Would FDA officials protect drug sales before protecting consumers?

Government Bailout

Given the choice, would FDA officials actually choose to protect the sales of a drug rather than protect consumers?

I’ll tell you a story – you be the judge.

Not exactly what they had in mind…

We’ll start with some back-story details.

Last year, the New England Journal of Medicine published the ENHANCE STUDY – a two-year trial that compared the effects of Zocor (a statin) with Vytorin (a combination of Zocor and Zetia – a drug that blocks cholesterol absorption) in 720 subjects with high cholesterol.

Results: Zocor and Vytorin both reduced LDL cholesterol, but in spite of the length of the study, there was no “significant difference in changes in intima-media thickness” (that is, in the thickness of artery walls) in the Zocor group compared to the Vytorin group.

Okay – here’s where it starts to get interesting.

There was no significant difference in changes in intima-media thickness. But what exactly were those changes? You’ll have to dig deep into the study to come up with this surprising note: “There was a slight increase in the mean intima-media thickness over time in both groups.”

Yeah! Devastating! Both drugs lowered LDL, and with both drugs, on average, subjects’ arteries became NARROWER.

As I noted in a couple of 2008 e-Alerts, this research was deeply controversial for the medical mainstream because statins are supposed to prevent arteries from narrowing by (all together now!) lowering cholesterol.

So the FDA stepped in and said, Okay, everyone calm down now. We’ll take a closer look at the study and get back to you when we figure out what’s REALLY going on here.

Well…the FDA just got back to us. Care to guess what they had to say?

Down the tunnel

I’ve got to hand it to the FDA – their ENHANCE report doesn’t ignore the elephant in the room. The report comes right out and admits that with both Vytorin and Zocor, thickness of artery walls increased.

But the report goes on to put greater stress on the “good” news: LDL dropped by more than 50 percent in the Vytorin group and nearly 40 percent in the Zocor group.

And this is presented like: So there! Ha! Is this stuff fantastic or what? High five!

Then the report takes a surprising turn. Based on a previous study, researchers anticipated two things: 1) that LDL would be lowered, and 2) that Zocor would increase artery wall thickness. That’s right: A similar two-year study, released in 2001, actually showed that Zocor reduced cholesterol, but artery walls narrowed.

So…at what point do we start acknowledging that Zocor might be dangerous? You would think the 2001 study would be a red flag, but researchers went ahead with the second study and gave the drug to hundreds of subjects for two years, even though (according to the FDA report), narrowing of artery walls was EXPECTED!

Is this insane tunnel-vision focus on using statins to lower cholesterol so pervasive that they don’t see the danger in narrowed arteries?

The answer to that question appears to be yes.

And then the FDA report offers this absolutely predictable advice: “Based on current available data, patients should not stop taking Vytorin or other cholesterol lowering medications.”

Sure! Go right ahead! And while you’re having your heart attack, you’ll be comforted by the knowledge that your LDL cholesterol is impressively low. Enjoy!

“Follow-Up to the January 25, 2008 Early Communication about an Ongoing Data Review for Ezetimibe/Simvastatin (marketed as Vytorin, Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor), Food and Drug Administration, January 2009, fda.gov
“Simvastatin With or Without Ezetimibe in Familial Hypercholesterolemia” The New England Journal of Medicine, Published online ahead of print, 3/30/08, content.nejm.org
“Drug Has No Benefit in Trial, Makers Say” Alex Berenson, The New York Times, 1/14/08, nytimes.com