Drug Manufacturers Put Safety of Children Last

"In medicine, children come last."
– Dr. Maureen Strafford, pediatric anesthesiologist and cardiologist, as quoted by the New Yorker, 1/10/2005

Every parent wants to ensure that their child receives adequate and safe protection from diseases. Vaccines and drugs, which are administered to children to prevent a host of ailments, such as chicken pox, measles, and asthma, can aid in this effort. However, disturbing facts are emerging about the safety of these vaccines and medications, which are subject to limited—if any—tests for pediatric use.

Medications that can be processed normally by adult metabolisms often have dangerous side effects in young people. But pharmaceutical manufacturers claim that such tests are too expensive and time-consuming. That is a risky gamble to take with the lives of children.

Children's Reactions to Medicines Differ Substantially from Adults

As children grow from newborns to adolescents, "their body size and composition, physiology, and cognitive and motor function change. The metabolism and toxicity of medications can vary substantially in children of different ages… The safety of a drug in children often cannot be extrapolated from data for adults; medications may be more or less toxic in children." (New England Journal of Medicine, Oct. 31, 2002, Vol. 347)

Doctors commonly administer smaller or diluted adult quantities of painkillers, anesthesia, or vaccines to children, but "even growing teenagers who weigh as much as adults tend to absorb and metabolize medicine more quickly than adults, since organs that break down drugs, such as the liver, or excrete chemicals, such as the kidneys, take years to mature. The rate of blood flow to the skin and lungs is also higher in children, so topical or inhaled agents may be more rapidly absorbed." (The New Yorker, Jan. 10, 2005)

Most Vaccines and Drugs Prescribed for Children are Never Tested on Children

According to the New England Journal of Medicine, "testing of medications for safety and effectiveness has mainly benefited adults, who outnumber children and take many more medicines. Medications, including many that are widely used in children, are rarely tested in children. Much of pediatric practice, particularly in hospitals and by specialists, has involved the 'off-label' use of medications and educated guesses about doses, safety, and effectiveness." (Oct. 31, 2003, Vol. 347)

Shockingly for parents, "approximately seventy five per cent of drugs approved for use in the United States have never been subjected to comprehensive pediatric studies. A physician, however, is allowed to use any F.D.A. approved drug in whatever way he deems beneficial, and he isn't required to inform parents if it hasn't been specifically tested on children." (The New Yorker, Jan. 10, 2005)

Drug Manufacturers Prioritize Profits, Not Safety for Children

Because children make up a smaller population of vaccine and prescription medications, there is less financial incentive for drug-makers to conduct studies in their age groups than in adults. Children also span a wide age range, and separate studies are often required for babies, toddlers, and teenagers.

As Dr. Stuart Siegel, director of the Children's Center for Cancer and Blood Diseases at Children's Hospital Los Angeles says, "I've had discussions with some leaders in the pharmaceutical industry. The feedback is consistent. They'll cite the cost and then they'll also cite the risk, in terms of an adverse event and what that would do to their profits and their stock."

Congress has offered carrot-and-stick rewards to pharmaceutical firms to pay for clinical pediatric studies—such as the Pediatric Exclusivity Provision, which requires companies working on new treatments for diseases that affect both adults and children to conduct pediatric studies. In exchange, the F.D.A. will offer a six-month extension of market "exclusivity." However, as result of exclusivity, patients are then forced to pay higher prices for brand-name medications for a longer period. In fact, the Wall Street Journal reported that the studies required to win exclusivity were usually small and inexpensive, but that a drug-maker could make hundreds of millions of dollars in sales for a popular medication.

Drug companies should stop putting financial gain ahead of safety, and make the short-term investment in pediatric studies. Otherwise, the long-term risks may be at the expense of our children's lives.

March 7, 2005