Uneasy alliance—clinical investigators and the pharmaceutical industry

“Since the 1990s, the majority of clinical trials are conducted in the private sector on a contractual basis by private practice physicians who are paid by pharmaceutical companies to recruit their own patients or local community members into drug studies (Bodenheimer, 2000).”

“Clinical trials are very expensive and are usually conducted by pharmaceutical companies with an eye to profit making [243,244].”

“…provides 70 percent of money for clinical drug trials; companies sponsoring these trials have forbidden publication of results without the company’s consent, have suppressed unfavorable reports, and have threatened researchers with unfavorable results with loss of future funding (Bodenheimer 2000).”

“CROs, serving as intermediaries between pharmaceutical companies and clinical research sites, employ physician-scientists, biostatisticians, research coordinators and managers to offer a wide range of services to oversee the conduct of clinical trials.(68) Pharmaceutical companies are opting more frequently to hire CR…”

“sector by physicians in private practices or for-profit, dedicated research centers (Bodenheimer 2000; Rettig 2000).”

“about the strong influence the pharmaceutical industry has on psychiatric practice(3) and the publication of research.(4,5) Many sections of the statement refer to”

“Potential bias in the report of the evidence by researchers Approximately 70% of the funding for clinical drug trials conducted in the United States is procured from industry [93].”

“…(Wazana, 2000), the extent to which continuing education is funded by the industry (Ross, Lurie, & Wolfe, 2000), and the degree to which research contracts restrict the dissemination and interpretation of findings (Bodenheimer, 2000; Choudhry, Stelfox, & Detsky, 2002; Davidoff et al., 2001).”

“While having a COI is not itself a type of research misconduct, COIs have been described as a “risk factor” for research misconduct in that they may encourage researchers to falsify or fabricate data or engage in illegal activities (Bodenheimer, 2000b; Committee on Government Operations, 1990).”

“• Publication This principle arises from a concern regarding how research findings from academicindustry partnerships are published and otherwise disseminated through the peer-reviewed literature and scientific and professional conferences [2, 38, 39, 49, 52, 53].”

“industry provides 70 % of funding for drug trials in the United States [3, 4].”

“” It may be time to take a careful look at who does pharmaceutical research, in what ways, for what purposes and with what consequences.(31,32) Certainly there is an important role to be played by the large patent-dependent pharmaceutical companies, although if current trends continue, it may be more in development th…”

“The first, and fundamental limitation is that, around 70% of drug evaluation (Bodenheimer 2000) is carried out by, or for, the pharmaceutical companies that plan to manufacture the new drug and stand to profit from its sales.”

“Currently in USA, the volume and investment of health research conducted by the pharmaceutical industry exceeds that of publicly funded research (Bodenheimer, 2000; Rettig, 2000).”

“This kind of situations has been mentioned occasionally.(28) We decided to publish the results.”

“Another concern is the increasingly recognized corrosive influence of industry sponsorship on the results of scientific studies [27–29].”

“Because growing numbers of university researchers have fi nancial and other ties to the pharmaceutical industry (Angell, 2004; Bodenheimer, 2000; Fishman, 2004; Wazana, 2000), it is likely that many of these seemingly unaligned ‘experts’ are in fact explicitly linked to that industry.”

“Regulations governing IRBs were promulgated initially at a time when human subject research primarily involved one investigator, one institution, and a locally or regionally accessible cohort of subjects.5 In the past two decades, industry-sponsored clinical trials and government-sponsored multisite, clinical research…”

“Consequently, questions have been raised as to how the nature of academic-industrial relationships should be managed [inter alia, Bodenheimer, 2000; Bok, 2003; Gelijns and Their, 2002; Nathan and Weatherall, 2002; New Scientist, 2002].”

“RECs in low- and middle-income countries may be under pressure to approve research protocols by external sponsors because of financial benefits to their institutions (Bodenheimer, 2000; Coleman & Bouesseau, 2008; Rothstein & Phuong, 2007).”

“They may also produce conflicts of interest (COI’s) for investigators that can compromise scientific objectivity (Rochon et al., 1998; Bodenheimer, 2000; and Reed and Camargo, 1999).”

“In spite of this social science interest in physicians and ethics, there has been little empirical examination of the involvement of private-sector physicians in pharmaceutical clinical trials (Bodenheimer, 2000).”

“Physicians and medical institutions are mistrusted, with widespread concern that entanglements among physicians, health centers, and big businesses (managed care companies and the pharmaceutical industry) motivate physicians to act out of interests other than their patients’ well-being (3, 4).”

“One of the reasons that the pharmaceutical industry has shifted its research from the academic sector is industry perception that academic research takes too long and costs too much (Bodenheimer, 2000; Washburn, 2001).”

“the nature of the reported findings (22,23).”

“This conflict and the increasing commercial influence on academic affairs have been considered in recent publications (Appelgate et al. 1996; Blumenthal et al. 1997; Larkin 1999; Agnew 2000a, 2000fc; Angell 2000; Bodenheimer 2000; Boyd and Bero 2000; Cho et al. 2000; DeAngelis 2000; Holden 2000; Korn 2000; Lo et al. 2…”

“” Over the past several decades this new research model pairing academic centers with industry has flourished, and this infusion of private funds into biomedical research has improved clinical medicine.(18) However, in the absence of an independent oversight committee charged with assessing and publicizing the impact…”

“1808 Conflict of interest or ideological divide: physicians and industry © 2006 LibRAPHARM LTD – Curr Med Res Opin 2006; 22(9) to industry from formulary committees; (4) prohibit pharmaceutical manufacturers from providing financial support to any ACCME-accredited programs and establish central repositories at AMCs fo…”

“Pharmaceutical support should be considered in evaluating studies because of the potential for conflicts of interest associated with the study design, data analysis, and publication bias [70].”

“Industry’s role in innovation and research is important, but concern continues that investor-owned corporations must perforce tend to business interests, and these could adversely influence research and compromise its integrity.(6-9) For individual physicians and sites, a partnership with industry may therefore create…”

“It has been suggested that the shift of commercially sponsored clinical research trials away from academic centers gives pharmaceutical companies greater control over the design of studies, analysis of data, and publication of results [59], including the likelihood that negative results do not get published.”

“The cause for concern about the influence of COI is legitimate (Bodenheimer, 2000; DeAngelis et al, 2001; Moses and Martin, 2001; Choudhry et al, 2002; Morin et al, 2002; Moses et al, 2002; Steinbrook, 2002a, b, 2004; Yarborough and Sharp, 2002; Bekelman et al, 2003; Johns et al, 2003; Warner and…”

“Yet considerable controversy surrounds such agreements and how they should be applied [8,13–15].”

“To avoid any industry bias, it is imperative that the design, implementation, data analysis, interpretation of results, and publication of a megatrial’s findings be guided exclusively by an independent steering committee.(48) This decision-making body is assisted by its subcommittees, such as the Substudy and Publicat…”

“In fact, financial relationships between clinical researchers and drug companies are a serious concern among many ( Bodenheimer, 2000a”

“With so much at stake, reports abound on the changing relationship between industry and academia (6, 19), the influence pharmaceutical companies are exerting over academic freedom (20, 21), and on how research is moving away from the academic medical center setting into the community with the evolution of commercially…”

“In most other circumstances, the default presumption would be that mODey buys influence (Bodenheimer, 2000), but psychiatrists deny that money from the pharmaceutical industry influences their thoughts and practices.”

“Yet publication in prestigious journals is important, to persuade physicians to prescribe the company’s products (Bodenheimer 2000).”

“…great deal of attention in recent years has been focused on the ethical issues surrounding financial conflicts of interest in clinical research (Angell, 2000; Bodenheimer, 2000; Boyd and Bero, 2000; Cho et al., 2000; Lo et al., 2000; Martin and Kasper, 2000; Blumenthal, 2003; Kassirer, 2004).”

“Several recent studies challenge the claim of scientists that “fundinggenerated” bias is eliminated by carefully planned, randomized, and controlled trials; these studies show results of clinical trials supported by industry to be skewed in favor of the sponsor (6, 7).”

“... research by manipulating data, suppressing unfavorable results, and creating conflicts of interests for researchers; that it “pushes” drugs on patients who don’t need them; that it receives a form of corporate welfare under the Bayh-Dole Act; and that it exerts a corrupting influence over physicians, pharmacists,…”

“Historically, industry-funded trials avoid active standard drug controlled trial methodology when they are unlikely to reveal the superiority of a new drug over available treatments (40).”

“In biomedical research, COI can lead to various types of research bias, such as manipulating or misinterpreting data, withholding information from subjects/patients, and not publishing unfavorable research results [53,54].”

“The fact that the majority of clinical trials in medicine are funded by industry did not seem to influence this belief [19, 20].”

“Conflicts of interest affecting trial conduct are a cause for concern [16–18].”

“Speed of testing is as crucial as recruiting sufficient numbers of patients. Thomas Bodenheimer mentions, without providing a source, that a single day's delay in getting a drug to market costs $1.3 million [”