Piercing the Veil of Corporate Secrecy about Clinical Trials

Abstract

In the last three decades, the pharmaceutical and biotechnology industry has burgeoned into one of the most profitable industries. With profit has come power. Backed by unprecedented financial means and pressured by stockholders' demand for investment returns, pharmaceutical companies have taken a much Larger stake in all stages of medical research. Corporate contributions to research and development in academia have risen by 875 percent between 1980 and 2000. (1) Over this time, the industry has extended its influence into all aspects of the process of creating and regulating scientific knowledge and health care products. As a result, ever more of those involved in research now have financial relationships with the industry. Academic researchers may top off their salaries with stock options or fees for consultations, speaking arrangements, and membership on advisory boards of pharmaceutical companies. Financial rewards are also offered to consumer and advocacy groups, primary care physicians, research recruiters, bioethics consultants and centers, and scientists at the National Institutes of Health. (2) And while financial compensation may be inappropriate for those directly involved in the federal drug approval process, industry can offer these officials wall-paying jobs when they leave their positions. In addition, being on a company's payroll has not prevented experts from functioning as members of governmental advisory panels that approve new drugs and evaluate clinical practice guidelines. Governmental policies and legislative initiatives such as the Bayh-Dole Act, which promoted the commercialization of academic research, have also contributed to a shift in institutional approaches to commercialization. They have normalized an academic culture in which researchers are encouraged to be as much concerned about the commercial potential of their research as they are about its intellectual value and potential public benefit. In short, commercial developments and changes within the research culture have blurted the lines between public and private in research and fundamentally altered the landscape of medical research. Interaction between industry and other stakeholders has become more cozy and friendly. This has surely led to the development of many new health care products, as promoters of these new partnerships in part intended. But the courting of researchers, patients, health care workers, medical institutions, and regulators is also part of aggressive, orchestrated, and well-developed marketing campaigns that contribute little to the common good. These trends raise many concerns. One of the larger and more general of these is the impact on research integrity. When commercial sponsors design the protocol, select research subjects, conduct the research, collect the data, interpret the results, control publication of the outcome, fund advocacy and support groups to lobby governments for approval or funding of the drug, and spend millions on commercial campaigns to promote a new drug, there is reason to worry about whether the process is generating reliable data. The Culture of Critique? Industry-funded studies are not necessarily flawed and without scientific merit. But the consequences of independent research can be so financially devastating that it would be naive to rely merely on the integrity of corporations. In 2002, Bristol-Myers Squibb sponsored a team of researchers to compare its cholesterol-lowering drug Pravachol to Pfizer's Lipitor. It surely expected, to hear that it was equally efficient. The study concluded, however, that people taking Lipitor were at a 16 percent lower risk for heart attack or death. (3) These results basically closed the door for Bristol-Myers Squibb to the $22 billion market for cholesterol-lowering drugs. Pravachol was its top-selling drug in 2003, with sales of about $2.8 billion. While we may welcome Bristol-Myers' initiative, this is bow the Wa//Street Journal formulates the corporate view: For Bristol-Myers, Challenging Pfizer Was A Big Mistake. …