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Cold-FX’s effectiveness questioned in class action lawsuit

Cold-FX’s effectiveness questioned in class action lawsuit

A new study has surfaced in an ongoing class action lawsuit against Valeant Pharmaceuticals, which bought Cold-FX maker Afexa Life Sciences in 2011, saying the popular cold and flu remedy makers sat on results showing the supplement could be no more effective than a placebo.

The suit, helmed by Vancouver lawyer John Green, takes issue with the company’s marketing claims that Cold-FX – essentially a fine-tuned dose of ginseng extract – could “stop cold and flu in their tracks” and bring “immediate relief” from cold and flu symptoms.

“If true, this kind of information should have been disclosed,” Green told the National Post. “If it had been disclosed, it would probably have been the end of Afexa Life Sciences.”

The company, which received endorsement from hockey personality Don Cherry, has since pared back its marketing on its website to suggest that “by boosting your immune system, Cold-FX helps reduce the frequency, severity and duration of cold and flu symptoms.”

But the revelations that the supplement makers might have kept data private from a 2004 trial conducted by top Alberta public-health official Dr. Gerry Predy suggesting efficacy might be overplayed, puts Cold-FX back in the spotlight.

“The fact that there was research and the company knew about it and didn’t disclose it, that’s terrible, it’s clearly unethical,” says Dr. Steven Hoffman, a professor and director of the Global Strategy Lab at the University of Ottawa’s Centre for Health Law, Policy and Ethics. “But it’s not illegal.”

Hoffman points out that in Canada health products are regulated in two different ways – medicines, that is prescribed remedies, have to go through an arduous process where companies are forced to declare all clinical trials and studies that both support and decry the efficacy of the drugs. The point is to make sure that what’s being prescribed is safe to take.

Natural health products, like Cold-FX or homeopathy fit into a different category.

“Regulations in Canada for natural health products are not robust – there are a lot of products out there that claim to be health products that really don’t have much to do with health at all,” says Hoffman. “And in Canada, we currently don’t require those types of companies to disclose studies.”

He says that while a change to natural health regulations may be on the horizon, the biggest challenge for Cold-FX comes down to more of an issue with false health claims.

“In Canada, we’re not allowed to just sell products and make claims that they promote health unless they actually promote health,” says Hoffman.

He points to Lululemon Athletica, which got in trouble with the Competition Bureau a few years ago for saying its fabric included seaweed helping with circulation.

“They were making a health claim, they were saying that this causes this to happen and as a result that means this happens,” he says. “To make a claim like that you have to get it approved by Health Canada.”

Without the science to back the claims, Lululemon had to remove the tags.

In the case of Cold-FX, the class action against Valeant will continue towards a hearing in April to determine if it goes to trial or just results in settlement.