I took time today to read the recently published results of the HPS-2 Thrive study. For those who don’t know, this is the study receiving a lot of media attention because it questions the benefit of Niacin in reducing bad outcomes (death for example) in patients who are at high risk (bad heart) and already taking a statin (#1 cholesterol medication class). After reading the article and doing a little digging on the history of the study drug Cordaptive (which I had never heard of), I came up with some interesting observations worth considering.
1. This is not new news. Sure it was published in the New England Journal of Medicine yesterday, but Merck (the manufacturer of the drug) decided to pull it’s FDA application over a year ago because of results in this study saying there were adverse effects (bad things) due to the medication. At that point the study was ended, which means no new results, which means the results were there over a year ago. Why did it take this long to get a full study on if Niacin works? You can be certain, though, that your doctor will start incorporating this “breaking news” into your health treatment today. Which leads me to the conclusion that maybe our current system of disseminating drug knowledge is not the fastest or most efficient. Granted, I understand the need for peer review, and I do want quality information. (Tweeting interim study results is no way to manage patients.) The questions still stands: Are we emphasizing the literature process a little too much? Especially given that we aren’t getting it right all the time anyway. For examples of failure see any law firm billboard in a metropolitan area.
2. The FDA got this right. The EU approved this drug and it was on the market (Tredaptive). The FDA did not. I’m not saying the FDA system is perfect, or even good, but it got this one right. I will be the first to criticize their slow pace on getting some items to market, but I should also give them credit for nailing this one. Good job, FDA. Don’t let it go to your head.
3. The system for post-approval research is abysmal. Niacin is not new. It’s a vitamin for goodness sake. We’ve used it for decades under various names. How did we discover that it might not be effective? Merck came up with a clever way to market an old product by adding something to reduce the side effects. Only because this combination required new drug approval and marketing did we conduct this study and find these results. Had Merck not been trying to skim easy money by repackaging an old drug, we probably wouldn’t have found this result. Good job Merck. Don’t let it go to your head… and sorry about the stock drop.
4. It’s possible that Niacin is still useful. WHAT!?! I just told you the study was discontinued early due to side effect, and you already know it didn’t prove to help people in the study. Remember, this was a 4 year study. It was supposed to run a lot longer to be able to detect a difference. They stopped it because of the adverse effects. If the researchers let the study continue, it could have shown that Niacin actually prevented bad outcomes. Did they do the right thing by stopping the study? I say yes, the harm outweighed the good at the time they stopped it, but the point stands. The results don’t mean Niacin wouldn’t have eventually been proven helpful.
Now over the next few days and weeks, experts will talk a lot about outcomes. “Why are we measuring HDL?” and “Does HDL actually affect death rates?” In my opinion, we’re missing the point. Forget about how to dissect these results. Look at the glaring systemic issues above, and think about how we can reboot what is done in medicine. Getting these kinds of results is important. How do we get them more quickly, and more consistently, into the hands of people educated to make decisions based on the information?