Thursday, September 3, 2009

The Pfizer US$2.3Bn fine,... and off-label use of drugs

I posted earlier on the ethics (or lack of) of off-label use of drugs. Now the latest news is that the pharmaceutical giant, Pfizer has just agreed to a payout of a massive US$2.3Bn for illegally promoting off-label use of its drugs. The chief target was Bextra, the painkiller that was withdrawn from the market in 2005, just barely 4 years after entering the market.

But this is unlikely to curb such unsavory practices. Pfizer, the largest research based pharmaceutical company (revenue of US$48.2Bn in 2008) has been cited as a repeat offender.

The incident highlights the growing pressures on pharmaceutical companies to push their drugs, often beyond the original proven indications just to grow the size of the pie. Drug development is a very scientific but expensive process and when drugs are licensed into the market place they are registered only to be used for the indications for which they have been tested. Companies often encourage doctors, indirectly and sometimes directly, to consider using their drugs for unproven indications. Use of the drugs in unproven situations, are termed off-label use. This is a very cheap and convenient way to generate better returns on their research investments, because you only need to invest in testing for one indication, but maximize returns by encouraging market use for a number of other unproven conditions.

So Pfizer was caught red-handed.

But what about other companies? I wonder what the HSA is doing about this problem. How does it police the pharmaceutical companies here in Singapore with respect to this? No point just citing the regulations. We need to know what is actually being done to curb this.

In my earlier post, I highlighted this as an ethical problem facing doctors. The SMC ethics guidelines specifically ruled against use of drugs for unproven indications. But we know it happens. And I don't think the SMC is really doing anything about it.

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