In the latest chapter in the controversy over pharmaceutical development and potential research bias, the World Health Organization (WHO) is calling on researchers to fully disclose the results of their clinical trials.
WHO officials said that clinicians have been able to skew results in a manner that spreads misinformation and impedes the health agency’s long-term public health goals. In a press statement this week, WHO said that the key findings of studies — positive or negative — should be published within a year of completion. The global health agency is also requesting the release of older, unreported clinical trials that could affect scientific research.
Under current guidelines, the full disclosure of trial data hinges on the study’s inclusion in accredited medical journals. According to critics of the system, that allows the trials with results that don’t fit researchers’ agenda to slip through the cracks of the regulatory system. Analyses of clinical trials have confirmed their worst fears, showing that a significant number of trials remain unreported several years after the completion of a study.
Researchers and consumer advocates have welcomed WHO’s stance on the issue, although some doctors caution that carrying out its demands will require practical implementation. However, Marie-Paule Kieny, WHO’s assistant director general, said that when it comes to holding pharmaceutical companies accountable to doctors and consumers, time is of the essence: “[The withholding of data] creates indirect costs for public and private entities, including patients themselves, who pay for sub-optimal or harmful treatments,” Paule-Kieny told Reuters.
Paule-Kieny has a point. A collection of survey data at Stanford University earlier this year found that nearly two percent of scientists admitted to falsifying their work and manipulating results. Fourteen percent of those surveyed also said they’ve witnessed misconduct among their peers, including omitting tests results that don’t fit their hypothesis and only publishing their most positive findings. Experts say that labs in the United States tend to give more positive results than their European counterparts, perhaps out of an urge to land in scientific journals.
A lack of oversight has proven detrimental for consumers. In February, a study published in JAMA Internal Medicine found that a significant number of published scientific studies didn’t reveal occurrences of research misconduct, even in some cases when the FDA found entire clinical trials to be unreliable. One case involved an experimental treatment that claimed all patients saw improvements in their condition when, in fact, one patient had a foot amputated less than two weeks after taking the treatment. Other instances of research misconduct led to patient deaths.
And the consequences of scientific misconduct extend beyond patients. Discoveries of fraud can cost well above $525,000 for an investigation process that has several phases. Other costs include the expenditure of institutional start-up funds, the loss of productivity by the research group, and the misdirection of research efforts in other labs. Parties affiliated with laboratories implicated in fraud stand a great chance of having their reputations tarnished. The funds of research labs that complied with the rules may also be in jeopardy, as well as the standing of the scientific journal that published the doctored findings.
“All these polluting factors detract from the ability of scientists and physicians to trust what they read, devalue legitimate science, undermine the ability to reproduce legitimate findings, impose huge costs on the publication process, and take a toll in terms of disability and death when tests, treatments, and interventions are founded on faulty claims,” New York University bioethicist Arthur Caplan recently wrote in a commentary published online in the journal Mayo Clinic Proceedings.
WHO’s latest efforts follow a 2005 call for the identification of all clinical trials and the establishment of the International Clinical Trials Registry Platform, a tool with which the health agency can track the findings of clinical trials around the world. The inception of the platform resulted from a summit on health research in the previous year.
When it comes to ensuring transparency, WHO hasn’t stopped at the research process. The health organization also wants to hold pharmaceutical companies accountable for distributing life-saving medication at affordable prices. In its recent report, WHO called for countries to make price negotiations with drug producers more transparent so that they can collaboratively close gaps in medicine pricing policies. Last November, WHO Director General Margaret Chan took a more direct approach, explicitly decrying pharmaceutical companies that have delayed the development of an Ebola vaccine in their pursuit of profit.