Who could ever again trust a drug maker that hid dangers from the FDA?

Fool us once…

Sound the alarm. Lock up your mothers, fathers, husbands, wives…anyone with a heart (an actual human one, that is.) Because Merck is laying the groundwork to introduce a new “miracle” cholesterol drug that’s expected to make billions.

And of course they’ve assured us that this drug’s first study shows it’s very safe. But I can’t help but think of Lucy telling Charlie Brown she won’t pull the football away.

Getting giddy

The new Merck drug is so new it doesn’t even have a brand name yet. So for now it goes by the generic name: anacetrapib.

As reported in NEJM, researchers gave anacetrapib or placebo to more than 1,600 patients at risk of heart disease. In the anacetrapib group, LDL scores plummeted to as low as 45, while HDL scores shot up–some higher than 100.

These are genuinely remarkable results. Unfortunately, mainstream researchers seem to be unaware (or CHOOSE to be unaware) that very low LDL can actually be harmful for some patients.

But “Low, Lower, Lowest” is their LDL mantra, so instead of restraint, there was jubilation.

“Doctors were stunned,” reports the Associated Press.

“We are the most excited we have been in decades,” gushed the lead researcher.

“We are trying not to be too giddy,” giggled a Merck executive.

Okay. Fine. I don’t know if he actually giggled, but that’s the general tone of the AP piece.

Now…let’s get real. Because when you look at this study, you see more red flags than when you were looking for gas in 1979.

First: Every single patient in the study was also taking a statin drug. If you have to take a statin for anacetrapib to be effective, then your treatment starts off in a dangerous hole.

Second: Anacetrapib is in the same class of drugs as Pfizer’s torcetrapib. And even though torcetrapib did a great job of raising HDL, Pfizer abandoned the drug’s development because of a high death rate in a clinical trial. (Just stop for one second to imagine how high a death rate would have to be for a drug company to abandon its trial.)

Third: The NEJM study does state that anacetrapib, “did not result in the adverse cardiovascular effects observed with torcetrapib.” Certainly a better start. But it was a six-month study for a drug that’s meant to be used indefinitely, like a statin. Anacetrapib is safe? Prove it — with a long-term study and real data.

Fourth: The study was sponsored by Merck. No surprise there. But several researchers were closely affiliated with Merck through employment, by benefiting from stock options, as Merck board members, etc.

Merck has already started work on a major anacetrapib study with a recruiting goal of 30,000 subjects. I wish those subjects luck. If history is any indication, there’s a good chance some might not make it out alive.

Sources:
“Safety of Anacetrapib in Patients with or at High Risk for Coronary Heart Disease” New England Journal of Medicine,  Published online ahead of print, 11/17/10, nejm.org
“Next big thing? Big cholesterol drop with new drug” Marilynn Marchione, Associated Press, 11/17/10, ap.org