Owing Your Soul to the Pharmaceutical Store

Description

This case addresses the issues of mentor responsibility to the student as well as a scientist's right to maintain scientific freedom.

Body

ABC, Inc. is a pharmaceutical company that has been very generous in its financial support of research performed in the department of Pharmacy Administration at a medium-sized university. ABC has collaborated on many occasions with Dr. Angstrom, head of the department, on research on the cost-effectiveness of certain drug therapies. Dr. Angstrom has come to rely heavily on the support of ABC, and the company trusts him as well.

Julie is a graduate student whose mentor is Dr. Angstrom. Dr. Angstrom has always been proactive in making sure that Julie gains experience in new methods that are used in their constantly evolving area of research.

With the help of Dr. Angstrom's influence and close relationship with ABC, Julie has obtained a grant from ABC to conduct her own study on the cost effectiveness of various drugs used in the treatment of AIDS. One of the drugs to be included in the study was developed by ABC.

As Julie is nearing the end of the data collection phase of her research, Dr. Angstrom walks into the graduate student office one day and drops a pile of papers on her desk. "This is just some paperwork that Joni from ABC dropped by the other day when she was in my office," he said. "It pertains to your dissertation grant and needs to be signed by you. Just drop it in my mailbox when you get around to it."

Later that day Julie looked through the paperwork and noticed that a stipulation in the contract stated that ABC reserved publishing rights. That meant that results of her study could not be published without the company's permission. Julie knew that her university did not allow such restrictions, so she called Joni immediately and set up a meeting to discuss the issue.

"Julie," Joni said, "please understand that generally Dr. Angstrom and I do work on his manuscripts together in deciding which aspects of a study are emphasized in the conclusion and discussion section. After all, not only do we want to see how our drug stacks up overall against our competitors, we want to find as many positive aspects of our drug as possible. I would hope that while nothing is in writing, we would have that type of working relationship as well. Take a couple days to think about it before signing the contract."

Julie pondered on her dilemma. Obviously, if the overall results of her study favored ABC's drug, there would not be a problem. But if the study cast an unfavorable light on many aspects of ABC's drug's performance, she might be asked to emphasize the positive aspects in her manuscript.

Julie had no other source of support for her research project. At this point, she had nearly collected all her data. Should she conduct a quick, informal analysis to get an idea of which way her results would lean before she bothered to worry about whether to sign the contract? After all, if ABC's drug were superior, there would not be a problem with publishing. Or should she refuse to sign the contract outright, claiming this provision would be an assault on her scientific freedom?

Julie had relied on Dr. Angstrom to take care of the contractual dealings with ABC. Perhaps this dilemma could have been avoided if she had been presented with the contract prior to beginning her research, and if he had explained how he and Joni worked in creating a manuscript. But her research was more than half completed at this point, and she shuddered to think of her own personal consequences if she did not sign the contract. What should she do? How could Julie's situation have been avoided in the first place?

Possible next steps for Julie include:

  • Refuse to sign the contract.
  • Perform a quick analysis of the data before making any further decisions.
  • Approach Dr. Angstrom and ask for advice.
  • Sign the contract and work with Joni on the manuscript.
  • Sign the contract and refuse to work with Joni on the manuscript. 
Notes

Used with permission of Association for Practical and Professional Ethics. Case drawn from Research Ethics: Cases and Commentaries, Volume Three, Brian Schrag, Ed., February 1999.

Citation
. . Owing Your Soul to the Pharmaceutical Store. Online Ethics Center. DOI:https://doi.org/10.18130/jq7e-ga22. https://onlineethics.org/cases/graduate-research-ethics-cases-and-commentaries-volume-3-1999/owing-your-soul-pharmaceutical.

Dr. Angstrom is the Faust who already has sold his professional soul to Mephistopheles. The problem is that the devil has an insatiable appetite and has come to collect the soul of a graduate student as a down payment.

Julie is in a no-win situation. One could say that she is at fault for not finding out about the arrangement with ABC before she started work with ABC's support, but that would be unfair. No graduate student would know to ask such questions when first starting out.

The courageous thing for Julie to do would be to sign the agreement, finish the research and get her degree. Publication can wait. If the negotiations with Joni do not result in a mutually agreeable paper, then Julie need not publish anything at all. She can leave the data to be used by Dr. Angstrom's laboratory and go off to find a position elsewhere. Alternatively, she can take the data with her and publish a paper later, away from the clutches of ABC and Joni.

But that, as I stated, is the courageous thing to do. There is no good and simple solution here, and all alternatives are difficult. In that sense, it is a good case study, but it is also a depressing one. I wish all graduate students better luck in finding their mentors and advisers.

Author: P. Aarne Vesilind, Duke University.

This case addresses the issues of mentor responsibility to the student as well as a scientist's right to maintain scientific freedom. Julie is faced with a dilemma that could have been avoided had her mentor played by the books and presented her with the contract before she began her research project. But even then, she would have had to decide whether to abide by ABC's unwritten agreement. However, now that she is placed in this difficult situation, all the parties involved are at risk of losing.

If she refuses to sign the contract, Julie stands to lose all the research work she has put in so far toward obtaining her degree, unless she can find another funding source. As she has nearly completed her data analysis, this loss could be substantial. She also stands to lose the support of her mentor, Dr. Angstrom. By creating friction with ABC, Julie could fall from favor with Dr. Angstrom, which could jeopardize the amount of knowledge she could gain from working with him, as well as the contacts that he could make for her when she begins looking for a job.

Dr. Angstrom and possibly other researchers at the university stand to lose a close relationship with a funder, ABC. If Julie and ABC are not able to work out their differences, this incident could create distrust or negative feelings toward the university from ABC's perspective. That could in turn result in ABC granting fewer contracts to the university.

Dr. Angstrom may find it necessary to take sides since he was the primary contact person between ABC and Julie. By siding with Julie, he may lose a significant source of funding. By siding with ABC, he may lose the respect of a graduate student. If Julie decides to make this incident public, he may lose respect within the university as well.

ABC stands to lose significant profits and reputation if its drug is proven less cost effective than competitors and Julie publishes these results. If ABC agrees to allow Julie to publish regardless of the results, the company runs the risk of funding a project that may severely damage them financially.

ABC may hold Joni responsible for this damage, and her job and reputation are also at stake.

Based on federal guidelines, Julie's academic freedom is legally protected from clauses such as the one presented by ABC. (Kodish 1996) However, the situation becomes difficult when she realizes that the way in which she decides to deal with ABC at this point could affect not only her professional career, but that of her mentor as well.

It appears that Julie's dilemma is not uncommon, given the increasingly closer relationships between academia and industry. (Blumenthal 1996) A potential conflict of interest exists in this situation because the way that Julie writes up her results is likely to be influenced by a secondary interest -- that of ABC. While Joni was not asking Julie to falsify the data or distort the results of the data analysis, she was implying that ABC would like Julie to provide more discussion of the positive results for ABC's drug. Julie could easily refuse to do so and still be protected by law -- she would not have to worry about losing the funding for her particular project. However, as a student of Dr. Angstrom's, Julie represents him as well, especially since she obtained this contract through his relationship with ABC. If Julie breaks the informal agreement made with ABC, it would appear to ABC that Dr. Angstrom has broken the informal agreement as well, since he oversees Julie's research project. His relationship with ABC could be forever tarnished by Julie's actions.

Julie could go along with the informal agreement, but that response would raise the issues of academic freedom and conflict of interest. Can Julie truly abide by the agreement without a loss of freedom?

A conflict of interest clearly exists, yet there is a fine line as to the extent of conflict and its ramifications. What could happen if her study were taken out of context due to a "skewed" manuscript? One possibility is that within a hospital drug formulary, ABC's drug could be chosen over a cheaper, equally effective AIDS treatment, and significantly higher drug costs would result in fewer people having access to the drug. In the most extreme case, death might occur earlier due to inadequate treatment because a patient could not afford the medication.

Another option for Julie is to explain her reservations to Dr. Angstrom and ask him for advice. This course of action could solve all her problems or make a decision even more difficult, depending on how Dr. Angstrom handles her request for advice. If Dr. Angstrom truly finds nothing ethically wrong with writing manuscripts in conjunction with ABC, it is likely that he would not understand Julie's concern, and he would suggest she sign the contract and agree with the informal agreement. Since he himself has had a similar relationship with ABC, that is the most likely case. However, if she is able to convince him that she has a conflict of interest, a possible course of action for Dr. Angstrom would be to help her to find an alternate source of funding for the project that is nearly completed.

If Julie were to perform a quick analysis of the data before making any further decisions, she may be solving her own immediate problem, but she would not really be addressing the ethical issue that she is facing. Throughout her whole career it is likely that she will be confronted with similar conflicts of interest, and it may be more appropriate to set a precedent in how she will carry herself in these future situations. Also, she must consider whether it is fair to future graduate students of Dr. Angstrom to be placed in the same situation, when she could have addressed the issue and perhaps come up with a solution.

Julie could always refuse to sign the contract with full knowledge that by doing so, she alienates herself from ABC and possibly from Dr. Angstrom as well. A more immediate concern would be how she would obtain funding for her project. If no funding is available, she faces the possibility of developing a completely new project for which she could obtain funding. If her relationship with Dr. Angstrom is tarnished because of this incident, finding a new funding source may prove to be difficult.

It is important in this case that the ramifications of all possible actions are explored and weighed individually. Consequences of Julie's actions affect not only herself, but the careers of others as well, and this consideration should weigh on her decision.

References

  • Blumenthal, D. "Ethics Issues in Academic-Industry Relationships in the Life Sciences: The Continuing Debate." Academic Medicine 71 (12, December 1996): 1291-1296.
  • Kodish E., T. Murray and P. Whitehouse. "Conflict of Industry in University-Industry Research Relationships: Realties, Politics and Values [Comment]." Academic Medicine 71 (12, December 1996): 1287-1290.