When it comes to medical research and advancement, we usually hear about the results of a successful study or a new drug in the latter stages of a clinical trial. Rarely does the media report on trials gone wrong or the unethical aspects of medical research.
This is starting to change.
A May 16 New York Times article, "Drug Trials Hide Conflicts for Doctors," presented a scathing view of the patient recruitment process, the result of a 10-month investigation. The report highlights the disturbing trend of pharmaceutical companies that offer doctors financial incentives to recruit patients in a timely fashion. The article detailed in one scenario a doctor who suggested his patient join the study of a new drug to shrink enlarged prostates, although the patient's prostate was fine. Since the patient had been previously hospitalized for a chronic slow heart rate, he should never have been included in the study. Immediately after joining the study, the patient complained of fatigue, a symptom of his heart problem and asked to be dropped from the study. Days later he was hospitalized and given a pacemaker.
This kind of media coverage of clinical trials is the tip of the iceberg.
The Denver Post health and fitness writer, Claire Martin (who is profiled in this issue on p. 8) says she will soon be reporting on the ethics of clinical studies.
Given the public's increasingly voracious appetite for medical news and the media's eagerness to fill this information void, it's inevitable that the coverage will delve more into the preliminary stages of research than simply clinical results and outcomes.
And PR professionals at research institutions must closely monitor how studies are conducted and be prepared for ethical questions involving their organization's research policy and methods for disclosing patient information.
Guinea Pig Factor
The New York Times article comes at a time when patient recruitment efforts already are difficult for some hospitals and public perception about clinical trials is often negative.
The "guinea pig" perception of clinical trials is prevalent and potential patients often are unaware of the variety of studies in the hopper.
Medical research is an area that screams for better patient education and informational campaigns that build broad awareness of the clinical trials process, including the advantages, side effects and overall patient rights.
Susan Phillips, associate dean for external relations at Mount Sinai-NYU Medical Center and Health System, says that hospitals and physicians need to go beyond patient consent forms to provide more general information about clinical research in layman's terms, including fact sheets and brochures on patient safeguards.
At Mount Sinai, nurses regularly brainstorm ways to make the research process more patient-information friendly. Earlier this year, their ideas were used to develop a new brochure that outlines clinical trials in "simple English" and the rights of patients to refuse participation without sacrificing quality medical care.
As to risks, patients must be made fully aware of any side effects the trial may involve using non-technical language, says Phyllis Marino, The Cleveland Clinic's acting chief marketing officer. This plain speaking by nurses and physicians is what helps the clinic maintain its reputation as a respected top-notch research facility.
Where financial incentives are concerned, patients should be better informed. Many hospitals, like Mt. Sinai, discuss how a study is funded in the patient consent form.
While there's a strong argument for disclosing this information elsewhere, Phillips isn't sure who should take the lead - the physician, research investigator or the hospital's internal review board.
Whatever the approach, the hospital's PR department should be aware of how this issue is resolved to prepare for what ethical questions may surface.
Educating the Media
The media's expanding interest in clinical trials represents an exciting opportunity to educate the media about the "behind the scenes" hard work that goes into clinical trials. The media's current focus on key advances in high-profile research areas like cancer, diabetes and cardiovascular health often creates unrealistic expectations for "cures," says Rob Whitehouse, media relations specialist at The Cleveland Clinic. But Whitehouse, who spends a quarter of his time promoting the Clinic's research, is noticing that more and more reporters are becoming interested in the earlier stages of trials.
To provide more comprehensive information about its clinical trials, the Clinic is looking to post more information on its Web site. "The Web is a great resource for reporters, particularly those working on stories involving the lesser known areas of medical research," says Whitehouse.
Hosting "mini medical schools" for reporters is another great way to inform the media and public about clinical research, says Phillips. Mt. Sinai holds these community forums on various medical topics and thinks it can be expanded to include clinical research issues. These efforts would paint a more realistic view of what clinical research entails and possibly foster a greater appreciation for medical advances when they occur.
(Mt. Sinai-NYU Medical Center, Susan Phillips, 212/241-7592; The Cleveland Clinic, Rob Whitehouse, Phyllis Marino, 216/444-8927)
Patient Recruitment Opps
Last year, Matthews Media Group, a Rockville, Md. consulting firm that specializes in recruiting patients for clinical trials, published a report that highlights the challenges of conducting clinical research in a managed care environment and offers strategies for increasing participation in medical research. Key suggestions for marketers include:
- Be realistic about the level of participation that can be expected by factoring in sufficient start up time at the beginning of recruitment and looking at recruitment rates of similar studies.
- Identify the most compelling reasons for participation, such as access to an otherwise unavailable treatment/drug or the opportunity to conquer a disease.
- Plan to reach prospective participants in multiple ways such as direct mail, placing articles in health newsletters, using community leaders and churches and soliciting support from healthcare providers.
- Offer incentives that communicate you value the participant, such as department store certificates, supermarket vouchers and free cosmetology consultations for women undergoing chemotherapy.
Source: Matthews Media Group, 301/984-7191, http://www.matthewsgroup.com