It was a banner week for the Food and Drug Administration. The agency proposed to: scare users of diet drugs, ban the active ingredient in the most-effective laxative products and seize more regulatory power over food processors.
It was so much activity I was reminded of the song "Dazed and Confused" from Led Zeppelin's debut album. Here are some of the lyrics (slightly modified):
Scaring diet drug users
Last July, Mayo Clinic researchers claimed the popular diet drug combination known as "fen/phen" (fenfluramine and phentermine) may be associated with valvular heart disease. This claim was based of 24 cases of heart disease among fen/phen users.
But I thought fen/phen hysteria was somewhat premature given: the wide use of the drugs (18 million prescriptions were written for fenfluramine and phentermine in the U.S. in 1996); a mere 24 cases of heart disease were reported (only 5 of which were confirmed histopathologically); and all the study subjects were obese and already good candidates for heart disease.
This week the FDA announced plans to require that fen/phen carry warnings saying the drugs can cause serious heart disease. To back up this announcement, the FDA announced receiving reports of 58 more cases of heart valve damage. But none of these cases of heart valve damage were scientifically tied to fen/phen. In fact, they could have resulted from newly vigilant physicians hearing heart murmurs that have been there all along.
But as with the FDA's unfounded and short-lived moratorium on silicone breast implants: panic first, science later.
And the panic has been successful (from an FDA perspective). According to the drug market research company IMS America, since July, new prescriptions for fenfluramine fell 40 percent; for phentermine, the decline was 18 percent.
Laxative-ingredient ban
Good news for the food fiber industry. The constipated masses will soon not be able to rely on laxative products containing phenolphthalein--the active ingredient in the most effective laxatives (like Ex-Lax).
This week the FDA announced it will propose to ban phenolphthalein in laxatives because the compound poses "a potential cancer risk to people who use this ingredient at higher than recommended doses for extended periods of time." (Note: The FDA did not indicate who these people were or whether any such people actually exist).
The proposal is based on recent studies reporting rodents fed 30 to 100 times the recommended human dose of phenolphthalein for up to 24 months developed various kinds of tumors. But do these studies justify a ban?
Forget about the fact the rodents were fed phenolphthalein in amounts that humans don't use, particularly over short periods of time. Forget about the fact the rodents were bred to be prone to cancer. And forget about the fact that extrapolating cancer risk from rodent bioassays to humans is basically guesswork.
Laxatives containing phenolphthalein have been used by humans for over 100 years! The FDA says that 15 to 20 percent of Americans use laxatives at one time or another. Yet no incidence of cancer in humans has ever been linked to phenolphthalein use.
But if the FDA has its way, Americans will be denied access to the most effective over-the-counter treatment for constipation.
If this bothers you, tell the FDA what you think. How? You could send in written comments to the FDA. But chances are your written comments will be ignored. So I suggest something a little more difficult to ignore. Use a phenolphthalein-based laxative and mail your... (ahem)... comments in a shoebox to the FDA. And for those in the Washington, D.C. area: put your... (ahem)... comments in a paperbag; take them over to the FDA headquarters in Rockville, Maryland; set the paperbag on fire; ring the doorbell and run!
Food safety power grab
Taking advantage of the recent ground beef hysteria (during which 25 million pounds of beef produced by Hudson Foods, Inc. were recalled), the FDA proposed new legislation giving it the power to order product recalls and to punish food processors who violate federal food safety standards. All this supposedly in the name of "food safety." But it's not. It's really about power-hungry bureaucrats who never met a law or regulation they didn't "need."
If the FDA was really interested in protecting the public from foodborne pathogens, it would promote food irradiation and proper food handling procedures -- both of which are more effective than FDA totalitarianism.
So after being left dazed and confused by the FDA, it's only fitting to end with the lyrics (slightly modified) from another song (Communication Breakdown) on Led Zeppelin's debut album: