To me, you can lay all of this squarely at the feet of the pharma companies, which had a slew of newish drugs come online in the 80s and 90s and wanted them taken by as many humans as possible—consequences for the patients be damned—and a crew of child psychiatrists at Harvard/MGH who see deeply-flawed, ill-for-life children where other psychiatrists might see personality disorders and issues that will burn out over time. The pharma companies and the Harvard crew worked hand-in-hand to bring America a generation of ADHD kids and bipolar children, and their profound influence can be seen in the millions of children and teens who now carry lifetime diagnoses and take gobs of psychotropic drugs each day, often to their detriment.
That may sound extreme to some people, but it's worth noting that the rest of the world has not embraced these diagnostic and treatment paradigms—except Britain, where there was an initial embrace of ADHD and stimulants, but where there's now a significant backlash. Meanwhile, in France and Italy ADHD is rarely diagnosed and it's difficult to see where French and Italian culture have suffered as a result. As for bipolar disorder in kids (meaning pre-teens and younger), it's simply not an issue in the rest of the world. The bipolar child is a purely American phenomenon, as big a metaphor of our times as credit swaps, subprime loans, and government bailouts.
Why do you think so many more teenage and younger boys than girls are being diagnosed with ADHD, and what does that say about our culture, education system, parental expectations, and so on?
The data I'm familiar with pegs the boy-to-girl ADHD ratio at 3 to 1, which is pretty dramatic. I suspect that boys get pegged with the diagnosis more than girls do for two reasons: One, boys have always been far more energetic and physically exuberant than girls, a point going back through history, perhaps because they are developing their hunter-gatherer beings. And, two, the hyperactivity piece of ADHD is quite easy to spot and probably leads to greater pressure for kids to be diagnosed because hyperactive boys can be disruptive, especially in school environments.
As out there as this may sound, I think we are as a culture cheating boys of their inherent natures and I have real questions about how that affects their psychosocial development long-term and what it will all mean for manhood a couple of generations down the road (I'm concerned about comparable issues with girls as well). What's more, I think the educational system places too much emphasis on having quiet, compliant kids—far more so than in the past. When I was a kid in the 1970s, boys were pretty much allowed to engage in all kinds of wildness at recess in elementary school and after school, but from what I hear that's being discouraged today. Why the change I couldn't say, but I do know that there's been a real push in our culture to silence outward signs of male aggressiveness, both in kids and adults.
As for parents, I think they are under a lot of self-imposed pressure to have perfect kids with high grades who get into top universities or they've somehow failed as parents. The ADHD drugs and the diagnosis itself have been foisted on them as a way to have their kids better liked among school peers and to achieve higher grades and perform better on the many, many standardized tests kids must take these days. What's interesting to me is that parents and our culture may well have been sold a bill of goods here, as the recently released MTA study (a long-term tracking study of kids through teens with ADHD, both on and off-meds) showed that long-term treatment with stimulants didn't appreciably improve GPAs and other test scores.
What influence do you think patent cycles exert over such diagnostic trends? I'm thinking especially of the move to "bundle" depression with bipolar disorder when the patents for so many SSRI antidepressants ran out.
I think there is some influence here, even though diagnostic trends should ideally be driven by unbiased science, independent of the needs of pharma companies. What I've noticed over time is that, as you suggest, there's been a great rush to get a drug approved for as many indications as possible as it nears the end of its on-patent life, likely because the drug companies can then market said drug directly to the public. Certainly, that's part of what went on with Paxil and social anxiety disorder in the late-1990s and, right now, I'm noticing an epic push by Eli Lilly and AstraZeneca to have their atypical antipsychotics (Zyprexa and Seroquel, respectively) approved for a wide range of indications (including ones like depression) before the drugs go off-patent in a few years.
Perhaps the most egregious example of a pharma company trying to influence diagnostic trends came in 2002 when Eli Lilly launched a massive sales campaign to convince PCPs that patients walking into their offices complaining of depression actually had bipolar disorder type 2 instead, and that Zyprexa was the perfect fix for that. The results were utterly disastrous for patients, what with all the weight gain and diabetes they experienced as a result. Interestingly, female patients were the primary target of the campaign.
Do you think the black-box warnings that the FDA issued against pediatric antidepressant use were effective as a deterrent?
I'm not sure they were much of a deterrent since there's been 14 percent growth in antidepressant prescriptions since 2004, according to IMS Health. But to the degree that the black box on suicidality gave patients and doctors important information that had long been hidden from them by both the pharma companies and some researchers, I think the warnings were a boon. It has at least forced people to think long and hard about what drugs they are taking, and to pay closer attention to side effects and any strange emotions that might arise upon first taking the drug or changing a dosage.
Why do you think Bipolar II disorder is controversial as a diagnosis?
I may be the only writer in America who thinks BP2 is controversial and I can hardly think of any doctors who do. For me, it's a questionable classification and something of a cop-out by the DSM writers for a couple of reasons: One, BP2 isn't bipolar disorder, properly understood. There's no mania, there's no hospitalization for mania, and there's no one running naked down the street. The most prominent features of BP2 are depression (and that covers the vast majority of a person's time who is diagnosed with BP2) and bursts of energy, broadly understood. To me, that sounds a whole lot more like depression and agitation than it does manic-depression.
Two, the minute someone gets hit with a bipolar disorder diagnosis of any subtype, then they are faced with a profoundly bad set of social assumptions; they get stigmatized by friends and family; and they lose their jobs. I know of multiple cases along these lines, including one of a sheriff's deputy in King County, Washington who was fired from her job as soon as the brass learned she had BP2, even though she had a stellar track record as a cop and had done nothing wrong on the job. That hardly seems fair when we're talking about a disorder that doesn't involve hallucinations or psychosis and has none of the off-the-charts impulsivity of true manic-depression. While it's nice of researchers and mental-health advocates to claim that we've got to end this kind of stigma, in the real world that would take generations and by then people with BP2 today will have reached the ends of their natural lives.
Why BP2 wasn't called something else is beyond me, but the diagnosis has sure caused a lot of unfair social damage.
Much of the rationale for medicating teens and preschoolers has to do with arguments about early intervention. You've written that you find such claims questionable and their underlying philosophies flawed. Explain why.
Let me restrict this to psychosis. What you are referring to is the prevention paradigm, or the use of psychotropics as prophylactics, all of it trading off kindling theories of mental illnesses and disorders. They are interesting theories, but in the real world they've not turned out to be successful. Simply put, there is very little long-term or short-term research to prove their validity. For example, the PRIME study at Yale—which sought to identify kids at risk of psychosis and then gave them Zyprexa to prevent psychosis from ever arising—was an epic failure and certainly raised questions about the ethics of giving kids dangerous drugs for disorders that they, at least in some of the cases, didn't even have.
The trouble is that the prevention paradigm is deeply seductive. If true, psychiatry would be like cardiology where high cholesterol is considered a risk factor for heart disease and people with high cholesterol are given statins to prevent heart attacks. But psychosis isn't so simple and—from what I've seen to date—researchers have not been able to predict with a high degree of accuracy who will develop psychosis. That's why I find the whole thing suspect. Perhaps I'll be warmer to researchers' claims here when they can predict psychosis with great accuracy and replicate their findings in many studies across different population subtypes.
As you noted on your site, the St. Petersburg Times recently reported that in 2007 23 infants less than one-year-old were given antipsychotics. Given all the media attention to the death of Rebecca Riley, aged 4, from an overdose of antipsychotics (and a diagnosis of bipolar disorder at age 2), how is it possible for psychiatrists to continue prescribing to infants in such numbers without more oversight?
Doctors have great powers to prescribe drugs off-label for whatever they see fit and, to a degree, that's fine. What's gone on with antipsychotics prescribed to infants and toddlers is simply inexplicable to me. The drugs are known to cause huge problems in adults, so why the heck would a doctor give them to little kids, especially infants? It boggles my small mind.
There probably is no acceptable way to introduce oversight into this situation—outside of insurance provider overview—without trampling all over doctors' traditional freedom to prescribe off-label. I'm no fan of bans or restrictions, but this does strike me as a situation where there needs to be a serious rethinking of what we are doing—and maybe there should be a ban on the use of these drugs in kids under, say, 6 years of age.
That said, perhaps the most effective short term fix is for parents themselves to get educated about the problems with these drugs and to demand a second opinion when a doctor tries to prescribe them to their child.
Your web site Furious Seasons, which has earned you awards, includes extensive documentation about Zyprexa. What will readers of your site learn about the drug and its side effects?
Hopefully, they'll learn that this is a drug that causes rapid weight gain, hypoglycemia, diabetes, lipid problems and the like in a high percentage of patients, and that it's a drug the use of which demands great caution. They'll also learn that Eli Lilly actively lied to doctors and patients about problems with the drug and that the company has had to settle almost $3 billion in lawsuits and has pleaded guilty to a criminal misdemeanor charge in federal court for off-label marketing of the drug for use in dementia.
One classic example: in April 2002, Japanese regulators forced Lilly to warn doctors in Japan abut hypoglycemia and diabetes problems with the drug, but at the time same time the company claimed in internal documents that this did nothing to affect the safety of the drug in the US market. Two months later, Lilly rolled out its extensive Zyprexa marketing campaign to PCPs, which I referred to above. That is some of the worst corporate behavior I have ever seen in my 15 years as a reporter.
Some months ago, the government's Clinical Trials web site signaled that the antipsychotic Seroquel was being tested for people with public-speaking anxiety. What can and should the FDA be doing to stop such clear signs of "mission creep" over pharmaceuticals?
I don't think the FDA has any interest in stopping this kind of behavior, and it likely doesn't even have the regulatory authority to do so. For instance, in the last two years the agency has approved antipsychotics for use in pediatric bipolar disorder and in treatment resistant depression. Neither diagnosis exists in the current edition of the DSM, but the agency seems just fine with this situation. It even went to great lengths to justify the diagnosis of pediatric "mania" bandied about by some researchers—which amounted to little more than agitation—to the point where the FDA's chief of psychiatry products, Thomas Laughren, was actively involved in a conference where researchers and pharma companies joined to design clinical trials of this kiddie mania.
Likely the best solution here is for Congress to pass legislation requiring the FDA to only approve psychiatric medications for disorders that appear in the then-current edition of the DSM. I cannot think of a more effective way to stop Big Pharma's making up of disorders which they then repurpose their drugs to "treat."
Final questions: How do you keep up with all the news in pharmacology, and what are your standard sources of information?
My sources are a mix of traditional media coverage of the field (although that's sadly declining as newspapers fade away), as well as original research in journals, plus items that get sent my way by my many dedicated readers. On top of that, I've been an investigative reporter (mostly of government and law enforcement) for a decade and I know where to snoop. Suffice to say, I read a ton of journal articles and reportage. It's gotten to the point where I've not read a novel or nonfiction book outside of the mental health world in about three years.
Philip Dawdy is the author and editor of the award-winning weblog Furious Seasons. Christopher Lane is the author of Shyness: How Normal Behavior Became a Sickness.