FDA Considers Asking for Your Help

Hearings are taking place today at the FDA about whether or not consumers should be alerted more heavily to side effects of prescription drugs in TV ads, and whether disclaimers should include information to help consumers report problems with those drugs, too.

I say -- YES TO BOTH!

I first explained the basis for this regulation last February when I told you about my friend and colleague Kim Witczak, whose husband died as a result of side effects that were known, but hidden from doctors and patients. Kim proposed this TV ad disclosure idea to the FDA, Consumer's Union helped her run with the ball, and today Kim is testifying in Washington to support this regulation.

So, why is it important?

You've seen the news -- in recent years, the FDA just can't get its act together, and we patients are the ones paying the price, sometimes the ultimate price -- death. A good example is the case of Vioxx, where Merck submitted Vioxx for approval, but withheld statistics from clinical trials that showed people died from taking Vioxx.

How could they do that? Because the FDA doesn't require disclosure of results of all clinical trials and their results. A dozen or more approved drugs have been pulled from the market in recent years because the FDA approved them too quickly.

So -- if the FDA isn't going to do it's job, the least it can do is make it easier for us patients to do their job for them.

Consumer's Union estimates we spend 100 minutes of TV drug ads for every minute we spend in the doctor's office. The idea, then, is to make sure those ads carry much more prominent warnings about side effects and contraindications. AND, easy access to ways to report problems. Each ad should be required to carry both a toll-free 800 number, and a web address where problems can be reported by those who are taking the drugs -- us patients.

I'm curious to see what the outcome will be of today's hearings. I have every confidence that Kim will make a good case. She's backed up by heavy-hitters.

We'll see whether those FDA officials who make these decisions have the backbone to stand up to big pharma, which is lobbying heavily against this requirement. I hope those decision-makers remember that we taxpayers pay them almost as much money as big pharma does. And when they fall down on the job, it's we patients, their benefactors, who are losing our lives.
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