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The great health grab: the world's giant drug companies pursue profit above all else. Dinyar Godrej inspects an industry that's more than a little sick - Big Pharma / Keynote
New Internationalist, Nov, 2003
'I THINK there's some mistake.' I said, pushing the pack of pills back across the counter.
'Nope. It's the same drug, just a different name,' replied the pharmacist with a patient smile.
It was high summer, the peak of the hay fever season and I expect she'd been dealing with quite a few quizzical customers. I picked up the pack again. Loratidine it read, instead of the expected Claritin--and, as I soon discovered, it worked just as well. What I didn't know then was that a battle royale had broken out to delay loratidine (the generic drug) from reaching the market in any form apart from the branded version that I, and millions of other allergy-sufferers, knew by name.
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[ILLUSTRATION OMITTED]
Claritin is the golden goose for US pharmaceutical giant Schering-Plough--a drug with global sales of three billion dollars a year. It's an effective medicine with relatively few side effects, and it soon dominated the anti-allergy market with nearly 40 per cent of sales. Schering promoted Claritin vigorously and pushed to have its patent monopoly extended beyond the standard 20-year limit, claiming the US Food and Drug Administration (FDA) had unfairly delayed the drug's clearance. It is true that the FDA did take six years to approve Claritin for sale, largely because studies supplied by the company were considered inadequate. The agency was also concerned about data regarding carcinogenity in tests on animals. In addition. Schering-Plough submitted 37 amendments to the FDA during the application process, nearly four times the norm.
Eventually, Schering did receive two extensions on its patent, totalling nearly four years. But with billions at stake, every day the company could extend the patent was worth fighting for.
So it was that a certain Senator Torricelli introduced a bill in the US Congress in 1999 that would give Claritin and six other drugs the chance of a patent extension. The day before the bill was introduced Schering had donated $50,000 to the Democratic Senatorial Campaign Committee of which Torricelli was Chair. Later another Senator who chaired the hearings on the bill was reported to have flown five times with his staff on the Schering-Plough executive jet. The stories leaked, public outrage ensued and the bill faltered.
Then in 2002, the year the patent was due to expire, US consumers were bombarded by ads for Schering's Clarinex--a 'new' product which is a more potent derivative of Claritin. It's not necessarily better, but is patented. Schering was also fighting in the courts to extend patent protection to Claritin again--under the new patents granted to Clarinex! (1)
My little pack of loratidine represented a victory of sorts. It meant that Schering had failed to stop the generic competitors from producing the drug and the price could be expected to fall by two-thirds. There was, however, a further twist. Inspecting my nonbrand medication, I discovered it was manufactured by none other than ... Schering-Plough. The company was clearly dipping into both the brand name and generics markets until the competition got serious.
But what if such wrangling had gone on around a drug that treats something a bit more serious than allergies to pollen and cat hair? The consequences could be deadly. They frequently are.
Free to die
In February this year, a delegation of South Korean leukaemia patients, many in an obviously debilitated condition, protested in front of the local offices of the Swiss drug transnational Novartis. They were clutching at straws really.
Leukaemia patients in South Korea had taken part in trails for Novartis' new drug Glivec (also marketed as Gleevec), helping to get it approved in record time. Glivec is a genuinely life-prolonging drug. But girded by patent exclusivity, the Korean leukaemia patients found it was prohibitively priced. It sells for $19 a tablet--a year's treatment of eight tablets a day costs over $50,000. In desperation, a group of patients who had been part of the trials in Korea decided to apply for 'compulsory licensing'. This is a World Trade Organization (WTO) provision from its warren of patenting rules which allows governments faced with a 'national emergency' or 'extreme urgency' to overrule patent rights and buy or produce a generic version of a drug. (The US had invoked it during the anthrax scare which followed 11 September 2001.) The Koreans soon found an Indian manufacturer who could produce the drug for less than a dollar a tablet.
[ILLUSTRATION OMITTED]
While the South Korean Ministry of Health was considering the application, the US Secretary of Commerce sent a written threat warning against compulsory licensing of Glivec. The Korean Health Minister favoured the proposal but soon lost his job in a cabinet reshuffle. He denounced the role Big Pharma's influence had played in his dismissal. That left the patients with little option but to talk to Novartis directly--with disastrous results. Rough-handed by the police, two sustained injuries that required hospitalization. (2)
