Show me the money
Researchers are feeling the pinch from the changing healthcare environment.
“(National Institutes of Health [NIH]) funding levels have decreased, resulting in cuts in current funding budgets and fewer grants being funded,” Dr. Paller says. “I don’t know what changes in healthcare are going to bring, but we are all concerned that new innovation will not receive the financial support it deserves. There will be a lot more repurposing of drugs.”
Dr. Martin predicts more of the reliance on pharmaceutical companies to recruit the best and brightest and provide them with the resources to continue their research.
“The scary part is there may not be sufficient funds provided by the government to facilitate young researchers with an idea that may or may not work. Sometimes a negative research result is equally important as a positive one for that future research. If the government does not fund basic science research, it’s going to be difficult to make the strides that we’re now seeing at this rate,” Dr. Martin says.
Profit, Dr. Siegel says, is the name of the game for industry.
“It’s far safer to come up with a minor variation of a product that could come to market quickly, than to spend a lot of money on something novel that might fail,” Dr. Siegel says.
On the funding and payer sides, health reform might block medical dermatology innovation. According to Dr. Siegel, industry isn’t going to spend a lot to research drugs for which insurance won’t pay.
“Companies are going to look for that they can make that people pay for out of pocket; hence the explosion of cosmetic devices, fillers and toxins,” Dr. Siegel says.
As a result, orphan drug innovation is likely to suffer. And there’s a ripple effect to that, according to Dr. Siegel.
“The understanding that we get about mechanisms when we research those (orphan) diseases help us treat other diseases,” he says.
The challenges traditionally facing pediatric dermatology research and innovation could get worse, according to Dr. Paller.
“It’s more difficult to do studies in children, especially if they involve any degree of invasiveness. Couple that with the fact that there are drugs that are now FDA-approved for adults, but not for children, despite testing and considerable off-label use,” Dr. Paller says. “There have been virtually no recent label approvals for pediatric drugs and nothing novel in the last several years. So, that’s also a very big concern of pediatric dermatologists and their patients, in addition to industry.”
If you can’t beat ‘em…
Dr. Siegel says he suspects innovation will come about out in novel ways, which we can’t predict.
“It may come out of university laboratories. It may come out of the rainforest or a remote area of the world,” he says.
In some cases, dermatologists are taking the wheel. One example: There is a need to increase research that has translational value for pediatric skin disease, according to Dr. Paller. As a result, she and colleagues from the Society for Pediatric Dermatology have launched the new Pediatric Dermatology Research Alliance (PeDRA). Formalized in 2012, PeDRA was awarded an NIH grant to hold its first free-standing meeting, with some 80 clinicians and scientists attending, in October 2013. PeDRA hopes to support research that cannot be performed at a single institution.
“(PeDRA) welcomes members who are not pediatric dermatologists — whether adult dermatologists, bench researchers, and clinical researchers who are doing exploring scientifically areas of particular interest to PeDRA,” Dr. Paller says. “PeDRA has four main disease foci right now: inflammatory skin disease (which includes atopic dermatitis, psoriasis, acne and autoimmune disorders), vascular lesions, epidermolysis bullosa, and disorders of cornification.”
Working groups are moving forward with research projects in each focus.
PeDRA is developing a database of members who perform research, their expertise, their infrastructure capabilities, and their history in collaborative research, which be helpful both to clinicians who seek help for their patients, scientists looking for partners, and industry looking for expertise in performing clinical trials.
“Something has to change,” Dr. Paller says. “We cannot continue to be a top-tier country and a leader in innovative research without increasing rather than decreasing funding toward research support.”
Disclosures: Dr. Siegel is a speaker and investigator for Genentech and consultant, investigator and speaker for LEO Pharma. Dr. Paller is co-chair of PeDRA and is a consultant for Anacor and Regeneron/Sanofi.