Diabetes drug: Should we trust health regulators?

One of the most convenient innovations in recent years is the telephone banking system that allows you to manage your accounts without standing in a queue for hours.

That's sort of how the giant drug companies have interacted with the US Food and Drug Administration (FDA) for years. The companies funded expensive studies and then generally breezed on through the approval process.

But it seems that in the wake of the Vioxx scandal and other FDA embarrassments, safety is getting more scrutiny. Have the drug companies' lost their fast track?

Don't bet on it.

Drug may get approval in US despite serious side effects
'New Diabetes Drug May Triple Death Risk'

Ouch. That's a headline from WebMD Medical News, and needless to say, it's not the kind of advance buzz you hope to get if you're the manufacturer of a new drug.

The drug is called Pargluva (a joint effort from Bristol-Myers Squibb and Merck) and it's purported to control blood glucose by improving insulin effectiveness, lowering triglycerides and raising HDL cholesterol. All well and good until researchers from the Cleveland Clinic (CC) reviewed Pargluva studies submitted to the FDA as part of the drug's approval process. The Cleveland assessment: Pargluva is associated with an 'excess incidence' of heart attack, stroke and congestive heart failure.

The Journal of the American Medical Association (JAMA) rushed the CC review into the spotlight, posting it online five weeks ahead of scheduled publication. And then a JAMA editor delivered a second roundhouse punch with an editorial noting that subjects who received Pargluva were three times as likely to develop cancer as subjects taking placebo or another drug.

But the most shocking thing is

All of this happened several weeks after an FDA panel reviewed the same studies and voted 8-1 to recommend approval of the drug.

In late September - just two days before the JAMA article appeared - FDA officials told B-MS/Merck that Pargluva was 'approvable' (the FDA generally rubber stamps the recommendations of its panels). According to US paper the Washington Post, the agency noted that the safety issue required additional information, but there was no specific request for a new study to examine safety.

Our safety should come first not company profits
So it seems the FDA may not be applying stricter safety criteria after all. But I wouldn't necessarily count on the Cleveland Clinic to take a permanent role as a safety watchdog, sniffing through the studies of all drugs submitted to the FDA for approval. The Washington Post isn't clear on exactly why the CC team singled out this particular drug for such careful scrutiny. One of the CC researchers has lead high-profile studies that were sponsored by Pfizer, so I can't help but wonder if drug company rivalry provided at least part of the motivation for the investigation.

It will be interesting to see how much squirming goes on at the FDA as this drama plays out. Maybe FDA officials will ask for an additional safety trial. Or maybe they'll allow B-MS/Merck to start marketing Pargluva immediately, along with a black box warning to inform type 2 diabetics that this drug may be a life-saver...if it doesn't kill them.

But this isnt the first time the FDA has acted dubiously and I doubt it will be the last. In past e-alerts I have told you about fixed advisory panels, missing documents, and experts with financial ties to drug companies.

In a logical world where decisions weren't based on gigantic corporate profits, dangerous drugs would simply be put aside and safety would be paramount. But we don't live in that world. So one thing is certain: When this 'approvable' drug is finally stamped with an official OK (any bets that it won't be?), it will provide doctors with one more handy pill to perpetuate the mainstream habit of simply writing a prescription to address health problems, rather than aggressively investigating and treating the root causes of those problems.

Lets hope that drug regulators here in the UK dont try the same underhand tactics unfortunately I cant guarantee that. I will be on the lookout for similar future trials of this drug in the UK.