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

Drug giants spend billions a year promoting their pills to children, ignoring FDA rules. Johnson & Johnson even advertises its latest anti-psychotic on Legos, ignoring evidence that the drug leads to diabetes and wild weight gain and sprouts breast in boths boys and girls.

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

By Walter Armstrong

08/05/11

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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.

But it's the corruption of the medical profession by the pharmaceutical industry that has proved most insidious, and nothing illustrates the perilous consequences better than J&J's illegal marketing of Risperdal to kids. Making 100,000 sales calls on psychiatrists and pediatricians, the company lined the pockets of willing MDs employing familiar pharma ploys, from the small-change items like lavishing free samples, free lunches and—this may be a first—even free colorful plastic Lego blocks printed with the word RISPERDAL for children to play with in the waiting room, to the big-ticket items such as "educational" meetings at fancy resorts and "advisory board" soirees at the Four Seasons. The company even paid certain leading specialists hundreds of thousands of dollars a year to conduct J&J-designed trials and sign their name to J&J-written studies published in the top medical journals—providing a "scientific" spin to the promotional materials. In this amorphous manner, a professional consensus emerged that the atypical anti-psychotics were effective in very young children for attacks of rage, poor impulse control, defiant and oppositional behavior—the transient, irrational, sometimes frightening "acting out" that sends overworked adults around the bend.

By means of this closed circle or deceit and kickbacks, J&J beat out the competition to grab 50 percent of the pediatric market for anti-psychotics. And although many other psychiatrists and pediatricians were arguing that anti-psychotics should never be given to children under 10 in the first place, the white wall of silence in the medical profession generally prevents doctors from becoming whistleblowers unless prodded by investigative news reporting.

Everybody was profiting, it seemed, except for the kids.

Consider Kyle Warren, who as an 18-month-old Louisiana toddler began taking Risperdal prescribed by a pediatrician on the J&J payroll (plastic RISPERDAL Legos and all). Kyle suffered from frequent temper tantrums, and his mother, Brandy Warren, then 22, was a new mother on Medicaid and, as she told the New York Times, "at my wit's end." But like any good mother, Brandy kept on searching for the right diagnosis and the right treatment, going from doctor to doctor and amassing a contradictory set of assessments, such as autism, psychosis, schizophrenia, bipolar disorder, and attention deficit hyperactivity disorder. By the time he was age three, Kyle's daily pill regimen resembled that of someone very old or very sick, including Risperdal, the antidepressant Prozac, uppers for ADHD and downers for insomnia. He was sedated, he drooled, and he was ballooning with fat from the side effects of the Risperdal—but, look Ma, no more temper tantrums!

 “All I had was a medicated little boy,” Brandy Warren told the Times. “I didn’t have my son. It’s like, you’d look into his eyes and you would just see just blankness.” Brandy got word of a high-quality program affiliated with Tulane University for low-income families with children with mental health problems. Over the next two years, Kyle was gradually weaned off the dangerous cocktail of drugs and given an ongoing exhaustive evaluation. His current diagnosis—attention-deficit hyperactivity disorder—is very common among boys his age; he takes a single long-acting stimulant to control it. At the time of the Times profile, in fall 2010, he was in his fourth week of first record and earning As in his first tests. There can be little doubt that the original course of treatment was a terrible medical error. 

Says Brandy Warren: “Once he came off the medication, he was Kyle again. He’s an intelligent person. He’s loud. He’s funny. He’s smart. He’s bouncy. I mean, there’s never a dull moment. He has a few little behavior issues. But he’s like any other normal 6-year-old.” Still, she worries that the many months he spent taking those drugs may have damaged his development. Will Kyle be more susceptible to mental health problems and addiction as he ages? No one knows. "I will never, ever let my children be put on these drugs again,” she told the Times, choking back tears. “I didn’t realize what I was doing.”

Surely some adults and even some children with behavioral problems have been helped by Risperdal, though rounds of scientific studies suggest that the wonder drug is no more beneficial to patients than less hazardous anti-psychotics that came before it. Ultimately,  its Johnson & Johnson (and its billionaire competitors) who may have real behavioral problems to deal with. According to a 2009 report by the FDA, an estimated 500,000 adolescents and children are on anti-psychotics, despite the fact that schizophrenia—the original condition that was supposed to be treated by these drugs—typically manifests only in the late teens. Despite all the bad publicity and billions of fines levied against the company, J&J continues to make a nifty profit off of Risperdal. Even in 2010, when the company's patent on the drug had expired, sales continued to climb. In fact, over the past decade  "atypical anti-psychotics" have emerged as one of the drug industry's most lucrative products, averaging about $15 billion in annual sales. But is America really experiencing an"epidemic" of psychosis among preschoolers? Far likelier that we are witnessing an epidemic of unethical and illegal collusion between Big Pharma and Big Medicine—a derangement of values, if you will. The pharmaceutical industry's craving for endless profits has progressed so far that executives feel free to prey on the most vulnerable members of our society.

Walter Armstrong is Deputy Editor of The Fix.

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