The reason why the cost of R&D is inflating so much is due to relentless addition of new regulations, new requirements, new safety-related trials demanded by the authorities. Add to that that almost every other country has specific requirements that do not fit with what was developed and proven before, and that's just another 2-3 years clinical trial you need to put up with. This is really getting insane and there is science to back all those regulatory differences, some driven by pure ideology.
As you mentioned the patent cliff is looming for a number of big pharma actors, and what this is going to result in is less innovation and more strategic moves to other "easier" markets such as generics or OTC drugs. This is just plain bad for everyone in the end.
Yeah, there are a lot of safety-related things because we keep getting a vioxx every so often that's killing people.
I'm not willing to increase my chance of getting killed by medicine on behalf of someone else's profit margin. They have a big, powerful lobby, they should suggest process improvements. And make some on their end, as well, nobody's charging them billions in fees, they spend that money on the typical big-company waste in the process of complying with those regs.
Note that we still got a Vioxx on the market even though we had those tons of regulations in place. There was a similar scandal in France recently with another drug called Mediator. Truth is, regulations do not replace ethics - Corporations knowlingly allowing patients to be hurt should be punished accordingly - there is no need to inflate regulations further and further, this has never solved the problem, just like regulations in the financial industry will not make crooks disappear.
I never mentioned about removing all regulations in place. But things can be done to restrict their scope to where they were before, to manage the development of drugs at a more reasonable cost.
Got any examples? The trial process for new medications isn't perfect, but without citing specific failures in the process it becomes to easy to discount the parts of the process that do work.
Weight loss drugs. Three new products were rejected by the FDA last year. Sure these drugs had risks, but what's the cost of obesity in terms of medical costs?
At this point in time the FDA has incredibly high standards of safety for weight loss drugs and not without reason. But what are the costs of the 40% of obese Americans who will get diabetes, cardiovascular disease, etc, etc?
Wait - so you want to take the at risk group and give them a drug that failed human safety tests?
EDIT: I am trying to say that while obesity is 'bad', giving them a drug that adds to their risk levels is not a solution.
If you are still pro your position, bear in mind that you are now throwing dice and hoping that: (people who improve) >= (people who suffer + nothing happens).
Are you qualified to play dice with peoples lives?
One of the reasons why the FDA rejected Qnexa was that one of the components in the drug was thought to cause cleft palates in babies born to mothers who take the drug.
Mind you, this drug is already approved for use in humans. The FDA made the call that preventing cleft palates in babies (mind you the company offered to restrict the label to "non-child bearing women") was more important that reducing levels of obesity.
The FDA "suggested" the company run a 10,000 person clinical trial (estimated at $100M) to prove it didn't.
Did a quick search, 3 drugs were removed and of them 1 had abused rumors in rat trials, the other increased risk for heart attacks and the final was qnexa.
Tht was in 2010.
From what it looks like the FDA is going to renew qnexa by April 2012.
He's not advocating giving drugs to anyone, what he advocates is letting the at risk group decide whether or not they want to roll the dice with their own lives. You advocate forbidding this to happen. In other words you're hoping that: (people who suffer + nothing happens) > (people who improve). If you're wrong, then preventing the release of the drug is literally killing people.
Uh. You are taking the opposite position on a random event. It's still a bet.
And we have already gone past "letting the at risk group decide for themselves." it's hard to be succinct and explain the many reasons why we dont use that particular system when it comes to medication.
The discussion should not be about "efficacy and no risks", but the comparison of risks versus the benefits the drug can provide. That should be the only rationale when you go on treatment: understanding the risks on each side. Just like cancer drugs are usually not harmless (side effects can be pretty nasty), they can make you live longer than if you go untreated.
The communication to the patient should be fully transparent, and it should be up to the patient to choose what they want to do, not just regulators.
As you mentioned the patent cliff is looming for a number of big pharma actors, and what this is going to result in is less innovation and more strategic moves to other "easier" markets such as generics or OTC drugs. This is just plain bad for everyone in the end.