ScienceDaily today has commentary on a fascinating debate between two experts on the subject of whether or not it’s ethical for drug companies to carry out the clinical trials of their own product.¬†It’s easy for us to call Conflict Of Interest on this one, and that conflict of interest has some significant potential for harm. The most obvious example to my immediate recollection is Vioxx, where allegations exist that the company actively fabricated test results to put their product in a better light, which led to numerous class action and wrongful death lawsuits against Merck.
However, we demand that the drug companies have almost instantaneous turnaround when it comes to the drugs they sell, and that the price of drugs be ridiculously cheap whenever possible. It’s the Wal Mart conundrum, we want top quality products priced to sell and widely available. In the world of computers, we have a saying: “Fast, Cheap, and Right. Choose any two.” And that saying applies to the drug companies.
Allowing them to test greatly improves that speed of testing. Their experts are already well-versed in the information around the drug. If every time they want to release a new drug (or a new iteration of a drug) they need to go through a mandatory third party testing cycle, that will obviously have an impact on the cost and speed associated.
Well, that’s very true. But the IT model I mentioned earlier is still related as far as I’m concerned. If I’m writing a three hundred line piece of software that handles some unimportant aspect of information, then maybe the rigorous testing isn’t a benefit. But if I’m writing something that could have serious repercussions, or even something that touches another system that might have serious repercussions, then I am ethically obligated to ensure that I’m releasing safe, reliable, tested code to the environment.
This is all personal opinion and I don’t pretend to be an expert in any of the economics behind this, but to me this is an open and shut case. This is the health and welfare of the people at risk. Errors cost lives, potentially. Those stakes are too high to expect that we can employ a Wal Mart model. And part of the problem is needs management.
Ladies and gentlemen, there are reasons we tested anything that we sell, from ride-on mowers to impotency drugs. We need to make sure they are safe. And that testing is going to impact the cost of the item. That’s all there is to it. If you want safe medicine, then it’s going to cost enough to offset all of the costs that went into developing it. That includes testing rigorously to ensure that your taking it is as safe as we can realistically allow.
This is made worse by the anti-vaxxers and the woo peddlers. We do not require them to properly test their solutions to our problems. We simply accept that since they’re the underdog, clearly they are right. This is foolhardy to the extreme.
A few days ago, friends of mine were talking about some hack they saw on late night TV claiming he had developed the cure for cancer, but the FDA and the drug companies wouldn’t let him sell it with that argument. This argument is crap. If the drug companies were aware of a legitimate cure for cancer, they would buy it, patent it, and proceed to charge us up the nuts for it. But without proper testing, with nothing more than testimonial evidence or biased research we cannot allow these cures to go out.
We do not know the potential adverse reactions of miracle cures because their creators do not submit them to proper evaluation. Someone who is selling you the cure for AIDS at $19.95 is out and out lying to you, unless they can show you proof that backs up their claims.
We have to move past the idea that all diseases can be cured for pennies, or that the minute a drug shows some promise it should be released to the masses. It’s not an FDA plot to keep the people dying, it’s exactly the opposite. We learned from thalidomide. If we don’t employ a little due diligence, people will die.
My suggestion? Well, I think that what we need is a neutral party conducting and peer-reviewing the testing of all drugs. The initial tests could be provided by the drug companies, but their findings have got to stand up to those basic checks and balances of the scientific method before we can legitimately say that we feel a drug is potentially safe.
No drug is bulletproof. If you test on 3000 people, you get a good view of what potential side effects there are, but what about the risks that are more like one in ten thousand? No amount of testing will ever guarantee that any substance is perfectly safe, because there IS no perfectly safe. People choke on apples, overdose on carrots, and have astonishing allergic reactions to peanuts. But proper testing will identify the vast majority of these issues and allow us to make informed, educated decisions on the threats of a given drug.
The “Wal-Mart Conundrum” is a misnomer. If you want “top quality products priced to sell and widely available,” don’t shop at Wal-Mart, because of those three things, you’re maybe only going to get the middle one. And maybe not even that, if you’re not shopping their numerous loss-leaders, and even then, given how many of their suppliers they’ve brow-beaten into submission, and how many of their product lines they’ve moved to their crappy in-house lines, you probably aren’t going to get anything resembling “top quality goods.”
Or hadn’t you noticed that they fill their shelves with umpteen identical units of the same piece of crap so you often can’t actually find the specific thing you’re looking for — although they’ll be only too pleased to sell you a vastly inferior knock-off for twenty cents cheaper than you’d get the better original somewhere else — and their idea of “quality control” mostly consists of a maximum (not minimum) standard?
Wal-Mart violates the laws of physics — it’s like a singularity of suck. It sucks constantly in all dimensions at once.
I agree with all of that, and perhaps it’s a bit of a poor comparison. When I mention Wal Mart in the same breath as cheap-fast-right, I’m implying that people always seem surprised when their $30 DVD player breaks after a week. Consumers in all areas demand perfection, but always want to pay discount prices.
Wal Mart has made a multinational out of the idea that people deep down don’t care about quality, they’d rather enjoy immediacy and cost effectiveness. That makes this a bit of a bad comparison, because what people want in the case of vaccinations is an unrealistic level of security tied into that cheap and readily available model. But you can’t have all three.