Manufacturing Reprise


Resident cites issues for cars, property owners The Logan Township supervisors seemed disinclined recently to accept a resident’s suggestion to do away with a road-maintenance practice designed to save money. Tar-and-chipping the roads generates loose stones, which is a problem for “enthusiasts” of cars, motorcycles and even bikes, as well as property owners, said Jeff MacAlarney of Briarcliff Road, which is off Davis Road in the Grandview area. The stones detach from the tar in which they’re placed or never bond to it, and then ding vehicle paintwork, while also accumulating in ditches and culverts, creating a nuisance, MacAlarney indicated. They’re especially problematic on Davis, Avalon and Castle Farm roads, which at times are heavily traveled, MacAlarney said. Better to spend a little more and pave those roads, MacAlarney said. Soon after an application of chips, there are loose stones, but soon, they “settle down,” especially after sweeping, said supervisors Chairman Jim Patterson. The tar-and-chipping extends the life of roadways at lower cost than paving, it’s approved by PennDOT and the township can pay for it through its annual liquid fuels tax allocations, Patterson said. The township could pay for paving by borrowing, MacAlarney said. The supervisors don’t want to raise taxes, Patterson said. Tar-and-chipping is a waste of money, MacAlarney said — adding that a member of the township’s road crew agreed with him. When the township puts the practice off too long, roads develop “spider cracks” in the winter, leading to deterioration, “If it was a waste of money, PennDOT wouldn’t allow us (to use it),” Patterson added. “It’s a PennDOT-approved process.” Moreover, the practice has “improved tremendously” over the last 30 years, and especially the last five or 10, Patterson said. Formerly, oil-based liquid was used, but now it’s a latex emulsion, he said. MacAlarney should visit his local lawmakers to argue for an increase in municipal funding for roads if he wants more paving done, Patterson said. The tar-and-chip process, which PennDOT calls “surface treatment,” extends the life of low-volume roads three to five years, according to a department webpage. Mirror Staff Writer William Kibler is at 814-949-7038.

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“Right now, most are saying no,” noted Mark McClellan, who was FDA commissioner from 2002 to 2004 and now runs the Duke-Margolis Center that hosted the private meeting. One possible outcome for the NCD would be for the agency to grant Coverage with Evidence Determination (CED), the same process currently used to cover amyloid PET scans in the IDEAS study. In this scenario, treatment would be covered as part of a clinical trial that gathers evidence of aducanumab’s effectiveness. McClellan helped develop the CED process while at CMS. He noted that such trials are usually not randomized. Instead, they may match people who decide to get the treatment versus those who don’t, or compare different dosages and timing of treatment. McClellan lamented that although the FDA has become more open to innovative trial designs, there has been no comparable innovation for figuring out how to cover expensive, groundbreaking therapies. “I hope [aducanumab] is a wake-up call. More innovative treatments are coming,” McClellan said at a July 15 meeting of the Institute for Clinical and Economic Review (ICER). ICER Doubles Down: Aducanumab Not Worth the Cost The purpose of the day-long ICER meeting was to review efficacy data for aducanumab and debate whether the treatment is cost-effective. Besides ICER scientists, representatives from Biogen, advocacy groups, and insurance companies attended, along with 15 members of the California Technology Assessment Forum. This forum included an academic geriatrician, neurologist, several other physicians, health policy and economics experts, an ethicist, and three patient advocates. Also attending the ICER meeting were two Alzheimer’s researchers, one of whom, Sarah Kremen of Cedars-Sinai Medical Center, Los Angeles, was a site PI for the aducanumab trials. In discussion, a sharp division of opinion became evident. On one side, representatives from Biogen, the Alzheimer’s Association, and Us Against Alzheimer’s, as well as a patient and caregiver affected by AD, spoke in favor of aducanumab. On the other side, independent experts from ICER and CTAF were unanimous in finding the efficacy data lacking. Kremen struck something of a middle ground, noting that some patients may benefit from aducanumab, but it would be challenging to determine who those could be, and whether the benefit would outweigh the health risks from ARIA. “From the standpoint of ‘do no harm,’ prescribing makes us uneasy,” Kremen noted in the discussion. Across the board, participants expressed intense concern over aducanumab’s cost.
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