Last month, the US Food and Drug Administration (FDA) took the unprecedented step of requesting that pharmaceutical companies take a list of cold remedies for children off the market. Rarely has such a sweeping and categorical ban ever occurred, but the evidence surfacing regarding deaths related to these drugs has become difficult to ignore, even for an agency as fond of Big Pharma as the FDA. We can only hazard a guess as to the damning nature of the evidence that would prompt so sanguine a federal body as the FDA to take such action. But it’s long overdue. As the Special Report in our latest issue reveals, many of the types of drugs routinely given to adults—antibiotics, asthma drugs, painkillers, cold and cough medicines—are highly dangerous to children and, more shockingly, have never ever been tested in any basic way to ensure that they are either safe or effective for this age group.
How could such a situation arise, considering all the regulatory bodies in the US and Europe? The answer lies in the medical model of children. Until recently, doctors operated under the assumption that a fetus, a baby, even a young child, wasn’t yet human—not in the fully formed sense of the word. In this view, as babies and young children don’t develop certain nerve receptors until age seven, they don’t, for instance, feel pain. We now know that idea to be completely fallacious—a fetus is as exquisitely sensitive as you or me. However, that mindset—that a child isn’t yet a proper human being—has enabled medicine to deny children the most basic regulatory protection.
Besides assuming that children don’t suffer as much pain or even side-effects as adults, medicine also assumes that children have ‘paradoxical’ effects with drugs, so that a drug with adverse effects in adults (such as amphetamines) can actually ‘improve’ children.
Astonishingly, doctors often don’t consider the basic fact of scale. Because a child may not, in their view, react to a drug in the same way an adult would, they often administer a drug dosage appropriate for a full-sized adult to a person one-third that size. Years ago, we reported on the shocking death of nine-year-old Lexie McConnell, who was given steroids at a dosage even higher than would be administered to adults (WDDTY vol 4 no 8).
As adverse drug effects aren’t tested in children, doctors operate with impunity. A hospital can insist on administering these drugs to children without having to ask for their parents’ permission, and many parents who resist emergency drug treatments risk losing custody of their children on a temporary basis. And because doctors haven’t the slightest idea what a drug can do in children, if it all goes wrong, they look elsewhere—usually at the parents.
Dr Mohammed Al-Bayati, a Los Angeles pathologist and toxicologist, is often called upon as an expert witness for the defence when parents are accused of killing their children. In virtually all the cases he’s handled, babies and children have died as a result of some cocktail of drugs: vaccines, antibiotics, steroids and even over-the-counter preparations.
For instance, Ezbjörn Hahne was convicted of killing his 40-day-old daughter Nadine, based on evidence that she died from old and new intracranial bleeding. However, Al-Bayati’s investigation discovered that the intercranial bleeding was likely to have been caused by the three doses of antibiotics prescribed by the hospital doctors.
At the moment, because no one considers deaths in children to be drug-related, we have no idea of the scale of the problem. But the FDA’s move is the most important first step in recognizing that current paediatric medicine is nothing but a house of cards.