Saturday, August 25, 2012

Big Pharma Innovation: New Packaging for Old Drugs

Donald W Light and Joel R Lexchin's paper in the British Medical Journal, 'Pharmaceutical research and development: what do we get for all that money?' make it clear that 'we' don't get very much at all; but pharmaceutical companies get handsome profits. Despite all the references we see to an 'innovation crisis' in the industry, this is just one of many ploys to maintain and even increase levels of protection against competition from generic equivalents.

Light and Lexchin point out that, despite the many new drugs that appear every year, very few represent any real therapeutic advance. And while there have been some benefits, there has also been "an epidemic of serious adverse reactions that have added to national healthcare costs". The bulk of the claimed costs of research carried out by Big Pharma is paid for by taxpayers, more than four fifths. Only 1.3% of revenues is spent by Big Pharma itself. And even the 1.3 billion dollars the industry claims to spend can be whittled down to something less than 60 million dollars once you adjust for the more imaginative accounting measures.

This might explain some recent moves to expand significantly the number of uses of antiretroviral drugs, even to people who are not infected with HIV, which could increase the market by several hundred percent in a few years. At present, say around 8 million people are receiving the drugs (depending on which figures you use); the number requiring the drugs to keep them alive is probably double this figure, or more. But the aim is not really to provide drugs for all those who need them, it's more to provide drugs to those who don't yet need them, to those who only need them for a while and to those who don't now, and may never, need them.

The first group fit into two categories, treatment as prevention, whereby anyone found to be HIV positive will receive the drugs because it is said to reduce onward transmission; and early treatment, whereby HIV positive people are put on treatment at a clinical stage far earlier than that used in the recent past. The second group includes mothers on prevention of mother to child transmission (PMTCT), who currently receive the drugs for a matter of months; the plan is to put them on treatment for life. And the third is pre-exposure prophylaxis (PrEP), whereby HIV negative people felt to be 'at risk' of being infected take antiretroviral drugs to reduce the probability of being infected if exposed.

While research often concentrates on how certain results could benefit Big Pharma, generally because they fund the research, less attention tends to be paid to any adverse effects on those taking the drugs, or even instances where there is no net benefit. That may sound like a good reason to question this sort of strategy to most people. But the main question for Big Pharma is about where the money will come from. Whether the eventual number of people on drugs is double the current figure, treble, or something much higher, is anyone's guess. As for any damage done, it's unlikely anyone is checking.

So it becomes clearer why Big Pharma constantly whinge about how much they spend on 'innovation'; the 1.3% of revenue (or whatever fraction that's really involved) is small beer. It's the 25% of revenue spent on 'marketing' "that an independent analysis estimates is spent on promotion, and gives a ratio of basic research to marketing of 1:19". Lobbying for public money and for legislation to support the industry, and for various forms of protection, are worth far more than a little research. Given that what Big Pharma churn out at grotesquely inflated prices can be produced at an affordable cost by makers of generic equivalents, the bulk of the industry's hundreds of billions in revenue comes from various forms of market protection, nothing more nothing less.

It's estimated that about 80% of ARVs currently used in developing countries are generics from India. If only about a third of those who need them are receiving them, how many would still receive them if the proposed EU-Free Trade agreement, which would prevent India from producing these generics, was signed? This agreement is not designed to cut off antiretrovirals from Europe or other rich countries, who tend not to depend on them so much. It is to cut off the supply of (relatively) affordable drugs to countries with the worst HIV epidemics, those who can least afford to subsidize Big Pharma.

The EU trade commissioner, Karel De Gucht, denies that the agreement will have any negative impact on supplies of affordable drugs to developing countries. But it doesn't take a genius to work out that the EU would have little interest in drawing up an agreement that would benefit poor nations. Or to put it another way, the EU has a strong interest in protecting Western manufacturers of drugs and other products; that's precisely what the union is for. so I don't know whether de Gucht thinks the public is a bunch of idiots or if he is just another glove puppet; perhaps the two are compatible.

Interestingly, UNAIDS doesn't accept de Gucht's bullshit. But unfortunately, they do accept the bullshit research that is used to support calls for early treatment, treatment as prevention, lifelong PMTCT and PrEP. UNAIDS is to the HIV industry what the EU is to protectionism more generally. The fact that they are putting their oar in suggests that they are just not happy with whatever is in it for them.

The form of protectionism that makes healthcare virtually unaffordable to those who need it most is patents. These patents do not, as is claimed, allow those doing the 'innovating' to claw back their costs and make a reasonable profit. Rather, the 'innovations' are just new ways of looking at existing medicines. The costs are orders of magnitude smaller than claimed and are mostly paid for by public funds. But Big Pharma profits dwarf almost everything, the exception being the massive amounts of disease, disability and loss of life that results from this cosy relationship between a bunch of ruthless bastards and the people and institutions that are supposed to protect us from such excesses.

[For more about non-sexual HIV transmission and mass male circumcision, see the Don't Get Stuck With HIV site.]


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