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The trials of reporting sex drug developments

January 14th, 2007

Dr Petra

Proving I got at least one of my new years sex predictions right this week the papers were full of promises about hormonal sex products to boost female desire.

The drug of choice this week was Flibanserin (which frankly sounds like a sci-fi baddy). According to news reports it’s a drug designed for depression that apparently also boosts female arousal by stimulating ‘the brain’.

That led to several newspapers covering the new ‘wonder drug’ (predictably either calling it the ‘new viagra for women’ or incorrectly suggesting it worked liked Viagra). In some coverage the drug was described as being ‘in trials’ but at what level wasn’t clear. Some reports implied it would be prescribed imminently, whilst most stated it ‘could’ be available in 2009.

Whilst Viagra was a drug designed for one purpose (a heart medication for chest pain) that was found to also affect other parts of the body, similar drugs designed for one purpose haven’t been so successfully transferred to treating sexual function. Pertinent to the Flibanserin case is the attempts by some pharmaceutical companies to use SSRIs (selective serotonin reuptake inhibitors – a class of anti depressants) as a routine treatment for premature ejaculation (PE). Some patients on SSRIs have noted it takes them longer to reach orgasm (or in some cases they are unable to reach orgasm). Drug companies’ felt they could extend this to giving healthy men without depression SSRIs, but the FDA (Food and Drug Administration) did not approve SSRIs for routine treatment of PE. So even if Flibanserin might have an effect on women it may not be safe to use routinely on otherwise healthy females.

There are several problems with journalists reporting these kinds of stories. Firstly they are simply doing a PR job for pharmaceutical companies – giving them free advertising for a forthcoming product. This creates a public concern that our sex lives need fixing and also reminds us a solution is on the horizon (even if it is not).

The second problem with this reporting is a science or health correspondent rarely writes it so you have writers who can’t ask critical questions about a pharmaceutical company press release.

They should be asking who is funding the research? What is their agenda? What risks are associated with the product? Who is the drug suitable for? Will efforts be made to prevent the drug being misused or sold online? What do other scientists and medics working in this area think? Does the spokesperson for the research have any links with a drug company that could mean their research comes with a conflict of interest? A simple google news search may also reveal if there have been previous problems with the drug, whilst a skim through PubMed will show if any tests have taken place and what their results were.

They should also be asking what stage of development the drug is in. I’m forever hearing journalists’ telling me how they’ve heard a drug has been ‘registered’ or ‘patented’ but this doesn’t mean it has been tested or shown to be safe for public use.

In case you don’t know the stages of clinical testing, they are as follows:

In the pre-clinical or laboratory stage a drug is tested on tissue samples, in computerised simulations or other in-vitro tests. Next ethical approval has to be obtained to complete the tests on animals and once approval has been granted animal testing begins. If the drug doesn’t appear to be toxic on animals then further ethical approval is applied for to test the drug on humans.

Testing on humans covers four phases
Phase I Trial – a small number of healthy human volunteers are tested to see if the drug is safe and if it causes any side effects.
Phase II Trial – a larger number of participants affected with the relevant health problem the drug is designed to address will take the drug to see if it does affect their symptoms and also to further test for any safety or side-effect problems.
Phase III Trial – an even larger group of people with health problems related to the drug will be tested

Ethical approval may need to be sought for every phase of the trial and each phase can take months to years to complete. Often results from each phase are published in peer reviewed scientific journals.

After Phase III the drug will move into Phase IV where the drug will be performance tested against existing medications in trials where participants (and usually researchers) will not know whether they are taking an existing drug or a new one. In all trials participants have to know the risks of taking part and be completely aware they are involved in a drug trial. In a (Phase IV) randomised control trial participants must be informed they are taking a drug that could be an existing medication or a new treatment.

So a careful journalist reporting on any drug story (even a sex drug story) should be asking at what stage of testing the drug’s at, have any adverse events or side effects been noted, and where ethical approval has been granted from. There are problems that many drugs (not just sex ones) are being tested on vulnerable people who cannot truly consent to research or where side effects are hushed up. A journalist should ask for all information on a drug in development before reporting on it – and if they do not understand the information sent get feedback from other impartial professionals who can help explain it to them. In such cases that a drug company won’t disclose this information their press release should not be covered.

Once you’ve got the hand of asking questions about the nature of a study it’s easy and quick to evaluate it. But if you’re not skilled at this and you’re on a busy newsdesk you can see why a journalist may not take the time out to ask pertinent questions about a study. My view is if they’re reporting on something accuracy is the key, but that’s not often going to be the same agenda of an editor who wants to see a ‘new sex superdrug’ headline promising us ‘great sex’ in a few years time.

Because journalists don’t do this routinely we have a third problem that incorrect information is given to the public about their health creating missed opportunities for addressing any questions or problems they may have. Interestingly journalists are also very selective about what they report on, so this week we saw two news stories about treatments for sex problems. One was the Flibanserin story (which got lots of coverage), the other explained how testosterone cream for men may be neither safe nor effective which got far less media attention. Funny that.

Obviously sex drugs represent a potentially very lucrative market and if you want to see what pharmaceutical companies are working on click here.

The latest ‘wonder sex drug’ story is only one in a long line of similar stories we’ve already seen and no doubt will continue see that are sent to journalists by pharmaceutical companies who see an opportunity to both create a disease and profit from it. The twist in the tale is that just because a drug is being tested and given media coverage doesn’t mean it will get approval for public use or even found to be safe. But the promise of profits means pharmaceutical companies (who spend far more of their budgets on PR than research) will continue to target the media and journalists will continue to report uncritically every pharma press release they are sent.

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