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AbstractAlthough information about risks, benefits, alternatives and costs is offered to human research participants in informed consentdocuments, information about how much the tested medical intervention is expected to cost future patients is not routinely madeavailable to research participants. Two arguments are offered in support of including this information. First, justice demands thatparticipants are given this information so that they do not inadvertently sign up for studies to test interventions that in the futurewill be out of their financial reach, or the reach of their family or community. Second, the cost of an intervention is rightly partof the risk/benefit profile of any medical intervention, and as such should be included so that research participants can make ajudgment comparing the tested intervention against the current standard of care, if one is available. Several objections to this newpractice are raised. Sharing the future costs of the treatment under investigation may be prohibitive to study sponsors who don'tyet have that information; it may be unhelpful to participants who won't know what to make of the information; finally, theinformation may not be relevant to current participants. Replies are offered to each objection. It is concluded that researchparticipants should be given information about the future costs of the medical interventions they are testing so that they mightbe fully informed about the risks and benefits of the medical intervention under study. significant bearing on whether participants would actually Prior to medical treatment patients are provided volunteer for clinical research studies. Here I propose an information about the risks, benefits, alternatives, and costs additional piece of information that should be integrated of the treatment. The patient's voluntary agreement to the into future informed consent documents: Informed consent treatment on the basis of an understanding of this documents for clinical research studies should disclose information is what is meant by informed consent. how much the new intervention is expected to cost future When research subjects, often referred to as research participants, give informed consent to participate In the course of my career I've served on three in a clinical trial, they are offered the same type of IRBs, I've chaired two, and currently chair one and sit on information. In terms of risks, informed consent another. And yet I have no recollection of ever seeing an documents may include lengthy discussions of the possible informed consent document that let prospective risks, the likelihood of those risks, and what to do to avoid participants know the sponsor's estimate of the future cost certain risks. In terms of benefits, Institutional Review Boards (IRBs) are very careful to make sure that thebenefits of a study are not over-sold, so that participants don't fall into a therapeutic misconception. Participants are Having this information would be important for told about the alternatives: If a potential participant does two reasons. First, participants should know if they are not wish to enroll, what other courses are available to him helping to gain approval for a medical intervention that or her? If the participant wishes to cease participation at would be financially out of reach for them as patients.
any time, what is the orderly means of withdrawing from Many bioethicists believe that it is morally wrong and the study? When it comes to costs, participants are told exploitive to have a cohort of research subjects test a drug who is paying for the study (the "study sponsor"), whether or device that is beyond that cohort's ability to obtain in the their time or efforts will be reimbursed, and whether future. This perceived injustice was the basis for many compensation is available for injuries incurred during the people's criticisms of the short-course AZT trial for vertical HIV prevention (Glantz, et al, 1998). This study For a long time now I've believed that detailing protocol recruited participants from Africa and Thailand.
only the above information about costs does not The protocol was successful in demonstrating that a sufficiently inform research participants. People are shorter course of AZT was superior to a placebo. The enrolling in clinical research studies, testing a new drug or short course study did not randomize subjects against the device, without a crucial piece of information about costs.
longer course, which had been demonstrated to work in the Furthermore, that missing piece of information may have 076 trial. However, the rates of vertical HIV transmission in the short course were found to be comparable to the Participants should be told up front how much more expensive long course of AZT in preventing sponsors expect to charge for the new drug, in comparison mother-to-child transmission of HIV [1]. Many took issue with Tamiflu, as part of the overall cost/benefit profile of with the short course trial because even though it the drug. After all, the costs of the drug are part of the costs and benefits that will be taken into account by future patients and practitioners. This information would also be helpful to IRBs: Sponsors who are undertaking a non-inferiority trial of new, wildly expensive drug X, in comparison with relatively cheap standard of care drug Y, should be asked a lot of hard questions by IRBs. Using the above example, the risks of using human research subjects to study a new drug which is expected to cost $2,000 a though it was tested in developing countries. There is an dose, to determine that the drug is no better than an injustice in allowing one group of people to bear the risks existing treatment that costs less than $500 a dose, do not of the study, while another group benefits from the appear to outweigh the benefits at all. Even if the trial demonstrates that the two drugs are of equal value Some may argue that the research subjects in the medically, the fact that one costs between four and nine short course trial were not exploited, and there was no times as much as the other significantly alters the injustice, as long as participants were given the cost/benefit analysis. Subjects will have been asked to test information needed to make an informed decision. If they a drug that no one is going use, without any benefit, the were given information about the risks, benefits, and costs, IRB should judge that risks of the trial are too high to and yet they still chose to participate, that was not exploitation. However, one of the essential pieces ofinformation they should have been given was that while they were testing the drug, the drug would be financially One objection to this proposal is that sponsors unavailable to their family and friends if ultimately may claim that they don't have the information about how approved. Participants in all clinical trials should be given much the drug while it is still under study, and they cannot information about how much a study drug is expected to be expected to give participants information they do not cost, so that they are not in the position of the African and have. I find this objection disingenuous [3]. First, many of Thai participants discussed above, experiencing the risks the drugs tested in clinical trials have already been of the research without their cohorts being able to gain approved for one condition, and now are being tested for from the expensive treatments if they are ultimately other conditions. As such, the sponsors have a very good idea how much the drugs would cost in the future, basedon current costs. The Argument From Disclosure of Risks and Benefits Sponsors may reply that there are too many Second, the costs of a new drug or device are unknowns to extrapolate future costs from current costs. If rightly part of the overall cost/benefit profile of that a drug is shown to work well for other conditions, the price intervention. If a sponsor knows that a new drug will cost may rise as demand exceeds supply, or the price may fall, four times as much as a competitor, but the medical as production of that drug increases and production costs benefits of the new drug are only marginally better than the are proportionally lowered. Even the best predictions can competitor, it isn't clear that the new drug is that much become obsolete as new information emerges. However, better. Fleck (2006) and Brock (2006) make this point in there is already a system that is designed to handle just articles discussing the costs of the anti-cancer drug such moving targets: IRBs are routinely given information Avastin, but similar points can be made when dealing with about changes in risk profiles, and adverse events, while medical conditions that are typically not as serious as clinical trials are underway, as new information emerges.
cancer. Imagine a new drug under development that If new medical information changes the risk/benefit profile promises to cut in half the days that people with the flu of a drug, then participants are given this information, as experience symptoms. The drug is being developed as a part of an ongoing process of informed consent. So, if new competitor for Tamiflu, and is being tested to determine if developments alter the predicted cost of a drug, the medical risks and benefits of the new drug are participants can still be given that information. comparable to Tamiflu. However, the new drug is expected Second, even for those interventions that are to cost $2,000 a dose, which is far more than Tamiflu, being newly introduced, sponsors have already run which can cost between $222 and $445 without insurance analyses as to how much the intervention would cost to develop, to produce, to store, to ship, etc. It is hard to believe that the sponsors haven't already done this participants, thus, this information should be included.
calculation, numerous times, in an attempt to determine Second, the costs of the new treatment under study are part what is best for their bottom line. To plea utter ignorance of the overall risk/benefit profile of the new treatment.
about the future costs of therapies currently under study is Participants should only enroll in clinical studies for which there is a positive overall risk/benefit ratio, but the benefits A second objection is that this information may of the study may accrue only to future patients, and not the not be helpful. Perhaps participants won't initially know participant him or herself. And yet, knowing that those what to do with these cost figures, and will be misled into benefits may exist is part of being informed. By the same falsely thinking a more expensive treatment is always token, knowing the risks of a new therapy, including its better (Angell, 2004, pp. 95-97). While this may happen, costs to future patients, is part of the overall risk/benefit it isn't a reason to leave the information out. Participants ratio. Knowing the cost of a new therapy to future patients probably don't know what to do initially with the is as essential to being informed as knowing that some information about numerous medical risks of experimental drugs. That doesn't mean that the information should be In keeping with the relevancy objection, some left out. Rather, having that information is part of an sponsors may be concerned that if participants knew how informed decision whether to enroll in a trial. much the experimental drugs might cost in the future that Participants should have the opportunity to the participants might demand their share of the profits, discuss with their healthcare provider, and the members of and as such, my recommendation would do more harm the research team, any information in an informed consent than good. In other words, if participants were reminded document about medical risks and costs. If participants that this was a profit-making enterprise they would don't have their questions answered, they haven't truly demand their share of profits, so perhaps it is best not to offered informed consent to research participation.
remind them. Whether or not participants are fairly Similarly, information should be included about the future compensated for their efforts is a hotly-debated question financial costs of the treatments under study. Participants (Abadie, 2010). Perhaps they are justly compensated, in should have the opportunity to ask questions about these which case telling participants of the costs to future facts and figures. Those discussions can help show that a patients should make no difference. Perhaps they are not more expensive intervention isn't always the best, just as justly compensated, in which case raising the issue may they can help explain other complex aspects of research correct a current injustice. Finally, it is perhaps the case participation, such as randomization or the weighing of that there is a disconnect between appearance and reality: maybe participants think they are being exploited, when A similar objection is that information about they really aren't, or maybe they don't think that they are future costs is not relevant to the participant, unlike being exploited, but they really are. Again, this is why it is information about current risks and costs. The side-effects essential for informed consent to include all of the of treatment are those the participant himself may have to information, as well as the opportunity for participants to bear, and reimbursement for cost (or lack thereof) directly ask questions, so that they can make a decision for impacts the financial situation of the participant. But themselves whether to participate in what may appear to be telling the participant about the future cost of the intervention, if the intervention is approved, is telling theparticipant about costs to future patients, not to the participant himself or herself. Why would this be relevant As it stands, there appear to be two good arguments in favor of including future costs of new There are two responses to this objection. First, medical interventions in informed consent documents, and researchers and IRBs may have no idea what is relevant to the objections to this new practice are unsound. If today's the participant, but it isn't their job to leave things out of a research participants volunteer to test medical consent form on the assumption that the participant won't interventions that someone else will pay for in the future, find it relevant. If there is any uncertainty, we should err they should be told how much those interventions are on the side of informed consent, and include the information. Researchers and IRBs should not have the lastword as to what is and is not relevant to research Notes1.See http://www.ed. for a summary of the comparison between long course and short course results. My thanksto Franklin G. Miller for his helpful clarification of this example. 2. According to Massachusetts General:; accessed 12-29-2010.
3. Marcia Angell and Jerry Avorn are two sources who agree with my skeptical stance towards the study sponsors.
ReferencesAbadie, R. (2010). The Professional Guinea Pig: Big Pharma and the Risky World of Human Subjects. Durham: DukeUniversity Press. Angell, M. (2004). The Truth About the Drug Companies. NY: Random House. Avorn, J. (2004). Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs. NY: Knopf.
Brock, D. W. (2006). How much is more life worth? Hasting Center Report, 36, 3, 17-19. Fleck, L. M. (2006). The costs of caring: Who pays? Who profits? Who panders? Hasting Center Report, 36, 3, 13-17.
Glantz, L. H. et al (1998). Research in developing countries: Taking benefit seriously. The Hastings Center Report, 28,6, 38-42.


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