The psychologist Abraham Maslow once wrote, “I suppose it is tempting, if the only tool you have is a hammer, to treat everything as if it were a nail.” This metaphor aptly describes the mindset that has plagued the field of psychiatry over the past couple of decades, particularly when it comes to treating children with severe forms of emotional and behavioral disturbance. The consequence of this one-tool-fits-all mentality has been an epidemic of Bipolar Disorder diagnoses and off-label prescribing of powerful anti-psychotic medications, which has often done more harm than good. Disturbingly, these trends persist—although there are signs that the pendulum may finally be swinging the other way, as reported by the New York Times:
OPELOUSAS, La. — At 18 months, Kyle Warren started taking a daily antipsychotic drug on the orders of a pediatrician trying to quell the boy’s severe temper tantrums.
Thus began a troubled toddler’s journey from one doctor to another, from one diagnosis to another, involving even more drugs. Autism, bipolar disorder, hyperactivity, insomnia, oppositional defiant disorder. The boy’s daily pill regimen multiplied: the antipsychotic Risperdal, the antidepressant Prozac, two sleeping medicines and one for attention-deficit disorder. All by the time he was 3.
He was sedated, drooling and overweight from the side effects of the antipsychotic medicine. Although his mother, Brandy Warren, had been at her “wit’s end” when she resorted to the drug treatment, she began to worry about Kyle’s altered personality. “All I had was a medicated little boy,” Ms. Warren said. “I didn’t have my son. It’s like, you’d look into his eyes and you would just see just blankness.”
Today, 6-year-old Kyle is in his fourth week of first grade, scoring high marks on his first tests. He is rambunctious and much thinner. Weaned off the drugs through a program affiliated with Tulane University that is aimed at helping low-income families whose children have mental health problems, Kyle now laughs easily and teases his family.
Ms. Warren and Kyle’s new doctors point to his remarkable progress — and a more common diagnosis for children of attention-deficit hyperactivity disorder — as proof that he should have never been prescribed such powerful drugs in the first place.
Kyle now takes one drug, Vyvanse, for his attention deficit. His mother shared his medical records to help document a public glimpse into a trend that some psychiatric experts say they are finding increasingly worrisome: ready prescription-writing by doctors of more potent drugs to treat extremely young children, even infants, whose conditions rarely require such measures.
More than 500,000 children and adolescents in America are now taking antipsychotic drugs, according to a September 2009 report by the Food and Drug Administration. Their use is growing not only among older teenagers, when schizophrenia is believed to emerge, but also among tens of thousands of preschoolers.
A Columbia University study recently found a doubling of the rate of prescribing antipsychotic drugs for privately insured 2- to 5-year-olds from 2000 to 2007. Only 40 percent of them had received a proper mental health assessment, violating practice standards from the American Academy of Child and Adolescent Psychiatry.
“There are too many children getting on too many of these drugs too soon,” Dr. Mark Olfson, professor of clinical psychiatry and lead researcher in the government-financed study, said. [full article]
(Cross-posted from my private practice site at kierstenmarek.com)
Nature Magazine has a new article in which a group of scientists and ethicists lay out a platform for supporting the idea that healthy people can and should seek cognitive enhancement through whatever means necessary — including psychiatric drugs. From the article:
Many people have doubts about the moral status of enhancement drugs for reasons ranging from the pragmatic to the philosophical, including concerns about short-circuiting personal agency and undermining the value of human effort. Kass, for example, has written of the subtle but, in his view, important differences between human enhancement through biotechnology and through more traditional means. Such arguments have been persuasively rejected (for example, ref. 17). Three arguments against the use of cognitive enhancement by the healthy quickly bubble to the surface in most discussions: that it is cheating, that it is unnatural and that it amounts to drug abuse.
In the context of sports, pharmacological performance enhancement is indeed cheating. But, of course, it is cheating because it is against the rules. Any good set of rules would need to distinguish today’s allowed cognitive enhancements, from private tutors to double espressos, from the newer methods, if they are to be banned.
As for an appeal to the ‘natural’, the lives of almost all living humans are deeply unnatural; our homes, our clothes and our food â€” to say nothing of the medical care we enjoy â€” bear little relation to our species’ ‘natural’ state. Given the many cognitive-enhancing tools we accept already, from writing to laptop computers, why draw the line here and say, thus far but no further?
As for enhancers’ status as drugs, drug abuse is a major social ill, and both medicinal and recreational drugs are regulated because of possible harms to the individual and society. But drugs are regulated on a scale that subjectively judges the potential for harm from the very dangerous (heroin) to the relatively harmless (caffeine). Given such regulation, the mere fact that cognitive enhancers are drugs is no reason to outlaw them.
Based on our considerations, we call for a presumption that mentally competent adults should be able to engage in cognitive enhancement using drugs.
I have written on Kmareka more extensively with concerns about the rapidly increasing use of psychiatric medication on children. While I have seen the benefits of medication use for children at times, I have also seen a full range of side effects including increased tolerance for the medications used, major medical problems, tics, sleep issues, growth issues, and more.
With adults, I think there is more room for accepting the idea that cognitive-enhancing use of medication is appropriate. Adults usually have a stronger sense of their baseline functioning and they are not as subject to developmental changes. But unlike the reasons for objecting to cognitive enhancements cited in the article (it’s cheating, it’s unnatural, and it amounts to drug abuse) my main concern remains that we do not know the long-term side effects of many of the drugs which are becoming more prevalent in their uses.
It comes down to what you consider to be a healthy level of caution when dealing with the unknown. Sometimes it seems like we’re playing with fire, but we humans have been known to enjoy playing with fire.
(This is cross-posted from my private practice site.)
Sharpbrains.com, one of the sites in our Technology & Helping Kids blogroll, has an article by Dr. David Rabiner in which he reviews some new research on teaching mindfulness meditation to teens and adults, and how study participants with attentional problems were helped by learning and practicing these techniques. The article also provides this summary for how study participants were trained in mindfulness meditation. From the article:
- Mindfulness Training -
Mindfulness meditation is described as involving 3 basic steps: 1) bringing attention to an “attentional anchor” such as breathing; 2) noting that distraction occurs and letting go of the distraction; and, 3) refocusing back to the “attentional anchor”.
This sequence is repeated many times during the course of each meditative session. As the individual becomes better able to maintain focus on the attentional anchor, the notion of “paying attention to attention” is introduced and individuals are encouraged to bring their attention to the present moment frequently during the course of the day.
By directing one’s attention to the process of paying attention, to noticing notice when one becomes distracted, and to refocusing attention when distraction occurs, mindfulness meditation training can be thought of as an “attention training” program. As such, examining the impact of such training on individuals with ADHD becomes a very interesting question to pursue.
The results of the study are encouraging, with 78% of participants reporting an overall reduction in ADHD symptoms. This was only a pilot study, but it’s a good indicator that meditation and mindfulness may play a key role in mental health.
I’m not a regular reader of Reader’s Digest, but this special report on the FDA provides a good examination of all the ways that the agency has become so compromised that they are barely doing the job they were set up to do. From the article:
Recent headlines have uncovered one shocking lapse after another at the Food and Drug Administration: A popular diabetes drug can sharply increase the risk of heart attack, a finding the agency knew but took two years to reveal. An FDA-approved antibiotic can destroy your liver in just five days. And despite mounting concerns about the safety of Chinese-made drugs, the agency had only enough field inspectors last year to check a mere 13 of the 714 Chinese factories that produce medicines for U.S. consumers.
Many of the nation’s leading doctors, scientists and lawmakers now agree that the FDA is in crisis. Lurching from one disaster to another, the 102-year-old agency learns of dangers too late and then moves too slowly to remedy them. Insiders say it’s woefully underfunded, dangerously understaffed and fractured by bitter internal tensions. Instead of depending on the FDA, Americans are doubting it — and for good reason.
The FDA is expected to regulate $1.5 trillion in food, drugs, vaccines, medical devices, blood and tissues, radiation-emitting machines, animal feeds and drugs, cell phones, dietary supplements, biotechnology and gene therapy — and, post-9/11, sniff out any food-borne terrorist plot. Yet the agency’s annual funding, $2 billion, is about what Fairfax County, Virginia, pays for its public schools.
“Think your pacemaker, heart valve, microwave oven or morning vitamin was inspected?” asks former associate commissioner William Hubbard. “Dream on.” [full text]
There is also a good related story about the drug Ketek, which somehow got through FDA approval even though it was so unsafe that it could ruin your liver in five days. The story provides frightening text from an FDA official’s email in which the official encouraged the drug makers to cover up the fact that many of the supposed participants in the clinical trials for the drug were fabricated.
The good news is that the public’s growing awareness of the problems with the FDA has finally led to some proactive change. But the changes are coming slowly and corporate influence still plays a major role in what drugs get to market and how fast. So for the time being, it’s every drug consumer for him/herself. Remember to use the tools available to you, particularly the internet and second opinions, in order to make informed decisions about medication use.
All cultural shifts are not created equal. When the culture shifts to the point where most Americans no longer find it unthinkable or undesirable for a woman or a black man to become President, that is progress. That is cultural growth. However, in a different milieu, when the culture shifts to the point where most Americans come to believe or expect that the solution to every physical, emotional, or behavioral problem lies in a pill (rather than, say, a healthier and more balanced lifestyle), that is not progress. That is cultural brainwashing, which only serves to stunt growth.
The young men and women who have cast their ballots for a presidential candidate for the first time this year have grown up in an era in which the widespread promotion and use of prescription drugs is more the rule than the exception. The wired generation has only known a time when the television shows that they watch, the magazines that they peruse, and the websites that they surf through have been saturated with ads from the pharmaceutical industry. They have only known a time when their physicians have been subjected to a full-court press from drug company sales representatives and been exposed to an increasing amount of medical research paid for by those same companies (while public funds for research have continued to dry up). They have only known a time when a good number of their peers have been labeled ADHD or depressed or bipolar and been placed on any number of medications (which have frequently not been formally approved for use on children). As our youth enter adulthood, they are in danger of accepting these practices and the rampant profiteering that underlies such as the norm. They are in danger of not only buying the drugs that are pushed upon them but buying the paradigm that the drugs are the answer to whatever may ail them. That is not progress.
From the New York Times:
John C. Lechleiter, an Eli Lilly official who is about to become the companyâ€™s top executive, wrote an e-mail message in 2003 that appears to have encouraged Lilly to promote its schizophrenia medicine Zyprexa for a use not approved by federal drug regulators.
Mr. Lechleiterâ€™s comments came in a March 2003 e-mail message he wrote to other Lilly executives, after he traveled to Cincinnati to watch Lilly sales representatives talk to doctors.
The e-mail message was discussed this week in an Anchorage courtroom in a lawsuit against Lilly by the State of Alaska. The suit seeks reimbursement for the medical costs of Medicaid patients who developed diabetes while taking Zyprexa.
The drug causes severe weight gain and cholesterol problems in many patients and has been linked to diabetes.
Zyprexa is federally approved only for use by adults diagnosed with schizophrenia or bipolar disorder. While doctors are free to prescribe it â€œoff labelâ€? for any patients for any use, it would be a violation of federal law for Lilly to actively encourage off-label use of the drug.
The federal government has investigated drug companies before for off-label promotion of their medicines, but Mr. Lechleiterâ€™s note provides rare documentation of a senior drug executiveâ€™s openly discussing the practice.
A spokeswoman for Eli Lilly said Mr. Lechleiter was not advocating off-label promotion in his note but simply wanted the company to respond to physiciansâ€™ requests for information.
In his e-mail message, Mr. Lechleiter discusses the use of Zyprexa by children and teenagers.
Mr. Lechleiter, who was then the companyâ€™s executive vice president for pharmaceutical products, noted to other Lilly officials that company representatives were already promoting Strattera, a second Lilly psychiatric drug, to pediatricians and child psychiatrists. The representatives could also discuss Zyprexa with such doctors, he said.
â€œThe fact we are now talking to child psychs and peds and others about Strattera means that we must seize the opportunity to expand our work with Zyprexa in this same child-adolescent population,â€? Mr. Lechleiter wrote in the message.
He also encouraged Lilly to get data on the use of Zyprexa in treating â€œdisruptive kidsâ€? in order to increase the drugâ€™s sales.
The company declined to make Mr. Lechleiter available for comment.
Because of Zyprexaâ€™s physical side effects, many psychiatrists now say it is appropriate only for severely mentally ill patients. Clinical trials have shown that its tendency to cause dangerous weight gain appears to be especially pronounced in younger patients. The Food and Drug Administration has for more than a year declined to act upon an application by Lilly to broaden the drugâ€™s label to allow its use in people under 18.
No worries for Eli Lilly, though, as the article goes on to say:
Since 2003, as information about the drugâ€™s risks has spread, prescriptions for Zyprexa have fallen sharply in the United States. But Lilly has repeatedly increased the drugâ€™s price to counteract the slumping prescriptions, and Zyprexa remains by far Lillyâ€™s best-selling product, with worldwide sales of $4.8 billion last year, about half in the United States. Zyprexa now costs about $8,000 a year at commonly prescribed doses. [full text]
As with many behavior problems, acknowledging that you have the problem is usually the first step to effective behavioral treatment. Unfortunately for children, we frequently skip right over behavioral treatment and give a drug, but that’s another subject. The point here is that, after tough questioning from Sheldon Whitehouse and others, the Drug Enforcement Agency (DEA) has recognized “the importance of establishing a rule to permit the responsible electronic prescribing of controlled substances.” But now they need to hand the issue off to two other huge bureaucracies, the Office of Management and Budget (OMB) and the Department of Justice, where solutions could be delayed for an undetermined amount of time. From the Whitehouse Press Office:
Studies show that widespread e-prescribing, used today in about 18 percent of doctorsâ€™ practices, could save $20 billion annually, as patients would experience fewer adverse drug events (ADEs) and would be more likely to adhere to a medication regimen. The Center for Information Technology Leadership (CITL) found that a national e-prescribing system could prevent 2.1 million ADEs –130,000 of which are life-threatening — and 190,000 hospitalizations per year.
Current DEA regulations require that doctors write paper prescriptions for controlled substances, such as pain medications, antidepressants and some drugs used to treat asthma in children. As a result, many doctors resort to writing all their prescriptions by hand rather than maintain a paper system for controlled substances and an electronic system for non-controlled substances.
During the Judiciary Committee hearing, Whitehouse and Senator Tom Coburn (R-Okla.) pressed DEA Deputy Assistant Administrator Joseph T. Rannazzisi, of the Office of Diversion Control, on DEA’s timeframe to revise the existing rules, stressing that further delay could slow the development and implementation of a nationwide, integrated system to support health information technology. “You’ve seen intense bipartisan concern about this. This is not an issue where we’re going to go away,” Whitehouse said at the hearing.
Rannazzisi agreed to inform the Committee, within two months, on when a proposed rule would be issued. Following the hearing, Whitehouse and 18 other senators wrote to Attorney General Michael Mukasey, asking him to review the issue and urging the Drug Enforcement Administration to issue new rules promptly.
As we create systems for e-prescribing, I hope we will also work on the problem of overprescribing, particularly as it relates to children and psychiatric care.
Apparently, aggressively using antipsychotic medication to treat aggression is now in question, as reported by Benedict Carey of the New York Times:
The drugs most widely used to manage aggressive outbursts in intellectually disabled people are no more effective than placebos for most patients and may be less so, researchers report.
The finding, being published Friday, sharply challenges standard medical practice in mental health clinics and nursing homes in the United States and around the world.
In recent years, many doctors have begun to use the so-called antipsychotic drugs, which were developed to treat schizophrenia, as all-purpose tranquilizers to settle threatening behavior â€” in children with attention-deficit problems, college students with depression, older people with Alzheimerâ€™s disease and intellectually handicapped people.
The new study tracked 86 adults with low I.Q.â€™s in community housing in England, Wales and Australia over more than a month of treatment. It found a 79 percent reduction in aggressive behavior among those taking dummy pills, compared with a reduction of 65 percent or less in those taking antipsychotic drugs.
The researchers focused on two drugs, Risperdal by Janssen, and an older drug, Haldol, but said the findings almost certainly applied to all similar medications. Such drugs account for more than $10 billion in annual sales, and research suggests that at least half of all prescriptions are for unapproved â€œoff labelâ€? uses â€” often to treat aggression or irritation.
The authors said the results were quite likely to intensify calls for a government review of British treatment standards for such patients, and perhaps to prompt more careful study of treatment for aggressive behavior in patients with a wide variety of diagnoses.
Other experts said the findings were also almost certain to inflame a continuing debate over the widening use of antipsychotic drugs. Patient advocates and some psychiatrists say the medications are overused. [full text]
I saw Elizabeth Roberts at a fundraiser we attended this past weekend. She said that the numbers showing up for the Healthy RI sessions increased from the first session to the second, and they are hoping for even greater attendance tomorrow. Details of tomorrow’s session are as follows:
PROVIDENCEâ€”Lt. Gov. Elizabeth Roberts will convene the third session of Mission: Healthy RI this Friday, December 7th from 7:30 to 9:00 a.m. at the Business Innovation Factory located at the Rhode Island Economic Development Corporation’s headquarters on Valley Street . This week, participants will hear from Christine Ferguson, the former director of the Rhode Island Department of Human Services under Governor Lincoln Almond and an expert in the state’s use of federal funds for health care, including RIte Care. Ferguson will lead a discussion on the current state of the Rhode Island Medicaid programs, the future of federal health funding, and the potential for leveraging public health care dollars as we move forward toward covering all Rhode Islanders.
Mission: Healthy RI is an advisory work group of representatives from the medical community, the insurance industry, hospitals, business owners, labor leaders, patients, and other stakeholders. The group will work with Roberts as she moves the state toward a plan to ensure that all Rhode Islanders have access to the highest quality health care at a cost they can afford. Roberts plans to introduce a package of health care reform legislation during the 2008 session.
Over the next two months, Lt. Gov. Roberts’ Mission: Healthy RI advisory work group will focus closely on specific issues that surround the complicated process of comprehensive health care reform. The deliberations and dialogue during each session will be framed by presentations from national and local experts who have experience in specific areas surrounding reform.
Mission: Healthy Rhode Island is open to the public. Invitations were sent out to key stakeholders and members of the public are encouraged both to attend and participate. All sessions will be on Friday morning and will start promptly at 7:30 a.m. and end by 9:00 a.m., with media availability of both the speaker and Lt. Gov. Roberts directly following the session. Sessions are scheduled for December 7th, 14th, 21st, January 4th, 11th, and 18th.
Who: Lt. Gov. Elizabeth Roberts; attendees of the Mission: Healthy RI advisory work group; members of the public
What: Lt. Gov. Elizabeth Roberts to host second session of Mission: Healthy RI
When: Friday, December 7, 2007
7:30 a.m.- 9:00 a.m.
Where: Economic Development Corporation Headquarters
Business Innovation Factory
American Locomotive Works Development
555 Valley Street, Providence
Though I am not able to attend tomorrow’s session, I hope to get to at least one of these and bring up some ideas on how to increase quality and decrease costs in health care. As I discussed in an earlier post, USA Today recently did a series of articles called called “Prescription for Change” which outlined a number of ways we could decrease costs and increase quality such as:
Advance Directives: One way is to allow states to give people the option of limiting their end of life care, helping them with forms that clarify advance directives. Some states are already doing this to good effect, and Rhode Island could follow their lead.
Reduce Costly and Ineffective Surgeries: Another way is for doctors to perform less surgeries that are costly and often ineffective. Government could support this practice by providing more public information online and in print for people to review the research on effectiveness for controversial surgeries.
Use Generic, Safer Medicines First: Another practice guideline that could be supported by government is better effectiveness and safety research on medicines before they are put on the market (i.e. regulations and guidelines that reduce corporate influence of the FDA). Generic, cheaper medicines should be given first consideration when the newer, expensive options are not proven to be more effective and may have more dangerous side effects.