Big Pharma's Dangerous Drive To Push Meds On Little Kids

Plastic Legos stamped "RISPERDAL" are a fixture at pediatricians' offices nationwide.

In the past decade, America's pharmaceutical industry has knowingly marketed dozens of dangerous drugs to millions of children, a group that executives apparently view as a lucrative, untapped market for their products. Most kids have no one to look out for their interests except anxious parents who put their trust in doctors. But that trust is often misplaced. Big Pharma spends massive amounts to entertain physicians, send them on luxury vacations, and ply them with an endless supply of free products. As a result, hundreds of thousands of American kids—some as young as three years old—have become dependent on amphetamines like Adderall and a pharmacopeia of other drugs that are meant to treat depression, insomnia, aggression and other mental health disorders.

The fact that none of these powerful mood-altering medications have been approved by the FDA to treat children under 10 has posed no obstacle to the industry's marketing masterminds. They've waved off objections by some some doctors who wonder how these complex drugs will affect the vulnerable brains and bodies of their young patients. Other experts have warned that children exposed to this multi-molecular barrage on their central nervous systems could potentially be at much higher risk of becoming adults who are addicted to chemicals, prescription and otherwise. But thanks to a billion-dollar advertising campaign, millions of kids across the nation are now taking pills to control a long litany of "behavioral problems."

Luckily, Johnson and Johnson is not getting off scot-free. Last week, Massachusetts Attorney General Martha Coakely announced that the state was suing the world's biggest pharmaceutical firm, Johnson & Johnson, for illegally promoting Risperdal, an "atypical anti-psychotic", for off-label treatment of childhood schizophrenia, bipolar disorder, autism, hyperactivity and attention deficit disorder, depression and anxiety, sleep disorders, anger management, mood enhancement or stabilization. As BNet's Placebo Effect blog recently reported, the list of maladies is grotesquely long. J&J, which prides itself on its high-minded credo of "always putting patients first," began moving its new drug into this new market as soon as Risperdal won approval in adults—even though the FDA explicitly forbid it from doing so, for the simple reason that the firm had never done a single test of the drug in children who suffered from these or any other conditions.

Though Risperdal was marketed as a less dangerous—if not more effective—alternative to older "typical" anti-psychotics, it quickly became apparent that the drug had many worrisome side effects in adults, including the rapid onset of diabetes and alarming weight gains. But despite a growing weight of evidence about the drugs, J&J only stepped up its promotion of the drug for children—aiming for more conditions and in ever-younger kids—no doubt to squeeze as many profits as possible out of this lemon before the FDA ordered them to stamp a warning on the label or withdraw it from the market altogether.

Not surprisingly, teens and kids soon started developing the same symptoms of drug-induced diabetes and weight gain that were experienced by their adult counterparts. Several also developed a bizarre condition called galactorrhea, in which milk flows spontaneously from the nipples of your breasts—girls and boys alike—a happening that is likely to drive even the most balanced teen around the bend. What may be even more bizarre, when doctors alerted J&J sales reps to this side effect, sales reps relayed the warning to their managers, who advised the sales reps to tell the doctors (in a frankly illegal reversal of medical protocol) that rather than take the kids off Risperdal, they could be treated with yet another drug.

The Massachusetts case is the third of about 10 state lawsuits in which jurors will be asked to pass judgment on whether J&J's Risperdal promotional practices constitute medical fraud. Class-action suits by patients (or parents) claiming injury are also in the works. The Obama administration has shown some guts in not simply allowing the giant drug makers to settle such lawsuits for giant fees ($2 billion is not unusual, however ho-hum to pharma) but in holding individual company executives personally liable for the criminal activity.

In fact this code of misconduct is what we have come to expect from the pharmaceutical industry: Always put profits first, break the law now, pay the fine years later. Given the high-risk nature of drug development—a novel compound costs close to $1 billion and a decade to get to market—Big Pharma has tried all manner of dark arts to increase its odds. Criminal activity, once largely limited to the sales divisions, has overtaken the entire endeavor. Clinical trials that produce negative data—including health risks—are hidden from the FDA. Early signals of serious side effects are covered up, as are promised follow-up studies upon which approval is conditioned. Like other industries, pharma and its lobbyists have regulators and Congress by the balls.