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Friday, July 13, 2012

Counterfeit Drugs

There's no question that counterfeit drugs are a problem, are killing people, and are resulting in the creation of more resistant strains of bacteria.  That's the theme of Roger Bate's book "Phake" as well as his recent op-ed in the Washington Post, "Medicine that is more placebo than cure".

Bates (who is with the American Enterprise Institute),

"purchased, off the shelf from local pharmacies, about 2,600 drugs to treat malaria, tuberculosis and bacterial infections in low- and middle-income countries, including Ghana, Nigeria, Turkey, India and China. We then tested these drugs to see how much active pharmaceutical ingredient — the chemical that performs the drug’s lifesaving function — they contained."

Sounds reasonable. He reports that:

"Drugs made by Chinese and, to a lesser extent, Indian manufacturers performed quite badly — sometimes a fifth of them failed basic quality-control tests. Most worryingly, more than 15 percent of the Chinese drugs approved by the WHO failed to include adequate amounts of active pharmaceutical ingredient."

This is an interesting blend of statistics.  All it says is that sometimes a fifth of them failed.  What does that mean for all the other times?  Why tell us that you tested 2600 drugs, without giving us some sense of how many passed overall?  Or whether there were pockets where sometimes 100% passed.  Why not tell us if some of the manufacturers were better than others?  Based on these statistics, maybe some were perfect.

More haziness:

"The Chinese and Indian manufacturers making substandard drugs are often significant producers, certainly capable of making high-quality products — they did so to obtain WHO approval. But given available, albeit limited, data, they are not doing so consistently."

So the ones making bad drugs are "often" significant producers.  To me that strongly suggests that some significant producers are NOT making bad drugs.

But this is serious:

"With little or no oversight, these companies may be cutting corners in the manufacturing process — or worse, watering down the active ingredient in their drugs, perhaps when the price of the raw material spikes and supply becomes harder to obtain. The drug most often with too low a dose in our samplings, for instance, involved the hard-to-get­ artemisinin, a key antimalarial ingredient."

Obviously, the drug companies that are profiteering by deliberately watering down drugs to save money on ingredients need to be banned from these programs.  But why not just name some names and be done with it?  How many companies out there showed proper levels of artemisinin in all the tests?

The other thing that's missing from this is a discussion of what other sources of these drugs are available and at what cost.  It looks like they are being bought through the WHO and other donor programs, which presumably make an attempt to get the best quality drugs at the lowest price -- presumably through a competitive bidding process.  My guess is that the solution to the problem is simple -- just fire the Indian and Chinese companies that are producing sub-standard drugs, and give the business to those (the vast majority, for all we know) that have consistently produced good drugs.  But that doesn't seem to be the agenda here.  If I had to guess (suspicious me!), the agenda is probably part of a much broader campaign designed to foster concern and fear about generic (or grey market, or internet-bought) drugs generally, and to steer those sales to the brand-name pharmaceutical companies.  It would be very interesting to know just who funded this work.

Ok, I saved looking him up until the very end.  He shows up on wikipedia as a free-market extremist -- pro-tobacco, anti-climate change, pro-DDT, and pro-genetically modified organisms.  Of course that doesn't mean he is wrong, and it doesn't mean he hasn't identified a real problem.  But it does suggest that he has an agenda.  And quite obviously (as I just said) that agenda is to steer more sales toward the tried and true brand name pharmaceuticals.

As always, it's quite interesting to see these "free-market" types jumping in and taking a "protectionist" approach in areas where intellectual property protection applies.  Isn't the market supposed to correct itself in situations like this -- i.e. producers won't supply bad drugs, because then they'll lose business in the long run?  

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