Dr. Harley Rotbart’s GERMBlog™

When a company markets a product as a “dietary supplement”, rather than as a drug, the FDA has little input into the production or quality of the product, nor does the FDA assess the safety or effectiveness of the supplement. This has allowed the deceitful marketing in health food stores and supermarkets of products with unfounded claims and unproven safety. On March 4, 2008, I detailed in this GERMBlog the story of a product called “Airborne”, a fizzy drink marketed to kids and adults as a “miracle cold buster”. As a result of a class action lawsuit (prompted by an investigation by ABC News), the company paid a lot of money to deceived customers and pulled all reference to “miracle”, “cold”, and “buster” from their packaging.  Yesterday, the company that manufacturers the zinc-containing  “Zicam” product line pulled a number of its products from the marketplace because of more than 130 complaints, compiled by the FDA, of long-term or permanent loss of the sense of smell. The manufacturers, while withdrawing the products, insisted they were safe.

Herbal products (dietary supplements) that purport to “boost” your immunity and “prevent” or “treat” infections like the common cold are plentiful. In researching my book, Germ Proof Your Kids - The Complete Guide to Protecting (without Overprotecting) Your Family from Infections (ASM Press, Washington, D.C., 2008), I went to the health food stores and found more than 2 dozen such products! I discuss each, along with the scientific data (or lack therof) to support their claims in Chapter 10 of Germ Proof.  Zinc products receive heavy scrutiny in Germ Proof Your Kids, and without wanting to say “I told you so”, I reported the complaints regarding loss of the sense of smell, as well as the even more concerning news (at least it’s news affecting many more than 130 users of Zicam) that zinc products have not been convincingly shown to work against the cold, especially in kids. Because FDA approval isn’t required for marketing dietary supplements, the studies showing effectiveness, if done at all, are often far less rigorous than studies for FDA-approved drugs.

To bring a dietary supplement to the shelves of your health food store, a company doesn’t have to prove the safety or effectiveness of the product, and doesn’t even have to prove that the product in the bottle is what’s shown on the label. The company doesn’t have to keep track of side effects. In lieu of all of that stringency that the FDA applies to registered drugs, the FDA only requires that dietary supplements bear a tepid disclaimer. When you see the words below, buyer beware - the product has not been rigorously proven to be safe or effective. Both “Airborne” and “Zicam” bore this disclaimer:

“This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease”.

New York has been hit hard by the current swine flu outbreak, and many schools in NY have been forced to close. A story in the New York Times today (As Schools Close Because of Flu, No Guidance on How to Rein It In, NYT 5/19/09) adds to the confusion regarding halting the spread of influenza. The article minimizes the potential importance of school disinfecting – the use of germ-killing solutions on inanimate surfaces.

Schools are well known as amplifiers of influenza and other community-wide infections, explaining why school closures are included in pandemic planning by the CDC and the WHO. While it is never absolutely clear in any particular outbreak what percentage of influenza cases in a school are spread directly person-to-person rather than by indirect contact with contaminated surfaces, both routes likely have a role. The ability of flu viruses, as well as other viral and bacterial contagions, to persist in infectious form on inanimate objects has been proven repeatedly. To state, as the article did, that “disinfecting closed schools is pointless” ignores the scientific reality that viruses persist on surfaces and that the greater the quantity of viruses, and the greater the number of contaminated surfaces, the greater the risk of acquiring an infection from an inanimate object.

Disinfecting reduces the surface viral “load”, and reduces the number of infected surfaces. Until evidence shows that spread of influenza from surfaces to people doesn’t occur, surfaces in highly trafficked sites in schools should be disinfected. This does not mean that schools must be closed to disinfect, nor does it mean that hand washing and alcohol hand sanitizers aren’t necessary. We should use all the weapons available to us when influenza enters our schools to prevent its further spread to those in the school building and those outside in the community; disinfecting is not “just for show”, as one of the experts says in the article.  

Remember Mad Cow Disease? That was the brain-rotting mystery disease that crossed over to humans from cows when humans ate parts of the cow’s brain or nervous system. The disease caused mass culling of infected bovine herds around the world, bans and boycotts of beef, and widespread panic throughout much of Europe. Some of the panic spread to the U.S.

Remember SARS (Severe Acute Respiratory Syndrome)? The respiratory infection that arose in Asia, with a few cases spreading to North America and Europe. The cover pictures on both Time and Newsweek magazines showed frightened women wearing masks, hoping to avoid certain death.

Each of these outbreaks were projected to infect millions and kill 100s of thousands. Each infected thousands and killed hundreds. Hundreds of deaths should not be minimized, but 100s of thousands of deaths, as occurred in the U.S. during the 1918 influenza pandemic, would have been unimaginable.

Where did Mad Cow Disease and SARS go? A combination of 2 factors made them disappear long before they reached their potential devastation: brisk responses by public health authorities; and, infections that were not nearly as severe as initially feared. That is, our response was effective and the germ was not.

Will today’s Swine Flu outbreak become the feared worldwide pandemic or will it go the way of Mad Cow Disease and SARS? Indications so far are for the latter path, and for the same reasons that made the other 2 infections disappear: effective public health response and a wimpier than expected germ. There’s a cautionary note here - this current outbreak, if it indeed fades away relatively harmlessly, can be seen as a call to readiness for the next, possibly more severe outbreak. Or, people may choose to say “they’re just crying ‘wolf’ again, next time we’ll be smarter and not react so quickly.”

I hope that all of you, and certainly my colleagues at the CDC and WHO, see this as a cautionary note and a reason to redouble our efforts to be ready for the next one. It would be a mistake to say that because we got lucky with this epidemic, we don’t have to react as briskly and as effectively the next time. On the other hand, the culling of millions of pigs, as is being done in some countries, and the statements by some elected officials (you know who they are) urging avoidance of planes and subways, are uninformed overreactions.

The past 2 weeks have been frightening ones for all of us who respect the power of influenza. As three previous pandemics (worldwide spread of an epidemic) have taught us, influenza (”flu”) is devious and potentially deadly. The strains of flu virus that have caused pandemics represent major shifts from the makeup of typical, or seasonal, flu - that’s the devious part. For extensive discussions about influenza, past pandemics, and the infamous 1976 swine flu scare, see Chapters 2,3,6, and 7 of Germ Proof Your Kids - The Complete Guide to Protecting (without Overprotecting) Your Family from Infections (ASM Press, Washington, D.C., 2008).

By way of brief review of the past weeks’ flu findings:

The outbreak appears to have begun, and remains centered in Mexico. Nearly a dozen countries have now reported proven or suspected cases of swine flu, including New Zealand, Canada, and several European nations. The U.S. now has approximately 50 proven cases, most of whom (as is true in other countries as well), recently visited Mexico or had close contact with someone who did. The swine flu strain causing this outbreak is susceptible to both of our best flu-fighting medicines, tamiflu and relenza. In Mexico, there have now been more than 100 fatalities among the estimated 2,000 cases identified so far; that is a death rate of 5%, but it is still too early to know if that rate will increase or decrease as more cases are identified. No cases outside of Mexico have died yet, but the numbers may be too small to take comfort - among the 50 cases in the U.S. so far, a 5% death rate would mean 2 or 3 deaths, and it’s possible that we just haven’t seen enough cases to begin seeing fatalities.  Today, the U.S. has taken steps to begin restricting travel to Mexico, something that the European Union did yesterday (when they also recommended against travel to the U.S. where the second largest number of cases worldwide have occurred).

Prevention

If there’s any good news in all of this, the swine flu strain of influenza spreads by exactly the same routes (respiratory droplet and direct contact) as the familiar seasonal flu - by direct contact and respiratory droplet (see Chapter 2 in Germ Proof Your Kids - The Complete Guide to Protecting (without Overprotecting) Your Family from Infections. As a result, strategies for prevention are also exactly the same as for seasonal flu. Here are the most important 5 swine flu prevention strategies:

1. Careful handwashing - vigorous scrubbing with soap and water for at least 20 seconds, fingertips to wrists; alcohol hand sanitizers are effective when soap and water are not available.

2. Timely handwashing - after contact with anyone sick; after contact with large groups of people (e.g. the “high five” line at the end of the soccer game or the receiving line at a wedding); after being in places where sick people might have concentrated (e.g. the doctor’s office!); after contact with lots of surfaces in public places (e.g. supermarkets); before eating and before bedtime.

3. Cough and sneeze etiquette - cough and sneeze into your elbow, and teach your kids to do the same. This is a very considerate gesture to protect others from catching the germs from your hands or sprayed into the air.

4. Surface disinfection - the surfaces in your homes, your workplace, and your kids’ school (or day care) should regularly be disinfected - cleaning is not enough. The best disinfectants contain bleach, which has not only bacteria-killing power, but also virus-killing power (flu, of course, is a virus).

5. Boost your immunity, and your kids’ immunity - the following scientifically proven methods (well known to moms and grandmothers for generations) will make you less likely to develop severe infections, including swine flu: regular, moderate exercise; bundle up in the cold weather; get adequate sleep (8 hours each night); and eat a healthy, vitamin C-rich diet. If you don’t believe these “old wives tales” about infection prevention, read the real science behind these recommendations in Chapter 11 of Germ Proof Your Kids - The Complete Guide to Protecting (without Overprotecting) Your Family from Infections.

As this strain of swine flu spreads, it is likely that there will be additional restrictions on travel as well as possible emergency use of medicines like Tamiflu and Relenza. A vaccine is less likely in the near term because of the time lag in developing an effective vaccine, and the painful memories of the vaccine complications associated with the last swine flu vaccine given during the scare of 1976 (Chapter 3, Germ Proof Your Kids - The Complete Guide to Protecting (without Overprotecting) Your Family from Infections.)

Another public health measure that may well become necessary is school closures. Influenza pandemics of the past were greatly amplified by the spread of infections in schools. It is not surprising that schools in Mexico City, from day care through university, have been closed in an effort to contain the epidemic in that country. Twenty-eight of the U.S. cases so far have occurred in a single NY school - if other school outbreaks occur in this country, closures are high on the list of recommended interventions.

Should you avoid large crowds of people or public events? Not yet in this country, although those measures are being recommended in Mexico City. If the numbers increase here and elsewhere, we may anticipate similar restrictions. Ditto air travel - other than to Mexico, it isn’t yet time to restrict airplane travel, but we may get there is the epidemic accelerates.

Stay tuned to Dr. Rotbart’sGERMBlog for timely updates as we learn more about this latest challenge to your health.

As I speak around the country about Germ Proofing kids and families, one of the most frequent questions I get involves how parents should pick a day care center for their kids. Day care centers are infamous amplifiers of infections - there are few germs of any genre that are not readily shared by kids in day care. Because many day care kids are not yet potty-trained, fecally-spread infections are among the most common. For much more on the types of school, day care, and community infections, as well as strategies to prevent and treat them, see: Germ Proof Your Kids - The Complete Guide to Protecting (without Overprotecting) Your Family from Infections (ASM Press, Washington, D.C., 2008).

Here is my list of Top Ten Questions to ask, and Top Ten Answers to hope you receive when screening day care centers for your kids:

1. What are the policies regarding excluding kids and staff members for illness?

There are long lists of inclusion and exclusion criteria published by the American Academy of Pediatrics, the CDC, and many state and county health departments to minimize the risk of spreading day care germs. The important answer that you want to get to this question is that the center has a policy, that it is written, and that you can review it (and perhaps take it to your child’s doctor to also review)

 2. When can kids come back after being home sick?

Return policies should be part of the inclusion/exclusion criteria of the center

 3. Is there a separate room for kids who have colds, other mild infections?

Often kids arrive at the center in the morning and are only noticed to be sick later that day (sometimes desperate parents conceal the illness – I know, hard to believe…). Ideally, a center should have a separate room or area for kids with minor infections to protect the other kids in the center. Some centers advertise this feature, allowing parents to bring their sick kids to the center without having to hide the sniffles or diarrhea.

 4. Do kids need to have up to date immunizations to attend?

Kids should not be permitted in the center if they do not have their age-appropriate immunizations. Only about half the states in the U.S. require immunizations for day care entry, but you should try to find a center in your state that requires vaccines even if the state itself does not.

 5. Do kids need a physical by a doctor before enrolling?

As with summer camp, some day care centers require a doctor’s exam and approval prior to day care enrollment. This feature of a center attests to its fastidiousness and carefulness in protecting kids – but it is not a common trait among centers.

 6.       Are health records kept by the center?

Centers should ideally keep a log of infections, at least the “major” ones like chickenpox, measles, meningitis, and hepatitis in the event that they need to help local health departments trace an outbreak.

 7.       What are the hand washing rules for staff?

These rules should also be written and posted prominently. Personnel should wash their hands with soap and water, or an alcohol hand sanitizer, after every diaper change, potty visit, and nose drip wipe-up event. Washing should also be required before snack preparation and serving. There should be sinks near the diaper changing areas, and separate sinks should be available for food preparation and washing eating utensils

8.       What are the hand washing rules for kids?

Kids must wash their hands before snacks, after the potty, after returning inside from a playground recess, and after touching pets or birds at the center. Policies for protecting kids from pet exposures should be followed (see “petting zoos” below).  

9.       How are toys, sleep mats, play surfaces, and diaper changing areas cleaned, and how often?

All washable toys and surfaces that kids come in contact with should be scrubbed down with a disinfectant (see above) every evening after the kids leave; this includes nap mattresses and pads. Diaper changing areas should be cleaned with disinfectant (bleach-containing solution is preferred) after each use or a disposable paper table cover should be disposed of after each use. Any surface contaminated with blood should be immediately cleaned with a 10% bleach solution; other blood precautions must be taken to prevent kids from contacting blood or blood-contaminated areas (see “personal hygiene” above). 

10.   How many kids are in the center each day, what are their ages, are potty-trained kids in contact with kids who are not potty trained, and what is the ratio of staff to kids?

Ideally, older kids should be kept separate from the younger ones to prevent the spread of fecal-oral germs. This is very difficult to accomplish, especially for smaller centers; the trade-off, however, is that smaller centers have fewer kids to spread germs to your kids. The lower the ratio of staff to kids, the better the chances for good hand washing and other hygienic measures. Kids not yet potty-trained should wear clothes over their diapers.