When you sneeze in your cubicle, Cold-FX is often the first thing recommended by your disgusted colleagues. After all, the ginseng-based product is the top-selling natural health product in Canada, with sales topping nearly $120-million as recently as 2011, according to reports.
Cold-FX also has the official backing of Health Canada, which has approved it for a number of claims, including the promise that it helps reduce the frequency, severity and duration of cold and flu symptoms. Last year, Health Canada gave the okay for Valeant Canada, which sells Cold-FX, to state that when combined with a flu shot, Cold-FX is clinically proven to reduce cold and flu symptoms.
But is it too good to be true?
Take two and call me in six months
How long do you need to take Cold-FX for it to start working? A few days? A week? The product label offers no clues.
But according to Valeant Canada's vice-president of medical and regulatory affairs, you must take it for a minimum of eight weeks – two whole months – before any potential benefit kicks in. The optimal duration for a healthy adult is four months. For seniors, that increases to six months.
"We cannot argue that Cold-FX can be used to treat symptoms that are already there," said Maxime Barakat. "We recommend a chronic usage."
That's right: In order to experience any positive effects, according to the research behind Cold-FX, you need to take capsules twice daily for months on end. At approximately $60 for 150 capsules, that can quickly add up to several hundred dollars per year.
This seems like important information that you should see somewhere on a Cold-FX product label, on the product's website or even in the fine print of advertisements. But you won't find it there.
Nor will you see any mention of the four– to six-month treatment regimen on the label for Cold-FX First Signs, a new daytime and nighttime powdered formulation.
The "first signs" of a problem …
According to the label for Cold-FX First Signs, you should take the product "at first signs of a cold to help relieve cold symptoms and promote healthy immune function."
Why the emphasis on first signs?
In fact, there is no benefit if you take Cold-FX at the onset of symptoms, according to the company's own research.
Cold-FX is a "preventative drug" and doesn't have an instantaneous effect at battling cold and flu symptoms, Mr. Barakat said.
When asked why the label directs consumers to take Cold-FX First Signs to relieve symptoms, Mr. Barakat said "we need to phrase it differently" and that he is "open to discuss with my colleagues."
Health Canada declined an interview. In an e-mail, a spokesperson said use of the term "first signs" passes muster because it "refers to when an individual should take the product" but doesn't make promises about effectiveness. (A few years ago, the makers of Cold-FX faced criticism for making an "immediate relief" efficacy claim on product labels.)
"The pure scientists might question it"
Even if you are prepared to take Cold-FX for the better part of a year, will you see positive results?
The developers of Cold-FX, Afexa Life Sciences Inc. (purchased by Valeant Canada in 2011), funded several studies to test the product, which were submitted to Health Canada for approval of the health claims. A quick read of the abstracts provides comforting reassurance of how well it works.
For instance, in a 2005 study published in the Canadian Medical Association Journal (CMAJ), 130 people took two Cold-FX capsules a day for four months, while 149 people took a placebo (the study participants didn't know if they were getting the active ingredient or a sugar pill). They were asked to record any cold and flu symptoms.
When it was all said and done, the study authors concluded Cold-FX reduces the number of colds per person, as well as the severity and duration of symptoms.
But taking a closer look at the raw data paints a different picture.
First, the researchers did not actually test participants to confirm if the coughs, sniffles or other symptoms they experienced were the result of a virus. Instead, they asked participants to record the severity of symptoms on a four-point scale, referred to as Jackson criteria.
This is important. Without confirming whether people were actually suffering from a respiratory illness, it's a leap to draw conclusions about the effectiveness of the remedy being studied.
At least, that is the perspective offered by Dr. Janet McElhaney, a geriatrician and senior scientist at the Advanced Medical Research Institute of Canada, who led several studies on Cold-FX. According to Dr. McElhaney, people who report having a stuffy nose or sniffles could be suffering from hay fever or another ailment unrelated to colds or the flu.
"You can decide whether or not that's scientifically valid," she said in an interview, referring to the reliance on self-reported symptoms rather than lab-confirmed illness.
Even if you put stock in self reports, Cold-FX didn't score well. The results of the CMAJ study show that over four months, the mean number of colds experienced by the group taking the placebo was 0.93. In those taking Cold-FX, it was 0.68. A difference of 0.25 colds over a four-month period. Does that seem like a compelling reason to shell out a few hundred bucks and take pills daily for months?
What if you add a needle?
A more recent study led by Dr. McElhaney forms the basis of the new bold claim that Cold-FX and the flu shot work better together. The study focused on flu-vaccinated seniors over age 65. Researchers had them take either a placebo, 400 or 800 milligrams of Cold-FX a day for six months. In this case, the researchers actually tested participants for the flu or other viruses in addition to using the self-reported symptom scorecards.
In the end, there was no meaningful difference between the number of viruses suffered by the placebo or treatment groups. The researchers concluded "the treatments had no significant effects on the number, severity, or duration of lab-confirmed clinical URIs [upper respiratory infections]."
Dr. McElhaney said the low numbers of people suffering from lab-confirmed infections that year made it impossible for them to draw any conclusions about the impact of Cold-FX. But researchers did find that the symptom scorecards among those taking Cold-FX was lower than those taking placebo. Twenty-nine per cent of the placebo group reported experiencing upper respiratory infections, compared with 20 per cent in the 400 milligram group and 19.4 per cent in the 800 milligram group.
But as Dr. McElhaney herself pointed out, the scientific validity of those scorecards is questionable.
"I don't know if I would call it a danger, but I can tell you that's where people start to, the pure scientists, might question it," she said.
So why, then, did Cold-FX win Health Canada's approval to declare that it works better when paired with a flu shot, considering the study didn't show the product made any meaningful difference between lab-confirmed cases of the flu or other viruses?
That's a good question.
Cold-FX is regulated as a natural health product. Compared with prescription drugs, the scope of evidence Health Canada requires for the approval of natural health products is far less rigorous – something many critics say has allowed too many ineffective and potentially unsafe products on the market.
As the examples above demonstrate, the data behind Cold-FX are not favourable, even though the company puts a positive spin on the results.
This speaks to a much larger issue enveloping Canada's billion-dollar natural-health product market.
If the top-selling natural health remedy in Canada is allowed to get away with scientifically questionable claims about how its product works, what other problems are out there?