Proposed FDA Action To Cut Doses of Tylenol Shows Need for Disclosure in Ads of Active Ingredients

Advertising for over-the-counter medicines should disclose the active ingredients in them.

That should be the take-home message today in response to the news that an FDA advisory panel has recommended that Tylenol be sold in doses of no more than 325 milligrams, and that Percocet and Vicodin be banned altogether.

The sad fact is that the need for disclosure has been apparent for years. Ten years ago, The Women's Consumer Foundation conducted a face-to-face survey of 181 inner-city women that found a dangerous lack of understanding of the most basic information about over-the-counter (OTC) drugs. Many of the women--almost half--were taking medicines like Tylenol without knowing what was in them, and many were taking more than the recommended doses without realizing the danger.

Fewer than half the women knew that acetaminophen is the active ingredient in Tylenol (they were given four possible answers from which to choose) despite the fact that Tylenol was the drug that the women said they bought most often.

And, most dangerous of all, 44 percent of the women said they knew people who very often, or somewhat often, took more than the recommended dosages; 25 percent admitted to doing so themselves.

At the time we first published these findings on our not-for-profit website, SIS (now defunct, as is the Women's Consumer Foundation), the drug manufacturers claimed that our findings were wrong, that people do read and understand labels and don't take more than the recommended doses.

This latest recommendation by the FDA panel puts the lie to those assertions because it was based on statistics showing that 400 people die every year, and 42,000 are hospitalized in the U.S. because they overdosed themselves. Percocet and Vicodin contain a narcotic and acetaminophen, which is a leading cause of liver damage.

The panel members agreed that consumers need to be better educated about OTC medicines, and I concur.

The simplest way to do that is via the ads for these drugs. The FDA should require that all advertising for OTC drugs disclose the generic names of their active ingredients.

This remedy was actually proposed by a Federal Trade Commission administrative law judge more than 20 years ago. Sadly, the commission decided not to follow the recommendation.

So in all the years since, consumers have been bombarded with billions of dollars of OTC drug ads that mis-educate them, that lead them to believe that Tylenol contains some unique ingredient. Ditto for Nyquil, TheraFlu, Alka-Seltzer, etc. In reality, these expensive brand name products contain inexpensive ingredients that can be bought generically for far less--often 50 percent less.

So hundreds of people are dying, thousands are ending up in hospitals and millions are wasting their money because of advertising that misinforms and fails to provide the most necessary, basic information: the active ingredients in the medications.

Antioxident Vitamins C & E Can Have Negative Effects

Put the word "antioxident" on a packaged food, and folks are a lot more likely to buy it, say market researchers. And, since food companies' goal is to entice you to buy their products, they've been busy taking advantage of that reaction.

The problem is, there's little proof that added antioxidents help us stay healthy; instead some new evidence suggests they actually interfere with some of the benefits of exercising and losing weight.

Nutritionist Marion Nestle, who monitors the sins of the food industry from her perch at New York University, says hundreds of products now tout the presence of antioxidents, but that we're being fooled. In her blog, she says there's a "lack of evidence" of the benefits of artificially adding antioxidents to your diet in the form, for example, of vitamins C & E.

(In case you've been living in a bubble, antioxidents appear to play a powerful role in fending off cancer and diabetes and fighting the effects of aging.)

Today came the news that if you're on a weight reduction program and/or exercise regularly, taking vitamin C & E for their antioxident effects may, in fact, work against your health.

The study, reported in The New York Times, found that our bodies' natural reaction to exercise and weight loss is not only to mobilize our built-in natural antioxident defenses from free oxygen, but also to make us more sensitive to insulin. When the two vitamins were added to the diets of study subjects who were exercising and losing weight, the study showed they short-circuited our natural responses.

There's no debate that unprocessed foods in their natural state--like berries, broccoli, garlic, tomatoes and spinach--contain potent antioxidents in combination with many other nutrients. This combination isn't replicated by supplements. Also, while our bodies have evolved to handle the amounts of antioxidents present in fruit and vegetables, ingesting large amounts via supplements changes our bodies' reaction.

The bottom line is the same old boring one: spend your money on eating more fruit and vegetables instead of buying expensive packaged products with added antioxidents of dubious value.

$18 for a Bag Full of Prescription Meds--in Italy

We visited an old friend of ours last year who has retired to Venice, Italy. Richard had a heart attack not long after he moved there, and had to be taken by boat-ambulance to the hospital in this magical city of canals.

He was most pleased by the care he received, and recovered very well. So well, in fact, that we had a hard time keeping up with him as he trotted us through the maze of alleys and up and over all the bridges as he showed us the city's fabulous sites. Then 79, Richard has just turned 80. 

One morning he told us we were on our own because he had to see his doctor to get renewals of his prescriptions. A few hours later, when we were all back at his apartment, he showed us a plastic bag full of his medications. Laughing gleefully, he asked us how much we thought he had paid for them.

Not knowing how he paid for health care in his adopted country, I guessed $1,000.

Oh no, he said. $18.

$18! Which prompted me to ask what he had paid for his stay in the hospital, all his follow-up care, and his regular visits to the doctor since then? A big fat zero. Zilch. 

To our amazement, as a permanent non-citizen resident who does not work, Richard pays only a few hundred dollars a year to be covered by Italy's system of universal health care. Wow.

I told this story the other night to a couple of acquaintances, and they both immediately raised the stereotypical objections to the U.S. switching to a similar system: So why do the Canadians all come here to the U.S. for surgery? Those systems make people wait for care. etc. etc. The government can't be trusted to run anything, and so on.

Now that Obama has appointed Tom Daschle to be his new Secretary of Health & Human Services, it's urgent that we re-open this discussion of how best to reform our unconscionably expensive and income-based health care system. Solving the inequities of our system and lowering its cost is fundamental to solving many of the persistent social problems we face as well as making our businesses more competitive.

While some doctors continue to see their self-interest in continuing our present system, the 60,000 members of Physicians for a National Health Program disagree. In a section on their website , they point out, for example, that "the government" wouldn't be running a single-payer system--doctors and patients would be.

As far as people having to wait for operations--a form of health care rationing--they point out that rationing of health care also occurs in the U.S. It's just done differently here. Instead of being based on the urgency of a person's need as in Canada and elsewhere, here we base it on ability to pay. Here, an estimated 18,000 Americans die every year because they can't afford care. 

Besides providing coverage for everyone regardless of means, moving to a universal, single-payer health care system, would eliminate a big source of corruption in our society. The Boston Globe recently reported that AARP earned nearly $500 billionin  2007 alone by selling seniors 17 varieties of insurance policies, including Medicare supplemental insurance for drugs. Despite the opposition of consumer organizations, AARP worked against the interest of its own members in 2003 by backing a form of coverage of prescription drug costs that raised costs for seniors with low income. For all seniors, the new plan also increased the complexity of Medicare, which is now so complicated that even a careful reading of explanatory booklets leaves you scratching your head. 

But the change was good for AARP: After its passage, AARP expanded its contract with the United Health Group to sell the new policies which, according to the Boston Globe article, are not the lowest cost choice available despite advertising to the contrary. 

Health care system lobbyists, of course, are one of the largest special interest groups that have a big hold members of Congress--from both parties--thanks to campaign contributions and other perks they offer.

It's time to put this whole bunch out of business.

Of course, a lot of Americans currently have jobs in the huge bureaucracy that wastes so much of our health care dollars. Moving to a single payer system can't be accomplished over night. 

But as the Obama Administration addresses this problem, it should be working to implement changes that in increments, over time, move us to a universal, single-payer system. Daschle understands the advantages of a single-payer system but, apparently, believes it is too radical an idea to promote since it's been smeared by opponents as socialized medicine..

But if not now, when change is in the air, when?  I fear we'll have to wait a very long time for another opportunity to move toward a universal system.