MUZZLE ON THE WATCHDOG

Health Sciences Institute e-Alert 

January 13, 2003 

******************

Dear Reader, 

Imagine a Snake Oil salesman rolls into town and gives a pitch that claims his product will rejuvenate the weary with no side effects. But the local sheriff knows that Snake Oil makes only one in five folks feel slightly less sluggish, and usually causes swelling of the feet. The sheriff asks the town's attorney to draw up an order to require the salesman to stop making his misleading claims. In the meantime he allows the salesman to continue his sales pitch. 

A few days later, when the legal order is ready, the salesman is long gone, having sold his product to townspeople who know and trust that the sheriff always carefully reviews the claims of traveling salesmen. Meanwhile, throughout town, most people are still feeling weary and feet are beginning to swell. 

Obviously, this is flawed system. Nevertheless, in our world, the role of the sheriff is being played by the FDA. 

--------------------------------------------------------------
Something's burning 
--------------------------------------------------------------

Ever since the FDA lifted an advertising ban for pharmaceuticals in 1996, drug companies have been allowed to advertise directly to the public. One caveat is that the FDA reviews drug company advertisements to check for misleading claims and to verify the inclusion of required warnings. But the loophole, (and since we're dealing with drug companies, you knew there had to be one) is that ads are allowed to run while they are still under review. Not only does this make the review process somewhat pointless, but potentially dangerous for consumers, as well. 

Here's a perfect example. 

Protopic is an ointment that treats eczema. The television ad for Protopic claimed that it "Soothes eczema anywhere on your body." The FDA ordered Protopic maker Fujisawa Healthcare to pull the ad, citing studies that showed how 25% of Protopic users experience itching, and almost half develop a burning sensation. So Fujisawa stopped running the ad, but by then who knows how many eczema patients had started to feel the burn? 

--------------------------------------------------------------
Who needs muscles anyway? 
--------------------------------------------------------------

Here's another good one. 

A print ad for Lipitor stated that other cholesterol-lowering drugs cause "serious muscle damage." The implication, of course, was that Lipitor does not cause muscle damage. But in fact ALL statin drugs have the potential to cause muscle damage, including Lipitor. So during the weeks the FDA was busy preparing a legal review of its cease and desist letter 
(which it's required to do by the Department of Health and Human Services), Pfizer (the maker of Lipitor) was free to run the ad. Meanwhile, almost certainly, a number of statin drug users asked their doctors to switch their medication to Lipitor, believing they were avoiding muscle damage. 

--------------------------------------------------------------
Regulation 101 
--------------------------------------------------------------

Now, admittedly, this is a bit of a gray area for me. I certainly believe in less regulation, not more. But if we're going to have it and we're going to pay for it (I'm sure the FDA review isn't cheap), make it mean something. 

Just these couple of examples demonstrate how ineffective this regulatory process is. Nevertheless, many in the mainstream medical establishment continue to call for the regulation of supplement manufacturers, as if the FDA has a reliable track record of sorting out the genuine from the false and putting effective controls in place. 

In an e-Alert I sent you last week ("The P Word" 1/6/03), we saw the FDA in typical form, giving approval to prescribe Prozac to kids as young as seven, while admitting that the long term effects of Prozac on developing brains is unknown - as if to say, "Oh, don't worry about that. How bad could it be?" This is the sort of arbitrary protection you get from lumbering bureaucracies: half-baked, at best. 

Meanwhile, in another recent e-Alert ("Consumer Retort" 
1/8/03), I told you how herbal product manufacturers responded when the dangers of the botanical ephedra became known. They regulated themselves. Without any laws being passed, and without any FDA directives, strict guidelines for ephedra dosage and label warnings were drafted by three different herbal product associations, and adopted by the Consumer Health Products Association. 

--------------------------------------------------------------
Home made 
--------------------------------------------------------------

Whether you and I look to the FDA as a source of protection or not, a vast majority of Americans do. So they believe that when a pharmaceutical company makes a claim in an advertisement, that claim has been screened for accuracy. Based on that expectation, people are making personal health care decisions. Drug companies (fully aware of the weaknesses of this process) take advantage of the situation to spread misinformation about their products. In many cases, by the time an FDA order to pull an offending advertisement is received, the ads have already had their run and are no longer being aired or printed. By then consumers are already making choices based on misinformation. 

This situation underlines the need for all health care consumers to understand the holes in the process and to ask questions and do their own research about any drug or supplement before beginning or changing a regimen. As always, the most reliable regulation starts at home. 

To Your Good Health, 

Jenny Thompson Health Sciences Institute

Copyright Issues?