Due to an editing error the headline should have read that the FDA’s policy aims to make physicians more Dx-friendly. It had incorrectly stated that the policy did not have this aim.
The US Food and Drug Administration is prescribing a “back to basics” treatment for doctors and researchers when it comes pharmacogenomics.
The agency is in the process of developing two new continuing medical education courses for pharmacogenomics with the goal of helping doctors and researchers understand the basic principles of genomics and genetics, according to an FDA official.
The courses, to be launched in mid-2007, will be provided through the American Medical Association and the American College of Clinical Pharmacology. The AMA course for MDs will focus on the clinical applicability of pharmacogenomics. The ACCP’s course will address PGx from a more mechanistic and molecular perspective for PhDs and PharmDs.
With these courses the FDA hopes to improve physicians’ and clinicians’ general pharmacogenomic knowledge. However, while the courses may help to familiarize participants with the principles of genomics and genetics, they are not meant to encourage physicians to incorporate genetic tests into their practice, according to Felix Frueh, associate director of genomics at the FDA.
He said the idea for the courses developed out of the FDA’s internal assessment of its staff’s limited knowledge about pharmacogenomics. In identifying a need to communicate effectively about PGx within the agency, the FDA created its own education programs in 2004.
“We started the genomics program two and a half years ago at FDA. The medical officers and the physicians here are fairly representative for physicians that we find everywhere else,” Frueh said. “What we realized very quickly is that the level of expertise for genetics and genomics is really not very extensive.”
“We felt that it is really necessary [that] if we want to get our message across [then] people here [must] understand our vocabulary, understand what genetics is really good for and have some basic means to judge when they look at a drug submission for example whether genetics has an impact,” Frueh continued.
As a result of these internal programs, the agency was contacted by people outside of the FDA and asked if the courses could be made available generally. “Then we had the idea of, ‘Why not formalize [FDA’s internal program]?’ because what counts for many physicians are the CME credits that they get,” Frueh said. “We felt it was a good idea to combine what we do” with a CME backbone.
The lack of physician education has been identified by industry observers as one of many reasons why more personalized medicines have not come to the market. However, these new CME courses may not be the silver bullet that cuts through physician reluctance to incorporate diagnostics into their practice.
“I sort of doubt” the courses will change physician behavior “because the courses are more basic,” Frueh explained. “What we’re trying to do is convey the general message of why genetic and genomic information is useful. Perhaps point less to very specific examples.”
“The problem is you can’t be comprehensive in a course like that and it would be outdated so quickly that [it] probably wouldn’t be appropriate” to try to change doctors’ behavior with these courses, he added.
For its part, FDA’s CME courses will address the needs of clinicians, a group that has been particularly singled out for lagging behind PGx developments.
In a 2005 issue of the American Journal of Pharmaceutical Education, Majiid Moridani, assistant professor at the Texas Tech University Health Sciences Center School of Pharmacy, wrote an article stating that of the three relevant arms of medical science, "diagnostic [scientists] are getting there, pharmacists are also getting there, but the issue is that clinicians are a little more resistant" to learning about pharmacogenomics [PGx Reporter 08-18-05].
“What we realized very quickly is that the level of expertise for genetics and genomics is really not very extensive” among medical officers at the FDA, which reflects a similar ignorance among most physicians in practice today.
A pilot survey conducted in the summer of 2004 by David Gurwitz, director of the National Laboratory for the Genetics of Israeli Populations at Tel-Aviv University, found that only "a minority" of medical schools in Europe and North America include pharmacogenomics as part of their core pharmacology courses.
In addition to the FDA’s planned CME courses, the US National Heart, Lung, and Blood Institute is also developing short courses on genomics and proteomics that will be intended largely for investigators. NHLBI is offering a total of $1.2 million over three years under the program, entitled Short Courses on Application of Genomics and Proteomics to Complex Heart, Lung, Blood, and Sleep Disorders.
Additionally, GenoMed and the Health Communication Research Institute, a CME firm, partnered a few years ago to offer a novel online course aiming to introduce MDs to personalized medicine and genomics [PGx Reporter 05-30-03].