Comment by leonth | Hacker News Reader

Comment by leonth | Hacker News Reader

Imagine that there were no FDA Iron Curtain and doctors prescribed afobazole because "the paper was good" (or more likely because the money was good). Then people taking this drug got hospitalized left and right (or - shudder - found dead) because of side effects.

FDA could not do anything to protect her dear US citizens. She couldn't sue the manufacturer or ask them to do further research or impose black box warning or pull the drug out of the market because it was simply beyond their jurisdiction. Doing any of that would constitute a version of the Iron Curtain.

So FDA is doing the right thing to prevent this from even happening by requiring the manufacturer to have everything in place before the drug sees the market.

Furthermore, a randomized controlled trial is no synonym of "drug is good to use". Do they work on US populations? How big is the sample size? Is the methodology sound? What is the side effect profile? Is there any long-term data (like 1 year after using the drug)? These are answered for FDA-approved drugs, but not necessarily for non-approved ones, especially if you are not a healthcare professional that speak Russian (even then, they have teams of professionals looking at drug applications, are you sure you're not overlooking anything?).

You're right that the solution shouldn't be automatic US approval for any drug used in Russia. It's reasonable to have standards for drug testing and require that any drug used in the US is tested to those standards.

The problem isn't (only) that US drug standards are strict. The problem is that the financial burden of testing a new drug, which is significant, lies solely on the manufacturer, who can only recoup those costs by selling patented drugs at high prices. This means that the incentives don't line up for drugs not covered by US patents: because there's no profit in selling them, no manufacturer can justify funding the clinical trials to get them approved. This despite the fact that society would, as a whole, benefit from having those studies done.

One obvious solution would be a government program whose mission is to identify promising treatments for which private incentives don't line up, and shepherd them through the approval process by funding clinical trials and so on. You could also imagine a free-market variant, in which the government just auctions off US patent rights for foreign drugs; the auction winner gets exclusive rights to sell the drug in the US for some limited period of time in exchange for agreeing to fund FDA approval.

> One obvious solution would be a government program whose mission is to identify promising treatments for which private incentives don't line up, and shepherd them through the approval process by funding clinical trials and so on

You already have this. It's called Orphan Drugs in the US. http://en.wikipedia.org/wiki/Orphan_drug

> a free-market variant, in which the government just auctions off US patent rights for foreign drugs

This will probably work. But once the barrier is too low, a lot of "useless" drugs will show up (i.e. providing more choices to prescribers but in reality does not really give much benefit) - and you need to fund those too using the taxpayers' money.

Cool, I wasn't familiar with the Orphan Drug program. From the Wiki page it looks like it's focused on development of new drugs for rare diseases, for which the market is inherently small and thus impossible to do large clinical trials, etc. That's similar to but not quite the same as the problem here, where a drug already exists and the market is potentially quite large, but the lack of patent protection prevents any one company from funding its approval. Do you know if the Orphan Drug Act specifically designates some government body with the mandate and funding to study and approve pre-existing foreign drugs? If not, maybe that could be a useful extension.

I see, it is indeed quite different. I'm not sure what the Orphan Drug Act specifically says though.

Actually if the market is potentially quite large, big pharmas should already be researching it. The problematic ones are those that are in-between orphan drug and market-quite-large drug. The society probably needs less of these drugs (there should be alternatives at the other ends), but if it's still needed, maybe expanding the scope of the Orphan Drug Act can be a good solution.

You can get a patent for 'novel' treatments for existing drugs which should in theory fix this issue.

Overthinking it. The Russian regulations presumably are adequate to protect her own citizens; its not necessary for US sufferers to sue in Russia to correct manufacturing problems there.

Its hubris, American regulatory groups sticking their fingers in the affairs of other countries. And its beyond their charter to try to regulate what Americans do; they're supposed to regulate what American manufacturers do, not private citizens?

The primary issue here is extremely well understood drugs for which the patent opportunity has expired. The only problem is profit incentive, not any serious question marks about safety or efficacy. There are European drugs in wide use for decades with reams of great research that nobody is ever going to bother pushing through approval in America because ultimately no profit would be made.

But the argument still stands, right? Who will be responsible if the "extremely well-understood drugs" have some problems in the US? They don't care about US population because it is such a small market for them. Let's say we lower teh barrier of entry by waiving these "extremely well-understood drugs" from proper research in US. There are instances of drugs that exhibit different side effect profile due to genetics in different population, and this sometimes tip off the risk-to-benefit balance, how do you account for that?

The more barrier you place for drug approval, the safer it will be. It is a classical risk-versus-benefit trade-off. If there is an option that may be slightly more effective than current practice but has unknown (or perceived less certain) side effect profile, healthcare industry mindset prefers the status quo.

"First, do no harm." http://en.wikipedia.org/wiki/Primum_non_nocere

I would be on the same page as you if the FDA and the American medical establishment had a great track record of protecting Americans from harm. As it is there's massive over-prescription of dangerous chemicals doing serious harm. Remember Vioxx? Remember estrogen hormone replacement therapy? There's currently massive, dangerous over-prescription of statins, amphetamines for kids, female hormones, and SSRIs.

Consequently I take a bit of a more libertarian perspective on pharmaceuticals. You can't really trust the government or most doctors anyway. So people might as well be more free to find helpful chemicals.

Over-prescription is the problem of the prescribers' and their incentives, not FDA. FDA opens the tap, prescribers put the water in the cup and give to patients. Patients do not access the water directly. Your concern is better directed to American Medical Association (AMA).

If you think you can find helpful chemicals on your own, you are either very confident to use your own body as a guinea pig or suffering from http://en.wikipedia.org/wiki/Dunning%E2%80%93Kruger_effect .

The FDA specifically on-label approved ritalin for kids, hormone replacement therapy, and statins for people with high cholesterol but no signs of heart disease. Your faith in regulation is misplaced. If you take FDA approval and a doctor's recommendation as proof a prescription is safe you are misguided. (The AMA is a lobbying organization to which about 15% of doctors belong and is irrelevant here.)

There is no reliable government organization out there stopping harmful medical treatments. I just want to acknowledge that as fact rather than pretend otherwise and deny people choices.

> The FDA specifically on-label approved ... statins for people with high cholesterol but no signs of heart disease.

You say this as if it were bad, but the net effect is to save lives (at a cost of money and increased diagnoses of diabetes). Statins are an example of the FDA and the industry actually doing the job they are supposed to do.

I may not be as well-informed as you, but I don't see a problem on those on-label uses you mentioned.

If you want to evaluate the safety of a prescription, I hope you have the right degree for that. Things can look safe on one paper and not safe on another. Or your condition may warrant a risk of greater side effect with the upside of better efficacy. It's true that doctors and FDA can make mistakes, but they are the best people you have.

Uh oh... Didn't know that your AMA is such a place. Do you have a association that represents all prescribers? Prescribing habits should be looked over by them.

Reply on news.ycombinator.com