Beyond The Standard of Care
words by maryann brinley /
photograph by dan katz
bout 15 years ago, Robert E. Hudrick, DO, was in a private practice when a woman came in with a brand new diagnosis of Alzheimer’s disease. His boss referred her to an expert at a large medical center but when she returned for a follow-up visit, her prospects were still bleak. She had been told nothing could be done to alleviate the condition or stop the deterioration in her brain.
A week later, the invitation to participate in a clinical trial for Alzheimer’s disease landed in their Philadelphia office. “Talk about timing,” recalls Hudrick, who is a past winner of the SOM Family Medicine Educator of the Year Award. “The truth is: we as physicians weren’t able to offer this patient a whole lot. The standard of care was failing her. So when we called her back with this option to join a research study, she jumped at the chance to try the new medicine.
“What clinical trials do for us is take the normal practice of medicine beyond that standard of care. When we can’t provide a solution, when patients are languishing in their diseases, when their health situations are not improving, or when they face a progressively deteriorating condition, does it then become incumbent upon a practicing physician to do more?” The answer for Hudrick is “Yes.”
As a result of his experience with that Alzheimer’s patient, Hudrick “gravitated toward doing more and more trials.” In fact, he takes this call to action so seriously now that his clinical investigations as medical director of the SOM Cherry Hill Clinic are numerous and all over the human map: from diabetes, pneumonia, migraine headaches, asthma, fibromyalgia, chronic bronchitis, hypertension, and cardiovascular disease to borderline personality disorder, depression, and schizophrenia. Four are actively enrolling. Three should start shortly and others are proceeding as part of long-term plans and protocols. “To be honest, I choose trials predicated on not just how interesting they might be, but on how my patients will benefit. Many of the trials are for innovative medications, not just the new brand of an old drug. Yes, there may be some minor risk but the trials are generally very safe. I would never expose our patients to known or certain danger. Safety is first and foremost.”
What also benefits participants, especially those without health insurance or adequate drug coverage, is the opportunity to receive free medicine and testing for what may be chronic health conditions. “I had one gentleman taking a prescribed diabetes medication who participated in a trial which compared three drugs that were already out there on the market.” Randomized as part of the trial protocol to one of the three, this patient ended up receiving the same medication he had been taking, but getting it free for a year.
Perhaps because of his energy and enthusiasm for this type of research medicine, Hudrick often has no trouble filling the patient quotas. He explains that a company usually has a reasonable idea of how difficult it will be to satisfy a trial’s need for human subjects, especially in complex situations where the parameters are very detailed for choosing willing individuals. “For example,” Hudrick explains, “we have a headache trial right now with seven people but the company expected us to find only five.” Communication between principal investigators and the drug companies is crucial, he believes. “You shouldn’t have to depend upon receiving a flyer, brochure or word of mouth about a new trial.” For Hudrick, the monitors who regularly oversee his investigations often alert him to upcoming studies being undertaken by their firms. What he envisions for UMDNJ and its affiliates are more organized, regular updates from drug companies. “These companies are looking for patients. We have them.”
The SOM clinical trials department under the stewardship of coordinators Marcia Fogle, RN, Karen Maslowski, RN, and Patricia DeVito, RN, is key to Hudrick’s success. “They are so experienced. There are no glitches.” When companies he works with — Eli Lilly, AstraZeneca, Johnson & Johnson, Merck, Oscient Pharmaceutical, Aventis, for example — see the work that these professionals do, “They say, ‘My goodness, here’s a place where I don’t need to worry about all the i’s being dotted and t’s crossed.’” In terms of cost benefit, he says that clinical trials can financially benefit the University. At SOM, he is part of a task force committee with the directive to resolve funding issues, to establish a working relationship with the pharmaceutical industry and the federal government and to further shorten the legal process. According to Hudrick, the Institutional Review Board (IRB) is doing very well in streamlining approvals and turning paperwork around faster.
Hudrick’s ultimate goal would be to design his own trials: “To meet the needs of our patients rather than simply waiting for a pre-designed study to come along.” Opening up the channels of communication with the pharmaceutical companies is a step in the right direction. “Our clinical docs and PhD researchers are working from the standpoint: Here’s a problem. Let’s find the answer. Too much lab work dies on the vine without ever getting to the patient.”
A Penn State graduate, Hudrick decided on a career in medicine in his senior year. “Really, it was spring of my last year there” in central Pennsylvania’s so-called Happy Valley. An undergraduate business major, he remembers thinking, “Why not give medicine a try? Medicine looked worthwhile and extremely challenging. And believe me, it is.”