Medication: The smart-pill oversell

Unlock-Your-PotentialGiven the simultaneous explosion in ADHD diagnosis, prescribed use of stimulants and non-medical use of stimulants, maybe it’s time to look at the cost/benefit ratio. We’ll it’s clear that the benefits aren’t all that. What to make of it?

Researchers are beginning to address this paradox. How can medication that makes children sit still and pay attention not lead to better grades?

One possibility is that children develop tolerance to the drug. Dosage could also play a part: as children grow and put on weight, medication has to be adjusted to keep up, which does not always happen. And many children simply stop taking the drugs, especially in adolescence, when they may begin to feel that it affects their personalities. Children may also stop treatment because of side effects, which can include difficulty sleeping, loss of appetite and mood swings, as well as elevated heart rate.

Or it could be that stimulant medications mainly improve behaviour, not intellectual functioning. In the 1970s, two researchers, Russell Barkley and Charles Cunningham, noted that when children with ADHD took stimulants, parents and teachers rated their academic performance as vastly improved9. But objective measurements showed that the quality of their work hadn’t changed. What looked like achievement was actually manageability in the classroom. If medication made struggling children appear to be doing fine, they might be passed over for needed help, the authors suggested. Janet Currie, an economist at Princeton University in New Jersey, says that she might have been observing just such a phenomenon in the Quebec study that found lower achievement among medicated students1.

And it may simply be that drugs are not enough. Stimulant medications have two core effects: they help people to sustain mental effort, and they make boring, repetitive tasks seem more interesting. Those properties help with many school assignments, but not all of them. Children treated with stimulants would be able to complete a worksheet of simple maths problems faster and more accurately than usual, explains Nora Volkow. But where flexibility of thought is required — for example, if each problem on a worksheet demands a different kind of solution — stimulants do not help.

What about those non-medical users? Don’t they get a boost?

In people without ADHD, such as students who take the drugs without a prescription to help with school work, the intellectual impact of stimulants also remains unimpressive. In a 2012 study of the effects of the amphetamine Adderall on people without ADHD, psychologists at the University of Pennsylvania in Philadelphia found no consistent improvement on numerous measures of cognition, even though people taking the medication believed that their performance had been enhanced10.

via Medication: The smart-pill oversell : Nature News & Comment.

Top Posts of 2011 #6 – The Epidemic of Mental Illness: Why?

CNN.com summarizes a NYT Book Review review of three recent books that challenge conventional wisdom about mental illness.

All of the authors of the new books agree on two thought-provoking viewpoints:

1. Our understanding of categories of mental illness and their treatments has been influenced by drug companies, through both legal and illegal marketing.
2. Mental illness is not caused by chemical imbalances in the brain.

You can view a talk from the author of Anatomy of an Epidemic here. He does not appear to be the gadfly one might expect. He appears pretty dispassionate and grounded in (ignored) research.

My impression is that it might be unfair to say that he argues  “mental illness is not caused by chemical imbalances in the brain”. This would give the impression that he believes mental illness is entirely exogenous. Rather, he seems to argue three points:

  1. That we have been barking up the wrong trees focusing on dopamine and serotonin regulation for psychiatric symptoms;
  2. that we overestimate the helpfulness of psychiatric drugs and underestimate the long term harms; and
  3. that the assumption that psychiatric symptoms indicate a chronic brain imbalance is wrong and that many people experiencing psychiatric symptoms might be better off if they are not placed on psychotropics on a long-term basis.
He suggests a different path for treatment that does include use of medications:
This does not mean that antipsychotics don’t have a place in psychiatry’s toolbox. But it does mean that psychiatry’s use of these drugs needs to be rethought, and fortunately, a model of care pioneered by a Finnish group in western Lapland provides us with an example of the benefit that can come from doing so. Twenty years ago, they began using antipsychotics in a selective, cautious manner, and today the long-term outcomes of their first-episode psychotic patients are astonishingly good. At the end of five years, 85% of their patients are either working or back in school, and only 20% are taking antipsychotics.
I also just noticed this unrelated paper finding high rates of recovery from borderline personality disorder. This conflicts with the conventional wisdom and raises the question of whether “personality disorder” is the proper way to characterize what’s going on with these patients.

Pain, meds and money

Money behing healthcare by truthout.org

A few stories on opioids caught my eye.

First, one about methadone, pain and class:

Map the deaths and you see the story.

Assign a dot to each person who has died in Washington by accidentally overdosing on methadone, a commonly prescribed drug used to treat chronic pain. Since 2003, there are 2,173 of these dots. That alone is striking, a graphic illustration of an ongoing epidemic.

But it’s the clusters that pop out — the concentration of dots in places with lower incomes.

Everett, whose residents earn less than the state average, has 99 dots. Bellevue, with more people and more money, has eight. Working-class Port Angeles has 40 dots. Mercer Island, upscale and more populous, has none.

And two articles investigating ties between pain advocates and drug companies.

The first one looks at a few leaders in the pain advocacy movement:

Google Dr. Scott Fishman, chairman and president of the American Pain Foundation, or Dr. Perry Fine, a prominent board member, and it’s quickly clear that their ties to the world of pain are legion.

[Fine] appeared at the 2010 criminal trial of Anna Nicole Smith’s boyfriend and two doctors accused of conspiracy in fostering the late celebrity’s addiction to drugs. Fine testified that the 1,500 pills a month Smith was given did not make her an addict, according to news reports.

Fishman, chief of pain medicine at the University of California, Davis, and Fine, a professor of anesthesiology at the University of Utah School of Medicine, have authored articles on the foundation’s website. They’ve testified in court cases and before state and federal committees, and each has been president of the American Academy of Pain Medicine, a doctors’ group.

Last year, the pair and a third physician wrote a strongly worded column in The Seattle Times opposing a bill passed by Washington state lawmakers that required doctors and others to consult pain specialists before prescribing high doses of opioids to non-cancer patients. The governor signed it into law nonetheless.

Like the American Pain Foundation, both men have had longstanding ties to the pharmaceutical industry — direct and indirect. The foundation received 88 percent of its $5 million income last year from drug and medical-device makers.

This fall, the physicians acknowledged they had failed to disclose all their potential conflicts of interest in a letter to the editor of the Journal of the American Medical Association, which had been published in July. The journal requires all authors, even of letters, to disclose commercial ties.

In his correction, Fine listed 12 more companies for which he consulted, gave legal advice, delivered promotional talks or provided medical education. Among other things, he listed a 5 percent stake in a medical education company whose programs are funded by drugmakers.

Fine also appears to have played a role in launching a painkiller in 2009, ProPublica found. A subsidiary of Johnson & Johnson quoted him in its media release touting its new opioid.

ProPublica also found discrepancies in Fine’s disclosures to his employer, the University of Utah. For example, Fine told the university that he had received less than $5,000 in 2010 from Johnson & Johnson for providing “educational” services. On its website, however, the company says it paid Fine $32,017 for consulting, promotional talks, meals and travel that year.

The other focuses on the foundation:

The news about narcotic painkillers is increasingly dire: Overdoses now kill nearly 15,000 people a year — more than heroin and cocaine combined. In some states, the painkiller death toll exceeds that of car crashes.

But the pills continue to have an influential champion in the American Pain Foundation, which describes itself as the nation’s largest advocacy group for pain patients. Its message: The risk of addiction is overblown, and the drugs are underused.

What the nonprofit doesn’t highlight is the money behind that message.

The foundation collected nearly 90 percent of its $5 million funding last year from the drug and medical-device industry — and closely mirrors its positions, an examination by ProPublica found.

Although the foundation maintains it is sticking up for the needs of millions of suffering patients, records and interviews show that it favors those who want to preserve access to the drugs over those who worry about their risks.

Some of the foundation’s board members have extensive financial ties to drugmakers, ProPublica found, and the group has lobbied against federal and state proposals to limit opioid use. Painkiller sales have increased fourfold since 1999, but the foundation argues that pain remains widely undertreated.

It also offers some details of their advocacy efforts:

The group has intervened in court cases in ways that appear to counter its stated mission. In one example, it sided with Purdue Pharma, its longtime funder, to block a 2001 class-action case filed by Ohio patients who had become addicted to or dependent on the company’s blockbuster painkiller, OxyContin.

And the foundation mobilizes patients to send “outraged” email messages to news organizations that run stories it believes reinforce “stigmas and stereotypes” about the risks of pain medication.

The group’s board includes some patients but also doctors who are paid to speak and consult for drug companies, a researcher whose clinic has relied on their funding for survival and a public-relations executive whose firm represents them.

Last year, one board member was the lead author of a study about a Cephalon drug. Cephalon sponsored the study, and its employees were co-authors. The study found that the drug, Fentora, was “generally safe and well-tolerated” in non-cancer patients even though it is only approved for severe cancer pain.

The article also discusses divisions among pain docs:

“We bought into this idea that opioids would be effective and that the risk of addiction would be low,” said Dr. Jane Ballantyne, a longtime pain expert and a professor at the University of Washington.

But along the way, pain doctors split. Some, like Ballantyne, began decrying the increasingly widespread use of opioids and questioned whether the drugs worked. Others, like the foundation’s leaders, said the drugs were being unfairly maligned, making pain patients feel like criminals and discouraging doctors from prescribing them.

Despite the debate, sales of the drugs have skyrocketed.

Last year, $8.5 billion worth of narcotic painkillers were sold in the United States…

Their patient education efforts:

Its patient guide, paid for by four companies, discusses several treatments for pain. It says such pain relievers as aspirin, ibuprofen and naproxen commonly cause gastrointestinal bleeding or ulcers, delay blood clotting, decrease kidney function and may increase the risk of stroke or heart attack. And it warns patients to use these pain pills at the lowest dose and stop them unless clearly needed.

The side effects of opioids, on the other hand, are minor, and most go away “after a few days,” the foundation’s guide says. The underuse of opioids, it says, “has been responsible for much unnecessary suffering.”

Patients, it says, shouldn’t worry if they need more of a drug. They are not developing an addiction.

“Many times when a person needs a larger dose of a drug,” the guide says, “it’s because their pain is worse or the problem causing their pain has changed.”

And their legal and legislative advocacy:

The foundation doesn’t just offer advice about opioids; it takes its arguments into court.

In 2005, it filed a friend-of-the-court brief in the U.S. Fourth Circuit Court of Appeals in support of Dr. William Hurwitz, a pain doctor in Virginia who had been convicted on 50 counts of drug trafficking.

The doctor had been accused of prescribing a single patient as many as 1,600 Roxicodone pain pills in one day. Hurwitz allegedly had prescribed that patient alone more than 500,000 pills between July 1999 and October 2002.

The pain foundation and its allies argued that the jury instructions in the case didn’t distinguish between criminal behavior and mistakes by a well-intentioned physician. “It is not drug dealing to prescribe opioids to patients that might be ‘suspected’ addicts or substance abusers,” the foundation and two other groups wrote in a brief.

Rowe said the foundation intervened in the case on principle, fearing the drugs would be “demonized.” The appeals court threw out the conviction, but Hurwitz was retried and convicted on 16 counts of trafficking.

Years earlier, the foundation opposed several pain patients who had sued Purdue Pharma in an Ohio county court for allegedly obscuring the risks of OxyContin.

The foundation filed a friend-of-the-court brief backing Purdue, arguing that the health of all pain patients would be harmed if the class-action lawsuit went forward because doctors would become fearful of prescribing opioids.

Ohio was plagued by “opiophobia” according to a brief co-authored by the foundation and two smaller pain nonprofits. “Consequently many, if not most, of the state’s residents had been deprived of adequate pain care,” it said.

The Ohio Supreme Court decided in 2004 not to allow a class action.

In a separate federal case in 2007, Purdue pleaded guilty to misbranding OxyContin “in an effort to mislead and defraud physicians and consumers,” according to a statement from prosecutors. The company agreed to pay $600 million in penalties. Three top officials also pleaded guilty to misdemeanors and agreed to pay $34.5 million.

Two months after the conviction, however, then-foundation chairman Dr. James Campbell praised Purdue in a statement to a U.S. Senate committee.

It’s so bad that it stirs echos of tobacco companies. Appalling.

Just to be clear. I want patients in pain to have access to whatever meds they need to ease their suffering. I oppose any attempt to interfere in their care. At the same time, their can be no doubt that there are serious problems with people seeking and receiving prescriptions for the purpose of getting high or selling the pills. In addition, some patients are clearly getting more meds than they can keep track of or use, resulting in them being diverted by family, friends and others. You’d think that finding solutions that balance these needs would be something that no one would oppose.

“they will panic”

Dawn Farm has seen a marked increase in clients with recent histories of benzodiazepine (drugs like Xanax, Valium and Klonopin) use. These drugs are especially noxious because”

  • it is easy for people to develop physical dependence without realizing it;
  • withdrawal can be dangerous and involves seizures,;
  • more serious withdrawal symptoms often do not begin for a week, leading users to think, “It can’t be withdrawal. I haven’t used in a week.”;
  • less severe withdrawal symptoms like sleep disturbance, agitation and stress-sensitivity can last weeks and, of course, relief is one pill away.
One community mental health center has been overwhelmed by the problem and is taking action:

Gayle Mink, a nurse practitioner at a community mental health center here, had tired of the constant stream of patients seeking Xanax, an anti-anxiety drug coveted for its swift calming effect.

“It is such a drain on resources,” said Ms. Mink, whose employer, Seven Counties Services, serves some 30,000 patients in Louisville and the surrounding region. “You’re funneling a great deal of your energy into pacifying, educating, bumping heads with people over Xanax.”

Because of the clamor for the drug, and concern over the striking number of overdoses involving Xanax here and across the country, Seven Counties took an unusual step — its doctors stopped writing new prescriptions for Xanax and its generic version, alprazolam, in April and plan to wean patients off it completely by year’s end.

Read the rest at the NY Times.

Unintended consequences

90 day humility by katyhutch

This is not an argument against the use of pills but a pair of studies point to an unintended consequence:

Have you ever had that feeling, after an energetic gym session, or perhaps a long walk, that you’ve earned the right to a mountainous slice of cake, or to lounge lazily in front of the telly? Psychologists call these licensing effects and a new study has documented a similar phenomenon following the simple act of taking a vitamin pill. The researchers say the finding could help explain why the explosive rise in the consumption of dietary supplements (approximately half the US population take them, according to recent data) has not led to a commensurate improvement in public health.

On average, are patients on statins less likely to improve their diet and exercise? Probably. Could the same apply to antidepressants or opiate replacement medications?

One of the key strategies in Motivational Interviewing is to try to elicit “change talk”—statements that express desire, ability, reasons and need for change. Medications can chip away at reasons and need.

Again, if a patient needs a medication, they need it. But, practitioners should be thinking about how to mitigate this unintended consequence.

Smoking-pill suicides overlooked

Yikes!

Hundreds of reports of suicides, psychotic reactions and other serious problems tied to the popular stop-smoking drug Chantix were left out of a crucial government safety review because Pfizer Inc., the drug’s manufacturer, submitted years of data through “improper channels.”

Some 150 suicides — more than doubling those previously known — were among 589 delayed reports of severe issues turned up in a new analysis by the non-profit Institute for Safe Medication Practices.

The Epidemic of Mental Illness: Why?

CNN.com summarizes a NYT Book Review review of three recent books that challenge conventional wisdom about mental illness.

All of the authors of the new books agree on two thought-provoking viewpoints:

1. Our understanding of categories of mental illness and their treatments has been influenced by drug companies, through both legal and illegal marketing.
2. Mental illness is not caused by chemical imbalances in the brain.

You can view a talk from the author of Anatomy of an Epidemic here. He does not appear to be the gadfly one might expect. He appears pretty dispassionate and grounded in (ignored) research.

My impression is that it might be unfair to say that he argues  “mental illness is not caused by chemical imbalances in the brain”. This would give the impression that he believes mental illness is entirely exogenous. Rather, he seems to argue three points:

  1. That we have been barking up the wrong trees focusing on dopamine and serotonin regulation for psychiatric symptoms;
  2. that we overestimate the helpfulness of psychiatric drugs and underestimate the long term harms; and
  3. that the assumption that psychiatric symptoms indicate a chronic brain imbalance is wrong and that many people experiencing psychiatric symptoms might be better off if they are not placed on psychotropics on a long-term basis.
He suggests a different path for treatment that does include use of medications:
This does not mean that antipsychotics don’t have a place in psychiatry’s toolbox. But it does mean that psychiatry’s use of these drugs needs to be rethought, and fortunately, a model of care pioneered by a Finnish group in western Lapland provides us with an example of the benefit that can come from doing so. Twenty years ago, they began using antipsychotics in a selective, cautious manner, and today the long-term outcomes of their first-episode psychotic patients are astonishingly good. At the end of five years, 85% of their patients are either working or back in school, and only 20% are taking antipsychotics.
I also just noticed this unrelated paper finding high rates of recovery from borderline personality disorder. This conflicts with the conventional wisdom and raises the question of whether “personality disorder” is the proper way to characterize what’s going on with these patients.

Pediatric Ritalin Use May Affect Developing Brain, New Study Suggests

A new study identifies neurochemical changes from ritalin use:

Use of the attention deficit/hyperactivity disorder (ADHD) drug Ritalin by young children may cause long-term changes in the developing brain, suggests a new study of very young rats by a research team at Weill Cornell Medical College in New York City.

The study is among the first to probe the effects of Ritalin (methylphenidate) on the neurochemistry of the developing brain. Between 2 to18 percent of American children are thought to be affected by ADHD, and Ritalin, a stimulant similar to amphetamine and cocaine, remains one of the most prescribed drugs for the behavioral disorder.

“The changes we saw in the brains of treated rats occurred in areas strongly linked to higher executive functioning, addiction and appetite, social relationships and stress. These alterations gradually disappeared over time once the rats no longer received the drug,” notes the study’s senior author Dr. Teresa Milner, professor of neuroscience at Weill Cornell Medical College.

It will be interesting to see more research on the subject, particularly as we learn more about brain plasticity in adolescents.