Two USF College of Public Health faculty members traveled to the Capitol area to provide input on their various areas of expertise. Dr. Kevin Kip, distinguished USF Health professor, served on the FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee and Dr. Thomas Bernard, professor of occupational health, gave his testimony at a congressional mandate to implement a heat stress standard.
From June 19-20, the FDA Circulatory System Devices Panel Advisory Committee discussed and made recommendations on information related to recent observations of increased late mortality in patients treated with paclitaxel-coated balloons and paclitaxel-eluting stents compared to patients treated without the coated devices.
The meeting was established after the article titled “Risk of Death Following Application of Paclitaxel-Coated Balloons and Stents in the Femoropopliteal Artery of the Leg: A Systematic Review and Meta-Analysis of Randomized Controlled Trials” was published in the Journal of the American Heart Association.
The article concluded that there is increased risk of death following application of paclitaxel‐coated balloons and stents in the femoropopliteal artery of the lower limbs and that further investigations are urgently warranted.
As a Special Government Employee, a program that allows professionals to serve on Federally-established advisory committees and industry employees to work alongside OSHA and participate in OSHA outreach and compliance assistance activities, Kip was called in to join the committee during the two-day meeting.
The panel discussed the following questions: is there a presence of a mortality signal, what is the class effect, what is the impact of missing data, were there trends in subgroup analyses, what is the cause of death, is there a paclitaxel dose and mortality relationship, are there trends in pre-clinical studies, what is the benefit-risk profile, are there post market studies and surveillance, should labeling be changed, should there be changes to the study design, and are there other indications.
They concluded that a late mortality signal associated with the use of paclitaxel-coated devices was present and agreed that the signal should be interpreted with caution because due of small sample size, pooling of studies of different paclitaxel-coated devices that were not intended to be combined, substantial amounts of missing study data, no clear evidence of a paclitaxel dose effect on mortality, and no known singular cause of late deaths. They also concluded that additional clinical study data are needed to fully evaluate the late mortality signal.
While the panel found that there was a late mortality signal, there are clinical benefits to paclitaxel-coated devices and those benefits should be considered along with the potential risks. Paclitaxel-coated devices do improve blood flow to the legs and decrease the likelihood of repeat procedures to reopen blocked blood vessels compared with uncoated devices.
“My sense is that it’d be hard to start a whole new trial and a whole new large definitive study that would require follow up of treated patients for a long period of time,” Kip said. “Therefore, I believe that the FDA should seek to maximize efforts from the existing studies, including understanding reasons for and minimizing the amount of missing data, and secondarily, to follow the previously treated patients longer, including from 5-10 years post-treatment. In other words, keep collecting data from the existing studies would be my recommendation.”
On July 10, 2019, U.S. House of Representatives Democrats released a bill that, if passed, would require OSHA to develop a federal standard on workplace heat stress. Under the proposed bill, OSHA would have two years to propose a heat protection standard to protect both indoor and outdoor workers.
Representative Judy Chu, D-Calif., and Representative Raúl M. Grijalva, D-Ariz., introduced the Asunción Valdivia Heat Illness and Fatality Prevention Act, which is named for Asunción Valdivia, a farmworker who died after picking grapes for a 10-hour shift in 105-degree heat.
Bernard was a part of the six-person panel addressing heat stress and occupational health from a science and policy point of view. Other panel members included workers who were exposed to heat stress as well as representatives from industries where heat stress is a problem.
Bernard believes that an enforceable OSHA standard can bring visibility and clarity to the structure and function of an effective heat stress management program.
“Heat stress is an underappreciated workplace hazard. We all have worked or played in hot environments, and may even have felt some of the symptoms of heat exhaustion,” Bernard said. “This common experience leads us to under-appreciate the real risks. Heat stress is serious when the workplace is not prepared to deal with it.”
“It is my opinion based on my experience and practice that an enforceable OSHA standard can bring visibility and clarity to the structure and function of an effective heat stress management program,” he said.
There are three states in the U.S. that already have standards for heat stress: California, Washington and Minnesota. While Bernard thinks that there’s a small chance of the bill passing, he does think that building public awareness surrounding it is a great outcome.
“I think we’re still at the stage where it’s building the public awareness and beginning to build an interest in doing something,” Bernard said. “I think a year ago I would have said that the chances of having a standard were zero. Today I can say that there’s something a little bit better than zero.”
Story by Caitlin Keough, USF College of Public Health
Tags: Capitol Hill, congress, FDA, FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee, heat stress, Journal of the American Heart Association, Kevin Kip, OSHA, paclitaxel-coated devices, Special Government Employee, Thomas Bernard