Regulators appear to have bowed to public pressure over a 'lifestyle drug'

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The Independent Online

It’s been quite a week for Sprout Pharmaceuticals, a company virtually nobody had heard of this time last week, and its founders Cindy and Robert Whitehead. The Food and Drug Administration (FDA) granted approval for its women’s libido booster on Wednesday, followed by a $1bn (£635m) bid from Valeant Pharmaceuticals on Thursday. So far the catchingly named Addyi’s main area of performance enhancement is on the wallets of Sprout’s executives.

We aren’t supposed to refer to it as “female Viagra”, so the fact that the pills are pink as opposed to blue must be purely coincidental. The drug actually works in a completely different way to Viagra, stimulating brain chemicals rather than a physical reaction in blood vessels. Essentially it’s yet another anti-depressant – as if the world needs more of those.

Despite FDA rejections in 2010 and 2013 and Addyi’s debatable efficacy, the regulators finally appear to have bowed to pressure, rather than scientific evidence, and granted it a licence. That’s a sequence of events that rarely ends well – think Donald Rumsfeld strong-arming aspartame through the FDA when he was chief executive at Searle in the early 1980s. Yes, that Donald Rumsfeld. George W Bush’s Defence Secretary is also responsible for aspartame.

Surprisingly, most of the political pressure for Addyi’s approval appears to have come from female Democrats, but unusually a lot has also come from the general public. People have signed petitions in their thousands, demanding that women have access to the same sort of benefits that Viagra gives men, even if the side-effects of taking Addyi daily appear serious enough to warrant extreme caution when taking it. Sprout may not have been a well-known name in the pharmaceutical industry but its public relations campaign was masterful – and has taken all of 24 hours to pay off.

So who is doing the cheering? Well, Sprout’s board and private investors are laughing loudest, but it’s probably a fair assumption that most of Addyi’s future customers (and presumably most of the people signing petitions demanding its approval) will be husbands rather than wives. Not to make light of the issue of low libido, which is real and damaging to relationships, but if anyone is dreaming about gangs of sexually aroused women roaming the streets they are going to be sorely disappointed.

The broader point is that lifestyle drugs, primarily Viagra, have brought about a revolution in the pharmaceuticals industry, and not necessarily a good one. Rather than applying their brains and their public relations dollars to saving lives, the pharmaceuticals industry saw the margins in lifestyle drugs and decided that saving lives was for wimps. While money is poured into tackling non-life-threatening but high-margin conditions, drugs that really make a life-or-death difference remain out of reach of millions of people who need them.

Another very obvious impact of the huge growth in lifestyle drugs, at least on this side of the pond, has been the huge boon to the television advertising market. It’s one  of those things that is hard for us Brits to get used to – a constant flow of adverts telling people to demand all kinds of prescription drugs from their physician, mainly to cure impotence.

Not that lifestyle drugs are a bad thing. The psychological problems brought about by physical imperfection are real, and (mostly) men are prepared to pay through the nose to treat them. Lifestyle drugs present a particularly unusual challenge for regulators. People will put up with a lot of nasty side-effects if they think something will stop them going bald or will turn their previously uninterested wife into an insatiable seductress.

In response, the FDA and regulators all over the world need to make sure they put science first and hyped-up public opinion last.

It’s a jungle at Amazon – but don’t expect things to change

Amazon has hardly been out of the headlines this week. The sound of wringing hands and gnashing teeth has been deafening.

Hat tip to The New York Times, proving beyond doubt that print media is far from dead. Even if most of the leg work over the last year and a half on working conditions at Amazon was already done by the media website Gawker and John Rossman, the author of The Amazon Way.

Anyone with a passing interest in how Amazon treats its workers should already know that conditions in its warehouses and competition in corporate are nothing short of gladiatorial, so this week’s outrage is a little baffling. Jeff Bezos set out to revolutionise retail a long time ago, and in doing so succeeded in getting people to accept working conditions that are nothing short of barbaric. This is not news.

Mr Bezos’s widely publicised, internal memo response, defending himself and Amazon and denying the existence of the practices The New York Times described, seemed to me as nothing short of pathetic.

And yet, people will continue to spend their money at Amazon and people will still line up to work there while locally owned businesses will continue to close. The huge fulfilment centres that dispatch millions of items here there and everywhere will continue to be built in places where unemployment is high – land is cheap, labour is cheap, desperate and plentiful, and Amazon gets to look benevolent. The deal with this particular devil was made a long time ago.

People will also continue to line up to work at Amazon corporate too. It doesn’t matter if you only last a year before someone backstabs you into getting fired. It’s there, on your CV, and that’s what counts. Make it there and you can make it anywhere, and people will beg for such an opportunity to be miserable.

Love it or loathe it, Amazon is also an amazing company and Bezos, for all of his alleged megalomania, inspires as much as he repulses, just as Steve Jobs did. Amazon has defied convention at almost every opportunity, ploughing profit back into the company’s creative ventures rather than passing it out to shareholders, and pushing the limits of what commerce is capable of.

Nothing is going to change the way Amazon treats people until consumers shop elsewhere or low-income workers collectively decide they want to be treated decently. Both of which are the stuff of fantasy.

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