Fun with numbers at the Vioxx hearing

At least one Food and Drug Administration official revealed her deep-seated pro-industry bias today at the Senate hearing on Vioxx.

Sandra Kweder, the acting director of the Office of New Drugs in the Center for Drug Evaluation and Research, which is responsible for approving new drugs, dismissed concerns about the heart problems associated with the drug. They were "numbers on a spread sheet," she said.

She added that the safety concerns raised by internal reviewer David Graham had ignored the benefits of the drug -- the reduced gastrointestinal distress that occasionally results from taking too many aspirin or ibuprofen.

Here are the numbers on that spreadsheet that show the benefits and risks of Vioxx, taken straight from the clinical trials:

If 1,000 people take Vioxx every day for a year, about 6 will get gastrointestinal complications such as ulcers or severe gastric distress. That's a small but noticeable improvement over the 14 that might suffer those fates while taking ibuprofen, naproxen or other non-steroidal anti-inflammatory drugs (NSAIDs).

As you can see, the problem Vioxx was meant to solve is fairly minor (the FDA label states about 2-4 percent of patients on NSAIDs may suffer gastrointestinal side effects). None of the people in the clinical trial died from their ulcers. And while industry-funded studies have suggested 16,500 people die per year from NSAIDs, that estimate is wildly overstated. The latest statistics from the Center for Disease Control show that fewer than 5,000 people die each year from all stomach acid disorders and most of those deaths have nothing to do with taking pain pills.

If that's the benefit, what's the risk? The latest trial of Vioxx (to see if it reduced colon polyps) was halted because for every 1,000 people who took the drug for a year, there were 6.3 additional heart attacks compared to the group on a placebo.

So now let's do our risk-benefit analysis. For every million people put on this drug (and this was a multi-billion dollar blockbuster), the head of the FDA's drug approval unit thinks it is worth risking 6,300 heart attacks in order to prevent about 8,000 ulcers.

Which do you think will cost the health care system more -- the heart attacks or the ulcers? Which do you think will lead to an excess of deaths?

And what choice would most Americans make if they knew the real numbers? Would they continue plunking down $90 a month for Vioxx (plus the cost of the doctor visit) and risk that heart attack? Or would they choose going to the drug store where for $15 they can get a month's supply of ibuprofen, which works just as well for pain and runs the minor (and roughly comparable) risk of getting an ulcer?

Footnote: Two months ago, I had a brief email exchange with Dr. Eric Topol of the Cleveland Clinic after he published a hard-hitting editorial in the New England Journal of Medicine calling for Congressional hearings into the FDA's malfeasance in the Vioxx case. I ran these numbers past him. He wrote back: "Your math is pretty close to what we've got."

Posted by gooznews at November 18, 2004 09:00 PM