Top US psychiatrist calls for ethics cleanup

The Boston Globe
By Carla K. Johnson
AP Medical Writer
March 23, 2010

FILE Photo- In this Sept. 13, 2006 file photo, National Institute of Mental Health Director Dr. Thomas Insel, left, testifies on Capitol Hill in Washington. American psychiatrists need to break away from a 'culture of influence' created by their financial dealings with the drug industry, Insel said in Journal of the American Medical Association. FILE - In this Sept. 13, 2006 file photo, National Institute of Mental Health Director Dr. Thomas Insel, left, testifies on Capitol Hill in Washington. American psychiatrists need to break away from a "culture of influence" created by their financial dealings with the drug industry, Insel said in Journal of the American Medical Association. (AP Photo/Dennis Cook, File)



CHICAGO—American psychiatrists need to break away from a "culture of influence" created by their financial dealings with the drug industry, the head of the National Institute of Mental Health said in a leading medical journal.

Dr. Thomas Insel stops short of calling researchers corrupt or asking them to stop taking money from drug companies. But he highlights a "bias in prescribing practices" that favors brand names drugs over cheaper generics and non-drug treatments. And he says the situation must change with new standards for transparency and full disclosure of psychiatry's collaborations with industry.

"We can show the rest of medicine how to clean up our act," Insel told The Associated Press. His commentary appears in Wednesday's Journal of the American Medical Association.

His efforts got a boost Tuesday with the signing of the health care overhaul legislation which requires drugmakers and others to file annual reports to the government on their financial ties to doctors. The law requires reporting of gifts, entertainment, food, research money and other fees and grants. Consumer advocates applaud the "sunshine" provision because it also requires a database the public can search for their own doctors' ties to industry.

"Transparency is the first step toward giving patients and the public the tools they need to evaluate those relationships," said Allan Coukell, director of the Pew Prescription Project, a consumer health project of the nonprofit Pew Charitable Trusts.

Current National Institutes of Health rules on financial disclosure are confusing, Insel said. They allow researchers seeking federal funds to make their own judgments about what constitutes a significant financial interest, which they must report to their academic or research institutions. The rules also exempt disclosures of anything below $10,000 annually or 5 percent equity interest in a company. Insel is helping oversee a revision of the NIH's rules, which date back to 1995.

Industry pays for much of the medical research in the United States and many scientists have financial relationships with drug and device makers. Researchers at many institutions are expected to fully disclose those ties to their universities, to the NIH and to the medical journals that publish their research.

Beginning in 2008, an inquiry by Sen. Chuck Grassley, R-Iowa, uncovered millions of dollars in unreported fees paid by drug industry to prominent researchers. The investigation prompted universities and NIH to reassess their conflict-of-interest policies.

When the Grassley inquiry accused seven psychiatrists of failing to report payments they received from drug companies, Insel, himself a psychiatrist, said he tried to determine whether psychiatrists were being targeted unfairly.

He found, instead, evidence that psychiatry may have more drug ties than other medical specialties. In Vermont, for example, which requires public disclosure of industry payments to doctors, psychiatrists receive more money from drug companies than do other types of doctors.

Psychiatric journals report slightly higher rates of industry funding of published studies than other medical journals. And one study found that 90 percent of the advisers who help write American Psychiatric Association guidelines had undisclosed financial ties to industry, Insel writes in JAMA.

Meanwhile, antidepressants and other drug treatments rack up multibillion-dollar annual sales while non-drug treatments such as therapy are "woefully underused," Insel writes.

Insel said he has no financial ties with the drug industry.

Dr. Alan Schatzberg, president of the American Psychiatric Association, told the AP that future leaders of guidelines work groups "will have zero financial relationships with industry during their terms."

Insel's commentary will be influential, said Dr. Emil Coccaro, psychiatry department chairman at the University of Chicago and a recipient of NIH grants.

"It's important that our potential patients and their family members know we're above reproach in terms of undue influence by Big Pharma," Coccaro said.

That's why he threw away all the coffee mugs and pens given to him by drug companies and is careful to report any payments he receives as a board member of a startup biomedical company, he said.

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On the Net:

JAMA: http://jama.ama-assn.org

When mental disorders aren't

Boston Herald
Psychiatrist Allen Francis
Monday, March 22, 2010

As chairman of the task force that created the current Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), which came out in 1994, I learned from painful experience how small changes in the definition of mental disorders can create huge, unintended consequences.

Our panel tried hard to be careful, but inadvertently contributed to three false “epidemics” - attention deficit disorder, autism and childhood bipolar disorder. Our net was cast too wide and captured many “patients” who might have been far better off never entering the mental health system.

The first draft of the next edition of the DSM, posted for comment last month, is filled with suggestions that would multiply our mistakes and extend the reach of psychiatry dramatically deeper into the ever-shrinking domain of the normal. This could create tens of millions of innocent bystanders who would be mislabeled as having a mental disorder. The pharmaceutical industry would have a field day.

The manual, prepared by the American Psychiatric Association, is psychiatry’s only official way of deciding who has a “mental disorder” and who is “normal.” The quotes are necessary because this distinction is very hard to make at the fuzzy boundary between the two.

Where the DSM-vs.-normality boundary is drawn also influences insurance coverage, eligibility for disability and services, and legal status - to say nothing of stigma.

What are some of the most egregious invasions of normality suggested for DSM-V? “Binge eating disorder” is defined as one eating binge per week for three months. (I, along with more than 6 percent of the population, would qualify.) “Minor neurocognitive disorder” would capture many people with no more than the expected memory problems of aging. Grieving after the loss of a loved one could be misread as “major depression.” “Mixed anxiety depression” is defined by commonplace symptoms difficult to distinguish from the emotional pains of everyday life.

The recklessly expansive suggestions go on. “Attention deficit disorder” would become much more prevalent in adults, encouraging the already rampant use of stimulants. A category for temper could capture kids with normal tantrums.

The sexual disorders section is particularly adventurous. “Hypersexuality disorder” would bring great comfort to philanderers. “Paraphilic coercive disorder” introduces the dangerous idea that rapists merit a diagnosis of mental disorder if they get sexual excitement from raping.

Experts have an almost universal tendency to expand their own favorite disorders. This therapeutic zeal creates a huge blind spot to the great risks that come with unnecessary treatment.
Allen Frances is former chairman of psychiatry at Duke University.

Medicating the Military, Use of Psychiatric Drugs has Spiked, Concerns furface about suicide, other dangers

Army Times
By Andrew Tilghman and Brendan McGarry
Wednesday Mar 17, 2010

At least one in six service members is on some form of psychiatric drug.

And many troops are taking more than one kind, mixing several pills in daily “cocktails” — for example, an antidepressant with an antipsychotic to prevent nightmares, plus an anti-epileptic to reduce headaches — despite minimal clinical research testing such combinations.

The drugs come with serious side effects: They can impair motor skills, reduce reaction times and generally make a war fighter less effective. Some double the risk for suicide, prompting doctors — and Congress — to question whether these drugs are connected to the rising rate of military suicides.

“It’s really a large-scale experiment. We are experimenting with changing people’s cognition and behavior,” said Dr. Grace Jackson, a former Navy psychiatrist.

A Military Times investigation of electronic records obtained from the Defense Logistics Agency shows DLA spent $1.1 billion on common psychiatric and pain medications from 2001 to 2009. It also shows that use of psychiatric medications has increased dramatically — about 76 percent overall, with some drug types more than doubling — since the start of the current wars.
THE FULL INVESTIGATION:

• Could meds be responsible for suicides?

• Downrange: ‘Any soldier can deploy on anything’

• How drugs enter the war zone

Troops and military health care providers also told Military Times that these medications are being prescribed, consumed, shared and traded in combat zones — despite some restrictions on the deployment of troops using those drugs.

The investigation also shows that drugs originally developed to treat bipolar disorder and schizophrenia are now commonly used to treat symptoms of post-traumatic stress disorder, such as headaches, nightmares, nervousness and fits of anger.

Such “off-label” use — prescribing medications to treat conditions for which the drugs were not formally approved by the FDA — is legal and even common. But experts say the lack of proof that these treatments work for other purposes, without fully understanding side effects, raises serious concerns about whether the treatments are safe and effective.

The DLA records detail the range of drugs being prescribed to the military community and the spending on them:

• Antipsychotic medications, including Seroquel and Risperdal, spiked most dramatically — orders jumped by more than 200 percent, and annual spending more than quadrupled, from $4 million to $16 million.

• Use of anti-anxiety drugs and sedatives such as Valium and Ambien also rose substantially; orders increased 170 percent, while spending nearly tripled, from $6 million to about $17 million.

• Antiepileptic drugs, also known as anticonvulsants, were among the most commonly used psychiatric medications. Annual orders for these drugs increased about 70 percent, while spending more than doubled, from $16 million to $35 million.

• Antidepressants had a comparatively modest 40 percent gain in orders, but it was the only drug group to show an overall decrease in spending, from $49 million in 2001 to $41 million in 2009, a drop of 16 percent. The debut in recent years of cheaper generic versions of these drugs is likely responsible for driving down costs.

Antidepressants and anticonvulsants are the most common mental health medications prescribed to service members. Seventeen percent of the active-duty force, and as much as 6 percent of deployed troops, are on antidepressants, Brig. Gen. Loree Sutton, the Army’s highest-ranking psychiatrist, told Congress on Feb. 24.

In contrast, about 10 percent of all Americans take antidepressants, according to a 2009 Columbia University study.
Suicide risks

Many of the newest psychiatric drugs come with strong warnings about an increased risk for suicide, suicidal behavior and suicidal thoughts.

Doctors — and, more recently, lawmakers — are questioning whether the drugs could be responsible for the spike in military suicides during the past several years, an upward trend that roughly parallels the rise in psychiatric drug use.

From 2001 to 2009, the Army’s suicide rate increased more than 150 percent, from 9 per 100,000 soldiers to 23 per 100,000. The Marine Corps suicide rate is up about 50 percent, from 16.7 per 100,000 Marines in 2001 to 24 per 100,000 last year. Orders for psychiatric drugs in the analysis rose 76 percent over the same period.

“There is overwhelming evidence that the newer antidepressants commonly prescribed by the military can cause or worsen suicidality, aggression and other dangerous mental states,” said Dr. Peter Breggin, a psychiatrist who testified at the same Feb. 24 congressional hearing at which Sutton appeared.

Other side effects — increased irritability, aggressiveness and hostility — also could pose a risk.

“Imagine causing that in men and women who are heavily armed and under a great deal of stress,” Breggin said.

He cited dozens of clinical studies conducted by drug companies and submitted to federal regulators, including one among veterans that showed “completed suicide rates were approximately twice the base rate following antidepressant starts in VA clinical settings.”

But many military doctors say the risks are overstated and argue that the greater risk would be to fail to fully treat depressed troops.

For suicide, “depression is a big risk factor,” too, said Army Reserve Col. (Dr.) Thomas Hicklin, who teaches clinical psychiatry at the University of Southern California. “To withhold the medications can be a huge problem.”

Nevertheless, Hicklin said the risks demand strict oversight. “The access to weapons is a very big concern with someone who is feeling suicidal,” he said. “It has to be monitored very carefully because side effects can occur.”

Defense officials repeatedly have denied requests by Military Times for copies of autopsy reports that would show the prevalence of such drugs in suicide toxicology reports.
‘Then it’s over’

Spc. Mike Kern enlisted in 2006 and spent a year deployed in 2008 with the 4th Infantry Division as an armor crewman, running patrols out of southwest Baghdad.

Kern went to the mental health clinic suffering from nervousness, sleep problems and depression. He was given Paxil, an antidepressant that carries a warning label about increased risk for suicide.

A few days later, while patrolling the streets in the gunner’s turret of a Humvee, he said he began having serious thoughts of suicide for the first time in his life.

“I had three weapons: a pistol, my rifle and a machine gun,” Kern said. “I started to think, ‘I could just do this and then it’s over.’ That’s where my brain was: ‘I can just put this gun right here and pull the trigger and I’m done. All my problems will be gone.’”

Kern said the incident scared him, and he did not take any more drugs during that deployment. But since his return, he has been diagnosed with PTSD and currently takes a variety of psychotropic medications.

Other side effects cited by troops who used such drugs in the war zones include slowed reaction times, impaired motor skills, and attention and memory problems.

One 35-year-old Army sergeant first class said he was prescribed the anticonvulsant Topamax to prevent the onset of debilitating migraines. But the drug left him feeling mentally sluggish, and he stopped taking it.

“Some people call it ‘Stupamax’ because it makes you stupid,” said the sergeant, who asked not to be identified because he said using such medication carries a social stigma in the military.

Being slow — or even “stupid” — might not be a critical problem for some civilians. But it can be deadly for troops working with weapons or patrolling dangerous areas in a war zone, said Dr. John Newcomer, a psychiatry professor at Washington University in St. Louis and a former fellow at the American Psychiatric Association.

“A drug that is really effective and it makes you feel happy and calm and sleepy … might be a great medication for the general population,” Newcomer said, “but that might not make sense for an infantryman in a combat arena.

“If it turns out that people on a certain combo are getting shot twice as often, you would start to worry if they were as ‘heads up’ as they should have been,” Newcomer said. “There is so much on the line, you’d really like to have more specific military data to inform the prescribing.”

Military doctors say they take a service member’s mission into consideration before prescribing.

“Obviously, one would be concerned about what the person does,” said Col. C.J. Diebold, chief of the Department of Psychiatry at Tripler Army Medical Center in Hawaii. “If they have a desk job, that may factor in what medication you may be recommending for the patient [compared with] if they are out there and they have to be moving around and reacting fairly quickly.”
Off-label use

Little hard research has been done on such unique aspects of psychiatric drug usage in the military, particularly off-label usage.

A 2009 VA study found that 60 percent of veterans receiving antipsychotics were taking them for problems for which the drugs are not officially approved. For example, only two are approved for treating PTSD — Paxil and Zoloft, according to the Food and Drug Administration. But in actuality, doctors prescribe a range of drugs to treat PTSD symptoms.

To win FDA approval, drug makers must prove efficacy through rigorous and costly clinical trials. But approval determines only how a drug can be marketed; once a drug is approved for sale, doctors legally can prescribe it for any reason they feel appropriate.

Such off-label use comes with some risk, experts say.

“Patients may be exposed to drugs that have problematic side effects without deriving any benefit,” said Dr. Robert Rosenheck, a professor of psychiatry at Yale University who studied off-label drug use among veterans. “We just don’t know. There haven’t been very many studies.”

Some military psychiatrists are reluctant to prescribe off-label.

“It’s a slippery slope,” said Hicklin, the Army psychiatrist. “Medication can be overused. We need to use medication when indicated and we hope that we are all on the same page … with that.”

Combinations of drugs pose another risk. Doctors note that most drugs are tested as a single treatment, not as one ingredient in a mixture of medications.

“In the case of poly-drug use – the ‘cocktail’ — where you are combining an antidepressant, an anticonvulsant, an antipsychotic, and maybe a stimulant to keep this guy awake — that has never been tested,” Breggin said.

Newcomer agreed. “When we go to the literature and try to find support for these complex cocktails, we’re not going to find it,” he said. “As the number of medications goes up, the probability of adverse events like hospitalization or death goes up exponentially.”
Looking for answers

Pinpointing the reasons for broad shifts in the military’s drug use today is difficult. Each doctor prescribes medications for the patient’s individual needs.

Nevertheless, many doctors in and outside the military point to several variables — some unique to the military, some not.

A close look at the data shows that use of the antipsychotic and anticonvulsant drugs, also known as “mood stabilizers,” are growing much faster than antidepressants. That may correlate to the challenges that deployed troops face when they arrive back home and begin to readjust to civilian social norms and family life.

“The ultimate effect of both of these drugs is to take the heightened arousal — the hypervigilance and all the emotions that served you once you were deployed — and help to turn that back down,” said Dr. Frank Ochberg, former associate director for the National Institute of Mental Health and a psychiatry professor at Michigan State University who reviewed the Military Times analysis.

Dr. Harry Holloway, a retired Army colonel and a psychiatry professor at the Uniformed Services University of the Health Sciences in Bethesda, Md., said the increased use of these medications is simply another sign of deployment stress on the force.

“For a long time, the ops tempo has been completely unrelieved and unrestrained,” Holloway said. “When you have an increased ops tempo, and you have certain scheduling that will make it hard for everyone, you will produce a more symptomatic force. Most commanders understand that and they understand the tradeoffs.”

Fact-Checking the New Yorker

The real results from the STAR*D trial
Psychology Today
from Robert Whitaker Mad In America Blog

March 14, 2010

In the March 1 issue of the New Yorker, Louis Menand surveyed the topsy-turvy world of treatments for depression, writing in part of the conflicting evidence regarding the efficacy of antidepressants. The strongest evidence for the drugs, he suggested, came from the NIMH's STAR*D trial. Here's what he wrote:

Response to antidepressants is extremely variable. It can take several different prescriptions to find a medication that works. Measuring a single antidepressant against a placebo is not a test of the effectiveness of antidepressants as a category. And there is a well-known study, called the Sequence Treatment Alternatives to Relieve Depression, or STAR*D trial, in which patients were given a series of different antidepressants. Though only thirty-seven percent recovered on the first drug, another nineteen percent recovered on the second drug, six percent after the third, and five percent after the fourth-a sixty-seven-percent effectiveness rate for antidepressant medication, far better than the rate achieved by a placebo.

That statistic--that two-thirds of the patients eventually "recovered" in the STAR*D trial--has become an oft-cited one. The implication is that if depressed patients try a succession of antidepressants, they are likely to find one that "works" and keeps them well. Unfortunately, the results from the STAR*D trial do not support that belief.

Here's the data that was reported by lead investigator John Rush and several of his colleagues in a 2006 article titled: "Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: A STAR*D report."

There were 3671 adults with major depression who entered the "first stage" of the study. Of that group, 1,346 patients (36.8%) saw their depressive symptoms remit. Of those who didn't remit, 1,439 entered the second stage of the study and switched to a new antidepressant (the rest of the non-remitters dropped out.) In this second stage, 439 remitted (30.6%). Only 390 non-remitted patients agreed to give a third antidepressant a try; 53 remitted in that stage (14%.) In stage four, 16 of 123 patients remitted (13%).

In sum, of the 3671 patients that entered the study, 1,854 remitted (50.5%). Yet, Rush and the other STAR*D investigators reported in their various articles that the "overall cumulative remission rate was 67%," which of course raises the question of where this number came from.

The higher remission rate was purely "theoretical." The researchers assumed that if those who dropped out during the various stages had instead stayed with the protocol all the way through stage four, they would have remitted at the same rate (in the various stages) as those who did stay in the study. This, of course, is a big assumption, and it also hides the fact that if this multiple drug-therapy strategy is employed in the real world, a significant percentage of patients won't stay with it.

This brings us to the second part of the STAR*D story: what percentage of the patients who saw their symptoms remit stayed well through a 12-month followup? In the New Yorker story--and this is how the data is usually presented to the public--the implication was that once a patient finds a drug that "works," he or she stays well. But this study didn't document any such long-term recovery.

According to the follow-up protocol, the remitted patients were supposed to make a call to an "interactive voice response system" monthly so that their depressive symptoms could be assessed. However, only 1,174 of the 1,854 remitted patients made at least one call to the interactive system. In other words, many remitted patients did not participate in the follow-up study, and even many of those who did only remained in it for a short time, rather than for a full year. During this incomplete followup, 37% of the 1,174 patients reported that they had relapsed.

In other words, of the 3,671 patients who entered the trial, only 737 individuals (20%) remitted and then reported, at some point during the 12-month followup, that they had stayed well. The remaining patients (80%) either never remitted, or dropped out at some point, or relapsed during the followup. Moreover, it's unclear from the published results how many of the 737 non-relapsed patients stayed in the followup study for a full year.

In short, the study data did not tell of a form of care that helps two-thirds of all patients recover and stay well for a longer period of time. The 67% recovery rate reported in the New Yorker, a figure that has been often cited to show that if patients are tried on multiple antidepressants they are very likely to find one that works for them, isn't a "real-world" number. It's a number that tells of a "theoretical" remission rate, and it hides the fact that many remitted patients then quickly relapse.

In his article, Louis Menand concluded that the STAR*D trial proved that antidepressants, as a class, have a much higher effectiveness rate than placebo. That claim raises a question to be explored in a follow-up post to this blog: What is the long-term recovery rate for unmedicated depression? Although there was no placebo group in the STAR*D study, in the past decade NIMH-funded investigators did conduct a study of the long-term course of untreated depression. Thus, we can compare the results from that study to see if STAR*D proved, as the New Yorker reported, that antidepressants, as a class, are much more effective than placebo in helping patients recover. Most readers, I believe, will find the results eye-opening.

Antidepressants May Permanently or Reversibly Affect Fetal Brain Development

Laurie Barclay, MD
Medscape.com

March 2, 2010 — Antidepressants may permanently or reversibly affect fetal brain development depending on the timing of exposure during pregnancy, according to the results of a study reported online February 22 in the March issue of Pediatrics.

"In animals, antidepressant exposure in early life causes changes that persist into adulthood," write Lars Henning Pedersen, MD, PhD, from Aarhus University in Aarhus, Denmark, and colleagues. "Results from human studies have been equivocal and either found no association between antidepressants and fetal brain development or suggested subtle effects on fine motor development."

The goal of the study was to evaluate whether there is an association between antidepressant exposure in utero and achievement of developmental milestones at ages 6 and 19 months, using data from the Danish National Birth Cohort. Of the pregnant women in this cohort who were eligible for the study, 415 reported use of antidepressant medication, 489 reported depression without medical treatment, and 81,042 reported neither depression nor use of psychotropic medication.

Compared with children of women not exposed to antidepressants, children with second- or third-trimester exposure to antidepressants were able to sit up 15.9 days later (95% confidence interval [CI], 6.8 - 25.0) and to walk 28.9 days later (95% CI, 15.0 - 42.7). However, these milestones were still within the normal range of development.

Compared with children of women not exposed to antidepressants, fewer children with second- or third-trimester exposure to antidepressants could sit without support at age 6 months (odds ratio [OR], 2.1; 95% CI, 1.23 - 3.60), and fewer could occupy themselves at age 19 months (OR, 2.1; 95% CI, 1.09 - 4.02). There were no statistically significant associations of any of the other milestones measured with in utero antidepressant exposure.

Limitations of this study include possible confounding by the severity of disease, lack of blinding of the participants or the interviewers, and not all women completing the 4 interviews.

"The results of this study suggest a permanent or reversible effect of antidepressant exposure on fetal brain development, which may depend on the timing of exposure during pregnancy," the study authors write. "We found associations between exposure to antidepressants in late pregnancy and motor development, particularly for boys. The clinical and public health relevance of the results is not known, and longer follow-up monitoring of the children is needed."

The Lundbeck Foundation funded this study, which also received support from the National Danish Research Foundation, Aarhus University, the Danish Society of Obstetrics and Gynecology, the Ville Heise Foundation, and the Rosalie Petersen Foundation. Drs. Pedersen and Olsen received grants from the Lundbeck Foundation, which is an independent foundation supported by the pharmaceutical company Lundbeck.

Pediatrics. Published online February 22, 2010.

]
Authors and Disclosures
Journalist
Laurie Barclay, MD

Freelance writer and reviewer, Medscape, LLC

Disclosure: Laurie Barclay, MD, has disclosed no relevant financial relationships.

Nursing Home Drug Use Puts Many at Risk, Antipsychotics given to some with dementia

The Boston Globe
By Kay Lazar, Globe Staff
March 8, 2010

Nearly 2,500 nursing home residents in Massachusetts were given powerful antipsychotic drugs last year that were not intended or recommended for their medical condition, a practice that is more common here than in most other states, according to a Globe analysis of federal data.

Data collected by the federal Centers for Medicare and Medicaid Services show that 28 percent of Massachusetts nursing home residents were given antipsychotics in 2009. Of that group, 22 percent - or 2,483 - did not have a medical condition that calls for such treatment.

That rate was the 12th highest in the nation, according to the federal data.

The use of such drugs is especially worrisome in nursing homes because a substantial number of residents suffer from dementia, a condition that puts them at greater risk of death when given antipsychotic medications.

The drugs, also known as “‘psychotropics,’’ were developed to treat people with severe mental illnesses such as schizophrenia, not dementia, which is the progressive loss of memory or other intellectual function than can result from aging or Alzheimer’s disease.

Twice in the past five years, federal regulators have issued nationwide alerts about troubling and sometimes fatal side effects when antipsychotics are taken by people with dementia, including increased confusion, sedation, and weight gain.

Scott Plumb, senior vice president of the Massachusetts Senior Care Association, the trade group representing the state’s 440 nursing homes, said Massachusetts’ consistent ranking as one of the heaviest users of psychotropic drugs indicates much more training is needed in nursing homes.

“We recognize the number is too high,’’ Plumb said, “and we are working to try to bring it down.’’

As the nation ages - up to 14 million baby boomers are expected to develop Alzheimer’s disease or a similar dementia - the drugging of such vulnerable patients takes on increasing urgency. While there has been much focus on the increasing use of antipsychotic drugs among children - highlighted by the recent overdose death of 4-year-old Rebecca Riley - much less attention has been paid to the similar problem among seniors.

“Way too many patients in nursing homes are treated with antipsychotics purely to sedate them or to control behaviors that are difficult for the staff,’’ said Robert A. Stern, an Alzheimer’s specialist and brain researcher at Boston University School of Medicine.

“To the defense of nursing homes and nursing home staff,’’ Stern said, “they are indeed understaffed, they are indeed under-trained, and it takes an awful lot of well-trained people to manage the difficult behaviors that can be exhibited by people with dementia.’’

While there is no barometer for what is considered an appropriate amount of antipsychotic use in nursing homes - and there is no law governing the matter - specialists in caring for the elderly note that the use of antipsychotics is much lower in some homes than others, and in some states than others.

They also point to the federal government’s recent legal action against the largest provider of drugs to nursing homes in the United States. The company, Omnicare, agreed in November to pay $98 million to settle charges that it took kickbacks from Johnson & Johnson to recommend the drug maker’s products, including the antipsychotic Risperdal. The government said Omnicare persuaded physicians to prescribe the medication to dementia patients with behavioral problems. A government suit against J&J is pending.

Specialists say antipsychotics can improve the quality of life for some dementia patients who suffer from extreme agitation and sleeplessness, common symptoms of Alzheimer’s. But too often nursing homes don’t regularly reevaluate patients’ medications to determine whether the antipsychotics are, in fact, effective and whether the dose can be lowered or eliminated, said psychologist Paul Raia, vice president of clinical services for the Massachusetts and New Hampshire Alzheimer’s Association.

Raia helps train nursing home staff in behavior management techniques that can ease agitation and the need for the drugs - skills and training that, specialists say, are often lacking in nursing homes in Massachusetts and across the country. In these homes, he said, as many as 80 percent of the residents are on antipsychotic drugs.

“And then I walk into a good place, one with training, and see 2 or 3 percent on these medications,’’ he said.

A nursing home’s track record for antipsychotic use often is a good predictor for future patients, according to new research from the University of Massachusetts Medical School. The scientists analyzed data from 1,257 nursing homes nationwide and found that patients newly admitted to facilities with some of the highest rates for prescribing antipsychotics are 37 percent more likely to receive the drugs than patients entering homes with the lowest prescribing rates.

Nicki Solomon of Norwood has seen those highs and lows. In 2007, she placed her mother, Corinne, in a nursing home. Although the retired surgical nurse suffered from dementia, she was still able to feed herself and converse clearly, but she had lost her short-term memory, was sometimes agitated and anxious, and would wander off.

Solomon said the nursing home, High Gate Manor in Dedham, asked her permission to prescribe her mother an antipsychotic but didn’t explain the potential side effects. Within weeks, Solomon said, her mother was transformed into someone she didn’t know.

“My mother was out of it all the time. She was asleep and noncommunicative,’’ Solomon said. “She was smothered.’’

She had been given Seroquel, Solomon said, one of the drugs that federal regulators months later would specifically warn against for dementia patients.

High Gate, citing patient confidentiality laws, declined to comment on Solomon’s care.

In June 2008, Solomon transferred her mother to a Needham nursing home that specializes in using alternatives to medication in caring for dementia patients. Her mother rebounded, she said, living another 15 months before her death last November.

Alice Bonner, the state’s top nursing home regulator as director of the Bureau of Health Care Safety and Quality, said “culture change,’’ including a growing consumer movement that focuses on more closely involving families and patients in care decisions, can lower the use of psychotropic drugs.

“We can do better, and use fewer drugs, and do more with behavioral interventions by changing the way we deliver care in nursing homes,’’ she said. Her agency is developing a brochure for nursing homes to give new residents and their families, encouraging them to ask y about the medications prescribed.

For Sharlene Hemp, a North Andover resident who says her father died from side effects of psychotropic drugs just 34 days after entering a nursing home, the answer is legislation. Her father had Alzheimer’s, but she said the family was never told about the medications nor of the potential lethal side effects, until after his death in 2001.

Hemp persuaded her state senator, Steven A. Baddour, to file legislation that would require all Massachusetts nursing homes and their prescribing physicians to obtain written permission from a patient’s health care proxy, which is often a family member, and a court appointed guardian before using antipsychotic medications. A public hearing was held on the bill in January, and it remains in committee.

“When you put a loved one in a nursing home, you are putting your trust in the nursing home and the doctor,’’ Hemp said. “But you don’t know when they go in that they are given all these drugs, and especially dementia patients, because they can’t tell you what they are given.’’

Kay Lazar can be reached at klazar@globe.com.
© Copyright 2010 The New York Times Company

AstraZeneca drops psychiatric, other drug research

Reuters
March 2, 2010

LONDON, March 2 (Reuters) - AstraZeneca (AZN.L) is to stop researching some disease areas that form the backbone of its current business -- including schizophrenia and acid reflux -- in a drive to focus R&D efforts and cut costs.

The Anglo-Swedish drugmaker, which faces one of the sector's worst "cliffs" of expiring drug patents, told its staff on Tuesday it would cease discovery in 10 of its current disease areas, or around one quarter of the total.

A wide-ranging overhaul had been expected since the group said in January it was cutting a further 8,000 staff, or some 12 percent of the workforce, including a net 1,800 in research. But it is only now that staff know where the axe will fall.

AstraZeneca is not alone in taking the knife to previously sacrosanct R&D, though its cuts are particularly deep. Pfizer (PFE.N) and GlaxoSmithKline (GSK.L) are also ditching drug discovery work that does not pay its way. [ID:nLDE61408I]

AstraZeneca will still invest across the same therapy areas but said it would drop discovery in schizophrenia, bipolar disease, depression, anxiety, acid reflux, thrombosis, ovarian and bladder cancers, systemic scleroderma and hepatitis C.

It also plans to end early vaccine research other than for flu and respiratory syncytial virus (RSV).

"AZ is going to continue to be a research-focused company. We will not diversify to the extent that some of the others are doing," development head Anders Ekblom told Reuters.

"We are focusing on the diseases areas where we would like to be."

UNPREDICTABLE TRIALS

The decision to drop psychiatry drug research reflects the unpredictable and risky nature of clinical trials to assess medicines working on the brain, as well as a lack of good scientific opportunities, he said.

For AstraZeneca, this a major shift, since its second biggest seller is schizophrenia drug Seroquel and it recently struck a deal worth up to $1.24 billion for an antidepressant from Targacept (TRGT.O). [ID:nGEE5B208U]

Ekblom said he remained confident about the Targacept drug, which is shortly to start final Phase III tests, but saw limited longer-term opportunities in the psychiatric field.

His views echo those of Glaxo CEO Andrew Witty, who last month said Glaxo would stop researching antidepressants because of uncertain returns.

The move away from acid reflux ends a line of AstraZeneca drug development that created the stomach ulcer and heartburn treatments Losec and Nexium, its biggest sellers, while exiting thrombosis comes just as its big new blood-thinner hope Brilinta awaits regulatory approval.

Despite the decision to exit certain areas, Ekblom said AstraZeneca would still advance those products already in the pipeline and might also license in drugs, if the opportunity was right.

There will be major changes for staff as the research machine is reorganised.

In the United States, early-stage discovery research will cease at Wilmington, Delaware, while the Swedish research site in Lund will close, as will the British site at Charnwood, as respiratory and inflammation work moves to Moelndal in Sweden.

AstraZeneca also aims to sell its Arrow Therapeutic antiviral business in London, acquired in 2007 for $150 million. (Editing by Jon Loades-Carter)

Connecting the Dots Between PhRMA and Congress

National Public Radio
February 22, 2010

The initial cost-cutting deal between PhRMA and Congress would have included $30 billion in savings related to the so-called doughnut hole in Medicare prescription-drug coverage.

The initial cost-cutting deal between PhRMA and Congress would have included $30 billion in savings related to the so-called doughnut hole in Medicare prescription-drug coverage.

Earlier this month, former congressman Billy Tauzin announced that he would step down from his position as president of the pharmaceutical industry's main lobbying group, the Pharmaceutical Research and Manufacturers of America — known by the shorthand PhRMA.

Last year, PhRMA spent $28 million lobbying in favor of a health care overhaul, after negotiating a deal with the White House and members of Congress. In that deal, the pharmaceutical industry pledged to reduce health care costs by $80 billion over 10 years.

By negotiating the secret deal, writer Paul Blumenthal explains, "the Obama administration got the biggest lobby in Washington and put them on the side of health care reform." Meanwhile, the pharmaceutical industry got a guarantee that "Congress would not legislate any cost-cutting measures that would make a dent in industry profits."

Blumenthal, a senior writer at the Sunlight Foundation, determined that Congress and PhRMA met dozens of times to negotiate that deal. He tells Terry Gross that he learned who attended the meetings by examining Federal Election Commission records, public visitor logs to the White House and the publicly available schedule of Sen. Max Baucus, the chairman of the Senate Finance Committee.

"The major people are President Obama, [Chief of Staff] Rahm Emanuel and Jim Messina," Blumenthal says. "Jim Messina is the former chief of staff and campaign manager to Sen. Max Baucus. You see Jim Messina pop up in meetings between pharmacy CEOs."

Blumenthal says that the CEOs of pharmaceutical giants Pfizer and AstraZeneca attended a series of meetings at the White House throughout the spring and summer, and agreed to spend more than $150 million on ads touting a health care overhaul. That spending and the subsequent lack of progress on the bill, Blumenthal notes, may be why Tauzin resigned.

"One of the key things to look at is the fact that pharmaceutical companies dumped $100 million to $150 million on ads and haven't gotten what they paid for," says Blumenthal. "They're not thrilled that they spent [that money] in ads, and this isn't going to pass."