Friday, May 28, 2010

Drugs for Kids: Biggest Growth in Pharma Sales

According to Reuters:

...The pharmacy benefit manager Medco reports that the fastest growth sector in pharmaceuticals is chronic-use drugs for children. Increase in presciption drug use was four times higher in kids than among the general population, with one in four kids overall, and 30 percent of adolescents, now taking some sort of medication chronically.

The big areas of growth were drugs for diabetes (blamed on the obesity epidemic) and antipsychotics (due in part to a cutback in the use of antidepressants among children with FDA black box warnings about antidepressants in kids, and an apparent felt need to switch the kids to different medicines rather than use non-medication approaches to behavior problems). Drugs for ADHD actually grew more in young adults than in kids.

The Medco folks expressed surprise at these figures and warned of increasing health care costs in the future as these kids reach adulthood--and presumably continue to need their drugs.

Tuesday, May 25, 2010

Warning: This Blog Is Not About Personal Medical Advice

Readers: I just took down a comment posted by "James" in response to the recent posting on the Whitaker book. James was asking for assistance in coming off a psychiatric drug that he has been taking for many years.

I wish James all the best for his future health. But I must remind all readers that this blog is about ethics and health policy. It is not designed to offer anyone personal medical advice and it would be highly irresponsible to interpret anything said on this blog as personal medical advice. You must consult the appropriate health professional to get personal medical advice. Everything discussed on this blog is general background information and cannot be applied to any specific individual's care without expert interpretation.

Sunday, May 23, 2010

Whitaker's Anatomy of an Epidemic: A Fundamental Challenge to Psychopharmacology

In the course of writing HOOKED and then doing this blog, I thought I was pretty much up on all the misinformation that had been spread about psychiatric drugs. As we've seen in previous posts, we are aware of the lack of evidence to show that mental illnesses result from specific chemical imbalances in the brain, or that psychiatric drugs are targeted to fix those imbalances. We are aware that drugs touted as almost free of serious side effects actually have an array of serious side effects. We have seen that drugs advertised as non-habit-forming in fact pose serious withdrawal risks.

I have just finished reading Robert Whitaker's Anatomy of an Epidemic, and have concluded that we don't yet know the half of it.

Whitaker's message is such a fundamental challenge to today's practice of psychiatry that I went searching on the web for any evidence that he's connected with Scientology or any of its fellow travelers. I found no such evidence (and will mention later how Whitaker's assertions part company with the wacko claims of the anti-psychiatry groups). Whitaker is a journalist and author of a previous book, Mad in America.

I have to explain first Whitaker's assertions about psychotropic drugs, and then his claims about the role of Pharma and psychiatry in misleading us about them.

Whitaker starts off with an epidemiological question. If you go back about 60 years, you discover that relatively few people in the US were diagnosed with mental illness, and that they often recovered and went back to leading normal lives in the vast majority of cases. A tiny percentage made up the chronically mentally ill that were warehoused in state hospitals. Then came the psychopharmacology revolution and the discovery of all the modern classes of psychotropic drugs. We have been told that these drugs revolutionized psychiatry and allowed those "warehoused" people to come out of the hospital and into the community. But when we look at the numbers we see a surprising thing. Not only are many more times the old number of people being diagnosed today with mental illness, but their long term prognosis seems to be abysmal, with a great many ending up on disability. If these new drugs do such a great job, how come we have so many more mentally ill and they do so much worse?

Whitaker then offers an answer, in terms of both basic biological mechanisms and actual patient outcome data. The mechanism answer is a great embarrassment to me personally because I never thought of it, despite having had what I thought was a good biology education in college and even writing papers about systems biology. The standard psychiatric theory, which seems correct, says that the new drugs alter the levels of neurotransmitters in the synapses between brain cells. Anyone with an ounce of knowledge of biology ought then to ask--and what happens next? Just about the fourth or fifth word we learned in biology class is homeostasis. If something comes along from the outside and disrupts any body system, the body almost always has a built-in regulator that seeks to restore the prior state of balance. And indeed, Whitaker tells us, scientists who have gone looking have found the homeostatic responses to these drugs. If the drug results in(say) an increase in dopamine in the synapse, the brain down-regulates its dopamine system, by putting out less dopamine from the first neuron, or by shutting down some of the dopamine receptor sites in the second neuron. In short, the drug, that was supposed to be correcting a disorder (which was actually not the cause of any mental illness anyway according to the best current evidence) has actually now induced a brain disorder.

Homeostasis works for a while, but if you stay on the drug long term, homeostasis eventually poops out. So what happens to people on the drug long-term may look quite different from what happens in the short-term. In any event we have mechanisms that can explain why you actually might induce a brain disorder from using these medications, rather than relieving an existing disorder.

That's at the mechanism level; what about with real people? Whitaker marshals a good deal of evidence from legitimate scientific studies to show that indeed, what the mechanism hints at is what happens. A regular refrain in the book is that there remains about 20% of patients who seem to need the medications and who do much better with them than without them. (That seems clearly to me to show that Whitaker has no truck with the Scientology line.) What about the other 80%? These people may have less symptoms for the first 6-8 weeks or so of treatment, and indeed most controlled trials confirm that advantage. However, after that initial response, the advantage seems to disappear. People treated with medication initially tend to do markedly worse at 1, 2, 5, and 10 years out from initiation of treatment compared to the few patients who somehow escape drug treatment. The standard psychiatric theory is that we see many more people today with bipolar disorder than in the past because when they go into the depression phase of the disorder, psychiatrists treat them with antidepressants, and they then develop symptoms suggestive of mania, meaning that the antidepressants have "unmasked" the true, underlying disease. Whitaker reviews data suggesting that it is much more likely that the antidepressants caused the manic reaction, and that a person who becomes bipolar following medication use cycles more rapidly in and out of mania and depression, and ultimately has a much poorer prognosis, than the classic bipolar patient of days gone by.

How good are the data Whitaker cites? Not knowing the psychiatric literature as a whole, I cannot exclude the possibility that he has carefully cherry-picked a set of studies that happen to confirm his thesis while ignoring a much larger body of studies that disprove it. I tried to get some input from psychiatrist friends but none had as yet read the book. So I remain open to being shown the error of my ways on that point.

Whitaker thus paints a picture by which the standard psychiatric practice has helped a few but has greatly harmed many others. He claims this has happened becaue we as a society have been systematically lied to about the data. The next question is how that set of lies came about.

(A brief detour here to do the "don't try this at home" disclaimer. If you are taking psychotropic drugs and read Whitaker's book, the first thing that crosses your mind is to stop taking the drugs. Do not do that. Quite apart from the fact that you might be among the 20% who do better with the drugs, a quick withdrawal will almost guarantee worsening and a greater dependency on drugs in the future. (Indeed, the standard belief system of psychiatry holds that we know psychiatric drugs do good, precisely because withdrawal worsening is so common.) Only slow, cautious drug withdrawal seems to work for most people.)

In writing HOOKED, I had a standard model of the medicine-Pharma relationship that I thought was based on historical research and fact. I assumed that the heavy financial entanglement between docs and drug companies today was a very slow, almost imperceptible process that occurred throughout the 20th century. The gradual nature of the entanglement explained why docs seemed to have developed no moral compass to guide them when things got seriously out of kilter.

Whitaker paints quite a different picture of the situation with psychiatry. He reminds us first how beleagured the field felt itself to be back in the late 1960s and early 1970s. First, internally, a pitched battle was beign fought among three camps--the newer drug-oriented shrinks; the traditional Freudians who sneered at drugs; and the emerging cadre of social psychiatrists who thought that environmental factors were more important in both causing and treating mental illness. From the outside, psychiatry was threatened with losing all its business as psychologists, psychiatric social workers, and other non-physician counselors set up shop and offered psychotherapy at lower rates. Finally, in academic circles, psychiatry was under attack from the anti-psychiatry movement of folks like Thomas Szasz (The Myth of Mental Illness), R.D. Laing, and, in popular culture, the film One Flew Over the Cuckoo's Nest.

The American Psychiatric Association responded to all this with what looks, for all intents and purposes, like a PR and marketing effort worthy of Toyota's recent efforts to restore America's confidence in its vehicles. Far from any "incremental" change, the dates at which all this happened can be readily determined, says Whitaker. It was in 1974 that the APA formed a task force to explore the possibility that the field could benefit from a large influx of Pharma dollars; and it was in 1980 that the APA adopted a new policy of encouraging drug companies to sponsor "scientific" talks at APA conventions.

Thus, says Whitaker, was formed an alliance unified to get the message out about the goodness of psychotropic drugs and the "chemical imbalance" view of mental illness. The APA and the drug companies both did their part in PR and public "education," and in suppressing as much as possible the dissemination of research results that did not hew to the party line. The NIMH joined forces by deciding that it should be a cheerleader for psychiatry; NIMH officials who harbored doubts about long term efficacy of drugs were forced out and few studies looking at dangers of drugs long-term, or nondrug treatment alternatives, could get funding. Finally, NAMI (National Alliance on Mental Illness), the grass-roots organization of patients and relatives, bought the claim that anyone who doubted the chemical-imbalance theory was denying that mental illness existed and telling NAMI members that your kid did not have a real mental illness, so it must be instead that you're just a bad parent. And of course the drug companies made sure generously to fund NAMI. (In light of this history the recent moves of the APA to distance itself from Pharma funding are even more noteworthy.)

Whitaker notes that the conventional party line has been so successful that he has had a great deal of trouble finding working examples of how mental illness, in his view, actually ought to be treated. He cites a handful of programs in Finland and the U.S. that do it the right way, starting off with nondrug approaches that stress human engagement with and human regard for the patient, and that resort of drugs only in the minority of cases that do not respond to repeated nondrug efforts. (The programs then try hard to get the patients off drugs after the initial symptoms resolve.) Again, to me, the recommendations he offers for solutions clearly put distance between him and disreputable sources such as Scientology.

Botton line-- this book poses serious challenges to many of our presuppositions. I await more insights from others as to its reliability.

Whitaker R. Anatomy of an Epidemic: Magic Bullets, Psychiatric Drugs, and the Astonishing Rise of Mental Illness in America. New York: Crown, 2010.

Thursday, May 6, 2010

Are We Seeing the New FDA Emerge?

According to a New York Times editorial--

--there may be positive changes in the air at the FDA, consistent with the more-hard-nosed team that the Obama administration had appointed to replace the generally pro-business folks of the previous regime. According to the Times:
  • The percentage of members of advisory boards granted waivers due to conflicts of interest has been reduced from 15 to 5 since 2007
  • Commissioner Margaret Hamburg has issued a letter to staff that any future proposed waivers have to be justified by descriptions of how hard the staff worked to try to find a neutral expert first
  • FDA will now release the name of the company involved in the conflict, and a rough dollar amount of the conflict, if a waiver is granted, as part of increased disclosure

The Times continues to hope that there will be less need for disclosure and no conflicts of interest, but also agrees these are all positive steps.

Upcoming Conference: Industry-Funded CME

Message from our esteemed colleague, Dr. Adriane Fugh-Berman of PharmedOut fame:

Please help us publicize our conference, "Prescription for Conflict:
Should Industry Fund Continuing Medical Education?" This is an issue that is critical to patients, providers and health care systems. While our primary audience is physicians, nurses, and other health care providers (6 CEU credits are available, and 5 CME credits are pending), it will be of interest to diverse groups, including educators, regulators, policymakers, ethicists, consumer activists, and students.
Our conference website for has just been updated. We have a new flyer , suitable for posting, available at ; the updated agenda is at
Thank you!
Adriane Fugh-Berman MD
Department of Physiology and Biophysics
Georgetown University Medical Center
Box 571460
Washington DC 20057-1460

Sunday, May 2, 2010

You Read It Here Second: Drug Giant Buys Belgium

Fortunately, this is just for laughs--this time:

(Thanks to our good friends at the Healthy Skepticism listserv for this tip.)