At 6:30 AM, I kissed my 14-week-old son Joe on the forehead and headed off to work at the hospital. By 3 PM I was back in bed with a hacking cough and a fever. I had influenza.
As a doctor training in infectious diseases, I knew that the flu can be dangerous in vulnerable populations like little babies. I had visions of Joe being admitted to the pediatric intensive care unit, as I swallowed a pill of oseltamivir (brand name “Tamiflu”) and shivered under the covers.
Should I also give my little boy Tamiflu to prevent him from getting sick? The answer should be clear to an infectious disease physician-in-training, right?
I felt competing instincts. Paternal: to “do something” to prevent Joe from getting the flu. Medical: “do nothing,” as the rampant overuse of antibiotics in children has had negative consequences and the same might be true for antivirals.
As I researched the question further, I learned that the decision to give prophylactic Tamiflu is anything but simple.
Close contacts of people with the flu (including babies) can receive Tamiflu if they are at high risk for influenza complications. One Greek study of 13 newborns found that the drug was safe but did not address its effectiveness. Moreover, the number of babies who would need to receive Tamiflu to prevent one serious case of influenza is unknown.
Another study found that Tamiflu protected against the spread of the influenza in families when the initial household case was treated. However, that study did not include babies under the age of one. In addition, that study was financed by the manufacturer, a relationship that some (myself included) have found to be problematic.
Over the past several years, controversy has been brewing regarding a lack of transparency in clinical trials of Tamiflu. Most recently, the journalist Jeanne Lenzer called attention to potential financial conflicts of interest at the Centers for Disease Control and Prevention (CDC) with respect to influenza drug treatment recommendations.
Especially concerning was a $174,800 grant that the manufacturer provided to the non-profit CDC Foundation to support qualitative research into flu prevention and treatment messaging. For anyone familiar with the marketing practices of the pharmaceutical industry, this sounded like a potentially large return on a small investment.
I believe that Jeanne Lenzer is correct in arguing that conflicts of interest between CDC and the pharmaceutical industry deserve attention. That said, we should also be mindful of the larger context. Public health in America is grossly underfunded (CDC’s operating budget is a paltry $11.5 billion dollars per year, compared to America’s $2.9 trillion in health care expenditures). A lack of adequate public health funding and regulation is likely why these relationships with industry exist. The Tamiflu controversy demonstrates that there needs to be stronger federal oversight of the relationships between industry and the government.
Full disclaimer: I am not an unbiased observer. From 2012 to 2014, I trained at CDC in the Epidemic Intelligence Service (“disease detectives”) program. I did not work in CDC’s influenza division, however. In addition, I have never received funding from the pharmaceutical industry.
So what to do for little Joe? I reached out to several physician acquaintances. Some suggested that we give the Tamiflu prophylactically, while others advised to wait and see if he developed a fever. Given the risks versus potential benefits, we somewhat ironically and reluctantly elected to give him the medication.
Did we make the right choice? It’s not easy to say. My son tolerated the first dose of Tamiflu and vomited the second. He played happily with his stuffed animals (which he was also doing before he started taking the drug) throughout my illness and never got sick.
What I knew all along, and want to make sure other parents know, is to get the flu shot each year. Usually it’s effective. If you do get influenza, minimize contact with others. Wash your hands. Drugs like Tamiflu used prophylactically in babies may or may not help. If I had to do it over again, I would not give him the medication.
The more I learn about the practice of medicine and the practice of parenting, the more I realize that we have to learn to live with uncertainty. Parents will worry, and doctor-parents are not immune from fretting. What’s important is to enjoy your children; they grow up quickly. And they usually turn out fine, even if they do come down with the flu once or twice along the way.
Philip Lederer is an Infectious Disease fellow at Massachusetts General Hospital and Brigham and Women’s Hospital, and a former Epidemic Intelligence Service Officer at the Centers for Disease Control and Prevention (CDC). His views do not represent any of those organizations.
A kid can easily get flu. It is important for parents to be careful when they have flu. Little babies have a weak immune system, you might want to keep away from the kid for a while.
This stuff is in new Molecular Biology textbooks, specifically Bruce Albert’s new book.
Pattern recognition receptors, PRRs, recognize microbial proteins and carbohydrates that are not self. Toll-like receptors are a transmembrane glycoprotein that recognizes many different external pathogens by using their PRR ability, and they are found on the surfaces of many cell types. NOD-receptors are similar but are in the cytoplasm. Both of these molecules tend to have leucine rich portions which are repeated. RIG-like receptors, also in the cytoplasm, recognize double stranded RNA which should not be in human cells and indicate virus invasion. Maybe a little boost of leucine in the diet might abet these natural immune defenses, although I don’t think leucine is rich in RIG receptors, only in the first two. It’s a pretty safe amino acid, I think, because it is taken by body builders a lot. They used to say that arginine, zinc, selenium, and Vit.C taken together would boost natural immunity. I think this is questioned now in the Am J Clin Nutrition.
Robert– agree, we need much more evidence.
This is an intriguing blog post; latest 2014 review of all studies surmises that data are not ideal and many studies suffer significant biases – so much so that we don’t know the true effects.
In addition, effect estimates are all over the board, and the measured outcomes pertaining to those effect sizes are all over the board. A nearly intractable problem for research especially the way studies are now being done. Best estimate of ARR is 8%, (2-20%) and this is for symptomatic disease, not proven influenza.
Harm is significant in terms of symptoms of nausea/vomiting, so trade-off of about 1:1 means less flu – more GI toxicity. I would accept the extra hours of flu, even if the data were true.
My take, we are bad at the science of this problem. We have no standards for definitions of outcomes, difficult measurements to make to know if influenza is even the culprit if we do get sick, too many cooks playing in small study sandboxes so we really don’t know if we should use it. Observational studies say may reduce mortality, but they are observational, which means we don’t know. While I get that a drug that only causes short term harm for a mortality benefit would make the use of this drug a moot point – yes – none can say for sure that that sort of trade-off exists. And to make informed choices, we need information of reason.
If we don’t know, we shouldn’t pay for it and no one should take it. If we don’t know and it is important, we should study it correctly. But, that is not our goal, obviously, or we would be doing better studies.
I’m linking this as a layman to read other responses from the professional community.
My instinct is to remember that mankind once knew nothing of germs and was forced to rely on whatever “natural” defenses we have. At our house we have something like quarantine, even for anyone who gets a cold. Somebody else handles dishes, endless handwashing, bleach solution wipe for door knobs and light switches, separate automobile, bathroom and phone if possible, no touching the TV remote, frequent laundry, etc.
I hope the baby stays okay. Sick babies are pitiful.
John- here’s another link on the CDC website which talks about drugs for flu.
William- I don’t know anything about this, do you have a reference?
Yes, Philip it is NEJM ” Circulating Interferon After Measles Vaccination ” by John K Petralli. et al NEJM 273: 198-201, 1965
Allan- People live in a world full of bacteria and viruses, and the innate immune system is our first barrier against microbes. It is inherited from parents to child. For example, peptides called lectins are proteins that bind carbohydrates. Galectins inhibit replication the flu virus. But the innate immune system isn’t enough, we also need the adaptive immune system (T cells and B cells). That’s why we get vaccines (like the flu vaccine), to boost our immune responses.
Thanks Phillip for your reply. I wasn’t suggesting that people avoid being vaccinated. I was wondering if actual infection didn’t give longer and broader immunity. Though I encouraged vaccination (flu) of my seniors and sick patients I didn’t push it on the young and healthy. My antiviral use was mostly in the group that were at high risk. My understanding was that viral adaptability would lead to these drugs not working and that these drugs didn’t work that well.
A CDC spokesperson provided this link to a new page stating the agency’s official position on antiviral drugs.
I have always ruminated about the discovery of interferon. Supposedly when one has one viral infection, you can’t acquire another because of interferon production induced by the first infection. That is where the name came from. This means that maybe measles vaccination may have been the proper way to prevent influenza in your son. Measles vaccine is a live virus and I have read that it induces interferon. Has anyone tried this?
I have long wondered if natural immunity (for the strong and healthy) doesn’t provide us with a better and broader immunity in the long term so that when we do become infirm we might be stronger.