A Marketplace of Ideas

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A Marketplace of Ideas?

• The Ethics of Scientific Bias

Joe Julian April 19, 2005
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Background

• Professor J works at an academic medical center.
• Her research
• Compares the effectiveness of similar drug
  products.
• Allows her to maintain a professional reputation.
• Will hopefully allow her to investigate the
  causes of diseases that interest her.
• Is well-funded by the manufacturers of the tested
  drugs.
• She is a paid consultant and a member of the
  speakers bureau for one of the manufacturers.
• She states her relationship to this manufacturer
  does not create a bias in her research because
  her studies are blinded.

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Background (cont.)

• Blind Studies
• In single-blind studies, the participants are
  unaware of what medication/treatment they are
  receiving.
• In double-blind studies, the participants and all
  professionals involved are unaware of the
  medications/treatments that the participants are
  receiving.
• For this case study, it will be assumed that Dr.
  J is involved in double-blind studies.

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Questions

• Does blinding eliminate all forms of bias? How
  or how not?
• When contrasted with findings for research with
  funders unknown to the researchers, studies have
  tended to show a strong correlation between
  researchers knowing the source of sponsorship of
  research and findings favorable to the sponsors
  products. Would it follow that to have such
  knowledge is morally questionable?
• How might research be structured so that funding
  is provided without researchers knowing its
  source?
• If skewed findings affect health care practice,
  and hence public health, should scientific bias
  be punishable by legal means, which it presently
  is?

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A. Does blinding eliminate all forms of bias?
How or how not?

• Yes, double-blinding eliminates most, if not all,
  forms of bias.
• In double-blind studies
• The participant is unaware of what treatment they
  are receiving so they can form their own opinion
  of the effectiveness of the treatment.
• The professional is unaware of what treatment the
  participant is receiving, so unintentional
  influence is not a factor.
• In single-blind studies
• Only the participants bias is eliminated.
• The professional can unknowingly influence the
  participants opinion through their body
  language.
• Called demand characteristics
• Double-blinding prevents bias from the
  participant as well as the professional.

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B. When contrasted with findings for research
with funders unknown to the researchers, studies
have tended to show a strong correlation between
researchers knowing the source of sponsorship of
research and findings favorable to the sponsors
products. Would it follow that to have such
knowledge is morally questionable?

• Yes, having such knowledge is morally
  questionable.
• Violates Kantian and Utilitarian views
• Kantian The drug manufacturers may not be
  respecting the integrity of the researchers
  scientific field. This is not respecting the
  rights of individuals because the manufacturers
  may be taking advantage of the researchers and
  using them as a means to an end (such as
  increased drug sales or approval of a specific
  drug.)
• Utilitarian The researchers may provide
  inaccurate data in order to obtain more funding
  from the manufacturers. This does not provide the
  greatest good for the greatest amount of people
  because only the researcher and the manufacturer
  are benefiting from the skewed results.

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C. How might research be structured so that
funding is provided without researchers knowing
its source?

• All manufacturers wishing to fund research would
  contribute to a central research fund that is
  regulated by the government.
• Funds that are donated for a specific field of
  study will only be used for that field of study.
• Funding for researchers will be distributed by a
  committee that oversees this central fund.
• However, government regulation may result in
  refusal to distribute funding to areas of
  research that are considered controversial,
  such as stem cell research.
• A better solution would be to require that all
  funding come from anonymous sources.

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D. If skewed findings affect health care
practice, and hence public health, should
scientific bias be punishable by legal means,
which it presently is?

• Yes, scientific bias should continued to be
  punished by legal means. Presently, the
  Department of Justice can investigate issues that
  are believed to present a criminal or civil fraud
  violation.
• Specifically, the U.S. Public Health Service
  (PHS) carries out investigations and issues
  sanctions.
• Most researchers that are found responsible
  consent to a Voluntary Exclusion Agreement.
• Issues that deal with peoples lives should not
  be taken lightly. Scientific bias issues should
  fall in the same category as malpractice issues.

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Additional Questions

• Is it ethical for drug manufacturers to pay
  consultant fees to professionals that are
  currently researching their drug?
• Is it ethical for professionals to accept these
  consultant fees?
• Is it unfair for professionals to be put into
  this position in the first place?
• Are the drug manufacturers as much to blame as
  the researchers when it comes to incidents of
  intentional altering of data?
• Should the government be allowed to regulate
  funding for research that comes from private drug
  manufacturers?

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Suggested Resolution

• All research should be conducted using
  double-blind studies in order to minimize any
  chance of bias.
• This eliminates the chance that researchers may
  alter data in order to obtain funding or
  consultant fees from drug manufacturers.
• Funding for research needs to come from sources
  that are anonymous to the researcher, but
  government regulation is probably a bad idea.
• Scientific bias should continue to be punished by
  legal means if skewed findings affect public
  health care practices.
• Public charges stemming from scientific bias
  should be treated as malpractice cases if they
  are not already.

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Bibliography

• Hockenbury, Don H. and Sandra E. Hockenbury.
  Discovering Psychology 3rd Edition. Worth
  Publishers. New York, 2003.
• Horn, Peter. Clinical Ethics Casebook 2nd
  Edition. Wadsworth/Thompson Learning. Ontario,
  2003.
• NIH Clinical Center. 2005. National Institute of
  Health. Accessed 17, April 2005.
  http//www.cc.nih.gov/participate/_pdf/partners.pd
  f.
• Office of Research Integrity. 2005. U.S.
  Department of Health and Human Services. Accessed
  18, April 2005. http//ori.dhhs.gov/.
• Steinbock, Bonnie John D. Arras and Alex John
  London. Ethical Issues in Modern Medicine 6th
  Edition. McGraw-Hill. Massachusetts, 2003.