February 7th, 2008
Recently the UK chain Superdrug announced they would be selling the herbal sex supplement Viapro in 116 stores nationwide. Packs of two tablets costing £7.97 will be available to buy without prescription – or any medical advice since Superdrug staff are not trained to provide any health advice to the public.
A spokesperson for Superdrug stated “This is a natural product that offers a credible and safe alternative to Viagra available without prescription that customers can just pick up off the shelf.” Which makes it seem like a product that’s completely safe – even though the makers of the product recommend a checkup with one’s doctor before taking the tablets.
Interestingly, Pfizer (the makers of Viagra) were none too happy about the claims made by Viapro and Superdrug, drawing attention to the fact that Viapro hasn’t been adequately tested. Pfizer also stressed how ED drugs are for a “very serious medical condition” – which is strange given how much of their marketing of late has been around convincing men that Viagra is more of a ‘lifestyle drug’.
As you might expect the media was very excited by this story and plugged Viapro and Superdrug no end – even proclaiming how the product had sold out in JUST TWO DAYS in some stores. Phew!
What nobody covering the story actually did – and what any responsible journalist should have done – was ask Superdrug and Viapro for the clinical evidence behind the product. After all, if any medical product is to be available without prescription within a high street store it would be good for us to know how the drug works – and how safe and effective it might be.
So in the absence of any investigative journalism I thought I’d see what I could find out about Superdrug and sex drugs.
I called Superdrug and was put through to the company who handles their publicity and was assured that I would be sent all the details about Superdrug’s decision to sell the drug by the end of the day. Nothing arrived. So I rang again the following day and asked for them to send me the information again. I gave them two email accounts they could use, but nothing turned up. The third time I called I explained I was writing this blog and would have to report they were refusing to send me information if they didn’t do as they kept promising. Again they said a report was coming my way, but it never did.
Meanwhile, I also contacted Viapro. I was eventually put through to a spokesperson for the product. I asked him if he would be able to tell me more about the trials of the drug – particularly questions around safety, efficacy and trial procedure. He stated he wasn’t able to do this and didn’t have any reports or data to hand. He wasn’t sure who had conducted the research but he would ask the MD of the company and they would get someone from the ‘clinical studies team’ to get back to me. I left my telephone and email details and again nothing happened. I called back again on several occasions only now everyone was in meetings and couldn’t take calls – although each time I was told information was going to be sent to me.
Now if I were a journalist I would be sniffing out a story here. If you’re a major high street company and someone calls asking for information about your product you would presumably be happy to send said information to them? After all, if you’re happily crowing to the press how fantastic your sales are you’d have thought that if anyone working within the area of men’s sexual problems calls you and wants to know about your product you’d be willing to give them information. Same goes for the company making the product.
You have to wonder why Superdrug and Viapro who were so keen to get publicity around product sales were so unwilling to validate the product further? Surely if it were as fantastic as they claim it would be worth sharing the data to prove this?
Within any kosher clinical research you are duty bound to share your findings if asked for them. That doesn’t mean revealing confidential participant data, but it does mean making transparent any studies you have completed, the tools used within any research, and declaring in full any adverse events. It also usually means publishing your findings in somewhere other than your own publicity material or product website. For a groundbreaking clinical product you’d expect to see it published in a peer reviewed journal. And if you ever went public on your research or product you would be prepared to receive calls from the public and professionals – and ready to send them out further details about your work. You have to wonder why this didn’t happen here.
Viapro claim their product is backed up by scientific research. You can tell this from their website which has a page called ‘research’ and a photo of a man in a white coat on it. The ‘research’ page lists a few of the 22 ingredients in the drug but nothing specific about the studies behind the product. Those are hidden at the bottom of the website as a ‘clinical trials’ link.
So far, so good. You want a drug to have undergone clinical testing and the page looks impressive with a photo of two scientists looking down microscopes.
Look closer and you’ll soon spot some major problems with the research. The company completed a randomised, double blind, placebo-controlled clinical study. That means that people were assigned to one of two groups at random, one group would receive Viapro, the other a placebo. But nobody in either group or the researcher would know whether the drug they were taking was the real deal or the placebo.
47 male participants with mild to moderate erectile dysfunction took part in the study. They took the drug or placebo for one month and completed questionnaires and a diary post sexual activity to assess sexual functioning. Safety was measured through blood tests and self report from participants.
The questionnaire used by participants in the Viapro trial (the International Index of Erectile Function – IIEF) is a recognised measure of sexual functioning. It was developed by Pfizer as part of their trials of Viagra, beginning as a 15 item questionnaire and now used in a 5 question format. It isn’t without limitations and certainly in my research on sexual dysfunction I’ve preferred to use more substantial measures of sexual problems. However it’s a reasonable measure to use within a study.
So in that sense they had done some things right. They’d set up a trial in a reasonable way, they had identified an acceptable measure of sexual functioning and were controlling for other issues with diaries and blood tests. And their website claims dramatic results for Viapro over placebo.
But there are still major flaws within the Viapro research. For starters 47 people is not adequate for a clinical trial. For a pilot study, yes, but not for a full trial to make conclusions about a products effectiveness and safety. We don’t know how many participants were assigned to each arm of the study – meaning that if only 10 people were on placebo and 37 were on the product this could have seriously affected outcomes. We’re told the study was blinded so the researchers didn’t know who was taking what product, but we don’t have enough additional evidence to be certain of this.
The study does not appear to be independent of the company meaning biases can be introduced and we have no idea who the participants were, how they were recruited for the research and why they volunteered?
The company is also remiss in its reporting of adverse events, since they do not specify what these were or how many people were affected. All they say is there were some ‘mild and temporary side effects’ which isn’t good enough to reassure us about safety.
If a product is as good as the Viapro trial claims you would expect it to be published in a medical journal. That way clinicians could see how good the product was and would be interested in recommending it to their patients. But if you search for Viapro across clinical peer-reviewed journals you find nothing. The only evidence that Viapro works is a small scale and badly reported study on the product’s on website.
Which is not good enough to show the product is safe or effective. Superdrug are misreading sales figures as a measure of a product’s efficacy. While men are buying the product it doesn’t mean it’s safe, or effective, or will do anything to help their sexual problems.
Men’s discussion forums are indicating men are taking these drugs and most have no erectile problems whatsoever. They just take the drug to give them a boost and no doubt most of the enhanced effects they report are down to the placebo effect (you believe you’ll get a bigger, stronger boner and whoa! you do).
Where this whole relationship between Superdrug and Viapro becomes more worrying is the drug was tested on a small number of men with mild/moderate erectile problems. Which means we’ve no idea what it does to men with no erectile problems or severe ones.
We know from reputable research on men’s sexual problems that many men are desperately ashamed of their erectile problems. They are often reluctant to seek help for their problem and don’t often want to admit their difficulties to a doctor or other professional. They may well delay in seeking help as a result. The opportunity to buy a drug or herbal product without having any consultation appeals to many men due to embarrassment or shame.
However, all this places men at risk. Erectile problems are often a sign of other health issues men may be experiencing – for example heart disease, diabetes or depression. We have no idea what will happen to men with an underlying and undiagnosed serious health problem if they take Viapro because the drug wasn’t tested on this group. But from other research on men taking herbal products to ‘treat’ erectile problems we can predict that it will result in a worsening of symptoms, problems with side effects and a delay in getting tested and treated for serious health difficulties.
There are several groups at fault within this story. Viapro haven’t completed strong enough studies to indicate their products are safe or effective. Superdrug don’t appear to have checked whether the products they’re selling and promoting are good for men – or considered the wider ramifications of men who’ll take Viapro rather than go for clinical care. And the media haven’t bothered to check out either Viapro or Superdrug – or the wider issues of men’s sexual health.
This is sadly an all too common problem. Herbal products are always seen as benign – so nobody checks whether the product or the way it’s used might cause harm. Sex products and stories are always seen as ‘light’ so journalists don’t consider there’s any need to check out the science behind the story. For them the headline is ‘sex drugs on sale on the highstreet’, nothing more needs to be done than regurgitate the press release.
But the result is very serious. Firstly it tells all men they should be functioning like a sexual stallion all the time. There’s no room for the occasional erectile problem or sexual lapse. You’ve got to be ready, big and hard for any sexual event – no matter what your age is, your health is like, or whatever’s going on in your life. It sets up a sexual standard for men that makes them very anxious – and prey to sex products they don’t really need.
Secondly, it encourages men who feel shy or ashamed about perceived or real sex problems that these must be treated. It leads to guys reaching for herbal products that at best will waste their cash and at worst could harm them or lead to real physical problems being ignored.
And finally it encourages men to think that sex problems are fixed with a tablet, rather than talking to someone about their problems, communicating with a partner or checking what could be the real underlying cause of their difficulties. If your erectile problems are down to you smoking or drinking, physical or psychological problems, work stress, lifestyle difficulties or relationship crises then no pill in the world’s going to make a change for you.
So if you’re a journalist reading this, perhaps you might consider trying to find out more about this story and reporting in a way that helps men.
If you’re a health professional you may wish to challenge why a high street store is endorsing a product with little evidence to support its safety and efficacy.
And if you’re a guy worried about his erections (or a partner of a guy with willy worries) then you can get confidential help and support from the Sexual Dysfunction Association or from your GP.
And if you’re still wondering if you should go to Superdrug and buy some Viapro? My answer is don’t. Until Viapro have completed independent large scale trials of their product we don’t know how safe or effective it is. And I would be worried about buying any product where a company or their distributor won’t give you any basic information when requested to do so.
If you have any concerns about your erections the last place you should be headed is the high street. You need to speak to your doctor in case the sex problems you have are masking an even greater threat to your health.Tweet