Dietary supplement sabotaged by halt of major study
The new niacin flush
Why shut down a major heart disease trial?
Obviously you would assume it’s because patients are in danger.
But what if patients aren’t in danger? What if the trial involves a vitamin supplement that’s successfully raising HDL (good) cholesterol and lowering triglycerides? Why would a trial like that be shut down a full year-and-a-half early?
I don’t want to wear a tin foil hat and throw around the word “conspiracy” (tin foil isn’t a good color on me anyway), but something isn’t right…
Getting the bum’s rush
If you heard anything about this trial in the news, you probably heard that researchers were very disappointed that niacin proved to be useless in preventing cardiovascular events.
You get the feeling that they can’t shove niacin out the door fast enough.
Nothing to see here, folks! Niacin was just leaving!
But before writing niacin off as a complete failure, you should know exactly what researchers were expecting this B vitamin to accomplish.
The theory was that niacin could reduce the rate of heart attacks and other adverse events in a large group of subjects who nearly all had heart disease. Also, many of them had already suffered heart attacks, and some had high blood pressure, type 2 diabetes, and other heart-risk conditions.
That’s a tough crowd!
National Heart, Lung, and Blood Institute (NHLBI) researchers recruited more than 3,400 subjects. About half the subjects received a high-dose niacin product called Niaspan, and half received a placebo. In addition, ALL subjects were given the statin drug Zocor, and more than 500 were also given another cholesterol-lowering drug called Zetia.
With mainstreamers like NHLBI, there’s obviously no such thing as overkill when it comes to cholesterol drugs!
The idea was that the cholesterol drugs would drive everyone’s LDL to crazy-low levels. Then those in the Niaspan group would have the advantage of higher HDL and lower triglycerides. So as time went by, fewer cardio events were supposed to occur in the Niaspan group, while more events were expected to add up in the Zocor group.
More than two-and-a-half years into the study, rates of cardio events in both groups were about even. So even though the niacin DID raise HDL levels and lower triglycerides, instead of proceeding to the end of the study period to see what would happen, the study was stopped short.
As the New York Times puts it, there was “almost no chance” that continuing to take Niaspan would prove beneficial.
Ummm…define “beneficial.” Because if any drug in creation raised HDL and lowered triglycerides, they’d be giving out prescriptions like they were grocery store receipts.
I think “follow the money” explains this one.
You don’t need to be a mad conspiracy theorist (and I am NOT) to understand that none of the major drug companies that produce statins want to share the market with an inexpensive dietary supplement. No way. The LAST thing they want is for anyone to get the idea that niacin can offer the protection they need without risking the growing list of serious adverse side effects linked with statin use.
So is it possible that someone figured that stopping the trial right now, while they were “ahead,” and while it appeared that niacin had no direct effect on CV events, would be in their best interest? I mean…anything is possible.
If this WAS a scam, it worked beautifully. Zocor came out looking like an LDL-lowering life-saver. But Niaspan is portrayed as pointless, in spite of raising HDL and lowering triglycerides — two factors that are known to be beneficial for many people at risk of cardiovascular problems.
As the Times pointed out, the results of this study are bound to lower use of Niaspan.
Looks like someone’s mission was accomplished.
Sources:
“NIH stops clinical trial on combination cholesterol treatment” National Heart, Lung, and Blood Institute, Press release, 5/26/11, public.nhlbi.nih.gov
“Study Questions Treatment Used in Heart Disease” Gardiner Harris, New York Times, 5/26/11, nytimes.com
