.

    Quick solvency: how much “proof” is proof? Especially when you’re dealing with people who can’t write. The mandates don’t procedure people who we know have behaved unethically, but just those who can’t prove they were ethical.

    So this could translate into a DA. If some records get lost (as can only be expected in third world countries), how many good drugs that could save lives might be banned? The problem is that this plan basically requires drug companies to prove their innocence. Whatever happened to innocent until proven guilty?

    • cogdebate says:

      Solvency: This would require some additional research I didn’t bother to do. I did run across some stuff on literacy and informed consent in some bioethics journal, and it doesn’t look like this would be a huge issue. I didn’t cut anything on it, though.

      DA: Since they lose patent protection, any random drug company can now sell the drug and make their millions. Everybody benefits except the unethical drug company. (See the Solvency section of the backup.)

      Innocent until proven guilty: Yeah. Like all the other FDA requirements for showing proof of X. :-)

      – Daniel

  3. Chrissy says:

    How many people in Russia are affected by this unethical drug testing tactics? (not the whole world, just Russia)

  4. Roy Stevens says:

    What’s Happening i’m new to this, I stumbled upon this I have found It absolutely helpful and it has helped me out loads. I hope to contribute & assist other users like its helped me. Great job.

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