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Table. Study Set Characteristics and Conclusions*
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1.
Smith R. Beyond conflict of interest: transparency is the key.  BMJ.1998;317:291-292.Google Scholar
2.
Krimsky S, Rothenberg LS. Financial interest and its disclosure in scientific publications.  JAMA.1998;280:225-226.Google Scholar
3.
Sorell T. Should industry sponsor research? tobacco company sponsorship discredits medical but not all research.  BMJ.1998;317:334.Google Scholar
4.
Edwards G. Should industry sponsor research? if the drinks industry does not clean up its act, pariah status is inevitable.  BMJ.1998;317:336.Google Scholar
5.
Rundall P. How much research in infant feeding comes from unethical marketing?  BMJ.1998;317:338-339.Google Scholar
6.
Gulati SC, Bitran JD. Cost-effectiveness analysis: sleeping with an enemy or a friend?  J Clin Oncol.1995;13:2152-2154.Google Scholar
7.
Stelfox HT, Chua G, O'Rourke K, Detsky A. Conflict of interest in the debate over calcium-channel antagonists.  N Engl J Med.1998;338:101-106.Google Scholar
8.
Rochon PA, Gurwitz JH, Simms RW.  et al.  A study of manufacturer-supported trials of nonsteroidal anti-inflammatory drugs in the treatment of arthritis.  Arch Intern Med.1994;154:157-163.Google Scholar
9.
Barnes DE, Bero LA. Why review articles on the health effects of passive smoking reach different conclusions.  JAMA.1998;279:1566-1570.Google Scholar
10.
Davidson RA. Source of funding and outcome of clinical trials.  J Gen Intern Med.1986;1:155-158.Google Scholar
11.
Azimi NA, Welch G. The effectiveness of cost-effectiveness analysis in containing costs.  J Gen Intern Med.1998;13:664-669.Google Scholar
12.
Bernini JC, Wooley R, Buchanan GR. Low-dose recombinant human granulocyte colony-stimulating factor therapy in children with symptomatic chronic idiopathic neutropenia.  J Pediatr.1996;129:551-558.Google Scholar
13.
Chouaid C, Bassinet L, Fuhrman C, Monnet I, Housset B. Routine use of granulocyte colony-stimulating factor is not cost-effective and does not increase patient comfort in the treatment of small-cell lung cancer: an analysis using a Markov model.  J Clin Oncol.1998;16:2700-2707.Google Scholar
14.
Ballatori E, Roila F, Berto P.  et al.  Cost and cost-effectiveness analysis of ondansetron versus metoclopramide regimens: a hospital perspective from Italy.  Pharmacoeconomics.1994;5:227-237.Google Scholar
15.
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16.
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17.
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18.
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19.
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20.
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21.
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22.
Clark RE, Shlebak AA, Creagh MD. Delayed commencement of granulocyte colony-stimulating factor following autologous bone marrow transplantation accelerates neutrophil recovery and is cost-effective.  Leuk Lymph.1994;16:141-146.Google Scholar
23.
Dranitsaris G, Sutcliffe SB. Economic analysis of prophylactic G-CSF after mini-BEAM salvage chemotherapy for Hodgkin's and non-Hodgkin's lymphoma.  Leuk Lymph.1995;17:139-145.Google Scholar
24.
Faucher C, le Corroller AG, Blaise D.  et al.  Comparison of G-CSF-primed peripheral blood progenitor cells and bone marrow auto transplantation: clinical assessment and cost-effectiveness.  Bone Marrow Transplant.1994;14:895-901.Google Scholar
25.
Glaspy JA, Bleecker G, Crawford J, Stoller R, Strauss M. The impact of therapy with filgrastim (recombinant granulocyte colony-stimulating factor) on the health care costs associated with cancer chemotherapy.  Eur J Cancer.1993;29A(suppl 7):S23-S30.Google Scholar
26.
Lyman GH, Balducci L. A cost analysis of hematopoietic colony-stimulating factors.  Oncology.1995;9(suppl):85-91. [Erratum: J Natl Cancer Inst. 1995;85:488-493].Google Scholar
27.
Mapelli V, Graf vond der Schulenburg JM, Laaser U, Allhoff PG, Rossi F. Economic evaluation of lenograstim (glycosylated rhug-csf) in the treatment of inflammatory breast cancer for Germany and Italy.  Pharmacoeconomics.1994;6(suppl 2):27-35.Google Scholar
28.
McQuaker IG, Hunter AE, Pacey S, Iqbal A, Russell NH. Low-dose filgrastim significantly enhances neutrophil recovery following autologous peripheral-blood stem-cell transplantation in patients with lymphoproliferative disorders: evidence for clinical and economic benefit.  J Clin Oncol.1997;15:451-457.Google Scholar
29.
Mitchell PL, Morland B, Stevens MC.  et al.  Granulocyte colony-stimulating factor in established febrile neutropenia: a randomized study of pediatric patients.  J Clin Oncol.1997;15:1163-1170.Google Scholar
30.
Riikonen P, Rahiala J, Slonvaara M, Perkkio M. Prophylactic administration of granulocyte colony-stimulating factor (filgrastim) after conventional chemotherapy in children with cancer.  Stem Cells.1995;13:289-294.Google Scholar
31.
Souetre E, Qing W, Penelaud PF. Economic analysis of the use of recombinant human granulocyte colony stimulating factor in autologous bone marrow transplantation.  Eur J Cancer.1996;32A(suppl):1162-1165.Google Scholar
32.
Uyl-de Groot CA, Richel DJ, Rutten FF. Peripheral blood progenitor cell transplantation mobilised by r-metHuG-CSF (filgrastim): a less costly alternative to autologous bone marrow transplantation.  Eur J Cancer.1994;30A(suppl):1631-1635.Google Scholar
33.
Zagonel V, Babare R, Merola MC.  et al.  Cost-benefit of granulocyte colony-stimulating factor administration in older patients with non-Hodgkin's lymphoma treated with combination chemotherapy.  Ann Oncol.1994;5(suppl 2):S127-S132.Google Scholar
34.
Dranitsaris G, Altmayer C, Quirt I. Cost-benefit analysis of prophylactic granulocyte colony-stimulating factor during CHOP antineoplastic therapy for Non-Hodgkin's lymphoma.  Pharmacoeconomics.1997;11:566-577.Google Scholar
35.
Drummond M, Davies L. Economic evaluation of lenograstim for prophylaxis of chemotherapy-induced neutropenia in patients with small cell lung cancer.  Pharmacoeconomics.1994;6:44-52.Google Scholar
36.
Duncan N, Hewetson M, Atra A, Dick G, Pinkerton R. An economic evaluation of the use of granulocyte colony-stimulating factor after bone marrow transplantation in children.  Pharmacoeconomics.1997;11:169-174.Google Scholar
37.
Messori A, Trippoli S, Tendi E. G-CSF for the prophylaxis of neutropenic fever in patients with small cell lung cancer receiving myelosuppressive antineoplastic chemotherapy: meta-analysis and pharmacoeconomic evaluation.  J Clin Pharm Ther.1996;21:57-63.Google Scholar
38.
Nichols CR, Fox EP, Roth BJ, Williams SD, Loehrer PJ, Einhorn LH. Incidence of neutropenic fever in patients treated with standard-dose combination chemotherapy for small-cell lung cancer and the cost impact of treatment with granulocyte colony-stimulating factor.  J Clin Oncol.1994;12:1245-1250.Google Scholar
39.
Peroutka JA, Mutnick AH. Use of decision analysis to evaluate the costs and benefits of filgrastim (G-CSF) therapy.  Formulary.1995;30:394-404.Google Scholar
40.
Pui CH, Boyett JM, Hughes WT.  et al.  Human granulocyte colony-stimulating factor after induction chemotherapy in children with acute lymphoblastic leukemia.  N Engl J Med.1997;336:1781-1787.Google Scholar
41.
Bennett CL, Golub R, Waters TM, Tallman MS, Rowe JM. Economic analyses of phase III cooperative trials: are they feasible?  Cancer Invest.1997;15:227-236.Google Scholar
42.
Gulati SC, Bennett CL. Granulocyte-macrophage colony-stimulating factor (GM-CSF) as adjunct therapy in relapsed Hodgkin disease.  Ann Intern Med.1992;116:177-182. [Erratum: Anticancer Drugs. 1993;4:13-16; Stem Cells. 1993;11:20-25.]Google Scholar
43.
Luce BR, Singer JW, Weschler JM.  et al.  Recombinant human granulocyte-macrophage colony-stimulating factor after autologous bone marrow transplantation for lymphoid cancer: an economic analysis of a randomised, double-blind, placebo-controlled trial.  Pharmacoeconomics.1994;6:42-48.Google Scholar
44.
Bennett CL, George SL, Vose JL.  et al.  Granulocyte-macrophage colony-stimulating factor as adjunct therapy in relapsed lymphoid malignancy: implications for economic analyses of phase III clinical trials.  Stem Cells.1995;13:414-420.Google Scholar
45.
Vellenga E, Uyl-de Groot CA, de Wit R.  et al.  Randomized placebo-controlled trial of gm-csf in patients with chemotherapy-related febrile neutropenia.  J Clin Oncol.1996;14:619-627.Google Scholar
46.
Buxton MJ, O'Brien BJ. Economic evaluation of ondansetron: preliminary analysis using clinical trial data prior to price setting.  Br J Cancer Suppl.1992;66:S64-S67.Google Scholar
47.
Splinter WM, Rhine EJ, Roberts DJ. Vomiting after strabismus surgery in children: ondansetron vs propofol.  Can J Anaesth.1997;44:825-829.Google Scholar
48.
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49.
Bleiberg H, Autier P, Michaux D. Cost-effectiveness analysis of antiemetic treatment.  Support Care Cancer.1994;2:145-149.Google Scholar
50.
Cunningham D, Gore M, Davidson N, Miocevich M, Manchanda M, Wells N. The real costs of emesis—an economic analysis of ondansetron vs. metoclopramide in controlling emesis in patients receiving chemotherapy for cancer.  Eur J Cancer.1993;29A(suppl):303-309.Google Scholar
51.
Johnson NE, Nash DB, Carpenter CE, Sistek CJ. Ondansetron: costs and resource utilisation in a US teaching hospital setting.  Pharmacoeconomics.1993;3:471-481.Google Scholar
52.
Tang J, Watcha MF, White PF. A comparison of costs and efficacy of ondansetron and droperidol as prophylactic antiemetic therapy for elective outpatient gynecologic procedures.  Anesth Analg.1996;83:304-313.Google Scholar
53.
Zbrozek AS, Cantor SB, Cardenas MP, Hill DP. Pharmacoeconomic analysis of ondansetron versus metoclopramide for cisplatin-induced nausea and vomiting.  Am J Hosp Pharm.1994;51:1555-1563.Google Scholar
54.
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55.
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56.
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57.
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58.
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59.
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60.
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61.
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62.
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63.
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64.
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65.
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Original Contribution
October 20, 1999

Evaluation of Conflict of Interest in Economic Analyses of New Drugs Used in Oncology

Author Affiliations

Author Affiliations: Institute for Health Services Research and Policy Studies (Dr Bennett) and Division of Hematology/Oncology, Northwestern University (Mr Friedberg and Drs Nelson and Bennett) and Lakeside Veterans Affairs Medical Center (Ms Stinson and Dr Bennett), Chicago, Ill; and the Department of Economics, Swarthmore College, Swarthmore, Pa (Dr Saffran).

JAMA. 1999;282(15):1453-1457. doi:10.1001/jama.282.15.1453
Abstract

Context Recent studies have found that when investigators have financial relationships with pharmaceutical or product manufacturers, they are less likely to criticize the safety or efficacy of these agents. The effects of health economics research on pharmaceutical company revenue make drug investigations potentially vulnerable to this bias.

Objective To determine whether there is an association between pharmaceutical industry sponsorship and economic assessment of oncology drugs.

Design MEDLINE and HealthSTAR databases (1988-1998) were searched for original English-language research articles of cost or cost-effectiveness analyses of 6 oncology drugs in 3 new drug categories (hematopoietic colony-stimulating factors, serotonin antagonist antiemetics, and taxanes), yielding 44 eligible articles. Two investigators independently abstracted each article based on specific criteria.

Main Outcome Measure Relationships between funding source and (1) qualitative cost assessment (favorable, neutral, or unfavorable) and (2) qualitative conclusions that overstated quantitative results.

Results Pharmaceutical company–sponsored studies were less likely than nonprofit-sponsored studies to report unfavorable qualitative conclusions (1/20 [5%] vs 9/24 [38%]; P=.04), whereas overstatements of quantitative results were not significantly different in pharmaceutical company–sponsored (6/20 [30%]) vs nonprofit-sponsored (3/24 [13%]) studies (P=.26).

Conclusions Although we did not identify bias in individual studies, these findings indicate that pharmaceutical company sponsorship of economic analyses is associated with reduced likelihood of reporting unfavorable results.

Financial conflict of interest is a pressing issue for the medical research community.1,2 Physicians' economic ties to tobacco, alcohol, baby formula, and pharmaceutical companies have all been criticized as possible nonscientific influences on medical research.3-6 Recent studies of research on calcium channel antagonists in cardiology, nonsteroidal anti-inflammatory drugs for the treatment of arthritis, and the health effects of secondhand smoke all found that physicians with financial ties to manufacturers were significantly less likely to criticize the safety or efficacy of these agents.7-9 Similarly, a study of clinical trial publications determined that there was a significant association between positive results in general internal medicine clinical trials and funding from a pharmaceutical manufacturer.10

While the debate over financial conflict of interest has surrounded issues of clinical efficacy and safety, only 1 prior study has addressed concerns related to reports on cost-effectiveness.11 In that study, Azimi and Welch11 reported that industry-financed cost-effectiveness analyses were more likely to support additional expenditures with investigational drugs than standard treatments. To further examine the existing pharmacoeconomic literature, we evaluated cost studies for 3 recent breakthrough areas in oncology: hematopoietic colony-stimulating factors, serotonin antagonist antiemetics, and taxanes. Economic studies of these agents have reported varying assessments of costs and cost-effectiveness.12-17 This study was designed to determine whether the apparent financially motivated bias seen in clinical efficacy and safety evaluations is also evident in economic analyses in oncology.

The major objective of this study was to determine whether there was an association between pharmaceutical industry sponsorship and economic assessments of breakthrough oncology drugs. The following questions were addressed: were pharmaceutical company–funded economic studies more likely than nonprofit-funded studies to report favorable qualitative assessments and less likely to report unfavorable qualitative assessments? and were pharmaceutical company–sponsored studies more likely than nonprofit-funded studies to state qualitatively favorable conclusions despite neutral or unfavorable quantitative results?

Methods

Economic analyses of 6 recently marketed breakthrough cancer drugs in 3 categories were chosen. The agents included hematopoietic growth factors (granulocyte colony-stimulating factor [G-CSF] and granulocyte-macrophage colony-stimulating factor [GM-CSF]), serotonin antagonist antiemetics (ondansetron hydrochloride and granisetron), and taxane chemotherapy agents (paclitaxel and docetaxel). These drugs were chosen because their cost-effectiveness is controversial, and they account for a large fraction of total pharmaceutical expenditures in many hospital pharmacies. Clinical reports have demonstrated efficacy in specific settings, but high acquisition and administration costs have raised concern about the widespread use of these agents.

We searched the MEDLINE (1988-1998) and HealthSTAR (1988-1998) databases to identify original research articles that contained an economic analysis of 1 or more of the study drugs. The following terms were searched: cost(s), cost-effective(ness), economic(s), dollar(s), pharmacoeconomic(s), and cost-benefit. Drugs were searched under generic and brand names. Abstracts, letters, editorials, review articles, and non–English-language articles were excluded. Abstracts from the remaining articles were reviewed, and all articles including an actual analysis of costs were identified. This search yielded 54 articles, of which 8 were head-to-head comparisons between drugs in a given category (eg, G-CSF vs GM-CSF) and 46 were comparisons with placebo or standard treatment. Head-to-head comparisons were excluded because they could not be classified according to our criteria; ie, the results would always be either favorable or neutral for 1 or the other of the study drugs. Another 2 articles18,19 were excluded because we were unable to obtain information about the funding source, despite repeated requests. Of the 44 articles studied, there were 28 articles for hematopoietic colony-stimulating factors,12,13,20-45 11 articles for antiemetics,14,15,46-54 and 5 articles for taxanes.16,17,55-57 The types of analyses included were cost-minimization or cost-identification (a comparison of the costs of treatment for 2 different agents with similar efficacy or outcomes) and cost-effectiveness (comparison of the costs of treatment for 2 agents normalized by their effectiveness, typically reported as cost per life-year gained). All of the articles fit 1 of these types, based on generally accepted definitions.58,59

Two investigators (M.F. and W.N.) independently abstracted information from each of the articles based on distinct, written, preset criteria. Information was collected on (1) the qualitative conclusion as stated in the abstract or manuscript conclusion, (2) the quantitative numerical results, (3) the timing of the study, and (4) the funding source.

Qualitative conclusions were rated according to the following criteria: favorable (the new drug "reduces costs" or is "cost-effective"), neutral (the new drug "is cost equivalent" or "may be cost-effective," or "does not require additional costs" over standard therapy), or unfavorable (the new drug has "higher costs" or is "not cost-effective"). Whenever the 2 investigators disagreed over an article's qualitative conclusion, a third investigator made the final decision.

Quantitative numerical results were also rated as favorable, neutral, or unfavorable. For cost-minimization studies, numerical results were classified as favorable when the costs of use of the new drug were less than standard treatment, neutral when there was no difference between the new drug and the standard, and unfavorable when the costs of use of the new drug were more than standard treatment. The total cost of treatment for each arm of the study was compared, including the cost of the study drug. When tests of statistical significance were available, significant differences were interpreted as favorable or unfavorable. Statistically insignificant differences were interpreted as neutral. For articles that did not include statistical analyses (typically, decision analyses), robust differences were interpreted as favorable or unfavorable. Nonrobust differences (which reversed direction under sensitivity analyses) were interpreted as neutral. For cost-effectiveness studies, any cost estimate of less than $50,000 per life-year gained was considered favorable, as is generally accepted in the literature.60 More expensive results were considered unfavorable.

Study timing was interpreted as either prospective (the study was initiated alongside the clinical trial) or retrospective (the economic study was begun after the results of the clinical study were known).

Funding source was abstracted after recording a study's qualitative conclusion, quantitative results, and timing. Investigators were not specifically blinded as to funding source during abstraction. Articles were classified as either pharmaceutical company–sponsored or nonprofit-sponsored (government agency, professional organization, nonprofit foundation, or academic institution). For publications not including an acknowledgment of funding (17/46), first and last authors were contacted via mail, e-mail, and/or telephone and queried regarding the funding source of their study. Authors from 13 of 17 articles replied that their studies were either not externally funded or funded by nonprofit sources, while authors of 2 of 17 articles reported that their studies were funded by pharmaceutical companies. Authors of the remaining 2 articles18,19 did not reply, and their studies were not included in our analyses.

Relationships between funding source and (1) qualitative conclusion (favorable, neutral, or unfavorable), (2) overstatement of results (a favorable qualitative conclusion despite neutral or unfavorable quantitative results or a neutral qualitative conclusion despite unfavorable quantitative results), (3) study agent (hematopoietic growth factor, antiemetic, or taxane), (4) study timing (prospective or retrospective), (5) analysis type (cost minimization or cost-effectiveness), (6) journal type (peer-reviewed or non–peer-reviewed), and (7) author affiliations (all academic, or at least 1 pharmaceutical company or consulting firm employee) were analyzed using Fisher exact tests (for 2 × 2 tables with an expected cell value less than 5) or Pearson χ2 tests. A 2-sided P value (against the null hypothesis of no relationship between conclusion and funding source) less than .05 was considered significant.

Results

Of the 44 articles, 20 were funded by pharmaceutical companies and 24 by nonprofit organizations. For those studies funded by pharmaceutical companies, the funding source was always the manufacturer of the investigational drug. Approximately 65% of studies analyzed hematopoietic growth factors, 25% antiemetics, and 10% taxanes (Table 1). This distribution was similar for both pharmaceutical- and nonprofit-sponsored studies. Study timing, analysis type, and journal type also did not differ significantly by funding source. All authors of nonprofit-sponsored studies had academic affiliations, whereas 40% of pharmaceutical company–sponsored studies had at least 1 author with a pharmaceutical company or consulting firm affiliation (divided evenly between pharmaceutical company and consulting firm employees).

There was a statistically significant relationship between funding source and qualitative conclusions (P=.04). Unfavorable conclusions were reached by 38% (9/24) of nonprofit-sponsored studies but by only 5% (1/20) of pharmaceutical company–sponsored studies (Table 1). Reports including only authors who had an academic affiliation appeared more likely to report unfavorable conclusions (28% [10/36]) than those including pharmaceutical or consulting firm employees (0% [0/8]), although this difference was not significant (P=.18). The 2 investigators agreed on the classification of qualitative conclusions in 87% of the articles, with the third investigator determining the classification of the remaining 13%.

In addition, pharmaceutical company–sponsored studies were somewhat more likely than nonprofit-sponsored studies to overstate quantitative results; ie, a favorable qualitative conclusion when quantitative results were neutral or unfavorable, or a neutral conclusion when quantitative results were unfavorable (30% [6/20] vs 13% [3/24]), although this finding was not statistically significant (P=.26).

Comment

This study investigated financial conflicts of interest in the debate over economic analyses of breakthrough oncology drugs. We found a significant association between authors' stated qualitative conclusions regarding the costs and cost-effectiveness of these drugs and study sponsorship by the drugs' manufacturers. Studies funded by pharmaceutical companies were nearly 8 times less likely to reach unfavorable qualitative conclusions than nonprofit-funded studies and 1.4 times more likely to reach favorable qualitative conclusions. We also determined that 1 in 5 articles contained qualitative overstatements of quantitative results.

A number of hypotheses can help explain our findings. First, the retrospective methods used in 89% of our sample studies allow investigators and pharmaceutical companies "early looks" at clinical results and associated resource profiles. These early clinical data can be used to selectively identify the trials most likely to yield positive outcomes, and the pharmaceutical companies can fund economic studies accordingly and therefore, can potentially exercise a limited power to censor unfavorable studies simply by withholding financial support.

Second, there is an evident bias in the body of pharmacoeconomics research (also seen in other areas of medical research) toward the publication of studies with "positive" results. Regardless of funding source, studies with unfavorable preliminary evidence are less likely to be completed, less likely to be submitted for peer review, and, once submitted, less likely to be published.61

Third, pharmaceutical companies can influence research in a variety of ways. Studies may be funded through unrestricted research grants, educational funds, or consultancies (paid directly to investigators). These may include contractual agreements requiring pharmaceutical company review of manuscripts before being submitted for publication. Researchers also may receive funding from the same companies in the form of honoraria or travel awards for scientific meetings and have equity interests in companies and profit directly from increased drug sales.62 It is possible that these factors may result in some unconscious bias (perhaps when qualitatively interpreting results) that could influence study conclusions.

Fourth, the pharmaceutical companies can collaborate directly with investigators in devising protocols for economic analyses and indirectly shape the economic evaluation criteria.

Our study has several limitations. First, we considered only 1 type of economic relationship between pharmaceutical companies and researchers: direct funding of the analysis reported. Second, our ability to investigate direct financial sponsorship of the individual studies was limited because we were unable to review contracts or grants. While we used published information and direct communication with authors, the nature and degree of the financial relationship were not investigated.

The correlation between pharmaceutical company funding and favorable study conclusions might add to public uncertainty regarding company-sponsored medical research.63,64 Although other sources of funds for pharmacoeconomic studies are needed, limiting the publication of pharmaceutical company–sponsored studies is probably not feasible or practical. Pharmaceutical companies provide valuable resources to many areas of academic medicine and are a primary source of funding for pharmacoeconomic studies.7,58 To improve the credibility of economic analyses, policies promoting full disclosure of all financial interests should be pursued. Conducting more prospective pharmacoeconomic analyses (in conjunction with phase 3 trials) would also increase credibility by eliminating the opportunity for selective funding based on clinical results.65 Finally, pharmacoeconomic literature would be more balanced if managed care organizations, government agencies, and nonprofit groups increased their support for high-quality prospective pharmacoeconomic studies.

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Stelfox HT, Chua G, O'Rourke K, Detsky A. Conflict of interest in the debate over calcium-channel antagonists.  N Engl J Med.1998;338:101-106.Google Scholar
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Rochon PA, Gurwitz JH, Simms RW.  et al.  A study of manufacturer-supported trials of nonsteroidal anti-inflammatory drugs in the treatment of arthritis.  Arch Intern Med.1994;154:157-163.Google Scholar
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Davidson RA. Source of funding and outcome of clinical trials.  J Gen Intern Med.1986;1:155-158.Google Scholar
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Bernini JC, Wooley R, Buchanan GR. Low-dose recombinant human granulocyte colony-stimulating factor therapy in children with symptomatic chronic idiopathic neutropenia.  J Pediatr.1996;129:551-558.Google Scholar
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