Are these "harmful drugs" safe enough to sell?

Hasty Pudding

I’m going to ask you to imagine something so far fetched that you’ll think I’ve lost my marbles.

Glucosamine is an effective natural therapy used to relieve arthritis pain. Now let’s imagine that a researcher at the FDA examined nearly one and a half million medical records and found that 27,000 heart attacks and sudden cardiac deaths could have been avoided if patients had not been using glucosamine.

Now let’s imagine that the FDA responded to this and other negative studies about glucosamine by convening an expert panel to review the evidence regarding glucosamine’s safety. Well it’s a slam dunk, right? All those THOUSANDS of heart attacks? Say goodbye to glucosamine!

But wait. Let’s imagine that the panel comes back with a recommendation that glucosamine can remain on the market, but products containing glucosamine should have a “black box” warning, and manufacturers of the pain killer should not be allowed to advertise their products unless the FDA wrote the ads.

I bet I lost you right at the end there. I admit, I pushed it way beyond the limits of credibility. Would the FDA allow the continued sale of a natural product that was known to cause thousands of heart attacks? Not on your life.

But if that product was a class of drugs that brought in billions of dollars of revenue every year – well! – then everything would be different!

Credibility? That’s a small price to pay to keep those billions rolling in.

Safe enough?

You probably recognize the details of that tall tale.

Last week the confusion over the use of Vioxx, Celebrex, Bextra and other pain-killing drugs got even more confusing when an FDA panel advised the agency to keep the drugs on the market. So the verdict is that the drugs are safe, right? Well, not exactly. They’re safe enough to sell, says the panel, but should carry a strict warning on the packaging.

Many arthritis patients find this class of drugs (COX-2 inhibitors) to be very effective. But there’s just that one nagging problem: Their use has been shown to sharply increase heart attack risk.

After the panel’s decision was announced last Friday, the chairman of the panel, Alastair Wood, M.D., told The New York Times: “It would be a brave man or woman who started a patient with a clear history of heart disease on these drugs.”

Brave? Maybe “brave” is FDA slang for “idiotic.”

Brave new world

Here’s my favorite part of the panel’s recommendations: The Times noted that most of the panelists were “adamant” that these drugs should not be advertised unless the FDA or an independent group writes the ads.

Amazing. You have to wonder if they really thought that one through. They’re actually suggesting that someone at the FDA should write advertising copy to promote the sale of a drug that’s been shown to significantly increase heart attack risk. That’s like asking a judge to make the closing argument for a defendant in a murder trial.

To say that this is sending a confusing message is to put it mildly. Earlier this week, a local television news anchor here in Baltimore described the panel’s decision this way: “First these drugs were good for you, then they were bad, and now it appears they’re okay.” I’m paraphrasing there, but the end of the sentence is an exact quote: “Now it appears they’re okay.”

If that’s the take from someone on TV who’s “reporting” to the public, then the message that’s trickling down to the average Joe must be something close to the nave idea that if it was really bad for you they wouldn’t sell it.

And no one understood that message better then the executives at Merck, the makers of Vioxx.

Last fall, Merck pulled Vioxx off the market voluntarily when a new study once again demonstrated that the heart attack risk associated with the drug was unacceptable. But now that the FDA panel has decreed that the risk for these drugs IS acceptable, the folks at Merck say that they may put Vioxx back on the market.

This is playground logic at its most basic: If THEY’RE getting away with it, why shouldn’t WE?

The FDA usually rubber stamps the results of advisory panels. In the upcoming days or weeks we’ll find out if the FDA really believes that a few thousand heart attacks here or there is an acceptable exchange for keeping the cash cows milking.


Note to women: You know you need calcium in your diet to protect your bones as you age. But if you’re thinking, “yes, I’ve heard it all before,” consider this: A study from Rutgers University shows that one specific group of women may be underestimating just how much calcium they need.

In yesterday’s e-Alert “Tissue? I Hardly Know You!” (2/23/05), I told you how a daily intake of 1,200 mg of calcium (from both diet and supplements) may significantly reduce the risk of colorectal cancer. And in other e-Alerts we’ve also looked at the ways that increased calcium intake can actually contribute to the success of a weight-loss diet. But the Rutgers study illustrates that an intake of calcium in excess of 1,200 mg provides more than an assist; for postmenopausal women who are trying to lose weight, it may be a necessity.

The Rutgers team examined calcium metabolism to estimate the amount of calcium that’s actually absorbed by postmenopausal women attempting to lose weight by combining an exercise program with a restricted calorie diet. In a trial of nearly 60 women, researchers found that women who exercised and reduced their calorie intake absorbed considerably less calcium than women who didn’t diet or exercise.

Women in the diet/exercise group who had a daily calcium intake of 1,200 mgs did not absorb enough calcium to support good bone health. For these women, 2,000 mg of calcium per day was required to prevent bone loss.

As I mentioned in yesterday’s e-Alert, simply upping the calcium supplement dosage may not be a good solution for everyone. Calcium binds acids, which may cause indigestion in some people, so be alert to potential digestive problems if you decide to increase your supplemental calcium.

To Your Good Health,

Jenny Thompson
Health Sciences Institute


“F.D.A. is Advised to Let Pain Pills Stay on Market” Gardiner Harris, The New York Times, 2/19/05,

“Vioxx May Return to Sale” Associated Press, 2/18/05,

“Weight Loss and Calcium Intake Influence Calcium Absorption in Overweight Postmenopausal Women” American Journal of Clinical Nutrition, Vol. 80, No. 1, July 2004,

“Dieting? Protect Your Bones With Extra Calcium” Kimberly Beauchamp, N.D., Healthnotes Newswire, 9/16/05,