It’s the job of the US FDA — the Food and Drug Administration — to regulate the sale of drugs, making sure that what we use is, to the best of our knowledge, effective and safe. A drug can fail in either of those aspects, though the situation isn’t always that simple to those needing the medicine.
Consider someone who’s in severe, chronic pain, or someone who’ll likely die without treatment. An drug that’s effective might be welcome in cases like that, regardless of some significant issues of safety.
Cold remedies are on the other side of the fence. We have no “cure”; existing medicines address symptom relief, and the symptoms are usually no more than annoying. One might want to stop a cough to avoid disturbing others, or to allow himself to give a speech without interruption. Symptom relief can help one sleep. But in the end, there’s an old saying that a cold will go away in seven days with treatment, and will last a whole week without.
And so we balance the risk. If one in 1000 patients experience nausea, that might be an acceptable risk to get rid of a nastily runny nose. If one in 10,000 experience heart arrhythmia, and one in 100 of those die, well, I think my nose would have to be running a double marathon before I’d consider that.
In recent years, we’ve seemed to prefer “multisymptom” products, sold over the counter. The “shotgun approach” taken by these remedies is easily seen in one of NyQuil’s tag lines (here, from the web site):
Get the sleep you need with NyQuil—the nighttime, sniffling, sneezing, coughing, aching, fever, best sleep you ever got with a cold... medicine.If you really have — and need relief from — most of those symptoms, then that sort of thing is fine, assuming that it works.
But suppose you don’t have a fever, you’re not achy, and you’re only coughing or sneezing occasionally. What’s keeping you from sleeping is just the sniffling, and that’s all you want to relieve. Should you still aim the shotgun?
Many say you shouldn’t, and I agree with them. I don’t like taking medication that I don’t need, and so I never use the multisymptom remedies. If I take anything, it’s to address specific symptoms that I’ve decided I need relief from at the time. And in any case, I’m not convinced that the multisymptom things are effective against all they claim to be.
And recently, the FDA has questioned that too, for certain remedies, specifically those aimed at small children:
The reviewers wrote that there is little evidence that these medicines are effective in young children, and there are increasing fears that they may be dangerous. From 1969 to 2006, at least 54 children died after taking decongestants, and 69 died after taking antihistamines, the report said. And it added that since adverse drug reactions are reported voluntarily and fitfully, the numbers were likely to significantly understate the medicines’ true toll.But if they’re not effective, why didn’t we know this before? Because of how the products are tested:
In the case of pediatric over-the-counter medicines, the agency decided decades ago that drug makers could market the medicines for children even though they had only been tested in adults. Back then, it was assumed that children’s bodies were simply smaller versions of adult ones.
That assumption has proven untrue. Indeed, a growing number of studies suggest that cough and cold medicines work no better in children than placebos.
OK, well... given that, it seems clear: why would you give a child something that doesn’t work, and that might kill the child? Who would want to give such products to their children?
Credulous people, that’s who. People who really want something to work, people who really, really hope something will work:
“I’d say I’m upset,” said Jennifer Lenn, a graphic designer with two sons, 5 and 2. “They were handy. They helped me a lot. The doctors tell you to steam the kids, use a humidifier, put them near a hot shower. But those just don’t work the way the medicines do.”
“Oh, I’ll probably ignore it,” Ms. Frank said, speaking over the cacophony of a four-children-in-a-brownstone play date that sounded more like New Year’s Eve on Times Square. “It’s miserable if they can’t sleep. So I’m afraid I’d use it, regardless. But sparingly. And if they were babies, I’d hesitate.”
Wishing will not make it so. Folks, watch the FDA’s lips: there’s no good evidence that they work. Most likely, they were “handy”, worked better than steam, helped them sleep... because the kids thought they were getting “medicine”, because you told them it would help. Or maybe it’s an effect from one of the “inert” ingredients, such as alcohol.
My father’s favourite cold remedy was hot tea with lemon, honey, and whiskey. That seemed to work too. But we never did a proper study on that, either.
Update, 25 Oct: I’m glad this has prompted the discussion it has — thanks to those who’ve added to the discussion. There’s a follow-up article in the NY Times; some significant excerpts here:
The medicines that earned the most scorn were those commonly sold to treat coughs, runny noses and congestion, including dextromethorphan and phenylephrine.
None of them have any proven effect on children’s cold symptoms. All have risks.
They do not relieve their symptoms or shorten the length of their illness, every recent study has found. There is no reason to give them to children of any age even when combined with Tylenol or Motrin, the committee found.
These medicines have been used for decades by tens of millions of parents, many of whom simply do not believe that they are useless. There is a chance that those parents are correct and cold medicines may provide some benefit that studies, either because of size or the measurements used, have yet to uncover. But any undiscovered benefit is likely to be small.
Take dextromethorphan, which has proved effective just for adults. Two hours after taking it, an adult who was coughing 20 times an hour will cough 16 times an hour, Dr. Paul said.
“Is that a benefit?” he asked.
In children, even this small benefit has yet to be proven. Medicines often react differently in children.
Parents who cling to the belief that the medicines work often fail to realize that their children would have improved without treatment. Colds are brief and generally resolve themselves.
In even rarer cases, children have suffered hallucinations and other bad outcomes after receiving the right dose. Since these medicines have no proven effect, the risks are not worth taking, the panel of the Food and Drug Administration voted.
To many parents, the recommendation came out of thin air. But among experts, pediatric cold medicines have long been infamous as expensive placebos.
The study solidified a growing view that pediatric cold medicines were not just useless but, on rare occasions, dangerous.
Experts are particularly adamant that products with antihistamines should not be used by children except those with allergies. Many such products, like Children’s Triaminic Syrup Night Time Cold & Cough, are labeled for “night time” relief. Antihistamines, including brompheniramine and chlorpheniramine, do not relieve cold symptoms.
The federal panel, outside experts and even the manufacturers say using antihistamines to sedate children is a bad idea.
Antihistamines increase the risks a child will stop breathing.
“A kid is already having a difficult time breathing through a stuffy nose, and you’re going to sedate them?” asked Dr. Paul, who speculated that such practices might explain some cases of sudden infant death syndrome.
Sick children who are sedated may vomit, be unable to clear their mouths and strangle, said Dr. Michael Shannon, a pediatrician and toxicologist from the Harvard Medical School.
“Even the doses that you believe to be correct are a bad idea,” said Dr. Shannon.