Last year may well be remembered as a public relations nightmare for the clinical trials industry.
Early in 2004, the American Medical Association and the publishers of prestigious, peer-reviewed medical journals such as
the New England Journal of Medicine called for a government-based clinical trial registry to provide greater disclosure of drug risks in order to address potential
bias in industry-sponsored clinical trials. That same month, the New York attorney general filed a lawsuit against GlaxoSmithKline
for deliberately suppressing negative clinical trial results for its antidepressant drug Paxil. Dr. Angell's controversial
and highly publicized summer 2004 book, The Truth About Drug Companies: How They Deceive Us and What to Do About It, argued that conflicts of interest guide industry-sponsored trials.
|
Later in the year, Merck withdrew its blockbuster COX-2 inhibitor Vioxx due to the drug's elevated risk of heart attacks shown
in a large clinical trial. The Office of the Inspector General next released a survey showing that one-third of FDA scientists
have doubts about the agency's ability to monitor the safety of new therapies during the review and approval process. And
late in 2004, clinical research results showed elevated risk of heart attack and stroke with Pfizer's widely used COX-2 inhibitors
Celebrex and Bextra. The press also reported on one study suggesting increased risk of cardiovascular events with over-the-counter
drug Aleve.
Poor public relations in 2004 are arguably part of a longer, five-year downward spiral that the clinical trials industry has
endured and largely ignored. Indeed, some of the media's scrutiny and skepticism has been warranted. In 1999 and 2000, several
tragic deaths of study volunteers participating in government- and industry-funded clinical trials (e.g., Gage Stevens, Jesse
Gelsinger, Ellen Roche) were widely publicized. In 2001, the Office of the Inspector General released a report documenting
a stretched and failing human subject protection system. That same year, the Food and Drug Administration reported dramatic
increases in the number of complaints filed against investigators for noncompliance and fraud. In 2002, the Institute of Medicine
issued its report calling for major reforms to the informed consent process. An assessment of major newspaper coverage during the past five years shows that the frequency of articles on the clinical
research enterprise is increasing, but the number of negative articles is growing at a disproportionately faster rate.1 In 2002, Time Magazine published its now-famous cover story "How Medical Testing has Turned Millions of Us into Human Guinea Pigs." The media's
reference in this article—and in dozens more since then—to study volunteers as "Guinea Pigs" fails to acknowledge the profound
decision that millions of people make each year when they give their consent to participate. The article also neglects to
report that volunteers are active participants in a study and that they have the option to withdraw at any time. Sadly, clinical
research professionals in government, foundations, and industry have done remarkably little to address the media's incomplete,
sensationalistic, and ill-informed portrayal. Yet the public and prospective volunteers derive most of their exposure to—and
education about—the clinical research process from the media.
A seriously inadequate education Public and volunteer communities know nearly nothing about clinical research and the important role that each party plays
in the process. Historically, the clinical research community has relied heavily on the informed consent (IC) process as the
primary means of educating study volunteers. Not only is the IC process reaching a narrow subset of the communities that it
must educate, but also recent assessments of the process show that it is failing to live up to its intended purpose. According
to a 2002 report, for example, the Institute of Medicine found the focus of the IC process to be largely the review of lengthy
and confusing documents designed to protect the investigative site from liability.
