India’s top drugmaker Ranbaxy Laboratories will pay a record fine in the US for lying to officials and selling badly made generic drugs.
Visit link: India drug firm pays record US fine
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Although the news of a baby being cured of HIV may be a medical miracle, don’t expect the makers of the drugs used to get a significant sales boost.
See original here: HIV ‘cure’ won’t boost drug stocks
Swiss drugs firm Novartis agrees with its departing chairman Daniel Vasella to scrap a scheme that could have paid him 72m Swiss francs over six years.
Visit link: Novartis scraps payment to chairman
For 80 years antibiotics have helped us to fight disease. But bacteria are growing resistant – so it’s time we stopped treating winter colds with such a powerful weapon
So it’s that time of year again. Just about everyone I know has a cough, a cold, a sniffle, a sore throat. We’re suffering from a general outbreak of snot, a seasonal plague of phlegm that descends on us with tedious predictability and makes us feel as cold and damp inside as it is outside.
But it’s the 21st century! Surely we should be able to come up with a cure for this misery?
Pharmaceutical companies’ balance sheets must be benefiting from cough and cold remedies (which merely offer limited relief from symptoms) – couldn’t they divert some funds into finding a real cure? There would be millions of punters lining up to buy such a drug. But much as we might all like a cure for the common cold, there’s a much more worrying problem looming when it comes to infections and our ability to fight them off.
Microbiologists have likened this impending crisis in healthcare to climate change – it’s big, scary, and we’re not doing much about it. The crisis? We’re running out of antibiotics, and quickly.
In the battle against bacteria, antibiotics have been formidable weapons. We’ve been using them widely for only 80 years, but in that time they have helped to transform our lives: we now expect our children to survive into adulthood, we expect to live to a ripe old age. The trouble is, antibiotics don’t last for ever, and the reason for that is evolution: bacteria evolve resistance. Drugs that would have killed their ancestors at 20 paces glance off newer generations of bugs.
If this were a conventional war, I think we would have realised the need for a concerted effort long before now. We would be cutting up railings to make into tanks and fighter planes. We’d be donating our silk underwear for parachutes. Instead, what we’re doing is sitting back on our (silk-lined) laurels. We’re being incredibly profligate in the way we’re firing off our limited arsenal, and we’re flirting dangerously with the enemy.
Every time we use antibiotics, we show populations of bacteria the weapons we’re going to use against them. If antibiotics are overprescribed, this just accelerates the problem. In the UK, most antibiotics are prescribed by GPs, and the evidence suggests that prescriptions could be significantly reduced without adverse effects – antibiotics don’t do much for runny noses, sore throats, bronchitis, sinusitis, or even middle ear infections. Unfortunately, GPs seem to be prescribing more of them. For instance, from 2003 to 2006 there was a 10% increase in prescriptions of antibiotics to children in the UK. Pressure from patients doesn’t help – in France, apparently more than 50% of people expect to be prescribed an antibiotic for flu-like illnesses. In China, physicians are financially rewarded if they prescribe more drugs. The problem with overuse isn’t restricted to humans. In fact, more than half of all antibiotics manufactured are used for animals as “growth promoters”, routinely added to their feed. You can keep livestock alive in dreadful conditions if you throw antibiotics at them.
Overuse and antibiotic resistance is a massive problem, but our weapons manufacturers are also failing us: pharmaceutical companies are not inventing the new weapons we need. There have been no new classes of antibiotics discovered since 1987 – the year that Bon Jovi released Livin’ on a Prayer, natch. In the 1990s it seemed that the revolution in genomics would lead to rapid development of new antimicrobials – but it hasn’t yet. Coming up with new antibiotics is a huge challenge; if we turn to “natural antibiotics” made by other bacteria, plants or fungi, it’s likely there will already be resistance to those compounds. Coming up with completely novel drugs to kill bacteria is tricky too. Semisynthetic antibiotics, made by tweaking or combining naturally occurring, antibacterial molecules, look promising. For pharmaceutical firms, though, trying to find new antibiotics is a challenge that doesn’t pay off.
We like to think we’re the top of the pile when it comes to life on the planet – we’ve eliminated or controlled most of our natural predators. But it’s not wolves, lions and tigers that we really need to fear. It’s these minuscule enemies that are still preying on us today just as they always have done. And if we start running out of effective drugs, that leaves us incredibly vulnerable. We won’t ever win the battle outright, but we need to make sure we’ve got the upper hand.
Somehow, we need to persuade pharmaceutical companies to back the war effort. Perhaps more collaboration between academia and private companies, and more open sharing of ideas might help. Revisiting old antibiotics could be useful, but we also need to look at other ways of controlling infection – expanding our arsenal by using vaccines, probiotics and things we’ve not even thought of yet. There’s an urgent need to rein in our overuse of antibiotics too, in both medicine and agriculture. Patients need to stop demanding antibiotics, doctors need to be even more judicious in prescribing them.
Back to those sniffles, then. I’m just going to have to wait for this damn virus to get out of my system. Antibiotics aren’t going to help, and I certainly don’t want to become a breeding ground for a new resistant strain of bacterium.
The US and EU’s explicit exemptions and waivers linked into the sanctions legislation are not working
UN measures including travel bans and asset freezes have been imposed for many years against named Iranians allegedly linked with nuclear weapons research and procurement. But those targeted sanctions have not worked and Iran has shown little inclination to obey security council demands to suspend uranium enrichment.
Over the past year, the US and the European Union have imposed sweeping financial sanctions and an oil embargo, partly in frustration and the failure of UN sanctions, partly in the hope of stalling Israeli military action.
Despite fundamental damage to the Iranian economy and accounts of deep divisions in the Tehran heirarchy as a result of the intense pressure, there is still no evidence that Iran is more willing to do a deal that would involve restricting its uranium enrichment programme, the focus of the impasse with the west.
At the moment, it is the Iranians who are dragging their heels over agreeing a date and a venue for the next diplomatic round. They have also been shy of direct bilateral talks with the Americans, thought by many as the quickest, surest path to a grand bargain that would avoid a conflict.
At the same time, the sweeping nature of the new sanctions has had an array of unintended consequences, worst of all is the crisis they triggered in the Iranian pharmaceutical market, and the impact that it has had on millions of Iranians with chronic health problems.
The US and EU have both ensured that explicit exemptions and waivers have been inked into the sanctions legislation, but the evidence on the streets and in the bazaars of Iran is that those exemptions are not working.
One of the reasons for the dysfunction is that having been warned for years of the potential for huge fines for doing business with Iran, many big companies, including pharmaceutical companies, do not think it worth the hassle and potential risk to their reputation.
“Their legal counsels stand a long way behind the red lines, and for good reason,” said Siamak Namazi, an Iranian-American business consultant who is coordinating a study on sanctions on the pharmaceutical industry.
More importantly, the humanitarian waivers granted to trade in medicines are not coordinated with any corresponding waivers in the US and EU bans on doing business with Iran’s main banks. So you might find suppliers willing to sell you the drugs your patients need but have no way of paying the bill.
Naser Naghdi, the head of the country’s largest pharmaceutical company, Darou Pakhsh told the Guardian: “Our biggest problem is the banking restrictions and the problem of transferring money. We have the currency but we can’t transfer it. We can’t pay companies outside Iran for the products.”
Mahak, a charity helping Iranian children with cancer, agreed. It said in a statement: “The main problem faced by Iran today is less related to non-availability of medicine and more related to limitations on international banking transfers and convertibility issues as a whole. Logic dictates that as long as financial sanctions are as severe as they are, shortages of pharmaceutical products will continue.”
As a result of the pariah status of the Iranian banking system, the bulk of transactions involving Iranian pharmaceutic purchases are being channelled through a single Turkish bank with a long backlog of clients and exponentially increasing facilitation fees.
There are many indirect ways in which sanctions squeeze Iran’s domestic pharmaceutical industry, which supplies 70% to 90% of the market. The oil embargo and the financial sanctions have triggered a currency run leading to multiple rates for the rial. The official rate is about 12,000 rials to the dollar. The market rate is 35,000 to the dollar. The prices dictated by the government for medicines is based on the official rate plus a mark-up. So pharmaceutical companies can only afford to buy imported drugs or chemical ingredients for their own production if they can get access to hard currency at the official rate. But they have to bribe and are kept out by firms with regime connections.
Meanwhile, domestic inflation is pushing up the costs of bottles, packaging and distribution squeezing profit margins further, to extent that medicines with narrow margins are no longer made.
US, UK and EU spokespeople point out that the Iranian regime could avoid problems if it focused resources on buying medicines as it does on the nuclear programme. However, ordinary Iranians were able to obtain the medicines under the same flawed government system before the West’s punitive measures. What has changed is the sanctions, and if Iranians start dying because hospitals cannot get their chemotherapy or haemophilia drugs, the west is unlikely to escape blame.
Should US states legailise drugs and tax them?
Astra’s share price is in the doldrums while bond investors are happy to lend to it at a low rate – they can’t both be right
Pascal Soriot, AstraZeneca’s new chief executive, knows how to make a splash. On his first day in the office after his arrival from Roche, Soriot suspended this year’s $4.5bn (£2.8bn) share buy-back programme with only half the cash spent. Removing a perceived short-term prop to the share price tends to go down badly, at least with investors who are focused on such things. But suspension looks the right decision for the company’s long-term health.
In broad terms, Soriot’s task at AstraZeneca is clear: he has to use the abundant current cash flows to reinvent the business for the time when patent expiries of big-selling drugs bite. And that time starts now: first-half revenues were down 15%. So critical decisions have to be made on how much cash to allocate for internal research on new drugs (probably not much more than currently) and how much for development of drugs that arrive via in-licensing and partnership deals (probably a lot more). But buy-backs are a distraction until that debate is settled.
In this context, it is intriguing to note the share market’s and the bond market’s wildly different assessments of the odds on a successful reinvention of AstraZeneca. The shares are priced at a miserable 7.5 times this year’s expected earnings and carry a dividend yield of 6%, which is the sort of rating associated with companies whose survival for the next decade or so is less than certain. Yet AstraZeneca last month issued a 30-year $1bn bond carrying an attractive (for the borrower) rate of 4%, suggesting fixed-income investors have no such doubts. Either the share price or the bond price must be wrong.
Growth-hungry Britain prizes innovation. But how do colossal TVs or self-sorting smart socks boost our standard of living?
Only 83 days left till Christmas so offer a vote of thanks to the folk at Sony, for they have seen off your gift-shopping migraines. I speak, of course, of the XBR-84X900: the 84in television. The “largest, highest resolution picture” Sony has ever produced for a TV, it displays images in 4K quality – which is, the press release assures me, a gazillion times better than HD, yet so bleeding edge that hardly a programme in the world is made in it. And, you lucky people, it goes on sale next month at £20,000. Unsporting types will doubtless sigh that this is over a tenth of the price of a house in Wales. The rest of us will recognise it as an absolute snip for what CEO Kaz Hirai promises is “an unprecedented and revolutionary viewing experience”.
Ah, innovation. Who would dare oppose it? One of the universal values of post-industrial societies, it stands in incontestable supremacy alongside “creative”, “entrepreneurial” and “iPhone”. To be an innovator in growth-hungry Britain is to have a government ministry dedicated to advancing your cause (Vince Cable’s Department of Business, Innovation and Skills). It is to invite the interest of David Cameron’s fixers, for the prime minister never looks happier than when wandering around some skinny-jeaned social-media startup in the East End of London. Politicians want to be photographed with you; civil servants sweat over policies on how to clone your success. In 2008, Gordon Brown laid out plans to turn Britain into an “innovation nation”, which even at the time sounded less like a white paper and more like a TV pilot featuring Anneka Rice.
Innovation is the badge that must be worn by seekers after arts funding. Public servants can no longer simply lay on schools and hospitals and social services; they must do so with private-sector sass and novelty. A word meant to sum up the commercial application of technological progress has seeped into all parts of our culture.
Yet look around at the fruits of innovation. A television too big for your house and too advanced for the broadcasters. A six-blade battery-powered razor (thank you, Gillette). “Smart socks” with microchips that will sort themselves (yours at £117 for 10 pairs).
I could go on into the realms of techno-lunacy, but you’ve seen enough glossy supplements. Each of these could be described as innovative, but really they are just unnecessary reiterations of basics (or not-so-basics) that already serve us fine. Their ultimate end is as expensive landfill.
But aren’t such baubles essential for economic growth? Not so. In August, the US economist Robert Gordon published what has already turned out to be one of this year’s most talked-about bits of academic research. He totted up the boosts to growth from three industrial revolutions: the first ran from 1750 to 1830 and delivered steam and railways; the second, from 1870 to 1900, provided flushing toilets and electric lights, and the third, from the 1960s on, might be termed the IT revolution.
The Northwestern University professor doesn’t deny that computers have enabled us to work more efficiently. But in terms of a boost to our standard of living, none of IT’s benefits have rivalled, say, the introduction of running water at the turn of the 20th century. Before that, every drop of water for drinking and bathing had to be drawn by hand, so that a housewife in North Carolina in 1885 would have to walk 148 miles per year to carry 35 tonnes of water.
Gordon’s paper seeks to make a bigger, if sketchier, argument, as hinted at in its title, “Is US economic growth over?” That interests me less than what he has say to about innovation. “Invention since 2000 has centred on entertainment and communication devices that are smaller, smarter, and more capable,” he argues, “but do not fundamentally change labour productivity or the standard of living in the way that electric light, motor cars, or indoor plumbing changed it.” You might love your iPhone, and I might spend too much time on Twitter, but we’d both be fine if they’d never been invented.
In a market economy, innovations should benefit both the seller and the buyer if they are to take off. It is easier to see how much the customer gains from Gordon’s earlier innovations than a Wii Fit, let alone Angry Birds.
And it is true of a lot else besides consumer electronics. Finance has produced plenty of innovation over the past three decades, and yet as the former US central banker Paul Volcker points out, none have been as useful as the cash machine and some have been downright disastrous.
The drugs industry pumps millions into developing drugs for luxury ailments, yet puts next to nothing into treating hookworm or other developing-world diseases. The Sabin Vaccine Institute calculates that 1,393 medicines were developed between 1975 and 2000, but only 16 were for diseases that predominantly blight developing countries.
As James Wilsdon, formerly of the Royal Society and now at Sussex University puts it: “Politicians welcome as innovative anything that’s new and of supposed economic value.” It’s time we got a lot more discriminating and demanding about what passes for innovation.