Anti-blindness pill at centre of scientific spat
Canadian firm, U.S. agency divided on safety
A tiny Canadian company and a powerful U. S. government research agency are locked in an unusual spat over the safety of a popular anti-blindness supplement, amid accusations both sides’ scientific opinions are tainted by commercial interests.
The vitamin- zinc pills are supposed to hold back the advance of macular degeneration — the leading cause of blindness in Canada.
But Toronto’s ArcticDX says DNA research indicates they actually boost the risk of vision loss for hundreds of thousands of North American patients with a particular genetic profile.
The genetic-testing firm says few doctors heed the warning, though, because of stiff opposition from Washington’s National Eye Institute ( NEI), whose landmark study led to broad use of the supplement.
The institute — and one of its senior scientists — also happen to take in millions of dollars in royalties from the Quebec- based drug giant that’s licensed to commercialize the supplement.
“I think the whole thing needs to be taken extremely seriously,” said Dr. Brent Zanke, the medical oncologist and geneticist who chairs ArcticDX. “We believe there is a group of individuals, about 15 per cent of all of those who take vitamins for AMD ( agerelated macular degeneration), who are actually experiencing a doubling of their risk … doubled risk of going blind, or of having the condition associated with blinding.”
But the institute says it investigated the concerns exhaustively and concluded the zinc- and- vitamin combination — known by such brand names as Preservision and Vitalux — is safe for all eligible patients with AMD.
“If they’re right and we are harming people, that’s a concern for me, because I don’t want to be harming patients,” said Dr. Emily Chew, a deputy director at the NEI, and a Canadian. “But we could not replicate anything that they did.”
Chew denies the institute has been influenced by its stake in the product — made by the Bausch & Lomb division of Quebec’s Valeant Pharmaceuticals — saying the money barely offsets the millions it has spent on research in the area.
Meanwhile, ArcticDx Inc. has its own conflict of interest: If its claim about the pills is ac- cepted widely, demand would likely soar for the genetic tests it has developed around AMD, a disease that affects about 1.4 million Canadians.
The debate has played itself out before the small community of ophthalmologists who specialize in retina disease — and handle the burgeoning macular- degeneration epidemic.
“It’s been a very hot topic at all the national and international meetings,” said Dr. James Whelan, president of the Canadian Retina Society.
In the end, though, he said he is not convinced that patients with any genetic profile are at risk from taking the supplement.
In its advanced, “wet” stage, macular degeneration can be treated with drug injections into the eye, though success is not guaranteed and the cost sky- high. There is no treatment for the earlier “dry” form of the disease — but the NEI’s Age-related Eye Disease Study ( AREDS) suggested in 2001 that a supplement containing high doses of anti- oxidant vitamins E and C, zinc and copper cut the risk of AMD advancing to the later, dangerous stage by 25 per cent.
ArcticDX, which has developed a genetic test to try to pinpoint the AMD patients most at risk, obtained DNA samples of almost 1,000 of the people in the ARED S study, hoping to learn more about the supplement’s effects.
Their analysis was provocative: 13 per cent faced twice the risk of the disease advancing when they took the vitamins, opposite of the desired effect.
Zanke says he and CEO Greg Hines immediately approached Chew about the findings, and since 2013 have published two studies detailing their work.
But the NE I scientist seemed to go out of her way to refute the new research at a string of conferences, charges Dr. Carl Awh, a Nashville, Tenn., ophthalmologist who consults for the Toronto firm and co-authored the studies.
Meanwhile, through a freedom of information request, the ArcticDX executives discovered that Dr. Frederick Ferris, a superior of Chew’s at the NEI, has personally earned US $1.8 million from the Bausch & Lomb patent. Such payments to federal employees are allowed under a U.S. law designed to encourage transfer of technology from government to industry.
Chew and her team published their own paper last year, analyzing DNA of 1,237 people in the eye-disease study, and declaring that genetics made no difference in how people responded to the pills.
An editorial in the journal Ophthalmology backed up their findings — though it was written by two scientists who had worked with Chew on AREDS — while the American Academy of Ophthalmology concluded that genetic testing generally for macular degeneration patients was not justified.
The dispute, however, didn’t end there.
Earlier this year, University of Toronto biostatistician Rafal Nustra concluded that the raw data in the NEI’s study actually supported ArcticDX’s contention — 19 per cent of patients had the genotypes that appear to fare worse on the supplement than on placebo.
What’s more, the institute’s article was full of statistical inconsistencies, charged Nustra, hired to analyze the work by a competitor of Bausch and Lomb. His conclusions were later confirmed by Bernard Rosner, a Harvard University biostatistician hired by ArcticDX. Neither of their reports, however, has been published in peer- reviewed journals.
Kristy Marks, a Bausch & Lomb spokeswoman, said the company stands by the supplement, saying there is no persuasive evidence that the formulation is unsafe for any patient.
Chew’s superior has made US$1.8 million