DC Medical Malpractice & Patient Safety Blog

The Practice Guideline for the Treatment of Patients with Major Depressive Disorder is the primary resource for clinicians who treat patients with depression, which often involves prescribing drugs. Researchers from the University of Massachusetts, Boston, examined financial and intellectual conflicts of interest involved in the process of defining the guidelines to see if outside influences affect patient care.

Their conclusion isn’t pretty: “The prevalence of conflicts of interest among panel members was high. The quality of the evidence cited raises questions about the validity of the recommendations.”

The study, published in the Journal of Evaluation in Clinical Practice, showed that all of the people who devised the guidelines, published by the American Psychiatric Association (APA), had numerous financial ties to drug companies that manufacture antidepressants.

That’s like compiling a buying guide for safe automobiles when all of the authors work for Ford.

A lot of attention has been paid lately to psychotropic drugs (those that affect brain function, emotions and behavior) because of widespread concern that they are overprescribed and misprescribed. (See our recent blog posts, “Misuse of Antipsychotic Drugs Is Off the Charts,” and “Atypical Antipsychotic Use High in Children.”)

We’re all familiar with the suspect marketing behavior of drug manufacturers, but this study is an indictment of the behavior of the people we personally must trust with our lives.

The researchers evaluated the quality of the evidence the committee used to advise prescribing antidepressant medication. The APA recommends drugs as a first-line treatment for all levels of depression, but the study found that more than one-third of the research panelists cited in support of drugs for depression did not examine outpatients with major depressive disorder; 17 percent of their references didn’t measure clinically relevant results.

“The recommendation for antidepressants for mild depression is not congruent with the evidence,” the researchers said, noting that guidelines produced by the National Institute for Clinical Excellence say that antidepressants should not be first-line intervention for mild depression, and that Dutch guidelines recommend them as first-line treatment only in cases of severe depression because people may be exposed to unnecessary harm.

In order not to put patients at risk, the researchers said, it’s critical for groups developing clinical practice guidelines to pay attention to the quality of the studies they cite as well as to any bias resulting from conflicts of interest.

Every member of the APA guideline committee disclosed financial ties to the pharmaceutical industry. Some members had nine such relationships; some had 33.

None of them should have any.

Most of the committee members participated in pharmaceutical companies’ speakers’ bureaus. According to a UMass news release about the study, doctors serving on a speakers bureau are known as “Key Opinion Leaders” or “KoLs” because they are so important to the marketing of a drug. And some members of a separate independent panel charged with mitigating any effect of committee conflicts had undeclared financial relationships with drug manufactures.

Do these sound like people who should be treating your disorder, much less advising other professionals how to do it? Or do they sound like people who should be kept as far away from a clinical setting as the moon is from the Earth?

Sometimes, we read an article or book about health, medicine and/or patient safety that’s fascinating but too long to summarize fairly in a blog post. So here’s a shout-out to a few recent stories you might want to look up, on a common theme.

According to the Centers for Disease Control and Prevention (CDC), drug overdose death rates in the U.S. have more than tripled since 1990 and have never been higher. Most of these deaths, says the CDC were caused by prescription drugs. In the last several months, the Los Angeles Times has published a series of investigative articles about the epidemic of prescription deaths. The four-part series explains how legal drugs have deadly outcomes, how reckless doctors and rogue pharmacists contribute to the problem, how regulatory authorities allow problems to fester and what they can do to address it. Link here.

Also, see our blog, “Doctors Don’t Know Dangers of Narcotics, and FDA Leaves Drug Makers in the Driver’s Seat.”

“NPR’s Akathisia Blind Spot,” was posted on Paul John Scott’s website devoted to “groupthink in science medicine and fitness—popular culture and the madness of crowds.” In the eloquent essay, he indicts the media for continuing to ignore a major side effect of a class of anti-depressant drugs known as SSRIs—selective serotonin reuptake inhibitors--including Celaxa and Lexapro. “[T] he problems with SSRIs and suicide seems no closer to being articulated in the culture at large, let alone resolved, beyond a few ardent voices and the small print on some drug labels that, thanks to the silent skepticism of so many, no one really knows what to think of.” Link here.

“Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients,” Dr. Ben Goldacre’s new book, addresses our culture’s willingness to believe that drug treatment is based on evidence, that doctors are familiar with the latest drug studies, that drug research is pure science unpolluted by conflicts of interest and that when it comes to drug safety, regulators have our back.

As readers of this blog know, that’s fiction. Goldacre shows how the manipulation of the prescription drug market has been protected from public scrutiny because it’s too complex to capture in a sound bite. Goldacre untangles the tale in the hope that all patients and medical professionals can understand the tricks and distortions inherent in Big Pharma. Link here.

Intensive care in hospitals includes extreme measures that can induce delirium in many patients, and that, doctors are now discovering, don't necessarily go away when the patient leaves the ICU.

About 3 in 4 ICU patients develop delirium, according to a story in the Philadelphia Inquirer, and delirium is associated with poorer survival rates and worse long-term outcomes.

It has long been known that ICU delirium sometimes includes delusions and hallucinations. Some ICU patients have believed that that they were being assaulted or imprisoned; that their nurses were plotting to kill them; that the walls were covered in blood; that huge spiders were riding bicycles in the room.

Medical professionals used to think patients left these disturbing adventures in the ICU, but now they acknowledge that sometimes they take their terrifying false memories home with them. A recent Johns Hopkins study found that 1 in 4 patients had post-traumatic stress symptoms two years after going home.

Many former ICU patients struggle with physical weakness, thinking problems, anxiety, depression and post-traumatic stress disorder (PTSD); you might be more familiar with that disorder as associated with soldiers returning from a war zone, or victims of sexual assault.

What’s unusual among hospital PTSD victims, the study said, is that their flashbacks are of delusions or hallucinations they had in the hospital, not events that actually occurred. “Having a life-threatening illness is itself frightening,” according to the Cambridge Journal blog, “but delirium in these patients — who are attached to breathing machines and being given sedatives and narcotics — may lead to ‘memories’ of horrible things that didn’t happen.”

Last year, the Society of Critical Care Medicine gave ICU PSTD its own name—post-intensive care syndrome (PICS). The society says that as many as 1 in 5 ICU patients might suffer from it. With a diagnosis, generally, comes a refocusing of professional resources on how not only to save lives in the ICU, but to address its effects after hospital care.

PICS can be tricky to fix because patients often look OK after they've been home for a while; their family and friends might not understand why they’re aren’t bouncing back. It’s also difficult to address, says The Inquirer, because it can take ICU doctors so long to notice the problem they often don’t see patients who recover enough to be moved to another floor.

So, critical care docs are learning how to educate their primary-care colleagues and others who manage a patient’s discharge and follow-up care.

Savvy ICU staff hope to minimize PICS with changes in how they care for their patients. The key is to reduce the delirium by administering less sedation, ensure 24-hour visitation, starting physical therapy sooner and making sure rooms are dark night to promote sleep.

An awareness of PICS, it’s thought, also can improve other ICU problems. Every year, approximately 1 million Americans are hooked to a ventilator in an ICU. That can lead to lung problems or sepsis, a serious infection. The PICS findings might translate to a broader group of delirious patients who were not in ICUs.

It’s estimated that at least half of ICU survivors have trouble with basic living activities a year after discharge. Of those with severe lung problems, 55 in 100 had cognitive impairment, according to one study, and 36 in 100 had depression.

But even if there’s no such diagnosis, former ICU patients still might be weak and tired long after they go home. They have trouble concentrating, making decisions and remembering; they might be emotionally fragile, and are plagued with upsetting memories.

Some of their delusions seem related to the patients’ legitimate care, such as placing catheters and breathing tubes. One patient who had gotten an MRI thought he was on a conveyor belt feeding into an oven.

If you have a breathing tube down your throat, you can’t even tell anyone what you believe is happening to you. Doctors have learned to suspect a trauma disorder if patients are particularly combative once the tubes are removed. And some ICUs now screen patients daily for delirium by asking questions such as: Can a stone float on water? Patients with delirium will say yes.

If your loved one is in ICU, make sure the staff knows you’re familiar with PICS, and ask what they know about the syndrome.

Also, visit as often as you can, and bring familiar objects from home. Hearing a familiar voice, said one expert interviewed by The Inquirer, is not only "vocal anesthesia," but helps to anchor the patients in reality. Make sure the room is as dark and quiet as possible during normal nighttime sleeping hours. Find out how much sedation the patient is being given, and ask if it’s the lowest dose possible.

And when it’s time for discharge, ask transition care team members how to recognize and address the effects of delirium. Make sure they have a plan for treating its long-lasting effects.

For the first time since 1994, the American Psychiatric Association (APA) has approved a revision to its primary guide, the Diagnostic and Statistical Manual of Mental Disorders (DSM).

It’s the fifth edition of the manual, dubbed DSM-5, which is like the dictionary of mental disorders. Its definitions are the foundation of how mental disorders are treated -- and how and whether that treatment gets compensated by insurance companies. The book’s formal release is in May.

We wrote about how the new DSM is likely to address substance abuse in our blog earlier this year. As described on MedPageToday.com, more than 160 clinicians and researchers worked on the DSM-5, assisted by hundreds of other clinical investigators and thousands of comments from health professionals and the general public.

Significant changes since DSM-4 include an end to the system of "axes," which classify diagnoses into broad groups. Instead, diagnostic groups will be restructured so that disorders believed to be biologically related fall under the same headings. There’s also now a measure to indicate the severity of symptom.

If that seems rather science-y—that is, something that might make you ask, How does this affect me?—well, NPR has some ideas how theory will filter down into practice. There’s always controversy when the DSM is revised, and the DSM-5, NPR says, is the most controversial edition of all.

Until May, there’s only speculation about the exact nature of its changes. But, according to NPR, these are likely to be among them:

• Elimination of Asperger's Syndrome. It’s a popular diagnosis often used by mental health professionals to identify people with mild autism. Instead, look for a spectrum of autism, and people who would once have been diagnosed with Asperger's will instead be diagnosed as mildly autistic. Many people with Asperger's syndrome oppose this change.

  As posted on MedPage Today, a statement from the chief science officer for Autism Speaks said the group remained "concerned about the impact of the new DSM-5 criteria when they are used in real world settings. The field trials are somewhat reassuring that the criteria are working well, but these trials are based on a relatively small number of children. We still have very little information about the impact of the DSM-5 on diagnosis of autism spectrum disorder in young children and adults."

  The group is concerned that autistic kids might be classified out of that diagnosis to a lesser one. As the statement continued, "We want to make sure that no one is excluded from obtaining a diagnosis and accessing services who needs them."

  As explained on NPR, if the disruptive behavior of a child is deemed to be a disorder — like attention deficit hyperactivity disorder (ADHD) or autism — schools pitch in with subsidized services. If not, kids can be seen simply as troublemakers, and can be penalized for behavior they might not be able to help.

• Advent of a new childhood disorder called disruptive mood dysregulation disorder. This proposal is the result of many clinicians believing that too many children were being categorized as having bipolar disorder and prescribed anti-psychotic drugs. The hope is that the new diagnosis will mean fewer kids are overdrugged and that diagnoses of bipolar diminish.


• Revision of the concept of bereavement. DSM-4 warned psychiatrists away from diagnosing major depression in people who had recently suffered the death of a loved one because grief in the face of loss was seen as a normal — not abnormal — response. Such a response is not illness, but an appropriate human experience. But telling psychiatrists that people who are grieving shouldn't be diagnosed as depressive, as one expert said, "excludes a bereaved person from being diagnosed with depression, if they have a depression, and no one wants to do that, either."

  If it seems like hair-splitting, NPR suggests that there’s a broader lesson: the expansion of behaviors considered abnormal, such as when shyness becomes "social phobia," and restlessness becomes ADHD.

Such is the torturous terrain of the human mind. As Dr. Roger Peele, secretary of the APA observed on NPR, "It's important that people not see the DSM as a bible, that they respect it but don't worship it."

The researchers, Peele said, worked hard to make the manual as good as they could figure, but its wisdom is really just their best guesses about how to think about mental disorders and, by extension, treat them.

The New York Times' Benedict Cary wrote an excellent piece this week summarizing the various controversies surrounding the new DSM and how they were worked out.

The advent of Medicare’s Part D drug plan introduced everyone to the concept of the “donut hole.” That’s the point at which prescription drug coverage ceases for a period during which the plan member pays full price. The gap closes when the patient has spent a set amount for drugs, and subsidies resume. As reported by Reuters Health, research has shown that this gap prompts seniors to stop taking medications for heart problems, diabetes and, now, depression.

According to the researchers of a new study published in the Archives of General Psychiatry, when these patients stop taking antidepressants, their risk of relapse increases. Such behavior, they said, “poses a serious risk.”

Once beneficiaries pay a deductible of a few hundred dollars, Part D drug plans usually cover 75 percent of drug costs until the threshold figure is reached. This year, for standard coverage, that amount is nearly $3,000. Then patients must shell out another $3,700 (amounts vary according to plan) before coverage resumes.

If the Affordable Care Act survives the current political upheaval, the donut hole will expire in 2020, when the legislation mandates that drug coverage be constant. But that’s a long time away, especially if you’re a senior citizen.

We’ve discussed how the insurance coverage options available to supplement Medicare are so confusing that seniors are less likely to enroll for additional coverage. But the study makes clear, however, that they are less likely to forgo their drugs if they have it.

The study involved more than 22,000 Medicare beneficiaries who had been diagnosed with depression and were prescribed antidepressants. Data was collected starting in 2007, the year after the Part D plan was initiated. Nearly 3,000 study subjects had supplemental insurance that filled the gap for generic drugs. Another 11,500 had complete coverage from other sources, including low-income subsidies. But more than 7,500 were stuck paying the gap amount.
Nearly 7 in 100 people who had generic drug gap coverage ceased taking their antidepressant meds, but more than 12 in 100 with no coverage did.

As the study notes, depression affects 13 in 100 Medicare beneficiaries 65 years or older. Many have additional chronic physical conditions. Treating and maintaining treatment of late-life depression with antidepressants prevents recurrent episodes of major depression. Caregivers generally recommend these patients take antidepressants for two years.

It’s a bad idea to stop taking these drugs cold turkey. As the lead researcher wrote, "If patients discontinue their appropriate medication therapy abruptly, they could be placing themselves at risk for medication withdrawal effects [including include dizziness, gastrointestinal distress, disturbing dreams, fatigue and irritability] and for (depression) relapse or recurrence."

Although the study didn’t find that rates of hospitalization were higher for the no-gap coverage group than the others in the study, the depressed elderly population remains vulnerable to the Part D donut hole.

If you or a loved one is in this situation, help is available. Contact the manufacturer of the relevant drug—they often have coupons or rebate/subsidy programs for the financially pinched. That link also includes contact information for other prescription assistance organizations, as well as general resources for seniors. For general information about Medicare’s prescription drug coverage, link here.

When psychiatrists, psychologists, researchers and insurers want to identify and classify a psychiatric disorder, they turn to the Diagnostic and Statistical Manual of Mental Disorders. Compiled by the American Psychiatric Association, and widely known as the DSM, the reference guide spells out criteria for making a given diagnosis. As the body of science grows and the understanding of mental disorders evolves, cultural priorities change. The DSM does too. It’s a dynamic resource.

Originally published in the 1950s, the DSM was intended as a public health service to document the incidence and prevalence of mental illness and to classify mental illnesses with objective criteria. By its third edition in 1980 (DSM-III), it had become the primary reference for clinicians. (A few years ago, we wrote about how some writers of the DSM-IV had financial links to the pharmaceutical industry.)

Another revision, DSM-V, is scheduled to be released next spring.

According to Kaiser Health News, the new changes affect more than a dozen categories of disorders including substance use and addiction.

Gone from the new guidelines would be the diagnostic categories of "substance abuse" (which embraces short-term problems including driving drunk) and "substance dependence" ( a chronic problem marked by tolerance or withdrawal). Instead, "substance use and addictive disorders" would cover both.

The merged criteria would be applied to the use of alcohol, cigarettes, illicit or prescription drugs and other substances into a single, 11-item list of problems typically associated with these disorders--being unable to reduce or control the use of the substance, and failing to meet one’s obligations.

Diagnoses would be based on how many criteria the patient meets: 0 to 1 = no disorder; 2 to 3 = mild disorder; 4 to 5 = moderate disorder; 6 or more = severe disorder.

Advocates contend that by creating a category for mild disorders, it might be easier to identify and address drug or alcohol problems before they become serious. It might be easier, they say, for primary care doctors to be reimbursed by insurers for screening for alcohol and drug problems, and conducting short counseling sessions that have been shown to be effective.

Under the federal health care reform law adopted in 2010, screening and behavioral counseling to reduce alcohol misuse is covered as a free preventive benefit for people in many health plans.

According to the National Institute on Alcohol Abuse and Alcoholism, a man is at risk for developing a substance use disorder if he drinks more than four drinks in a single day and more than 14 drinks per week; a woman’s risk is three drinks in a single day and more than seven drinks per week.

Some experts interviewed by KHN are troubled by the 11-point list of criteria that moves substance use disorders along a continuum from mild to severe. They say that clinical research does not support a natural escalation from nonuse to occasional use to risky use to addiction.

Some people, they point out, suffer sadness or transient depression when bad things happen to them, but that doesn’t mean they’ll progress to psychotic depression. The same could be true for substance abuse.

What if a college student had an episode of frat-party binge drinking and missed classes because of it (earning a score of 2)? What if he’s labeled as having a mild addictive disorder that might not be accurate? What if he resists treatment because he resents the label of “addict”?

Still, if your pattern is to drink heavily only in a social or recreational setting, you might be at risk for a substance use disorder. Consider that you might be putting yourself and others in danger.

Substance abuse might not have affected your work or personal life, but if certain events regularly prompt you to drink too much or take illicit drugs, you have a much higher risk of having a car accident or liver problems. If that describes you, consult your primary care doctor about the possibility of short-term treatment.

The hospital’s emergency room is filled with patients representing a range of urgent problems. The kid with a broken ankle, courtesy a bumpy slide at second base. The woman wearing dark sunglasses and cradling her migrained head. The guy pressing a towel into the web of his hand to stanch the blood from a knife meant to cut a bagel. The hyperactive, foot-tapping college student who alternates between nonstop chatter and low, howling moans, in the throes of an anxiety attack, schizophrenia or who knows what.

Who will be seen first, who will get treated quickly, how long will it take to admit someone who should be an inpatient?

This is a hypothetical example. But it’s pretty certain not to be the patient with the mental disorder. A study published in the Annals of Emergency Medicine showed people presenting at hospital emergency departments and trauma centers with psychiatric problems spent more than 11 hours in the ER, and that they wait even longer if they must be transferred for admission.

If the psych patient is older, intoxicated or uninsured, according the study, the wait is even longer. The time doubled if the patient was discharged not home but to an outside facility.

As reported on MedPageToday, the conclusions highlight how interrelated is mental health care, and how much room there is for improvement for to coordinate care.

This isn’t news. National Center for Health Statistics showed that the average wait for mental health services in an emergency department was 42 percent greater than the wait for other health issues.

In a survey by the American College of Emergency Physicians, 40 percent of emergency department medical directors said psychiatric patients waited more than eight hours from disposition decision to discharge from the ED. Only 7 percent of the directors said medical patients had to wait that long.

In addition to being inconvenient and distressing, waiting too long in an ER can be harmful. See our post, “ER delays cause patients to skip care.”

Some ERs are better able to process psych patients than others.

"Emergency departments (EDs) that are embedded within a larger system of care and have ready access to various levels of after care options,” the researchers wrote, “are likely to be better positioned to more rapidly transition patients through the ED."

There’s still not much authoritative data about just how much psychiatric patients are penalized in the ER because their disorder isn’t visible or exciting or … what? So the latest research was aimed at identifying patient-related and clinical management factors associated with longer ED waits.

Psychiatric patients seeking emergency consultation at five urban hospitals—two academic and three community—were studied. More than 1,000 patients were included. The median age was 39, and the gender representation was equal. About 7 in 10 were non-Hispanic white; two-thirds had public insurance; 13 percent were homeless.

The most common complaints were depression or anxiety (37 percent) and suicidal thoughts or nonlethal self-harm (33 percent). One in 3 showed evidence of alcohol use, with or without other drugs.

On discharge, the most common diagnoses were mood disorder (69 percent) and substance use disorder (41 percent). Nearly 300 patients were discharged to home and nearly 600 were admitted to the hospital or transferred to a psychiatric unit.

The average wait times and average added times were:

• transfer outside the care system, 15 hours;


• transfer within the system, 12.9 hours;


• transfer to psychiatric unit in hospital, 11 hours;


• age: 12.6 hours for ages 60 and older, 11.9 hours for ages 41 to 59, 10.7 hours for ages 18 to 40;


• positive screen for alcohol, more than 6.2 hours;


• diagnostic imaging, more than 3.2 hours;


• use of a restraint, more than 4.2 hours;


• uninsured, more than 4 hours.

Being admitted or transferred resulted in an additional wait of 3.3 to 7.4 hours. The long wait after diagnosis and before admission/transfer, the researchers said, was the single biggest influence on how long a patient would be confined to care.

"Approximately two-thirds of all patients receiving emergency mental health care … were either admitted or transferred to a psychiatric unit. Although these hospitalized patients tended to be seen and assessed more quickly than patients discharged home, they had significantly longer overall length of stay because of the extended wait time between the decision to admit and the ED discharge."

In some ways, Alzheimer’s is like arthritis. Its symptoms can wax and wane, making it difficult to determine if a particular treatment is successful. Who’s to say if a symptom subsided because a drug worked or because it was going to diminish anyway?

And, like arthritis, Alzheimer’s cannot be cured, only moderated. That can lead sufferers and the people who care for them to become desperate for any new treatment—what have they got to lose?

So dementia leaves its victims particularly vulnerable to new, if not improved, ways to treat it, and one such recent attempt raised the ire of two professors at Dartmouth’s Institute for Health Policy and Clinical Practice. As reported by Merrill Goozner, Drs. Lisa Schwartz and Steven Woloshin claim that the FDA has “breached [its] own regulatory standard” in approving a new dosage of a best-selling Alzheimer’s drug.

Aricept, whose generic name is donepezil, is earning its manufacturers $2 billion a year for improving memory lapses in the short term. With its patent about to expire (Aricept was introduced in 1996), and generic manufactures poised to compete with their own versions, manufacturers Eisai and Pfizer were motivated to keep the cash flowing. They appealed to the FDA to approve a higher dosage, claiming that a trial of 1,400 patients demonstrated improvements in the ability to think. The feds gave the drug makers three more years to market the stronger drug exclusively.

But as Schwartz and Woloshin wrote in the British Medical Journal (BMJ), patients had only slightly better cognition on the higher dose, and it had absolutely no effect on day-to-day functioning, the measure by which caregivers determine disease status. Unfortunately, the stronger Aricept conferred significantly negative side effects, including nausea and vomiting. For patients with dementia, that can lead to pneumonia. The FDA had told the trial sponsors that the drug wouldn’t be approved unless it had a positive impact that patient caregivers could notice.

So at best, the contrary approval makes the FDA look dysfunctional; at worst, it looks incompetent and corrupt.

Aricept’s manufacturers went merrily along their marketing way, their advertisements implying to consumers that the drug helped the Alzheimer brain function better, but not mentioning the severity of side effects. And the ads aimed at doctors, Schwartz and Woloshin charged, were worse: “[They contain] a stunningly erroneous statement in a large bold font: ‘Patients on Aricept 23 mg/day experienced important clinical benefit on both measures [cognition and overall functioning],’ which is simply not true. In fact, this statement is directly contradicted by a statement in a smaller plain font that says that the results for global function ‘did not show statistical significance.’”

That doctors are considered easy marks for Big Pharma is depressingly old news.

Unless drug company labels make inaccurate claims, the FDA does not intervene, even if a drug's risks, benefits and uncertainties aren't communicated.

As explained in the Los Angeles Times, drug companies commonly respond to an expiring patent with a practice called "evergreening." To prolong the profitability of successful drugs, they make a slight change to a drug's formula or dosage, or combine it with another drug. These are legal measures that require FDA approval.

Aricept’s new 23-milligram tablet, The Times story explained, “created a dose that couldn't be reproduced by any combination of Aricept's existing 5- and 10-milligram pills, making the product new enough to win a three-year reprieve from low-cost competitors.”

Dr. Howard Brody, a medical ethicist at the University of Texas Medical Branch in Galveston, told The Times that the Aricept 23 case is “a perfect storm” of commercial marketing and regulatory failure whose victims are patients who are desperate, discouraged and vulnerable.

As Dr. Marcia Angell, former editor of the New England Journal of Medicine, told the newspaper, Big Pharma’s manipulative ads illustrate “very well how drug companies exaggerate the benefits of their drugs, minimize the side effects and through misleading marketing to both doctors and the public convince them that a new version of a drug, with a new patent, is better than the old one, whose patent has expired."

If your loved one is prescribed Aricept for his or her Alzheimer’s disease, ask the doctor what is the dose. If it’s 23 milligrams, ask for a lower dosage. It’s just that simple.

First published on Technorati.

Off-label use of drugs—that is, taking medication to address a problem other than the one for which it was developed and approved by the FDA—is a common and often appropriate practice.

Unfortunately, off-label use is also commonly abused and sometimes dangerous. Among the more alarming off-label practices these days is taking antipsychotic drugs—those used to treat severe mental disabilities—for lesser problems such as insomnia.

As reported recently in the Washington Post in association with Kaiser Health News, until the last decade, an expensive class of drugs called atypical antipsychotics was reserved for only the 3 in 100 people suffering from the most disabling mental illnesses such as schizophrenia. The most popular—Seroquel, Zyprexa and Abilify—are being prescribed off-label for anxiety and attention deficit disorder. Shockingly, as The Post/KHN notes, “Two recent reports have found that youths in foster care, some less than a year old, are taking more psychotropic drugs than other children, including those with the severest forms of mental illness.”

We’ve addressed the overmedicating of children here and here, and the general misuse of depression drugs.

Pharmaceutical companies, of course, couldn’t be happier. Antipsychotics accounted for more than $16 billion in sales in 2010, and often sell better than meds that lower cholesterol. A Stanford studyfrom last year concluded that off-label antipsychotic prescriptions doubled between 1995 and 2008

Although manufacturers are not allowed by law to market drugs for off-label uses, nothing prevents physicians from prescribing them. Thanks, critics say, to hype—TV commercials promote these powerful drugs, which can cost $500 per month—many professionals believe that they are safer and that the newer drugs address more disorders than their predecessors.

Big Pharma has been so successful in encouraging this perception that it has been willing to pay, according the The Post, more than $2 billion in the last few years to settle lawsuits about illegal marketing. In 2009, Eli Lilly and Co. shelled out $1.4 billion to settle charges that it marketed Zyprexa to nursing homes, among other health-care providers, as a sleep aid. We wrote about another such settlement recently.

And consumers pay the price. As quoted by The Post/KHN, Dr. Allen Frances, former chair of psychiatry at Duke University School of Medicine, said, “Antipsychotics are overused, overpriced and oversold.” If some off-label use is appropriate for people for whom other treatments have not worked for, Frances called their widespread use promiscuous and reckless.

Why would anyone take a drug designed to moderate hallucinations and delusions solely to alleviate occasional anxiety when the side effects can include rapid weight gain of 40 pounds, Type 2 diabetes, breast development in boys, irreversible facial tics and an increased risk of death among elderly patients?

Taking these drugs to solve what can be deemed “problems of living” is like using a machete to slice apples. Doctors might find that a suitable way to make fruit salad, says Wayne Blackmon, a psychiatrist and attorney, because of the financial incentive to prescribe quick-fix drugs instead of taking the time to evaluate nondrug treatments. It’s also about insurance companies quick to subsidize pills but not behavioral therapy.

When military operations exceed their stated purpose, it’s known as mission creep. When doctors ascribe difficulty coping as mental illness, it’s diagnosis creep. And the proper response is not to medicate in hopes of moderating symptoms. It’s to re-evaluate the pressures on both patients and doctors to solve a problem via the path of least resistance instead of the more painstaking path of education and information.

If your doctor, particularly if he or she is not a psychiatrist, prescribes an antipsychotic medication for a disorder other than extreme mental illness, ask:

• what alternative treatments are available?


• what are the possible side effects?


• would you take this drug?

As one year ends and a new one begins, some people think about ways to start over. Be happier. Renew energy. Often, they turn to psychotherapy, and in many cases, it works, or at least provides a roadmap to a more satisfying life.

But mental health is like physical health—some things just don’t change. In an effort to help prospective patients understand what psychotherapy can and cannot do, a recent post on the Psychcentral.com website enumerates five things therapy won’t cure.

The advice isn’t just a reality-check; it’s an effort to help people save time, money and frustration. “Therapists, by their nature, tend to want to help every person who comes through their door,” writes John M. Grohol. “Even well-meaning therapists may not fully appreciate when they are largely going to be ineffectual in treatment because of the type of problem presented. After all, psychotherapy isn’t some magical elixir. Talking about some topics simply won’t do much to help the situation.”

Five Things Psychotherapy Won’t Change

1. Personality

Personality disorders are recognized as mental disorders. Typically, they’re more ingrained and more difficult to change than most other mental disorders. They begin in childhood and are shaped by experiences. “You can’t expect to undo decades of personality development in a few months’ worth of psychotherapy. (Years, maybe.)”

But psychotherapy can help mitigate some of the worst features of the problem. For instance, someone with narcissistic personality disorder may continue thinking he or she is better than everyone else, but awareness can help him or her tone it down in interpersonal relationships to become less of a social and work impediment. Another example: Introverted people will still be introverted, but can learn how to relax in social situations.

2. Childhood

No one can go back and fix a lousy childhood. It’s a piece of personal history.

But through therapy, someone can see how he or she interprets what happened in childhood affects behavior now. Then a choice can be made whether to indulge those issues, or grow through them by understanding their significance. A patient will still have had bad parents, rotten siblings, an unsafe childhood home or neighborhood. But those things are afforded a perspective that renders them less hurtful in the present.

3. Half a Relationship

A healthy relationship is a joint effort. Psychotherapy can help couples through rocky times, but only if both parties approach counseling with an open mind and a willingness to work on the relationship. Attendance counts, but work product is key.

That doesn’t mean it isn’t worthwhile if only one-half of a couple goes for therapy; often that helps the patient cope better with the situation or decide to end it. But if the goal is to maintain and sustain a relationship, it takes two to tango.

4. Broken Heart

The side effects of lost love can be long term. Professional counseling isn’t likely to help much, but talk therapy can if the listener is a close friend. Common activities and shared experiences make the painful time seem shorter.

Psychotherapy might help, however, in situations where someone is “stuck” ruminating over details of an old relationship, even years later. If someone can’t move on, talking to a professional might help bring perspective in the same way it does to childhood issues.

5. Bereavement

Typically, grief isn’t considered a mental illness in need of treatment, but its hallmark is depression. Despite popular common wisdom about the stages of grief, the reality is that everyone’s grief is unique.

Psychotherapy won’t help speed the natural processes of time and perspective. Like lost love, grief needs space for remembrance and reflection. It’s done best mindfully and with patience. And like love, it can help someone who cannot get over the loss, even years later. But for most people, “psychotherapy is both unnecessary and overkill for what is a normal process of life and living.”

Choosing a medical caregiver, like any good consumer behavior, involves comparison shopping.

Mindful of the restrictions of your health-care plan, cost, geography and/or time, choosing a psychological therapist is no different from choosing any other medical provider. In some ways, it’s even more important to have a good match between doctor and patient, because for most people, the mind is the most difficult body part to open to scrutiny.

Writing on PsychCentral.com, clinical psychologist Charles H. Elliott offers therapy shoppers several tips to ensure a good marriage between therapist and patient.

A range of factors can undermine the therapeutic relationship. Maybe the therapist reminds you of someone you dislike or with whom you have an uncomfortable history. Maybe you don’t even know why it just doesn’t feel right.

It doesn’t matter, Elliott advises, whether or not you can identify a reason for a rocky relationship. The fact that you’re uncomfortable is reason enough to question whether a practitioner is the right one for you. If he or she isn’t, you’re not getting the best care.

After a couple of sessions, ask yourself these questions in order to assess if the match seems to promise a successful outcome:

• Do I feel at ease in discussing almost anything with my therapist that I feel is important?


• Do I feel safe when I’m talking with my therapist?


• Does it seem like my therapist understands and truly hears what I have to say?


• Does my therapist look interested in what I have to say?


• Do my therapists’ reactions to what I say feel nonjudgmental and uncritical?


• Does it feel like my therapist cares about me and my problems?

If you’re uncertain about several answers, or if any one is a strong “no,” that’s a clue to discuss your concerns with your therapist. If he or she is defensive or evasive, if the discussion makes you feel uncomfortable, you probably need a different caregiver.

The one exception is if you have relationship problems in general, and struggle to feel safe talking even with close friends or family. That’s a tip that communication/relationship issues should be part of the therapy itself.

As reported in the journal Health Affairs, antidepressant drugs are the third most commonly prescribed class of medications in the U.S. Much of the growth of these drugs has been fueled by prescriptions written by nonpsychiatrist caregivers, and are not accompanied by a psychiatric diagnosis.

Between 1996 and 2007, the proportion of doctor visits at which antidepressants were prescribed but no psychiatric diagnoses were noted increased from 59.5% to 72.7%.

Researchers aren’t saying that this remarkable growth necessarily represents inappropriate use of antidepressants, and depression is underdiagnosed and undertreated in this country. But the rapid and marked increase of such prescribing habits have prompted researchers to call for scrutiny of the pattern to better understand the factors driving the trend and to develop “effective policy responses.”

Ramin Mojtabai, one of the study’s authors and a professor in the department of mental health at Johns Hopkins in Baltimore, said to WebMD, “What we are observing is that Americans are increasingly viewing psychiatric medications as a solution for a wide range of social and interpersonal problems and for dealing with daily stress [and] general medical providers appear to be going along with this trend. The irony is that many patients with major depression or anxiety disorders who could potentially benefit from treatment with antidepressant medications do not receive these treatments.”

Another source told WebMD that there may be another story line here. Doctors often get reimbursed at lower rates for treating psychiatric conditions, so they might be motivated to prescribe antidepressants but record them in patient charts as treatment for a nonpsychiatric problem. And there’s still a stigma attached to psychiatric illnesses, which could skew diagnoses.

The study authors suggest that if antidepressants are being prescribed for uses not supported by clinical evidence, there might be a need to improve providers’ prescribing practices, revamp drug formularies or vigorously pursue implementation of broad reforms of the health-care system. The point is to improve communication between primary care providers and mental health specialists.

An article by Jane Brody in the New York Times, "When Your Looks Take Over Your Life," draws attention to a tragic mental health issue called "body dysmorphic disorder."

These are people who are obsessed about a "flaw" in some aspect of their bodily appearance, and who sometimes subject themselves to repeated rounds of cosmetic surgery to "cure" this problem. And of course the surgery never works because the problem is much deeper than the skin. A malpractice lawsuit is not the answer for these patients, as I explained in a comment on the New York Times' "Well" blog:

As a malpractice attorney who represents patients, I have been consulted several times by potential clients whom I later realized had body dysmorphic disorder. When they called for the appointment, the story on the telephone was that they had been grotesquely disfigured by a cosmetic surgeon, often with repeat surgery. Then when I met them, I would not be able to see anything wrong with their appearance, even when they pointed it out to me.

One man in his mid-20s had had his nose operated on three times by the same surgeon. All I could see was that one nostril was slightly larger than the other. He was talking about needing to have yet another surgery. I politely urged him to see a psychiatrist first, and told him I could not represent him in any legal action against the surgeon.

My personal belief is that an ethical cosmetic surgeon would decline to operate on anyone with obvious signs of body dysmorphic disorder (if for no other reason than that this will be a hard-to-please patient), but a willing patient with the means to pay for the surgery can be persuasive for some surgeons, it seems. (Witness Michael Jackson.)

The legal system does not have good answers for these patients. A lawsuit would only perpetuate the patient's idea that their appearance can be "fixed" and that it's the doctor's fault for not doing so. Still, my heart goes out to people with this disorder especially when they subject themselves to a fruitless round of surgeries. They definitely need counseling.

Read more comments on the Well blog here.

A new study that concluded that two commonly prescribed antidepressant drugs don't work for people with mild depression has opened an interesting discussion about the quality of mental health care in America. The quality score: C-minus, for lots of reasons.

Judith Warner wrote in the New York Times that the news media reports about the new study (which really wasn't an original study but a number-crunching of selected older studies) were too simplistic. She noted many of the shortcomings of mental health treatment, starting with the fact that general practitioners do a lot of the medication prescribing and aren't as skilled as specialists in screening who really needs the medications.

Ms. Warner concluded: "The trouble is not that the drugs don't work, it's that the care is not very good."

She also said:

This is the big picture of mental health care in America: not perfectly healthy people popping pills for no reason, but people with real illnesses lacking access to care; facing barriers like ignorance, stigma and high prices; or finding care that is ineffective.

Her Op-Ed piece brought a round of thoughtful comments in the letters">letters to the editor column at the Times, including:

* Brown University psychiatry professor Lawrence Price writes:

Medications that work for depression are commonly misused, and types of psychotherapy that work for depression are commonly not used at all. The reasons for this state of affairs include mistrust of authority, stigma, big-stakes health care economics, cross-discipline rivalries and simplistic thinking (within the mental health care field as well as the general public).

* James Brush, a psychologist in Cincinnati, writes:

While researchers can investigate treatments in laboratory conditions, few clients fit into simple categories. Try applying an “evidence-based treatment” for a depressed, sexually abused child from a divorced family in which one parent is alcoholic and the child has a learning disability. Such clients do not tend to show up for laboratory studies and don’t tend to respond to simple bromides.

* Neil Brooks, former president of the American Academy of Family Practice, argues that family practitioners by necessity have to treat patients with depression who might be better off with a specialist. Dr. Brooks writes:

Many of those who need treatment have no access to psychiatrists because of geographical distribution, restrictive insurance coverage, cost or a perceived stigma to being cared for by a psychiatrist. Thus, distortion or misinterpretation of the evidence about the treatment of depression will result in those who desperately need help not obtaining it.

The Times also published a rebuttal to the new study by psychiatry professor Richard Friedman, M.D. of Cornell, who cited a number of caveats that limit the usefulness of the new study. He concluded:

Every once in a while, a landmark study comes along and overturns everyone’s cherished ideas about a particular treatment. But the current study is not one of them. So it would be a shame if it discouraged depressed patients from taking antidepressants.

Experts may disagree about what constitutes the best treatment for depression, and for whom. But there is no question that the safety and efficacy of antidepressants rest on solid scientific evidence.

Bottom line: Don't throw out your antidepressants just yet. But if they don't seem to be helping, do talk to a good therapist about trying another approach.