USA Today Point-Counterpoint Editorial Debates Conflict-of-Interest in Clinical Drug Trials

Although advances in drug treatment are partially accountable for the nation's rising drug costs, much of the increase has resulted from "the huge sums drug companies spend to influence virtually every corner of the drug industry," a USA Today editorial states. The editorial says that drug companies spend "billions of dollars" each year to "sway prescribing decisions" through strategies such as direct-to-consumer advertising and bestowing "gifts" on doctors who write prescriptions. However, the "most troubling" tactic adopted by pharmaceutical companies is "the roughly $9 billion that drug companies spent in 2000 to sponsor the clinical trials of their own products," the editorial states. The editorial explains that when pharmaceutical firms run their own clinical trials, they "have access to a trial's design, data and analysis and can tweak any of them." If a clinical trial "goes sour," the firm can "refuse researchers permission to publish," the editorial notes. The editorial states that pharmaceutical companies have put forth the "vigorous defense" that clinical trials are subject to FDA regulation and that the potential for liability also prevents the publication of "distorted data." But the editorial points out that the FDA is "understaffed and underfunded, and numerous studies have raised questions about the objectivity of industry-funded trials." Although the "obvious solution" might be to halt company-sponsored trials, finding $9 billion to replace the lost funding will prove difficult, the editorial states. The editorial proposes a number of other options, including having the FDA require companies to give "complet[e]" control over a trial to outside investigators; having drug makers "surrender" their ability to withhold data or "squelch results"; and having the drug industry "strengthen its code of ethics." The editorial concludes, "Skyrocketing drug spending may show that the industry is meeting the nation's health care needs. It is also a signal, however, that the industry's authority to run its own trials and validate its own products requires urgent rethinking" (USA Today, 5/9).

PhRMA Offers Counterpoint
"Pharmaceutical companies conduct thousands of tests on each potential drug, audited by the FDA, and have a strong interest in making sure the data generated are accurate," Dr. Bert Spilker, senior vice president for scientific and regulatory affairs of the Pharmaceutical Research and Manufacturers of America, writes in an accompanying USA Today opinion piece. Spilker states that "an unsafe drug on the market can mean lawsuits and a vote of no confidence by investors and customers," adding, "Companies want to weed out unsafe or ineffective drugs early in the development process, so scarce resources can go to other projects." Spilker writes that the protocols for clinical trials are reviewed by both the FDA and an Institutional Review Board composed of "laypersons and professionals not involved with the trial." In addition, "key trials" are "double blind," meaning that "neither patients nor investigators know which patients are receiving which treatment," Spilker adds. He states, "These and other safeguards protect patients and ensure the integrity of the data." Regarding researchers, Spilker states that "the academic and other investigators who conduct trials have reputations to uphold. It is in their interest to conduct ethical trials that generate accurate data." Meanwhile, the trials are often "peer-reviewed" by other scientists both before they begin and when the reports are published. Spilker concludes, "Our system for ensuring the safety of medicines is working. Companies and regulators will continue to be vigilant, and consumers can have confidence that the medicines they take are the safest in the world" (Spilker, USA Today, 5/9).