Understanding the Children's Medicine Recall

When I read that the FDA is recalling 40+ children's medicines manufactured by McNeil Consumer Healthcare, including some lots (batches) of children's Tylenol, Motrin, Zyrtec, and Benadryl, I had one of those "oh, crap!" parenting moments. What parents of young children don't have a bottle of one of these products kicking around the medicine cabinet?

In a news release on May 1, the FDA described the reasons for the voluntary recall. To quote from the release:

McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. As a precautionary measure, parents and caregivers should not administer these products to their children. Some of the products included in the recall may contain a higher concentration of active ingredient than specified; others contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles.

Let me parse this vaguely-worded statement: during a plant inspection, McNeil and/or the FDA found that some of the products have too much medicine in them. Some of the products have contaminated or ineffective ingredients. And some of the products contain tiny particles - of what? Plastic? Metal?

I found the bottle of children's Benadryl that we bought recently and checked the NDC number (printed above the name) in McNeil's online database of recalled products. Fortunately, the lot of the Benadryl we bought was not on the recall list.

I'm relieved, but the larger question remains: what happened? McNeil is owned by Johnson & Johnson, and an employee blog designed to improve customer relations briefly discussed the recalls. Some comments on the blog, however, blamed the problems on plant managers for not listening to safety concerns raised by workers, and others said that the timing of the recall announcement was designed to minimize the problem.

It turns out that this is the second recall this year of medicines manufactured by McNeil.

In January, McNeil recalled hundreds of lots of over-the-counter products, including Children's Motrin, Children's Tylenol, Benadryl, and Extra-Strength Tylenol, in response to consumer complaints that the products had a "moldy, musty, or mildew-like odor" and the products gave some people gastrointestinal problems. Company investigations found that these products were contaminated with a chemical used to treat wood pallets used in manufacturing facilities.


McNeil dragged its feet for over a year on recalling the moldy medicine. As Natasha Singer explains in an excellent analysis of the January recall, written on January 18 for The New York Times:

According to a federal inspection report, the response was anything but swift. The recall came 20 months after McNeil first began receiving consumer complaints about moldy-smelling bottles of Tylenol Arthritis Relief caplets, according to a warning letter sent by the Food and Drug Administration to the company on Friday.

Safety first? I don't think so. It sounds like some people at McNeil were either not doing their jobs, or not putting the consumer first. People still need medicines such as Tylenol and Benadryl, and Singer points out that they will abandon brand names for generics if they don't trust the brand. So if McNeil/Johnson & Johnson can't (quickly) fix their manufacturing problems, it will harm the company as well as consumers.

Maybe McNeil should take a lesson from parents: do your best, and try to keep the kids safe.

Texting to Save Infants

The United States ranks 30th worldwide in infant mortality rates, and one out of every eight U.S. babies is born prematurely (an expensive medical condition, as I explained in a 2008 blog post). Medical and lifestyle factors that contribute to preterm birth include inadequate prenatal care, smoking and drinking, domestic violence, stress, diabetes, high blood pressure, and being under- or overweight, according to the March of Dimes. To address the problems of both infant mortality and preterm births, the text4baby campaign was created and launched in February 2010 to improve the health of expectant mothers and their infants. 

"Hispanics and African Americans are about 2.5 times as likely as whites to put off prenatal care until the third trimester or to get no prenatal care at all," explains TIME Magazine writer Bonnie Rochman on the text4baby website. "But they are likely to be avid texters." Since 91% of Americans own cellphones, according to the wireless association CTIA, text messaging is an effective way to reach these women.

To register for this free program, participants simply text "Baby" or "Bebe" (for the Spanish version) to 511411. Once registered, they receive three text messages a week, covering relevant health topics such as prenatal care, vaccines, breastfeeding, mental health, and car seat safety.

Text4baby is an unusual public/private partnership, whose motley crew of partners include (but are not limited to) the mobile technology firm Voxiva, the health insurance company WellPoint, the U.S. Department of Health and Human Services (whose secretary, Kathleen Sebelius, just criticized WellPoint for canceling the policies of women with breast cancer), and MTV Networks (producers of the disturbing reality show 16 and Pregnant).


Voxiva is a veteran at text-messaging health campaigns, primarily in international settings. The Washington Post's Mike Musgrove explains that:

Voxiva has launched about 150 health-related text-message services around the world, mainly in developing countries where access to doctors is scarce. Such projects, typically underwritten by governments or pharmaceutical firms, have often been used as a tool to disseminate news about treating diseases such as diabetes or AIDS.

So will the text4baby program really improve maternal and infant health among the participants? It's too soon to know, but I'm curious to find out. If it does, other health-related text messaging campaigns will surely follow, as the federal government focuses on prevention and wellness to offset the cost of health care reform.

Three Cheers for Bacteria

After I read that the FDA is investigating the safety of the antibacterial agent triclosan, a chemical widely used in toothpastes, cosmetics, soaps, and plastics, we did a quick audit of some of these products in our house. Triclosan might affect hormone function and contribute to antibiotic resistance in bacteria.

Unfortunately, we have plenty of triclosan at home. Sitting on the bathroom sink, a tube of Colgate Total (Active ingredient: 0.30 % triclosan); in the broom closet, a container of Target's antibacterial hand soap (Active ingredient: triclosan 0.115%). I'll be phasing those out of our household post haste, and looking for triclosan-free alternatives. I'm glad to make the switch, because bacteria are my favorite microorganisms.

Over the past year, "bad" bacteria have caused plenty of havoc in my family, from sinus infections to scarlet fever (which happened, most ironically, just after we had watched a movie version of The Velveteen Rabbit, in which scarlet fever strikes the main character). It is true that problems such as bacterial meningitis and  MRSA infections have hurt or killed far too many people, and I will happily sing the praises of both antibiotics (used judiciously and correctly) and vaccines (such as the tetanus, pertussis, and Hib vaccines) to prevent dangerous bacterial infections.

But bacteria have an important role in biology, and I have no desire to wipe out more bacteria than medically necessary. Prokaryotic bacteria have been around for billions (billions!) of years, one of the oldest and simplest microorganisms - just one cell big, with no nucleus. Bacteria in our digestive tract help us digest our food and make a vitamin that helps our blood clot. Bacteria in the reproductive tract destroy fungi that can cause infections. And many antibiotics, of course, are made from bacteria.

Outside our bodies, bacteria keep soil healthy and break down dead plants. We use bacteria to make yogurt and cheese and to process sewage. Bacteria are wily and adaptable, and can even survive in the Antarctic's Lake Vostok.

Although bacterial problems such as salmonella outbreaks in the food supply make the news more often, far more types of bacteria are helpful than harmful to humans. Why do these fascinating organisms get such a bad rap (hey, go pick on viruses!)? Our obsession with eliminating the bacteria around us creates its own problems, such as questionable ingredients in household products and antibiotic resistance. I think it's time to show bacteria a little more respect - maybe a Bacteria Appreciation Week?

Travel Trumps Food

During a recent family trip to soggy Massachusetts I realized how hard it is to eat well when you travel with kids. Unless you trust fruit of questionable provenance, there is only one healthy food that is widely available for U.S. travelers: yogurt parfaits. You can find them at airports, Starbucks, Au Bon Pains. But I just can't eat them for seven days in a row.

My kids, on the other hand, won't eat them at all. Who can blame them, when yogurt parfaits are displayed next to glistening frosted scones, cheese danishes, blueberry muffins and red velvet cupcakes? Vacation, for them, was not just a change of scene but also a break from our standard healthy-snack repertoire at home of fruit, yogurt, cereal, cheese, and crackers.
 
I had brought the excellent Frommer's guide to Boston on the trip with restaurants bookmarked, and we did make it to one restaurant on my list, the tasty waterfront seafood shack The Barking Crab. But by most mealtimes, the kids were starting to tire of all the walking that our tour of colonial New England entailed, and I was happy to stop at the nearest reasonable-looking place that might have a kids' menu and a clean bathroom.

At one point, after I had tossed my guidebooks and printouts aside, I said "that restaurant must be good - it has a huge sign." Admittedly, we had been on the Mass Pike for an hour in the rain, and my younger daughter had just gotten carsick in my hat, which I had tossed to her in the nick of time. I wasn't feeling too picky, as long as we got off the turnpike.

In fact, the restaurant with the huge sign was pretty good. I put aside my foodie inclinations and spent the week eating clam chowder, fried fish, turkey burgers, and pizza as we retraced Paul Revere's ride from Boston to Concord, viewed the flooded Old North Bridge where the revolutionary war began, and (my favorite moment) watched the gray and stormy Atlantic from the windows of Salem's House of Seven Gables just after a fierce storm had blown through.

We weren't there to eat gourmet food, nor to play the role of the food police. And living healthy (like raising kids) isn't just about getting everyone to eat their vegetables. When we saw our city kids freak out with joy because they got to chase a herd of sheep across a muddy New England village green, it didn't really matter to me that, as a vacation treat, they had eaten Fruit Loops and donuts for breakfast.

219 Democrats

With gangs of protesters roaming Washington, D.C. this weekend, and Republican congressmen egging them on by holding up "Kill the Bill" signs from the Senate balcony (see slideshow), with spitting and name-calling, with emotions and political influence tangled up together on both sides of the abortion debate, the Senate's health-care bill narrowly passed in the House of Representatives on Sunday with 219 votes (all Democrats).

On Tuesday, President Obama is expected to sign the bill, as the men and women of Congress continue to hash out the details of reconciling the Senate and House versions. It seems that health care reform is all over but the shouting, and there's been plenty of that already.

I've been in favor of health care reform for a long time, primarily because I believe that it would keep Americans healthier and protect them financial ruin if they do become seriously ill. Thirty-two million uninsured Americans will be covered by this new bill, easing the considerable logistical and financial strain that the uninsured place on our emergency rooms and hospitals when they don't have access to regular medical care that can keep them out of the ER and hospital in the first place.

The bill will also make health insurers take more responsibility for the people who pay their premiums. Health care insurers will now be required to invest in preventing disease (and ultimately saving money on health care costs) by covering annual check-ups and and childhood immunizations. Reform will create larger pools of payees, including healthy young adults, to offset the costs of treating the patients who have expensive (often chronic) illnesses, and eliminate the lifetime cap on how much health care an insurer will provide to a patient. (Note to uninsured twenty-somethings who will now need to purchase health insurance: some day you, too, will have an expensive and/or chronic medical problem, for which you deserve - and no doubt will demand - quality care.)

Recent headlines such as "Eight healthcare lobbyists for every member of Congress" (Fierce Healthcare) and "Big Jump in Blue Cross Premiums Sparks Outrage" (San Francisco Chronicle) have made it clear that health care consumers have had little influence, and their needs have not been met, under the current insurance system. It was time for some legislation.

The Washington Post has an interesting chart showing how the House members voted, how much funding they get from the health care industry, and the percentage of uninsured people in their districts. Wondering how reform will affect you? The Post's interactive graph explains the costs and benefits of the bill, based on your income, marital status, and the size of your family.

Going Green

In honor of Saint Patrick's Day (but not before suggesting that you read some glorious Irish poetry by William Butler Yeats instead of drinking green beer this year), I want to write about the other way that people take pride in all things green: the huge popularity of the "green living" movement in the United States. 

I'm all in favor of reducing pollution and environmental toxins by supporting local farmers and organic foods, using nontoxic household cleaners, and eliminating the use of plastic shopping bags in stores (as San Francisco legislated a while ago). Organic cotton baby clothes? Sustainable bamboo flooring? Bring it on!

I have my favorite green sites, like the lovely, soothing Low Impact Living. But I don't think this trend goes very deep for most people, and sometimes it rings false to me as well.

Consuming less, not buying more, can truly help the environment by, among other things, decreasing the (fossil fuel) energy demands of producing and shipping products, and decreasing the amount of things that end up in a landfill (if you feel guilty about tossing old things out, check out Freecycle). Much harder than buying is getting rid of things, and making space (literal and figurative) for what really matters in life: health, family, friendships, adventures.

The green movement is both an ideology and a marketing tool for new products (if it's "green," it sells).  To a degree, buying green can help you live a healthier life as well. But it's important that consumers don't bury their sense of public responsibility under a mound of green products. Because no matter how many bottles of Method nontoxic cleaners I might buy, my choices won't outweigh the public health benefits of one new worker safety rule by OSHA, or an increase in the number of food inspectors employed in a state.