Reverse John le Carre

Not an MNC pharma firm, but an Indian company’s been caught out

Sunil Jain

In search of a new bad guy, once the Cold War ended, the world’s best-known spy writer John le Carre came up with the unbridled capitalist, the pharmaceutical multinational who would test new drugs on tribal Africa to iron out the bugs before the drug hit the US and Europe. In The Constant Gardener, the firm Karel Vita Hudson decides to test its tuberculosis drug Dypraxa in Kenya, and enlists the support of the British government to cover up when the wife of a British diplomat stumbles onto its secret. Tessa Quayle chronicles 37 case histories of people who go blind, start bleeding and have liver collapses after being administered the drug. The British government is anxious to help KVH as the evil capitalist is making big investments in the UK, bringing in wealth and prosperity.

Well, le Carre’s plot appears to be coming true in a sense, though with a twist. An Indian firm’s been caught using unethical methods, in India, as reported by The Indian Express. Briefly, there’s an anti-cancer drug called Neupogen which is manufactured by the Swiss firm Hoffman La Roche and sold in India by Nicholas Piramal. The drug is what is called a Filgrastim. While Neupogen was first sold around a decade ago, another Indian firm, Dr Reddy’s Labs, began working on its own anti-cancer drug in 1998, and by July this year, came up with its drug called Grastim, and on its package also said it was a Filgrastim Injection.

Piramal challenged Dr Reddy’s product literature which stated its Grastim could be used for treating various kinds of cancers, including on children, and patients suffering from renal and hepatic impairments along with cancer. Dr Reddy’s product literature even said that the drug was approved in February 1991 by the US Food and Drug Administration (it was Hoffman’s Neupogen which was cleared then), and (incorrectly) uses research citations for Neupogen to back Grastim’s properties.

The long and short of the matter is that, on September 25, the Drugs Controller of India wrote to Dr Reddy’s saying that while its product literature stated that the drug could treat several kinds of cancer, the Drugs Controller had not certified the drug could treat these types. It also said that information about paediatric use had not been approved, and that Dr Reddy’s didn’t have enough clinical data to justify its statements on renal and hepatic impairments. Dr Reddy’s was asked to withdraw its current batches of Grastim, change the product literature, and then put it out again. Dr Reddy’s agreed to this, though as The Express found, Grastim could be bought with the old product literature more than three weeks later. The literature’s now been changed.

How contrite was Dr Reddy’s? Some company officials admitted to this writer that ‘some mistakes were made’ but claim off-the-record that these were not very serious. The only official statement comes in the form of an affidavit, to the monopolies court, by the company’s executive vice president in charge of developing the product. He had the gall to say ‘a few statements were inaccurate and (we) took immediate steps to have them removed’ — as if they didn’t really make any difference to a patient’s health.

That’s as far as Dr Reddy’s is concerned. More shocking is the behaviour of those in charge of drug licensing in India. Dr Reddy’s original application for a drugs licence, and the clearance given on June 28, 2001 was for ‘Human Recombinant Granulocyte Colony Stimulating Factor’. Dr Reddy’s, however, then goes on to call its drug Grastim, and on the package also calls it a Filgrastim Injection. Let’s give Dr Reddy’s the benefit of doubt right now –– after all, India still does not have product patents which would protect Filgrastim as Hoffman’s copyright.

Yet, on October 1, five days after the Drugs Controller orders Dr Reddy’s to withdraw its drug and submit new product literature for approval, the Drugs Controller issues it a curious letter. It clears the new literature, but this time says the approval is for ‘Human Recombinant .... — Filgrastim Injection’. By one stroke of the pen, the Filgrastim trademark is awarded to Dr Reddy’s. The letter is signed not by the Drugs Controller General Ashwini Kumar, but by his deputy A K Ramteke.

When this was pointed out, on October 12 the Drugs Controller (Ashwini Kumar) sends another note to Dr Reddy’s, saying there are various kinds of Grastims, and that Dr Reddy’s compound is not exactly the same as Hoffman’s Filograstim — its amino acid chain, molecular weight, and retention times are all different. In the event, he directs them not to use the word Filgrastim in their drug. Reddy’s hasn’t complied.

These events show two things. One, the Drugs Controllers’ office is either open to influence, or plain careless. Second, it’s clear that no one really monitors if firms actually produce what they’re licensed to. In this case, if Nicholas Piramal hadn’t been alert, the matter would never have come to light. Imagine the havoc that could be wrought by a really exploitative MNC from le Carre’s stable in a situation like this.