The idea of malicious drug development is a little media driven in itself. I would hesitate to say that drug’s for profit is a major problem, but given the governments (at least in the UK) tendancy to rely on charity funding for academic research, and not state funding – we as a people are actively promotiing drug company health ethics, becuase we do not demand social health ethics as a mandate of our state.

I think #1 would severely restrict any trial because of the shareholder demographic. As much as anything, I’d love to see how the pharmacokinetics of a drug would be determined in a pension scheme!

AUC = hr*ng/share?

There are other ways to ensure that drugs are tested in a safe manner. Here’s two suggestions

1. Require that the financial beneficiaries of a successful drug e.g. the major shareholders in the companies concerned (5% of shares perhaps) and financial backers who would share in profits be available for selection as testees.

2. Make unlimited insurance cover on the London insurance market a requirement of allowing the tests to proceed.

These two measures would go a long way to ensuring that the drugs are made as safe as can be before tests proceed, and that compensation for any subsequent damage is not a problem. If one capitalist organisation (big Pharma) cannot persuade another (Insurance) that the trials are safe, then perhaps they shouldn’t proceed in the first place.

Unusual could be instant gruesome death of the volutneer, or it may be more worthwhile.

I think minoxidil (for the folllically challanged) was discovered as a side effect of the drugs orginal use – for heart conditions.

I’m not saying a cure for male pattern baldness is the greatest discovery for all mankind (though it would probably makes as much money as a cure for cancer…) but it does provide an example of the reasons why it is important to test, as safely as possible, potential drugs.

if you were sat down rationing out research effort instead of leaving it to market forces, me-toos might not get as much attention as they do, and when you came to test them, you would definitely do a better job of it than the biased studies on them currently, because you would want a fair test, giving the most useful answer for doctors and patients. now, the shortcomings of these tests are there in the write-ups for all to see, nothing’s hidden, this is no excuse for “you cant trust a study on account of who funded it” weakmindedness, because you can critique the studies quite adequately on the basis of the write up, the paper itself. but it is an argument for saying they are a waste of resources, of which patient time and flesh seems the most heinous to me.

this was going to be a two-parter on how research regulation has missed the point, focussing next week on how ethics committees have restricted research locally without recognising the global impact that has on restricting the development of new knowledge that saves lives.

i could randomly decide to give half my patients one drug, for fun – of course i wouldn’t – and half of them another, and the regulations on informed consent would be the usual gmc (almost but not quite “whatever you reasonably think is best under the circumstances”) line; if they were in a trial, i’d have to fill out six forms and inform them to hell and back whilst being watched by crowds of onlookers. i’m not saying one is right and one is wrong, i’m just not sure the disparity is justified, and i think a lot of good work is held back by restrictions that are well intentioned but disproportionate.

now of course i just want to attack the postmodernists and leave this second and more interesting half of the argument for another year…

IMHO, if there are diseases that private big pharma corporations are not interested in (for reasons of shareholder value, which legally is there only concern), government agencies such as MRC and BBSRC (in UK, NIH in US, etc) ought to be able to step in and fund extensive research into drugs/therapies etc. it would cost the government a proverbial limb to do so, but to paraphrase Chomsky (God i need to get out more…), “whilst a private corporation would never run an enterprise or project at a loss, for a state entity it may be worth it, because to develop a drug (or make steel in his original example, or indeed run a railway) at a cost of X, then ‘sell the service’ at half X, may represent a loss in itself, but could save billions elsewhere in avoidable healthcare and environmental costs…”

does that rambling post make any bleeding sense by the way…? i’m writing a phd thesis so my mind’s an effing muddle to say the least…!!

This is less about me-too pharmacy, more about ‘orphan drugs’; drugs that either are for such a small patient base or are so cheap to make like MgSO4, that a drug company cannot afford to do the work that makes it marketable.

However, I remember that tamoxifen was once such an orphan. ICI first synthesized it in the Fifties; its patent was nearly run out by the time it was marketed in the Seventies for use in ovulation induction. When it was used against breast cancer, there was fear that it would remain an orphan, but due praise to ICI/Astra-Zeneca for taking on developement for a different use.

John

3) Simultaneous research. Say a target is identified by an academic lab, who publish it, a whole bunch of companies are going to prick up their ears, start twitching their noses and think to themselves ‘hold on lads, I’ve got an idea..’ As a result, 5 (or any other number) companies are going to launch into there drug discovery, lead opt process and about 10 years down the line they’ve each got a candidate drug to dope into some willing volunteer. One of them manages to rush through trials and gets approval for their drug. Now what are the other n-1 companies going to do? Say, ‘well it was a good race, decent sports that lot, fair play to them, we’ll just put these proto-drugs back where we found them’? No, and I think it would be detrimental to expect them to.

Or, for another take, have a look at this blokes blog:More From the Me-Too Front

1) Competition is good, having a competitive drug market should keep prices down. A company with the rights to the only drug in class can charge what they like for it, if there’s someone else making one then they need to compete.

2) If you’re going after a me-too target you may end up with a drug that has a better safety profile or a more efficacious one, there’s no way of knowing how that’s going to turn out until you run the trials.

3) Simultaneous research. Say a target is identified by an academic lab, who publish it, a whole bunch of companies are going to prick up their ears, start twitching their noses and think to themselves ‘hold on lads, I’ve got an idea..’ As a result, 5 (or any other number) companies are going to launch into there drug discovery, lead opt process and about 10 years down the line they’ve each got a candidate drug to dope into some willing victim volunteer. One of them manages to rush through trials and gets approval for their drug. Now what are the other n-1 companies going to do? Say, ‘well it was a good race, decent sports that lot, fair play to them, we’ll just put these proto-drugs back where we found them’? No, and I think it would be detrimental to expect them to.

Or, for another take, have a look at this blokes blog:More From the Me-Too Front

Why is that too much to ask? I ask it, indeed I demand it. I’m realistic in having little expectation that this demand will be successful, but I think it has to come down to that.