I remember reading about this maybe 6 years ago. What was memorable was that the gel was even cheaper than the syringe. It's sad how slow these things move and that we're not going to have that in North-America for a good time.
I wish it could go faster, but the truth is this is exactly the sort of thing that should go slowly. It is much better for birth control to have a certain effectiveness, after all. Since this is an injection, probably best to have good tests with longevity as well. It isn't bad to go back every couple years for this, but this is the sort of information one needs to know upfront.
Unfortunately, finding this initial stuff out takes time.
A problem in the US is that the company that wants to sell this is the company that needs to pay for the studies required to make it legal. However because it is so cheap, it's difficult for the company to make a profit. The same thing can be found with many supplements. For example, N-acetylcysteine has shown to be helpful in several forms of addiction and mood disorders, but because it is so cheap, no company will front the money needed to make it a medication. We need to change the system so that the research is paid for by the government somehow, in my opinion.
The US has orphan and rare disease programs that give bonuses to companies for tackling rare issues but you're right that we currently have a hole in the system. I wish there were a non-profit drug foundation that could go after stuff like that but I'm not aware of one.
One nit though: A ton of research is funded by the government, including drug research. We just don't have a federal program that requires commercialization of research to pay a royalty back into the program. If we did it would be a nice virtuous cycle, assuming some research continued to lead to viable products over time. Some universities have such programs in place for obvious reasons.
> However because it is so cheap, it's difficult for the company to make a profit.
Why does it have to be cheap for the consumer? They can charge $5k for this (honestly a bargain) even if the gel and syringe cost $5 to make. Isn't that what patents are for?
Many of these drugs are cheap because the patent has expired. Many times, it's not until the patent has expired that they learn the new use for the drug, but by that point, they can't make money off of it.
It shames me to think that we have a for-profit healthcare system.
That is most definitely an issue, but not one that is so much tied to the regulations making things take longer. My solution would be to reimburse the R&D costs directly (to help with risk) in addition to having govenrment-financed labs whose sole mission is to improve medicine in general. I'm not sure how this stuff works in other countries: I'm from the US and don't know all the ins and outs of the healthcare system here yet.
It'd still take some years to get some things to market, however, because some things need studied for a longer time.
This kind of thinking is harmfully simplistic. When you rely on rules of thumb ("this sort of thing should go slowly") to make public health decisions, you are going to harm people.
In the US, we suffer from an insane degree of regulatory medical conservatism. No one else in the world takes as long to approve life-saving medications as the FDA, and this is not rational; it's a reflexive political reaction to the Thalidomide disaster that isn't grounded in sound reason or statistics.
Here is an extensively cited analysis demonstrating that the FDA's extreme standards kill vastly more people than they save.
As a quick aside, your source also advocates for free-market healthcare and rejects national healthcare legislation and Medicare under the guise of individual choice.
It has _also_ published such gems as "The Scientific Case against the Global Climate Treaty" and “New Perspectives in Climate Change: What the EPA Isn't Telling Us”.
In light of that, I'll take their advocacy with a grain of salt.
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On topic, while I can't comment on the EMA specifically, during my (extremely) brief period working alongside a medical device manufacturer, fear of FDA was oftentimes the primary motivating factor in keeping them honest.
While that's entirely anecdotal, when there are _significant_ financial incentives on the table people's morals tend to get more than a little flexible. Pharmaceuticals represent an area with _significant_ financial incentives, and, while I do agree that the FDA takes more time than is strictly necessary, it's a little fallacious to say they "kill vastly more people than they save" through regulation.
It'll be tens of dollars in India but hundreds of dollars here. It would probably be close to the same price to fly to India, have the procedure, and fly home. Plus you get a nice vacation out of it. If this becomes mainstream there I'd do it in a heartbeat, I've always wanted to visit New Delhi.
