If the reader believes that certain conflicts are unavoidable, it is worth noting that some authors have argued that conflicts of interests or researcher biases are unavoidable, and because of this, it is only proper to consider the conflicts in a graded fashion. Thus, there should be no per se prohibition against these conflicts depending where they fall on the continuum from minor to serious. See generally GallinJ. I. and OgnibeneF. P., eds., Principles and Practice of Clinical Research (Burlington, MA: Academic Press, 2007): at 248.
2.
See, e.g., StosselT. P., “Regulating Academic-Industrial Research Relationships – Solving Problems or Stifling Progress?”New England Journal of Medicine353, no. 10 (2005): 1060–1065, at 1061 (“The death rate in industry-sponsored phase 1 oncology trials has not changed during the past 10 years, despite growing collaboration between academe and industry. To conclude that the hope of financial gain contributed at all to any errors leading to Gelsinger's death, in the absence of a confession or other evidence, is purely speculative.”)
3.
AndersenM.KragstrupJ. and SondergaardJ., “How Conducting a Clinical Trial Affects Physicians' Guideline Adherence and Drug Preferences,”JAMA295, no. 23 (2006): 2759–2764; BrennanT. A., “Health Industry Practices That Create Conflicts of Interest: A Policy Proposal for Academic Medical Centers”, JAMA295, no. 4 (2006): 429–433.
4.
See Andersen, supra note 3, at 2764.
5.
BekelmanJ. E.LiY. and GrossC. P., “Scope and Impact of Financial Conflicts of Interest in Biomedical Research: A Systematic Review,”JAMA289, no. 4 (2003): 454–465, at463 (“Despite the prevalence of these relationships and the broad concerns they have generated, a relative paucity of data has been published describing the impact of financial ties on biomedical research.”); FriedmanL. S. and RichterE. D., “Relationship Between Conflicts of Interest and Research Results”, Journal of General Internal Medicine19 (2004): 51–56, available at <http://www.medscape.com/viewarticle/468818> (last visited May 27, 2009) (“Because of the limitations of our data, we are unable to determine the reasons for the observed association between [conflicts of interest] and reported findings.”)
6.
See, e.g., CampbellE. G., “Financial Relationships between Institutional Review Board Members and Industry,”New England Journal of Medicine355, no. 22 (2006): 2321–2329; see Brennan, supra note 3; ColliverV., “UCSF Study Questions Drug Trial Results”, San Francisco Chronicle, June 5, 2007, at B-1.
7.
KornD., “Conflict of Interest in Biomedical Research,” available at <http://www.hhs.gov/ohrp/coi/korn.htm> (last visited May 27, 2009). (However, “the existence of conflicts of interest cannot be eradicated; their existence must be accepted and not equated with professional misconduct.”)
8.
See Campbell, supra note 6, at 2323 (emphasis mine). The authors conclude that one potential limitation with their study is that the conflicts of interests identified were de minimis because they treated rather insignificant financial interests the same as significant financial interests. This is part of the ongoing problem of defining “conflict of interest” that is slowly developing into a catchall that tells us little; a binary treatment of this issue does not get us away from simple correlations to actual causation.
9.
Id.
10.
BodenheimerT., “Uneasy Alliance – Clinical Investigators and the Pharmaceutical Industry,”New England Journal of Medicine342, no. 20 (2000): 1539–1544, at1543 (quoting Lee Goldman, chairman of the Department of Medicine, University of California at San Francisco, “…companies translate biological advances into useable products for patients. They do it for a profit motive, but they do it, and it needs to be done.”) Another example is the hepatitis B vaccine that resulted from the biotechnology industry that formed after a joint venture of academic researchers and venture capitalist. See Stossel, supra note 2, at 1060. Also, DeAngelisC. D., Editorial, “The Influence of Money on Medical Science,”JAMA296, no. 8 (2006): 996–998, at 996 (“The discovery of new medications, devices, and techniques is funded primarily by for-profit companies; testing new modalities of treatment is funded primarily by for-profit companies; and the manufacture and profitable marketing aspects of these modalities appropriately falls in the purview of this industry.”)
11.
See generally Bodenheimer, supra note 8, at 1539 (“The infusion of industry dollars into an industry-investigator partnership has clearly improved clinical practice.”)
12.
See, e.g., PorterR. and MaloneT., Biomedical Research: Collaboration and Conflict of Interest (Maryland: The Johns Hopkins University Press, 1992): at 128 (“…the role of a talented consultant – who may also have equity in the company – in bringing a product to the marketplace may be invaluable; such a person may play a very positive, constructive role.”)
13.
Industry professionals are no less ethical than their contemporaries are, and it is in the best interest of industry to seek the truth. Quoting Bloch, a company's fundamental approach to science is “antithetical to biased reporting or interpretation of research results.” This is so because, eventually, the “truth will out” any failures or misbehavior when the product is being used by patients. Thus, it is in the best interest to avoid any biases because it will harm both the patients whom they serve, and the companies themselves. See Porter, supra note 12, at 132.
PorterR. J., Conflicts of Interest in Research: The Fundamentals in Biomedical Research: Collaboration and Conflict of Interest, PorterR. J. and MaloneT. E., eds. (Baltimore and London: The Johns Hopkins University Press, 1992): at 122–123.
16.
See Bekelman, supra note 5, at 464; ChopraS., “Industry Funding of Clinical Trials: Benefit or Bias?”JAMA290, no. 1 (2003): 113–114.
17.
It is worth noting that government sponsored clinical trials are not immune to conflicts of interests. See BarclayL., “BMJ: Pharmaceutical Industry-Physician ‘Entanglement’ Affects Research, Care,”Medscape Medical News, June 3, 2003, available at <http://www.medscape.com/viewarticle/456554> (last visited May 28, 2009). (Quoting LexchinJoel, M.D., associate professor of health policy and management at York University in Toronto, Ontario, Canada “Government-funded studies may have biases too; for example, their bias might be to show that the least expensive drug for a given indication is as good as the most expensive.”)
18.
The study recognizes the limitations of interviewing patients with serious lifethreatening illnesses; more research on the patients' perspective on financial conflicts of interest is Hampsonwelcome. L., “Patients' Views on Financial Conflicts of Interest in Cancer Research Trials,”New England Journal of Medicine355, no. 22 (2006): 2330–2337, at 2330.
19.
NabelE. G., Editorial, “Conflict of Interest – or Conflict of Priorities?”New England Journal of Medicine355, no. 22 (2006): 2365–2367, at2633.
20.
Despite the rarity of deceit in clinical trials, there is circumstantial evidence that trials conducted with blinding result in even less incorrect results due to bias than trials without blinding. See Gallin, supra note 1, at 246.
21.
This method is used by the federal government in their prohibition against employees participating in an official capacity in matters affecting their own financial interests. See generally Gallin, supra note 1, at 115. For a discussion of the potential problems with requiring disclosure, see OssorioP. N., “Pills, Bills and Shills: Physician-Researcher's Conflicts of Interest”, Widener Law Symposium8, no. 1 (2001): 75–103, at 100–102.
See generally Campbell supra note 6; “There are even disagreements about the definition of a conflict of interest. Many attach qualifiers, such as ‘potential’ or ‘apparent,’ in an attempt, it often seems, to be delicate or nonjudgmental.” KassirerJ. P. and AngellM., Editorial, “Financial Conflicts of Interest in Biomedical Research,”New England Journal of Medicine329 no. 8 (1993): 570–571. The one noteworthy exception is Ossorio, supra note 21.
26.
See Porter, supra note 12, at 125 (quoting PalcaJ., “NIH Grapples with Conflict of Interest”, Ethics in Science245, no. 4913 [1989]: at 23.)
27.
“Conflict of interest”, Merriam-Webster Online Dictionary, 2007, available at <http://www.merriam-webster.com> (last visited May 28, 2009).
28.
GarnerB. A., ed., Black's Law Dictionary, 8th ed. (St. Paul: West Group, 2004).
29.
We use the words “official” and “professional,” “personal” and “private,” and “responsibilities” and “duties” interchangeably. We realize that they do not mean exactly the same thing, but for the purposes of this discussion, the distinctions are negligible.
30.
Nor does the American Bar Association or the American Medical Association provide a definition of “appearance of impropriety.” Both organizations provide multiple examples of which might cause an appearance of impropriety but do not specifically give a definition.
See RotundaR., “Judicial Ethics, the Appearance of Impropriety, and the Proposed New ABA Judicial Code,”Hofstra Law Review34, no. 4 (2006): 1337–1377, at 1337 (2006). (The ABA has not defined the “appearance of impropriety” with any precision and specifically avoided including a restriction on appearances of impropriety for lawyers, Professor Rotunda strongly urges that the same rule be removed from the ABA Judicial Codes for the same reasons.)
34.
This distinction has been made concerning presidential campaigns, but we believe the point lends itself well to medical ethics. See generally LevinR. M., “Fighting the Appearance of Corruption,” available at <http://www.wulaw.wustl.edu/journal/6/p171_Levin.pdf> (last visited May 28, 2009).
35.
For a similar distinction and suggestion see Porter, supra note 12, at 128.
36.
“Interest,” Merriam-Webster Online Dictionary, 2007, available at <http://www.merriam-webster.com> (last visited May 28, 2009).
37.
“Obligation,” Merriam-Webster Online Dictionary, 2007, available at <http://www.merriam-webster.com> (last visited May 28, 2009).
38.
SalmondJ., Jurisprudence, or, the Theory of Law (London: Stevens and Haynes, 1907): at 427.
39.
This fundamental confusion between research subjects and patients is affecting the media and others alike. It is important for all to remember that experiments are experiments, thus the ex ante justification (if rightful and noble) for engaging in an experiment ought to be paramount to any ex post criticism absent any willful and negligent disregard for the participant's life and well-being.
See Andersen, supra note 3, at 2759; GotzscheP. C., Research Letter to Editor, “Constraints on Publication Rights in Industry-Initiated Clinical Trials,”JAMA295, no. 14 (2006): 1645–1646, at 1645.
42.
See Campbell, supra note 6.
43.
Pilar Ossorio makes this point. It is “merely good business” to direct money towards promising drugs. Thus, arguments that articles sponsored by a single pharmaceutical company are more likely to support outcomes favoring that company's drug are not necessarily spawned by financial conflicts. “Pharmaceutical manufacturers presumably support researchers whose preliminary data suggest a favorable outcome for the manufacturer's drug.” See Ossorio, supra note 21, at 92.
44.
MooreT. J., “Serious Adverse Drug Events Reported to the Food and Drug Administration, 1998–2005,”Archives of Internal Medicine167, no. 16 (2007): 1752–1759, at1752.
45.
The authors conclude only that, “the results highlight the importance of this public health problem and illustrate the need for improved systems to manage the risks of prescription drugs.” Id.
46.
The authors themselves dismiss this possibility as “unlikely” but go on to state that there is insufficient data to accurately decide one way or another. Thus, as unlikely as Thomas Moore and his colleagues would like this possibility to be, they admit the rate of increase in adverse events could be possible due to an increase in reporting. They try to argue against this possibility by pointing out that the reporting for some drugs has not gone up, but has actually gone down, and that this is proof that there has not been a general trend towards more reporting. But, they defeat their own argument when they admit that the rate of adverse events vary from one drug to another and for the same drug over time. They also argue that if the increase in adverse events reported were due to an increase in reporting, then the rate of reporting by physicians should increase at the same rate as the rate of reporting by manufacturers. This is a simple non sequitur. All that can be deduced from this observation is that whatever has motivated an increase in reporting by manufacturers has not motivated the same rate of reporting by health professionals or consumers, neither of which is proof that the actual rate of adverse events has gone up.
KennedyE., “Comments regarding the Prescription Drug User Fee Amendments of 2007,”Congressional Record, 110th Cong., 1st Session (2007) 153, no. 76, daily edition (May 9, 2007): S5764.
50.
ChoudhryN., “Should Patients Receive Secondary Prevention Medications for Free After a Myocardial Infarction? An Economic Analysis,”Health Affairs26, no. 1 (2007): 186–194.
51.
GrijalvaC., “Decline in Pneumonia Admissions After Routine Childhood Immunisation with Pneumococcal Conjugate Vaccine in the USA: A Time Series Analysis,”The Lancet369 (2007): 1179–1186.
52.
See Ossorio, supra note 21, at 98.
53.
WolfeR. M., “Expenditures for U.S. Industrial R&D Continue to Increase in 2005; R&D Performance Geographically Concentrated,”National Science Foundation Info Brief: Science Source Statistics, NSF 07–335 (2007), available at <http://www.nsf.gov/statistics/infbrief/nsf07335/nsf07335.pdf> (last visited June 2, 2009).
54.
BuchkowskyS. S. and JewessonP. J., “Industry Sponsorship and Authorship of Clinical Trials Over 20 Years,”Annals Pharmacotherapy38, no. 4 (2004): 579–585.
55.
Id.
56.
CohenJ. J. and SiegelE. K., “Academic Medical Centers and Medical Research: The Challenges Ahead,”JAMA294, no. 11 (2005): 1367–1372.
57.
BrodyH., Hooked: Ethics, The Medical Profession, and the Pharmaceutical Industry (New York: Rowman & Littlefield Publishers, Inc., 2007). For an additional “solution,” see TereskerzP., Riding the Green Wave: Financial Conflicts of Interest in Industry-Sponsored Clinical Research (Hagerstown, Maryland: University Publishing Group, 2007): at 159, 164 (Tereskerz, argues for the establishment of “a U.S. government research brokerage firm or clearing house” which would “rank all the proposals [for new drugs] it receives, based on scientific merit” and then decide which of competing investigators would be granted the privilege of doing the necessary clinical trials at the companies expense, including funding the government clearing house through a “required indirect cost rate added to all study budgets.”)
