Archives for 2006

more often than usual due to their excellent World Cup coverage, but I have also been reading other articles and tonight I came across an interesting article that demonstrates that even fine media sources have real difficulty with medical/pharmaceutical stories. They quite simply get them wrong, and I am convinced they do so because it strokes their readers positively to do so by making out pharma to be the big bad wolves of the medical scene.

The article is entitled, Drugs firm blocks cheap blindness cure, a shock title which is only true in an extremely limited sense. Anyhow the piece goes on to note that a particular product used to treat colon cancer, Avastin, can also be used in very low doses to treat a relatively common yet debilitating condition that tends to strike the elderly. Then the article notes that the company (Genentech) is seeking regulatory approval for a specifically engineered version, which would cost a great deal more than the original drug, and so is “blocking” the use of the the cheaper alternative.

The trouble is that according to the article itself, that is not what’s happening at all. What has happened is that Genentech noted the benefits of the product in this totally unrelated disease site and has been studying how to address this with a product for ten years. In other words, they’ve spent at least a million dollars a year for a decade to try and get this to the point that it might be approvable by regulatory agencies.

There is no option for a pharma company in a situation like this. They are compelled to do the research before seeking approval of a product. And no amount of anecdotal evidence will ever be considered adequate by any regulatory agency – can you imagine? “Oh, we think this might do something, this one doc in Montreal seems to think it’s OK, will you allow us to market this product?” Of course no one would ever accept such standards from our public health and regulatory agencies.

What the article leaves out is that the real issue is a political issue – and the very fact that this is a problem indicates that the politicians – in this case in the UK, but it happens all the time in Canada and particularly the US – have already failed. There are two solutions to this issue. The first one would be to pro-rate or fold in the cost of all of the research into this off-label usage of Avastin into the marketed price of the drug for everyone, no matter whether they’re colon cancer patients or wet macular degeneration patients. Of course if the company were to do that, they would probably not succeed since most countries strictly control pharma pricing (usually using reference pricing, BTW, which means that this would have to be attempted in a dozen countries simultaneously).

The other option is very simple: the government could fund and organize a double-blind study of the non-specialized product itself. And, if the government had drawn up laws in a truly independent fashion, it wouldn’t fall ONLY to the company to submit a product for regulatory approval, and there would at least be an alternative path that could be used in exceptional situations such as this one. If we want sane regulations of things like pharma products, then governments simply have to set rules that privilege health, not simply commerce. Pharma companies generally – especially outside the US – play within a very strict rule set and are only too happy to comply if the rules are clearly communicated and fairly enforced. If our politicians don’t set those rules, then it is they who are at fault for such ridiculous situations.